CODE OF FEDERAL REGULATIONS
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The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further subdivided into parts covering specific regulatory areas.
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Title 40—
Chapter I—Environmental Protection Agency appears in all twenty-eight volumes. An alphabetical Listing of Pesticide Chemicals Index appears in parts 150-189. Regulations issued by the Council on Environmental Quality appear in the volume containing part 790 to End. The OMB control numbers for title 40 appear in § 9.1 of this chapter.
For this volume, Elmer Barksdale was Chief Editor. The Code of Federal Regulations publication program is under the direction of Frances D. McDonald, assisted by Alomha S. Morris.
(This book contains part 790 to End)
Nomenclature changes to chapter I appear at 65 FR 47324, 47325, Aug. 2, 2000, and 66 FR 34375, 34376, June 28, 2001.
15 U.S.C. 2603.
(a) This part establishes procedures for gathering information, conducting negotiations, and developing and implementing test rules or consent agreements on chemical substances and mixtures under section 4 of TSCA.
(b) Section 4 of the Act authorizes EPA to require manufacturers and processors of chemical substances and mixtures to test these chemicals to determine whether they have adverse health or environmental effects. Section 4 (a) empowers the Agency to promulgate rules which require such testing. In addition, EPA has implied authority to enter into enforceable consent agreements requiring testing where they provide procedural safeguards equivalent to those that apply where testing is conducted by rule.
(c) EPA intends to use enforceable consent agreements to accomplish testing where a consensus exists among EPA, affected manufacturers and/or processors, and interested members of the public concerning the need for and scope of testing. If such a consensus does not exist and the Agency believes that it can make the findings specified in section 4(a), EPA will initiate proceedings to promulgate test rules which will be codified in part 799 of this chapter.
(d) Appendix A to this part presents timetables for various steps in the evaluation of chemicals under consideration for testing, the initiation and completion of negotiations to develop consent agreements, and the proposal and promulgation of test rules. All deadlines which are imposed by the Act are binding on EPA and will be observed by the Agency. The remaining deadlines represent target dates that EPA intends to meet.
This part is applicable to manufacturers and processors of chemical substances or mixtures who are subject to the testing requirements of a consent agreement or a rule under section 4(a) of the Act. The procedures for test rules are applicable to each test rule in part 799 or this chapter unless otherwise stated in specific test rules in part 799 of this chapter.
Terms defined in the Act and not explicitly defined herein are used with the meaning given in the Act. For the purpose of this part:
(a) All submissions to EPA under this part must bear the Code of Federal Regulations (CFR) section number of the subject chemical test rule, or indicate the identity of the consent agreement. For all submissions under this part, six copies must be provided to EPA.
(b) Submissions containing both confidential business information or non-confidential business information must be addressed to the Document Control
(a) Any person subject to the requirements of a consent agreement or a test rule under section 4 of the Act may assert a claim of confidentiality for certain information submitted to EPA in response to the consent agreement or the test rule. Any information claimed as confidential will be treated in accordance with the procedures in part 2 of this title and section 14 of the Act. Failure to assert a claim of confidentiality at the time the information is submitted will result in the information being made available to the public without further notice to the submitter.
(b) A claim of confidentiality must be asserted by circling or otherwise marking the specific information claimed as confidential and designating it with the words “confidential business information,” “trade secret,” or another appropriate phrase indicating its confidential character.
(c) If a person asserts a claim of confidentiality for study plan information described in §§ 790.50(c)(1)(iii)(D), (iv), (v), and (vi) and 790.62(b)(6), (7), (8), (9), and (10), the person must provide a detailed written substantiation of the claim by answering the questions in this paragraph. Failure to provide written substantiation at the time the study plan information is submitted will be considered a waiver of the claim of confidentiality, and the study plan information will be disclosed to the public without further notice.
(1) Would disclosure of the study plan information disclose processes used in the manufacture or processing of a chemical substance or mixture? Describe how this would occur.
(2) Would disclosure of the study plan information disclose the portion of a mixture comprised by any of the substances in the mixture? Describe how this would occur.
(3) What harmful effects to your competitive position, if any, do you think would result from disclosure of this information? How would a competitor use such information? How substantial would the harmful effects be? What is the causal relationship between disclosure and the harmful effects?
(4) For what period of time should confidential treatment be given? Until a specific date, the occurrence of a specific event, or permanently? Why?
(5) What measures have you taken to guard against disclosure of this information to others?
(6) To what extent has this information been disclosed to others? What precautions have been taken in connection with such disclosures?
(7) Has this information been disclosed to the public in any forms? Describe the circumstances.
(8) Has the information been disclosed in a patent?
(9) Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality determination regarding this information? If so, copies of such determinations must be included in the substantiation.
(d) If the substantiation provided under paragraph (c) of this section contains information which the submitter considers confidential, the submitter must assert a separate claim of confidentiality for that information at the time of submission in accordance with paragraph (b) of this section.
(a)
(1) When the ITC identifies a chemical substance or mixture that it believes should receive expedited consideration by EPA for testing, the ITC may add the substance or mixture to its list of chemicals recommended for testing and include a statement that the ITC intends to designate the substance or mixture for action by EPA in accordance with section 4(e)(1)(B) of the Act.
(2) Chemical substances or mixtures selected for expedited review under paragraph (a)(1) of this section may, at a later time, be designated for EPA action within 12 months of such designation. The ITC's subsequent decision would be based on the ITC's review of TSCA sections 8(a) and 8(d) data and other relevant information.
(3) Where the ITC concludes that a substance or mixture warrants testing consideration but that expedited EPA review of testing needs is not justified, the ITC will add the substance or mixture to its list of testing recommendations without expressing an intent to designate the substance or mixture for EPA action in accordance with section 4(e)(1)(B) of the Act.
(4) The ITC reserves its right to designate any chemical that it determines the Agency should, within 12 months of the date first designated, initiate a proceeding under section 4(a) of the Act.
(b)
(i) Initiate rulemaking proceedings under section 4(a) of the Act.
(ii) Publish a
(2) Where a substance or mixture has been recommended for testing by the ITC without an intent to designate, EPA will use its best efforts to act on the ITC's recommendations as rapidly as possible consistent with its other priorities and responsiblities. EPA may respond to the ITC's recommendations either by:
(i) Initiating rulemaking proceedings under section 4(a) of the Act.
(ii) Publishing a
(iii) Entering into a consent agreement in accordance with this subpart.
(a)
(1) EPA will publish the ITC report in the
(2) EPA will publish a
(3) EPA will hold a public “focus meeting” to discuss the ITC's testing recommendations and obtain comments and information from interested parties.
(4) EPA will evaluate submissions received under the sections 8(a) and 8(d) reporting requirements, comments filed on the ITC's recommendations, and other information and data compiled by the Agency.
(5) EPA will make a preliminary staff determination of the need for testing and, where testing appears warranted, will tentatively select the studies to be performed.
(6) EPA will hold a public meeting to announce its preliminary testing determinations.
(b)
(1) In the
(2) Persons who respond to EPA's notice by the announced date of the Agency's course-setting meeting will be deemed “interested parties” for purposes of any negotiations that EPA conducts.
(3) Following the course-setting meeting announcing EPA's preliminary testing determinations, the Agency will meet with manufacturers, processors and other interested parties for the purpose of attempting to negotiate a consent agreement. To facilitate attendance at these meetings, EPA will contact all interested parties who have expressed a desire to participate in or monitor negotiations under paragraph (b)(2) of this section and advise them of meeting dates.
(4) All negotiating meetings will be open to members of the public. The minutes of each meeting will be prepared by EPA. Meeting minutes, testing proposals, background documents and other materials exchanged at or prepared for negotiating meetings will be included in the public file established by EPA on each ITC-recommended chemical. Materials in this file will be made available for inspection in the OPPTS Reading Room during EPA working hours.
(5) While negotiations are underway, EPA will promptly circulate meeting minutes, testing proposals, correspondence and other relevant materials to interested parties who expressed a desire to participate in or monitor negotiations pursuant to paragraph (b)(2) of this section.
(6) As negotiations progress, EPA will make a tentative decision either to proceed with formulation of a consent agreement or to initiate rulemaking. EPA will terminate negotiations after 10 weeks and proceed with rulemaking unless negotiations are likely to result in a draft consent agreement within 4 additional weeks. By the end of this 4-week period, EPA either will have prepared a draft consent agreement reflecting the apparent consensus of the parties or will terminate negotiations and proceed with rulemaking. If EPA decides to proceed with rulemaking, no further opportunity for negotiations will be provided. EPA will promptly send written notice to all interested parties of the termination of negotiations.
(7) Where EPA prepares a draft consent agreement, it will be circulated for comment to all interested parties who expressed a desire to participate in or monitor negotiations under paragraph (b)(2) of this section. A period of 4 weeks will be provided for submitting comments or written objections under § 790.24(a).
(8) If necessary, EPA will hold a public meeting to discuss comments on the draft consent agreement and to determine whether revisions in the agreement are appropriate.
(9) Where a consensus exists concerning the contents of a draft consent agreement, it will be circulated to EPA management and interested parties for final approval and signature.
(10) Upon final approval of a consent agreement, EPA will publish a
(a) EPA will enter into consent agreements only where there is a consensus among the Agency, one or more manufacturers and/or processors who agree to conduct or sponsor the testing, and all other interested parties who identify themselves in accordance with § 790.22(b)(2). EPA will not enter into a consent agreement in either of the following circumstances:
(1) EPA and affected manufacturers and/or processors cannot reach a consensus on the testing requirements or other provisions to be included in the consent agreement.
(2) A draft consent agreement is considered inadequate by other interested parties who, pursuant to § 790.22(b)(2), have asked to participate in or monitor negotiations; and these parties have submitted timely written objections to the draft consent agreement which provide a specific explanation of the grounds on which the draft agreement is objectionable.
(b) EPA may reject objections described in paragraph (a)(2) of this section only where the Agency concludes the objections are either:
(1) Not made in good faith.
(2) Untimely.
(3) Do not involve the adequacy of the proposed testing program or other features of the agreement that may affect EPA's ability to fulfill the goals and purposes of the Act.
(4) Not accompanied by a specific explanation of the grounds on which the draft agreement is considered objectionable.
(c) The unwillingness of some manufacturers and/or processors of a prospective test chemical to sign the draft consent agreement does not, in itself, establish a lack of consensus if EPA concludes that those manufacturers and/or processors who are prepared to sign the agreement are capable of accomplishing the testing to be required and that the draft agreement will achieve the purposes of the Act in all other respects.
(a) Where EPA concludes that a consensus does not exist concerning the provisions of a draft consent agreement and that the findings specified by section 4(a) can be made, the Agency will proceed with rulemaking under section 4(a) of TSCA.
(b) When EPA decides to proceed with rulemaking under paragraph (a) of this section, the Agency intends to publish a rulemaking proposal and a final rule or a notice terminating the rulemaking proceeding in accordance with the schedule specified in Appendix A
(c) Where the testing recommendations of the ITC raise unusually complex and novel issues that require additional Agency review and opportunity for public comment, the Agency may publish an Advance Notice of Proposed Rulemaking (ANPR). The schedule that EPA intends to follow for rulemaking proceedings initiated by publication of an ANPR is presented in appendix A
(a) Where EPA believes that testing is needed, it may also develop consent agreements and/or test rules on chemical substances or mixtures that either:
(1) Have been recommended but not “recommended with intent to designate” by the ITC.
(2) Have been selected for testing consideration by EPA on its own initiative.
(b) When EPA wishes to initiate negotiations concerning chemicals described in paragraph (a) of this section, it will publish a
(c) EPA will enter into consent agreements on chemicals described in paragraph (a) of this section only if there is a consensus among EPA, affected manufacturers and/or processors, and any other persons who have asked to participate in or monitor negotiations. In determining whether such a consensus exists, EPA will employ the criteria specified in § 790.24. In the absence of consensus, EPA will initiate rulemaking if it concludes that the findings specified in section 4(a) of the Act can be made. The schedule for initiating and completing such rulemaking proceedings will, to the extent feasible, follow the schedule specified in appendix A
(a) If EPA determines that it is necessary to test a chemical substance or mixture by rule under section 4 of the Act, it will promulgate a test rule in part 799 of this chapter.
(b) EPA will promulgate specific test rules in part 799 of this chapter either by a single-phase rulemaking procedure or by a two-phase rulemaking procedure.
(1) Under single-phase test rule development, EPA will promulgate a test rule in part 799 of this chapter through a notice and comment rulemaking which specifies the following:
(i) Identification of the chemical for which testing is required under the rule.
(ii) The health or environmental effect or effects or other characteristics for which testing is being required.
(iii) Which test substance(s) must be tested.
(iv) Standards for the development of test data.
(v) The EPA Good Laboratory Practice requirements for the required testing.
(vi) Schedule for submission of interim reports and/or final reports to EPA.
(vii) Who must submit either letters of intent to conduct testing or exemption applications.
(viii) What types of data EPA will examine in determining equivalence if more than one test substance is to be tested.
(2) Under two-phase test rule development, EPA will promulgate a Phase I test rule in part 799 of this chapter through a notice and comment rulemaking which specifies the following:
(i) Identification of the chemical for which testing is required under the rule.
(ii) The health or environmental effect or effects or other characteristics for which testing is being required.
(iii) Which test substance(s) must be tested.
(iv) A reference to appropriate guidelines for the development of test data.
(v) The EPA Good Laboratory Practice requirements for the required testing.
(vi) Who must submit either letters of intent to conduct testing and study plans, or exemption applications.
(vii) What types of data EPA will examine in determining equivalence if more than one test substance is to be tested.
(3) Under two-phase test rule development, test standards and schedules will be developed in a second phase of rulemaking as described in §§ 790.50 and 790.52.
(a) Each test rule described in § 790.40 will specify whether manufacturers, processors, or both are subject to the requirement for testing of the subject chemical under section 4(b)(3)(B) of the
(1) If testing is being required to allow evaluation of risks:
(i) Primarily associated with manufacture of the chemical, or
(ii) Associated with both manufacturer and processing of the chemical, or
(iii) Associated with distribution in commerce, use, and/or disposal activities concerning the chemical, each manufacturer of the chemical will be subject and must comply with the requirements of the test rule.
(2) While legally subject to the test rule in circumstances described in paragraphs (a)(1) (ii) and (iii) of this section, processors of the chemical must comply with the requirements of the test rule only if processors are directed to do so in a subsequent notice as set forth in § 790.48(b).
(3) If testing is being required to allow evaluation of risks associated solely with processing of the chemical, processors will be subject and must comply with the requirements of the test rule.
(4) While legally subject to the test rule in circumstances described in paragraph (a)(1) of this section, persons who manufacture less than 500 kg (1,100 lb) of the chemical annually during the period from the effective date of the test rule to the end of the reimbursement period, must comply with the requirements of the test rule only if such manufacturers are directed to do so in a subsequent notice as set forth in § 790.48, or if directed to do so in a particular test rule.
(5) While legally subject to the test rule in circumstances described in paragraph (a)(1) of this section, persons who manufacture small quantities of the chemical solely for research and development (meaning quantities that are not greater than those necessary for purposes of scientific experimentation or analysis or chemical research on, or analysis of, such chemical or another chemical, including such research or analysis for development of a product) from the effective date of the test rule to the end of the reimbursement period, must comply with the requirements of the test rule only if such manufacturers are directed to do so in subsequent notice set forth in § 790.48, or if directed to do so in a particular test rule.
(6) If testing is being required to allow evaluation of risks associated primarily with manufacture of a chemical for research and development (R & D) purposes, manufacturers of the chemical for R & D will be subject and must comply with the requirements of the test rule.
(b) [Reserved]
(a) No later than 30 days after the effective date of a test rule described in § 790.40, each person subject to that rule and required to comply with the requirements of that rule as provided in § 790.42(a) must, for each test required, either notify EPA by letter of his or her intent to conduct testing or submit to EPA an application for an exemption from testing requirements for the test.
(b) EPA will consider letters of intent to test as commitments to sponsor the tests for which they are submitted unless EPA agrees to the substitution of an exemption application in instances where more than one person indicates an intent to sponsor equivalent tests.
(c) Each letter of intent to conduct testing must include:
(1) Identification of test rule.
(2) Name, address, and telephone number of the firm(s) which will be sponsoring the tests.
(3) Name, address, and telephone number of the appropriate individual to contact for further information.
(4) For sponsors participating in a testing consortium—a list of all members of the consortium, the signature of an authorized representative of each member, and a designation of who is to serve as principal sponsor.
(5) A list of the testing requirements for which the sponsor(s) intends to conduct tests.
(6) If EPA is requiring testing of more than one representative substance—which test substance the sponsor(s) intends to use in each of the tests.
(d)(1) Any person not manufacturing or processing the subject chemical as of the effective date of the test rule describing in § 790.40 or by 30 days after the effective date of the rule who, before the end of the reimbursement period, manufacturers or processes the test chemical and who is subject to and required to comply with the requirements of the test rule must submit the letter of intent to test or an exemption application required by paragraph (a) of this section by the date manufacture or processing begins, or
(2) When both manufacturers and processors are subject to the rule, any person not processing the subject chemical as of the effective date of -the test rule described in § 790.40 or by -30 days after publication of the
(e) Manufacturers subject to a test rule described in § 790.40 who do not submit to EPA either a letter of their intent to conduct tests or a request for an exemption from testing for each test for which testing is required in the test rule will be considered in violation of that rule beginning on the 31st day after the effective date of the test rule described in § 790.40 or on the date manufacture begins as described in paragraph (d) of this section.
(f) Processors subject to a test rule described in § 790.40 and required to comply with the requirements of test rule pursuant to § 790.42(a)(2) or a
(a)
(2) If no manufacturer subject to the test rule has notified EPA of its intent to conduct one or more of the required tests within 30 days after the effective date of the test rule described in § 790.40, EPA will notify all manufacturers, including those described in § 790.42(a)(4) and (a)(5), by certified mail or by publishing a notice of this fact in the
(3) If no manufacturer submits a letter of intent to conduct one or more of the required tests within 30 days after receipt of the certified letter or publication of the
(b)
(2) If no manufacturer subject to the rule has notified EPA of its intent to conduct testing for one or more of the required tests within 30 days after the effective date of the test rule described in § 790.40, EPA will publish a notice in the
(3) No later than 30 days after the date of publication of the
(4) If no manufacturer or processor of the test chemical has submitted a letter of intent to conduct one or more of the required tests within 30 days after the date of publication of the
(5) If no manufacturer or processor submits a letter of intent to conduct one or more of the required tests within 30 days after receipt of the certified letter or publication of the
(c)
(2) If no processor subject to the rule has notified EPA of its intent to conduct one or more of the required tests within 30 days after the effective date of the test rule described in § 790.40, EPA will notify all the processors by certified mail or publish a notice in the
(3) If no processor submits a letter of intent to conduct one or more of the required tests within 30 days after receipt of the certified letter or publication of the
(a)
(2) Persons who notify EPA of their intent to conduct tests in compliance with the requirements of a Phase I test rule as described in § 790.40(b)(2) must submit the proposed study plans for those tests on or before 90 days after the effective date of the Phase I rule; or, for processors complying with the notice described in § 790.48(b)(2), 90 days after the publication date of that notice; or 60 days after the date manufacture or processing begins as described in § 790.45(d), as appropriate, to the address in § 790.5(b).
(3) Study plans must be prepared according to the requirements of this subpart B and part 792 of this chapter. Only one set of study plans should be prepared and submitted by persons who are jointly sponsoring testing.
(4) Any person subject to a test rule may submit a study plan for any test
(5) Unless EPA has granted an extension of time for submission of proposed study plans, manufacturers who notify EPA that they intend to conduct testing in compliance with the requirements of a Phase I test rule as described in § 790.40(b)(2) and who do not submit proposed study plans for those tests on or before 90 days after the effective date of the Phase I test rule or 60 days after the date manufacture begins as described in § 790.45(d) will be considered in violation of the test rule as if no letter of intent to test had been submitted.
(6) Unless EPA has granted an extension of time for submission of proposed study plans, processors who notify EPA that they intend to conduct testing in compliance with the requirements of a Phase I test rule as described in § 790.40(b)(2) and who do not submit proposed study plans for those tests on or before 90 days after the effective date of the Phase I test rule or 90 days after the publication date of the notice described in § 790.48(b)(2), or 60 days after the date processing begins as described in § 790.45(d), as appropriate, will be considered in violation of the test rule as if no letter of intent to test had been submitted.
(b)
(2) Under two-phase rulemaking, extension requests must be submitted to EPA within 60 days after the effective date of the Phase I test rule as described in § 790.40(b)(2); or for processors complying with the notice described in § 790.48(b)(2), 60 days after the publication date of that notice; or 30 days after the date manufacture or processing begins as described in § 790.45(d), as appropriate.
(3) EPA will notify the submitter by certified mail of EPA's decision to grant or deny an extension request.
(4) Persons who have been granted an extension of time for submission of study plans as described in paragraph (b)(1) of this section and who do not submit proposed study plans in compliance with the requirements of a Phase I test rule in accordance with the new deadline granted by EPA will be considered in violation of the test rule -as if no letter of intent to test had been submitted as described in § 790.45(e) and (f).
(c)
(i) Identity of the test rule.
(ii) The specific test requirements of that rule to be covered by the study plan.
(iii)(A) The names and addresses of the test sponsors.
(B) The names, addresses, and telephone numbers of the responsible administrative officials and project manager(s) in the principal sponsor's organization.
(C) The name, address, and telephone number of the appropriate individual to contact for oral and written communications with EPA.
(D)(
(
(iv) Identity and data on the chemical substance(s) being tested, including physical constants, spectral data, chemical analysis, and stability under test and storage conditions, as appropriate.
(v) Study protocol, including the rationale for any combination of test protocols; the rationale for species/strain selection; dose selection (and supporting data); route(s) or method(s) of exposure; description of diet to be used and its source; including nutrients
(vi) Schedule for initiation and completion of each short-term test and of each major phase of long-term tests; dates for submission of interim progress and final reports to EPA that are within the reporting deadlines specified by EPA In the final test rule.
(2) Information required in paragraph (c)(1)(iii)(D) of this section is not required in proposed study plans submitted in compliance with the requirements of a Phase I test rule if the information is not available at the time of study plan submission; however, the information must be submitted before the initiation of testing.
(d)
(2) The submitter will have 15 days after the day it receives this notice to submit appropriate information to make the study plan complete.
(3) If the submitter fails to provide appropriate information to complete a proposed study plan submitted in compliance with the requirements of a Phase I test rule on or before 15 days after receipt of the notice, the submitter will be considered in violation of the test rule as if no letter of intent to conduct the test had been submitted as described in § 790.45(e) and (f).
(e)
(a) If EPA determines that the proposed study plan described in § 790.50(a)(2) complies with § 790.50(c), EPA will publish a proposed Phase II test rule in the
(b) EPA will provide a 45-day comment period and will provide an opportunity for an oral presentation upon the request of any person. EPA may extend the comment period if it appears from the nature of the issues raised by EPA's review or from public comments that further comment is warranted.
(c) After receiving and considering public comments on the study plan, EPA will adopt, as proposed or as modified in response to EPA review and public comments, the study protocol section of the study plan, as defined by § 790.50(c)(1)(v) of this chapter, as the test standard for the required testing, and the schedule section of the study plan, as defined by § 790.50(c)(1)(vi) of this chapter, as the schedule for the required testing in a final Phase II test rule.
(a)
(b)
(2) Where, in EPA's judgment, the requested modification of the test standard or schedule would not alter the scope of the test or significantly change the schedule for completing the test, EPA will not ask for public comment before approving the modification. EPA will notify the test sponsor by letter of EPA's approval. EPA will place copies of each application and EPA approval letter in the rulemaking record for the test rule in question. EPA will publish a notice annually in the
(3) Where, in EPA's judgment, the requested modification of a test standard or schedule would significantly alter the scope of the test or significantly change the schedule for completing the test, EPA will publish a notice in the
(4) For purposes of this paragraph (b), a requested modification of a test standard or schedule for a test required under a test rule would alter the scope of the test or significantly change the schedule for completing the test if the modification would:
(i) Change the test species.
(ii) Change the route of administration of the test chemical.
(iii) Change the period of time during which the test species is exposed to the test chemical.
(iv) Except as provided in paragraph (b)(3) of this section, extend the final reporting deadline more than 12 months from the date specified in the final rule.
(c)
(d)
(2) EPA will not normally approve any test schedule extensions submitted less than 30 days before the reporting deadline for the test in question.
(3) Except as provided in paragraph (b)(3) of this section, EPA may grant extensions for up to 1 year but will normally limit extensions to a period of time equal to the in-life portion of the test plus 60 days.
(4) EPA will normally approve only one deadline extension for each test.
(5) Test sponsors should submit requests for test standard modifications as soon as they determine that the test
(a) Persons who notified EPA of their intent to conduct a test required in a test rule in part 799 of this chapter and who fail to conduct the test in accordance with the test standards and schedules adopted in the test rule, or as modified in accordance with § 790.55, will be in violation of the rule.
(b) Any person who fails or refuses to comply with any aspect of this part or a test rule under part 799 of this chapter is in violation of section 15 of the Act. EPA will treat violations of the Good Laboratory Practice standards as indicated in § 792.17 of this chapter.
(a)
(1) Identification of the chemical(s) to be tested.
(2) The health effects, environmental effects and/or other characteristics for which testing will be required.
(3) The names and addresses of each manufacturer and/or processor who will sign the agreement.
(4) The name and address of the manufacturer, processor or other entity who has agreed to act as the principal test sponsor.
(5) The technical or commercial grade, level of purity or other characteristics of the test substances(s) or mixture(s).
(6) Standards for the development of test data.
(7) A requirement that testing will be conducted in accordance with the EPA Good Laboratory Practice (GLP) regulations (40 CFR part 792).
(8) Schedules with reasonable deadlines for submitting interim progress and/or final reports to EPA.
(9) A requirement that the principal sponsor will submit a study plan to EPA in accordance with § 790.62.
(10) A statement that the results of testing conducted pursuant to the consent agreement will be announced to the public in accordance with the procedures specified in section 4(d) of the Act and that the disclosure of data generated by such testing will be governed by section 14(b) of the Act.
(11) A requirement that the manufacturers and/or processors signing the consent agreement will comply with the notification requirements of section 12(b)(1) of the Act and part 707 of this chapter if they export or intend to export the substance or mixture for which the submission of data is required under the agreement and a statement that any other person who exports or intends to export such substance or mixture is subject to the above cited export notification requirements.
(12) A requirement that, in the event EPA promulgates a significant new use rule applicable to the test chemical under section 5(a)(2), the consent agreement will have the status of a test rule for purposes of section 5(b)(1)(A) and manufacturers and/or processors signing the agreement will comply with the data submission requirements imposed by that provision.
(13) A statement that each manufacturer and/or processor signing the agreement agrees that violation of its requirements will constitute a “prohibited act” under section 15(1) of the Act and will trigger all provisions of TSCA applicable to a violation of section 15.
(14) A statement that, in the event one or more provisions of the agreement are determined to be unenforceable by a court, the remainder of the agreement would not be presumed to be valid and EPA will then either initiate a rulemaking proceeding or publish in the
(15) A statement that the Agency may conduct laboratory inspections and/or study audits of the testing being conducted pursuant to the consent agreement in accordance with the authority and procedures contained in section 11 of the Act.
(16) A statement that EPA acceptance of a consent agreement constitutes “final agency action” for purposes of 5 U.S.C. 704.
(17) Any other requirements that the parties agree are necessary to achieve the purposes of the Act.
(b)
(c)
(a)
(b)
(1) Identity of the consent agreement under which testing will be performed.
(2) The specific test requirements to be covered by the study plan.
(3) The name and address of the principal test sponsor.
(4) The names, addresses, and telephone numbers of the responsible administrative official[s] and project manager[s] in the principal sponsor's organization.
(5) The names, addresses, and telephone numbers of the technical contacts at each manufacturer and/or processor subject to the agreement.
(6) The names and addresses of the testing facilities responsible for the testing and the names, addresses, and telephone numbers of the administrative officials[s] and project manager[s] assigned to oversee the testing program at these facilities.
(7) Brief summaries of the training and experience of each professional involved in the study, including study director, veterinarian[s], toxicologist[s], pathologist[s], chemist[s], micro-bio-logist[s], and laboratory assistants.
(8) Identity and supporting data on the chemical substance[s] being tested, including physical constants, spectral data, chemical analysis, and stability under test and storage conditions, as appropriate.
(9) Study protocol, including the rationale for any combination of test protocols; the rationale for species/strain selection; dose selection (and supporting data); route(s) or method(s) of exposure; description of diet to be used and its source, including nutrients and contaminants and their concentrations; for
(10) A schedule, with reasonable timeables and deadlines, for initiation and completion of each short-term test and of each major phases of long-term tests, and submission of interim progress and/or final reports to EPA.
(c)
(2) The submitter will have 15 days after the day it receives a notice under paragraph (c)(1) of this section to submit appropriate information to make the study plan complete.
(3) If the submitter fails to provide appropriate information to complete a study plan within 15 days after having received a notice under paragraph (c)(1) of this section, the submitter will be considered to be in violation of the consent agreement and subject to enforcement proceedings pursuant to § 790.65 (c) and (d).
(4) The test sponsor shall submit any amendments to study plans to EPA at the address specified in § 790.5(b).
(d)
(a) Manufacturers and/or processors who have signed a consent agreement and who fail to comply with the test requirements, test standards, GLP regulations, schedules, or other provisions contained in the consent agreement, or in modifications to the agreement adopted pursuant to § 790.68, will be in violation of the consent agreement.
(b) The Agency considers failure to comply with any aspect of a consent agreement to be a “prohibited act” under section 15 of TSCA, subject to all of the provisions of the Act applicable to violations of section 15. Section 15(1) of TSCA makes it unlawful for any person to fail or refuse to comply with any rule or order issued under section 4. Consent agreements adopted pursuant to this part are “orders issued under section 4” for purposes of section 15(1) of TSCA.
(c) Manufacturers and/or processors who violate consent agreements are subject to criminal and/or civil liability. Under the penalty provisions of section 16 of TSCA, such firms could be subject to a civil penalty of up to $25,000 per violation with each day in violation constituting a separate violation of section 15. Intentional violations could lead to the imposition of criminal penalties of up to $25,000 for each day of violation and imprisonment for up to one year. In addition, EPA could invoke the remedies available under section 17 of TSCA, including seeking an injunction to compel adherence to the requirements of the consent agreement.
(d) Noncompliance with a consent agreement will constitute conduct “in violation of this Act” under section 20(a)(1) of TSCA. Thus, failure to comply with the requirements of a consent agreement could result in a citizens' civil action under section 20(a)(1) of TSCA.
(a)
(2) The scope of testing required by a consent agreement will be modified only where there is a consensus concerning the modified testing requirements among EPA, affected manufacturers and/or processors, and other persons who have asked to participate in or monitor negotiations under paragraph (a)(1) of this section. In determining whether a consensus exists, EPA will employ the criteria specified in § 790.24. In the absence of consensus, EPA may initiate rulemaking under section 4(a) of the Act if it concludes that any testing beyond that required by the consent agreement is necessary and that the other statutory findings required by section 4(a) can be made. While such rulemaking proceedings are underway, the consent agreement will remain in effect unless EPA finds that the testing required by the agreement is or may be unnecessary in view of the testing requirements included in EPA's proposed rule.
(b)
(2)(i) Where EPA concludes that the requested modification of a test standard or schedule for a test required under a consent agreement is appropriate, EPA will proceed in accordance with this paragraph (b)(2).
(ii) Where, in EPA's judgment, the requested modification of a test standard or schedule would not alter the scope of the test or significantly change the schedule for completing the test, EPA will not ask for public comment before approving the modification. EPA will notify the test sponsor, and any other persons who have signed the consent agreement, by letter of EPA's approval. EPA will place copies of each application and EPA approval letter in the administrative record maintained for the consent agreement in question. EPA will publish a notice annually in the
(iii) Where, in EPA's judgment, the requested modification of a test standard or schedule would significantly alter the scope of the test or significantly change the schedule for completing the test, EPA will publish a notice in the
(iv) For purposes of this paragraph (b)(2), a requested modification of a test standard of schedule for a test required under a consent agreement would alter the scope of the test or significantly change the schedule for completing the test if the modification would:
(A) Change the test species.
(B) Change the route of administration of the test chemical.
(C) Change the period of time during which the test species is exposed to the test chemical.
(D) Except as provided in paragraph (b)(2)(iii) of this section, extend the final reporting deadline more than 12 months from the date specified in the consent order.
(3) Where EPA concludes that the requested modification of a test standard or schedule for a test requirement under a consent agreement is not appropriate, EPA will so notify the test sponsor in writing.
(c)
(2) EPA will not normally approve any test schedule extensions submitted less than 30 days before the reporting deadline for the test in question.
(3) Except as provided in paragraph (b)(2)(iii) of this section, EPA may grant extensions as shown necessary for up to 1 year but will normally limit extensions to a period of time equal to the in-life portion of the test plus 60 days.
(4) EPA will normally approve only one deadline extension for each test.
(5) Test sponsors should submit requests for test standard modifications as soon as they determine that the test cannot be successfully completed according to the test standard specified in the consent order.
(a)
(2) Processors will not be required to apply for an exemption or conduct testing unless EPA so specifies in a test rule or in a special
(i) If testing is being required to allow evaluation of risks associated with manufacturing and processing or with distribution in commerce, use, or disposal of the chemical and manufacturers do not submit notice(s) of intent to conduct the required testing; or
(ii) If testing is being required solely to allow evaluation of risks associated with processing of the chemical.
(b)
(2) Exemption applications must be filed by the date manufacture or processing begins by any person not manufacturing or processing the subject chemical as of the effective date of the test rule described in § 790.40 or by 30 days after the effective date of the test rule described in § 790.40, who, before the end of the reimbursement period, manufactures or processes the test substance and who is subject to the requirement to submit either a letter of
(3) When both manufacturers and processors are subject to the rule, exemption applications must be filed by the date processing begins by any person not processing as of the effective date of the test rule described in § 790.40 or by 30 days after publication of the
(c)
The exemption application must contain:
(a) The identity of the test rule, the chemical identity, and the CAS No. of the test substance on which the application is based.
(b) The specific testing requirement(s) from which an exemption is sought and the basis for the exemption request.
(c) Name, address, and telephone number of applicant.
(d) Name, address, and telephone number of appropriate individual to contact for further information.
(e)(1) If required in the test rule to establish equivalence:
(i) The chemical identity of the test substance on which the application is based.
(ii) Equivalence data specified in § 790.85.
(2) If a test rule requires testing of a single representative substance, EPA will consider all forms of the chemical subject to that rule to be equivalent and will not require the submission of equivalence data as described in § 790.85.
If EPA requires in a test rule promulgated under section 4 of the Act the testing of two or more test substances which are forms of the same chemical, each exemption applicant must submit the following data:
(a) The chemical identity of each technical-grade chemical substance or mixture manufactured and/or processed by the applicant for which the exemption is sought. The exact type of identifying data required will be specified in the test rule, but may include all characteristics and properties of the applicant's substance or mixture, such as boiling point, melting point, chemical analysis (including identification and amount of impurities), additives, spectral data, and other physical or chemical information that may be relevant in determining whether the applicant's substance or mixture is equivalent to the specific test substance.
(b) The basis for the applicant's belief that the substance or mixture is equivalent to the test substance or mixture.
(c) Any other data which exemption applicants are directed to submit in the test rule which may bear on a determination of equivalence. This may include a description of the process by which each technical-grade chemical substance or mixture for which an exemption is sought is manufactured or processed prior to use or distribution in commerce by the applicant.
(a) EPA will conditionally approve exemption applications if:
(1)(i) For single-phase test rules, EPA has received a letter of intent to conduct the testing from which exemption is sought;
(ii) For two-phase test rules, EPA has received a complete proposed study plan for the testing from which exemption is sought and has adopted the study plan, as proposed or modified, as test standards and schedules in a final Phase II test rule; and
(2) The chemical substance or mixture with respect to which the application was submitted is equivalent to a test substance or mixture for which the
(3) Submission of the required test data concerning that chemical substance or mixture would be duplicative of data which have been or are being submitted to EPA in accordance with a test rule.
(b)(1) If a single representative substance is to be tested under a test rule, EPA will consider all forms of the chemical subject to that rule to be equivalent and will contact the exemption applicant only if information is missing or unclear.
(2) If two or more representative substances are to be tested under a test rule, EPA will evaluate equivalence claims made in each exemption application according to the criteria discussed in the test rule.
(i) If EPA finds an equivalence claim to be in error or inadequately supported, the applicant will be notified by certified mail. The applicant will be given 15 days to provide clarifying information.
(ii) Exemption applicants will be notified that equivalence has been accepted or rejected.
(c) The final Phase II test rule which adopts the study plans in two-phase rulemaking, a separate
(a) EPA may deny any exemption application if:
(1) EPA determines that the applicant has failed to demonstrate that the applicant's chemical is equivalent to the test substance; or
(2) The exemption applicant fails to submit any of the information specified in § 790.82; or
(3) The exemption applicant fails to submit any of the information specified in § 790.85 if required in the test rule; or
(4)(i) For single-phase test rules, EPA has not received a letter of intent to conduct the test for which exemption is sought; or
(ii) For two-phase test rules, EPA has not received an adequate study plan for the test for which exemption is sought; or
(5) The study sponsor(s) fails to initiate the required testing by the deadlines adopted in the test rule; or
(6) The study sponsor(s) fails to submit data as required in the test standard and deadlines for submission of test data as adopted in the test rule or as modified in accordance with § 790.55.
(b) EPA will notify the exemption applicant by certified mail or
(a) Within 30 days after receipt of notification that EPA has denied an application for exemption, the applicant may file an appeal with EPA.
(b) The appeal shall indicate the basis for the applicant's request for reconsideration.
(c)(1) The applicant may also include a request for a hearing. Hearings will be held according to the procedures described in § 790.97.
(2) Hearing requests must be in writing and must be received by EPA within 30 days of receipt of the letter or publication of the
(d) If EPA determines that there are material issues of fact, then the request for a hearing will be granted. If EPA denies a hearing request, EPA will base its decision on the written submission.
(e) EPA will notify the applicant of its decision within 60 days after EPA receives the appeal described in paragraph (a) of this section or within 60 days after completion of a hearing described in paragraph (c) of this section.
(f) The filing of an appeal from the denial of an exemption shall not act to stay the applicant's legal obligations under a test rule promulgated under section 4 of the Act.
(a) EPA shall terminate a conditional exemption if it determines that:
(1) The test which provided the basis for approval of the exemption application has not been started by the deadlines for initiation of testing adopted in the test rule or modified in accordance with § 790.55; or
(2) Data required by the test rule have not been generated in accordance with the test standards or submitted in accordance with the deadlines for submission of test data that were adopted in the test rule or modified in accordance with § 790.55; or
(3) The testing has not been conducted or the data have not been generated in accordance with the Good Laboratory Practice requirements in part 792 of this chapter.
(b) If EPA determines that one or more of the criteria listed in paragraph (a) of this section has been met, EPA will notify each holder of an affected conditional exemption by certified mail or
(c) Within 30 days after receipt of a letter of notification or publication of a notice in the
(d)(1) The exemption holder may also include a request for a hearing. Hearings will be held in accordance with the procedures set forth in § 790.97.
(2) Hearing requests must be in writing and must be received by EPA within 30 days after receipt of the letter or publication in the
(e) EPA will notify the exemption holder by certified letter or by
(a) Hearing requests must be in writing to EPA and must include the applicant's basis for appealing EPA's decision.
(b) If more than one applicant has requested a hearing on similar grounds, all of those appeals will be considered at the same hearing unless confidentiality claims preclude a joint hearing.
(c) EPA will notify each applicant of EPA's decision within 60 days after the hearing.
Each applicant for an exemption shall submit the following sworn statement with his or her application:
I understand that if this application is granted before the reimbursement period described in section 4(c)(3)(B) of TSCA expires, I must pay fair and equitable reimbursement to the person or persons who incurred or shared in the costs of complying with the requirement to submit data and upon whose data the granting of my application was based.
EPA intends to follow the schedule set forth in this Appendix to evaluate testing candidates, conduct negotiations, develop consent agreements where appropriate, and propose and promulate test rules in those instances where testing can be required under section 4(a) of TSCA but agreement cannot be reached in timely manner on a consent agreement. Where deadlines are imposed by the statute, they are binding on EPA and will be observed by the Agency. The remaining dates represent targets that EPA intends to meet.
This schedule is based on what EPA currently believes are reasonable target dates. As EPA gains experience with the process and determines the feasibility of these schedules, it may adjust the schedule accordingly. EPA will solicit public comment before implementing any changes in the schedule.
15 U.S.C. 2603 and 2607.
(a) This part establishes procedures and criteria to be used in determining fair amounts of reimbursement for testing costs incurred under section 4(a) of the Toxic Substances Control Act (TSCA) (15 U.S.C. 2603(a)).
(b) Section 4(c) of TSCA requires EPA to develop rules for the determination of fair and equitable reimbursement (15 U.S.C. 2603 (c)).
(a) This rule is potentially applicable to all manufacturers, importers and processors who may be required by a specific test rule promulgated under section 4(a) of TSCA to conduct tests and submit data, and who seek the assistance of the Administrator in determining the amount or method of reimbursement. Persons subject to a test rule have an obligation from the date the test rule becomes effective until the end of the reimbursement period, either to test or to obtain an exemption and pay reimbursement.
(b) The provisions of this rule will take effect only when private efforts to resolve a dispute have failed and a manufacturer or processor requests EPA's assistance.
Terms defined in the Act, and not explicitly defined herein, are used with the meanings given in the Act.
(a)
(b)
(c)
(d)
(e)
(f)
(g) A
(1) Seeks reimbursement from another person under these rules, or
(2) From whom reimbursement is sought under these rules.
(h)
(i)
(j)
(a) When persons subject to a test rule are unable to reach an agreement on the amount or method of reimbursement for test data development as described in TSCA section 4(c)(3)(A), any of them may initiate a proceeding by filing two signed copies of a request for a hearing with a regional office of the American Arbitration Association and mailing a copy of the request to EPA, and to each person from whom they seek reimbursement, or who seeks reimbursement from them.
(b) The request for hearing must contain the following:
(1) The names and addresses of the filing party and its counsel, if any.
(2) Identification of the test rule under which the dispute arose.
(3) A list of the parties from whom reimbursement is sought or who are seeking reimbursement, a brief description of the attempts to reach agreement and a concise explanation of the issues on which the parties are unable to agree.
(c) The request for a hearing shall be accompanied by the appropriate administrative fee, as provided in a current Fee Schedule of the American Arbitration Association.
(a) Promptly upon receipt of the request for a hearing, the Administrator will publish a notice in the
(b) Any other person wishing to participate in the hearing shall so notify EPA within 45 days of the
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(a)
(b)
(c)
(d)
(e)
(2) The hearing officer may, at the beginning of the hearing, ask for statements clarifying the issues involved.
(3) The party or parties seeking reimbursement shall then present a claim and proofs and witnesses, who shall submit to questions or other examination. The party or parties from whom reimbursement is sought shall then present a defense and proofs and witnesses, who shall submit to questions or other examination. The hearing officer has discretion to vary this procedure but shall afford full and equal opportunity to all parties for the presentation of any material or relevant proofs.
(4) Exhibits, when offered by any party, shall be received in evidence by the hearing officer. The names and addresses of all witnesses and exhibits in order received shall be made a part of the record.
(f)
(g)
(2) All documents not filed with the hearing officer at the hearing, but arranged for by agreement of the parties, shall be filed with the American Arbitration Association for transmission to the hearing officer, according to the agreed-upon schedule. All parties shall be afforded opportunity to examine such documents.
(h)
(i)
(j)
(k)
(l)
(m)
(n)
Unless the American Arbitration Association in its discretion determines otherwise, the Expedited Procedures described in this section shall be applied in any case where the total claim of any party does not exceed $5,000, exclusive of interest and hearing costs, and may be applied in other cases if the parties agree.
(a)
(b)
(c)
(d)
(e)
(f)
(a) Each party shall be deemed to have consented that any papers, notices or process necessary or proper for the initiation or continuation of a hearing under these rules and for any appeal to EPA or any court action in connection therewith may be served upon such party by mail addressed to such party or its attorney at its last known address or by personal service, within or without the state wherein the arbitration is to be held (whether such party be within or without the United States of America), provided that reasonable opportunity to be heard with regard thereto has been granted such party.
(b) The American Arbitration Association shall, upon the written request of a party, furnish to such party, at its expense, certified facsimiles of any papers in the American Arbitration Association's possession that may be required in appeal to EPA or judicial proceedings relating to the hearing.
(a)
(b)
(c)
(a)
(2) The administrative fees shall be advanced by the initiating party or parties, subject to final apportionment by the hearing officer in the award. The administrative fee is increased by 10 percent of the original for each additional party.
(3) Fees and expenses in excess of the limit contained in section 26(b) of TSCA ($2,500 per person, or $100 per small business) will be paid by EPA.
(b)
(c)
(a) The hearing officer shall propose a fair and equitable amount of reimbursement. The formula in paragraph (b) of this section shall be presumed to be fair and equitable as applied to all persons subject to a test rule. However, the hearing officer has the discretion to modify the formula, or to use some other basis for allocation if necessary. Additional factors that may be taken into account include, but are not limited to, relative amounts of exposure attributable to each person and the effect of the reimbursement share on competitive position.
(b) In general, each person's share of the test cost shall be in proportion to its share of the total production volume of the test chemical:
(c) The burden of proposing modifications to the formula shall lie with the party requesting the modification.
(a) Generally, processors will be deemed to have fulfilled their testing and reimbursement responsibilities indirectly, through higher prices passed on by those directly responsible, the manufacturers. There are three circumstances in which processors will have a responsibility to provide reimbursement directly to those paying for the testing:
(1) When a test rule or subsequent
(2) When one or more manufacturers demonstrate to the hearing officer that it is necessary to include processors in order to provide fair and equitable reimbursement in a specific case.
(3) When one or more processors voluntarily agree to reimburse manufacturers for a portion of test costs. Only those processors who volunteer will incur the obligation.
(b) A hearing including processors shall be initiated in the same way as those including only manufacturers. Voluntary negotiations must be attempted in good faith first, and the request for a hearing must contain the names of the parties and a description of the unsuccessful negotiations.
(c) When processors as well as manufacturers are required to provide reimbursement, the hearing officer will decide for each case how the reimbursement should be allocated among the participating parties. When a test rule is applicable solely to processors, the hearing officer will apply the formula to the amount of the test chemical purchased or processed.
(a) Production volume will be measured over a period that begins one calendar year before publication of the final test rule in the
(b) For the purpose of determining fair reimbursement shares, production volume shall include amounts of the test chemical imported in bulk form and mixtures, and the total domestic production of the chemical including that produced as a byproduct. Impurities will not be included unless the test rule specifically includes them.
(c) Amounts of the test chemical manufactured for export will not be included unless covered by a finding under TSCA section 12(a)(2).
(d) Chemicals excluded from the jurisdiction of TSCA by section 3(2)(B) need not be included in the computation of production volume. (Chemicals used as intermediates to produce pesticides are covered by TSCA.)
(e) The burden of establishing the fact that particular amounts of the test chemical are produced for exempt purposes lies with the party seeking to exclude those amounts from the calculation of his production volume.
(a) All costs reasonable and necessary to comply with the test rule, taking into account the practices of other laboratories in conducting similar tests, are eligible for reimbursement. Necessary costs include:
(1) Direct and indirect costs of planning, conducting, analyzing and submitting the test results to EPA.
(2) A reasonable profit, and a reasonable rate of interest and depreciation on the tester's initial capital investment.
(3) The cost of repeating or repairing tests where failure was demonstrably due to some cause other than negligence of the tester.
(b) Costs attributable to tests beyond those specified by EPA shall not be eligible for reimbursement under this rule.
When more than one of a particular kind of test required by the test rule is performed, the additional costs will be shared among all those holding exemptions. The costs of all the tests will be added together and each exemption holder shall be responsible for a share of the total which is equal to its share of the total production of the test chemical. The exemption holders shall divide their shares between test sponsors in proportion to the costs of their respective tests. Those sponsoring a particular test do not have to obtain exemptions for that test and therefore do not have reimbursement responsibilities for the same tests done by others.
(a) The hearing officer's proposed order shall become the final Agency order 30 days after issuance unless within the 30-day period one of the parties requests Agency review or the Administrator of his own initiative decides to review the proposed order.
(b) The proposed order may be reviewed upon the record of the hearing and the petitions for review. If necesary, the Administrator may order the transcription of the stenographic record of the hearing, written briefs, oral arguments or any other reasonable aids to making an equitable decision.
(c) The final Agency order may be reviewed in federal court as provided by 26 U.S.C. 2603(c).
The final Agency order shall be available to the public for inspection and copying pursuant to 5 U.S.C. 552(a)(2), subject to necessary confidentiality restrictions.
Failure to provide information required by the Agency or to pay the amounts awarded under this rule within time alloted in the final order shall constitute a violation of 15 U.S.C. 2614(1) or 2614(3).
15 U.S.C. 2603.
(a) This part prescribes good laboratory practices for conducting studies relating to health effects, environmental effects, and chemical fate testing. This part is intended to ensure the quality and integrity of data submitted pursuant to testing consent agreements and test rules issued under section 4 of the Toxic Substances Control Act (TSCA) (Pub. L. 94-469, 90 Stat. 2006, 15 U.S.C. 2603
(b) This part applies to any study described by paragraph (a) of this section which any person conducts, initiates, or supports on or after September 18, 1989.
(c) It is EPA's policy that all data developed under section 5 of TSCA be in accordance with provisions of this part. If data are not developed in accordance with the provisions of this part, EPA will consider such data insufficient to evaluate the health and environmental effects of the chemical substances unless the submitter provides additional information demonstrating that the data are reliable and adequate.
As used in this part the following terms shall have the meanings specified:
(1) A person who initiates and supports, by provision of financial or other resources, a study;
(2) A person who submits a study to the EPA in response to a TSCA section 4(a) test rule and/or a person who submits a study under a TSCA section 4 testing consent agreement or a TSCA section 5 rule or order to the extent the agreement, rule or order references this part; or
(3) A testing facility, if it both initiates and actually conducts the study.
When a sponsor or other person utilizes the services of a consulting laboratory, contractor, or grantee to perform all or a part of a study to which this part applies, it shall notify the consulting laboratory, contractor, or grantee that the service is, or is part of, a study that must be conducted in compliance with the provisions of this part.
Any person who submits to EPA a test required by a testing consent agreement or a test rule issued under section 4 of TSCA shall include in the submission a true and correct statement, signed by the sponsor and -the study director, of one of the following types:
(a) A statement that the study was conducted in accordance with this part; or
(b) A statement describing in detail all differences between the practices used in the study and those required by this part; or
(c) A statement that the person was not a sponsor of the study, did not conduct the study, and does not know whether the study was conducted in accordance with this part.
(a) A testing facility shall permit an authorized employee or duly designated representative of EPA or FDA, at reasonable times and in a reasonable manner, to inspect the facility and to inspect (and in the case of records also to copy) all records and specimens required to be maintained regarding studies to which this part applies. The records inspection and copying requirements shall not apply to quality assurance unit records of findings and problems, or to actions recommended and taken, except the EPA may seek production of these records in litigation or formal adjudicatory hearings.
(b) EPA will not consider reliable for purposes of showing that a chemical substance or mixture does not present a risk of injury to health or the environment any data developed by a testing facility or sponsor that refuses to permit inspection in accordance with this part. The determination that a study will not be considered reliable does not, however, relieve the sponsor of a required test of any obligation under any applicable statute or regulation to submit the results of the study to EPA.
(c) Since a testing facility is a place where chemicals are stored or held, it is subject to inspection under section 11 of TSCA.
(a) The sponsor or any other person who is conducting or has conducted a test to fulfill the requirements of a testing consent agreement or a test rule issued under section 4 of TSCA will be in violation of section 15 of TSCA if:
(1) The test is not being or was not conducted in accordance with any requirement of this part;
(2) Data or information submitted to EPA under this part (including the statement required by § 792.12) include information or data that are false or misleading, contain significant omissions, or otherwise do not fulfill the requirements of this part; or
(3) Entry in accordance with § 792.15 for the purpose of auditing test data or inspecting test facilities is denied. Persons who violate the provisions of this part may be subject to civil or criminal penalties under section 16 of TSCA, legal action in United States district court under section 17 of TSCA, or criminal prosecution under 18 U.S.C. 2 or 1001.
(b) EPA, at its discretion, may not consider reliable for purposes of showing that a chemical substance or mixture does not present a risk of injury to health or the environment any study which was not conducted in accordance with this part. EPA, at its discretion, may rely upon such studies for purposes of showing adverse effects. The determination that a study will not be considered reliable does not, however, relieve the sponsor of a required test of the obligation under any applicable statute or regulation to submit the results of the study to EPA.
(c) If data submitted to fulfill a requirement of a testing consent agreement or a test rule issued under section 4 of TSCA are not developed in accordance with this part, EPA may determine that the sponsor has not fulfilled its obligations under section 4 of TSCA and may require the sponsor to develop data in accordance with the requirements of this part in order to satisfy such obligations.
(a) Each individual engaged in the conduct of or responsible for the supervision of a study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions.
(b) Each testing facility shall maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a study.
(c) There shall be a sufficient number of personnel for the timely and proper conduct of the study according to the protocol.
(d) Personnel shall take necessary personal sanitation and health precautions designed to avoid contamination of test, control, and reference substances and test systems.
(e) Personnel engaged in a study shall wear clothing appropriate for the duties they perform. Such clothing shall be changed as often as necessary to prevent microbiological, radiological, or chemical contamination of test systems and test, control, and reference substances.
(f) Any individual found at any time to have an illness that may adversely affect the quality and integrity of the study shall be excluded from direct contact with test systems, test, control, and reference substances and any other operation or function that may adversely affect the study until the condition is corrected. All personnel shall be instructed to report to their immediate supervisors any health or medical conditions that may reasonably be considered to have an adverse effect on a study.
For each study, testing facility management shall:
(a) Designate a study director as described in § 792.33 before the study is initiated.
(b) Replace the study director promptly if it becomes necessary to do so during the conduct of a study.
(c) Assure that there is a quality assurance unit as described in § 792.35.
(d) Assure that test, control, and reference substances or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable.
(e) Assure that personnel, resources, facilities, equipment, materials and methodologies are available as scheduled.
(f) Assure that personnel clearly understand the functions they are to perform.
(g) Assure that any deviations from these regulations reported by the quality assurance unit are communicated to the study director and corrective actions are taken and documented.
For each study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the study director. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation, and reporting of results, and represents the single point of study control. The study director shall assure that:
(a) The protocol, including any change, is approved as provided by § 792.120 and is followed.
(b) All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.
(c) Unforeseen circumstances that may affect the quality and integrity of the study are noted when they occur, and corrective action is taken and documented.
(d) Test systems are as specified in the protocol.
(e) All applicable good laboratory practice regulations are followed.
(f) All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study.
(a) A testing facility shall have a quality assurance unit which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in
(b) The quality assurance unit shall:
(1) Maintain a copy of a master schedule sheet of all studies conducted at the testing facility indexed by test substance and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director.
(2) Maintain copies of all protocols pertaining to all studies for which the unit is responsible.
(3) Inspect each study at intervals adequate to ensure the integrity of the study and maintain written and properly signed records of each periodic inspection showing the date of the inspection, the study inspected, the phase or segment of the study inspected, the person performing the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for re-inspection. Any problems which are likely to affect study integrity found during the course of an inspection shall be brought to the attention of the study director and management immediately.
(4) Periodically submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken.
(5) Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.
(6) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the study.
(7) Prepare and sign a statement to be included with the final study report which shall specify the dates inspections were made and findings reported to management and to the study director.
(c) The responsibilities and procedures applicable to the quality assurance unit, the records maintained by the quality assurance unit, and the method of indexing such records shall be in writing and shall be maintained. These items including inspection dates, the study inspected, the phase or segment of the study inspected, and the name of the individual performing the inspection shall be made available for inspection to authorized employees or duly designated representatives of EPA or FDA.
(d) An authorized employee or a duly designated representative of EPA or FDA shall have access to the written procedures established for the inspection and may request testing facility management to certify that inspections are being implemented, performed, documented, and followed up in accordance with this paragraph.
Each testing facility shall be of suitable size and construction to facilitate the proper conduct of studies. Testing facilities which are not located within an indoor controlled environment shall be of suitable location to facilitate the proper conduct of studies. Testing facilities shall be designed so that there is a degree of separation that will prevent any function or activity from having an adverse effect on the study.
(a) A testing facility shall have a sufficient number of animal rooms or other test system areas, as needed, to ensure: proper separation of species or test systems, isolation of individual projects, quarantine or isolation of animals or other test systems, and routine or specialized housing of animals or other test systems.
(1) In tests with plants or aquatic animals, proper separation of species can be accomplished within a room or area by housing them separately in different chambers or aquaria. Separation of species is unnecessary where the protocol specifies the simultaneous exposure of two or more species in the
(2) Aquatic toxicity tests for individual projects shall be isolated to the extent necessary to prevent cross-contamination of different chemicals used in different tests.
(b) A testing facility shall have a number of animal rooms or other test system areas separate from those described in paragraph (a) of this section to ensure isolation of studies being done with test systems or test, control, and reference substances known to be biohazardous, including volatile substances, aerosols, radioactive materials, and infectious agents.
(c) Separate areas shall be provided, as appropriate, for the diagnosis, treatment, and control of laboratory test system diseases. These areas shall provide effective isolation for the housing of test systems either known or suspected of being diseased, or of being carriers of disease, from other test systems.
(d) Facilities shall have proper provisions for collection and disposal of contaminated water, soil, or other spent materials. When animals are housed, facilities shall exist for the collection and disposal of all animal waste and refuse or for safe sanitary storage of waste before removal from the testing facility. Disposal facilities shall be so provided and operated as to minimize vermin infestation, odors, disease hazards, and environmental contamination.
(e) Facilities shall have provisions to regulate environmental conditions (e.g., temperature, humidity, photo-period) as specified in the protocol.
(f) For marine test organisms, an adequate supply of clean sea water or artificial sea water (prepared from deionized or distilled water and sea salt mixture) shall be available. The ranges of composition shall be as specified in the protocol.
(g) For freshwater organisms, an adequate supply of clean water of the appropriate hardness, pH, and temperature, and which is free of contaminants capable of interfering with the study shall be available as specified in the protocol.
(h) For plants, an adequate supply of soil of the appropriate composition, as specified in the protocol, shall be available as needed.
(a) There shall be storage areas, as needed, for feed, nutrients, soils, bedding, supplies, and equipment. Storage areas for feed, nutrients, soils, and bedding shall be separated from areas where the test systems are located and shall be protected against infestation or contamination. Perishable supplies shall be preserved by appropriate means.
(b) When appropriate, plant supply facilities shall be provided. These include:
(1) Facilities, as specified in the protocol, for holding, culturing, and maintaining algae and aquatic plants.
(2) Facilities, as specified in the protocol, for plant growth, including but not limited to, greenhouses, growth chambers, light banks, and fields.
(c) When appropriate, facilities for aquatic animal tests shall be provided. These include but are not limited to aquaria, holding tanks, ponds, and ancillary equipment, as specified in the protocol.
(a) As necessary to prevent contamination or mixups, there shall be separate areas for:
(1) Receipt and storage of the test, control, and reference substances.
(2) Mixing of the test, control, and reference substances with a carrier, e.g., feed.
(3) Storage of the test, control, and reference substance mixtures.
(b) Storage areas for test, control, and/or reference substance and for test, control, and/or reference mixtures shall be separate from areas housing the test systems and shall be adequate to preserve the identity, strength, purity, and stability of the substances and mixtures.
Separate laboratory space and other space shall be provided, as needed, for the performance of the routine and specialized procedures required by studies.
Space shall be provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and specimens from completed studies.
Equipment used in the generation, measurement, or assessment of data and equipment used for facility environmental control shall be of appropriate design and adequate capacity to function according to the protocol and shall be suitably located for operation, inspection, cleaning, and maintenance.
(a) Equipment shall be adequately inspected, cleaned, and maintained. Equipment used for the generation, measurement, or assessment of data shall be adequately tested, calibrated, and/or standardized.
(b) The written standard operating procedures required under § 792.81(b)(11) shall set forth in sufficient detail the methods, materials, and schedules to be used in the routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment, and shall specify, when appropriate, remedial action to be taken in the event of failure or malfunction of equipment. The written standard operating procedures shall designate the person responsible for the performance of each operation.
(c) Written records shall be maintained of all inspection, maintenance, testing, calibrating, and/or standardizing operations. These records, containing the date of the operation, shall describe whether the maintenance operations were routine and followed the written standard operating procedures. Written records shall be kept of nonroutine repairs performed on equipment as a result of failure and malfunction. Such records shall document the nature of the defect, how and when the defect was discovered, and any remedial action taken in response to the defect.
(a) A testing facility shall have standard operating procedures in writing, setting forth study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. All deviations in a study from standard operating procedures shall be authorized by the study director and shall be documented in the raw data. Significant changes in established standard operating procedures shall be properly authorized in writing by management.
(b) Standard operating procedures shall be established for, but not limited to, the following:
(1) Test system room preparation.
(2) Test system care.
(3) Receipt, identification, storage, handling, mixing, and method of sampling of the test, control, and reference substances.
(4) Test system observations.
(5) Laboratory or other tests.
(6) Handling of test systems found moribund or dead during study.
(7) Necropsy of test systems or postmortem examination of test systems.
(8) Collection and identification of specimens.
(9) Histopathology.
(10) Data handling, storage and retrieval.
(11) Maintenance and calibration of equipment.
(12) Transfer, proper placement, and identification of test systems.
(c) Each laboratory or other study area shall have immediately available manuals and standard operating procedures relative to the laboratory or field procedures being performed. Published literature may be used as a supplement to standard operating procedures.
(d) A historical file of standard operating procedures, and all revisions thereof, including the dates of such revisions, shall be maintained.
All reagents and solutions in the laboratory areas shall be labeled to indicate identity, titer or concentration,
(a) There shall be standard operating procedures for the housing, feeding, handling, and care of animals and other test systems.
(b) All newly received test systems from outside sources shall be isolated and their health status or appropriateness for the study shall be evaluated. This evaluation shall be in accordance with acceptable veterinary medical practice or scientific methods.
(c) At the initiation of a study, test systems shall be free of any disease or condition that might interfere with the purpose or conduct of the study. If during the course of the study, the test systems contract such a disease or condition, the diseased test systems should be isolated, if necessary. These test systems may be treated for disease or signs of disease provided that such treatment does not interfere with the study. The diagnosis, authorization of treatment, description of treatment, and each date of treatment shall be documented and shall be retained.
(d) Warm-blooded animals, adult reptiles, and adult terrestrial amphibians used in laboratory procedures that require manipulations and observations over an extended period of time, or in studies that require these test systems to be removed from and returned to their test system-housing units for any reason (e.g., cage cleaning, treatment, etc.), shall receive appropriate identification (e.g., tattoo, color code, ear tag, ear punch, etc.). All information needed to specifically identify each test system within the test system-housing unit shall appear on the outside of that unit. Suckling mammals and juvenile birds are excluded from the requirement of individual identification unless otherwise specified in the protocol.
(e) Except as specified in paragraph (e)(1) of this section, test systems of different species shall be housed in separate rooms when necessary. Test systems of the same species, but used in different studies, should not ordinarily be housed in the same room when inadvertent exposure to test, control, or reference substances or test system mixup could affect the outcome of either study. If such mixed housing is necessary, adequate differentiation by space and identification shall be made.
(1) Plants, invertebrate animals, aquatic vertebrate animals, and organisms that may be used in multispecies tests need not be housed in separate rooms, provided that they are adequately segregated to avoid mixup and cross contamination.
(2) [Reserved]
(f) Cages, racks, pens, enclosures, aquaria, holding tanks, ponds, growth chambers, and other holding, rearing, and breeding areas, and accessory equipment, shall be cleaned and sanitized at appropriate intervals.
(g) Feed, soil, and water used for the test systems shall be analyzed periodically to ensure that contaminants known to be capable of interfering with the study and reasonably expected to be present in such feed, soil, or water are not present at levels above those specified in the protocol. Documentation of such analyses shall be maintained as raw data.
(h) Bedding used in animal cages or pens shall not interfere with the purpose or conduct of the study and shall be changed as often as necessary to keep the animals dry and clean.
(i) If any pest control materials are used, the use shall be documented. Cleaning and pest control materials that interfere with the study shall not be used.
(j) All plant and animal test systems shall be acclimatized to the environmental conditions of the test, prior to their use in a study.
(a) The identity, strength, purity, and composition, or other characteristics which will appropriately define the test, control, or reference substance shall be determined for each batch and shall be documented before its use in a study. Methods of synthesis, fabrication, or derivation of the test, control,
(b) When relevant to the conduct of the study the solubility of each test, control, or reference substance shall be determined by the testing facility or the sponsor before the experimental start date. The stability of the test, control or reference substance shall be determined before the experimental start date or concomitantly according to written standard operating procedures, which provide for periodic analysis of each batch.
(c) Each storage container for a test, control, or reference substance shall be labeled by name, chemical abstracts service number (CAS) or code number, batch number, expiration date, if any, and, where appropriate, storage conditions necessary to maintain the identity, strength, purity, and composition of the test, control, or reference substance. Storage containers shall be assigned to a particular test substance for the duration of the study.
(d) For studies of more than 4 weeks experimental duration, reserve samples from each batch of test, control, and reference substances shall be retained for the period of time provided by § 792.195.
(e) The stability of test, control, and reference substances under storage conditions at the test site shall be known for all studies.
Procedures shall be established for a system for the handling of the test, control, and reference substances to ensure that:
(a) There is proper storage.
(b) Distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage.
(c) Proper identification is maintained throughout the distribution process.
(d) The receipt and distribution of each batch is documented. Such documentation shall include the date and quantity of each batch distributed or returned.
(a) For each test, control, or reference substance that is mixed with a carrier, tests by appropriate analytical methods shall be conducted:
(1) To determine the uniformity of the mixture and to determine, periodically, the concentration of the test, control, or reference substance in the mixture.
(2) When relevant to the conduct of the experiment, to determine the solubility of each test, control, or reference substance in the mixture by the testing facility or the sponsor before the experimental start date.
(3) To determine the stability of the test, control or reference substance in the mixture before the experimental start date or concomitantly according to written standard operating procedures, which provide for periodic analysis of each batch.
(b) Where any of the components of the test, control, or reference substance carrier mixture has an expiration date, that date shall be clearly shown on the container. If more than one component has an expiration date, the earliest date shall be shown.
(c) If a vehicle is used to facilitate the mixing of a test substance with a carrier, assurance shall be provided that the vehicle does not interfere with the integrity of the test.
(a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The protocol shall contain but shall not necessarily be limited to the following information:
(1) A descriptive title and statement of the purpose of the study.
(2) Identification of the test, control, and reference substance by name, chemical abstracts service (CAS) number or code number.
(3) The name and address of the sponsor and the name and address of the testing facility at which the study is being conducted.
(4) The proposed experimental start and termination dates.
(5) Justification for selection of the test system.
(6) Where applicable, the number, body weight, sex, source of supply, species, strain, substrain, and age of the test system.
(7) The procedure for identification of the test system.
(8) A description of the experimental design, including methods for the control of bias.
(9) Where applicable, a description and/or identification of the diet used in the study as well as solvents, emulsifiers and/or other materials used to solubilize or suspend the test, control, or reference substances before mixing with the carrier. The description shall include specifications for acceptable levels of contaminants that are reasonably expected to be present in the dietary materials and are known to be capable of interfering with the purpose or conduct of the study if present at levels greater than established by the specifications.
(10) The route of administration and the reason for its choice.
(11) Each dosage level, expressed in milligrams per kilogram of body or test system weight or other appropriate units, of the test, control, or reference substance to be administered and the method and frequency of administration.
(12) The type and frequency of tests, analyses, and measurements to be made.
(13) The records to be maintained.
(14) The date of approval of the protocol by the sponsor and the dated signature of the study director.
(15) A statement of the proposed statistical method.
(b) All changes in or revisions of an approved protocol and the reasons therefor shall be documented, signed by the study director, dated, and maintained with the protocol.
(a) The study shall be conducted in accordance with the protocol.
(b) The test systems shall be monitored in conformity with the protocol.
(c) Specimens shall be identified by test system, study, nature, and date of collection. This information shall be located on the specimen container or shall accompany the specimen in a manner that precludes error in the recording and storage of data.
(d) In animal studies where histopathology is required, records of gross findings for a specimen from postmortem observations shall be available to a pathologist when examining that specimen histopatho-logically.
(e) All data generated during the conduct of a study, except those that are generated by automated data collection systems, shall be recorded directly, promptly, and legibly in ink. All data entries shall be dated on the day of entry and signed or initialed by the person entering the data. Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or identified at the time of the change. In automated data collection systems, the individual responsible for direct data input shall be identified at the time of data input. Any change in automated data entries shall be made so as not to obscure the original entry, shall indicate the reason for change, shall be dated, and the responsible individual shall be identified.
(a) All provisions of the GLPs shall apply to physical and chemical characterization studies designed to determine stability, solubility, octanol water partition coefficient, volatility, and persistence (such as bio-de-gra-dation, photodegradation, and chemical degradation studies).
(b) The following GLP standards shall not apply to studies designed to determine physical and chemical characteristics of a test, control, or reference substance:
(a) A final report shall be prepared for each study and shall include, but not necessarily be limited to, the following:
(1) Name and address of the facility performing the study and the dates on which the study was initiated and was completed, terminated, or discontinued.
(2) Objectives and procedures stated in the approved protocol, including any changes in the original protocol.
(3) Statistical methods employed for analyzing the data.
(4) The test, control, and reference substances identified by name, chemical abstracts service (CAS) number or code number, strength, purity, and composition, or other appropriate characteristics.
(5) Stability, and when relevant to the conduct of the study, the solubility of the test, control, and reference substances under the conditions of administration.
(6) A description of the methods used.
(7) A description of the test system used. Where applicable, the final report shall include the number of animals or other test organisms used, sex, body weight range, source of supply, species, strain and substrain, age, and procedure used for identification.
(8) A description of the dosage, dosage regimen, route of administration, and duration.
(9) A description of all circumstances that may have affected the quality or integrity of the data.
(10) The name of the study director, the names of other scientists or professionals and the names of all supervisory personnel, involved in the study.
(11) A description of the transformations, calculations, or operations performed on the data, a summary and analysis of the data, and a statement of the conclusions drawn from the analysis.
(12) The signed and dated reports of each of the individual scientists or other professionals involved in the study, including each person who, at the request or direction of the testing facility or sponsor, conducted an analysis or evaluation of data or specimens from the study after data generation was completed.
(13) The locations where all specimens, raw data, and the final report are to be stored.
(14) The statement prepared and signed by the quality assurance unit as described in § 792.35(b)(7).
(b) The final report shall be signed and dated by the study director.
(c) Corrections or additions to a final report shall be in the form of an amendment by the study director. The amendment shall clearly identify that part of the final report that is being added to or corrected and the reasons for the correction or addition, and shall be signed and dated by the person responsible. Modification of a final report to comply with the submission requirements of EPA does not constitute a correction, addition, or amendment to a final report.
(d) A copy of the final report and of any amendment to it shall be maintained by the sponsor and the test facility.
(a) All raw data, documentation, records, protocols, specimens, and final reports generated as a result of a study shall be retained. Specimens obtained from mutagenicity tests, specimens of soil, water, and plants, and wet specimens of blood, urine, feces, and biological fluids, do not need to be retained after quality assurance verification. Correspondence and other documents relating to interpretation and evaluation of data, other than those documents contained in the final report, also shall be retained.
(b) There shall be archives for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports. Conditions of storage shall minimize deterioration of the documents or
(c) An individual shall be identified as responsible for the archives.
(d) Only authorized personnel shall enter the archives.
(e) Material retained or referred to in the archives shall be indexed to permit expedient retrieval.
(a) Record retention requirements set forth in this section do not supersede the record retention requirements of any other regulations in this subchapter.
(b)(1) Except as provided in paragraph (c) of this section, documentation records, raw data, and specimens pertaining to a study and required to be retained by this part shall be retained in the archive(s) for a period of at least ten years following the effective date of the applicable final test rule.
(2) In the case of negotiated testing agreements, each agreement will contain a provision that, except as provided in paragraph (c) of this section, documentation records, raw data, and specimens pertaining to a study and required to be retained by this part shall be retained in the archive(s) for a period of at least ten years following the publication date of the acceptance of a negotiated test agreement.
(3) In the case of testing submitted under section 5, except for those items listed in paragraph (c) of this section, documentation records, raw data, and specimens pertaining to a study and required to be retained by this part shall be retained in the archive(s) for a period of at least five years following the date on which the results of the study are submitted to the agency.
(c) Wet specimens, samples of test, control, or reference substances, and specially prepared material which are relatively fragile and differ markedly in stability and quality during storage, shall be retained only as long as the quality of the preparation affords evaluation. Specimens obtained from mutagenicity tests, specimens of soil, water, and plants, and wet specimens of blood, urine, feces, biological fluids, do not need to be retained after quality assurance verification. In no case shall retention be required for longer periods than those set forth in paragraph (b) of this section.
(d) The master schedule sheet, copies of protocols, and records of quality assurance inspections, as required by § 792.35(c) shall be maintained by the quality assurance unit as an easily accessible system of records for the period of time specified in paragraph (b) of this section.
(e) Summaries of training and experience and job descriptions required to be maintained by § 792.29(b) may be retained along with all other testing facility employment records for the length of time specified in paragraph (b) of this section.
(f) Records and reports of the maintenance and calibration and inspection of equipment, as required by § 792.63 (b) and (c), shall be retained for the length of time specified in paragraph (b) of this section.
(g) If a facility conducting testing or an archive contracting facility goes out of business, all raw data, documentation, and other material specified in this section shall be transferred to the archives of the sponsor of the study. The EPA shall be notified in writing of such a transfer.
(h) Specimens, samples, or other non-documentary materials need not be retained after EPA has notified in writing the sponsor or testing facility holding the materials that retention is no longer required by EPA. Such notification normally will be furnished upon request after EPA or FDA has completed an audit of the particular study to which the materials relate and EPA has concluded that the study was conducted in accordance with this part.
(i) Records required by this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records.
15 U.S.C. 2603.
(a)
(2) In general, both indirect and direct processes can proceed simultaneously. Under favorable conditions the measurement of a photoreaction rate constant in sunlight (K
(3) In pure water only, direct photoreaction is possible, although hydrolysis, biotransformation, sorption, and volatilization also can decrease the concentraton of a test chemical. By measuring k
(4) Two protocols have been written that measure k
(5) This protocol provides a cost effective test method for measuring k
(6) To correct for variations in solar irradiance during the reaction period, an actinometer is simultaneously insolated. From these data, an indirect photoreaction rate constant is calculated that is applicable to clear-sky, near-surface, conditions in fresh water bodies.
(7) In contrast to k
(8) The value of k
(9) This protocol consists of three separate phases that should be completed in the following order: In Phase 1, SHW is prepared and adjusted; in Phase 2, the test chemical is irradiated in SHW and pure water (PW) to obtain approximate sunlight photoreaction rate constants and to determine whether direct and indirect photoprocesses are important; in Phase 3, the test chemical is again irradiated in PW and SHW. To correct for photobleaching of SHW and also solar irradiance variations, tubes containing SHW and actinometer solutions are exposed simultaneously. From these data k
(b)
(ii) The indirect photoreactivity of a chemical in a natural water will depend on its response to these reactive intermediates, and possibly others yet unknown, as well as the ability of the water to generate such species. This latter feature will vary from water-to-water in an unpredictable way, judged by the complexity of the situation.
(iii) The approach to standardizing a test for indirect photoreactivity is to use a synthetic humic water (SHW) prepared by water-extracting commercial humic material. This material is inexpensive, and available to any laboratory, in contrast to a specific natural water. The SHW can be diluted to a dissolved organic carbon (DOC) content and uv-visible absorbance typical of most surface fresh waters.
(iv) In recent studies it has been found that the reactivity of SHW mixtures depends on pH, and also the history of sunlight exposure (Mill et al. (1983) under paragraph (f)(11) of this section). The SHW solutions initially photobleach with a time-dependent rate constant. As such, an SHW test system has been designed that is buffered to maintain pH and is pre-aged in sunlight to produce, subsequently, a predictable bleaching behavior.
(v) The purpose of Phase 1 is to prepare, pre-age, and dilute SHW to a
(2)
(ii) Pre-aging is accomplished by exposing the concentrated solution in the 2-liter flask to direct sunlight for 4 days in early spring or late fall; 3 days in late spring, summer, or early fall. At this time the absorbance of the solution is measured at 370 nm, and a dilution factor is calculated to decrease the absorbance to 0.50 in a 1 cm path length cell. If necessary, the pH is re-adjusted to 7.0. Finally, the mixture is brought to exact dilution with a precalculated volume of reagent-grade water to give a final absorbance of 0.500 in a 1-cm path length cell at 370 nm. It is tightly capped and refrigerated.
(iii) This mixture is SHW stock solution. Before use it is diluted 10-fold with 0.010 M phosphate buffer to produce a pH 7.0 mixture with an absorbance of 5.00×10
(3)
(c)
(ii) In Phase 2, sunlight photo-reaction rate constants are measured in round tubes containing SHW and then mathematically corrected to a flat water surface geometry. These rate constants are not corrected to clear-sky conditions.
(2)
(ii) This solution should be mixed 9.00:1.00 by volume with PW or SHW stock solution to provide working solutions. In the case of SHW, it gives a ten-fold dilution of SHW stock solution. Six mL aliquots of each working solution should then be transferred to separate 12 × 100 mm quartz tubes with screw tops and tightly sealed with Mininert valves.
(iii) The sample tubes are mounted in a photolysis rack with the tops facing geographically north and inclined 30° from the horizontal. The rack should be placed outdoors over a black background in a location free of shadows and excessive reflection.
(iv) Reaction progress should be measured with an analytical technique that provides a precision of at least ±5 percent. High pressure liquid chromatography (HPLC) or gas chromatograph (GC) have proven to be the most general and precise analytical techniques.
(v) Sample and control solution concentrations are calculated by averaging analytical measurements for each solution. Control solutions should be analyzed at least twice at zero time and at other times to determine whether any loss of chemical in controls or samples has occurred by some adventitious process during the experiment.
(vi) Whenever possible the following procedures should be completed in clear, warm, weather so that solutions will photolyze more quickly and not freeze.
(A) Starting at noon on day zero, expose to sunlight 24 sample tubes mounted on the rack described above. Tape 24 foil-wrapped controls to the bottom of the rack.
(B) Analyze two sample tubes and two unexposed controls in PW and SHW for chemical at 24 hours. Calculate the round tube photolysis rate constants (k
(C) If less than 20 percent conversion occurs in SHW in 1 day, repeat the procedure for SHW and PW at 2 days, 4 days, 8 days, or 16 days, or until 20 percent conversion is reached. Do not extend the experiment past 16 days. If less than 20 percent photoreaction occurs in SHW at the end of 16 days the chemical is “photoinert”. Phase 3 is not applicable.
(D) If more than 80 percent photoreaction occurs at the end of day 1 in SHW, repeat the experiment with eight each of the remaining foil-wrapped PW and SHW controls. Divide these sets into four sample tubes each, leaving four foil-wrapped controls taped to the bottom of the rack.
(
(
(
(
(vii) Since the rate of photolysis in tubes is faster than the rate in natural water bodies, values of near-surface photolysis rate constants in natural and pure water bodies, k
(3)
(ii) Rate constants determined by the Phase 2 protocol depend upon latitude, season, and weather conditions. Note that (k
(4)
(5)
(ii) The test procedure is simple and inexpensive, but does require that the chemical dissolve in water at sufficient concentrations to be measured by some analytical technique but not have appreciable absorbance in the range 290 to 825 nm. Phase 2 tests should be done during a clear-sky period to obtain the best results. Testing will be less accurate for chemicals with half-lives of less than 1 day because dramatic fluctuations in sunlight intensity can arise from transient weather conditions and the difficulty of assigning equivalent reaction times. Normal diurnal variations also affect the photolysis rate constant. Phase 3 tests should be started as soon as possible after the Phase 2 tests to ensure that the (k
(6)
(ii) The SHW solution of A was photolyzed in sealed quartz tubes (12×100 mm) in the fall season starting on October 1. At the end of 1 and 2 days, respectively, the concentration of A was found to be 1.13×10
(iii) The tube photolysis rate constant of chemical A was calculated from Equation 2 under paragraph (c)(2)(vi)(B) of this section. The first time point at day 1 was used because the fraction of A remaining was in the range 20 to 80 percent:
(iv) From this value, k
(v) From measurements in pure water, k
(d)
(i) The purpose of Phase 3 is to measure k
(ii) In the case (k
(iii) The actinometer used is the
(iv) SHW is subject to photobleaching that decreases its ability to promote indirect photolysis based on its ability to absorb sunlight. This effect will be significant when the test period exceeds a few days. To correct for photobleaching, tubes containing SHW are irradiated in action to the other tubes above.
(v) At any time, the loss of test chemical is given by Equation 8 assuming actinometric correction to constant light flux:
(vi) The indirect photolysis rate constant, k
(vii) To evaluate k
(viii) To obtain k
(ix) Then, (k
(x) Finally, k
(2)
(A) The variable k
(B) The variable k
(ii) Once [PYR] is determined, an actinometer solution is prepared by adding 1.00 mL of 1.0×10
(iii) The following solutions should be prepared and individually added in 6.00 mL aliquots to 12/100 mm quartz sample tubes; 8 tubes should be filled with each solution:
(A) PNAP/PYR actinometer solution.
(B) Test chemical in pH 7.0, 0.010 M phosphate buffer.
(C) Test chemcial in pH 7.0, 0.010 M phosphate buffer/SHW.
(D) pH 7.0, 0.010 M phosphate buffer/SHW. Four tubes of each set are wrapped in foil and used as controls.
(iv) The tubes are placed in the photolysis rack (Phase 2, Procedure) at 0900 hours on day zero, with the controls taped to the bottom of the rack. One tube of each composition is removed, along with their respective controls, according to a schedule found in Table 2, which categorizes sampling times on the basis of (k
(v) The tubes containing PNAP, test chemical, and their controls are analyzed for residual concentrations soon after the end of the experiment. PNAP is conveniently analyzed by HPLC, using a 30 cm C
(vi) If controls are well-behaved and show no significant loss of chemical or absorbance change, then k
(vii) According to Equation 12 under paragraph (d)(1)(vii) of this section, plot the quantities Pn(A
(viii) Then, using Equation 13a under paragraph (d)(1)(vii) of this section, determine the slope (S3) by least squares linear regression. Under the assumptions of the protocol, S3 is equal to (k
(ix) From Equation 18
(x) The indirect photoreaction rate constant, k
(xi) The rate constant k
(xii) Then, (k
(xiii) Finally, k
(3)
(4)
(5)
(6)
(ii) The actinometer solution was made up by adding a volume of pyridine (1.95 mL) calculated from equation 16 under paragraph (d)(2)(ii) of this section to a 1 liter volumetric flask containing 1.00 mL of 1.00 × 10
(A) Chemical A (1.53×10
(B) Chemical A (1.53×10
(C) SHW standard solution diluted with water 0.90 to 1.00 to match solution A.
(D) PNAP/PYR actinometer solution. Ten additional foil-wrapped controls of each mixture were taped to the bottom of the rack.
(iii) The test chemical had been placed in category B, Table 2 under the paragraph (d)(2)(iv) of this section, on the basis of its Phase 2 rate constant under paragraph (c) of this section. Accordingly, two tubes of each irradiated solution and two tubes of each blank solution were removed at 0, 1, 2, 4, and 8 days at 1,200 hours. The averaged analytical results obtained at the end of the experiment are shown in the following Table 3.
(A) From these items the functions Pn(C
(B) Slope S1=(k
(C) Slope S2=(k/k
(D) Using the data in columns 3 and 6 in Table 4 under paragraph (d)(6)(iii)(A) of this section, slope S3 was calculated by regression from Equation 13a under paragraph (d)(1)(viii) of this section and was found to be 0.428 with correlation coefficient euqal to 0.99997.
(E) Using Equation 18 under paragraph (d)(2)(ix) of this section, k
(F) The values of S1, S2, and k
(G) The rate constant k
(H) The sum of k
(I) Since k
(e)
(B) If extraction methods were used to separate the solute from the aqueous solution, provide a description of the extraction method as well as the recovery data.
(ii)
(B) Report the dates of photolysis, weather conditions, times of exposure, and the duration of exposure.
(C) If acetonitrile was used to solubilize the test chemical, report the volume percent.
(D) If a significant loss of test chemical occurred in the control solutions for pure water and SHW, indicate the causes and how they were eliminated or minimized.
(2)
(B) Report the molar concentration of test chemical, C
(C) Report the molar concentration of test chemical for each replicate control sample and the mean value for each time point.
(D) Report the values of (k
(E) If small losses of test chemical were observed in SHW and pure water, report a first-order rate constant loss, (k
(F) Report the value of R calculated from Equation 4 under paragraph (c)(2)(vi)(D)(
(G) Report the values of k
(ii) Phase 3—Indirect photoreaction with actinometer. (A) Report the initial molar concentration of test chemical, C
(B) Report the initial absorbance A
(C) Report the initial molar concentration of PNAP of each replicate and the mean value in the actinometer. Report the concentration of pyridine used in the actinometer which was obtained from Equation 15 under paragraph (d)(2)(i) of this section.
(D) Report the time and date the photolysis experiments were started, the time and date the experiments were completed, and the elapsed photolysis time in days.
(E) For each time point t, report the separate values of the absorbance of the SHW solution, and the mean values.
(F) For each time point for the controls, report the separate values of the molar concentrations of test chemical in pure water and SHW, and the absorbance of the SHW solution, and the mean values.
(G) Tabulate and report the following data: t, [C]
(H) From the data in (G), tabulate and report the following data: t, Pn(C
(I) From the linear regression analysis of the appropriate data in step (H) in Equation 17 under paragraph (d)(2)(vi) of this section, report the slope S1 and the correlation coefficient.
(J) From the linear regression analysis of the appropriate data in step (H) in Equation 12 under paragraph (d)(1)(vii) of this section, report the slope S2 and the correlation coefficient.
(K) From the linear regression analysis of the appropriate data in step (H) in Equation 13a under paragraph (d)(1)(viii) of this section, report the slope S3 and the correlation coefficient.
(L) If loss of chemical was observed during photolysis in pure water and SHW, then report the data Pn(C
(M) Report the value of the actinometer rate constant obtained from Equation 18 under paragraph (d)(2)(ix) of this section.
(N) Report the value of k
(O) Report the value of k
(P) Report the value of (k
(Q) Report the half-life, t
(f)
(1) Cooper W.J., Zika R.G. “Photochemical formation of hydrogen peroxide in surface and ground waters exposed to sunlight.”
(2) Draper W.M., Crosby D.G. “The photochemical generation of hydrogen peroxide in natural waters.”
(3) Draper, W.M. and Crosby D.G. “Solar photooxidation of pesticides in dilute hydrogen peroxide.”
(4) Draper W.M., Crosby D.G. “Hydrogen peroxide and hydroxyl radical:
(5) Dulin D., Mill T. “Development and evaluation of sunlight actino-meters.”
(6) Haag H.R., Hoigne J., Gassman E., Braun A.M. “Singlet oxygen in surface waters—Part I; Furfuryl alcohol as a trapping agent.”
(7) Haag W.R., Hoigne J., Gassman E., Braun A.M. “Singlet oxygen in surface waters—Part II: Quantum yields of its production by some natural humic materials as a function of wavelength.”
(8) Mill T., Winterle J.S., Fischer A., Tse D., Mabey W.R., Drossman H., Liu A., Davenport J.E. Toxic substances process data generation and protocol development. Work assignment 12, test standard development. “Section 3. Indirect photolysis.” Draft final report. EPA Contract No. 68-03-2981. Environmental Research Laboratory, Office of Research and Development, EPA, Athens, GA, and Office of Pollution Prevention and Toxics, EPA, Washington, DC. (1984).
(9) Mill T., Mabey W.R., Bomberger D.C., Chou T.W., Hendry D.G., Smith J.H. “Laboratory protocols for evaluating the fate of organic chemicals in air and water. Chapter 3. Photolysis in water. Chapter 4. Oxidation in water.” EPA 600/3-82-022. Environmental Research Laboratory, Office of Research and Development, EPA, Athens, GA. (1981).
(10) Mill T., Mabey W.R., Winterle J.S., Davenport J.E., Barich V.P., Dulin D.E., Tse D.S., Lee G. “Design and validation of screening and detailed methods for environmental processes. Apendix C. Lower-tier direct photolysis protocol.” Draft final report. EPA Contract No. 68-01-6325. Office of Pollution Prevention and Toxics, EPA, Washington, DC. (1982).
(11) Mill T., Davenport J.E., Winterle J.S., Mabey W.R., Dossman H., Tse D., Liu A. Toxic substances process data generation and protocol development. Work assignment 12. “Appendix B. Upper-tier protocol for direct photolysis in water.” Draft final report. EPA Contract No. 68-03-2981. Environmental Research Laboratory, Office of Research and Development, EPA, Athens, GA, and Office of Pollution Prevention and Toxics, EPA, Washington, DC. (July 1983).
(12) Winterle J.S., Mill T. Toxic substances process data generation and protocol development. Work assignment 18. “Indirect photoreaction protocol.” Draft EPA special report. EPA Contract No. 68-03-2981. Environmental Research Laboratory, Office of Research and Development, EPA, Athens, GA and Office of Pollution Prevention and Toxics, EPA, Washington, DC. (1985).
(13) Mill T., Hendry D.G., Richardson H. “Free radical oxidants in natural waters.”
(14) U.S. Environmental Protection Agency (USEPA), Office of Pollution Prevention and Toxics (OPPT). “Chemical fate test guidelines. Test guideline (CG, CS-6000). Photolysis in aqueous solution.” EPA-560/6-84-003. NTIS publication PB-84-233287. (1984).
(15) USEPA, OPPT. “Chemical fate test guidelines. Test guildeline (CG, CS-6010). Laboratory determination of the direct photolysis reaction quantum yield in aqueous solution and sunlight photolysis.” EPA-560/6-84-003. NTIS publication PB-84-233287. (1984).
(16) Wolff C.J.M., Halmans M.T.H., Van der Heijde H.B. “The formation of singlet oxygen in surface waters.”
(17) Zepp R.G., Baughman G.L., Schlotzhauer P.F. “Comparison of photochemical behavior of various humic substances in water: I. Sunlight induced reactions of aquatic pollutants photosensitized by humic substances.”
(18) Zepp R.G., Baughman G.L., Schlozhauer P.F. “Comparison of photochemical behavior of various humic substances in water: II. Photo-sen-si-tized oxygenations.”
(19) Zepp R.G., Cline D.M. “Rates of direct photolysis in aquatic environments.”
(20) Zepp, R.G., Wolfe N.L., Baugh-man G.L., Hollis R.C. “Singlet oxygen in natural waters.”
(21) Zepp R.G., Schlotzhauer P.F., Merritt S.R. “Photosensitized transformations involving electronic energy transfer in natural waters: role of humic substances.”
(a)
(b)
(c)
(2) [Reserved]
(3)
(ii) The gammarids shall be exposed to a wide-range of concentrations of the test substance (e.g., 1, 10, 100 mg/1, etc.), usually under static conditions.
(iii) A minimum of five gammarids should be exposed to each concentration of test substance for a period of 96 hours. The exposure period may be shortened if data suitable for determining concentrations in the definitive test can be obtained in less time. Nominal concentrations of the test substance may be acceptable.
(4)
(ii) A minimum of 20 gammarids per concentration shall be exposed to five or more concentrations of the test substance chosen in a geometric series in which the ratio is between 1.5 and 2.0 (e.g., 2, 4, 8, 16, 32, 64 mg/L). The range
(iii) Every test shall include a concurrent control using gammarids from the same population or culture container. The control group shall be exposed to the same dilution water, conditions and procedures, except that none of the test substance shall be is added to the chamber.
(iv) The dissolved oxygen concentration, temperature and pH of the test solution shall be measured at the beginning of the test and at 24, 48, 72 and 96 hours in at least one replicate each of the control, and the highest, lowest and middle test concentrations.
(v) The test duration is 96 hours. The test is unacceptable if more than 10 percent of the control organisms die during the test.
(vi) In addition to death, any abnormal behavior or appearance shall also be reported.
(vii) Gammarids shall be randomly assigned to the test chambers. Test chambers shall be positioned within the testing area in a random manner or in a way in which appropriate statistical analyses can be used to determine whether there is any variation due to placement.
(viii) Gammarids shall be introduced into the test chambers after the test substance has been added.
(ix) Observations on compound solubility shall be recorded. The investigator should record the appearance of surface slicks, precipitates, or material adhering to the sides of the test chambers.
(5) [Reserved]
(6)
(ii)
(iii)
(B) The analytical methods used to measure the amount of test substance in a sample shall be validated before beginning the test. This involves adding a known amount of the test substance to each of three water samples taken from a chamber containing dilution water and the same number of gammarids as are placed in each test chamber. The nominal concentrations of the test substance in these samples should span the concentration range to be used in the test. Validation of the analytical method should be performed on at least two separate days prior to starting the test.
(C) An analytical method is not acceptable if likely degradation products of the test substance give positive or negative interferences, unless it is shown that such degradation products are not present in the test chambers during the test.
(D) Among replicate test chambers, the measured concentrations shall not
(E) The mean measured concentration of dissolved test substance shall be used to calculate all LC50's and to plot all concentration-response curves.
(d)
(B) Gammarids can be cultured in the laboratory or collected from natural sources. If collected, they must be held in the laboratory for at least 14 days prior to testing.
(C) Gammarids used in a particular test shall be of similar age and/or size and from the same source or culture population.
(ii)
(iii)
(iv)
(2)
(
(
(
(
(
(B) Facilities should be well ventilated and free of fumes and disturbances that may affect the test organism.
(C) Test chambers shall be covered loosely to reduce the loss of test solution or dilution water due to evaporation and to minimize the entry of dust or other particulates into the solutions.
(ii)
(iii)
(iv)
(v)
(vi)
(B) If the dilution water is from a ground or surface water source, conductivity and total organic carbon (TOC) or chemical oxygen demand (COD) shall be measured. Reconstituted water can be made by adding specific amounts of reagent-grade chemicals to deionized or distilled water. Glass-distilled or carbon-filtered deionized water with a conductivity less than 1 micromho/cm is acceptable as the diluent for making reconstituted water.
(C) The concentration of dissolved oxygen in the dilution water shall be between 90 and 100 percent saturation. If necessary, the dilution water can be aerated before the addition of the test substance. All reconstituted water should be aerated before use.
(3)
(i) Water temperature of 18 ± 1 °C.
(ii) Dissolved oxygen concentration between 60 and 105 percent saturation.
(iii) The number of gammarids placed in a test chamber shall not be so great as to affect the results of the test. Ten gammarids per liter is the recommended level of loading for the static test. Loading requirements for the flow-through test will vary depending on the flow rate of dilution water. The loading should not cause the dissolved oxygen concentration to fall below the recommended levels.
(iv) Photoperiod of 16 hours light and 8 hours darkness.
(e)
(1) Name and address of the facility performing the study and the dates on which the study was initiated and completed.
(2) Objectives and procedures stated in the approved protocol, including any changes in the original protocol.
(3) Statistical methods employed for analyzing the data.
(4) The test substance identified by name, Chemical Abstracts (CAS) number or code number, source, lot or batch number, strength, purity, and
(5) Stability of the test substance under the conditions of the test.
(6) A description of the methods used, including:
(i) The source of the dilution water, its chemical characteristics (e.g., hardness, pH, etc.) and a description of any pretreatment.
(ii) A description of the test substance delivery system, test chambers, the depth and volume of solution in the chamber, the way the test was begun (e.g., test substance addition), the loading, the lighting, and the flow rate.
(iii) Frequency and methods of measurements and observations.
(7) The scientific name, weight, length, source, and history of the organisms used, and the acclimation procedures and food used.
(8) The concentrations tested, the number of gammarids and replicates per test concentration. The reported results should include:
(i) The results of dissolved oxygen, pH and temperature measurements.
(ii) If solvents are used, the name and source of the solvent, the nominal concentration of the test substance in the stock solution, the highest solvent concentration in the test solution and a description of the solubility determination in water and solvents.
(iii) The measured concentration of the test substance in each test chamber just before the start of the test and at all subsequent sampling periods.
(iv) In each test chamber at each observation period, the number of dead and live test organisms, the percentage of organisms that died, and the number of test organisms that showed any abnormal effects in each test chamber at each observation period.
(v) The 48, 72 and 96-hour LC50's and their 95 percent confidence limits. When sufficient data have been generated, the 24-hour LC50 value also. These calculations should be made using the mean measured test substance concentrations.
(vi) The observed no-effect concentration (the highest concentration tested at which there were no mortalities or abnormal behavioral or physiological effects), if any.
(vii) Methods and data for all chemical analyses of water quality and test substance concentrations, including method validations and reagent blanks.
(9) A description of all circumstances that may have affected the quality or integrity of the data.
(10) The names of the sponsor, study director, principal investigator, names of other scientists or professionals, and the names of all supervisory personnel involved in the study.
(11) A description of the transformations, calculations, or operations performed on the data, a summary and analysis of the data, and a statement of the conclusions drawn from the analysis. Results of the analysis of data should include the calculated LC50 value, 95 percent confidence limits, slope of the transformed concentration-response line, and the results of a goodness-of-fit test (e.g., chi-square test).
(12) The signed and dated reports prepared by any individual scientist or other professional involved in the study, including each person who, at the request or direction of the testing facility or sponsor, conducted an analysis or evaluation of data or specimens from the study after data generation was completed.
(13) The locations where all specimens, raw data, and the final report are stored.
(14) The statement prepared and signed by the quality assurance unit.
(a)
(1) The absorption of diethylene glycol butyl ether (DGBE) after administration by the dermal route.
(2) The biotransformation of DGBE administered dermally.
(3) The dermal absorption of DGBE and diethylene glycol butyl ether acetate (DGBA).
(b)
(ii)
(iii)
(B) During the acclimatization period, the rats should be housed in cages on hardwood chip bedding. All animals shall be provided with conventional laboratory diets and water ad libitum.
(2)
(ii)
(B) For dermal treatment, the doses shall be applied in a volume adequate to deliver the prescribed doses. The backs of the rats should be lightly shaved with an electric clipper shortly before treatment. The dose shall be applied with a micropipette on a specific area (for example, 2 cm
(iii)
(iv)
(B) Eight animals shall be dosed once dermally with the high dose of
(C) Eight animals shall be dosed once dermally with the low dose of
(D) Eight animals shall be dosed once dermally with the high dose of
(E) The high and low doses of
(3)
(ii)
(c)
(2)
(3)
(i) Species, strain, and supplier of laboratory animals.
(ii) Information on the degree (i.e., specific activity for a radiolabel) and sites of labeling of the test substances.
(iii) A full description of the sensitivity and precision of all procedures used to produce the data.
(iv) Relative percent absorption by the dermal route for rats administered low and high doses of
(v) Quantity of isotope, together with percent recovery of the administered dose, in feces and urine.
(vi) Biotransformation pathways and quantities of DGBE and metabolites in urine collected after administering single high and low dermal doses to rats.
(a)
(1) Ascertain whether the pharmacokinetics and metabolism of a chemical substance or mixture (“test substance”) are similar after oral and dermal administration.
(2) Determine bioavailability of a test substance after oral and dermal administration.
(3) Examine the effects of repeated dosing on the pharmacokinetics and metabolism of the test substance.
(b)
(2)
(3)
(4)
(c)
(ii)
(iii)
(B) During the acclimatization period, the animals shall be housed in suitable cages. All animals shall be
(2)
(ii)
(B)
(C)
(
(iii)
(
(
(
(
(
(
(
(B)
(
(
(
(
(3)
(B)
(ii)
(4)
(A)
(
(
(
(
(B)
(ii)
(A)
(
(d)
(1)
(2)
(3)
(i) Species and strains of laboratory animals.
(ii) Chemical characterization of the test substance, including:
(A) For the radioactive test substances, information on the site(s) and degree of radiolabeling, including type of label, specific activity, chemical purity, and radiochemical purity.
(B) For the nonradioactive compound, information on chemical purity.
(C) Results of chromatography.
(iii) A full description of the sensitivity, precision, and accuracy of all procedures used to generate the data.
(iv) Percent of absorption of test substance after oral and dermal exposures to rats and dermal exposure to mini-pigs.
(v) Quantity and percent recovery of radioactivity in feces, urine, expired air, and blood. In dermal studies on rats and mini-pigs, include recovery data for skin, skin washings, and residual radioactivity in the covering as well as results of the washing efficacy study.
(vi) Tissue distribution reported as quantity of radioactivity in blood and in various tissues, including bone, brain, fat, gastrointestinal tract, gonads, heart, kidney, liver, lung, muscle, skin and in residual carcass of rats.
(vii) Materials balance developed from each study involving the assay of body tissues and excreta.
(viii) Biotransformation pathways and quantities of test substance and metabolites in excreta collected after administering single high and low doses to rats.
(ix) Biotransformation pathways and quantities of the test substance and metabolites in excreta collected after administering repeated low doses to rats.
(x) Pharmacokinetics model(s) developed from the experimental data.
(a)
(1) Ascertain whether the pharmacokinetics and metabolism of the “test substance” are similar after oral and inhalation administration.
(2) Determine bioavailability of the test substance after oral and inhalation administration.
(3) Examine the effects of repeated dosing on the pharmacokinetics and metabolism of the test substance.
(b)
(2) “
(3) “
(c)
(ii)
(iii)
(B) The animals should be housed in environmentally controlled rooms with at least 10 air changes per hour. The rooms shall be maintained at a temperature of 22±2 °C and humidity of 50±20 percent with a 12-hour light/dark cycle per day. The animals shall be kept in a quarantine facility for at least 7 days prior to use and shall be acclimated to the experimental environment for a minimum of 48 hours prior to treatment.
(C) During the acclimatization period, the animals should be housed in suitable cages. All animals shall be provided with certified feed and tap water
(2)
(ii)
(B)
(C)
(iii)
(A)
(B)
(
(C)
(
(
(D)
(3)
(ii)
(4)
(A)
(B)
(C)
(D)
(E)
(F)
(G)
(ii) [Reserved]
(d)
(1)
(2)
(3)
(i) Species and strains of laboratory animals.
(ii) Chemical characterization of the test substance, including:
(A) For the radioactive test substance, information on the site(s) and degree of radiolabeling, including type of label, specific activity, chemical purity, and radiochemical purity.
(B) For the nonradioactive substance, information on chemical purity.
(C) Results of chromatography.
(iii) A full description of the sensitivity, precision, and accuracy of all procedures used to generate the data.
(iv) Extent of absorption of the test substance as indicated by: percent absorption of the administered oral dose; and total body burden after inhalation exposure.
(v) Quantity and percent recovery of radioactivity in feces, urine, expired air, and blood.
(vi) Tissue distribution reported as quantity of radioactivity in blood and in various tissues, including bone, brain, fat, gastrointestinal tract, gonads, heart, kidney, liver, lung, muscle, skin, spleen and in residual carcass of each rat.
(vii) Biotransformation pathways and quantities of the test substance and metabolites in excreta collected after administering single high and low doses to rats.
(viii) Biotransformation pathways and quantities of the test substance and metabolites in excreta collected after administering repeated low doses to rats.
(ix) Pharmacokinetics model(s) developed from the experimental data.
(a)
(1) Determine the bioavailability of the test substances after dermal and inhalation administration.
(2) Compare the pharmacokinetics and metabolism of the test substances after intravenous, dermal, and inhalation administration.
(3) Examine the effects of repeated doses on the pharmacokinetics and metabolism of the test substances.
(b)
(2)
(3)
(4)
(5)
(6)
(c)
(ii)
(iii)
(B) The animals shall be housed in environmentally controlled rooms with at least 10 air changes per hour. The rooms shall be maintained at a temperature of 18 to 26 degrees centigrade and humidity of 40 to 70 percent with a 12-hour light/dark cycle per day. The animal subjects shall be kept in a quarantine facility for at least 7 days prior to use, and shall be acclimated to the experimental environment for a minimum of 48 hours prior to treatment.
(C) During the acclimatization period, the rats shall be housed in suitable cages. All animals shall be provided with certified feed and tap water
(2)
(ii)
(B)
(C)
(iii)
(A)
(B)
(
(
(C)
(
(
(D)
(3)
(ii)
(4)
(A)
(B)
(C)
(D)
(E)
(ii)
(A)
(B)
(d)
(1)
(2)
(3)
(i) Strain of laboratory animals.
(ii) Chemical characterization of the test substances, including:
(A) For the radiolabeled test substances, information on the sites and degree of radiolabeling, including type of label, specific activity, chemical purity prior to mixing with the unlabeled hexane mixture, and radiochemical purity.
(B) For the unlabeled test substance, information on lot number and the percentage of MCP and
(C) Results of chromatography.
(iii) A full description of the sensitivity, precision, and accuracy of all procedures used to obtain the data.
(iv) Percent and rate of absorption of the test substance after inhalation and dermal exposures.
(v) Quantity and percent recovery of radioactivity in feces, urine, expired air, and blood. For dermal studies, include recovery data for skin and residual radioactivity in the covering apparatus.
(vi) Tissue distribution reported as quantity of radioactivity in blood, in various tissues including bone, brain, fat, gastrointestinal tract, gonads, heart, kidney, liver, lung, muscle, skin, spleen, thymus, and in residual carcass.
(vii) Biotransformation pathways, to the extent possible, and quantities of the test substances and metabolites in excreta collected after administering single high and low doses.
(viii) Biotransformation pathways, to the extent possible, and quantities of test substances and metabolites in excreta collected after administering repeated low doses.
(ix) Pharmacokinetics models to the extent they can be developed from the experimental data.
(a)
(b)
(c)
(ii)
(iii)
(iv)
(A) On day 4 after birth, the size of each litter should be adjusted by eliminating extra pups by random selection to yield, as nearly as possible, 4 males and 4 females per litter. Whenever the number of male or female pups prevents having 4 of each sex per litter, partial adjustment (for example, 5 males and 3 females) is permitted. Adjustments are not appropriate for litters of less than 8 pups. Elimination of runts only is not appropriate. Individual pups should be identified uniquely after standardization of litters. A method that may be used can be found in Adams et al. (1985) under paragraph (e)(1) of this section.
(B) After standardization of litters, males and females shall be randomly assigned to one of each of three behavioral tasks. Alternatively, more than one of the behavioral tasks may be conducted in the same animal. In the
(C) One male and one female shall be randomly selected from each litter for sacrifice at weaning as specified in paragraph (c)(8) of this section.
(2)
(3)
(ii) If the substance has been shown to be developmentally toxic either in a standard developmental toxicity study or a pilot study, the highest dose level shall be the maximum dose which will not induce
(iii) In the absence of standard developmental toxicity, unless limited by the physicochemical nature or biologicial properties of the substance, the highest dose level shall induce some overt maternal toxicity but shall not result in a reduction in weight gain exceeding 20 percent during gestation and lactation.
(iv) The lowest dose should not produce any grossly observable evidence of either maternal or developmental neurotoxicity.
(v) The intermediate dose(s) shall be equally spaced between the highest and lowest dose.
(4)
(5)
(6)
(ii) During the treatment and observation periods, cage-side observations shall include:
(A) Any responses with respect to body position, activity level, coordination of movement, and gait.
(B) Any unusual or bizarre behavior including, but not limited to headflicking, head searching, compulsive biting or licking, self-mutilation, circling, and walking backwards.
(C) The presence of:
(
(
(
(
(
(
(
(
(
(
(iii) Signs of toxicity shall be recorded as they are observed, including the time of onset, the degree and duration.
(iv) Animals shall be weighed at least weekly.
(v) The day of delivery of litters shall be recorded.
(7)
(B) All offspring shall be examined outside the cage for gross signs of toxicity whenever they are weighed or removed from their cages for behavioral testing. The offspring shall be observed by trained technicians, who are blind with respect to the animal's treatment
(C) Any gross signs of toxicity in the offspring shall be recorded as they are observed, including the time of onset, the degree, and duration.
(ii)
(A)
(B)
(iii)
(B) Each animal shall be tested individually. The test session shall be long enough to demonstrate habituation of motor activity in control animals, i.e., to approach asymptotic levels by the last 20 percent of the session. Animals' activity counts shall be collected in equal time periods of no greater than 10 minutes duration. All sessions shall have the same duration. Treatment groups shall be counter-balanced across test times.
(C) Efforts shall be made to ensure that variations in the test conditions are minimal and are not systematically related to treatment. Among the variables which can affect motor activity are sound level, size, and shape of the test cage, temperature, relative humidity, lighting conditions, odors, use of home cage or novel test cage, and environmental distractions.
(D) Additional information on the conduct of a motor activity study may be obtained in the TSCA motor activity guideline, in § 798.6200 of this chapter.
(iv)
(v)
(A) Mean number of shuttles during the adaptation period preceding each daily session.
(B) Mean number and latency of avoidances per session, presented in blocks of 10 trials (2 blocks of 10 trials per session across 5 sessions).
(C) Mean number and latency of escapes per session, presented in blocks of 10 trials as above.
(D) Mean duration of shocks per session, presented in blocks of 10 trials as above.
(E) Mean number of shuttles during the inter-trial intervals.
(8)
(ii)
(A)
(B)
(C)
(iii)
(d)
(1)
(ii) Positive control data from the laboratory performing the test that demonstrate the sensitivity of the procedures being used. These data do not have to be from studies using prenatal exposures. However, the laboratory must demonstrate competence in testing neonatal animals perinatally exposed to chemicals and establish test norms for the appropriate age group.
(iii) Procedures for calibrating and assuring the equivalence of devices and balancing treatment groups.
(iv) A short justification explaining any decisions where professional judgement is involved such as fixation technique and choice of stains.
(2)
(i) In tabular form, data for each animal shall be provided showing:
(A) Its identification number and litter from which it came.
(B) Its body weight and score on each developmental landmark at each observation time; total session activity counts and intrasession subtotals on each day measured; auditory startle response magnitude session counts and intrasession subtotals on each day measured; avoidance session counts and intrasession counts on each day measured; time and cause of death (if appropriate); locations, nature or frequency, and severity of the lesions; total brain weight; absolute weight of each of the four sections; and weight of each section as a percentage of total brain weight. A commonly used scale such as 1+, 2+, 3+, and 4+ for degree of severity of lesions ranging from very slight to extensive may be used for morphologic evaluation. Any diagnoses derived from neurologic signs and lesions, including naturally occurring diseases or conditions, shall also be recorded.
(ii) Summary data for each group shall include:
(A) The number of animals at the start of the test.
(B) Body weights of the dams during gestation and lactation.
(C) Litter size and mean weight at birth.
(D) The number of animals showing each observation score at each observation time.
(E) The percentage of animals showing each abnormal sign at each observation time.
(F) The mean and standard deviation for each continuous end point at each observation time. These will include body weight, motor activity counts, acoustic startle responses, performance in active avoidance tests, and brain weights (both absolute and relative).
(G) The number of animals in which any lesion was found.
(H) The number of animals affected by each different type of lesion, the average grade of each type of lesion, and the frequency of each different type and/or location of lesions.
(3)
(e)
(1) Adams, J., Buelke-Sam, J., Kimmel, C.A., Nelson, C.J., Reiter, L.W., Sobotka, T.J., Tilson, H.A., and Nelson, B.K. “Collaborative behavioral teratology study: Protocol design and testing procedure.”
(2) Brush, F.R. “The effects of inter-trial interval on avoidance learning in the rat.”
(3) Brush, F.R. “Retention of aversively motivated behavior.” In: “Adverse Conditioning and Learning.” Brush, F.R., ed., New York: Academic Press. (1971).
(4) Brush, F.R. and Knaff, P.R. “A device for detecting and controlling automatic programming of avoidance-conditioning in a shuttle-box.”
(5) Dixon, W.J. and Massey, E.J. “Introduction to Statistical Analysis.” 2nd ed. New York: McGraw-Hill. (1957).
(6) Glowinski, J. and Iversen, L.L. “Regional studies of catecholamines in the rat brain-I.”
(7) Ison, J.R. “Reflex modification as an objective test for sensory processing following toxicant exposure.”
(8) Jensen, D.R. “Some simultaneous multivariate procedures using Hotel-ling's T2 Statistics.”
(9) McAllister, W.R. and McAllister, D.E. “Behavioral measurement of conditioned fear.” In: “Adverse Conditioning and Learning.” Brush, F.R., ed., New York: Academic Press (1971).
(10) Neter, J. and Wasserman, W. “Applied Linear Statistical Models.” Homewood: Richard D. Irwin, Inc. (1974).
(11) Sokal, R.P. and Rohlf, E.J. “Biometry.” San Francisco: W.H. Freeman and Co. (1969).
(12) Spencer, P.S., Bischoff, M.C., and Schaumburg, H.H., “Neuropathological methods for the detection of neurotoxic disease.” In: “Experimental and Clinical Neurotoxicology.” Spencer, P.S. and Schaumburg, H.H., eds., Baltimore, MD: Williams & Wilkins, pp. 743-757. (1980).
15 U.S.C. 2603.
(a)
(ii) Structural formula.
(2)
(b)
(B) Degradation will depend upon the total energy absorbed in specific wavelength regions. Such energy absorption is characterized by both molar absorption coefficient (molar extinction coefficient) and band width. However, the absence of measurable absorption does not preclude the possibility of photodegradation.
(ii)
(iii)
(B) Reference compounds appropriate for the calibration of the system are:
(
(
(
(iv)
(v)
(B) In the event that a recording double-beam instrument is not available, it will be necessary to determine the absorbance of the test solution in a single-beam instrument at 5-nm intervals over the entire wavelength range and at 1-nm intervals where there are indicated absorbance maxima. Wavelength and absorbance tests should be done as with the double-beam instrument.
(2)
(
(
(
(B)
(C)
(ii)
(c)
(ii) For each peak which is capable of being resolved, either as recorded or by extrapolated symmetrical peaks, the bandwidth should be recorded.
(2)
(ii) For each maximum in each spectrum, the ε value and bandwidth (when applicable) should be calculated and reported, along with the wavelength of the maximum. This should be presented in tabular form.
(iii) The various test conditions should be included, such as scan speed, the name and model of the spectrophotom-eter, the slit width (where available), cell type and path length, the concentrations of the test substance, and the nature and acidity of the solvent medium. A recent test spectrum on appropriate reference materials for photometric and wavelength accuracy should also be submitted (see Reproducibility and sensitivity).
(d)
(1) Milazzo, G., Caroli, S., Palumbo-Doretti, M., Violante, N.,
(2) Katelaar, J.A.A.,
(3) Chemical Rubber Company,
(a)
(ii) Chemicals with relatively low vapor pressures, high adsorptivity onto solids, or high solubility in water are less likely to vaporize and become airborne than chemicals with high vapor pressures or with low water solubility or low adsorptivity to solids and sediments. In addition, chemicals that are likely to be gases at ambient temperatures and which have low water solubility and low adsorptive tendencies are less likely to transport and persist in soils and water. Such chemicals are less likely to biodegrade or hydrolyze and are prime candidates for atmospheric oxidation and photolysis (e.g., smog formation or stratospheric alterations). On the other hand, nonvolatile chemicals are less frequently involved in atmosphere transport, so that concerns regarding them should focus on soils and water.
(iii) Vapor pressure data are an important consideration in the design of other chemical fate and effects tests; for example, in preventing or accounting for the loss of violatile chemicals during the course of the test.
(2)
(ii) “Pascal” (Pa) is the standard international unit of vapor pressure and is defined as newtons per square meter (N/m
(iii) The “torr” is a unit of pressure which equals 133.3 pascals or 1 mm Hg at 0 °C.
(iv) “Vapor pressure” is the pressure at which a liquid or solid is in equilibrium with its vapor at a given temperature.
(v) “Volatilization” is the loss of a substance to the air from a surface or from solution by evaporation.
(3)
(ii) Gas saturation (or transpiration) procedures use a current of inert gas passed through or over the test material slowly enough to ensure saturation and subsequent analysis of either the loss of material or the amount (and sometimes kind) of vapor generated. Gas saturation procedures have been described by Spencer and Cliath (1969) under paragraph (d)(2) of this section. Results are easy to obtain and can be quite precise. The same procedures also can be used to study volatilization from laboratory scale environmental simulations. Vapor pressure is computed on the assumption that the total pressure of a mixture of gases is equal to the sum of the pressures of the separate or component gases and that the ideal gas law is obeyed. The partial pressure of the vapor under study can be calculated from the total gas volume and the weight of the material vaporized. If v is the volume which contains w grams of the vaporized material having a molecular weight M, and if p is the pressure of the vapor in equilibrium at temperature T (K), then the vapor pressure, p, of the sample is calculated by
(iii) In an effort to improve upon the procedure described by Spencer and Cliath (1969) under paragraph (d)(2) of this section, and to determine the applicability of the gas saturation method to a wide variety of chemical types and structures, EPA has sponsored research and development work at SRI International (EPA 1982) under paragraph (d)(1) of this section. The procedures described in this Test Guideline are those developed under that contract and have been evaluated with a wide variety of chemicals of differing structure and vapor pressures.
(4)
(ii) With respect to the isoteniscope method, if compounds that boil close to or form azeotropes with the test material are present, it is necessary to remove the interfering compounds and use pure test material. Impurities more volatile than the sample will tend to increase the observed vapor pressure above its true value but the purification steps will tend to remove these impurities. Soluble, nonvolatile impurities will decrease the apparent vapor pressure. However, because the iso-teni-scope procedure is a static, fixed-volume method in which an insignificant fraction of the liquid sample is vaporized, it is subject to only slight error for samples containing non-vola-tile impurities. That is, the non-vola-tile impurities will not be concentrated due to vaporization of the sample.
(iii) The gas saturation method is applicable to solid or liquid chemicals. Since the vapor pressure measurements are made at ambient temperatures, the need to extrapolate data from high temperatures is not necessary and high temperature extrapolation, which can often cause serious errors, is avoided. The method is most reliable for vapor pressures below 10
(b)
(ii) The apparatus used in the gas saturation method is described in paragraph (b)(2)(ii) of this section.
(2)
(ii)
p=(w/M)(RT/v).
(B) Solid samples are loaded into 5 mm i.d. glass tubing between glass wool plugs. The following Figure 2 depicts a drawing of a sample holder and absorber system.
(C) Liquid samples are contained in a holder as shown in the following Figure 3.
(D) At very low vapor pressures and sorbent loadings, adsorption of the chemical on the glass wool separating the sample and the sorbent and on the glass surfaces may be a serious problem. Therefore, very low loadings should be avoided whenever possible. Incoming nitrogen gas (containing no interfering impurities) passes through a coarse frit and bubbles through a 38 cm column of liquid sample. The stream passes through a glass wool column to trap aerosols and then through a sorbent tube, as described above. The pressure drop across the glass wool column and the sorbent tube are negligible.
(E) With both solid and liquid samples, at the end of the sampling time, the front and backup sorbent sections are analyzed separately. The compound on each section is desorbed by adding the sorbent from that section to 1.0 ml of desorption solvent in a small vial and allowing the mixture to stand at a suitable temperature until no more test compound desorbs. It is extremely important that the desorption solvent contain no impurities which would interfere with the analytical method of choice. The resulting solutions are analyzed quantitatively by a suitable analytical method to determine the weight of sample desorbed from each section. The choice of the analytical method,
(F) Measure the desorption efficiency for every combination of sample, sorbent, and solvent used. The desorption efficiency is determined by injecting a known mass of sample onto a sorbent and later desorbing it and analyzing for the mass recovered. For each combination of sample, sorbent, and solvent used, carry out the determination in triplicate at each of three concentrations. Desorption efficiency may vary with the concentration of the actual sample and it is important to measure the efficiency at or near the concentration of sample under gas saturation test procedure conditions.
(G) To assure that the gas is indeed saturated with test compound vapor, sample each compound at three differing gas flow rates. Appropriate flow rates will depend on the test compound and test temperature. If the calculated vapor pressure shows no dependence on flow rate, then the gas is assumed to be saturated.
(c)
(2) Provide a description of analytical methods used to analyze for the test material and all analytical results.
(3) For the isoteniscope procedure, include the plot of p vs. the reciprocal of the temperature in K, developed during the degasing step and showing linearity in the region of 298.15 K (25 °C) and any other required test temperatures.
(4) For the gas saturation procedure, include the data on the calculation of vapor pressure at three or more gas flow rates at each test temperature, showing no dependence on flow rate. Include a description of sorbents and solvents employed and the desorption efficiency calculations.
(5) Provide a description of any difficulties experienced or any other pertinent information.
(d)
(1) U.S. Environmental Protection Agency.
(2) Spencer, W.F. and Cliath, M.M. “Vapor Density of Dieldrin,”
(3) Spencer, W.F. and Cliath, M.M. “Vapor Density and Apparent Vapor Pressure of Lindane,”
(a)
(2)
(ii) “Clay mineral analysis” is the estimation or determination of the kinds of clay-size minerals and the amount present in a sediment or soil.
(iii) “Organic matter” is the organic fraction of the sediment or soil; it includes plant and animal residues at various stages of decomposition, cells and tissues of soil organisms, and substances synthesized by the microbial population.
(iv) “Particle size analysis” is the determination of the various amounts of the different particle sizes in a sample (i.e., sand, silt, clay), usually by sedimentation, sieving, micrometry, or combinations of these methods. The names and diameter range commonly used in the United States are:
(v) The “pH” of a sediment or soil is the negative logarithm to the base ten of the hydrogen ion activity of the sediment or soil suspension. It is usually measured by a suitable sensing electrode coupled with a suitable reference electrode at a 1/1 solid/solution ratio by weight.
(vi) The adsorption ratio, “K
(vii) “Sediment” is the unconsolidated inorganic and organic material that is suspended in and being transported by surface water, or has settled out and has deposited into beds.
(viii) “Soil” is the unconsolidated mineral material on the immediate surface of the earth that serves as a natural medium for the growth of land plants. Its formation and properties are determined by various factors such as parent material, climate, macro- and microorganisms, topography, and time.
(ix) “Soil aggregate” is the combination or arrangement of soil separates (sand, silt, clay) into secondary units. These units may be arranged in the soil profile in a distinctive characteristic pattern that can be classified according to size, shape, and degree of distinctness into classes, types, and grades.
(x) “Soil classification” is the systematic arrangement of soils into groups or categories. Broad groupings are based on general soil characteristics while subdivisions are based on more detailed differences in specific properties. The soil classification system used in this standard and the one used today in the United States is the 7th Approximation-Comprehensive System. The ranking of subdivisions under this system is: Order, Suborder, Great group, family, and series.
(xi) A “soil horizon” is a layer of soil approximately parallel to the land surface. Adjacent layers differ in physical, chemical, and biological properties such as color, structure, texture, consistency, kinds and numbers of organisms present, and degree of acidity or alkalinity.
(xii) “Soil Order” is the broadest category of soil classification and is based on the general similarities of soil physical/chemical properties. The formation of soil by similar general genetic processes causes these similarities. The Soil Orders found in the United States are: Alfisol, Aridisol, Entisol, Histosol, Inceptisol, Mollisol, Oxisol, Spodosol, Ultisol, and Vertisol.
(xiii) “Soil series” is the basic unit of soil classification and is a subdivision of a family. A series consists of soils that were developed under comparable climatic and vegetational conditions. The soils comprising a series are essentially alike in all major profile characteristics except for the texture of the “A” horizon (i.e., the surface layer of soil).
(xiv) “Soil texture” is a classification of soils that is based on the relative proportions of the various soil separates present. The soil textural classes are: clay, sandy clay, silty clay, clay loam, silty clay loam, sandy clay loam, loam, silt loam, silt, sandy loam, loamy sand, and sand.
(3)
(ii) In order to estimate the environmental movement of the test chemical, the values K and l/n are compared with the values of other chemicals whose behavior in soil and sediment systems is well-documented in scientific literature.
(iii) The adsorption isotherm (AI) test has many desirable features. First, adsorption results are highly reproducible. The test provides excellent quantitative data readily amenable to statistical analyses. Also, it has relatively modest requirements for chemicals, soils, laboratory space, and equipment. It allows solution phase organic chemical determinations that are relatively uncomplicated. A chemical extraction-mass balance procedure to elicit information on chemical transformations occurring at colloid interfaces can be incorporated into this test. The ease of performing the isotherm test and mass balance will depend upon the physical/chemical properties of the test chemical and the availability of suitable analytical techniques to measure the chemical.
(iv) The papers by Aharonson and Kafkafi (1975) under paragraph (d)(1) of this section, Harvey (1974) under paragraph (d)(3) of this section, Murray (1975) under paragraph (d)(4) of this section, Saltzman (1972) under paragraph (d)(5) of this section, Weber (1971) under paragraph (d)(6) of this section, and Wu (1975) under paragraph (d)(7) of this section served as the basis for this section. The soil and colloid chemistry literature and the analytical chemistry literature substantiate the experimental conditions and procedures specified in this guideline as accepted, standard procedures.
(4)
(b)
(B) Containers shall be composed of material that (
(C) A 150 micron (100 mesh) stainless-steel or brass sieve.
(D) Drying oven, with circulating air, that can attain 100 °C.
(E) Vortex mixer or a comparable device.
(F) Rotary shaker or a comparable device.
(G) High speed temperature-controlled centrifuge capable of sedimenting particles greater than 0.5 micron from aqueous solution.
(ii)
(iii)
(iv)
(A) Decrease the water content, air or oven-dry soils at or below 50 °C.
(B) Reduce aggregate size before and during sieving, crush and grind dried soil very gently.
(C) Eliminate microbial growth during the test period using a chemical or physical treatment that does not alter or minimally alters the soil surface properties.
(D) Sieve soils with a 100 mesh stainless-steel or brass sieve.
(E) Store all solutions and soils at temperatures between 0 and 5 °C.
(v)
(A) Decrease the H
(B) Eliminate microbial growth during the test period by using a chemical and/or physical treatment that does not alter or minimally alters the colloid surface's properties.
(C) Store at temperatures between 0 and 5°C.
(vi)
(vii)
(A) Equilibrate one solution containing a known concentration of the test chemical with the sediment or soil in a solid/solution ratio equal to or greater than
(B) Measure the concentration of the chemical in the solution phase at frequent intervals during the equilibration period.
(C) Determine the equilibration time by plotting the measured concentration versus time of sampling; the equilibration time is the minimum period of time needed to establish a rate of change of solution concentration of 5 percent or less per 24 hours.
(viii)
(ix)
(x)
(2)
(A) Immediately after the solutions are added to the solids, tightly cap the containers and vigorously agitate them for several minutes with a vortex mixture or similar device.
(B) Shake the containers throughout the equilibration period at a rate that suspends all solids in the solution phase.
(ii)
(iii)
(B) Extract the chemical adsorbed on the sediment or soil colloid surfaces with solvent.
(iv)
(c)
(1) Temperature at which the test was conducted.
(2) Detailed description of the analytical technique(s) used in the chemical extraction, recovery, and quantitative analysis of the parent chemical.
(3) Amount of parent test chemical applied, the amount recovered, and the percent recovered.
(4) Extent of adsorption by containers and the approach used to correct the data for adsorption by containers.
(5) The individual observations, the mean values, and graphical plots of x/m as a function of C
(6) The quantities K, n, and l/n.
(7) Soil information: Soil Order, series, texture, sampling location, horizon, general clay fraction mineralogy.
(8) Sediment information: sampling location, general clay fraction mineralogy.
(9) Sediment and soil physical-chemical properties: percent sand, silt, and clay (particle size analysis); percent organic matter; pH (1/1 solids/H
(10) The procedures used to determine the physical/chemical properties listed under paragraphs (c) (7) through (9) of this section.
(d)
(1) Aharonson, N., Kafkafi, U. “Adsorption, mobility and persistence of thiabendazole and methyl 2-benzimidasole carbamate in soils,”
(2) Goring, C.A.I., Hamaker, J.W., (eds).
(3) Harvey, R.G. et al. “Soil adsorption and volatility of dinitroaniline herbicides,”
(4) Murray, D.S. et al. “Comparative adsorption, desorption, and mobility of dipropetryn and prometryn in soil,”
(5) Saltzman, S.L. et al. “Adsorption, desorption of parathion as affected by soil organic matter,”
(6) Weber, J.B. “Model soil system, herbicide leaching, and sorption,”
(7) Wu, C.H., et al. “Napropamide adsorption, desorption, and movement in soils,”
(a)
(ii) On the contrary, a low biodegradation result may have other causes than poor biodegradability of the test substance. Inhibition of the microbial inoculum by the test substance at the test concentration may be observed. In such cases, further work is needed to assess the aerobic aquatic bio-degrad-ability and to determine the concentrations at which toxic effects are evident. An estimate of the expected environmental concentration will help to put toxic effects into perspective.
(2)
(ii) “Ultimate Biodegradability” is the breakdown of an organic compound to CO
(iii) “Ready Biodegradability” is an expression used to describe those substances which, in certain bio-de-grada-tion test procedures, produce positive results that are unequivocal and which lead to the reasonable assumption that the substance will undergo rapid and ultimate bio-de-grada-tion in aerobic aquatic environments.
(3)
(4)
(5)
(ii) Information on the toxicity of the chemical may be useful in the interpretation of low results and in the selection of appropriate test concentrations.
(6)
(7)
(8)
(9)
(10)
(b)
(ii)
(B) Yeast extract.
(C) Vitamin-free casamino acids.
(D) 70 percent O
(E) 0.2N Ba(OH)
(F) 0.1 N HCl.
(G) 20 percent H
(H) Phenolphthalein.
(I) Dilution water—distilled, deionized water (DIW).
(iii)
(iv)
(2)
(ii) For each set of experiments, each test substance shall be tested in triplicate.
(iii) For each set of experiments, one or two reference compounds are included to assess the microbial activity of the test medium. Duplicate reference flasks are prepared by adding reference compound equivalent to 10 mg/liter carbon to each of two flasks containing the test medium. Reference compounds which are positive for ultimate biodegradability include: sodium citrate, dextrose, phthalic acid, tri-mel-litic acid, and aniline.
(iv) For each test set, triplicate controls receiving inoculated medium and no test compound, plus all test and reference flasks, are analyzed for CO
(v) A test system containing a growth inhibitor should be established as a control for each substance tested for biodegradation by this method. That inhibited system must contain the same amount of water, mineral nutrients, inoculum, and test substance used in the uninhibited test systems, plus 50 mg/L mercuric chloride (HgCl
(vi) Flasks shall be incubated in the dark to minimize both photochemical reactions and algal growth. Appropriate sterile controls or controls containing a metabolic inhibitor, such as 50 mg/1 HgCl
(3)
(c)
100 (for 10 mg/L test compound carbon)
(ii) The cumulative percent CO
(iii) The percent DOC disappearance from the test compound is calculated from the following equation:
(iv) The difference between the amount of 0.1 N HCl used for the Ba(OH)
(v) CO
(vi) Inhibition by the test compound is indicated by lower CO
(vii) The use of
(2)
(ii) Information on the inoculum, including source, collection date, handling, storage and adaptation possibilities (i.e., that the inoculum might have been exposed to the test substance either before or after collection and prior to use in the test).
(iii) Results from each test, reference, inhibited (with HgCl
(iv) Average cumulative percent theoretical CO
(v) Dissolved organic carbon due to test compound at each sampling time (DTF-DCF).
(vi) Average percent DOC removal at each sampling time.
(vii) Twenty-eight day standard deviation for percent CO
(d)
(1) Gledhill, W.E. “Screening Test for Assessment of Ultimate Bio-de-grada-bility: Linear Alkyl Benzene Sulfonate,”
(2) Pramer, D., Bartha, R. ‘'Preparation and Processing of Soil Samples for Biodegradation Testing,”
(a)
(ii) Since hydrolysis can be such an important degradation path for certain classes of chemicals, it is necessary, in assessing the fate of these chemicals in the environment, to know whether, at what rate, and under what conditions a substance will hydrolyze. Some of these reactions can occur so rapidly that there may be greater concern about the products of the transformation than about the parent compounds. In other cases, a substance will be resistant to hydrolysis under typical environmental conditions, while, in still other instances, the substance may have an intermediate stability that can result in the necessity for an assessment of both the original compound and its transformation products. The importance of transformation of chemicals via hydrolysis in aqueous media in the environment can be determined quantitatively from data on hydrolysis rate constants. This hydrolysis Test Guideline represents a test to allow one to determine rates of hydrolysis at any pH of environmental concern at 25°C.
(2)
(ii) “Elimination” is defined in this Test Guideline to be a reaction of an organic chemical (RX) in water in which the X group is lost. These reactions generally follow the same type of rate laws that hydrolysis reactions follow and, thus, are also covered in this Test Guideline.
(iii) A “first-order reaction” is defined as a reaction in which the rate of disappearance of the chemical substance being tested is directly proportional to the concentration of the chemical substance and is not a function of the concentrations of any other substances present in the reaction mixture.
(iv) The “half-life” of a chemical is defined as the time required for the concentration of the chemical substance being tested to be reduced to one-half its initial value.
(v) “Hydrolysis” refers to a reaction of an organic chemical with water such that one or more bonds are broken and the reaction products incorporate the elements of water (H
(A) Another result of hydrolysis can be the incorporation of both H and OH in a single product. An example of this is the hydrolysis of epoxides, which can be represented by
(B) The hydrolysis reaction can be catalyzed by acidic or basic species, including OH
(C) At a given pH, Equation 2 under paragraph (a)(2)(v)(B) of this section contains three unknowns, k
(D) The equations under paragraph (a)(2) of this section apply whether the test chemical has one or more hydrolyzable groups. In the latter case, the rate may be written as:
(3)
(4)
(b)
(B) A pH meter that can resolve differences of 0.05 pH units or less.
(C) Stoppered volumetric flasks (no grease) or glass ampoules that can be sealed.
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
(viii)
(ix)
(x)
(xi)
(2)
(
(
(
(B)
(
(
(
(
(C)
(
(D)
(
(3)
(i)
(ii)
(iii)
(B) If the pH at the end of concentration measurements employing any of the above three procedures has changed by more than 0.05 units from the initial pH, repeat the experiment using a solution having a test chemical concentration lowered sufficiently to keep the pH variation within 0.05 pH units.
(iv)
(c)
(ii) If Procedure 3 was employed in making rate measurements, use the mean initial concentration (C
(iii) For each set of three concentration replicates, calculate the mean value of C and the standard deviation.
(iv) For test chemicals that are not ionized or protonated between pH 3 and 11, calculate k
(2)
(ii) If extraction methods were used to separate the solute from the aqueous solution, provide a description of the extraction method as well as the recovery data.
(3)
(ii) For Procedure 3, report k
(iii) If, after 672 hours, the concentration (C) is the same as the initial concentration (C
15 U.S.C. 2603.
(a)
(b)
(1)
(2)
(3)
(4)
(5)
(c)
(ii) At the end of 96 hours enumerate the algal cells in all containers to determine inhibition or stimulation of growth in test containers compared to controls. Use data to define the concentration-response curve, and calculate the EC
(2) [Reserved]
(3)
(A) If definitive testing is necessary.
(B) Test chemical concentrations for the definitive test.
(ii) Algae are exposed to a widely spaced (e.g., log interval) chemical concentration series. The lowest value in the series, exclusive of controls, should be at the chemical's detection limit. The upper value, for water soluble compounds, should be the saturation concentration. No replicates are required; and nominal concentrations of the chemical are acceptable unless definitive testing is not required.
(iii) The test is performed once for each of the recommended algal species or selected alternates. Test chambers should contain equal volumes of test solution and approximately 1×10
(iv) Definitive testing is not necessary if the highest chemical concentration tested (water saturation concentration or 1000 mg/l) results in less than a 50 percent reduction in growth or if the lowest concentration tested (analytical detection limit) results in greater than a 50 percent reduction in growth.
(4)
(ii) Algae should be exposed to five or more concentrations of the test chemical in a geometric series in which the ratio is between 1.5 and 2.0 (e.g., 2, 4, 8, 16, 32, and 64 mg/l). Algae shall be placed in a minimum of three replicate test containers for each concentration of test chemical and control. More than three replicates may be required to provide sufficient quantities of test solution for determination of test substance concentration at the end of the test. Each test chamber should contain equal volumes of test solution and approximately 1×10
(iii) Every test shall include a control consisting of the same nutrient medium, conditions, procedures, and
(iv) The test begins when algae from 5- to 10-day-old stock cultures are placed in the test chambers containing test solutions having the appropriate concentrations of the test substance. Algal growth in controls should reach the logarithmic growth phase by 96 hours. If logarithmic growth cannot be demonstrated, the test shall be repeated. At the end of 24, 48, 72, and 96 hours the algal growth response (number or weight of algal cells/ml) in all test containers and controls shall be determined by an indirect (spec-tro-pho-tom-etry, electronic cell counters, dry weight, etc.) or a direct (actual microscopic cell count) method. Indirect methods shall be calibrated by a direct microscopic count. The percentage inhibition or stimulation of growth for each concentration, EC
(v) At the end of the definitive test, the following additional analyses of algal growth response shall be performed:
(A) Determine whether the altered growth response between controls and test algae was due to a change in relative cell numbers, cell sizes or both. Also note any unusual cell shapes, color differences, flocculations, adherence of algae to test containers, or aggregation of algal cells.
(B) In test concentrations where growth is maximally inhibited, algistatic effects may be differentiated from algicidal effects by the following two methods for
(
(
(5) [Reserved]
(6)
(B) At the end of the test and after aliquots have been removed for algal growth-response determinations, microscopic examination, mortal staining, or subculturing, the replicate test containers for each chemical concentration may be pooled into one sample. An aliquot of the pooled sample may then be taken and the concentration of test chemical determined. In addition, the concentration of test chemical associated with the algae alone should be determined. Separate and concentrate the algal cells from
(ii)
(d)
(2)
(B) Disposal facilities should be adequate to accommodate spent glassware, algae and test solutions at the end of the test and any bench covering, lab clothing, or other contaminated materials.
(ii)
(iii)
(iv)
(v)
(B) Dilution water used for preparation of nutrient medium and test solutions should be filtered, deionized or glass distilled. Saltwater for marine algal nutrient medium and test solutions should be prepared by adding a commercial, synthetic, sea salt formulation or a modified synthetic seawater formulation to distilled/deionized water to a concentration of 30 parts per thousand.
(vi)
(3)
(ii) Test chambers containing
(iii) Stock algal cultures should be shaken twice daily by hand. Test containers shall be placed on a rotary shaking apparatus and oscillated at approximately 100 cycles/minute for
(iv) The pH of nutrient medium in which algae are subcultured shall be 7.5 (±0.1) for
(v) Light intensity shall be monitored at least daily during the test at the level of the test solution.
(e)
(1) Detailed information about the test organisms, including the scientific name, method of verification, and source.
(2) A description of the test chambers and containers, the volumes of solution in the containers, the way the test was begun (e.g., conditioning, test substance additions, etc.), the number of replicates, the temperature, the lighting, and method of incubation, oscillation rates, and type of apparatus.
(3) The concentration of the test chemical in the control and in each treatment at the end of the test and the pH of the solutions.
(4) The number of algal cells per milliliter in each treatment and control and the method used to derive these values at the beginning, 24, 48, and 72 hours, and end of the test; the percentage of inhibition or stimulation of growth relative to controls; and other adverse effect in the control and in each treatment.
(5) The 96-hour EC
(6) Methods and data records of all chemical analyses of water quality and test substance concentrations, including method validations and reagent blanks.
(7) The results of any optional analyses such as: Microscopic appearance of algae, size or color changes, percent mortality of cells and the fate of subcultured cells, the concentration of test substance associated with algae and test solution supernate or filtrate.
(8) If the range-finding test showed that the highest concentration of the chemical tested (not less than 1000 mg/l or saturation concentration) had no effect on the algae, report the results and concentration and a statement that the chemical is of minimum phytotoxic concern.
(9) If the range-finding test showed greater than a 50 percent inhibition of algal growth at a test concentration below the analytical detection limit, report the results, concentration, and a statement that the chemical is phytotoxic below the analytical detection limit.
(a)
(b)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(c)
(ii) Dissolved oxygen concentration, pH, temperature, the concentration of test chemical and other water quality parameters are measured at specified intervals in selected test chambers. Data are collected during the test to develop concentration-response curves and determine EC
(2) [Reserved]
(3)
(ii) The daphnids should be exposed to a series of widely spaced concentrations of the test chemical (e.g., 1, 10, 100 mg/1, etc.), usually under static conditions.
(iii) A minimum of five daphnids should be exposed to each concentration of test chemical for a period of 48 hours. The exposure period may be shortened if data suitable for the purpose of the range-finding test can be obtained in less time. No replicates are required and nominal concentrations of the chemical are acceptable.
(4)
(ii) A minimum of 20 daphnids per concentration shall be exposed to five or more concentrations of the chemical chosen in a geometric series in which the ratio is between 1.5 and 2.0 (e.g., 2, 4, 8, 16, 32, and 64 mg/l). An equal number of daphnids shall be placed in two or more replicates. If solvents, solubilizing agents or emulsifiers have to be used, they shall be commonly used carriers and shall not possess a synergistic or antagonistic effect on the toxicity of the test chemical. The concentration of solvent should not exceed 0.1 mg/l. The concentration ranges shall be selected to determine the concentration-response curves and EC
(iii) Every test shall include controls consisting of the same dilution water, conditions, procedures and daphnids from the same population (culture container), except that none of the chemical is added.
(iv) The dissolved oxygen concentration, temperature and pH shall be measured at the beginning and end of the test in each chamber.
(v) The test duration is 48 hours. The test is unacceptable if more than 10 percent of the control organisms are immobilized during the 48-hour test period. Each test chamber shall be checked for immobilized daphnids at 24 and 48 hours after the beginning of the test. Concentration-response curves and 24-hour and 48-hour EC
(vi) In addition to immobility, any abnormal behavior or appearance shall also be reported.
(vii) Test organisms shall be impartially distributed among test chambers in such a manner that test results show no significant bias from the distributions. In addition, test chambers within the testing area shall be positioned in a random manner or in a way in which appropriate statistical analyses can be used to determine the variation due to placement.
(viii) The concentration of the test chemical in the chambers should be measured as often as is feasible during the test. In the static test the concentration of test chemical shall be measured, at a minimum, at the beginning of the test and at the end of the test in each test chamber. In the flow-through test the concentration of test chemical shall be measured at a minimum:
(A) In each chamber at the beginning of the test and at 48 hours after the start of the test;
(B) In at least one appropriate chamber whenever a malfunction is detected in any part of the test substance delivery system.
(5) [Reserved]
(6)
(ii)
(d)
(B) Daphnids to be used in acute toxicity tests should be cultured at the
(C) Daphnids shall not be used for a test (
(ii)
(B) During culturing and acclimation to the dilution water, daphnids should be maintained in facilities with background colors and light intensities similar to those of the testing area.
(iii)
(B) Smooth glass tubes (I.D. greater than 5 mm) equipped with rubber bulb should be used for transferring daphnids with minimal culture media carry-over. Care should be exercised to introduce the daphnids below the surface of any solution to avoid trapping air under the carapace.
(iv)
(2)
(B) Facilities should be well ventilated and free of fumes and disturbances that may affect the test organisms.
(C) Test chambers shall be loosely covered to reduce the loss of test solution or dilution water due to evaporation and to minimize the entry of dust or other particulates into the solutions.
(ii)
(B) For static tests, daphnids can be conveniently exposed to the test chemical in 250 ml beakers or other suitable containers.
(C) For flow-through tests, daphnids can be exposed in glass or stainless steel containers with stainless steel or nylon screen bottoms. The containers should be suspended in the test chamber in such a manner to insure that the test solution flows regularly into and out of the container and that the daphnids are always submerged in at least 5 centimeters of test solution. Test chambers can be constructed using 250 ml beakers or other suitable containers equipped with screened overflow holes, standpipes or V-shaped notches.
(iii)
(B) The above water quality parameters under paragraph (d)(2)(iii)(A) of this section shall be measured at least twice a year or whenever it is suspected that these characteristics may have changed significantly. If de-chlo-ri-nated tap water is used, daily chlorine analysis shall be performed.
(C) If the diluent water is from a ground or surface water source, conductivity and total organic carbon (TOC) or chemical oxygen demand (COD) shall be measured. Reconstituted water can be made by adding specific amounts of reagent-grade chemicals to deionized or distilled water. Glass distilled or carbon-filtered de-i-on-ized water with a conductivity less than 1 μohm/cm is acceptable as the diluent for making reconstituted water.
(iv)
(v)
(3)
(i) The test temperature shall be 20 °C. Excursions from the test temperature shall be no greater than ±2 °C.
(ii) Dissolved oxygen concentration between 60 and 105 percent saturation. Aeration, if needed to achieve this level, shall be done before the addition of the test chemical. All treatment and control chambers shall be given the same aeration treatment.
(iii) The number of daphnids placed in a test chamber shall not affect test results. Loading shall not exceed 40 daphnids per liter test solution in the static system. In the flow-through test, loading limits will vary depending on the flow rate of dilution water. Loading shall not cause the dissolved oxygen concentration to fall below the recommended levels.
(iv) Photoperiod of 16 hours light and 8 hours darkness.
(e)
(1) The name of the test, sponsor, testing laboratory, study director, principal investigator, and dates of testing.
(2) A detailed description of the test chemical including its source, lot number, composition (identity and concentration or major ingredients and major impurities), known physical and chemical properties and any carriers or other additives used and their concentrations.
(3) The source of the dilution water, its chemical characteristics (e.g., conductivity, hardness, pH, etc.) and a description of any pretreatment.
(4) Detailed information about the daphnids used as brood stock, including the scientific name and method of
(5) A description of the test chambers, the volume of solution in the chambers, the way the test was begun (e.g., conditioning, test chemical additions), the number of test organisms per test chamber, the number of replicates per treatment, the lighting, the method of test chemical introduction or the test substance delivery system and the flow rate (in flow-through test) expressed as volume additions per 24 hours.
(6) The concentration of the test chemical in each test chamber at times designated for static and flow-through tests.
(7) The number and percentage of organisms that were immobilized or showed any adverse effects in each test chamber at each observation period.
(8) Utilizing the average measured test chemical concentration, concentration-response curves should be fitted to immobilization data at 24 and 48 hours. A statistical test of goodness-of-fit should be performed and the results reported.
(9) The 24- and 48-hour EC
(10) All chemical analyses of water quality and test chemical concentrations, including methods, method validations and reagent blanks.
(11) The data records of the culture, acclimation and test temperatures.
(12) Any deviation from this test guideline and anything unusual about the test, e.g., diluter failure, temperature fluctuations, etc.
(a)
(b)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(c)
(ii) The test is started within 30 minutes after the test substance has been added and uniformly distributed in the test chambers in the renewal test or after the concentration of test substance in each test chamber of the flow-through test system reaches the prescribed level and remains stable. At the initiation of the test, daphnids which have been cultured or acclimated in accordance with the test design, are randomly placed into the test chambers. Daphnids in the test chambers are observed periodically during the test, immobile adults and offspring produced are counted and removed, and the findings are recorded. Dissolved oxygen concentration, pH, temperature, the concentration of test substance, and other water quality parameters are measured at specified intervals in selected test chambers. Data are collected during the test to determine any significant differences (p≦0.05) in immobilization and reproduction as compared to the control.
(2) [Reserved]
(3)
(ii) The daphnids should be exposed to a series of widely spaced concentrations of the test substance (e.g., 1, 10, 100 mg/l), usually under static conditions.
(iii) A minimum of five daphnids should be exposed to each concentration of test substance for a period of time which allows estimation of appropriate chronic test concentrations. No replicates are required and nominal concentrations of the chemical are acceptable.
(4)
(ii) A minimum of 20 daphnids per concentration shall be exposed to five or more concentrations of the chemical chosen in a geometric series in which the ratio is between 1.5 and 2.0 (e.g., 2, 4, 8, 16, 32, 64 mg/l). An equal number of daphnids shall be placed in two or more replicates. The concentration ranges shall be selected to determine the concentration-response curves, EC
(iii) Every test shall include controls consisting of the same dilution water, conditions, procedures and daphnids from the same population (culture container), except that none of the chemical is added.
(iv) The test duration is 21 days. The test is unacceptable if:
(A) More than 20 percent of the control organisms appear to be immobilized, stressed or diseased during the test.
(B) Each control daphnid living the full 21 days produces an average of less than 60 young.
(C) Any ephippia are produced by control animals.
(v) The number of immobilized daphnids in each chamber shall be recorded on day 21 of the test. After offspring are produced, they shall be counted and removed from the test chambers every 2 or 3 days. Concentration-response curves, EC
(vi) In addition to immobility, any abnormal behavior or appearance shall also be reported.
(vii) Test organisms shall be impartially distributed among test chambers in such a manner that test results show
(5) [Reserved]
(6)
(ii)
(d)
(B) First instar daphnids, ≦24 hours old, are to be used to start the test.
(ii)
(B) Daphnids shall not be used for a test if:
(
(
(
(
(
(iii)
(B) The food concentration depends on the type used. Food concentrations should be sufficient to support normal growth and development and to allow for asexual (parthenogenic) reproduction. For automatic feeding devices, a suggested rate is 5 to 7 mg food (either solids or algal cells, dry weight) per liter dilution water or test solution. For manual once-a-day feeding, a suggested rate is 15 mg food (dry weight) per liter dilution water or test solution.
(iv)
(v)
(B) Organisms should be handled as little as possible. When handling is necessary it should be done as gently, carefully, and quickly as possible. During culturing and acclimation, daphnids should be observed carefully for ephippia and other signs of stress, physical damage, and mortality. Dead and abnormal individuals shall be discarded. Organisms that touch dry surfaces or are dropped or injured during handling shall be discarded.
(C) Smooth glass tubes (I.D. greater than 5mm) equipped with a rubber bulb can be used for transferring daphnids with minimal culture media carry-over.
(D) Care should be exercised to introduce the daphnids below the surface of any solution so as not to trap air under the carapace.
(vi)
(B) During culturing and acclimation to the dilution water, daphnids should be maintained in facilities with background colors and light intensities similar to those of the testing area.
(2)
(
(
(
(
(
(
(B) Facilities should be well ventilated and free of fumes and other disturbances that may affect the test organisms.
(ii)
(B) For renewal tests, daphnids can be conveniently exposed to the test solution in 250 ml beakers or other suitable containers.
(C) For flow-through tests daphnids can be exposed in glass or stainless steel containers with stainless steel or nylon screen bottoms. Such containers shall be suspended in the test chamber in such a manner to ensure that the test solution flows regularly into and out of the container and that the daphnids are always submerged in at least 5 centimeters of test solution. Test chambers can be constructed using 250 ml beakers or other suitable containers equipped with screened overflow holes, standpipes or V-shaped notches.
(D) Test chambers shall be loosely covered to reduce the loss of test solution or dilution water due to evaporation and to minimize the entry of dust or other particulates into the solutions.
(iii)
(B) The test substance delivery system shall be calibrated before each test. Calibration includes determining the flow rate through each chamber and the concentration of the test substance in each chamber. The general operation of the test substance delivery system should be checked twice daily during a test. The 24-hour flow rate through a test chamber shall be equal to at least five times the volume
(iv)
(B) The water quality characteristics listed above shall be measured at least twice a year or when it is suspected that these characteristics may have changed significantly. If dechlorinated tap water is used, daily chlorine analysis shall be performed.
(C) If the diluent water is from a ground or surface water source, conductivity and total organic carbon (TOC) or chemical oxygen demand (COD) shall be measured. Reconstituted water can be made by adding specific amounts of reagent-grade chemicals to deionized or distilled water. Glass distilled or carbon filtered deionized water with a conductivity of less than 1 microohm/cm is acceptable as the diluent for making reconstituted water.
(D) If the test substance is not soluble in water an appropriate carrier should be used.
(v)
(3)
(A) The test temperature shall be 20 °C. Excursions from the test temperature shall be no greater than ±2 °C.
(B) Dissolved oxygen concentration between 60 and 105 percent saturation. Aeration, if needed to achieve this level, shall be done before the addition of the test substance. All treatment and control chambers shall be given the same aeration treatment.
(C) Photoperiod of 16-hours light and 8-hours darkness.
(ii) Additional measurements include:
(A) The concentration of the test substance in the chambers shall be measured during the test.
(B) At a minimum, the concentration of test substance should be measured as follows:
(
(
(
(
(C) The dissolved oxygen concentration, temperature and pH shall be measured at the beginning of the test and on days 7, 14, and 21 in at least two chambers of the high, middle, low, and control test concentrations.
(e)
(1) The name of the test, sponsor, testing laboratory, study director, principal investigator, and dates of testing.
(2) A detailed description of the test substance including its source, lot number, composition (identity and concentration of major ingredients and major impurities), known physical and chemical properties, and any carriers or other additives used and their concentrations.
(3) The source of the dilution water, its chemical characteristics (e.g., conductivity, hardness, pH), and a description of any pretreatment.
(4) Detailed information about the daphnids used as brood stock, including the scientific name and method of verification, age, source, treatments, feeding history, acclimation procedures, and culture methods. The age of the daphnids used in the test shall be reported.
(5) A description of the test chambers, the volume of solution in the chambers, the way the test was begun (e.g., conditioning, test substance additions), the number of test organisms per test chamber, the number of replicates per treatment, the lighting, the renewal process and schedule for the renewal chronic test, the test substance delivery system and flow rate expressed as volume additions per 24 hours for the flow-through chronic test, and the method of feeding (manual or continuous) and type of food.
(6) The concentration of the test substance in test chambers at times designated for renewal and flow-through tests.
(7) The number and percentage of organisms that show any adverse effect in each test chamber at each observation period.
(8) The cumulative adult and offspring immobilization values and the progeny produced at designated observation times, the time (days) to first brood and the number of offspring per adult in the control replicates and in each treatment replicate.
(9) All chemical analyses of water quality and test substance concentrations, including methods, method validations and reagent blanks.
(10) The data records of the culture, acclimation, and test temperatures.
(11) Any deviation from this test guideline, and anything unusual about the test, (e.g., dilution failure, temperature fluctuations).
(12) The MATC to be reported is calculated as the geometric mean between the lowest measured test substance concentration that had a significant (p≦0.05) effect and the highest measured test substance concentration that had no significant (p≦0.05) effect on day 21 of the test. The most sensitive of the test criteria (number of adult animals immobilized, the number of young per female and the number of immobilized young per female) is used to calculate the MATC. The criterion selected for MATC computation is the one which exhibits an effect (a statistically significant difference between treatment and control groups; p≦0.05) at the lowest test substance concentration for the shortest period of exposure. Appropriate statistical tests (analysis of variance, mean separation test) shall be used to test for significant test substance effects. The statistical tests employed and the results of these tests shall be reported.
(13) Concentration-response curves utilizing the average measured test substance concentration shall be fitted to cumulative adult immobilization data at 21 days. A statistical test of goodness-of-fit shall be performed and the results reported.
(14) An EC
(a)
(b)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(c)
(ii) The test substance is introduced into each test chamber. In a flow-through test, the amount of test substance which is added to the dilution water is adjusted to establish and maintain the desired concentration of test substance in each test chamber.
(iii) Test fish which have been acclimated in accordance with the test design are introduced into the test and control chambers by stratified random assignment.
(iv) Fish in the test and control chambers are observed periodically during the test; dead fish are removed at least twice each day and the findings are recorded.
(v) The dissolved oxygen concentration, pH, temperature and the concentration of test substance are measured at intervals in selected test chambers.
(vi) Concentration-response curves and LC
(2) [Reserved]
(3)
(4)
(ii) For exposure to each concentration of a test substance, an equal number of test fish shall be placed in two or more replicate test chambers. Test fish
(iii) Every test shall include a control consisting of the same dilution water, conditions, procedures, and fish from the same group used in the test, except that none of the test substance is added.
(iv) Mortality data collected during the test are used to calculate a 96-hour LC
(v) Test fish shall not be fed while they are being exposed to the test substance under static conditions or during the first 96 hours of flow-through testing. If the test continues past 96 hours, the fish should be fed a suitable food at a maintenance level every other day beginning on test day 5. Any excess food and the fecal material should be removed when observed.
(5)
(ii) In addition to death, any abnormal behavior such as, but not limited to, erratic swimming, loss of reflex, increased excitability, lethargy, or any changes in appearance or physiology such as discoloration, excessive mucous production, hyperventilation, opaque eyes, curved spine, or hemorrhaging shall be recorded.
(iii) Observations on compound solubility shall be recorded. The investigator shall report the appearance of surface slicks, precipitates, or material adhering to the sides of the test chamber.
(iv) Each test and control chamber shall be checked for dead fish and observations recorded at 24, 48, 72, and 96 hours after the beginning of the test or within one hour of the designated times. If the test is continued past 96 hours, additional observations shall be made every 24 hours until termination.
(v) The mortality data is used to calculate LC
(vi) A test is unacceptable if more than 10 percent of the control fish die or exhibit abnormal behavior during a 96-hour test. If a flow-through test is continued past 96 hours, the maximum allowable additional mortality is 10 percent.
(6)
(B) During static tests, the dissolved oxygen concentration, temperature, and pH shall be measured in each test chamber at the beginning and end of the test. The test solution volume shall not be reduced by more than 10 percent as a result of these measurements.
(C) During flow-through tests, dissolved oxygen, temperature and pH measurements shall be made in each chamber at the beginning and end of the test.
(ii)
(iii)
(
(
(
(
(B) Filters and their holders used for determining the dissolved test substance concentrations should be prewashed with several volumes of distilled water and undergo a final rinse with test solution. Glass or stainless steel filter holders are best for organic test substances, while plastic holders are best for metals. The sample should be filtered within 30 minutes after it is taken from the test chamber.
(C) The analytical methods used to measure the amount of test substance in a sample shall be validated before beginning the test. The accuracy of a method should be verified by a method such as using known additions. This involves adding a known amount of the test substance to three water samples taken from a chamber containing dilution water and the same number and species of fish as are used in the test. The nominal concentration of the test substance in those samples should span the concentration range to be used in the test.
(D) An analytical method is not acceptable if likely degradation products of the test substance give positive or negative interferences, unless it is shown that such degradation products are not present in the test chambers during the test.
(E) In addition to analyzing samples of test solution, at least one reagent blank, containing all reagents used, should also be analyzed.
(F) If the measured concentrations of dissolved test substance are considerably lower (e.g., <50 percent) than the nominal concentrations, the total test substance concentration should be measured in the highest test concentration.
(G) Among replicate test chambers, the measured concentrations shall not vary more than 20 percent. The measured concentration of the test substance in any chamber during the test should not vary more than 30 percent from the measured concentration at time 0.
(H) The mean measured concentration of test substance shall be used to calculate all LC
(d)
(ii)
(B) All newly acquired fish should be quarantined and observed for at least 14 days prior to use in a test.
(C) Fish shall not be used for a test if they appear stressed or if more than five percent die during the 48 hours immediately prior to the test.
(iii)
(B) During the final 48-hours of acclimation, fish should be maintained in facilities with background colors and light intensities similar to those of the testing area and should not be fed.
(2)
(A) Flow-through tanks for holding and acclimating fish.
(B) A mechanism for controlling and maintaining the water temperature
(C) Apparatus for straining particulate matter, removing gas bubbles, or insufficient dissolved oxygen, respectively.
(D) Apparatus for providing a 16-hour light and 8-hour dark photoperiod with a 15- to 30-minute transition period.
(E) Chambers for exposing test fish to the test substance.
(F) A test substance delivery system for flow-through tests.
(ii)
(iii)
(iv)
(v)
(vi)
(B) The concentration of dissolved oxygen in the dilution water should be between 90 and 100 percent saturation; 9.8 to 10.9 mg/l for tests with trout, and 8.0 to 8.9 mg/l for tests with bluegill or fathead minnow at sea level. If necessary, the dilution water can be aerated before the addition of the test substance. All reconstituted water should be aerated before use. Buffered soft water should be aerated before but not after the addition of buffers.
(C) If disease organisms are present in the dilution water in sufficient numbers to cause infection, they should be killed or removed by suitable equipment.
(D) Glass distilled or carbon filtered deionized water with a conductivity less than 1 micromho/cm is acceptable for use in making reconstituted water. If the reconstituted water is prepared from a ground or surface water source, conductivity, and total organic carbon (TOC) or chemical oxygen demand
(vii)
(B) Triethylene glycol and dimethyl formamide are the prefered carriers, but acetone may also be used. The concentration of triethylene glycol in the test solution should not exceed 80 mg/1. The concentration of dimethyl formamide or acetone in the test solution should not exceed 5.0 mg/1.
(3)
(ii)
(B) During flow-through tests the dissolved oxygen concentration shall be maintained above 8.2 mg/1 in tests with trout and above 6.6 mg/l in tests with bluegills or fathead minnows.
(iii)
(iv)
(e)
(1) The source of the dilution water, a description of any pretreatment, and the measured hardness, acidity, alkalinity, pH, conductivity, TOC or COD and particulate matter.
(2) A description of the test chambers, the depth and volume of solution in the chamber, the specific way the test was begun (e.g., conditioning, test substance additions), and for flow-through tests, a description of the test substance delivery system.
(3) Detailed information about the test fish, including the scientific name and method of verification, average weight (grams, wet weight), standard length, age, source, history, observed diseases, treatments, and mortalities, acclimation procedures, and food used.
(4) The number of replicates used, the number of organisms per replicate, the loading rate, and the flow rate for flow-through tests.
(5) The measured DO, pH and temperature and the lighting regime.
(6) The solvent used, the test substance concentration in the stock solution, the highest solvent concentration in the test solution and a description of the solubility determinations in water and solvents if used.
(7) The concentrations of the test substance at each test concentration just before the start of the test and at all subsequent sampling periods.
(8) The number of dead and live tests organisms, the percentage of organisms that died, and the number that showed any abnormal effects in the control and in each test chamber at each observation period.
(9) The 96-hour LC
(10) When observed, the observed no effect concentration (the highest concentration tested at which there were no mortalities or abnormal behavioral or physiological effects).
(11) The concentration-response curve at each observation period for which a LC
(12) Methods and data records of all chemical analyses of water quality parameters and test substance concentrations, including method validations and reagent blanks.
(a)
(b)
(1) “Acclimation” physiological or behavioral adaptation of organisms to one or more environmental conditions associated with the test method (e.g., temperature, hardness, pH).
(2) “Carrier” solvent or other agent used to dissolve or improve the solubility of the test substance in dilution water.
(3) “Conditioning” exposure of construction materials, test chambers, and testing apparatus to dilution water or to the test solution prior to the start of the test in order to minimize the sorption of test substance onto the test facilities or the leachig of substances from test facilities into the dilution water or the test solution.
(4) “Control” an exposure of test organisms to dilution water only or dilution water containing the test solvent or carrier (no toxic agent is intentionally or inadvertently added).
(5) “Dilution water” the water used to produce the flow-through conditions of the test to which the test substance is added and to which the test species is exposed.
(6) “Early life stage toxicity test” a test to determine the minimum concentration of a substance which produces a statistically significant observable effect on hatching, survival, development and/or growth of a fish species continuously exposed during the period of their early development.
(7) “Embryo cup” a small glass jar or similar container with a screened bottom in which the embryos of some species (i.e., minnow) are placed during the incubation period and which is normally oscillated to ensure a flow of water through the cup.
(8) “Flow through” refers to the continuous or very frequent passage of fresh test solution through a test chamber with no recycling.
(9) “Hardness” the total concentration of the calcium and magnesium ions in water expressed as calcium carbonate (mg CaCO
(10) “Loading” the ratio of biomass (grams of fish, wet weight) to the volume (liters) of test solution passing through the test chamber during a specific interval (normally a 24-hr. period).
(11) “No observed effect concentration (NOEC)” the highest tested concentration in an acceptable early life stage test: (i) which did not cause the occurrence of any specified adverse effect (statistically different from the control at the 95 percent level); and (ii) below which no tested concentration caused such an occurrence.
(12) “Observed effect concentration (OEC)” the lowest tested concentration in an acceptable early life stage test: (i) Which caused the occurrence of any specified adverse effect (statistically different from the control at the 95 percent level); and (ii) above which all
(13) “Replicate” two or more duplicate tests, samples, organisms, concentrations, or exposure chambers.
(14) “Stock solution” the source of the test solution prepared by dissolving the test substance in dilution water or a carrier which is then added to dilution water at a specified, selected concentration by means of the test substance delivery system.
(15) “Test chamber” the individual containers in which test organisms are maintained during exposure to test solution.
(16) “Test solution” dilution water with a test substance dissolved or suspended in it.
(17) “Test substance” the specific form of a chemical substance or mixture that is used to develop data.
(c)
(ii) A minimum of five exposure (treatment) concentrations of a test substance and one control are required to conduct an early life stage toxicity test. The concentration of the test substance in each treatment is usually 50 percent of that in the next higher treatment level.
(iii) For each exposure concentration of the test substance and for each control (i.e., regular control and carrier control is required) there shall be:
(A) At least two replicate test chambers, each containing one or more embryo incubation trays or cups; and there shall be no water connections between the replicate test chambers;
(B) At least 60 embryos divided equally in such a manner that test results show no significant bias from the distributions, between the embryo incubation trays or cups for each test concentration and control (i.e., 30 per embryo cup with 2 replicates);
(C) All surviving larvae divided equally between the test chambers for each test concentration and control (e.g., 30 larvae per test chamber with 2 replicates).
(iv)
(B) For brook trout and rainbow trout a test begins when newly fertilized trout embryos (less than 96-hours old) are placed in the embryo trays or cups and are exposed to the test solution concentrations. The test terminates following 60 days of post-hatch exposure (for an approximate total exposure period of 90 days).
(C) For silverside a test begins with newly fertilized embryos (less than or equal to 48 hours old) and is terminated 28 days after hatching. The chorionic fibrils should be cut before randomly placing the embryos in the egg incubation cups.
(2) [Reserved]
(3)
(ii) The highest concentration selected for the early life stage toxicity test should approximate the lowest concentration indicated in any previous testing to cause a significant reduction in survival. The range of concentrations selected is expected to include both observed effect and no-observed effect levels. The dilution factor between concentrations is normally 0.50, however, other dilution factors may be used as necessary.
(4)
(B) New holding and test facilities should be tested with sensitive organisms (i.e., juvenile test species or daphnids) before use to assure that the facilities or substances possibly leaching from the equipment will not adversely affect the test organisms during an actual test.
(C) Embryos should be acclimated for as long as practical to the test temperature and dilution water prior to the initiation of the test.
(D) When embryos are received from an outside culture source (i.e., rainbow and brook trout) at a temperature at variance with the recommended test temperature they shall be acclimated to the test temperature. When eggs are received, they should be immediately unpacked and the temperature of the surrounding water determined. Sudden temperature changes should be avoided. Acclimation to the appropriate test temperature should be accomplished within a period of 6 hours, and should incorporate the use of dilution water.
(E) Embryos should be visually inspected prior to placement in the embryo cups or screen trays. All dead embryos shall be discarded. Dead embryos can be discerned by a change in coloration from that of living embryos (e.g., trout embryos turn white when dead). During visual inspection, empty shells, opaque embryos, and embryos with fungus or partial shells attached shall be removed and discarded. If less than 50 percent of the eggs to be used appear to be healthy, all embryos in such a lot shall be discarded.
(ii)
(B) Each day until hatch the embryos are visually examined. Minnow embryos may be examined with the aid of a magnifying viewer. Trout embryos should not be touched. Trout embryos should be maintained in low intensity light or in darkness until 1-week post hatch, and are usually examined with the aid of a flashlight or under low intensity light. Dead embryos should be removed and discarded. Any embryos which are heavily infected with fungus shall be discarded and shall be subtracted from the initial number of embryos used as a basis for the calculations of percentage hatch.
(C) When embryos begin to hatch they should not be handled.
(iii)
(B) If necessary, fry can be transferred from one replicate embryo cup to the other replicate within a test concentration to achieve equal numbers in each replicate chamber.
(C) The number of live fry, live normal fry, live embryos, dead embryos and unaccounted for embryos for each
(iv)
(B) For the first seven days, feeding shall be done at minimum intervals of four hours (i.e., 8 am, 12 noon, and 4 pm); thereafter the fry shall be fed as indicated below.
(v)
(B) An identical amount of food should be provided to each chamber. Fish should be fed
(C) Fish should not be fed for the last 24 hours prior to termination of the test.
(vi)
(vii)
(viii)
(ix)
(x)
(B) When hatching commences, daily records of the number of embryos remaining in each embryo cup are required. This information is necessary to quantify the hatching success. A record of all deformed larvae shall be kept throughout the entire post-hatch exposure. Time to swim-up shall be recorded for the trout. Upon transfer of fry from the embryo cups to the test chambers, daily counts of the number of live fish should be made. At a minimum, live fish shall be counted on days 4, 11, 18, 25 and (weekly thereafter for the trout species) finally on termination of the test.
(C) The criteria for death of young fish is usually immobility, especially absence of respiratory movement, and lack of reaction to gentle prodding. Deaths should be recorded daily and dead fish removed when discovered.
(D) Daily and at termination of the test, the number of fish that appear (without the use of a magnifying viewer) to be abnormal in behavior (e.g., swimming erratic or uncoordinated, obviously lethargic, hyperventilating, or over excited, etc.) or in physical appearance (e.g., hemorrhaging, producing excessive mucous, or are discolored, deformed, etc.) shall be recorded and reported in detail.
(E) All physical abnormalities (e.g., stunted bodies, scoliosis, etc.) shall be photographed and the deformed fish which die, or are sacrificed at the termination of the test, shall be preserved for possible future pathological examination.
(F) At termination, all surviving fish shall be measured for growth. Standard length measurements should be made directly with a caliper, but may be measured photographically. Measurements shall be made to the nearest millimeter (0.1 mm is desirable). Weight measurements shall also be made for each fish alive at termination (wet, blotted dry, and to the nearest 0.01 g for the minnows and 0.1 g for the trout). If the fish exposed to the toxicant appear to be edematous compared to control fish, determination of dry, rather than wet, weight is recommended.
(G) Special physiological, bio-chem-ical and histological investigations on embryos, fry, and juveniles may be deemed appropriate and shall be performed on a case by case basis.
(5)
(ii) The significance level for all statistical testing shall be a minimum of P=0.05 (95 percent confidence level).
(A)
(
(
(
(B)
(
(
(
(
(
(
(
(C) It is important that fish length and weight measurements be associated with individual test chambers since the density of the fish and available food should be considered in the growth of the organism.
(iii)
(B) In addition to obtaining significant effects on the exposed test species, a measure of acceptability in the response of control fish is also required.
(C) A test is not acceptable if the average survival of the control fish at the end of the test is less than 80 percent or if survival in any one control chamber is less than 70 percent. For silversides, a test is not acceptable if the average overall survival of the control embryos and fish at the end of the test is less than 60 percent.
(D) If a carrier is used, the criteria for effect (mortality of embryos and fry, growth, etc.) used in the comparison of control and exposed test organisms shall also be applied to the control and control with carrier chambers. For the test to be considered acceptable, no significant difference shall exist between these criteria.
(E) A test is not acceptable if the relative standard deviation (RSD=100 times the standard deviation divided by the mean) of the weights of the fish that were alive at the end of the test in any control test chamber is greater than 40 percent.
(6)
(ii)
(iii)
(iv)
(B) The measured concentration of test substance in any chamber should be no more than 30 percent higher or lower than the concentration calculated from the composition of the stock solution and the calibration of the test substance delivery system. If the difference is more than 30 percent, the concentration of test substance in the solution flowing into the exposure chamber (influent) should be analyzed. These results will indicate whether the problem is in the stock solution, the test substance delivery system or in the test chamber. Measurement of degradation products of the test substance is recommended if a reduction of the test substance concentration occurs in the test chamber.
(v)
(B) For measurement of the test substance, water samples shall be taken midway between the top, bottom, and sides of the test chamber and should not include any surface scum or material stirred up from the bottom or sides. Samples of test solutions shall be handled and stored appropriately to minimize loss of test substance by microbial degradation, photodegradation, chemical reaction, volatilization, or sorption.
(C) Chemical and physical analyses shall be performed using standardized methods whenever possible. The analytical method used to measure the concentration of the test substance in the test solution shall be validated before the beginning of the test. At a minimum, a measure of the accuracy of the method should be obtained on each of two separate days by using the method of known additions, and using dilution water from a tank containing test organisms. Three samples should be analyzed at the next-to-lowest test substance concentration. It is also desirable to study the accuracy and precision of the analytical method for test guideline determination by use of reference (split) samples, or in-ter-lab-or-a-tory studies, and by comparison with alternative, reference, or corroborative methods of analysis.
(D) An analytical method is not acceptable if likely degradation products of the test substance, such as hydrolysis and oxidation products, give positive or negative interferences, unless it is shown that such degradation products are not present in the test chambers during the test. In general, atomic absorption spectrophotometric methods for metals and gas chro-ma-to-graphic methods for organic com-pounds are pre-fer-able to colori-metric methods.
(E) In addition to analyzing samples of test solution, at least one reagent blank also should be analyzed when a reagent is used in the analysis. Also, at least one sample for the method of known additions should be prepared by adding test substance at the concentration used in the toxicity test.
(d)
(A) Fathead minnow (
(B) Sheepshead minnow (
(C) Brook trout (
(D) Rainbow trout (
(E) Atlantic silverside (
(F) Tidewater silverside (
(ii) Embryos used to initiate the early life stage test shall be less than 48 hours old for the fathead and sheepshead minnows, silversides, and less than 96 hours old for the brook trout and rainbow trout. In addition, the following requirements shall be met:
(A) All embryos used in the test shall be from the same source. Embryos shall be obtained from a stock cultured in-house when possible, and maintained under the same parameters as specified for the test conditions. When it is necessary to obtain embryos from an external source, caution should be exercised to ensure embryo viability and to minimize the possibility of fungal growth. A description of the brood stock history or embryo source shall be made available to EPA upon request.
(B) Test species shall be cared for and handled properly in order to avoid unnecessary stress. To maintain test species in good condition and to maximize growth, crowding shall be prevented, and the dissolved oxygen level shall be maintained near saturation.
(C) Embryos and fish shall be handled as little as possible. Embryos shall be counted and periodically inspected until hatching begins. When larvae begin to hatch, they shall not be handled. Transfer of minnow larvae from embryo cups to test chambers shall not involve the use of nets. No handling is necessary following introduction into the test chambers until termination of the test.
(D) If fathead minnow embryos are obtained from in-house culture units, the embryos should be gently removed from the spawning substrate. The method for separating the fertilized eggs from the substrate is important and can affect the viability of the embryos; therefore the finger-rolling procedure is recommended.
(E) Disease treatment. Chemical treatments to cure or prevent diseases should not be used before, and should not be used during a test. All prior treatments of brood stock should be reported in detail. Severely diseased organisms should be destroyed.
(2)
(ii)
(B) Many different sizes of test chambers have been used successfully. The size, shape and depth of the test chamber is acceptable if the specified flow rate and loading requirements can be achieved.
(C) The actual arrangement of the test chambers can be important to the statistical analysis of the test data.
(iii)
(B) The trout embryo incubation trays can be made from stainless steel screen (or other acceptable material such as plastic) of about 3-4 mm mesh. The screen tray should be supported above the bottom of the test chamber by two folds of screen or other devices which function as legs or supports. The edges of the screen tray should be turned up to prevent bump spills and to prevent the embryos from rolling off in the event of excessive turbulence. Suspending or supporting the screen tray off the bottom ensures adequate water circulation around the embryos and avoids contact of embryos with possible bottom debris.
(iv)
(B) The proportional diluter and modified proportional diluter systems and metering pump systems have proven suitable and have received extensive use.
(C) Mixing chambers shall be used between the diluter and the test chamber(s). This may be a small container or flow-splitting chamber to promote mixing of test substance stock solution and dilution water, and is positioned between the diluter and the test chambers for each concentration. If a proportional diluter is used, separate delivery tubes shall run from the flow-splitting chamber to each replicate test chamber. Daily checks on this latter system shall be made.
(D) Silverside fry are injured easily and are susceptible to impingement on the mesh of the incubation cups. Consequently, water flow into and out of the cups when counting fry must be at a slow rate. This can be accomplished by using small diameter (e.g., 2 mm I.D.) capillary tubes to drain the test solution from spitter boxes into the replicate test chambers. The use of a self-starting siphon to gradually lower (i.e., less than or equal to 1 min.) the water level approximately 2 cm in the test chamber is recommended. A minimum water depth of 5 cm should be maintained in the cups. Although it may be satisfactory, a rocker-arm type apparatus has not yet been used with silversides.
(v)
(B) An apparatus for aerating water.
(C) A suitable magnifying viewer for examination of minnow embryos.
(D) A suitable apparatus for the precise measurement of growth of the fish, including both length (e.g., with metric or ruler caliper or photographic equipment) and weight.
(E) Facilities for providing a continuous supply of live brine shrimp nauplii (
(F) For silversides, facilities for providing a supply of rotifers (
(G) Facilities (or access to facilities) for performing the required water chemistry analyses.
(vi)
(B) Debris can be removed with a rubber bulb and large pipette or by siphoning with a glass tube attached to a flexible hose. Debris should be run into a bucket light enough to observe that no live fish are accidentally discarded.
(vii)
(
(
(B)
(
(
(C)
(
(3)
(ii)
(B) A lower loading or higher flow rate or both shall be used if necessary to meet the following three criteria at all times during the test in each chamber containing live test organisms:
(
(
(
(iii)
(
(
(
(
(B) Excursions from the test temperature shall be no greater than ±2.0°C. It is recommended that the test system be equipped with an automatic alarm system to alert staff of instantaneous temperature changes in excess of 2 °C. If the water is heated (i.e., for minnow species), precautions should be taken to ensure that supersaturation of dissolved gases is avoided. Temperatures shall be recorded in all test chambers at the beginning of the test and weekly thereafter. The temperature shall be recorded at least hourly in one test chamber throughout the test.
(iv)
(B) For fathead and sheepshead minnows, a 16-hour light and 8-hour dark (or 12:12) photoperiod shall be used throughout the test period.
(C) For silversides, a 14-hour light and 10-hour dark photoperiod shall be used throughout the test period.
(D) A 15-minute to 30-minute transition period between light and dark is optional.
(E) Light intensities ranging from 30 to 100 lumens at the water surface shall be provided; the intensity selected should be duplicated as closely as possible for all test chambers.
(e)
(1) Name of test, sponsor, investigator, laboratory, and dates of test duration.
(2) Detailed description of the test substance including its source, lot number, composition (identity and concentration of major ingredients and major impurities), known physical and chemical properties, and any carriers (solvents) or other additives used.
(3) The source of the dilution water, its chemical characteristics, and a description of any pretreatment.
(4) Detailed information about the test organisms including scientific name and how verified and source history, observed diseases, treatments, acclimation procedure, and concentration of any contaminants and the method of measurement.
(5) A description of the experimental design and the test chambers, the depth and volume of the solution in the chambers, the way the test was begun, the number of organisms per treatment, the number of replicates, the
(6) Detailed information on feeding of fish during the toxicity test, including type of food used, its source, feeding frequency and results of analysis (i.e., concentrations) for contaminants.
(7) Number of embryos hatched, number of healthy embryos, time to hatch, mortality of embryos and fry, measurements of growth (weight and length), incidence of pathological or histological effects and observations of other effects or clinical signs, number of healthy fish at end of test.
(8) Number of organisms that died or showed an effect in the control and the results of analysis for concentration(s) of any contaminant in the control(s) should mortality occur.
(9) Methods used for, and the results of (with standard deviation), all chemical analyses of water quality and test substance concentration, including validation studies and reagent blanks; the average and range of the test temperature(s).
(10) Anything unusual about the test, any deviation from these procedures, and any other relevant information.
(11) A description of any abnormal effects and the number of fish which were affected during each period between observations in each chamber, and the average concentration of test substance in each test chamber.
(12) Reference to the raw data location.
(a)
(b)
(1) “Death” means the lack of reaction of a test organism to gentle prodding.
(2) “Flow-through” means a continuous or an intermittent passage of test solution or dilution water through a test chamber or a holding or acclimation tank, with no recycling.
(3) “LC
(4) “Loading” means the ratio of test organisms biomass (grams, wet weight) to the volume (liters) of test solution in a test chamber.
(5) “Retention chamber” means a structure within a flow-through test chamber which confines the test organisms, facilitating observation of test organisms and eliminating loss of organisms in outflow water.
(6) “Static system” means a test chamber in which the test solution is not renewed during the period of the test.
(c)
(2) [Reserved]
(3)
(A) Which life stage (juvenile or young adult) is to be utilized in the definitive test.
(B) The test solution concentrations for the definitive test.
(ii) The mysids should be exposed to a series of widely spaced concentrations of test substance (e.g., 1, 10, 100 mg/l, etc.), usually under static conditions.
(iii) This test should be conducted with both newly hatched juvenile (< 24 hours old) and young adult (5 to 6 days old) mysids. For each age class (juvenile or young adult), a minimum of 10 mysids should be exposed to each concentration of test substance for up to 96 hours. The exposure period may be shortened if data suitable for the purpose of the range-finding test can be obtained in less time. The age class which is most sensitive to the test substance in the range-finding test shall be utilized in the definitive test. When no apparent difference in sensitivity of the two life stages is found, juveniles shall be utilized in the definitive test. No replicates are required, and nominal concentrations of the chemical are acceptable.
(4)
(ii) The definitive test shall be conducted on the mysid life stage (juveniles or young adults) which is most sensitive to the test substance being evaluated.
(iii) A minimum of 20 mysids per concentration shall be exposed to five or more concentrations of the chemical chosen in a geometric series in which the ratio is between 1.5 and 2.0 (e.g., 2, 4, 8, 16, 32, and 64 mg/l). An equal number of mysids shall be placed in two or more replicates. If solvents, solubilizing agents or emulsifiers have to be used, they shall be commonly used carriers and shall not possess a synergistic or antagonistic effect on the toxicity of the test substance. The concentration of solvent shall not exceed 0.1 ml/1. The concentration ranges shall be selected to determine the concentration-response curves and LC
(iv) Every test shall include controls consisting of the same dilution water, conditions, procedures, and mysids from the same population or culture container, except that none of the chemical is added.
(v) The dissolved oxygen concentration temperature, salinity, and pH shall be measured at the beginning and end of the test in each chamber.
(vi) The test duration is 96 hours. The test is unacceptable if more than 10 percent of the control organisms die or exhibit abnormal behavior during the 96 hour test period. Each test chamber should be checked for dead mysids at 24, 48, 72, and 96 hours after the beginning of the test. Concentration-response curves and 24-, 48-, 72- and 96-hour LC
(vii) In addition to death, any abnormal behavior or appearance shall also be reported.
(viii) Test organisms shall be impartially distributed among test chambers in such a manner that test results show no significant bias from the distributions. In addition, test chambers within the testing area shall be positioned in a random manner or in a way in which appropriated statistical analyses can be used to determine the variation due to placement.
(ix) The concentration of the test substance in the chambers should be measured as often as is feasible during the test. At a minimum, during static tests the concentration of test substance shall be measured at each concentration at the beginning and at the end of the test. During the flow-through test, the concentration of test substance should be measured at the beginning and end of the test and in at
(5) [Reserved]
(6)
(ii)
(d)
(B) Mysids to be used in chronic toxicity tests should originate from laboratory cultures in order to ensure the individuals are of similar age and experimental history. Mysids used for establishing laboratory cultures may be purchased commercially or collected from appropriate natural areas. Because of similarities with other mysids species, taxonomic verification should be obtained from the commercial supplier by experienced laboratory personnel or by an outside expert.
(C) Mysids used in a particular test shall be of similar age and be of normal size and appearance for their age. Mysids shall not be used for a test if they exhibit abnormal behavior or if they have been used in a previous test, either in a treatment or in a control group.
(ii)
(B) During acclimation mysids should be maintained in facilities with background colors and light intensities similar to those of the testing areas.
(iii)
(iv)
(2)
(B) Test chambers shall be loosely covered to reduce the loss of test solution or dilution water due to evaporation and to minimize the entry of dust or other particulates into the solutions.
(ii)
(iii)
(B) For use in the flow-through test, retention chambers utilized for confinement of test organisms can be constructed with netting material of appropriate mesh size.
(iv)
(B) Natural seawater shall be filtered through a filter with a pore size of <20 microns prior to use in a test.
(C) Artificial seawater can be prepared by adding commercially available formulations or by adding specific amounts of reagent-grade chemicals to deionized water. Deionized water with a conductivity less than 1 μ ohm/cm at 12 °C is acceptable for making artificial seawater. When deionized water is prepared from a ground or surface water source, conductivity and total organic carbon (or chemical oxygen demand) shall be measured on each batch.
(v)
(3)
(i) The test temperature shall be 25°C. Excursions from the test temperature shall be not greater than ± 2°C.
(ii) Dissolved oxygen concentration between 60 and 105 percent saturation. Aeration, if needed to achieve this level, shall be done before the addition of the test substance. All treatment and control chambers shall be given the same aeration treatment.
(iii) The number of mysids placed in a test solution shall not be so great as to affect results of the test. Loading shall not exceed 30 mysids per liter for a static test. Loading requirements for the flow-through test will vary depending on the flow rate of dilution water. The loading shall not cause the dissolved oxygen concentration to fall below the recommended levels.
(iv) Photoperiod of 14 hours light and 10 hours darkness, with a 15 to 30 minute transition period.
(v) Salinity of 20 parts per thousand ±3 percent.
(e)
(1) The source of the dilution water, its chemical characteristics (e.g., salinity, pH, etc.) and a description of any pretreatment.
(2) Detailed information about the test organisms, including the scientific name and method of verification, age, source, history, abnormal behavior, acclimation procedures and food used.
(3) A description of the test chambers, the depth and volume of solution in the chamber, the way the test was
(4) The measured concentration of test substance in test chambers at the times designated.
(5) The number and percentage of organisms that died or showed any other adverse effects in the control and in each treatment at each observation period.
(6) Concentration-response curves shall be fitted to mortality data collected at 24, 48, 72, and 96 hours. A statistical test of goodness-of-fit shall be performed and the results reported.
(7) The 96-hour LC
(8) Methods and data records of all chemical analyses of water quality and test substance concentrations, including method validations and reagent blanks.
(9) The data records of the holding, acclimation and test temperature and salinity.
(f)
(1) U.S. Environmental Protection Agency, “Bioassay Procedures for the Ocean Disposal Permit Program,” EPA Report No. 600-9-78-010 (Gulf Breeze, Florida, 1978).
(2) [Reserved]
(a)
(b)
(1) “Chronic toxicity test” means a method used to determine the concentration of a substance that produces an adverse effect from prolonged exposure of an organism to that substance. In this test, mortality, number of young per female and growth are used as measures of chronic toxicity.
(2) “Death” means the lack of reaction of a test organism to gentle prodding.
(3) “Flow-through” means a continuous or an intermittent passage of test solution or dilution water through a test chamber or a holding or acclimation tank, with no recycling.
(4) “G1 (Generation 1)” means those mysids which are used to begin the test, also referred to as adults; G2 (Generation 2) are the young produced by G1.
(5) “LC
(6) “Loading” means the ratio of test organism biomass (gram, wet weight) to the volume (liters) of test solution in a test chamber.
(7) “MATC” (Maximum Acceptable Toxicant Concentration) means the maximum concentration at which a chemical can be present and not be toxic to the test organism.
(8) “Retention chamber” means a structure within a flow-through test chamber which confines the test organisms, facilitating observation of test organisms and eliminating washout from test chambers.
(c)
(ii) Dissolved oxygen concentration, pH, temperature, salinity, the concentration of test substance and other water quality characteristics are measured at specified intervals in selected test chambers.
(iii) Data collected during the test are used to develop a MATC (Maximum Acceptable Toxicant Concentration) and quantify effects on specific chronic parameters.
(2) [Reserved]
(3)
(ii) The mysids should be exposed to a series of widely spaced concentrations of the test substance (e.g., 1, 10, 100 -mg/l), usually under static conditions.
(iii) A minimum of 10 mysids should be exposed to each concentration of test substance for a period of time which allows estimation of appropriate chronic test concentrations. No replicates are required and nominal concentrations of the chemical are acceptable.
(4)
(ii) A minimum of 40 mysids per concentration shall be exposed to four or more concentrations of the chemical chosen in a geometric series in which the ratio is between 1.5 and 2.0 (e.g., 2, 4, 8, 16, 32, and 64 mg/1). An equal number of mysids shall be placed in two or more replicates. If solvents, solubilizing agents or emulsifiers have to be used, they shall be commonly used carriers and shall not possess a synergistic or antagonistic effect on the toxicity of the test substance. The concentration of solvent should not exceed 0.1 ml/1. The concentration ranges should be selected to determine the concentration response curves, LC
(iii) Every test should include controls consisting of the same dilution water, conditions, procedures and mysids from the same population or culture container, except that none of the chemical is added.
(iv) The dissolved oxygen concentration, temperature, salinity, and pH shall be measured weekly in each chamber.
(v) The test duration is 28 days. The test is unacceptable if more than 20 percent of the control organisms die, appear stressed or are diseased during the test. The number of dead mysids in each chamber shall be recorded on days 7, 14, 21, and 28 of the test. At the time when sexual characteristics are discernible in the mysids (approximately 10 to 12 days in controls; possible delays may occur in mysids exposed to test substances), the number of males and females (identified by ventral brood pouch) in each chamber shall be recorded. Body length (as measured by total midline body length, from the anterior tip of the carapace to the posterior margin of the uropod) shall be recorded for males and females at the time when sex can be determined simultaneously for all mysids in control and treatment groups. This time cannot be specified because of possible delays in sexual maturation of mysids exposed to test substances. A second observation of male and female body lengths shall be conducted on day 28 of the test. To reduce stress on the mysids, body lengths can be recorded by photography through a ster-e-o-micro-scope with appropriate scal-ing in-for-ma-tion. As offspring are produced by the G1 mysids (approximately 13 to 16 days in controls), the young shall be counted and separated into retention chambers at the same test substance concentration as the chambers where they originated. If available prior to
(vi) In addition to death, any abnormal behavior or appearance shall also be reported.
(vii) Test organisms shall be impartially distributed among test chambers in such a manner that test results show no significant bias from the distributions. In addition, test chambers within the testing area shall be positioned in a random manner or in a way in which appropriate statistical analyses can be used to determined the variation due to placement.
(viii) The concentration of the test substance in the chambers should be measured as often as is feasible during the test. The concentration of test substance shall be measured:
(A) At each test concentration at the beginning of the test and on days 7, 14, 21, and 28; and
(B) In at least one appropriate chamber whenever a malfunction is detected in any part of the test substance delivery system.
(5) [Reserved]
(6)
(ii)
(B) A 7-, 14-, 21- and 28-day LC
(d)
(B) Mysids to be used in chronic toxicity tests should originate from laboratory cultures in order to ensure the individuals are of similar age and experimental history. Mysids used for establishing laboratory cultures may be purchased commercially or collected from appropriate natural areas. Because of similarities with other mysid species, taxonomic verification should be obtained from the commercial supplier, by experienced laboratory personnel, or by an outside expert.
(C) Mysids used in a particular test shall be of similar age and be of normal size and appearance for their age.
(D) Mysids shall not be used for a test if they exhibit abnormal behavior, or if they have been used in a previous test, either in a treatment or in a control group.
(ii)
(B) During acclimation mysids should be maintained in facilities with background colors and light intensities similar to those of the testing areas.
(iii)
(iv)
(2)
(B) Facilities should be well ventilated and free of fumes and disturbances that may affect test organisms.
(C) Test chambers shall be loosely covered to reduce the loss of test solution or dilution water due to evaporation and to minimize the entry of dust or other particulates into the solutions.
(ii)
(iii)
(B) Retention chambers utilized for confinement of test organisms can be constructed with netting material of appropriate mesh size.
(iv)
(B) Natural seawater shall be filtered through a filter with a pore size of > 20 microns prior to use in a test.
(C) Artificial seawater can be prepared by adding commercially available formulations or by adding specific amounts of reagent-grade chemicals to deionized or glass-distilled water. Deionized water with a conductivity less than 1 μ ohm/cm at 12 °C is acceptable as the diluent for making artificial seawater. When deionized water is prepared from a ground or surface water source, conductivity and total organic carbon (or chemical oxygen demand) shall be measured on each batch.
(v)
(3)
(i) The test temperature shall be 25 °C. Excursions from the test temperature shall be no greater than ±2 °C.
(ii) Dissolved oxygen concentration between 60 and 105 percent saturation. Aeration, if needed to achieve this
(iii) The number of mysids placed in a test solution shall not be so great as to affect results of the test. Loading requirements for the test will vary depending on the flow rate of dilution water. The loading shall not cause the dissolved oxygen concentration to fall below the recommended levels.
(iv) Photoperiod of 14 hours light and 10 hours darkness, with a 15-30 minute transition period.
(v) Salinity of 20 parts per thousand ±3 percent.
(e)
(1) The source of the dilution water, its chemical characteristics (e.g., salinity, pH, etc.) and a description of any pretreatment.
(2) Detailed information about the test organisms, including the scientific name and method of verification, average length, age, source, history, observed diseases, treatments, acclimation procedures and food used.
(3) A description of the test chambers, the depth and volume of solution in the chamber, the way the test was begun (e.g., conditioning, test substance additions, etc.), the number of organisms per treatment, the number of replicates, the loading, the lighting, the test substance delivery system, and the flow rate expressed as volume additions per 24 hours.
(4) The measured concentration of test substance in test chambers at the times designated.
(5) The first time (day) that sexual characteristics can be observed in controls and in each test substance concentration.
(6) The length of time for the appearance of the first brood for each concentration.
(7) The means (average of replicates) and respective 95 percent confidence intervals for:
(i) Body length of males and females at the first observation day (depending on time of sexual maturation) and on day 28.
(ii) Cumulative number of young produced per female on day 28.
(iii) Cumulative number of dead adults on day 7, 14, 21 and 28.
(iv) If available prior to test termination (day 28), effects on G2 mysids (number of males and females, body length of males and females and cumulative mortality).
(8) The MATC is calculated as the geometric mean between the lowest measured test substance concentration that had a significant (P<0.05) effect and the highest measured test substance concentration that had no significant (P<0.05) effect in the chronic test. The most sensitive of the test criteria for adult (Gl) mysids (cumulative number of dead mysids, body lengths of males and females or the number of young per female) is used to calculate the MATC. The criterion selected for MATC computation is the one which exhibits an effect (a statistically significant difference between treatment and control groups; P<0.05) at the lowest test substance concentration for the shortest period of exposure. Appropriate statistical tests (analysis of variance, mean separation test) should be used to test for significant chemical effects. The statistical tests employed and the results of these tests shall be reported.
(9) Concentration-response curves shall be fitted to the cumulative number of adult dead for days 7, 14, 21, and 28. A statistical test of goodness-of-fit shall be performed and the results reported.
(10) An LC
(11) Methods and data records of all chemical analyses of water quality and test substance concentrations, including method validations and reagent blanks.
(12) The data records of the holding, acclimation and test temperature and salinity.
(f)
(1) U.S. Environmental Protection Agency, “Bioassay Procedures for the Ocean Disposal Permit Program,” EPA Report No. 600/9-78-010 (Gulf Breeze, Florida, 1978).
(2) [Reserved]
15 U.S.C. 2603.
(a)
(b)
(2) Dose in a dermal test is the amount of test substance applied to the skin (applied daily in subchronic tests).
(3) No-effect level/No-toxic-effect level/No-adverse-effect level/No-observed-effect level is the maximum dose used in a test which produces no observed adverse effects. A no-observed-effect level is expressed in terms of the weight of a test substance given daily per unit weight of test animal (mg/kg).
(4) Cumulative toxicity is the adverse effects of repeated doses occurring as a result of prolonged action on, or increased concentration of the administered test substance or its metabolites in susceptible tissues.
(c)
(d)
(e)
(ii)
(iii)
(B) The females shall be nulliparous and nonpregnant.
(iv)
(B) If interim sacrifices are planned, the number shall be increased by the number of animals scheduled to be sacrificed before completion of the study.
(2)
(3)
(4)
(ii) The highest dose level should result in toxic effects but not produce severe skin irritation or an incidence of fatalities which would prevent a meaningful evaluation.
(iii) The lowest dose level should not produce any evidence of toxicity. Where there is a usable estimation of human exposure, the lowest dose level should exceed this.
(iv) Ideally, the intermediate dose level(s) should produce minimal observable toxic effects. If more than one
(v) In the low and intermediate groups and in the controls the incidence of fatalities should be low, to permit a meaningful evaluation of the results.
(5)
(6)
(ii) Animals in the satellite group scheduled for followup observations should be kept for at least 28 days further without treatment to detect recovery from, or persistence of, toxic effects.
(7)
(ii) Not less than 10 percent of the body surface area should be clear for the application of the test substance. The weight of the animal should be taken into account when deciding on the area to be cleared and on the dimensions of any covering used.
(iii) When testing solids, which may be pulverized if appropriate, the test substance should be moistened sufficiently with water or, where necessary, a suitable vehicle to ensure good contact with the skin. When a vehicle is used, the influence of the vehicle on toxicity of and penetration of the skin by the test substance should be taken into account.
(8)
(ii) During the exposure period, the test substance shall be held in contact with the skin with a porous gauze dressing and nonirritating tape. The test site shall be further covered in a suitable manner to retain the gauze dressing and test substance and ensure that the animals cannot ingest the test substance. Restrainers may be used to prevent the ingestion of the test substance, but complete immobilization is not a recommended method.
(9)
(ii) Additional observations shall be made daily with appropriate actions taken to minimize loss of animals to the study (e.g., necropsy or refrigeration of those animals found dead and isolation or sacrifice of weak or moribund animals).
(iii) Signs of toxicity shall be recorded as they are observed, including the time of onset, the degree, and duration.
(iv) Cage-side observations shall include, but not be limited to, changes in skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern.
(v) Animals shall be weighed weekly. Feed consumption shall also be determined weekly if abnormal body weight changes are observed.
(vi) At the end of the study period, all survivors in the nonsatellite treatment groups shall be sacrificed. Moribund animals shall be removed and sacrificed when noticed.
(10)
(A) Certain hematology determinations shall be carried out at least two times during the test period on all groups of animals including concurrent controls: After 30 days of test and just prior to terminal sacrifice at the end of the test period. Hematology determinations which are appropriate to all studies: Hematocrit, hemoglobin con-cen-tra-tion, erythrocyte count, total and
(B) Certain clinical biochemistry determinations on blood should be carried out at least two times during the test period on all groups of animals including concurrent controls: After 30 days of test and just prior to terminal sacrifice at the end of the test period. Clinical biochemistry test areas which are considered appropriate to all studies: Electrolyte balance, carbohydrate metabolism, and liver and kidney function. The selection of specific tests will be influenced by observations on the mode of action of the substance. Suggested determinations: Calcium, phosphorus, chloride, sodium, potassium, fasting glucose (with period of fasting appropriate to the species), serum glutamic pyruvic transaminase (now known as serum alanine ami-no-trans-ferase), serum glutamic oxaloacetic transaminase (now known as serum aspartate ami-no-trans-ferase), ornithine de-car-boxylase, gamma glutamyl transpeptidase, urea nitrogen, albumen blood creatinine, total bilirubin, and total serum protein meas-ure-ments. Other de-ter-mi-na-tions which may be necessary for an adequate tox-i-co-log-i-cal evaluation include: Analyses of lipids, hormones, acid/base balance, methemoglobin, and cholinesterase activity. Additional clinical biochemistry may be employed, where necessary, to extend the investigation of observed effects.
(ii) The following examinations shall be made on high dose and control groups. If changes in the eyes are detected all animals should be examined.
(A) Ophthalmological examination, using an ophthalmoscope or equivalent suitable equipment, shall be made prior to exposure to the test substance and at the termination of the study.
(B) Urinalysis is not recommended on a routine basis, but only when there is an indication based on expected or observed toxicity.
(11)
(ii) The liver, kidneys, adrenals, brain, and gonads shall be weighed wet, as soon as possible after dissection, to avoid drying. In addition, for the rodent, the brain; for the non-rodent, the thyroid with parathyroids also shall be weighed wet.
(iii) The following organs and tissues, or representative samples thereof, shall be preserved in a suitable medium for possible future histopathological examination: All gross lesions; lungs—which should be removed intact, weighed, and treated with a suitable fixative to ensure that lung structure is maintained (perfusion with the fixative is considered to be an effective procedure); nasopharyngeal tissues; brain—including sections of medulla/pons, cerebellar cortex, and cerebral cortex; pituitary; thyroid/parathyroid; thymus; trachea; heart; sternum with bone marrow; salivary glands; liver; spleen; kidneys; adrenals; pancreas; gonads; uterus; accessory genital organs (epididymis, prostate, and, if present, seminal vesicles); aorta; (skin); gall bladder (if present); esophagus; stomach; duodenum; jejunum; ileum; cecum; colon; rectum; urinary bladder; representative lymph node; (mammary gland); (thigh musculature); peripheral nerve; (eyes); (femur—including articular surface); (spinal cord at three levels—cervical, midthoracic, and lumbar); and (zymbal and exorbital lachrymal glands).
(12)
(i) Full histopathology on normal and treated skin and on organs and tissues, listed above, of all animals in the control and high dose groups.
(ii) All gross lesions in all animals.
(iii) Target organs in all animals.
(iv) The tissues listed in parenthesis in paragraph (e)(11)(iii) of this section, if indicated by signs of toxicity or expected target organ involvement.
(v) Lungs of animals (rodents) in the low and intermediate dose groups shall be subjected to histopathological examination for evidence of infection, since this provides a convenient assessment of the state of health of the animals.
(vi) When a satellite group is used, histopathology shall be performed on
(f)
(ii) All observed results, quantitative and incidental, should be evaluated by an appropriate statistical method. Any generally accepted statistical method may be used; the statistical methods should be selected during the design of the study.
(2)
(3)
(i)
(A) Number of animals dying.
(B) Number of animals showing signs of toxicity.
(C) Number of animals exposed.
(ii)
(B) Date of observation of each abnormal sign and its subsequent course.
(C) Body weight data.
(D) Feed consumption data when collected.
(E) Hematological tests employed and all results.
(F) Clinical biochemistry tests employed and all results.
(G) Necropsy findings.
(H) Detailed description of all histopathological findings.
(I) Statistical treatment of results where appropriate.
(g)
(1) Draize, J.H. “Dermal toxicity,”
(2) Fitzhugh, O.G. “Subacute toxicity,”
(3) National Academy of Sciences. “Principles and Procedures for Evaluating the Toxicity of Household Substances,” a report prepared by the Committee for the Revision of NAS Publication 1138, under the auspices of the Committee on Toxicology, National Research Council, National Academy of Sciences, Washington, DC (1977).
(4) World Health Organization. “Part I. Environmental Health Criteria 6,”
(a)
(b)
(2) Aerodynamic diameter applies to the size of particles of aerosols. It is the diameter of a sphere of unit density which behaves aerodynamically as the particle of the test substance. It is used to compare particles of different size and densities and to predict where in the respiratory tract such particles may be deposited. This term is used in contrast to measured or geometric diameter which is representative of actual diameters which in themselves cannot be related to deposition within the respiratory tract.
(3) The geometric mean diameter or the median diameter is the calculated aerodynamic diameter which divides the particles of an aerosol in half based on the weight of the particles. Fifty percent of the particles by weight will be larger than the median diameter and 50 percent of the particles will be smaller than the median diameter. The median diameter describes the particle size distribution of any aerosol based on the weight and size of the particles.
(4) Inhalable diameter refers to that aerodynamic diameter of a particle which is considered to be inhalable for the organism. It is used to refer to particles which are capable of being inhaled and may be deposited anywhere within the respiratory tract from the trachea to the alveoli. For man, inhalable diameter is considered as 15 micrometers or less.
(5) Dose refers to an exposure level. Exposure is expressed as weight or volume of test substance per volume of air (mg/l), or as parts per million (ppm).
(6) No-effect level/No-toxic-effect level/No-adverse-effect level/No-observed-effect level is the maximum dose used in a test which produces no observed adverse effects. A no-observed-effect level is expressed in terms of weight or volume of test substance given daily per unit volume of air (mg/l or ppm).
(7) Cumulative toxicity is the adverse effects of repeated doses occuring as a result of prolonged action on, or increased concentration of the administered test substance or its metabolites in susceptible tissues.
(c)
(d)
(ii)
(iii)
(B) Females shall be nulliparous and nonpregnant.
(iv)
(B) If interim sacrifices are planned, the number of animals shall be increased by the number of animals
(2)
(3)
(4)
(ii) The highest concentration should result in toxic effects but not produce an incidence of fatalities which would prevent a meaningful evaluation.
(iii) The lowest concentration should not produce any evidence of toxicity. Where there is a usable estimation of human exposure the lowest concentration should exceed this.
(iv) Ideally, the intermediate concentration level(s) should produce minimal observable toxic effects. If more than one intermediate concentration level is used, the concentrations should be spaced to produce a gradation of toxic effects.
(v) In the low and intermediate groups and in the controls the incidence of fatalities should be low, to permit a meaningful evaluation of the results.
(vi) In the case of potentially explosive test substances, care should be taken to avoid generating explosive concentrations.
(5)
(6)
(ii) Animals in a satellite group scheduled for followup observations should be kept for at least 28 days further without treatment to detect recovery from, or persistence of, toxic effects.
(7)
(ii) A dynamic inhalation system with a suitable flow control system shall be used. The rate of air flow shall be adjusted to ensure that conditions throughout the exposure chamber are essentially the same. Maintenance of slight negative pressure inside the chamber will prevent leakage of the test substance into surrounding areas.
(iii) The temperature at which the test is performed should be maintained at 22 °C (±2°). Ideally, the relative humidity should be maintained between 40 to 60 percent, but in certain instances (e.g., tests of aerosols, use of
(8)
(i) The rate of air flow shall be monitored continuously and recorded at least every 30 minutes.
(ii) The actual concentrations of the test substance shall be measured in the breathing zone. During the exposure period the actual concentrations of the test substance shall be held as constant as practicable, monitored continuously or intermittently depending on the method of analysis, and recorded at least at the beginning, at an intermediate time, and at the end of the exposure period.
(iii) During the development of the generating system, particle size analysis shall be performed to establish the stability of aerosol concentrations with respect to particle size. During exposure, analysis shall be conducted as often as necessary to determine the consistency of particle size distribution.
(iv) Temperature and humidity shall be monitored continuously but shall be recorded at least every 30 minutes.
(9)
(10)
(ii) Additional observations should be made daily with appropriate actions taken to minimize loss of animals to the study (e.g., necropsy or refrigeration of those animals found dead and isolation or sacrifice of weak or moribund animals).
(iii) Signs of toxicity shall be recorded as they are observed including the time of onset, the degree, and duration.
(iv) Cage-side observations should include, but not be limited to, changes in the skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern.
(v) Animals shall be weighed weekly. Feed consumption shall also be determined weekly if abnormal body weight changes are observed.
(vi) At the end of the study period all survivors in the nonsatellite treatment groups shall be sacrificed. Moribund animals shall be removed and sacrificed when noticed.
(11)
(A) Certain hematology determinations shall be carried out at least two times during the test period on all groups of animals including concurrent controls: After 30 days of test and just prior to terminal sacrifice at the end of the test period. Hematology determinations which are appropriate to all studies: Hematocrit, hemoglobin concentration, erythrocyte count, total and differential leukocyte count, and a measure of clotting potential such as clotting time, prothrombin time, thromboplastin time, or platelet count.
(B) Certain clinical biochemistry determinations on blood should be carried out at least two times during the test period on all groups of animals including concurrent controls: After 30 days of test and just prior to terminal sacrifice at the end of the test period. Clinical biochemistry test areas which are considered appropriate to all studies: Electrolyte balance, carbohydrate metabolism, and liver and kidney function. The selection of specific tests will be influenced by observations on the mode of action of the substance. Suggested determinations: calcium, phosphorus, chloride, sodium, potassium, fasting glucose (with period of fasting appropriate to the species), serum glutamic-pyruvic transaminase, (now known as serum alanine ami-no-trans-ferase), serum glutamic-oxaloacetic transaminase (now known as serum aspartate aminotransferase), ornithine de-car-boxylase, gamma glutamyl trans-pep-ti-dase, urea nitrogen, albumen, blood creatinine, total bilirubin, and total serum protein measurements. Other determinations which may be necessary for an adequate toxicological evaluation include: Analyses of lipids, hormones, acid/base balance, methemoglobin, and cholinesterase activity. Additional clinical biochemistry may be employed, where
(ii) The following examinations shall be made on high dose and control groups. If changes in the eyes are detected, all animals shall be examined:
(A) Ophthalmological examination, using an ophthalmoscope or equivalent suitable equipment, shall be made prior to exposure to the test substance and at the termination of the study.
(B) Urinalysis is not recommended on a routine basis, but only when there is an indication based on expected and/or observed toxicity.
(12)
(ii) At least the liver, kidneys, adrenals, brain, and gonads shall be weighed wet, as soon as possible after dissection to avoid drying. In addition, for the rodent, the brain; for the non-rodent, the thyroid with parathyroids also shall be weighed wet.
(iii) The following organs and tissues, or representative samples thereof, shall be preserved in a suitable medium for possible future histopathological examination: All gross lesions; lungs—which should be removed intact, weighed, and treated with a suitable fixative to ensure that lung structure is maintained (perfusion with the fixative is considered to be an effective procedure); nasopharyngeal tissues; brain—including sections of medulla/pons cerebellar cortex and cerebral cortex; pituitary; thyroid/parathyroid; thymus; trachea; heart; sternum with bone marrow; salivary glands; liver; spleen; kidneys; adrenals; pancreas; gonads; uterus; accessory genital organs (epididymis, prostate, and, if present, seminal vesicles); aorta; (skin); gall bladder (if present); esophagus; stomach; duodenum; jejunum; ileum; cecum; colon; rectum; urinary bladder; representative lymph node; (mammary gland); (thigh musculature); peripheral nerve; (eyes); (femur—including articular surface); (spinal cord at three levels—cervical, midthoracic, and lumbar); and (zymbal and exorbital lachrymal glands).
(13)
(i) Full histopathology on the respiratory tract and other organs and tissues, listed above, of all animals in the control and high dose groups.
(ii) All gross lesions in all animals.
(iii) Target organs in all animals.
(iv) The tissues mentioned in brackets (listed above) if indicated by signs of toxicity or target organ involvement.
(v) Lungs of animals (rodents) in the low and intermediate dose groups shall also be subjected to histopathological examination, primarily for evidence of infection since this provides a convenient assessment of the state of health of the animals.
(vi) When a satellite group is used, histopathology shall be performed on tissues and organs identified as showing effects in the treated groups.
(e)
(ii) All observed results, quantitative and incidental, should be evaluated by an appropriate statistical method. Any generally accepted statistical method may be used; the statistical methods should be selected during the design of the study.
(2)
(3)
(i)
(B) The equipment for measuring temperature, humidity, and particulate aerosol concentrations and size shall be described.
(ii)
(A) Airflow rates through the inhalation equipment.
(B) Temperature and humidity of air.
(C) Nominal concentration (total amount of test substance fed into the inhalation equipment divided by volume of air).
(D) Actual concentration in test breathing zone.
(E) Particle size distribution (e.g., median aerodynamic diameter of particles with standard deviation from the mean).
(iii)
(A) Number of animals dying.
(B) Number of animals showing signs of toxicity.
(C) Number of animals exposed.
(iv)
(B) Date of observation of each abnormal sign and its subsequent course.
(C) Body weight data.
(D) Feed consumption data when collected.
(E) Hematological tests employed and all results.
(F) Clinical biochemistry tests employed and all results.
(G) Necropsy findings.
(H) Detailed description of all histopathological findings.
(I) Statistical treatment of results where appropriate.
(f)
(1) Cage, J.C. “Experimental Inhalation Toxicology,”
(2) Casarett, L.J., Doull, J. “Chapter 9.”
(3) MacFarland, H.N. “Respiratory Toxicology,”
(4) National Academy of Sciences. “Principles and Procedures for Evaluating the Toxicity of Household Substances,” a report prepared by the Committee for the Revision of NAS Publication 1138, under the auspices of the Committee on Toxicology, National Research Council, National Academy of Sciences, Washington, DC (1977).
(5) World Health Organization. “Part I. Environmental Health Criteria 6,”
(a)
(b)
(2) Dose is the amount of test substance administered. Dose is expressed as weight of test substance (g, mg) per unit weight of test animal (e.g., mg/kg), or as weight of test substance per unit weight of food or drinking water.
(3) No-effect level/No-toxic-effect level/No-adverse-effect level/No-observed-effect level is the maximum dose used in a test which produces no observed adverse effects. A no-observed-effect level is expressed in terms of the weight of a substance given daily per unit weight of test animal (mg/kg). When administered to animals in food or drinking water the no-observed-effect level is expressed as mg/kg of food or mg/ml of water.
(4) Cumulative toxicity is the adverse effects of repeated doses occurring as a result of prolonged action on, or increased concentration of, the administered test substance or its metabolites in susceptible tissue.
(c)
(d)
(e)
(ii)
(B)
(C)
(iii)
(B) The females shall be nulliparous and nonpregnant.
(iv)
(B)
(C) If interim sacrifices are planned, the number shall be increased by the number of animals scheduled to be sacrificed before the completion of the study.
(2)
(3)
(4)
(ii) The highest dose level in rodents should result in toxic effects but not produce an incidence of fatalities which would prevent a meaningful evaluation; for non-rodents there should be no fatalities.
(iii) The lowest dose level should not produce any evidence of toxicity. Where there is a usable estimation of human exposure the lowest dose level should exceed this.
(iv) Ideally, the intermediate dose level(s) should produce minimal observable toxic effects. If more than one intermediate dose is used, the dose levels should be spaced to produce a gradation of toxic effects.
(v) For rodents, the incidence of fatalities in low and intermediate dose groups and in the controls should be low, to permit a meaningful evaluation of the results; for non-rodents, there should be no fatalities.
(5)
(6)
(ii) Animals in the satellite group scheduled for followup observations should be kept for at least 28 days further without treatment to detect recovery from, or persistence of, toxic effects.
(7)
(ii) All animals shall be dosed by the same method during the entire experimental period.
(iii) Where necessary, the test substance is dissolved or suspended in a suitable vehicle. If a vehicle or diluent is needed, ideally it should not elicit important toxic effects itself nor substantially alter the chemical or toxicological properties of the test substance. It is recommended that wherever possible the usage of an aqueous solution be considered first, followed by consideration of a solution of oil and then by possible solution in other vehicles.
(iv) For substances of low toxicity, it is important to ensure that when administered in the diet the quantities of the test substance involved do not interfere with normal nutrition. When the test substance is administered in the diet either a constant dietary concentration (ppm) or a constant dose level in terms of the animals' body weight shall be used; the alternative used shall be specified.
(v) For a substance administered by gavage or capsule, the dose shall be given at approximately the same time each day, and adjusted at intervals (weekly or bi-weekly) to maintain a constant dose level in terms of animal body weight.
(8)
(ii) Additional observations shall be made daily with appropriate actions taken to minimize loss of animals to the study (e.g., necropsy or refrigeration of those animals found dead and isolation or sacrifice of weak or moribund animals).
(iii) Signs of toxicity shall be recorded as they are observed including the time of onset, degree and duration.
(iv) Cage-side observations shall include, but not be limited to, changes in skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern.
(v) Measurements shall be made weekly of feed consumption or water consumption when the test substance
(vi) Animals shall be weighed weekly.
(vii) At the end of the 90-day period all survivors in the nonsatellite treatment groups shall be sacrificed. Moribund animals shall be removed and sacrificed when noticed.
(9)
(A) Certain hematology determinations shall be carried out at least two times during the test period on all groups of animals including concurrent controls: After 30 days of test and just prior to terminal sacrifice at the end of the test period. Hematology determinations which are appropriate to all studies: Hematocrit, hemoglobin concentration, erythrocyte count, total and differential leukocyte count, and a measure of clotting potential such as clotting time, prothrombin time, thromboplastin time, or platelet count.
(B) Certain clinical biochemistry determinations on blood should be carried out at least two times during the test period on all groups of animals including concurrent controls: After 30 days of test and just prior to terminal sacrifice at the end of the test period. Clinical biochemistry test areas which are considered appropriate to all studies: Electrolyte balance, carbohydrate metabolism, and liver and kidney function. The selection of specific tests will be influenced by observations on the mode of action of the substance. Suggested determinations: Calcium, phosphorus, chloride, sodium, potassium, fasting glucose (with period of fasting appropriate to the species), serum glutamic-pyruvic transaminase (now known as serum alanine ami-no-trans-ferase), serum glutamic oxaloacetic trans-am-i-nase (now known as serum aspartate aminotransferase), ornithine decarboxylase, gamma glutamyl transpeptidase, urea nitrogen, albumen, blood creatinine, total bilirubin, and total serum protein measurements. Other determinations which may be necessary for an adequate toxicological evaluation include: Analyses of lipids, hormones, acid/base balance, methemoglobin, and cholinesterase activity. Additional clinical biochemistry may be employed, where necessary, to extend the investigation of observed effects.
(ii) The following examinations shall be made on high dose and control groups. If changes in the eyes are detected, all animals should be examined.
(A) Ophthalmological examination, using an ophthalmoscope or equivalent suitable equipment, shall be made prior to the administration of the test substance and at the termination of the study.
(B) Urinalysis is not recommended on a routine basis, but only when there is an indication based on expected and or observed toxicity.
(10)
(ii) At least the liver, kidneys, adrenals, and gonads shall be weighed wet, as soon as possible after dissection to avoid drying. In addition, for the rodent, the brain; for the non-rodent, the thyroid with parathyroids also shall be weighed wet.
(iii) The following organs and tissues, or representative samples thereof, shall be preserved in a suitable medium for possible future histopathological examination: All gross lesions; lungs—which should be removed intact, weighed, and treated with a suitable fixative to ensure that lung structure is maintained (perfusion with the fixative is considered to be an effective procedure); nasopharyngeal tissues; brain— including sections of medulla/pons, cerebellar cortex, and cerebral cortex; pituitary; thyroid/parathyroid; thymus; trachea; heart; sternum with bone marrow; salivary glands; liver; spleen; kidneys; adrenals; pancreas; gonads; uterus; accessory genital organs (epididymis, prostate, and, if present, seminal vesicles); aorta; (skin); gall bladder (if present); esophagus; stomach; duodenum; jejunum; ileum; cecum; colon; rectum; urinary bladder; representative lymph node; (mammary gland); (thigh musculature); peripheral nerve; (eyes); (femur—including articular surface); (spinal cord at three levels—cervical, midthoracic, and lumbar); and
(11)
(i) Full histopathology on the organs and tissues, listed above, of all rodents in the control and high dose groups, all non-rodents, and all rodents that died or were killed during the study.
(ii) All gross lesions in all animals.
(iii) Target organs in all animals.
(iv) The tissues mentioned in brackets (listed above) if indicated by signs of toxicity of target organ involvement.
(v) Lungs, liver and kidneys of all animals. Special attention to examination of the lungs of rodents shall be made for evidence of infection since this provides a convenient assessment of the state of health of the animals.
(vi) When a satellite group is used (rodents), histopathology shall be performed on tissues and organs identified as showing effects in the treated groups.
(f)
(ii) All observed results, quantitative and incidental, should be evaluated by an appropriate statistical method. Any generally accepted statistical methods may be used; the statistical methods should be selected during the design of the study.
(2)
(ii) In any study which demonstrates an absence of toxic effects, further investigation to establish absorption and bioavailability of the test substance should be considered.
(3)
(i)
(A) Number of animals dying.
(B) Number of animals showing signs of toxicity.
(C) Number of animals exposed.
(ii)
(B) Date of observation of each abnormal sign and its subsequent course.
(C) Body weight data.
(D) Feed consumption data when collected.
(E) Hematological tests employed and all results.
(F) Clinical biochemistry tests employed and all results.
(G) Necropsy findings.
(H) Detailed description of all histopathological findings.
(I) Statistical treatment of results where appropriate.
(g)
(1) Boyd, E.M. “Chapter 14—Pilot Studies, 15—Uniposal Clinical Parameters, 16—Uniposal Autopsy Parameters.”
(2) Fitzhugh, O.G. “Subacute Toxicity,”
(3) Food Safety Council. “Subchronic Toxicity Studies,”
(4) National Academy of Sciences. “Principles and Procedures for Evaluating the Toxicity of Household Substances,” a report prepared by the Committee for the Revision of NAS Publication 1138, under the auspices of the Committee on Toxicology, National Research Council, National Academy of Sciences, Washington, DC (1977).
(5) World Health Organization. “Part I. Environmental Health Criteria 6,”
(a)
(b)
(ii)
(B) Dosing of dogs should begin between 4 and 6 months of age and in no case later than 9 months of age.
(C) At commencement of the study the weight variation of animals used should not exceed ±20 percent of the mean weight for each sex.
(iii)
(B) The females should be nulliparous and non-pregnant.
(iv)
(B) If interim sacrifices are planned, the number should be increased by the number of animals scheduled to be sacrificed during the course of the study.
(C) The number of animals at the termination of the study must be adequate for a meaningful and valid statistical evaluation of chronic effects.
(2)
(ii) In special circumstances such as in inhalation studies involving aerosols or the use of an emulsifier of uncharacterized biological activity in oral studies, a concurrent negative control group should be utilized. The negative control group should be treated in the same manner as all other test animals except that this control group should not be exposed to either the test substance or any vehicle.
(3)
(ii) The high dose level in rodents should elicit some signs of toxicity without causing excessive lethality; for non-rodents, there should be signs of toxicity but there should be no fatalities.
(iii) The lowest dose level should not produce any evidence of toxicity. Where there is a usable estimation of human exposure the lowest dose level should exceed this even though this dose level may result in some signs of toxicity.
(iv) Ideally, the intermediate dose level(s) should produce minimal observable toxic effects. If more than one intermediate dose is used, the dose level should be spaced to produce a gradation of toxic effects.
(v) For rodents, the incidence of fatalities in low and intermediate dose groups and in the controls should be low to permit a meaningful evaluation of the results. For non-rodents, there should be no fatalities.
(4)
(5)
(6)
(i)
(B) If the test substance is administered in the drinking water, or mixed in the diet, exposure is continuous.
(C) For a diet mixture, the highest concentration should not exceed 5 percent.
(ii)
(B) Fur should be clipped from the dorsal area of the trunk of the test animals. Care must be taken to avoid abrading the skin which could alter its permeability.
(C) The test substance should be applied uniformly over a shaved area which is approximately 10 percent of the total body surface area. With highly toxic substances, the surface area covered may be less, but as much of the area should be covered with as thin and uniform a film as possible.
(D) During the exposure period, the test substance may be held if necessary, in contact with the skin with a porous gauze dressing and non-irritating tape. The test site should be further covered in a suitable manner to retain the gauze dressing and test substance and ensure that the animals cannot ingest the test substance.
(iii)
(B) The temperature at which the test is performed should be maintained at 22 °C (±2°). Ideally, the relative humidity should be maintained between 40 to 60 percent, but in certain instances (e.g., tests of aerosols, use of water vehicle) this may not be practicable.
(C) Feed and water should be withheld during each daily 6 hour exposure period.
(D) A dynamic inhalation system with a suitable analytical concentration control system should be used. The rate of air flow should be adjusted to ensure that conditions throughout the equipment are essentially the same. Maintenance of slight negative
(7)
(ii) Additional observations should be made daily with appropriate actions taken to minimize loss of animals to the study (e.g., necropsy or refrigeration of those animals found dead and isolation or sacrific of weak or moribund animals).
(iii) Clinical signs of toxicity including suspected tumors and mortality should be recorded as they are observed, including the time of onset, the degree and duration.
(iv) Cage-side observations should include, but not be limited to, changes in skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern.
(v) Body weights should be recorded individually for all animals once a week during the first 13 weeks of the test period and at least once every 4 weeks thereafter unless signs of clinical toxicity suggest more frequent weighings to facilitate monitoring of health status.
(vi) When the test substance is administered in the feed or drinking water, measurements of feed or water consumption, respectively, should be determined weekly during the first 13 weeks of the study and then at approximately monthly intervals unless health status or body weight changes dictate otherwise.
(vii) At the end of the study period all survivors should be sacrificed. Moribund animals should be removed and sacrificed when noticed.
(8)
(i) The rate of air flow should be monitored continuously, but should be recorded at intervals of at least once every 30 minutes.
(ii) During each exposure period the actual concentrations of the test substance should be held as constant as practicable, monitored continuously and measured at least three times during the test period: at the beginning, at an intermediate time and at the end of the period.
(iii) During the development of the generating system, particle size analysis should be performed to establish the stability of aerosol concentrations. During exposure, analysis should be conducted as often as necessary to determine the consistency of particle size distribution and homogeneity of the exposure stream.
(iv) Temperature and humidity should be monitored continuously, but should be recorded at intervals of at least once every 30 minutes.
(9)
(i) Certain hematology determinations (e.g., hemoglobin content, packed cell volume, total red blood cells, total white blood cells, platelets, or other measures of clotting potential) should be performed at termination and should be performed at 3 months, 6 months and at approximately 6 month intervals thereafter (for studies extending beyond 12 months) on blood samples collected from all non-rodents and from 10 rats per sex of all groups. These collections should be from the same animals at each interval. If clinical observations suggest a deterioration in health of the animals during the study, a differential blood count of the affected animals should be performed. A differential blood count should be performed on samples from those animals in the highest dosage group and the controls. Differential blood counts should be performed for the next lower group(s) if there is a major discrepancy between the highest group and the controls. If hematological effects were noted in the subchronic test, he-ma-tolog-ical testing should be performed at 3, 6, 12, 18, and 24 months for a two year study and at 3, 6, and 12 months for a 1-year study.
(ii) Certain clinical biochemistry determinations on blood should be carried out at least three times during the test period: just prior to initiation of dosing (base line data), near the middle and at the end of the test period. Blood samples should be drawn for clinical chemistry measurements from all non-
(iii) Urine samples from rodents at the same intervals as the he-ma-to-log-i-cal examinations under paragraph (b)(9)(i) of this section should be collected for analysis. The following determinations should be made from either individual animals or on a pooled sample/sex/group for rodents: appearance (volume and specific gravity), protein, glucose, ketones, bilirubin, occult blood (semi-quan-ti-ta-tively); and microscopy of sediment (semi-quantitatively).
(iv) Ophthalmological examination, using an ophthalmoscope or equivalent suitable equipment, should be made prior to the administration of the test substance and at the termination of the study. If changes in eyes are detected all animals should be examined.
(10)
(ii) The liver, kidneys, adrenals, brain and gonads should be weighed wet, as soon as possible after dissection to avoid drying. For these organs, at least 10 rodents per sex per group and all non-rodents should be weighed.
(iii) The following organs and tissues, or representative samples thereof, should be preserved in a suitable medium for possible future his-to-patho-log-i-cal examination: All gross lesions and tumors; brain—including sections of medulla/pons, cerebellar cortex, and cerebral cortex; pituitary; thyroid/parathyroid; thymus; lungs; trachea; heart; sternum and/or femur with bone marrow; salivary glands; liver; spleen; kidneys; adrenals; esophagus; stomach; duodenum; jejunum; ileum; cecum; colon; rectum; urinary bladder; representative lymph nodes; pancreas; gonads; uterus; accessory genital organs (epididymis, prostate, and, if present, seminal vesicles; female mammary gland; aorta; gall bladder (if present); skin; musculature; peripheral nerve; spinal cord at three levels—cervical, midthoracic, and lumbar; and eyes. In inhalation studies, the entire respiratory tract, including nose, pharynx, larynx, and paranasal sinuses should be examined and preserved. In dermal studies, skin from sites of skin painting should be examined and preserved.
(iv) Inflation of lungs and urinary bladder with a fixative is the optimal method for preservation of these tissues. The proper inflation and fixation of the lungs in inhalation studies is considered essential for appropriate and valid histopathological examination.
(v) If other clinical examinations are carried out, the information obtained from these procedures should be available before microscopic examination, since they may provide significant guidance to the pathologist.
(11)
(A) Full histopathology on the organs and tissues, listed above, of all non-rodents, of all rodents in the control and high dose groups and of all rodents that died or were killed during the study.
(B) All gross lesions in all animals.
(C) Target organs in all animals.
(D) Lungs, liver and kidneys of all animals. Special attention to examination of the lungs of rodents should be made for evidence of infection since this provides an assessment of the state of health of the animals.
(ii) If excessive early deaths or other problems occur in the high dose group compromising the significance of the data, the next dose level should be examined for complete histopathology.
(iii) In case the results of an experiment give evidence of substantial alteration of the animals' normal longevity or the induction of effects that might affect a toxic response, the next lower dose level should be examined fully, as described under paragraph (b)(11)(i) of this section.
(iv) An attempt should be made to correlate gross observations with microscopic findings.
(c)
(ii) All observed results, quantitative and incidental, should be evaluated by an appropriate statistical method. Any generally accepted statistical methods may be used; the statistical methods should be selected during the design of the study.
(2)
(ii) In any study which demonstrates an absence of toxic effects, further investigation to establish absorption and bioavailability of the test substance should be considered.
(3)
(A)
(
(
(
(B)
(
(
(
(
(
(
(
(
(
(ii) In addition, for inhalation studies the following should be reported:
(A)
(
(B)
(
(
(
(
(
(d)
(1) Benitz, K.F. “Measurement of Chronic Toxicity,”
(2) D'Aguanno, W. “Drug Safety Evaluation—Pre-Clinical Considerations,”
(3) Fitzhugh, O.G. Third Printing: 1975. “Chronic Oral Toxicity,”
(4) Goldenthal, E.I., D'Aguanno, W. “Evaluation of Drugs,”
(5) National Academy of Sciences. “Principles and Procedures for Evaluating the Toxicity of Household Substances,” a report prepared by the Committee for the Revision of NAS Publication 1138, under the auspices of the Committee on Toxicology, National Research Council, National Academy of Sciences, Washington, DC (1977).
(6) National Center for Toxicological Research. “Appendix B,”
(7) Page, N.P. “Chronic Toxicity and Carcinogenicity Guidelines,”
(8) Schwartz, E. “Toxicology of Neuroleptic Agents,”
(9) United States Pharmaceutical Manufacturers Association.
(10) World Health Organization. “Guidelines for Evaluation of Drugs for Use in Man,”
(11) World Health Organization. “Part I. Environmental Health Criteria 6,”
(12) World Health Organization. “Principles for Pre-Clinical Testing of Drug Safety,”
(a)
(b)
(ii)
(B) At commencement of the study, the weight variation of animals used shall not exceed ±20 percent of the mean weight for each sex.
(C) Studies using prenatal or neonatal animals may be recommended under special conditions.
(iii)
(B) The females shall be nulliparous and non-pregnant.
(iv)
(B) If interim sacrifices are planned the number shall be increased by the number of animals scheduled to be sacrificed during the course of the study.
(C) The number of animals at the termination of the study should be adequate for a meaningful and valid statistical evaluation of long term exposure. For a valid interpretation of negative results, it is essential that survival in all groups does not fall below 50 percent at the time of termination.
(2)
(ii) In special circumstances such as in inhalation studies involving aerosols or the use of an emulsifier of uncharacterized biological activity in oral studies, a concurrent negative control group shall be utilized. The negative control group shall be treated in the same manner as all other test animals except that this control group shall not be exposed to either the test substance or any vehicle.
(iii) The use of historical control data (i.e., the incidence of tumors and other suspect lesions normally occurring under the same laboratory conditions and in the same strain of animals employed in the test) is desirable for assessing the significance of changes observed in exposed animals.
(3)
(ii) The high dose level should elicit signs of minimal toxicity without substantially altering the normal life span.
(iii) The lowest dose should not interfere with normal growth, development and longevity of the animal; and it should not otherwise cause any indication of toxicity. In general, this should not be lower than ten percent of the high dose.
(iv) The intermediate dose(s) should be established in a mid-range between the high and low doses, depending upon the toxicokinetic properties of the chemical, if known.
(v) The selection of these dose levels should be based on existing data, preferably on the results of subchronic studies.
(4)
(5)
(6)
(i)
(B) If the test substance is administered in the drinking water, or mixed in the diet, exposure shall be continuous.
(C) For a diet mixture, the highest concentration should not exceed 5 percent.
(ii)
(B) Fur should be clipped from the dorsal area of the trunk of the test animals. Care should be taken to avoid abrading the skin which could alter its permeability.
(C) The test substance shall be applied uniformly over a shaved area which is approximately 10 percent of the total body surface area. With highly toxic substances, the surface area covered may be less, but as much of the area shall be covered with as thin and uniform a film as possible.
(D) During the exposure period, the test substance may be held, if necessary, in contact with the skin with a porous gauze dressing and non-irritating tape. The test site should be further covered in a suitable manner to retain the gauze dressing and test substance and ensure that the animals cannot ingest the test substance.
(iii)
(B) The temperature at which the test is performed should be maintained at 22 °C (±2°). Ideally, the relative humidity should be maintained between 40 to 60 percent, but in certain instances (e.g. tests of aerosols, use of water vehicle) this may not be practicable.
(C) Feed and water shall be withheld during each daily 6-hour exposure period.
(D) A dynamic inhalation system with a suitable flow control system shall be used. The rate of air flow shall be adjusted to ensure that conditions throughout the equipment are essentially the same. Maintenance of slight negative pressure inside the chamber will prevent leakage of the test substance into the surrounding areas.
(7)
(ii) Additional observations shall be made daily with appropriate actions taken to minimize loss of animals to the study (e.g., necropsy or refrigeration of those animals found dead and isolation or sacrifice of weak or moribund animals).
(iii) Clinical signs and mortality shall be recorded for all animals. Special attention should be paid to tumor development. The day of onset, location, dimensions, appearance and progression of each grossly visible or palpable tumor shall be recorded.
(iv) Body weights shall be recorded individually for all animals once a week during the first 13 weeks of the test period and at least once every 4 weeks thereafter unless signs of clinical toxicity suggest more frequent weighings to facilitate monitoring of health status.
(v) When the test substance is administered in the feed or drinking water, measurements of feed or water consumption, respectively, shall be determined weekly during the first 13 weeks of the study and then at approximately monthly intervals unless health status or body weight changes dictate otherwise.
(vi) At the end of the study period all survivors are sacrificed. Moribund animals shall be removed and sacrificed when noticed.
(8)
(i) The rate of air flow shall be monitored continuously and recorded -at intervals of at least once every 30 minutes.
(ii) During each exposure period the actual concentrations of the test substance shall be held as constant as practicable, monitored continuously and recorded at least three times during the test period: at the beginning, at an intermediate time and at the end of the period.
(iii) During the development of the generating system, particle size analysis shall be performed to establish the
(iv) Temperature and humidity shall be monitored continuously, but shoud be recorded at intervals of at least once every 30 minutes.
(9)
(10)
(ii) The following organs and tissues or representative samples thereof, shall be preserved in a suitable medium for possible future histopathological examination: All gross lesions and tumors of all animals shall be preserved; brain—including sections of medulla/pons, cerebellar cortex and cerebral cortex; pituitary; thyroid/parathyroid; thymus; lungs; trachea; heart; spinal cord at three levels—cervical, midthoracic and lumbar; sternum and/or femur with bone marrow; salivary glands; liver; spleen; kidneys; adrenals; esophagus; stomach; duodenum; jejunum; ileum; cecum; colon; rectum; urinary bladder; representative lymph nodes; pancreas; gonads; uterus; accessory genital organs (epididymis, prostate, and, if present, seminal vesicles); mammary gland; skin; musculature; peripheral nerve; and eyes. In inhalation studies, the entire respiratory tract shall be preserved, including nasal cavity, pharynx, larynx and paranasal sinuses. In dermal studies, skin from sites of skin painting shall be examined and preserved.
(iii) Inflation of lungs and urinary bladder with a fixative is the optimal method for preservation of these tissues. The proper inflation and fixation of the lungs in inhalation studies is required for appropriate and valid histopathological examination.
(iv) If other clinical examinations are carried out, the information obtained from these procedures shall be available before microscopic examination, since they may provide significant guidance to the pathologist.
(11)
(A) Full histopathology on organs and tissues listed above of all animals in the control and high dose groups and all animals that died or were killed during the study.
(B) All gross lesions in all animals.
(C) Target organs in all animals.
(ii) If a significant difference is observed in hyperplastic, pre-neoplastic or neoplastic lesions between the highest dose and control groups, microscopic examination shall be made on that particular organ or tissue of all animals in the study.
(iii) If excessive early deaths or other problems occur in the high dose group, compromising the significance of the data, the next lower dose level shall be examined for complete histopathology.
(iv) In case the results of an experiment give evidence of substantial alteration of the animals' normal longevity or the induction of effects that might affect a neoplastic response, the next lower dose level shall be examined fully as described in this section.
(v) An attempt shall be made to correlate gross observations with microscopic findings.
(c)
(ii) All observed results, quantitative and incidental, shall be evaluated by
(2)
(ii) In any study which demonstrates an absence of toxic effects, further investigation to establish absorption and bioavailability of the test substance should be considered.
(iii) In order for a negative test to be acceptable, it shall meet the following criteria: no more than 10 percent of any group is lost due to autolysis, cannibalism, or management problems; and survival in each group should be no less than 50 percent at 18 months for mice and hamsters and at 24 months for rats.
(3)
(A)
(
(
(
(B)
(
(
(
(
(
(
(
(
(
(
(ii) In addition, for inhalation studies the following shall be reported:
(A)
(
(B)
(
(
(
(
(
(d)
(1) Department of Health and Welfare.
(2) Food and Drug Administration Advisory Committee on Protocols for Safety Evaluation: Panel on Carcinogenesis. “Report on Cancer Testing in the Safety of Food Additives and Pesticides,”
(3) International Union Against Cancer. “Carcinogenicity Testing,”
(4) Leong, B.K.J., Laskin, S. “Number and Species of Experimental Animals for Inhalation Carcinogenicity Studies” Paper presented at Conference on Target Organ Toxicity, September 1975, Cincinnati, Ohio.
(5) National Academy of Sciences. “Principles and Procedures for Evaluating the Toxicity of Household Substances.” A report prepared by the Committee for the Revision of NAS Publication 1138, under the auspices of the Committee on Toxicology, National Research Council, National Academy of Sciences, Washington, DC (1977).
(6) National Cancer Institute.
(7) National Center for Toxicological Research. “Appendix B,”
(8) Page, N.P. “Chronic Toxicity and Carcinogenicity Guidelines,”
(9) Page, N.P. “Concepts of a Bioassay Program in Environmental Carcinogenesis,”
(10) Sontag, J.M., Page N.P., Saffiotti, U.
(11) United States Pharmaceutical Manufacturers Association.
(12) World Health Organization. “Principles for the Testing and Evaluation of Drugs for Carcinogenicity,”
(13) World Health Organization. “Part I. Environmental Health Criteria 6,”
(a)
(b)
(ii)
(B) At commencement of the study, the weight variation of animals used should not exceed ±20 percent of the mean weight for each sex.
(C) Studies using prenatal or neonatal animals may be recommended under special conditions.
(iii)
(B) The females should be nulliparous and nonpregnant.
(iv)
(B) If interim sacrifices are planned, the number of animals should be increased by the number of animals scheduled to be sacrificed during the course of the study.
(C) The number of animals at the termination of each phase of the study should be adequate for a meaningful and valid statistical evaluation of long term exposure. For a valid interpretation of negative results, it is essential that survival in all groups not fall below 50 percent at the time of termination.
(2)
(ii) In special circumstances such as inhalation studies involving aerosols or the use of an emulsifier of uncharacterized biological activity in oral studies, a concurrent negative control group should be utilized. The negative control group should be treated in the same manner as all other test animals, except that this control group should not be exposed to the test substance or any vehicle.
(iii) The use of historical control data (i.e., the incidence of tumors and other suspect lesions normally occuring under the same laboratory conditions and in the same strain of animals employed in the test) is desirable for assessing the significance of changes observed in exposed animals.
(3)
(ii) The highest dose level in rodents should elicit signs of toxicity without substantially altering the normal life span due to effects other than tumors.
(iii) The lowest dose level should produce no evidence of toxicity. Where there is a usable estimation of human exposure, the lowest dose level should exceed this even though this dose level may result in some signs of toxicity.
(iv) Ideally, the intermediate dose level(s) should produce minimal observable toxic effects. If more than one intermediate dose is used the dose levels should be spaced to produce a gradation of toxic effects.
(v) For rodents, the incidence of fatalities in low and intermediate dose groups and in the controls should be low to permit a meaningful evaluation of the results.
(vi) For chronic toxicological assessment, a high dose treated satellite and a concurrent control satellite group should be included in the study design. The highest dose for satellite animals should be chosen so as to produce frank toxicity, but not excessive lethality, in order to elucidate a chronic toxicological profile of the test substance. If more than one dose level is selected for satellite dose groups, the doses should be spaced to produce a gradation of toxic effects.
(4)
(5)
(i) Generally, the termination of the study should be at 18 months for mice and hamsters and 24 months for rats; however, for certain strains of animals with greater longevity and/or low spontaneous tumor rate, termination should be at 24 months for mice and hamsters and at 30 months for rats. For longer time periods, and where any other species are used, consultation with the Agency in regard to duration of the test is advised.
(ii) However, termination of the study is acceptable when the number of survivors of the lower doses or of the control group reaches 25 percent. In the case where only the high dose group dies prematurely for obvious reasons of toxicity, this should not trigger termination of the study.
(iii) The satellite groups and the concurrent satellite control group should be retained in the study for at least 12 months. These groups should be scheduled for sacrifice for an estimation of test-substance-related pathology uncomplicated by geriatric changes.
(6)
(i)
(B) If the test substance is administered in the drinking water, or mixed in the diet, exposure is continuous.
(C) For a diet mixture, the highest concentration should not exceed 5 percent.
(ii)
(B) Fur should be clipped from the dorsal area of the trunk of the test animals. Care should be taken to avoid abrading the skin which could alter its permeability.
(C) The test substance should be applied uniformly over a shaved area which is approximately 10 percent of the total body surface area. With highly toxic substances, the surface area covered may be less, but as much of the area as possible should be covered with as thin and uniform a film as possible.
(D) During the exposure period, the test substance may be held, if necessary, in contact with the skin with a porous gauze dressing and nonirritating tape. The test site should be further covered in a suitable manner to retain the gauze dressing and test substance and ensure that the animals cannot ingest the test substance.
(iii)
(B) The temperature at which the test is performed should be maintained at 22 °C (±2°). Ideally, the relative humidity should be maintained between
(C) Feed and water should be withheld during each daily 6-hour exposure period.
(D) A dynamic inhalation system with a suitable analytical concentration control system should be used. The rate of air flow should be adjusted to ensure that conditions throughout the equipment are essentially the same. Maintenance of slight negative pressure inside the chamber will prevent leakage of the test substance into the surrounding areas.
(7)
(ii) Additional observations should be made daily with appropriate actions taken to minimize loss of animals to the study (e.g., necropsy or refrigeration of those animals found dead and isolation or sacrifice of weak or moribund animals).
(iii) Clinical signs and mortality should be recorded for all animals. Special attention should be paid to tumor development. The time of onset, location, dimensions, appearance and progression of each grossly visible or palpable tumor should be recorded.
(iv) Body weights should be recorded individually for all animals once a week during the first 13 weeks of the test period and at least once every 4 weeks thereafter, unless signs of clinical toxicity suggest more frequent weighings to facilitate monitoring of health status.
(v) When the test substance is administered in the feed or drinking water, measurements of feed or water consumption, respectively, should be determined weekly during the first 13 weeks of the study and then at approximately monthly intervals unless health status or body weight changes dictate otherwise.
(vi) At the end of the study period, all survivors are sacrificed. Moribund animals should be removed and sacrificed when noticed.
(8)
(i) The rate of airflow should be monitored continuously, but should be recorded at intervals of at least once every 30 minutes.
(ii) During each exposure period the actual concentrations of the test substance should be held as constant as practicable, monitored continuously and recorded at least three times during the test period: At the beginning, at an intermediate time and at the end of the period.
(iii) During the development of the generating system, particle size analysis should be performed to establish the stability of aerosol concentrations. During exposure, analyses should be conducted as often as necessary to determine the consistency of particle size distribution and homogeneity of the exposure stream.
(iv) Temperature and humidity should be monitored continuously, but should be recorded at intervals of at least once every 30 minutes.
(9)
(A) Certain hematology determinations (e.g., hemoglobin content, packed cell volume, total red blood cells, total white blood cells, platelets, or other measures of clotting potential) should be performed at termination and should be performed at 3 months, 6 months and at approximately 6-month intervals thereafter (for those groups on test for longer than 12 months) on blood samples collected from 20 rodents per sex of all groups. These collections should be from the same animals at each interval. If clinical observations suggest a deterioration in health of the animals during the study, a differential blood count of the affected animals should be performed. A differential blood count should be performed on samples from animals in the highest dosage group and the controls. Differential blood counts should be performed for the next lower group(s) if there is a major discrepancy between the highest group and the controls. If hematological effects were noted in the subchronic test, hematological testing should be performed at 3, 6, 12, 18 and 24 months for a year study.
(B) Certain clinical biochemistry determinations on blood should be carried out at least three times during the test period: Just prior to initiation of dosing (baseline data), near the middle and at the end of the test period. Blood samples should be drawn for clinical measurements from at least ten rodents per sex of all groups; if possible, from the same rodents at each time interval. Test areas which are considered appropriate to all studies: electrolyte balance, carbohydrate metabolism and liver and kidney function. The selection of specific tests will be influenced by observations on the mode of action of the substance and signs of clinical toxicity. Suggested chemical determinations: Calcium, phosphorus, chloride, sodium, potassium, fasting glucose (with period of fasting appropriate to the species), serum glutamic-pyruvic transaminase (now known as serum alanine aminotransferase), serum glutamic oxaloacetic transaminase (now known as serum aspartate ami-no-trans-ferase), ornithine de-car-boxylase, gamma glutamyl trans-pep-ti-dase, blood urea nitrogen, albumen, creatinine phos-pho-ki-nase, total cholesterol, total bilirubin and total serum protein measurements. Other de-ter-mi-na-tions which may be necessary for an adequate toxi-co-log-i-cal evaluation include analyses of lipids, hormones, acid/base balance, meth-e-mo-glo-bin and cho-lin-es-ter-ase activity. Additional clin-i-cal bio-chem-is-try may be employed where necessary to extend the in-ves-ti-ga-tion of observed effects.
(ii) The following should be performed on at least 10 rodents of each sex per dose level:
(A) Urine samples from the same rodents at the same intervals as hematological examination above, should be collected for analysis. The following determinations should be made from either individual animals or on a pooled sample/sex/group for rodents: appearance (volume and specific gravity), protein, glucose, ketones, bilirubin, occult blood (semi-quantitatively) and microscopy of sediment (semi-quantitatively).
(B) Ophthalmological examination, using an ophthalmoscope or equivalent suitable equipment, should be made prior to the administration of the test substance and at the termination of the study. If changes in the eyes are detected, all animals should be examined.
(10)
(ii) The liver, kidneys, adrenals, brain and gonads should be weighed wet, as soon as possible after dissection to avoid drying. For these organs, at least 10 rodents per sex per group should be weighed.
(iii) The following organs and tissues, or representative samples thereof, should be preserved in a suitable medium for possible future histo-path-o-log-i-cal examination: All gross lesions and tumors; brain-including sections of medulla/pons, cerebellar cortex, and cerebral cortex; pituitary; thyroid/parathyroid; thymus; lungs; trachea; heart; sternum and/or femur with bone marrow; salivary glands; liver; spleen; kidneys; adrenals; esophagus; stomach; duodenum; jejunum; ileum; cecum; colon; rectum; urinary bladder; representative lymph nodes; pancreas; gonads; uterus; accessory genital organs (epididymis, prostate, and, if present, seminal vesicles); female mammary gland; aorta; gall bladder (if present); skin; musculature; peripheral nerve; spinal cord at three levels—cervical, midthoracic, and lumbar; and eyes. In inhalation studies, the entire respiratory tract, including nose, pharynx, larynx and paranasal sinuses should be examined and preserved. In dermal studies, skin from sites of skin painting should be examined and preserved.
(iv) Inflation of lungs and urinary bladder with a fixative is the optimal method for preservation of these tissues. The proper inflation and fixation of the lungs in inhalation studies is considered essential for appropriate and valid histopathological examination.
(v) If other clinical examinations are carried out, the information obtained from these procedures should be available before microscopic examination, since they may provide significant guidance to the pathologist.
(11)
(A) Full histopathology on the organs and tissues, listed above, of all non-rodents, of all rodents in the control and high dose groups and of all rodents that died or were killed during the study.
(B) All gross lesions in all animals.
(C) Target organs in all animals.
(D) Lungs, liver and kidneys of all animals. Special attention to examination of the lungs of rodents should be made for evidence of infection since this provides an assessment of the state of health of the animals.
(ii) If excessive early deaths or other problems occur in the high dose group compromising the significance of the data, the next dose level should be examined for complete histopathology.
(iii) In case the results of the experiment give evidence of substantial alteration of the animals' normal longevity or the induction of effects that might affect a toxic response, the next lower dose level should be examined as described above.
(iv) An attempt should be made to correlate gross observations with microscopic findings.
(c)
(ii) All observed results, quantitative and incidental, should be evaluated by an appropriate statistical method. Any generally accepted statistical methods may be used; the statistical methods should be selected during the design of the study.
(2)
(ii) In any study which demonstrates an absence of toxic effects, further investigation to establish absorption and bioavailablity of the test substance should be considered.
(iii) In order for a negative test to be acceptable, it should meet the following criteria: No more than 10 percent of any group is lost due to autolysis, cannibalism, or management problems; and survival in each group is no less than 50 percent at 18 months for mice and hamsters and at 24 months for rats.
(3)
(A)
(
(
(
(B)
(
(
(
(
(
(
(
(
(
(
(ii) In addition, for inhalation studies the following should be reported:
(A)
(
(B)
(
(
(
(
(
(d)
(1) Benitz, K.F. “Measurement of Chronic Toxicity,”
(2) D'Aguanno, W. “Drug Safety Eval-u-ation—Pre-Clinical Considerations,” “
(3) Department of Health and Welfare.
(4) Fitzhugh, O.G. “Chronic Oral Toxicity,”
(5) Food and Drug Administration Advisory Committee on Protocols for Safety Evaluation: Panel on Carcinogenesis. “
(6) Goldenthal, E.I., and D'Aguanno, W. “Evaluation of Drugs,”
(7) International Union Against Cancer. “Carcinogenicity Testing,”
(8) Leong, B.K.J., and Laskin, S. “Number and Species of Experimental Animals for Inhalation Carcinogenicity Studies,” Paper presented at Conference on Target Organ Toxicity. September, 1975, Cincinnati, Ohio.
(9) National Academy of Sciences. “Principles and Procedures for Evaluating the Toxicity of Household Substances,” A report prepared by the Committee for the Revision of NAS Publication 1138, under the auspices of the Committee on Toxicology, National Research Council, National Academy of Sciences, Washington, DC (1977).
(10) National Cancer Institute.
(11) National Center for Toxicological.
(12) Page, N.P. “Chronic Toxicity and Carcinogenicity Guidelines,”
(13) Page, N.P. “Concepts of a Bioassay Program in Environmental Carcinogenesis,”
(14) Schwartz, E. 1974. “Toxicology of Neuroleptic Agents,”
(15) Sontag, J.M., Page, N.P., and Saffiotti, U.
(16) United States Pharmaceutical Manufacturers Association.
(17) World Health Organization. “Principles for the Testing and Evaluation of Drugs for Carcinogenicity,”
(18) World Health Organization. “Guidelines for Evaluation of Drugs for Use in Man,”
(19) World Health Organization. “Part I. Environmental Health Criteria 6,”
(20) World Health Organization. “Principles for Pre-Clinical Testing of Drug Safety,”
(a)
(b)
(2) Induction period is a period of at least 1 week following a sensitization exposure during which a hypersensitive state is developed.
(3) Induction exposure is an experimental exposure of a subject to a test substance with the intention of inducing a hypersensitive state.
(4) Challenge exposure is an experimental exposure of a previously treated subject to a test substance following an induction period, to determine whether the subject will react in a hypersensitive manner.
(c)
(d)
(i) Freund's complete adjuvant test.
(ii) Guinea-pig maximization test.
(iii) Split adjuvant technique.
(iv) Buehler test.
(v) Open epicutaneous test.
(vi) Mauer optimization test.
(vii) Footpad technique in guinea pig.
(2) Removal of hair is by clipping, shaving, or possibly by depilation, depending on the test method used.
(3)
(ii)
(B) The females should be nulliparous and nonpregnant.
(4)
(ii) Animals may act as their own controls or groups of induced animals can be compared to groups which have received only a challenge exposure.
(5)
(6)
(ii) Regardless of method selected, initial and terminal body weights should be recorded.
(7)
(e)
(2)
(3)
(i) A description of the method used and the commonly accepted name.
(ii) Information on the positive control study, including positive control used, method used, and time conducted.
(iii) The number and sex of the test animals.
(iv) Species and strain.
(v) Individual weights of the animals at the start of the test and at the conclusion of the test.
(vi) A brief description of the grading system.
(vii) Each reading made on each individual animal.
(f)
(1) Buehler, E.V. “Delayed Contact Hypersensitivity in the Guinea Pig,”
(2) Draize, J.H. “Dermal Toxicity,”
(3) Klecak, G. “Identification of Contact Allergens: Predictive Tests in Animals,”
(4) Klecak, G., Geleick, H., Grey, J.R. “Screening of Fragrance Materials for Allergenicity in the Guinea Pig.-1. Comparison of Four Testing Methods,”
(5) Magnusson, B., Kligman, A.M. “The Identification of Contact Allergens by Animal Assay,” The Guinea Pig Maximization Test.
(6) Maguire, H.C. “The Bioassay of Contact Allergens in the Guinea Pig”
(7) Maurer, T., Thomann, P., Weirich, E.G., Hess, R. “The Optimization Test in the Guinea Pig. A Method for the Predictive Evaluation of the Contact Allergenicity of Chemicals,”
(8) Maurer, T., Thomann, P., Weirich, E.G., Hess, R. “The Optimization Test in the Guinea Pig: A Method for the Predictive Evaluation of the Contact Allergenicity of Chemicals,”
(a)
(b)
(2) “Aerodynamic diameter” applies to the behavioral size of particles of aerosols. It is the diameter of a sphere of unit density which behaves aerodynamically like the particles of the test substance. It is used to compare particles of different sizes, shapes, and densities and to predict where in the respiratory tract such particles may be deposited. This term is used in contrast to “optical,” “measured” or ‘'geometric” diameters which are representation of actual diameters which in themselves cannot be related to deposition within the respiratory tract.
(3) “Geometric mean diameter” or “median diameter” is the calculated aerodynamic diameter which divides the particles of an aerosol in half based on the weight of the particles. Fifty percent of the particles by weight will be larger than the median diameter and 50 percent of the particles will be smaller than the median diameter. The median diameter and its geometeric standard deviation are used to statistically describe the particle size distribution of any aerosol based on the weight and size of the particles.
(4) “Inhalable diameter” refers to that aerodynamic diameter of a particle which is considered to be inhalable for the organism. It is used to refer to particles which are capable of being inhaled and may be deposited anywhere within the respiratory tract from the trachea to the deep lung (the alveoli). For man, the inhalable diameter is considered here as 15 micrometers or less.
(5) “Concentration” refers to an exposure level. Exposure is expressed as weight or volume of test substance per volume of air (mg/1), or as parts per million (ppm).
(6) “No-observed-effect level” is the maximum concentration in a test which produces no observed adverse effects. A no-observed-effect level is expressed in terms of weight or volume of test substance given daily per unit volume of air.
(c)
(d)
(e)
(ii)
(iii)
(iv)
(2)
(3)
(ii) The vehicle shall neither be developmentally toxic nor have effects on reproduction.
(iii) To select the appropriate concentration levels, a pilot or trial study may be advisable. Since pregnant animals have an increased minute ventilation as compared to non-pregnant animals, it is recommended that the trial study be conducted in pregnant animals. Similarly, since presumably the minute ventilation will vary with progression of pregnancy, the animals should be exposed during the same period of gestation as in the main study. In the trial study, the concentration producing embryonic or fetal lethalities or maternal toxicity should be determined.
(iv) Unless limited by the physical/chemical nature or biological properties of the substance, the highest concentration level shall induce some overt maternal toxicity such as reduced body weight or body weight gain, but not more than 10 percent maternal deaths.
(v) The lowest concentration level should not produce any grossly observable evidence of either maternal or developmental toxicity.
(vi) Ideally, the intermediate concentration level(s) shall produce minimal observable toxic effects. If more than one intermediate concentration is used, the concentration levels shall be spaced to produce a gradation of toxic effects.
(4)
(5)
(6)
(B) Pregnant animals shall not be subjected to beyond the minimum amount of stress. Since whole-body exposure appears to be the least stressful mode of exposure, it is the method preferred. In general oro-nasal or head-only exposure, which is sometimes used to avoid concurrent exposure by the dermal or oral routes, is not recommended because of the associated stress accompanying the restraining of the animals. However, there may be specific instances where it may be more appropriate than whole-body exposure. The tester shall provide justification/reasoning for its selection.
(ii) A dynamic inhalation system with a suitable flow control system shall be used. The rate of air flow shall be adjusted to ensure that conditions throughout the exposure chamber are essentially the same. Test material distribution should be established before animals are committed to dosing. Maintenance of slight negative pressure inside the chamber will prevent leakage of the test substance into the surrounding areas.
(iii) The temperature at which the test is performed should be maintained at 22 °C (±2°) for rodents or 20 °C (±3°) for rabbits. Ideally, the relative humidity should be maintained between 40 to 60 percent, but in certain instances (e.g., tests of aerosols, use of water vehicle) this may not be practicable.
(7)
(i) The rate of airflow shall be monitored continuously but shall be recorded at least every 30 minutes.
(ii) The actual concentration of the test substance shall be measured in the breathing zone. During the exposure period the actual concentrations of the test substance shall be held as constant as practicable, monitored continously or intermittently depending on the method of analysis and measured at least at the beginning, at an intermediate time and at the end of the exposure period.
(iii) During the development of the generating system, particle size analysis shall be performed to establish the stability of aerosol concentrations with respect to particle size. During exposure, analysis shall be conducted as often as necessary to determine the consistency of particle size distribution.
(iv) Temperature and humidity shall be monitored continuously and be recorded at least every 30 minutes.
(8)
(9)
(ii) Additional observations should be made daily with appropriate actions taken to minimize loss of animals to the study (e.g., necropsy or refrigeration of animals found dead and isolation or sacrifice of weak or moribund animals).
(iii) Signs of toxicity shall be recorded as they are observed, including the time of onset, the degree and duration.
(iv) Cage-side observations shall include, but not be limited to: Changes in skin and fur, eye and mucous membranes, as well as respiratory, autonomic and central nervous systems, somatomotor activity and behavioral pattern. Particular attention should be directed to observation of tremors, convulsions, salivation, diarrhea, lethargy, sleep, and coma.
(v) Measurements should be made weekly of food consumption for all animals in the study.
(vi) Animals shall be weighed at least weekly.
(vii) Females showing signs of abortion or premature delivery shall be sacrificed and subjected to a thorough macroscopic examination.
(10)
(ii) Immediately after sacrifice or death, the uterus shall be removed, weighed, and the contents examined for embryonic or fetal deaths and the number of viable fetuses. Gravid uterine weights should not be obtained from dead animals if autolysis or where decomposition has occurred. The degree of resorption shall be described in order to help estimate the relative time of death.
(iii) The number of corpora lutea shall be determined for all species except mice.
(iv) The sex of the fetuses shall be determined and they shall be weighed individually, the weights recorded, and the mean fetal weight derived.
(v) Following removal, each fetus shall be examined externally.
(vi) For rats, mice and hamsters, one-third to one-half of each litter shall be prepared and examined for skeletal anomalies, and the remaining part of each litter shall be prepared and examined for soft tissue anomalies using appropriate methods.
(vii) For rabbits, each fetus shall be examined by careful dissection for visceral anomalies and then examined for skeletal anomalies.
(f)
(2)
(3)
(i)
(B) The equipment for measuring temperature, humidity, and particulate aerosol concentrations and size shall be described.
(ii)
(A) Airflow rates through the inhalation equipment.
(B) Temperature of air.
(C) Nominal concentration—total amount of test substance fed into the inhalation equipment divided by volume of air (no standard deviation).
(D) Measured total concentrations (particulate and/or gaseous phases) in test breathing zone.
(E) Particle size distribution (e.g., median aerodynamic diameter of particles with geometric standard deviation) including estimates of the percents of inhalable and non-inhalable portions for the test animals.
(iii)
(B) Species and strain.
(C) Date of death during the study or whether animals survived to termination.
(D) Date of onset and duration of each abnormal sign and its subsequent course.
(E) Feed, body weight and uterine weight data.
(F) Pregnancy and litter data.
(G) Fetal data (live/dead, sex, soft tissue and sketetal defects, resorptions).
(g)
(1) Department of Health and Welfare.
(2) National Academy of Sciences. “Principles and Procedures for Evaluating the Toxicity of Household Substances.” A report prepared by the Committee for the Revision of NAS Publication 1138, under the auspices of the Committee on Toxicology, National Research Council, National Academy of Sciences, Washington, DC (1977).
(3) World Health Organization.
(a)
(b)
(c)
(ii)
(iii)
(B) The females shall be nulliparous and non-pregnant.
(iv)
(2)
(ii) If a vehicle is used in administering the test substance, the control group shall receive the vehicle in the highest volume used.
(iii) If a vehicle or other additive is used to facilitate dosing, it shall not interfere significantly with absorption of the test substance or produce toxic effects.
(3)
(ii) The highest dose level should induce toxicity but not high levels of mortality in the parental (P) animals.
(iii) The lowest dose level should not produce any grossly observable evidence of toxicity.
(iv) Ideally the intermediate dose level(s) should produce minimal observable toxic effects. If more than one intermediate dose is used, dose levels should be spaced to produce a gradation of toxic effects.
(4)
(i) Dosing, mating, delivery, and sacrifice schedule.
(A) Daily dosing of the parental (P) males and females shall begin when they are 5 to 8 weeks old. For both sexes, dosing shall be continued for at least 10 weeks before the mating period.
(B) Dosing of P males shall continue through the 3 week mating period. At the end of the mating period, P males may be sacrificed and examined, or may be retained for possible production of a second litter. If these animals are retained for a second litter, dosing shall be continued. Dosing of the F
(C) Daily dosing of the P females shall continue through the three week mating period, pregnancy, and to the weaning of the F
(ii) All animals are sacrificed as scheduled.
(A) All P males should be sacrificed at the end of the 3-week mating period, or may be retained for possible production of a second litter. If these animals are retained for a second litter, dosing shall be continued.
(B) F
(C) F
(D) The P females should be sacrificed upon weaning of their F
(E) F
(5)
(B) If administered by gavage or capsule, the dosage administered to each animal prior to mating shall be based on the individual animal's body weight and adjusted weekly. During pregnancy the dosage shall be based on the body weight at day 0 and 6 of pregnancy.
(ii) If another route of administration is used, the tester should provide justification and reasoning for its selection.
(6)
(B) Those pairs that fail to mate should be evaluated to determine the cause of the apparent infertility. This may involve such procedures as additional opportunities to mate with proven fertile males or females, histological examination of the reproductive organs, and examination of the estrus or spermatogenic cycles.
(C) Each day, the females shall be examined for presence of sperm or vaginal plugs. Day 0 of pregnancy is defined as the day vaginal plugs or sperm are found.
(ii)
(B) F
(iii)
(iv)
(B) Whenever the number of male or female pups prevents having 4 of each sex per litter, partial adjustment (for example, 5 males and 3 females) is permitted. Adjustments are not appropriate for litters of less than 8 pups.
(C) Elimination of runts only is not appropriate.
(D) Adjustments of the F
(7)
(ii) The duration of gestation shall be calculated from day 0 of pregnancy.
(iii) Each litter should be examined as soon as possible after delivery for the number of pups, stillbirths, live births, sex, and the presence of gross anomalies. Live pups should be counted and litters weighed at birth or soon thereafter, and on days 4, 7, 14, and 21 after parturition.
(iv) Physical or behavioral abnormalities observed in the dams of offspring shall be recorded.
(v) P males and females shall be weighed on the first day of dosing and weekly thereafter. F
(8)
(ii) Special attention shall be directed to the organs of the reproductive system.
(iii) The following organs and tissues, or representative samples thereof, shall be preserved in a suitable medium for possible future histopathological examination: Vagina; uterus; ovaries; testes; epididymides; seminal vesicles; prostate, pituitary gland; and, target organ(s) when previously identified of all P and F
(9)
(i) Full histopathology on the organs listed above for all high dose, and control P
(ii) Organs demonstrating pathology in these animals shall then be examined in animals from the other dose groups.
(iii) Microscopic examination shall be made of all tissues showing gross pathological changes.
(d)
(2)
(ii) In any study which demonstrates an absence of toxic effects, further investigation to establish absorption and bioavailability of the test substance should be considered.
(3)
(i) Toxic response data by sex and dose, including fertility, gestation, viability and lactation indices, and length of gestation.
(ii) Species and strain.
(iii) Date of death during the study or whether animals survived to termination.
(iv) Toxic or other effects on reproduction, offspring, or postnatal growth.
(v) Date of observation of each abnormal sign and its subsequent course.
(vi) Body weight data for P, F
(vii) Necropsy findings.
(viii) Detailed description of all histopathological findings.
(ix) Statistical treatment of results where appropriate.
(e)
(1) Clermont, Y., Perry, B. “Quantitative Study of the Cell Population of the Seminiferous Tubules in Immature Rats,”
(2) Goldenthal, E.I.
(3) Hasegawa, T., Hayashi, M., Ebling, F.J.G., Henderson, I.W.
(4) Oakberg, E.F. “Duration of Spermatogenesis in the Mouse and Timing of Stages of the Cycle of the Seminiferous Epithelium,”
(5) Roosen-Runge, E.C. “The Process of Spermatogenesis in Mammals,”
(a)
(b)
(2) Dose is the amount of test substance administered. Dose is expressed as weight of test substance (g, mg) per unit weight of a test animal (e.g., mg/kg).
(3) No-observed-effect level is the maximum concentration in a test which produces no observed adverse effects. A no-observed-effect level is expressed in terms of weight of test substance given daily per unit weight of test animal (mg/kg)
(c)
(d)
(e)
(ii)
(iii)
(iv)
(2)
(3)
(ii) The vehicle shall neither be developmentally toxic nor have effects on reproduction.
(iii) To select the appropriate dose levels, a pilot or trial study may be advisable. It is not always necessary to carry out a trial study in pregnant animals. Comparison of the results from a trial study in non-pregnant, and the main study in pregnant animals will demonstrate if the test substance is more toxic in pregnant animals. If a trial study is carried out in pregnant animals, the dose producing embryonic or fetal lethalities or maternal toxicity shall be determined.
(iv) Unless limited by the physical/chemical nature or biological properties of the substance, the highest dose level shall induce some overt maternal toxicity such as reduced body weight or body weight gain, but not more than 10 percent maternal deaths.
(v) The lowest dose level should not produce any grossly observable evidence of either maternal or developmental toxicity.
(vi) Ideally, the intermediate dose level(s) should produce minimal observable toxic effects. If more than one intermediate concentration is used, the concentration levels should be spaced to produce a gradation of toxic effects.
(4)
(5)
(6)
(7)
(ii) Additional observations shall be made daily with appropriate actions taken to minimize loss of animals to the study (e.g., necropsy or refrigeration of those animals found dead and isolation or sacrifice of weak or moribund animals).
(iii) Signs of toxicity shall be recorded as they are observed, including the time of onset, the degree and duration.
(iv) Cage-side observations shall include, but not be limited to: changes in skin and fur, eye and mucous membranes, as well as respiratory, autonomic and central nervous systems, somatomotor activity and behavioral pattern.
(v) Measurements should be made weekly of food consumption for all animals in the study.
(vi) Animals shall be weighed at least weekly.
(vii) Females showing signs of abortion or premature delivery shall be sacrificed and subjected to a thorough macroscopic examination.
(8)
(ii) Immediately after sacrifice or as soon as possible after death, the uterus shall be removed and the contents examined for embryonic or fetal deaths and the number of viable fetuses. The degree of resorption shall be described in order to help estimate the relative time of death of the conceptus. The weight of the gravid uterus should be recorded for dams that are sacrificed. Gravid uterine weights should not be obtained from dead animals if autolysis or decomposition has occurred.
(iii) The number of corpora lutea shall be determined for all species except mice.
(iv) The sex of the fetuses shall be determined and they shall be weighed individually, the weights recorded, and the mean fetal weight derived.
(v) Following removal, each fetus shall be examined externally.
(vi) For rats, mice and hamsters, one-third to one-half of each litter shall be prepared and examined for skeletal anomalies, and the remaining part of each litter shall be prepared and examined for soft tissue anomalies using appropriate methods.
(vii) For rabbits, each fetus shall be examined by careful dissection for visceral anomalies and then examined for skeletal anomalies.
(f)
(2)
(3)
(i) Toxic response data by concentration.
(ii) Species and strain.
(iii) Date of death during the study or whether animals survived to termination.
(iv) Date of onset and duration of each abnormal sign and its subsequent course.
(v) Food, body weight and uterine weight data.
(vi) Pregnancy and litter data.
(vii) Fetal data (live/dead, sex, soft tissue and skeletal defects, re-sorp-tions).
(g)
(1) Department of Health and Welfare.
(2) National Academy of Sciences. “Principles and Procedures for Evaluating the Toxicity of Household Substances.” A report prepared by the Committee for the Revision of NAS Publication 1138, under the auspices of the Committee on Toxicology, National Research Council, National
(3) World Health Organization.
(a)
(b)
(2) The germ line is comprised of the cells in the gonads of higher eukaryotes, which are the carriers of the genetic information for the species.
(c)
(d)
(2)
(3)
(ii)
(iii)
(A) The production of concurrent spontaneous controls.
(B) The use of positive controls.
(C) The power of the test.
(4)
(ii)
(5)
(ii)
(iii)
(e)
(2)
(ii)
(iii)
(iv)
(f)
(2)
(3)
(ii) A test chemical which does not produce a statistically significant increase in the frequency of elec-troph-oretic mutations over the spontaneous frequency, or a statistically significant and reproducible positive response for at least one of the test points, is considered non-muta-genic in this system, provided that the sample size is sufficient to exclude a biologically significant increase in mutation frequency.
(iii) Both biological and statistical significance should be considered together in the evaluation.
(4)
(ii) Negative results indicate that, under the test conditions, the test chemical does not induce heritable genemutations in a mammalian species.
(5)
(i) Strain, age and weight of animals used; numbers of animals of each sex in experimental and control groups.
(ii) Test chemical vehicle, doses used, rationale for dose selection, and toxicity data, if available.
(iii) Route and duration of exposure.
(iv) Mating schedule.
(v) Number of loci screened for both treated and spontaneous data.
(vi) Criteria for scoring mutants.
(vii) Number of mutants found/locus.
(viii) Loci at which mutations were found.
(ix) Use of concurrent negative and positive controls.
(x) Dose-response relationship, if applicable.
(g)
(1) Personal communication from Susan E. Lewis, Ph.D. to Dr. Michael Cimino, U.S. EPA, OPPT, October 5, 1989.
(2) Johnson, F.M., G.T. Roberts, R.K. Sharma, F.Chasalow, R. Zweidinger, A. Morgan, R.W. Hendren, and S.E.Lewis. “The detection of mutants in mice by electrophoresis: Results of a model induction experiment with pro-car-ba-zine.”
(3) Johnson, F.M. and S.E. Lewis. “Mutation rate determinations based on electrophoretic analysis of laboratory mice.”
(4) Johnson, F.M. and S.E. Lewis. “Electrophoretically detected germinal mutations induced by ethylnitrosourea in the mouse.”
(5) Lewis, S.E., C. Felton, L.B. Barnett, W. Generoso, N. Cacheiro, and M.D. Shelby. “Dominant visible and electrophoretically expressed mu-ta-tions induced in male mice exposed to ethylene oxide by inhalation.”
(h)
(a)
(b)
(2) The germ line is the cells in the gonads of higher eukaryotes which are the carriers of the genetic information for the species.
(c)
(d)
(ii) Three variations of the method currently exist for detecting newly arising point mutations in mouse germ cells:
(A) The visible specific locus test using either 5 or 7 loci.
(B) The biochemical specific locus test using up to 20 enzymes.
(C) The test for mutations at histocompatibility loci.
(iii) Of the three tests, the visible specific locus test has been most widely used in assessing genetic hazard due to environmental agents. It is the method described in this guideline.
(2)
(3)
(ii)
(iii)
(A) The use of either historical or concurrent controls.
(B) The power of the test.
(C) The minimal rate of induction required.
(D) The use of positive controls.
(E) The level of significance desired.
(iv)
(4)
(ii)
(5)
(ii)
(iii)
(e)
(2)
(ii) Nonmutant progeny should be discarded. Mutant progeny shall be subjected to genetic tests for verification.
(f)
(2)
(3)
(ii) A test substance which does not produce either a statistically significant dose-related increase in the number of specific locus mutations or a statistically significant and reproducible positive response at any one of the test points is considered nonmutagenic in this system.
(iii) Both biological and statistical significance should be considered together in the evaluation.
(4)
(ii) Negative results indicate that under the test conditions the test substance does not induce heritable gene mutations in the test species.
(5)
(i) Strain, age and weight of animals used, number of animals of each sex in experimental and control groups.
(ii) Test chemical vehicle, doses used and rationale for dose selection, toxicity data.
(iii) Route and duration of exposure.
(iv) Mating schedule.
(v) Time of examination for mutant progeny.
(vi) Criteria for scoring mutants.
(vii) Use of concurrent or negative controls.
(viii) Dose response relationship, if applicable.
(g)
(1) Russell, L.B., Shelby, P.B., von Halle, E., Sheridan, W., Valcovic, L. The mouse specific locus test with agents other than radiations: interpretation of data and recommendations for future work: A report of the U.S. EPA's Gene-Tox Program,”
(2) [Reserved]
(h)
(a)
(b)
(2) Base pair mutagens are agents which cause a base change in the DNA. In a reversion assay, this change may occur at the site of the original mutation or at a second site in the chromosome.
(3) Frameshift mutagens are agents which cause the addition or deletion of single or multiple base pairs in the DNA molecule.
(c)
(d)
(2)
(i) The direct plate incorporation method.
(ii) The preincubation method.
(iii) The azo-reduction method.
(3)
(ii)
(iii)
(4)
(5)
(ii)
(A) Strain TA 1535, TA 100, sodium azide.
(B) TA 98, 2-nitrofluorene.
(C) TA 1537, 9-aminoacridine.
(iii)
(iv)
(6)
(ii)
(B) Generally, a maximum of 5 mg/plate for pure substances is considered acceptable. At least 5 different amounts of test substance shall be tested with adequate intervals between test points.
(C) When appropriate, a single positive response shall be confirmed by testing over a narrow range of concentrations.
(e)
(2)
(ii) For tests without metabolic activation, 0.5 ml of buffer should be used in place of the 0.5 ml of S-9 mix. All other procedures shall be the same as those used for the test with metabolic activation.
(3)
(4)
(5)
(6)
(f)
(2)
(3)
(ii) A test substance which does not produce either a statistically significant dose-related increase in the number of revertants or a statistically significant and reproducible positive response at any one of the test points is considered nonmutagenic in this system.
(iii) Both biological and statistical significance should be considered together in the evaluation.
(4)
(ii) Negative results indicate that under the test conditions the test substance is not mutagenic in
(5)
(i) Bacterial strain used.
(ii) Metabolic activation system used (source, amount and cofactor); details of preparations of S-9 mix.
(iii) Dose levels and rationale for selection of dose.
(iv) Positive and negative controls.
(v) Individual plate counts, mean number of revertant colonies per plate, standard deviation.
(vi) Dose-response relationship, if applicable.
(g)
(1) Ames, B.N., McCann, J., Yamasaki, E. “Methods for detecting carcinogens and mutagens with the
(2) de Serres, F.J., Shelby, M.D. “The
(3) Prival, M.J., Mitchell, V.D. “Analysis of a method for testing azo dyes for mutagenic activity in
(4) Vogel, H.J., Bonner, D.M. “Acetylornithinase of
(a)
(b)
(2) Recessive mutation is a change in the genome which is expressed in the homozygous or hemizygous condition.
(3) Sex-Linked genes are present on the sex (X or Y) chromosomes. Sex-linked genes in the context of this guideline refer only to those located on the X-chromosome.
(c)
(d)
(2)
(3)
(4)
(ii)
(iii)
(iv)
(5)
(ii)
(iii)
(e)
(2)
(3)
(ii) Test results should be confirmed in a separate experiment.
(f)
(2)
(3)
(ii) A test substance which does not produce either a statistically significant dose-related increase in the number of sex-linked recessive lethals or a statistically significant and reproducible positive response at any one of the test points is considered non-mutagenic in this system.
(iii) Both biological and statistical significance should be considered together in the evaluation.
(4)
(ii) Negative results indicate that under the test conditions the test substance is not mutagenic in
(5)
(i)
(ii) Test chemical vehicle, treatment and sampling schedule, exposure levels, toxicity data, negative (vehicle) and positive controls, if appropriate.
(iii) Criteria for scoring lethals.
(iv) Number of chromosomes tested, number of chromosomes scored, number of chromosomes carrying a lethal mutation.
(v) Historical control data, if available.
(vi) Dose-response relationship, if applicable.
(g)
(1) Sobels, F.H., Vogel, E. “The capacity of
(2) Wurgler F.E., Sobels F.H., Vogel E. “
(a)
(b)
(2) Base pair mutagens are agents which cause a base change in the DNA.
(3) Frameshift mutagens are agents which cause the addition or deletion of single or multiple base pairs in the DNA molecule.
(4) Phenotypic expression time is a period during which unaltered gene products are depleted from newly mutated cells.
(c)
(d)
(2)
(3)
(ii)
(4)
(5)
(6)
(ii)
(B) Several concentrations (usually at least 4) of the test substance shall be used. Generally, these shall yield a concentration-related toxic effect. The highest concentration shall produce a low level of survival (approximately 10 percent), and the survival in the lowest concentration shall approximate the negative control. Cytotoxicity shall be determined after treatment with the test substance both in the presence and in the absence of an exogenous metabolic activation system. Relatively insoluble substances should be tested up to their limit of solubility under culture conditions. For freely-soluble nontoxic substances the highest concentration used should be determined on a case-by-case basis.
(e)
(2) At the end of the exposure period, cells shall be washed and cultured to determine viability and to allow for expression of the mutant phenotype.
(3) At the end of the expression period, which shall be sufficient to allow near optimal phenotypic expression of induced mutants, cells should be grown
(4) Results shall be confirmed in an independent experiment. When appropriate, a single positive response should be confirmed by testing over a narrow range of concentrations.
(f)
(2)
(3)
(ii) A test substance which does not produce either a statistically significant concentration-related increase in the mutant frequency or a statistically significant and reproducible positive response at any one of the test points is considered nonmutagenic in this system.
(iii) Both biological and statistical significance should be considered together in the evaluation.
(4)
(ii) Negative results indicate that, under the test conditions, the test substance does not induce gene mutations in the cultured mammalian cells used.
(5)
(i) Cell type used, number of cell cultures, methods used for maintenance of cell cultures.
(ii) Rationale for selection of concentrations and number of cultures.
(iii) Test conditions: composition of media, CO
(iv) Methods used to enumerate numbers of viable and mutant cells.
(v) Dose-response relationship, where possible.
(g)
(1) Amacher, D.E., Paillet, S.C., Ray, V. “Point mutations at the thymidine kinase locus in L5178Y mouse lymphoma cells. I. Application to genetic toxicology testing,”
(2) Amacher, D.E., Paillet, S.C., Turner, G.N., Ray, V.A. Salsburg, V.A. “Point mutations at the thymidine kinase locus in L5178Y mouse lymphoma cells. II. Test validation and interpretation,”
(3) Bradley, M.O., Bhuyan B., Francis, M.C., Langenback, R., Peterson, A., Huberman, E. “Mutagenesis by chemical agents in V-79 Chinese hamster cells: a review and analysis of the literature: a report of the Gene-Tox Program,”
(4) Clive, D., Johnson, K.O., Spector, J.F.S., Batson, A.G., Brown, M.M. “Validation and characterization of the L5178Y TK
(5) Clive, D., Spector, J.F.S. “Laboratory procedures for assessing specific locus mutations at the TK locus in cultured L5178Y mouse lymphoma cells,”
(6) Hsie, A.W., Casciano, D.A., Couch, D.B., Krahn, D.F., O'Neill, J.P., Whitfield, B.L. “The use of Chinese
(a)
(b)
(2) Chromatid-type aberrations are damage expressed as breakage of single chromatids or breakage and/or reunion between chromatids.
(c)
(d)
(2)
(3)
(ii)
(4)
(5)
(6)
(ii)
(e)
(2)
(3)
(4)
(5)
(ii) For human lymphocyte cultures, the substance to be tested may be added to the cultures at various times after mitogen stimulation so that there is a single harvest time after the initiation of the cell culture. Alternatively, a single treatment may be followed by multiple harvest times. Harvest time should be extended for those chemicals which induce an apparent cell cycle delay. Because the population of human lymphocytes is only partially synchronized, a single treatment, at, or close to, the time when metaphase stages first appear in the culture will include cells in all phases of the division cycle. Therefore, a single harvest at the time of second mitosis may be carried out for screening purposes.
(iii) Cell cultures shall be treated with a spindle inhibitor, (e.g., colchicine or Colcemid®), 1 or 2 hours prior to harvesting. Each culture shall be harvested and processed separately for the preparation of chromosomes.
(6)
(7)
(8)
(f)
(2)
(3)
(ii) A test substance which does not produce either a statistically significant dose-related increase in the number of structural chromosomal aberrations or a statistically significant and reproducible positive response at any one of the test points is considered nonmutagenic in this system.
(iii) Both biological and statistical significance should be considered together in the evaluation.
(4)
(ii) Negative results indicate that under the test conditions the test substance does not induce chromosomal aberrations in cultured mammalian somatic cells.
(5)
(i) Cells used, density and passage number at time of treatment, number of cell cultures.
(ii) Methods used for maintenance of cell cultures including medium, temperature and CO
(iii) Test chemical vehicle, concentration and rationale for the selection of the concentrations used in the assay, duration of treatment.
(iv) Details of both the protocol used to prepare the metabolic activation system and of its use in the assay.
(v) Identity of spindle inhibitor, its concentration and duration of treatment.
(vi) Date of cell harvest.
(vii) Positive and negative controls.
(viii) Methods used for preparation of slides for microscopic examination.
(ix) Number of metaphases analysed.
(x) Mitotic index where applicable.
(xi) Criteria for scoring aberrations.
(xii) Type and number of aberrations, given separately for each treated and control culture, total number of aberrations per group; frequency distribution of number of chromosomes in established cell lines and strains.
(xiii) Dose-response relationship, if applicable.
(g)
(1) Ames, B.N., McCann, J., Yamasaki, E. “Methods for detecting carcinogens and mutagens with the
(2) Evans, H.J. “Cytological methods for detecting chemical mutagens,”
(3) Howard, P.N., Bloom, A.D., Krooth, R.S. “Chromosomal aberrations induced by N-methyl-N′-nitro-N-nitrosoguanidine in mammalian cells,”
(4) Ishidate, M. Jr., Odashima, S. “Chromosome tests with 134 compounds on Chinese hamster cells in vitro: A screening for chemical carcinogens,”
(5) Preston, R.J., Au, W., Bender, M.A., Brewen, J.G., Carrano, A.V., Heddle, J.A., McFee, A.F., Wolff, S., Wassom, J.S., “Mammalian in vivo and in vitro cytogenetic assays: A report of the Gene-tox Program,”
(a)
(b)
(2) Chromatid-type aberrations are damage expressed as breakage of single chromatids or breakage and/or reunion between chromatids.
(c)
(d)
(2)
(3)
(ii)
(iii)
(iv)
(4)
(ii)
(5)
(ii)
(iii)
(iv)
(e)
(ii) If a repeated treatment schedule is used at the selected dose(s), samples shall be taken 6 and 24 hours after the last treatment; other sampling times may be used if justified. Where the additional dose levels are tested in a subsequent experiment, samples shall be taken at the predetermined most sensitive interval or, if this is not established, at 6 hours after the last treatment.
(2)
(3)
(4)
(f)
(2)
(3)
(ii) A test substance which does not produce either a statistically significant dose-related increase in the number of chromosomal aberrations or abnormal metaphase figures or a statistically significant and reproducible positive response at any one of the test points is considered nonmutagenic in this system.
(iii) Both biological and statistical significance should be considered together in the evaluation.
(4)
(ii) Negative results indicate that under the test conditions, the test substance does not induce chromosomal aberrations in the bone marrow of the test species.
(5)
(i) Species, strain, age, weight, number and sex of animals in each treatment and control group.
(ii) Test chemical vehicle, dose levels used, rationale for dose selection.
(iii) Route of administration, treatment and sampling schedules, toxicity data, negative and positive controls.
(iv) Identity of spindle-inhibitor, its concentration and duration of treatment.
(v) Details of the protocol used for chromosome preparation, number of cells scored per animal, type and number of aberrations given separately for each treated and control animal.
(vi) Mitotic index, where applicable.
(vii) Criteria for scoring aberrations.
(viii) Number and frequency of aberrant cells per animal in each treatment and control groups.
(ix) Total number of aberrations per group.
(x) Number of cells with aberrations per group.
(xi) Dose-response relationship, if applicable.
(g)
(1) Adler, I.D., Ramarao, G., Epstein, S.S. “In vivo cytogenetic effects of trimethyl-phosphate and of TEPA on bone marrow cells of male rats,”
(2) Evans, H.J. “Cytological methods for detecting chemical mutagens,”
(3) Kilian, J.D., Moreland, F.E. Benge, M.C., Legator, M.S., Whorton, E.B. Jr. “A collaborative study to measure intralaboratory variation with the in vivo bone morrow metaphase procedure,”
(4) Preston, J.R., Au, W., Bender, M.A., Brewen, J.G., Carrano, A.V. Heddle, J.A., McFee, A.F., Wolff, S., Wassom, J. “Mammalian in vivo and vitro cytogenetics assays: Report of the Gene-Tox Program,”
(a)
(b)
(c)
(d)
(ii) Micronuclei may also be detected in other test systems:
(A) Tissue culture.
(B) Plants.
(C) Blood smears.
(D) Fetal tissues.
(E) Meiotic cells.
(F) Hepatic cells.
(iii) The present guideline is based on the mammalian bone marrow assay.
(2)
(3)
(ii)
(iii)
(iv)
(4)
(ii)
(5)
(ii)
(iii)
(iv)
(e)
(ii) If a repeated treatment schedule is used, samples shall be taken at least three times, starting not earlier than 12 hours after the last treatment and at appropriate intervals following the first sample, but not extending beyond 72 hours.
(iii) Bone marrow shall be obtained immediately after sacrifice. Cells shall be prepared, put on slides, spread as a smear and stained.
(2)
(f)
(2)
(3)
(ii) A test substance which does not produce either a statistically significant dose-related increase in the number of micronucleated polychromatic erythrocytes or a statistically significant and reproducible positive response at any one of the test points is considered nonmutagenic in this system.
(iii) Both biological and statistical significance should be considered together in the evaluation.
(4)
(ii) Negative results indicate that under the test conditions the test substance does not produce micronuclei in the bone marrow of the test species.
(5)
(i) Species, strain, age, weight, number and sex of animals in each treatment and control group.
(ii) Test chemical vehicle, dose levels used, rationale for dose selection.
(iii) Rationale for and description of treatment and sampling schedules, toxicity data, negative and positive controls.
(iv) Details of the protocol used for slide preparation.
(v) Criteria for identifying mic-ro-nu-cle-ated e-ry-thro-cytes.
(vi) Dose-response relationship, if applicable.
(g)
(1) Cihak, R. “Evaluation of benzidine by the micronucleus test,”
(2) Cole, R.J., Taylor, N., Cole, J., Arlett, C.F. “Short-term tests for transplacentally active carcinogens. 1. Micronucleus formation in fetal and maternal mouse erythroblasts,”
(3) Kliesch, U., Danford, N., Adler, I.D. “Micronucleus test and bone-marrow chromosome analysis. A comparison of 2 methods in vivo for evaluating chemically induced chromosomal alterations,”
(4) Matter, B., Schmid, W. “Trenimon-induced chromosomal damage in bone-marrow cells of six mammalian species, evaluated by the micronucleus test,”
(5) Schmid, W. “The micronucleus test,”
(6) Schmid, W. “The micronucleus test for cytogenetic analysis,”
(7) Heddle, J.A., Hite, M., Kurkhart, B., Mavournin, K., MacGregor, J.T., Newell, G.W., Salamone, M.F. “The induction of micronuclei as a measure of genotoxicity. A report of the U.S. Environmental Protection Agency Gene-Tox Program,”
(a)
(b)
(c)
(d)
(2)
(ii) Individual males are mated sequentially to virgin females at appropriate intervals. The number of matings following treatment is governed by the treatment schedule and should ensure that germ cell maturation is adequately covered. Females are sacrificed in the second half of pregnancy and the uterine contents examined to determine the total number of implants and the number of live and dead embryos.
(3)
(ii)
(iii)
(iv)
(4)
(ii)
(5)
(ii)
(iii)
(e)
(2) The number of matings following treatment should be governed by the treatment schedule and should ensure that germ cell maturation is adequately covered.
(3) Females should be sacrificed in the second half of pregnancy and uterine contents examined to determine the number of implants and live and dead embryos. The ovaries may be examined to determine the number of corpora lutea.
(f)
(2)
(3)
(ii) A test substance which does not produce either a statistically significant dose-related increase in the number of dominant lethals or a statistically significant and reproducible positive response at any one of the test points is considered nonmutagenic in this system.
(iii) Both biological and statistical significance should be considered together in the evaluation.
(4)
(ii) A negative result suggests that under the conditions of the test the test substance may not be genotoxic in the germ cells of the treated sex of the test species.
(5)
(i) Species, strain, age and weights of animals used, number of animals of each sex in experimental and control groups.
(ii) Test substance, vehicle used, dose levels and rationale for dosage selection, negative (vehicle) and positive controls, experimental observations, including signs of toxicity.
(iii) Route and duration of exposure.
(iv) Mating schedule.
(v) Methods used to determine that mating has occurred (where applicable).
(vi) Criteria for scoring dominant lethals including the number of early and late embryonic deaths.
(vii) Dose-response relationship, if applicable.
(g)
(1) Brewen, J.G., Payne, H.S., Jones, K.P., Preston, R.J. “Studies on chemically induced dominant lethality. I. The cytogenetic basis of MMS-induced dominant lethality in post-meiotic germ cells”
(2) Ehling, U.H., Machemer, L., Buselmaier, E., Dycka, D., Frohberg, H., Kratochvilova, J., Lang, R., Lorke, D., Muller, D., Pheh, J., Rohrborn, G., Roll, R., Schulze-Schencking, M., Wiemann, H. “Standard protocol for the dominant lethal test on male mice. Set up by the Work Group “Dominant lethal mutations of the ad hoc Committee Chemogenetics,”
(a)
(b)
(2) Diakinesis and metaphase I are stages of meiotic prophase scored cytologically for the presence of multivalent chromosome association characteristic of translocation carriers.
(c)
(d)
(i)
(A) Translocations between non-homologous chromosomes in which at least one of the breaks occurs close to one end of a chromosome.
(B) Those that carry multiple translocations. The majority of male translocation heterozygotes are semisterile—they carry one or (rarely) two translocations. The degree of semisterility is dependent upon the proportions of balanced and unbalanced (duplication-deficiency) gametes produced in the ejaculate as a function of meiotic segregation. Balanced and unbalanced sperm are equally capable of fertilizing an egg. Balanced sperm lead to viable progeny. Unbalanced sperm result in early embryonic lethality.
(ii)
(2)
(3)
(ii)
(iii)
(
(
(
(
(
(B) [Reserved]
(iv)
(4)
(ii)
(5)
(ii)
(iii)
(e)
(2)
(i)
(B)
(ii)
(f)
(ii) These data shall be presented for both treated and control groups. Historical or concurrent controls shall be specified, as well as the randomization procedure used for concurrent controls.
(2)
(3)
(ii) A test substance which does not produce either a statistically significant dose-related increase in the number of heritable translocations or a statistically significant and reproducible positive response at any one of the test points is considered nonmutagenic in this system.
(iii) Both biological and statistical significance should be considered together in the evaluation.
(4)
(ii) Negative results indicate that under the test conditions the test substance does not cause heritable chromosomal damage in the test species.
(5)
(i) Species, strain, age, weight and number of animals of each sex in each group.
(ii) Test chemical vehicle, route and schedule of administration, toxicity data.
(iii) Dosing regimen, doses tested and rationale for dosage selection.
(iv) Mating schedule, number of females mated to each male.
(v) The use of historical or concurrent controls.
(vi) Screening procedure including the decision criteria used and the method by which they were determined.
(vii) Dose-response relationship, if applicable.
(g)
(1) Generoso, W.M., Bishop, J.B., Goslee, D.G., Newell, G.W., Sheu, G-J, von Halle, E. “Heritable translocation test in mice,”
(2) [Reserved]
(a)
(b)
(c)
(d)
(2)
(i) Tests performed on solid medium (diffusion tests).
(ii) Tests performed in liquid culture (suspension tests).
(3)
(ii)
(4)
(5)
(6)
(ii)
(iii)
(iv)
(v)
(7)
(ii)
(e)
(A) A single strain of bacteria may be added to an agar overlay or spread on the surface of the agar and the test chemical placed on a filter disc on the surface of the agar or;
(B) DNA repair proficient and DNA repair deficient bacteria may be streaked in a line on the surface of the agar of the same plate and a disc saturated with test chemical placed on the surface of the agar in contact with the streaks.
(ii)
(2)
(ii) Nonturbid suspensions of bacteria may be exposed to serial dilutions of the test agent and a minimal inhibitory concentration for each strain determined, as evidenced by the presence or absence of visible growth after a period of incubation.
(iii) Paired bacterial suspensions (usually with some initial turbidity) may be treated with a single dose of the chemical. Positive results are indicated by a differential inhibition in the rate of increase of turbidity of the paired cultures.
(3)
(4)
(f)
(ii)
(B) Results can also be expressed as the concentrations required to effect a predetermined survival rate (e.g., D
(C) Similarly, results can be expressed as minimal inhibitory concentration or as minimal lethal dose. The former is determined by the absence of visible growth in liquid medium and the latter is determined by plating dilutions onto semisolid media.
(iii) In all tests, concentrations must be given as the final concentrations during the treatment. Raw data, prior to transformation, should be provided. These should include actual quantities measured, e.g., neat numbers. For measurement of diffusion, the diameters of the discs and/or well should be indicated and the measurements should indicate whether the diameter of the discs and/or well was subtracted. Moreover, mention should be made as to whether the test chemical gave a sharp, diffuse, or double-zone of growth inhibition. If it is the latter, the investigator should indicate whether the inner or the outer zone was measured.
(iv) Viability data should be given as the actual plate counts with an indication of the dilution used and the volume plated or as derived titers (cells per ml). Transformed data alone in the absence of experimental data are not acceptable (i.e, ratios, differences, survival fraction).
(2)
(3)
(ii) A test substance which does not produce either a statistically significant dose-related preferential inhibition or killing of the repair deficient strain or a statistically significant and reproducible positive response at any one of the test points is considered not to interact with the genetic material of the organisms used in assay.
(iii) Both biological and statistical significance should be considered together in the evaluation.
(4)
(5)
(i) Bacterial strains used.
(ii) Phase of bacterial cell growth at time of use in the assay.
(iii) Media composition.
(iv) Details of both the protocol used to prepare the metabolic activation system and its use in the assay.
(v) Treatment protocol, including doses used and rationale for dose selection, positive and negative controls.
(vi) Method used for determination of degree of cell kill.
(vii) Dose-response relationship, if applicable.
(g)
(1) Ames, B.N., McCann, J., Ya-ma-saki, E. “Methods for detecting carcinogens and mutagens with the
(2) Kada, T., Sadie, Y., Tutikawa, K. “In vitro and host-mediated “rec-assay” procedures for screening chemical mutagens; and phloxine, a mutagenic red dye detected,”
(3) Leifer, Z., Kada, T., Mandel, M., Zeiger, E., Stafford, R., Rosenkranz, H.S. “An evaluation of bacterial DNA repair tests for predicting genotoxicity and carcinogenicity: A report of the U.S. EPA's Gene-Tox Program,”
(4) Slater, E.E., Anderson, M.D., Rosenkranz, H.S. “Rapid detection of mutagens and carcinogens.”
(a)
(b)
(2) Reciprocal translocations are chromosomal translocations resulting from reciprocal exchanges between two or more chromosomes.
(3) Heritable translocations are reciprocal translocations transmitted from parent to the succeeding progeny.
(c)
(d)
(2)
(i)
(ii) [Reserved]
(3)
(4)
(ii) Negative (vehicle) controls should be included. The size of the negative (vehicle) control group should be determined by the availability of appropriate laboratory historical control data.
(iii) If the historical control data are of sufficient numbers, concurrent controls may not be necessary.
(5)
(ii)
(iii)
(e)
(ii) Mass matings may be performed because the control rate for translocations in the available literature is very low (near 0) and clustered events are extremely rare. Mated females may be aged for 2 weeks in order to recover an enhanced incidence of translocation due to the storage effect. The females are then allowed to lay eggs and F
(2)
(3)
(4)
(f)
(2)
(3)
(ii) A test substance which does not produce either a statistically significant dose-related increase in the number of heritable translocations or a statistically significant and reproducible positive response at any one of the test points is considered nonmutagenic in this system.
(iii) Both biological and statistical significance should be considered together in the evaluation.
(4)
(ii) Negative results indicate that under the test conditions the test substance does not cause chromosomal damage in
(5)
(i)
(ii) Test chemical vehicle, treatment and mating schedule, exposure levels, toxicity data, dose and route of exposure.
(iii) Positive and negative (vehicle) controls.
(iv) Historical control data, if available.
(v) Number of chromosomes scored.
(vi) Criteria for scoring mutant chromosomes.
(vii) Dose-response relationship, if applicable.
(g)
(1) Wurgler, F.E., Sobels, F.H., Vogel, E. “
(2) [Reserved]
(a)
(b)
(2) A toxic effect is an adverse change in the structure or function of an experimental animal as a result of exposure to a chemical substance.
(c)
(d)
(ii)
(iii)
(B) The females shall be nulliparous and nonpregnant.
(2)
(3)
(ii) Concurrent or historic data from the laboratory performing the testing shall provide evidence of the ability of the procedures used to detect major neurotoxic endpoints such as limb weakness or paralysis (e.g., acrylamide), CNS stimulation (e.g., β, β′-iminodiproprionitrile) autonomatic signs (e.g., physostigmine).
(iii) A satellite group may be treated with the high dose level for the duration of exposure and observed for reversibility, persistence, or delayed occurrence of toxic effects for a post-
(4)
(i) The highest dose shall produce (A) clear behavioral effects or (B) life-threatening toxicity.
(ii) The data from the lower doses must show either (A) graded dose-dependent effects at 2 dose levels or (B) no effects at 2 dose levels, respectively.
(5)
(6)
(7)
(8)
(ii) The following is a minimal list of observations that shall be noted:
(A) Any unusual responses with respect to body position, activity level, coordination of movement, and gait.
(B) Any unusual or bizarre behavior including, but not limited to, headflicking, head searching, compulsive biting or licking, self-mutilation, circling, and walking backwards.
(C) The presence of:
(
(
(
(
(
(
(
(
(
(
(D) Forelimb/hindlimb grip strength. The procedure described by Meyer et al. (1979), under paragraph (f)(9) of this section is recommended.
(E) Sensory function. A simple assessment of sensory function (vision, audition, pain perception) shall be made. Marshall et al. (1971) under paragraph (f)(8) of this section have described a neurologic exam for this purpose; these procedures are also discussed by Deuel (1977), under paragraph (f)(4) of this section. Irwin (1968) under paragraph (f)(7) of this section described a number of reflex tests intended to detect gross sensory deficits, including the visual placing response, Preyer reflex, and tail pinch. Many procedures have been developed for assessing pain perception (e.g., Ankier, 1974 under paragraph (f)(1) of this section; D'Amour and Smith 1941 under paragraph (f)(3) of this section; Evans
(e)
(1)
(ii) Positive control data from the laboratory performing the test that demonstrate the sensitivity of the procedures being used. Historic data may be used if all aspects of the experimental protocol are the same, including personnel.
(2)
(i) In tabular form, data for each animal must be provided showing:
(A) Its identification number.
(B) Its body weight and score on each sign at each observation time, the time and cause of death (if appropriate).
(ii) Summary data for each group must include:
(A) The number of animals at the start of the test.
(B) The number of animals showing each observation score at each observation time.
(C) The percentage of animals showing each abnormal sign at each observation time.
(D) The mean and standard deviation for each continuous endpoint at each observation time.
(3)
(f)
(1) Ankier, S.I. “New hot plate tests to quantify antinociceptic and narcotic antagonist activities,”
(2) Coughenour, L.L., McLean, J.R. and Parker, R.B. “A new device for the rapid measurement of impaired motor function in mice,”
(3) D'Amour, F.E., Smith, D.L. “A method for determining loss of pain sensation,”
(4) Deuel, R.K. “Determining sensory deficits in animals,”
(5) Edwards, P.M., Parker, V.H. “A simple, sensitive and objective method for early assessment of acrylamide neuropathy in rats,”
(6) Evans, W.O. “A new technique for the investigation of some analgesic drugs on reflexive behavior in the rat,”
(7) Irwin, S. “Comprehensive observational assessment: Ia. A systematic quantitative procedure for assessing the behavioral and physiologic state of the mouse,”
(8) Marshall, J.F., Turner, B.H., Teitlbaum, P. “Sensory neglect produced by lateral hypothalamic damage,”
(9) Meyer, O.A., Tilson, H.A., Byrd, W.C., Riley, M.T. “A method for the routine assessment of fore- and hindlimb grip strength of rats and mice,”
(a)
(2)
(3)
(b)
(2) Motor activity is any movement of the experimental animal.
(3) A toxic effect is an adverse change in the structure or function of an experimental animal as a result of exposure to a chemical substance.
(c)
(d)
(ii)
(iii)
(B) The females shall be nulliparous and nonpregnant.
(2)
(3)
(ii) Positive control data are required to demonstrate the sensitivity and reliability of the activity measuring device and testing procedure. These data should demonstrate the ability to detect increases or decreases in activity and to generate a dose-effect curve or its equivalent using three values of the dose or equivalent independent variable. A single administration of the dose (or equivalent) is sufficient. It is recommended that chemical exposure be used to collect positive control data. Positive control data shall be collected at the time of the test study unless the laboratory can demonstrate the adequacy of historical data for this purpose.
(iii) A satellite group may be treated with the high dose level for 90 days and observed for reversibility, persistence or delayed occurrence of toxic effects for a post-treatment period of appropriate length, normally not less than 28 days.
(4)
(i) The highest dose shall produce (A) clear effects on motor activity or (B) life-threatening toxicity.
(ii) The data from the lower doses must show either (A) graded dose-dependent effects at 2 dose levels or (B) no effects at 2 dose levels, respectively.
(5)
(6)
(7)
(8)
(ii)
(iii)
(e)
(1)
(ii) Procedures for calibrating and assuring the equivalence of devices and balancing treatment groups.
(2)
(i) In tabular form, data must be provided showing for each animal:
(A) Its identification number.
(B) Body weight, total session activity counts, and intrasession subtotals for each date measured.
(ii) Group summary data should also be reported.
(3)
(f)
(1) Dixon, W.J., Massey, E.J.
(2) Finger, F.W. “Measuring behavioral activity,”
(3) Jensen, D.R. “Some simultaneous multivariate procedures using Hotelling's T
(4) Kinnard, E.J. and Watzman, N. “Techniques utilized in the evaluation of psychotropic drugs on animals activity,” Journal of Phar-ma-ceu-ti-cal Sciences, 55:995-1012 (1966).
(5) Neter, J. and Wasserman, W.
(6) Reiter, L.E. “Use of activity measures in behavioral toxicology,”
(7) Reiter, L.W. and MacPhail, R.C. “Motor Activity: A survey of methods with potential use in toxicity testing,”
(8) Robbins, T.W. “A critique of the methods available for the measurement of spontaneous motor activity,”
(9) Sokal, R.P. and Rohlf, E.J.
(a)
(b)
(c)
(d)
(ii)
(iii)
(2)
(3)
(ii) A satellite group of animals may be treated with the high level for 90 days and observed for reversibility, persistence, or delayed occurrence of toxic effects for a post-treatment period of appropriate length; normally not less than 28 days.
(4)
(i) The highest dose shall produce (A) clear behavioral effects or (B) life-threatening toxicity.
(ii) The data from the lower doses must show either (A) graded dose-dependent effects at two dose levels or (B) no effects at two dose levels, respectively.
(5)
(6)
(7)
(8)
(ii)
(B)
(C)
(D)
(iii)
(iv)
(B)
(C)
(D)
(E)
(
(
(
(
(F)
(
(
(
(
(e)
(1)
(2)
(i)
(ii)
(A) The number of animals used in each group, the number of animals displaying specific neurologic signs, and the number of animals in which any lesion was found;
(B) The number of animals affected by each different type of lesion, the average grade of each type of lesion, and the frequency of each different type and/or location of lesion.
(iii)
(B) The evaluation of dose-response, if existent, for various groups shall be given, and a description of statistical method must be presented. The evaluation of neuropathology data should include, where applicable, an assessment in conjunction with other neurotoxicity studies performed (eg. electrophysiological, behavioral, neurochemical).
(f)
(1) AFIP.
(2) Chang, L.W.
(3) Hayat, M.A. “Vol. 1. Biological applications,”
(4) Palay S.L., Chan-Palay, V.
(5) Ralis, H.M., Beesley, R.A., Ralis, Z.A.
(6) Spencer, P.S., Schaumburg, H.H. (eds).
(7) Zeman, W., JRM Innes, J.R.M.
(a)
(2) This guideline defines procedures for conducting studies of schedule-controlled operant behavior, one way of evaluating functional neurotoxic effects (Dews, 1972 under paragraph (f)(1) of this section; NAS 1975, 1977, 1982 under paragraphs (f)(4), (5) and (6) of this section). Our purpose is to evaluate the effects of acute and repeated exposures on the rate and pattern of responding under schedules of reinforcement. Operant behavior tests may be used to evaluate many other aspects of behavior (Laties, 1978 under paragraph (f)(3) of this section). Additional tests may be necessary to completely assess the behavioral effects of any substance. Behavioral evaluation should be used in conjunction with neuropathologic evaluation and the evaluation of other toxic effects.
(b)
(2)
(3)
(c)
(d)
(2)
(B) Under some circumstances other species may be recommended.
(ii)
(iii)
(B) Virgin females should be used.
(iv)
(3)
(4)
(ii)
(5)
(i) The highest dose shall produce: (A) Clear behavioral effects; or (B) life-threatening toxicity.
(ii) The data from the lower doses must show either: (A) Graded dose-dependent effects at 2 dose levels; or (B) no effects at 2 dose levels, respectively.
(6)
(7)
(8)
(ii)
(iii)
(B) Subjects must be trained until they display demonstrable stability in performance across days prior to exposure. One simple and useful criterion is a minimum number of sessions on the schedule and no systematic trend during the 5 days before exposure.
(C) Cumulative records of cumulative responding over time for each animal should be presented to demonstrate that the pattern of responding is representative of that generated by the schedule of reinforcement.
(iv)
(B)
(C)
(
(v)
(e)
(1)
(ii) A description of the experimental design including counterbalancing procedures, and the stability criterion.
(iii) A description and statistical evaluation of positive control and other control data, including standard measures of central tendency, variability, coefficient of variation of response rates, and the slope of the dose-effect curve.
(2)
(ii) A description and statistical evaluation of the test results: With particular reference to the overall statistical procedures (e.g., parametric or nonparametric) dose-effect curve, and calculation of slope. Presentation of calculations is encouraged.
(f)
(1) Dews, P.B. “Assessing the Effects of Drugs,”
(2) Ferster, C.B. Skinner, B.F. Schedules of Reinforcement. (New York: Appleton-Century-Crofts, 1957).
(3) Laties, V.G. “How Operant Conditioning can Contribute to Behavioral Toxicology,” Environmental Health Perspectives, 28: 29-35 (1978).
(4) National Academy of Science.
(5) National Academy of Science.
(6) National Academy of Science. “Strategies to determine needs and priorities for toxicity testing,” Appendix 3B.
(a)
(b)
(c)
(d)
(2)
(3)
(ii)
(4)
(5)
(6)
(7)
(ii)
(B)
(e)
(i) Toxic response data by group with a description of clinical manifestations of nervous system damage; where a grading system is used the criteria should be defined.
(ii) For each animal, time of death during the study or whether it survived to termination.
(iii) The day of observation of each abnormal sign and its subsequent course.
(iv) Body weight data.
(v) Necropsy findings for each animal, when performed.
(vi) A detailed description of all histopathological findings.
(vii) Statistical treatment of results, where appropriate.
(2)
(ii) All observed results should be evaluated by an appropriate statistical method. Any generally accepted statistical method may be used; the statistical methods should be selected during the design of the study.
(3)
(f)
(1) Abou-Donia, M.B. “Organo-phos-phor-us ester-induced delayed neurotoxicity” Annual Review of Pharmacology and Toxicology, 21:511-548 (1981).
(2) Abou-Donia, M.B., Pressing, S.H. “Delayed neurotoxicity from continuous low-dose oral administration of leptophos to hens.”
(3) Baron, R.L. (ed). “Pesticide Induced Delayed Neurotoxicity,” Proceedings of a Conference, February 19-20, 1976, Washington, DC. U.S. Environmental Protection Agency. EPA Report No. 600/1-76-025, Washington, DC (1976).
(4) Cavanaugh, J.B. “Peripheral neuropathy caused by chemical agents”
(5) Johannsen, F.R., Wright, P.L., Gordon, D.E., Levinskas, G.L., Radue, R.W., Graham, P.R. “Evaluation of delayed neurotoxicity and dose-response relationship of phosphate esters in the adult hen,”
(6) Johnson, M.K. “Organophosphorus esters causing delayed neurotoxic effects: mechanism of action and structure/activity studies,”
15 U.S.C. 2603, 2611, 2625.
(a) This part identifies the chemical substances, mixtures, and categories of substances and mixtures for which data are to be developed, specifies the persons required to test (manufacturers, including importers, and/or processors), specifies the test substance(s) in each case, prescribes the tests that are required including the test standards, and provides deadlines for the submission of reports and data to EPA.
(b) This part requires manufacturers and/or processors of chemical substances or mixtures (“chemicals”) identified in subpart B to submit letters of intent to test, exemption applications, and study plans in accordance with EPA test rule development and exemption procedures contained in part 790 of this chapter and any modifications to such procedures contained in this part.
(c) This part requires manufacturers and/or processors of chemicals identified in subpart B to conduct tests and submit data in accordance with the test standards contained in this part in order to develop data on the health and
(d) This part contains certain TSCA test guidelines which are cross-referenced in the test rules contained in this part.
This part is applicable to each person who manufactures or intends to manufacture (including import) and/or to each person who processes or intends to process a chemical substance or mixture identified in subpart B for testing during the period commencing with the effective date of the specific chemical test rule until the end of the reimbursement period. Each set of testing requirements in subpart B specifies whether those requirements apply to manufacturers only, to processors only, or to both manufacturers and processors.
The definitions in section 3 of the Toxic Substances Control Act (TSCA) and the definitions of § 790.3 of this chapter apply to this part.
Information (letters, study plans, reports) submitted to EPA under this part must bear the Code of Federal Regulations section number of the subject chemical test rule (e.g., § 799.1285 for Cumene) and must be addressed to the Document Control Office (7407), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Room G-099, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
Testing required under subpart B must be performed using a study plan prepared according to the requirements of parts 790 and 792 of this chapter unless modified in specific chemical test rules in subpart B. All raw data, documentation, records, protocols, specimens and reports generated as a result of a study under subpart B must be developed, reported, and retained in accordance with TSCA Good Laboratory Practice Standards (GLP's) in part 792 of this chapter. These items must be made available during an inspection or submitted to EPA upon request by EPA or its authorized representative. Laboratories conducting testing for submission to the Agency in response to a test rule promulgated under section 4 of TSCA must adhere to the TSCA GLP's. Sponsors must notify the laboratory that the study is being conducted pursuant to TSCA section 4. Sponsors are also responsible for ensuring that laboratories conducting the test abide by the TSCA GLP standards. In accordance with § 792.12 of this chapter, a certification concerning adherence to the TSCA GLP's must be submitted to EPA.
(a) The TSCA and FIFRA guidelines for the various study plans are available from the National Technical Information Service (NTIS). Address and telephone number: National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703-487-4650).
(b) The OECD guidelines for the various study plans are available from the following address: OECD Publication and Information Center, 1750 Pennsylvania Ave., NW., Washington, DC 20006 (202-724-1857).
Except as set forth in specific chemical test rules in subpart B of this part, a positive or negative test result in any of the tests required under subpart B is defined in the TSCA test guidelines published by NTIS.
Any person who fails or refuses to comply with any aspect of this part or part 790 is in violation of section 15 of TSCA. EPA will treat violations of Good Laboratory Practice Standards as indicated in § 792.17 of this chapter.
The following table lists substances and mixtures that have been the subjects of section 4 testing actions and for which the testing reimbursement period has terminated (sunset). The
Persons who export or who intend to export substances listed in subpart B or subpart C of this part are subject to the requirements of part 707 of this title.
(a)
(2) The substances identified in paragraph (a)(1) of this section shall be 99 percent pure and shall be used as the test substances in each of the tests specified.
(3) For health effects testing required under paragraph (e) of this section, the test substance shall not contain more than 0.05 percent benzene and 0.05 percent hexachlorobenzene.
(b)
(2) Persons subject to this section are not subject to the requirements of § 790.50(a) (2), (5), (6) and (b) and § 790.87(a)(1)(ii) of this chapter.
(3) Persons who notify EPA of their intent to conduct tests in compliance with the requirements of this section must submit plans for those tests no later than 30 days before the initiation of each of those tests.
(4) In addition to the requirements of § 790.87(a)(2) and (3) of this chapter, EPA will conditionally approve exemption applications for this rule if EPA has received a letter of intent to conduct the testing from which exemption is sought and EPA has adopted test standards and schedules in a final Phase II test rule.
(5) For health effects testing required under paragraph (e) of this section, all persons who manufacture (import) or process 1,2,4-trichlorobenzene, other than as an impurity, after the effective date of this rule (August 21, 1986) to the end of the reimbursement period shall submit letters of intent to conduct testing or exemption applications, submit study plans, conduct tests, and submit data as specified in this section, subpart A of this part, and parts 790 and 792 of this chapter for single-phase rulemaking.
(c) [Reserved]
(d)
(1)
(ii)
(iii)
(B) An interim progress report shall be submitted to the Agency within 6 months after the effective date of the final Phase II rule.
(2)
(ii)
(iii)
(B) An interim progress report shall be submitted to EPA 6 months after the effective date of the final Phase II rule.
(3)
(ii)
(iii)
(B) An interim progress report shall be submitted to EPA 6 months after the effective date of the final Phase II rule.
(4)
(ii)
(iii)
(B) An interim progress report shall be submitted to EPA 6 months after the effective date of the final Phase II rule.
(5)
(ii)
(iii)
(B) Progress reports shall be submitted to EPA at 6-month intervals, beginning 6 months after of the effective date of the final Phase II rule and until the final report is submitted to EPA.
(e)
(B) The route of administration for the oncogenicity testing for 1,2,4-TCB shall be via the animal feed.
(C) Two rodent species shall be used and one shall be the Fischer-344 rat.
(ii)
(B) Progress reports shall be submitted to the Agency every 6 months after the effective date of the final rule.
(2) [Reserved]
(f) [Reserved]
(g)
(2) The guidelines and other test methods cited in this rule are referenced as they exist on the effective date of the final rule.
(a)
(2) DGBE of at least 95 percent purity and DGBA of at least 95 percent purity shall be used as the test substances.
(b)
(c)
(B) For the purpose of this section, the following provisions also apply:
(
(
(
(
(
(
(
(
(
(
(ii)
(B) Progress reports shall be submitted to EPA every 6 months, beginning 6 months from the effective date of the final rule until submission of the final report to EPA.
(2)
(
(
(
(
(
(B)(
(
(
(
(
(
(
(
(C)(
(
(
(
(
(
(ii)
(B) Interim progress reports shall be submitted to EPA at 6-month intervals, beginning 6 months from the effective date of the final rule until submission of the applicable final report to EPA.
(3)
(ii)
(B) Progress reports shall be submitted to EPA every 6 months, beginning 6 months after the date of notification that the testing shall be initiated, until submission of the final report to EPA.
(4)
(B) For the purpose of this section, the following provisions also apply:
(
(
(ii)
(B) A progress report shall be submitted to EPA 6 months from the effective date of the final amendment.
(d)
(1) Lamb, J.C. and Chapin, R.E. “Experimental models of male reproductive toxicology.” In: “Endocrine Toxicology.” Thomas, J.A., Korach, K.S., and McLachlan, J.A., eds. New York, NY: Raven Press. pp. 85-115. (1985).
(2) Clermont, Y. and Perey, B. “Quantitative study of the cell population of the seminiferous tubules in immature rats.”
(3) Sadleir, R.M.F.S. “Cycles and seasons.” In: “Reproduction in Mammals: I. Germ Cells and Fertilization.” Austin, C.R. and Short, R.V., eds. New York, NY: Cambridge Press. Chapter 4. (1978).
(4) Mattison, D.R. and Thorgiersson, S.S. “Ovarian aryl hydrocarbon hydroxylase activity and primordial oocyte toxicity of polycyclic aromatic hydrocarbons in mice.”
(5) Pederson, T. and Peters, H. “Proposal for classification of oocytes and follicles in the mouse ovary.
(6) Spencer, P.S., Bischoff, M.C., and Schaumburg, H.H. “Neuropathological methods for the detection of neurotoxic disease.” In: “Experimental and Clinical Neurotoxicology.” Spencer, P.S. and Schaumburg, H.H., eds. Baltimore, MD: Williams & Wilkins, pp. 743-757. (1980).
(7) Hafez, E.S., ed., “Reproduction and Breeding Techniques for Laboratory Animals.” Chapter 10. Philadelphia: Lea & Febiger (1970).
(e)
(2) The guidelines and other test methods cited in this rule are referenced as they exist on the effective date of the final rule.
(a)
(2) Diethylenetriamine of at least 99 percent purity shall be used as the test substances in all tests.
(b)
(c)
(B) A mouse specific locus assay shall be conducted with DETA, if the sex-linked recessive lethal test in
(ii)
(B) The testing for the mouse visible specific locus assay shall be conducted in accordance with the following revised EPA-approved modified study plan (June 19, 1986) originally submitted by the Diethylenetriamine Producers/Importers Alliance (DPIA): “Mouse specific locus test for visible markers.”
(C) These revised EPA-approved modified study plans are available for inspection in the Non-Confidential Information Center (NCIC) (7407), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Room B-607 NEM, 401 M St., SW., Washington, DC 20460, between the hours of 12 p.m. and 4 p.m. weekdays excluding legal holidays.
(iii)
(B) If required pursuant to paragraph (c)(1)(i)(B) of this section, the mouse specific locus test of DETA for visible markers shall be completed and a final report submitted to the Agency within 48 months from the designated date contained in EPA's notification of the test sponsor by certified letter or
(2)
(B) An
(C) A dominant lethal assay shall be conducted with DETA, if either the
(D) A heritable translocation assay shall be conducted with DETA, if the dominant lethal assay conducted pursuant to paragraph (c)(2)(i)(C) of this section produces a positive result.
(ii)
(B) Other testing for cytogenetic effects shall be conducted in accordance with the following revised EPA-approved modified study plans (June 19, 1986) originally submitted by the Diethylenetriamine Producers/Importers Alliance (DPIA): “Dominant lethal assay of diethylenetriamine in CD rats,” and “Heritable translocation of diethylenetriamine in CD-1 mice.”
(C) These revised EPA-approved modified study plans are available for inspection in the Non-Confidential Information Center (NCIC) (7407), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Room B- 607 NEM, 401 M St., SW., Washington, DC 20460, between the hours of 12 p.m. and 4 p.m. weekdays excluding legal holidays.
(iii)
(B) If required pursuant to paragraph (c)(2)(i)(B) of this section, the
(C) If required pursuant to paragraph (c)(2)(i)(C) of this section, the dominant lethal testing of DETA shall be completed and a final report submitted to the Agency within 20 months of the effective date of the final Phase II rule.
(D) If required pursuant to paragraph (c)(2)(i)(D) of this section, the heritable translocation testing of DETA shall be completed and a final report submitted to the Agency within 18 months of the designated date contained in EPA's notification of the test sponsor by certified letter or
(3)
(ii)
(iii)
(d)
(2)
(3)
(e)
(f)
(2) The guidelines and other test methods cited in this rule are referenced as they exist on the effective date of the final rule.
(a)
(2) 2-Ethylhexanol of at least 99.0-percent purity shall be used as the test substance.
(b)
(c)
(B) For the purpose of this section, the following provisions also apply to the oncogenicity tests: (
(
(ii)
(B) The oncogenicity testing shall be completed and final report submitted to the Agency within 53 months of the effective date of this final rule if 2-ethylhexanol is administered by gavage or within 56 months of the effective date of this final rule if administered by microencapsulation.
(C) Interim progress reports shall be submitted to EPA at 6-month intervals beginning 6 months after the effective date of the final rule, until the final report is submitted to EPA.
(2) [Reserved]
(d)
(a)
(2) VF, VDF, TFE, and HFP of at least 99 percent purity shall be used as the test substances.
(b)
(c)
(
(B)(
(
(
(C)(
(
(
(ii)
(B) Progress reports shall be submitted to the Agency every 6 months beginning 6 months after the effective date of the final rule or receipt of notice that testing shall be initiated.
(2)
(
(
(B)(
(
(
(
(
(
(C)(
(
(
(
(
(ii)
(B) Progress reports shall be submitted to the Agency every 6 months beginning 6 months after the effective date of the final rule or receipt of notice that testing shall be initiated.
(3)
(B) For the purpose of this section the following provisions also apply:
(
(
(
(ii)
(B) Progress reports shall be submitted to the Agency every 6 months beginning 6 months after the effective date of the final rule.
(4)
(
(
(
(B) Oncogenicity testing shall be conducted in mice with VDF in accordance with § 798.3300 of this chapter.
(C) [Reserved]
(D) Oncogenicity tests shall also be conducted by inhalation in both rats and mice with TFE in accordance with § 798.3300 of this chapter if TFE yields a positive test result in any one of the following mutagenicity tests: The
(ii)
(B) Progress reports shall be submitted every 6 months beginning 6 months after the effective date of the final rule for VF and VDF and beginning 6 months after notification by certified letter or
(d)
(2) The guidelines and other test methods cited in this rule are referenced as they exist on the effective date of the final rule.
(a)
(2) The commercial hexane test substance, for purposes of this section, is a product which conforms to the specifications of ASTM D1836 and contains at least 40 liquid volume percent but no more than 55 liquid volume percent
(b)
(c)
(B) For the purposes of this section, the following provisions also apply:
(
(
(ii)
(B) Interim progress reports shall be submitted to EPA for the subchronic inhalation toxcity test at 6-month intervals beginning 6 months after the effective date of the final rule, until the final report is submitted to EPA.
(2)
(B) For the purposes of this section, the following provisions also apply:
(
(
(ii)
(B) Interim progress reports shall be submitted to EPA for the oncogenicity test at 6-month intervals beginning 6 months after the effective date of the final rule, until the final report is submitted to EPA.
(3)
(B) For the purposes of this section, the following provisions also apply:
(
(
(ii)
(B) Interim progress reports shall be submitted to EPA for the reproduction and fertility effects test at 6-month intervals beginning 6 months after the effective date of the final rule, until the final report is submitted to EPA.
(4)
(B) For the purposes of this section, the following provisions also apply:
(
(
(ii)
(B) Interim progress reports shall be submitted to EPA for the inhalation developmental toxicity test at 6-month intervals beginning 6 months after the effective date of the final rule, until the final report is submitted to EPA.
(5)
(
(
(
(B)(
(
(
(
(C)(
(
(
(
(D)(
(
(
(
(ii)
(
(
(
(
(B) Interim progress reports for each test shall be submitted to EPA for the gene mutation in mammalian cells assay and
(C) Interim progress reports for either the mouse visible specific locus test or the mouse biochemical specific locus test shall be submitted to EPA at 6-month intervals, beginning 6 months after EPA's notification of the test sponsor that testing should be initiated, until the applicable final report is submitted to EPA.
(6)
(
(
(
(B)(
(
(
(
(
(C)(
(
(
(
(
(D)(
(
(
(
(
(
(
(
(
(B) Interim progress reports for each test shall be submitted to EPA for the
(C) Interim progress reports shall be submitted to EPA for the heritable translocation assay at 6-month intervals beginning 6 months after the date of EPA's notification of the test sponsor that testing shall be initiated, until the final report is submitted to EPA.
(7)
(
(
(
(
(B)(
(
(
(
(
(C)(
(
(
(
(
(D)(
(
(
(
(
(ii)
(B) Interim progress reports for each test shall be submitted to EPA for the schedule-controlled operant behavior, functional observation battery, motor activity, and neuropathology tests at 6-month intervals beginning 6 months after the effective date of the applicable final rule, until the applicable final report is submitted to EPA.
(8)
(B) For the purposes of this section, the following provisions also apply:
(
(
(ii)
(B) Interim progress reports shall be submitted to EPA for the inhalation and dermal pharmacokinetics tests at 6-month intervals, beginning 6 months after the effective date specified in paragraph (d)(1) of this section, until the final report is submitted to EPA.
(d)
(2) The guidelines and other test methods cited in this rule are referenced as they exist on the effective date of the final rule.
(a)
(2) Isopropanol of at least 99.8 percent purity shall be used as the test substance.
(b)
(c)
(ii)
(B) Progress reports shall be submitted to EPA for the subchronic inhalation toxicity test at 6-month intervals beginning 6 months after the date specified in paragraph (d)(1) of this section until submission of the final report.
(2)
(ii)
(B) Progress reports shall be submitted at 6-month intervals beginning 6 months after the date specified in paragraph (d)(1) of this section until submission of the final report.
(3)
(ii)
(B) A progress report shall be submitted 6 months after the date specified in paragraph (d)(1) of this section.
(4)
(B)(
(
(
(
(C)(
(
(
(
(ii)
(
(
(
(B) Progress reports shall be submitted to EPA for the
(C) Progress reports shall be submitted to EPA for the mouse visible specific locus test at 6-month intervals beginning 6 months after the date of EPA's notification of the test sponsor that testing shall be initiated until submission of the final report.
(5)
(
(
(
(B)(
(
(
(
(C)(
(
(
(
(ii)
(
(
(
(B) Progress reports shall be submitted to EPA for the the micronucleus and the dominant lethal assays at 6-month intervals beginning 6 months after the date specified in paragraph (d)(1) of this section until submission of the final report.
(C) Progress reports shall be submitted to EPA for the heritable translocation assay at 6-month intervals beginning 6 months after the date of EPA's notification of the test sponsor that testing shall be initiated until submission of the final report.
(6)
(
(
(
(B)(
(
(
(
(C)(
(
(
(
(D) The developmental neurotoxicity test shall be conducted with iso-pro-pa-nol in accordance with § 795.250 of this chapter, except for paragraph (c)(1)(iv).
(
(
(
(
(ii)
(B) Progress reports shall be submitted to EPA for the functional observation battery, motor activity, neu-ro-path-o-logy, and developmental neurotoxicity tests at 6-month intervals beginning 6 months after the date specified in paragraph (d)(1) of this section until submission of the applicable final report.
(7)
(ii)
(B) Progress reports shall be submitted to EPA for the pharmacokinetics test at 6-month intervals beginning 6 months after the date specified in paragraph (d)(1) of this section until submission of the final report.
(8)
(ii)
(B) Progress reports shall be submitted at 6-month intervals beginning 6 months after the date specified in paragraph (d)(1) of this section until submission of the final report.
(d)
(2) The guidelines and other test methods cited in this rule are references as they exist on the effective date of the final rule.
(a)
(2) MBT of at least 97.6 percent purity (plus or minus 1.5 percent) shall be used as the test substance.
(b)
(c)
(ii)
(B) An interim progress report shall be submitted to EPA 6 months after the effective date of the final rule.
(2)
(ii)
(B) An interim progress report shall be submitted to EPA 6 months after the effective date of the final rule.
(3)
(ii)
(B) An interim progress report shall be submitted to EPA 6 months after the effective date of this final rule.
(d)
(B) For the purpose of this section, the following provisions also apply:
(
(
(
(
(
(
(
(
(ii)
(B) An interim progress report shall be submitted to EPA 6 months after the effective date of the final rule.
(2)
(B) For the purposes of this section, the following provisions also apply:
(
(
(
(ii)
(B) An interim progress report shall be submitted to EPA 6 months after the effective date of the final rule.
(e)
(ii)
(B) An interim progress report shall be submitted to EPA 6 months after the effective date of the final rule.
(2)
(ii)
(B) Progress reports shall be submitted to EPA at 6-month intervals beginning 6 months after the effective date of the final rule until submission of the final report.
(3)
(
(
(
(B)(
(
(
(
(C)(
(
(
(
(ii)
(B) A progress report shall be submitted to EPA for the functional observation battery, motor activity, and neuropathology tests, respectively, 6 months after the effective date of the final rule.
(4)
(B) A heritable translocation assay shall be conducted with MBT in accordance with the test guideline specified in § 798.5460 of this chapter if MBT produces a positive result in the dominant lethal assay conducted pursuant to paragraph (e)(4)(i)(A) of this section and if, after a public program review, EPA issues a
(ii)
(B) For the dominant lethal assay, an interim progress report shall be submitted to EPA 6 months after the effective date of the final rule; for the heritable translocation assay, progress reports shall be submitted to EPA at 6-month intervals beginning 6 months after the date of EPA's notification of the test sponsor that testing shall be initiated until submission of the final report.
(f)
(2) The guidelines and other test methods cited in this rule are referenced as they exist on the effective date of the final rule.
(a)
(2) MEKO of at least 99 percent purity shall be used as the test substance.
(b)
(c)
(ii) [Reserved]
(2)
(ii)
(iii)
(B) Interim progress reports shall be submitted to EPA at 6-month intervals, beginning 6 months after the date specified in paragraph (e) of this section, until submission of the final report to EPA.
(3)
(ii)
(iii)
(B) Interim progress reports shall be submitted to EPA at 6-month intervals, beginning 6 months after the date specified in paragraph (e) of this section.
(4)
(B) For the purpose of this section, the following provisions also apply:
(
(
(
(
(
(
(ii)
(B) Interim progress reports shall be submitted to EPA at 6-month intervals, beginning six months after the date specified in paragraph (e) of this section until submission of the final report to EPA.
(5)
(ii)
(B) Interim progress reports shall be submitted to EPA at 6-month intervals beginning 6 months after the date specified in paragraph (e) of this section.
(6)
(B) For the purpose of this section, the following provisions also apply if § 798.5385 of this chapter is used in conducting the test:
(
(
(C) For the purpose of this section, the following provisions also apply if § 798.5395 of this chapter is used in conducting the test:
(
(
(ii)
(B) Interim progress reports shall be submitted to EPA at 6-month intervals, beginning 6 months after the date specified in paragraph (e) of this section.
(7)
(
(
(
(
(B)
(
(
(
(
(C)
(
(
(
(
(
(ii)
(B) Interim progress reports shall be submitted to EPA at 6-month intervals beginning 6 months after the date specified in paragraph (e) of this section until submission of the final report to EPA.
(d)
(1) Lamb, J. and Chapin, R.E. “Experimental models of male reproductive toxicology.” In: “Endocrine Toxicity.” Thomas, J.A., Korach, K.S., and McLachlan, J.A., eds. New York, NY: Raven Press. pp. 85-115. (1985).
(2) Clermont, Y. and Percey, B. “Quantitative study of the cell population of the seminiferous tubules in immature rats.” “American Journal of Anatomy.” 100:241-267. (1957).
(3) Sadleir, R.M.F.S. “Cycles and seasons.” In: “Reproduction in Mammals: I. Germ Cells and Fertilization.” Austin, R. and Short R.V., eds. New York, NY: Cambridge Press. Chapter 4. (1978).
(4) Mattison, D.R. and Thorgiersson, S.S. “Ovarian aryl hydrocarbon hy-drox-ylase activity and pri-mor-dial oocyte toxi-city of pol-y-cyclic aromatic hy-dro-carbons in mice.” “Cancer Research.” 39:3471-3475. (1979).
(5) Pederson, T. and Peters, H. “Proposal for classification of oocytes and follicles in the mouse ovary.” “Journal of Reproduction and Fertility.” 17:555-557. (1968).
(6) Spencer, P.S., Bischoff, M., and Schaumburg, H.H. “Neuropathological methods for the detection of neurotoxic disease.” In: “Experimental and Clinical Neurotoxicology.” Spencer, P.S. and Schaumburg, H.H., eds. Baltimore, MD: Williams and Wilkins, pp. 743-757 (1980).
(7) Hafez, E.S., ed., “Reproduction and Breeding Techniques for Laboratory Animals.” Chapter 10. Philadelphia: Lea and Febiger. (1970).
(e)
(2) The guidelines and other test methods cited in this section are referenced here as they exist on October 27, 1989.
(a)
(2)
(b)
(2) All persons who manufacture (including import or by-product manufacture) or process
(3) All persons who manufacture (including import or by-product manufacture) or process
(c)
(B) If the SLRL assay conducted pursuant to paragraph (c)(1)(i)(A) of this section is positive, either the mouse visible specific locus test (MVSL) or the mouse biochemical specific locus test (MBSL) shall be conducted for
(C) The mouse bone marrow cytogenetics: micronucleus (MBMC) assay shall be conducted on
(D) If the MBMC assay conducted pursuant to paragraph (c)(1)(i)(C) of this section is positive, the dominant
(E) If the DL conducted pursuant to paragraph (c)(1)(i)(D) of this section is positive, heritable translocation (HT) testing in the mouse on
(ii)
(B) If required, the DL test shall be completed and the final report shall be received by EPA no later than 24 months after the effective date of this final rule.
(C) If required, the MVSL or the MBSL shall be completed and the final report shall be received by EPA no later than 51 months after EPA issues a
(D) If required, the HT test shall be completed and the final report shall be submitted to EPA not later than 36 months after the date on which EPA notifies the test sponsor under paragraph (c)(1)(i)(E) of this section to begin testing.
(E) Interim reports for the SLRL assay and MBMC are required at 6-month intervals beginning 6 months after the effective date of this section. If the DL is triggered, interim reports are required at 6 month intervals beginning with the date of initiation of the study.
(F) Interim reports for the HT and either the MBSL or MVSL are required at 6-month intervals beginning 6 months after the date of notification by EPA that testing shall be initiated, and ending when the final report is submitted.
(2)
(ii) [Reserved]
(iii)
(B) Interim reports for the onco-genicity study are required at 6-month intervals beginning 6 months after the date of notification by EPA that testing shall be initiated and ending when the final report is submitted.
(3)
(B) If neurotoxic effects are observed at 24 hours, or longer, during the testing conducted pursuant to paragraph (c)(3)(i)(A) of this section, then 90-day subchronic neurotoxic FOB and MAT tests shall be conducted in accordance with §§ 798.6050 and 798.6200 of this chapter, respectively, for each isomer showing such effects. At the end of these tests, the animals shall be -sacrificed and the nervous tissue pre-served and examined as described -in the neuropathology test stand-ard, § 798.6400 of this chapter.
(ii)
(B) [Reserved]
(d)
(ii)
(B) The final report shall include a calculation of the predicted environmental concentration (PEC), 100×PEC, and 1,000×PEC for each isomer. PEC shall be calculated by using results from the indirect photolysis studies and solving the following equations for the appropriate isomer:
(2) [Reserved]
(e)
(B) Acute flow-through studies on the freshwater invertebrate
(C) If the concentration affecting 50 percent of the population (LC
(ii)
(A) Testing on the rainbow trout shall be completed and submitted to EPA 9 months after the effective date of the final rule for
(B) The acute toxicity testing in freshwater
(2)
(B) An invertebrate life-cycle flow-through toxicity test shall be conducted in
(ii)
(B) The invertebrate life-cycle flow-through toxicity test shall be completed and the final report submitted to EPA no later than January 15, 1993.
(C) Progress reports shall be submitted at 6 month intervals after the effective date of the final rule.
(f)
(2) The guidelines and other test methods cited in this rule are referenced as they exist on the effective date of the final rule.
(a)
(2) TBP of at least 99 percent purity shall be used as the test substance.
(b)
(c)
(
(
(
(
(B)(
(
(
(
(
(C)(
(
(
(
(
(ii)
(B) An interim progress report for these neurotoxicity tests shall be submitted to EPA 6 months after the effective date of the final rule.
(2)
(B) for the purpose of this section, the following provision also applies:
(
(
(ii)
(B) An interim progress report shall be submitted to EPA 6 months after the effective date of the final rule.
(3)
(B) for the purpose of this section, the following provisions also apply:
(
(
(ii)
(B) Interim program reports shall be submitted to EPA at 6 month intervals, beginning 6 months after the effective date of the final rule, until the final report is submitted to EPA.
(4)
(B)(
(
(
(
(
(
(5)
(B)(
(
(
(
(C)(
(
(
(
(D)(
(
(
(
(ii)
(
(
(
(B) Interim progress reports shall be submitted to EPA at 6 month intervals beginning 6 months after initiation of the rodent dominant lethal assay and the rodent heritable translocation assay respectively, if required, until the applicable final reports are submitted to EPA.
(6)
(B) For the purpose of this section, the following provisions also apply:
(
(
(
(ii)
(B) Interim progress reports shall be submitted to EPA at 6 month intervals beginning 6 months after the effective date of the final rule, until the final report is submitted to EPA.
(7)
(ii)
(8)
(B) For the purposes of this section, the following provisions also apply:
(
(
(ii)
(B) Interim 6 month progress reports shall be submitted to EPA beginning at 6 months after the effective date of the final rule and continuing until submission of the final report.
(d)
(B) For the purpose of this section, the following provisions also apply:
(
(
(ii)
(2)
(B) For the purpose of this section, the following provisions also apply:
(
(
(ii)
(3)
(B) For the purpose of this section, the following provisions also apply:
(
(
(ii)
(4)
(B) For the purpose of this section, the following provisons also apply:
(
(
(ii)
(5)
(B) For the purpose of this section, the following provisions also apply:
(
(
(ii)
(B) An interim progress report shall be submitted to EPA 6 months after the initiation of the test.
(6)
(ii)
(B) An interim progress report shall be submitted to EPA 6 months after the initiation of the test.
(7)
(B) The benthic sediment invertebrate bioassay shall be conducted according to the test procedure specified in the American Society for Testing and Materials, Special Technical Publication 854 (ASTM STP 854) entitled, “Aquatic Safety Assessment of Chemicals Sorbed to Sediments,” by W.J. Adams, R.A. Kimerle, and R.G. Mosher, published in
(ii)
(B) An interim progress report shall be submitted to EPA for the benthic sediment invertebrate bioassy 6 months after the initiation of the test.
(e)
(ii)
(2)
(ii)
(B) For the purpose of this section, the following provisions also apply:
(
(
(3)
(ii)
(f)
(2) The guidelines and other test methods cited in this rule are referenced as they exist on the effective date of the final rule.
(a)
(2) TGME of at least 90 percent purity shall be used as the test substance.
(b)
(c)
(2) For the purpose of this section, the following provisions also apply:
(i)
(ii)
(3)
(ii) Progress reports shall be submitted to EPA at 6- month intervals, beginning six months after the initiation of the test.
(d)
(2) The guidelines and other test methods cited in this rule are referenced as they exist on the effective date of the final rule.
This section sets forth a list of substances and mixtures which are the subject of testing consent orders adopted under 40 CFR part 790. Listed below in Chemical Abstract Service (CAS) Registry Number order are the substances and mixtures which are the subject of these orders and the
This section sets forth a list of mixtures (with no Chemical Abstracts Service Registry Numbers) which are the subject of testing consent orders adopted under 40 CFR part 790. Listed below are the mixtures which are the subject of these orders and the
(a)
(2) Substances of at least 98-percent purity shall be used as the test substances.
(b)
(c)
(d)
(ii)
(2)
(ii)
(e)
(B) For Bis(2-chloroethoxy)methane, an oral gavage subchronic toxicity test shall be conducted in the rat in accordance with § 798.2650 of this chapter except for the provisions in paragraphs (e)(9)(i)(A) and (e)(9)(i)(B). For Bis(2-chloroethoxy)methane, the following provisions also apply:
(
(
(ii)
(B) Progress reports for each test shall be submitted to the Agency 6 months after the effective date of the final rule.
(2) [Reserved]
(f)
(2) The guidelines and other test methods cited here are referenced as they exist on the effective date of the final rule.
(a)
(2) A test substance of at least 99 percent purity shall be used for Chloroethane, 1,1-dichloroethane, and 1,3,5-trimethylbenzene. A test substance of at least 98 percent purity shall be used for 1,1,2,2-tetrachloroethane.
(b)
(c)
(B) For the purpose of this section, the following provisions also apply:
(
(
(
(
(
(
(
(
(
(
(
(
(
(
(
(ii)
(B) Except for 1,3,5-trimethylbenzene, a progress report shall be submitted to EPA for each test beginning 6 months after the date specified in paragraph (d)(1) of this section and at 6-month intervals thereafter until the final report is submitted to EPA . The progress report for 1,3,5-trimethylbenzene shall be submitted to EPA by April 10, 1995.
(2)
(B) For the purpose of this section, the following provisions also apply:
(
(
(ii)
(B) For each test, a progress report shall be submitted to EPA beginning 9 months after the date specified in paragraph (d)(1) of this section and at 6-month intervals thereafter until the final report is submitted to EPA.
(d)
(2) The guidelines and other test methods cited in this section are referenced as they exist on the effective date of the final rule.
(a)
(b)
(2) If you do not know or cannot reasonably ascertain that you manufacture or process a chemical substance listed in Table 2 in paragraph (j) of this section during the time period described in paragraph (b)(1) of this section (based on all information in your possession or control, as well as all information that a reasonable person similarly situated might be expected to possess, control, or know, or could obtain without an unreasonable burden), you are not subject to this section with respect to that chemical substance.
(c)
(ii) Table 1 in paragraph (c)(1)(i) of this section expands the list of persons specified in § 790.42(a)(2), (a)(4), and (a)(5) of this chapter, who, while legally subject to this section, must comply with the requirements of this section only if directed to do so by EPA under the circumstances set forth in paragraphs (c)(4) through (c)(7) and (c)(10) of this section.
(2) If you are in Tier 1 with respect to a chemical substance listed in Table 2 in paragraph (j) of this section, you must, for each test required under this section for that chemical substance, either submit to EPA a letter of intent to test or apply to EPA for an exemption from testing. The letter of intent to test or the exemption application must be received by EPA no later than June 25, 2004.
(3) If you are in Tier 2 with respect to a chemical substance listed in Table 2 in paragraph (j) of this section, you are considered to have an automatic conditional exemption and you will be required to comply with this section with regard to that chemical substance only if directed to do so by EPA under paragraphs (c)(5), (c)(7), or (c)(10) of this section.
(4) If no person in Tier 1 has notified EPA of its intent to conduct one or more of the tests required by this section on any chemical substance listed in Table 2 in paragraph (j) of this section by June 25, 2004, EPA will publish a
(5) If you are in Tier 2A with respect to a chemical substance listed in Table 2 in paragraph (j) of this section, and if you manufacture this chemical substance as of May 26, 2004, or within 30 days after publication of the
(6) If no manufacturer in Tier 1 or Tier 2A has notified EPA of its intent to conduct one or more of the tests required by this section on any chemical substance listed in Table 2 in paragraph (j) of this section within 30 days after the publication of the
(7) If you are in Tier 2B with respect to a chemical substance listed in Table 2 in paragraph (j) of this section, and if you process this chemical substance as of May 26, 2004, or within 30 days after publication of the
(8) If no manufacturer or processor has notified EPA of its intent to conduct one or more of the tests required by this section for any of the chemical substances listed in Table 2 in paragraph (j) of this section within 30 days after the publication of the
(9) If no manufacturer or processor has notified EPA of its intent to conduct one or more of the tests required by this section for any of the chemical substances listed in Table 2 in paragraph (j) of this section within 30 days after receipt of the certified letter or publication of the
(10) If a problem occurs with the initiation, conduct, or completion of the required testing or the submission of the required data with respect to a chemical substance listed in Table 2 in paragraph (j) of this section, under the procedures in § § 790.93 and 790.97 of this chapter, EPA may initiate termination proceedings for all testing exemptions with respect to that chemical substance and may notify persons in Tier 1 and Tier 2 that they are required to submit letters of intent to test or exemption applications within a specified period of time.
(11) If you are required to comply with this section, but your manufacturing or processing of a chemical substance listed in Table 2 in paragraph (j) of this section begins after the applicable compliance date referred to in paragraphs (c)(2), (c)(5), (c)(7), or (c)(10) of this section, you must either submit a letter of intent to test or apply to EPA for an exemption. The letter of intent to test or the exemption application must be received by EPA no later than the day you begin manufacturing or processing.
(d)
(2) For each test with respect to which you submit to EPA a letter of intent to test, you must conduct the testing specified in paragraph (h) of this section and submit the test data to EPA.
(3) You must also comply with the procedures governing test rule requirements in part 790 of this chapter, as
(e)
(f)
(g)
(h)
(1)
(2)
(3)
(4)
(5)
(B)
(C)
(D)
(
(
(
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
(B)
(viii)
(B)
(6)
(ii)
(7)
(i)
(B) A description of the source, identity, and purity of the test substance and the source, identity, and handling of the test skin. There must be a detailed description of the test procedure and all materials, devices used and doses tested, as well as a detailed description and illustration of static or flow-through cell design. There must also be a description of the skin preparation method, including measurements of the skin membrane thickness.
(C) A description of the analytical techniques to be used, including their accuracy, precision, and detection limits (in particular for non-radiolabeled tests), and, if a radiolabel is used, there must be a description of the radiolabel (e.g., type, location of, and radiochemical purity of the label).
(D) All data must be clearly identified as to dose and specimen. Derived values (means, permeability coefficient, graphs, charts, etc.) are not sufficient.
(ii)
(A) Monitoring of testing parameters.
(B) Temperature of chamber.
(C) Receptor fluid pH.
(D) Barrier property validation.
(E) Analysis of receptor fluid for radioactivity or test chemical
(iii)
(8)
(i) Bronaugh, R.L., Stewart, R.F., and Simon, M. Methods for
(ii) Bronaugh, R.L. and Stewart, R.F. Methods for
(iii) Bronaugh, R.L., Stewart, R.F., and Storm, J.E. Extent of Cutaneous Metabolism During Percutaneous Absorption of Xenobiotics.
(iv) Walker, J.D., Whittaker, C. and McDougal, J.N. Role of the TSCA Interagency Testing Committee in Meeting the U.S. Government Data Needs: Designating Chemicals for Percutaneous Absorption Rate Testing.
(v) Bronaugh, R.L., and Collier, S.W. Protocol for
(i)
(j)
(k)
(a)
(2)
(b)
(2)
(3)
(4)
(c)
(2)
(3)
(4)
(5)
(ii)
(iii)
(iv)
(d)
(2)
(ii)
(iii)
(3)
(i) The preliminary assessment of the P as discussed in paragraph (d)(1) of this section).
(ii) The minimum quantity of test substance required for the analytical procedure.
(iii) The limitation of a maximum concentration in either phase of 0.01 mol/L.
(iv) Three tests are carried out. In the first, the calculated volume ratio is added; in the second, twice the volume of
(4)
(5)
(6)
(ii)
(7)
(ii) The aqueous phase should be sampled by the following procedure to minimize the risk of including traces of the
(iii) The concentration in the two-separated phases should preferably be determined by a substance-specific method. Examples of physical-chemical determinations which may be appropriate are:
(A) Photometric methods.
(B) Gas chromatography.
(C) HPLC.
(D) Back-extraction of the aqueous phase and subsequent gas chromatography.
(e)
(2)
(i) Name of the substance, including its purity.
(ii) Temperature of the determination.
(iii) The preliminary estimate of the P and its manner of determination.
(iv) Data on the analytical procedures used in determining concentrations.
(v) The measured concentrations in both phases for each determination. This means that a total of 12 concentrations must be reported.
(vi) The weight of the test substance, the volume of each phase employed in each test vessel, and the total calculated amount of test substance present in each phase after equilibration.
(vii) The calculated values of the P and the mean should be reported for each set of test conditions as should the mean for all determinations. If there is a suggestion of concentration dependency of the P, this should be noted in the report.
(viii) The standard deviation of individual P values about their mean should be reported.
(ix) The mean P from all determinations should also be expressed as its logarithm (base 10).
(f)
(1) Neely, W.B. et al. Partition Coefficients to Measure Bioconcentration Potential of Organic Chemicals in Fish.
(2) Leo, A. et al. Partition Coefficients and Their Uses.
(3) Miyake, K. and H. Terada, Direct measurements of partition coefficients in an octanol-water system.
(4) Veith G.D. and R.T. Morris, A Rapid Method for Estimating Log P for Organic Chemicals, EPA-600/3-78-049 (1978).
(5) Mirrless, M.S. et al., Direct measurement of octanol-water partition coefficient by high pressure liquid chromatography.
(6) EPA Draft Guidance of September 8, 1978 (F-16).
(7) Konemann H. et al. Determination of log P
(8)
(a)
(2)
(b)(1)
(ii) In the study of the environmental fate of organic chemicals, the K
(iii) Of the three properties that can be estimated from K
(iv) Direct correlations between K
(v) This section describes a method for determining the K
(2)
(3)
(ii) Since the HPLC method is only applicable to compounds that absorb in the UV, an alternate GC method, or any other reliable quantitative procedure must be used for those compounds that do not absorb in the UV. In the GC method the saturated solutions produced in the generator column are extracted using an appropriate organic solvent that is subsequently injected into the GC, or any other suitable analytical device, for analysis of the test compound.
(4)
(ii) The recommended values listed in table 1 of this section have been provided primarily so that the generator column method can be calibrated and to allow the chemical laboratory the opportunity to compare its results with these values. The testing laboratory has the option of choosing its reference chemicals, but references must be given to establish the validity of the measured values of log
(5)
(c)
(
(
(B) Constant temperature bath with circulation pump-bath and capable of controlling temperature to 25 ±0.05 °C. (Procedures A and B, as described in paragraphs (c)(3)(iii) and (c)(3)(iv) of this section, respectively).
(C) HPLC equipped with a variable wavelength UV absorption detector operating at a suitable wavelength and a recording integrator (Procedure A, as described in paragraph (c)(3)(iii) of this section).
(D) Extractor column—6.6 × 0.6 centimeter (cm) stainless steel tube with end fittings containing 5 micron frits filled with a superficially porous phase
(E) Two 6-port high-pressure rotary switching valves (Procedure A, as described in paragraph (c)(3)(iii) of this section).
(F) Collection vessel—8 ×
(G) GC, or any other reliable analytic equipment, equipped with a detector sensitive to the solute of interest (Procedure B, as described in paragraph (c)(3)(iv) of this section).
(ii)
(iii)
(iv)
(2)
(ii)
(3)
(i)
(ii)
(A) The saturated aqueous solution leaving the generator column shall be
(B) The efficiency of removal of the solute (the test chemical) by solvent extraction from the extractor column shall be determined and used in the determination of the K
(iii)
(B) The general procedure for analyzing the aqueous phase after equilibration is as follows; a detailed procedure is given in paragraph (c)(3)(iii)(C)(
(
(
(
(
(
(C)(
(
(
(
(
(
(
(
(
(
(
(
(iv)
(A)
(
(B)
(C)
(D)
(
(
(v)
(vi)
(d)
(ii) For each run provide the molar concentration of the test substance in water for each of three determinations, the mean value, and the standard deviation.
(iii) For each of the three determinations calculate the K
(iv) Report the temperature (± 0.05 °C) at which the generator column was controlled during the test.
(v) For each reference compound report the individual values of log
(vi) For compounds that decompose at a rate such that a precise value for the solubility cannot be obtained, provide a statement to that effect.
(2)
(A) The method used to determine the sample-loop volume and the average and standard deviation of that volume.
(B) The average and standard deviation of the RF.
(C) The extraction solvent and the extraction efficiency used.
(D) Any changes made or problems encountered in the test procedures.
(ii) For the GC method report:
(A) The column and GC operating conditions of temperature and flow rate.
(B) The average and standard deviation of the average area per microliter obtained for each of the standard solutions.
(C) The form of the regression equation obtained in the calibration procedure.
(D) The extracting solvent and extraction efficiency used.
(E) The average and standard deviation of solute concentration in each collection vessel.
(F) Any changes made or problems encountered in the test procedure.
(iii) If another approved analytical method is used to determine the concentration of the test chemical in water, then all the important test conditions shall be reported.
(iv) If the concentration of the test substance in
(e)
(1) Banerjee, S. et al., Water solubility and octanol/water partition coefficient of organics. Limitation of the solubility-partition coefficient correlation.
(2) Bruggemann W.A. et al., Reversed-phase thin-layer chromatography of polynuclear aromatic hydrocarbons and chlorinated biphenyls. Relationship with hydrophobicity as measured by aqueous solubility and octanol/water partition coefficient.
(3) Chiou, C.T. et al. Partition coefficient and bioaccumulation of selected organic chemicals.
(4) Chiou, C.T. and Schmedding, D.W., Partitioning of organic compounds in octanol/water systems.
(5) Chiou, C.T et al., Partition equilibria of nonionic organic compounds between soil, organic matter, and water.
(6) DeVoe, H. et al. “Generator Columns and High Pressure Liquid Chromatography for Determining Aqueous Solubilities and Octanol-Water Partition Coefficients of Hydrophobic Substances,”
(7) Fujita, T. et al. “A New Substituent Constant, Derived from Partition Coefficients.”
(8) Hansch, C. and Leo, A. 1985 MEDCHEM Project, version 26. Pomona College, Claremont, CA. USA.
(9) Hansch, C. and Leo, A. Medchem Software Manual. CLOGP3 Users Guide. Release 3.32. December 1984. Medicinal Chemistry Project, Pomona College, Claremont, CA.
(10) Hawker, D.W. and Connell, D.W. Octanol-water partition coefficients of polychlorinated biphenyl congeners.
(11) May, W.E. et al. “Determination of the aqueous solubility of polynuclear aromatic hydrocarbons by a coupled column liquid chromatographic technique,”
(12) May, W.E. et al. “Determination of the Solubility Behavior of Some Polycyclic Aromatic Hydrocarbons in Water,”
(13) Miller, M.M. et al. Aqueous solubilities, octanol/water partition coefficients and entropies of melting of chlorinated benzenes and biphenyls.
(14) Neely, W.B. et al. Partition Coefficient to Measure Bioconcentration Potential of Organic Chemicals in Fish,
(15) Rappaport, R.A. and Eisenrich, S.J. Chromatographic determination of octanol-water partition coefficients (K
(16) Tewari, Y.B. et al. Aqueous solubility and octanol/water partition coefficients of organic compounds at 25 °C.
(17) Tulp, M.T.M. and Hutzinger, O. Some thoughts on aqueous solubilities and partition coefficients of PCB, and the mathematical correlation between bioaccumulation and physio-chemical properties.
(18) Veith, G.D. et al. A rapid method for estimating log
(19) Wasik, S.P. et al. Octanol/water partition coefficient and aqueous solubilities of organic compounds, Report NBSIR 81-2406 (1981). National Bureau of Standards, U.S. Department of Commerce, Washington, DC.
(20) Woodburn, K.B. Measurement and application of the octanol/water partition coefficients for selected polychlorinated biphenyls. Master's Thesis (1982), University of Wisconsin at Madison, Madison, WI.
(21) Woodburn, K.B. et al. Generator column determination of octanol/water partition coefficients for selected polychlorinated biphenyl congeners.
(22) ASTM D 1193-91 (Approved Sep 15, 1991), “Standard Specification for Reagent Water.” American Society for Testing and Materials (ASTM), 1916 Race St., Philadelphia, PA 19103.
(a)
(2)
(b)
(2)
(3)
(ii) The column elution method is not suitable for volatile substances. The carrier material used here may not yet be optimal. This method is intended for material with solubilities below approximately 10
(iii) The flask method is intended for materials with solubility above 10
(c)
(ii) Solubility in water is a significant parameter because:
(A) The spatial and temporal movement (mobility) of a substance is largely determined by its solubility in water.
(B) Water soluble substances gain ready access to humans and other living organisms.
(C) The knowledge of the solubility in water is a prerequisite for testing biological degradation and bioaccumulation in water and for other tests.
(iii) No single method is available to cover the whole range of solubilities in water, from relatively soluble to very low-soluble chemicals. A general test guideline for the determination of the solubility in water must include methods which cover the whole range of water soluble substances. Therefore, this section includes two methods:
(A) One which applies to substances with low solubilities (<10
(B) The other which applies to substances with higher solubilities (≤10
(2)
(3)
(4)
(i)
(ii)
(5)
(ii)
(iii)
(A) Pure substance.
(B) Substances that are stable in water.
(C) Slightly soluble substances, i.e. <10
(D) Organic substances for the column elution method.
(iv)
(d)
(
(
(B)
(
(
(
(
(2)
(3)
(4)
(B) After each addition of water to give the indicated total volume, the mixture is shaken vigorously for 10 min and is visually checked for any undissolved parts of the sample. If, after a total of 10 mL of water has been added (step 5), the sample or parts of it remain undissolved, the contents of the measuring cylinder is transferred to a 100 mL measuring cylinder which is then filled up with water to 100 mL (step 6) and shaken. At lower solubilities the time required to dissolve a substance can be considerably long (24 h should be allowed). The approximate solubility is given in the table under that volume of added water in which complete dissolution of the sample occurs. If the substance is still apparently insoluble, further dilution should be undertaken to ascertain whether the column elution or flask solubility method should be used.
(ii)
(
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(B)
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(iii)
(iv)
(e)
(ii)
(A) The individual concentrations, flow rates and pHs of each samples.
(B) The means and standard deviations from at least five samples from the saturation plateau of each run.
(C) The average of the two successive, acceptable runs.
(D) The temperature of the runs.
(E) The method of analysis employed.
(F) The nature of the carrier material employed.
(G) Loading of carrier material.
(H) Solvent used.
(I) Statement that the identity of the substance in the saturated solution has been proved.
(2)
(ii)
(A) The individual analytical determinations and the average where more than one value was determined for each flask.
(B) The average of the value for the different flasks which were in agreement.
(C) The test temperature.
(D) The analytical method employed.
(f)
(1) Veith, G.D. and V.M. Comstock. Apparatus for continuously saturating water with hydrophobic organic chemicals.
(2)
(a)
(2)
(b)
(ii) Water provides the medium in which many organisms live, and water is a major component of the internal environment of all living organisms (except for dormant stages of certain life forms). Even organisms which are adapted to life in a gaseous environment require water for normal functioning. Water is thus the medium through which most other chemicals are transported to and into living cells. As a result, the extent to which chemicals dissolve in water will be a major determinant for movement through the environment and entry into living systems.
(iii) The water solubility of a chemical also has an effect on its sorption into and desorption from soils and sediments, and on volatilization from aqueous media. The more soluble a chemical substance is, the less likely it is to sorb to soils and sediments and the less likely it is to volatilize from water. Finally, the design of most chemical tests and many ecological and health tests requires precise knowledge of the water solubility of the chemical to be tested.
(2)
(3)
(ii) Since the HPLC method is only applicable to compounds that absorb in the UV, an alternate GC method, or any other reliable procedure (which must be approved by OPPTS), can be used for those compounds that do not absorb in the UV. In the GC method the saturated solutions produced in the generator column are extracted using an appropriate organic solvent that is subsequently injected into the GC, or any other suitable analytical device, for analysis of the test compound.
(4)
(5)
(ii) This section is designed to determine the water solubility of a solid or liquid test chemical in the range of 1 ppb to 5,000 ppm. For chemicals whose solubility is below 1 ppb, the water solubility should be characterized as “less than 1 ppb” with no further quantification. For solubilities greater than 5,000 ppm, the shake flask method should be used, see paragraph (e)(15) of this section.
(c)
(
(B) Constant temperature bath with circulation pump-bath and capable of controlling temperature to ± 0.05 °C, see paragraph (c)(3) of this section.
(C) HPLC equipped with a variable wavelenth UV absorption detector operating at a suitable wavelength and a recording integrator in paragraph (c)(3)(ii) of this section.
(D) Extractor column—6.6 × 0.6 cm stainless steel tube with end fittings containing 5 μm frits filled with a superficially porous phase packing (Bondapack C
(E) Two 6-port high-pressure rotary switching valves in paragraph (c)(3)(ii) of this section.
(F) Collection vessel—8 ×
(G) GC, or any other reliable analytical equipment, which has a detector sensitive to the solute of interest in paragraph (c)(3)(iii) of this section.
(ii)
(iii)
(iv)
(v)
(2)
(A) pH 3.0—to 250 mL of 0.10M potassium hydrogen phosphate add 111 mL of 0.10 M hydrochloric acid; adjust the final volume to 500 mL with reagent grade water.
(B) pH 5.0—to 250 mL of 0.1M potassium hydrogen phthalate add 113 mL of 0.1M sodium hydroxide; adjust the final volume to 500 mL with reagent grade water.
(C) pH 7.0—to 250 mL of 0.1M potassium dihydrogen phosphate add 145 mL of 0.1M sodium hydroxide; adjust the final volume to 500 mL with reagent grade water.
(D) pH 9.0—to 250 mL of 0.075M borax add 69 mL of 0.1M HCl; adjust the final volume to 500 mL with reagent grade water.
(E) pH 11.0—to 250 mL of 0.05 M sodium bicarbonate add 3 mL of 0.10 M
(ii) Check the pH of each buffer solution with a pH meter at 25 °C and adjust to pH 5.0, 7.0, or 9.0, if necessary. If the pH of the solution has changed by ±0.2 pH units or more after the addition of the test compound, then a more concentrated buffer is required for that pH determination. The sponsor should then choose a more suitable buffer.
(iii)
(3)
(i) Prior to the determination of the water solubility of the test chemical, two procedures shall be followed.
(A) The saturated aqueous solution leaving the generator column must be tested for the presence of an emulsion, using a Tyndall procedure. If colloids are present, they must be eliminated prior to the injection into the extractor column. This may be achieved by lowering the flow rate of the water.
(B) The efficiency of the removal of the solute (i.e. test chemical) by the solvent extraction from the extraction column must be determined and used in the determination of the water solubility of the test chemical.
(ii)
(
(
(
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(
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(B)
(
(
(
(
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(iii)
(B)
(C)
(
(
(
(
(
(
(iv)
(d)
(ii) For compounds that decompose at a rate such that a precise value for the water solubility cannot be obtained, provide a statement to that effect.
(iii) For compounds with water solubility below 1 ppb, report the value as “less than 1 ppb.”
(2)
(A) The method used to determine the sample-loop volume and the average and standard deviation of that volume.
(B) The average and standard deviation of the RF.
(C) Any changes made or problems encountered in the test procedure.
(ii) For the GC, or any other analytical, method report:
(A) The column and GC operating conditions of temperature and flow rate, or the operating conditions of any other analytical method used.
(B) The average and standard deviation of the average area per microliter obtained for each of the standard solutions.
(C) The form of the regression equation obtained in the calibration procedure.
(D) The extracting solvent used, and its extraction efficiency.
(E) The average and standard deviation of solute concentration in each collection vessel.
(F) Any changes made or problems encountered in the test procedure.
(G) If applicable, a complete description of the analytical method which was used instead of the GC method.
(e)
(1) DeVoe, H. et al., Generator columns and high pressure liquid chromatography for determining aqueous solubilities and octanol-water partition coefficients of hydrophobic substances.
(2) Hansch, C. et al., The linear free-energy relationship between partition coefficients, and the aqueous solubility of organic liquids.
(3) Leifer, A. et al., Environmental transport and transformation of polychlorinated biphenyls. Chapter 1. U.S. Environmental Protection Agency Report: EPA-560/5-83-005 (1983).
(4) Mackay, D. et al., Relationships between aqueous solubility and octanol-water partition coefficient.
(5) May, W.E. et al., Determination of the aqueous solubility of polynuclear aromatic hydrocarbons by a coupled column liquid chromatographic technique.
(6) May, W.E. et al. Determination of the solubility behavior of some polycyclic aromatic hydrocarbons in the water.
(7) Miller, N.M. et al., Aqueous solubilities, octanol/water partition coefficients, and entropy of melting of chlorinated benzenes and biphenyls.
(8) OECD/Organization for Economic Cooperation and Development. Test Guideline No. 105. Water solubility column elution-flask method (1981).
(9) Sutton, C. and Calder, J.A., Solubility of alkylbenzenes in distilled water and seawater at 25 °C.
(10) Tewari, Y.B. et al., Aqueous solubility and octanol/water partition coefficient of organic compounds at 25 °C.
(11) Wasik, S.P. et al., Octanol/Water Partition Coefficient and Aqueous Solubilities of Organic Compounds. NBS Report NBSIR 81-2406. Washington, DC: National Bureau of Standards, U.S. Department of Commerce (1981).
(12) Yalkowski, S.H. et al., “Aquasol database of aqueous solubilities of organic compounds”; Fifth Edition. University of Arizona, College of Pharmacy, Tucson, AZ 85721 (1990) (available at http://www.pharm.arizona.edu/aquasol/index.html).
(13) ASTM D 1193-91,
(a)
(b)
(c)
(d)
(i)
(A) The up and down procedure as described in OECD Guideline 425 referenced in paragraph (f)(4) of this section.
(B) The acute toxic class method as described in OECD Guideline 423 and referenced in paragraph (f)(6) of this section.
(C) The fixed dose method as described in OECD Guideline 420 and referenced in paragraph (f)(5) of this section.
(ii)
(2) [Reserved]
(e)
(2)
(3)
(ii)
(B)
(C)
(
(
(D)
(E)
(
(
(
(
(iii)
(B)
(C)
(D)
(iv)
(B) The test substance must be administered in a single dose by gavage, using a stomach tube or suitable intubation cannula.
(C) If a single dose is not possible, the dose may be given in smaller fractions over a period not exceeding 24 hours. Where a dose is administered in fractions, it may be necessary to provide the animals with food and water, depending on the length of the dosing period.
(D) After the substance has been administered, feed may be withheld for an additional 3-4 hours.
(v)
(vi)
(B) Additional observations must be made daily, especially in the early days of the study. Appropriate actions should be taken to minimize loss of animals to the study (e.g., necropsy or refrigeration of those animals found dead and isolation of weak or moribund animals).
(C) Observations must be detailed and carefully recorded, preferably using explicitly defined scales. Observations should include, but not be limited to, evaluation of skin and fur, eyes and mucous membranes, respiratory and circulatory effects, autonomic effects such as salivation, central nervous system effects, including tremors and convulsions, changes in the level of activity, gait and posture, reactivity to handling or sensory stimuli, altered strength, and stereotypies or bizarre behavior (e.g., self-mutilation, walking backwards).
(D) Individual weights of animals must be determined shortly before the test substance is administered, weekly thereafter, and at death. Changes in weights should be calculated and recorded when survival exceeds 1 day.
(E) The time of death should be recorded as precisely as possible.
(vii)
(B) A gross necropsy must be performed on all animals under test. All gross pathology changes should be recorded.
(C) If necropsy cannot be performed immediately after a dead animal is discovered, the animal should be refrigerated (not frozen) at temperatures low enough to minimize autolysis. Necropsies should be performed as soon as practicable, normally within a day or two.
(viii)
(ix)
(B)
(C)
(
(
(
(
(
(
(
(
(
(
(
(
(
(
(
(
(f)
(1) Chanter, D.O. and Heywood, R. The LD
(2) Finney, D.J. Chapter 3—Estimation of the median effective dose and Chapter 4—Maximum likelihood estimation,
(3) Finney, D.J. The Median Lethal Dose and Its Estimation.
(4) Organization for Economic Cooperation and Development. OECD Guidelines for the Testing of Chemicals. OECD Guideline 425: Acute Oral Toxicity: Up-and-Down Procedure, Approved: June 1998.
(5) Organization for Economic Cooperation and Development. OECD
(6) Organization for Economic Cooperation and Development. OECD Guidelines for Testing of Chemicals. Guideline 423: Acute Oral Toxicity—Acute Toxic Class Method, Adopted: March 22, 1996.
(7) Organization for Economic Cooperation and Development. OECD Guidelines for Testing of Chemicals. Guideline 401: Acute Oral Toxicity, Adopted: February 24, 1987.
(a)
(b)
(c)
(d)
(i) Using data from substantially similar mixtures. In order to minimize the need for animal testing, the Agency encourages the review of existing acute toxicity information on mixtures that are substantially similar to the mixture under investigation. In certain cases it may be possible to glean enough information to make preliminary hazard evaluations that may reduce the need for further animal testing.
(ii)
(2) [Reserved]
(e)
(2)
(3)
(ii)
(B)
(C)
(
(
(D)
(E)
(
(
(
(
(iii)
(B)
(C)
(iv)
(v)
(vi)
(B) The test substance must be held in contact with the skin with a porous gauze dressing (<8 ply) and nonirritating tape throughout a 24-hour exposure period. The test site must be further covered in a suitable manner to retain the gauze dressing and test substance and ensure that the animals cannot ingest the test substance. Restrainers may be used to prevent the ingestion of the test substance, but complete immobilization is not a recommended method. Although a semiocclusive dressing is preferred, an occlusive dressing will also be acceptable.
(C) At the end of the exposure period, residual test substance should be removed where practicable using water or an appropriate solvent.
(vii)
(viii)
(B) Additional observations must be made daily, especially in the early days of the study. Appropriate actions should be taken to minimize loss of animals to the study (e.g., necropsy or refrigeration of those animals found dead and isolation of weak or moribund animals).
(C) Observations must be detailed and carefully recorded, preferably using explicitly defined scales. Observations should include, but not be limited to, evaluation of skin and fur, eyes and mucous membranes, respiratory and circulatory effects, autonomic effects such as salivation, central nervous system effects, including tremors and convulsions, changes in the level of activity, gait and posture, reactivity to handling or sensory stimuli, altered strength, and stereotypies or bizarre behavior (
(D) Individual weights of animals must be determined shortly before the test substance is administered, weekly thereafter, and at death. Changes in weights should be calculated and recorded when survival exceeds one day.
(E) The time of death should be recorded as precisely as possible.
(ix)
(B) A gross necropsy must be performed on all animals under test. All gross pathology changes should be recorded.
(C) If necropsy cannot be performed immediately after a dead animal is discovered, the animal should be refrigerated (not frozen) at temperatures low enough to minimize autolysis. Necropsies should be performed as soon as practicable, normally within a day or two.
(x)
(xi)
(B)
(C)
(
(
(
(
(
(
(
(
(
(
(
(
(
(
(
(
(f)
(1) Chanter, D.O. and Heywood, R., The LD
(2) Finney, D.J. Chapter 3—Estimation of the median effective dose and Chapter 4-Maximum likelihood estimation,
(3) Finney, D.J. The Median Lethal Dose and Its Estimation.
(4) Organization for Economic Cooperation and Development. OECD Guideline for the Testing of Chemicals. OECD Guideline 425: Acute Oral Toxicity: Up-and-Down Procedure. Adopted: September 21, 1998.
(5) Organization for Economic Cooperation and Development. OECD Guidelines for Testing of Chemicals. Guideline 420: Acute Oral Toxicity—Fixed Dose Method. Adopted: July 17, 1992.
(6) Organization for Economic Cooperation and Development. OECD Guidelines for Testing of Chemicals. Guideline 423: Acute Oral Toxicity—Acute Toxic Class Method. Adopted: March 22, 1996
(7) Organization for Economic Cooperation and Development. OECD Guidelines for Testing of Chemicals. Guideline 402: Acute Dermal Toxicity. Adopted: February 24, 1987.
(a)
(b)
(c)
(d)
(i) Using data from substantially similar mixtures. In order to minimize the need for animal testing, the Agency encourages the review of existing acute toxicity information on mixtures that are substantially similar to mixtures under investigation. In certain cases, it may be possible to get enough information to make preliminary hazard evaluations that may reduce the need for further animal testing.
(ii) Limit test. When data on structurally related chemicals are inadequate, a limit test may be considered. In the limit test, a single group of five males and five females is exposed to 2 mg/L for 4 hours, or where this is not possible due to physical or chemical properties of the test substance, the maximum attainable concentration where a particle size distribution having an MMAD between 1 and 4 μm cannot be maintained, using the procedures described under paragraph (e) of this section. For fibers, the bivariate distribution of length and diameter must ensure inhalability. For gases and vapors, the concentrations need not be greater than 50,000 ppm or 50% of the lower explosive limit, whichever is lower. If a test at an aerosol or particulate exposure of 2 mg/L (actual concentration of respirable substance) for 4 hours or, where this is not feasible, the maximum attainable concentration, using the procedures described for this study, produces no observable toxic effects, then a full study using three concentrations will not be necessary. Similarly, if a test at a gas or vapor exposure of 50,000 ppm or 50% of the lower explosive limit, whichever is lower, produces no observable toxic effects, then a full study using three concentrations will not be necessary.
(2) [Reserved]
(e)
(2)
(3)
(ii)
(
(B)
(C)
(
(
(D)
(
(E)
(
(
(
(F)
(
(
(G)
(
(
(
(
(
(iii)
(B)
(C) When the physical and chemical properties of the test substance show a low flash point or the test substance is otherwise known or thought to be explosive, care must be taken to avoid exposure level concentrations that could result in an exposure chamber explosion during the test.
(iv)
(v)
(B) Additional observations should be made daily with appropriate actions taken to minimize loss of animals to the study, e.g., necropsy or refrigeration of those animals found dead and isolation of weak or moribund animals.
(C) Observations must be detailed and carefully recorded, preferably using explicitly defined scales. Observations should include, but not be limited to, evaluation of skin and fur, eyes and mucous membranes, respiratory and circulatory effects, autonomic effects such as salivation, central nervous system effects, including tremors and convulsions, changes in the level of activity, gait and posture, reactivity to handling or sensory stimuli, altered strength, and stereotypies or bizarre behavior (e.g., self mutilation, walking backwards).
(D) Individual weights of animals must be determined pre-exposure and post-exposure, weekly after exposure, and at death. Changes in weights should be calculated and recorded when survival exceeds 1 day.
(E) The time of death should be recorded as precisely as possible.
(vi)
(
(
(
(B) If necropsy cannot be performed immediately after a dead animal is discovered during the observation period, the animal should be refrigerated (not frozen) at temperatures low enough to minimize autolysis. Necropsies should be performed as soon as possible after death (normally within 24 to 48 hours).
(vii)
(f)
(2)
(3)
(i) Test conditions. (A) Description of exposure apparatus including design, type, dimensions.
(B) Source of air, system for generating the test article as particle, aerosol, gas, or vapor.
(C) Method for conditioning air, equipment for measuring temperature, humidity, particle size or particulate aerosol concentration size, and actual concentration.
(D) Treatment of exhaust air and the method of housing the animals in a test chamber when this is used.
(ii) Exposure data. The exposure data must be tabulated and presented with mean values and a measure of variability (e.g., standard deviation) and should include:
(A) Chemical purity of the test material.
(B) Airflow rates through the inhalation equipment.
(C) Temperature and humidity of the air.
(D) Nominal concentration (total amount of test substance fed into the inhalation equipment divided by volume of air).
(E) Actual (analytical or gravimetric) concentration in test breathing zone.
(F) Particle size distribution (calculated MMAD and GSD) and the bivariate distribution of fiber length and diameter, where appropriate.
(G) Explanation as to why the desired chamber concentration and/or particle size could not be achieved (if applicable), and the efforts taken to comply with these aspects of this section.
(iii) Species, strain, sex, and source of test animals.
(iv) Method of randomization in assigning animals to test and control groups.
(v) Rationale for selection of species, if other than that recommended.
(vi) Results. Tabulation of individual and test group data by sex and exposure concentration level (e.g., number of animals exposed, number of animals showing signs of toxicity and number of animals that died or were sacrificed during the test).
(A) Description of toxic effects including time of onset, duration, reversibility, and relationship to the exposure concentration levels.
(B) Pre-exposure and post-exposure body weight change in animals, and weight change during the observation period.
(C) Time of dosing and time of death during or following exposure.
(D) Concentration-response curves for mortality and other toxic effects (when permitted by the method of determination).
(E) Gross pathology necropsy findings in the test animals and vehicle control animals, if included. Data must be tabulated to show the counts and incidence of gross alterations observed for each group tested and the number of animals affected by each type of lesion along with the location and frequency of each type of lesion.
(F) Histopathology findings and any additional evaluations (e.g., clinical chemistry), if performed.
(vii) Description of any pretest conditioning, including diet, quarantine and treatment for disease.
(viii) Description of caging conditions, including: number (or change in number) of animals per cage, bedding material, ambient temperature and humidity, photoperiod, and identification of diet of test animals.
(ix) Manufacturer (source), lot number, and purity of test substance.
(x) Identification and composition of any vehicles (e.g., diluents, suspending agents, and emulsifiers) or other materials , if used in administering the test substance.
(xi) A list of references cited in the body of the report. References to any published literature used in developing the test protocol, performing the testing, making and interpreting observations, and compiling and evaluating the results.
(g)
(1) Chanter, D.O. and Heywood, R. The L
(2) Finney, D.G. Chapter 3 Estimation of the median effective dose, Chapter 4 Maximum likelihood estimation.
(3) Finney, D.J. The Median Lethal Dose and Its Estimation,
(4) Organization for Economic Cooperation and Development. OECD Guidelines for the Testing of Chemicals. Final Draft OECD Guideline 425: Acute Oral Toxicity: Up-and-Down Procedure to be adopted in the Tenth Addendum to the OECD Guidelines for the Testing of Chemicals.
(5) Organization for Economic Cooperation and Development. OECD Guidelines for Testing of Chemicals. Guideline 403: Acute Inhalation Toxicity. Adopted: May 12, 1981.
(6) Organization for Economic Cooperation and Development. OECD Guidelines for Testing of Chemicals. Guideline 420: Acute Oral Toxicity Fixed Dose Method. Adopted: July 17, 1992.
(7) Organization for Economic Cooperation and Development. OECD Guidelines for Testing of Chemicals. Guideline 423: Acute Oral Toxicity Acute Toxic Class Method. Adopted: March 22, 1996.
(8) U. S. EPA. Interim Policy for Particle Size and Limit Concentration Issues in Inhalation Toxicity Studies. 2/1/94. Health Effects Division, Office of Pesticide Programs.
(a)
(b)
(c)
(1) The extrathoracic region or upper respiratory tract that includes the nose, mouth, nasopharynx, oropharynx, laryngopharynx, and larynx.
(2) The tracheobronchial region that includes the trachea, bronchi, and bronchioles (including the terminal bronchioles).
(3) The alveolar region that includes the respiratory bronchioles (if present in the species), alveolar ducts, alveolar sacs, and alveoli.
(1) The initial histopathologic examination (respiratory tract, liver, kidney, gross lesions); or
(2) The retrospective histopathologic examination of archived organs triggered by their identification as targets of toxicity in a 90-day study.
(d)
(e)
(ii)
(iii)
(iv)
(v)
(2)
(3)
(4)
(i)
(ii)
(5)
(i)
(ii)
(iii)
(6)
(i) Chemical purity of the test material shall be analyzed.
(ii) The rate of airflow shall be monitored continuously, but shall be recorded at least every 30 minutes.
(iii) The actual concentrations of the test substance shall be measured in the breathing zone. During the exposure period, the actual concentrations of the test substance shall be held as constant as practical, monitored continuously or intermittently depending on the method of analysis, and recorded at least at the beginning, at an intermediate time, and at the end of the exposure period. Well-established and published monitoring methods should be used where available. If no standard methods are available, then accuracy and precision information must be supplied.
(iv) During the development of the generating system, appropriate particle size analysis shall be performed to establish the stability of the aerosol. During exposure, analysis should be conducted as often as necessary to determine the consistency of particle size distribution. The particle size distribution shall have an MMAD between 1 and 4 μm. The particle size of hygroscopic materials shall be small enough when dry to assure that the size of the particle at saturation will still have an MMAD between 1 and 4 μm. Characterization for fibers shall include the bivariate distribution of length and diameter; this distribution must ensure inhalability.
(v) If the test substance is present in a mixture, the mass and composition of the entire mixture, as well as the principal compound, shall be measured.
(vi) Temperature and humidity shall be monitored continuously, but shall be recorded at least every 30 minutes.
(7)
(8)
(9)
(ii) At least the lungs, liver, kidneys, adrenals, brain, and gonads shall be weighed wet, as soon as possible after dissection to avoid drying.
(iii) The following organs and tissues, or representative samples thereof, shall be preserved in a suitable medium for possible future histopathological examination: All gross lesions; brain-including sections of medulla/pons; cerebellar cortex and cerebral cortex; pituitary; thyroid/parathyroid; thymus; heart; sternum with bone marrow; salivary glands; liver; spleen; kidneys; adrenals; pancreas; gonads; accessory genital organs (epididymis, prostrate, and, if present, seminal vesicles); aorta; skin; gall bladder (if present); esophagus; stomach; duodenum; jejunum; ileum; cecum; colon; rectum; urinary bladder; representative lymph nodes; thigh musculature; peripheral nerve; spinal cord at three levels cervical, midthoracic, and lumbar; and eyes. Respiratory tract tissues shall also be preserved in a suitable medium.
(10)
(i) Full histopathology shall be performed on the respiratory tract, liver and kidney of all animals in the control and high concentration groups. The histopathology of the respiratory tract is described under paragraph (e)(11) of this section.
(ii) All gross lesions which differ from controls in frequency, distribution, type, or severity in all concentration groups.
(iii) Target organs in all animals, as indicated by the observations in the high concentration group in this study. Histopathologic examination of target organs in animals at all concentration levels (rather than only to the extent necessary to define the NOAEL) can support the application of exposure-response analyses such as the benchmark concentration approach.
(iv) Archived organs identified as targets of toxicity from results of the 90-day study (if a 90-day study is required for this substance) should be elevated in high concentration animals of the 4-hr acute study to determine if they are also targets of acute toxicity.
(11)
(ii) Care shall be taken that the method used to kill the animal does not result in damage to the tissues of the upper or lower respiratory tract. The lungs shall be infused with a fixative while in an inflated state of fixed pressure.
(iii) The upper respiratory tract shall be examined for histopathologic lesions. This examination shall use a minimum of four sections located as specified under paragraphs (e)(11)(iii)(A) through (e)(11)(iii)(D) of this section. An evaluation of the nasal vestibule shall be conducted. The method described by the reference under paragraph (h)(11) of this section should be given consideration. The use of additional sections shall be left to the discretion of the study pathologist, but consideration should be given to additional sections as recommended in the reference under paragraph (h)(8) of this section to ensure adequate evaluation of the entire upper respiratory tract, particularly the nasopharyngeal meatus. The following transverse sections shall be examined:
(A) Immediately posterior to the upper incisor teeth.
(B) At the incisor papilla.
(C) At the second palatal ridge.
(D) At the level of the first upper molar teeth.
(iv) The laryngeal mucosa shall be examined for histopathologic changes. Sections of the larynx to be examined include the epithelium covering the base of the epiglottis, the ventral pouch, and the medial surfaces of the vocal processes of the arytenoid cartilages.
(12)
(ii) Care should be taken that the method used to kill the animal results in minimum changes in the fluid of the lungs of the test animals.
(iii) At the appropriate time, the test animals shall be killed and the heart-lung including trachea removed in bloc. Alternatively, lungs can be lavaged in situ. If the study will not be compromised, one lobe of the lungs may be used for lung lavage while the other is fixed for histologic evaluation. The lungs should be lavaged using physiological saline. The lavages shall consist of two washes, each of which consists of approximately 80% (e.g., 5 ml in rats and 1 ml in mice) of the total lung volume. Additional washes merely tend to reduce the concentrations of the material collected. The lung lavage fluid shall be stored on ice at 5 °C until assayed.
(iv) The following parameters shall be determined in the lavage fluid as indicators of cellular damage in the lungs: total protein, cell count, and percent leukocytes. In addition, a phagocytosis assay shall be performed to determine macrophage activity. Assay methods described in the references under paragraphs (h)(1) and (h)(3) of this section may be used.
(13)
(f)
(g)
(1)
(i) Description of exposure apparatus, including design, type, dimensions, source of air, system for generating particles, aerosols, gasses, and vapors, method of conditioning air, treatment of exhaust air, and the method of housing animals in a test chamber.
(ii) Description of the equipment for measuring temperature, humidity, and particulate aerosol concentration and size.
(iii) Exposure data shall be tabulated and presented with mean values and measure of variability (e.g., standard deviation) and should include:
(A) Chemical purity of the test material.
(B) Airflow rates through the inhalation equipment.
(C) Temperature and humidity of air.
(D) Nominal concentration (total amount of test substance fed into the inhalation equipment divided by the volume of air).
(E) Actual concentration in test breathing zone.
(F) Particle size distribution (e.g., MMAD with GSD) and the bivariate distribution of fiber length and diameter, where appropriate.
(2)
(A) Number of animals exposed.
(B) Number of animals dying.
(C) Number of animals showing overt signs of toxicity.
(D) Pre- and post-exposure body weight change in animals, and weight change during the observation period.
(ii)
(A) The number of animals used in each group and the number of animals in which any gross lesions were found.
(B) The number of animals affected by each different type of lesion, and the locations and frequency of each type of lesion.
(iii)
(A) The number of animals used in each group and the number of animals in which any histopathologic lesions were found.
(B) The number of animals affected by each different type of lesion, and the locations, frequency, and average grade of each type of lesion.
(iv)
(A) The number of animals used in each group and the number of animals in which any histopathologic lesions were found.
(B) The number of animals affected by each different type of lesion, and the locations, frequency, and average grade of each type of lesion.
(v)
(A) The amount of administered lavage fluid and recovered lavage fluid for each test animal.
(B) The magnitude of change of biochemical and cytologic indices in lavage fluids at each test concentration for each animal.
(C) Results shall be quantified as amount of constituent/mL of lavage fluid. This assumes that the amount of lavage fluid recovered is a representative sample of the total lavage fluid.
(3)
(h)
(1) Burleson, G.R., Fuller, L.B.,
(2) Gardner, D.E., Crapo, J.D., and McClellan, R.O. (Eds.)
(3) Gilmour, G.I., and Selgrade, M.K. A comparison of the pulmonary defenses against streptococcal infection in rats and mice following O3 exposure: Differences in disease susceptibility and neutrophil recruitment.
(4) Henderson, R.F., Benson, J.M., Hahn, F.F., Hobbs, C.H., Jones, R.K., Mauderly, J.L., McClellan, R.O., and Pickrell, J.A. New approaches for the evaluation of pulmonary toxicity: Bronchoalveolar lavage fluid analysis.
(5) Henderson, R.F. Use of bronchoalveolar lavage to detect lung damage.
(6) Henderson, R.F., Rebar, A.H., Pickrell, J.A., and Newton, G.J. Early damage indicators in the lung. III. Biochemical and cytological response of the lung to inhaled metal salts.
(7) McClellan, R.O. and Henderson, R.F. (Eds.) Second edition.
(8) Mery, S., Gross, E.A., Joyner, D.R., Godo, M., and Morgan, K.T. Nasal Diagrams: A Tool for Recording the Distribution of Nasal Lesions in Rats and Mice.
(9) Phalen, R.F. (Ed)
(10) Renne, R.A., Gideon, K.M., Miller, R.A., Mellick, P.W., and Grumbein, S.L. Histologic methods and interspecies variations in the laryngeal histology of F344/N rats and B6C3F1 mice.
(11) Young, J.T. Histopathologic examination of the rat nasal cavity.
(a)
(2)
(b)
(2) This section places emphasis on neurological effects as a specific endpoint, and the need for careful clinical observations of the animals, so as to obtain as much information as possible, is stressed. The method should identify chemicals with neurotoxic potential, which may warrant further in-depth investigation of this aspect. In addition, the method may give an indication of immunological effects and reproductive organ toxicity.
(c)
(d)
(e)
(2)
(3)
(4)
(ii) Where necessary, the test substance is dissolved or suspended in a suitable vehicle. It is recommended that, wherever possible, the use of an
(f)
(2)
(ii) Dose levels should be selected taking into account any existing toxicity and (toxico-) kinetic data available for the test compound or related materials. The highest dose level should be chosen with the aim of inducing toxic effects but not death or severe suffering. Thereafter, a descending sequence of dose levels should be selected with a view to demonstrating any dosage related response and NOEL at the lowest dose level. Two to four fold intervals are frequently optimal for setting the descending dose levels and addition of a fourth test group is often preferable to using very large intervals (e.g., more than a factor of 10) between dosages.
(3)
(4)
(ii) For substances administered via the diet or drinking water it is important to ensure that the quantities of the test substance involved do not interfere with normal nutrition or water balance. When the test substance is administered in the diet either a constant dietary concentration (parts per million (ppm)) or a constant dose level in terms of the animals' body weight may be used; the alternative used must be specified. For a substance administered by gavage, the dose should be given at similar times each day, and adjusted as necessary to maintain a constant dose level in terms of animal body weight. Where a repeated dose study is used as a preliminary to a long term study, a similar diet should be used in both studies.
(5)
(ii) General clinical observations should be made at least once a day, preferably at the same time(s) each day and considering the peak period of anticipated effects after dosing. The health condition of the animals should be recorded. At least twice daily, all animals are observed for morbidity and mortality.
(iii) Once before the first exposure (to allow for within-subject comparisons), and at least once a week thereafter, detailed clinical observations should be made in all animals. These observations should be made outside the home cage in a standard arena and preferably at the same time, each time. They should be carefully recorded, preferably using scoring systems, explicitly defined by the testing laboratory. Effort should be made to ensure that variations in the test conditions are minimal and that observations are preferably conducted by observers unaware of the treatment. Signs noted should include, but not be limited to, changes in skin, fur, eyes, mucous membranes, occurrence of secretions and excretions and autonomic activity (e.g., lacrimation, piloerection, pupil size, unusual respiratory pattern). Changes in gait, posture and response to handling as well as the presence of clonic or tonic movements, stereotypies (e.g., excessive grooming, repetitive circling) or bizarre behaviour (e.g., self-mutilation, walking backwards) should also be recorded.
(iv) In the fourth exposure week sensory reactivity to stimuli of different types (see paragraph (h)(2) of this section) (e.g., auditory, visual and proprioceptive stimuli), assessment of grip strength and motor activity assessment should be conducted. Further details of the procedures that could be followed are given in the respective references. However, alternative procedures than those referenced could also be used. Examples of procedures for observation are described in the references in paragraphs (h)(1), (h)(2), (h)(3), (h)(4), and (h)(5) of this section.
(v) Functional observations conducted in the fourth exposure week may be omitted when the study is conducted as a preliminary study to a subsequent subchronic (90-day) study. In that case, the functional observations should be included in this follow-up study. On the other hand, the availability of data on functional observations from the repeated dose study may enhance the ability to select dose levels for a subsequent subchronic study.
(vi) Exceptionally, functional observations may also be omitted for groups that otherwise reveal signs of toxicity to an extent that would significantly interfere with the functional test performance.
(6)
(7)
(ii) Blood samples should be taken from a named site just prior to or as part of the procedure for sacrificing the animals, and stored under appropriate conditions.
(8)
(ii) Optionally, the following urinalysis determinations could be performed during the last week of the study using timed urine volume collection; appearance, volume, osmolality or specific gravity, pH, protein, glucose and blood and blood cells.
(iii) In addition, studies to investigate serum markers of general tissue damage should be considered. Other determinations that should be carried out if the known properties of the test substance may, or are suspected to, affect related metabolic profiles include calcium, phosphate, fasting triglycerides, specific hormones, methemoglobin and cholinesterase. These must to be identified for chemicals in certain classes or on a case-by-case basis.
(iv) Overall, there is a need for a flexible approach, depending on the species and the observed and/or expected effect with a given compound.
(v) If historical baseline data are inadequate, consideration should be given to determination of hematological and clinical biochemistry variables before dosing commences.
(9)
(B) The following tissues should be preserved in the most appropriate fixation medium for both the type of tissue and the intended subsequent histopathological examination: all gross lesions, brain (representative regions including cerebrum, cerebellum and pons), spinal cord, stomach, small and large intestines (including Peyer's patches), liver, kidneys, adrenals, spleen, heart, thymus, thyroid, trachea and lungs (preserved by inflation with fixative and then immersion), ovaries, uterus, testes, epididymides, accessory sex organs (e.g., prostate, seminal vesicles), urinary bladder, lymph nodes (preferably one lymph node covering the route of administration and another one distant from the route of administration to cover systemic effects), peripheral nerve (sciatic or tibial) preferably in close proximity to the muscle, and a section of bone marrow (or, alternatively, a fresh mounted bone marrow aspirate). The clinical and other findings may suggest the need to examine additional tissues. Also any organs considered likely to be target organs based on the known properties of the test substance should be preserved.
(ii)
(B) All gross lesions must be examined.
(C) When a satellite group is used, histopathology should be performed on tissues and organs identified as showing effects in the treated groups.
(g)
(ii) When possible, numerical results should be evaluated by an appropriate and generally acceptable statistical method. The statistical methods should be selected during the design of the study.
(2)
(i) Test substance:
(A) Physical nature, purity and physicochemical properties.
(B) Identification data.
(ii) Vehicle (if appropriate): Justification for choice of vehicle, if other than water.
(iii) Test animals:
(A) Species/strain used.
(B) Number, age and sex of animals.
(C) Source, housing conditions, diet, etc.
(D) Individual weights of animals at the start of the test.
(iv) Test conditions:
(A) Rationale for dose level selection.
(B) Details of test substance formulation/diet preparation, achieved concentration, stability and homogeneity of the preparation.
(C) Details of the administration of the test substance.
(D) Conversion from diet/drinking water test substance concentration (parts per million (ppm)) to the actual dose (mg/kg body weight/day), if applicable.
(E) Details of food and water quality.
(v) Results:
(A) Body weight/body weight changes.
(B) Food consumption, and water consumption, if applicable.
(C) Toxic response data by sex and dose level, including signs of toxicity.
(D) Nature, severity and duration of clinical observations (whether reversible or not).
(E) Sensory activity, grip strength and motor activity assessments.
(F) Hematological tests with relevant base-line values.
(G) Clinical biochemistry tests with relevant base-line values.
(H) Body weight at sacrificing and organ weight data.
(I) Necropsy findings.
(J) A detailed description of all histopathological findings.
(K) Absorption data if available.
(L) Statistical treatment of results, where appropriate.
(vi) Discussion of results.
(vii) Conclusions.
(h)
(1) Tupper, D.E., Wallace, R.B. (1980). Utility of the Neurologic Examination in Rats.
(2) Gad, S.C. (1982). A Neuromuscular Screen for Use in Industrial Toxicology.
(3) Moser, V.C., McDaniel, K.M., Phillips, P.M. (1991). Rat Strain and Stock Comparisons Using a Functional Observational Battery: Baseline Values and Effects of Amitraz.
(4) Meyer O.A., Tilson H.A., Byrd W.C., Riley M.T. (1979). A Method forthe Routine Assessment of Fore- and Hindlimb Grip Strength of Rats and Mice.
(5) Crofton K.M., Howard J.L., Moser V.C., Gill M.W., Reiter L.W., Tilson
(a)
(b)
(c)
(d)
(e)
(ii)
(B) Dosing of rodents should generally begin no later than 8-9 weeks of age.
(C) At the commencement of the study the weight variation of animals used must be within 20% of the mean weight for each sex.
(iii)
(iv)
(B) If interim sacrifices are planned, the number must be increased by the number of animals scheduled to be sacrificed before the completion of the study.
(C) To avoid bias, the use of adequate randomization procedures for the proper allocation of animals to test and control groups is required.
(D) Each animal must be assigned a unique identification number. Dead animals, their preserved organs and tissues, and microscopic slides must be identified by reference to the animal's unique number.
(v)
(B) The temperature of the experimental animal rooms should be at 22 ± 3 °C.
(C) The relative humidity of the experimental animal rooms should be 50 ± 20%.
(D) Where lighting is artificial, the sequence should be 12 hours light/12 hours dark.
(E) Control and test animals must be fed from the same batch and lot. The feed should be analyzed to assure adequacy of nutritional requirements of the species tested and for impurities that might influence the outcome of the test. For feeding, conventional laboratory diets may be used with an unlimited supply of drinking water.
(F) The study should not be initiated until animals have been allowed a period of acclimatization/quarantine to environmental conditions, nor should animals from outside sources be placed on test without an adequate period of quarantine. An acclimation period of at least five days is recommended.
(2)
(ii) If possible, one lot of the test substance tested should be used throughout the duration of the study and the research sample should be stored under conditions that maintain its purity and stability. Prior to the initiation of the study, there should be a characterization of the test substance, including the purity of the test compound and, if technically feasible, the names and quantities of contaminants and impurities.
(iii) If the test or control substance is to be incorporated into feed or another vehicle, the period during which the test substance is stable in such a mixture should be determined prior to the initiation of the study. Its homogeneity and concentration should be determined prior to the initiation of the study and periodically during the study. Statistically randomized samples of the mixture should be analyzed to ensure that proper mixing, formulation, and storage procedures are being followed, and that the appropriate concentration of the test or control substance is contained in the mixture.
(3)
(4)
(5)
(ii) The highest dose level should result in toxic effects but not produce an incidence of fatalities which would prevent a meaningful evaluation.
(iii) The intermediate dose levels should be spaced to produce a gradation of toxic effects.
(iv) The lowest dose level should produce no evidence of toxicity.
(6)
(ii) All animals must be dosed by the same method during the entire experimental period.
(iii) For substances of low toxicity, it is important to ensure that when administered in the diet the quantities of the test substance involved do not interfere with normal nutrition. When the test substance is administered in the diet, either a constant dietary concentration (parts per million) or a constant dose level in terms of body weight should be used; the alternative used should be specified.
(iv) For a substance administered by gavage, the dose should be given at approximately the same time each day, and adjusted at intervals (weekly or biweekly) to maintain a constant dose level in terms of body weight.
(7)
(ii) Animals in the satellite group (if used) scheduled for follow-up observations should be kept for at least 28 days further without treatment to detect recovery from, or persistence of, toxic effects.
(8)
(ii) A careful clinical examination must be made at least once weekly. Observations should be detailed and carefully recorded, preferably using explicity defined scales. Observations should include, but not be limited to, evaluation of skin and fur, eyes and mucous membranes, respiratory and circulatory effects, autonomic effects such as salivation, central nervous system effects, including tremors and convulsions, changes in the level of activity, gait and posture, reactivity to handling or sensory stimuli, altered strength, and stereotypes or bizarre behavior (e.g., self-mutilation, walking backwards).
(iii) Signs of toxicity should be recorded as they are observed including the time of onset, degree and duration.
(iv) Measurements of food consumption and water consumption, if drinking water is the exposure route, must be made weekly.
(v) Individual weights of animals must be determined shortly before the test substance is administered, weekly thereafter, and at death.
(vi) Moribund animals should be removed and sacrificed when noticed and the time of death should be recorded as precisely as possible.
(vii) At termination, all survivors in the treatment and control groups must be sacrificed.
(9)
(i)
(ii)
(B) The recommended clinical chemistry determinations are potassium, sodium, glucose, total cholesterol, urea nitrogen, creatinine, total protein and albumin. More than 2 hepatic enzymes, (such as alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sorbitol dehydrogenase, or gamma glutamyl transpeptidase) should also be measured. Measurements of addtional enzymes (of hepatic or other origin) and bile acids, may also be useful.
(C) If a test chemical has an effect on the hematopoietic system, reticulocyte counts and bone marrow cytology may be indicated.
(D) Other determinations that should be carried out if the test chemical is known or suspected of affecting related measures include calcium, phosphorus, fasting triglycerides, hormones, methemoglobin, and cholinesterases.
(iii) Optionally, the following urinalysis determinations could be performed during the last week of the study using timed urine volume collection: appearance, volume, osmolality or specific gravity, pH, protein, glucose and blood/blood cells.
(10)
(11)
(ii) The liver, kidneys, adrenals, testes, epididymides, ovaries, uterus, thymus, spleen, brain, and heart must be trimmed and weighed wet, as soon as possible after dissection.
(iii) The following organs and tissues, or representative samples thereof, should be preserved in a suitable medium for possible future histopathological examination:
(A) Digestive system—salivary glands, esophagus, stomach, duodenum, jejunum, ileum, cecum, colon, rectum, liver, pancreas, gallbladder (when present).
(B) Nervous system—brain (including sections of medulla/pons, cerebellum and cerebrum), pituitary, peripheral nerve (sciatic or tibial, preferably in close proximity to the muscle), spinal cord (three levels: cervical, mid-thoracic and lumbar), eyes (retina, optic nerve).
(C) Glandular system—adrenals, parathyroid, thyroid.
(D) Respiratory system—trachea, lungs, pharynx, larynx, nose.
(E) Cardiovascular/hemopoietic system—aorta, heart, bone marrow (and/or fresh aspirate), lymph nodes (preferably one lymph node covering the route of administration and another one distant from the route of administration to cover systemic effects), spleen, thymus.
(F) Urogenital system—kidneys, urinary bladder, prostate, testes, epididymides, seminal vesicle(s), uterus, ovaries, female mammary gland.
(G) Others—all gross lesions and masses, skin.
(12)
(A) Full histopathology on the organs and tissues, listed in paragraph (e)(11)(iii) of this section, of all rodents in the control and high dose groups, and all rodents that died or were sacrificed during the study.
(B) All gross lesions in all animals.
(C) Target tissues in all animals.
(D) When a satellite group is used, histopathology should be performed on tissues and organs identified as showing effects in the treated groups.
(ii) If excessive early deaths or other problems occur in the high dose group compromising the significance of the data, the next dose level should be examined for complete histopathology.
(iii) An attempt should be made to correlate gross observations with microscopic findings.
(iv) Tissues and organs designated for microscopic examination should be fixed in 10% buffered formalin or a recognized suitable fixative as soon as necropsy is performed and no less than 48 hours prior to trimming.
(f)
(ii) When applicable, all observed results, qualitative and quantitative, should be evaluated by an appropriate and generally accepted statistical method. Any generally accepted statistical methods may be used; the statistical methods, including significance criteria, should be selected during the design of the study.
(2)
(3)
(i) Test substance characterization should include:
(A) Chemical identification.
(B) Lot or batch number.
(C) Physical properties.
(D) Purity/impurities.
(ii) Identification and composition of any vehicle used.
(iii) Test system should contain data on:
(A) Species and strain of animals used and rationale for selection if other than that recommended.
(B) Age including body weight data and sex.
(C) Test environment including cage conditions, ambient temperature, humidity, and light/dark periods.
(D) Identification of animal diet.
(E) Acclimation period.
(iv) Test procedure should include the following data:
(A) Method of randomization used.
(B) Full description of experimental design and procedure.
(C) Dose regimen including levels, methods, and volume.
(v) Test results should include:
(A) Group animal data. Tabulation of toxic response data by species, strain, sex and exposure level for:
(
(
(
(B) Individual animal data. Data should be presented as summary (group mean) as well as for individual animals.
(
(
(
(
(5) Achieved dose (mg/kg/day) as a time-weighted average if the test substance is administered in the diet or drinking water.
(
(
(
(
(
(
(
(g)
(h)
(1) Boyd, E.M. Chapter 14. Pilot Studies, 15. Uniposal Clinical Parameters, 16. Uniposal Autopsy Parameters. Predictive Toxicometrics. Williams and Wilkins, Baltimore (1972).
(2) Fitzhugh, O.G.
(3) Organization for Economic Cooperation and Development. OECD uidelines for Testing of Chemicals. Guideline 408: Subchronic Oral Toxicity-Rodent: 90-day Study, Adopted: May 12, 1981.
(4) Weingand K., Brown G., Hall R. et al. Harmonization of Animal Clinical Pathology Testing in Toxicity and Safety Studies.
(a)
(b)
(c)
(d)
(e)
(ii)
(B) Dosing should generally begin in guinea pigs between 5-6 weeks of age, in rats between 8-9 weeks of age, and in rabbits at least 12 weeks old.
(C) At the commencement of the study, the weight variation of animals used must be within 20% of the mean weight for each sex.
(iii)
(iv)
(B) If interim sacrifices are planned, the number must be increased by the number of animals scheduled to be sacrificed before completion of the study.
(C) To avoid bias, the use of adequate randomization procedures for the proper allocation of animals to test and control groups is required.
(D) Each animal must be assigned a unique identification number. Dead animals, their preserved organs and tissues, and microscopic slides must be identified by reference to the animal's unique number.
(v)
(B) The temperature of the experimental animal rooms should be at 22 ± 3 °C
(C) The relative humidity of the experimental animal rooms should be 50 ± 20%.
(D) Where lighting is artificial, the sequence should be 12 hours light/12 hours dark.
(E) Control and test animals must be fed from the same batch and lot. The feed should be analyzed to assure adequacy of nutritional requirements of the species tested and for impurities that might influence the outcome of the test. For feeding, conventional laboratory diets may be used with an unlimited supply of drinking water.
(F) The study should not be initiated until animals have been allowed a period of acclimatization/quarantine to environmental conditions, nor should animals from outside sources be placed on test without an adequate period of quarantine. An acclimation period of at least five days is recommended.
(2)
(ii) One lot of the test substance should be used, if possible, throughout the duration of the study, and the research sample should be stored under conditions that maintain its purity and stability. Prior to the initiation of the study, there should be a characterization of the test substance, including the purity of the test compound and if technically feasible, the name and
(iii) If the test substance is dissolved or suspended in a vehicle, the period during which the test substance is stable in such a mixture should be determined prior to the initiation of the study. Its homogeneity and concentration should be determined prior to the initiation of the study and periodically during the study. Statistically randomized samples of the mixture should be analyzed to ensure that proper mixing, formulation, and storage procedures are being followed, and that the appropriate concentration of the test or control substance is contained in the mixture.
(3)
(4)
(5)
(ii) The highest dose level should elicit signs of toxicity but not produce severe skin irritation or an incidence of fatality which would prevent a meaningful evaluation. If application of the test substance produces severe skin irritation, the concentration may be reduced, although this may result in a reduction in, or absence of, other toxic effects at the high dose level. If the skin has been badly damaged early in the study, it may be necessary to terminate the study and undertake a new one at lower concentrations.
(iii) The intermediate dose levels should be spaced to produce a gradation of toxic effects.
(iv) The lowest dose level should not produce any evidence of toxic effects.
(6)
(7)
(ii) Solids should be pulverized when possible. The substance should be moistened sufficiently with water or, when necessary, a suitable vehicle to ensure good contact with the skin. When a vehicle is used, the influence of the vehicle on toxicity of, and penetration of the skin by, the test substance should be taken into account.
(iii) The volume of application should be kept constant, e.g., less than 300 μL for the rat; different concentrations of test solution shall be prepared for different dose levels.
(8)
(ii) Ideally, the animals should be treated with test substance for at least 6 hours per day on a 7-day per week basis. However, based on practical considerations, application on a 5-day per week basis is acceptable. Dosing should be conducted at approximately the same time each day.
(iii) The test substance must be applied uniformly over the treatment site.
(iv) The surface area covered may be less for highly toxic substances. As much of the area should be covered with as thin and uniform a film as possible.
(v) During the exposure period, the test substance must be held in contact with the skin with a porous gauze dressing (less than or equal to 8 ply). The test site must be further covered with nonirritating tape to retain the gauze dressing and the test substance and to ensure that the animals cannot ingest the test substance. Restrainers may be used to prevent the ingestion of the test substance, but complete immobilization is not recommended. The test substance may be wiped from the skin after the six-hour exposure period to prevent ingestion.
(9)
(ii) A careful clinical examination must be made at least once weekly. Observations should be detailed and carefully recorded, preferably using explicity defined scales. Observations should include, but not be limited to, evaluation of skin and fur, eyes and mucous membranes, respiratory and circulatory effects, autonomic effects such as salivation, central nervous system effects, including tremors and convulsions, changes in the level of activity, gait and posture, reactivity to handling or sensory stimuli, altered strength, and stereotypes or bizarre behavior (e.g., self-mutilation, walking backwards).
(iii) Signs of toxicity should be recorded as they are observed including the time of onset, degree and duration.
(iv) Individual weights of animals must be determined shortly before the test substance is administered, weekly thereafter, and at death.
(v) Food consumption must also be determined weekly if abnormal body weight changes are observed.
(vi) Moribund animals should be removed and sacrificed when noticed and the time of death should be recorded as precisely as possible.
(vii) At termination, all survivors in the control and treatment groups must be sacrificed.
(10)
(i)
(ii)
(B) The recommended clinical chemistry determinations are potassium, sodium, glucose, total cholesterol, urea nitrogen, creatinine, total protein and albumin. More than 2 hepatic enzymes, (such as alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sorbitol dehydrogenase, or gamma glutamyl transpeptidase)
(C) If a test chemical has an effect on the hematopoietic system, reticulocyte counts and bone marrow cytology may be indicated.
(D) Other determinations that should be carried out if the test chemical is known or suspected of affecting related measures include calcium, phosphorus, fasting triglycerides, hormones, methemoglobin, and cholinesterases.
(iii) Optionally, the following urinalysis determinations could be performed during the last week of the study using timed urine volume collection: appearance, volume, osmolality or specific gravity, pH, protein, glucose and blood/blood cells.
(11)
(12)
(ii) The liver, brain, kidneys, spleen, adrenals, testes, epididymides, uterus, ovaries, thymus and heart must be trimmed and weighed wet, as soon as possible after dissection.
(iii) The following organs and tissues, or representative samples thereof, must be preserved in a suitable medium for possible future histopathological examination:
(A) Digestive system—salivary glands, esophagus, stomach, duodenum, jejunum, ileum, cecum, colon, rectum, liver, pancreas, gallbladder (when present).
(B) Nervous system—brain (multiple sections, including cerebrum, cerebellum and medulla/pons), pituitary, peripheral nerve (sciatic or tibial, preferably in close proximity to the muscle), spinal cord (three levels, cervical, mid-thoracic and lumbar), eyes (retina, optic nerve).
(C) Glandular system—adrenals, parathyroid, thyroid.
(D) Respiratory system—trachea, lungs, pharynx, larynx, nose.
(E) Cardiovascular/Hematopoietic system—aorta, heart, bone marrow (and/or fresh aspirate), lymph nodes (preferably one lymph node covering the route of administration and another one distant from the route of administration to cover systemic effects), spleen, thymus.
(F) Urogenital system—kidneys, urinary bladder, prostate, testes, epididymides, seminal vesicle(s), uterus, ovaries, female mammary gland.
(G) Other—all gross lesions and masses, skin (both treated and adjacent untreated areas).
(13)
(A) Full histopathology on the organs and tissues, listed in paragraph (e)(12)(iii) of this section, of all animals in the control and high dose groups and all animals that died or were sacrificed during the study.
(B) All gross lesions in all animals.
(C) Target organs in all animals.
(D) When a satellite group is used, histopathology must be performed on tissues and organs identified as showing toxic effects in the treated groups.
(ii) If excessive early deaths or other problems occur in the high dose group compromising the significance of the data, the next dose level must be examined for complete histopathology.
(iii) An attempt should be made to correlate gross observations with microscopic findings.
(iv) Tissues and organs designated for microscopic examination should be fixed in 10% buffered formalin or a recognized suitable fixative as soon as necropsy is performed and no less than 48 hours prior to trimming.
(f)
(ii) When applicable, all observed results, qualitative and quantitative,
(2)
(3)
(i) Test substance characterization should include:
(A) Chemical identification.
(B) Lot or batch numbers.
(C) Physical properties.
(D) Purity/impurities.
(ii) Identification and composition of any vehicle if used.
(iii) Test system should contain data on:
(A) Species and strain of animals used and rationale for selection if other than that recommended.
(B) Age including body weight data and sex.
(C) Test environment including cage conditions, ambient temperature, humidity, and light/dark periods.
(D) Identification of animal diet.
(E) Acclimation period.
(iv) Test procedure should include the following data:
(A) Method of randomization used.
(B) Full description of experimental design and procedure.
(C) Dose regime including levels, method, and volume.
(v) Test results should include:
(A) Group animal data. Tabulation of toxic response data by species, strain, sex and exposure level for:
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(B) Individual animal data. Data should be presented as summary (group mean) as well as for individual animals.
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(g)
(h)
(1) Organization for Economic Cooperation and Development. Guidelines
(2) Weingand K, Brown G, Hall R et al. (1996). Harmonization of Animal Clinical Pathology Testing in Toxicity and Safety Studies.
(a)
(b)
(c)
(d)
(e)
(ii)
(B) Dosing of rodents should generally begin no later than 8 weeks of age.
(C) At the commencement of the study the weight variation of animals used shall not exceed ± 20% of the mean weight for each sex.
(iii)
(B) Females shall be nulliparous and nonpregnant.
(iv)
(B) If interim sacrifices are planned, the number of animals shall be increased by the number of animals scheduled to be sacrificed before the completion of the study.
(C) To avoid bias, the use of adequate randomization procedures for the proper allocation of animals to test and control groups is required.
(D) Each animal shall be assigned a unique identification number. Dead animals, their preserved organs and tissues, and microscopic slides shall be identified by reference to the animal's unique number.
(v)
(B) The temperature of the experimental animal rooms should be at 22 ±3 °C.
(C) The relative humidity of the experimental animal rooms should be 30-70%.
(D) Where lighting is artificial, the sequence should be 12 h light/12 h dark.
(E) Control and test animals should be fed from the same batch and lot. The feed should be analyzed to assure adequacy of nutritional requirements of the species tested and for impurities that might influence the outcome of the rest. For feeding, conventional laboratory diets may be used with an unlimited supply of drinking water.
(F) The study should not be initiated until animals have been allowed a period of acclimatization/quarantine to environmental conditions, nor should animals from outside sources be placed on test without an adequate period of quarantine. An acclimatization period of at least 5 days is recommended.
(2)
(ii) One lot of the test substance should be used, if possible throughout the duration of the study, and the research sample should be stored under conditions that maintain its purity and stability. Prior to the initiation of the study, there should be a characterization of the test substance, including the purity of the test substance and, if technically feasible, the name and quantities of unknown contaminants and impurities.
(3)
(4)
(5)
(ii) The highest concentration should result in toxic effects but not produce an incidence of fatalities which would prevent a meaningful evaluation.
(iii) The intermediate concentrations should be spaced to produce a gradation of toxic effects.
(iv) The lowest concentration should produce no evidence of toxicity.
(v) In the case of potentially explosive test substances, care should be taken to avoid generating explosive concentrations.
(6)
(7)
(8)
(ii) The selection of a dynamic inhalation chamber should be appropriate for the test substance and test system. Where a whole body chamber is used to expose animals to an aerosol, individual housing must be used to minimize crowding of the test animals and maximize their exposure to the test substance. To ensure stability of a chamber atmosphere, the total volume occupied by the test animals shall not exceed 5% of the volume of the test chamber. It is recommended, but not required, that nose-only or head-only exposure be used for aerosol studies in order to minimize oral exposures due to animals licking compound off their fur. Heat stress should be minimized.
(iii) The temperature at which the test is performed should be maintained at 22 ± 2 °C. The relative humidity should be maintained between 40 and 60%, but in certain instances (e.g., use of water vehicle) this may not be practicable.
(9)
(i) The rate of airflow shall be monitored continuously but recorded at least three times during the exposure.
(ii) The actual concentrations of the test substance shall be measured in the animal's breathing zone. During the exposure period, the actual concentrations of the test substance shall be held as constant as practicable and monitored continuously or intermittently depending on the method of analysis. Chamber concentration may be measured using gravimetric or analytical methods as appropriate. If trial run measurements are reasonably consistent ± 10% for liquid, aerosol, gas, or vapor; ± 20% for dry aerosol), then two measurements should be sufficient. If measurements are not consistent, three to four measurements should be taken. Whenever the test substance is a formulation, or it is necessary to formulate the test substance with a vehicle for aerosol generation, the analytical concentration must be reported for the total formulation, and not just for the active ingredient (AI). If, for example, a formulation contains 10% AI and 90% inerts, a chamber analytical limit concentration of 2 mg/L would consist
(iii) During the development of the generating system, particle size analysis shall be performed to establish the stability of aerosol concentrations with respect to particle size. The MMAD particle size range should be between 1-3 μm. The particle size of hygroscopic materials should be small enough when dry to assure that the size of the swollen particle will still be within the 1-3 μm range. Measurements of aerodynamic particle size in the animal's breathing zone should be measured during a trial run. If MMAD valves for each exposure level are within 10% of each other, then two measurements during the exposures should be sufficient. If pretest measurements are not within 10% of each other, three to four measurements should be taken.
(iv) Temperature and humidity shall be monitored continuously and recorded at least three times during an exposure.
(10)
(11)
(ii) Observations shall be made at least once each day for morbidity and mortality. Appropriate actions should be taken to minimize loss of animals to the study (e.g., Necropsy or refrigeration of those animals found dead and isolation or sacrifice of weak or moribund animals).
(iii) A careful clinical examination shall be made at least once weekly. Observations should be detailed and carefully recorded, preferably using explicitly defined scales. Observations should include, but not be limited to, evaluation of skin and fur, eyes and mucous membranes, respiratory and circulatory effects, autonomic effects such as salivation, central nervous system effects, including tremors and convulsions, changes in the level of activity, gait and posture, reactivity to handling or sensory stimuli, altered strength, and stereotypes or bizarre behavior (e.g., self-mutilation, walking backwards).
(iv) Signs of toxicity should be recorded as they are observed including the time of onset, degree and duration.
(v) Individual weights of animals shall be determined shortly before the test substance is administered, and weekly thereafter.
(vi) Food consumption shall also be determined weekly if abnormal body weight changes are observed.
(vii) Moribund animals should be removed and sacrificed when noticed and the time of death should be recorded as precisely as possible.
(viii) At termination, all survivors in the treatment groups shall be sacrificed.
(12)
(i) Hematology. The recommended parameters are red blood cell count, hemoglobin concentration, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration, white blood cell count, differential leukocyte count, platelet count, and a measure of clotting potential, such as prothrombin time or activated partial thromboplastin time.
(ii) Clinical chemistry. (A) Parameters which are considered appropriate to all studies are electrolyte balance, carbohydrate metabolism, and liver and kidney function. The selection of specific tests will be influenced by observations on the mode of action of the substance and signs of clinical toxicity.
(B) The recommended clinical chemistry determinations are potassium, sodium, glucose, total cholesterol, urea nitrogen, creatinine, total protein and albumin. More than 2 hepatic enzymes, (such as alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sorbitol dehydrogenase, or gamma glutamyl transpeptidase) should also be measured. Measurements of addtional enzymes (of hepatic or other origin) and bile acids, may also be useful.
(C) If a test chemical has an effect on the hematopoietic system, reticulocyte counts and bone marrow cytology may be indicated.
(D) Other determinations that should be carried out if the test chemical is known or suspected of affecting related measures include calcium, phosphorus, fasting triglycerides, hormones, methemoglobin, and cholinesterases.
(iii) Optionally, the following urinalysis determinations could be performed during the last week of the study using timed urine volume collection: appearance, volume, osmolality or specific gravity, pH, protein, glucose, and blood/blood cells.
(13)
(14)
(ii) At least the liver, kidneys, brain, and gonads shall be trimmed and weighed wet, as soon as possible after dissection to avoid drying.
(iii) The following organs and tissues, or representative samples thereof, shall be preserved in a suitable medium for possible future histopathological examination:
(A) Digestive system.
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(B) Nervous system.
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(C) Glandular system.
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(D) Respiratory system.
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(E) Cardiovascular/hematopoietic system.
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(F) Urogenital system.
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(G) Other.
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(15)
(A) Full histopathology on the respiratory tract and other organs and tissues, listed under paragraph (e)(15)(iii) of this section, of all animals in the control and high exposure groups and all animals that died or were killed during the study.
(B) All gross lesions in all animals.
(C) Target organs in all animals.
(D) Lungs of all animals. Special attention to examination of the respiratory tract should be made for evidence of infection as this provides a convenient assessment of the state of health of the animals.
(E) When a satellite group is used, histopathology shall be performed on tissues and organs identified as showing effects in the treated groups.
(ii) If excessive early deaths or other problems occur in the high exposure group compromising the significance of the data, the next concentration should be examined for complete histopathology.
(iii) An attempt should be made to correlate gross observations with microscopic findings.
(iv) Tissues and organs designated for microscopic examination should be fixed in 10% buffered formalin or a recognized suitable fixative as soon as necropsy is performed and no less than 48 hrs prior to trimming. Tissues should be trimmed to a maximum thickness of 0.4 cm for processing.
(f)
(ii) All observed results (quantitative and qualitative) should be evaluated by an appropriate statistical method. Any generally accepted statistical method may be used; the statistical methods including significance criteria should be selected during the design of the study.
(2)
(3)
(i) Test substance characterization shall include:
(A) Chemical identification.
(B) Lot or batch number.
(C) Physical properties.
(D) Purity/impurities.
(E) Identification and composition of any vehicle used.
(ii) Test system information shall include:
(A) Species and strain of animals used and rationale for selection if other than that recommended.
(B) Age, sex, and body weight.
(C) Test environment including cage conditions, ambient temperature, humidity, and light/dark periods.
(D) Identification of animal diet.
(E) Acclimation period.
(iii) Test procedure information shall include:
(A) Method of randomization used.
(B) Full description of experimental design and procedure.
(C) Exposure regimen including concentration levels, methods, and volume.
(D) Description of test conditions; the following exposure conditions shall be reported:
(
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(E) Exposure data shall be tabulated and presented with mean values and a measure of variability (e.g., standard deviation) and include:
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(iv) Test results information shall include:
(A)
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(B)
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(g)
(h)
(1) Cage, J.C. Ed. Paget, G.E.
(2) Casarett, L.J. and Doull. Chapter 9.
(3) U.S. Environmental Protection Agency, Office of Pesticide Programs, Health Effects Division. Interim policy for particle size and limit concentration issues in inhalation toxicity studies (February 1, 1994).
(4) MacFarland, H.N. Ed. Hayes, W.J. Vol. 7.
(5) Organisation for Economic Co-operation and Development. Guidelines for testing of chemicals, section 4-health effects, part 413.
(a)
(2)
(b)
(2) This screening test guideline can be used to provide initial information on possible effects on reproduction and/or development, either at an early stage of assessing the toxicological properties of chemicals, or on chemicals of high concern. It can also be used as part of a set of initial screening tests for existing chemicals for which little or no toxicological information is available, as a dose range finding study for more extensive reproduction/developmental studies, or when otherwise considered relevant.
(3) This test does not provide complete information on all aspects of reproduction and development. In particular, it offers only limited means of detecting postnatal manifestations of prenatal exposure, or effects that may be induced during postnatal exposure. Due (amongst other reasons) to the relatively small numbers of animals in the dose groups, the selectivity of the end points, and the short duration of the study, this method will not provide evidence for definite claims of no effects.
(c)
(d)
(2) Females should be dosed throughout the study. This includes two weeks prior to mating (with the objective of covering at least two complete oestrous cycles), the variable time to conception, the duration of pregnancy and at least four days after delivery, up to and including the day before scheduled sacrifice.
(3) Duration of study, following acclimatization, is dependent on the female performance and is approximately 54 days, (at least 14 days premating, (up to) 14 days mating, 22 days gestation, 4 days lactation).
(4) During the period of administration, the animals are observed closely each day for signs of toxicity. Animals which die or are sacrificed during the test period are necropsied and, at the conclusion of the test, surviving animals are sacrificed and necropsied.
(e)
(2)
(ii) Animals may be housed individually or be caged in small groups of the same sex; for group caging, no more than five animals should be housed per cage. Mating procedures should be carried out in cages suitable for the purpose. Pregnant females should be caged individually and provided with nesting materials.
(3)
(4)
(ii) Where necessary, the test substance is dissolved or suspended in a suitable vehicle. It is recommended that, wherever possible, the use of an aqueous solution/suspension be considered first, followed by consideration of a solution/emulsion in oil (e.g., corn oil) and then by possible solution in other vehicles. For vehicles other than water the toxic characteristics of the vehicle must be known. The stability of the test substance in the vehicle should be determined.
(f)
(2)
(ii) Dose levels should be selected taking into account any existing toxicity and (toxico-) kinetic data available for the test compound or related materials. The highest dose level should be chosen with the aim of inducing toxic effects but not death or severe suffering. Thereafter, a descending sequence of dose levels should be selected in order to demonstrate any dose response relationships and no adverse effects at the lowest dose level. Two to four fold intervals are frequently optimal for setting the descending dose levels and addition of a fourth test group is often preferable to using very large intervals (e.g., more than a factor of 10) between dosages.
(3)
(4)
(ii) For substances administered via the diet or drinking water, it is important to ensure that the quantities of the test substance involved do not interfere with normal nutrition or water balance. When the test substance is administered in the diet either a constant dietary concentration (parts per million (ppm)) or a constant dose level in terms of the animals' body weight may be used; the alternative used must be specified. For a substance administered by gavage, the dose should be given at similar times each day, and adjusted at least weekly to maintain a constant dose level in terms of animal body weight.
(5)
(ii) Daily dosing of the parental females should continue throughout pregnancy and at least up to, and including, day 3 post-partum or the day before sacrifice. For studies where the test substance is administered by inhalation or by the dermal route, dosing should be continued at least up to, and including, day 19 of gestation.
(iii) The experimental schedule is given in the following figure 1.
(6)
(7)
(ii) The duration of gestation should be recorded and is calculated from day 0 of pregnancy. Each litter should be examined as soon as possible after delivery to establish the number and sex of pups, stillbirths, live births, runts (pups that are significantly smaller than corresponding control pups) and the presence of gross abnormalities.
(iii) Live pups should be counted and sexed and litters weighed within 24 hours of parturition (day 1) and on day 4 post-partum. In addition to the observations on parent animals, described by paragraph (f)(7) of this section, any abnormal behaviour of the offspring should be recorded.
(8)
(ii) During pre-mating, pregnancy and lactation, food consumption should be measured at least weekly. The measurement of food consumption during mating is optional. Water consumption during these periods should also be
(9)
(B) The testes and epididymides of all male adult animals should be weighed.
(C) Dead pups and pups sacrificed at day 4 post-partum, or shortly thereafter, should, at least, be carefully examined externally for gross abnormalities.
(D) The ovaries, testes, epididymides, accessory sex organs and all organs showing macroscopic lesions of all adult animals should be preserved. Formalin fixation is not recommended for routine examination of testes and epididymides. An acceptable method is the use of Bouin's fixative for these tissues.
(ii)
(B) Detailed testicular histopathological examination (e.g., using Bouin's fixative, paraffin embedding and transverse sections of 4-5 ±m thickness) should be conducted with special emphasis on stages of spermatogenesis and histopathology interstitial testicular cell structure. The evaluation should identify treatment-related effects such as retained spermatids, missing germ cell layers or types, multinucleated giant cells or sloughing of spermatogenic cells into the lumen (the specifications for the evaluation are discussed in paragraph (g)(2) of this section). Examination of the intact epididymis should include the caput, corpus, and cauda, which can be accomplished by evaluation of a longitudinal section. The epididymis should be evaluated for leukocyte infiltration, change in prevalence of cell types, aberrant cell types, and phagocytosis of sperm. PAS and hematoxylin staining may be used for examination of the male reproductive organs. Histopathological examination of the ovary should detect qualitative depletion of the primordial follicle population.
(g)
(2)
(ii) Because of the short period of treatment of the male, the histopathology of the testis and epididymus must be considered along with the fertility data, when assessing male reproductive effects.
(iii) Due to the limited dimensions of the study, statistical analysis in the form of tests for “significance” are of limited value for many endpoints, especially reproductive endpoints. If statistical analyses are used then the method chosen should be appropriate for the distribution of the variable examined, and be selected prior to the start of the study. Because of the small group size, the use of historic control data (e.g.,
(3)
(i) Test substance:
(A) Physical nature and, where relevant, physicochemical properties.
(B) Identification data.
(ii) Vehicle (if appropriate): Justification for choice of vehicle if other than water.
(iii) Test animals:
(A) Species/strain used.
(B) Number, age and sex of animals.
(C) Source, housing conditions, diet, etc.
(D) Individual weights of animals at the start of the test.
(iv) Test conditions:
(A) Rationale for dose level selection.
(B) Details of test substance formulation/diet preparation, achieved concentrations, stability and homogeneity of the preparation.
(C) Details of the administration of the test substance.
(D) Conversion from diet/drinking water test substance concentration (parts per million (ppm)) to the actual dose (mg/kg body weight/day), if applicable.
(E) Details of food and water quality.
(v) Results (toxic response data by sex and dose):
(A) Time of death during the study or whether animals survived to termination.
(B) Nature, severity and duration of clinical observations (whether reversible or not).
(C) Body weight/body weight change data.
(D) Food consumption and water consumption, if applicable.
(E) Effects on reproduction, including information on mating/precoital interval, fertility, fecundity and gestation duration.
(F) Effects on offspring, including number of pups born (live and dead), sex ratio, postnatal growth (pup weights) and survival (litter size), gross abnormalities and clinical observations during lactation.
(G) Body weight at termination and organ weight data for the parental animals.
(H) Necropsy data, including number of implantations and number of corpora lutea.
(I) Calculations of pre- and postimplantation loss.
(J) Detailed description of histopathological findings.
(K) Statistical treatment of results, where appropriate.
(vi) Discussion of results.
(vii) Conclusions.
(4)
(h)
(1) OECD (1995). Reproduction/Developmental Toxicity Screening Test, OECD 421, OECD Guidelines for Testing of Chemicals.
(2) [Reserved]
(a)
(2)
(b)
(2) This test does not provide complete information on all aspects of reproduction and development. In particular, it offers only limited means of detecting postnatal manifestations of prenatal exposure, or effects that may be induced during postnatal exposure. Due (amongst other reasons) to the selectivity of the end points, and the short duration of the study, this method will not provide evidence for definite claims of no reproduction/developmental effects.
(3) This test can be used to provide initial information either at an early stage of assessing the toxicological properties of chemicals, or chemicals of high concern. It can also be used as part of a set of initial screening tests for existing chemicals for which little or no toxicological information is available or when otherwise considered relevant. It also can serve as an alternative to conducting two separate screening tests for repeated dose toxicity as described in § 799.9305 of this part and reproductive/developmental toxicity as described in § 799.9355 of this part.
(c)
(d)
(2) Females should be dosed throughout the study. This includes 2 weeks prior to mating (with the objective of covering at least two complete oestrous cycles), the variable time to conception, the duration of pregnancy and at least 4 days after delivery, up to and including the day before scheduled sacrifice.
(3) Duration of study, following acclimatization, is dependent on the female performance and is approximately 54 days, (at least 14 days pre-mating, (up to) 14 days mating, 22 days gestation, 4 days lactation).
(4) During the period of administration, the animals are observed closely each day for signs of toxicity. Animals which die or are sacrificed during the test are necropsied and, at the conclusion of the test, surviving animals are sacrificed and necropsied.
(e)
(2)
(ii) Animals may be housed individually or be caged in small groups of the same sex; for group caging, no more than five animals should be housed per cage. Mating procedures should be carried out in cages suitable for the purpose. Pregnant females should be caged individually and provided with nesting materials.
(3)
(4)
(ii) Where necessary, the test substance is dissolved or suspended in a suitable vehicle. It is recommended that, wherever possible, the use of an aqueous solution/suspension be considered first, followed by consideration of a solution/emulsion in oil (e.g., corn oil) and then by possible solution in other vehicles. For non-aqueous vehicles the toxic characteristics of the vehicle must be known. The stability of the test substance in the vehicle should be determined.
(f)
(2)
(ii) Dose levels should be selected taking into account any existing toxicity and (toxico-) kinetic data available for the test compound or related
(3)
(4)
(ii) For substances administered via the diet or drinking water, it is important to ensure that the quantities of the test substance involved do not interfere with normal nutrition or water balance. When the test substance is administered in the diet either a constant dietary concentration (parts per million (ppm)) or a constant dose level in terms of the animals' body weight may be used; the alternative used must be specified. For a substance administered by gavage, the dose should be given at similar times each day, and adjusted at least weekly to maintain a constant dose level in terms of animal body weight.
(5)
(ii) Daily dosing of the parental females should continue throughout pregnancy and at least up to, and including, day 3 post-partum or the day before sacrifice. For studies where the test substance is administered by inhalation or by the dermal route, dosing should be continued at least up to, and including, day 19 of gestation.
(iii) Animals in a satellite group scheduled for follow-up observations, if included, must not mated. They should be kept at least for a further 14 days after the first scheduled sacrifice of dams, without treatment to detect delayed occurrence, or persistence of, or recovery from toxic effects.
(iv) The experimental schedule is given in the following figure 1.
(6)
(7)
(ii) Once before the first exposure (to allow for within-subject comparisons), and at least once a week thereafter, detailed clinical observations should be made in all animals. These observations should be made outside the home cage in a standard arena and preferably at the same time, each day. They should be carefully recorded; preferably using scoring systems, explicitly defined by the testing laboratory. Effort should be made to ensure that variations in the test conditions are minimal and that observations are preferably conducted by observers unaware of the treatment. Signs noted should include, but not be limited to, changes in skin, fur, eyes, mucous membranes, occurrence of secretions and excretions and autonomic activity (e.g., lacrimation, piloerection, pupil size, unusual respiratory pattern). Changes in gait, posture and response to handling as well as the presence of clonic or tonic movements, stereotypies (e.g., excessive grooming, repetitive circling), difficult or prolonged parturition or bizarre behaviour (e.g., self-mutilation, walking backwards) should also be recorded.
(iii) At one time during the study, sensory reactivity to stimuli of different modalities (e.g., auditory, visual and proprioceptive stimuli) assessment of grip strength and motor activity assessment should be conducted in five males and five females, randomly selected from each group. Further details of the procedures that could be followed are given in the respective references. However, alternative procedures than those referenced could also be used. In males, these functional observations should be made towards the end of their dosing period, shortly before scheduled sacrifice but before blood sampling for hematology or clinical chemistry. Females should be in a physiologically similar state during these functional tests and should preferably be tested during lactation, shortly before scheduled sacrifice. In order to avoid hypothermia of pups, dams should be removed from the pups for not more than 30 to 40 minutes. Examples of procedures for observation are described in the references in paragraphs (h)(3), (h)(4), (h)(5), (h)(6), and (h)(7) of this section.
(iv) Functional observations made once towards the end of the study may be omitted when the study is conducted as a preliminary study to a subsequent subchronic (90-day) or long-term study. In that case, the functional observations should be included in this follow-up study. On the other hand, the availability of data on functional observations from this repeated dose study may enhance the ability to select dose levels for a subsequent subchronic or long-term study.
(v) Functional observations may also be omitted for groups that otherwise reveal signs of toxicity to an extent that would significantly interfere with the functional test performance.
(vi) The duration of gestation should be recorded and is calculated from day 0 of pregnancy. Each litter should be examined as soon as possible after delivery to establish the number and sex of pups, stillbirths, live births, runts (pups that are significantly smaller than corresponding control pups), and the presence of gross abnormalities.
(vii) Live pups should be counted and sexed and litters weighed within 24 hours of parturition (day 0 or 1 post-partum) and on day 4 post-partum. In addition to the observations on parental animals, described by paragraphs (f)(7)(ii) and (f)(7)(iii) of this section, any abnormal behaviour of the offspring should be recorded.
(8)
(ii) During pre-mating, pregnancy and lactation, food consumption should be measured at least weekly. The measurement of food consumption during mating is optional. Water consumption during these periods should also be measured, when the test substance is administered by that medium.
(9)
(ii) Blood samples should be taken from a named site. Females should be in a physiologically similar state during sampling. In order to avoid practical difficulties related to the variability in the onset of gestation, blood collection in females may be done at the end of the pre-mating period as an alternative to sampling just prior to, or as part of, the procedure for sacrificing the animals. Blood samples of males should preferably be taken just prior to, or as part of, the procedure for sacrificing the animals. Alternatively, blood collection in males may also be done at the end of the pre-mating period when this time point was preferred for females.
(iii) Blood samples should be stored under appropriate conditions.
(10)
(ii) Optionally, the following urinalysis determinations could be performed in five randomly selected males of each group during the last week of the study using timed urine volume collection; appearance, volume, osmolality or specific gravity, pH, protein, glucose and blood or blood cells.
(iii) In addition, studies to investigate serum markers of general tissue damage should be considered. Other determinations that should be carried out if the known properties of the test substance may, or are suspected to, affect related metabolic profiles include calcium, phosphate, fasting triglycerides and fasting glucose, specific hormones, methemoglobin and cholinesterase. These need to be identified on a case-by-case basis.
(iv) Overall, there is a need for a flexible approach, depending on the observed and/or expected effect with a given compound.
(v) If historical baseline data are inadequate, consideration should be given to determination of hematological and clinical biochemistry variables before dosing commences.
(11)
(B) The testes and epididymides of all adult males should be weighed and the ovaries, testes, epididymides, accessory sex organs, and all organs showing macroscopic lesions of all adult animals, should be preserved.
(C) In addition, for five adult males and females, randomly selected from each group, the liver, kidneys, adrenals, thymus, spleen, brain and heart should be trimmed of any adherent tissue, as appropriate and their wet weight taken as soon as possible after dissection to avoid drying. Of the selected males and females, the following tissues should also be preserved in the most appropriate fixation medium for both the type of tissue and the intended subsequent histopathological examination: all gross lesions, brain (representative regions including cerebrum, cerebellum and pons), spinal cord, stomach, small and large intestines (including Peyer's patches), liver, kidneys, adrenals, spleen, heart, thymus, thyroid, trachea and lungs (preserved by inflation with fixative and then immersion), uterus, urinary bladder, lymph nodes (preferably 1 lymph node covering the route of administration and another one distant from the route of administration to cover systemic effects), peripheral nerve (sciatic or tibial) preferably in close proximity to the muscle, and a section of bone marrow (or, alternatively, a fresh mounted marrow aspirate).
(D) Formalin fixation is not recommended for routine examination of testes and epididymides. An acceptable method is the use of Bouin's fixative for these tissues. The clinical and other findings may suggest the need to examine additional tissues. Also, any organs
(E) Dead pups and pups sacrificed at day 4 post-partum, or shortly thereafter, should, at least, be carefully examined externally for gross abnormalities.
(ii)
(B) Detailed testicular histopathological examination (e.g., using Bouin's fixative, paraffin embedding and transverse sections of 4-5 ±m thickness) should be conducted with special emphasis on stages of spermatogenesis and histopathology interstitial testicular cell structure. The evaluation should identify treatment-related effects such as retained spermatids, missing germ cell layers or types, multinucleated giant cells or sloughing of spermatogenic cells into the lumen (the specifications for the evaluation are discussed in paragraph (g)(2) of this section). Examination of the intact epididymis should include the caput, corpus, and cauda, which can be accomplished by evaluation of a longitudinal section. The epididymis should be evaluated for leukocyte infiltration, change in prevalence of cell types, aberrant cell types, and phagocytosis of sperm. Periodic acid-Schiff (PAS) and hematoxylin staining may be used for examination of the male reproductive organs. Histopathological examination of the ovary should detect qualitative depletion of the primordial follicle population.
(C) When a satellite group is used, histopathology should be performed on tissues and organs identified as showing effects in the treated groups.
(g)
(2)
(ii) Because of the short period of treatment of the male, the histopathology of the testes and epididymides must be considered along with the fertility data, when assessing male reproduction effects. The use of historic control data on reproduction/development (e.g. for litter size) where available may also be useful as an aid to the interpretation of the study.
(iii) When possible, numerical results should be evaluated by an appropriate and general acceptable statistical method. The statistical methods should be selected during the design of the study. Due to the limited dimensions of the study, statistical analysis in the form of tests for “significance” are of limited value for many endpoints, especially reproductive endpoints. Some of the most widely used methods, especially parametric tests for measures of central tendency, are inappropriate. If statistical analyses are used then the method chosen should be appropriate for the distribution of the variable examined and be selected prior to the start of the study.
(3)
(i) Test substance:
(A) Physical nature and, where relevant, physicochemical properties.
(B) Identification data.
(ii) Vehicle (if appropriate): Justification for choice of vehicle, if other than water.
(iii) Test animals:
(A) Species/strain used.
(B) Number, age and sex of animals.
(C) Source, housing conditions, diet, etc.
(D) Individual weights of animals at the start of the test.
(iv) Test conditions:
(A) Rationale for dose level selection.
(B) Details of test substance formulation/diet preparation, achieved concentration, stability and homogeneity of the preparation.
(C) Details of the administration of the test substance.
(D) Conversion from diet/drinking water test substance concentration (parts per mission (ppm)) to the actual dose (mg/kg body weight/day), if applicable.
(E) Details of food and water quality.
(v) Results (toxic response data by sex and dose):
(A) Time of death during the study or whether animals survived to termination.
(B) Nature, severity and duration of clinical observations (whether reversible or not).
(C) Body weight/body weight change data.
(D) Food consumption and water consumption, if applicable.
(E) Sensory activity, grip strength and motor activity assessments.
(F) Hematological tests with relevant baseline values,
(G) Clinical biochemistry tests with relevant baseline values.
(H) Effects on reproduction, including information on mating/precoital interval, fertility, fecundity and gestation duration.
(I) Effects on offspring, including number of pups born (live and dead), sex ratio, postnatal growth (pup weights) and survival (litter size), gross abnormalities and clinical observations during lactation.
(J) Body weight at termination and organ weight data for the parental animals.
(K) Necropsy data, including number of implantations and number of corpora lutea.
(L) Calculations of pre- and postimplantation loss.
(M) Detailed description of histopathological findings.
(N) Statistical treatment of results, where appropriate.
(vi) Discussion of results.
(vii) Conclusions.
(h)
(1) Mitsumori, K., Kodama, Y., Uchida, O., Takada, K., Saito, M. Naito, K., Tanaka, S., Kurokawa, Y., Usami, M., Kawashima, K., Yasuhara, K., Toyoda, K., Onodera, H., Furukawa, F., Takahashi, M. and Hayashi, Y., (1994). Confirmation Study, Using Nitro-Benzene, of the Combined Repeat Dose and Reproductive/ Developmental Toxicity Test Protocol Proposed by the Organization for Economic Cooperation and Development (OECD).
(2) Tanaka, S., Kawashima, K., Naito, K., Usami, M., Nakadate, M., Imaida, K., Takahashi, M., Hayashi, Y., Kurokawa, Y. and Tobe, M. (1992). Combined Repeat Dose and Reproductive/Developmental Toxicity Screening Test (OECD): Familiarization Using Cyclophosphamide.
(3) Tupper D.E., Wallace R.B. (1980). Utility of the Neurologic Examination in Rats.
(4) Gad S.C. (1982). A Neuromuscular Screen for Use in Industrial Toxicology.
(5) Moser V.C., McDaniel K.M., Phillips P.M. (1991). Rat Strain and Stock Comparisons Using a Functional Observational Battery: Baseline Values and Effects of Amitraz.
(6) Meyer O.A., Tilson H.A., Byrd W.C., Riley M.T. (1979). A Method for the Routine Assessment of Fore- and Hindlimb Grip Strength of Rats and
(7) Crofton K.M., Howard J.L., Moser V.C., Gill M.W., Reiter L.W., Tilson H.A., MacPhail R.C. (1991). Interlaboratory Comparison of Motor Activity Experiments: Implication for Neurotoxicological Assessments.
(a)
(b)
(c)
(d)
(e)
(ii)
(iii)
(iv)
(2)
(B) It is desirable that additional information on metabolism and pharmacokinetics of the test substance be available to demonstrate the adequacy of the dosing regimen. This information should be available prior to testing.
(C) The highest dose tested need not exceed 1,000 mg/kg/day by oral or dermal administration, or 2 mg/L (or the maximum attainable concentration) by inhalation, unless potential human exposure data indicate the need for higher doses. If a test performed at the limit dose level, using the procedures described for this study, produces no observable toxicity and if an effect would not be expected based upon data from structurally related compounds, then a full study using three-dose levels may not be considered necessary.
(ii)
(B) The vehicle control group should receive the vehicle in the highest volume used.
(C) If a vehicle or other additive is used to facilitate dosing, consideration should be given to the following characteristics: Effects on the absorption, distribution, metabolism, or retention of the test substance; effects on the chemical properties of the test substance which may alter its toxic characteristics; and effects on the food or water consumption or the nutritional status of the animals.
(iii)
(B) If another route of administration is used, for example, when the route of administration is based upon the principal route of potential human exposure, the tester shall provide justification and reasoning for its selection, and appropriate modifications may be necessary. Care should be taken to minimize stress on the maternal animals. For materials administered by inhalation, whole-body exposure is preferable to nose-only exposure due to the stress of restraint required for nose-only exposure.
(C) The test substance shall be administered at approximately the same time each day.
(D) When administered by gavage or dermal application, the dose to each animal shall be based on the most recent individual body weight determination.
(iv)
(f)
(ii) Animals shall be weighed on day 0, at termination, and at least at 3-day intervals during the dosing period.
(iii) Food consumption shall be recorded on at least 3-day intervals, preferably on days when body weights are recorded.
(iv) (A) Females shall be terminated immediately prior to the expected day of delivery.
(B) Females showing signs of abortion or premature delivery prior to scheduled termination shall be killed and subjected to a thorough macroscopic examination.
(v) At the time of termination or death during the study, the dam shall be examined macroscopically for any structural abnormalities or pathological changes which may have influenced the pregnancy. Evaluation of the dams during cesarean section and subsequent fetal analyses should be conducted without knowledge of treatment group in order to minimize bias.
(vi) (A) Immediately after termination or as soon as possible after death, the uteri shall be removed and the pregnancy status of the animals ascertained. Uteri that appear nongravid shall be further examined (e.g. by ammonium sulfide staining) to confirm the nonpregnant status.
(B) Each gravid uterus (with cervix) shall be weighed. Gravid uterine weights should not be obtained from
(C) The number of corpora lutea shall be determined for pregnant animals.
(D) The uterine contents shall be examined for embryonic or fetal deaths and the number of viable fetuses. The degree of resorption shall be described in order to help estimate the relative time of death of the conceptus.
(2)
(ii) Each fetus shall be examined for external anomalies.
(iii) Fetuses shall be examined for skeletal and soft tissue anomalies (e.g. variations and malformations or other categories of anomalies as defined by the performing laboratory).
(A) For rodents, approximately one-half of each litter shall be prepared by standard techniques and examined for skeletal alterations, preferably bone and cartilage. The remainder shall be prepared and examined for soft tissue anomalies, using appropriate serial sectioning or gross dissection techniques. It is also acceptable to examine all fetuses by careful dissection for soft tissue anomalies followed by an examination for skeletal anomalies.
(B) For rabbits, all fetuses shall be examined for both soft tissue and skeletal alterations. The bodies of these fetuses should be evaluated by careful dissection for soft-tissue anomalies, followed by preparation and examination for skeletal anomalies. An adequate evaluation of the internal structures of the head, including the eyes, brain, nasal passages, and tongue, should be conducted for at least half of the fetuses.
(g)
(2)
(i) Maternal and fetal test results, including an evaluation of the relationship, or lack thereof, between the exposure of the animals to the test substance and the incidence and severity of all findings.
(ii) Criteria used for categorizing fetal external, soft tissue, and skeletal anomalies.
(iii) When appropriate, historical control data to enhance interpretation of study results. Historical data (on litter incidence and fetal incidence within litter), when used, should be compiled, presented, and analyzed in an appropriate and relevant manner. In order to justify its use as an analytical tool, information such as the dates of study conduct, the strain and source of the animals, and the vehicle and route of administration should be included.
(iv) Statistical analysis of the study findings should include sufficient information on the method of analysis, so that an independent reviewer/statistician can reevaluate and reconstruct the analysis. In the evaluation of study data, the litter should be considered the basic unit of analysis.
(v) In any study which demonstrates an absence of toxic effects, further investigation to establish absorption and bioavailability of the test substance should be considered.
(3)
(i) Species and strain.
(ii) Maternal toxic response data by dose, including but not limited to:
(A) The number of animals at the start of the test, the number of animals surviving, the number pregnant, and the number aborting.
(B) Day of death during the study or whether animals survived to termination.
(C) Day of observation of each abnormal clinical sign and its subsequent course.
(D) Body weight and body weight change data, including body weight change adjusted for gravid uterine weight.
(E) Food consumption and, if applicable, water consumption data.
(F) Necropsy findings, including gravid uterine weight.
(iii) Developmental endpoints by dose for litters with implants, including:
(A) Corpora lutea counts.
(B) Implantation data, number and percent of live and dead fetuses, and resorptions (early and late).
(C) Pre- and postimplantation loss calculations.
(iv) Developmental endpoints by dose for litters with live fetuses, including:
(A) Number and percent of live offspring.
(B) Sex ratio.
(C) Fetal body weight data, preferably by sex and with sexes combined.
(D) External, soft tissue, and skeletal malformation and variation data. The total number and percent of fetuses and litters with any external, soft tissue, or skeletal alteration, as well as the types and incidences of individual anomalies, should be reported.
(v) The numbers used in calculating all percentages or indices.
(vi) Adequate statistical treatment of results.
(vii) A copy of the study protocol and any amendments should be included.
(h)
(1) Aliverti, V.L.
(2) Barrow, M.V. and W.J. Taylor. A rapid method for detecting malformations in rat fetuses.
(3) Burdi, A.R. Toluidine blue-alizarin red S staining of cartilage and bone in whole-mount skeltons
(4) Edwards, J.A. Ed. Woolam,D.H.M. The external development of the rabbit and rat embryo. Vol. 3.
(5) Fritz, H. Prenatal ossification in rabbits as indicative of fetal maturity.
(6) Fritz, H. and Hess, R. Ossification of the rat and mouse skeleton in the perinatal period.
(7) Gibson, J.P.
(8) Inouye, M. Differential staining of cartilage and bone in fetal mouse skeleton by alcian blue and alizarin red S.
(9) Igarashi, E.
(10) Kimmel, C.A.
(11) Kimmel, C.A. and Francis, E.Z. Proceedings of the workshop on the acceptability and interpretation of dermal developmental toxicity studies.
(12) Kimmel, C.A. and C. Trammell. A rapid procedure for routine double staining of cartilage and bone in fetal and adult animals.
(13) Kimmel, C.A. and Wilson, J.G. Skeletal deviation in rats: malformations or variations?
(14) Marr, M.C.
(15) Marr, M.C.
(16) McLeod, M.J. Differential staining of cartilage and bone in whole mouse fetuses by Alcian blue and alizarin red S.
(17) Monie, I.W.
(18) Organisation for Economic Co-operation and Development, No. 414: Teratogenicity, Guideline for Testing of Chemicals. [C(83)44 (Final)] (1983).
(19) Salewski (Koeln), V.E. Faerbermethode zum makroskopischen
(20) Spark, C. and Dawson,A.B. The order and time of appearance of centers of ossification in the fore and hind limbs of the albino rat, with special reference to the possible influence of the sex factor.
(21) Staples, R.E. Detection of visceral alterations in mammalian fetuses.
(22) Staples, R.E. and Schnell, V.L. Refinements in rapid clearing technique in the KOH—alizarin red S method for fetal bone.
(23) Strong, R.M. The order time and rate of ossification of the albino rat (
(24) Stuckhardt, J.L. and Poppe, S.M. Fresh visceral examination of rat and rabbit fetuses used in teratogenicity testing.
(25) Van Julsingha, E.B. and Bennett,C.G. Eds. Neubert, D., Merker, H.J., and Kwasigroch, T.E. A dissecting procedure for the detection of anomalies in the rabbit foetal head.
(26) Whitaker, J. and Dix, D.M. Double-staining for rat foetus skeletons in teratological studies.
(27) Wilson, J.G. Eds. Wilson, J.G. and Warkany, J. Embryological considerations in teratology.
(a)
(b)
(c)
(d)
(e)
(ii)
(iii)
(B) The females shall be nulliparous and nonpregnant.
(iv)
(v)
(2)
(B) It is desirable that additional information on metabolism and pharmacokinetics of the test substance be available to demonstrate the adequacy of the dosing regimen. This information should be available prior to testing.
(C) The highest dose tested should not exceed 1,000 mg/kg/day (or 20,000 ppm in the diet), unless potential human exposure data indicate the need for higher doses. If a test performed at the limit dose level, using the procedures described for this study, produces no observable toxicity and if an effect would not be expected based upon data from structurally related compounds, then a full study using three dose levels may not be considered necessary.
(ii)
(B) If a vehicle is used in administering the test substance, the control group shall receive the vehicle in the highest volume used.
(C) If a vehicle or other additive is used to facilitate dosing, consideration should be given to the following characteristics: Effects on the absorption, distribution, metabolism, or retention of the test substance; effects on the chemical properties of the test substance which may alter its toxic characteristics; and effects on the food or water consumption or the nutritional status of the animals.
(D) If a test substance is administered in the diet and causes reduced dietary intake or utilization, the use of a pair-fed control group may be considered necessary.
(iii)
(B) If administered by gavage or dermal application, the dosage administered to each animal prior to mating and during gestation and lactation shall be based on the individual animal body weight and adjusted weekly at a minimum.
(C) If another route of administration is used, for example, when the route of administration is based upon the principal route of potential human exposure, the tester should provide justification and reasoning for its selection, and appropriate modifications may be necessary. Care should be taken to minimize stress on the maternal animals and their litters during gestation and lactation.
(D) All animals should be dosed by the same method during the appropriate experimental period.
(iv)
(B) Daily dosing of the parental (P) males and females shall begin when they are 5 to 9 weeks old. Daily dosing of the F1 males and females shall begin at weaning. For both sexes (P and F1), dosing shall be continued for at least 10 weeks before the mating period.
(C) Daily dosing of the P and F1 males and females shall continue until termination.
(3)
(B) Vaginal smears shall be collected daily and examined for all females during mating, until evidence of copulation is observed.
(C) Each day, the females shall be examined for presence of sperm or vaginal plugs. Day 0 of pregnancy is defined as the day a vaginal plug or sperm are found.
(ii)
(iii)
(iv)
(v)
(B) If standardization is performed, the following procedure should be used. On day 4 after birth, the size of each litter may be adjusted by eliminating extra pups by random selection to yield, as nearly as possible, four males and four females per litter or five males and five females per litter. Selective elimination of pups, i.e. based upon body weight, is not appropriate. Whenever the number of male or female pups prevents having four (or five) of each sex per litter, partial adjustment (for example, five males and three females, or four males and six females) is acceptable. Adjustments are not appropriate for litters of eight pups or less.
(4)
(B) Parental animals (P and F1) shall be weighed on the first day of dosing and weekly thereafter. Parental females (P and F1) should be weighed at a minimum on approximately gestation days 0, 7, 14, and 21, and during lactation on the same days as the weighing of litters.
(C) During the premating and gestation periods, food consumption shall be measured weekly at a minimum. Water consumption should be measured weekly at a minimum if the test substance is administered in the water.
(D) Estrous cycle length and pattern should be evaluated by vaginal smears for all P and F1 females during a minimum of 3 weeks prior to mating and throughout cohabitation; care should
(E) For all P and F1 males at termination, sperm from one testis and one epididymis shall be collected for enumeration of homogenization-resistant spermatids and cauda epididymal sperm reserves, respectively. In addition, sperm from the cauda epididymis (or vas deferens) should be collected for evaluation of sperm motility and sperm morphology.
(
(
(
(ii)
(B) Live pups should be counted, sexed, and weighed individually at birth, or soon thereafter, at least on days 4, 7, 14, and 21 of lactation, at the time of vaginal patency or balanopreputial separation, and at termination.
(C) The age of vaginal opening and preputial separation should be determined for F1 weanlings selected for mating. If there is a treatment-related effect in F1 sex ratio or sexual maturation, anogenital distance should be measured on day 0 for all F2 pups.
(5)
(ii) F1 offspring not selected for mating and all F2 offspring should be terminated at comparable ages after weaning.
(6)
(ii) Dead pups or pups that are terminated in a moribund condition should be examined for possible defects and/or cause of death.
(iii) At the time of necropsy, a vaginal smear should be examined to determine the stage of the estrous cycle. The uteri of all cohabited females should be examined, in a manner which does not compromise histopathological evaluation, for the presence and number of implantation sites.
(7)
(A) Uterus (with oviducts and cervix), ovaries.
(B) Testes, epididymides (total weights for both and cauda weight for either one or both), seminal vesicles (with coagulating glands and their fluids), and prostate.
(C) Brain, pituitary, liver, kidneys, adrenal glands, spleen, and known target organs.
(ii) For F1 and F2 weanlings that are examined macroscopically, the following organs shall be weighed for one randomly selected pup per sex per litter.
(A) Brain.
(B) Spleen and thymus.
(8)
(i) For the parental (P and F1) animals:
(A) Vagina, uterus with oviducts, cervix, and ovaries.
(B) One testis (preserved in Bouins fixative or comparable preservative), one epididymis, seminal vesicles, prostate, and coagulating gland.
(C) Pituitary and adrenal glands.
(D) Target organs, when previously identified, from all P and F1 animals selected for mating.
(E) Grossly abnormal tissue.
(ii) For F1 and F2 weanlings selected for macroscopic examination: Grossly abnormal tissue and target organs, when known.
(9)
(ii)
(f)
(2)
(ii) When appropriate, historical control data should be used to enhance interpretation of study results. Historical data, when used, should be compiled, presented, and analyzed in an appropriate and relevant manner. In order to justify its use as an analytical tool, information such as the dates of study conduct, the strain and source of the animals, and the vehicle and route of administration should be included.
(iii) Statistical analysis of the study findings should include sufficient information on the method of analysis, so that an independent reviewer/statistician can reevaluate and reconstruct the analysis.
(iv) In any study which demonstrates an absence of toxic effects, further investigation to establish absorption and bioavailability of the test substance should be considered.
(3)
(i) Species and strain.
(ii) Toxic response data by sex and dose, including indices of mating, fertility, gestation, birth, viability, and lactation; offspring sex ratio; precoital interval, including the number of days until mating and the number of estrous periods until mating; and duration of gestation calculated from day 0 of pregnancy. The report should provide the numbers used in calculating all indices.
(iii) Day (week) of death during the study or whether animals survived to termination; date (age) of litter termination.
(iv) Toxic or other effects on reproduction, offspring, or postnatal growth.
(v) Developmental milestone data (mean age of vaginal opening and preputial separation, and mean anogenital distance, when measured).
(vi) Number of P and F1 females cycling pattern and mean estrous cycle length.
(vii) Day (week) of observation of each abnormal sign and its subsequent course.
(viii) Body weight and body weight change data by sex for P, F1, and F2 animals.
(ix) Food (and water, if applicable) consumption, food efficiency (body weight gain per gram of food consumed), and test material consumption for P and F1 animals, except for the period of cohabitation.
(x) Total cauda epididymal sperm number, homogenization-resistant testis spermatid number, number and percent of progressively motile sperm, number and percent of morphologically normal sperm, and number and percent of sperm with each identified anomaly.
(xi) Stage of the estrous cycle at the time of termination for P and F1 parental females.
(xii) Necropsy findings.
(xiii) Implantation data and postimplantation loss calculations for P and F1 parental females.
(xiv) Absolute and adjusted organ weight data.
(xv) Detailed description of all histopathological findings.
(xvi) Adequate statistical treatment of results.
(xvii) A copy of the study protocol and any amendments should be included.
(g)
(1) Gray, L.E.
(2) Heindel, J.J.
(3) Korenbrot, C.C.
(4) Linder, R.E.
(5) Manson, J.M. and Kang, Y.J. Ed. Hayes, A.W. Test methods for assessing female reproductive and developmental toxicology.
(6) Organisation for Economic Co-operation and Development, No. 416: Two Generation Reproduction Toxicity Study, Guidelines for Testing of Chemicals. [C(83)44 (Final)] (1983).
(7) Pederson, T. and Peters, H. Proposal for classification of oocytes and follicles in the mouse ovary.
(8) Seed, J., Chapin, R.E. E.D. Clegg, L.A. Dostal, R.H. Foote, M.E. Hurtt, G.R. Klinefelter, S.L. Makris, S.D. Perreault, S. Schrader, D. Seyler, R. Sprando, K.A. Treinen, D.N.R. Veeramachaneni, and Wise, L.D. Methods for assessing sperm motility, morphology, and counts in the rat, rabbit, and dog: a consensus report.
(9) Smith, B.J.
(10) Thomas, J.A. Eds. M.O. Amdur, J. Doull, and C.D. Klaassen. Toxic responses of the reproductive system.
(11) Working, P.K. and Hurtt, M. Computerized videomicrographic analysis of rat sperm motility.
(12) Zenick, H.
(a)
(2)
(b)
(c)
(d)
(e)
(ii)
(B) Dosing of rodents should generally begin no later than 8 weeks of age.
(C) Dosing of non-rodents should begin between 4 and 6 months of age and in no case later than 9 months of age.
(D) At commencement of the study, the weight variation of animals used should be within 20% of the mean weight for each sex.
(E) Studies using prenatal or neonatal animals may be recommended under special conditions.
(iii)
(B) Females should be nulliparous and nonpregnant.
(iv)
(B) If interim sacrifices are planned, the number should be increased by the number of animals scheduled to be sacrificed during the course of the study.
(C) The number of animals at the termination of the study must be adequate for a meaningful and valid statistical evaluation of chronic effects. The Agency must be notified if excessive early deaths or other problems are encountered that might compromise the integrity of the study.
(D) To avoid bias, the use of adequate randomization procedures for the proper allocation of animals to test and control groups is required.
(E) Each animal should be assigned a unique identification number. Dead animals, their preserved organs and tissues, and microscopic slides should be identified by reference to the unique numbers assigned.
(v)
(B) The temperature of the experimental animal rooms should be at 22 ± 3 °C.
(C) The relative humidity of the experimental animal rooms should be 50 ± 20%.
(D) Where lighting is artificial, the sequence should be 12 hours light/12 hours dark.
(E) Control and test animals should be fed from the same batch and lot. The feed should be analyzed to assure adequacy of nutritional requirements of the species tested and for impurities that might influence the outcome of the test. Animals should be fed and watered ad libitum with food replaced at least weekly.
(F) The study should not be initiated until animals have been allowed a period of acclimatization/quarantine to environmental conditions, nor should animals from outside sources be placed on test without an adequate period of quarantine. An acclimation period of at least 5 days is recommended.
(2)
(ii) One lot of the test substance should be used, if possible, throughout the duration of the study, and the research sample should be stored under conditions that maintain its purity and stability. Prior to the initiation of the study, there should be a characterization of the test substance, including the purity of the test compound, and, if technically feasible, the names and quantities of contaminants and impurities.
(iii) If the test or control substance is to be incorporated into feed or another vehicle, the period during which the test substance is stable in such a mixture should be determined prior to the initiation of the study. Its homogeneity and concentration should be determined prior to the initiation of the study and periodically during the study. Statistically randomized samples of the mixture should be analyzed to ensure that proper mixing, formulation, and storage procedures are being followed, and that the appropriate concentration of the test or control substance is contained in the mixture.
(3)
(4)
(5)
(ii) The highest-dose level should elicit signs of toxicity without substantially altering the normal life span of the animal. The highest dose should be determined based on the findings from a 90-day study to ensure that the dose used is adequate to assess the chronic toxicity of the test substance. Thus, the selection of the highest dose to be tested is dependent upon changes observed in several toxicological parameters in subchronic studies. The highest dose tested need not exceed 1,000 mg/kg/day. If dermal application of the test substance produces severe skin irritation, then it may be necessary either to terminate the study and choose a lower high-dose level or to reduce the dose level. Gross criteria for defining severe irritation would include ulcers, fissures, exudate/crust(eschar), dead tissue, or anything leading to destruction of the functional integrity of the epidermis (e.g. caking,
(iii) The intermediate dose levels should be spaced to produce a gradation of toxic effects.
(iv) The lowest-dose level should produce no evidence of toxicity.
(6)
(i)
(ii)
(B) Preparation of test substance. Liquid test substances are generally used undiluted, except as indicated in paragraph (e)(5)(ii) of this section. Solids should be pulverized when possible. The substance should be moistened sufficiently with water or, when necessary, with a suitable vehicle to ensure good contact with the skin. When a vehicle is used, the influence of the vehicle on toxicity of, and penetration of the skin by, the test substance should be taken into account.The volume of application should be kept constant, e.g., less than 100 μL for the mouse and less than 300 μL for the rat. Different concentrations of test solution should be prepared for different dose levels.
(C) Administration of test substance. The duration of exposure should be at least for 12 months. Ideally, the animals should be treated with test substance for at least 6 hours per day on a 7-day per week basis. However, based on practical considerations, application on a 5-day per week basis is acceptable. Dosing should be conducted at approximately the same time each day. The test substance should be applied uniformly over the treatment site. The surface area covered may be less for highly toxic substances. As much of the area should be covered with as thin and uniform a film as possible. For rats, the test substance may be held in contact with the skin with a porous gauze dressing and nonirritating tape if necessary. The test site should be further covered in a suitable manner to retain the gauze dressing plus test substance and to ensure that the animals cannot ingest the test substance. The application site should not be covered when the mouse is the species of choice. The test substance may be wiped from the skin after the six-hour exposure period to prevent ingestion.
(iii)
(B) The animals should be tested in dynamic inhalation equipment designed to sustain a minimum air flow of 10 air changes per hour, an adequate oxygen content of at least 19%, and uniform conditions throughout the exposure chamber. Maintenance of slight negative pressure inside the chamber will prevent leakage of the test substance into surrounding areas. It is not
(C) The selection of a dynamic inhalation chamber should be appropriate for the test substance and test system. When a whole body chamber is used, individual housing must be used to minimize crowding of the test animals and maximize their exposure to the test substance. To ensure stability of a chamber atmosphere, the total volume occupied by the test animals should not exceed 5% of the volume of the test chamber. It is recommended, but not required, that nose-only or head-only exposure be used for aerosol studies in order to minimize oral exposures due to animals licking compound off their fur. The animals should be acclimated and heat stress minimized.
(D) The temperature at which the test is performed should be maintained at 22 ± 2 °C. The relative humidity should be maintained between 40-60%, but in certain instances (e.g., use of water vehicle) this may not be practicable.
(E) The rate of air flow should be monitored continuously but recorded at least three times during the exposure.
(F) Temperature and humidity should be monitored continuously but should be recorded at least every 30 min.
(G) The actual concentrations of the test substance should be measured in the breathing zone. During the exposure period, the actual concentrations of the test substance should be held as constant as practicable, monitored continuously or intermittently depending on the method of analysis. Chamber concentration may be measured using gravimetric or analytical methods, as appropriate. If trial run measurements are reasonably consistent (± 10% for liquid aerosol, gas, or vapor; ± 20% for dry aerosol), then two measurements should be sufficient. If measurements are not consistent, three to four measurements should be taken. If there is some difficulty measuring chamber analytical concentration due to precipitation, nonhomogeneous mixtures, volatile components, or other factors, additional analysis of inert components may be necessary.
(H) During the development of the generating system, particle size analysis should be performed to establish the stability of aerosol concentrations with respect to particle size. The mass median aerodynamic diameter (MMAD) particle size range should be between 1-3 μm. The particle size of hygroscopic materials should be small enough when dry to assure that the size of the swollen particle will still be within the 1-3 μm range. Measurements of aerodynamic particle size in the animal's breathing zone should be measured during a trial run. If MMAD values for each exposure level are within 10% of each other, then two measurements during the exposures should be sufficient. If pretest measurements are not within 10% of each other, three to four measurements should be taken.
(I) Feed should be withheld during exposure. Water may also be withheld during exposure.
(7)
(ii) Animals in a satellite group (if used) scheduled for follow-up observations should be kept for at least 28 days further without treatment to detect recovery from, or persistence of, toxic effects.
(8)
(ii) A careful clinical examination should be made at least once prior to the initiation of treatment (to allow for within subject comparisons) and once weekly during treatment in all animals. These observations should be made outside the home cage, preferably in a standard arena, and at similar times on each occasion. Effort should be made to ensure that variations in the observation conditions
(iii) Once, near the end of the first year of the exposure period and in any case not earlier than in month 11, assessment of motor activity, grip strength, and sensory reactivity to stimuli of different types (e.g., visual, auditory, and proprioceptive stimuli) should be conducted in rodents. Further details of the procedures that could be followed are described in the references listed under paragraphs (h)(2), (h)(7), (h)(8), and (h)(11) of this section.
(iv) Functional observations conducted towards the end of the study may be omitted when data on functional observations are available from other studies and the daily clinical observations did not reveal any functional deficits.
(v) Exceptionally, functional observations may be omitted for groups that otherwise reveal signs of toxicity to an extent that would significantly interfere with functional test performance.
(vi) Body weights should be recorded individually for all animals once prior to the administration of the test substance, once a week during the first 13 weeks of study and at least once every 4 weeks thereafter, unless signs of clinical toxicity suggest more frequent weighing to facilitate monitoring of health status.
(vii) Measurements of feed consumption should be determined weekly during the first 13 weeks of the study and at approximately monthly intervals thereafter unless health status or body weight changes dictate otherwise. Measurements of water consumption should be determined at the same intervals if the test substance is administered in the drinking water.
(viii) Moribund animals should be removed and sacrificed when noticed and the time of death should be recorded as precisely as possible. All survivors should be sacrificed at the end of the study period.
(9)
(i)
(ii)
(B) The recommended clinical chemistry determinations are potassium, sodium, calcium (nonrodent), phosphorus (nonrodent), chloride (nonrodent), glucose, total cholesterol, urea nitrogen, creatinine, total protein, total bilirubin (nonrodent), and albumin. More than two hepatic enzymes, (such as alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sorbitol dehydrogenase, or
(C) If a test chemical has an effect on the hematopoietic system, reticulocyte counts and bone marrow cytology may be indicated.
(D) Other determinations that should be carried out if the test chemical is known or suspected of affecting related measures include calcium, phosphorus, fasting triglycerides, hormones, methemoglobin, and cholinesterases.
(iii)
(10)
(11)
(ii) At least the liver, kidneys, adrenals, testes, epididymides, ovaries, uterus, nonrodent thyroid (with parathyroid), spleen, brain, and heart should be weighed wet as soon as possible after dissection to avoid drying. The lungs should be weighed if the test substance is administered by the inhalation route.
(iii) The following organs and tissues, or representative samples thereof, should be preserved in a suitable medium for possible future histopathological examination:
(A) Digestive system—salivary glands, esophagus, stomach, duodenum, jejunum, ileum, cecum, colon, rectum, liver, pancreas, gallbladder (when present).
(B) Nervous system—brain (multiple sections, including cerebrum, cerebellum and medulla/pons), pituitary, peripheral nerve (sciatic or tibial, preferably in close proximity to the muscle), spinal cord (three levels, cervical, mid-thoracic and lumbar), eyes (retina, optic nerve).
(C) Glandular system—adrenals, parathyroid, thyroid.
(D) Respiratory system—trachea, lungs, pharynx, larynx, nose.
(E) Cardiovascular/hematopoietic system—aorta, heart, bone marrow (and/or fresh aspirate), lymph nodes (preferably one lymph node covering the route of administration and another one distant from the route of administration to cover systemic effects), spleen.
(F) Urogenital system—kidneys, urinary bladder, prostate, testes, epididymides, seminal vesicle(s), uterus, ovaries, female mammary gland.
(G) Other—all gross lesions and masses, skin.
(iv) In inhalation studies, the entire respiratory tract, including nose, pharynx, larynx, and paranasal sinuses should be examined and preserved. In dermal studies, skin from treated and adjacent control skin sites should be examined and preserved.
(v) Inflation of lungs and urinary bladder with a fixative is the optimal method for preservation of these tissues. The proper inflation and fixation of the lungs in inhalation studies is considered essential for appropriate and valid histopathological examination.
(vi) Information from clinical pathology and other in-life data should be considered before microscopic examination, since they may provide significant guidance to the pathologist.
(12)
(A) Full histopathology on the organs and tissues (listed under paragraph (e)(11)(iii) of this section) of all rodents and nonrodents in the control and high-dose groups, and all rodents
(B) All gross lesions in all animals.
(C) Target tissues in all animals.
(ii) If the results show substantial alteration of the animal's normal life span, or other effects that might compromise the significance of the data, the next lower levels should be examined fully as described in paragraph (e)(12)(i) of this section.
(iii) An attempt should be made to correlate gross observations with microscopic findings.
(iv) Tissues and organs designated for microscopic examination should be fixed in 10% buffered formalin or a recognized suitable fixative as soon as necropsy is performed and no less than 48 hours prior to trimming.
(f)
(ii) When applicable, all observed results (quantitative and qualitative) should be evaluated by an appropriate statistical method. Any generally accepted statistical methods may be used; the statistical methods including significance criteria should be selected during the design of the study.
(2)
(3)
(i) Test substance characterization should include:
(A) Chemical identification.
(B) Lot or batch number.
(C) Physical properties.
(D) Purity/impurities.
(ii) Identification and composition of any vehicle used.
(iii) Test system should contain data on:
(A) Species and strain of animals used and rationale for selection if other than that recommended.
(B) Age including body weight data and sex.
(C) Test environment including cage conditions, ambient temperature, humidity, and light/dark periods.
(D) Identification of animal diet.
(E) Acclimation period.
(iv) Test procedure should include the following data:
(A) Method of randomization used.
(B) Full description of experimental design and procedure.
(C) Dose regimen including levels, methods, and volume.
(v) Test results.
(A) Group animal data. Tabulation of toxic response data by species, strain, sex and exposure level for:
(
(
(
(B) Individual animal data. Data should be presented as summary (group mean) as well as for individual animals.
(
(
(
(
(
(
(
(
(
(
(
(
(
(vi) In addition, for inhalation studies the following should be reported:
(A) Test conditions. The following exposure conditions must be reported:
(
(
(B) Exposure data. These data should be tabulated and presented with mean values and a measure of variability (e.g., standard deviation) and should include:
(
(
(
(
(
(
(g)
(h)
(1) Benitz, K.F. Measurement of Chronic Toxicity.
(2) Crofton K.M., Howard J.L., Moser V.C., Gill M.W., Leiter L.W., Tilson H.A., MacPhail, R.C. Interlaboratory Comparison of Motor Activity Experiments: Implication for Neurotoxicological Assessments.
(3) D'Aguanno, W. Drug Safety Evaluation--Pre-Clinical Considerations.
(4) Fitzhugh, O.G. Chronic Oral Toxicity, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. The Association of Food and Drug Officials of the United States. pp. 36-45 (1959, 3rd Printing 1975).
(5) Gad S.C. A Neuromuscular Screen for Use in Industrial Toxicology.
(6) Goldenthal, E.I. and D'Aguanno, W. Evaluation of Drugs, Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics. The Association of Food and Drug Officials of the United States. pp. 60-67 (1959, 3rd Printing 1975).
(7) Meyer O.A., Tilson H.A., Byrd W.C., Riley M.T. A Method for the Routine Assessment of Fore- and Hind-Limb Grip Strength of Rats and Mice.
(8) Moser V.C., McDaniel K.M., Phillips P.M. Rat Strain and Stock Comparisons using a Functional Observational Battery: Baseline Values and Effects of Amitraz.
(9) Organization for Economic Cooperation and Development. Guidelines for Testing of Chemicals, Section 4-Health Effects, Part 452 Chronic Toxicity Studies, Paris (1981).
(10) Page, N.P. Chronic Toxicity and Carcinogenicity Guidelines.
(11) Tupper, D.E., Wallace R.B. Utility of the Neurologic Examination in Rats.
(12) Weingand K., Brown G., Hall R. et al. (1996). Harmonization of Animal Clinical Pathology Testing in Toxicity and Safety Studies.
(a)
(b)
(c)
(d)
(ii)
(B) Dosing should generally begin no later than 8 weeks of age.
(C) At commencement of the study, the weight variation of animals used shall not exceed ± 20% of the mean weight for each sex.
(D) Studies using prenatal or neonatal animals may be recommended under special conditions.
(iii)
(B) Females shall be nulliparous and nonpregnant.
(iv)
(B) If interim sacrifices are planned, the number shall be increased by the number of animals scheduled to be sacrificed during the course of the study.
(C) For a meaningful and valid statistical evaluation of long term exposure and for a valid interpretation of negative results, the number of animals in any group should not fall below 50% at 15 months in mice and 18 months in rats. Survival in any group should not fall below 25% at 18 months in mice and 24 months in rats.
(D) The use of adequate randomization procedures for the proper allocation of animals to test and control groups is required to avoid bias.
(E) Each animal shall be assigned a unique identification number. Dead
(v)
(B) The temperature of the experimental animal rooms should be at 22 ± 3 °C.
(C) The relative humidity of the experimental animal rooms should be 30 to 70%.
(D) Where lighting is artificial, the sequence should be 12 h light/12 h dark.
(E) Control and test animals should be fed from the same batch and lot. The feed should be analyzed to assure uniform distribution and adequacy of nutritional requirements of the species tested and for impurities that might influence the outcome of the test. Animals should be fed and watered ad libitum with food replaced at least weekly.
(F) The study should not be initiated until animals have been allowed a period of acclimatization/quarantine to environmental conditions, nor should animals from outside sources be placed on test without an adequate period of quarantine.
(2)
(ii) One lot of the test substance should be used, if possible, throughout the duration of the study, and the research sample should be stored under conditions that maintain its purity and stability. Prior to the initiation of the study, there should be a characterization of the test substance, including the purity of the test compound, and, if possible, the name and quantities of contaminants and impurities.
(iii) If the test or control substance is to be incorporated into feed or another vehicle, the period during which the test substance is stable in such a mixture should be determined prior to the initiation of the study. Its homogeneity and concentration should be determined prior to the initiation of the study and periodically during the study. Statistically randomized samples of the mixture should be analyzed to ensure that proper mixing, formulation, and storage procedures are being followed, and that the appropriate concentration of the test or control substance is contained in the mixture.
(3)
(4)
(ii) The highest dose level should elicit signs of toxicity without substantially altering the normal life span due to effects other than tumors. The highest dose should be determined based on the findings from a 90-day study to ensure that the dose used is adequate to asses the carcinogenic potential of the test substance. Thus, the selection of the highest dose to be tested is dependent upon changes observed in several toxicological parameters in subchronic studies. The highest dose tested need not exceed 1,000 mg/kg/day.
(iii) The intermediate-dose level should be spaced to produce a gradation of toxic effects.
(iv) The lowest dose level should produce no evidence of toxicity.
(v) For skin carcinogenicity studies, when toxicity to the skin is a determining factor, the highest dose selected should not destroy the functional integrity of the skin, the intermediate dose should be a minimally irritating dose, and the low dose should be the highest nonirritating dose.
(vi) The criteria for selecting the dose levels for skin carcinogenicity studies, based on gross and histopathologic dermal lesions, are as follows:
(A) Gross criteria for reaching the high dose:
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(B) Histologic criteria for reaching the high dose:
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(C) Gross criteria for exceeding the high dose:
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(D) Histologic criteria for exceeding the high dose:
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(5)
(i)
(ii)
(B) Fur should be clipped weekly from the dorsal area of the trunk of the test animals. Care should be taken to avoid abrading the skin which could alter its permeability. A minimum of 24 hrs should be allowed for the skin to recover before the next dosing of the animal.
(C) Preparation of test substance. Liquid test substances are generally used undiluted, except as indicated in paragraph (e)(4)(vi) of this section. Solids should be pulverized when possible. The substance should be moistened sufficiently with water or, when necessary, with a suitable vehicle to ensure good contact with the skin. When a vehicle is used, the influence of the vehicle on toxicity of, and penetration of the skin by, the test substance should be taken into account. The volume of application should be kept constant, e.g. less than 100 uL for the mouse and less than 300 uL for the rat. Different concentrations of test solution should be prepared for different dose levels.
(D) The test substance shall be applied uniformly over a shaved area which is approximately 10 percent of the total body surface area. In order to dose approximately 10 percent of the body surface, the area starting at the
(iii)
(B) The animals shall be tested in dynamic inhalation equipment designed to sustain a minimum air flow of 10 air changes per hr, an adequate oxygen content of at least 19%, and uniform conditions throughout the exposure chamber. Maintenance of slight negative pressure inside the chamber will prevent leakage of the test substance into surrounding areas.
(C) The selection of a dynamic inhalation chamber should be appropriate for the test substance and test system. Where a whole body chamber is used to expose animals to an aerosol, individual housing must be used to minimize crowding of the test animals and maximize their exposure to the test substance. To ensure stability of a chamber atmosphere, the total volume occupied by the test animals shall not exceed 5% of the volume of the test chamber. It is recommended, but not required, that nose-only or head-only exposure be used for aerosol studies in order to minimize oral exposures due to animals licking compound off their fur. Heat stress to the animals should be minimized.
(D) The temperature at which the test is performed should be maintained at 22 ± 2 °C. The relative humidity should be maintained between 40 to 60%, but in certain instances (e.g., tests of aerosols, use of water vehicle) this may not be practicable.
(E) The rate of air flow shall be monitored continuously but recorded at least three times during exposure.
(F) Temperature and humidity shall be monitored continuously but should be recorded at least every 30 minutes.
(G) The actual concentration of the test substance shall be measured in the breathing zone. During the exposure period, the actual concentrations of the test substance should be held as constant as practicable, monitored continuously or intermittently depending on the method of analysis. Chamber concentrations may be measured using gravimetric or analytical methods as appropriate. If trial run measurements are reasonably consistent (plus or minus 10 percent for liquid aerosol, gas, or vapor; plus or minus 20 percent for dry aerosol), the two measurements should be sufficient. If measurements are not consistent, then three to four measurements should be taken.
(H) During the development of the generating system, particle size analysis shall be performed to establish the stability of aerosol concentrations with respect to particle size. Measurement of aerodynamic particle size in the animals's breathing zone should be measured during a trial run. If median aerodynamic diameter (MMAD) values for each exposure level are within 10% of each other, then two measurements during the exposures should be sufficient. If pretest measurements are not within 10% of each other, three to four measurements should be taken. The MMAD particle size range should be between 1-3 μm. The particle size of hygroscopic materials should be small enough to allow pulmonary deposition once the particles swell in the moist environment of the respiratory tract.
(I) Feed shall be withheld during exposure. Water may also be withheld during exposure.
(6)
(7)
(ii) A careful clinical examination shall be made at least once weekly. Observations should be detailed and carefully recorded, preferably using explicitly defined scales. Observations should include, but not be limited to, evaluation of skin and fur, eyes and mucous membranes, respiratory and circulatory effects, autonomic effects such as salivation, central nervous system effects, including tremors and convulsions, changes in the level of activity, gait and posture, reactivity to handling or sensory stimuli, altered strength and stereotypes or bizarre behavior (e.g., self-mutilation, walking backwards).
(iii) Body weights shall be recorded individually for all animals; once a week during the first 13 weeks of the study and at least once every 4 weeks, thereafter, unless signs of clinical toxicity suggest more frequent weighing to facilitate monitoring of health status.
(iv) Measurements of feed consumption should be determined weekly during the first 13 weeks of the study and at approximately monthly intervals thereafter unless health status or body weight changes dictate otherwise. Measurement of water consumption should be determined at the same intervals if the test substance is administered in the drinking water.
(v) Moribund animals shall be removed and sacrificed when noticed and the time of death should be recorded as precisely as possible. At the end of the study period, all survivors shall be sacrificed.
(8)
(9)
(ii) At least the liver, kidneys, adrenals, testes, epididymides, ovaries, uterus, spleen, brain, and heart should be weighed wet as soon as possible after dissection to avoid drying. The lungs should be weighed if the test substance is administered by the inhalation route. The organs should be weighed from interim sacrifice animals as well as from at least 10 animals per sex per group at terminal sacrifice.
(iii) The following organs and tissues, or representative samples thereof, shall be preserved in a suitable medium for possible future histopathological examination.
(A) Digestive system.
(
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(B) Nervous system.
(
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(C) Glandular system.
(
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(D) Respiratory system.
(
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(E) Cardiovascular/hematopoietic system.
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(F) Urogenital system.
(
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(G) Other.
(
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(iv) In inhalation studies, the entire respiratory tract, including nose, pharynx, larynx, and paranasal sinuses should be examined and preserved. In dermal studies, skin from treated and adjacent control skin sites should be examined and preserved.
(v) Inflation of lungs and urinary bladder with a fixative is the optimal method for preservation of these tissues. The proper inflation and fixation of the lungs in inhalation studies is essential for appropriate and valid histopathological examination.
(vi) Information from clinical pathology, and other in-life data should be considered before microscopic examination, since they may provide significant guidance to the pathologist.
(10)
(A) Full histopathology on the organs and tissues under paragraph (d)(9) (iii) of this section of all animals in the control and high dose groups and all animals that died or were killed during the study.
(B) All gross lesions in all animals.
(C) Target organs in all animals.
(ii) If the results show substantial alteration of the animal's normal life span, the induction of effects that might affect a neoplastic response, or other effects that might compromise the significance of the data, the next lower dose levels shall be examined as described in paragraph (d)(10)(i) of this section.
(iii) An attempt should be made to correlate gross observations with microscopic findings.
(iv) Tissues and organs designated for microscopic examination should be fixed in 10 percent buffered formalin or a recognized suitable fixative as soon as necropsy is performed and no less than 48 hours prior to trimming.
(e)
(ii) All observed results (quantitative and qualitative) shall be evaluated by an appropriate statistical method. Any generally accepted statistical methods may be used; the statistical methods including significance criteria shall be selected during the design of the study.
(2)
(ii) In any study which demonstrates an absence of toxic effects, further investigation to establish absorption and bioavailablity of the test substance should be considered.
(iii) In order for a negative test to be acceptable, it must meet the following criteria: No more than 10% of any group is lost due to autolysis, cannibalism, or management problems; and survival in each group is no less than 50% at 15 months for mice and 18 months for rats. Survival should not fall below 25% at 18 months for mice and 24 months for rats.
(iv) The use of historical control data from an appropriate time period from the same testing laboratory (i.e., the incidence of tumors and other suspect
(3)
(A) Test substance characterization should include:
(
(
(
(
(
(B) Test system should contain data on:
(
(
(
(
(
(C) Test procedure should include the following data:
(
(
(
(4)
(A) Number of animals exposed.
(B) Number of animals showing signs of toxicity.
(C) Number of animals dying.
(ii)
(A) Time of death during the study or whether animals survived to termination.
(B) Time of observation of each abnormal sign and its subsequent course.
(C) Body weight data.
(D) Feed and water consumption data, when collected.
(E) Results of clinical pathology and immunotoxicity screen when performed.
(F) Necropsy findings including absolute/relative organ weight data.
(G) Detailed description of all histopathological findings.
(H) Statistical treatment of results where appropriate.
(I) Historical control data.
(J) Achieved dose (mg/kg/day) as a time-weighted average if the test substance is administered in the diet or drinking water.
(iii)
(A)
(
(
(B)
(
(
(
(
(
(
(f)
(g)
(1) Benitz, K.F. Ed. Paget, G.E. Measurement of Chronic Toxicity.
(2) Fitzhugh, O.G. Chronic Oral Toxicity, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. The Association of Food and Drug Officials of the United States. pp. 36-45 (1959, 3rd Printing 1975).
(3) Goldenthal, E.I. and D'Aguanno, W. Evaluation of Drugs, Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics. The Association of Food and Drug Officials of the United States. pp. 60-67 (1959, 3rd Printing 1975).
(4) Organisation for Economic Co-operation and Development. Guidelines for Testing of Chemicals, Section 4-Health Effects, Part 451 Carcinogenicity Studies (Paris, 1981).
(5) Page, N.P. Chronic Toxicity and Carcinogenicity Guidelines.
(6) Page, N.P. Eds. Kraybill and Mehlman. Concepts of a Bioassay Program in Environmental Carcinogenesis. Vol.3.
(7) Sontag, J.M.
(a)
(b)
(c)
(d)
(e)
(ii)
(B) Dosing should generally begin no later than 8 weeks of age.
(C) At commencement of the study, the weight variation of animals used must be within 20% of the mean weight for each sex.
(D) Studies using prenatal or neonatal animals may be recommended under special conditions.
(iii)
(B) Females must be nulliparous and nonpregnant.
(iv)
(B) For a meaningful and valid statistical evaluation of long term exposure and for a valid interpretation of negative results, the number of animals in any group should not fall below 50% at 15 months in mice and 18 months in rats. Survival in any group should not fall below 25% at 18 months in mice and 24 months in rats.
(C) To avoid bias, the use of adequate randomization procedures for the proper allocation of animals to test and control groups is required.
(D) Each animal must be assigned a unique identification number. Dead animals (and their preserved organs) and tissues, and microscopic slides shall be identified by reference to the unique numbers assigned.
(v)
(B) The temperature of the experimental animal rooms should be at 22 ± 3 °C.
(C) The relative humidity of the experimental animal rooms should be 50 ± 20%.
(D) Where lighting is artificial, the sequence should be 12 hours light/12 hours dark.
(E) Control and test animals should be fed from the same batch and lot. The feed should be analyzed to assure uniform distribution and adequacy of nutritional requirements of the species tested and for impurities that might influence the outcome of the test. Animals should be fed and watered ad libitum with food replaced at least weekly.
(F) The study should not be initiated until animals have been allowed a period of acclimatization/quarantine to environmental conditions, nor should animals from outside sources be placed on test without an adequate period of quarantine. An acclimation period of at least five days is recommended.
(2)
(ii) One lot of the test substance should be used throughout the duration of the study if possible, and the research sample should be stored under conditions that maintain its purity and stability. Prior to the initiation of the study, there should be a characterization of the test substance, including the purity of the test compound, and, if possible, the name and quantities of contaminants and impurities.
(iii) If the test or control substance is to be incorporated into feed or another vehicle, the period during which the test substance is stable in such a mixture should be determined prior to the initiation of the study. Its homogeneity and concentration should be determined prior to the initiation of the study and periodically during the study. Statistically randomized samples of the mixture should be analyzed to ensure that proper mixing, formulation, and storage procedures are being followed, and that the appropriate concentration of the test or control substance is contained in the mixture.
(3)
(4)
(ii) The highest dose level in rodents should elicit signs of toxicity without substantially altering the normal life span due to effects other than tumors. The highest dose should be determined based on the findings from a 90-day study to ensure that the dose used is adequate to assess the chronic toxicity and the carcinogenic potential of the test substance. Thus, the selection of the highest dose to be tested is dependent upon changes observed in several toxicological parameters in subchronic studies. The highest dose tested need not exceed 1,000 mg/kg/day.
(iii) The intermediate-dose levels should be spaced to produce a gradation of toxic effects.
(iv) The lowest-dose level should produce no evidence of toxicity.
(v) For skin carcinogenicity studies, when toxicity to the skin is a determining factor, the highest dose selected should not destroy the functional integrity of the skin, the intermediate doses should be a minimally irritating dose and the low dose should be the highest nonirritating dose.
(vi) The criteria for selecting the dose levels for skin carcinogenicity studies, based on gross and histopathologic dermal lesions, are as follows:
(A) Gross criteria for reaching the high dose:
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(B) Histologic criteria for reaching the high dose:
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(C) Gross criteria for exceeding the high dose:
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(D) Histologic criteria for exceeding the high-dose:
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(5)
(i)
(ii)
(B) Preparation of test substance. Liquid test substances are generally used undiluted, except as indicated in paragraph (e)(4)(vi) of this section. Solids should be pulverized when possible. The substance should be moistened sufficiently with water or, when necessary, with a suitable vehicle to ensure good contact with the skin. When a vehicle is used, the influence of the vehicle on toxicity of, and penetration of the skin by, the test substance should be taken into account.The volume of application should be kept constant, e.g., less than 100 μL for the mouse and less than 300 μL for the rat. Different concentrations of test solution should be prepared for different dose levels.
(C) Administration of test substance. The duration of exposure should be at least 18 months for mice and hamsters and 24 months for rats. Ideally, the animals should be treated with test substance for at least 6 hours per day on a 7-day per week basis. However, based on practical considerations, application on a 5-day per week basis is acceptable. Dosing should be conducted at approximately the same time each day. The test substance must be applied uniformly over the treatment site.The surface area covered may be less for highly toxic substances. As much of the area should be covered with as thin and uniform a film as possible. For rats, the test substance may be held in contact with the skin with a porous gauze dressing and nonirritating tape if necessary. The test site should be further covered in a suitable manner to retain the gauze dressing plus test substance and to ensure that the animals cannot ingest the test substance. The application site should not be covered when the mouse is the species of choice. The test substance may
(iii)
(B) The animals must be tested in dynamic inhalation equipment designed to sustain a minimum air flow of 10 air changes per hour, an adequate oxygen content of at least 19%, and uniform conditions throughout the exposure chamber. Maintenance of slight negative pressure inside the chamber will prevent leakage of the test substance into surrounding areas. It is not normally necessary to measure chamber oxygen concentration if airflow is adequate.
(C) The selection of a dynamic inhalation chamber should be appropriate for the test substance and test system. Where a whole body chamber is used, individual housing must be used to minimize crowding of the test animals and maximize their exposure to the test substance. To ensure stability of a chamber atmosphere, the total volume occupied by the test animals shall not exceed 5% of the volume of the test chamber. It is recommended, but not required, that nose-only or head-only exposure be used for aerosol studies in order to minimize oral exposures due to animals licking compound off their fur. The animals should be acclimated and heat stress minimized.
(D) The temperature at which the test is performed should be maintained at 22 ± 2 °C. The relative humidity should be maintained between 40 to 60%, but in certain instances (e.g., tests of aerosols, use of water vehicle) this may not be practicable.
(E) The rate of air flow must be monitored continuously but recorded at least three times during the exposure.
(F) Temperature and humidity must be monitored continuously but should be recorded at least every 30 minutes.
(G) The actual concentrations of the test substance must be measured in the animal's breathing zone. During the exposure period, the actual concentrations of the test substance must be held as constant as practicable and monitored continuously or intermittently depending on the method of analysis. Chamber concentration may be measured using gravimetric or analytical methods as appropriate. If trial run measurements are reasonably consistent (± 10% for liquid aerosol, gas, or vapor; ± 20% for dry aerosol), then two measurements should be sufficient. If measurements are not consistent, three to four measurements should be taken. If there is some difficulty in measuring chamber analytical concentration due to precipitation, nonhomogeneous mixtures, volatile components, or other factors, additional analyses of inert components may be necessary.
(H) During the development of the generating system, particle size analysis must be performed to establish the stability of aerosol concentrations with respect to particle size. The mass median aerodynamic diameter (MMAD) particle size range should be between 1-3 μm. The particle size of hygroscopic materials should be small enough when dry to assure that the size of the swollen particle will still be within the 1-3 μm range. Measurements of aerodynamic particle size in the animal's breathing zone should be measured during a trial run. If MMAD values for each exposure level are within 10% of each other, then two measurements during the exposures should be sufficient. If pretest measurements are not within 10% of each other, three to four measurements should be taken.
(I) Feed must be withheld during exposure. Water may also be withheld during exposure.
(J) When the physical and chemical properties of the test substance show a low flash point or the test substance is otherwise known or thought to be explosive, care must be taken to avoid exposure level concentrations that could result in an exposure chamber explosion during the test.
(6)
(ii) Animals in a satellite group to assess chronic toxicity should be observed for 12 months.
(7)
(ii) A careful clinical examination must be made at least once weekly. Observations should be detailed and carefully recorded, preferably using explicity defined scales. Observations should include, but not be limited to, evaluation of skin and fur, eyes and mucous membranes, respiratory and circulatory effects, autonomic effects such as salivation, central nervous system effects, including tremors and convulsions, changes in the level of activity, gait and posture, reactivity to handling or sensory stimuli, altered strength, and stereotypes or bizarre behavior (e.g., self-mutilation, walking backwards).
(iii) Signs of toxicity should be recorded as they are observed including the time of onset, degree and duration.
(iv) Body weights must be recorded individually for all animals once prior to administration of the test substance, once a week during the first 13 weeks of the study and at least once every 4 weeks thereafter unless signs of clinical toxicity suggest more frequent weighing to facilitate monitoring of health status.
(v) Measurements of feed consumption should be determined weekly during the first 13 weeks of the study and then at approximately monthly intervals unless health status or body weight changes dictate otherwise. Measurements of water consumption should be determined at the same intervals if the test material is administered in drinking water.
(vi) Moribund animals must be removed and sacrificed when noticed and the time of death should be recorded as precisely as possible. At the end of the study period, all survivors must be sacrificed. Animals in the satellite group must be sacrificed after 12 months of exposure to the test substance (interim sacrifice).
(8)
(i)
(ii)
(B) The recommended clinical chemistry determinations are potassium, sodium, glucose, total cholesterol, urea nitrogen, creatinine, total protein, and albumin. More than two hepatic enzymes, (such as alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sorbitol dehydrogenase, or gamma glutamyl transpeptidase) should also be measured. Measurements of addtional enzymes (of hepatic or other origin) and bile acids, may also be useful.
(iii) If a test chemical has an effect on the hematopoietic system,
(iv) Other determinations that should be carried out if the test chemical is known or suspected of affecting related measures include calcium, phosphorus, fasting triglycerides, hormones, methemoglobin, and cholinesterases.
(v)
(9)
(10)
(ii) At least, the liver, kidneys, adrenals, testes, epididymides, ovaries, uterus, spleen, brain, and heart should be trimmed and weighed wet, as soon as possible after dissection to avoid drying. The lungs should be weighed if the test substance is administered by the inhalation route. The organs should be weighed from interim sacrifice animals as well as from at least 10 animals per sex per group at terminal sacrifice.
(iii) The following organs and tissues, or representative samples thereof, must be preserved in a suitable medium for possible future histopathological examination:
(A) Digestive system—salivary glands, esophagus, stomach, duodenum, jejunum, ileum, cecum, colon, rectum, liver, pancreas, gallbladder (when present) .
(B) Nervous system—brain (multiple sections, including cerebrum, cerebellum and medulla/pons), pituitary, peripheral nerve (sciatic or tibial, preferably in close proximity to the muscle), spinal cord (three levels, cervical, mid-thoracic, and lumbar), eyes (retina, optic nerve).
(C) Glandular system—adrenals, parathyroid, thyroid.
(D) Respiratory system—trachea, lungs, pharynx, larynx, nose.
(E) Cardiovascular/Hematopoietic system—aorta, heart, bone marrow (and/or fresh aspirate), lymph nodes (preferably one lymph node covering the route of administration and another one distant from the route of administration to cover systemic effects), spleen.
(F) Urogenital system—kidneys, urinary bladder, prostate, testes, epididymides, seminal vesicle(s), uterus, ovaries, female mammary gland.
(G) Other—all gross lesions and masses, skin.
(iv) In inhalation studies, the entire respiratory tract, including nose, pharynx, larynx, and paranasal sinuses should be examined and preserved. In dermal studies, skin from treated and adjacent control skin sites should be examined and preserved.
(v) Inflation of lungs and urinary bladder with a fixative is the optimal method for preservation of these tissues. The proper inflation and fixation of the lungs in inhalation studies is essential for appropriate and valid histopathological examination.
(vi) Information from clinical pathology and other in-life data should be considered before microscopic examination, since these data may provide significant guidance to the pathologist.
(11) [Reserved]
(12)
(A) Full histopathology on the organs and tissues, listed in paragraph (e)(10)(iii) of this section of all animals in the control and high dose groups and of all animals that died or were sacrificed during the study.
(B) All gross lesions in all animals.
(C) Target organs in all animals.
(ii) If the results show substantial alteration of the animal's normal life span, the induction of effects that might affect a neoplastic response, or other effects that might compromise the significance of the data, the next lower levels should be examined fully as described in paragraph (e)(12)(i) of this section.
(iii) An attempt should be made to correlate gross observations with microscopic findings.
(iv) Tissues and organs designated for microscopic examination should be fixed in 10% buffered formalin or a recognized suitable fixative as soon as necropsy is performed and no less than 48 hours prior to trimming.
(f)
(ii) When applicable, all observed results, quantitative and qualitative, must be evaluated by an appropriate statistical method. Any generally accepted statistical methods may be used; the statistical methods including significance criteria should be selected during the design of the study.
(2)
(ii) In any study which demonstrates an absence of toxic effects, further investigation to establish absorption and bioavailablity of the test substance should be considered.
(iii) In order for a negative test to be acceptable, it should meet the following criteria—no more than 10% of any group is lost due to autolysis, cannibalism, or management problems, and survival in each group is no less than 50% at 15 months for mice and 18 months for rats. Survival should not fall below 25% at 18 months for mice and 24 months for rats.
(iv) The use of historical control data from an appropriate time period from the same testing laboratory (i.e, the incidence of tumors and other suspect lesions normally occurring under the same laboratory conditions and in the same strain of animals employed in the test) is helpful for assessing the significance of changes observed in the current study.
(3)
(A) Test substance characterization should include:
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(B) Test system should contain data on:
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(C) Test procedure should include the following data:
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(4)
(A) Number of animals exposed.
(B) Number of animals showing signs of toxicity.
(C) Number of animals dying.
(ii) Individual animal data. Data should be presented as summary (group mean) as well as for individual animals.
(A) Time of death during the study or whether animals survived to termination.
(B) Time of observation of each abnormal sign and its subsequent course.
(C) Body weight data.
(D) Feed and water consumption data, when collected.
(E) Achieved dose (milligrams/kilogram body weight) as a time-weighed average is the test substance is administered in the diet or drinking water.
(F) Results of ophthalmological examination, when performed.
(G) Results of hematological tests performed.
(H) Results of clinical chemistry tests performed.
(I) Results of urinalysis tests performed.
(J) Results of observations made.
(K) Necropsy findings including absolute/relative organ weight data.
(L) Detailed description of all histopathological findings.
(M) Statistical treatment of results where appropriate.
(N) Historical control data.
(iii) In addition, for inhalation studies the following should be reported:
(A) Test conditions. The following exposure conditions must be reported.
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(B) Exposure data. These must be tabulated and presented with mean values and a measure of variability (e.g., standard deviation) and should include:
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(g)
(h)
(1) Benitz, K.F.
(2) Crofton K.M., Howard J.L., Moser V.C., Gill M.W., Leiter L.W., Tilson H.A., MacPhail, R.C. Interlaboratory Comparison of Motor Activity Experiments: Implication for Neurotoxicological Assessments. Neurotoxicol. Teratol. 13, 599-609. (1991)
(3) D'Aguanno, W.
(4) Fitzhugh, O.G.
(5) Goldenthal, E.I. and D'Aguanno, W.
(6) Organization for Economic Cooperation and Development. Guidelines for Testing of Chemicals, Section 4-Health Effects, Part 453 Combined Chronic Toxicity/Carcinogenicity Studies, Paris. (1981).
(7) Page, N.P. Chronic Toxicity and Carcinogenicity Guidelines.
(8) Page, N.P. Concepts of a Bioassay Program in Environmental Carcinogenesis, Advances in Modern Toxicology. Vol.3, Ed. Kraybill and
(9) Sontag, J.M. et al. Guidelines for Carcinogen Bioassay in Small Rodents. NCI-CS-TR-1 (Bethesda: United States Cancer Institute, Division of Cancer Control and Prevention, Carcinogenesis Bioassay Program.
(10) Summary of the EPA Workshop on Carcinogenesis Bioassay via the Dermal Route. EPA Report 50/6-89-002; 50/6-89-003. Washington, DC.
(11) The Atlas Of Dermal Lesions, EPA Report 20T-004, U.S Environmental Protection Agency, Washington, DC.
(a)
(1) The bacterial reverse mutation test uses amino-acid requiring strains of
(2) Point mutations are the cause of many human genetic diseases and there is substantial evidence that point mutations in oncogenes and tumor suppressor genes of somatic cells are involved in tumor formation in humans and experimental animals. The bacterial reverse mutation test is rapid, inexpensive and relatively easy to perform. Many of the test strains have several features that make them more sensitive for the detection of mutations, including responsive DNA sequences at the reversion sites, increased cell permeability to large molecules and elimination of DNA repair systems or enhancement of error-prone DNA repair processes. The specificity of the test strains can provide some useful information on the types of mutations that are induced by genotoxic agents. A very large data base of results for a wide variety of structures is available for bacterial reverse mutation tests and well-established methodologies have been developed for testing chemicals with different physico-chemical properties, including volatile compounds.
(b)
(c)
(d)
(2) The bacterial reverse mutation test is commonly employed as an initial screen for genotoxic activity and, in particular, for point mutation-inducing activity. An extensive data base has demonstrated that many chemicals that are positive in this test also exhibit mutagenic activity in other tests. There are examples of mutagenic agents which are not detected by this
(3) The bacterial reverse mutation test may not be appropriate for the evaluation of certain classes of chemicals, for example highly bactericidal compounds (e.g. certain antibiotics) and those which are thought (or known) to interfere specifically with the mammalian cell replication system (e.g. some topoisomerase inhibitors and some nucleoside analogues). In such cases, mammalian mutation tests may be more appropriate.
(4) Although many compounds that are positive in this test are mammalian carcinogens, the correlation is not absolute. It is dependent on chemical class and there are carcinogens that are not detected by this test because they act through other, non-genotoxic mechanisms or mechanisms absent in bacterial cells.
(e)
(ii) Several procedures for performing the bacterial reverse mutation test have been described. Among those commonly used are the plate incorporation method, the preincubation method, the fluctuation method, and the suspension method. Suggestions for modifications for the testing of gases or vapors are described in the reference in paragraph (g)(12) of this section.
(iii) The procedures described in this section pertain primarily to the plate incorporation and preincubation methods. Either of them is acceptable for conducting experiments both with and without metabolic activation. Some compounds may be detected more efficiently using the preincubation method. These compounds belong to chemical classes that include short chain aliphatic nitrosamines, divalent metals, aldehydes, azo-dyes and diazo compounds, pyrollizidine alkaloids, allyl compounds and nitro compounds. It is also recognized that certain classes of mutagens are not always detected using standard procedures such as the plate incorporation method or preincubation method. These should be regarded as “special cases” and it is strongly recommended that alternative procedures should be used for their detection. The following “special cases” could be identified (together with examples of procedures that could be used for their detection): azo-dyes and diazo compounds (alterative procedures are described in the references in paragraphs (g)(3), (g)(5), (g)(6), and (g)(13) of this section), gases and volatile chemicals (alterative procedures are described in the references in paragraphs (g)(12), (g)(14), (g)(15), and (g)(16) of this section), and glycosides (alterative procedures are described in the references in paragraphs (g)(17) and (g)(18) of this section). A deviation from the standard procedure needs to be scientifically justified.
(2)
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(B)
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(B)
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(3)
(B) For the preincubation method the test substance/test solution is preincubated with the test strain (containing approximately 10
(C) For an adequate estimate of variation, triplicate plating should be used at each dose level. The use of duplicate plating is acceptable when scientifically justified. The occasional loss of a plate does not necessarily invalidate the assay.
(D) Gaseous or volatile substances should be tested by appropriate methods, such as in sealed vessels (methods described in the references under paragraphs (g)(12), (g)(14), (g)(15), and (g)(16) of this section may be used).
(ii)
(f)
(ii) Individual plate counts, the mean number of revertant colonies per plate and the standard deviation shall be presented for the test substance and positive and negative (untreated and/or solvent) controls.
(iii) There is no requirement for verification of a clear positive response. Equivocal results shall be clarified by further testing preferably using a modification of experimental conditions. Negative results need to be confirmed on a case-by-case basis. In those cases where confirmation of negative results is not considered necessary, justification should be provided. Modification of study parameters to extend the range of conditions assessed should be considered in follow-up experiments. Study parameters that might be modified include the concentration spacing, the method of treatment (plate incorporation or liquid preincubation), and metabolic activation conditions.
(2)
(ii) A test substance for which the results do not meet the criteria described under paragraph (f)(2)(i) of this section is considered non-mutagenic in this test
(iii) Although most experiments will give clearly positive or negative results, in rare cases the data set will preclude making a definite judgement about the activity of the test substance. Results may remain equivocal or questionable regardless of the number of times the experiment is repeated.
(iv) Positive results from the bacterial reverse mutation test indicate that a substance induces point mutations by base substitutions or frameshifts in the genome of either
(3)
(i) Test substance:
(A) Identification data and CAS no., if known.
(B) Physical nature and purity.
(C) Physicochemical properties relevant to the conduct of the study.
(D) Stability of the test substance, if known.
(ii) Solvent/vehicle:
(A) Justification for choice of solvent/vehicle.
(B) Solubility and stability of the test substance in solvent/vehicle, if known.
(iii) Strains:
(A) Strains used.
(B) Number of cells per culture.
(C) Strain characteristics.
(iv) Test conditions:
(A) Amount of test substance per plate (mg/plate or ml/plate) with rationale for selection of dose and number of plates per concentration.
(B) Media used.
(C) Type and composition of metabolic activation system, including acceptability criteria.
(D) Treatment procedures.
(v) Results:
(A) Signs of toxicity.
(B) Signs of precipitation.
(C) Individual plate counts.
(D) The mean number of revertant colonies per plate and standard deviation.
(E) Dose-response relationship, where possible.
(F) Statistical analyses, if any.
(G) Concurrent negative (solvent/vehicle) and positive control data, with ranges, means and standard deviations.
(H) Historical negative (solvent/vehicle) and positive control data, with e.g. ranges, means and standard deviations.
(vi) Discussion of the results.
(vii) Conclusion.
(g)
(1) Ames, B.N., McCann, J., and Yamasaki, E. Methods for Detecting Carcinogens and Mutagens With the Salmonella/Mammalian-Microsome Mutagenicity Test.
(2) Maron, D.M. and Ames, B.N. Revised Methods for the Salmonella Mutagenicity Test.
(3) Gatehouse, D., Haworth, S., Cebula, T., Gocke, E., Kier, L., Matsushima, T., Melcion, C., Nohmi, T., Venitt, S., and Zeiger, E. Recommendations for the Performance of Bacterial Mutation Assays.
(4) Kier, L.D., Brusick, D.J., Auletta, A.E., Von Halle, E.S., Brown, M.M., Simmon, V.F., Dunkel, V., McCann, J., Mortelmans, K., Prival, M., Rao, T.K., and Ray V. The Salmonella Typhimurium/Mammalian Microsomal Assay: A Report of the U.S. Environmental Protection Agency Gene-Tox Program.
(5) Yahagi, T., Degawa, M., Seino, Y.Y., Matsushima, T., Nagao, M., Sugimura, T., and Hashimoto, Y. Mutagenicity of Carcinogen Azo Dyes and Their Derivatives.
(6) Matsushima, M., Sugimura, T., Nagao, M., Yahagi, T., Shirai, A., and
(7) Gatehouse, D.G., Rowland, I.R., Wilcox, P., Callender, R.D., and Foster, R. Bacterial Mutation Assays. Ed. Kirkland, D.J.
(8) Aeschbacher, H.U., Wolleb, U., and Porchet, L.J. Liquid Preincubation Mutagenicity Test for Foods.
(9) Green, M.H.L., Muriel, W.J., and Bridges, B.A. Use of a Simplified Fluctuation Test to Detect Low Levels of Mutagens.
(10) Hubbard, S.A., Green, M.H.L., Gatehouse, D., and J.W. Bridges. The Fluctuation Test in Bacteria. 2nd Edition. Ed. Kilbey, B.J., Legator, M., Nichols, W., and Ramel C.
(11) Thompson, E.D. and Melampy, P.J. An Examination of the Quantitative Suspension Assay for Mutagenesis With Strains of Salmonella Typhimurium.
(12) Araki, A., Noguchi, T., Kato, F., and T. Matsushima. Improved Method for Mutagenicity Testing of Gaseous Compounds by Using a Gas Sampling Bag.
(13) Prival, M.J., Bell, S.J., Mitchell, V.D., Reipert, M.D., and Vaughn, V.L. Mutagenicity of Benzidine and Benzidine-Congener Dyes and Selected Monoazo Dyes in a Modified Salmonella Assay.
(14) Zeiger, E., Anderson, B. E., Haworth, S, Lawlor, T., and Mortelmans, K. Salmonella Mutagenicity Tests. V. Results from the Testing of 311 Chemicals. Environ. Mol.
(15) Simmon, V., Kauhanen, K., and Tardiff, R.G. Mutagenic Activity of Chemicals Identified in Drinking Water. Ed. Scott, D., Bridges, B., and Sobels, F.
(16) Hughes, T.J., Simmons, D.M., Monteith, I.G., and Claxton, L.D. Vaporization Technique to Measure Mutagenic Activity of Volatile Organic Chemicals in the Ames/Salmonella Assay.
(17) Matsushima, T., Matsumoto, A., Shirai, M., Sawamura, M., and Sugimura, T. Mutagenicity of the Naturally Occurring Carcinogen Cycasin and Synthetic Methylazoxy Methane Conjugates in Salmonella Typhimurium.
(18) Tamura, G., Gold, C., Ferro-Luzzi, A., and Ames. B.N. Fecalase: A Model for Activation of Dietary Glycosides to Mutagens by Intestinal Flora. Proc. National Academy of Science. (USA, 1980) 77, 4961-4965.
(19) Wilcox, P., Naidoo, A., Wedd, D. J., and Gatehouse, D. G. Comparison of Salmonella Typhimurium TA 102 With Escherichia Coli WP2 Tester Strains.
(20) Matsushima, T., Sawamura, M., Hara, K., and Sugimura, T. A Safe Substitute for Polychlorinated Biphenyls as an Inducer of Metabolic Activation Systems. Ed. F.J. de Serres
(21) Elliott, B.M., Combes, R.D., Elcombe, C.R., Gatehouse, D.G., Gibson, G.G., Mackay, J.M., and Wolf, R.C. Alternatives to Aroclor 1254-Induced S9 in
(22) Maron, D., Katzenellenbogen, J., and Ames, B.N. Compatibility of Organic Solvents With the Salmonella/Microsome Test.
(23) Claxton, L.D., Allen, J., Auletta, A., Mortelmans, K., Nestmann, E., and Zeiger, E. Guide for the Salmonella Typhimurium/Mammalian Microsome Tests for Bacterial Mutagenicity.
(24) Mahon, G.A.T., Green, M.H.L., Middleton, B., Mitchell, I., Robinson, W.D., and Tweats, D.J. Analysis of Data from Microbial Colony Assays. UKEMS Sub-Committee on Guidelines for Mutagenicity Testing Part II. Ed.
(a)
(b)
(c)
(d)
(2) This test is used to screen for possible mammalian mutagens and carcinogens. Many compounds that are positive in this test are mammalian carcinogens; however, there is not a perfect correlation between this test and carcinogenicity. Correlation is dependent on chemical class and there is increasing evidence that there are carcinogens that are not detected by this test because they appear to act through other, non-genotoxic mechanisms or mechanisms absent in bacterial cells.
(e)
(ii) Cells in suspension or monolayer culture shall be exposed to the test substance, both with and without metabolic activation, for a suitable period of time and subcultured to determine cytotoxicity and to allow phenotypic expression prior to mutant selection. Cytotoxicity is usually determined by measuring the relative cloning efficiency (survival) or relative total growth of the cultures after the treatment period. The treated cultures shall be maintained in growth medium for a sufficient period of time, characteristic of each selected locus and cell type, to allow near-optimal phenotypic expression of induced mutations. Mutant frequency is determined by seeding known numbers of cells in medium containing the selective agent to detect mutant cells, and in medium without selective agent to determine the cloning efficiency (viability). After a suitable incubation time, colonies shall be counted. The mutant frequency is derived from the number of mutant colonies in selective medium and the number of colonies in non-selective medium.
(2)
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(B)
(C)
(D)
(E)
(ii)
(B)
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(C)
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(3)
(B) Either duplicate or single treated cultures may be used at each concentration tested. When single cultures are used, the number of concentrations should be increased to ensure an adequate number of cultures for analysis (e.g. at least eight analyzsable concentrations). Duplicate negative (solvent) control cultures should be used.
(C) Gaseous or volatile substances should be tested by appropriate methods, such as in sealed culture vessels. Methods described in the references under paragraphs (g)(20) and (g)(21) of this section may be used.
(ii)
(B) Each locus has a defined minimum time requirement to allow near optimal phenotypic expression of newly induced mutants (HPRT and XPRT require at least 6-8 days, and TK at least 2 days). Cells are grown in medium with and without selective agent(s) for determination of numbers of mutants and cloning efficiency, respectively. The measurement of viability (used to calculate mutant frequency) is initiated at the end of the expression time by plating in non-selective medium.
(C) If the test substance is positive in the L5178Y TK
(f)
(ii) Survival (relative cloning efficiencies) or relative total growth shall be given. Mutant frequency shall be expressed as number of mutant cells per number of surviving cells.
(iii) Individual culture data shall be provided. Additionally, all data shall be summarized in tabular form.
(iv) There is no requirement for verification of a clear positive response. Equivocal results shall be clarified by further testing preferably using a modification of experimental conditions. Negative results need to be confirmed on a case-by-case basis. In those cases where confirmation of negative results is not considered necessary, justification should be provided. Modification of study parameters to extend the range of conditions assessed should be considered in follow-up experiments for either equivocal or negative results. Study parameters that might be modified include the concentration spacing, and the metabolic activation conditions.
(2)
(ii) A test substance, for which the results do not meet the criteria described in paragraph (f)(2)(i) of this section is considered non-mutagenic in this system.
(iii) Although most studies will give clearly positive or negative results, in rare cases the data set will preclude making a definite judgement about the activity of the test substance. Results may remain equivocal or questionable regardless of the number of times the experiment is repeated.
(iv) Positive results for an
(3)
(i) Test substance:
(A) Identification data and CAS no., if known.
(B) Physical nature and purity.
(C) Physicochemical properties relevant to the conduct of the study.
(D) Stability of the test substance.
(ii) Solvent/vehicle:
(A) Justification for choice of vehicle/solvent.
(B) Solubility and stability of the test substance in solvent/vehicle, if known.
(iii) Cells:
(A) Type and source of cells.
(B) Number of cell cultures.
(C) Number of cell passages, if applicable.
(D) Methods for maintenance of cell cultures, if applicable.
(E) Absence of mycoplasma.
(iv) Test conditions:
(A) Rationale for selection of concentrations and number of cell cultures including e.g., cytotoxicity data and solubility limitations, if available.
(B) Composition of media, CO
(C) Concentration of test substance.
(D) Volume of vehicle and test substance added.
(E) Incubation temperature.
(F) Incubation time.
(G) Duration of treatment.
(H) Cell density during treatment.
(I) Type and composition of metabolic activation system including acceptability criteria.
(J) Positive and negative controls.
(K) Length of expression period (including number of cells seeded, and subcultures and feeding schedules, if appropriate).
(L) Selective agent(s).
(M) Criteria for considering tests as positive, negative or equivocal.
(N) Methods used to enumerate numbers of viable and mutant cells.
(O) Definition of colonies of which size and type are considered (including criteria for “small” and “large” colonies, as appropriate).
(v) Results:
(A) Signs of toxicity.
(B) Signs of precipitation.
(C) Data on pH and osmolality during the exposure to the test substance, if determined.
(D) Colony size if scored for at least negative and positive controls.
(E) Laboratory's adequacy to detect small colony mutants with the L5178Y TK
(F) Dose-response relationship, where possible.
(G) Statistical analyses, if any.
(H) Concurrent negative (solvent/vehicle) and positive control data.
(I) Historical negative (solvent/vehicle) and positive control data with ranges, means, and standard deviations.
(J) Mutant frequency.
(vi) Discussion of the results.
(vii) Conclusion.
(g)
(1) Chu, E.H.Y. and Malling, H.V. Mammalian Cell Genetics. II. Chemical Induction of Specific Locus Mutations in Chinese Hamster Cells
(2) Liber, H.L. and Thilly, W.G. Mutation Assay at the Thymidine Kinase Locus in Diploid Human Lymphoblasts.
(3) Moore, M.M., Harrington-Brock, K., Doerr, C.L., and Dearfield, K.L. Differential Mutant Quantitation at the Mouse Lymphoma TK and CHO HGPRT Loci.
(4) Aaron, C.S. and Stankowski, Jr., L.F. Comparison of the AS52/XPRT and the CHO/HPRT Assays: Evaluation of Six Drug Candidates.
(5) Aaron, C.S., Bolcsfoldi, G., Glatt, H.R., Moore, M., Nishi, Y., Stankowski, L., Theiss, J., and Thompson, E. Mammalian Cell Gene Mutation Assays Working Group Report. Report of the International Workshop on Standardization of Genotoxicity Test Procedures.
(6) Scott, D., Galloway, S.M., Marshall, R.R., Ishidate, M., Brusick, D., Ashby, J., and Myhr, B.C. Genotoxicity Under Extreme Culture Conditions. A report from ICPEMC Task Group 9.
(7) Clive, D., McCuen, R., Spector, J.F.S., Piper, C., and Mavournin, K.H. Specific Gene Mutations in L5178Y Cells in Culture. A Report of the U.S. Environmental Protection Agency Gene-Tox Program.
(8) Li, A.P., Gupta, R.S., Heflich, R.H., and Wasson, J. S. A Review and Analysis of the Chinese Hamster Ovary/Hypoxanthine Guanine Phosphoribosyl Transferase System to Determine the Mutagenicity of Chemical Agents: A Report of Phase III of the U.S. Environmental Protection Agency Gene-Tox Program.
(9) Li, A.P., Carver, J.H., Choy, W.N., Hsie, A.W., Gupta, R.S., Loveday, K.S., O'Neill, J.P., Riddle, J.C., Stankowski, Jr., L.F., and Yang, L.L. A Guide for the Performance of the Chinese Hamster Ovary Cell/Hypoxanthine-Guanine Phosphoribosyl Transferase Gene Mutation Assay.
(10) Liber, H.L., Yandell, D.W., and Little, J.B. A Comparison of Mutation
(11) Stankowski, L.F. Jr., Tindall, K.R., and Hsie, A.W. Quantitative and Molecular Analyses of Ethyl Methanesulfonate- and ICR 191-Induced Molecular Analyses of Ethyl Methanesulfonate- and ICR 191-Induced Mutation in AS52 Cells.
(12) Turner, N.T., Batson, A.G., and Clive, D. Eds. Kilbey, B.J. et al. Procedures for the L5178Y/TK
(13) Arlett, C.F., Smith, D.M., Clarke, G.M., Green, M.H.L., Cole, J., McGregor, D.B., and Asquith, J.C. Ed. Kirkland, D.J. Mammalian Cell Gene Mutation Assays Based Upon Colony Formation.
(14) Abbondandolo, A., Bonatti, S., Corti, G., Fiorio, R., Loprieno, N., and Mazzaccaro, A. Induction of 6-Thioguanine-Resistant Mutants in V79 Chinese Hamster Cells by Mouse-Liver Microsome-Activated Dimethylnitrosamine.
(15) Ames, B.N., McCann, J., and Yamasaki, E. Methods for Detecting Carcinogens and Mutagens with the Salmonella/Mammalian-Microsome Mutagenicity Test.
(16) Clive, D., Johnson, K.O., Spector, J.F.S., Batson, A.G., and Brown M.M.M. Validation and Characterization of the L5178Y/TK
(17) Maron, D.M. and Ames, B.N. Revised Methods for the Salmonella Mutagenicity Test.
(18) Elliott, B.M., Combes, R.D., Elcombe, C.R., Gatehouse, D.G., Gibson, G.G., Mackay, J.M., and Wolf, R.C. Alternatives to Aroclor 1254-Induced S9 in
(19) Matsushima, T., Sawamura, M., Hara, K., and Sugimura, T. A Safe Substitute for Polychlorinated Biphenyls as an Inducer of Metabolic Activation Systems. (Eds.) de Serres, F.J., Fouts, J.R., Bend, J.R., and Philpot, R.M.
(20) Krahn, D.F., Barsky, F.C., and McCooey, K.T. Eds. Tice, R.R., Costa, D.L., and Schaich, K.M. CHO/HGPRT Mutation Assay: Evaluation of Gases and Volatile Liquids.
(21) Zamora, P.O., Benson, J.M., Li, A.P., and Brooks, A.L. Evaluation of an Exposure System Using Cells Grown on Collagen Gels for Detecting Highly Volatile Mutagens in the CHO/HGPRT Mutation Assay.
(22) Applegate, M.L., Moore, M.M., Broder, C.B., Burrell, A., and Hozier, J.C. Molecular Dissection of Mutations at the Heterozygous Thymidine Kinase Locus in Mouse Lymphoma Cells. Proc. National Academy Science (USA, 1990) 87, 51-55.
(23) Moore, M.M., Clive, D., Hozier, J.C., Howard, B.E., Batson, A.G., Turner, N.T., and Sawyer, J. Analysis of Trifluorothymidine-Resistant (TFT
(24) Yandell, D.W., Dryja, T.P., and Little J.B. Molecular Genetic Analysis of Recessive Mutations at a Heterozygous Autosomal Locus in Human Cells.
(25) Moore, M.M. and Doerr, C.L. Comparison of Chromosome Aberration Frequency and Small-Colony TK-Deficient Mutant Frequency in L5178Y/TK
(a)
(2)
(b)
(2) The
(c)
(d)
(2) This test is used to screen for possible mammalian mutagens and carcinogens. Many compounds that are positive in this test are mammalian carcinogens; however, there is not a perfect correlation between this test and carcinogenicity. Correlation is dependent on chemical class and there is increasing evidence that there are carcinogens that are not detected by this test because they appear to act through mechanisms other than direct DNA damage.
(e)
(f)
(ii)
(iii)
(B)
(iv)
(v)
(2)
(ii)
(B) Cytotoxicity should be determined with and without metabolic activation in the main experiment using an appropriate indication of cell integrity and growth, such as degree of confluency, viable cell counts, or mitotic index. It may be useful to determine cytotoxicity and solubility in a preliminary experiment.
(C) At least three analyzable concentrations should be used. Where cytotoxicity occurs, these concentrations should cover a range from the maximum to little or no toxicity; this will usually mean that the concentrations should be separated by no more than a factor between 2 and √10. At the time of harvesting, the highest concentration should show a significant reduction in degree of confluency, cell count or mitotic index, (all greater than 50%). The mitotic index is only an indirect measure of cytotoxic/cytostatic effects and depends on the time after treatment. However, the mitotic index is acceptable for suspension cultures in which other toxicity measurements may be cumbersome and impractical. Information on cell-cycle kinetics, such as average generation time (AGT), could be used as supplementary information. AGT, however, is an overall average that does not always reveal the existence of delayed subpopulations, and even slight increases in average generation time can be associated with very substantial delay in the time of optimal yield of aberrations. For relatively non-cytotoxic compounds the maximum concentration should be 5 μg/ml, 5mg/ml, or 0.01M, whichever is the lowest.
(D) For relatively insoluble substances that are not toxic at concentrations lower than the insoluble concentration, the highest dose used should be a concentration above the limit of solubility in the final culture medium at the end of the treatment period. In some cases (e.g., when toxicity occurs only at higher than the lowest insoluble concentration) it is advisable to test at more than one concentration with visible precipitation. It may be useful to assess solubility at the beginning and the end of the treatment, as solubility can change during the course of exposure in the test system due to presence of cells, S9, serum etc. Insolubility can be detected by using the unaided eye. The precipitate should not interfere with the scoring.
(iii)
(B) Positive controls must employ a known clastogen at exposure levels expected to give a reproducible and detectable increase over background which demonstrates the sensitivity of the test system. Positive control concentrations should be chosen so that the effects are clear but do not immediately reveal the identity of the coded slides to the reader. Examples of positive-control substances include:
(C) Other appropriate positive control substances may be used. The use of chemical class-related positive-control chemicals may be considered, when available.
(D) Negative controls, consisting of solvent or vehicle alone in the treatment medium, and treated in the same way as the treatment cultures, must be included for every harvest time. In addition, untreated controls should also be used unless there are historical-control data demonstrating that no deleterious or mutagenic effects are induced by the chosen solvent.
(g)
(ii) Duplicate cultures must be used at each concentration, and are strongly recommended for negative/solvent control cultures. Where minimal variation between duplicate cultures can be demonstrated (the test techniques described in the references under paragraphs (i)(13) and (i)(14) of this section
(iii) Gaseous or volatile substances should be tested by appropriate methods, such as in sealed culture vessels (the test techniques described in the references under paragraphs (i)(15) and (i)(16) of this section may be used).
(2)
(3)
(4)
(ii) Though the purpose of the test is to detect structural chromosome aberrations, it is important to record polyploidy and endoreduplication when these events are seen.
(h)
(ii) Concurrent measures of cytotoxicity for all treated and negative control cultures in the main aberration experiment(s) should also be recorded.
(iii) Individual culture data should be provided. Additionally, all data should be summarized in tabular form.
(iv) There is no requirement for verification of a clear positive response. Equivocal results should be clarified by further testing preferably using modification of experimental conditions. The need to confirm negative results has been discussed in paragraph (g)(2) of this section. Modification of study parameters to extend the range of conditions assessed should be considered in follow-up experiments. Study parameters that might be modified include the concentration spacing and the metabolic activation conditions.
(2)
(ii) An increase in the number of polyploid cells may indicate that the test substance has the potential to inhibit mitotic processes and to induce numerical chromosome aberrations. An increase in the number of cells with
(iii) A test substance for which the results do not meet the criteria in paragraphs (h)(2)(i) and (h)(2)(ii) of this section is considered nonmutagenic in this system.
(iv) Although most experiments will give clearly positive or negative results, in rare cases the data set will preclude making a definite judgement about the activity of the test substance. Results may remain equivocal or questionable regardless of the number of times the experiment is repeated.
(v) Positive results from the
(3)
(i) Test substance.
(A) Identification data and CAS no., if known.
(B) Physical nature and purity.
(C) Physicochemical properties relevant to the conduct of the study.
(D) Stability of the test substance, if known.
(ii) Solvent/vehicle.
(A) Justification for choice of solvent/vehicle.
(B) Solubility and stability of the test substance in solvent/vehicle, if known.
(iii) Cells.
(A) Type and source of cells.
(B) Karyotype features and suitability of the cell type used.
(C) Absence of
(D) Information on cell-cycle length.
(E) Sex of blood donors, whole blood or separated lymphocytes, mitogen used.
(F) Number of passages, if applicable.
(G) Methods for maintenance of cell cultures if applicable.
(H) Modal number of chromosomes.
(iv) Test conditions.
(A) Identity of metaphase arresting substance, its concentration and duration of cell exposure.
(B) Rationale for selection of concentrations and number of cultures including, e.g., cytotoxicity data and solubility limitations, if available.
(C) Composition of media, CO
(D) Concentration of test substance.
(E) Volume of vehicle and test substance added.
(F) Incubation temperature.
(G) Incubation time.
(H) Duration of treatment.
(I) Cell density at seeding, if appropriate.
(J) Type and composition of metabolic activation system, including acceptability criteria.
(K) Positive and negative controls.
(L) Methods of slide preparation.
(M) Criteria for scoring aberrations.
(N) Number of metaphases analyzed.
(O) Methods for the measurements of toxicity.
(P) Criteria for considering studies as positive, negative or equivocal.
(v) Results.
(A) Signs of toxicity, e.g., degree of confluency, cell-cycle data, cell counts, mitotic index.
(B) Signs of precipitation.
(C) Data on pH and osmolality of the treatment medium, if determined.
(D) Definition for aberrations, including gaps.
(E) Number of cells with chromosome aberrations and type of chromosome aberrations given separately for each treated and control culture.
(F) Changes in ploidy if seen.
(G) Dose-response relationship, where possible.
(H) Statistical analyses, if any.
(I) Concurrent negative (solvent/vehicle) and positive control data.
(J) Historical negative (solvent/vehicle) and positive control data, with ranges, means and standard deviations.
(vi) Discussion of the results.
(vii) Conclusion.
(i)
(1) Evans, H.J. Cytological Methods for Detecting Chemical Mutagens. Chemical Mutagens, Principles and Methods for their Detection, Vol. 4, Hollaender, A. Ed. Plenum Press, New York and London, pp. 1-29 (1976).
(2) Ishidate, M. Jr. and Sofuni, T. The
(3) Galloway, S.M. et al. Chromosome aberration and sister chromatid exchanges in Chinese hamster ovary cells: Evaluation of 108 chemicals.
(4) Scott, D. et al.. Genotoxicity under Extreme Culture Conditions. A report from ICPEMC Task Group 9.
(5) Morita, T. et al. Clastogenicity of Low pH toVarious Cultured Mammalian Cells.
(6) Ames, B.N., McCann, J. and Yamasaki, E. Methods for Detecting Carcinogens and Mutagens with the Salmonella/Mammalian Microsome Mutagenicity Test.
(7) Maron, D.M. and Ames, B.N. Revised Methods for the Salmonella Mutagenicity Test.
(8) Natarajan, A.T. et al. Cytogenetic Effects of Mutagens/Carcinogens after Activation in a Microsomal System In Vitro, I. Induction of Chromosome Aberrations and Sister Chromatid Exchanges by Diethylnitrosamine (DEN) and Dimethylnitrosamine (DMN) in CHO Cells in the Presence of Rat-Liver Microsomes.
(9) Matsuoka, A., Hayashi, M. and Ishidate, M., Jr. Chromosomal Aberration Tests on 29 Chemicals Combined with S9 Mix In Vitro.
(10) Elliot, B.M. et al. Report of UK Environmental Mutagen Society Working Party. Alternatives to Aroclor 1254-induced S9 in In Vitro Genotoxicity Assays.
(11) Matsushima, T. et al. A Safe Substitute for Polychlorinated Biphenyls as an Inducer of Metabolic Activation Systems. de Serres, F.J., Fouts, J.R., Bend, J.R. and Philpot, R.M. Eds. In Vitro Metabolic Activation in Mutagenesis Testing, Elsevier, North-Holland, pp. 85-88 (1976).
(12) Galloway, S.M. et al. Report from Working Group on In Vitro Tests for Chromosomal Aberrations.
(13) Richardson, C. et al. Analysis of Data from In Vitro Cytogenetic Assays. Statistical Evaluation of Mutagenicity Test Data. Kirkland, D.J., Ed. Cambridge University Press, Cambridge, pp. 141-154 (1989).
(14) Soper, K.A. and Galloway S.M. Replicate Flasks are not Necessary for In Vitro Chromosome Aberration Assays in CHO Cells.
(15) Krahn, D.F., Barsky, F.C. and McCooey, K.T. CHO/HGPRT Mutation Assay: Evaluation of Gases and Volatile Liquids. Tice, R.R., Costa, D.L., Schaich, K.M. Eds. Genotoxic Effects of Airborne Agents. New York, Plenum, pp. 91-103 (1982).
(16) Zamora, P.O. et al. Evaluation of an Exposure System Using Cells Grown on Collagen Gels for Detecting Highly Volatile Mutagens in the CHO/HGPRT Mutation Assay.
(17) Locke-Huhle, C. Endoreduplication in Chinese hamster cells during alpha-radiation induced G2 arrest.
(18) Huang, Y., Change, C. and Trosko, J.E. Aphidicolin—induced endoreduplication in Chinese hamster cells.
(a)
(b)
(c)
(d)
(2) This chromosome aberration test is especially relevant to assessing mutagenic hazard in that it allows consideration of factors of
(3) If there is evidence that the test substance, or a reactive metabolite, will not reach the target tissue, it is not appropriate to use this test.
(e)
(2)
(B)
(C)
(D)
(ii)
(B)
(
(
(3)
(ii)
(B) Samples shall be taken at two separate times following treatment on one day. For rodents, the first sampling interval is 1.5 normal cell cycle length (the latter being normally 12-18 hr) following treatment. Since the time required for uptake and metabolism of the test substance as well as its
(C) Prior to sacrifice, animals shall be injected intraperitoneally with an appropriate dose of a metaphase arresting agent (e.g. Colcemid® or colchicine). Animals are sampled at an appropriate interval thereafter. For mice this interval is approximately 3-5 hrs; for Chinese hamsters this interval is approximately 4-5 hrs. Cells shall be harvested from the bone marrow and analyzed from chromosome aberrations.
(iii)
(iv)
(v)
(vi)
(vii)
(B) At least 100 cells should be analyzed for each animal. This number could be reduced when high numbers of aberrations are observed. All slides, including those of positive and negative controls, shall be independently coded before microscopic analysis. Since slide preparation procedures often result in the breakage of a proportion of metaphases with loss of chromosomes, the cells scored should therefore contain a number of centromeres equal to the number 2n ± 2.
(f)
(2)
(ii) An increase in polyploidy may indicate that the test substance has the potential to induce numerical chromosome aberrations. An increase in endoreduplication may indicate that the test substance has the potential to inhibit cell cycle progression. This phenomenon is described in the references under paragraphs (g)(7) and (g)(8) of this section.
(iii) A test substance for which the results do not meet the criteria described in paragraph (f)(2)(i) of this section is considered non-mutagenic in this test.
(iv) Although most experiments will give clearly positive or negative results, in rare cases the data set will preclude making a definite judgment about the activity of the test substance. Results may remain equivocal or questionable regardless of the number of experiments performed.
(v) Positive results from the
(vi) The likelihood that the test substance or its metabolites reach the general circulation or specifically the target tissue (e.g., systemic toxicity) should be discussed.
(3)
(i) Test substance:
(A) Identification data and CAS No., if known.
(B) Physical nature and purity.
(C) Physicochemical properties relevant to the conduct of the study.
(D) Stability of the test substance, if known.
(ii) Solvent/vehicle:
(A) Justification for choice of vehicle.
(B) Solubility and stability of the test substance in solvent/vehicle, if known.
(iii) Test animals:
(A) Species/strain used.
(B) Number, age and sex of animals.
(C) Source, housing conditions, diet, etc.
(D) Individual weight of the animals at the start of the test, including body weight range, mean and standard deviation for each group.
(iv) Test conditions:
(A) Positive and negative (vehicle/solvent) controls.
(B) Data from range-finding study, if conducted.
(C) Rationale for dose level selection.
(D) Details of test substance preparation.
(E) Details of the administration of the test substance.
(F) Rationale for route of administration.
(G) Methods for verifying that the test substance reached the general circulation or target tissue, if applicable.
(H) Conversion from diet/drinking water test substance concentration parts per million (ppm) to the actual dose (mg/kg body weight/day), if applicable.
(I) Details of food and water quality.
(J) Detailed description of treatment and sampling schedules.
(K) Methods for measurement of toxicity.
(L) Identity of metaphase arresting substance, its concentration and duration of treatment.
(M) Methods of slide preparation.
(N) Criteria for scoring aberrations.
(O) Number of cells analyzed per animal.
(P) Criteria for considering studies as positive, negative or equivocal.
(v) Results:
(A) Signs of toxicity.
(B) Mitotic index.
(C) Type and number of aberrations, given separately for each animal.
(D) Total number of aberrations per group with means and standard deviations.
(E) Number of cells with aberrations per group with means and standard deviations.
(F) Changes in ploidy, if seen.
(G) Dose-response relationship, where possible.
(H) Statistical analyses, if any.
(I) Concurrent negative control data.
(J) Historical negative control data with ranges, means and standard deviations.
(K) Concurrent positive control data.
(vi) Discussion of the results.
(vii) Conclusion.
(g)
(1) Adler, I.D. Eds. S. Venitt and J.M. Parry. Cytogenetic Tests in Mammals.
(2) Preston, R.J., Dean, B.J., Galloway, S., Holden, H., McFee, A.F., and Shelby, M. Mammalian
(3) Richold, M., Chandley, A., Ashby, J., Gatehouse, D.G., Bootman, J., and Henderson, L. Ed. D.J. Kirkland.
(4) Tice, R.R., Hayashi, M., MacGregor, J.T., Anderson, D., Blakey, D.H., Holden, H.E., Kirsch-Volders, M., Oleson Jr., F.B., Pacchierotti, F., Preston, R.J., Romagna, F., Shimada, H., Sutou, S., and Vannier, B. Report from the Working Group on the
(5) Fielder, R.J., Allen, J.A., Boobis, A.R., Botham, P.A., Doe, J., Esdaile, D.J., Gatehouse, D.G., Hodson-Walker, G., Morton, D.B., Kirkland, D. J., and Richold, M. Report of British Toxicology Society/UK Environmental Mutagen Society Working Group: Dose Setting in
(6) Lovell, D.P., Anderson, D., Albanese, R., Amphlett, G.E., Clare, G., Ferguson, R., Richold, M., Papworth, D.G., and Savage, J.R.K. Ed. Kirkland,D. J. Statistical Analysis of
(7) Locke-Huhle, C. Endoreduplication in Chinese Hamster Cells During Alpha-Radiation Induced G2 Arrest.
(8) Huang, Y., Change, C., and Trosko, J. E. Aphidicolin-Induced Endoreduplication in Chinese Hamster Cells.
(a)
(1) The mammalian erythrocyte micronucleus test is used for the detection of damage induced by the test substance to the chromosomes or the mitotic apparatus of erythroblasts by analysis of erythrocytes as sampled in bone marrow and/or peripheral blood cells of animals, usually rodents.
(2) The purpose of the micronucleus test is to identify substances that cause cytogenetic damage which results in the formation of micronuclei containing lagging chromosome fragments or whole chromosomes.
(3) When a bone marrow erythroblast develops into a polychromatic erythrocyte, the main nucleus is extruded; any micronucleus that has been formed may remain behind in the otherwise anucleated cytoplasm. Visualization of micronuclei is facilitated in these cells because they lack a main nucleus. An increase in the frequency of micronucleated polychromatic erythrocytes in treated animals is an indication of induced chromosome damage.
(b)
(c)
(d)
(2) If there is evidence that the test substance, or a reactive metabolite, will not reach the target tissue, it is not appropriate to use this test.
(e)
(2)
(B)
(C)
(D)
(ii)
(B)
(
(
(
(3)
(ii)
(B) The test may be performed in two ways:
(
(
(C) Other sampling times may be used in addition, when relevant.
(iii)
(iv)
(v)
(vi)
(vii)
(f)
(2)
(ii) A test substance for which the results do not meet the criteria in paragraph (f)(2)(i) of this section is considered non-mutagenic in this test.
(iii) Although most experiments will give clearly positive or negative results, in rare cases the data set will preclude making a definite judgement about the activity of the test substance. Results, may remain equivocal or questionable regardless of the number of times the experiment is repeated. Positive results in the micronucleus test indicate that a substance induces micronuclei which are the result of chromosomal damage or damage to the mitotic apparatus in the erythroblasts of the test species. Negative results indicate that, under the test conditions, the test substance does not produce micronuclei in the immature erythrocytes of the test species.
(iv) The likelihood that the test substance or its metabolites reach the general circulation or specifically the target tissue (e.g. systemic toxicity) should be discussed.
(3)
(i) Test substance:
(A) Identification data and CAS no., if known.
(B) Physical nature and purity.
(C) Physiochemical properties relevant to the conduct of the study.
(D) Stability of the test substance, if known.
(ii) Solvent/vehicle:
(A) Justification for choice of vehicle.
(B) Solubility and stability of the test substance in the solvent/vehicle, if known.
(iii) Test animals:
(A) Species/strain used.
(B) Number, age, and sex of animals.
(C) Source, housing conditions, diet, etc.
(D) Individual weight of the animals at the start of the test, including body weight range, mean and standard deviation for each group.
(iv) Test conditions:
(A) Positive and negative (vehicle/solvent) control data.
(B) Data from range-finding study, if conducted.
(C) Rationale for dose level selection.
(D) Details of test substance preparation.
(E) Details of the administration of the test substance.
(F) Rationale for route of administration.
(G) Methods for verifying that the test substance reached the general circulation or target tissue, if applicable.
(H) Conversion from diet/drinking water test substance concentration parts per million (ppm) to the actual dose (mg/kg body weight/day), if applicable.
(I) Details of food and water quality.
(J) Detailed description of treatment and sampling schedules.
(K) Methods of slide preparation.
(L) Methods for measurement of toxicity.
(M) Criteria for scoring micronucleated immature erythrocytes.
(N) Number of cells analyzed per animal.
(O) Criteria for considering studies as positive, negative or equivocal.
(v) Results:
(A) Signs of toxicity.
(B) Proportion of immature erythrocytes among total erythrocytes.
(C) Number of micronucleated immature erythrocytes, given separately for each animal.
(D) Mean =± standard deviation of micronucleated immature erythrocytes per group.
(E) Dose-response relationship, where possible.
(F) Statistical analyses and method applied.
(G) Concurrent and historical negative control data.
(H) Concurrent positive control data.
(vi) Discussion of the results.
(vii) Conclusion.
(g)
(1) Heddle, J.A. A Rapid
(2) Schmid, W. The Micronucleus Test.
(3) Mavournin, K.H., Blakey, D.H., Cimino, M.C., Salamone, M.F., and Heddle, J.A. The
(4) Hayashi, M., Morita, T., Kodama, Y., Sofuni, T., and Ishidate, Jr., M. The Micronucleus Assay with Mouse Peripheral Blood Reticulocytes Using Acridine Orange-Coated Slides.
(5) The Collaborative Study Group for the Micronucleus Test (1992). Micronucleus Test with Mouse Peripheral Blood Erythrocytes by Acridine Orange Supravital Staining: The Summary Report of the 5th Collaborative Study by CSGMT/JEMS. MMS.
(6) The Collaborative Study Group for the Micronucleus Test (CSGMT/JEMMS.MMS, The Mammalian Mutagenesis Study Group of the Environmental Mutagen Society of Japan) Protocol recommended for the short-term mouse peripheral blood micronucleus test.
(7) Hayashi, M., Tice, R.R., MacGregor, J.T., Anderson, D., Blakey, D.H., Kirsch-Volders, M., Oleson, Jr. F.B., Pacchierotti, F., Romagna, F., Shimada, H., Sutou, S., and Vannier, B.
(8) Higashikuni, N. and Sutou, S. An optimal, generalized sampling time of 30
(9) Fielder, R.J., Allen, J.A., Boobis, A.R., Botham, P.A., Doe, J., Esdaile, D.J., Gatehouse, D.G., Hodson-Walker, G., Morton, D.B., Kirkland, D. J., and Richold, M. Report of British Toxicology Society/UK Environmental Mutagen Society Working Group: Dose Setting in
(10) Hayashi, M., Sofuni, T., and Ishidate, Jr., M. An Application of Acridine Orange Fluorescent Staining to the Micronucleus Test.
(11) MacGregor, J.T., Wehr, C.M., and Langlois, R.G. A Simple Fluorescent Staining Procedure for Micronuclei and RNA in Erythrocytes Using Hoechst 33258 and Pyronin Y.
(12) Romagna, F. and Staniforth, C.D. The automated bone marrow micronucleus test.
(13) Gollapudi, B. and McFadden, L.G. Sample size for the estimation of polychromatic to normochromatic eruthrocyte ratio in the bone marrow micronucleus test.
(14) Richold, M., Ashby, J., Bootman, J., Chandley, A., Gatehouse, D.G., and Henderson, L. Ed. Kirkland, D.J.
(15) Lovell, D.P., Anderson, D., Albanese, R., Amphlett, G.E., Clare, G., Ferguson, R., Richold, M., Papworth, D.G., and Savage, J.R.K. Ed. D.J. Kirkland. Statistical Analysis of
(16) Heddle, J.A., Salamone, M.F., Hite, M., Kirkhart, B., Mavournin, K., MacGregor, J.G., and Newell, G.W. The
(17) MacGregor, J.T., Heddle, J.A., Hite, M., Margolin, G.H., Ramel C., Salamone, M.F., Tice, R.R., and Wild, D. Guidelines for the Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes.
(18) MacGregor, J.T., Wehr, C.M., Henika, P.R., and Shelby, M.E. (1990). The
(19) MacGregor, J.T., Schlegel, R. Choy, W.N., and Wehr, C.M. Eds. Hayes, A.W., Schnell, R.C., and Miya, T.S. Micronuclei in Circulating Erythrocytes: A Rapid Screen for Chromosomal Damage During Routine Toxicity Testing in Mice.
(a)
(b)
(c)
(d)
(e)
(ii)
(iii)
(2)
(3)
(ii) Positive control data from the laboratory performing the testing shall provide evidence of the ability of the observational methods used to detect major neurotoxic endpoints including limb weakness or paralysis, tremor, and autonomic signs. Positive control data are also required to demonstrate the sensitivity and reliability of the activity-measuring device and testing procedures. These data should demonstrate the ability to detect chemically induced increases and decreases in activity. Positive control groups exhibiting central nervous system pathology and peripheral nervous system pathology are also required. Separate groups for peripheral and central neuropathology are acceptable (e.g. acrylamide and trimethyl tin). Permanently injurious substances need not be used for the behavioral tests. Historical data may be used if the essential aspects of the experimental procedure remain the same. Periodic updating of positive control data is recommended. New positive control data should also be collected when personnel or some other critical element in the testing laboratory has changed.
(4)
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(iii)
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(f)
(1)
(i) A detailed description of the procedures used to standardize observations, including the arena and scoring criteria.
(ii) Positive control data from the laboratory performing the test that demonstrate the sensitivity of the procedures being used. Historical data may be used if all essential aspects of the experimental protocol are the same. Historical control data can be critical in the interpretation of study findings. The Agency encourages submission of such data to facilitate the rapid and complete review of the significance of effects seen.
(2)
(i) In tabular form, data for each animal shall be provided showing:
(A) Its identification number.
(B) Its body weight and score on each sign at each observation time, the time and cause of death (if appropriate), total session activity counts, and intrasession subtotals for each day measured.
(ii) Summary data for each group must include:
(A) The number of animals at the start of the test.
(B) The number of animals showing each observation score at each observation time.
(C) The mean and standard deviation for each continuous endpoint at each observation time.
(D) Results of statistical analyses for each measure, where appropriate.
(iii) All neuropathological observations shall be recorded and arranged by test groups. This data may be presented in the following recommended format:
(A)
(B)
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(3)
(g)
(1) Bennet, H.S.
(2) Di Sant Agnese, P.A. and De Mesy Jensen, K. Dibasic staining of large epoxy sections and application to surgical pathology.
(3) Edwards, P.M. and Parker, V.H. A simple, sensitive and objective method for early assessment of acrylamide neuropathy in rats.
(4) Finger, F.W. Ed. Myers, R.D. Measuring Behavioral Activity. Vol. 2.
(5) Gad, S. A neuromuscular screen for use in industrial toxicology.
(6) Irwin, S. Comprehensive observational assessment: Ia. A systematic quantitative procedure for assessing the behavioral physiological state of the mouse.
(7) Kinnard, E.J. and Watzman, N. Techniques utilized in the evaluation of psychotropic drugs on animals activity.
(8) Meyer, O.A.
(9) Moser V.C.
(10) O'Callaghan, J.P. Quantification of glial fibrillary acidic protein: Comparison of slot-immunobinding assays with a novel sandwich ELISA.
(11) Pender, M.P. A simple method for high resolution light microscopy of nervous tissue.
(12) Reiter, L.W. Use of activity measures in behavioral toxicology.
(13) Reiter, L.W. and MacPhail, R.C. Motor activity: A survey of methods with potential use in toxicity testing.
(14) Robbins, T.W. Eds. Iversen, L.L., Iverson, D.S., and Snyder, S.H. A critique of the methods available for the measurement of spontaneous motor activity. Vol 7.
(a)
(2)
(b)
(c)
(d)
(ii)
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(B) On postnatal day 4, the size of each litter should be adjusted by eliminating extra pups by random selection to yield, as nearly as possible, four male and four females per litter. Whenever the number of pups of either sex prevents having four of each sex per litter, partial adjustment (for example, five males and three females) is permitted. Testing is not appropriate for litters of less than seven pups. Elimination of runts only is not appropriate. Individual pups should be identified uniquely after standardization of litters. A method that may be used for identification can be found under paragraph (f)(1) of this section.
(v)
(2)
(3)
(ii) If the test substance has been shown to be developmentally toxic either in a standard developmental toxicity study or in a pilot study, the highest dose level must be the maximum dose which will not induce in utero or neonatal death or malformations sufficient to preclude a meaningful evaluation of neurotoxicity.
(iii) If a standard developmental toxicity study has not been conducted, the highest dose level, unless limited by the physicochemical nature or biological properties of the substance, must induce some overt maternal toxicity, but must not result in a reduction in weight gain exceeding 20 percent during gestation and lactation.
(iv) The lowest dose should not produce any grossly observable evidence of either maternal or developmental neurotoxicity.
(v) The intermediate doses must be equally spaced between the highest and lowest doses used.
(4)
(5)
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(ii) Ten dams per group must be observed outside the home cage at least twice during the gestational dosing period (days 6-21) and twice during the lactational dosing period (days 1-10) for signs of toxicity. The animals must be observed by trained technicians who are unaware of the animals' treatment, using standardized procedures to maximize interobserver reliability. Where possible, it is advisable that the same observer be used to evaluate the animals in a given study. If this is not possible, some demonstration of interobserver reliability is required.
(iii) During the treatment and observation periods under paragraph (d)(6)(ii) of this section, observations must include:
(A) Assessment of signs of autonomic function, including but not limited to:
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(B) Description, incidence, and severity of any convulsions, tremors, or abnormal movements.
(C) Description and incidence of posture and gait abnormalities.
(D) Description and incidence of any unusual or abnormal behaviors, excessive or repetitive actions (stereotypies), emaciation, dehydration, hypotonia or hypertonia, altered fur appearance, red or crusty deposits around the eyes, nose, or mouth, and any other observations that may facilitate interpretation of the data.
(iv) Signs of toxicity must be recorded as they are observed, including the time of onset, degree, and duration.
(v) Animals must be weighed at least weekly and on the day of delivery and postnatal days 11 and 21 (weaning) and such weights must be recorded.
(vi) The day of delivery of litters must be recorded and considered as postnatal day 0.
(7)
(B) A total of 10 male offspring and 10 female offspring per dose group must be examined outside the cage for signs of toxicity on days 4, 11, 21, 35, 45, and 60. The offspring must be observed by trained technicians, who are unaware of the treatment being used, using standardized procedures to maximize interobserver reliability. Where possible, it is advisable that the same observer be used to evaluate the animals in a given study. If this is not possible, some demonstration of interobserver reliability is required. At a minimum, the end points outlined in paragraph (d)(6)(iii) of this section must be monitored as appropriate for the developmental stage being observed.
(C) Any gross signs of toxicity in the offspring must be recorded as they are observed, including the time of onset, degree, and duration.
(ii)
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(e)
(1)
(i) A detailed description of the procedures used to standardize observations and procedures as well as operational definitions for scoring observations.
(ii) Positive control data from the laboratory performing the test that demonstrate the sensitivity of the procedures being used. These data do not have to be from studies using prenatal exposures. However, the laboratory must demonstrate competence in evaluation of effects in neonatal animals perinatally exposed to chemicals and establish test norms for the appropriate age group.
(iii) Procedures for calibrating and ensuring the equivalence of devices and the balancing of treatment groups in testing procedures.
(iv) A short justification explaining any decisions involving professional judgement.
(2)
(i) In tabular form, data for each animal must be provided showing:
(A) Its identification number and the litter from which it came.
(B) Its body weight and score on each developmental landmark at each observation time.
(C) Total session activity counts and intrasession subtotals on each day measured.
(D) Auditory startle response amplitude per session and intrasession amplitudes on each daymeasured.
(E) Appropriate data for each repeated trial (or session) showing acquisition and retention scores on the tests of learning and memory on each day measured.
(F) Time and cause of death (if appropriate); any neurological signs observed; a list of structures examined as well as the locations, nature, frequency, and extent of lesions; and brain weights.
(ii) The following data should also be provided, as appropriate:
(A) Inclusion of photomicrographs demonstrating typical examples of the type and extent of the neuropathological alterations observed is recommended.
(B) Any diagnoses derived from neurological signs and lesions, including naturally occurring diseases or conditions, should also be recorded.
(iii) Summary data for each treatment and control group must include:
(A) The number of animals at the start of the test.
(B) The body weight of the dams during gestation and lactation.
(C) Litter size and mean weight at birth.
(D) The number of animals showing each abnormal sign at each observation time.
(E) The percentage of animals showing each abnormal sign at each observation time.
(F) The mean and standard deviation for each continuous endpoint at each observation time. These will include body weight, motor activity counts, auditory startle responses, performance in learning and memory tests, regional brain weights and whole brain weights (both absolute and relative).
(G) The number of animals in which any lesion was found.
(H) The number of animals affected by each different type of lesion, the location, frequency and average grade of each type of lesion for each animal.
(I) The values of all morphometric measurements made for each animal listed by treatment group.
(3)
(f)
(1) Adams, J., Buelke-Sam, J., Kimmel, C.A., Nelson, C.J., Reiter, L.W., Sobotka, T.J., Tilson, H.A., and Nelson, B.K. Collaborative behavioral teratolgy study: Protocol design and testing procedures.
(2) Bennett, H.S., Wyrick, A.D., Lee, S.W., and McNeil, J.H. Science and art in preparing tissues embedded in plastic for light microscopy, with special reference to glycol methacrylate, glass knives and simple stains.
(3) Bushnell, P.J. Effects of delay, intertrial interval, delay behavior and trimethyltin on spatial delayed response in rats.
(4) Campbell, B.A. and Haroutunian, V. Effects of age on long-term memory: Retention of fixed interval responding.
(5) Cory-Slechta, D.A., Weiss, B., and Cox, C. Delayed behavioral toxicity of lead with increasing exposure concentration.
(6) Di Sant Agnese, P. A. and De Mesy Jensen, K.L. Dibasic staining of large epoxy tissue sections and application to surgical pathology.
(7) U.S. Environmental Protection Agency. Neurotoxicity Screening Battery. In: Pesticide Assessment Guidelines, Subdivision F, Addendum 10. EPA 540/09-91-123. NTIS PB 91-154617 (1991).
(8) Friede, R. L.
(9) Green, R.J. and Stanton, M.E. Differential ontogeny of working memory and reference memory in the rat.
(10) Ison, J.R. Reflex modification as an objective test for sensory processing following toxicant exposure.
(11) Korenbrot, C.C., Huhtaniemi, I.T., and Weiner, R.I. Preputial separation as an external sign of pubertal development in the male rat.
(12) Krasnegor, N.A., Blass, E.M., Hofer, M.A., and Smotherman, W.P. (eds.)
(13) Kucharski, D. and Spear, N.E. Conditioning of aversion to an odor paired with peripheral shock in the developing rat.
(14) Luna, L. G. (editor).
(15) Miale, I. L. and Sidman, R.L. An autoradiographic analysis of histogenesis in the mouse cerebellum.
(16) Miller, D.B. and Eckerman, D.A. Learning and memory measures. In:
(17) Pender, M.P. A simple method for high resolution light microscopy of nervous tissue.
(18) Ralis, H.M., Beesley, R.A., and Ralis, Z.A.
(19) Rodier, P.M. and Gramann, W.J. Morphologic effects of interference with cell proliferation in the early fetal period.
(20) Spear, N.E. and Campbell, B.A. (eds.)
(21) Spencer, P.S., Bischoff, M.C., and Schaumburg, H.H. Neuropathological methods for the detection of neurotoxic disease. In:
(22) Suzuki, K. Special vulnerabilities of the developing nervous system to toxic substances. In:
(a)
(2) Metabolism data can also be used to assist in determining whether animal toxicity studies have adequately addressed any toxicity concerns arising from exposure to plant metabolites, and in the setting of tolerances, if any, for those metabolites in raw agricultural commodities.
(b)
(c)
(d)
(e)
(1)
(2)
(ii)
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(B) The label should follow the test compound and/or its major metabolites until excreted. The radiopurity of the radioactive test substance shall be the highest attainable for a particular test substance (ideally it should be greater than 95%) and reasonable effort should be made to identify impurities present at or above 2%. The purity, along with the identity of major impurities which have been identified, shall be reported. For other segments of the study, nonradioactive test substance may be used if it can be demonstrated that the analytical specificity and sensitivity of the method used with nonradioactive test substance is equal to or greater than that which could be obtained with the radiolabeled test substance. The radioactive and nonradioactive test substances shall be analyzed using an appropriate method to establish purity and identity. Additional guidance will be provided in chemical specific test rules to assist in the definition and specifications of test substances composed of mixtures and methods for determination of purity.
(ii)
(4)
(ii) The first tier data set is a definitive study by the appropriate route of exposure conducted in male rats to determine the routes and rate of excretion and to identify excreted metabolites. First tier data will also provide basic information for additional testing (Tier 2) if such testing is considered necessary. In the majority of cases, Tier 1 data are expected to satisfy regulatory requirements for biotransformation and pharmacokinetic data on test chemicals.
(iii) Second tier testing describes a variety of metabolism/kinetic experiments which address specific questions based on the existing toxicology data base and/or those results of Tier 1 testing impacting significantly on the risk assessment process. For conduct of these studies, individualized protocols may be necessary. Protocols for these studies, if required, can be developed as a cooperative effort between Agency and industry scientists.
(f)
(1)
(2)
(ii) For test substances of low toxicity a maximum dose of 1,000 mg/kg should be used; chemical-specific considerations may necessitate a higher maximum dose and will be addressed in specific test rules.
(3)
(B) If a pilot study has shown that no significant amount of radioactivity is excreted in expired air, then expired air need not be collected in the definitive study.
(C) Each animal must be placed in a separate metabolic unit for collection of excreta (urine, feces and expired air). At the end of each collection period, the metabolic units must be rinsed with appropriate solvent to ensure maximum recovery of radiolabel. Excreta collection must be terminated at 7 days, or after at least 90% of the administered dose has been recovered, whichever occurs first. The total quantities of radioactivity in urine must be determined at 6, 12, and 24 hours on day 1 of collection, and daily thereafter until study termination, unless pilot studies suggest alternate or additional time points for collection. The total quantities of radioactivity in feces should be determined on a daily basis beginning at 24 hours post-dose, and daily thereafter until study termination. The collection of CO
(ii)
(iii)
(g)
(1)
(ii) For the intravenous study, a single dose (not to exceed the oral dose used in Tier 1) of test chemical using an appropriate vehicle should be administered in a suitable volume (e.g., 1 mL/kg) at a suitable site to at least three male rats (both sexes might be used if warranted). The disposition of the test chemical should be monitored for oral dosing as outlined in paragraph (f)(3)(i) of this section. Metabolite identification will not be required for this study.
(iii) If a biliary excretion study is chosen the oral route of administration may be requested. In this study, the bile ducts of at least three male rats (or of both sexes, if warranted) should be appropriately cannulated and a single dose of the test chemical should be administered to these rats. Following administration of the test chemical, excretion of radioactivity in bile should be monitored as long as necessary to determine if a significant percentage of the administered dose is excreted via this route.
(2)
(ii) For this type of study, three rats per time point will be administered an appropriate oral dose of test chemical, and the time course of distribution monitored in selected tissues. Only one sex may be required, unless target organ toxicity is observed in sex-specific organs. Assessment of tissue distribution will be made using appropriate techniques for assessment of total amount distributed to tissue and for assessment of metabolite distribution.
(3)
(4)
(A) Available evidence indicates a relationship between induced metabolism and enhanced toxicity.
(B) The available toxicity data indicate a nonlinear relationship between dose and metabolism.
(C) The results of Tier 1 metabolite identification studies show identification of a potentially toxic metabolite.
(D) Induction can plausibly be invoked as a factor in such effects where status may depend on the level of inducible enzymes present. Several
(ii) [Reserved]
(iii) If toxicologically significant alterations in the metabolic profile of the test chemical are observed through either
(5)
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(A) Justification for modification of exposure conditions, if applicable.
(B) Justification for selection of dose levels for pharmacokinetic and metabolism studies.
(C) Description of pilot studies used in the experimental design of the pharmacokinetic and metabolism studies, if applicable.
(D) Quantity and percent recovery of radioactivity in urine, feces, and expired air, as appropriate. For dermal studies, include recovery data for treated skin, skin washes, and residual radioactivity in the covering apparatus and metabolic unit as well as results of the dermal washing study.
(E) Tissue distribution reported as percent of administered dose and microgram equivalents per gram of tissue.
(F) Material balance developed from each study involving the assay of body tissues and excreta.
(G) Plasma levels and pharmacokinetic parameters after administration by the relevant routes of exposure.
(H) Rate and extent of absorption of the test substance after administration by the relevant routes of exposure.
(I) Quantities of the test substance and metabolites (reported as percent of the administered dose) collected in excreta.
(J) Individual animal data.
(v)
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(B) The author(s) should be able to derive a concise conclusion that can be supported by the findings of the study.
(vi)
(i)
(ii)
(B) Unless precluded by corrosiveness, the test substance must be applied and kept on the skin for a minimum of 6 hours. At the time of removal of the covering, the treated area must be washed following the procedure as outlined in the dermal washing study. Both the covering and the washes must be analyzed for residual test substance. At the termination of the studies, each animal must be sacrificed and the treated skin removed. An appropriate section of treated skin must be analyzed to determine residual radioactivity.
(2)
(a)
(b)
(c)
(d)
(2) In the event the test substance produces significant suppression of the anti-SRBC response, expression of phenotypic markers for major lymphocyte populations (total T and total B), and T cell subpopulations (T helpers (CD
(e)
(f)
(ii)
(B) Dosing shall begin when the test animals are between 6 and 8 weeks old.
(iii)
(iv)
(B) To avoid bias, the use of adequate randomization procedures for the proper allocation of animals to test and control groups is required.
(C) Each animal shall be assigned a unique identification number. Dead animals, their preserved organs and tissues, and microscopic slides shall be identified by reference to the animal's unique number.
(v)
(B) The temperature of the experimental animal rooms shall be at 22 ± 3 °C.
(C) The relative humidity of the experimental animal rooms shall be between 30 and 70%.
(D) Where lighting is artificial, the sequence shall be 12 hrs light, 12 hrs dark.
(E) Control and test animals shall be maintained on the same type of bedding and receive feed from the same lot. The feed shall be analyzed to assure adequacy of nutritional requirements of the species tested and for impurities that might influence the outcome of the test. Rodents shall be fed and watered
(F) The study shall not be initiated until the animals have been allowed an adequate period of acclimatization or quarantine to environmental conditions. The period of acclimatization shall be at least 1 week in duration.
(2)
(ii) One lot of the test substance shall be used, if possible, throughout the duration of the study, and the research sample shall be stored under conditions that maintain its purity and stability. Prior to the initiation of the study, there shall be a characterization of the test substance, including the purity of the test compound and if technically feasible, the name and quantities of any known contaminants and impurities.
(iii) If the test or positive control substance is to be incorporated into feed or another vehicle, the period during which the test substance is stable in such a mixture shall be determined prior to the initiation of the study. Its homogeneity and concentration shall also be determined prior to the initiation of the study and periodically during the study. Statistically randomized samples of the mixture shall be analyzed to ensure that proper mixing, formulation, and storage procedures are being followed, and that the appropriate concentration of the test or control substance is contained in the mixture.
(3)
(ii) A separate untreated control group is required if the toxicity of the vehicle is unknown.
(iii) A positive control group with a known immunosuppressant (e.g., cyclophosphamide) shall be included in the study. A group of at least eight animals shall be given the immunosuppressive chemical.
(4)
(ii) The highest dose level shall not produce significant stress, malnutrition, or fatalities, but ideally should produce some measurable sign of general toxicity (e.g., a 10% loss of body weight).
(iii) The lowest dose level ideally shall not produce any evidence of immunotoxicity.
(5)
(ii) If the test substance is administered by gavage, the animals are dosed with the test substance ideally on a 7-days-per-week basis. However, based primarily on practical considerations, dosing by gavage on a 5-days-per-week basis shall be acceptable. If the test substance is administered in the drinking water, or mixed directly into the diet, then exposure shall be on a 7-days-per-week basis.
(A) For substances of low toxicity, it is important to ensure that when administered in the diet, the quantities of the test substance involved do not interfere with normal nutrition. When the test substance is administered in the diet, either a constant dietary concentration in parts per million (ppm) or a constant dose level in terms of the animal's body weight shall be used; the alternative used should be specified.
(B) For a substance administered by gavage, the dose shall be given at approximately the same time each day, and adjusted at intervals (weekly for mice, twice per week for rats) to maintain a constant dose level in terms of the animal's body weight.
(iii) If the test substance is administered dermally, use paragraphs (f)(5)(iii)(A) through (f)(5)(iii)(D) of this section.
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(iv) If the test substance is administered by the inhalation route, use the procedures under paragraphs (e)(2), (e)(3), (e)(6), (e)(8), (e)(9), and (e)(10) of 40 CFR 799.9346. The exposure time for the anti-SRBC test shall be at least 28 days.
(6)
(7)
(ii) A careful clinical examination shall be made at least once a week. Observations shall be detailed and carefully recorded, preferably using explicitly defined scales. Observations shall include, but not be limited to: evaluation of skin and fur, eyes and mucous membranes; respiratory and circulatory effects; autonomic effects, such as salivation; central nervous system effects, including tremors and convulsions, changes in the level of motor activity, gait and posture, reactivity to handling or sensory stimuli, grip strength, and stereotypes or bizarre behavior (e.g., self-mutilation, walking backwards).
(iii) Signs of toxicity shall be recorded as they are observed, including the time of onset, degree and duration.
(iv) Food and water consumption shall be determined weekly.
(v) Animals shall be weighed immediately prior to dosing, weekly (twice per week for rats) thereafter, and just prior to euthanasia.
(vi) Any moribund animals shall be removed and euthanized when first noticed. Necropsies shall be conducted on all moribund animals, and on all animals that die during the study.
(vii) The spleen and thymus shall be weighed in all animals at the end of the study.
(g)
(i)
(A) The T cell-dependent antigen, SRBC, shall be injected intravenously or intraperitoneally, usually at 24 days
(B) The activity of each new batch of complement shall be determined. For any given study, the SRBCs shall be from a single sheep, or pool of sheep, for which the shelf life and dose for optimum response has been determined.
(C) Modifications of the PFC assay described in paragraph (g)(1)(i) of this section exist and may prove useful; however, the complete citation shall be made for the method used, any modifications to the method shall be reported, and the source and, where appropriate, the activity or purity of important reagents shall be given. Justification or rationale shall be provided for each protocol modification. Discussions of modifications of the PFC assay are available in the references under paragraphs (j)(5),(j)(6), and (j)(10) of this section
(D) Samples shall be randomized and shall be coded for PFC analysis, so that the analyst is unaware of the treatment group of each sample examined.
(E) Spleen cell viability shall be determined.
(F) The numbers of IgM PFC per spleen, and the number of IgM PFC per 10
(ii)
(iii)
(A) Assay controls shall be included to account for spontaneous release of radiolabel from target cells in the absence of effector cells, and also for the determination of total release of radiolabel.
(B) Target cells other than YAC-1 lymphoma cells may be appropriate for use in the assay. In all cases, target cell viability shall be determined.
(C) Modifications of the protocol exist that may prove useful. However, complete citation shall be made to the method used. Modifications shall be reported, and where appropriate, the source, activity, and/or purity of the reagents should be given. Justification or rationale shall be provided for each protocol modification.
(2)
(h)
(ii) All observed results, quantitative and incidental, shall be evaluated by an appropriate statistical method. Any generally accepted statistical methods may be used; the statistical methods including significance criteria shall be selected during the design of the study.
(2)
(3)
(i) The test substance characterization shall include:
(A) Chemical identification.
(B) Lot or batch number.
(C) Physical properties.
(D) Purity/impurities.
(E) Identification and composition of any vehicle used.
(ii) The test system shall contain data on:
(A) Species, strain, and rationale for selection of animal species, if other than that recommended.
(B) Age, body weight data, and sex.
(C) Test environment including cage conditions, ambient temperature, humidity, and light/dark periods.
(D) When inhalation is the route of exposure, a description of the exposure equipment and data shall be included as follows:
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(
(
(E) Identification of animal diet.
(iii) The test procedure shall include the following data:
(A) Method of randomization used.
(B) Full description of experimental design and procedure.
(C) Dose regimen including levels, methods, and volume.
(iv) Test results should include the following data:
(A) Group animal toxic response data shall be tabulated by species, strain, sex, and exposure level for:
(
(
(
(B) Individual animal data shall be presented, as well as summary (group mean data).
(C) Date of death during the study or whether animals survived to termination.
(D) Date of observation of each abnormal sign and its subsequent course.
(E) Absolute and relative spleen and thymus weight data.
(F) Feed and water consumption data, when collected.
(G) Results of immunotoxicity tests.
(H) Necropsy findings of animals that were found moribund and euthanized or died during the study.
(I) Statistical treatment of results, where appropriate.
(i)
(j)
(1) Cornacoff, J.B., Graham, C.S., and LaBrie, T.K. Eds. Burleson, G.R., Dean, J.H., and Munson, A.E. Phenotypic identification of peripheral blood mononuclear leukocytes by flow cytometry as an adjunct to immunotoxicity evaluation. Vol. 1.
(2) Cunningham, A.J. A method of increased sensitivity for detecting single antibody-forming cells.
(3) Djeu, Julie Y. Eds. Burleson, G.R., Dean, J.H., and Munson, A.E. Natural Killer Activity.
(4) Holsapple, M.P. Eds. Burleson, G.R., Dean, J.H., and Munson, A.E. The plaque-forming cell (PFC) response in Immunotoxicology: An approach to monitoring the primary effector function of B lymphocytes. Vol. 1.
(5) Ladics, G.S. and Loveless, S.E. Cell surface marker analysis of splenic lymphocyte populations of the CD rat for use in immunotoxicological studies.
(6) Ladics, G.S., Smith, C., Heaps, K., and Loveless, S.E. Evaluation of the humoral immune response of CD rats following a 2-week exposure to the pesticide carbaryl by the oral, dermal, or inhalation routes.
(7) Ladics., G.S., Smith, C., Heaps, K., Elliot, G.S., Slone, T.W., and Loveless, S.E. Possible incorporation of an immunotoxicological functional assay for assessing humoral immunity for hazard identification purposes in rats on standard toxicology study.
(8) Luster, M.I., Portier, C., Pait, D.G., White, K.L., Jr., Gennings, C., Munson, A.E., and Rosenthal, G.J. Risk assessment in immunotoxicology I. Sensitivity and predictability of immune tests.
(9) Luster, M.I., Portier, C., Pait, D.G., Rosenthal, G.J. Germolec. D.R., Corsini, E., Blaylock, B.L., Pollock, P., Kouchi, Y., Craig, W., White, D.L., Munson, A.E., and Comment, C.E. Risk Assessment in Immunotoxicology II. Relationships Between Immune and Host Resistance Tests.
(10) Temple, L., Kawabata, T. T., Munson, A. E., and White, Jr., K. L. Comparison of ELISA and plaque-forming cell assays for measuring the humoral immune response to SRBC in rats and mice treated with benzo[a]pyrene or cyclophosphamide.
(11) Temple, L., Butterworth, L., Kawabata, T.T., Munson, A.E., and White, Jr., K.L. Eds. Burleson, G.R., Dean, J.H., and Munson, A.E. ELISA to Measure SRBC Specific Serum IgM: Method and Data Evaluation. Vol. 1.
42 U.S.C. 7401-7671(q).
At 69 FR 39213, June 29, 2004, part 1039 was added, effective Aug. 30, 2004.
(a) The regulations in this part 1039 apply for all new, compression-ignition nonroad engines (defined in § 1039.801), except as provided in § 1039.5.
(b) This part 1039 applies as follows:
(1) This part 1039 applies for all engines subject to the emission standards specified in subpart B of this part starting with the model years noted in the following table:
(2) If you use the provisions of § 1039.104(a) to certify an engine to the emission standards of this part before the model years shown in Table 1 of this section, all the requirements of this part apply for those engines.
(3) See 40 CFR part 89 for requirements that apply to engines not yet subject to the requirements of this part 1039.
(4) This part 1039 applies for other compression-ignition engines as follows:
(i) The provisions of paragraph (c) of this section and § 1039.801 apply for stationary engines beginning January 1, 2006.
(ii) The provisions of § 1039.620 and § 1039.801 apply for engines used solely for competition beginning January 1, 2006.
(c) The definition of nonroad engine in 40 CFR 1068.30 excludes certain engines used in stationary applications.
(d) In certain cases, the regulations in this part 1039 apply to engines at or above 250 kW that would otherwise be covered by 40 CFR part 1048. See 40 CFR 1048.620 for provisions related to this allowance.
This part does not apply to the following nonroad engines:
(a)
(i) Engines in locomotives subject to the standards of 40 CFR part 92.
(ii) Engines in locomotives that are exempt from the standards of 40 CFR part 92 pursuant to the provisions of 40 CFR part 92 (except for the provisions of 40 CFR 92.907). For example, an engine that is exempt under 40 CFR 92.906 because it is in a manufacturer-owned locomotive is not subject to the provisions of this part 1039.
(2) The following locomotive engines are subject to the provisions of this part 1039:
(i) Engines in locomotives exempt from 40 CFR part 92 pursuant to the provisions of 40 CFR 92.907.
(ii) Locomotive engines excluded from the definition of locomotive in 40 CFR 92.2.
(b)
(i) Engines subject to the standards of 40 CFR part 94.
(ii) Engines not subject to the standards of 40 CFR part 94 only because they were produced before the standards of 40 CFR part 94 started to apply.
(iii) Engines that are exempt from the standards of 40 CFR part 94 pursuant to the provisions of 40 CFR part 94 (except for the provisions of 40 CFR 94.907). For example, an engine that is exempt under 40 CFR 94.906 because it is a manufacturer-owned engine is not subject to the provisions of this part 1039.
(iv) Engines with rated power below 37 kW.
(v) Engines on foreign vessels.
(2) Marine engines are subject to the provisions of this part 1039 if they are exempt from 40 CFR part 94 based on the engine-dressing provisions of 40 CFR 94.907.
(c)
(d)
The regulations in this part 1039 contain provisions that affect both engine manufacturers and others. However, the requirements of this part are generally addressed to the engine manufacturer. Unless we specifically state otherwise, the term “you” means the engine manufacturer, as defined in § 1039.801. This part 1039 is divided into the following subparts:
(a) Subpart A of this part defines the applicability of part 1039 and gives an overview of regulatory requirements.
(b) Subpart B of this part describes the emission standards and other requirements that must be met to certify engines under this part. Note that § 1039.102 and § 1039.104 discuss certain interim requirements and compliance provisions that apply only for a limited time.
(c) Subpart C of this part describes how to apply for a certificate of conformity.
(d) [Reserved]
(e) Subpart E of this part describes general provisions for testing in-use engines.
(f) Subpart F of this part describes how to test your engines (including references to other parts of the Code of Federal Regulations).
(g) Subpart G of this part and 40 CFR part 1068 describe requirements, prohibitions, and other provisions that apply to engine manufacturers, equipment manufacturers, owners, operators, rebuilders, and all others.
(h) Subpart H of this part describes how you may generate and use emission credits to certify your engines.
(i) Subpart I of this part contains definitions and other reference information.
(a) Part 1065 of this chapter describes procedures and equipment specifications for testing engines. Subpart F of this part 1039 describes how to apply the provisions of part 1065 of this chapter to determine whether engines meet the emission standards in this part.
(b) The requirements and prohibitions of part 1068 of this chapter apply to everyone, including anyone who manufactures, imports, installs, owns, operates, or rebuilds any of the engines subject to this part 1039, or equipment containing these engines. Part 1068 of this chapter describes general provisions, including these seven areas:
(1) Prohibited acts and penalties for engine manufacturers, equipment manufacturers, and others.
(2) Rebuilding and other aftermarket changes.
(3) Exclusions and exemptions for certain engines.
(4) Importing engines.
(5) Selective enforcement audits of your production.
(6) Defect reporting and recall.
(7) Procedures for hearings.
(c) Other parts of this chapter apply if referenced in this part.
The provisions of this section apply for engines built on or after January 1, 2006.
(a) You must add a permanent label or tag to each new engine you produce or import that is excluded under § 1039.1(c) as a stationary engine. To meet labeling requirements, you must do the following things:
(1) Attach the label or tag in one piece so no one can remove it without destroying or defacing it.
(2) Secure it to a part of the engine needed for normal operation and not normally requiring replacement.
(3) Make sure it is durable and readable for the engine's entire life.
(4) Write it in English.
(5) Follow the requirements in § 1039.135(g) regarding duplicate labels if the engine label is obscured in the final installation.
(b) Engine labels or tags required under this section must have the following information:
(1) Include the heading “EMISSION CONTROL INFORMATION”.
(2) Include your full corporate name and trademark. You may instead include the full corporate name and trademark of another company you choose to designate.
(3) State the engine displacement (in liters) and maximum engine power.
(4) State: “THIS ENGINE IS EXCLUDED FROM THE REQUIREMENTS OF 40 CFR PART 1039 AS A “STATIONARY ENGINE.” INSTALLING OR USING THIS ENGINE IN ANY OTHER APPLICATION MAY BE A VIOLATION OF FEDERAL LAW SUBJECT TO CIVIL PENALTY.”.
The exhaust emission standards of this section apply after the 2014 model year. Certain of these standards also apply for model year 2014 and earlier. This section presents the full set of emission standards that apply after all the transition and phase-in provisions of § 1039.102 and § 1039.104 expire. See § 1039.102 and 40 CFR 89.112 for exhaust emission standards that apply to 2014 and earlier model years. Section 1039.105 specifies smoke standards.
(a)
(1) Engines above 560 kW.
(2) Constant-speed engines.
(b)
(c)
(d)
(1)
(2)
(e)
(1) Measure emissions using the procedures described in subpart F of this part.
(2) Except as noted in paragraph (e)(7) of this section, the NTE standard, rounded to the same number of decimal places as the applicable standard in Table 1 of this section, is determined from the following equation:
(3) The NTE multiplier for each pollutant is 1.25, except in the following cases:
(4) There are two sets of specifications of ambient operating regions that will apply for all NTE testing of engines in an engine family. You must choose one set for each engine family and must identify your choice of ambient operating regions in each application for certification for an engine family. You may choose separately for each engine family. Choose one of the following ambient operating regions:
(i) All altitudes less than or equal to 5,500 feet above sea level during all ambient temperature and humidity conditions.
(ii) All altitudes less than or equal to 5,500 feet above sea level, for temperatures less than or equal to the temperature determined by the following equation at the specified altitude:
(5) Temperature and humidity ranges for which correction factors are allowed are specified in 40 CFR 86.1370-2007(e).
(i) If you choose the ambient operating region specified in paragraph (e)(4)(i) of this section, the temperature and humidity ranges for which correction factors are allowed are defined in 40 CFR 86.1370-2007(e)(1).
(ii) If you choose the ambient operating region specified in paragraph (e)(4)(ii) of this section, the temperature and humidity ranges for which
(6) For engines equipped with exhaust-gas recirculation, the NTE standards of this section do not apply during the cold operating conditions specified in 40 CFR 86.1370-2007(f).
(7) For engines certified to a PM FEL less than or equal to 0.01 g/kW-hr, the PM NTE standard is 0.02 g/kW-hr.
(f)
(1) Alcohol-fueled engines: THCE emissions.
(2) Other engines: NMHC emissions.
(g)
(1) The useful life values are shown in the following table, except as allowed by paragraph (g)(2) of this section:
(2) You may request in your application for certification that we approve a shorter useful life for an engine family. We may approve a shorter useful life if we determine that these engines will rarely operate longer than the alternate useful life. Your demonstration must include documentation from in-use engines. Your demonstration must also include any overhaul interval that you recommend and any mechanical warranty that you offer for the engine.
(h)
The exhaust emission standards of this section apply for 2014 and earlier model years. See § 1039.101 for exhaust emission standards that apply to later model years. See 40 CFR 89.112 for exhaust emission standards that apply to model years before the standards of this part 1039 take effect.
(a)
(1) The transient standards in this section do not apply for the following engines:
(i) Engines below 37 kW for model years before 2013.
(ii) Engines certified under Option #1 of Table 3 of this section. These are the small-volume manufacturer engines certified to the Option #1 standards for model years 2008 through 2015 under § 1039.104(c), and other engines certified to the Option #1 standards for model years 2008 through 2012.
(iii) Engines certified to an alternate FEL during the first four years of the Tier 4 standards for the applicable power category, as allowed in § 1039.104(g). However, you may certify these engines to the transient standards in this section to avoid using temporary compliance adjustment factors, as described in § 1039.104(g)(2). Note that in some cases this four-year period extends into the time covered by the standards in § 1039.101.
(iv) Constant-speed engines.
(v) Engines above 560 kW.
(2) The transient standards in this section for gaseous pollutants do not apply to phase-out engines that you certify to the same numerical standards (and FELs if the engines are certified using ABT) for gaseous pollutants as you certified under the Tier 3 requirements of 40 CFR part 89. However, except as specified by paragraph (a)(1) of this section, the transient PM emission standards apply to these engines.
(b) Emission standards for steady-state testing. Steady-state exhaust emissions from your engines may not exceed the applicable emission standards in Tables 1 through 7 of this section. Measure emissions using the applicable steady-state test procedures described in subpart F of this part. See paragraph (c) of this section for a description of provisions related to the phase-in and phase-out standards shown in Tables 4 through 6 of this section.
(c)
(1) For each model year before 2014 noted in Tables 4 through 6 of this section, you must certify engine families representing at least 50 percent of your U.S.-directed production volume for each power category to the applicable phase-in standards, except as allowed by paragraph (c)(3), (d)(2), or (e) of this section. Any engines not certified to the phase-in standards must be certified to the corresponding phase-out standards.
(2) Engines certified to the phase-out standards in Tables 4 through 6 of this section must comply with all other requirements that apply to Tier 4 engines, except as otherwise specified in this section.
(3) At the time of certification, show how you intend to meet the phase-in requirements of this paragraph (c) based on projected U.S.-directed production volumes. If your actual U.S.-directed production volume fails to meet the phase-in requirements for a given model year, you must make up the shortfall (in terms of number of engines) by the end of the model year representing the final year of the phase-in period. For example, if you plan in good faith to produce 50 percent of a projected 10,000 engines in the 56-130 kW power category (
(i) For engine families certified according to the alternate phase-in schedule described in paragraph (d)(2) of this section, for model years prior to the final year of the phase-in, 5 percent of your actual U.S.-directed production volume for that power category in that model year.
(ii) For all other engine families, for model years prior to the final year of the phase-in, 25 percent of your actual U.S.-directed production volume for that power category in that model year.
(iii) No shortfall is allowed in the final year of the phase-in.
(4) Engines you introduce into commerce beyond the limits described in paragraphs (c)(3) of this section will be considered not covered by a certificate of conformity and in violation of § 1068.101(a)(1).
(5) For the purposes of this part, the term “phase-in” means relating to a standard that is identified in this section as a phase-in standard and the term “phase-out” means relating to a standard that is identified in this section as a phase-out standard. For example, a 200-kW engine from the 2012 model year that is certified to the 4.0 g/kW-hr NO
(d)
(1) For model years 2012 through 2014, you may use banked NO
(2) Instead of meeting the phase-in requirements of paragraph (c)(1) of this section, you may certify engine families representing at least 25 percent of your U.S.-directed production volume for each model year from 2012 through 2014 to the applicable phase-in standards in Tables 4 and 5 of this section, except as allowed by paragraph (c)(3) or (e) of this section. Any engines not certified to the phase-in standards must be certified to the corresponding phase-out standards. Engines certified under this paragraph (d)(2) may generate NO
(e)
(1) For engines in the 56-130 kW power category, apply the following alternate NO
(i) If you use the provisions of paragraph (d)(1) of this section, your alternate NO
(ii) If you use the provisions of paragraph (d)(2) of this section, your alternate NO
(iii) If you do not use the provisions of paragraph (d) of this section, you may apply the alternate NO
(2) For engines in the 130-560 kW power category, the alternate NO
(f)
(1) Identify any split engine families in your application for certification. Your engines must comply with all the standards and requirements applicable to Tier 4 engines, except as noted in this paragraph (f). You may calculate emission credits relative to different emission standards (
(2) For example, a 10,000-unit engine family in the 75-130 kW power category may be certified to meet the standards for PM, NMHC, and CO that apply to phase-in engines, with a 0.8 g/kW-hr FEL for NO
(g)
(1)
(i) All engines below 37 kW for model years before 2013.
(ii) All engines certified under Option #1 of Table 3 of this section. These are small-volume manufacturer engines certified to the Option #1 standards for model years 2008 through 2015 under § 1039.104(c), and other engines certified to the Option #1 standards for model years 2008 through 2012.
(iii) All engines less than or equal to 560 kW that are certified to an FEL under the alternate FEL program during the first four years of the Tier 4 standards for the applicable power category, as described in § 1039.104(g). However, if you apply to meet transient emission standards for these engines under § 1039.102(a)(1)(iii), you must also meet the NTE standards in this paragraph (g)(1).
(iv) Gaseous pollutants for phase-out engines that you certify to the same numerical standards and FELs for gaseous pollutants to which you certified under the Tier 3 requirements of 40 CFR part 89. However, the NTE standards for PM apply to these engines.
(2)
(3)
(4)
(i) State the applicable PM standard on the emission control information label.
(ii) Add information to the emission-related installation instructions to clarify the equipment manufacturer's obligations under § 1039.104(f).
The provisions in this section apply instead of other provisions in this part. This section describes when these interim provisions apply.
(a)
(1) For early-compliant engines to generate offsets for use either under this paragraph (a) or under § 1039.627, you must meet the following general provisions:
(i) You may not generate offsets from engines below 19 kW.
(ii) You must begin actual production of engines covered by the corresponding certificate by the following dates:
(A) For engines at or above 19 kW and below 37 kW: September 1, 2012.
(B) For engines at or above 37 kW and below 56 kW: September 1, 2012 if you choose Option #1 in Table 3 of § 1039.102, or September 1, 2011 if you do not choose Option #1 in Table 3 of § 1039.102.
(C) For engines in the 56-130 kW power category: September 1, 2011.
(D) For engines in the 130-560 kW power category: September 1, 2010.
(E) For engines above 560 kW: September 1, 2014.
(iii) Engines you produce after December 31 of the year shown in paragraph (a)(1)(ii) of this section may not generate offsets.
(iv) You may not use ABT credits to certify offset-generating engines.
(v) Offset-generating engines must be certified to the Tier 4 standards and requirements under this part 1039.
(2) If equipment manufacturers decline offsets for your offset-generating engines under § 1039.627, you may not generate ABT credits with these engines, but you may reduce the number of engines that are required to meet the standards in § 1039.101 or 1039.102 as follows:
(3) Example: If you produce 100 engines in the 56-130 kW power category in model year 2008 that are certified to the 56-130 kW standards listed in § 1039.101, and you produced 10,000 engines in this power category in model year 2015, then only 9,850 of these model year 2015 engines would need to comply with the standards listed in § 1039.101. The 100 offset-generating engines in model year 2008 could not use or generate ABT credits.
(4) Offset-using engines (that is, those not required to certify to the standards of § 1039.101 or § 1039.102 under paragraph (a)(2) of this section) are subject to the following provisions:
(i) If the offset is being used under paragraph (a)(2)(i) of this section for an engine that would otherwise be certified to the model year 2013 or 2014 standards in Table 2 of § 1039.102 or the standards in Table 1 of § 1039.101, this engine must be certified to the standards and requirements of this part 1039, except that the only PM standard that applies is the steady-state PM standard that applies for model year 2012. Such an engine may not generate ABT credits.
(ii) If the offset is being used under paragraph (a)(2)(ii) of this section for an engine that would otherwise be certified to the phase-out standards in Tables 4 through 6 of § 1039.102, this engine must be certified to the standards and requirements of this part 1039, except that the PM standard is the Tier 3 PM standard that applies for this engine's maximum power. Such an engine will be treated as a phase-out engine for purposes of determining compliance with percentage phase-in requirements. Such an engine may not generate ABT credits.
(iii) All other offset-using engines must meet the standards and other provisions that apply in model year 2011 for engines in the 19-130 kW power categories, in model year 2010 for engines in the 130-560 kW power category, or in model year 2014 for engines above 560 kW. Show that engines meet these emission standards by meeting all the
(5) If an equipment manufacturer claims offsets from your engine for use under § 1039.627, the engine generating the offset must comply with the requirements of paragraph (a)(1) of this section. You may not generate offsets for use under paragraphs (a)(2) and (5) of this section for these engines. You may generate ABT credits from these engines as follows:
(i) To generate emission credits for NO
(ii) Calculate credits according to § 1039.705 but use as the applicable standard the numerical value of the standard to which the engine would have otherwise been subject if it had not been certified under this paragraph (a).
(iii) For the production volume, use the number of engines certified under this paragraph (a) for which you do not claim offsets under paragraph (a)(2) of this section.
(6) You may include engines used to generate offsets under this paragraph (a) and engines used to generate offsets under § 1039.627 in the same engine family, subject to the provisions of § 1039.230. The engine must be certified to FELs, as specified in paragraph (a)(5)(i) of this section. The FELs must be below the standard levels specified in paragraph (a)(2) of this section and those specified in § 1039.627. In the reports required in § 1039.730, include the following information for each model year:
(i) The total number of engines that generate offsets under this paragraph (a).
(ii) The number of engines used to generate offsets under paragraph (a)(2) of this section.
(iii) The names of equipment manufacturers that intend to use your offsets under § 1039.627 and the number of offsets involved for each equipment manufacturer.
(b)
(c)
(1) You may delay complying with certain otherwise applicable Tier 4 emission standards and requirements as described in the following table:
(2) To use the provisions of this paragraph (c) for engines at or above 37 kW and below 56 kW, choose one of the following:
(i) If you comply with the 0.30 g/kW-hr PM standard in § 1039.102 in all model years from 2008 through 2012 without using PM credits, you may continue meeting that standard through 2015.
(ii) If you do not choose to comply with paragraph (c)(2)(i) of this section, you may continue to comply with the standards and requirements in 40 CFR part 89 for model years through 2012, but you must begin complying in 2013 with Tier 4 standards and requirements specified in Table 3 of § 1039.102 for model years 2013 and later.
(3) After the delays indicated in paragraph (c)(1) and (2) of this section, you must comply with the same Tier 4 standards and requirements as all other manufacturers.
(4) For engines not in the 19-56 kW power category, if you delay compliance with any standards under this paragraph (c), you must do all the following things for the model years when you are delaying compliance with the otherwise applicable standards:
(i) Produce engines that meet all the emission standards and other requirements under 40 CFR part 89 applicable for that model year, except as noted in this paragraph (c).
(ii) Meet the labeling requirements in 40 CFR 89.110, but use the following compliance statement instead of the compliance statement in 40 CFR 89.110(b)(10): “THIS ENGINE COMPLIES WITH U.S. EPA REGULATIONS FOR [CURRENT MODEL YEAR] NONROAD COMPRESSION-IGNITION ENGINES UNDER 40 CFR 1039.104(c).”.
(iii) Notify the equipment manufacturer that the engines you produce under this section are excluded from the production volumes associated with the equipment-manufacturer allowance program in § 1039.625.
(5) For engines in the 19-56 kW power category, if you delay compliance with any standards under this paragraph (c), you must do all the following things for the model years when you are delaying compliance with the otherwise applicable standards:
(i) Produce engines in those model years that meet all the emission standards and other requirements that applied for your model year 2008 engines in the same power category.
(ii) Meet the labeling requirements in § 1039.135, but use the following compliance statement instead of the compliance statement in § 1039.135: “THIS ENGINE COMPLIES WITH U.S. EPA REGULATIONS FOR [CURRENT MODEL YEAR] NONROAD COMPRESSION-IGNITION ENGINES UNDER 40 CFR 1039.104(c).”.
(iii) Notify the equipment manufacturer that the engines you produce under this section are excluded from the production volumes associated with the equipment-manufacturer allowance program in § 1039.625.
(6) The provisions of this paragraph (c) may not be used to circumvent the requirements of this part.
(d)
(1) Request our approval for specific deficiencies in your application for certification, or before you submit your application. We will not approve deficiencies retroactively to cover engines already certified. In your request, identify the scope of each deficiency and describe any auxiliary emission-control devices you will use to control emissions to the lowest practical level, considering the deficiency you are requesting.
(2) We will approve a deficiency only if compliance would be infeasible or unreasonable considering such factors as the technical feasibility of the given hardware and the applicable lead time and production cycles—including schedules related to phase-in or phase-out of engines. We may consider other relevant factors.
(3) Our approval applies only for a single model year and may be limited to specific engine configurations. We may approve your request for the same deficiency in the following model year if correcting the deficiency would require unreasonable hardware or software modifications and we determine that you have demonstrated an acceptable level of effort toward complying.
(4) You may ask for any number of deficiencies in the first three model years during which NTE standards apply for your engines. For the next four model years, we may approve up to three deficiencies per engine family. Deficiencies of the same type that apply similarly to different power ratings within a family count as one deficiency per family. We may condition approval of any such additional deficiencies during these four years on any additional conditions we determine to be appropriate. We will not approve deficiencies after the seven-year period specified in this paragraph (d)(4).
(e)
(1) Use the following test fuels in 2010 and earlier model years:
(i) Unless otherwise specified, the diesel test fuel is low-sulfur diesel fuel specified in 40 CFR part 1065.
(ii) In model years 2007 through 2010, you may use ultra low-sulfur diesel fuel as the test fuel for any engine family that employs sulfur-sensitive technology if you can demonstrate that in-use engines in the family will use diesel fuel with a sulfur concentration no greater than 15 ppm.
(iii) You may use ultra low-sulfur diesel fuel as the test fuel for engine families in any power category below 56 kW, as long as none of the engines in your engine family employ sulfur-sensitive technologies, you ensure that ultimate purchasers of equipment using these engines are informed that ultra low-sulfur diesel fuel is recommended, and you recommend to equipment manufacturers that a label be applied at the fuel inlet recommending 15 ppm fuel.
(iv) For the engines described in § 1039.101(c) that are certified to the 0.60 g/kW-hr PM standard in Table 1 of § 1039.102 in the 2010 model year, you may test with the ultra low-sulfur fuel specified in 40 CFR part 1065.
(2) Meet the labeling requirements of this paragraph (e)(2) (or other labeling requirements we approve) to identify the applicable test fuels specified in paragraph (e)(1) of this section. Provide instructions to equipment manufacturers to ensure that they are aware of these labeling requirements.
(i) For engines certified under the provisions of paragraph (e)(1)(i) of this section, include the following statement on the emission control information label and the fuel-inlet label specified in § 1039.135: “LOW SULFUR FUEL OR ULTRA LOW SULFUR FUEL ONLY”.
(ii) For engines certified under the provisions of paragraph (e)(1)(ii) of this section, include the following statement on the emission control information label and the fuel-inlet label specified in § 1039.135: “ULTRA LOW SULFUR FUEL ONLY”.
(iii) For engines certified under the provisions of paragraph (e)(1)(iii) of this section, include the following statement on the emission control information label specified in § 1039.135: “ULTRA LOW SULFUR FUEL RECOMMENDED”.
(3) For model years 2010 and earlier, we will use the test fuel that you use under paragraph (e)(1) of this section, subject to the conditions of paragraph (e)(1) of this section.
(f)
(1) For equipment you produce with 2012 model year engines at or above 37 kW and below 56 kW, determine the minimum number of these engines that must be certified to the Option #2 standards in Table 3 of § 1039.102 as follows:
(i) If all the equipment you produce using 2008 through 2011 model year engines use engines certified to Tier 3 standards under Option #2 of Table 3 of § 1039.102, then all the 2012 model year engines you install must be certified to the Option #2 standards of Table 3 of § 1039.102.
(ii) If you produce equipment using 2008 through 2011 model year engines with some engines certified to Option #1 standards of Table 3 of § 1039.102 and some engines certified to Tier 3 standards under Option #2 standards of Table 3 of § 1039.102, calculate the minimum number of 2012 model year engines you must install that are certified to the Option #2 standards of Table 3 of § 1039.102 from the following equation:
(2) As needed for the calculation required by this paragraph (f), keep records of all equipment you produce using 2008-2012 model year engines at or above 37 kW and below 56 kW. If you fail to keep these records, you may not use any 2012 model year engines certified to Option #1 standards in your equipment.
(3) If you fail to comply with the provisions of this paragraph (f), then using 2012 model year engines certified under Option #1 of Table 3 of § 1039.102 (or certified to less stringent standards) in such equipment violates the prohibitions in § 1068.101(a)(1).
(g)
(1) The provisions of this paragraph (g) apply during the model years shown in Table 1 of this section. During this period, the number of engines certified to the FEL caps in Table 1 of this section must not exceed 20 percent in any single model year in each power category. The sum of percentages over the four-year period must not exceed a total of 40 percent in each power category. If you certify an engine under an alternate FEL cap in this paragraph (g) for any pollutant, count it toward the allowed percentage of engines certified to the alternate FEL caps.
(2) If your engine is not certified to transient emission standards under the provisions of § 1039.102(a)(1)(iii), you must adjust your FEL upward by a temporary compliance adjustment factor (TCAF) before calculating your negative emission credits under § 1039.705, as follows:
(i) The temporary compliance adjustment factor for NO
(ii) The temporary compliance adjustment factor for PM is 1.5.
(iii) The adjusted FEL (FEL
(iv) The unadjusted FEL (FEL
(3) These alternate FEL caps may not be used for phase-in engines.
(4) Do not apply TCAFs to gaseous emissions for phase-out engines that you certify to the same numerical standards (and FELs if the engines are certified using ABT) for gaseous pollutants as you certified under the Tier 3 requirements of 40 CFR part 89.
(a) The smoke standards in this section apply to all engines subject to emission standards under this part, except for the following engines:
(1) Single-cylinder engines.
(2) Constant-speed engines.
(3) Engines certified to a PM emission standard or FEL of 0.07 g/kW-hr or lower.
(b) Measure smoke as specified in § 1039.501(c). Smoke from your engines may not exceed the following standards:
(1) 20 percent during the acceleration mode.
(2) 15 percent during the lugging mode.
(3) 50 percent during the peaks in either the acceleration or lugging modes.
There are no evaporative emission standards for diesel-fueled engines, or engines using other nonvolatile or nonliquid fuels (for example, natural gas). If your engine uses a volatile liquid fuel, such as methanol, you must meet the evaporative emission requirements of 40 CFR part 1048 that apply to spark-ignition engines, as follows:
(a) Follow the steps in 40 CFR 1048.245 to show that you meet the requirements of 40 CFR 1048.105.
(b) Do the following things in your application for certification:
(1) Describe how your engines control evaporative emissions.
(2) Present test data to show that equipment using your engines meets the evaporative emission standards we specify in this section if you do not use design-based certification under 40 CFR 1048.245. Show these figures before and after applying deterioration factors, where applicable.
Engines subject to this part must meet the following requirements, except as noted elsewhere in this part:
(a)
(1) Engines may discharge crankcase emissions to the ambient atmosphere if the emissions are added to the exhaust emissions (either physically or mathematically) during all emission testing.
(2) If you take advantage of this exception, you must do the following things:
(i) Manufacture the engines so that all crankcase emissions can be routed into the applicable sampling systems specified in 40 CFR part 1065.
(ii) Account for deterioration in crankcase emissions when determining exhaust deterioration factors.
(3) For purposes of this paragraph (a), crankcase emissions that are routed to the exhaust upstream of exhaust aftertreatment during all operation are not considered to be discharged directly into the ambient atmosphere.
(b)-(d) [Reserved]
(e)
(f)
(g)
(1) The conditions of concern were substantially included in the applicable test procedures described in subpart F of this part.
(2) You show your design is necessary to prevent engine (or equipment) damage or accidents.
(3) The reduced effectiveness applies only to starting the engine.
(a)
(1) It is designed, built, and equipped so it conforms at the time of sale to the ultimate purchaser with the requirements of this part.
(2) It is free from defects in materials and workmanship that may keep it from meeting these requirements.
(b)
(c)
(d)
(e)
Give the ultimate purchaser of each new nonroad engine written instructions for properly maintaining and using the engine, including the emission-control system. The maintenance instructions also apply to service accumulation on your emission-data engines, as described in § 1039.245 and in 40 CFR part 1065.
(a)
(1) You demonstrate that the maintenance is reasonably likely to be done at the recommended intervals on in-use engines. We will accept scheduled maintenance as reasonably likely to occur if you satisfy any of the following conditions:
(i) You present data showing that, if a lack of maintenance increases emissions, it also unacceptably degrades the engine's performance.
(ii) You present survey data showing that at least 80 percent of engines in the field get the maintenance you specify at the recommended intervals.
(iii) You provide the maintenance free of charge and clearly say so in maintenance instructions for the customer.
(iv) You otherwise show us that the maintenance is reasonably likely to be done at the recommended intervals.
(2) For engines below 130 kW, you may not schedule critical emission-related maintenance more frequently than the following minimum intervals, except as specified in paragraphs (a)(4), (b), and (c) of this section:
(i) For EGR-related filters and coolers, PCV valves, and fuel injector tips (cleaning only), the minimum interval is 1,500 hours.
(ii) For the following components, including associated sensors and actuators, the minimum interval is 3000 hours: fuel injectors, turbochargers, catalytic converters, electronic control units, particulate traps, trap oxidizers, components related to particulate traps and trap oxidizers, EGR systems (including related components, but excluding filters and coolers), and other add-on components. For particulate traps, trap oxidizers, and components related to either of these, maintenance is limited to cleaning and repair only.
(3) For engines at or above 130 kW, you may not schedule critical emission-related maintenance more frequently than the following minimum intervals, except as specified in paragraphs (a)(4), (b), and (c) of this section:
(i) For EGR-related filters and coolers, PCV valves, and fuel injector tips (cleaning only), the minimum interval is 1,500 hours.
(ii) For the following components, including associated sensors and actuators, the minimum interval is 4500 hours: fuel injectors, turbochargers, catalytic converters, electronic control units, particulate traps, trap oxidizers, components related to particulate traps and trap oxidizers, EGR systems (including related components, but excluding filters and coolers), and other add-on components. For particulate traps, trap oxidizers, and components related to either of these, maintenance is limited to cleaning and repair only.
(4) If your engine family has an alternate useful life under § 1039.101(g) that is shorter than the period specified in paragraph (a)(2) or (a)(3) of this section, you may not schedule critical emission-related maintenance more frequently than the alternate useful life, except as specified in paragraph (c) of this section.
(b)
(c)
(d)
(e)
(f)
(1) Provide a component or service without charge under the purchase agreement.
(2) Get us to waive this prohibition in the public's interest by convincing us the engine will work properly only
(g)
(1) Each affected component was not in general use on similar engines before the applicable dates shown in paragraph (6) of the definition of
(2) The primary function of each affected component is to reduce emissions.
(3) The cost of the scheduled maintenance is more than 2 percent of the price of the engine.
(4) Failure to perform the maintenance would not cause clear problems that would significantly degrade the engine's performance.
(h)
(a) If you sell an engine for someone else to install in a piece of nonroad equipment, give the engine installer instructions for installing it consistent with the requirements of this part. Include all information necessary to ensure that an engine will be installed in its certified configuration.
(b) Make sure these instructions have the following information:
(1) Include the heading: “Emission-related installation instructions”.
(2) State: “Failing to follow these instructions when installing a certified engine in a piece of nonroad equipment violates federal law (40 CFR 1068.105(b)), subject to fines or other penalties as described in the Clean Air Act.”.
(3) Describe the instructions needed to properly install the exhaust system and any other components consistent with the requirements of § 1039.205(u).
(4) [Reserved]
(5) Describe any limits on the range of applications needed to ensure that the engine operates consistently with your application for certification. For example, if your engines are certified only for constant-speed operation, tell equipment manufacturers not to install the engines in variable-speed applications.
(6) Describe any other instructions to make sure the installed engine will operate according to design specifications in your application for certification. This may include, for example, instructions for installing aftertreatment devices when installing the engines.
(7) State: “If you install the engine in a way that makes the engine's emission control information label hard to read during normal engine maintenance, you must place a duplicate label on the equipment, as described in 40 CFR 1068.105.”.
(8) Describe equipment-labeling requirements consistent with § 1039.135. State whether you are providing the label for the fuel inlet or the equipment manufacturer must provide the label.
(c) You do not need installation instructions for engines you install in your own equipment.
(d) Provide instructions in writing or in an equivalent format. For example, you may post instructions on a publicly available website for downloading or printing. If you do not provide the instructions in writing, explain in your application for certification how you will ensure that each installer is informed of the installation requirements.
(a) Assign each engine a unique identification number and permanently affix, engrave, or stamp it on the engine in a legible way.
(b) At the time of manufacture, affix a permanent and legible label identifying each engine. The label must be—
(1) Attached in one piece so it is not removable without being destroyed or defaced. However, you may use two-piece labels for engines below 19 kW if there is not enough space on the engine to apply a one-piece label.
(2) Secured to a part of the engine needed for normal operation and not normally requiring replacement.
(3) Durable and readable for the engine's entire life.
(4) Written in English.
(c) The label must—
(1) Include the heading “EMISSION CONTROL INFORMATION”.
(2) Include your full corporate name and trademark. You may identify another company and use its trademark instead of yours if you comply with the provisions of § 1039.640.
(3) Include EPA's standardized designation for the engine family (and subfamily, where applicable).
(4) State the power category or subcategory from § 1039.101 or § 1039.102 that determines the applicable emission standards for the engine family.
(5) State the engine's displacement (in liters); however, you may omit this from the label if all the engines in the engine family have the same per-cylinder displacement and total displacement.
(6) State the date of manufacture [MONTH and YEAR]. You may omit this from the label if you keep a record of the engine-manufacture dates and provide it to us upon request.
(7) State the FELs to which the engines are certified if certification depends on the ABT provisions of subpart H of this part.
(8) Identify the emission-control system. Use terms and abbreviations consistent with SAE J1930 (incorporated by reference in § 1039.810). You may omit this information from the label if there is not enough room for it and you put it in the owners manual instead.
(9) For diesel-fueled engines, unless otherwise specified in § 1039.104(e)(2), state: “ULTRA LOW SULFUR FUEL ONLY'.
(10) Identify any additional requirements for fuel and lubricants that do not involve fuel-sulfur levels. You may omit this information from the label if there is not enough room for it and you put it in the owners manual instead.
(11) State the useful life for your engine family if we approve a shortened useful life under § 1039.101(g)(2).
(12) State: “THIS ENGINE COMPLIES WITH U.S. EPA REGULATIONS FOR [MODEL YEAR] NONROAD DIESEL ENGINES.”.
(13) For engines above 560 kW, include the following things:
(i) For engines certified to the emission standards for generator-set engines, add the phrase “FOR GENERATOR SETS AND OTHER APPLICATIONS”.
(ii) For all other engines, add the phrase “NOT FOR USE IN A GENERATOR SET”.
(14) If your engines are certified only for constant-speed operation, state “USE IN CONSTANT-SPEED APPLICATIONS ONLY”.
(d) You may add information to the emission control information label to identify other emission standards that the engine meets or does not meet (such as European standards). You may also add other information to ensure that the engine will be properly maintained and used.
(e) Except as specified in § 1039.104(e)(2), create a separate label with the statement: “ULTRA LOW SULFUR FUEL ONLY”. Permanently attach this label to the equipment near the fuel inlet or, if you do not manufacture the equipment, take one of the following steps to ensure that the equipment will be properly labeled:
(1) Provide the label to the equipment manufacturer and include the appropriate information in the emission-related installation instructions.
(2) Confirm that the equipment manufacturers install their own complying labels.
(f) You may ask us to approve modified labeling requirements in this part 1039 if you show that it is necessary or appropriate. We will approve your request if your alternate label is consistent with the requirements of this part.
(g) If you obscure the engine label while installing the engine in the equipment, you must place a duplicate label on the equipment. If others install your engine in their equipment in a way that obscures the engine label, we require them to add a duplicate label on the equipment (see 40 CFR 1068.105); in that case, give them the number of duplicate labels they request and keep the following records for at least five years:
(1) Written documentation of the request from the equipment manufacturer.
(2) The number of duplicate labels you send and the date you sent them.
(a) An engine configuration's maximum engine power is the maximum brake power point on the nominal power curve for the engine configuration, as defined in this section. Round the power value to the nearest whole kilowatt.
(b) The nominal power curve of an engine configuration is the relationship between maximum available engine brake power and engine speed for an engine, using the mapping procedures of 40 CFR part 1065, based on the manufacturer's design and production specifications for the engine. This information may also be expressed by a torque curve that relates maximum available engine torque with engine speed.
(c) The nominal power curve must be within the range of the actual power curves of production engines considering normal production variability. If after production begins it is determined that your nominal power curve does not represent production engines, we may require you to amend your application for certification under § 1039.225.
(d) Throughout this part, references to a specific power value or a range of power values for an engine are based on maximum engine power. For example, the group of engines with maximum engine power above 560 kW may be referred to as engines above 560 kW.
(a) You must send us a separate application for a certificate of conformity for each engine family. A certificate of conformity is valid from the indicated effective date until December 31 of the model year for which it is issued.
(b) The application must contain all the information required by this part and must not include false or incomplete statements or information (see § 1039.255).
(c) We may ask you to include less information than we specify in this subpart, as long as you maintain all the information required by § 1039.250.
(d) You must use good engineering judgment for all decisions related to your application (see 40 CFR 1068.5).
(e) An authorized representative of your company must approve and sign the application.
(f) See § 1039.255 for provisions describing how we will process your application.
(g) We may require you to deliver your test engines to a facility we designate for our testing (see § 1039.235(c)).
This section specifies the information that must be in your application, unless we ask you to include less information under § 1039.201(c). We may require you to provide additional information to evaluate your application.
(a) Describe the engine family's specifications and other basic parameters of the engine's design and emission controls. List the fuel type on which your engines are designed to operate (for example, ultra low-sulfur diesel fuel). List each distinguishable engine configuration in the engine family. For each engine configuration, list the maximum engine power and the range of values for maximum engine power resulting from production tolerances, as described in § 1039.140.
(b) Explain how the emission-control system operates. Describe in detail all system components for controlling exhaust emissions, including all auxiliary-emission control devices (AECDs) and all fuel-system components you will install on any production or test engine. Identify the part number of each component you describe. For this paragraph (b), treat as separate AECDs any devices that modulate or activate differently from each other. Include all the following:
(1) Give a general overview of the engine, the emission-control strategies, and all AECDs.
(2) Describe each AECD's general purpose and function.
(3) Identify the parameters that each AECD senses (including measuring, estimating, calculating, or empirically deriving the values). Include equipment-based parameters and state
(4) Describe the purpose for sensing each parameter.
(5) Identify the location of each sensor the AECD uses.
(6) Identify the threshold values for the sensed parameters that activate the AECD.
(7) Describe the parameters that the AECD modulates (controls) in response to any sensed parameters, including the range of modulation for each parameter, the relationship between the sensed parameters and the controlled parameters and how the modulation achieves the AECD's stated purpose. Use graphs and tables, as necessary.
(8) Describe each AECD's specific calibration details. This may be in the form of data tables, graphical representations, or some other description.
(9) Describe the hierarchy among the AECDs when multiple AECDs sense or modulate the same parameter. Describe whether the strategies interact in a comparative or additive manner and identify which AECD takes precedence in responding, if applicable.
(10) Explain the extent to which the AECD is included in the applicable test procedures specified in subpart F of this part.
(11) Do the following additional things for AECDs designed to protect engines or equipment:
(i) Identify the engine and/or equipment design limits that make protection necessary and describe any damage that would occur without the AECD.
(ii) Describe how each sensed parameter relates to the protected components' design limits or those operating conditions that cause the need for protection.
(iii) Describe the relationship between the design limits/parameters being protected and the parameters sensed or calculated as surrogates for those design limits/parameters, if applicable.
(iv) Describe how the modulation by the AECD prevents engines and/or equipment from exceeding design limits.
(v) Explain why it is necessary to estimate any parameters instead of measuring them directly and describe how the AECD calculates the estimated value, if applicable.
(vi) Describe how you calibrate the AECD modulation to activate only during conditions related to the stated need to protect components and only as needed to sufficiently protect those components in a way that minimizes the emission impact.
(c) [Reserved]
(d) Describe the engines you selected for testing and the reasons for selecting them.
(e) Describe the test equipment and procedures that you used, including any special or alternate test procedures you used (see § 1039.501).
(f) Describe how you operated the emission-data engine before testing, including the duty cycle and the number of engine operating hours used to stabilize emission levels. Explain why you selected the method of service accumulation. Describe any scheduled maintenance you did.
(g) List the specifications of the test fuel to show that it falls within the required ranges we specify in 40 CFR part 1065.
(h) Identify the engine family's useful life.
(i) Include the maintenance instructions you will give to the ultimate purchaser of each new nonroad engine (see § 1039.125).
(j) Include the emission-related installation instructions you will provide if someone else installs your engines in a piece of nonroad equipment (see § 1039.130).
(k) Describe your emission control information label (see § 1039.135).
(l) Identify the emission standards or FELs to which you are certifying engines in the engine family. Identify the ambient operating regions that will apply for NTE testing under § 1039.101(e)(4).
(m) Identify the engine family's deterioration factors and describe how you developed them (see § 1039.245). Present any emission test data you used for this.
(n) State that you operated your emission-data engines as described in the application (including the test procedures, test parameters, and test fuels) to show you meet the requirements of this part.
(o) Present emission data for hydrocarbons (such as NMHC or THCE, as applicable), NO
(p) State that all the engines in the engine family comply with the not-to-exceed emission standards we specify in subpart B of this part for all normal operation and use when tested as specified in § 1039.515. Describe any relevant testing, engineering analysis, or other information in sufficient detail to support your statement.
(q) For engines above 560 kW, include information showing how your emission controls will function during normal in-use transient operation. For example, this might include the following:
(1) Emission data from transient testing of engines using measurement systems designed for measuring in-use emissions.
(2) Comparison of the engine design for controlling transient emissions with that from engines for which you have emission data over the transient duty cycle for certification.
(3) Detailed descriptions of control algorithms and other design parameters for controlling transient emissions.
(r) Report all test results, including those from invalid tests or from any other tests, whether or not they were conducted according to the test procedures of subpart F of this part. If you measure CO
(s) Describe all adjustable operating parameters (see § 1039.115(e)), including production tolerances. Include the following in your description of each parameter:
(1) The nominal or recommended setting.
(2) The intended physically adjustable range.
(3) The limits or stops used to establish adjustable ranges.
(4) Information showing why the limits, stops, or other means of inhibiting adjustment are effective in preventing adjustment of parameters on in-use engines to settings outside your intended physically adjustable ranges.
(t) Provide the information to read, record, and interpret all the information broadcast by an engine's onboard computers and electronic control units. State that, upon request, you will give us any hardware, software, or tools we would need to do this. If you broadcast a surrogate parameter for torque values, you must provide us what we need to convert these into torque units. You may reference any appropriate publicly released standards that define conventions for these messages and parameters. Format your information consistent with publicly released standards.
(u) Confirm that your emission-related installation instructions specify how to ensure that sampling of exhaust emissions will be possible after engines are installed in equipment and placed in service. If this cannot be done by simply adding a 20-centimeter extension to the exhaust pipe, show how to sample exhaust emissions in a way that prevents diluting the exhaust sample with ambient air.
(v) State whether your certification is limited for certain engines. If this is the case, describe how you will prevent use of these engines in applications for which they are not certified. This applies for engines such as the following:
(1) Constant-speed engines.
(2) Engines used for transportation refrigeration units that you certify under the provisions of § 1039.645.
(3) Hand-startable engines certified under the provisions of § 1039.101(c).
(4) Engines above 560 kW that are not certified to emission standards for generator-set engines.
(w) Unconditionally certify that all the engines in the engine family comply with the requirements of this part, other referenced parts of the CFR, and the Clean Air Act.
(x) Include estimates of U.S.-directed production volumes.
(y) Include the information required by other subparts of this part. For example, include the information required by § 1039.725 if you participate in the ABT program.
(z) Include other applicable information, such as information specified in this part or 40 CFR part 1068 related to requests for exemptions.
If you send us information before you finish the application, we will review it and make any appropriate determinations, especially for questions related to engine family definitions, auxiliary emission-control devices, deterioration factors, testing for service accumulation, maintenance, and NTE deficiencies and carve-outs. Decisions made under this section are considered to be preliminary approval, subject to final review and approval. If you request preliminary approval related to the upcoming model year or the model year after that, we will make best-efforts to make the appropriate determinations as soon as practicable. We will generally not provide preliminary approval related to a future model year more than two years ahead of time.
You may amend your emission-related maintenance instructions after you submit your application for certification, as long as the amended instructions remain consistent with the provisions of § 1039.125. You must send the Designated Compliance Officer a request to amend your application for certification for an engine family if you want to change the emission-related maintenance instructions in a way that could affect emissions. In your request, describe the proposed changes to the maintenance instructions. We will disapprove your request if we determine that the amended instructions are inconsistent with maintenance you performed on emission-data engines.
(a) If you are decreasing the specified maintenance, you may distribute the new maintenance instructions to your customers 30 days after we receive your request, unless we disapprove your request. We may approve a shorter time or waive this requirement.
(b) If your requested change would not decrease the specified maintenance, you may distribute the new maintenance instructions anytime after you send your request. For example, this paragraph (b) would cover adding instructions to increase the frequency of a maintenance step for engines in severe-duty applications.
(c) You need not request approval if you are making only minor corrections (such as correcting typographical mistakes), clarifying your maintenance instructions, or changing instructions for maintenance unrelated to emission control.
Before we issue you a certificate of conformity, you may amend your application to include new or modified engine configurations, subject to the provisions of this section. After we have issued your certificate of conformity, you may send us an amended application requesting that we include new or modified engine configurations within the scope of the certificate, subject to the provisions of this section. You must amend your application if any changes occur with respect to any information included in your application.
(a) You must amend your application before you take either of the following actions:
(1) Add an engine (that is, an additional engine configuration) to an engine family. In this case, the engine added must be consistent with other engines in the engine family with respect to the criteria listed in § 1039.230.
(2) Change an engine already included in an engine family in a way that may affect emissions, or change any of the
(b) To amend your application for certification, send the Designated Compliance Officer the following information:
(1) Describe in detail the addition or change in the engine model or configuration you intend to make.
(2) Include engineering evaluations or data showing that the amended engine family complies with all applicable requirements. You may do this by showing that the original emission-data engine is still appropriate with respect to showing compliance of the amended family with all applicable requirements.
(3) If the original emission-data engine for the engine family is not appropriate to show compliance for the new or modified nonroad engine, include new test data showing that the new or modified nonroad engine meets the requirements of this part.
(c) We may ask for more test data or engineering evaluations. You must give us these within 30 days after we request them.
(d) For engine families already covered by a certificate of conformity, we will determine whether the existing certificate of conformity covers your new or modified nonroad engine. You may ask for a hearing if we deny your request (see § 1039.820).
(e) For engine families already covered by a certificate of conformity, you may start producing the new or modified nonroad engine anytime after you send us your amended application, before we make a decision under paragraph (d) of this section. However, if we determine that the affected engines do not meet applicable requirements, we will notify you to cease production of the engines and may require you to recall the engines at no expense to the owner. Choosing to produce engines under this paragraph (e) is deemed to be consent to recall all engines that we determine do not meet applicable emission standards or other requirements and to remedy the nonconformity at no expense to the owner. If you do not provide information required under paragraph (c) of this section within 30 days, you must stop producing the new or modified nonroad engines.
(a) Divide your product line into families of engines that are expected to have similar emission characteristics throughout the useful life. Your engine family is limited to a single model year.
(b) Group engines in the same engine family if they are the same in all the following aspects:
(1) The combustion cycle and fuel.
(2) The cooling system (water-cooled vs. air-cooled).
(3) Method of air aspiration.
(4) Method of exhaust aftertreatment (for example, catalytic converter or particulate trap).
(5) Combustion chamber design.
(6) Bore and stroke.
(7) Number of cylinders (for engines with aftertreatment devices only).
(8) Cylinder arrangement (for engines with aftertreatment devices only).
(9) Method of control for engine operation other than governing (
(10) Power category.
(11) Numerical level of the emission standards that apply to the engine.
(c) You may subdivide a group of engines that is identical under paragraph (b) of this section into different engine families if you show the expected emission characteristics are different during the useful life.
(d) You may group engines that are not identical with respect to the things listed in paragraph (b) of this section in the same engine family if you show that their emission characteristics during the useful life will be similar.
(e) If you combine engines from different power categories into a single engine family under paragraph (d) of this section, you must certify the engine family to the more stringent set of standards from the two power categories in that model year.
This section describes the emission testing you must perform to show compliance with the emission standards in § 1039.101(a) and (b) or § 1039.102(a) and (b). See § 1039.205(p) regarding emission testing related to the NTE standards. See § 1039.240, § 1039.245, and 40 CFR part 1065, subpart E, regarding service accumulation before emission testing.
(a) Test your emission-data engines using the procedures and equipment specified in subpart F of this part.
(b) Select an emission-data engine from each engine family for testing. Select the engine configuration with the highest volume of fuel injected per cylinder per combustion cycle at the point of maximum torque—unless good engineering judgment indicates that a different engine configuration is more likely to exceed (or have emissions nearer to) an applicable emission standard or FEL. If two or more engines have the same fueling rate at maximum torque, select the one with the highest fueling rate at rated speed. In making this selection, consider all factors expected to affect emission-control performance and compliance with the standards, including emission levels of all exhaust constituents, especially NO
(c) We may measure emissions from any of your test engines or other engines from the engine family, as follows:
(1) We may decide to do the testing at your plant or any other facility. If we do this, you must deliver the test engine to a test facility we designate. The test engine you provide must include appropriate manifolds, aftertreatment devices, electronic control units, and other emission-related components not normally attached directly to the engine block. If we do the testing at your plant, you must schedule it as soon as possible and make available the instruments, personnel, and equipment we need.
(2) If we measure emissions on one of your test engines, the results of that testing become the official emission results for the engine. Unless we later invalidate these data, we may decide not to consider your data in determining if your engine family meets applicable requirements.
(3) Before we test one of your engines, we may set its adjustable parameters to any point within the physically adjustable ranges (see § 1039.115(e)).
(4) Before we test one of your engines, we may calibrate it within normal production tolerances for anything we do not consider an adjustable parameter.
(d) You may ask to use emission data from a previous model year instead of doing new tests, but only if all the following are true:
(1) The engine family from the previous model year differs from the current engine family only with respect to model year.
(2) The emission-data engine from the previous model year remains the appropriate emission-data engine under paragraph (b) of this section.
(3) The data show that the emission-data engine would meet all the requirements that apply to the engine family covered by the application for certification.
(e) We may require you to test a second engine of the same or different configuration in addition to the engine tested under paragraph (b) of this section.
(f) If you use an alternate test procedure under 40 CFR 1065.10 and later testing shows that such testing does not produce results that are equivalent to the procedures specified in subpart F of this part, we may reject data you generated using the alternate procedure.
(a) For purposes of certification, your engine family is considered in compliance with the applicable numerical emission standards in § 1039.101(a) and (b) or in § 1039.102(a) and (b) if all emission-data engines representing that family have test results showing deteriorated emission levels at or below these standards. (
(b) Your engine family is deemed not to comply if any emission-data engine representing that family has test results showing a deteriorated emission level above an applicable FEL or emission standard from § 1039.101 for any pollutant.
(c) To compare emission levels from the emission-data engine with the applicable emission standards, apply deterioration factors to the measured emission levels for each pollutant. Section 1039.245 specifies how to test your engine to develop deterioration factors that represent the deterioration expected in emissions over your engines' full useful life. Your deterioration factors must take into account any available data from in-use testing with similar engines. Small-volume engine manufacturers may use assigned deterioration factors that we establish. Apply deterioration factors as follows:
(1)
(2)
(3)
(4)
(d) Collect emission data using measurements to one more decimal place than the applicable standard. Apply the deterioration factor to the official emission result, as described in paragraph (c) of this section, then round the adjusted figure to the same number of decimal places as the emission standard. Compare the rounded emission levels to the emission standard for each emission-data engine. In the case of NO
(e) For engines subject to NMHC standards, you may base compliance on total hydrocarbon (THC) emissions. Indicate in your application for certification if you are using this option. If you do, measure THC emissions and calculate NMHC emissions as 98 percent of THC emissions, as shown in the following equation:
Establish deterioration factors to determine whether your engines will meet emission standards for each pollutant throughout the useful life, as described in §§ 1039.101 and 1039.240. This
(a) You may ask us to approve deterioration factors for an engine family with established technology based on engineering analysis instead of testing. Engines certified to a NO
(b) You may ask us to approve deterioration factors for an engine family based on emission measurements from similar highway or nonroad engines if you have already given us these data for certifying the other engines in the same or earlier model years. Use good engineering judgment to decide whether the two engines are similar. We will approve your request if you show us that the emission measurements from other engines reasonably represent in-use deterioration for the engine family for which you have not yet determined deterioration factors.
(c) If you are unable to determine deterioration factors for an engine family under paragraph (a) or (b) of this section, select engines, subsystems, or components for testing. Determine deterioration factors based on service accumulation and related testing to represent the deterioration expected from in-use engines over the full useful life. You must measure emissions from the emission-data engine at least three times with evenly spaced intervals of service accumulation. You may use extrapolation to determine deterioration factors once you have established a trend of changing emissions with age for each pollutant. You may use an engine installed in nonroad equipment to accumulate service hours instead of running the engine only in the laboratory. You may perform maintenance on emission-data engines as described in § 1039.125 and 40 CFR part 1065, subpart E. Use good engineering judgment for all aspects of the effort to establish deterioration factors under this paragraph (c).
(d) Include the following information in your application for certification:
(1) If you use test data from a different engine family, explain why this is appropriate and include all the emission measurements on which you base the deterioration factor.
(2) If you determine your deterioration factors based on engineering analysis, explain why this is appropriate and include a statement that all data, analyses, evaluations, and other information you used are available for our review upon request.
(3) If you do testing to determine deterioration factors, describe the form and extent of service accumulation, including a rationale for selecting the service-accumulation period and the method you use to accumulate hours.
(a) Within 30 days after the end of the model year, send the Designated Compliance Officer a report describing the following information about engines you produced during the model year:
(1) Report the total number of engines you produced in each engine family by maximum engine power, total displacement, and the type of fuel system.
(2) If you produced exempted engines under the provisions of § 1039.625, report the number of exempted engines you produced for each engine model and identify the buyer or shipping destination for each exempted engine.
(b) Organize and maintain the following records:
(1) A copy of all applications and any summary information you send us.
(2) Any of the information we specify in § 1039.205 that you were not required to include in your application.
(3) A detailed history of each emission-data engine. For each engine, describe all of the following:
(i) The emission-data engine's construction, including its origin and buildup, steps you took to ensure that it represents production engines, any components you built specially for it, and all the components you include in your application for certification.
(ii) How you accumulated engine operating hours (service accumulation), including the dates and the number of hours accumulated.
(iii) All maintenance, including modifications, parts changes, and other service, and the dates and reasons for the maintenance.
(iv) All your emission tests, including documentation on routine and standard tests, as specified in part 40 CFR part 1065, and the date and purpose of each test.
(v) All tests to diagnose engine or emission-control performance, giving the date and time of each and the reasons for the test.
(vi) Any other significant events.
(4) Production figures for each engine family divided by assembly plant.
(5) Keep a list of engine identification numbers for all the engines you produce under each certificate of conformity.
(c) Keep data from routine emission tests (such as test cell temperatures and relative humidity readings) for one year after we issue the associated certificate of conformity. Keep all other information specified in paragraph (a) of this section for eight years after we issue your certificate.
(d) Store these records in any format and on any media, as long as you can promptly send us organized, written records in English if we ask for them. You must keep these records readily available. We may review them at any time.
(e) Send us copies of any engine maintenance instructions or explanations if we ask for them.
(a) If we determine your application is complete and shows that the engine family meets all the requirements of this part and the Act, we will issue a certificate of conformity for your engine family for that model year. We may make the approval subject to additional conditions.
(b) We may deny your application for certification if we determine that your engine family fails to comply with emission standards or other requirements of this part or the Act. Our decision may be based on a review of all information available to us. If we deny your application, we will explain why in writing.
(c) In addition, we may deny your application or suspend or revoke your certificate if you do any of the following:
(1) Refuse to comply with any testing or reporting requirements.
(2) Submit false or incomplete information (paragraph (e) of this section applies if this is fraudulent).
(3) Render inaccurate any test data.
(4) Deny us from completing authorized activities despite our presenting a warrant or court order (see 40 CFR 1068.20). This includes a failure to provide reasonable assistance.
(5) Produce engines for importation into the United States at a location where local law prohibits us from carrying out authorized activities.
(6) Fail to supply requested information or amend your application to include all engines being produced.
(7) Take any action that otherwise circumvents the intent of the Act or this part.
(d) We may void your certificate if you do not keep the records we require or do not give us information when we ask for it.
(e) We may void your certificate if we find that you intentionally submitted false or incomplete information.
(f) If we deny your application or suspend, revoke, or void your certificate, you may ask for a hearing (see § 1039.820).
As specified elsewhere in this part or in 40 CFR part 1068, you may in some cases introduce engines into commerce that are exempt from the requirement
(a) Your engines must meet the alternate standards we specify in the exemption section, and all other requirements applicable to engines that are subject to such standards.
(b) You need not apply for and receive a certificate for the exempt engines. However, you must comply with all the requirements and obligations that would apply to the engines if you had received a certificate of conformity for them, unless we specifically waive certain requirements.
(c) You must have emission data from testing engines using the appropriate procedures that demonstrate compliance with the alternate standards, unless the engines are identical in all material respects to engines that you have previously certified to standards that are the same as, or more stringent than, the alternate standards.
(d) Unless we specify otherwise elsewhere in this part or in 40 CFR part 1068, you must meet the labeling requirements in § 1039.135, with the following exceptions:
(1) Instead of the engine family designation specified in § 1039.135(c)(3), use a modified designation to identify the group of engines that would otherwise be included in the same engine family.
(2) Instead of the compliance statement in § 1039.135(c)(12), add the following statement: “THIS ENGINE MEETS U.S. EPA EMISSION STANDARDS UNDER 40 CFR 1039.260.”.
(e) You may not generate ABT credits with engines meeting requirements under the provisions of this section.
(f) Keep records to show that you meet the alternate standards, as follows:
(1) If your exempted engines are identical to previously certified engines, keep your most recent application for certification for the certified engine family.
(2) If you previously certified a similar engine family, but have modified the exempted engine in a way that changes it from its previously certified configuration, keep your most recent application for certification for the certified engine family, a description of the relevant changes, and any test data or engineering evaluations that support your conclusions.
(3) If you have not previously certified a similar engine family, keep all the records we specify for the application for certification and the additional records we specify in § 1039.250(b)(3).
(g) We may require you to send us an annual report of the engines you produce under this section.
We may perform in-use testing of any engine subject to the standards of this part. However, we will limit recall testing to the first 75 percent of each engine's useful life as specified in § 1039.101(g).
(a) Use the equipment and procedures for compression-ignition engines in 40 CFR part 1065 to determine whether engines meet the duty-cycle emission standards in § 1039.101(a) and (b). Measure the emissions of all the pollutants we regulate in § 1039.101 as specified in 40 CFR part 1065. Note that we do not allow partial-flow sampling for measuring PM emissions on a laboratory dynamometer for transient testing. Use the applicable duty cycles specified in §§ 1039.505 and 1039.510.
(b) Section 1039.515 describes the supplemental procedures for evaluating whether engines meet the not-to-exceed emission standards in § 1039.101(e).
(c) Measure smoke using the procedures in 40 CFR part 86, subpart I, for evaluating whether engines meet the smoke standards in § 1039.105, except that you may test two-cylinder engines with an exhaust muffler like those installed on in-use engines.
(d) Use the fuels specified in § 1039.104(e) and 40 CFR part 1065 to perform valid tests.
(1) For service accumulation, use the test fuel or any commercially available fuel that is representative of the fuel that in-use engines will use.
(2) For diesel-fueled engines, use the appropriate diesel fuel specified in 40 CFR part 1065 for emission testing. Unless we specify otherwise, the appropriate diesel test fuel is the ultra low-sulfur diesel fuel. If we allow you to use a test fuel with higher sulfur levels, identify the test fuel in your application for certification and ensure that the emission control information label is consistent with your selection of the test fuel (see § 1039.135(c)(9)). For example, do not test with ultra low-sulfur diesel fuel if you intend to label your engines to allow use of diesel fuel with sulfur concentrations up to 500 ppm.
(e) You may use special or alternate procedures to the extent we allow them under 40 CFR 1065.10.
(f) This subpart is addressed to you as a manufacturer, but it applies equally to anyone who does testing for you, and to us when we perform testing to determine if your engines meet emission standards.
This section describes how to test engines under steady-state conditions. In some cases, we allow you to choose the appropriate steady-state duty cycle for an engine. In these cases, you must use the duty cycle you select in your application for certification for all testing you perform for that engine family. If we test your engines to confirm that they meet emission standards, we will use the duty cycles you select for your own testing. We may also perform other testing as allowed by the Clean Air Act.
(a) You may perform steady-state testing with either discrete-mode or ramped-modal cycles, as follows:
(1) For discrete-mode testing, sample emissions separately for each mode, then calculate an average emission level for the whole cycle using the weighting factors specified for each mode. Calculate cycle statistics for the sequence of modes and compare with the specified values in 40 CFR part 1065 to confirm that the test is valid. Operate the engine and sampling system as follows:
(i)
(ii)
(2) For ramped-modal testing, start sampling at the beginning of the first mode and continue sampling until the end of the last mode. Calculate emissions and cycle statistics the same as for transient testing.
(b) Measure emissions by testing the engine on a dynamometer with one of the following duty cycles to determine whether it meets the steady-state emission standards in § 1039.101(b):
(1) Use the 5-mode duty cycle or the corresponding ramped-modal cycle described in Appendix II of this part for constant-speed engines. Note that these cycles do not apply to all engines used in constant-speed applications, as described in § 1039.801.
(2) Use the 6-mode duty cycle or the corresponding ramped-modal cycle described in Appendix III of this part for variable-speed engines below 19 kW. You may instead use the 8-mode duty cycle or the corresponding ramped-modal cycle described in Appendix IV of this part if some engines from your engine family will be used in applications that do not involve governing to maintain engine operation around rated speed.
(3) Use the 8-mode duty cycle or the corresponding ramped-modal cycle described in Appendix IV of this part for variable-speed engines at or above 19 kW.
(c) During idle mode, operate the engine with the following parameters:
(1) Hold the speed within your specifications.
(2) Set the engine to operate at its minimum fueling rate.
(3) Keep engine torque under 5 percent of maximum test torque.
(d) For full-load operating modes, operate the engine at its maximum fueling rate. However, for constant-speed engines whose design prevents full-load operation for extended periods, you may ask for approval under 40 CFR 1065.10(c) to replace full-load operation with the maximum load for which the engine is designed to operate for extended periods.
(e) See 40 CFR part 1065 for detailed specifications of tolerances and calculations.
(f) For those cases where transient testing is not necessary, perform the steady-state test according to this section after an appropriate warm-up period, consistent with 40 CFR part 1065, subpart F.
(a) Measure emissions by testing the engine on a dynamometer with one of the following transient duty cycles to determine whether it meets the transient emission standards in § 1039.101(a):
(1) For variable-speed engines, use the transient duty cycle described in Appendix VI of this part.
(2) [Reserved]
(b) The transient test sequence consists of an initial run through the transient duty cycle from a cold start, 20 minutes with no engine operation, then a final run through the same transient duty cycle. Start sampling emissions immediately after you start the engine. Calculate the official transient emission result from the following equation:
(c) Cool the engine down between tests as described in 40 CFR 86.1335-90.
(d) For validating cycle statistics, you may delete from your regression analysis speed, torque, and power points for the first 23 seconds and the last 25 seconds of the transient duty cycle.
(a)
(b)
(1) If the C speed is below 2400 rpm, exclude the speed and load points to the right of or below the line formed by connecting the following two points on a plot of speed-vs.-power:
(i) 30% of maximum power at the B speed; however, use the power value corresponding to the engine operation at 30% of maximum torque at the B speed if this is greater than 30% of maximum power at the B speed.
(ii) 70% of maximum power at 100% speed.
(2) If the C speed is at or above 2400 rpm, exclude the speed and load points to the right of the line formed by connecting the two points in paragraphs (b)(2)(i) and (ii) of this section (the 30% and 50% torque/power points) and below the line formed by connecting the two points in paragraphs (b)(2)(ii) and (iii) of this section (the 50% and 70% torque/power points). The 30%, 50%, and 70% torque/power points are defined as follows:
(i) 30% of maximum power at the B speed; however, use the power value corresponding to the engine operation at 30% of maximum torque at the B speed if this is greater than 30% of maximum power at the B speed.
(ii) 50% of maximum power at 2400 rpm.
(iii) 70% of maximum power at 100% speed.
Sections 1039.240 and 1039.245 describe the method for testing that must be performed to establish deterioration factors for an engine family.
This section describes how to adjust emission results from engines using aftertreatment technology with infrequent regeneration events. For this section, “regeneration” means an intended event during which emission levels change while the system restores aftertreatment performance. For example, exhaust gas temperatures may increase temporarily to remove sulfur from adsorbers or to oxidize accumulated particulate matter in a trap. For this section, “infrequent” refers to regeneration events that are expected to occur on average less than once over the applicable transient duty cycle or ramped-modal cycle, or on average less than once per typical mode in a discrete-mode test.
(a)
(1) You may disregard this section if regeneration does not significantly affect emission levels for an engine family (or configuration) or if it is not practical to identify when regeneration occurs. If you do not use adjustment factors under this section, your engines must meet emission standards for all testing, without regard to regeneration.
(2) If your engines use aftertreatment technology with extremely infrequent regeneration and you are unable to apply the provisions of this section, you may ask us to approve an alternate methodology to account for regeneration events.
(b)
(c)
(1) If regeneration does not occur during a test segment, add an upward adjustment factor to the measured emission rate. Determine the upward adjustment factor (UAF) using the following equation:
(2) If regeneration occurs or starts to occur during a test segment, subtract a downward adjustment factor from the measured emission rate. Determine the downward adjustment factor (DAF) using the following equation:
(d)
Engine and equipment manufacturers, as well as owners, operators, and rebuilders of engines subject to the requirements of this part, and all other persons, must observe the provisions of this part, the requirements and prohibitions in 40 CFR part 1068, and the provisions of the Act.
(a)
(b)
(c)
(d)
(1) Your engine must be covered by a valid certificate of conformity issued under 40 CFR part 86.
(2) You must not make any changes to the certified engine that could reasonably be expected to increase its exhaust emissions for any pollutant, or its evaporative emissions if it is subject to evaporative-emission standards. For example, if you make any of the following changes to one of these engines, you do not qualify for this exemption:
(i) Change any fuel system parameters from the certified configuration.
(ii) Change, remove, or fail to properly install any other component, element of design, or calibration specified in the engine manufacturer's application for certification. This includes aftertreatment devices and all related components.
(iii) Modify or design the engine cooling system so that temperatures or heat rejection rates are outside the original engine manufacturer's specified ranges.
(3) You must show that fewer than 50 percent of the engine model's total sales for the model year, from all companies, are used in nonroad applications, as follows:
(i) If you are the original manufacturer of the engine, base this showing on your sales information.
(ii) In all other cases, you must get the original manufacturer of the engine to confirm this based on its sales information.
(4) You must ensure that the engine has the label we require under 40 CFR part 86.
(5) You must add a permanent supplemental label to the engine in a position where it will remain clearly visible after installation in the equipment. In the supplemental label, do the following:
(i) Include the heading: “NONROAD ENGINE EMISSION CONTROL INFORMATION”.
(ii) Include your full corporate name and trademark. You may instead include the full corporate name and trademark of another company you choose to designate.
(iii) State: “THIS ENGINE WAS ADAPTED FOR NONROAD USE WITHOUT AFFECTING ITS EMISSION CONTROLS. THE EMISSION-CONTROL SYSTEM DEPENDS ON THE USE OF FUEL MEETING SPECIFICATIONS THAT APPLY FOR MOTOR-VEHICLE APPLICATIONS. OPERATING THE ENGINE ON OTHER FUELS MAY BE A VIOLATION OF FEDERAL LAW.”.
(iv) State the date you finished modifying the engine (month and year), if applicable.
(6) The original and supplemental labels must be readily visible after the engine is installed in the equipment or, if the equipment obscures the engine's emission control information label, the equipment manufacturer must attach duplicate labels, as described in 40 CFR 1068.105.
(7) You must make sure that nonroad equipment produced under this section will have the fueling label we specify in § 1039.135(c)(9)(i).
(8) Send the Designated Compliance Officer a signed letter by the end of each calendar year (or less often if we tell you) with all the following information:
(i) Identify your full corporate name, address, and telephone number.
(ii) List the engine models you expect to produce under this exemption in the coming year.
(iii) State: “We produce each listed engine model for nonroad application without making any changes that could increase its certified emission levels, as described in 40 CFR 1039.605.”.
(e)
(f)
(a)
(b)
(c)
(d)
(1) Your equipment must be covered by a valid certificate of conformity as a motor vehicle issued under 40 CFR part 86.
(2) You must not make any changes to the certified vehicle that we could reasonably expect to increase its exhaust emissions for any pollutant, or its evaporative emissions if it is subject to evaporative-emission standards. For example, if you make any of the following changes, you do not qualify for this exemption:
(i) Change any fuel system parameters from the certified configuration.
(ii) Change, remove, or fail to properly install any other component, element of design, or calibration specified in the vehicle manufacturer's application for certification. This includes aftertreatment devices and all related components.
(iii) Modify or design the engine cooling system so that temperatures or heat rejection rates are outside the original vehicle manufacturer's specified ranges.
(iv) Add more than 500 pounds to the curb weight of the originally certified motor vehicle.
(3) You must show that fewer than 50 percent of the total sales as a motor vehicle or a piece of nonroad equipment, from all companies, are used in nonroad applications, as follows:
(i) If you are the original manufacturer of the vehicle, base this showing on your sales information.
(ii) In all other cases, you must get the original manufacturer of the vehicle to confirm this based on their sales information.
(4) The equipment must have the vehicle emission control information and fuel labels we require under 40 CFR 86.007-35.
(5) You must add a permanent supplemental label to the equipment in a position where it will remain clearly visible. In the supplemental label, do the following:
(i) Include the heading: “NONROAD ENGINE EMISSION CONTROL INFORMATION”.
(ii) Include your full corporate name and trademark. You may instead include the full corporate name and trademark of another company you choose to designate.
(iii) State: “THIS VEHICLE WAS ADAPTED FOR NONROAD USE WITHOUT AFFECTING ITS EMISSION CONTROLS. THE EMISSION-CONTROL SYSTEM DEPENDS ON THE USE OF FUEL MEETING SPECIFICATIONS THAT APPLY FOR MOTOR-VEHICLE APPLICATIONS. OPERATING THE ENGINE ON OTHER FUELS MAY BE A VIOLATION OF FEDERAL LAW.”.
(iv) State the date you finished modifying the vehicle (month and year), if applicable.
(6) The original and supplemental labels must be readily visible in the fully assembled equipment.
(7) Send the Designated Compliance Officer a signed letter by the end of each calendar year (or less often if we
(i) Identify your full corporate name, address, and telephone number.
(ii) List the equipment models you expect to produce under this exemption in the coming year.
(iii) State: “We produce each listed engine or equipment model for nonroad application without making any changes that could increase its certified emission levels, as described in 40 CFR 1039.610.”.
(e)
(f)
In § 1039.115(e), we generally require that engines meet emission standards for any adjustment within the full range of any adjustable parameters. For engines that use noncommercial fuels significantly different than the specified test fuel of the same type, you may ask to use the parameter-adjustment provisions of this section instead of those in § 1039.115(e). Engines certified under this section must be in a separate engine family.
(a) If we approve your request, the following provisions apply:
(1) You must certify the engine using the test fuel specified in § 1039.501.
(2) You may produce the engine without limits or stops that keep the engine adjusted within the certified range.
(3) You must specify in-use adjustments different than the adjustable settings appropriate for the specified test fuel, consistent with the provisions of paragraph (b)(1) of this section.
(b) To produce engines under this section, you must do the following:
(1) Specify in-use adjustments needed so the engine's level of emission control for each regulated pollutant is equivalent to that from the certified configuration.
(2) Add the following information to the emission control information label specified in § 1039.135:
(i) Include instructions describing how to adjust the engine to operate in a way that maintains the effectiveness of the emission-control system.
(ii) State: “THIS ENGINE IS CERTIFIED TO OPERATE IN APPLICATIONS USING NONCOMMERCIAL FUEL. MALADJUSTMENT OF THE ENGINE IS A VIOLATION OF FEDERAL LAW SUBJECT TO CIVIL PENALTY.”.
(3) Keep records to document the destinations and quantities of engines produced under this section.
The provisions of this section apply for new engines built on or after January 1, 2006.
(a) Equipment manufacturers may use uncertified engines if the vehicles or equipment in which they are installed will be used solely for competition.
(b) The definition of nonroad engine in 40 CFR 1068.30 excludes engines used solely for competition. These engines are not required to comply with this part 1039 or 40 CFR part 89, but 40 CFR 1068.101 prohibits the use of competition engines for noncompetition purposes.
(c) We consider a vehicle or piece of equipment to be one that will be used solely for competition if it has features that are not easily removed that would make its use other than in competition unsafe, impractical, or highly unlikely.
(d) As an engine manufacturer, your engine is exempt without our prior approval if you have a written request for an exempted engine from the equipment manufacturer showing the basis for believing that the equipment will be used solely for competition. You
(e) We may discontinue an exemption under this section if we find that engines are not used solely for competition.
The provisions of this section allow equipment manufacturers to produce equipment with engines that are subject to less stringent emission standards after the Tier 4 emission standards begin to apply. To be eligible to use these provisions, you must follow all the instructions in this section.
(a)
(1) These provisions are available for the years shown in the following table, except as provided in paragraph (a)(2) of this section:
(2) If you do not use any allowances in a power category before the earliest dates shown in the following table, you may delay the start of the seven-year period for using allowances under this section as follows:
(b)
(1)
(2)
(i) You may produce up to 700 units with exempted engines within a power category during the seven-year period specified in paragraph (a) of this section, with no more than 200 units in any single year within a power category, except as provided in paragraph (m) of this section. Engines within a
(ii) For engines below 130 kW, you may produce up to 525 units with exempted engines within a power category during the seven-year period specified in paragraph (a) of this section, with no more than 150 units in any single year within a power category, except as provided in paragraph (m) of this section. For engines at or above 130 kW, you may produce up to 350 units with exempted engines within a power category during the seven-year period, with no more than 100 units in any single year within a power category.emptions under this paragraph (b)(2)(ii) may apply to engines from multiple engine families in a given year.
(c)
(d)
(1) If you use the provisions of § 1068.105(a) to use up your inventories of engines not certified to new emission standards, do not include these units in your count of equipment with exempted engines under paragraph (b) of this section. However, you may include these units in your count of total equipment you produce for the given year for the percentage calculation in paragraph (b)(1) of this section.
(2) If you install engines that are exempted from the Tier 4 standards for any reason, other than for equipment-manufacturer allowances under this section, do not include these units in your count of exempted engines under paragraph (b) of this section. However, you may include these units in your count of total equipment you produce for the given year for the percentage calculation in paragraph (b)(1) of this section. For example, if we grant a hardship exemption for the engine manufacturer, you may count these as compliant engines under this section. This paragraph (d)(2) applies only if the engine has a permanent label describing why it is exempted from the Tier 4 standards.
(3) Do not include equipment using model year 2008 or 2009 engines certified under the provisions of § 1039.101(c) in your count of equipment using exempted engines. However, you may include these units in your count of total equipment you produce for the given year for the percentage calculation in paragraph (b)(1) of this section.
(4) You may start using the allowances under this section for engines that are not yet subject to Tier 4 standards, as long as the seven-year period for using allowances under the Tier 2 or Tier 3 program has expired (see 40 CFR 89.102(d)). Table 3 of this section shows the years for which this applies. To use these early allowances, you must use engines that meet the emission standards described in paragraph (e) of this section. You must also count these units or calculate these percentages as described in paragraph (c) of this section and apply them toward the total number or percentage of equipment with exempted engines we allow for the Tier 4 standards as described in paragraph (b) of this section. The maximum number of cumulative early allowances under this paragraph (d)(4) is 10 percent under the percent-of-production allowance or 100 units under the small-volume allowance. For example, if you produce 5 percent of your equipment with engines between 130 and 560 kW that use allowances under this paragraph (d)(4) in 2009, you may use up to an additional 5 percent of your allowances in 2010. If you use allowances for 5 percent of your equipment in both 2009 and 2010, your 80 percent allowance for 2011-2017 in the 130-560 kW power category decreases to 70 percent. Manufacturers using allowances under this paragraph (d)(4) must comply with the notification and reporting requirements specified in paragraph (g) of this section.
(e)
(1) If you are using the provisions of paragraph (d)(4) of this section, engines must meet the applicable Tier 1 emission standards described in § 89.112.
(2) If you are using the provisions of paragraph (a)(2) of this section, engines must be certified under this part 1039 as follows:
(3) In all other cases, engines at or above 37 kW and at or below 560 kW must meet the appropriate Tier 3 standards described in § 89.112. Engines below 37 kW and engines above 560 kW must meet the appropriate Tier 2 standards described in § 89.112.
(f)
(1) The label heading “EMISSION CONTROL INFORMATION”.
(2) Your corporate name and trademark.
(3) The calendar year in which the equipment is manufactured.
(4) The name, e-mail address, and phone number of a person to contact for further information.
(5) The following statement:
(g)
(1) Before January 1 of the first year you intend to use the provisions of this section, send the Designated Compliance Officer and the Designated Enforcement Officer a written notice of your intent, including:
(i) Your company's name and address, and your parent company's name and address, if applicable.
(ii) Whom to contact for more information.
(iii) The calendar years in which you expect to use the exemption provisions of this section.
(iv) The name and address of the company that produces the engines you will be using for the equipment exempted under this section.
(v) Your best estimate of the number of units in each power category you will produce under this section and whether you intend to comply under paragraph (b)(1) or (b)(2) of this section.
(vi) The number of units in each power category you have sold in previous calendar years under 40 CFR 89.102(d).
(2) For each year that you use the provisions of this section, send the Designated Compliance Officer and the Designated Enforcement Officer a written report by March 31 of the following year. Include in your report the total number of engines you sold in the preceding year for each power category, based on actual U.S.-directed production information. Also identify the percentages of U.S.-directed production that correspond to the number of units in each power category and the cumulative numbers and percentages of units for all the units you have sold under this section for each power category. You may omit the percentage figures if you include in the report a statement that you will not be using the percent-of-production allowances in paragraph (b)(1) of this section.
(h)
(1) The model number, serial number, and the date of manufacture for each engine and piece of equipment.
(2) The maximum power of each engine.
(3) The total number or percentage of equipment with exempted engines, as described in paragraph (b) of this section and all documentation supporting your calculation.
(4) The notifications and reports we require under paragraph (g) of this section.
(i)
(j)
(k)
(l) [Reserved]
(m)
(1) We may approve additional exemptions if extreme and unusual circumstances that are clearly outside your control and that could not have been avoided with reasonable discretion have resulted in technical or engineering problems that prevent you from meeting the requirements of this part. You must show that you exercised prudent planning and have taken all reasonable steps to minimize the scope of your request for additional allowances.
(2) To apply for exemptions under this paragraph (m), send the Designated Compliance Officer and the Designated Enforcement Officer a written request as soon as possible before you are in violation. In your request, include the following information:
(i) Describe your process for designing equipment.
(ii) Describe how you normally work cooperatively or concurrently with
(iii) Describe the engineering or technical problems causing you to request the exemption and explain why you have not been able to solve them. Describe the extreme and unusual circumstances that led to these problems and explain how they were unavoidable.
(iv) Describe any information or products you received from your engine supplier related to equipment design—such as written specifications, performance data, or prototype engines—and when you received it.
(v) Compare the design processes of the equipment model for which you need additional exemptions and that for other models for which you do not need additional exemptions. Explain the technical differences that justify your request.
(vi) Describe your efforts to find and use other compliant engines, or otherwise explain why none is available.
(vii) Describe the steps you have taken to minimize the scope of your request.
(viii) Include other relevant information. You must give us other relevant information if we ask for it.
(ix) Estimate the increased percent of production you need for each equipment model covered by your request, as described in paragraph (m)(3) of this section. Estimate the increased number of allowances you need for each equipment model covered by your request, as described in paragraph (m)(4) of this section.
(3) We may approve your request to increase the allowances under paragraph (b)(1) of this section, subject to the following limitations:
(i) The additional allowances will not exceed 70 percent for each power category.
(ii) You must use up the allowances under paragraph (b)(1) of this section before using any additional allowance under this paragraph (m).
(iii) Any allowances we approve under this paragraph (m)(3) expire 24 months after the provisions of this section start for a given power category, as described in paragraph (a) of this section. You may use these allowances only for the specific equipment models covered by your request.
(4) We may approve your request to increase the allowances for the 19-56 kW power category under paragraph (b)(2) of this section, subject to the following limitations:
(i) You are eligible for additional allowances under this paragraph (m)(4) only if you are a small equipment manufacturer and you do not use the provisions of paragraph (m)(3) of this section to obtain additional allowances for the 19-56 kW power category.
(ii) You must use up all the available allowances for the 19-56 kW power category under paragraph (b)(2) of this section in a given year before using any additional allowances under this paragraph (m)(4).
(iii) Base your request only on equipment you produce with engines at or above 19 kW and below 37 kW. You may use any additional allowances only for equipment you produce with engines at or above 19 kW and below 37 kW.
(iv) The total allowances under either paragraph (b)(2)(i) or (ii) of this section for the 19-56 kW power category will not exceed 1,100 units.
(v) Any allowances we approve under this paragraph (m)(4) expire 36 months after the provisions of this section start for this power category, as described in paragraph (a) of this section. These additional allowances are not subject to the annual limits specified in paragraph (b)(2) of this section. You may use these allowances only for the specific equipment models covered by your request.
(5) For purposes of this paragraph (m),
This section describes requirements that apply to equipment manufacturers using the provisions of § 1039.625 for equipment produced outside the United States. Note that § 1039.625 limits these provisions to equipment manufacturers that install some engines and have primary responsibility for designing and manufacturing equipment. Companies that import equipment into the United States without meeting these criteria are not eligible for these allowances. Such importers may import equipment with exempted engines only as described in paragraph (b) of this section.
(a) As a foreign equipment manufacturer, you or someone else may import equipment with exempted engines under this section if you comply with the provisions in § 1039.625 and commit to the following:
(1) Give any EPA inspector or auditor complete and immediate access to inspect and audit, as follows:
(i) Inspections and audits may be announced or unannounced.
(ii) Inspections and audits may be by EPA employees or EPA contractors.
(iii) You must provide access to any location where—
(A) Any nonroad engine, equipment, or vehicle is produced or stored.
(B) Documents related to manufacturer operations are kept.
(C) Equipment, engines, or vehicles are tested or stored for testing.
(iv) You must provide any documents requested by an EPA inspector or auditor that are related to matters covered by the inspections or audit.
(v) EPA inspections and audits may include review and copying of any documents related to demonstrating compliance with the exemptions in § 1039.625.
(vi) EPA inspections and audits may include inspection and evaluation of complete or incomplete equipment, engines, or vehicles, and interviewing employees.
(vii) You must make any of your employees available for interview by the EPA inspector or auditor, on request, within a reasonable time period.
(viii) You must provide English language translations of any documents to an EPA inspector or auditor, on request, within 10 working days.
(ix) You must provide English-language interpreters to accompany EPA inspectors and auditors, on request.
(2) Name an agent for service of process located in the District of Columbia. Service on this agent constitutes service on you or any of your officers or employees for any action by EPA or otherwise by the United States related to the requirements of this part.
(3) The forum for any civil or criminal enforcement action related to the provisions of this section for violations of the Clean Air Act or regulations promulgated thereunder shall be governed by the Clean Air Act.
(4) The substantive and procedural laws of the United States shall apply to any civil or criminal enforcement action against you or any of your officers or employees related to the provisions of this section.
(5) Provide the notification required by § 1039.625(g). Include in the notice of intent in § 1039.625(g)(1) a commitment to comply with the requirements and obligations of § 1039.625 and this section. This commitment must be signed by the owner or president.
(6) You, your agents, officers, and employees must not seek to detain or to impose civil or criminal remedies against EPA inspectors or auditors, whether EPA employees or EPA contractors, for actions performed within the scope of EPA employment related to the provisions of this section.
(7) By submitting notification of your intent to use the provisions of § 1039.625, producing and exporting for resale to the United States nonroad equipment under this section, or taking other actions to comply with the requirements of this part, you, your agents, officers, and employees, without exception, become subject to the full operation of the administrative and judicial enforcement powers and provisions of the United States as described in 28 U.S.C. 1605(a)(2), without limitation based on sovereign immunity, for conduct that violates the requirements applicable to you under
(8) Any report or other document you submit to us must be in the English language, or include a complete translation in English.
(9) You must post a bond to cover any potential enforcement actions under the Clean Air Act before you or anyone else imports your equipment under this section, as follows:
(i) The value of the bond is based on the per-engine bond values shown in Table 1 of this section and on the highest number of engines in each power category you produce in any single calendar year under the provisions of § 1039.625. For example, if you have projected U.S.-directed production volumes of 100 exempt engines in the 19-56 kW power category and 300 exempt engines in the 56-130 kW power category in 2013, the appropriate bond amount is $180,000. If your estimated or actual engine imports increase beyond the level appropriate for your current bond payment, you must post additional bond to reflect the increased sales within 90 days after you change your estimate or determine the actual sales. You may not decrease your bond.
(ii) You may meet the bond requirements of this section with any of the following methods:
(A) Get a bond from a third-party surety that is cited in the U.S. Department of Treasury Circular 570, “Companies Holding Certificates of Authority as Acceptable Sureties on Federal Bonds and as Acceptable Reinsuring Companies.” Maintain this bond for five years after the applicable allowance period expires, or five years after you use up all the available allowances under § 1039.625, whichever comes first.
(B) Get the Designated Enforcement Officer to approve a waiver from the bonding requirement, as long as you can show that you have assets of an appropriate liquidity and value readily available in the United States.
(iii) If you forfeit some or all of your bond in an enforcement action, you must post any appropriate bond for continuing importation within 90 days after you forfeit the bond amount.
(iv) You will forfeit the proceeds of the bond posted under this paragraph (a)(9) if you need to satisfy any United States administrative final order or judicial judgment against you arising from your conduct in violation of this part 1039, including such conduct that violates 18 U.S.C. 1001, 42 U.S.C. 7413(c)(2), or other applicable provisions of the Clean Air Act.
(b) The provisions of this paragraph (b) apply to importers that do not install engines into equipment and do not have primary responsibility for designing and manufacturing equipment. Such importers may import equipment with engines exempted under § 1039.625 only if each engine is exempted under an allowance provided to an equipment manufacturer meeting the requirements of § 1039.625 and this section. You must notify us of your intent to use the provisions of this section and send us an annual report, as follows:
(1) Before January 1 of the first year you intend to use the provisions of this section, send the Designated Compliance Officer and the Designated Enforcement Officer a written notice of your intent, including:
(i) Your company's name and address, and your parent company's name and address, if applicable.
(ii) The name and address of the companies that produce the equipment and engines you will be importing under this section.
(iii) Your best estimate of the number of units in each power category you will import under this section in the upcoming calendar year, broken down by equipment manufacturer and power category.
(iv) The number of units in each power category you have imported in previous calendar years under 40 CFR 89.102(d).
(2) For each year that you use the provisions of this section, send the Designated Compliance Officer and the Designated Enforcement Officer a written report by March 31 of the following year. Include in your report the total number of engines you imported under this section in the preceding calendar year, broken down by engine manufacturer and by equipment manufacturer.
This section allows equipment manufacturers to generate additional allowances under the provisions of § 1039.625 by producing equipment using engines at or above 19 kW certified to specified levels earlier than otherwise required.
(a) For early-compliant engines to generate offsets for use under this section, the following general provisions apply:
(1) The engine manufacturer must comply with the provisions of § 1039.104(a)(1) for the offset-generating engines.
(2) Engines you install in your equipment after December 31 of the years specified in § 1039.104(a)(1) do not generate allowances under this section, even if the engine manufacturer generated offsets for that engine under § 1039.104(a).
(3) Offset-generating engines must be certified to the following standards under this part 1039:
(b)
(i) For each engine offset, you may increase the number of available allowances under § 1039.625(b) for that power category by one engine for the years indicated.
(ii) For engines in 56-560 kW power categories, you may transfer engine offsets across power categories within this power range. Calculate the number of additional allowances by scaling the number of generated engine offsets according to the ratio of engine power for offset and allowance engines. Make this calculation for all your offset engines for which you will transfer offsets under this paragraph (b)(1)(ii), then round the result to determine the total number of available power-weighted allowances. For example, if you generate engine offsets for 75 500-kW engines, you may generate up to 37,500 kW-engines of power-weighted allowances. You may apply this to 375 100-kW engines or any other combination that totals 37,500 kW-engines.
(2) You may decline to use the offsets. If you decline, the engine manufacturer may use the provisions of § 1039.104(a)(1).
(c)
(d)
(1) The name of each engine family involved.
(2) The number of engines from each power category.
(3) The maximum engine power of each engine.
(4) For engines above 560 kW, whether you use engines certified to the standards for generator-set engines.
(e)
If you qualify for the economic hardship provisions specified in 40 CFR 1068.255, we may approve your hardship application subject to the following additional conditions:
(a) You must show that you have used up the allowances to produce equipment with exempted engines under § 1039.625.
(b) You may produce equipment under this section for up to 12 months total (or 24 months total for small-volume manufacturers).
If you qualify for the hardship provisions specified in 40 CFR 1068.245, we may approve a period of delayed compliance for up to one model year total (or two model years total for small-volume manufacturers). If you qualify for the hardship provisions specified in 40 CFR 1068.250 for small-volume manufacturers, we may approve a period of delayed compliance for up to two model years total.
The following provisions apply if you identify the name and trademark of another company instead of your own on your emission control information label, as provided by § 1039.135(c)(2):
(a) You must have a contractual agreement with the other company that obligates that company to take the following steps:
(1) Meet the emission warranty requirements that apply under § 1039.120. This may involve a separate agreement
(2) Report all warranty-related information to the certificate holder.
(b) In your application for certification, identify the company whose trademark you will use and describe the arrangements you have made to meet your requirements under this section.
(c) You remain responsible for meeting all the requirements of this chapter, including warranty and defect-reporting provisions.
Manufacturers may choose to use the provisions of this section for engines used in transportation refrigeration units (TRUs). The operating restrictions and characteristics in paragraph (f) of this section define engines that are not used in TRUs. All provisions of this part apply for TRU engines, except as specified in this section.
(a) You may certify engines under this section with the following special provisions:
(1) The engines are not subject to the transient emission standards of subpart B of this part.
(2) The steady-state emission standards in subpart B of this part apply for emissions measured over the steady-state test cycle described in paragraph (b) of this section instead of the otherwise applicable duty cycle described in § 1039.505.
(b) Measure steady-state emissions using the procedures specified in § 1039.505, except for the duty cycles, as follows:
(1) The following duty cycle applies for discrete-mode testing:
(2) The following duty cycle applies for ramped-modal testing:
(c) Engines certified under this section must be certified in a separate engine family that contains only TRU engines.
(d) You must do the following for each engine certified under this section:
(1) State on the emission control information label: “THIS ENGINE IS CERTIFIED TO OPERATE ONLY IN
(2) State in the emission-related installation instructions all steps necessary to ensure that the engine will operate only in the modes covered by the test cycle described in this section.
(3) Keep records to document the destinations and quantities of engines produced under this section.
(e) All engines certified under this section must comply with NTE standards, as described in § 1039.101 or § 1039.102 for the applicable model year, except that the NTE standards are not limited with respect to operating speeds and loads. In your application for certification, certify that all the engines in the engine family comply with the not-to-exceed emission standards for all normal operation and use. The deficiency provisions of § 1039.104(d) do not apply to these engines. This paragraph (e) applies whether or not the engine would otherwise be subject to NTE standards.
(f) An engine is not considered to be used in a TRU if any of the following is true:
(1) The engine is installed in any equipment other than refrigeration units for railcars, truck trailers, or other freight vehicles.
(2) The engine operates in any mode not covered by the test cycle described in this section, except as follows:
(i) The engine may operate briefly at idle. Note, however, that TRU engines must meet NTE emission standards under any type of operation, including idle, as described in paragraph (e) of this section.
(ii) The engine may have a minimal amount of transitional operation between two allowable modes. As an example, a thirty-second transition period would clearly not be considered minimal.
(iii) The engine as installed may experience up to a 2-percent decrease in load at a given setpoint over any 10-minute period, and up to a 15-percent decrease in load at a given setpoint over any 60-minute period.
(3) The engine is sold in a configuration that allows the engine to operate in any mode not covered by the test cycle described in this section. For example, this section does not apply to an engine sold without a governor limiting operation only to those modes covered by the test cycle described in this section.
(4) The engine is subject to Tier 3 or earlier standards, or phase-out Tier 4 standards.
(a) The prohibitions in § 1068.101(a)(1) do not apply to an engine if the following conditions are met:
(1) The engine is intended for use and will be used in Guam, American Samoa, or the Commonwealth of the Northern Mariana Islands.
(2) The engine meets the latest applicable emission standards in 40 CFR 89.112.
(3) You meet all the requirements of § 1039.260.
(b) If you introduce an engine into commerce in the United States under this section, you must meet the labeling requirements in 40 CFR 89.110, but add the following statement instead of the compliance statement in 40 CFR 89.110(b)(10):
(c) Introducing into commerce an engine exempted under this section in any state or territory of the United States other than Guam, American Samoa, or the Commonwealth of the Northern Mariana Islands, throughout its lifetime, violates the prohibitions in 40 CFR 1068.101(a)(1), unless it is exempt under a different provision.
Under § 1039.801, certain engines are considered to be new engines when they are imported into the United States, even if they have previously been used outside the country. Independent Commercial Importers may use the provisions of 40 CFR part 89, subpart G, and 40 CFR 89.906(b) to receive a certificate of conformity for engines meeting all the requirements of this part 1039.
(a) You may average, bank, and trade (ABT) emission credits for purposes of certification as described in this subpart to show compliance with the standards of this part. Participation in this program is voluntary.
(b) Section 1039.740 restricts the use of emission credits to certain averaging sets.
(c) The definitions of Subpart I of this part apply to this subpart. The following definitions also apply:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(d) You may not use emission credits generated under this subpart to offset any emissions that exceed an FEL or standard. This applies for all testing, including certification testing, in-use testing, selective enforcement audits, and other production-line testing. However, if emissions from an engine exceed an FEL or standard (for example, during a selective enforcement audit), you may use emission credits to recertify the engine family with a higher FEL that applies only to future production.
(e) Engine families that use emission credits for one or more pollutants may not generate positive emission credits for another pollutant.
(f) Emission credits may be used in the model year they are generated or in future model years. Emission credits may not be used for past model years.
(g) You may increase or decrease an FEL during the model year by amending your application for certification under § 1039.225. The new FEL may apply only to engines you have not already introduced into commerce. Each engine's emission control information label must include the applicable FELs.
The provisions of this section apply separately for calculating emission credits for NO
(a) Calculate positive emission credits for an engine family that has an FEL below the otherwise applicable standard. Calculate negative emission credits for an engine family that has an FEL above the otherwise applicable standard.
(b) For each participating engine family, calculate positive or negative emission credits relative to the otherwise applicable emission standard. Round calculated emission credits to the nearest kilogram (kg), using consistent units throughout the following equation:
(c) In your application for certification, base your showing of compliance on projected production volumes for engines whose point of first retail sale is in the United States. As described in § 1039.730, compliance with the requirements of this subpart is determined at the end of the model year based on actual production volumes for engines whose point of first retail sale is in the United States. Do not include any of the following engines to calculate emission credits:
(1) Engines exempted under subpart G of this part or under 40 CFR part 1068.
(2) Exported engines.
(3) Engines not subject to the requirements of this part, such as those excluded under § 1039.5.
(4) [Reserved]
(5) Any other engines, where we indicate elsewhere in this part 1039 that they are not to be included in the calculations of this subpart.
(a) Averaging is the exchange of emission credits among your engine families. You may average emission credits only within the same averaging set.
(b) You may certify one or more engine families to an FEL above the applicable standard, subject to the FEL caps and other provisions in subpart B of this part, if you show in your application for certification that your projected balance of all emission-credit transactions in that model year is greater than or equal to zero.
(c) If you certify an engine family to an FEL that exceeds the otherwise applicable standard, you must obtain enough emission credits to offset the engine family's deficit by the due date for the final report required in § 1039.730. The emission credits used to address the deficit may come from your other engine families that generate emission credits in the same model year, from emission credits you have banked, or from emission credits you obtain through trading.
(a) Banking is the retention of emission credits by the manufacturer generating the emission credits for use in averaging or trading in future model years. You may use banked emission credits only within the averaging set in which they were generated.
(b) In your application for certification, designate any emission credits you intend to bank. These emission credits will be considered reserved credits. During the model year and before the due date for the final report, you may redesignate these emission credits for averaging or trading.
(c) You may use banked emission credits from the previous model year for averaging or trading before we verify them, but we may revoke these emission credits if we are unable to verify them after reviewing your reports or auditing your records.
(d) Reserved credits become actual emission credits only when we verify them in reviewing your final report.
(a) Trading is the exchange of emission credits between manufacturers. You may use traded emission credits for averaging, banking, or further trading transactions. Traded emission credits may be used only within the averaging set in which they were generated.
(b) You may trade actual emission credits as described in this subpart. You may also trade reserved emission credits, but we may revoke these emission credits based on our review of your records or reports or those of the company with which you traded emission credits.
(c) If a negative emission credit balance results from a transaction, both the buyer and seller are liable, except
(a) You must declare in your application for certification your intent to use the provisions of this subpart for each engine family that will be certified using the ABT program. You must also declare the FELs you select for the engine family for each pollutant for which you are using the ABT program. Your FELs must comply with the specifications of subpart B of this part, including the FEL caps. FELs must be expressed to the same number of decimal places as the applicable standards.
(b) Include the following in your application for certification:
(1) A statement that, to the best of your belief, you will not have a negative balance of emission credits for any averaging set when all emission credits are calculated at the end of the year.
(2) Detailed calculations of projected emission credits (positive or negative) based on projected production volumes. If your engine family will generate positive emission credits, state specifically where the emission credits will be applied (for example, to which engine family they will be applied in averaging, whether they will be traded, or whether they will be reserved for banking). If you have projected negative emission credits for an engine family, state the source of positive emission credits to offset the negative emission credits. Describe whether the emission credits are actual or reserved and whether they will come from averaging, banking, trading, or a combination of these. Identify from which of your engine families or from which manufacturer the emission credits will come.
(a) If any of your engine families are certified using the ABT provisions of this subpart, you must send an end-of-year report within 90 days after the end of the model year and a final report within 270 days after the end of the model year. We may waive the requirement to send the end-of year report, as long as you send the final report on time.
(b) Your end-of-year and final reports must include the following information for each engine family participating in the ABT program:
(1) Engine-family designation.
(2) The emission standards that would otherwise apply to the engine family.
(3) The FEL for each pollutant. If you changed an FEL during the model year, identify each FEL you used and calculate the positive or negative emission credits under each FEL. Also, describe how the applicable FEL can be identified for each engine you produced. For example, you might keep a list of engine identification numbers that correspond with certain FEL values.
(4) The projected and actual production volumes for the model year with a point of retail sale in the United States. If you changed an FEL during the model year, identify the actual production volume associated with each FEL.
(5) Maximum engine power for each engine configuration, and the sales-weighted average engine power for the engine family.
(6) Useful life.
(7) Calculated positive or negative emission credits for the whole engine family. Identify any emission credits that you traded, as described in paragraph (d)(1) of this section.
(c) Your end-of-year and final reports must include the following additional information:
(1) Show that your net balance of emission credits from all your engine families in each averaging set in the applicable model year is not negative.
(2) State whether you will reserve any emission credits for banking.
(3) State that the report's contents are accurate.
(d) If you trade emission credits, you must send us a report within 90 days after the transaction, as follows:
(1) As the seller, you must include the following information in your report:
(i) The corporate names of the buyer and any brokers.
(ii) A copy of any contracts related to the trade.
(iii) The engine families that generated emission credits for the trade, including the number of emission credits from each family.
(2) As the buyer, you must include the following information in your report:
(i) The corporate names of the seller and any brokers.
(ii) A copy of any contracts related to the trade.
(iii) How you intend to use the emission credits, including the number of emission credits you intend to apply to each engine family (if known).
(e) Send your reports electronically to the Designated Compliance Officer using an approved information format. If you want to use a different format, send us a written request with justification for a waiver.
(f) Correct errors in your end-of-year report or final report as follows:
(1) You may correct any errors in your end-of-year report when you prepare the final report, as long as you send us the final report by the time it is due.
(2) If you or we determine within 270 days after the end of the model year that errors mistakenly decrease your balance of emission credits, you may correct the errors and recalculate the balance of emission credits. You may not make these corrections for errors that are determined more than 270 days after the end of the model year. If you report a negative balance of emission credits, we may disallow corrections under this paragraph (f)(2).
(3) If you or we determine anytime that errors mistakenly increase your balance of emission credits, you must correct the errors and recalculate the balance of emission credits.
(a) You must organize and maintain your records as described in this section. We may review your records at any time.
(b) Keep the records required by this section for eight years after the due date for the end-of-year report. You may use any appropriate storage formats or media, including paper, microfilm, or computer diskettes.
(c) Keep a copy of the reports we require in § 1039.725 and § 1039.730.
(d) Keep the following additional records for each engine you produce that generates or uses emission credits under the ABT program:
(1) Engine family designation.
(2) Engine identification number.
(3) FEL and useful life.
(4) Maximum engine power.
(5) Build date and assembly plant.
(6) Purchaser and destination.
(e) We may require you to keep additional records or to send us relevant information not required by this section.
The following restrictions apply for using emission credits:
(a)
(b)
(2) Emission credits generated from marine engines certified under the provisions of 40 CFR part 89 may not be used under this part.
(3) See 40 CFR part 89 for other restrictions that may apply for using emission credits generated under that part.
(c)
(d)
(a) For each engine family participating in the ABT program, the certificate of conformity is conditional upon full compliance with the provisions of this subpart during and after the model year. You are responsible to establish to our satisfaction that you fully comply with applicable requirements. We may void the certificate of conformity for an engine family if you fail to comply with any provisions of this subpart.
(b) You may certify your engine family to an FEL above an applicable standard based on a projection that you will have enough emission credits to offset the deficit for the engine family. However, we may void the certificate of conformity if you cannot show in your final report that you have enough actual emission credits to offset a deficit for any pollutant in an engine family.
(c) We may void the certificate of conformity for an engine family if you fail to keep records, send reports, or give us information we request.
(d) You may ask for a hearing if we void your certificate under this section (see § 1039.820).
The following definitions apply to this part. The definitions apply to all subparts unless we note otherwise. All undefined terms have the meaning the Act gives to them. The definitions follow:
(1) Electronic control units, aftertreatment devices, fuel-metering components, EGR-system components, crankcase-ventilation valves, all components related to charge-air compression and cooling, and all sensors and actuators associated with any of these components.
(2) Any other component whose primary purpose is to reduce emissions.
(1) For multiplicative deterioration factors, the ratio of emissions at the end of useful life to emissions at the low-hour test point.
(2) For additive deterioration factors, the difference between emissions at the end of useful life and emissions at the low-hour test point.
(1) Has been determined not to be a nonroad engine, as specified in 40 CFR 1068.30; or
(2) Is a nonroad engine that, according to § 1039.5, is not subject to this part 1039.
(1) For in-use fuels,
(2) For testing,
(1) For in-use fuels,
(2) For testing,
(1)
(2)
(1) For freshly manufactured equipment and engines (see definition of “new nonroad engine,” paragraph (1)), model year means one of the following:
(i) Calendar year.
(ii) Your annual new model production period if it is different than the calendar year. This must include January 1 of the calendar year for which the model year is named. It may not begin before January 2 of the previous calendar year and it must end by December 31 of the named calendar year.
(2) For an engine that is converted to a nonroad engine after being placed into service as a motor-vehicle engine or a stationary engine, model year means the calendar year in which the engine was originally produced (see definition of “new nonroad engine,” paragraph (2)).
(3) For a nonroad engine excluded under § 1039.5 that is later converted to operate in an application that is not excluded, model year means the calendar year in which the engine was originally produced (see definition of “new nonroad engine,” paragraph (3)).
(4) For engines that are not freshly manufactured but are installed in new nonroad equipment, model year means the calendar year in which the engine is installed in the new nonroad equipment (see definition of “new nonroad engine,” paragraph (4)).
(5) For imported engines:
(i) For imported engines described in paragraph (5)(i) of the definition of “new nonroad engine,”
(ii) For imported engines described in paragraph (5)(ii) of the definition of “new nonroad engine,”
(1) A freshly manufactured nonroad engine for which the ultimate purchaser has never received the equitable or legal title. This kind of engine might commonly be thought of as “brand new.” In the case of this paragraph (1), the engine becomes new when it is fully assembled for the first time. The engine is no longer new when the ultimate purchaser receives the
(2) An engine originally manufactured as a motor-vehicle engine or a stationary engine that is later intended to be used in a piece of nonroad equipment. In this case, the engine is no longer a motor-vehicle or stationary engine and becomes a “new nonroad engine”. The engine is no longer new when it is placed into nonroad service.
(3) A nonroad engine that has been previously placed into service in an application we exclude under § 1039.5, where that engine is installed in a piece of equipment that is covered by this part 1039. The engine is no longer new when it is placed into nonroad service covered by this part 1039. For example, this would apply to a marine diesel engine that is no longer used in a marine vessel.
(4) An engine not covered by paragraphs (1) through (3) of this definition that is intended to be installed in new nonroad equipment. The engine is no longer new when the ultimate purchaser receives a title for the equipment or the product is placed into service, whichever comes first. This generally includes installation of used engines in new equipment.
(5) An imported nonroad engine, subject to the following provisions:
(i) An imported nonroad engine covered by a certificate of conformity issued under this part that meets the criteria of one or more of paragraphs (1) through (4) of this definition, where the original engine manufacturer holds the certificate, is new as defined by those applicable paragraphs.
(ii) An imported nonroad engine covered by a certificate of conformity issued under this part, where someone other than the original engine manufacturer holds the certificate (such as when the engine is modified after its initial assembly), becomes new when it is imported. It is no longer new when the ultimate purchaser receives a title for the engine or it is placed into service, whichever comes first.
(iii) An imported nonroad engine that is not covered by a certificate of conformity issued under this part at the time of importation is new, but only if it was produced on or after the dates shown in the following table. This addresses uncertified engines and equipment initially placed into service that someone seeks to import into the United States. Importation of this kind of new nonroad engine (or equipment containing such an engine) is generally prohibited by 40 CFR part 1068.
(1) A nonroad piece of equipment for which the ultimate purchaser has never received the equitable or legal title. The product is no longer new when the ultimate purchaser receives this title or the product is placed into service, whichever comes first.
(2) An imported nonroad piece of equipment with an engine not covered by a certificate of conformity issued under this part at the time of importation and manufactured after the requirements of this part start to apply (see § 1039.1).
(1) Engines with maximum power below 19 kW.
(2) Engines with maximum power at or above 19 kW but below 56 kW.
(3) Engines with maximum power at or above 56 kW but below 130 kW.
(4) Engines with maximum power at or above 130 kW but at or below 560 kW.
(5) Engines with maximum power above 560 kW.
(1) For in-use fuels,
(2) For testing,
The following symbols, acronyms, and abbreviations apply to this part:
Documents listed in this section have been incorporated by reference into this part. The Director of the Federal Register approved the incorporation by reference as prescribed in 5 U.S.C. 552(a) and 1 CFR part 51. Anyone may inspect copies at the U.S. EPA, Air and Radiation Docket and Information Center, 1301 Constitution Ave., NW., Room B102, EPA West Building, Washington, DC 20460 or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(a)
(b)
(a) Clearly show what you consider confidential by marking, circling, bracketing, stamping, or some other method.
(b) We will store your confidential information as described in 40 CFR part 2. Also, we will disclose it only as specified in 40 CFR part 2. This applies both to any information you send us and to any information we collect from inspections, audits, or other site visits.
(c) If you send us a second copy without the confidential information, we will assume it contains nothing confidential whenever we need to release information from it.
(d) If you send us information without claiming it is confidential, we may make it available to the public without further notice to you, as described in 40 CFR 2.204.
(a) You may request a hearing under certain circumstances, as described elsewhere in this part. To do this, you must file a written request, including a description of your objection and any supporting data, within 30 days after we make a decision.
(b) For a hearing you request under the provisions of this part, we will approve your request if we find that your request raises a substantial factual issue.
(c) If we agree to hold a hearing, we will use the procedures specified in 40 CFR part 1068, subpart G.
(a) The following duty cycle applies for discrete-mode testing of constant-speed engines:
(b) The following duty cycle applies for ramped-modal testing of constant-speed engines:
(a) The following duty cycle applies for discrete-mode testing of variable-speed engines with maximum power below 19 kW:
(b) The following duty cycle applies for ramped-modal testing of variable-speed engines with maximum power below 19 kW:
(a) The following duty cycle applies for discrete-mode testing of variable-speed engines with maximum power at or above 19 kW:
(b) The following duty cycle applies for ramped-modal testing of variable-speed engines with maximum power at or above 19 kW:
42 U.S.C. 7401-7671(q).
(a) This part applies to you if you manufacture or import new, spark-ignition, nonroad engines (defined in § 1048.801) with maximum brake power above 19 kW, unless we exclude them under § 1048.5. See § 1048.20 for the requirements that apply to excluded engines.
(b) If you manufacture or import engines with maximum brake power at or below 19 kW that would otherwise be covered by 40 CFR part 90, you may choose to meet the requirements of this part instead. In this case, all the provisions of this part apply for those engines.
(c) As noted in subpart G of this part, 40 CFR part 1068 applies to everyone, including anyone who manufactures, installs, owns, operates, or rebuilds any of the engines this part covers or equipment containing theseengines.
(d) You need not follow this part for engines you produce before January 1, 2004, unless you certify voluntarily. See §§ 1048.101 through 1048.115 and § 1048.145 and the definition of model year in § 1048.801 for moreinformation about the timing of new requirements.
(e) See §§ 1048.801 and 1048.805 for definitions and acronyms that apply to this part. The definition section contains significant regulatory provisions and it is very important that you read them.
(a) This part does not apply to the following nonroad engines:
(1) Engines certified to meet the requirements of 40 CFR part 1051 (for
example, engines used in snowmobiles and all-terrain vehicles).
(2) Propulsion marine engines. See 40 CFR part 91. This part applies with respect to auxiliary marine engines.
(b) See subpart G of this part and 40 CFR part 1068, subpart C, for exemptions of specific engines.
(c) Send the Designated Officer a written request if you want us to determine whether this part covers or excludes certain engines. Excludingengines from this part's requirements does not affect other requirements that may apply to them.
See 40 CFR part 87 for engines used in aircraft.)
(d) As defined in § 1048.801, stationary engines are not required to comply with this part (because they are not nonroad engines), except that you mustmeet the requirements in § 1048.20. In addition, the prohibitions in 40 CFR 1068.101 restrict the use of stationary engines for non-stationary purposes.
(a) You must have a certificate of conformity from us for each engine family before you do any of the following with a new nonroad engine covered by this part: sell, offer for sale, introduce into commerce, distribute or deliver for introduction into commerce, or import it into the United States. “New” engines may include some already placed in service (see the definition of “new nonroad engine” and “new nonroad equipment” in § 1048.801). You must get a new certificate of conformity for each new model year.
(b) To get a certificate of conformity and comply with its terms, you must do six things:
(1) Meet the emission standards and other requirements in subpart B of this part.
(2) Perform preproduction emission tests.
(3) Apply for certification (see subpart C of this part).
(4) Do routine emission testing on production engines as required by subpart D of this part.
(5) Do emission testing on in-use engines, as we direct under subpart E of this part.
(6) Follow our instructions throughout this part.
(c) Subpart F of this part describes how to test your engines (including references to other parts).
(d) Subpart G of this part and 40 CFR part 1068 describe requirements and prohibitions that apply to engine manufacturers, equipment manufacturers,owners, operators, rebuilders, and all others.
(a) Part 1065 of this chapter describes procedures and equipmentspecifications for testing engines. Subpart F of this part describes how to apply the provisions of part 1065 of this chapter to show you meet the emission standards in this part.
(b) Part 1068 of this chapter describes general provisions, including these seven areas:
(1) Prohibited acts and penalties for engine manufacturers, equipment manufacturers, and others.
(2) Rebuilding and other aftermarket changes.
(3) Exclusions and exemption for certain engines.
(4) Importing engines.
(5) Selective enforcement audits of your production.
(6) Defect reporting and recall.
(7) Procedures for hearings.
(c) Other parts of this chapter affect you if referenced in this part.
(a) Engine manufacturers producing an engine excluded under § 1048.5(d) must add a permanent label or tag identifyingeach engine. This applies equally to importers. To meet labeling requirements, you must do the following things:
(1) Attach the label or tag in one piece so no one can remove it without destroying or defacing it.
(2) Make sure it is durable and readable for the engine's entire life.
(3) Secure it to a part of the engine needed for normal operation and not normally requiring replacement.
(4) Write it in block letters in English.
(5) Instruct equipment manufacturers that they must place a duplicate label as described in 40 CFR 1068.105 if they obscure the engine's label.
(b) Engine labels or tags required under this section must have the following information:
(1) Include the heading “Emission Control Information”.
(2) Include your full corporate name and trademark.
(3) State the engine displacement (in liters) and maximum brake power.
(4) State: “THIS ENGINE IS EXCLUDED FROM THE REQUIREMENTS OF 40 CFR PART 1048 AS A “STATIONARY ENGINE.” INSTALLING OR USING THIS ENGINE IN ANY OTHER APPLICATION MAY BE A VIOLATION OF FEDERAL LAW SUBJECT TO CIVIL PENALTY.”.
Apply the exhaust emission standards in this section by model year. You may choose to certify engines earlier than we require. The Tier 1 standards apply only to steady-state testing, as described in paragraph (b) of this section. The Tier 2 standards apply to steady-state, transient, and field testing, as described in paragraphs (a), (b), and (c) of this section.
(a)
(1) The Tier 2 HC+NO
(2) You may optionally certify your engines according to the following formula instead of the standards in paragraph (a)(1) of this section:(HC+NO
(b)
(1) The following table shows the Tier 1 exhaust emission standards that apply to engines from 2004 through 2006 model years:
(2) Starting in the 2007 model year, engines must meet the Tier 2 exhaust emission standards in paragraph (a) of this section for both steady-state and transient testing. See paragraph (d) of this section for alternate standards that apply for certain engines.
(c)
(1) The HC+NO
(2) You may apply the following formula to determine alternate emission standards that apply to your engines instead of the standards in paragraph (c)(1) of this section: (HC+NO
(d)
(1) Show that enrichment is necessary to protect the engine from damage.
(2) Show that you limit enrichment to operating modes that require additional cooling to protect the engine from damage.
(3) Show in your application for certification that enrichment will rarely occur in use in the equipment in which your engines are installed. For example, an engine that is expected to operate 5 percent of the time in use with enrichment would clearly not qualify.
(4) Include in your installation instructions any steps necessary for someone installing your engines to prevent enrichment during normal operation (see § 1048.130).
(e)
(1) Gasoline- and LPG-fueled engines: THC emissions.
(2) Natural gas-fueled engines: NMHC emissions.
(3) Alcohol-fueled engines: THCE emissions.
(f)
(g)
(1) Specify a longer useful life in hours for an engine family under either of two conditions:
(i) If you design, advertise, or market your engine to operate longer than the minimum useful life (your recommended hours until rebuild may indicate a longer design life).
(ii) If your basic mechanical warranty is longer than the minimum useful life.
(2) You may request a shorter useful life for an engine family if you have documentation from in-use engines showing that these engines will rarely operate longer than the alternate useful life. The useful life value may not be shorter than any of the following:
(i) 1,000 hours of operation.
(ii) Your recommended overhaul interval.
(iii) Your mechanical warranty for the engine.
(h)
(a) Starting in the 2007 model year, engines that run on a volatile liquid fuel (such as gasoline), must meet the following evaporative emissions standards and requirements:
(1) Evaporative hydrocarbon emissions may not exceed 0.2 grams per gallon of fuel tank capacity when measured with the test procedures for evaporative emissions in subpart F of this part.
(2) For nonmetallic fuel lines, you must specify and use products that meet the Category 1 specifications in SAE J2260 (incorporated by reference in § 1048.810).
(3) Liquid fuel in the fuel tank may not reach boiling during continuous engine operation in the final installation at an ambient temperature of 30 °C. Note that gasoline with a Reid vapor pressure of 62 kPa (9 psi) begins to boil at about 53 °C.
(b) Note that § 1048.245 allows you to use design-based certification instead of generating new emission data.
(c) If other companies install your engines in their equipment, give them any appropriate instructions, as described in § 1048.130.
(a)
(1) If your emission-control strategy depends on maintaining air-fuel ratios at stoichiometry, an acceptable diagnostic design would identify malfunction whenever the air-fuel ratio does not cross stoichiometry for one minute of intended closed-loop operation. You may use other diagnostic strategies if we approve them in advance.
(2) If the protocol described in paragraph (a)(1) of this section does not apply to your engine, you must use an alternative approach that we approve in advance. Your alternative approach must generally detect when the emission-control system is not functioning properly.
(b)
(1) When a malfunction occurs, as described in paragraph (a) of this section.
(2) When the diagnostic system cannot send signals to meet the requirement of paragraph (b)(1) of this section.
(3) When the engine's ignition is in the “key-on” position before starting or cranking. The MIL should go out after engine starting if the system detects no malfunction.
(c)
(d)
(e)
(f)
(g)
(1) ISO 9141-2 Road vehicles-Diagnostic systems—Part 2: CARB requirements for interchange of digital information, February 1994.
(2) ISO 14230-4 Road vehicles—Diagnostic systems—Keyword Protocol 2000—Part 4: Requirements for emission-related systems, June 2000.
Your engines must meet the following requirements:
(a)
(b)
(c)
(d)
(e)
(1) We do not consider an operating parameter adjustable if you permanently seal it or if ordinary tools cannot readily access it.
(2) We may require that you set adjustable parameters to any specification within the adjustable range during certification testing, production-line testing, selective enforcement auditing, or any in-use testing.
(f)
(g)
(1) The conditions of concern were substantially included in your prescribed duty cycles.
(2) You show your design is necessary to prevent catastrophic engine (or equipment) damage or accidents.
(3) The reduced effectiveness applies only to starting the engine.
(a)
(1) It is designed, built, and equipped it to conform at the time of sale with the requirements of this part.
(2) It is free from defects in materials and workmanship that may keep it from meeting these requirements.
(b)
(c)
(d)
(1) The component was in general use on similar engines, and was subject to scheduled maintenance, before January 1, 2000.
(2) Failure of the component would clearly degrade the engine's performance enough that the operator would need to repair or replace it.
(e)
(f)
Give the ultimate buyer of each new nonroad engine written instructions for properly maintaining and using the engine, including the emission-control system. The maintenance instructions also apply to service accumulation on your test engines, as described in 40 CFR part 1065, subpart E.
(a)
(1) You may ask us to approve critical emission-related maintenance only if it meets two criteria:
(i) Operators are reasonably likely to do the maintenance you call for.
(ii) Engines need the maintenance to meet emission standards.
(2) We will accept scheduled maintenance as reasonably likely to occur in use if you satisfy any of four conditions:
(i) You present data showing that, if a lack of maintenance increases emissions, it also unacceptably degrades the engine's performance.
(ii) You present survey data showing that 80 percent of engines in the field get the maintenance you specify at the recommended intervals.
(iii) You provide the maintenance free of charge and clearly say so in maintenance instructions for the customer.
(iv) You otherwise show us that the maintenance is reasonably likely to be done at the recommended intervals.
(3) You may not schedule critical emission-related maintenance more frequently than the following intervals, except as specified in paragraph (a)(4) of this section:
(i) For catalysts, fuel injectors, electronic control units, superchargers, and turbochargers: the useful life of the engine family.
(ii) For gaseous fuel-system components (cleaning without disassembly only) and oxygen sensors: 2,500 hours.
(4) If your engine family has an alternate useful life shorter than the period specified in paragraph (a)(3)(ii) of this section, you may not schedule maintenance on those components more frequently than the alternate useful life (
(b)
(c)
(d)
(e)
(f)
(1) Provide a component or service without charge under the purchase agreement.
(2) Get us to waive this prohibition in the public's interest by convincing us the engine will work properly only with the identified component or service.
At 69 FR 39259, June 29, 2004, § 1048.125 was amended by revising
(a)
(d)
(a) If you sell an engine for someone else to install in a piece of nonroad equipment, give the buyer of the engine written instructions for installing it consistent with the requirements of this part. Include all information necessary to ensure that engines installed this way will meet emission standards.
(b) Make sure these instructions have the following information:
(1) Include the heading: “Emission-related installation instructions”.
(2) State: “Failing to follow these instructions when installing a certified engine in a piece of nonroad equipment violates federal law (40 CFR 1068.105(b)), subject to fines or other penalties as described in the Clean Air Act.”.
(3) Describe any other instructions needed to install an exhaust aftertreatment device and to locate exhaust sampling ports consistent with your application for certification.
(4) Describe the steps needed to control evaporative emissions, as described in §§ 1048.105 and 1048.245.
(5) Describe any necessary steps for installing the diagnostic system described in § 1048.110.
(6) Describe any limits on the range of applications needed to ensure that the engine operates consistently with your application for certification. For example, if your engines are certified only for constant-speed operation, tell equipment manufacturers not to install the engines in variable-speed applications. Also, if you need to avoid sustained high-load operation to meet the field-testing emission standards we specify in § 1048.101(c) or to comply with the provisions of § 1048.101(d), describe how the equipment manufacturer must properly size the engines for a given application.
(7) Describe any other instructions to make sure the installed engine will operate according to design specifications in your application for certification.
(8) State: “If you install the engine in a way that makes the engine's emission control information label hard to read during normal engine maintenance, you must place a duplicate label on the vehicle, as described in 40 CFR 1068.105.”.
(c) You do not need installation instructions for engines you install in your own equipment.
(a) Assign each production engine a unique identification number and permanently and legibly affix, engrave, or stamp it on the engine.
(b) At the time of manufacture, add a permanent emission control information label identifying each engine. To meet labeling requirements, do four things:
(1) Attach the label in one piece so it is not removable without being destroyed or defaced.
(2) Design and produce it to be durable and readable for the engine's entire life.
(3) Secure it to a part of the engine needed for normal operation and not normally requiring replacement.
(4) Write it in block letters in English.
(c) On your engine's emission control information label, do 13 things:
(1) Include the heading “EMISSION CONTROL INFORMATION”.
(2) Include your full corporate name and trademark.
(3) State: “THIS ENGINE IS CERTIFIED TO OPERATE ON [specify operating fuel or fuels].”.
(4) Identify the emission-control system; your identifiers must use names and abbreviations consistent with SAE J1930 (incorporated by reference in § 1048.810).
(5) List all requirements for fuel and lubricants.
(6) State the date of manufacture (DAY (optional), MONTH, and YEAR); if you stamp this information on the engine and print it in the owner's manual, you may omit it from the emission control information label.
(7) State: “THIS ENGINE MEETS U.S. ENVIRONMENTAL PROTECTION AGENCY REGULATIONS FOR (MODEL YEAR) LARGE NONROAD SI ENGINES.”.
(8) Include EPA's standardized designation for the engine family (and subfamily, where applicable).
(9) State the engine's displacement (in liters) and maximum brake power.
(10) State the engine's useful life (see § 1048.101(g)).
(11) List specifications and adjustments for engine tuneups; show the proper position for the transmission during tuneup and state which accessories should be operating.
(12) Describe other information on proper maintenance and use.
(13) Identify the emission standards to which you have certified the engine.
(d) Some of your engines may need more information on the emission control information label.
(1) If you have an engine family that has been certified only for constant-speed engines, add to the engine label “CONSTANT-SPEED ONLY”.
(2) If you have an engine family that has been certified only for variable-speed engines, add to the engine label “VARIABLE-SPEED ONLY”.
(3) If you have an engine family that has been certified only for high-load engines, add to the engine label “THIS ENGINE IS NOT INTENDED FOR OPERATION AT LESS THAN 75 PERCENT OF FULL LOAD.”.
(4) If you certify an engine to the voluntary standards in § 1048.140, add to the engine label “BLUE SKY SERIES”.
(5) If you produce an engine we exempt from the requirements of this part, see subpart G of this part and 40 CFR part 1068, subparts C and D, for more label information.
(6) If you certify an engine family under § 1048.101(d) (and show in your application for certification that in-use engines will experience infrequent high-load operation), add to the engine label “THIS ENGINE ISNOT INTENDED FOR OPERATION AT MORE THAN _ PERCENT OF FULL LOAD.”. Specify the appropriate percentage of full load based on the nature of the engine protection. You may add other statements to discourage operation in engine-protection modes.
(e) Some engines may not have enough space for an emission control information label with all the required information. In this case, you may omit the information required in paragraphs (c)(3), (c)(4), (c)(5), and (c)(12) of this section if you print it in the owner's manual instead.
(f) If you are unable to meet these labeling requirements, you may ask us to modify them consistent with the intent of this section.
This section defines voluntary standards for a recognized level of superior emission control for engines designated as “Blue Sky Series” engines. Blue Sky Series engines must meet one of the following standards:
(a) For the 2003 model year, to receive a certificate of conformity, a “Blue Sky Series” engine family must meet all the requirements in this part that apply to 2004 model year engines. This includes all testing and reporting requirements.
(b) For the 2003 through 2006 model years, to receive a certificate of conformity, a “Blue Sky Series” engine family must meet all the requirements in this part that apply to 2007 model year engines. This includes all testing and reporting requirements.
(c) For any model year, to receive a certificate of conformity as a “Blue Sky Series” engine family must meet all the requirements in this part, while certifying to the following exhaust emission standards:
(1) 0.8 g/kW-hr HC+NO
(2) 1.1 g/kW-hr HC+NO
(d) If you certify an engine family under this section, it is subject to all the requirements of this part as if these voluntary standards were mandatory.
The provisions in this section apply instead of other provisions in this part. This section describes when these interim provisions expire.
(a)
(1) Delay certification of another engine family with an average power rating of 100 kW of up to 600 engines for one model year.
(2) Delay certification of another engine family with an average power rating of 100 kW of up to 200 engines for three model years.
(3) Delay certification of one engine family with an average power rating of 100 kW of up to 400 engines for one model year and a second engine family with an average power rating of 200 kW of up to 50 engines for two model years.
(b)
(c)
(d)
(e) [Reserved]
(f)
(g)
(h)
(i)
(a) Send us an application for a certificate of conformity for each engine family. Each application is valid for only one model year.
(b) The application must not include false or incomplete statements or information (see § 1048.255).
(c) We may choose to ask you to send us less information than we specify in this subpart, but this would not change your recordkeeping requirements.
(d) Use good engineering judgment for all decisions related to your application (see 40 CFR 1068.5).
(e) An authorized representative of your company must approve and sign the application.
In your application, do all the following things unless we ask you to send us less information:
(a) Describe the engine family's specifications and other basic parameters of the engine's design. List the types of fuel you intend to use to certify the engine family (for example, gasoline, liquefied petroleum gas, methanol, or natural gas).
(b) Explain how the emission-control systems operate.
(1) Describe in detail all the system components for controlling exhaust emissions, including auxiliary emission-control devices and all fuel-system components you will install on any production or test engine. Explain why any auxiliary emission-control devices are not defeat devices (see § 1048.115(g)). Do not include detailed calibrations for components unless we ask for them.
(2) Describe the evaporative emission controls.
(c) Explain how the engine diagnostic system works, describing especially the engine conditions (with the corresponding diagnostic trouble codes) that cause the malfunction-indicator light to go on. Propose what you consider to be extreme conditions under which the diagnostic system should disregard trouble codes, as described in § 1048.110.
(d) Describe the engines you selected for testing and the reasons for selecting them.
(e) Describe any special or alternate test procedures you used (see § 1048.501).
(f) Describe how you operated the engine or vehicle prior to testing, including the duty cycle and the number of engine operating hours used to stabilize emission levels. Describe any scheduled maintenance you did.
(g) List the specifications of the test fuel to show that it falls within the required ranges we specify in 40 CFR part 1065, subpart C.
(h) Identify the engine family's useful life.
(i) Propose maintenance and use instructions for the ultimate buyer of each new nonroad engine (see § 1048.125).
(j) Propose emission-related installation instructions if you sell engines for someone else to install in a piece of nonroad equipment (see § 1048.130).
(k) Identify each high-cost warranted part and show us how you calculated its replacement cost, including the estimated retail cost of the part, labor rates, and labor hours to diagnose and replace defective parts.
(l) Propose an emission control information label.
(m) Present emission data to show that you meet emission standards.
(1) Present exhaust emission data for HC, NO
(2) If your engine family includes a volatile liquid fuel (and you do not use design-based certification under § 1048.245) present evaporative test data to show your vehicles meet the evaporative emission standards we specify in subpart B of this part. Show these figures before and after applying deterioration factors, where applicable.
(n) Report all test results, including those from invalid tests or from any nonstandard tests (such as measurements based on exhaust concentrations in parts per million).
(o) Identify the engine family's deterioration factors and describe how you developed them. Present any emission test data you used for this.
(p) Describe all adjustable operating parameters (see § 1048.115(e)), including the following:
(1) The nominal or recommended setting.
(2) The intended physically adjustable range, including production tolerances if they affect the range.
(3) The limits or stops used to establish adjustable ranges.
(q) Describe everything we need to read and interpret all the information broadcast by an engine's onboard computers and electronic control modules and state that you will give us any hardware or tools we would need to do this. You may reference any appropriate publicly released standards that define conventions for these messages and parameters. Format your information consistent with publicly released standards.
(r) State whether your engine will operate in variable-speed applications, constant-speed applications, or both. If your certification covers only constant-speed or only variable-speed applications, describe how you will prevent use of these engines in the applications for which they are not certified.
(s) Starting in the 2007 model year, state that all the engines in the engine family comply with the field-testing emission standards we specify in § 1048.101(c) for all normal operation and use (see § 1048.515). Describe in detail any testing, engineering analysis, or other information on which you base this statement.
(t) State that you operated your test engines according to the specified procedures and test parameters using the fuels described in the application to show you meet the requirements of this part.
(u) State unconditionally that all the engines in the engine family comply with the requirements of this part, other referenced parts, and the CleanAir Act.
(v) Include estimates of U.S.-directed production volumes.
(w) Show us how to modify your production engines to measure emissions in the field (see § 1048.115(d)).
(x) Add other information to help us evaluate your application if we ask for it.
If you send us information before you finish the application, we will review it and make any appropriate determinations listed in § 1048.215(b)(1) through (7). Decisions made under this section are considered to be preliminary approval. We will generally not disapprove applications under § 1048.215(b)(1) through (5) where we have given you preliminary approval, unless we find new and substantial information supporting a different decision.
(a) If you request preliminary approval related to the upcoming model year or the model year after that, we will make a “best-efforts” attempt to make the appropriate determinations as soon as possible. We will generally not provide preliminary approval related to a future model year more than two years ahead of time.
(b) You may consider full compliance with published guidance to be preliminary approval only if the guidance includes a statement that we intend you to consider it as such.
(a) If any of the information in your application changes after you submit it, amend it as described in § 1048.225.
(b) We may deny your application (that is, determine that we cannot approve it without revision) if the engine family does not meet the requirements of this part or the Act. For example:
(1) If you inappropriately use the provisions of § 1048.230(c) or (d) to define a broader or narrower engine family, we will require you to redefine your engine family.
(2) If we determine you did not appropriately select the useful life under § 1048.101(g), we will require you to lengthen it.
(3) If we determine you did not appropriately select deterioration factors under § 1048.240(c), we will require you to revise them.
(4) If your diagnostic system is inadequate for detecting significant malfunctions in emission-control systems, as described in § 1048.110(b), we will require you to make the system more effective.
(5) If your diagnostic system inappropriately disregards trouble codes under certain conditions, as described in § 1048.110(f), we will require you to change the system to operate under broader conditions.
(6) If your proposed emission control information label is inconsistent with § 1048.135, we will require you to change it (and tell you how, if possible).
(7) If you require or recommend maintenance and use instructions inconsistent with § 1048.125, we will require you to change them.
(8) If we find any other problem with your application, we will tell you what the problem is and what needs to be corrected.
(c) If we determine your application is complete and shows that the engine family meets all the requirements of this part and the Act, we will issue a certificate of conformity for your engine family for that model year. If we deny the application, we will explain why in writing. You may then ask us to hold a hearing to reconsider our decision (see § 1048.820).
Send the Designated Officer a request to amend your application for certification for an engine family if you want to change the emission-related maintenance instructions in a way that could affect emissions. In your request, describe the proposed changes to the maintenance instructions.
(a) If you are decreasing the specified level of maintenance, you may distribute the new maintenance instructions to your customers 30 days after we receive your request, unless we disapprove your request. We may approve a shorter time or waive this requirement.
(b) If your requested change would not decrease the specified level of maintenance, you may distribute the new maintenance instructions anytime after you send your request.
(c) If you are correcting or clarifying your maintenance instructions or if you are changing instructions for maintenance unrelated to emission controls, the requirements of this section do not apply.
(a) You must amend your application for certification before you take either of the following actions:
(1) Add an engine to a certificate of conformity (this includes any changes you make in selecting emission standards under § 1048.205(m)(1)).
(2) Make a design change for a certified engine family that may affect emissions or an emission-related part over the engine's lifetime.
(b) Send the Designated Officer a request to amend the application for certification for an engine family. In your request, do all of the following:
(1) Describe the engine model or configuration you are adding or changing.
(2) Include engineering evaluations or reasons why the original test engine is or is not still appropriate.
(3) If the original test engine for the engine family is not appropriate to show compliance for the new or modified nonroad engine, include new test data showing that the new or modified nonroad engine meets the requirements of this part.
(c) You may start producing the new or modified nonroad engine anytime after you send us your request. If we determine that the affected engines do not meet applicable requirements, we will require you to cease production of the engines and to recall and correct the engines at no expense to the owner. If you choose to produce engines under this paragraph (c), we will consider that to be consent to recall all engines that we determine do not meet applicable standards or other requirements and to remedy the nonconformity at no expense to the owner.
(d) You must give us test data within 30 days if we ask for more testing, or stop producing the engine if you cannot do this. You may give us an engineering evaluation instead of test data if we agree that you can address our questions without test data.
(e) If we determine that the certificate of conformity would not cover your new or modified nonroad engine, we will send you a written explanation of our decision. In this case, you may no longer produce these engines, though you may ask for a hearing for us to reconsider our decision (see § 1048.820).
(a) Divide your product line into families of engines that you expect to have similar emission characteristics. Your engine family is limited to a single model year.
(b) Group engines in the same engine family if they are the same in all of the following aspects:
(1) The combustion cycle.
(2) The cooling system (water-cooled vs. air-cooled).
(3) Configuration of the fuel system (for example, fuel injection vs. carburetion).
(4) Method of air aspiration.
(5) The number, location, volume, and composition of catalytic converters.
(6) The number, arrangement, and approximate bore diameter of cylinders.
(7) Evaporative emission controls.
(c) In some cases you may subdivide a group of engines that is identical under paragraph (b) of this section into different engine families. To do so, you must show you expect emission characteristics to be different during the useful life or that any of the following engine characteristics are different:
(1) Method of actuating intake and exhaust timing (poppet valve, reed valve, rotary valve, etc.).
(2) Location or size of intake and exhaust valves or ports.
(3) Configuration of the combustion chamber.
(4) Cylinder stroke.
(5) Exhaust system.
(6) Type of fuel.
(d) If your engines are not identical with respect to the things listed in paragraph (b) of this section, but you show that their emission characteristics during the useful life will be similar, we may approve grouping them in the same engine family.
(e) If you cannot appropriately define engine families by the method in this section, we will define them based on features related to emission characteristics.
(f) You may ask us to create separate families for exhaust emissions and evaporative emissions. If we do this, list both families on the emission control information label.
(g) Where necessary, you may divide an engine family into sub-families to meet different emission standards, as specified in § 1048.101(a)(2). For issues related to compliance and prohibited actions, we will generally apply decisions to the whole engine family. For engine labels and other administrative provisions, we may approve your request for separate treatment of sub-families.
This section describes the emission testing you must perform to show compliance with the emission standards in §§ 1048.101(a) and (b) and 1048.105 during certification. See § 1048.205(s) regarding
(a) Test your emission-data engines using the procedures and equipment specified in subpart F of this part. For any testing related to evaporative emissions, use good engineering judgment to include a complete fuel system with the engine.
(b) Select engine families according to the following criteria:
(1) For exhaust testing, select from each engine family a test engine for each fuel type with a configuration that is most likely to exceed the exhaust emission standards, using good engineering judgment. Consider the emission levels of all exhaust constituents over the full useful life of the engine when operated in a piece of equipment.
(2) For evaporative testing, select from each engine family a test fuel system for each fuel type with a configuration that is most likely to exceed the evaporative emission standards, using good engineering judgment.
(c) You may use previously generated emission data in either of the following cases:
(1) You may submit emission data for equivalent engine families from previous years instead of doing new tests, but only if the data show that the test engine would meet all the requirements for the latest engine models. We may require you to do new emission testing if we believe the latest engine models could be substantially different from the previously tested engine.
(2) You may submit emission data for equivalent engine families performed to show compliance with other standards (such as California standards) instead of doing new tests, but only if the data show that the test engine would meet all of this part's requirements.
(d) We may choose to measure emissions from any of your test engines (or other engines from the engine family).
(1) If we do this, you must provide the test engine at the location we select. We may decide to do the testing at your plant or any other facility. If we choose to do the testing at your plant, you must schedule it as soon as possible and make available the instruments and equipment we need.
(2) If we measure emissions on one of your test engines, the results of that testing become the official data for the engine. Unless we later invalidate this data, we may decide not to consider your data in determining if your engine family meets the emission standards.
(3) Before we test one of your engines, we may set its adjustable parameters to any point within the physically adjustable ranges (see § 1048.115(e)).
(4) Calibrate the test engine within normal production tolerances for anything we do not consider an adjustable parameter (see § 1048.205(p)).
(a) For certification, your engine family is considered in compliance with the numerical emission standards in § 1048.101 (a) and (b), if all emission-data engines representing that family have test results showing emission levels at or below these standards.
(b) Your engine family does not comply if any emission-data engine representing that family has test results showing emission levels above the standards from § 1048.101 (a) and (b) for any pollutant.
(c) To compare emission levels from the test engine with the emission standards, apply deterioration factors to the measured emission levels. The deterioration factor is a number that shows the relationship between exhaust emissions at the end of useful life and at the low-hour test point. Specify the deterioration factors based on emission measurements using four significant figures, consistent with good engineering judgment. For example, deterioration factors must be consistent with emission increases observed from in-use testing with similar engines (
(1) For engines that use aftertreatment technology, such as catalytic converters, the deterioration factor is the ratio of exhaust emissions at the end of useful life to exhaust
(2) For engines that do not use aftertreatment technology, the deterioration factor is the difference between exhaust emissions at the end of useful life and exhaust emissions at the low-hour test point. Adjust the official emission results for each tested engine at the selected test point by adding the factor to the measured emissions. If the factor is less than zero, use zero.
(d) After adjusting the emission levels for deterioration, round them to the same number of decimal places as the emission standard. Compare the rounded emission levels to the emission standard for each test engine.
(a) For certification, your engine family is considered in compliance with the evaporative emission standards in subpart B of this part if you do either of the following:
(1) You have test results showing that evaporative emissions in the family are at or below the standards throughout the useful life.
(2) Where applicable, you comply with the design specifications in paragraph (e) of this section.
(b) Your engine family does not comply if any fuel system representing that family has test results showing emission levels above the standards.
(c) Use good engineering judgment to develop a test plan to establish deterioration factors to show how much emissions increase at the end of useful life.
(d) If you adjust the emission levels for deterioration, round them to the same number of decimal places as the emission standard. Compare the rounded emission levels to the emission standard for each test fuel system.
(e) You may demonstrate that your engine family complies with the evaporative emission standards by demonstrating that you use the following control technologies:
(1) For certification to the standards specified in § 1048.105(a)(1), with the following technologies:
(i) Use a tethered or self-closing gas cap on a fuel tank that stays sealed up to a positive pressure of 24.5 kPa (3.5 psig) or a vacuum pressure of 10.5 kPa (1.5 psig).
(ii) [Reserved]
(2) For certification to the standards specified in § 1048.105(a)(3), demonstrating that you use design features to prevent fuel boiling under all normal operation. You may do this using fuel temperature data measured during normal operation.
(3) We may establish additional options for design-based certification where we find that new test data demonstrate that a technology will ensure compliance with the emission standards in this section.
(a) Organize and maintain the following records to keep them readily available; we may review these records at any time:
(1) A copy of all applications and any summary information you sent us.
(2) Any of the information we specify in § 1048.205 that you did not include in your application.
(3) A detailed history of each emission-data engine. In each history, describe all of the following:
(i) The test engine's construction, including its origin and buildup, steps you took to ensure that it represents production engines, any components you built specially for it, and all emission-related components.
(ii) How you accumulated engine operating hours, including the dates and the number of hours accumulated.
(iii) All maintenance (including modifications, parts changes, and other service) and the dates and reasons for the maintenance.
(iv) All your emission tests, including documentation on routine and standard tests, as specified in part 40 CFR part 1065, and the date and purpose of each test.
(v) All tests to diagnose engine or emission-control performance, giving the date and time of each and the reasons for the test.
(vi) Any other significant events.
(b) Keep data from routine emission tests (such as test cell temperatures and relative humidity readings) for one year after we issue the associated certificate of conformity. Keep all other information specified in paragraph (a) of this section for eight years after we issue your certificate.
(c) Store these records in any format and on any media, as long as you can promptly send us organized, written records in English if we ask for them.
(d) Send us copies of any engine maintenance instructions or explanations if we ask for them.
(a) We may deny your application for certification if your engine family fails to comply with emission standards or other requirements of this part or the Act. Our decision may be based on any information available to us showing you do not meet emission standards or other requirements, including any testing that we conduct under paragraph (f) of this section. If we deny your application, we will explain why in writing.
(b) In addition, we may deny your application or revoke your certificate if you do any of the following:
(1) Refuse to comply with any testing or reporting requirements.
(2) Submit false or incomplete information (paragraph (d) of this section applies if this is fraudulent).
(3) Render inaccurate any test data.
(4) Deny us from completing authorized activities despite our presenting a warrant or court order (see 40 CFR 1068.20).
(5) Produce engines for importation into the United States at a location where local law prohibits us from carrying out authorized activities.
(c) We may void your certificate if you do not keep the records we require or do not give us information when we ask for it.
(d) We may void your certificate if we find that you intentionally submitted false or incomplete information.
(e) If we deny your application or revoke or void your certificate, you may ask for a hearing (see § 1048.820). Any such hearing will be limited to substantial and factual issues.
(f) We may conduct confirmatory testing of your engines as part of certification. We may deny your application for certification or revoke your certificate if your engines fail to comply with emission standards or other requirements during confirmatory testing.
(a) If you produce engines that are subject the requirements of this part, you must test them as described in this subpart.
(b) We may suspend or revoke your certificate of conformity for certain engine families if your production-line engines do not meet the requirements of this part or you do not fulfill your obligations under this subpart (see §§ 1048.325 and 1048.340).
(c) Other requirements apply to engines that you produce. Other regulatory provisions authorize us to suspend, revoke, or void your certificate of conformity, or order recalls for engines families without regard to whether they have passed these production-line testing requirements. The requirements of this part do not affect our ability to do selective enforcement audits, as described in part 1068 of this chapter. Individual engines in families that pass these production-line testing requirements must also conform to all applicable regulations of this part and part 1068 of this chapter.
(d) You may ask to use an alternate program for testing production-line engines. In your request, you must show us that the alternate program gives equal assurance that your production-line engines meet the requirements of this part. If we approve your alternate program, we may waive some or all of this subpart's requirements.
(e) If you certify an engine family with carryover emission data, as described in § 1048.235(c), and these equivalent engine families consistently pass
(f) We may ask you to make a reasonable number of production-line engines available for a reasonable time so we can test or inspect them for compliance with the requirements of this part.
(a)
(b)
(1) You document the need for doing so in your procedures for assembling and inspecting all your production engines and make the action routine for all the engines in the engine family.
(2) This subpart otherwise specifically allows your action.
(3) We approve your action in advance.
(c)
(d)
(1) We may adjust idle speed outside the physically adjustable range as needed only until the engine has stabilized emission levels (see paragraph (e) of this section). We may ask you for information needed to establish an alternate minimum idle speed.
(2) We may make or specify adjustments within the physically adjustable range by considering their effect on emission levels, as well as how likely it is someone will make such an adjustment with in-use engines.
(e)
(1) 50 hours.
(2) The number of hours you operated your emission-data engine for certifying the engine family (see 40 CFR part 1065, subpart E).
(f)
(g)
(a) Use test results from two engines for each engine family to calculate the required sample size for the model year. Update this calculation with each test.
(b) Early in each calendar quarter, randomly select and test two engines
(c) Calculate the required sample size for each engine family. Separately calculate this figure for HC+NO
(1) Determine the 95% confidence coefficient, t
(2) Calculate the standard deviation, σ, for the test sample using the following formula:
(d) Use final deteriorated test results to calculate the variables in the equations in paragraph (c) of this section (see § 1048.315(a)).
(e) After each new test, recalculate the required sample size using the updated mean values, standard deviations, and the appropriate 95-percent confidence coefficient.
(f) Distribute the remaining engine tests evenly throughout the rest of the year. You may need to adjust your schedule for selecting engines if the required sample size changes. Continue to randomly select engines from each engine family; this may involve testing engines that operate on different fuels.
(g) Continue testing any engine family for which the sample mean, x, is greater than the emission standard. This applies if the sample mean for either HC+NO
(1) The sample size, n, for an engine family is greater than the required sample size, N, and the sample mean, x, is less than or equal to the emission standard. For example, if N = 3.1 after the third test, the sample-size calculation does not allow you to stop testing.
(2) The engine family does not comply according to § 1048.325.
(3) You test 30 engines from the engine family.
(4) You test one percent of your projected annual U.S.-directed production volume for the engine family.
(5) You choose to declare that the engine family does not comply with the requirements of this subpart.
(h) If the sample-size calculation allows you to stop testing for a pollutant, you must continue measuring emission levels of that pollutant for any additional tests required under this section. However, you need not continue making the calculations specified in this section for that pollutant. This paragraph (h) does not affect the requirements in section § 1048.320.
(i) You may elect to test more randomly chosen engines than we require. Include these engines in the sample-size calculations.
This section describes the pass/fail criteria for the production-line testing requirements. We apply this criteria on an engine-family basis. See § 1048.320 for the requirements that apply to individual engines that fail a production-line test.
(a) Calculate your test results. Round them to the number of decimal places in the emission standard expressed to one more decimal place.
(1)
(2)
(b) Construct the following CumSum Equation for each engine family (for HC+NO
(c) Use final deteriorated test results to calculate the variables in the equation in paragraph (b) of this section (see § 1048.315(a)).
(d) After each new test, recalculate the CumSum statistic.
(e) If you test more than the required number of engines, include the results from these additional tests in the CumSum Equation.
(f) After each test, compare the current CumSum statistic, C
(g) If the CumSum statistic exceeds the Action Limit in two consecutive tests, the engine family fails the production-line testing requirements of this subpart. Tell us within ten working days if this happens.
(h) If you amend the application for certification for an engine family (see § 1048.225), do not change any previous calculations of sample size or CumSum statistics for the model year.
If you have a production-line engine with final deteriorated test results exceeding one or more emission standards (see § 1048.315(a)), the certificate of conformity is automatically suspended for that failing engine. You must take the following actions before your certificate of conformity can cover that engine:
(a) Correct the problem and retest the engine to show it complies with all emission standards.
(b) Include in your written report a description of the test results and the remedy for each engine (see § 1048.345).
(a) We may suspend your certificate of conformity for an engine family if it fails under § 1048.315. The suspension may apply to all facilities producing engines from an engine family, even if you find noncompliant engines only at one facility.
(b) We will tell you in writing if we suspend your certificate in whole or in part. We will not suspend a certificate until at least 15 days after the engine family fails. The suspension is effective when you receive our notice.
(c) Up to 15 days after we suspend the certificate for an engine family, you may ask for a hearing (see § 1048.820). If we agree before a hearing that we used erroneous information in deciding to suspend the certificate, we will reinstate the certificate.
(d) Section § 1048.335 specifies steps you must take to remedy the cause of the production-line failure. All the engines you have produced since the end of the last test period are presumed noncompliant and should be addressed in your proposed remedy. We may require you to apply the remedy to engines produced earlier if we determine that the cause of the failure is likely to have affected the earlier engines.
You may sell engines that you produce after we suspend the engine
(a) You test each engine you produce and show it complies with emission standards that apply.
(b) We conditionally reinstate the certificate for the engine family. We may do so if you agree to recall all the affected engines and remedy any noncompliance at no expense to the owner if later testing shows that the engine family still does not comply.
(a) Send us a written report asking us to reinstate your suspended certificate. In your report, identify the reason for noncompliance, propose a remedy for the engine family, and commit to a date for carrying it out. In your proposed remedy include any quality control measures you propose to keep the problem from happening again.
(b) Give us data from production-line testing that shows the remedied engine family complies with all the emission standards that apply.
(a) We may revoke your certificate for an engine family in the following cases:
(1) You do not meet the reporting requirements.
(2) Your engine family fails to comply with the requirements of this subpart and your proposed remedy to address a suspended certificate under § 1048.325 is inadequate to solve the problem or requires you to change the engine's design or emission-control system.
(b) To sell engines from an engine family with a revoked certificate of conformity, you must modify the engine family and then show it complies with the requirements of this part.
(1) If we determine your proposed design change may not control emissions for the engine's full useful life, we will tell you within five working days after receiving your report. In this case we will decide whether production-line testing will be enough for us to evaluate the change or whether you need to do more testing.
(2) Unless we require more testing, you may show compliance by testing production-line engines as described in this subpart.
(3) We will issue a new or updated certificate of conformity when you have met these requirements.
Do all the following things unless we ask you to send us less information:
(a) Within 30 calendar days of the end of each calendar quarter, send us a report with the following information:
(1) Describe any facility used to test production-line engines and state its location.
(2) State the total U.S.-directed production volume and number of tests for each engine family.
(3) Describe how you randomly selected engines.
(4) Describe your test engines, including the engine family's identification and the engine's model year, build date, model number, identification number, and number of hours of operation before testing for each test engine.
(5) Identify where you accumulated hours of operation on the engines and describe the procedure and schedule you used.
(6) Provide the test number; the date, time and duration of testing; test procedure; initial test results before and after rounding; final test results; and final deteriorated test results for all tests. Provide the emission results for all measured pollutants. Include information for both valid and invalid tests and the reason for any invalidation.
(7) Describe completely and justify any nonroutine adjustment, modification, repair, preparation, maintenance, or test for the test engine if you did not report it separately under this subpart. Include the results of any emission measurements, regardless of the procedure or type of equipment.
(8) Provide the CumSum analysis required in § 1048.315 for each engine family.
(9) Report on each failed engine as described in § 1048.320.
(10) State the date the calendar quarter ended for each engine family.
(b) We may ask you to add information to your written report, so we can determine whether your new nonroad engines conform with the requirements of this subpart.
(c) An authorized representative of your company must sign the following statement:
We submit this report under Sections 208 and 213 of the Clean Air Act.Our production-line testing conformed completely with the requirements of 40 CFR part 1048. We have not changed production processes or quality-control procedures for the engine family in a way that might affect the emission control from production engines. All the information in this report is true and accurate, to the best of my knowledge. I know of the penalties for violating the Clean Air Act and the regulations. (Authorized Company Representative)
(d) Send electronic reports of production-line testing to the Designated Officer using an approved information format. If you want to use a different format, send us a written request with justification for a waiver.
(e) We will send copies of your reports to anyone from the public who asks for them. See § 1048.815 for information on how we treat information you consider confidential.
(a) Organize and maintain your records as described in this section. We may review your records at any time, so it is important to keep required information readily available.
(b) Keep paper records of your production-line testing for one full year after you complete all the testing required for an engine family in a model year. You may use any additional storage formats or media if you like.
(c) Keep a copy of the written reports described in § 1048.345.
(d) Keep the following additional records:
(1) A description of all test equipment for each test cell that you can use to test production-line engines.
(2) The names of supervisors involved in each test.
(3) The name of anyone who authorizes adjusting, repairing, preparing, or modifying a test engine and the names of all supervisors who oversee this work.
(4) If you shipped the engine for testing, the date you shipped it, the associated storage or port facility, and the date the engine arrived at the testing facility.
(5) Any records related to your production-line tests that are not in the written report.
(6) A brief description of any significant events during testing not otherwise described in the written report or in this section.
(7) Any information specified in § 1048.345 that you do not include in your written reports.
(e) If we ask, you must give us projected or actual production figures for an engine family. We may ask you to divide your production figures by maximum brake power, displacement, fuel type, or assembly plant (if you produce engines at more than one plant).
(f) Keep a list of engine identification numbers for all the engines you produce under each certificate of conformity. Give us this list within 30 days if we ask for it.
(g) We may ask you to keep or send other information necessary to implement this subpart.
(a) If you produce engines that are subject to the requirements of this part, you must test them as described in this subpart. This generally involves testing engines in the field or removing them for measurement in a laboratory.
(b) We may approve an alternate plan for showing that in-use engines comply with the requirements of this part if one of the following is true:
(1) You produce 200 or fewer engines per year in the selected engine family.
(2) Removing the engine from most of the applications for that engine family causes significant, irreparable damage to the equipment.
(3) You identify a unique aspect of your engine applications that keeps you from doing the required in-use testing.
(c) We may void your certificate of conformity for an engine family if you do not meet your obligations under this part.
(d) Independent of your responsibility to test in-use engines, we may choose at any time to do our own testing of your in-use engines.
(e) If in-use testing shows that engines fail to meet emission standards or other requirements of this part, we may pursue a recall or other remedy as allowed by the Act (see § 1048.415).
(a) You must test in-use engines, for exhaust emissions, from the families we select. We may select up to 25 percent of your engine families in any model year—or one engine family if you have three or fewer families. We will select engine families for testing before the end of the model year. When we select an engine family for testing, we may specify that you preferentially test engines based on fuel type or equipment type. In addition, we may identify specific modes of operation or sampling times. You may choose to test additional engine families that we do not select.
(b) Send us an in-use testing plan within 12 calendar months after we direct you to test a particular engine family. Complete the testing within 24 calendar months after we approve your plan.
(c) You may need to test engines from more than one model year at a given time.
(a) You may make arrangements to select representative test engines from your own fleet or from other independent sources.
(b) For the selected engine families, select engines that you or your customers have—
(1) Operated for at least 50 percent of the engine family's useful life (see § 1048.101(d));
(2) Not maintained or used in an abnormal way; and
(3) Documented in terms of total hours of operation, maintenance, operating conditions, and storage.
(c) Use the following methods to determine the number of engines you must test in each engine family:
(1) Test at least two engines if you produce 2,000 or fewer engines in the model year from all engine families, or if you produce 500 or fewer engines from the selected engine family. Otherwise, test at least four engines.
(2) If you successfully complete an in-use test program on an engine family and later certify an equivalent engine family with carryover emission data, as described in § 1048.235(c), then test at least one engine instead of the testing rates in paragraph (c)(1) of this section.
(3) If you test the minimum required number of engines and all comply fully with emission standards, you may stop testing.
(4) For each engine that fails any applicable standard, test two more. Regardless of measured emission levels, you do not have to test more than ten engines in an engine family. You may do more tests than we require.
(5) You may concede that the engine family does not comply before testing a total of ten engines.
(d) You may do minimal maintenance to set components of a test engine to specifications for anything we do not consider an adjustable parameter (see § 1048.205(p)). Limit maintenance to what is in the owner's instructions for engines with that amount of service and age. Document all maintenance and adjustments.
(e) Do at least one valid exhaust emission test for each test engine.
(f) For a test program on an engine family, choose one of the following methods to test your engines:
(1) Remove the selected engines for testing in a laboratory. Use the applicable steady-state and transient procedures in subpart F of this part to show compliance with the duty-cycle standards in § 1048.101(a) and (b). We may direct you to measure emissions on the dynamometer using the supplemental test procedures in § 1048.515 to show compliance with the field-testing standards in § 1048.101(c).
(2) Test the selected engines while they remain installed in the equipment. Use the field testing procedures in subpart F of this part.Measure emissions during normal operation of
(g) You may ask us to waive parts of the prescribed test procedures if they are not necessary to determine in-use compliance.
(h) Calculate the average emission levels for an engine family from the results for the set of tested engines. Round them to the number of decimal places in the emission standards expressed to one more decimal place.
(a) Determine the reason each in-use engine exceeds the emission standards.
(b) If the average emission levels calculated in § 1048.410(h) exceed any of the emission standards that apply, notify us within fifteen days of completing testing on this family. Otherwise follow the reporting instructions in § 1048.420.
(c) We will consider failure rates, average emission levels, and any defects—among other things—to decide on taking remedial action under this subpart (see 40 CFR 1068.505). We may consider the results from any voluntary additional testing you conduct. We may also consider information related to testing from other engine families showing that you designed them to exceed the minimum requirements for controlling emissions. We may order a recall before or after you complete testing of an engine family if we determine a substantial number of engines do not conform to section 213 of the Act or to this part.
(d) If in-use testing reveals a design or manufacturing defect that prevents engines from meeting the requirements of this part, you must correct the defect as soon as possible for any future production for engines in every family affected by the defect.
(e) You may voluntarily recall an engine family for emission failures, as described in 40 CFR 1068.535, unless we have ordered a recall for that family under 40 CFR 1068.505.
(f) You have the right to a hearing before we order you to recall your engines or implement an alternative remedy (see § 1048.820).
(a) In a report to us within three months after you finish testing an engine family, do all the following:
(1) Identify the engine family, model, serial number, and date of manufacture.
(2) For each engine inspected or considered for testing, identify whether the diagnostic system was functioning.
(3) Describe the specific reasons for disqualifying any engines for not being properly maintained or used.
(4) For each engine selected for testing, include the following information:
(i) Estimate the hours each engine was used before testing.
(ii) Describe all maintenance, adjustments, modifications, and repairs to each test engine.
(5) State the date and time of each test attempt.
(6) Include the results of all emission testing, including incomplete or invalidated tests, if any.
(b) Send electronic reports of in-use testing to the Designated Officer using an approved information format. If you want to use a different format, send us a written request with justification for a waiver.
(c) We will send copies of your reports to anyone from the public who asks for them. See § 1048.815 for information on how we treat information you consider confidential.
(d) We may ask for more information.
(a) Organize and maintain your records as described in this section. We may review your records at any time, so it is important to keep required information readily available.
(b) Keep paper records of your in-use testing for one full year after you complete all the testing required for an engine family in a model year.You may use any additional storage formats or media if you like.
(c) Keep a copy of the written reports described in § 1048.420.
(d) Keep any additional records related to the procurement process.
(a) Use the equipment and procedures for spark-ignition engines in 40 CFR part 1065 to show your engines meet the duty-cycle emission standards in § 1048.101(a) and (b). Measure HC, NO
(b) We describe in § 1048.515 the supplemental procedures for showing that your engines meet the field-testing emission standards in § 1048.101(c).
(c) Use the fuels specified in 40 CFR part 1065, subpart C, for all the testing we require in this part, except as noted in § 1048.515. Use these test fuels or any commercially available fuel for service accumulation.
(d) To test engines for evaporative emissions, use the equipment and procedures specified for testing diurnal emissions in 40 CFR 86.107-96 and 86.133-96 with fuel meeting the specifications in 40 CFR part 1065, subpart C. Measure emissions from a test engine with a complete fuel system.Reported emission levels must be based on the highest emissions from three successive 24-hour periods of cycling temperatures. Note that you may not be required to test for evaporative emissions during certification if you certify by design, as specified in § 1048.245.
(e) You may use special or alternate procedures, as described in 40 CFR 1065.10.
(f) We may reject data you generate using alternate procedures if later testing with the procedures in 40 CFR part 1065 shows contradictory emission data.
(a) Measure emissions by testing the engine on a dynamometer with one or more of the following sets of steady-state duty cycles to show that the engine meets the steady-state standards in § 1048.101(b):
(1) Use the 7-mode duty cycle described in the following table for engines from an engine family that will be used only in variable-speed applications:
(2) Use the 5-mode duty cycle described in the following table if you certify an engine family for operation only at a single, rated speed:
(3) Use both of the duty cycles described in paragraphs (a)(1) and (a)(2) of this section if you will not restrict an engine family to constant-speed or variable-speed applications.
(4) Use only the duty cycle specified in paragraph (a)(2) of this section for all severe-duty engines.
(5) Use the 2-mode duty cycle described in the following table for high-load engines instead of the other duty cycles in this paragraph (a):
(b) If we test an engine to confirm that it meets the duty-cycle emission standards, we will use the steady-state duty cycles that apply for that engine family.
(c) During idle mode, operate the engine with the following parameters:
(1) Hold the speed within your specifications.
(2) Keep the throttle at the idle-stop position.
(3) Keep engine torque under 5 percent of the peak torque value at maximum test speed.
(d) For the full-load operating mode, operate the engine at wide-open throttle.
(e) See 40 CFR part 1065 for detailed specifications of tolerances and calculations.
(f) In the normal test sequence described in 40 CFR part 1065, subpart F, steady-state testing generally follows the transient test. For those cases where we do not require transient testing, perform the steady-state test after an appropriate warm-up period, consistent with good engineering judgment.
(a) Starting with the 2007 model year, measure emissions by testing the engine on a dynamometer with one of the following transient duty cycles to show that the engine meets the transient emission standards in § 1048.101(a):
(1) If you certify an engine family for constant-speed operation only, use the transient duty-cycle described in Appendix I of this part.
(2) For all other engines, use the transient duty-cycle described in Appendix II of this part.
(b) If we test an engine to confirm that it meets the duty-cycle emission standards, we will use the transient duty cycle that applies for that engine family.
(c) Warm up the test engine as follows:
(1) Operate the engine for the first 180 seconds of the appropriate duty cycle, then allow it to idle without load for 30 seconds. At the end of the 30-second idling period, start measuring emissions as the engine operates over the prescribed duty cycle. For severe-duty engines, this engine warm-up procedure may include up to 15 minutes of operation over the appropriate duty cycle.
(2) If the engine was already operating before a test, use good engineering judgment to let the engine cool down enough so measured emissions during the next test will accurately represent those from an engine starting at room temperature. For example, if an engine starting at room temperature warms up enough in three minutes to start closed-loop operation and achieve full catalyst activity, then minimal engine cooling is necessary before starting the next test.
(3) You are not required to measure emissions while the engine is warming up. However, you must design your emission-control system to start working as soon as possible after engine
(a) This section describes the procedures to determine whether your engines meet the field-testing emission standards in § 1048.101(c). These procedures may include any normal engine operation and ambient conditions that the engines may experience in use. Paragraph (b) of this section defines the limits of what we will consider normal engine operation and ambient conditions. Use the test procedures we specify in § 1048.501, except for the provisions we specify in this section. Measure emissions with one of the following procedures:
(1) Remove the selected engines for testing in a laboratory. You can use an engine dynamometer to simulate normal operation, as described in this section.
(2) Test the selected engines while they remain installed in the equipment. In 40 CFR part 1065, subpart J, we describe the equipment and sampling methods for testing engines in the field. Use fuel meeting the specifications of 40 CFR 1065.210 or a fuel typical of what you would expect the engine to use in service.
(b) An engine's emissions may not exceed the levels we specify in § 1048.101(c) for any continuous sampling period of at least 120 seconds under the following ranges of operation and operating conditions:
(1) Engine operation during the emission sampling period may include any normal operation, subject to the following restrictions:
(i) Average power must be over 5 percent of maximum brake power.
(ii) Continuous time at idle must not be greater than 120 seconds.
(iii) The sampling period may not begin until the engine has reached stable operating temperatures. For example, this would exclude engine operation after starting until the thermostat starts modulating coolant temperature.
(iv) The sampling period may not include engine starting.
(v) For engines that qualify for the alternate Tier 2 emission standards in § 1048.101(d), operation at 90 percent or more of maximum power must be less than 10 percent of the total sampling time. You may request our approval for a different power threshold.
(2) Engine testing may occur under any normal conditions without correcting measured emission levels, subject to the following restrictions:
(i) Barometric pressure must be between 80.0 and 103.3 kPa (600 and 775 mm Hg).
(ii) Ambient air temperature must be between 13° and 35 °C.
Engine and equipment manufacturers, as well as owners, operators, and rebuilders of these engines, and all other persons, must observe the requirements and prohibitions in 40 CFR part 1068 and the requirements of the Act. The compliance provisions in this subpart apply only to the engines we regulate in this part.
(a) This section applies to you if you are an engine manufacturer. See § 1048.610 if you are not an engine manufacturer.
(b) The only requirements or prohibitions from this part that apply to an engine that is exempt under this section are in this section.
(c) If you meet all the following criteria and requirements regarding your new nonroad engine, it is exempt under this section:
(1) You must produce it by modifying an engine covered by a valid certificate of conformity under 40 CFR part 86.
(2) Do not make any changes to the certified engine that we could reasonably expect to increase its exhaust or evaporative emissions. For example, if you make any of the following changes to one of these engines, you do not qualify for this exemption:
(i) Change any fuel system or evaporative system parameters from the certified configuration (this does not apply to refueling emission controls).
(ii) Change any other emission-related components.
(iii) Modify or design the engine cooling system so that temperatures or heat rejection rates are outside the original engine manufacturer's specified ranges.
(3) Demonstrate that fewer than 50 percent of the engine model's total sales, from all companies, are used in nonroad applications.
(4) The engine must have the label we require under 40 CFR part 86.
(5) Add a permanent supplemental label to the engine in a position where it will remain clearly visible after installation in the equipment. In your engine's emission control information label, do the following:
(i) Include the heading: “Nonroad Engine Emission ControlInformation”.
(ii) Include your full corporate name and trademark.
(iii) State: “THIS ENGINE WAS ADAPTED FOR NONROAD USE WITHOUTAFFECTING ITS EMISSION CONTROLS.”.
(iv) State the date you finished modifying the engine (month and year).
(6) The original and supplemental labels must be readily visible after the engine is installed in the equipment or, if the equipment obscures the engine's emission control information label, the equipment manufacturer must attach duplicate labels, as described in 40 CFR 1068.105.
(7) Send the Designated Officer a signed letter by the end of each calendar year (or less often if we tell you) with all the following information:
(i) Identify your full corporate name, address, and telephone number.
(ii) List the engine models you expect to produce under this exemption in the coming year.
(iii) State: “We produce each listed engine model for nonroad application without making any changes that could increase its certified emission levels, as described in 40 CFR 1048.605.”.
(d) If your engines do not meet the criteria listed in paragraph (c) of this section, they will be subject to the standards and prohibitions of this part. Producing these engines without a valid exemption or certificate of conformity would violate the prohibitions in 40 CFR 1068.101.
(e) If you are the original engine manufacturer of both the highway and nonroad versions of an exempted engine, you must send us emission test data on the applicable nonroad duty cycle(s). You may include the data in your application for certification or in your letter requesting the exemption.
(f) If you are the original engine manufacturer of an exempted engine that is modified by another company under this exemption, we may require you to send us emission test data on the applicable nonroad duty cycle(s). If we ask for this data, we will allow a reasonable amount of time to collect it.
(g) The engine exempted under this section must meet all applicable requirements from 40 CFR part 86. This applies to engine manufacturers, equipment manufacturers who use these engines, and all other persons as if these engines were used in a motor vehicle.
If you are not an engine manufacturer, you may produce nonroad equipment from complete or incomplete motor vehicles with the motor vehicle engine if you meet three criteria:
(a) The engine or vehicle is certified to 40 CFR part 86.
(b) The engine is not adjusted outside the engine manufacturer's specifications (see § 1048.605(c)(2)).
(c) The engine or vehicle is not modified in any way that may affect its emission control. This applies to exhaust and evaporative emission controls, but not refueling emission controls.
This section is intended for engines designed for lawn and garden applications, but it applies to any engines meeting the size criteria in paragraph (a) of this section.
(a) If an engine meets all the following criteria, it is exempt from the requirements of this part:
(1) The engine must have a total displacement of 1,000 cc or less.
(2) The engine must have a maximum brake power of 30 kW or less.
(3) The engine must be in an engine family that has a valid certificate of conformity showing that it meets emission standards for Class II engines under 40 CFR part 90.
(b) The only requirements or prohibitions from this part that apply to an engine that meets the criteria in paragraph (a) of this section are in this section.
(c) If your engines do not meet the criteria listed in paragraph (a) of this section, they will be subject to the provisions of this part. Producing these engines without a valid exemption or certificate of conformity would violate the prohibitions in 40 CFR 1068.101.
(d) Engines exempted under this section are subject to all the requirements affecting engines under 40 CFR part 90. The requirements and restrictions of 40 CFR part 90 apply to anyone manufacturing these engines, anyone manufacturing equipment that uses these engines, and all other persons in the same manner as if these engines had a total maximum brake power at or below 19 kW.
(a) If an engine meets all the following criteria, it is exempt from the requirements of this part:
(1) The engine must operate solely on natural gas.
(2) The engine must have maximum brake power 250 kW or higher.
(3) The engine must be in an engine family that has a valid certificate of conformity showing that it meets emission standards for engines of that power rating under 40 CFR part 89.
(b) The only requirements or prohibitions from this part that apply to an engine that is exempt under this section are in this section.
(c) If your engines do not meet the criteria listed in paragraph (a) of this section, they will be subject to the provisions of this part. Producing these engines without a valid exemption or certificate of conformity would violate the prohibitions in 40 CFR 1068.101.
(d) Engines exempted under this section are subject to all the requirements affecting engines under 40 CFR part 89. The requirements and restrictions of 40 CFR part 89 apply to anyone manufacturing these engines, anyone manufacturing equipment that uses these engines, and all other persons in the same manner as if these were nonroad diesel engines.
(e) You may request an exemption under this section by submitting an application for certification for the engines under 40 CFR part 89.
If you are unable to meet this part's requirements with engines using noncommercial fuels (such as unrefined natural gas released by oil wells), the following provisions apply for those engines:
(a) Create a separate engine family.
(b) Disregard the limits on adjustable parameters in § 1048.115(e), but make sure the engines meet emission standards with normal settings when the engine is using fuel meeting the specifications of 40 CFR part 1065, subpart C.
(c) Add the following information to the emission control information label specified in § 1048.135:
(1) Include instructions describing how to adjust the engine to operate in a way that maintains the effectiveness of the emission-control system.
(2) State: “THIS ENGINE IS CERTIFIED TO OPERATE IN APPLICATIONS USINGNONCOMMERCIAL FUEL. USING IT IN AN APPLICATION INVOLVING ONLY COMMERCIAL FUELS MAY BE A VIOLATION OF FEDERAL LAW SUBJECT TO CIVIL PENALTY.”.
(d) Keep records to document the destinations and quantities of engines produced under this section.
The following definitions apply to this part. The definitions apply to all subparts unless we note otherwise. All undefined terms have the meaning the Act gives to them. The definitions follow:
(1)
(2)
(1) For freshly manufactured engines (see definition of “new nonroad engine,” paragraph (1)), model year means one of the following:
(i) Calendar year.
(ii) Your annual new model production period if it is different than the calendar year. This must include January 1 of the calendar year for which the model year is named. It may not begin before January 2 of the previous calendar year and it must end by December 31 of the named calendar year.
(2) For an engine that is converted to a nonroad engine after being placed into service in a motor vehicle, model year means the calendar year in which the engine was originally produced (see definition of “new nonroad engine,” paragraph (2)).
(3) For a nonroad engine excluded under § 1048.5 that is later converted to operate in an application that is not excluded, model year means the calendar year in which the engine was originally produced (see definition of “new nonroad engine,” paragraph (3)).
(4) For engines that are not freshly manufactured but are installed in new nonroad equipment, model year means the calendar year in which the engine is installed in the new nonroad equipment. This installation date is based on the time that final assembly of the equipment is complete (see definition of “new nonroad engine,” paragraph (4)).
(5) For an engine modified by an importer (not the original engine manufacturer) who has a certificate of conformity for the imported engine (see definition of “new nonroad engine,” paragraph (5)), model year means one of the following:
(i) The calendar year in which the importer finishes modifying and labeling the engine.
(ii) Your annual production period for producing engines if it is different than the calendar year; follow the guidelines in paragraph (1)(ii) of this definition.
(6) For an engine you import that does not meet the criteria in paragraphs (1) through (5) of the definition of “new nonroad engine,” model year means the calendar year in which the engine manufacturer completed the original assembly of the engine. In general, this applies to used equipment that you import without conversion or major modification.
(1) Vehicles having a maximum ground speed over level, paved surfaces no higher than 40 km per hour (25 miles per hour).
(2) Vehicles that lack features usually needed for safe, practical use on streets or highways—for example, safety features required by law, a reverse gear (except for motorcycles), or a differential.
(3) Vehicles whose operation on streets or highways would be unsafe, impractical, or highly unlikely. Examples are vehicles with tracks instead of wheels, very large size, or features associated with military vehicles, such as armor or weaponry.
(1) A freshly manufactured nonroad engine for which the ultimate buyer has never received the equitable or legal title. This kind of vehicle might commonly be thought of as “brand new.” In the case of this paragraph (1), the engine is no longer new when the ultimate buyer receives this title or the product is placed into service, whichever comes first.
(2) An engine originally manufactured as a motor vehicle engine that is later intended to be used in a piece of nonroad equipment. In this case, the engine is no longer a motor vehicle engine and becomes a “new nonroad engine”. The engine is no longer new when it is placed into nonroad service.
(3) A nonroad engine that has been previously placed into service in an application we exclude under § 1048.5, where that engine is installed in a piece of equipment for which these exclusions do not apply. The engine is no longer new when it is placed into nonroad service. For example, this would apply to a stationary engine that is no longer used in a stationary application.
(4) An engine not covered by paragraphs (1) through (3) of this definition that is intended to be installed in new nonroad equipment. The engine is no longer new when the ultimate buyer receives a title for the equipment or the product is placed into service, whichever comes first. This generally includes installation of used engines in new equipment.
(5) An imported nonroad engine covered by a certificate of conformity issued under this part, where someone other than the original engine manufacturer modifies the engine after its initial assembly and holds the certificate. The engine is no longer new when it is placed into nonroad service.
(6) An imported nonroad engine that is not covered by a certificate of conformity issued under this part at the time of importation. This addresses uncertified engines and vehicles that have been placed into service in other countries and that someone seeks to import into the United States. Importation of this kind of new nonroad engine (or vehicle containing such an engine) is generally prohibited by 40 CFR part 1068.
(1) A nonroad vehicle or other piece of equipment for which the ultimate buyer has never received the equitable or legal title. The product is no longer new when the ultimate buyer receives this title or the product is placed into service, whichever comes first.
(2) An imported nonroad piece of equipment with an engine not covered by a certificate of conformity issued under this part at the time of importation and manufactured after the date for applying the requirements of this part.
At 69 FR 39259, June 29, 2004, § 1048.801 was amended by adding a definition for “Critical emmission-related component” in alphabetical order, effective Aug. 30, 2004. For the convenience of the user, the added text is set forth as follows:
(2) Any other component whose primary purpose is to reduce emissions.
The following symbols, acronyms, and abbreviations apply to this part:
We have incorporated by reference the documents listed in this section. The Director of the Federal Register approved the incorporation by reference as prescribed in 5 U.S.C. 552(a) and 1 CFR part 51. Anyone may inspect copies at the U.S. EPA, Air and Radiation Docket and Information Center, 1301 Constitution Ave., NW., Room B102, EPA West Building, Washington, DC 20460 or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(a)
(b)
(c)
(a) Clearly show what you consider confidential by marking, circling, bracketing, stamping, or some other method. We will store your confidential information as described in 40 CFR part 2. Also, we will disclose it only as specified in 40 CFR part 2.
(b) If you send us a second copy without the confidential information, we will assume it contains nothing confidential whenever we need to release information from it.
(c) If you send us information without claiming it is confidential, we may make it available to the public without further notice to you, as described in 40 CFR 2.204.
See 40 CFR part 1068, subpart G, for information related to hearings.
The following table shows the transient duty-cycle for constant-speed engines, as described in § 1048.510:
The following table shows the transient duty-cycle for engines that are not constant-speed engines, as described in § 1048.510:
42 U.S.C. 7401-7671(q).
(a) This part applies to you if you manufacture or import any of the following recreational vehicles or engines used in them, unless we exclude them under § 1051.5:
(1) Snowmobiles.
(2) Off-highway motorcycles.
(3) All-terrain vehicles (ATVs).
(4) Offroad utility vehicles with engines with displacement less than or equal to 1000 cc, maximum brake power less than or equal to 30 kW, and maximum vehicle speed of 25 miles per hour or higher. Offroadutility vehicles that are subject to this part are subject to the same requirements as ATVs. This means that any requirement that applies to ATVs also applies to these offroad utility vehicles, without regard to whether the regulatory language mentions offroad utility vehicles.
(b) [Reserved]
(c) As noted in subpart G of this part, 40 CFR part 1068 applies to everyone, including anyone who manufactures, installs, owns, operates, or rebuilds any of the vehicles or engines this part covers.
(d) You need not follow this part for vehicles you produce before the 2006 model year, unless you certify voluntarily. See §§ 1051.103 through 1051.110, § 1051.145, and the definition of “model year” in § 1051.801 for more information about the timing of the requirements.
(e) The requirements of this part begin to apply when a vehicle is new. See the definition of “new” in § 1051.801 for more information. In some cases, vehicles or engines that have been previously used may be considered “new” for the purposes of this part.
(f) See §§ 1051.801 and 1051.805 for definitions and acronyms that apply to this part. The definition section contains significant regulatory provisions and it is very important that you read them.
(g) This part also applies to engines under 50 cc used in motorcycles that are motor vehicles if the manufacturer uses the provisions of 40 CFR 86.447-2006 to meet the emission standards in this part instead of the requirements of 40 CFR part 86. Compliance with the provisions of this part is a required condition of that exemption.
(h) The evaporative emission requirements of this part applies to highway motorcycles as specified in 40 CFR part 86.
(a) You may exclude vehicles with compression-ignition engines. See 40 CFR part 89 for regulations that cover these engines.
(b) See subpart G of this part and 40 CFR part 1068, subpart C, for exemptions of specific engines.
(c) We may require you to label an engine or vehicle (or both) if this section excludes it and other requirements in this chapter do not apply.
(d) Send the Designated Officer a written request with supporting documentation if you want us to determine whether this part covers or excludes certain vehicles. Excluding engines from this part's requirements does not affect other requirements that may apply to them.
(a) You must get a certificate of conformity from us for each engine family before you do any of the following things with a new vehicle or new engine covered by this part: sell, offer for sale, introduce into commerce, distribute or deliver for introduction into commerce, or import it into the United States. “New” vehicles or engines may include some already placed in service (see the definition of “new” in § 1051.801). You must get a new certificate of conformity for each new model year.
(b) To get a certificate of conformity and comply with its terms, you must do five things:
(1) Meet the emission standards and other requirements in subpart B of this part.
(2) Perform preproduction emission tests.
(3) Apply for certification (see subpart C of this part).
(4) Do routine emission testing on production vehicles or engines as required by subpart D of this part.
(5) Follow our instructions throughout this part.
(c) Subpart F of this part describes how to test your engines or vehicles(including references to other parts) and when you may test the engine alone instead of the entire vehicle.
(d) Subpart G of this part and 40 CFR part 1068 describe requirements and prohibitions that apply to manufacturers, owners, operators, rebuilders, and all others. They also describe exemptions available for special circumstances.
(a) Parts 86 and 1065 of this chapter describe procedures and equipment specifications for testing vehicles and engines. Subpart F of this part describes how to apply part 86 or 1065 of this chapter to show you meet the emission standards in this part.
(b) Part 1068 of this chapter describes general provisions, including these seven areas:
(1) Prohibited actions and penalties for manufacturers and others.
(2) Rebuilding and other aftermarket changes.
(3) Exemptions and exclusions for certain vehicles and engines.
(4) Importing vehicles and engines.
(5) Selective enforcement audits of your production.
(6) Defect reporting and recall.
(7) Procedures for hearings.
(c) Other parts of this chapter affect you if referenced in this part.
(a) You may certify engines sold separately from vehicles in either of two cases:
(1) If you manufacture recreational engines but not recreational vehicles, you may ask to certify the engine alone. In your request, explain why you cannot certify the entire vehicle.
(2) If you manufacture complete recreational vehicles containing engines you also sell separately, you may ask to certify all these engines in a single engine family or in separate engine families.
(b) If you certify an engine under this section, you must use the test procedures in subpart F of this part. If the test procedures require vehicle testing, use good engineering judgment to install the engine in an appropriate vehicle for measuring emissions.
(c) If we allow you to certify recreational engines, the vehicles must meet the applicable emission standards (including evaporative emission standards) with the engines installed in the appropriate vehicles. You must prepare installation instructions as described in § 1051.130 and use good engineering judgment so that the engines will meet emission standards after proper installation in the vehicle.
(d) Identify and label engines you produce under this section consistent with the requirements of § 1051.135. On the emission control information label, identify the manufacturing date of the engine rather than the vehicle.
(e) You may not use the provisions of this section to circumvent or reduce the stringency of this part's standards or other requirements.
(f) If you certify under paragraph (a)(1) of this section, you may ask us to allow you to perform production-line testing on the engine. If you certify under paragraph (a)(2) of this section, use good engineering judgment to ensure that these engines are produced in the same manner as the engines you produce for your vehicles, so that your production-line testing results under subpart D of this part would apply to them.
(a) If you manufacture recreational vehicles with engines certified under § 1051.20, you need not also certify the vehicle under this part. The vehicle must nevertheless meet emission standards with the engine installed.
(b) You must follow the engine manufacturer's emission-related installation instructions, as described in § 1051.135 and 40 CFR 1068.105. For example, you must use a fuel system that meets the permeation requirements of this part, consistent with the engine manufacturer's instructions.
(c) If you install the engine in a way that makes the engine's emission control information label hard to read during normal engine maintenance, you must place a duplicate label on the vehicle, as described in 40 CFR 1068.105.
(a) You must show that your vehicles meet the following:
(1) The applicable exhaust emission standards in § 1051.103,§ 1051.105, or § 1051.107.
(i) For snowmobiles, see § 1051.103.
(ii) For off-highway motorcycles, see § 1051.105.
(iii) For all-terrain vehicles and offroad utility vehicles subject to this part, see § 1051.107.
(2) The evaporative emission standards in § 1051.110.
(3) All the requirements in § 1051.115.
(b) The certification regulations in subpart C of this part describe how you make this showing.
(c) These standards and requirements apply to all testing, including production-line and in-use testing, as described in subparts D and E of this part.
(d) Other sections in this subpart describe other requirements for manufacturers such as labeling or warranty requirements.
(e) It is important that you read § 1051.145 to determine if there are other interim requirements or interim compliance options that apply for a limited time.
(f) As is described in § 1051.1(a)(4), offroad utility vehicles that are subject to this part are subject to the same requirements as ATVs.
(a) Apply the exhaust emission standards in this section by model year. Measure emissions with the snowmobile test procedures in subpart F of this part.
(1) Follow Table 1 of this section for exhaust emission standards. You may use the averaging, banking, and trading provisions of subpart H of this part to show compliance with these standards (an engine family meets emission standards even if its family emission limit is higher than the standard, as long as you show that the whole averaging set of applicable engine families meet the applicable emission standards using emission credits, and the vehicles within the family meet the family emission limit). Table 1 also shows the maximum value you may specify for a family emission limit, as follows:
(2) For Phase 3, the HC+NO
(i) Prior to production, select the HC+NO
(ii) Your corporate average HC+NO
(iii) Your corporate average CO standard may not be higher than 275 g/kW-hr.
(iv) You may use the averaging and banking provisions of subpart H of this part to show compliance with these HC+NO
(b) Apply the exhaust emission standards in this section for snowmobiles using each type of fuel specified in 40 CFR part 1065, subpart C, for which they are designed to operate. You must meet the numerical emission standards for hydrocarbons in this section based on the following types of hydrocarbon emissions for snowmobiles powered by the following fuels:
(1) Gasoline- and LPG-fueled snowmobiles: THC emissions.
(2) Natural gas-fueled snowmobiles: NMHC emissions.
(3) Alcohol-fueled snowmobiles: THCE emissions.
(c) Your snowmobiles must meet emission standards over their full useful life (§ 1051.240 describes how to use deterioration factors to show this). The minimum useful life is 8,000 kilometers, 400 hours of engine operation, or five calendar years, whichever comes first. You must specify a longer useful life in terms of kilometers and hours for the engine family if the average service life of your vehicles is longer than the minimum value, as follows:
(1) Except as allowed by paragraph (c)(2) of this section, your useful life (in kilometers and hours) may not be less than either of the following:
(i) Your projected operating life from advertisements or other marketing materials for any vehicles in the engine family.
(ii) Your basic mechanical warranty for any engines in the engine family.
(2) Your useful life may be based on the average service life of vehicles in the engine family if you show that the average service life is less than the useful life required by paragraph (c)(1) of this section, but more than the minimum useful life (8,000 kilometers or 400 hours of engine operation). In determining the actual average service life of vehicles in an engine family, we will consider all available information and analyses. Survey data is allowed but not required to make this showing.
(a) Apply the exhaust emission standards in this section by model year. Measure emissions with the off-highway motorcycle test procedures in subpart F of this part.
(1) Follow Table 1 of this section for exhaust emission standards. You may use the averaging, banking, and trading provisions of subpart H of this part to show compliance with the HC+NO
(2) For model years 2007 and later you may choose to certify all of your off-highway motorcycles to an HC+NO
(i) You may not request an exemption for any off-highway motorcycles under § 1051.620
(ii) At least ten percent of your off-highway motorcycles for the model year must have four of the following features:
(A) The absence of a headlight or other lights.
(B) The absence of a spark arrestor.
(C) The absence of manufacturer warranty.
(D) Suspension travel greater than 10 inches.
(E) Engine displacement greater than 50 cc.
(F) The absence of a functional seat.
(iii) You may use the averaging and banking provisions of subpart H of this part to show compliance with this HC+NO
(3) You may certify off-highway motorcycles with engines that have total displacement of 70 cc or less to the exhaust emission exhaust standards in § 1051.615 instead of certifying them to the exhaust emission standards of this section.
(b) Apply the exhaust emission standards in this section for off-highway motorcycles using each type of fuel specified in 40 CFR part 1068, subpart C, for which they are designed to operate. You must meet the numerical emission standards for hydrocarbons in this section based on the following types of hydrocarbon emissions for off-highway motorcycles powered by the following fuels:
(1) Gasoline- and LPG-fueled off-highway motorcycles: THC emissions.
(2) Natural gas-fueled off-highway motorcycles: NMHC emissions.
(3) Alcohol-fueled off-highway motorcycles: THCE emissions.
(c) Your off-highway motorcycles must meet emission standards over their full useful life (§ 1051.240 describes how to use deterioration factors to show this). The minimum useful life is 10,000 kilometers or five years, whichever comes first. You must specify a longer useful life for the engine family in terms of kilometers if the average service life of your vehicles is longer than the minimum value, as follows:
(1) Except as allowed by paragraph (c)(2) of this section, your useful life (in kilometers) may not be less than either of the following:
(i) Your projected operating life from advertisements or other marketing materials for any vehicles in the engine family.
(ii) Your basic mechanical warranty for any engines in the engine family.
(2) Your useful life may be based on the average service life of vehicles in the engine family if you show that the average service life is less than the useful life required by paragraph (c)(1) of this section, but more than the minimum useful life (10,000 kilometers). In determining the actual average service life of vehicles in an engine family, we will consider all available information and analyses. Survey data is allowed but not required to make this showing.
This section specifies the exhaust emission standards that apply to ATVs. As is described in § 1051.1(a)(4), offroad utility vehicles that are subject to this part are subject to these same standards.
(a) Apply the exhaust emission standards in this section by model year. Measure emissions with the ATV test procedures in subpart F of this part.
(1) Follow Table 1 of this section for exhaust emission standards. You may use the averaging, banking, and trading provisions of subpart H of this part to show compliance with these HC+NO
(2) You may certify ATVs with engines that have total displacement of less than 100 cc to the exhaust emission exhaust standards in § 1051.615 instead of certifying them to the exhaust emission standards of this section.
(b) Apply the exhaust emission standards in this section for ATVs using each type of fuel specified in 40 CFR 1065, subpart C for which they are designed to operate. You must meet the numerical emission standards for hydrocarbons in this section based on the following types of hydrocarbon emissions for ATVs powered by the following fuels:
(1) Gasoline- and LPG-fueled ATVs: THC emissions.
(2) Natural gas-fueled ATVs: NMHC emissions.
(3) Alcohol-fueled ATVs: THCE emissions.
(c) Your ATVs must meet emission standards over their full useful life (§ 1051.240 describes how to use deterioration factors to show this). The minimum useful life is 10,000 kilometers, 1000 hours of engine operation, or five years, whichever comes first. You must specify a longer useful life for the engine family in terms of kilometers and hours if the average service life of your vehicles is longer than the minimum value, as follows:
(1) Except as allowed by paragraph (c)(2) of this section, youruseful life (in kilometers) may not be less than either of the following:
(i) Your projected operating life from advertisements or other marketing materials for any vehicles in the engine family.
(ii) Your basic mechanical warranty for any engines in the engine family.
(2) Your useful life may be based on the average service life of vehicles in the engine family if you show that the
All of your new vehicles must meet the emission standards of this section over their full useful life, as specified in this section. Note that § 1051.245 allows you to use design-based certification instead of generating new emission data.
(a) Beginning with the 2008 model year, permeation emissions from your vehicle's fuel tank(s) may not exceed 1.5 grams per square-meter per day when measured with the test procedures for tank permeation in subpart F of this part. You may use the averaging, banking, and trading provisions of subpart H of this part to show compliance.
(b) Beginning with the 2008 model year, permeation emissions from your vehicle's fuel lines may not exceed 15 grams per square-meter per day when measured with the test procedures for fuel-line permeation in subpart F of this part. Use the inside diameter of the hose to determine the surface area of the hose.
Your vehicles must meet the following requirements:
(a)
(b)
(c)
(1) We do not consider an operating parameter adjustable if you permanently seal it or if ordinary tools cannot readily access it.
(2) We may require you to adjust the engine to any specification within the adjustable range during certification testing, production-line testing, selective enforcement auditing, or in-use testing.
(d)
(1) In your application for certification, specify the adjustable range of air-fuel ratios you expect to occur in use. You may specify it in terms of engine parts (such as the carburetor jet size and needle configuration as a function of atmospheric conditions).
(2) This adjustable range (specified in paragraph (d)(1) of this section) must include all air-fuel ratios between the lean limit and the rich limit, unless you can show that some air-fuel ratios will not occur in use.
(i) The lean limit is the air-fuel ratio that produces the highest engine power output (averaged over the test cycle).
(ii) The rich limit is the richest of the following air-fuel ratios:
(A) The air-fuel ratio that would result from operating the vehicle as you produce it at the specified test conditions.This paragraph (d)(2)(ii)(A) does not apply if you produce the vehicle with an unjetted carburetor so that the vehicle must be jetted by the dealer or operator.
(B) The air-fuel ratio of the engine when you do durability testing.
(C) The richest air-fuel ratio that you recommend to your customers for the applicable ambient conditions.
(3) If the air-fuel ratio of your vehicle is adjusted primarily by changing the carburetor jet size and/or needle configuration, you may submit your recommended jetting chart instead of the range of air-fuel ratios required by paragraph (d)(1) of this section if the following criteria are met:
(i) Good engineering judgment indicates that vehicle operators would not have an incentive to operate the vehicle with richer air-fuel ratios than recommended.
(ii) The chart is based on use of a fuel that is equivalent to the specified test fuel(s). As an alternative you may submit a chart based on a representative in-use fuel if you also provide instructions for converting the chart to be applicable to the test fuel(s).
(iii) The chart is specified in units that are adequate to make it practical for an operator to keep the vehicle properly jetted during typical use. For example, charts that specify jet sizes based on increments of temperature smaller than 20 °F (11.1 °C) or increments of altitude less than 2000 feet would not meet this criteria. Temperature ranges must overlap by at least 5 °F(2.8 °C).
(iv) You follow the jetting chart for durability testing.
(v) You do not produce your vehicles with jetting richer than the jetting chart recommendation for the intended vehicle use.
(4) We may require you to adjust the engine to any specification within the adjustable range during certification testing, production-line testing, selective enforcement auditing, or in-use testing. If we allow you to submit your recommended jetting chart instead of the range of air-fuel ratios required by paragraph (d)(1) of this section, adjust the engine to the richest specification within the jetting chart for the test conditions, unless we specify a leaner setting. We may not specify a setting leaner than that described in paragraph(d)(2)(i) of this section.
(e)
(f)
(1) The conditions of concern were substantially included in your prescribed duty cycles.
(2) You show your design is necessary to prevent catastrophic vehicle damage or accidents.
(3) The reduced effectiveness applies only to starting the engine.
(g)
(a)
(1) It is designed, built, and equipped to conform at the time of sale with the requirements of this part.
(2) It is free from defects in materials and workmanship that may keep it from meeting these requirements.
(b)
(c)
(d)
(1) The component was in general use on similar engines, and was subject to scheduled maintenance, before January 1, 2000.
(2) Failure of the component would clearly degrade the engine's performance enough that the operator would need to repair or replace it.
(e)
(f)
Give the ultimate buyer of each new vehicle written instructions for properly maintaining and using the vehicle, including the emission-control system. The maintenance instructions also apply to service accumulation on your test vehicles or engines, as described in 40 CFR part 1065, subpart E.
(a)
(1) You may ask us to approve critical emission-related maintenance only if it meets two criteria:
(i) Operators are reasonably likely to do the maintenance you call for.
(ii) Vehicles need the maintenance to meet emission standards.
(2) We will accept scheduled maintenance as reasonably likely to occur in use if you satisfy any of four conditions:
(i) You present data showing that, if a lack of maintenance increases emissions, it also unacceptably degrades the vehicle's performance.
(ii) You present survey data showing that 80 percent of vehicles in the field get the maintenance you specify at the recommended intervals.
(iii) You provide the maintenance free of charge and clearly say so in maintenance instructions for the customer.
(iv) You otherwise show us that the maintenance is reasonably likely to be done at the recommended intervals.
(3) You may not schedule critical emission-related maintenance within the minimum useful life period for aftertreatment devices, pulse-air valves, fuel injectors, oxygen sensors, electronic control units, superchargers, or turbochargers.
(b)
(c)
(d)
(e)
(f)
(1) Provide a component or service without charge under the purchase agreement.
(2) Get us to waive this prohibition in the public's interest by convincing us the vehicle will work properly only with the identified component or service.
At 69 FR 39529, June 29, 2004, § 1051.125 was amended by revising paragraph (a) introductory text and paragraph (d), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows;
(a)
(d)
(a) If you sell an engine for someone else to install in a recreational vehicle, give the engine buyer written instructions for installing it consistent with the requirements of this part. Include all information necessary to ensure that engines installed this way will meet emission standards.
(b) These instructions must have the following information:
(1) Include the heading: “Emission-related installation instructions”.
(2) State: “Failing to follow these instructions when installing a certified
(3) Describe any other instructions needed to install an exhaust aftertreatment device consistent with your application for certification.
(4) Describe the steps needed to comply with the evaporative emission standards in § 1051.110.
(5) Describe any limits on the range of applications needed to ensure that the engine operates consistently with your application for certification. For example, if your engines are certified only to the snowmobile standards, tell vehicle manufacturers not to install the engines in other vehicles.
(6) Describe any other instructions to make sure the installed engine will operate according to any design specifications you describe in your application for certification.
(7) State: “If you install the engine in a way that makes the engine's emission control information label hard to read during normal engine maintenance, you must place a duplicate label on the vehicle, as described in 40 CFR 1068.105.”.
(c) You do not need installation instructions for engines you install in your own vehicles.
Each of your vehicles must have three labels: a vehicle identification number as described in paragraph (a) of this section, an emission control information label as described in paragraphs (b) through (e) of this section, and a consumer information label as described in paragraph (g) of this section.
(a) Assign each production vehicle a unique identification number and permanently and legibly affix, stamp, or engrave it on the vehicle.
(b) At the time of manufacture, add a permanent label identifying the emission controls for each vehicle. This is the vehicle's “emission control information label.” To meet labeling requirements, do the following things:
(1) Attach the label in one piece so it is not removable without being destroyed or defaced.
(2) Design and produce it to be durable and readable for the vehicle's entire life.
(3) Secure it to a part of the vehicle (or engine) needed for normal operation and not normally requiring replacement.
(4) Write it in block letters in English.
(5) Attach the label in a location where it can be easily read.
(c) On your label, do these things:
(1) Include the heading “EMISSION CONTROL INFORMATION”.
(2) Include your full corporate name and trademark.
(3) State: “THIS VEHICLE IS CERTIFIED TO OPERATE ON [specify operating fuel or fuels].”.
(4) Identify the emission-control system; your identifiers must use names and abbreviations consistent with SAE J1930 (incorporated by reference in § 1051.810).
(5) List all requirements for fuel and lubricants.
(6) State the date of manufacture [DAY (optional), MONTH, and YEAR]; if you stamp it on the engine and print it in the owner's manual, you may omit this information from the emission control information label.
(7) State: “THIS VEHICLE MEETS U.S. ENVIRONMENTAL PROTECTION AGENCYREGULATIONS FOR [MODEL YEAR] [SNOWMOBILES or OFF-ROAD MOTORCYCLES orATVs].”.
(8) Include EPA's standardized designation for the engine family.
(9) State the engine's displacement (in liters) and maximum brake power. You do not need to include the engine's displacement and power on the emission control information label if the vehicle is permanently labeled with a unique model name that corresponds to a specific displacement/power configuration.
(10) State the engine's useful life if it is different than the minimum value.
(11) List specifications and adjustments for engine tuneups; show the proper position for the transmission during tuneup and state which accessories should be operating.
(12) Identify the emission standards or family emission limits to which you have certified the engine.
(d) Some of your engines may need more information on the emission control information label. If you produce an engine or vehicle that we exempt from the requirements of this part, see subpart G of this part and 40 CFR part 1068, subparts C and D, for more label information.
(e) Some engines may not have enough space for an emission control information label with all the required information. In this case, you may omit the information required in paragraphs (c)(3), (c)(4), and (c)(5) of this section if you print it in the owner's manual instead.
(f) If you are unable to meet these labeling requirements, you may ask us to modify them consistent with the intent of this section.
(g) Label every vehicle certified under this part with a removable hang-tag showing its emission characteristics relative to other models. The label should be attached securely to the vehicle before it is offered for sale in such a manner that it would not be accidentally removed prior to sale. Use the applicable equations of this paragraph (g) to determine the normalized emission rate (NER) from the FEL for your vehicle. If the vehicle is certified without using the averaging provisions of subpart H, use the final deteriorated emission level. Round the resulting normalized emission rate for your vehicle to the nearest whole number. We may specify a standardized format for labels. At a minimum, the tag should include: The manufacturer's name, vehicle model name, engine description (500 cc two-stroke with DFI), the NER, and a brief explanation of the scale (for example, note that 0 is the cleanest and 10 is the least clean).
(1) For snowmobiles, use the following equation:
(2)(i) For off-highway motorcycles with HC+NO
(ii) For off-highway motorcycles with HC+NO
(3)(i) For ATVs with HC+NO
(ii) For ATVs with HC+NO
Apply the following provisions instead of others in this part for the periods and circumstances specified in this section.
(a)
(1) You may delay complying with otherwise applicable emission standards (and other requirements) for two model years.
(2) If you are a small-volume manufacturer of snowmobiles, only 50 percent of the models you produce (instead of all of the models you produce) must meet emission standards in the first two years they apply to you as a small-volume manufacturer, as described in paragraph (a)(1) of this section. For example, this alternate phase-in allowance would allow small-volume snowmobile manufacturers to
(3) Your vehicles for model years before 2011 may be exempt from the exhaust standards of this part if you meet the following criteria:
(i) Produce your vehicles by installing engines covered by a valid certificate of conformity under 40 CFR part 90 that shows the engines meet standards for Class II engines for each engine's model year.
(ii) Do not change the engine in a way that we could reasonably expect to increase its exhaust emissions.
(iii) The engine meets all applicable requirements from 40 CFR part 90. This applies to engine manufacturers, vehicle manufacturers who use these engines, and all other persons as if these engines were not used in recreational vehicles.
(iv) Demonstrate that fewer than 50 percent of the engine model's total sales, from all companies, are used in recreational vehicles regulated under this part.
(4) All vehicles certified or exempted under this paragraph (a) must be labeled according to our specifications. The label must include the following:
(i) The heading “EMISSION CONTROL INFORMATION”.
(ii) Your full corporate name and trademark.
(iii) A description of the provisions under which the vehicle is either exempted or certified.
(iv) Other information that we specify to you in writing.
(b)
(1) Follow Table 1 of this section for exhaust emission standards, while meeting all the other requirements of § 1051.107. You may use emission credits to show compliance with these standards (see subpart H of this part). You may not exchange emission credits with engine families meeting the standards in § 1051.107(a). You may also not exchange credits between engine families certified to the standards for engines above 225 cc and engine families certified to the standards for engines below 225 cc. The phase-in percentages in the table specify the percentage of your U.S.-directed production that must comply with the emission standards for those model years. Table 1 follows:
(2) Measure emissions by testing the engine on a dynamometer with the steady-state duty cycle described in Table 2 of this section.
(i) During idle mode, hold the speed within your specifications, keep the throttle fully closed, and keep engine torque under 5 percent of the peak torque value at maximum test speed.
(ii) For the full-load operating mode, operate the engine at its maximum fueling rate.
(iii) See part 1065 of this chapter for detailed specifications of tolerances and calculations.
(iv) Table 2 follows:
(3) For ATVs certified to the standards in this paragraph (b) use the following equation to determine the normalized emission rate required by § 1051.135(g):
(c)
(d)
(1) Submit a plan during the certification process for the first model year of the phase-in showing how you project to meet the sales requirement of the phase-in.
(2) Notify us less than 30 days after you determine that you are likely to fail to comply with the sales requirement of the phase-in.
(3) Propose a remedy that will achieve equivalent or greater emission reductions compared to the specified phase-in requirements, and that will offset the deficit within one model year.
(e)
(f)
(1) You may certify one or more snowmobile engine families to FELs (HC and CO) below the numerical level of the Phase 2 standards prior to the date when compliance with the Phase 1 standard is otherwise required. Credits are calculated relative to the Phase 2 standards. Credits generated under this paragraph (f)(1) may be used at any time before 2012.
(2) You may certify a snowmobile engine family to FELs (HC and CO) below the numerical level of the Phase 1 standards prior to the date when compliance with the Phase 1 standard is
(g)
(1) Pull-ahead tanks meeting the 3.0 g/m
(2) Tanks for which compliance with the 1.5 g/m
(3) You may delay compliance with the 1.5 g/m
(4) You may not use credits for a tank that is larger than the tank from which you generated the credits.
(a) Send us an application for a certificate of conformity for each engine family. Each application is valid for only one model year.
(b) The application must not include false or incomplete statements or information (see § 1051.255).
(c) We may choose to ask you to send us less information than we specify in this subpart, but this would not change your recordkeeping requirements.
(d) Use good engineering judgment for all decisions related to your application (see § 1068.5 of this chapter).
(e) An authorized representative of your company must approve and sign the application.
In your application, do all the following things unless we ask you to sendus less information:
(a) Describe the engine family's specifications and other basic parameters of the vehicle design. List the types of fuel you intend to use to certify the engine family (for example, gasoline, liquefied petroleum gas, methanol, or natural gas). List vehicle configurations and model names that are included in the engine family.
(b) Explain how the emission-control systems operate.
(1) Describe in detail all the system components for controlling exhaust emissions, including auxiliary emission-control devices and all fuel-system components you will install on any production or test vehicle or engine. Explain why any auxiliary emission-control devices are not defeat devices (see § 1051.115(f)). Do not include detailed calibrations for components unless we ask for them.
(2) Describe the evaporative emission controls.
(c) Describe the vehicles or engines you selected for testing and the reasons for selecting them.
(d) Describe any special or alternate test procedures you used (see § 1051.501).
(e) Describe how you operated the engine or vehicle prior to testing, including the duty cycle and the number of engine operating hours used to stabilize emission levels, and any scheduled maintenance you performed.
(f) List the specifications of the test fuels to show that they fall within the required ranges.
(g) Identify the engine family's useful life.
(h) Propose maintenance and use instructions for the ultimate buyer of each new vehicle (see § 1051.125).
(i) Propose emission-related installation instructions if you sell engines for someone else to install in a vehicle (see § 1051.130).
(j) Propose an emission control information label.
(k) Present emission data to show that you meet emission standards.
(1) Present exhaust emission data for HC, NO
(2) Present evaporative test data for HC to show your vehicles meet the evaporative emission standards we specify in subpart B of this part. Show these figures before and after applying deterioration factors for each vehicle or engine, where applicable. If you did not perform the testing, identify the source of the test data.
(3) Note that § 1051.235 and 1051.245 allows you to submit an application in certain cases without new emission data.
(l) Report all test results, including those from invalid tests or from any nonstandard tests (such as measurements based on exhaust concentrations in parts per million).
(m) Identify the engine family's deterioration factors and describe how you developed them. Present any emission test data you used for this.
(n) Describe all adjustable operating parameters and other adjustments(see § 1051.115 (c) and (d)), including the following:
(1) The nominal or recommended setting.
(2) The intended physically adjustable range, including production tolerances if they affect the range.
(3) The limits or stops used to establish adjustable ranges.
(4) The air-fuel ratios or jet chart specified in § 1051.115(d).
(o) State that you operated your test vehicles or engines according to the specified procedures and test parameters using the fuels described in the application to show you meet the requirements of this part.
(p) State unconditionally that all the vehicles (and/or engines) in the engine family comply with the requirements of this part, other referenced parts, and the Clean Air Act.
(q) Include estimates of U.S.-directed production volumes.
(r) Show us how to modify your production vehicles to measure emissions in the field (see § 1051.115).
(s) Add other information to help us evaluate your application if we ask for it.
If you send us information before you finish the application, we will review it and make any appropriate determinations listed in § 1051.215(b)(1) through (5). Decisions made under this section are considered to be preliminary approval. We will generally not disapprove applications under § 1051.215(b)(1) through (5) where we have given you preliminary approval, unless we find new and substantial information supporting a different decision.
(a) If you request preliminary approval related to the upcoming model year or the model year after that, we will make a “best-efforts” attempt to make the appropriate determinations as soon as possible. We will generally not provide preliminary approval related to a future model year more than two years ahead of time.
(b) If we have published general guidance that serves as our determination for your situation, you may consider that to be preliminary approval.
(a) If any of the information in your application changes after you submit it, amend it as described in § 1051.225.
(b) We may deny your application (that is, determine that we cannot approve it without revision) if the engine family does not meet the requirements of this part or the Act. For example:
(1) If you inappropriately use the provisions of § 1051.230(c) or (d) to define a broader or narrower engine family, we will require you to redefine your engine family.
(2) If we determine you did not appropriately select the useful life as specified in § 1051.103(c), § 1051.105(c), or § 1051.107(c), we will require you to lengthen it.
(3) If we determine you did not appropriately select deterioration factors under § 1051.240(c), we will require you to revise them.
(4) If your proposed emission control information label is inconsistent with § 1051.135, we will require you to change it (and tell you how, if possible).
(5) If you require or recommend maintenance and use instructions inconsistent with § 1051.125, we will require you to change them.
(6) If we find any other problem with your application, we will tell you what the problem is, and what needs to be corrected.
(c) If we determine your application is complete and shows that the engine family meets all the requirements of this part and the Act, we will issue a certificate of conformity for your engine family for that model year. If we deny the application, we will explain why in writing. You may then askus to hold a hearing to reconsider our decision (see § 1051.820).
Send the Designated Officer a request to amend your application for certification for an engine family if you want to change the emission-related maintenance instructions in a way that could affect emissions. In your request, describe the proposed changes to the maintenance instructions.
(a) If you are decreasing the specified level of maintenance, you may distribute the new maintenance instructions to your customers 30 days after we receive your request, unless we disapprove your request. We may approve a shorter time or waive this requirement.
(b) If your requested change would not decrease the specified level of maintenance, you may distribute the new maintenance instructions anytime after you send your request.
(c) If you are correcting or clarifying your maintenance instructions or if you are changing instructions for maintenance unrelated to emission controls, the requirements of this section do not apply.
(a) You must amend your application for certification before you take either of the following actions:
(1) Add a vehicle to a certificate of conformity.
(2) Make a design change for a certified engine family that may affect emissions or an emission-related part over the vehicle's lifetime.
(3) Modify an FEL for an engine family, as described in paragraph (f) of this section.
(b) Send the Designated Officer a request to amend the application for certification for an engine family. In your request, do all of the following:
(1) Describe the vehicle model or configuration you are adding or changing.
(2) Include engineering evaluations or reasons why the original test vehicle or engine is or is not still appropriate.
(3) If the original test vehicle or engine for the engine family is not appropriate to show compliance for the new or modified vehicle, include new test data showing that the new or modified vehicle meets the requirements of this part.
(c) You may start producing the new or modified vehicle anytime after the time at which you send us your request (for example, the day you mail your request). If we determine that the affected vehicles do not meet applicable requirements, we will require you to cease production of the vehicles and to recall and correct the vehicles at no expense to the owner. If you choose to produce vehicles under this paragraph, we will consider that to be consent to recall all vehicles that we determine do not meet applicable standards and other requirements and to remedy the nonconformity at no expense to the owner.
(d) You must give us test data within 30 days if we ask for more testing, or stop producing the vehicle if you are not able to do this. You may give us an engineering evaluation instead of test data if we agree that you can address our questions without test data.
(e) If we determine that the certificate of conformity would not cover your new or modified vehicle, we will send you a written explanation of our decision. In this case, you may no longer produce these vehicles, though you may ask for a hearing for us to reconsider our decision (see § 1051.820).
(f) You may ask to change your FEL in the following cases:
(1) You may ask to raise your FEL for your engine family after the start of production. You must use the higher FEL for the entire family to calculate your average emission level under subpart H of this part. In your request, you must demonstrate that you will still be able to comply with the applicable average emission standards as specified in subparts B and H of this part.
(2) You may ask to lower the FEL for your engine family after the start of production only when you have test data from production vehicles indicating that your vehicles comply with the lower FEL. You may create a separate subfamily with the lower FEL. Otherwise, you must use the higher FEL for the family to calculate your average emission level under subpart H of this part.
(3) If you change the FEL during production, you must include the new FEL on the emission control information label for all vehicles produced after the change.
(a) Divide your product line into families of vehicles that you expect to have similar emission characteristics. Your engine family is limited to a single model year.
(b) Group vehicles in the same engine family if they are the same in all of the following aspects:
(1) The combustion cycle.
(2) The cooling system (water-cooled vs. air-cooled).
(3) Configuration of the fuel system (for example, port fuel injection vs. carburetion).
(4) Method of air aspiration.
(5) The number, location, volume, and composition of catalytic converters.
(6) Type of fuel.
(7) The number, arrangement, and approximate bore diameter of cylinders.
(8) Evaporative emission controls.
(c) In some cases you may subdivide a group of vehicles that is identical under paragraph (b) of this section into different engine families. To do this under normal circumstances, you must show you expect emission characteristics to be different during the useful life or that any of the following engine characteristics are different:
(1) Method of actuating intake and exhaust timing (poppet valve, reed valve, rotary valve, etc.).
(2) Location or size of intake and exhaust valves or ports.
(3) Configuration of the combustion chamber.
(4) Cylinder stroke or actual bore diameter.
(5) Exhaust system.
(d) In some cases, you may include different engines in the same engine family, even though they are not identical with respect to the things listed in paragraph (b) of this section.
(1) If different engines have similar emission characteristics during the useful life, we may approve grouping them in the same engine family.
(2) If you are a small-volume manufacturer, you may group engines from any vehicles subject to the same emission standards into a singleengine family. This does not change any of the requirements of this part for showing that an engine family meets emission standards.
(e) If you cannot appropriately define engine families by the method in this section, we will define them based on features related to emission characteristics.
(f) You may ask us to create separate families for exhaust emissions and evaporative emissions. If we do this, list both families on the emission control information label.
This section describes the emission testing you must perform to show compliance with the emission standards in subpart B of this part during certification.
(a) Test your emission-data vehicles using the procedures and equipment specified in subpart F of this part. Where specifically required or allowed, test the engine instead of the vehicle. For evaporative emissions, test the fuel system components separate from the vehicle.
(b) Select from each engine family a test vehicle or engine, and a fuel system for each fuel type with a configuration that is most likely to exceed the emission standards, using good engineering judgment, consider the emission levels of all exhaust constituents over the full useful life of the vehicle.
(c) You may use previously generated emission data in the following cases:
(1) You may submit emission data for equivalent engine families from previous years instead of doing new tests, but only if the data show that the test vehicle or engine would meet all the requirements for the latest vehicle or engine models. We may require you to do new emission testing if we believe the latest vehicle or engine models could be substantially different from the previously tested vehicle or engine.
(2) You may submit emission data for equivalent engine families performed to show compliance with other standards (such as California standards) instead of doing new tests, but only if the data show that the test vehicle or engine would meet all of this part's requirements.
(3) You may submit evaporative emission data measured by a fuel system supplier. We may require you to verify that the testing was conducted in accordance with the applicable regulations.
(d) We may choose to measure emissions from any of your test vehicles or engines (or other vehicles or engines in the engine family).
(1) If we do this, you must provide the test vehicle or engine at the location we select. We may decide to do the testing at your plant or any other facility. If we choose to do the testing at your plant, you must schedule it as soon as possible and make available the instruments and equipment we need.
(2) If we measure emissions on one of your test vehicles or engines, the results of that testing become the official data for the vehicle or engine. Unless we later invalidate this data, we may decide not to consider your data in determining if your engine family meets the emission standards.
(3) Before we test one of your vehicles or engines, we may set its adjustable parameters to any point within the physically adjustable ranges (see § 1051.115(c)). We may also adjust the air-fuel ratio within the adjustable range specified in § 1051.115(d).
(4) Calibrate the test vehicle or engine within normal production tolerances for anything not covered by § 1051.115(c) and (d) of this section.
(e) If you are a small-volume manufacturer, you may certify by design on the basis of preexisting exhaust emission data for similar technologies and other relevant information, and in accordance with good engineering judgment. In those cases, you are not required to test your vehicles.
This is called “design-certification” or “certifying by design.” To certify by design, you must show that the technology used on your engines is sufficiently similar to the previously tested technology that a person reasonably familiar with emission-control technology would believe that your engines will comply with the emission standards.
(f) For fuel tanks that are certified based on permeability treatments for plastic fuel tanks, you do not need to test each engine family. However, you must use good engineering judgment to determine permeation rates for the tanks. This requires that more than one fuel tank be tested for each set of treatment conditions. You may not use test data from a given tank for any other tanks that have thinner walls. You may, however, use test data from a given tank for other tanks that have thicker walls. This applies to both low-hour (
(a) For certification, your engine family is considered to be in compliance with the numerical exhaust emission standards in subpart B of this part if all emission-data vehicles representing that family have test results showing emission levels at or below the standards.
(b) Your engine family does not comply if any emission-data vehicle representing that family has test results showing emission levels above the standards for any pollutant.
(c) To compare emission levels from the emission-data vehicle with the emission standards, apply deterioration factors (to three significant figures) to the measured emission levels. The deterioration factor is a number that shows the relationship between exhaust emissions at the end of useful life and at the low-hour test point. Section 1051.520 specifies how to test your vehicle to develop deterioration factors that estimate the change in emissions over your vehicle's full useful life. Small-volume manufacturers may use assigned deterioration factors that we establish. Apply the deterioration factors as follows:
(1) For vehicles that use aftertreatment technology, such as catalytic converters, the exhaust deterioration factor is the ratio of exhaust emissions at the end of useful life to exhaust emissions at the low-hour test point. Adjust the official emission results for each tested vehicle at the selected test point by multiplying the measured emissions by the deterioration factor. If the factor is less than one, use one.
(2) For vehicles that do not use aftertreatment technology, the exhaust deterioration factor is the difference between exhaust emissions at the end of useful life and exhaust emissions at the low-hour test point. Adjust the official emission results for each tested vehicle at the selected test point by adding the factor to the measured emissions. If the factor is less than zero, use zero.
(d) After adjusting the emission levels for deterioration, round them to the same number of decimal places as the emission standard. Compare the rounded emission levels to the emission standard for each test vehicle.
(a) For certification, your engine family is considered in compliance with the evaporative emission standards in subpart B of this part if you doeither of the following:
(1) You have test results showing permeation emission levels from the fuel tanks and fuel lines in the family are at or below the standards in § 1051.110 throughout the useful life.
(2) You comply with the design specifications in paragraph (e) of this section.
(b) Your engine family does not comply if any fuel tank or fuel line representing that family has test results showing emission levels above the standards.
(c) To compare emission levels with the emission standards, apply deterioration factors (to three significant figures) to the measuredemission levels. The deterioration factor is a number that shows the relationship between emissions at the end of useful life and at the low-hour test point. For permeation emissions, the deterioration factor is the difference between evaporative emissions at the end of useful life and evaporative emissions at the low-hour test point. Adjust the official emission results for each tested vehicle at the selected test point by adding the factor to the measured emissions. If the factor is less than zero, use zero.
(1) Section 1051.515 specifies how to test your fuel tanks to develop deterioration factors that estimate the change in emissions over your vehicle's full useful life. Small-volume manufacturers may use assigned deterioration factors that we establish. Apply the deterioration factors as follows:
(i) Calculate the deterioration factor from emission tests performed before and after the durability tests as described in § 1051.515(c) and (d) and using good engineering judgment. The durability tests described in § 1051.515(d) represent the minimum requirements for determining a deterioration factor. You may not use a deterioration factor
(ii) Do not apply the deterioration factor to test results for tanks that have already undergone these durability tests.
(2) Determine the deterioration factor for fuel lines using good engineering judgment.
(d) After adjusting the emission levels for deterioration, round them to the same number of decimal places as the emission standard. Compare the rounded emission levels to the emission standard for each test vehicle.
(e) You may demonstrate for certification that your engine family complies with the evaporative emission standards by demonstrating that you use the following control technologies:
(1) For certification to the standards specified in § 1051.110(a) with the control technologies shown in the following table:
(2) For certification to the standards specified in § 1051.110(b) with the control technologies shown in the following table:
(3) We may establish additional design certification options where we find that new test data demonstrate that the use of other technology designs will ensure compliance with the applicable emission standards.
(a) Organize and maintain the following records to keep them readily available; we may review these records at any time:
(1) A copy of all applications and any summary information you sent us.
(2) Any of the information we specify in § 1051.205 that you did not include in your application.
(3) A detailed history of each emission-data vehicle. In each history, describe all of the following:
(i) The emission-data vehicle's construction, including its origin and buildup, steps you took to ensure that it represents production vehicles, any components you built specially for it, and all emission-related components.
(ii) How you accumulated vehicle or engine operating hours, including the dates and the number of hours accumulated.
(iii) All maintenance (including modifications, parts changes, and other service) and the dates and reasons for the maintenance.
(iv) All your emission tests, including documentation on routine and standard tests, as specified in part 1065 of this chapter or other applicable test procedures regulations, and the date and purpose of each test.
(v) All tests to diagnose engine or emission-control performance, giving the date and time of each and the reasons for the test.
(vi) Any other significant events.
(b) Keep routine data from emission tests (such as test cell temperatures and relative humidity readings) for one year after we issue the associated certificate of conformity. Keep all other information specified in paragraph (a) of this section for eight years after we issue your certificate.
(c) Store these records in any format and on any media, as long as you can promptly send us organized, written records in English if we ask for them.
(d) Send us copies of any maintenance instructions or explanations if we ask for them.
(a) We may deny your application for certification if your engine family fails to comply with emission standards or other requirements of the regulation or the Act. Our decision may be based on any information available to us showing you do not meet emission standards or other requirements, including any testing that we conduct under paragraph (g) of this section. If we deny your application, we will explain why in writing.
(b) In addition, we may deny your application or revoke your certificate if you do any of the following:
(1) Refuse to comply with any testing or reporting requirements.
(2) Submit false or incomplete information (paragraph (d) of this section applies if this is fraudulent).
(3) Render inaccurate any test data.
(4) Deny us from completing authorized activities despite our presenting a warrant or court order (see § 1068.20 of this chapter).
(5) Produce vehicle or engines for importation into the United States at a location where local law prohibits us from carrying out authorized activities.
(c) We may void your certificate if you do not keep the records we require or do not give us information when we ask for it.
(d) We may void your certificate if we find that you intentionally submitted false or incomplete information.
(e) We may void your certificate for any family certified to an FEL above the allowable average if you fail to show in your end-of-year report that your average emission levels are below the applicable standards in subpartB of this part, or that you have sufficient credits to offset a credit deficit for the model year.
(f) If we deny your application or revoke or void your certificate, you may ask for a hearing (see § 1051.820). Any such hearing will be limited to substantial and factual issues.
(g) We may conduct confirmatory testing of your vehicles as part of certification. We may deny your application for certification or revoke your certificate if your vehicles fail to comply with emission standards or other requirements during confirmatory testing.
(a) If you certify vehicles to the standards of this part, you must test them as described in this subpart. If your vehicle is certified to g/kW-hr standards, then test the engine; otherwise, test the vehicle. The provisions of this subpart do not apply to small-volume manufacturers.
(b) We may suspend or revoke your certificate of conformity for certain engine families if your production-line vehicles or engines do not meet the requirements of this part or you do not fulfill your obligations under this subpart (see §§ 1051.325 and 1051.340).
(c) Other requirements apply to vehicles and engines that you produce. Other regulatory provisions authorize us to suspend, revoke, or void your certificate of conformity, or order recalls for engines families without regard to whether they have passed these production-line testing requirements. The requirements of this subpart do not affect our ability to do selective enforcement audits, as described in part 1068 of this chapter. Individual vehicles and engines in families that pass these production-line testing requirements must also conform to all applicable regulations of this part and part 1068 of this chapter.
(d) You may ask to use an alternate program for testing production-line vehicles or engines. In your request, you must show us that the alternate program gives equal assurance that your products meet the requirements of this part. If we approve your alternate program, we may waive some or all of this subpart's requirements.
(e) If you certify an engine family with carryover emission data, as described in § 1051.235(c), and these equivalent engine families consistently pass the production-line testing requirements over the preceding two-year period, you may ask for a reduced testing rate for further production-line testing for that family. The minimum testing rate is one vehicle or engine per engine family. If we reduce your testing rate, we may limit our approval to a any number of model years. In determining whether to approve your request, we may consider the number of vehicles or engines that have failed the emission tests.
(f) We may ask you to make a reasonable number of production-line vehicles or engines available for a reasonable time so we can test or inspect them for compliance with the requirements of this part.
(g) The requirements of this subpart do not apply to engine families certified under the provisions of § 1051.630.
(a)
(b)
(1) You document the need for doing so in your procedures for assembling and inspecting all your production vehicles or engines and make the action routine for all the vehicles or engines in the engine family.
(2) This subpart otherwise specifically allows your action.
(3) We approve your action in advance.
(c)
(d)
(1) We may adjust idle speed outside the physically adjustable range as needed only until the vehicle or engine has stabilized emission levels (see paragraph (e) of this section). We may ask you for information needed to establish an alternate minimum idle speed.
(2) We may make or specify adjustments within the physically adjustable range by considering their effect on emission levels, as well as how likely it is someone will make such an adjustment with in-use vehicles.
(3) We may adjust the air-fuel ratio within the adjustable range specified in § 1051.115(d).
(e)
(1) 50 hours.
(2) The number of hours you operated the emission-data vehicle used for certifying the engine family (see 40 CFR part 1065, subpart E, or the applicable regulations governing how you should prepare your test vehicle or engine).
(f)
(g)
(a) Use test results from two vehicles or engines for each engine family to calculate the required sample size for the test period. Update this calculation with each test.
(1) For engine families with projected annual sales of at least 1600, the test periods are consecutive quarters (3 months). If your annual production period is less than 12 months long, define your test periods by dividing your annual production period into approximatelyequal segments of 70 to 125 calendar days.
(2) For engine families with projected annual sales below 1600, the test period is the whole model year.
(b) Early in each test period, randomly select and test an engine from the end of the assembly line for each engine family.
(1) In the first test period for newly certified engines, randomly select and test one more engine. Then, calculate the required sample size for the test period as described in paragraph (c) of this section.
(2) In later test periods or for engine families relying on previously submitted test data, combine the new test result with the last test result from the previous test period. Then, calculate the required sample size for the new test period as described in paragraph (c) of this section.
(c) Calculate the required sample size for each engine family. Separately calculate this figure for HC, NO
(1) Determine the 95% confidence coefficient, t
(2) Calculate the standard deviation, σ, for the test sample using the following formula:
(d) Use final deteriorated test results to calculate the variables in the equations in paragraph (c) of this section (see § 1051.315(a)).
(e) After each new test, recalculate the required sample size using the updated mean values, standard deviations, and the appropriate 95-percent confidence coefficient.
(f) Distribute the remaining vehicle or engine tests evenly throughout the rest of the year. You may need to adjust your schedule for selecting vehicles or engines if the required sample size changes. Continue to randomly select vehicles or engines from each engine family; this may involve testing
(g) Continue testing any engine family for which the sample mean, x, is greater than the emission standard. This applies if the sample mean for either HC, NO
(1) The sample size, n, for an engine family is greater than the required sample size, N, and the sample mean, x, is less than or equal to the emission standard. For example, if N = 3.1 after the third test, the sample-size calculation does not allow you to stop testing.
(2) The engine family does not comply according to § 1051.325.
(3) You test 30 vehicles or engines from the engine family.
(4) You test one percent of your projected annual U.S.-directed production volume for the engine family.
(5) You choose to declare that the engine family fails the requirements of this subpart. (h) If the sample-size calculation allows you to stop testing for a pollutant, you must continue measuring emission levels of that pollutant for any additional tests required under this section. However, you need not continue making the calculations specified in this section for that pollutant. This paragraph does not affect the requirements in section § 1051.320.
(i) You may elect to test more randomly chosen vehicles or engines than we require. Include these vehicles or engines in the sample-size calculations.
This section describes the pass-fail criteria for the production-line testing requirements. We apply this criteria on an engine family basis. See § 1051.320 for the requirements that apply to individual vehicles or engines that fail a production-line test. (a) Calculate your test results. Round them to the number of decimal places in the emission standard expressed to one more decimal place.
(1)
(2)
(b) Construct the following CumSum Equation for each engine family for HC, NO
(c) Use final deteriorated test results to calculate the variables in the equation in paragraph (b) of this section (see § 1051.315(a)).
(d) After each new test, recalculate the CumSum statistic.
(e) If you test more than the required number of vehicles or engines, include the results from these additional tests in the CumSum Equation.
(f) After each test, compare the current CumSum statistic, C
(g) If the CumSum statistic exceeds the Action Limit in two consecutive tests, the engine family fails the production-line testing requirements of this subpart. Tell us within ten working days if this happens. You may request to amend the application for certification to raise the FEL of the engine family at this point if you meet the requirements of § 1051.225(f).
(h) If you amend the application for certification for an engine family under § 1051.225, do not change any previous calculations of sample size or CumSum statistics for the model year.
(a) If you have a production-line vehicle or engine with final deteriorated test results exceeding one or more
(1) Correct the problem and retest the vehicle or engine to show it complies with all emission standards.
(2) Include in your written report a description of the test results and the remedy for each vehicle or engine (see § 1051.345).
(b) You may request to amend the application for certification to raise the FEL of the entire engine family at this point (see § 1051.225).
(a) We may suspend your certificate of conformity for an engine family if it fails under § 1051.315. The suspension may apply to all facilities producing vehicles or engines from an engine family, even if you find noncompliant vehicles or engines only at one facility.
(b) We will tell you in writing if we suspend your certificate in whole or in part. We will not suspend a certificate until at least 15 days after the engine family fails. The suspension is effective when you receive our notice.
(c) Up to 15 days after we suspend the certificate for an engine family, you may ask for a hearing (see § 1051.820). If we agree before a hearing that we used erroneous information in deciding to suspend the certificate, we will reinstate the certificate.
(d) Section 1051.335 specifies steps you must take to remedy the cause of the production-line failure. All the vehicles you have produced since the end of the last test period are presumed noncompliant and should be addressed in your proposed remedy. We may require you to apply the remedy to engines produced earlier if we determine that the cause of the failure is likely to have affected the earlier engines.
(e) You may request to amend the application for certification to raise the FEL of the engine family before or after we suspend your certificate if you meet the requirements of § 1051.225(f).
You may sell vehicles that you produce after we suspend the engine family's certificate of conformity under § 1051.315 only if one of the following occurs:
(a) You test each vehicle or engine you produce and show it complies with emission standards that apply.
(b) We conditionally reinstate the certificate for the engine family. We may do so if you agree to recall all the affected vehicles and remedy any noncompliance at no expense to the owner if later testing shows that the engine family still does not comply.
(a) Send us a written report asking us to reinstate your suspended certificate. In your report, identify the reason for noncompliance, propose a remedy for the engine family, and commit to a date for carrying it out. In your proposed remedy include any quality control measures you propose to keep the problem from happening again.
(b) Give us data from production-line testing that shows the remedied engine family complies with all the emission standards that apply.
(a) We may revoke your certificate for an engine family in the following cases:
(1) You do not meet the reporting requirements.
(2) Your engine family fails to comply with the requirements of this subpart and your proposed remedy to address a suspended certificate under § 1051.325 is inadequate to solve the problem or requires you to change the vehicle's design or emission-control system.
(b) To sell vehicles from an engine family with a revoked certificate of conformity, you must modify the engine family and then show it complies with the requirements of this part.
(1) If we determine your proposed design change may not control emissions for the vehicle's full useful life, we will
(2) Unless we require more testing, you may show compliance by testing production-line vehicles or engines as described in this subpart.
(3) We will issue a new or updated certificate of conformity when you have met these requirements.
Do all the following things unless we ask you to send us less information:
(a) Within 30 calendar days of the end of each calendar quarter, send us a report with the following information:
(1) Describe any facility used to test production-line vehicles or engines and state its location.
(2) State the total U.S.-directed production volume and number of tests for each engine family.
(3) Describe how you randomly selected vehicles or engines.
(4) Describe your test vehicles or engines, including the engine family's identification and the vehicle's model year, build date, model number, identification number, and number of hours of operation before testing for each test vehicle or engine.
(5) Identify where you accumulated hours of operation on the vehicles or engines and describe the procedure and schedule you used.
(6) Provide the test number; the date, time and duration of testing; test procedure; initial test results before and after rounding; final test results; and final deteriorated test results for all tests. Provide the emission results for all measured pollutants. Include information for both valid and invalid tests and the reason for any invalidation.
(7) Describe completely and justify any nonroutine adjustment, modification, repair, preparation, maintenance, or test for the test vehicle or engine if you did not report it separately under this subpart. Include the results of any emission measurements, regardless of the procedure or type of vehicle.
(8) Provide the CumSum analysis required in § 1051.315 for each engine family.
(9) Report on each failed vehicle or engine as described in § 1051.320.
(10) State the date the calendar quarter ended for each engine family.
(b) We may ask you to add information to your written report, so we can determine whether your new vehicles conform with the requirements of this subpart.
(c) An authorized representative of your company must sign the following statement:
We submit this report under Sections 208 and 213 of the Clean Air Act. Our production-line testing conformed completely with the requirements of 40 CFR part 1051. We have not changed production processes or quality-control procedures for the engine family in a way that might affect the emission control from production vehicles (or engines). All the information in this report is true and accurate, to the best of my knowledge. I know of the penalties for violating the Clean Air Act and the regulations. (Authorized Company Representative)
(d) Send electronic reports of production-line testing to the Designated Officer using an approved information format. If you want to use a different format, send us a written request with justification for a waiver.
(e) We will send copies of your reports to anyone from the public who asks for them. See § 1051.815 for information on how we treat information you consider confidential.
(a) Organize and maintain your records as described in this section. We may review your records at any time, so it is important to keep required information readily available.
(b) Keep paper records of your production-line testing for one full year after you complete all the testing required for an engine family in a model year. You may use any additional storage formats or media if you like.
(c) Keep a copy of the written reports described in § 1051.345.
(d) Keep the following additional records:
(1) A description of all test equipment for each test cell that you can use to test production-line vehicles or engines.
(2) The names of supervisors involved in each test.
(3) The name of anyone who authorizes adjusting, repairing, preparing, or modifying a test vehicle or engine and the names of all supervisors who oversee this work.
(4) If you shipped the vehicle or engine for testing, the date you shipped it, the associated storage or port facility, and the date the vehicle or engine arrived at the testing facility.
(5) Any records related to your production-line tests that are not in the written report.
(6) A brief description of any significant events during testing not otherwise described in the written report or in this section.
(7) Any information specified in § 1051.345 that you do not include in your written reports.
(e) If we ask, you must give us projected or actual production figures for an engine family. We may ask you to divide your production figures by rated brake power, displacement, fuel type, or assembly plant (if you produce vehicles or engines at more than one plant).
(f) Keep a list of vehicle or engine identification numbers for all the vehicles or engines you produce under each certificate of conformity. Giveus this list within 30 days if we ask for it.
(g) We may ask you to keep or send other information necessary to implement this subpart.
This section describes test procedures that you use to show compliance with the requirements of this part. See § 1051.235 to determine when testing is required for certification. See subpart D of this part for the production-line testing requirements.
(a)
(b)
(c)
(2) Prior to permeation testing of fuel hose, the hose must be preconditioned by filling the hose with the fuel specified in (d)(3) of this section, sealing the openings, and soaking the hose for 4 weeks at 23 °C±5 °C. To measure fuel-line permeation emissions, use the equipment and procedures specified in SAE J30 (incorporated by reference in § 1051.810). The measurements must be performed at 23 °C using the fuel specified in paragraph (d)(3) of this section.
(d)
(1)
(2)
(ii) For the permeation measurement test in § 1051.515(b), use the fuel specified in Table 1 of § 1065.210 of this chapter. As an alternative, you may use the fuel specified in paragraph (d)(2)(i) of this section.
(3) Fuel Hose Permeation. Use the fuel specified in Table 1 of § 1065.210 of this chapter blended with 10 percent ethanol by volume for permeation testing of fuel lines. As an alternative, you may use Fuel CE10, which is Fuel C as specified in ASTM D 471-98 (incorporated by reference in § 1051.810) blended with 10 percent ethanol by volume.
(e)
(2) We may reject data you generate using alternate procedures if later testing with the procedures in part 1065 of this chapter shows contradictory emission data.
(f)
(2) We may reject data you generate using alternate procedures if later testing with the otherwise specified procedures shows contradictory emission data.
(3)(i) The test procedures specified for vehicle testing are intended to produce emission measurements equivalent to those that would result from measuring emissions during in-use operation using the same vehicle configuration. If good engineering judgment indicates that use of the procedures in this part for a vehicle would result in measurements that are not representative of in-use operation of that vehicle, you must notify us. If we determine that using these procedures would result in measurements that are significantly unrepresentative and that changes to the procedures will result in more representative measurements that do not decrease the stringency of emission standards or other requirements, we will specify changes to the procedures. In your notification to us, you should recommend specific changes you think are necessary.
(ii) You may ask to use emission data collected using other test procedures, such as those of the California Air Resources Board or the International Organization for Standardization. We will allow this only if you show us that these data are equivalent to data collected using our test procedures.
(iii) You may ask to use alternate procedures that produce measurements equivalent to those obtained using the specified procedures. In this case, send us a written request showing that your alternate procedures are equivalent to the test procedures of this part. If you prove to us that the procedures are equivalent, we will allow you to use them. You may not use alternate procedures until we approve them.
(iv) You may ask to use special test procedures if your vehicle cannot be tested using the specified test procedures (forexample, it is incapable of operating on the specified transient cycle). In this case, send us a written request showing that you cannot satisfactorily test your engines using the test procedures of this part. We will allow you to use special test procedures if we determine that they would produce emission measurements that are representative of those that would result from measuringemissions during in-use operation. You may not use special procedures until we approve them.
Use the following special provisions for testing snowmobiles:
(a) Measure emissions by testing the engine on a dynamometer with the steady-state duty cycle described in the following Table:
(b) During idle mode, operate the engine with the following parameters:
(1) Hold the speed within your specifications.
(2) Keep the throttle at the idle-stop position.
(3) Keep engine torque under 5 percent of the peak torque value at maximum test speed.
(c) For the full-load operating mode, operate the engine at wide-open throttle.
(d) Ambient temperatures during testing must be between 20 °C and 30 °C (68 °F and 86 °F), or other representative test temperatures, as specified in paragraph (g) of this section.
(e) See part 1065 of this chapter for detailed specifications of tolerances and calculations.
(f) You may test snowmobiles at ambient temperatures below 20 °C or using intake air temperatures below 20 °C if you show that such testing complies with § 1065.10(c)(1) of this chapter. You must get our approval before you begin the emission testing. For example, the following approach would be appropriate to show that such testing complies with § 1065.10(c)(1) of this chapter:
(1) Using good engineering judgment, instrument a representative snowmobile built with a representative engine from the family being tested with an appropriate temperature measuring device located in the intake air plenum where fuel spitback is not likely to occur.
(2) Choose a time and location with the following weather conditions: windspeed less than 10 knots, no falling precipitation, air temperature between −20 °C and 0 °C (−4 °F and 32 °F).
(3) Operate the snowmobile until its engine reaches a steady operating temperature.
(4) Operate the snowmobile on a level surface free of other vehicle traffic. Operate the snowmobile at each specified engine speed corresponding to each mode in the emissions test specific to the engine being tested. When readings are stable, record the temperature in the intake air plenum and the ambient temperature. Calculate the temperature difference between the air in the plenum and the ambient air for each mode.
(5) Calculate the nominal intake air test temperature for each test mode as −10 °C (14 °F) plus the temperature difference for the corresponding mode determined in (g)(4) of this section.
(6) Before the emissions test, select the appropriate carburetor jetting for −10 °C (14 °F) conditions according to the jet chart. For each mode, maintain the inlet air temperature within 5 °C of the corresponding modal temperature calculated in (g)(5) of this section.
(7) Adjust other operating parameters to be consistent with operation at −10 °C (14 °F). For example, this may require that you modify the engine cooling system used in the laboratory to make its performance representative of cold-temperature operation.
Measure permeation emissions by weighing a sealed fuel tank before and after a temperature-controlled soak.
(a)
(1) Fill the tank with the fuel specified in § 1051.501(d)(2)(i), seal it, and allow it to soak at 28 ±5 °C for 20 weeks. Alternatively, the tank may be soaked for a shorter period of time at a higher temperature if you can show that the hydrocarbon permeation rate has stabilized.
(2) Determine the fuel tank's internal surface area in square-meters accurate to at least three significant figures. You may use less accurate estimates of the surface area if you make sure not to overestimate the surface area.
(3) Fill the fuel tank with the test fuel specified in § 1051.501(d)(2)(ii) to its nominal capacity. If you fill the tank inside the temperature-controlled room or enclosure, do not spill any fuel.
(4) Allow the tank and its contents to equilibrate to 28±2 °C.
(5) Seal the fuel tank using nonpermeable fittings, such as metal or Teflon
(b)
(1) Weigh the sealed fuel tank and record the weight to the nearest 0.1 grams. (You may use less precise weights as long as the difference in mass from the start of the test to the end of the test has at least three significant figures.)
(2) Carefully place the tank within a ventilated temperature-controlled room or enclosure. Do not spill any fuel.
(3) Close the room or enclosure and record the time.
(4) Ensure that the measured temperature in the room or enclosure is 28±2 °C.
(5) Leave the tank in the room or enclosure for 2 to 4 weeks, consistent with good engineering judgment (based on the permeation rate). Do not stop soaking before 4 weeks unless you know that you can measure the weight loss during the test to at least three significant figures earlier.
(6) Hold the temperature of the room or enclosure to 28±2 °C; measure and record the temperature at least daily.
(7) At the end of the soak period, weigh the sealed fuel tank and record the weight to the nearest 0.1 grams. (You may use less precise weights as long as the difference in mass from the start of the test to the end of the test has at least three significant figures.)
(8) Subtract the weight of the tank at the end of the test from the weight of the tank at the beginning of the test; divide the difference by the internal surface area of the fuel tank. Divide this g/m
(9) Round your result to the same number of decimal places as the emission standard.
(c)
(d)
(1)
(2)
(3)
(4)
(e)
This section applies for durability testing to determine deterioration factors for exhaust emissions. Small-volume manufacturers may omit durability testing if they use our assigned deterioration factors that we establish based on our projection of the likely deterioration in the performance of specific emission controls.
(a) Calculate your deterioration factor by testing a vehicle or engine that is representative of your engine family at a low-hour test point and the end of its useful life. You may also test at intermediate points.
(b) Operate the vehicle or engine over a representative duty cycle for a period at least as long as the useful life (in hours or kilometers). You may operate the vehicle or engine continuously.
(c) You may perform critical emission-related maintenance during durability testing, consistent with § 1051.125(a). You may not perform any other emission-related maintenance during durability testing.
(d) Use a linear least-squares fit of your test data for each pollutant to calculate your deterioration factor.
(e) You may ask us to allow you to use other testing methods to determine deterioration factors, consistent with good engineering judgment.
Engine and vehicle manufacturers, as well as owners, operators, and rebuilders of these vehicles, and all other persons, must observe the requirements and prohibitions in part 1068 of this chapter and the requirements of the Act. The compliance provisions in this subpart apply only to the vehicles and engines we regulate in this part.
(a) You may ask for an exemption under this section if you are the manufacturer of an engine certified under the motor-vehicle program or the Large Spark-ignition program. See § 1051.610 if you are not the engine manufacturer.
(b)(1) The only requirements or prohibitions from this part that apply to a vehicle that is exempt under this section are in this section and § 1051.610.
(2) If the vehicles do not meet the criteria listed in paragraph (c) of this section, they will be subject to the standards and prohibitions of this part. Producing these vehicles without a valid exemption or certificate of conformity would violate the prohibitions in § 1068.101 of this chapter.
(3) Vehicles exempted under this section are subject to all the requirements affecting engines and vehicles under 40 CFR part 86 or part 1048, as applicable. The requirements and restrictions of 40 CFR part 86 or 1048 apply to anyone manufacturing these engines, anyone manufacturing vehicles that use these engines, and all other persons in the same manner as if these engines were used in a motor vehicle or other nonrecreational application.
(c) If you meet all the following criteria regarding your engine, the vehicle using the engine is exempt under this section:
(1) The vehicle is produced using an engine or incomplete vehicle covered by a valid certificate of conformity under 40 CFR part 86 or part 1048.
(2) No changes are made to the certified engine or vehicle that we could reasonably expect to increase any of its regulated emissions. For example, if any of the following changes are made to the engine, it does not qualify for this exemption:
(i) Any fuel system or evaporative system parameters are changed from the certified configuration (this does not apply to refueling emission controls).
(ii) Any other emission-related components are changed.
(iii) The engine cooling system is modified or assembled so that temperatures or heat rejection rates are outside the original engine's specified ranges.
(3) The engine must have the emission control information label we require under 40 CFR part 86 or part 1048.
(4) You must demonstrate that fewer than 50 percent of the engine model's total sales, from all companies, are used in recreational vehicles.
(d) If you manufacture both the engine and vehicle under this exemption, you must do all of the following to keep the exemption valid:
(1) Make sure the original emission control information label is intact.
(2) Add a permanent supplemental label to the engine in a position where it will remain clearly visible after installation in the vehicle. In your engine's emission control information label, do the following:
(i) Include the heading: “Recreational Vehicle Emission Control Information”.
(ii) Include your full corporate name and trademark.
(iii) State: “THIS ENGINE WAS ADAPTED FOR RECREATIONAL USE WITHOUT AFFECTING ITS EMISSION CONTROLS.”.
(iv) State the date you finished installation (month and year).
(3) Make sure the original and supplemental labels are readily visible after the engine is installed in the vehicle or, if the vehicle obscures the engine's emission control information label, make sure the vehicle manufacturer attaches duplicate labels, as described in § 1068.105 of this chapter.
(4) Send the Designated Officer a signed letter by the end of each calendar year (or less often if we tell you) with all the following information:
(i) Identify your full corporate name, address, and telephone number.
(ii) List the models you expect to produce under this exemption in the coming year.
(iii) State: “We produce each listed model for recreational application without making any changes that could increase its certified emission levels, as described in 40 CFR 1051.605.”.
(e) If we request it, you must send us emission test data on the applicable recreational duty cycle(s). You may include the data in your application for certification under 40 CFR part 86 or part 1048, or in your letter requesting the exemption. We will generally not ask you for these data under normal circumstances, especially when they are more readily available from another source.
(a) You may produce a recreational vehicle without certifying it under this part by using a certified motor vehicle engine, or Large SI engine. This section does not apply if you manufacture the engine yourself; see § 1051.605. In order to produce recreational vehicles under this section, you must meet all of the following criteria:
(1) The engine or vehicle is certified to 40 CFR part 86 or part 1048.
(2) The engine is not adjusted outside the certifying manufacturer's specifications (see § 1051.605(c)(2)).
(3) The engine or vehicle is not modified in any way that may affect its emission control. This does not apply to refueling emission controls.
(4) The vehicle is labeled consistent with paragraph (c) of this section.
(b)(1) The only requirements or prohibitions from this part that apply to a vehicle that is exempt under this section are in this section and § 1051.605.
(2) If the vehicles do not meet the criteria listed in § 1051.605(c) and paragraph (c) of this section, they will be subject to the standards and prohibitions of this part. Producing these vehicles without a valid exemption or certificate of conformity would violate the prohibitions in § 1068.101 of this chapter.
(3) Vehicles exempted under this section are subject to all the requirements affecting engines and vehicles under 40 CFR part 86 or part 1048, as applicable. The requirements and restrictions of 40 CFR part 86 or 1048 apply to anyone manufacturing these engines, anyone manufacturing vehicles that use these engines, and all other persons in the same manner as if these engines were used in a motor vehicle or other nonrecreational application.
(c)(1) Make sure the original emission control information label is intact after assembly in the vehicle.
(2) Add a permanent supplemental label to the vehicle in a position where it will be clearly visible. In this emission control information label, do the following:
(i) Include the heading: “Recreational Vehicle Emission Control Information”.
(ii) Include your full corporate name and trademark.
(iii) State: “THIS ENGINE WAS ADAPTED FOR RECREATIONAL USE WITHOUT AFFECTING ITS EMISSION CONTROLS.”.
(iv) State the date you finished installation (month and year).
(3) Send the Designated Officer a signed letter by the end of each calendar year (or less often if we tell you) with all the following information:
(i) Identify your full corporate name, address, and telephone number.
(ii) List the models you expect to produce under this exemption in the coming year.
(iii) State: “We produce each listed model for recreational application without making any changes that could increase its certified emission levels, as described in 40 CFR 1051.605.”.
(d) If you build recreational vehicles under this section, we may require (as a condition of the exemption) that you comply with the emission-related warranty and recall responsibilities of this part.
(e) If you build a recreational vehicle using a motor vehicle engine that was certified as part of a vehicle-based engine family, we may require you to certify under this part instead of granting you an exemption under this part. If we do this, we may allow you to submit an abbreviated application for certification to show that you comply with the requirements of this part. You may reference the information in the original motor vehicle application.
(a) You may certify ATVs with engines that have total displacement of less than 100 cc to the following emission exhaust standards instead of certifying them to the exhaust emission standards of subpart B of this part:
(1) 25.0 g/kW-hr HC+NO
(2) 500 g/kW-hr CO.
(b) You may certify off-highway motorcycles with engines that have total displacement of 70 cc or less to the following emission exhaust standards instead of certifying them to the exhaust emission standards of subpart B of this part:
(1) 16.1 g/kW-hr HC+NO
(2) 519 g/kW-hr CO.
(c) You may use the averaging, banking, and trading provisions of subpart H of this part to show compliance with this HC+NO
(d) Measure emissions by testing the engine on a dynamometer with the steady-state duty cycle described in Table 1 of this section.
(1) During idle mode, hold the speed within your specifications, keep the throttle fully closed, and keep engine torque under 5 percent of the peak torque value at maximum test speed.
(2) For the full-load operating mode, operate the engine at wide-open throttle.
(3) See part 1065 of this chapter for detailed specifications of tolerances and calculations.
(4) Table 1 follows:
(e) All other requirements and prohibitions of this part apply to these engines and vehicles.
(a) We may grant you an exemption from the standards and requirements of this part for a new recreational vehicle on the grounds that it is to beused solely for competition. The provisions of this part other than those in this section do not apply to recreational vehicles that we exempt for use solely for competition.
(b) We will exempt vehicles that we determine will be used solely for competition. The basis of our determinations are described in paragraphs (b)(1), (b)(2), and (c) of this section. Exemptions granted under this section are good for only one model year and you must request renewal for each subsequent model year. We will not approve your renewal request if we determine the vehicles will not be used solely for competition.
(1)
(i) The absence of a headlight or other lights.
(ii) The absence of a spark arrestor.
(iii) The absence of manufacturer warranty.
(iv) Suspension travel greater than 10 inches.
(v) Engine displacement greater than 50 cc.
(vi) The absence of a functional seat. (For example, a seat less with than 30 square inches of seating surface would generally not be considered a functional seat).
(2)
(i) The vehicle or engine may not be displayed for sale in any public dealership.
(ii) Sale of the vehicle must be limited to professional racers or other qualified racers.
(iii) The vehicle must have performance characteristics that are substantially superior to noncompetitive models.
(c) Vehicles not meeting the applicable criteria listed in paragraph (b) of this section will be exempted only in cases where the manufacturer has clear and convincing evidence that the vehicles will be used solely for competition.
(d) You must permanently label vehicles exempted under this section to clearly indicate that they are to be used only for competition. Failure to properly label a vehicle will void the exemption for that vehicle.
(e) If we request it, you must provide us any information we need to determine whether the vehicles are used solely for competition.
(a) If you are a small-volume manufacturer, we may permit you to produce up to 600 snowmobiles per year that are certified to less stringent emission standards than those in § 1051.103, as long as you meet all the conditions and requirements in this section.
(b) To apply for alternate standards under this section, send the Designated Officer a written request. In your request, do two things:
(1) Show that the snowmobile has unique design, calibration, or operating characteristics that make it atypical and infeasible or highly impractical to meet the emission standards in § 1051.103, considering technology, cost, and other factors.
(2) Identify the level of compliance you can achieve, including a description of available emission-control technologies and any constraints that may prevent more effective use of these technologies.
(c) You must give us other relevant information if we ask for it.
(d) An authorized representative of your company must sign the request and include the statement: “All the information in this request is true and accurate, to the best of my knowledge.”.
(e) Send your request for this extension at least nine months before the relevant deadline. If different deadlines apply to companies that are not small-volume manufacturers, do not send your request before the regulations in question apply to the other manufacturers.
(f) If we approve your request, we will set alternate standards for your qualifying snowmobiles. These standards will not be above 400 g/kW-hr for CO or 150 g/kW-hr for HC.
(g) You may produce these snowmobiles to meet the alternate standards we establish under this section as long as you continue to produce them at the same or lower emission levels.
(h) You may not include snowmobiles you produce under this section in any averaging, banking, or trading calculations under Subpart H of this part.
(i) You must meet all the requirements of this part, except as noted in this section.
(a) We may permit you to produce up to 600 snowmobiles per year that are certified to the FELs listed in this section without new test data, as long as you meet all the conditions and requirements in this section.
(b) You may certify these snowmobiles with FELs of 560 g/kW-hr for CO and 270 g/kW-hr for HC (using the normal certification procedures).
(c) The emission levels described in this section are intended to represent worst-case emission levels. You may not certify snowmobilesunder this section if good engineering judgment indicates that they haveemission rates higher than these levels.
(d) Include snowmobiles you produce under this section in your averaging calculations under Subpart H of this part.
(e) You must meet all the requirements of this part, unless the regulations of this part specify otherwise.
(a) If you are a small business (as defined by the Small BusinessAdministration) that manufactures recreational vehicles, but does not otherwise qualify for the small-volume manufacturer provisions of this part, you may ask us to designate you to be a small-volume manufacturer.You may do this whether you began manufacturing recreational vehicles before, during, or after 2002.
(b) We may set other reasonable conditions that are consistent with the intent of this section and the Act. For example, we may place sales limits on companies that we designate to be small-volume manufacturers under this section.
You may ask to exempt custom-designed off-highway motorcycles that are substantially similar to highway motorcycles under the display exemption provisions of 40 CFR 86.407-78(c). Motorcycles exempt under this provision are subject to the restrictions of 40 CFR 86.407-78(c) and are considered to be motor vehicles for the purposes of this part 1051.
(a) You may average, bank, and trade emission credits for purposes of certification as described in this subpart to show compliance with the standards of this part. To do this you must show that your averageemission levels are below the applicable standards in subpart B of this part, or that you have sufficient credits to offset a credit deficit for the model year (as calculated in § 1051.720). If you cannot show in your end-of-year report that your average emission levels are below the applicable standards in subpart B of this part, or that you have sufficient credits to offset a credit deficit for the model year, we may void the certificates for all families certified to FELs above the allowable average. (b) The following averaging set restrictions apply:
(1) You may not average together engine families that are certified to different standards. You may, however, use banked credits that were generated relative to different standards, except as prohibited by paragraphs (b)(2) and (3) of this section, paragraph (e) of this section, or by other provisions in this part. For example, you may not average together within a model year off-highway motorcycles that are certified to the standards in § 1051.105(a)(1) and § 1051.105(a)(2); but you may use banked credits generated by off-highway motorcycles that are certified to the standards in § 1051.105(a)(1) to show compliance with the standards in § 1051.105(a)(2) in a later model year, and vice versa.
(2) There are separate averaging, banking, and trading programs for snowmobiles, ATVs, and off-highway motorcycles. You may not average orexchange banked or traded credits from engine families of one type of vehicle with those from engine families of another type of vehicle.
(3) You may not average or exchange banked or traded credits with other engine families if you use fundamentally different measurement procedures for the different engine families (for example, ATVs certified to chassis-based vs. engine-based standards). This paragraph(b)(3) does not restrict you from averaging together engine families that use test procedures that we determine provide equivalent emission results.
(4) You may not average or exchange banked or traded exhaust credits with evaporative credits, or vice versa.
(c) The definitions of Subpart I of this part apply to this subpart. The following definitions also apply:
(1)
(2)
(3)
(4)
(5)
(6)
(d) Do not include any exported vehicles in the certification averaging, banking, and trading program. Include only vehicles certified under this part.
(a) As specified in subpart B of this part, certify each vehicle to a family emission limit (FEL).
(b) Calculate a preliminary average emission level according to § 1051.720
(c) After the end of your model year, calculate a final average emission level according to § 1051.720 for each type of recreational vehicle or engine you manufacture or import. Use actual U.S.-directed production volumes.
(d) If your preliminary average emission level is below the allowable average standard, see § 1051.710 for information about generating and banking emission credits. These credits will be considered reserved until we verify them in reviewing the end-of-year report.
(a) If your average emission level is below the average standard, you may calculate credits according to § 1051.720.
(b) You may generate credits if you are a certifying manufacturer.
(c) You may bank unused emission credits, but only after the end of the calendar year and after we have reviewed your end-of-year reports. Credits you generate do not expire.
(d) During the calendar year and before you send in your end-of-year report, you may consider reserved any credits you originally designate for banking during certification. You may redesignate these credits for trading in your end-of-year report, but they are not valid to demonstrate compliance until verified.
(e) You may use for averaging or trading any credits you declared for banking from the previous calendar year that we have not reviewed. But, we may revoke these credits later—following our review of your end-of-year report or audit actions. For example, this could occur if we find that credits are based on erroneous calculations; or that emission levels are misrepresented, unsubstantiated, or derived incorrectly in the certification process.
(a) You may trade only banked emission credits, not reserved credits.
(b) You may trade banked credits to any certifying manufacturer.
(c) If a negative credit balance results from a credit trade, both buyers and sellers are liable, except in cases involving fraud. We may void the certificates of all emission families participating in a negative trade.
(1) If you buy credits but have not caused the negative credit balance, you must only supply more credits equivalent to the amount of invalid credits you used.
(2) If you caused the credit shortfall, you may be subject to the requirement sof § 1051.730(b)(6).
(a) Calculate your average emission level for each type of recreational vehicle or engine for each model year according to the following equation and round it to the nearest tenth of a g/km or g/kW-hr. Use consistentunits throughout the calculation.
(1) For exhaust emissions:
(i) Calculate the average emission level as:
(ii) Use U.S.-directed production projections for initial certification, and actual U.S.-directed production volumes to determine compliance at the end of the model year.
(2) For vehicles that have standards expressed as g/kW-hr and a useful life in km, convert the useful life to kW-hr based on the maximum power output observed over the emission test and an
(3) For evaporative permeation standards expressed as g/m
(b) If your average emission level is below the average standard, calculate credits available for banking according to the following equation and round them to the nearest tenth of a gram:
(c) If your average emission level is above the average standard, calculate your preliminary credit deficit according to the followingequation, rounding to the nearest tenth of a gram:
(a) Maintain and keep five types of properly organized and indexed records for each engine family:
(1) Model year and EPA engine family.
(2) FEL.
(3) Useful life.
(4) Projected U.S.-directed production volume for the model year.
(5) Actual U.S.-directed production volume for the model year.
(b) Keep paper records of this information for three years from the duedate for the end-of-year report. You may use any additional storage formats or media if you like.
(c) Keep a copy of all of the information you send us under § 1051.730.
(d) We may ask you to keep or send other information necessary to implement this subpart.
(a) Include the following information in each of your applications for certification:
(1) A statement that, to the best of your belief, you will not have a negative credit balance for any type of recreational vehicle or engine when all credits are calculated. This means that if you believe that your average emission level will be above the standard (i.e., that you will have a deficit for the model year), you must have banked
(2) Detailed calculations of projected emission credits (zero, positive, or negative) based on U.S.-directed production projections. If you project a credit deficit, state the source of credits needed to offset the credit deficit.
(b) At the end of each model year, send an end-of-year report.
(1) Your report must include three things:
(i) Calculate in detail your average emission level and any emission credits (positive, or negative) based on actual U.S.-directed production volumes.
(ii) If your average emission level is above the allowable average standard, demonstrate that you have the credits needed to offset the credit deficit. If you cannot demonstrate that you have the credits at the time you submit your end-of-year report, we may void the certificates for all families certified to FELs above the allowable average.
(iii) If your average emission level is below the allowable average standard, state whether you will reserve the credits for banking.
(2) Base your U.S.-directed production volumes on the point of first retail sale. You may consider distributors to be the point of first retail sale if all their engines are sold to ultimate buyers in the United States.
(3) Send end-of-year reports to the Designated Officer within 120 days of the end of the model year. If you send reports later, you are violating the Act.
(4) If you generate credits for banking and you do not send your end-of-year reports within 120 days after the end of the model year, you may not use or trade the credits until we receive and review your reports. You may not use projected credits pending our review.
(5) You may correct errors discovered in your end-of-year report, including errors in calculating credits according to the following table:
(6) If our review of a your end-of year-report shows a negative balance, you may buy credits to bring your credit balance to zero. But you must buy 1.1 credits for each 1.0 credit needed. If enough credits are not available to bring your credit balance to zero within 90 days of when we notify you, we may void the certificates for all families certified to FELs above the allowable average.
(c) Within 90 days of any credit trade, you must send the Designated Officer a report of the trade that includes three types of information:
(1) The corporate names of the buyer, seller, and any brokers.
(2) Copies of contracts related to credit trading from the buyer, seller, and broker, as applicable.
(d) Include in each report a statement certifying the accuracy and authenticity of its contents.
(e) We may void a certificate of conformity for any emission family if you do not keep the records this section requires or give us the information when we ask for it.
For snowmobiles, you may only use credits for the same phase or set of
(a)
(2) You may not use Phase 1 HC credits for Phase 2 HC compliance. However, because the Phase 1 and Phase 2 CO standards are the same, you may use Phase 1 CO credits for compliance with the Phase 2 CO standards.
(b)
(1) If your corporate average emission level at the end of the model year exceeds the applicable (current) phase of standards (without the use of traded or previously banked credits), you may choose to redesignate some of your snowmobile production to a calculation to generate credits for a future phase of standards. To generate credits the snowmobiles designated must have an FEL below the emission level of that set of standards. This can be done on a pollutant specific basis.
(2) Do not include the snowmobiles that you redesignate in the final compliance calculation of your average emission level for the otherwise applicable (current) phase of standards. Your average emission level for the remaining (non-redesignated) snowmobiles must comply with the otherwise applicable (current) phase of standards.
(3) Include the snowmobiles that you redesignate in a separate calculation of your average emission level for redesignated engines. Calculate credits using this average emission level relative to the specific pollutant in the future phase of standards. These credits may be used for compliance with the future standards.
(4) For generating early Phase 3 credits, you may generate credits for HC+NO
(i) To determine if you qualify to generate credits in accordance with paragraphs (b)(1) through (3) of this section, you must meet the credit trigger level. For HC+NO
(ii) HC+NO
(5) Credits can also be calculated for Phase 3 using both sets of standards. Without regard to the trigger level values, if your netemission reduction for the redesignated averaging set exceeds the requirements of Phase 3 in § 1051.103 (using both HC+NO
The following definitions apply to this part. The definitions apply to all subparts unless we note otherwise. All undefined terms have the meaning the Act gives to them. The definitions follow:
(1) Vehicles designed to travel on four low pressure tires, having a seat designed to be straddled by the operator and handlebars for steering controls, and intended for use by a single operator and no other passengers are all-terrain vehicles.
(2) Other all-terrain vehicles have three or more wheels and one or more seats, are designed for operation over rough terrain, and are intended primarily for transportation. Golf carts generally do not meet these criteria since they are generally not designed for operation over rough terrain.
(3) Vehicles that meet the definition of “offroad utility vehicle” in this section are not all-terrain vehicles. However, § 1051.1(a) specifies that some offroad utility vehicles are required to meet the same requirements as all-terrain vehicles.
(1) For freshly manufactured vehicles or engines (see definition of “new,” paragraph (1)), model year means one of the following:
(i) Calendar year.
(ii) Your annual new model production period if it is different than the calendar year. This must include January 1 of the calendar year for which the model year is named. It may not begin before January 2 of the previous calendar year and it must end by December 31 of the named calendar year.
(2) For a vehicle or engine that is converted to a nonroad vehicle or engine after being placed into service in a motor vehicle, model year means the calendar year in which the vehicle or engine was originally produced (see definition of “new,” paragraph (2)).
(3) For a nonroad vehicle excluded under § 1051.5 that is later converted to operate in an application that is not excluded, model year means the calendar year in which the vehicle was originally produced (see definition of “new,” paragraph (3)).
(4) For engines that are not freshly manufactured but are installed in new nonroad vehicles, model year means the calendar year in which the engine is installed in the new nonroad vehicle. This installation date is based on the time that final assembly of the vehicle is complete (see definition of “new,” paragraph (4)).
(5) For a vehicle or engine modified by an importer (not the original manufacturer) who has a certificate of conformity for the imported vehicle or engine (see definition of “new,” paragraph (5)), model year means one of the following:
(i) The calendar year in which the importer finishes modifying and labeling the vehicle or engine.
(ii) Your annual production period for producing vehicles or engines if it is different than the calendar year; follow the guidelines in paragraph (1)(ii) of this definition.
(6) For a vehicle or engine you import that does not meet the criteria in paragraphs (1) through (5) of the definition of “new” model year means the calendar year in which the manufacturer completed the original assembly of the vehicle or engine. In general, this applies to used equipment that you import without conversion or major modification.
(1) Vehicles having a maximum ground speed over level, paved surfaces no higher than 40 km per hour (25 miles per hour).
(2) Vehicles that lack features usually needed for safe, practical use on streets or highways-for example, safety features required by law, a reverse gear (except for motorcycles), or a differential.
(3) Vehicles whose operation on streets or highways would be unsafe, impractical, or highly unlikely. Examples are vehicles with tracks instead of wheels, very large size, or features associated with military vehicles, such as armor or weaponry.
(1) A freshly manufactured engine or vehicle for which the ultimate buyer has never received the equitable or legal title. This kind of vehicle might commonly be thought of as “brand new.” In the case of this paragraph (1), the vehicle or engine is no longer new when the ultimate buyer receives this title or the product is placed into service, whichever comes first.
(2) An engine originally manufactured as a motor vehicle engine that is later intended to be used in a piece of nonroad equipment. In this case, the engine ceases being a motor vehicle engine and becomes a “new nonroad engine”. The engine is no longer new when it is placed into nonroad service.
(3) A nonroad engine that has been previously placed into service in an application we exclude under § 1051.5 or exempt under 1051.620, where that engine is installed in a piece of equipment for which these exclusions or exemptions do not apply. The engine is no longer new when it is placed into nonroad service. For example, this would apply to a competition vehicle that is no longer used solely for competition.
(4) An engine not covered by paragraphs (1) through (3) of this definition that is intended to be installed in new nonroad equipment. The engine is no longer new when the ultimate buyer receives a title for the equipment or the product is placed into service, whichever comes first. This generally includes installation of used engines in new vehicles.
(5) An imported nonroad vehicle or engine covered by a certificate of conformity issued under this part, where someone other than the original manufacturer modifies the vehicle or engine after its initial assembly and holds the certificate. The vehicle or engine is no longer new when it is placed into nonroad service.
(6) An imported nonroad vehicle or engine that is not covered by a certificate of conformity issued under this part at the time of importation. This addresses uncertified engines and vehicles that have been placed into service in other countries and that someone seeks to import into the United States. Importation of this kind of new nonroad engine or vehicle is generally prohibited by part 1068 of this chapter.
(1) For motorcycles and ATVs, a manufacturer that sold motorcycles or ATVs before 2003 and had annual U.S.-directed production of no more than 5,000 off-road motorcycles and ATVs (combined number) in 2002 and all earlier calendar years. For manufacturers owned by a parent company, the limit applies to the production of the parent company and all of its subsidiaries.
(2) For snowmobiles, a manufacturer that sold snowmobiles before 2003 and had annual U.S.-directed production of no more than 300 snowmobiles in 2002 and all earlier model years. For manufacturers owned by a parent company, the limit applies to the production of the parent company and all of its subsidiaries.
(3) A manufacturer that we designate to be a small-volume manufacturer under § 1051.635.
(1) The expected average service life before the vehicle is remanufactured or retired from service.
(2) The minimum useful life value.
At 69 FR 39259, June 29, 2004, § 1051.180 was amended by adding a definition for “Critical emission-related component” in alphabetical order, effective Aug. 30, 2004. For the convenience of the user, the added text is set forth as follows:
(2) Any other component whose primary purpose is to reduce emissions.
The following symbols, acronyms, and abbreviations apply to this part:
We have incorporated by reference the documents listed in this section.
(a)
(b)
(a) Clearly show what you consider confidential by marking, circling, bracketing, stamping, or some other method. We will store your confidential information as described in 40 CFR part 2. Also, we willdisclose it only as specified in 40 CFR part 2.
(b) If you send us a second copy without the confidential information, we will assume it contains nothing confidential whenever we need to release information from it.
(c) If you send us information without claiming it is confidential, we may make it available to the public without further notice to you, as described in § 2.204 of this chapter.
See 40 CFR part 1068, subpart G, for information related to hearings.
42 U.S.C. 7401-7671(q).
(a) This part describes the procedures that apply to testing that we require for the following engines or for equipment using the following engines:
(1) Large nonroad spark-ignition engines we regulate under 40 CFR part 1048.
(2) Vehicles that we regulate under 40 CFR part 1051 (
(b) This part does not apply to any of the following engine or vehicle categories:
(1) Light-duty highway vehicles (see 40 CFR part 86).
(2) Heavy-duty highway Otto-cycle engines (see 40 CFR part 86).
(3) Heavy-duty highway diesel engines (see 40 CFR part 86).
(4) Aircraft engines (see 40 CFR part 87).
(5) Locomotive engines (see 40 CFR part 92).
(6) Land-based nonroad diesel engines (see 40 CFR part 89).
(7) General marine engines (see 40 CFR parts 89 and 94).
(8) Marine outboard and personal watercraft engines (see 40 CFR part 91).
(9) Small nonroad spark-ignition engines (see 40 CFR part 90).
(c) This part is addressed to you as a manufacturer, but it applies equally to anyone who does testing for you, and to us when we conduct testing to determine if you meet emission standards.
(d) Paragraph (a) of this section identifies the parts of the CFR that define emission standards and other requirements for particular types of engines. In this part 1065, we refer to each of these other parts generically as the “standard-setting part.” For example, 40 CFR part 1051 is always the standard-setting part for snowmobiles. Follow the standard-setting part if it differs from this part.
(e) For equipment subject to this part and regulated under equipment-based or vehicle-based standards, interpret the term “engine” in this part to include equipment and vehicles(see 40 CFR 1068.30).
At 69 FR 39260, June 29, 2004, § 1065.1 was amended by revising paragraph (a) and removing and reserving paragraph (b)(6), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(a) This part describes the procedures that apply to testing that we require for the following engines or for equipment using the following engines:
(1) Large nonroad spark-ignition engines we regulate under 40 CFR part 1048.
(2) Vehicles that we regulate under 40 CFR part 1051 (
(3) Land-based nonroad compression-ignition engines we regulate under 40 CFR part 1039.
(a) Some of the provisions of this part do not apply to all types of engines. For example, measurement of particulate matter is generally not required for spark-ignition engines. See the standard-setting part to determine which provisions in this part may not apply. Before using this part's procedures, read the standard-setting part to answer at least the following questions:
(1) How should I warm up the test engine before measuring emissions? Do I need to measure cold-start emissions during this warm-up segment of the duty cycle?
(2) Do I measure emissions while the warmed-up engine operates over a steady-state schedule, a transient schedule, or both?
(3) What are the speed and load points of the test cycle(s)?
(4) Which exhaust constituents do I need to measure?
(5) Does testing require full-flow dilute sampling? Is raw sampling acceptable? Is partial-flow dilute sampling acceptable?
(6) Do any unique specifications apply for test fuels?
(7) What maintenance steps may I do before or between tests on an emission-data engine?
(8) Do any unique requirements apply to stabilizing emission levels on a new engine?
(9) Do any unique requirements apply to testing conditions, such as ambient temperatures or pressures?
(10) Are there special emission standards that affect engine operation and ambient conditions?
(11) Are there different emission standards that apply to field testing under normal operation?
(b) The following table shows how this part divides testing specifications into subparts:
(a)
(b)
(c)
(1) The test procedures in this part are intended to produce emission measurements equivalent to those that would result from measuring emissions during in-use operation using the same engine configuration installed in a piece of equipment. If good engineering judgment indicates that use of the procedures in this part for an engine would result in measurements that are not representative of in-use operation of that engine, you must notify us. If we determine that using these procedures would result in measurements that are significantly unrepresentative and that changing the procedures will result in more representative measurements and not decrease the stringency of emission standards, we will specify changes to the procedures. In your notification to us, you should recommend specific changes you think are necessary.
(2) You may ask to use emission data collected using other test procedures, such as those of the California Air Resources Board or the International Organization for Standardization. We will allow this only if you show us that these data are equivalent to data collected using our test procedures.
(3) You may ask to use alternate procedures that produce measurements equivalent to those from the specified procedures. If you send us a written request showing your procedures are equivalent, and we agree that they are equivalent, we will allow you to use them. You may not use an alternate procedure until we approve them, either by: telling you directly that you may use this procedure; or issuing guidance to all manufacturers, which allows you to use the alternate procedure without additional approval.
(4) You may ask to use special test procedures if your engine cannot be tested under the specified procedures (for example, your engine cannot operate on the specified transient cycle). In this case, tell us in writing why you cannot satisfactorily test your engines using this part's procedures and ask to use a different approach. We will approve your special test procedures if we determine they would produce emission measurements that are representative of those that would result from measuring emissions during in-use operation. You may not use special procedures until we approve them.
(5) The standard-setting part may contain other specifications for test procedures that apply for your engines. In cases where it is not possible to comply with both the test procedures in those parts and the test procedures in this part, you must comply with the test procedures specified in the standard-setting part. Those other parts may also allow you to deviate from the test procedures of this part for other reasons.
At 69 FR 39260, June 29, 2004, § 1065.10 was amended by revising paragraph (c)(3), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(c) * * *
(3) You may ask to use alternate procedures that produce measurements equivalent to those from the specified procedures. If you send us a written request showing your procedures are equivalent, and we agree that they are equivalent, we will allow you to use them. You may not use an alternate procedure until we approve them, either by: telling you directly that you may use this procedure; or issuing guidance to all manufacturers, which allows you to use the alternate procedure without additional approval. You may use the statistical procedures specified in 40 CFR 86.1306-07(d) to demonstrate equivalence, except that you test for equal variances by performing the F-test as follows, instead of the method specified in § 86.1306-07(d)(5)(iv)(C):
(a) This part describes the procedures for performing exhaust emission tests on engines that must meet emission standards.
(b) Generally, you must test an engine while operating it on a laboratory dynamometer over a prescribed sequence. (Subpart J of this part describes in-use testing of engines installed in vehicles or equipment.) You need to sample and analyze the exhaust gases generated during engine operation to determine the concentration of the regulated pollutants.
(c) Concentrations are converted into units of grams of pollutant per kilowatt-hour (g/kW-hr) or similar units for comparison to emission standards. If the applicable emission standards are expressed as g/bhp-hr, references in this part to kW should generally be interpreted to mean horsepower.
(a) Unless specified elsewhere in this chapter, you may conduct tests to determine compliance with duty-cycle emission standards at ambient temperatures of 20-30° C (68-86° F), ambient pressures of 600-775 mm Hg, and any ambient humidity level.
(b) Follow the standard-setting part for ambient conditions when testing to determine compliance with not-to-exceed or other off-cycle emission standards.
(c) For engine testing in a laboratory, you may heat, cool, and/or dehumidify the dilution air before it enters the CVS.
(d) For engine testing in a laboratory, if the barometric pressure observed while generating the maximum-torque curve changes by more than 25 mm Hg from the value measured when you started mapping, you must remap the engine. Also, to have a valid test, the average barometric pressure observed during the exhaust emission test must be within 25 mm Hg of the average observed during the maximum torque curve generation (see § 1065.510).
This subpart describes equipment and analyzers for measuring emissions. Subpart D of this part describes how to calibrate these devices and subpart C of this part defines the accuracy and purity specifications of analytical gases.
(a) The engine dynamometer system must be able to control engine torque and speed simultaneously over the applicable test cycles within the accuracies specified in § 1065.530. If your dynamometer cannot meet the accuracy requirements in § 1065.530, you must get our approval before using it. For transient testing, issue command set points for engine torque and speed at 5 Hz or greater (10 Hz recommended). Record feedback engine torque and speed at least once every second during the test. In addition to these general requirements, make sure your engine or dynamometer's readout signals for speed and torque meet the following accuracies for all testing:
(1) Engine speed readout must be accurate to within ±2 percent of the absolute standard value. A 60-tooth (or greater) wheel in combination with a common mode rejection frequency counter is considered an absolute standard for engine or dynamometer speed.
(2) Engine flywheel torque readout must meet one of the two following standards for accuracy:
(i) Within ±3 percent of the NIST true value torque (as defined in § 1065.315).
(ii) The following accuracies:
(3) Option: You may use internal dynamometer signals (such as armature current) to measure torque if you can show that the engine flywheel torque
(b) To verify that the test engine has followed the test cycle correctly, collect the dynamometer or engine readout signals for speed and torque so you can statistically correlate the engine's actual performance with the test cycle (see § 1065.530). Normally, to do this, you would convert analog signals from the dynamometer or engine into digital values for computer storage, but all conversions must meet two criteria:
(1) Speed values used to evaluate cycles must be accurate to within 2 percent of the readout value for dynamometer or engine speed.
(2) Engine flywheel torque values used to evaluate cycles must be accurate to within 2 percent of the readout value for dynamometer or engine flywheel torque.
(c) You may combine the tolerances in paragraphs (a) and (b) of this section if you use the root mean square (RMS) method and refer accuracies of the RMS values to absolute-standard or NIST true values.
(1) Speed values used to evaluate cycles must be accurate to within ±2.8 percent of the absolute standard values, as defined in paragraph (a)(1) of this section.
(2) Engine flywheel torque values used to evaluate cycles must be accurate to within ±3.6 percent of NIST true values, as determined in § 1065.315.
(a)
(1) Do not let the CVS or dilution air inlet system artificially lower exhaust system backpressure. To verify proper backpressures, measure pressure in the raw exhaust immediately upstream of the inlet to the CVS. Continuously measure and compare the static pressure of the raw exhaust observed during a transient cycle—with and without the CVS operating. Static pressure measured with the CVS system operating must remain within ±5 inches of water (1.2 kPa) of the static pressure measured when disconnected from the CVS, at identical moments in the test cycle. (Note: We will use sampling systems that can maintain the static pressure to within ±1 inch of water (0.25 kPa) if your written request shows that this closer tolerance is necessary.) This requirement serves as a design specification for the CVS/dilution air inlet system, and should be performed as often as good engineering practice dictates (for example, after installing an uncharacterized CVS, adding an unknown inlet restriction on the dilution air, or otherwise altering the system).
(2) The system for measuring temperature (sensors and readout) must have an accuracy and precision of ±3.4° F (±1.9° C). The temperature measuring system for a CVS without a heat exchanger must respond within 1.50 seconds to 62.5 percent of a temperature change (as measured in hot silicone oil). For a CVS with a heat exchanger, there is no specific requirement for response time.
(3) The system for measuring pressure (sensors and readout) must have an accuracy and precision of ±3 mm Hg (0.4 kPa).
(4) The flow capacity of the CVS must be large enough to keep water from condensing in the system. You may dehumidify the dilution air before it enters the CVS. You also may heat or cool the air if three conditions exist:
(i) The air (or air plus exhaust gas) temperature does not exceed 250° F (121° C).
(ii) You calculate the CVS flow rate necessary to prevent water condensation based on the lowest temperature in the CVS before sampling. (We recommend insulating the CVS system when you use heated dilution air.)
(iii) The dilution ratio is high enough to prevent condensation in bag samples as they cool to room temperature.
(5) Bags for collecting dilution air and exhaust samples must be big enough for samples to flow freely.
(6) The general CVS sample system consists of a dilution air filter (optional) and mixing assembly, cyclone particulate separator (optional), a sample line for the bag sample or other sample lines a dilution tunnel, and associated valves and sensors for pressure and temperature. Except for the system to sample hydrocarbons from two-stroke engines, the temperature of the sample lines must be more than 3° C above the mixture's maximum dew point and less than 121° C. We recommend maintaining them at 113 ± 8° C. For the hydrocarbon sampling system with two-stroke engines, the temperature of the sample lines should be maintained at 191 ± 11° C. A general schematic of the SI sampling system is shown in Figure 1065.110-1, which follows:
(b)
(c)
(d)
(e)
(1) The system must meet all the requirements in paragraph (b) of this section.
(2) The ratio of sample flow to CVS flow must not vary by more than ±5 percent from the test's setpoint.
(3) Sample flow totalizers must meet the accuracy specifications in § 1065.150. You may obtain total volumes from the flow controllers, with our advance approval, if you can show they meet these accuracies.
(f)
(1) Include a heat exchanger.
(2) Use positive-displacement pumps for the CVS flow and sampling-system flow. You do not need sampling venturis or a venturi for the dilution tunnel. All pumps must operate at a constant flow rate.
(3) All pumps must operate at a nominally constant temperature. Maintain the gas mixture's temperature—measured at a point just ahead of the positive-displacement pump (and after the heat exchanger for the main CVS pump)—within ±10° F (±5.6° C) of the average operating temperature observed during the test. (You may estimate the average operating temperature from the temperatures observed during similar tests.) The system for measuring temperature (sensors and readout) must have an accuracy and precision of ±3.4° F (1.9° C), and response time consistent with good engineering judgment.
(g)
Use one of the following systems and procedures to measure emissions from compression-ignition engines:
(a) Full-flow dilution sampling as specified in 40 CFR 86.1310.
(b) Raw-gas sampling during steady-state tests as specified in 40 CFR 89.412 through 89.418.
(c) Partial-flow sampling for measuring gaseous emission constituents during steady-state tests as specified in 40 CFR 89.112(c).
At 69 FR 39260, June 29, 2004, text is added to § 1065.115, effective Aug. 30, 2004.
(a)
(1) The analyzers for measuring hydrocarbon, NO
(2) The analytical equipment for measuring particulate emissions is specified in Subpart H of this part.
(3) The analytical equipment for measuring emissions of oxygenated compounds (for example, methanol) is specified in Subpart I of this part.
(4) The analytical equipment for measuring in-use emissions is specified in Subpart J of this part.
(b)
(1) For steady-state testing and transient testing with bag sample analysis, the analyzer must reach at least 90 percent of its final response within 5.0 seconds after any step change to the input concentration at or above 80 percent of full scale.
(2) For transient testing with continuous measurement, the analyzer must reach at least 90 percent of its final response within 1.0 second after any step change to the input concentration at or above 80 percent of full scale.
(c)
(1) Precision must be no worse than ±1 percent of full-scale concentration for each range used above 155 ppm (or ppmC), or ±2 percent for each range used below 155 ppm (or ppmC). For this paragraph (c)(1), we define precision as 2.5 times the standard deviation of 10 repetitive responses to a given calibration or span gas.
(2) Peak-to-peak response to zero and calibration or span gases over any 10-second period must be no more than 2 percent of full-scale chart deflection on all ranges used.
(d)
(1) The zero-response drift during one hour must be less than 2 percent of full-scale chart deflection on the lowest range used. Zero-response is the mean response, including noise, to a zero-gas during a 30-second interval.
(2) The span drift during one hour must be less than 2 percent of full-scale chart deflection on the lowest range used. Span is the difference between the span-response and the zero-response. Span-response is the mean response, including noise, to a span gas during a 30-second interval.
(e)
This section describes the requirements for flame ionization detectors (FIDs) used to measure hydrocarbons.
(a) Fuel the FID with a mixture of hydrogen in helium and calibrate it using propane.
(b) If you use a heated FID (required only for diesels and two-stroke, spark-ignition engines), keep the temperature 191 ±11° C).
(c) Use an overflow sampling system for heated continuous FIDs. (In an overflow system excess zero gas or span gas spills out of the probe when you are doing zero or span checks.)
(d) Do not premix the FID fuel and burner air.
(e) Make sure the FID meets accuracy and precision specifications in
This section describes the requirements for chemiluminescent detectors (CLD) used to measure NO
(a) A CLD must meet the following requirements:
(1) Make sure your CLD meets the accuracy and precision specifications in ISO 8178-1 (incorporated by reference in § 1065.1010).
(2) The NO to NO
(3) Use an overflow sampling system for continuous CLDs. (In an overflow system excess zero gas or span gas spills out of the probe when you are doing zero or span checks.)
(4) You do not need a heated CLD to test spark-ignition engines.
(b) Using CLDs is generally acceptable even though they measure only NO and NO
This section describes the requirements for non-dispersive infrared absorption detectors (NDIR) to measure CO and CO
(a) The NDIR must meet the applicable accuracy and precision specifications of ISO 8178-1 (incorporated by reference in § 1065.1010).
(b) The NDIR must meet the applicable quench and interference requirements of ISO 8178-1 (incorporated by reference in § 1065.1010).
(a) Flow meters must have accuracy and precision of ±2 percent of point or better and be traceable to NIST standards.
(b) You may correct flow measurements for temperature or pressure, if your temperature and pressure measurements have accuracy and precision of ±2 percent of point or better (absolute).
(a) Except where we specify otherwise in this part, must meet the applicable accuracy and precision specifications of ISO 8178-1(incorporated by reference in § 1065.1010).
(b) Use good engineering judgment to design and operate your temperature and pressure measuring systems to minimize delays in response time and avoid hysteresis.
(a) For all emission tests, use test fuels meeting the specifications in this subpart, unless the standard-setting part directs otherwise. For any service accumulation on a test engine, if we do not specify a fuel, use the specified test fuel or a fuel typical of what you would expect the engine to use in service.
(b) We may require you to test the engine with each type of fuel it can use (for example, gasoline and natural gas).
(c) If you will produce engines that can run on a type of fuel (or mixture of fuels) that we do not specify in this subpart, we will allow you to test with fuel representing commercially available fuels of that type. However, we must approve your fuel's specifications before you may use it for emission testing.
(d) You may use a test fuel other than those we specify in this subpart if you do all of the following:
(1) Show that it is commercially available.
(2) Show that your engines will use only the designated fuel in service.
(3) Show that operating the engines on the fuel we specify would increase emissions or decrease durability.
(4) Get our written approval before you start testing.
(e) We may allow you to use other test fuels (for example, California Phase 2 gasoline) if they do not affect the demonstration of compliance.
(a)(1) There are three grades of #2 diesel fuel specified for use as a test
(2) [Reserved]
(b) There are no specifications for #1 diesel fuel. See § 1065.201(d) if your engines are designed to operate only on #1 diesel fuel.
At 69 FR 39260, June 29, 2004, text was added to § 1065.205, effective Aug. 30, 2004.
Gasoline used as a test fuel must meet the following specifications:
(a) Unless the standard-setting part requires testing with fuel appropriate for low temperatures, use gasoline test fuels meeting the specifications in the following table:
(b) If the standard-setting part requires testing with fuel appropriate for low temperatures, use gasoline test fuels meeting the specifications in the following table:
(c) Use gasoline test fuel with octane values that represent commercially available fuels for the appropriate application.
(a) Natural gas used as a test fuel must meet the specifications in the following table:
(b) At ambient conditions, the fuel must have a distinctive odordetectable down to a concentration in air of not more than one-fifth of the lower flammability limit.
(a) Liquefied petroleum gas used as a test fuel must meet the specifications in the following table:
(b) At ambient conditions, the fuel must have a distinctive odordetectable down to a concentration in air of not over one-fifth of the lower flammability limit.
Lubricating oils you use to comply with this part must be commercially available and represent the oil that will be used with your in-use engines.
Analytical gases that you use to comply with this part must meet the accuracy and purity specifications of this section. You must record the expiration date specified by the gas supplier and may not use any gas after the expiration date.
(a)
(b)
(c)
(1) Use the following gas mixtures, as applicable, for calibrating and spanning your analytical instruments:
(i) Propane in purified synthetic air. You may ask us to allow you to use propane in purified nitrogen for high concentrations of propane.
(ii) CO in purified nitrogen.
(iii) NO and NO
(iv) Oxygen in purified nitrogen.
(v) CO
(vi) Methane in purified synthetic air.
(2) The calibration gases in paragraph (c)(1) of this section must be traceable to within one percent of NIST gas standards or other gas standards we have approved. Span gases in paragraph (c)(1) of this section must be accurate to within two percent of true concentration, where true concentration refers to NIST gas standards, or other gas standards we have approved. Record concentrations of calibration gas as volume percent or volume ppm.
(3) You may use gases for species other than those in paragraph (c)(1) of this section (such as methanol in air gases used to determine response factors), as long as they meet the following criteria:
(i) They are traceable to within ±2 percent of NIST gas standards or other standards we have approved.
(ii) They remain within ±2 percent of the labeled concentration. Show this by measuring quarterly with a precision of ±2 percent (two standard deviations) or by using another method we approve. You may take multiple measurements. If the true concentration of the gas changes by more than two percent, but less than ten percent, you may relabel the gas with the new concentration.
(4) You may generate calibration and span gases using precision blending devices (gas dividers) to dilute gases with purified nitrogen or with purified synthetic air. Make sure the mixing device produces a concentration of blended calibration gases that is accurate to within ± 1.5 percent. To do so, you must know the concentration of primary gases used for blending to an accuracy of at least ± 1 percent, traceable to NIST gas standards or other gas standards we have approved. For each calibration incorporating a blending device, verify the blending accuracy between 15 and 50 percent of full scale. You may optionally check the blending device with an instrument that is linear by nature (for example, using NO gas with a CLD). Adjust the instrument's span value with the span gas connected directly to it. Check the blending device at the used settings to ensure that the difference between nominal values and measured concentrations at each point stays within ± 0.5 percent of the nominal value.
(d)
Calibrate all analyzers and equipment at least annually, but make the actual frequency consistent with good engineering judgment. We mayestablish other guidelines as appropriate. Calibrate following specifications in one of three sources:
(a) Recommendations from the manufacturer of the analyzers or equipment.
(b) 40 CFR part 86, subpart F or subpart N.
(c) 40 CFR part 90, subparts D and E, as applicable.
(a) You may ask to use international standards for calibration.
(b) You need not ask for approval to use standards that have been shown to be traceable to NIST standards.
Use the procedures of 40 CFR 86.1319-90 to calibrate the CVS.
At 69 FR 39261, June 29, 2004, text was added to § 1065.310, effective Aug. 30, 2004.
You must use one of two techniques to calibrate torque: the lever-arm
(a) The lever-arm dead-weight technique involves placing known weights at a known horizontal distance from the torque-measuring device's center of rotation. You need two types of equipment:
(1)
(2)
(b) The transfer technique involves calibrating a master load cell(dynamometer case load cell). You may calibrate the master load cell with known calibration weights at known horizontal distances. Or you may use a hydraulically actuated, precalibrated, master load cell and then transfer this calibration to the device that measures the flywheel torque. The transfer technique involves three main steps:
(1) Precalibrate a master load cell or calibrate it following paragraph (a)(1) of this section. Use known weights traceable to NIST with the lever arms specified in paragraph (b)(2) of this section. Run or vibrate the dynamometer during this calibration to reduce static hysteresis.
(2) Use lever arms at least 20 inches long. The horizontal distances from the master load cell's centerline to the dynamometer's centerline and to the point where you apply weight or force must be accurate to within ±0.10 inches. Balance the arms or know their net hanging torque to within ±0.1 ft-lbs.
(3) Transfer calibration from the case or master load cell to the torque-measuring device with the dynamometer operating at a constant speed. Calibrate the torque-measurement device's readout to the master load cell's torque readout at a minimum of six loads spaced aboutequally across the full useful ranges of both measurement devices.(Good engineering practice requires that both devices have about the same useful ranges of torque measurement.) Transfer the calibration so it meets the accuracy requirements in § 1065.105(a)(2) for readouts from the torque-measurement device.
While all engine configurations within a certified engine family must comply with the applicable standards in the standard-setting part, you are not required to test each configuration for certification.
(a) Select for testing according to the following guidance the engine configuration within the engine family that is most likely to exceed an emission standard:
(1) Test the engine that we specify, whether we do this through general guidance or give you specific instructions.
(2) If we do not tell you which engine to test, follow any instructions in the standard-setting part.
(3) If we do not tell you which engine to test and the standard-setting part does not include specifications for selecting test engines, use good engineering judgment to select the engine configuration within the engine family that is most likely to exceed an emission standard.
(b) In the absence of other information, the following characteristics are
(1) Maximum fueling rates.
(2) Maximum in-use engine speed (governed or ungoverned, as applicable).
(3) Highest sales volume.
(c) We may select any engine configuration within the engine family for our testing.
(a) If you are testing an emission-data engine for certification, make sure you have built it to represent production engines.
(b) Run the test engine, with all emission-control systems operating, long enough to stabilize emission levels. If you accumulate 50 hours of operation, you may consider emission levels stable without measurement.
(c) Do not service the test engine before you stabilize emission levels, unless we approve other maintenance in advance. This prohibition does not apply to your recommended oil and filter changes for newly produced engines, or to idle-speed adjustments.
(d) Select engine operation for accumulating operating hours on your test engines to represent normal in-use operation for the engine family.
(e) If you need more than 50 hours to stabilize emission levels, record your reasons and the method you use to do this. Give us these records if we ask for them.
At 69 FR 39261, June 29, 2004, § 1065.405 is amended by revising paragraph (b), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(b) Run the test engine, with all emission-control systems operating, long enough to stabilize emission levels.
(1) For SI engines, if you accumulate 50 hours of operation, you may consider emission levels stable without measurement.
(2) For CI engines, if you accumulate 125 hours of operation, you may consider emission levels stable without measurement.
(a) After you stabilize the test engine's emission levels, you may do scheduled maintenance, other than during emission testing, as the standard-setting part specifies.
(b) You may not do any unscheduled maintenance to the test engine or its emission-control system or fuel system without our advance approval. Unscheduled maintenance includes adjusting, repairing, removing, disassembling, cleaning, or replacing the test engine. We may approve routine maintenance that is not scheduled such as maintaining the proper oil level.
(1) We may approve other unscheduled maintenance if all of the following occur:
(i) You determine that a part failure or system malfunction (orthe associated repair) does not make the engine unrepresentative of production engines in the field and does not require anyone to access the combustion chamber.
(ii) Something clearly malfunctions (such as persistent misfire, engine stall, overheating, fluid leakage, or loss of oil pressure) and needs maintenance or repair.
(iii) You give us a chance to verify the extent of the malfunction before you do the maintenance.
(2) If we determine that a part's failure or a system's malfunction (or the associated repair) has made the engine unrepresentative of production engines, you may no longer use it as a test engine.
(3) You may not do unscheduled maintenance based on emission measurements from the test engine.
(4) Unless we approve otherwise in advance, you may not use equipment, instruments, or tools to identify bad engine components unless you specify they should be used for scheduled maintenance on production engines. In this case, if they are not generally available, you must also make them available at dealerships and other service outlets.
(c) If you do maintenance that might affect emissions, you must completely test the engine for emissions before and after the maintenance, unless we waive this requirement.
(d) If your test engine has a major mechanical failure that requires you to take it apart, you may no longer use it as a test engine.
If the standard-setting part requires durability testing, you must accumulate service in a way that represents how you expect the engine to operate in use. You may accumulate service hours using an accelerated schedule, such as through continuous operation.
(a)
(1) You may perform scheduled maintenance that you recommend to operators, but only if it is consistent with the standard-setting part's restrictions.
(2) You may perform additional maintenance only if we approve it in advance, as specified in § 1065.410(b).
(3) If your test engine has a major mechanical failure that requires you to take it apart, you may no longer use it as a test engine.
(b)
(1) Perform emission tests to determine deterioration factors consistent with good engineering judgment. Evenly space any tests between the first and last test points throughout the durability period.
(2) Perform emission tests following the provisions of this part and the standard-setting part.
(a) The engine dynamometer test procedure measures brake-specific emissions of hydrocarbons (total and nonmethane, as applicable), carbon monoxide, and oxides of nitrogen. To perform this test procedure, you first dilute exhaust emissions with ambient air and collect a continuous proportional sample for analysis, then analyze the composite samples (either in bags after the test or continuously during the test). The general test procedure consists of a test cycle made of one or more segments (check the standard-setting part for specific cycles):
(1) Either a cold-start cycle (where you measure emissions) or a warm-up cycle (where you do not measure emissions).
(2) A hot-start transient test (some test cycles may omit engine starting from the “hot-start” cycle).
(3) A steady-state test.
(b) Measure power using the dynamometer's feedback signals for torque and speed. The power measurement produces a brake kilowatt-hour value that allows you to calculate brake-specific emissions (see Subpart G of this part).
(c) Prepare engines for testing consistent with § 1065.10(c)(1) and according to the following provisions:
(1) When you test an engine or operate it for service accumulation, use the complete engine with all emission-control devices installed and functioning.
(2) Install the fan for any air-cooled engine (if applicable).
(3) You may install accessories such as an oil cooler, alternators, and air compressors or simulate their loading if they are typical of in-use operation. Apply this loading during all testing operations, including mapping.
(4) You may install a production-type starter on the engine.
(5) Cool the engine in a way that will maintain its operating temperatures including the intake air, oil, water temperatures about the same as they would be during normal operation. You may use auxiliary fans if necessary. You may use rust inhibitors and lubrication additives, up to the levels that the additive manufacturer recommends. You may also use antifreeze mixtures and other coolants typical of those approved for use by the manufacturer.
(6) Use representative exhaust and air-intake systems. Make sure the exhaust restriction is 80 to 100 percent of the recommended maximum specified exhaust restriction and the air inlet restriction is between that of a clean filter and the maximum restriction specification. As the manufacturer, you are liable for emission compliance from the minimum in-use restrictions to the
(a)
(1) Warm up the engine so oil and water temperatures (on an absolute scale such as the Kelvin scale) vary by less than two percent for two minutes; or until the thermostat opens if the engine-coolant system includes a thermostat.
(2) Operate the engine at the warm no-load idle speed.
(3) Fully open the throttle.
(4) While maintaining wide-open throttle and full-load, keep the engine at minimum speed for at least 15 seconds. Record the average torqueduring the last 5 seconds.
(5) In increments of 100±20 rpm, determine the maximum torque curve for the full speed range. Hold each test point for 15 seconds and recordthe average torque over the last 5 seconds. You may use larger increments for engines with maximum test speed over 4000 rpm, as long as you include at least 40 points and space them evenly.
(6) Fit all data points recorded with a cubic spline, Akima, or other technique we approve in advance. The resultant curve must be accurate to within ±1.0 ft-lbs. of all recorded engine torques.
(b)
(c)
(d)
(1) Good engineering judgment determines that an unreasonable amount of time has passed since the last map.
(2) The barometric pressure before the test begins has changed more than 25 mm Hg from the average barometric pressure observed during the map.
(3) The engine has undergone physical changes or recalibration that might affect its performance.
(e)
(f)
(1) You need not perform the entire torque or power map, as long as you map the engines for speeds between 75 and 105 percent of the maximumtest speed.
(2) You need not remap an engine according to paragraph (d) of this section. You need only verify the maximum torque or power at maximumtest speed.
(a)
(1) Torque is normalized to a maximum-torque value. Check the standard-setting part to see if it is normalized based on the maximum torque at the given speed or based on the maximum torque for all speeds. Todenormalize the torque values in the cycle, use the engine's maximum-torque point or its torque map (§ 1065.510 describes how to generate the torque map).
(2) Power is normalized to a maximum-power value. Check the standard-setting part to see if it is normalized based on the maximum power at the given speed or based on the maximum power for all speeds. Todenormalize the power values in the cycle, use the engine's maximum-power point or its power map (§ 1065.510 describes how to generate the power map).
(3) To denormalize speed, use the following equation:
(4) Paragraph (d) of this section describes how to calculate maximum test speed.
(b)
(1)
(2)
(c)
(d)
(1)
(2)
(i) Identify the point (power and speed) on the lug curve where maximum power occurs.
(ii) Normalize the power values of the lug curve—divide them by the maximum power and multiply the resulting values by 100.
(iii) Normalize the engine speed values of the lug curve—divide them by the speed at which maximum power occurs and multiply the resulting values by 100.
(3)
(i) For a given power-speed point, the speed factor is the normalized distance to the power-speed point from the zero-power, zero-speed point. Compute the speed factor's value:
(ii) Determine the maximum value of speed factors for all the power-speed data points on the lug curve. Maximum test speed is the speed at which the speed factor's maximum value occurs. Note that this maximum test speed is
(e)
(1) If peak torque speed is 60 to 75 percent of the maximum test speed, the intermediate speed point is at that same speed.
(2) If peak torque speed is less than 60 percent of the maximum test speed, the intermediate speed point is at 60 percent of maximum test speed.
(3) If peak torque speed is greater than 75 percent of the maximum test speed, the intermediate speed point is at 75 percent of maximum test speed.
Unless the standard-setting part specifies otherwise, follow the steps in this section to start and shut down the test engine:
(a)
(1) If the engine does not start after 15 seconds of cranking, stop cranking and determine the reason it failed to start. While diagnosingthe problem, turn off the device that measures gas flow (or revolution counter) on the constant-volume sampler (and all integrators when measuring emissions continuously). Also, turn off the constant-volume sampler or disconnect the exhaust tube from the tailpipe. If failure to start is an operational error, reschedule the engine for testing (this may require soaking the engine if the test requires a cold-start).
(2) If longer cranking times are necessary, you may use them instead of the 15-second limit, as long as the owner's manual and the service-repair manual describe the longer cranking times as normal.
(3) If an engine malfunction causes a failure to start, you may correct it in less than 30 minutes and continue the test. Reactivate the sampling system at the same time cranking begins. When the engine starts, begin the timing sequence. If an engine malfunction causes a failure to start, and you cannot restart the engine, the test is void.
(b)
(1) If the engine stalls during the warm-up period, the initial idle period of test, or the steady-state segment, you may restart the engine immediately using the appropriate starting procedure and continue the test.
(2) If the engine stalls at any other time, the test is void.
(c)
Take the following steps for each test:
(a) Prepare the engine, dynamometer, and sampling system. Change filters or other replaceable items and check for leaks as necessary.
(b) If you are using bag samples, connect evacuated sample-collection bagsto the collection system for the dilute exhaust and dilution air sample.
(c) Attach the CVS to the engine's exhaust system any time before startingthe CVS.
(d) Start the CVS (if not already started), the sample pumps, the engine cooling fans, and the data-collection system. Before the test begins, preheat the CVS's heat exchanger (if used) and the heated components of any continuous sampling systems to designated operating temperatures.
(e) Adjust the sample flow rates to the desired levels and set to zero the devices in the CVS that measure gas flow. The venturi design fixes the sample flow rate in a CFV-CVS.
(f) Start the engine if engine starting is not part of the test cycle, as specified in the standard-setting part.
(g) Run the test cycle specified in the standard-setting part and collect the test data.
(h) As soon as practical after the test cycle is complete, analyze the bag samples.
(a)
(b)
(1)
(2)
(3)
(i) Perform linear regressions of feedback value on reference value for speed, torque, and brake power on 1 Hz data after the feedback shift has occurred (see paragraph (b)(1) of this section). Use the method of least squares, with the best-fit equation having the form:
(ii) Calculate the standard error of estimate (SE) of y on x and the coefficient of determination (r
(iii) For a valid test, make sure the feedback cycle's integrated brake kilowatt-hour is within 5 percent of the reference cycle's integrated brake kilowatt-hour. Also, ensure that the slope, intercept, standard error, and coefficient of determination meet the criteria in the following table (you may delete individual points from the regression analyses, consistent with good engineering judgment):
(c)
At 69 FR 39261, June 29, 2004, § 1065.530 is amended by revising paragraph (b)(3)(iii) and adding paragraphs (d) and (e), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(b) * * *
(3) * * *
(iii) For a valid test, make sure the feedback cycle's integrated brake kilowatt-hour is within 5 percent of the reference cycle's integrated brake kilowatt-hour. Also, ensure that the slope, intercept, standard error, and coefficient of determination meet the criteria in the following tables (you may delete individual points from the regression analyses, consistent with paragraph (e) of this section and good engineering judgment):
(d)
(e)
(1) Feedback torque and power during motoring reference commands when operator demand is at its minimum.
(2) Feedback speed and power during idle-speed oscillations, if all the following are true:
(i) Reference command is 0% speed and 0% torque.
(ii) Operator demand (
(iii) Absolute value of feedback torque is less than the sum of the reference torque plus 2% of the maximum mapped torque.
(3) Feedback power and either speed or torque for a given point when approaching maximum demand, if all the following are true:
(i) Operator demand (
(ii) Either feedback speed is less than reference speed or feedback torque is less than reference torque, but both are not less than their respective reference values.
(4) Feedback power and either speed or torque for a given point, when approaching minimum demand, if all the following are true:
(i) Operator demand (
(ii) Either feedback speed is greater than 105% of reference speed or feedback torque is
This subpart describes how to use the responses on the analyzers and other meters to calculate final gram per kilowatt-hour emission rates.
Volume and density values used in these calculations are generally corrected to standard conditions of 20°C and 101.3 kPa.)
Retain the following information for each test:
(a) Test number.
(b) System or device tested (brief description).
(c) Date and time of day for each part of the test schedule.
(d) Test results.
(e) Operator's name.
(f) Engine: ID number, manufacturer, model year, emission standards, engine family, basic engine description, fuel system, engine code, and idle speed, as applicable.
(g) Dynamometer: Dynamometer identification, records to verify compliance with the duty cycle requirements of the test.
(h) Gas analyzers: Analyzer bench identification, analyzer ranges, recordings of analyzer output during zero, span, and sample readings.
(i) Recorder charts: Test number, date, identification, operator's name, and identification of the measurements recorded.
(j) Test cell barometric pressure, ambient temperature, and humidity as required. (Some test systems may require continuous measurements; others may require a single measurement, or measurements before and after the test.)
(k) Temperatures: Records to verify compliance with the ambient temperature requirements throughout the test procedure.
(l) CFV-CVS: Total dilute exhaust volume (Vmix) for each phase of the exhaust test.
(m) PDP-CVS: Test measurements for calculating the total dilute exhaust volume (Vmix), and the Vmix for each phase of the exhaust test.
(n) The humidity of the dilution air.
If you do not use conditioning columns, this measurement is not necessary. If you use conditioning columns and take the dilution air from the test cell, you mayuse the ambient humidity for this measurement.
(a) Zero the analyzers and obtain a stable zero reading. Recheck after tests.
(b) Introduce span gases and set instrument gains. To avoid errors, span and calibrate at the same flow rates used to analyze the test sample. Span gases should have concentrations equal to 75 to 100 percent of full scale. If gain has shifted significantly on the analyzers, check the calibrations. Show actual concentrations on the chart.
(c) Check zeroes; if necessary, repeat the procedure in paragraphs (a) and(b) of this section.
(d) Check flow rates and pressures.
(e) Measure HC, CO, CO
(f) Check zero and span points. If the difference is greater than 2 percent of full scale, repeat the procedure in paragraphs (a) through (e) of this section.
(a) Calculate the dilution factor. The dilution factor is the ratio of the total volume of the raw exhaust to the total volume of the diluted exhaust. It is calculated as 134,000 divided by the sum of the diluted ppmC concentrations of carbon-containing compounds in the exhaust, as follows:
(b) Calculate mass emission rates (g/test) for the transient segment usingthe general equation in paragraph (b)(1) of this section:
(1) The general equation is:
(2) The equation to calculate C
(c) Calculate total brake work (kW-hr) done during the emissions sampling period of each segment or mode.
(d) Calculate emissions in g/kW-hr by dividing the mass emission rate(g/test segment) by the total brake work for the test segment.
(e) Apply deterioration factors or other adjustment factors to the brake-specific emission rate in paragraph (e) as specified in the standard-setting part.
At 69 FR 39262, June 29, 2004, § 1065.615 was amended by revising paragraphs (c), (d) and (e), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(c) Calculate total brake work (kW-hr) done during the emissions sampling period of each segment or mode and then weight it by the applicable test cycle weighting factors.
(d) Calculate emissions in g/kW-hr by dividing the total weighted mass emission rate (g/test) by the total cycle-weighted brake work for the test.
(e) Apply deterioration factors or other adjustment factors to the brake-specific emission rate in paragraph (d) of this section, as specified in the standard-setting part.
Use the sample analysis procedures and calculations of 40 CFR part 86, subpart N, for continuous samples.
At 69 FR 39262, June 29, 2004, § 1065.620 was added to subpart G, effective Aug. 30, 2004.
Use the particulate sampling system and procedures specified in 40 CFR part 86, subpart N, to measure particulate emissions from compression-ignition nonroad engines.
At 69 FR 39262, June 29, 2004, § 1065.701 was added to subpart G, effective Aug. 30, 2004.
(a) This subpart applies for testing with oxygenated fuels. Except where specified otherwise in the standard-setting part, compliance with this subpart is not required for fuels that contain less than 25 percent oxygenated compounds by volume. For example, you generally would not needto follow the requirements of this subpart for tests performed using a fuelthat was 10 percent ethanol and 90 percent gasoline, but you would need to follow these requirements for tests performed using a fuel that was 85 percent ethanol and 15 percent gasoline.
(b) This subpart specifies sampling procedures and calculations that are different than those used for non-oxygenated fuels. The other test procedures of this part apply for testing with oxygenated fuels.
(a) Use the sampling procedures specified in 40 CFR part 86 for methanol and formaldehyde to measure alcohols and aldehydes in the exhaust. This requires the following:
(1) Bubbling a sample of the exhaust through water to collect the alcohols.
(2) Passing a sample of the exhaust through cartridges impregnated with 2,4-dinitrophenylhydrazine to measure aldehydes.
(b) Use good engineering judgment to measure other oxygenated compounds in the exhaust.
(a)
(2) Calculate carbon-equivalent mass of each measured oxygenated species from the following equation:
(b)
(1) The sum of the mass of the nonoxygenated nonmethane hydrocarbons in the exhaust and the carbon-equivalent mass of each measured oxygenated species in the exhaust.
(2) THCE minus the mass of methane in the exhaust.
(c)
(2) The carbon-equivalent of the masses of oxygenated compounds are:
(i) 13.8756 × 100.00/(46.068/2) = 60.24 grams of ethanol.
(ii) 13.8756 × 10.00/(44.052/2) = 6.30 grams of acetaldehyde.
(iii) 13.8756 × 1.00/(30.026) = 0.46 grams of formaldehyde.
(3) THCE = 40.00 + 60.24 + 6.30 + 0.46 = 107.00 grams per test.
(a) The test procedures in this subpart measure brake-specific emissions from engines while they remain installed in vehicles or equipment in the field.
(b) These test procedures apply to your engines as specified in the standard-setting part. For example, part 1048 of this chapter specifiesemission standard to be used for in-use tests conducted in accordance withthe provisions of this part. Unless this subpart is specifically mentioned in the standard-setting part, compliance with the provisions of this subpart is not required.
(a) Unless the standard-setting part specifies deviations from the provisions of this subpart, testing conducted under this subpart must conform to all of the provisions of this subpart.
(b) Testing conducted under this subpart may include any normal in-use operation of the engine.
(a) Measurement systems used for in-use testing must be accurate to within±5 percent compared to engine dynamometer testing conducted according to the test procedures of this part that are applicable for your engine.These systems must also have a precision of ±5 percent or better.Determine accuracy and precision of an in-use system by simultaneously measuring emissions using the engine-dynamometer test procedures of this part and the in-use system. To have a statistically valid sample, measureemissions during at least 3 tests each for at least 3 different engines.You must conduct these verification tests using the test cycle specified in the standard-setting part, unless we approve a different test cycle.
(1) A system must meet the following conditions to be considered sufficiently accurate:
(i) The correlation coefficient (r) for a least-squares linear fit that includes the origin must be 0.95 or higher.
(ii) The average ratio (for all tests) of the emission rate from the in-use system divided by the emission rate from the dynamometer procedure must be 0.97 to 1.05.
(2) For a system to be considered sufficiently precise, the average coefficient of variance for all engines must be 5 percent or less for each pollutant.
Increasing the length of the sampling period may be an effective way to improve precision.
(b) Measurement systems that conform to the provisions of §§ 1065.915 through 1065.950 are considered to be in compliance with the accuracy and precision requirements of paragraph (a) of this section.
At 69 FR 39262, June 29, 2004, § 1065.910 was revised, effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
Measurement systems used for field testing have accuracy and precision comparable to those of dynamometer testing. Measurement systems that conform to the provisions of §§ 1065.915 through 1065.950 are deemed to be in compliance with the accuracy and precision requirements of paragraph of this section. If you use other field testing measurement systems you need to have documentation indicating that it is comparable to a dynamometer system.
(a) The two systems must be calibrated independently to NIST traceable standards or equivalent national standards for this comparison. We may approve the use of other standards. Calculations of emissions results for this test should be consistent with the field testing data reduction scheme for both the in-use equipment and the dynamometer equipment, and each complete test cycle will be considered one “summing interval”, Si as defined in the field-testing data reduction scheme.
(b) While other statistical analyses may be acceptable, we recommend that the comparison be based on a minimum of seven (7) repeats of colocated and simultaneous tests. Perform this comparison over the applicable steady-state and transient test cycles using an engine that is fully warmed up such that its coolant temperature is thermostatically controlled. If there is no applicable transient test cycle, use the applicable steady-state cycle. Anyone who intends to submit an alternative comparison is encouraged to first contact EPA Office of Transportation and Air Quality, Assessment and Standards Division to discuss the applicant's intended statistical analysis. The Division may provide further guidance specific to the appropriate statistical analysis for the respective application.
(c) The following statistical tests are suggested. If the comparison is paired, it must demonstrate that the alternate system passes a two-sided, paired t-test. If the test is unpaired, it must demonstrate that the alternate system passes a two-sided, unpaired t-test. The average of these tests for the reference system must return results less than or equal to the applicable emissions standard. The t-test is performed as follows, where “n” equals the number of tests:
(1) Calculate the average of the in-use system results; this is Iavg.
(2) Calculate the average of the results of the system to which the in-use system was Referenced; this is Ravg.
(3) Calculate the “n-1” standard deviations for the in-use and reference averages; these are Isd and Rsd respectively. Form the F ratio: F = (Isd/Rsd) 2. F must be less than the critical F value, Fcrit at a 95% confidence interval for “n-1” degrees of freedom. Table 1 of this section lists 95% confidence interval Fcrit values for n-1 degrees of freedom. Note that n
(4) For an unpaired comparison, calculate the t-value:
(5) For a paired comparison, calculate the “n-1” standard deviation (squared) of the differences, d
(6) For a paired comparison, calculate the t-value:
(d) The absolute value of t must be less than the critical t value, t
This section describes equipment you may use to measure in-use emissions.You may use other equipment and measurement systems that conform to the requirements of §§ 1065.905 and 1065.910.
(a) The primary components of the in-use measurement system are a mass air flow sensor, a portable FID, a zirconia-based NO
(1) The mass air flow sensor must meet the requirements of § 1065.930.
(2) The portable FID must meet the requirements of § 1065.935.
(3) The NO
(4) The NDIR analyzer must meet the requirements of § 1065.945.
(b) You must measure the following parameters continuously at a rate of 3 Hz or higher and store the data electronically:
(1) THC, NO
(2) Mass air-fuel ratio.
(3) Intake air flow rate.
(4) Engine speed.
(5) Parameters used to calculate torque.
(c) You must minimize sample line length for any analyzers that require a physical sample be drawn from the exhaust to the analyzer (
(d) You may insert the sample probes and sensors into the exhaust pipe, or mount them in an exhaust extension that is connected to the exhaust pipe with negligible leaking. Place the sample probes and sensors close enoughto the center line of the exhaust pipe to minimize boundary layer effects from the wall.
This section describes how to set up the equipment specified in § 1065.915, and how to use it to measure in-use emissions from SI engines.
(a) Inspect the vehicle or equipment to determine whether it meets any applicable requirements of the standard-setting part. This may include requirements related to model year, accumulated hours of operation, fuel specifications, maintenance history, engine temperatures, etc.
(b) Perform calibrations as specified in this subpart. In the field, this generally will require only zeroing and spanning the instruments. However,each instrument must have been fully calibrated according to the instrument manufacturer's specifications. Nonlinear calibrations generated previously from the full calibration may be used after zeroing and spanning the instruments. Spanning can be performed using a single gas bottle, consistent with good engineering practice, and provided that stability of the span mixture has been demonstrated.
(c) Connect the data recorder (with any necessary signal interpreters or converters) to the engine's electronic control module.
(d) Disconnect the air intake system, as necessary, to attach the mass air flow sensor. Reconnect the system after attaching the mass air flow sensor.
(e) Attach the sample extension to the exhaust outlet.
(f) Turn on instruments and allow them to warm up as necessary.
(g) Begin sampling. You do not need to begin recording the data at this point.
(h) Begin operating the vehicle or equipment in a normal manner.
We may require you to operate the vehicle or equipment in a specific manner.
(i) Begin recording engine speed, engine torque (or surrogate), intake air flow, emissions data (THC, NO
(j) Continue recording data and operating the vehicle or equipment in a normal manner until the end of the sampling period. The length of the sampling period is based on good engineering practice, the precision requirements of § 1065.910, and applicable limits in the standard-setting part.
(k) You may measure background concentrations and correct measured emission values accordingly. However, if any background corrections are equivalentto 5 percent or more of the maximum emissions allowed by the applicable standard, the test shall be voided and repeated in an environment with lower background concentrations.
(a) [Reserved]
(b) Convert emission analyzer data to instantaneous concentrations in ppm(ppmC for the FID).
(c) Calculate instantaneous exhaust volumetric flow rates in standard m
(1) If you do not know the instantaneous density of the exhaust, use the minimum density of the exhaust that occurs over the course of the test, corrected to standard conditions.
(2) For gasoline-fueled engines designed to be operated at stoichiometric fuel/air ratios, you may assume that the density of the exhaust is 1202 g/m
(3) For LPG-fueled engines designed to be operated at stoichiometric fuel/air ratios, you may assume that the density of the exhaust is 1175 g/m
(4) For CNG-fueled engines designed to be operated at stoichiometric fuel/air ratios, you may assume that the density of the exhaust is 1149 g/m
(d) Calculate instantaneous emission rates (g/hr) using the following general equation:
(e) Integrate instantaneous emission rates for the entire specified sample period.
(f) Determine instantaneous brake torque and speed.
(g) Calculate instantaneous brake power.
(h) Integrate instantaneous brake power for the entire specified sample period.
(i) Divide the integrated emission rates by the integrated brake power. These are your final brake-specific emission rates.
(a) Measure the intake air flow using the engine's mass air flow sensor. If the engine is not equipped with a mass air flow sensor, you need to install one.
(b) The sensor design must have an accuracy and precision of ±5 percentunder steady-state laboratory conditions.
(c) The sensor must reach at least 90 percent of its final response within 0.3 seconds after any step change to the flow rate greater than or equal 80 percent of full scale.
(d) Calibrate the sensor according to good engineering practice. Verify for each engine before testing that the sensor accurately reads the idle intake air flow rate based on measured manifold
(a) Use a flame ionization detector (FID).
(b) The analyzer must have an accuracy and precision of ±2 percent of point or better under steady-state laboratory conditions.
(c) The analyzer must reach at least 90 percent of its final response within 1.0 second after any step change to the input concentration greater than or equal 80 percent of full scale.
(d) Zero and span the analyzer daily during testing. Calibrate it accordingto the analyzer manufacturer's specifications.
(a) Use stabilized zirconia-based sensors.
(b) The sensors must have an accuracy and precision of ±2 percent of point or better under steady-state laboratory conditions.
(c) The sensors must reach at least 90 percent of its final response within 1.0 second after any step change to the input concentration greater than orequal 80 percent of full scale.
(d) The sensors must be zeroed and spanned daily during testing, and must be calibrated according to the sensor manufacturer's specifications.
(a) Use a non-dispersive infrared (NDIR) detector that is compensated for CO
(b) The analyzer must have an accuracy and precision of ±2 percent of point or better under steady-state laboratory conditions.
(c) The analyzer must reach at least 90 percent of its final response within 5.0 second after any step change to the input concentration greater than or equal 80 percent of full scale.
(d) The analyzer must be zeroed and spanned daily during testing, and must be calibrated according to the analyzer manufacturer's specifications.
(a) Determine torque from a previously determined relationship of torque and engine speed, throttle position, and/or manifold absolute pressure. Torque estimates must be between 85 percent and 105 percent of the true value. You can demonstrate compliance with this accuracy requirement using steady-state laboratory data.
(b) Measure speed from the engine's electronic control module. Speed estimates must be within ±5 rpm of the true value.
The following definitions apply to this part. The definitions apply to all subparts unless we note otherwise. All undefined terms have the meaning the Act gives to them. The definitions follow:
Warm idle speed is the idle speed of a warmed-up engine.
(1) For throttled engines, the torque output observed at wide-open throttle at a given speed.
(2) For non-throttled engines, the torque output observed with the maximum fueling rate possible at a given speed.
At 69 FR 39263, June 29, 2004, § 1063.1001 was amended by adding the definition for “Operator demand” in alphabetical order, effective Aug. 30, 2004. For the convenience of the user, the added text is set forth as follows:
The following symbols, acronyms, and abbreviations apply to this part:
We have incorporated by reference the documents listed in this section. The Director of the Federal Register approved the incorporation by reference as prescribed in 5 U.S.C. 552(a) and 1 CFR part 51. Anyone may inspect copies at the U.S. EPA, Air and Radiation Docket and Information Center, 1301 Constitution Ave., NW., Room B102, EPA West Building, Washington, DC 20460 or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(a)
(b)
At 69 FR 39263, June 29, 2004, § 1065.1010 was amended by revising the entry for ASTM D 86-01 and by adding entries to Table 1 in alphanumeric order, effective Aug. 30, 2004. For the convenience of the user, the added entries are set forth as follows:
(a) * * *
(a) Clearly show what you consider confidential by marking, circling, bracketing, stamping, or some other method. We will store your confidential information as described in 40 CFR part 2. Also, we will disclose it only as specified in 40 CFR part 2.
(b) If you send us a second copy without the confidential information, we will assume it contains nothing confidential whenever we need to release information from it.
(c) If you send us information without claiming it is confidential, we may make it available to the public without further notice to you, as described in § 2.204 of this chapter.
42 U.S.C. 7401-7671(q).
(a) The provisions of this part apply to everyone with respect to the following engines or to equipment using the following engines (including owners, operators, parts manufacturers, and persons performing maintenance):
(1) Large nonroad spark-ignition engines we regulate under 40 CFR part 1048.
(2) Recreational SI engines and vehicles that we regulate under 40 CFR part 1051 (such as snowmobiles and off-highway motorcycles).
(b) This part does not apply to any of the following engine or vehicle categories:
(1) Light-duty motor vehicles (see 40 CFR part 86).
(2) Heavy-duty motor vehicles and motor vehicle engines (see 40 CFR part 86).
(3) Aircraft engines (see 40 CFR part 87).
(4) Locomotive engines (see 40 CFR part 92).
(5) Land-based nonroad diesel engines (see 40 CFR part 89).
(6) Marine diesel engines (see 40 CFR parts 89 and 94)
(7) Marine outboard and personal watercraft engines (see 40 CFR part 91).
(8) Small nonroad spark-ignition engines (see 40 CFR part 90).
(c) For equipment subject to this part and regulated under equipment-based standards, interpret the term “engine” in this part to include equipment(see § 1068.30).
(d) Paragraph (a)(1) of this section identifies the parts of the CFR that define emission standards and other requirements for particular types of engines and vehicles. This part 1068 refers to each these other parts generically as the “standard-setting part.” For example, 40 CFR part 1051 is always the standard-setting part for snowmobiles. Follow the provisions of the standard-setting part if they are different than any of the provisions in this part.
At 69 FR 39263, June 29, 2004, § 1068.1 was amended by revising paragraphs (a),(b)(5), and (d) and adding paragraph (e), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(a) The provisions of this part apply to everyone with respect to the following engines and to equipment using the following engines (including owners, operators, parts
(1) Large nonroad spark-ignition engines we regulate under 40 CFR part 1048.
(2) Recreational SI engines and vehicles that we regulate under 40 CFR part 1051 (such as snowmobiles and off-highway motorcycles).
(3) Land-based nonroad diesel engines that we regulate under 40 CFR part 1039.
(b) * * *
(5) Land-based nonroad diesel engines that we regulate under 40 CFR part 89.
(d) Paragraph (a)(1) of this section identifies the parts of the CFR that define emission standards and other requirements for particular types of engines and vehicles. This part 1068 refers to each of these other parts generically as the “standard-setting part.” For example, 40 CFR part 1051 is always the standard-setting part for snowmobiles. Follow the provisions of the standard-setting part if they are different than any of the provisions in this part.
(e)(1) The provisions of §§ 1068.30, 1068.310, and 1068.320 apply for stationary spark-ignition engines built on or after January 1, 2004, and for stationary compression-ignition engines built on or after January 1, 2006.
(2) The provisions of §§ 1068.30 and 1068.235 apply for the types of engines listed in paragraph (a) of this section beginning January 1, 2004, where they are used solely for competition.
(a) You must use good engineering judgment for decisions related to any requirements under this chapter. This includes your applications for certification, any testing you do to show that your production-line or in-use engines comply with requirements that apply to them, and how you select, categorize, determine, and apply these requirements.
(b) If we send you a written request, you must give us a written description of the engineering judgment in question. Respond within 15 working days of receiving our request unless we allow more time.
(c) We may reject your decision if it is not based on good engineering judgment or is otherwise inconsistent with the requirements that apply, based on the following provisions:
(1) We may suspend, revoke, or void a certificate of conformity if we determine you deliberately used incorrect information or overlooked important information, that you did not decide in good faith, or that your decision was not rational.
(2) If we believe a different decision would better reflect good engineering judgment, but none of the provisions of paragraph (c)(1) of this section apply, we will tell you of our concern (and its basis). You will have 30 days to respond to our concerns, or more time if we agree that you need it to generate more information. After considering your information, we will give you a final ruling. If we conclude that you did not use good engineering judgment, we may reject your decision and apply the new ruling to similar situations as soon as possible.
(d) We will tell you in writing of the conclusions we reach under paragraph (c) of this section and explain our reasons for them.
(e) If you disagree with our conclusions, you may file a request for a hearing with the Designated Officer as described in subpart F of this part. In your request, specify your objections, include data or supporting analysis, and get your authorized representative's signature. If we agreethat your request raises a substantial factual issue, we will hold the hearing according to subpart F of this part.
At 69 FR 39263, June 29, 2004, § was amended by revising paragraphs (a) and (e), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(a) You must use good engineering judgment for decisions related to any requirements under this chapter. This includes your applications for certification, any testing you do to show that your certification, production-line, and in-use engines comply with requirements that apply to them, and how you select, categorize, determine, and apply these requirements.
(e) If you disagree with our conclusions, you may file a request for a hearing with the Designated Officer as described in subpart G of this part. In your request, specify your objections, include data or supporting analysis, and get your authorized representative's signature. If we agree that your request raises
(a) Clearly identify any information you consider confidential by marking, circling, bracketing, stamping, or some other method. We will store your confidential information as described in 40 CFR part 2. Also, we willdisclose it only as specified in 40 CFR part 2. This procedure appliesequally to the Environmental Appeals Board.
(b) If you send us a second copy without the confidential information, we will assume it contains nothing confidential whenever we need to release information from it.
(c) If you send us information without claiming it is confidential, we may make it available to the public without further notice to you, as described in § 2.204 of this chapter.
(a) The Administrator of the Environmental Protection Agency or any official to whom the Administrator has delegated specific authority may represent the Agency. For more information, ask for a copy of the relevant sections of the EPA Delegation Manual from the Designated Officer.
(b) The regulations in this part and in the standard-setting part have specific requirements describing how to get EPA approval before you take specific actions. These regulations also allow us to waive some specific requirements. For provisions or flexibilities that we address frequently, we may choose to provide detailed guidance in supplemental compliance instructions for manufacturers. Such instructions will generally state howthey relate to the need for pre-approval. Unless we explicitly state so, you should not consider full compliance with the instructions to beequivalent to EPA approval.
(a) We may inspect your engines, testing, manufacturing processes, engine storage facilities (including port facilities for imported engines or other relevant facilities), or records, as authorized by the Act, to enforce the provisions of this chapter. Inspectors will have authorizing credentials and will limit inspections to reasonable times—usually, normal operating hours.
(b) If we come to inspect, we may or may not have a warrant or court order.
(1) If we do not have a warrant or court order, you may deny us entry.
(2) If we have a warrant or court order, you must allow us to enter the facility and carry out the activities it describes.
(c) We may seek a warrant or court order authorizing an inspection described in this section, whether or not we first tried to get your permission to inspect.
(d) We may select any facility to do any of the following:
(1) Inspect and monitor any aspect of engine manufacturing, assembly, storage, or other procedures, and any facilities where you do them.
(2) Inspect and monitor any aspect of engine test procedures or test-related activities, including test engine selection, preparation, service accumulation, emission duty cycles, and maintenance and verification of your test equipment's calibration.
(3) Inspect and copy records or documents related to assembling, storing, selecting, and testing an engine.
(4) Inspect and photograph any part or aspect of engines and components you use for assembly.
(e) You must give us reasonable help without charge during an inspection authorized by the Act. For example, you may need to help us arrange an inspection with the facility's managers, including clerical support, copying, and translation. You may also need to show us how the facility operates and answer other questions. If we ask in writing to see a particular employee at the inspection, you must ensure that he or
(f) If you have facilities in other countries, we expect you to locate them in places where local law does not keep us from inspecting as described in this section. We will not try to inspect if we learn that local law prohibits it, but we may suspend your certificate if we are not allowed to inspect.
If you are subject to the requirements of this part, we may require you to give us information to evaluate your compliance with any regulations that apply, as authorized by the Act. This includes the following things:
(a) You must provide the information we require in this chapter.
(b) You must establish and maintain records, perform tests, make reports and provide additional information that we may reasonably require under section 208 of the Act. This also applies to engines we exempt from emission standards.
At 69 FR 39264, June 29, 2004, § was amended by revising paragraph (b), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(b) You must establish and maintain records, perform tests, make reports and provide additional information that we may reasonably require under section 208 of the Act (42 U.S.C. 7542). This also applies to engines we exempt from emission standards or prohibited acts.
If we request it, you must make a reasonable number of production-line engines available for a reasonable time so we can test or inspect them for compliance with the requirements of this chapter.
At 69 FR 39264, June 29, 2004, § 1068.27 was added, effective Aug. 30, 2004.
The following definitions apply to this part. The definitions apply to all subparts unless we note otherwise. All undefined terms have the meaning the Act gives to them. The definitions follow:
(1) Except as discussed in paragraph (2) of this definition, a nonroad engine is any internal combustion engine:
(i) In or on a piece of equipment that is self-propelled or serves a dual purpose by both propelling itself and performing another function(such as garden tractors, off-highway mobile cranes and bulldozers); or
(ii) In or on a piece of equipment that is intended to be propelled while performing its function (such as lawnmowers and string trimmers); or
(iii) That, by itself or in or on a piece of equipment, is portable or transportable, meaning designed to be and capable of being carried or moved from one location to another. Indicia of transportability include, but are not limited to, wheels, skids, carrying handles, dolly, trailer, or platform.
(2) An internal combustion engine is not a nonroad engine if:
(i) The engine is used to propel a motor vehicle or a vehicle used solely for competition, or is subject to standards promulgated under section 202 of the Act; or
(ii) The engine is regulated by a federal New Source Performance Standard promulgated under section 111 of the Act; or
(iii) The engine otherwise included in paragraph (1)(iii) of this definition remains or will remain at a location for more than 12 consecutive months or a shorter period of time for an engine located at a seasonal source. A location is any single site at a building, structure, facility, or installation. Any engine (or engines) that replaces an engine at a location and that is intended to perform the same or similar function as the engine replaced will be included in calculating the consecutive time period. An engine located at a seasonal source is an engine that remains at a seasonal source during the full annual operating period of the seasonal source. A seasonal source is a stationary source that remains in a single location on a permanent basis (
(1) For engine storage areas or facilities, times during which people other than custodians and security personnel are at work near, and can access, a storage area or facility.
(2) For other areas or facilities, times during which an assembly line operates or any of the following activities occurs:
(i) Testing, maintenance, or service accumulation.
(ii) Production or compilation of records.
(iii) Certification testing.
(iv) Translation of designs from the test stage to the production stage.
(v) Engine manufacture or assembly.
At 69 FR 39264, June 29, 2004, § 1068.30 was amended by revising the definitions for “Act”, “Certificate holder”, “Emission-related defect”, “Engine-based”, “Engine manufacturer”, “Equipment-based”, “Equipment manufacturer”, “Manufacturer”, “Nonroad engine”, “Operating hours”, and “Ultimate purchaser”, and “U.S.-directed production volume” and adding definitions for “Aftertreatment” and in alphabetical order, effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(1) Except as discussed in paragraph (2) of this definition, a nonroad engine is any internal combustion engine:
(i) In or on a piece of equipment that is self-propelled or serves a dual purpose by both propelling itself and performing another function (such as garden tractors, off-highway mobile cranes and bulldozers); or
(ii) In or on a piece of equipment that is intended to be propelled while performing its function (such as lawnmowers and string trimmers); or
(iii) That, by itself or in or on a piece of equipment, is portable or transportable, meaning designed to be and capable of being carried or moved from one location to another. Indicia of transportability include, but are not limited to, wheels, skids, carrying handles, dolly, trailer, or platform.
(2) An internal combustion engine is not a nonroad engine if:
(i) The engine is used to propel a motor vehicle, an aircraft, or equipment used solely
(ii) The engine is regulated by a federal New Source Performance Standard promulgated under section 111 of the Act (42 U.S.C. 7411); or
(iii) The engine otherwise included in paragraph (1)(iii) of this definition remains or will remain at a location for more than 12 consecutive months or a shorter period of time for an engine located at a seasonal source. A location is any single site at a building, structure, facility, or installation. Any engine (or engines) that replaces an engine at a location and that is intended to perform the same or similar function as the engine replaced will be included in calculating the consecutive time period. An engine located at a seasonal source is an engine that remains at a seasonal source during the full annual operating period of the seasonal source. A seasonal source is a stationary source that remains in a single location on a permanent basis (
(1) For engine storage areas or facilities, times during which people other than custodians and security personnel are at work near, and can access, a storage area or facility.
(2) For other areas or facilities, times during which an assembly line operates or any of the following activities occurs:
(i) Testing, maintenance, or service accumulation.
(ii) Production or compilation of records.
(iii) Certification testing.
(iv) Translation of designs from the test stage to the production stage.
(v) Engine manufacture or assembly.
The following symbols, acronyms, and abbreviations apply to this part:
This section specifies actions that are prohibited and the maximum civil penalties that we can assess for each violation. The maximum penalty values listed in paragraphs (a) and (b) of this section are shown for calendar year 2002. As described in paragraph (e) of this section, maximum penalty limits for later years are set forth in 40 CFR part 19.
(a) The following prohibitions and requirements apply to manufacturers of new engines and manufacturers of equipment containing these engines, except as described in subparts C and D of this part:
(1) You may not sell, offer for sale, or introduce or deliver into commerce in the United States or import into the United States any newengine or equipment after emission standards take effect for that engine or equipment, unless it has a valid certificate of conformity for its model year and the required label or tag. You also may not take any of the actions listed in the previous sentence with respect to anyequipment containing an engine subject to this part's provisions, unlessthe engine has a valid certificate of conformity for its model year andthe required engine label or tag. This requirement also covers newengines you produce to replace an older engine in a piece of equipment,unless the engine qualifies for the replacement-engine exemption in § 1068.240. We may assess a civil penalty up to $31,500 for each engine in violation.
(2) This chapter requires you to record certain types of information to show that you meet our standards. You must comply with these requirements to make and maintain required records
(3) You may not keep us from entering your facility to test engines or inspect if we are authorized to do so. Also, you must perform the tests we require (or have the tests done for you). Failure to perform thistesting is prohibited. We may assess a civil penalty up to $31,500 for each day in violation.
(b) The following prohibitions apply to everyone with respect to the engines to which this part applies:
(1) You may not remove or disable a device or element of design that may affect an engine's emission levels. This restriction applies before and after the engine is placed in service. Section 1068.120 describes how this applies to rebuilding engines. For a manufacturer or dealer, we may assess a civil penalty up to $31,500 for each engine in violation. For anyone else, we may assess a civil penalty up to $3,150 for each engine in violation. This does not apply in any of the following situations:
(i) You need to repair an engine and you restore it to proper functioning when the repair is complete.
(ii) You need to modify an engine to respond to a temporaryemergency and you restore it to proper functioning as soon as possible.
(iii) You modify a new engine that another manufacturer has already certified to meet emission standards, intending to recertify it under your own engine family. In this case you musttell the original manufacturer not to include the modified engines in the original engine family.
(2) You may not knowingly manufacture, sell, offer to sell, or install, an engine part if one of its main effects is to bypass, impair, defeat, or disable the engine's control of emissions. We may assess a civil penalty up to $3,150 for each part in violation.
(3) For an engine that is excluded from any requirements of this chapter because it is a stationary engine, you may not move it or install it in any mobile equipment, except as allowed by the provisions of this chapter. You may not circumvent or attempt to circumvent the residence-time requirements of paragraph (2)(iii) of the nonroad enginedefinition in § 1068.30. We may assess a civil penalty up to $31,500 for each day in violation.
(4) For an uncertified engine or piece of equipment that is excluded orexempted from any requirements of this chapter because it is to be used solely for competition, you may not use it in a manner that is inconsistent with use solely for competition. We may assess a civil penalty up to $31,500 for each day in violation.
(5) You may not import an uncertified engine or piece of equipment if it is defined to be new in the standard-setting part, and it would have been subject to standards had it been built in the United States. We may assess a civil penalty up to $31,500 for each day in violation.Note the following:
(i) The definition of new is broad for imported engines; uncertified engines and equipment (including used engines andequipment) are generally considered to be new when imported.
(ii) Engines that were originally manufactured before applicableEPA standards were in effect are generally not subject to emission standards.
(c) Exemptions from these prohibitions are described in subparts C and D of this part.
(d) The standard-setting parts describe more requirements and prohibitionsthat apply to manufacturers (including importers) and others under this chapter.
(e) The maximum penalty values listed in paragraphs (a) and (b) of this section are shown for calendar year 2002. Maximum penalty limits for later years may be adjusted based on the Consumer Price Index. The specific regulatory provisions for changing the maximum penalties, published in 40CFR part 19, reference the applicable U.S. Code citation on which the prohibited action is based. The following table is shown here for informational purposes:
At 69 FR 39265, June 29, 2004, § 1068.101 was amended by revising paragraphs (a) and (b), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(a) The following prohibitions and requirements apply to manufacturers of new engines and manufacturers of equipment containing these engines, except as described in subparts C and D of this part:
(1)
(2)
(3)
(b) The following prohibitions apply to everyone with respect to the engines to which this part applies:
(1)
(i) You need to repair an engine and you restore it to proper functioning when the repair is complete.
(ii) You need to modify an engine to respond to a temporary emergency and you restore it to proper functioning as soon as possible.
(iii) You modify a new engine that another manufacturer has already certified to meet emission standards and recertify it under your own engine family. In this case you must tell the original manufacturer not to include the modified engines in the original engine family.
(2)
(3)
(4)
(5)
(i) The definition of new is broad for imported engines; uncertified engines and equipment (including used engines and equipment) are generally considered to be new when imported.
(ii) Engines that were originally manufactured before applicable EPA standards were in effect are generally not subject to emission standards.
(6)
(a)
(b)
(c)
(1) Permanently attach to your equipment a duplicate label. Secure itto a part needed for normal operation and not normally requiring replacement.
(2) Make sure your label is identical to the engine label. You may make the label yourself or get it from the engine manufacturer.
(3) Make sure an average person can easily read it.
(d)
(1) The engine or vehicle is certified to 40 CFR part 86.
(2) The engine is not adjusted outside the manufacturer's specifications.
(3) The engine or vehicle is not modified in any way that may affect its emission control. This applies to evaporative emission controls, but not refueling emission controls.
At 69 FR 39265. June 29, 2004, § 1068.105 is amended by revising paragraph (c) and adding introductory text, effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
This section describes general provisions that apply to equipment manufacturers. See the standard-setting part for any requirements that apply for certain applications.
(c)
(1) Send a request for duplicate labels in writing with your company's letterhead to the engine manufacturer. Include the following information in your request:
(i) Identify the type of equipment and the specific engine and equipment models needing duplicate labels.
(ii) Identify the engine family (from the original engine label).
(iii) State the reason that you need a duplicate label for each equipment model.
(iii) Identify the number of duplicate labels you will need.
(2) Permanently attach the duplicate label to your equipment by securing it to a part needed for normal operation and not normally requiring replacement. Make sure an average person can easily read it.
(3) Destroy any unused duplicate labels if you find that you will not need them.
(4) Keep the following records for at least eight years after the end of the model year identified on the engine label:
(i) Keep a copy of your written request.
(ii) Keep drawings or descriptions that show how you apply the duplicate labels to your equipment.
(iii) Maintain a count of those duplicate labels you use and those you destroy.
(a)
(b)
(c)
(d)
(e)
At 69 FR 39266, June 29, 2004, § 1068.110 is amended by revising paragraphs (b), (c), (d), and (e), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(b)
(c)
(d)
(e)
Section 207(a) of the Clean Air Act (42 U.S.C. 7541(a)) requires certifying manufacturers to warrant to purchasers that their engines are designed, built, and equipped to conform at the time of sale to the applicable regulations for their full useful life, including a warranty that the engines are free from defects in materials and workmanship that would cause an engine to fail to conform to the applicable regulations during the specified warranty period. This section codifies the warranty requirements of section 207(a) without intending to limit these requirements.
(a) As a certifying manufacturer, you may deny warranty claims for failures that have been caused by the owner's or operator's improper maintenance or use. For example, you would not need to honor warranty claims for failures that have been directly caused by the operator's abuse of an engine or the operator's use of the engine in a manner for which it was not designed, and are not attributable to you in any way.
(b) As a certifying manufacturer, you may not deny emission-related warranty claims based on any of the following:
(1) Maintenance or other service you or your authorized facilities performed.
(2) Engine repair work that an operator performed to correct an unsafe, emergency condition attributable to you, as long as the operator triesto restore the engine to its proper configuration as soon as possible.
(3) Any action or inaction by the operator unrelated to the warranty claim.
(4) Maintenance that was performed more frequently than you specify.
(5) Anything that is your fault or responsibility.
(6) The use of any fuel that is commonly available where the engine operates, unless your written maintenance instructions state that this fuel would harm the engine's emission control system and operators can readily find the proper fuel.
(a) This section describes the steps to take when rebuilding engines to avoid violating the tampering prohibition in § 1068.101(b)(1). These requirements apply to anyone rebuilding an engine subject to this part, but the recordkeeping requirements in paragraphs (j) and (k) of this section apply only to businesses.
(b) The term “rebuilding” refers to a rebuild of an engine or engine system, including a major overhaul in which you replace the engine's pistons or power assemblies or make other changes that significantly increase the service life of the engine. It also includes replacing or rebuilding an engine's turbocharger or aftercooler or the engine's systems for fuel metering or electronic control so that it significantly increasesthe service life of the engine. For these provisions, rebuilding may or may not involve removing the engine from the equipment. Rebuilding
(1) Scheduled emission-related maintenance that the standard-setting part allows during the useful life period (such as replacing fuel injectors).
(2) Unscheduled maintenance that occurs commonly within the useful life period. For example, replacing a water pump is not rebuilding.
(c) For maintenance or service that is not rebuilding, you may not make changes that might increase emissions, but you do not need to keep any records.
(d) If you rebuild an engine or engine system, you must have a reasonabletechnical basis for knowing that the rebuilt engine has the same emissions performance as the engine in its certified configuration. Identify the model year of the resulting engine configuration. You have a reasonable basis if you meet two main conditions:
(1) Install parts—new, used, or rebuilt—so a person familiar with engine design and function would reasonably believe that the engine withthose parts will control emissions to the same degree as with the original parts. For example, it would be reasonable to believe that parts performing the same function as the original parts (and to the same degree) would control emissions to the same degree as the original parts.
(2) Adjust parameters or change design elements only according to the original engine manufacturer's instructions. Or, if you differ from these instructions, you must have data or some other technical basis to show you should not expect in-use emissions to increase.
(e) If the rebuilt engine remains installed or is reinstalled in the same piece of equipment, you must rebuild it to the original configuration or another certified configuration of the same or later model year.
(f) If the rebuilt engine replaces another engine in a piece of equipment, you must rebuild it to a certified configuration that equals the emissions performance of the engine you are replacing.
(g) Do not erase or reset emission-related codes or signals from onboard monitoring systems without diagnosing and responding appropriately to anydiagnostic codes. This requirement applies regardless of the manufacturer's reason for installing the monitoring system and regardless of its form or interface. Clear any codes from diagnostic systems when you return the rebuilt engine to service. Do not disable a diagnostic signal without addressing its cause.
(h) When you rebuild an engine, check, clean, adjust, repair, or replace all emission-related components (listed in Appendix I of this part) as needed according to the original manufacturer's recommended practice. In particular, replace oxygen sensors, replace the catalyst if there isevidence of malfunction, clean gaseous fuel system components, and replace fuel injectors (if applicable), unless you have a reasonable technical basis for believing they do not need replacement.
(i) If you are installing an engine that someone else has rebuilt, check all emission-related components listed in Appendix I of this part as needed according to the original manufacturer's recommended practice.
(j) Keep at least the following records:
(1) Identify the hours of operation (or mileage, as appropriate) at time of rebuild.
(2) Identify the work done on the engine or any emission-related control components, including a listing of parts and components youused.
(3) Describe any engine parameter adjustments.
(4) Identify any emission-related codes or signals you responded to and reset.
(k) You must show us or send us your records if we ask for them. Keep records for at least two years after rebuilding an engine. Keep them in any format that allows us to readily review them.
(1) You do not need to keep information that is not reasonably available through normal business practices. We do not expect you to have information that you cannot reasonably access.
(2) You do not need to keep records of what other companies do.
(3) You may keep records based on engine families rather than individual
At 69 FR 39266, June 29, 2004, § 1068.120 was amended by revising paragraphs (b)(2), (c), (d), (f), and (h), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(b) * * *
(2) Unscheduled maintenance that occurs commonly within the useful life period. For example, replacing a water pump is not rebuilding an engine.
(c) For maintenance or service that is not rebuilding, you may not make changes that might increase emissions of any pollutant, but you do not need to keep any records.
(d) If you rebuild an engine or engine system, you must have a reasonable technical basis for knowing that the rebuilt engine's emission-control system performs as well as, or better than, it performs in its certified configuration. Identify the model year of the resulting engine configuration. You have a reasonable basis if you meet two main conditions:
(1) Install parts—new, used, or rebuilt—so a person familiar with engine design and function would reasonably believe that the engine with those parts will control emissions of all pollutants at least to the same degree as with the original parts. For example, it would be reasonable to believe that parts performing the same function as the original parts (and to the same degree) would control emissions to the same degree as the original parts.
(2) Adjust parameters or change design elements only according to the original engine manufacturer's instructions. Or, if you differ from these instructions, you must have data or some other technical basis to show you should not expect in-use emissions to increase.
(f) If the rebuilt engine replaces another certified engine in a piece of equipment, you must rebuild it to a certified configuration of the same model year as, or a later model year than, the engine you are replacing.
(h) When you rebuild an engine, check, clean, adjust, repair, or replace all emission-related components (listed in Appendix I of this part) as needed according to the original manufacturer's recommended practice. In particular, replace oxygen sensors, replace the catalyst if there is evidence of malfunction, clean gaseous fuel system components, and replace fuel injectors (if applicable), unless you have a reasonable technical basis for believing any of these components do not need replacement.
(a)
(1) To determine the amount of a civil penalty and reach a just conclusion, the court considers these main factors:
(i) The seriousness of your violation.
(ii) How much you benefitted or saved because of the violation.
(iii) The size of your business.
(iv) Your history of compliance with Title II of the Act.
(v) What you did to remedy the violation.
(vi) How the penalty will affect your ability to continue in business.
(vii) Such other matters as justice may require.
(2) Subpoenas for witnesses who must attend a district court in any district may apply to any other district.
(b)
(1) To determine the amount of an administrative penalty, we will consider the factors described in paragraph (a)(1) of this section.
(2) An administrative order we issue under this paragraph (b) becomes final 30 days after we issue it, unless you ask for judicial review by that time (see paragraph (c) of this section). You may ask for review by any of the district courts listed in paragraph (a) of this section. Send the Administrator a copy of the filing by certified mail.
(3) We will not pursue an administrative action for a violation if either of the following two conditions is true:
(i) We are separately prosecuting the violation under this part.
(ii) We have issued a final order for a violation, no longer subject to judicial review, for which you have already paid a penalty.
(c)
(1) The judge may set aside or remand any order issued under this section only if one of the following is true:
(i) Substantial evidence does not exist in the record, taken as a whole, to support finding a violation.
(ii) The Administrator's assessment of the penalty is an abuse of discretion.
(2) The judge may not add civil penalties unless our penalty is an abuse of discretion that favors you.
(d)
(e)
(1) Once a penalty assessment is final, if you do not pay it, the Administrator will ask the Attorney General to bring a civil action in an appropriate district court to recover the money. We may collect interest from the date of the final order or final judgment at rates established by the Internal Revenue Code of 1986 (26 U.S.C. 6621(a)(2)). In this action to collect overdue penalties, the court will not review the validity, amount, and appropriateness of the penalty.
(2) In addition, if you do not pay the full amount of a penalty on time, you must then pay more to cover interest, enforcement expenses (including attorney's fees and costs for collection), and a quarterly nonpayment penalty for each quarter you do not pay. The nonpayment penalty is 10 percent of your total penalties plus any unpaid nonpayment penalties from previous quarters.
At 69 FR 39266, June 29, 2004, § 1068.125 was amended by revising paragraphs (a)(1)(iv), (b)(3), and (e)(2), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(a) * * *
(1) * * *
(iv) Your history of compliance with Title II of the Act (42 U.S.C. 7401-7590).
(b) * * *
(3) We will not pursue an administrative penalty for a particular violation if either of the following two conditions is true:
(i) We are separately prosecuting the violation under this subpart.
(ii) We have issued a final order for a violation, no longer subject to judicial review, for which you have already paid a penalty.
(e) * * *
(2) In addition, if you do not pay the full amount of a penalty on time, you must then pay more to cover interest, enforcement expenses (including attorney's fees and costs for collection), and a quarterly nonpayment penalty for each quarter you do not pay. The quarterly nonpayment penalty is 10 percent of your total penalties plus any unpaid nonpayment penalties from previous quarters.
We may exempt new engines from the prohibited acts in subpart B of this
(a) This subpart identifies which engines qualify for exemptions and what information we need. We may ask for more information.
(b) If you violate any of the terms, conditions, instructions, or requirements to qualify for an exemption, we may void the exemption.
(c) If you use an exemption under this subpart, we may require you to add a permanent label to your exempted engines. You may ask us to approve wording on the emission label different than we specify in this subpart if it is more appropriate for your engine.
(d) If you produce engines we exempt under this subpart, we may require youto make and keep records, perform tests, make reports and provide information as needed to reasonably evaluate the validity of the exemption.
(e) If you own or operate engines we exempt under this subpart, we may require you to provide information as needed to reasonably evaluate the validity of the exemption.
(f) Subpart D of this part describes how we apply these exemptions to engines you import (or intend to import).
(g) If you want to ask for an exemption or need more information, write to the Designated Officer.
(h) You may ask us to modify the administrative requirements for the exemptions described in this subpart. We may approve your request if wedetermine that such approval is consistent with the intent of this part.For example, waivable administrative requirements might include some reporting requirements, but would not include any eligibility requirements or use restrictions.
(i) If you want to take an action with respect to an exempted or excludedengine that is prohibited by the exemption or exclusion, such as selling it, you need to certify the engine. We will issue a certificate of conformity if you send us an application for certification showing that you meet all the applicable requirements from the standard-setting part. Also, in some cases, it may be sufficient to modify the engine as needed to make it identical to engines already covered by a certificate. Make sure theseengines have emission control information labels that accurately describetheir status.
At 69 FR 39266, June 29, 2004, § 1068.201 was amended by revising the introductory text and paragraph (i), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
We may exempt new engines from some or all of the prohibited acts or requirements of this part under provisions described in this subpart. We may exempt an engine already placed in service in the United States from the prohibition in § 1068.101(b)(1) if the exemption for engines used solely for competition applies (see § 1068.235). In addition, see § 1068.1 and the standard-setting parts to determine if other engines are excluded from some or all of the regulations in this chapter.
(i) If you want to take an action with respect to an exempted or excluded engine that is prohibited by the exemption or exclusion, such as selling it, you need to certify the engine. We will issue a certificate of conformity if you send us an application for certification showing that you meet all the applicable requirements from the standard-setting part. Also, in some cases, we may allow manufacturers to modify the engine as needed to make it identical to engines already covered by a certificate. We would base such an approval on our review of any appropriate documentation. These engines must have emission control information labels that accurately describe their status.
(a) We may exempt engines that are not exempted under other sections of this part that you will use for research, investigations, studies,demonstrations, or training.
(b) Anyone may ask for a testing exemption.
(c) If you are a certificate holder, you may request an exemption forengines
(1) In your request, tell us the maximum number of engines involved anddescribe how you will make sure exempted engines are used only for thistesting.
(2) Give us the information described in paragraph (d) of this section if we ask for it.
(d) If you are not a certificate holder do all of the following:
(1) Show that the proposed test program has a valid purpose under paragraph (a) of this section.
(2) Show you need an exemption to achieve the purpose of the test program (time constraints may be a basis for needing an exemption, but the cost of certification alone is not).
(3) Estimate the duration of the proposed test program and the number of engines involved.
(4) Allow us to monitor the testing.
(5) Describe how you will ensure that you stay within this exemption's purposes. Address at least the following things:
(i) The technical nature of the test.
(ii) The test site.
(iii) The duration and accumulated engine operation associated with the test.
(iv) Ownership of the engines involved in the test.
(v) The intended final disposition of the engines.
(vi) How you will identify, record, and make available the engine identification numbers.
(vii) The means or procedure for recording test results.
(e) If we approve your request for a testing exemption, we will send you a letter or a memorandum for your signature describing the basis and scope of the exemption. The exemption does not take effect until we receive the signed letter or memorandum from you. It will also include any necessaryterms and conditions, which normally require you to do the following:
(1) Stay within the scope of the exemption.
(2) Create and maintain adequate records that we may inspect.
(3) Add a permanent, legible label, written in block letters in English, to a readily visible part of each exempted engine. This label must include at least the following items:
(i) The label heading “EMISSION CONTROL INFORMATION”.
(ii) Your corporate name and trademark.
(iii) Engine displacement, engine family identification (as applicable), and model year of the engine; or whom to contact for further information.
(iv) The statement “THIS ENGINE IS EXEMPT UNDER 40 CFR 1068.210FROM EMISSION STANDARDS AND RELATED REQUIREMENTS.”.
(4) Tell us when the test program is finished.
(5) Tell us the final disposition of the engines.
(6) Send us a written confirmation that you meet the terms and conditions of this exemption.
At 69 FR 39267, June 29, 2004, § 1068.210 was amended by revising paragraphs (d)(5)(iv) and (e)(3)(iv), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(d) * * *
(5) * * *
(iv) Ownership and control of the engines involved in the test.
(e) * * *
(3) * * *
(iv) The statement “THIS ENGINE IS EXEMPT UNDER 40 CFR 1068.210 OR 1068.215 FROM EMISSION STANDARDS AND RELATED REQUIREMENTS.”.
(a) You are eligible for the exemption for manufacturer-owned engines only if you are a certificate holder.
(b) An engine may be exempt without a request if it is a nonconforming engine under your ownership and control and you operate it to develop products, assess production methods, or promote your engines in the marketplace. You may not lease, sell, or use the engine to generate revenue, either by itself or in a piece of equipment.
(c) To use this exemption, you must do three things:
(1) Establish, maintain, and keep adequately organized and indexed information on each exempted engine, including the engine identificationnumber, the use of the engine on exempt status, and the finaldisposition of any engine removed from exempt status.
(2) Let us access these records, as described in § 1068.20.
(3) Add a permanent, legible label, written in block letters in English, to a readily visible part of each exempted engine. This label must include at least the following items:
(i) The label heading “EMISSION CONTROL INFORMATION”.
(ii) Your corporate name and trademark.
(iii) Engine displacement, engine family identification, and model year of the engine or whom to contact for further information.
(iv) The statement “THIS ENGINE IS EXEMPT UNDER 40 CFR 1068.215 FROM EMISSION STANDARDS AND RELATED REQUIREMENTS.”.
At 69 FR 39267, June 29, 2004, § 1068.215 was amended by revising paragraphs (b), (c)(3)(iii), and (c)(3)(iv), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(b) An engine may be exempt without a request if it is a nonconforming engine under your ownership and control and you operate it to develop products, assess production methods, or promote your engines in the marketplace. You may not loan, lease, sell, or use the engine to generate revenue, either by itself or in a piece of equipment.
(c) * * *
(3) * * *
(iii) Engine displacement, engine family identification (as applicable), and model year of the engine or whom to contact for further information.
(iv) The statement “THIS ENGINE IS EXEMPT UNDER 40 CFR 1068.210 OR 1068.215 FROM EMISSION STANDARDS AND RELATED REQUIREMENTS.”.
(a) Anyone may request an exemption for display engines.
(b) A nonconforming display engine will be exempted if it is used only for displays in the interest of a business or the general public. Thisexemption does not apply to engines displayed for private use or any other purpose we determine is inappropriate for a display exemption.
(c) You may operate the exempted engine, but only if we approve specific operation that is part of the display.
(d) You may sell or lease the exempted engine only with our advance approval; you may not use it to generate revenue.
(e) To use this exemption, you must add a permanent, legible label, written in block letters in English, to a readily visible part of eachexempted engine. This label must include at least the following items:
(1) The label heading “EMISSION CONTROL INFORMATION”.
(2) Your corporate name and trademark.
(3) Engine displacement, engine family identification, and model year of the engine or whom to contact for further information.
(4) The statement “THIS ENGINE IS EXEMPT UNDER 40 CFR 1068.220 FROM EMISSION STANDARDS AND RELATED REQUIREMENTS.”.
(f) We may set other conditions for approval of this exemption.
At 69 FR 39267, June 29, 2004, § 1068.220 was amended by revising paragraphs (b) and (e)(3), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(b) A nonconforming display engine will be exempted if it is used only for displays in the interest of a business or the general public. This exemption does not apply to engines displayed for private use, private collections, or any other purpose we determine is inappropriate for a display exemption.
(e) * * *
(3) Engine displacement, engine family identification (as applicable), and model year
(a) You are eligible for the exemption for national security only if you are a manufacturer.
(b) Your engine is exempt without a request if you produce it for a piece of equipment owned or used by an agency of the federal government responsible for national defense, where the equipment has armor, permanently attached weaponry, or other substantial features typical of military combat.
(c) You may request a national security exemption for engines not meeting the conditions of paragraph (b) of this section, as long as your request is endorsed by an agency of the federal government responsible for national defense. In your request, explain why you need the exemption.
At 69 FR 39267, June 29, 2004, § 1068.225 was amended by adding paragraph (d), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(d) Add a legible label, written in block letters in English, to each engine exempted under this section. The label must be permanently secured to a readily visible part of the engine needed for normal operation and not normally requiring replacement, such as the engine block. This label must include at least the following items:
(1) The label heading “EMISSION CONTROL INFORMATION”.
(2) Your corporate name and trademark.
(3) Engine displacement, engine family identification (as applicable), and model year of the engine or whom to contact for further information.
(4) The statement “THIS ENGINE HAS AN EXEMPTION FOR NATIONAL SECURITY UNDER 40 CFR 1068.225.”.
(a) If you export a new engine to a country with emission standards identical to ours, we will not exempt it. These engines must comply with our certification requirements.
(b) If you export an engine to a country with different emission standards or no emission standards, it is exempt from the prohibited acts in this part without a request. If you produce an exempt engine for export and it is sold or offered for sale to someone in the United States (except for export), we will void the exemption.
(c) Label each exempted engine and shipping container with a label or tag showing the engine is not certified for sale or use in the United States. The label must include at least the statement “THIS ENGINE IS SOLELY FOR EXPORT AND IS THEREFORE IS EXEMPT UNDER 40 CFR 1068.230 FROM U.S. EMISSION STANDARDS AND RELATED REQUIREMENTS.”.
At 69 FR 39267, June 29, 2004, § 1068.230 was amended by revising paragraph (c), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(c) Label each exempted engine and shipping container with a label or tag showing the engine is not certified for sale or use in the United States. These labels need not be permanently attached to the engines. The label must include at least the statement “THIS ENGINE IS SOLELY FOR EXPORT AND IS THEREFORE EXEMPT UNDER 40 CFR 1068.230 FROM U.S. EMISSION STANDARDS AND RELATED REQUIREMENTS.”.
(a) New engines you produce that are used solely for competition are generally excluded from emission standards. See the standard-setting parts for specific provisions where applicable.
(b) If you modify an engine after it has been placed into service in the United States so it will be used solely for competition, it is exempt without request. This exemption applies only to the prohibition in § 1068.101(b)(1) and is valid only as long as the engine is used solely for competition.
(c) If you modify an engine under this exemption, you must destroy the original emission label. If you sell or give one of these engines to someone else, you must tell the new owner in writing that it may be used only for competition.
At 69 FR 39267, June 29, 2004, § 1068.235 was amended by revising paragraph (c), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(c) If you modify an engine under paragraph (b) of this section, you must destroy the original emission label. If you loan, lease, sell, or give one of these engines to someone else, you must tell the new owner (or operator, if applicable) in writing that it may be used only for competition.
(a) You are eligible for the exemption for new replacement engines only if you are a certificate holder.
(b) The prohibitions in § 1068.101(a)(1) do not apply to an engine if all the following conditions apply:
(1) You produce a new engine to replace an engine already placed in service in a piece of equipment.
(2) The engine being replaced was manufactured before the emission standards that would otherwise apply to the new engine took effect.
(3) No engine certified to current emission requirements is available with the appropriate physical or performance characteristics for the piece of equipment.
(4) You or your agent takes possession of the old engine.
(5) You make the replacement engine in a configuration identical in all material respects to the engine being replaced (or that of another certified engine of the same or later model year). This requirement applies only if the old engine was certified to emission standards less stringent than those in effect when you produce the replacement engine.
(c) If the old engine was not certified to any emission standards under this chapter, clearly label the replacement engine with the following language:
THIS ENGINE DOES NOT COMPLY WITH FEDERAL NONROAD OR HIGHWAY EMISSION REQUIREMENTS. SELLING OR INSTALLING THIS ENGINE FOR ANY PURPOSE OTHER THAN AS A REPLACEMENT ENGINE IN A VEHICLE OR PIECE OF EQUIPMENT BUILT BEFORE JANUARY 1, [Insert appropriate year reflecting when standards began to apply to engines of that size and type] IS A VIOLATION OF FEDERAL LAW SUBJECT TO CIVIL PENALTY.
(d) If the old engine was certified to emission standards less stringent than those in effect when you produce the replacement engine, clearly label the replacement engine with the following language:
THIS ENGINE DOES NOT COMPLY WITH CURRENT FEDERAL NONROAD OR HIGHWAY EMISSION REQUIREMENTS. SELLING OR INSTALLING THIS ENGINE FOR ANY PURPOSE OTHER THAN AS A REPLACEMENT ENGINE IN A VEHICLE OR PIECE OF EQUIPMENT BUILT BEFORE JANUARY 1, [Insert appropriate year reflecting when the earlier tier of emission standards began to apply to the old engine] IS A VIOLATION OF FEDERAL LAW SUBJECT TO CIVIL PENALTY.
At 69 FR 39267, June 29, 2004, § 1068.240 was revised, effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(a) You are eligible for the exemption for new replacement engines only if you are a certificate holder.
(b) The prohibitions in § 1068.101(a)(1) do not apply to an engine if all the following conditions apply:
(1) You produce a new engine to replace an engine already placed in service in a piece of equipment.
(2) The engine being replaced was manufactured before the emission standards that would otherwise apply to the new engine took effect.
(3) You determine that you do not produce an engine certified to meet current requirements that has the appropriate physical or performance characteristics to repower the equipment. If the engine being replaced was made by a different company, you must make this determination also for engines produced by this other company.
(4) You or your agent takes possession of the old engine or confirms that the engine has been destroyed.
(5) You make the replacement engine in a configuration identical in all material respects to the engine being replaced (or that of another certified engine of the same or later model year). This requirement applies only if the old engine was certified to emission standards less stringent than those in effect when you produce the replacement engine.
(c) If the engine being replaced was not certified to any emission standards under this chapter, add a permanent label with your corporate name and trademark and the following language:
(d) If the engine being replaced was certified to emission standards less stringent than those in effect when you produce the replacement engine, add a permanent label with your corporate name and trademark and the following language:
(e) The provisions of this section may not be used to circumvent emission standards that apply to new engines under the standard-setting part.
(a) After considering the circumstances, we may permit you to introduce into commerce engines or equipment that do not comply with emission standards if all the following conditions apply:
(1) Unusual circumstances that are clearly outside your control and that could not have been avoided with reasonable discretion prevent you from meeting requirements from this chapter.
(2) You exercised prudent planning and were not able to avoid the violation; you have taken all reasonable steps to minimize the extent of the nonconformity.
(3) Not having the exemption will jeopardize the solvency of your company.
(4) No other allowances are available under the regulations in this chapter to avoid the impending violation.
(b) To apply for an exemption, you must send the Designated Officer a written request as soon as possible before you are in violation. In your request, show that you meet all the conditions and requirements in paragraph (a) of this section.
(c) Include in your request a plan showing how you will meet all the applicable requirements as quickly as possible.
(d) You must give us other relevant information if we ask for it.
(e) We may include reasonable additional conditions on an approval granted under this section, including provisions to recover or otherwise address the lost environmental benefit or paying fees to offset any economic gain resulting from the exemption. For example, in the case of multiple tiers of emission standards, we may require that you meet the less stringent standards.
(f) Add a permanent, legible label, written in block letters in English, to a readily visible part of each engine exempted under this section. This label must include at least the following items:
(1) The label heading “EMISSION CONTROL INFORMATION”.
(2) Your corporate name and trademark.
(3) Engine displacement (in liters), rated power, and model year of the engine or whom to contact for further information.
(4) The statement “THIS ENGINE IS EXEMPT UNDER 40 CFR 1068.245 FROM EMISSION STANDARDS AND RELATED REQUIREMENTS.”.
At 69 FR 39268, June 29, 2004, § 1068.245 was amended by revising paragraphs (a) introductory text and (e), effective Aug. 30, 2004. For the convenience of
(a) After considering the circumstances, we may permit you to introduce into commerce engines or equipment that do not comply with emission-related requirements for a limited time if all the following conditions apply:
(e) We may include reasonable additional conditions on an approval granted under this section, including provisions to recover or otherwise address the lost environmental benefit or paying fees to offset any economic gain resulting from the exemption. For example, in the case of multiple tiers of emission standards, we may require that you meet the standards from the previous tier.
(a) After considering the circumstances, we may extend the compliance deadline for you to meet new or revised emission standards, as long as you meet all the conditions and requirements in this section.
(b) To be eligible for this exemption, you must qualify under the standard-setting part for special provisions for small businesses or small-volume manufacturers.
(c) To apply for an extension, you must send the Designated Officer a written request. In your request, show that all the following conditions and requirements apply:
(1) You have taken all possible business, technical, and economic steps to comply.
(i) In the case of importers of engines produced by other companies, show that you attempted to find a manufacturer capable of supplying complying products as soon as you became aware of the applicable requirements, but were unable to do so.
(ii) For all other manufacturers, show that the burden of compliance costs prevents you from meeting the requirements of this chapter.
(2) Not having the exemption will jeopardize the solvency of your company.
(3) No other allowances are available under the regulations in this chapter to avoid the impending violation.
(d) In describing the steps you have taken to comply under paragraph (c)(1) of this section, include at least the following information:
(1) Describe your business plan, showing the range of projects active or under consideration.
(2) Describe your current and projected financial standing, with and without the burden of complying fully with the applicable regulations in this chapter.
(3) Describe your efforts to raise capital to comply with regulations in this chapter (this may not apply for importers).
(4) Identify the engineering and technical steps you have taken or plan to take to comply with regulations in this chapter.
(5) Identify the level of compliance you can achieve. For example, you may be able to produce engines that meet a somewhat less stringentemission standard than the regulations in this chapter require.
(e) Include in your request a plan showing how you will meet all the applicable requirements as quickly as possible.
(f) You must give us other relevant information if we ask for it.
(g) An authorized representative of your company must sign the request and include the statement: “All the information in this request is true and accurate, to the best of my knowledge.”.
(h) Send your request for this extension at least nine months before the relevant deadline. If different deadlines apply to companies that are not small-volume manufacturers, do not send your request before the regulations in question apply to the other manufacturers. Otherwise, do not send your request more than three years before the relevant deadline.
(i) We may include reasonable requirements on an approval granted under this section, including provisions to recover or otherwise address the lost environmental benefit. For example,
(j) We will approve extensions of up to one year. We may review and revise an extension as reasonable under the circumstances.
(k) Add a permanent, legible label, written in block letters in English, to a readily visible part of each engine exempted under this section. This label must include at least the following items:
(1) The label heading “EMISSION CONTROL INFORMATION”.
(2) Your corporate name and trademark.
(3) Engine displacement (in liters), rated power, and model year of the engine or whom to contact for further information.
(4) The statement “THIS ENGINE IS EXEMPT UNDER 40 CFR 1068.250 FROM EMISSION STANDARDS AND RELATED REQUIREMENTS.”.
At 69 FR 39268, June 29, 2004, § 1068.250 was amended by revising paragraphs (d)(2), (d)(4), and (j), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(d) * * *
(2) Describe your current and projected financial status, with and without the burden of complying fully with the applicable regulations in this chapter.
(4) Identify the engineering and technical steps you have taken or those you plan to take to comply with regulations in this chapter.
(j) We will approve extensions of up to one model year. We may review and revise an extension as reasonable under the circumstances.
This section describes how, in unusual circumstances, we may exempt certain engines to prevent a hardship to an equipment manufacturer or a secondary engine manufacturer. This section does not apply to products that are subject to vehicle-based emission standards.
(a)
(1) The number of engines to be exempted.
(2) The size of your company and your ability to endure the hardship.
(3) The amount of time you had to redesign your equipment to accommodate a complying engine.
(4) Whether there was any breach of contract by an engine supplier.
(5) The potential for market disruption.
(b)
(1) The label heading “EMISSION CONTROL INFORMATION”.
(2) Your corporate name and trademark.
(3) Engine displacement (in liters), rated power, and model year of the engine or whom to contact for further information.
(4) The statement “THIS ENGINE IS EXEMPT UNDER 40 CFR 1068.255 FROM EMISSION STANDARDS AND RELATED REQUIREMENTS.”.
(c)
(1) For the purpose of this section, a secondary engine manufacturer is a manufacturer that produces an engine by modifying an engine that is made by a different manufacturer for a different type of application. This includes, for example, automotive engines converted for use in industrial applications, or land-based engines converted for use in marine applications. This applies whether the secondary engine manufacturer is modifying a complete or partially complete engine and whether the engine was previously certified to emission standards or not. To be a secondary engine manufacturer, you must not be controlled by the manufacturer of the base engine (or by an entity that also controls the manufacturer of the base engine). In addition, equipment manufacturers that substantially modify engines become secondary engine manufacturers. For the purpose of this definition, “substantially modify” means changing an engine in a way that could change its emission characteristics.
(2) The provisions in paragraph (a) of this section that apply to equipment manufacturers requesting an exemption apply equally to you,except that you may manufacture the engines. Before we can approve the exemption under this section, you must commit to a plan to make up the lost environmental benefit.
(i) If you produce uncertified engines under this exemption, we will calculate the lost environmental benefit based on our bestestimate of uncontrolled emission rates for your engines.
(ii) If you produce engines under this exemption that are certified to a compliance level less stringent than the emission standards that would otherwise apply, we will calculate the lost environmental benefit based on the compliance level you select for your engines.
(3) The labeling requirements in paragraph (b) of this section apply to your exempted engines; however, if you certify engines to specific compliance levels, state on the label the compliance levels that apply to each engine.
At 69 FR 39268, June 29, 2004, § 1068.255 was amended by revising paragraph (c) introductory text, effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(c)
(a) Shipping an engine separately from an aftertreatment component that you have specified as part of its certified configuration will not be a violation of the prohibitions in
(1) Apply for and receive a certificate of conformity for the engine and its emission-control system before shipment.
(2) Provide installation instructions in enough detail to ensure that the engine will be in its certified configuration if someone follows these instructions.
(3) Have a contractual agreement with an equipment manufacturer obligating the equipment manufacturer to complete the final assembly of the engine so it is in its certified configuration when installed in the equipment. This agreement must also obligate the equipment manufacturer to provide the affidavits and cooperate with the audits required under paragraph (a)(6) of this section.
(4) Include the cost of all aftertreatment components in the cost of the engine.
(5) Ship the aftertreatment components directly to the equipment manufacturer, or arrange for separate shipment by the component manufacturer directly to the equipment manufacturer.
(6) Take appropriate additional steps to ensure that all engines will be in their certified configuration when installed by the equipment manufacturer. At a minimum do the following:
(i) Obtain annual affidavits from every equipment manufacturer to whom you, your distributors, or your dealers sell engines under this section. The affidavits must list the part numbers of the aftertreatment devices that equipment manufacturers install on each engine they purchase from you, your distributors, or your dealers under this section.
(ii) If you sell more than 50 engines per model year under this section, you must annually audit four equipment manufacturers to whom you sell engines under this section. To select individual equipment manufacturers, divide all the affected equipment manufacturers into quartiles based on the number of engines they buy from you; select a single equipment manufacturer from each quartile each model year. Vary the equipment manufacturers you audit from year to year, though you may repeat an audit in a later model year if you find or suspect that a particular equipment manufacturer is not properly installing aftertreatment devices. If you sell engines to fewer than 16 equipment manufacturers under the provisions of this section, you may instead set up a plan to audit each equipment manufacturer on average once every four model years. Audits must involve the assembling companies' facilities, procedures, and production records to monitor their compliance with your instructions, must include investigation of some assembled engines, and must confirm that the number of aftertreatment devices shipped were sufficient for the number of engines produced. Where an equipment manufacturer is not located in the United States, you may conduct the audit at a distribution or port facility in the United States. You must keep records of these audits and provide a report describing any uninstalled or improperly installed aftertreatment components to us within 90 days of the audit.
(iii) If you sell up to 50 engines per model year under this section, you must conduct audits as described in paragraph (a)(6)(ii) of this section or propose an alternative plan for ensuring that equipment manufacturers properly install aftertreatment devices.
(7) Describe the following things in your application for certification:
(i) How you plan to use the provisions of this section.
(ii) A detailed plan for auditing equipment manufacturers, as described in paragraph (a)(6) of this section.
(iii) All other steps you plan to take under paragraph (a)(6) of this section.
(8) Keep records to document how many engines you produce under this exemption. Also, keep records to document your contractual agreements under paragraph (a)(3) of this section. Keep all these records for five years after the end of the model year and make them available to us upon request.
(9) Make sure the engine has the emission control information label we require under the standard-setting part. Apply an additional temporary
(b) An engine you produce under this section becomes new when it is fully assembled, except for aftertreatment devices, for the first time. Use this date to determine the engine's model year.
(c) Once the equipment manufacturer takes possession of an engine exempted under this section, the exemption expires and the engine is subject to all the prohibitions in 40 CFR 1068.101.
(d) You must notify us within 15 days if you find from an audit or another source that an equipment manufacturer has failed to meet its obligations under this section.
(e) We may suspend, revoke, or void an exemption under this section, as follows:
(1) We may suspend or revoke your exemption for the entire engine family if we determine that any of the engines are not in their certified configuration after installation in the equipment, or if you fail to comply with the requirements of this section. If we suspend or revoke the exemption for any of your engine families under this paragraph (d), this exemption will not apply for future certificates unless you demonstrate that the factors causing the nonconformity do not apply to the other engine families. We may suspend or revoke the exemption for shipments to a single facility where final assembly occurs.
(2) We may void your exemption for the entire engine family if you intentionally submit false or incomplete information or fail to keep and provide to EPA the records required by this section.
(f) You are liable for the in-use compliance of any engine that is exempt under this section. It is also a violation of § 1068.101(b)(1) for any person to complete assembly of the exempted engine without complying fully with the installation instructions.
At 69 FR 39268, June 29, 2004, § 1068.260 was added, effective Aug. 30, 2004.
(a) This subpart applies to you if you import into the United States engines or equipment subject to our emission standards or equipment containing engines subject to our emission standards.
(b) In general, engines that you import must be covered by a certificate of conformity unless they were built before emission standards started to apply. This subpart describes the limited cases where we allow importation of exempt or excluded engines.
(c) The U.S. Customs Service may prevent you from importing an engine if you do not meet the requirements of this subpart. In addition, U.S. Customs Service regulations may contain other requirements for engines imported into the United States (see 19 CFR Chapter I).
(a) Complete the appropriate EPA declaration form before importing any nonconforming engine. These forms are available on the Internet at http://www.epa.gov/OMS/imports/ or by phone at 202-564-9660.
(b) If we ask for it, prepare a written request in which you do the following:
(1) Give your name, address, telephone number, and taxpayer identification number.
(2) Give the engine owner's name, address, telephone number, and taxpayer identification number.
(3) Identify the make, model, identification number, and original production year of each engine.
(4) Identify which exemption or exclusion in this subpart allows you to import a nonconforming engine and describe how your engine qualifies.
(5) Tell us where you will keep your engines if you might need to store them until we approve your request.
(6) Authorize us to inspect or test your engines as the Act allows.
(c) We may ask for more information.
(d) You may import the nonconforming engines you identify in your request if you get prior written approval from us. The U.S. Customs Service may require you to show them the approval letter. We may temporarily or permanently approve the exemptions or exclusions, as described in this subpart.
(e) Make sure the engine meets any labeling requirements that apply.
At 69 FR 39269, June 29, 2004, § 1068.305 was amended by revising paragraphs (a) and (e), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(a) Complete the appropriate EPA declaration form before importing any nonconforming engine. These forms are available on the Internet at
(e) Meet the requirements specified for the appropriate exemption in this part or the standard-setting part, including any labeling requirements that apply.
Emission standards do not apply to excluded engines that you import. If you show us that your engines qualify under one of the paragraphs of this section, we will approve your request to import excluded engines. You must have our approval to import an engine under paragraph (a) of this section. You may, but are not required to request our approval for the other exclusions in this section. The following engines are excluded:
(a)
(b)
(c)
At 69 FR 39269, June 29, 2004, § 1068.310 was revised, effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
If you show us that your engines qualify under one of the paragraphs of this section, we will approve your request to import such excluded engines. You must have our approval to import an engine under paragraph (a) of this section. You may, but are not required to request our approval to import the engines under paragraph (b) or (c) of this section. The following engines are excluded:
(a)
(b)
(c)
We may approve a permanent exemption for an imported engine under the following conditions:
(a)
(b)
(c)
(d)
(e)
(f)
(1) You may import only the following engines under this exemption:
(i) Large nonroad spark-ignition engines (see part 1048 of this chapter).
(ii) Recreational nonroad spark-ignition engines and equipment (see part 1051 of this chapter).
(2) You must meet all the following criteria:
(i) You have owned the engine for at least one year.
(ii) You agree not to sell, lease, donate, trade, or otherwise transfer ownership of the engine for at least five years, or until the engine is eligible for the exemption in paragraph (g) of this section. During this period, the only acceptable way to dispose of the engine is to destroy or export it.
(iii) You use data or evidence sufficient to show that the engine is in a configuration that is the same as an engine the original manufacturer has certified to meet emission standards that apply at the time the manufacturer finished assembling or modifying the engine in question. If you modify the engine to make it identical, you must follow the original manufacturer's complete written instructions.
(3) We will tell you in writing if we find the information insufficient to show that the engine is eligible for this exemption. In this case, we will not consider your request further until you address our concerns.
(g)
At 69 FR 39269, June 29, 2004, § 1068.315 was amended by revising the introductory text and paragraph (a) and adding paragraph (f)(1)(iii), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
We may approve a permanent exemption from the restrictions on imports under § 1039.301(b) under the following conditions:
(a)
(f) * * *
(1) * * *
(iii) Land-based nonroad diesel engines (see part 1039 of this chapter).
(a) For engines imported under § 1068.315 (a), (b), (c), (d), or (e), you must place a permanent label or tag on each engine. If no specific label requirements from subpart C of this part apply, you must meet the following requirements:
(1) Attach the label or tag in one piece so no one can remove it without destroying or defacing it.
(2) Make sure it is durable and readable for the engine's entire life.
(3) Secure it to a part of the engine needed for normal operation and not normally requiring replacement.
(4) Write it in block letters in English.
(5) Make it readily visible to the average person after the engine is installed in the equipment.
(b) On the engine label or tag, do the following:
(1) Include the heading “Emission Control Information.”
(2) Include your full corporate name and trademark.
(3) State the engine displacement (in liters) and rated power. If the engine's rated power is not established, state the approximate power rating accurately enough to allow a detemination of which stanadards would otherwise apply.
(4) State: “THIS ENGINE IS EXEMPT FROM THE REQUIREMENTS OF [identify the part referenced in 40 CFR 1068.1(a) that would otherwise apply], AS PROVIDED IN [identify the paragraph authorizing the exemption (for example, “40 CFR 1068.315(a)”)]. INSTALLING THIS ENGINE IN ANY DIFFERENT APPLICATION IS A VIOLATION OF FEDERAL LAW SUBJECT TO CIVIL PENALTY.”.
(c) Get us to approve alternate label language if it is more accurate for your engine.
At 69 FR 39269, June 29, 2004, § 1068.320 was amended by revising the section heading and paragraphs (a) introductory text and (b), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(a) For engines imported under § 1068.310(a) or (b), you must place a permanent label or tag on each engine. If no specific label requirements in the standard-setting part apply for these engines, you must meet the following requirements:
(b) On the engine label or tag, do the following:
(1) Include the heading “EMISSION CONTROL INFORMATION”.
(2) Include your full corporate name and trademark.
(3) State the engine displacement (in liters) and rated power. If the engine's rated power is not established, state the approximate power rating accurately enough to allow a determination of which standards would otherwise apply.
(4) State: “THIS ENGINE IS EXEMPT FROM THE REQUIREMENTS OF [identify the part referenced in 40 CFR 1068.1(a) that would otherwise apply], AS PROVIDED IN [identify the paragraph authorizing the exemption (for example, “40 CFR 1068.315(a)”)]. INSTALLING THIS ENGINE IN ANY DIFFERENT APPLICATION MAY BE A VIOLATION OF FEDERAL LAW SUBJECT TO CIVIL PENALTY.”.
If we approve a temporary exemption for an engine, you may import it under the conditions in this section. We may ask the U.S. Customs Service to require a specific bond amount to make sure you comply with the requirements of this subpart. You may not sell or lease one of theseengines while it is in the United States. You must eventually export the engine as we describe in this section unless you get a certificate of conformity for it or it qualifies for one of the permanent exemptions in § 1068.315. Section 1068.330 specifies an additional temporary exemptionallowing you to import certain engines you intend to sell or lease.
(a)
(b)
(c)
(d)
(e)
At 69 FR 39269, June 29, 2004, § 1068.325 was amended by revising the introductory text and paragraphs (a) and (b) and adding paragraph (f), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
If we approve a temporary exemption from the restrictions on importing an engine under § 1039.301(b), you may import it under the conditions in this section. We may ask the U.S. Customs Service to require a specific bond amount to make sure you comply with the requirements of this subpart. You may not sell or lease one of these engines while it is in the United States. You must eventually export the engine as we describe in this section unless you get a certificate of conformity for it or it qualifies for one of the permanent exemptions in § 1068.315. Section 1068.330 specifies an additional temporary exemption allowing you to import certain engines you intend to sell or lease.
(a)
(b)
(f)
This section allows you to import engines in configurations different than their final configuration. This exemption is temporary, as described in paragraph (d) of this section.
(a) This section applies in the following cases:
(1) You import a partially complete engine with the intent to manufacture complete engines for which you have either a certificate of conformity or an exemption that allows you to sell completed engines.
(2) You import an uncertified complete engine with the intent to modify it for installation in an application different than its otherwise intended application (for example, you import a land-based engine to modify it for a marine application). In this case, to qualify for an exemption under this section, you need either a certificate of conformity or an exemption that allows you to sell completed engines.
(3) You import a complete or partially complete engine to modify for an application for which emission standards do not apply.
(b) You may request this exemption in an application for certification. Otherwise, send your request to the Designated Officer. Your request must include:
(1) The name of the supplier of the partially complete engine, or the original manufacturer of the complete engine.
(2) A description of the certificate or exemption that will apply to the engines in the final configuration, or an explanation why a certificate or exemption is not needed.
(3) A brief description of how and where final assembly will be completed.
(4) An unconditional statement that the engines will comply with all applicable regulations in their final configuration.
(c) If we approve a temporary exemption for an engine, you may import it under the conditions in this section. We may ask the U.S. Customs Service to require a specific bond amount to make sure you comply with the requirements of this subpart.
(d) These provisions are intended only to allow you to import engines in the specific circumstances identified in this section, so any exemptionunder this section expires when you complete the assembly of the engine in its final configuration. If the engine in its final configuration is subject to emission standards, then it must be covered by a certificate ora different exemption before you introduce it into commerce.
(a)
(b)
At 69 FR 39270, June 29, 2004, § 1068.335 was amended by revising paragraph (a), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(a)
(a) We may conduct or require you to conduct emission tests on your production engines in a selective enforcement audit. This requirement is independent of any requirement for you to routinely test production-lineengines.
(b) If we send you a signed test order, you must follow its directions and the provisions of this subpart. We will tell you where to test the engines. This may be where you produce the engines or any other emissiontesting facility.
(c) If we select one or more of your engine families for a selective enforcement audit, we will send the test order to the person who signed the application for certification or we will deliver it in person.
(d) Within one working day of receiving the test order, notify the Designated Officer which test facility you have selected for emissiontesting.
(e) You must do everything we require in the audit without delay.
At 69 FR 39270, June 29, 2004, § 1068.401 was revised, effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(a) We may conduct or require you to conduct emission tests on your production engines in a selective enforcement audit. This requirement is independent of any requirement for you to routinely test production-line engines.
(b) If we send you a signed test order, you must follow its directions and the provisions of this subpart. We may tell you where to test the engines. This may be where you produce the engines or any other emission testing facility.
(c) If we select one or more of your engine families for a selective enforcement audit, we will send the test order to the person who signed the application for certification or we will deliver it in person.
(d) If we do not select a testing facility, notify the Designated Officer within one working day of receiving the test order where you will test your engines.
(e) You must do everything we require in the audit without delay.
(a) In the test order, we will specify the following things:
(1) The engine family and configuration (if any) we have identified for testing.
(2) The engine assembly plant, storage facility, or (if you import the engines) port facility from which you must select engines.
(3) The procedure for selecting engines for testing, including a selection rate.
(4) The test procedures, duty cycles, and test points, as appropriate, for testing the engines to show that they meet emission standards.
(b) We may state that we will select the test engines.
(c) We may identify alternate engine families or configurations for testing in case we determine the intended engines are not available for testing or if you do not produce enough engines to meet the minimum rate for selectingtest engines.
(d) We may include other directions or information in the test order.
(e) We may ask you to show us that you meet any additional requirements that apply to your engines (closed crankcases, for example).
(f) In anticipation of a potential audit, you may give us a list of your preferred engine families and the corresponding assembly plants, storage facilities, or (if you import the engines) port facilities from which we should select engines for testing. The information would apply only for a single model year, so it would be best to include this information in yourapplication for certification. If you give us this list before we issue a test order, we will consider your recommendations, but we may selectengines differently.
(g) If you also do routine production-line testing with the selected engine family in the same time period, the test order will tell you what changes you might need to make in your production-line testing schedule.
(a)
(b)
(1) Notify us directly if you make any change in your production, assembly, or quality control processes that might affect emissions between the time you receive the test order and the time you finish selecting test engines.
(2) If you do not fully assemble engines at the specified location, we will describe in the test order how to select components to finishassembling the engines. Assemble these components onto the test enginesusing your documented assembly and quality control procedures.
(c)
(1) You document the need for doing so in your procedures for assembling and inspecting all your production engines and make the action routine for all the engines in the engine family.
(2) This subpart otherwise allows your action.
(3) We approve your action in advance.
(d)
(e)
(1) We may adjust idle speed outside the physically adjustable range as needed until the engine has stabilized emission levels (see paragraph (e) of this section). We may ask you for information needed to establish an alternate minimum idle speed.
(2) We may make or specify adjustments within the physically adjustable range by considering their effect on emission levels, as well as how likely it is someone will make such an adjustment with in-use engines.
(f)
(1) 50 hours.
(2) The number of hours you operated your emission-data engine for certifying the engine family (see 40 CFR part 1065, subpart E).
(g)
(h)
(i)
At 69 FR 39270, June 29, 2004, § 1068.410 was amended by revising paragraphs (e)(1), (g), and (i), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(e) * * *
(1) We may adjust or require you to adjust idle speed outside the physically adjustable range as needed until the engine has stabilized emission levels (see paragraph (f) of this section). We may ask you for information needed to establish an alternate minimum idle speed.
(g)
(i)
(a) Use the test procedures specified in the standard-setting part for showing that your engines meet emission standards. The test order will give further testing instructions.
(b) If no test cells are available at a given facility, you may make alternate testing arrangements with our approval.
(c) Test at least two engines in each 24-hour period (including void tests). However, if your projected U.S. nonroad engine sales within the engine family are less than 7,500 for the year, you may test a minimum of one engine per 24-hour period. If you request and justify it, we mayapprove a lower testing rate.
(d) Accumulate service on test engines at a minimum rate of 6 hours perengine during each 24-hour period. The
(e) Test engines is the same order you select them.
At 69 FR 39270, June 29, 2004, § 1068.415 was amended by revising paragraphs (d) and (e), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(d) Accumulate service on test engines at a minimum rate of 6 hours per engine during each 24-hour period. The first 24-hour period for service accumulation begins when you finish preparing an engine for testing. The minimum service accumulation rate does not apply on weekends or holidays. You may ask us to approve a lower service accumulation rate. Plan your service accumulation to allow testing at the rate specified in paragraph (c) of this section. Select engine operation for accumulating operating hours on your test engines to represent normal in-use engine operation for the engine family.
(e) Test engines in the same order you select them.
(a) A failed engine is one whose final deteriorated test results exceed an applicable emission standard for any regulated pollutant.
(b) Continue testing engines until you reach a pass decision for all pollutants or a fail decision for one pollutant.
(c) You reach a pass decision for the SEA requirements when the number of failed engines is less than or equal to the pass decision number in Appendix A to this subpart for the total number of engines tested. You reach a fail decision for the SEA requirements when the number of failedengines is greater than or equal to the fail decision number in Appendix Ato this subpart for the total number of engines you test. An acceptable quality level of 40 percent is the basis for the pass or fail decision.
(d) Consider test results in the same order as the engine testing sequence.
(e) If you reach a pass decision for one pollutant, but need to continue testing for another pollutant, we will disregard these later test results for the pollutant with the pass decision.
(f) Appendix A to this subpart lists multiple sampling plans. Use the sampling plan for the projected sales volume you reported in yourapplication for the audited engine family.
(g) We may choose to stop testing after any number of tests.
(h) If we test some of your engines in addition to your own testing, we may decide not to include your test results as official data for thoseengines if there is substantial disagreement between your testing and ourtesting. We will reinstate your data as valid if you show us that we madean error and your data are correct.
(i) If we rely on our test data instead of yours, we will notify you in writing of our decision and the reasons we believe your facility is notappropriate for doing the tests we require under this subpart. You may request in writing that we consider your test results from the same facility for future testing if you show us that you have made changes to resolve the problem.
(a) If one of your production-line engines fails to meet one or more emission standards (see § 1068.420), the certificate of conformity is automatically suspended for that engine. You must take the following actions before your certificate of conformity can cover that engine:
(1) Correct the problem and retest the engine to show it complies with all emission standards.
(2) Include in your written report a description of the test results and the remedy for each engine (see § 1068.450).
(b) You may at any time ask for a hearing to determine whether the tests and sampling methods were proper (see subpart G of this part).
(a) We may suspend your certificate of conformity for an engine family if it fails the SEA under § 1068.420. The suspension may apply to all facilities producing engines from an engine family, even if you findnoncompliant engines only at one facility.
(b) We will tell you in writing if we suspend your certificate in whole or in part. We will not suspend a certificate until at least 15 days afterthe engine family fails the SEA. The suspension is effective when you receive our notice.
(c) Up to 15 days after we suspend the certificate for an engine family, you may ask for a hearing to determine whether the tests and sampling methods were proper (see subpart G of this part). If we agree before a hearing that we used erroneous information in deciding to suspend the certificate, we will reinstate the certificate.
You may sell engines that you produce after we suspend the engine family's certificate of conformity only if one of the following occurs:
(a) You test each engine you produce and show it complies with emission standards that apply.
(b) We conditionally reinstate the certificate for the engine family. We may do so if you agree to recall all the affected engines and remedy anynoncompliance at no expense to the owner if later testing shows thatengines in the engine family still do not comply.
(a) Send us a written report asking us to reinstate your suspended certificate. In your report, identify the reason for the SEA failure, propose a remedy, and commit to a date for carrying it out. In your proposed remedy include any quality control measures you propose to keepthe problem from happening again.
(b) Give us data from production-line testing showing that engines in the remedied engine family comply with all the emission standards that apply.
(a) We may revoke your certificate for an engine family in the following cases:
(1) You do not meet the reporting requirements.
(2) Your engine family fails an SEA and your proposed remedy to address a suspended certificate is inadequate to solve the problem or requires you to change the engine's design or emission-control system.
(b) To sell engines from an engine family with a revoked certificate of conformity, you must modify the engine family and then show it complies with the applicable requirements.
(1) If we determine your proposed design change may not control emissions for the engine's full useful life, we will tell you within five working days after receiving your report. In this case we willdecide whether production-line testing will be enough for us to evaluatethe change or whether you need to do more testing.
(2) Unless we require more testing, you may show compliance by testing production-line engines as described in this subpart.
(3) We will issue a new or updated certificate of conformity when you have met these requirements.
At 69 FR 39270, June 29, 2004, § 1068.445 was amended by revising paragraph (a)(1), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(a) * * *
(1) You do not meet the reporting requirements under this subpart.
(a) Within 30 calendar days of the end of each audit, send us a report with the following information:
(1) Describe any facility used to test production-line engines and state its location.
(2) State the total U.S.-directed production volume and number of tests for each engine family.
(3) Describe your test engines, including the engine family's identification and the engine's model year, build date, model number, identification number, and number of hours of operation before testing for each test engine.
(4) Identify where you accumulated hours of operation on the enginesand describe the procedure and schedule you used.
(5) Provide the test number; the date, time and duration of testing; test procedure; initial test results before and after rounding; finaltest results; and final deteriorated test results for all tests.Provide the emission figures for all measured pollutants. Include information for both valid and invalid tests and the reason for any invalidation.
(6) Describe completely and justify any nonroutine adjustment, modification, repair, preparation, maintenance, or test for the testengine if you did not report it separately under this subpart. Includethe results of any emission measurements, regardless of the procedure ortype of equipment.
(7) Report on each failed engine as described in § 1068.425.
(b) We may ask you to add information to your written report, so we candetermine whether your new engines conform with the requirements of this subpart.
(c) An authorized representative of your company must sign the following statement:
We submit this report under Sections 208 and 213 of the Clean Air Act. Ourtesting conformed completely with the requirements of 40 CFR part1068. We have not changed production processes or quality-control procedures for the engine family in a way that might affect the emission control from production engines. All the information in this report istrue and accurate, to the best of my knowledge. I know of the penalties for violating the Clean Air Act and the regulations. (Authorized Company Representative)
(d) Send reports of your testing to the Designated Officer using an approved information format. If you want to use a different format, sendus a written request with justification for a waiver.
(e) We will send copies of your reports to anyone from the public who asks for them. We will release information about your sales or production volumes, which is all we will consider confidential.
At 69 FR 39270, June 29, 2004, § 1068.450 was amended by revising paragraph (e), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(e) We may post test results on publicly accessible databases and we will send copies of your reports to anyone from the public who asks for them. We will not release information about your sales or production volumes, which is all we will consider confidential.
(a) We may review your records at any time, so it is important to keep required information readily available. Organize and maintain your recordsas described in this section.
(b) Keep paper records for testing under this subpart for one full yearafter you complete all the testing required for the selective enforcementaudit. For additional storage, you may use any format or media.
(c) Keep a copy of the written reports described in § 1068.450.
(d) Keep the following additional records:
(1) The names of supervisors involved in each test.
(2) The name of anyone who authorizes adjusting, repairing, preparing, or modifying a test engine and the names of all supervisors who overseethis work.
(3) If you shipped the engine for testing, the date you shipped it, the associated storage or port facility, and the date the engine arrived at the testing facility.
(4) Any records related to your audit that are not in the written report.
(5) A brief description of any significant events during testing not otherwise described in the written report or in this section.
(e) If we ask, you must give us projected or actual production for an engine family. Include each assembly
(f) We may ask you to keep or send other information necessary to implement this subpart.
The following tables describe sampling plans for selective enforcementaudits, as described in § 1068.420:
(a)
(1) The term emission-related component includes those components listed in Appendix I of this part. For the purposes of this section, completeengines shall also be considered an emissions-related component. Italso includes factory settings of emission-related parameters and specifications listed in Appendix II of this part.
(2) For the purposes of this section, defects do not include damage to emission-related components (or maladjustment of parameters) caused by owners improperly maintaining or abusing their engine.
(3) You must track the information specified in paragraph (b)(1) of this section. You are not required to collect additional information otherthan that specified in paragraph (b)(1) of this section before reachingthe threshold for an investigation specified in paragraph (e) of this section.
(4) You may ask us to allow you to use alternate methods for tracking, investigating, reporting, and correcting emission-related defects. In your request, explain and demonstrate why you believe your alternate system will be at least as effective in tracking, identifying, investigating, evaluating, reporting, and correcting potential and actual emissions-related defects as the requirements in this section.
(5) If we determine that emission-related defects result in a substantial number of properly maintained and used engines not conforming to the regulations of this chapter during their useful life, we may order you to conduct a recall of your engines (see § 1068.505).
(6) Send the defect reports and status reports required by this section to the Designated Officer.
(b)
(1) You must track warranty claims, parts shipments, and the other information specified in paragraph (b)(1)(iii) of this section. You must classify an engine as possibly having a defective component if any of the following is true:
(i) A warranty claim is submitted for the component, whether this is under your emission-related warranty or any other warranty.
(ii) You ship a replacement component other than for normally scheduled maintenance during the useful life of the engine.
(iii) You receive any other information indicating the component may be defective, such as information from dealers or hot line complaints.
(2) Your investigation must be prompt, thorough, consider all relevant information, follow scientific and engineering principles, and bedesigned to obtain all the information specified in paragraph (d) of this section.
(3) Your investigation only needs to consider defects that occur within the useful life period, or within five years after the end of the model year, whichever is longer.
(4) You must continue your investigation until you are able to obtain all the information specified for a defect report in paragraph (d) of this section. Send us an updated defect report anytime you have significant additional information.
(5) If a component believed to be defective is used in additional engine families or model years, you must investigate whether the component or part is defective when used in these additional engine families or model years, and include these results as part of your defect report.
(6) If your initial investigation concludes that the number of engines with a defect is fewer than the thresholds specified in paragraph (f) of this section, but other information becomes available that may show thatthe number of engines with a defect exceeds
(c)
(1) Your investigation shows that the number of engines with a defect exceeds the thresholds specified in paragraph (f) of this section. Send the defect report within 15 days after the date you identify this number of defective engines.
(2) You know a defective emission-related component exists in a number of engines that exceeds the thresholds specified in paragraph (f) of this section, regardless of how you obtain this information. Send the defect report within 15 days after you learn that the number of defectsexceeds one of these thresholds.
(d)
(1) Your corporate name and a person to contact regarding this defect.
(2) A description of the defect, including a summary of any engineering analyses and associated data, if available.
(3) A description of the engines that may have the defect, including engine families, models, and range of production dates. Note that you must address all model years for the engines, not just the model year for which you triggered the reporting requirement.
(4) An estimate of the number and percentage of each class or category of affected engines that have or may have the defect, and an explanation of how you determined this number.
(5) An estimate of the defect's impact on emissions, with an explanation of how you calculated this estimate and a summary of any emission datademonstrating the impact of the defect, if available.
(6) A description of your plan for addressing the defect or an explanation of your reasons for not believing the defects must be remedied.
(e)
(1) For engine with rated power under 560 kW:
(i) When the component is a catalytic converter (or other aftertreatment device), if the number of engines in an engine family that may have the defect exceeds 2 percent of the total number of engines in the engine family or 2,000 engines, whichever is less.
(ii) When the emission-related component is anything but a catalytic converter (or other aftertreatment device), if the number of engines in an engine family that may have the defect exceeds 4 percent of the total number of engines in the engine family or 4,000 engines, whichever is less.
(2) For engine with rated power greater than or equal to 560 kW, if the number of engines in an engine family that may have the defect exceeds 1 percent of the total number of engines in the engine family or 5engines, whichever is greater.
(f)
(1) For engine with rated power under 560 kW:
(i) When the component is a catalytic converter (or other aftertreatment device), if the number of engines in an engine family that has the defect exceeds 0.125 percent of the total number of engines in the engine family or 125 engines, whichever is less.
(ii) When the emission-related component is anything but a catalytic converter (or other aftertreatment device), if the number of engines in an engine family that has the defect exceeds 0.250 percent of the total number of engines in the engine family or 250 engines, whichever is less.
(2) For engine with rated power greater than or equal to 560 kW, if the number of engines in an engine family that has the defect exceeds 0.5 percent of the total number of engines in the engine family or 2 engines, whichever is greater.
(g)
(h)
(i)
At 69 FR 39270, June 29, 2004, § 1068.501 was revised, effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
This section addresses your responsibility to investigate and report emission-related defects in design, materials, or workmanship. The provisions of this section do not limit your liability under this part or the Clean Air Act. For example, selling an engine that does not conform to your application for certification is a violation of § 1068.101(a)(1), independent of the requirements of this section.
(a)
(1) This section addresses defects for any of the following emission-related components, or systems containing the following components:
(i) Electronic control units, aftertreatment devices, fuel-metering components, EGR-system components, crankcase-ventilation valves, all components related to charge-air compression and cooling, and all sensors associated with any of these components.
(ii) Any other component whose primary purpose is to reduce emissions.
(iii) Any other component whose failure might increase emissions of any pollutant without significantly degrading engine performance.
(2) The requirements of this section relate to defects in any of the components or systems identified in paragraph (a)(1) of this section if the defects might affect any of the parameters or specifications in Appendix II of this part or might otherwise affect an engine's emissions of any pollutant.
(3) For the purposes of this section, defects do not include damage to emission-related components or systems (or maladjustment of parameters) caused by owners improperly maintaining or abusing their engines.
(4) The requirements of this section do not apply to emission control information labels. Note however, that § 1068.101(a)(1) prohibits the sale of engines without proper labels, which also applies to misprinted labels.
(5) You must track the information specified in paragraph (b)(1) of this section. You must assess this data at least every three months to evaluate whether you exceed the thresholds specified in paragraphs (e) and (f) of this section. Where thresholds are based on a percentage of engines in the engine family, use actual sales figures for the whole model year when they become available. Use projected sales figures until the actual sales figures become available. You are not required to collect additional information other than that specified in paragraph (b)(1) of this section before reaching a threshold for an investigation specified in paragraph (e) of this section.
(6) You may ask us to allow you to use alternate methods for tracking, investigating, reporting, and correcting emission-related defects. In your request, explain and demonstrate why you believe your alternate system will be at least as effective in the aggregate in tracking, identifying, investigating, evaluating, reporting, and correcting potential and actual emissions-related defects as the requirements in this section. In this case, provide all available data necessary to demonstrate why an alternate system is appropriate for your engines and how it will result in a system at least as effective as that required under this section.
(7) If we determine that emission-related defects result in a substantial number of properly maintained and used engines not conforming to the regulations of this chapter during their useful life, we may order you to
(8) Send all reports required by this section to the Designated Officer.
(9) This section distinguishes between defects and possible defects. A possible defect exists anytime there is an indication that an emission-related component or system might have a defect, as described in paragraph (b)(1) of this section.
(b)
(1) If the number of engines that have a possible defect, as defined by this paragraph (b)(1), exceeds a threshold specified in paragraph (e) of this section, you must conduct an investigation to determine if an emission-related component or system is actually defective. You must classify an engine component or system as having a possible defect if any of the following sources of information shows there is a significant possibility that a defect exists:
(i) A warranty claim is submitted for the component, whether this is under your emission-related warranty or any other warranty.
(ii) Your quality-assurance procedures suggest that a defect may exist.
(iii) You receive any other information for which good engineering judgment would indicate the component or system may be defective, such as information from dealers, field-service personnel, hotline complaints, or engine diagnostic systems.
(2) If the number of shipped replacement parts for any individual component is high enough that good engineering judgment would indicate a significant possibility that a defect exists, you must conduct an investigation to determine if it is actually defective. Note that this paragraph (b)(2) does not require data-tracking or recording provisions related to shipment of replacement parts.
(3) Your investigation must be prompt, thorough, consider all relevant information, follow accepted scientific and engineering principles, and be designed to obtain all the information specified in paragraph (d) of this section.
(4) Your investigation needs to consider possible defects that occur only within the useful life period, or within five years after the end of the model year, whichever is longer.
(5) You must continue your investigation until you are able to show that there is no emission-related defect or you obtain all the information specified for a defect report in paragraph (d) of this section. Send us an updated defect report anytime you have significant additional information.
(6) If a component with a possible defect is used in additional engine families or model years, you must investigate whether the component may be defective when used in these additional engine families or model years, and include these results in any defect report you send under paragraph (c) of this section.
(7) If your initial investigation concludes that the number of engines with a defect is fewer than any of the thresholds specified in paragraph (f) of this section, but other information later becomes available that may show that the number of engines with a defect exceeds a threshold, then you must resume your investigation. If you resume an investigation, you must include the information from the earlier investigation to determine whether to send a defect report.
(c)
(1) Your investigation shows that the number of engines with a defect exceeds a threshold specified in paragraph (f) of this section. Send the defect report within 21 days after the date you identify this number of defective engines. See paragraph (h) of this section for reporting requirements that apply if the number of engines with a defect does not exceed any of the thresholds in paragraph (f) of this section.
(2) You know there are emission-related defects for a component or system in a number of engines that exceeds a threshold specified in paragraph (f) of this section, regardless of how you obtain this information. Send the defect report within 21 days after you learn that the number of defects exceeds a threshold.
(d)
(1) Your corporate name and a person to contact regarding this defect.
(2) A description of the defect, including a summary of any engineering analyses and associated data, if available.
(3) A description of the engines that have the defect, including engine families, models, and range of production dates.
(4) An estimate of the number and percentage of each class or category of affected engines that have the defect, and an explanation of how you determined this number. Describe any statistical methods you used under paragraph (g)(6) of this section.
(5) An estimate of the defect's impact on emissions, with an explanation of how you calculated this estimate and a summary of any emission data demonstrating the impact of the defect, if available.
(6) A description of your plan for addressing the defect or an explanation of your reasons for not believing the defects must be addressed.
(e)
(1) For engines with maximum engine power at or below 560 kW:
(i) For engine families with annual sales below 500 units: 50 or more engines.
(ii) For engine families with annual sales from 500 to 50,000 units: more than 10.0 percent of the total number of engines in the engine family.
(iii) For engine families with annual sales above 50,000 units: 5,000 or more engines.
(2) For engines with maximum engine power greater than 560 kW:
(i) For engine families with annual sales below 250 units: 25 or more engines.
(ii) For engine families with annual sales at or above 250 units: more than 10.0 percent of the total number of engines in the engine family.
(f)
(1) For engines with maximum engine power at or below 560 kW:
(i) For engine families with annual sales below 1,000 units: 20 or more engines.
(ii) For engine families with annual sales from 1,000 to 50,000 units: more than 2.0 percent of the total number of engines in the engine family.
(iii) For engine families with annual sales above 50,000 units: 1,000 or more engines.
(2) For engines with maximum engine power greater than 560 kW:
(i) For engine families with annual sales below 150 units: 10 or more engines.
(ii) For engine families with annual sales from 150 to 750 units: 15 or more engines.
(iii) For engine families with annual sales above 750 units: more than 2.0 percent of the total number of engines in the engine family.
(g)
(2) Within an engine family, track defects together for all components or systems that are the same in all material respects. If multiple companies separately supply a particular component or system, treat each company's component or system as unique.
(3) If a possible defect is not attributed to any specific part of the engine, consider the complete engine a distinct component for evaluating whether you exceed a threshold in paragraph (e) of this section.
(4) If you correct defects before they reach the ultimate purchaser as a result of your quality-assurance procedures, count these against the investigation thresholds in paragraph (e) of this section unless you routinely check every engine in the engine family. Do not count any corrected defects as actual defects under paragraph (f) of this section.
(5) Use aggregated data from all the different sources identified in paragraph (b)(1) of this section to determine whether you exceed a threshold in paragraphs (e) and (f) of this section.
(6) If information is readily available to conclude that the possible defects identified in paragraph (b)(1) of this section are actual defects, count these toward the reporting thresholds in paragraph (f) of this section.
(7) During an investigation, use appropriate statistical methods to project defect rates for engines that you are not otherwise able to evaluate. For example, if 75 percent of the components replaced under warranty are available for evaluation, it would be appropriate to extrapolate known information on failure rates to the components that are unavailable for evaluation. Take steps as necessary to prevent bias in sampled data. Make adjusted calculations to take into account any bias that may remain.
(h)
(1) While you are investigating, send us mid-year and end-of-year reports to describe the methods you are using and the status of the investigation. Send these status reports no later than June 30 and December 31 of each year.
(2) If you find that the number of components or systems with an emission-related defect exceeds a threshold specified in paragraph (f) of this section, send us a report describing your findings within 21 days after the date you reach this conclusion.
(3) If you find that the number of components or systems with an emission-related defect does not exceed any of the thresholds specified in paragraph (f) of this section, send us a final report supporting this conclusion. For example, you may exclude warranty claims that resulted from misdiagnosis and you may exclude defects caused by improper maintenance, improper use, or misfueling. Send this report within 21 days after the date you reach this conclusion.
(i)
(a) If we make a determination that a substantial number of properly maintained and used engines do not conform
(b) You may ask for a hearing if you disagree with our determination (see subpart G of this part).
(c) Unless we withdraw the determination of noncompliance, you must respond to it by sending a remedial plan to the Designated Officer by the later of these two deadlines:
(1) Within 60 days after we notify you.
(2) Within 60 days after a hearing.
(d) Once you have sold an engine to the ultimate purchaser, we may inspect or test the engine only if he or she permits it, or if state or local inspection programs separately provide for it.
(e) You may ask us to allow you to conduct your recall differently than specified in this subpart, consistent with section 207(c) of the Act.
At 69 FR 39272, June 29, 2004, § 1068.505 was amended by revising paragraphs (a) and (e) and adding paragraph (f), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(a) If we make a determination that a substantial number of properly maintained and used engines do not conform to the regulations of this chapter during their useful life, you must submit a plan to remedy the nonconformity of your engines. We will notify you of our determination in writing. Our notice will identify the class or category of engines affected and describe how we reached our conclusion. If this happens, you must meet the requirements and follow the instructions in this subpart. You must remedy at your expense noncompliant engines that have been properly maintained and used, as described in § 1068.510(a)(7). You may not transfer this expense to a dealer or equipment manufacturer through a franchise or other agreement.
(e) You may ask us to allow you to conduct your recall differently than specified in this subpart, consistent with section 207(c) of the Act (42 U.S.C. 7541(c)).
(f) You may do a voluntary recall under § 1068.535, unless we have made the determination described in § 1068.535(a).
(a) In your remedial plan, describe all of the following:
(1) The class or category of engines to be recalled, including the number of engines involved and the model year or other informationneeded to identify the engines.
(2) The modifications, alterations, repairs, corrections, adjustments, or other changes you will make to correct the affected engines.
(3) A brief description of the studies, tests, and data that support the effectiveness of the remedy you propose to use.
(4) The instructions you will send to those who will repair the engines under the remedial plan.
(5) How you will determine the owners' names and addresses.
(6) How you will notify owners; include copies of any notification letters.
(7) The proper maintenance or use you will specify, if any, as a condition to be eligible for repair under the remedial plan. Describe how owners should show they meet your conditions.
(8) The steps owners must take for you to do the repair. You may set a date or a range of dates, specify the amount of time you need, and designate certain facilities to do the repairs.
(9) Which company (or group) you will assign to do or manage the repairs.
(10) If your employees or authorized warranty agents will not be doing the work, state who will and say they can do it.
(11) How you will ensure an adequate and timely supply of parts.
(12) The effect of proposed changes on fuel consumption, driveability, and safety of the engines you will recall;
(13) How you intend to label the engines you repair and where you will place the label on the engine (see § 1068.515).
(b) We may require you to add information to your remedial plan.
(c) We may require you to test the proposed repair to show it will remedy the noncompliance.
(d) Use all reasonable means to locate owners. We may require you to use government or commercial registration lists to get owners' names and addresses, so your notice will be effective.
(e) The maintenance or use that you specify as a condition for eligibility under the remedial plan may include only things you can show would cause noncompliance. Do not require use of a component or service identified by brand, trade, or corporate name, unless we approved this approach with your original certificate of conformity. Also, do not place conditions on who maintained the engine.
(f) We may require you to adjust your repair plan if we determine owners would be without their engines or equipment for an unreasonably long time.
(g) We will tell you in writing within 15 days of receiving your remedial plan whether we have approved or disapproved it. We will explain our reasons for any disapproval.
(h) Begin notifying owners within 15 days after we approve your remedial plan. If we hold a hearing, but do not change our position about the noncompliance, you must begin notifying owners within 60 days after we complete the hearing, unless we specify otherwise.
At 69 FR 39273, June 29, 2004, § 1068.510 was amended by revising paragraph (a)(7), effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
(a) * * *
(7) The proper maintenance or use you will specify, if any, as a condition to be eligible for repair under the remedial plan. Describe how these specifications meet the provisions of paragraph (e) of this section. Describe how the owners should show they meet your conditions.
(a) Attach a label to each engine you repair under the remedial plan. At your discretion, you may label or mark engines you inspect but do not repair.
(b) Make the label from a durable material suitable for its planned location. Make sure no one can remove the label without destroying or defacing it.
(c) On the label, designate the specific recall campaign and state where you repaired or inspected the engine.
(d) We may waive or modify the labeling requirements if we determine they are overly burdensome.
(a) Notify owners by first class mail, unless we say otherwise. We may require you to use certified mail. Include the following in your notice:
(1) State: “The U.S. Environmental Protection Agency has determined that your engine may be emitting pollutants in excess of the Federal emission standards, as defined in Title 40 of the Code of Federal Regulations. These emission standards were established to protect the public health or welfare from air pollution”.
(2) State that you (or someone you designate) will repair these engines at your expense.
(3) If we approved maintenance and use conditions in your remedial plan, state that you will make these repairs only if owners show their engines meet the conditions for proper maintenance and use. Describe these conditions and how owners should prove their engines are eligible for repair.
(4) Describe the components your repair will affect and say generally how you will repair the engines.
(5) State that the engine, if not repaired, may fail an emission inspection test if state or local law requires one.
(6) Describe any adverse effects on its performance or driveability that would be caused by not repairing the engine.
(7) Describe any adverse effects on the functions of other engine components that would be caused by not repairing the engine.
(8) Specify the date you will start the repairs, the amount of time you will need to do them, and where you will do them. Include any other information owners may need to know.
(9) Include a self-addressed card that owners can mail back if they have sold the engine (or equipment in which the engine is installed); include a space for owners to write the name and address of a buyer.
(10) State that owners should call you at a phone number you give to report any difficulty in obtaining repairs.
(11) State: “To ensure your full protection under the emission warranty on your engine by federal law, and your right to participate in future recalls, we recommend you have your engine serviced as soon as possible. We may consider your not servicing it to be improper maintenance”.
(b) We may require you to add information to your notice or to send more notices.
(c) You may not in any communication with owners or dealers say or imply that your noncompliance does not exist or that it will not degrade air quality.
(a) Send us a copy of all communications related to the remedial plan you sent to dealers and others doing the repairs. Mail or e-mail us the information at the same time you send it to others.
(b) From the time you begin to notify owners, send us a report within 25 days of the end of each calendar quarter. Send reports for six consecutive quarters or until all the engines are inspected, whichever comes first. Inthese reports, identify the following:
(1) The range of dates you needed to notify owners.
(2) The total number of notices sent.
(3) The number of engines you estimate fall under the remedial plan(explain how you determined this number).
(4) The cumulative number of engines you inspected under the remedial plan.
(5) The cumulative number of these engines you found needed the specified repair.
(6) The cumulative number of these engines you have repaired.
(7) The cumulative number of engines you determined to be unavailable due to exportation, theft, retirement, or other reasons (specify).
(8) The cumulative number of engines you disqualified for not being properly maintained or used.
(c) If your estimated number of engines falling under the remedial plan changes, change the estimate in your next report and add an explanation for the change.
(d) We may ask for more information.
(e) We may waive reporting requirements or adjust the reporting schedule.
(f) If anyone asks to see the information in your reports, we will follow the provisions of § 1068.10 for handling confidential information.
We may review your records at any time, so it is important that you keep required information readily available. Keep records associated with your recall campaign for three years after you complete your remedial plan. Organize and maintain your records as described in this section.
(a) Keep a paper copy of the written reports described in § 1068.525.
(b) Keep a record of the names and addresses of owners you notified. For each engine, state whether you did any of the following:
(1) Inspected the engine.
(2) Disqualified the engine for not being properly maintained or used.
(3) Completed the prescribed repairs.
(c) You may keep the records in paragraph (b) of this section in any form we can inspect, including computer databases.
At 69 FR 39273, June 29, 2004, § 1068.530 was amended by revising the introductory text, effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
We may review your records at any time, so it is important that you keep required information readily available. Keep records associated with your recall campaign for three
If we have made a determination that a substantial number of properly maintained and used engines do not conform to the regulations of this chapter during their useful life, you may not use a voluntary recall or other alternate means to meet your obligation to remedy the noncompliance. Thus, this section only applies where you learn that your engine family does not meet the requirements of this chapter and we have not made such a determination.
(a) To do a voluntary recall under this section, first send the Designated Officer a plan, following the guidelines in § 1068.510. Within 15 days, we will send you our comments on your plan.
(b) Once we approve your plan, start notifying owners and carrying out the specified repairs.
(c) From the time you start the recall campaign, send us a report within 25 days of the end of each calendar quarter, following the guidelines in § 1068.525(b). Send reports for six consecutive quarters or until all the engines are inspected, whichever comes first.
(d) Keep your reports and the supporting information as described in § 1068.530.
The following terms apply to this subpart:
If we agree to hold a hearing related to our decision to order a recall under § 1068.505, we will hold the hearing according to the provisions of 40 CFR 85.1807. For any other issues, you may request an informal hearing, as described in 40 CFR 86.1853-01.
This appendix specifies emission-related components that we refer to for describing such things as emission-related defects or requirements relatedto rebuilding engines.
At 69 FR 39273, June 29, 2004, Appendix I to part 1068 was amended by removing paragraph IV and revising the introductory text, effective Aug. 30, 2004. For the convenience of the user, the revised text is set forth as follows:
This appendix specifies emission-related components that we refer to for describing such things as emission-related warranty or requirements related to rebuilding engines.
This appendix specifies emission-related parameters and specifications that we refer to for describing such things as emission-related defects or requirements related to rebuilding engines.
42 U.S.C. 7412(r)(7)(H)(ii).
Stationary sources subject to the Chemical Accident Prevention Provisions of 40 CFR part 68 are required to analyze the potential harm to public health and welfare of hypothetical chemical accidents and submit the results of their analyses to the U.S. Environmental ProtectionAgency as part of risk management plans. This part governs access by the public and by government officials to the portions of risk management plans containing the results of those analyses and certain related materials. This part also restricts dissemination of that information by government officials.
For the purposes of this part:
(a)
(b)
(c)
(d)
(1) An officer or employee of the United States; and
(2) An officer or employee of an agent or contractor of the Federal government.
(e)
(1) An officer or employee of a State or local government;
(2) An officer or employee of an agent or contractor of a State or local government;
(3) An individual affiliated with an entity that has been given, by a state or local government, responsibility for preventing, planning for, or responding to accidental releases, such as a member of a Local Emergency Planning Committee (LEPC) or a State EmergencyResponse Commission (SERC), or a paid or volunteer member of a fire or police department; or
(4) An officer or employee or an agent or contractor of an entity described in paragraph (e)(3) of this section.
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
(o)
(p)
(q)
(r)
(s)
(a)
(b)
(c)
(d)
(e)
(1) Ascertained the person's identity by viewing photo identification issued by a Federal, State, or local government agency to the person; and
(2) Obtained the person's signature on a sign-in sheet and a certification that the person has not received access to OCA information for more than 10 stationary sources for that calendar month.
(f)
(1) Ascertained where the person lives or works by viewing appropriate documentation; and
(2) Obtained the person's signature on a sign-in sheet.
(g)
(a)
(b)
The Administrator shall include only the following OCA data elements in the risk management plan database available on the Internet:
(a) The concentration of the chemical (RMP Sections 2.1.b; 3.1.b);
(b) The physical state of the chemical (RMP Sections 2.2; 3.2);
(c) The statistical model used (RMP Sections 2.3; 3.3; 4.2; 5.2);
(d) The endpoint used for flammables in the worst-case scenario (RMP Section 4.5);
(e) The duration of the chemical release for the worst-case scenario (RMP Section 2.7);
(f) The wind speed during the chemical release (RMP Sections 2.8; 3.8);
(g) The atmospheric stability (RMP Sections 2.9; 3.9);
(h) The topography of the surrounding area (RMP Sections 2.10; 3.10);
(i) The passive mitigation systems considered (RMP Sections 2.15; 3.15; 4.10; 5.10); and
(j) The active mitigation systems considered (RMP Sections 3.16; 5.11).
(a)
(b)
(2) LEPCs and related local government agencies that provide read-only access to the OCA sections of RMPs under this paragraph (b) are not required to limit the number of stationary sources for which a person can gain access, ascertain a person's identity or place of residence or work, or keep records of public access provided.
(3) SERCs and related state government agencies are authorized and encouraged to allow any person to read, but not remove or mechanically copy, a paper copy of the OCA sections of RMPs for the same stationary sources that the LEPC in whose jurisdiction the person lives or works would be authorized to make available to that person under paragraph (b)(1) of this section.
(4) Any LEPC, SERC, or related local or State government agency that allows a person to read the OCA sections of RMPs in a manner consistent with this paragraph (b) shall not be in violation of 42 U.S.C. 7412(r)(7)(H)(v) or any other provision of federal law.
The Administrator shall provide OCA information to government officials as provided in this subpart. Any OCA information provided to government officials shall be accompanied by a copy of the notice prescribed by 42 U.S.C. 7412(r)(7)(H)(vi).
The Administrator shall provide any Federal government official with the OCA information requested by the official for official use. The Administrator shall provide the OCA information to the official in electronic form, unless the official specifically requests the information in paper form. The Administrator may charge a fee to cover the cost of copyingOCA information in paper form.
(a) The Administrator shall make available to any State or local government official for official use the OCA information for stationary sources located in the official's state.
(b) The Administrator also shall make available to any State or local government official for official use the OCA information for stationary sources not located in the official's state, at the request of the official.
(c) The Administrator shall provide OCA information to a State or local government official in electronic form, unless the official specifically requests the information in paper form. The Administrator may charge a fee to cover the cost of copying OCA information in paper form.
(d) Any State or local government official is authorized to provide, for official use, OCA information relating to stationary sources located in the official's state to other State or local government officials in that state and to State or local government officials in a contiguous state.
Except as authorized by this part and by 42 U.S.C. 7412(r)(7)(H)(v)(III), Federal, State, and local government officials, and qualified researchers are prohibited from disseminating OCA information and OCA rankings to the public. Violation of this provision subjects the violator to criminal liability as provided in 42 U.S.C. 7412(r)(7)(H)(v)
Except as authorized by this part and by 42 U.S.C. 7412(r)(7)(H)(v)(III), Federal, State, and local government officials, and qualified researchers are prohibited from disseminating OCA information to State and local government officials. Violation of this provision subjects the violator to civil liability as provided in 42 U.S.C. 7413.
The Administrator is authorized to provide OCA information, including facility identification, to qualified researchers pursuant to a system developed and implemented under 42U.S.C. 7412(r)(7)(H)(vii), in consultation with the Attorney General.
The Administrator is authorized to establish, pursuant to 42 U.S.C. 7412(r)(7)(H)(viii), an information technology system that makes available to the public off-site consequence analysis information by means of a central database under the control of the Federal government that contains information that users may read, but that provides no means by which an electronic or mechanical copy of the information may be made.
NEPA, the Environmental Quality Improvement Act of 1970, as amended (42 U.S.C. 4371
(a) The National Environmental Policy Act (NEPA) is our basic national charter for protection of the environment. It establishes policy, sets goals (section 101), and provides means (section 102) for carrying out the policy. Section 102(2) contains “action-forcing” provisions to make sure that federal agencies act according to the letter and spirit of the Act. The regulations that follow implement section 102(2). Their purpose is to tell federal agencies what they must do to comply with the procedures and achieve the goals of the Act. The President, the federal agencies, and the courts share responsibility for enforcing the Act so as to achieve the substantive requirements of section 101.
(b) NEPA procedures must insure that environmental information is available to public officials and citizens before decisions are made and before actions are taken. The information must be of high quality. Accurate scientific analysis, expert agency comments, and public scrutiny are essential to implementing NEPA. Most important, NEPA documents must concentrate on the issues that are truly significant to the action in question, rather than amassing needless detail.
(c) Ultimately, of course, it is not better documents but better decisions that count. NEPA's purpose is not to generate paperwork—even excellent paperwork—but to foster excellent action. The NEPA process is intended to help public officials make decisions that are based on understanding of environmental consequences, and take actions that protect, restore, and enhance the environment. These regulations provide the direction to achieve this purpose.
Federal agencies shall to the fullest extent possible:
(a) Interpret and administer the policies, regulations, and public laws of the United States in accordance with the policies set forth in the Act and in these regulations.
(b) Implement procedures to make the NEPA process more useful to decisionmakers and the public; to reduce paperwork and the accumulation of extraneous background data; and to emphasize real environmental issues and alternatives. Environmental impact statements shall be concise, clear, and to the point, and shall be supported by evidence that agencies have made the necessary environmental analyses.
(c) Integrate the requirements of NEPA with other planning and environmental review procedures required by law or by agency practice so that all such procedures run concurrently rather than consecutively.
(d) Encourage and facilitate public involvement in decisions which affect the quality of the human environment.
(e) Use the NEPA process to identify and assess the reasonable alternatives to proposed actions that will avoid or minimize adverse effects of these actions upon the quality of the human environment.
(f) Use all practicable means, consistent with the requirements of the Act and other essential considerations of national policy, to restore and enhance the quality of the human environment and avoid or minimize any possible adverse effects of their actions upon the quality of the human environment.
Parts 1500 through 1508 of this title provide regulations applicable to and binding on all Federal agencies for implementing the procedural provisions of the National Environmental Policy Act of 1969, as amended (Pub. L. 91-190, 42 U.S.C. 4321
Agencies shall reduce excessive paperwork by:
(a) Reducing the length of environmental impact statements (§ 1502.2(c)), by means such as setting appropriate page limits (§§ 1501.7(b)(1) and 1502.7).
(b) Preparing analytic rather than encyclopedic environmental impact statements (§ 1502.2(a)).
(c) Discussing only briefly issues other than significant ones (§ 1502.2(b)).
(d) Writing environmental impact statements in plain language (§ 1502.8).
(e) Following a clear format for -environmental impact statements (§ 1502.10).
(f) Emphasizing the portions of the environmental impact statement that are useful to decisionmakers and the public (§§ 1502.14 and 1502.15) and reducing emphasis on background material (§ 1502.16).
(g) Using the scoping process, not only to identify significant environmental issues deserving of study, but also to deemphasize insignificant issues, narrowing the scope of the environmental impact statement process accordingly (§ 1501.7).
(h) Summarizing the environmental impact statement (§ 1502.12) and circulating the summary instead of the entire environmental impact statement if the latter is unusually long (§ 1502.19).
(i) Using program, policy, or plan environmental impact statements and tiering from statements of broad scope to those of narrower scope, to eliminate repetitive discussions of the same issues (§§ 1502.4 and 1502.20).
(j) Incorporating by reference (§ 1502.21).
(k) Integrating NEPA requirements with other environmental review and consultation requirements (§ 1502.25).
(l) Requiring comments to be as specific as possible (§ 1503.3).
(m) Attaching and circulating only changes to the draft environmental impact statement, rather than rewriting and circulating the entire statement when changes are minor (§ 1503.4(c)).
(n) Eliminating duplication with State and local procedures, by providing for joint preparation (§ 1506.2), and with other Federal procedures, by providing that an agency may adopt appropriate environmental documents prepared by another agency (§ 1506.3).
(o) Combining environmental documents with other documents (§ 1506.4).
(p) Using categorical exclusions to define categories of actions which do not individually or cumulatively have a significant effect on the human environment and which are therefore -exempt from requirements to prepare -an environmental impact statement (§ 1508.4).
(q) Using a finding of no significant impact when an action not otherwise excluded will not have a significant effect on the human environment and is therefore exempt from requirements to prepare an environmental impact statement (§ 1508.13).
Agencies shall reduce delay by:
(a) Integrating the NEPA process into early planning (§ 1501.2).
(b) Emphasizing interagency cooperation before the environmental impact statement is prepared, rather than submission of adversary comments on a completed document (§ 1501.6).
(c) Insuring the swift and fair resolution of lead agency disputes (§ 1501.5).
(d) Using the scoping process for an early identification of what are and what are not the real issues (§ 1501.7).
(e) Establishing appropriate time limits for the environmental impact statement process (§§ 1501.7(b)(2) and 1501.8).
(f) Preparing environmental impact statements early in the process (§ 1502.5).
(g) Integrating NEPA requirements with other environmental review and consultation requirements (§ 1502.25).
(h) Eliminating duplication with State and local procedures by providing for joint preparation (§ 1506.2) and with other Federal procedures by providing that an agency may adopt appropriate environmental documents prepared by another agency (§ 1506.3).
(i) Combining environmental documents with other documents (§ 1506.4).
(j) Using accelerated procedures for proposals for legislation (§ 1506.8).
(k) Using categorical exclusions to define categories of actions which do not individually or cumulatively have a significant effect on the human environment (§ 1508.4) and which are therefore exempt from requirements to prepare an environmental impact statement.
(l) Using a finding of no significant impact when an action not otherwise excluded will not have a significant effect on the human environment (§ 1508.13) and is therefore exempt from requirements to prepare an environmental impact statement.
Each agency shall interpret the provisions of the Act as a supplement to its existing authority and as a mandate to view traditional policies and missions in the light of the Act's national environmental objectives. Agencies shall review their policies, procedures, and regulations accordingly and revise them as necessary to insure full compliance with the purposes and provisions of the Act. The phrase “to the fullest extent possible” in section 102 means that each agency of the Federal Government shall comply with that section unless existing law applicable to the agency's operations expressly prohibits or makes compliance impossible.
NEPA, the Environmental Quality Improvement Act of 1970, as amended (42 U.S.C. 4371
The purposes of this part include:
(a) Integrating the NEPA process into early planning to insure appropriate consideration of NEPA's policies and to eliminate delay.
(b) Emphasizing cooperative consultation among agencies before the environmental impact statement is prepared rather than submission of adversary comments on a completed document.
(c) Providing for the swift and fair resolution of lead agency disputes.
(d) Identifying at an early stage the significant environmental issues deserving of study and deemphasizing insignificant issues, narrowing the scope of the environmental impact statement accordingly.
(e) Providing a mechanism for putting appropriate time limits on the environmental impact statement process.
Agencies shall integrate the NEPA process with other planning at the earliest possible time to insure that planning and decisions reflect environmental values, to avoid delays later in the process, and to head off potential conflicts. Each agency shall:
(a) Comply with the mandate of section 102(2)(A) to “utilize a systematic, interdisciplinary approach which will insure the integrated use of the natural and social sciences and the environmental design arts in planning and in decisionmaking which may have an impact on man's environment,” as specified by § 1507.2.
(b) Identify environmental effects and values in adequate detail so they can be compared to economic and technical analyses. Environmental documents and appropriate analyses shall be circulated and reviewed at the same time as other planning documents.
(c) Study, develop, and describe appropriate alternatives to recommended courses of action in any proposal which involves unresolved conflicts concerning alternative uses of available resources as provided by section 102(2)(E) of the Act.
(d) Provide for cases where actions are planned by private applicants or other non-Federal entities before Federal involvement so that:
(1) Policies or designated staff are available to advise potential applicants of studies or other information foreseeably required for later Federal action.
(2) The Federal agency consults early with appropriate State and local agencies and Indian tribes and with interested private persons and organizations when its own involvement is reasonably foreseeable.
(3) The Federal agency commences its NEPA process at the earliest possible time.
(a) Agencies shall prepare an environmental assessment (§ 1508.9) when necessary under the procedures adopted by individual agencies to supplement these regulations as described in § 1507.3. An assessment is not necessary if the agency has decided to prepare an environmental impact statement.
(b) Agencies may prepare an environmental assessment on any action at any time in order to assist agency planning and decisionmaking.
In determining whether to prepare an environmental impact statement the Federal agency shall:
(a) Determine under its procedures supplementing these regulations (described in § 1507.3) whether the proposal is one which:
(1) Normally requires an environmental impact statement, or
(2) Normally does not require either an environmental impact statement or an environmental assessment (categorical exclusion).
(b) If the proposed action is not covered by paragraph (a) of this section, prepare an environmental assessment (§ 1508.9). The agency shall involve environmental agencies, applicants, and the public, to the extent practicable, in preparing assessments required by § 1508.9(a)(1).
(c) Based on the environmental assessment make its determination whether to prepare an environmental impact statement.
(d) Commence the scoping process (§ 1501.7), if the agency will prepare an environmental impact statement.
(e) Prepare a finding of no significant impact (§ 1508.13), if the agency determines on the basis of the environmental assessment not to prepare a statement.
(1) The agency shall make the finding of no significant impact available to the affected public as specified in § 1506.6.
(2) In certain limited circumstances, which the agency may cover in its procedures under § 1507.3, the agency shall make the finding of no significant impact available for public review (including State and areawide clearinghouses) for 30 days before the agency makes its final determination whether to prepare an environmental impact statement and before the action may begin. The circumstances are:
(i) The proposed action is, or is closely similar to, one which normally requires the preparation of an environmental impact statement under the procedures adopted by the agency pursuant to § 1507.3, or
(ii) The nature of the proposed action is one without precedent.
(a) A lead agency shall supervise the preparation of an environmental impact statement if more than one Federal agency either:
(1) Proposes or is involved in the same action; or
(2) Is involved in a group of actions directly related to each other because of their functional interdependence or geographical proximity.
(b) Federal, State, or local agencies, including at least one Federal agency, may act as joint lead agencies to prepare an environmental impact statement (§ 1506.2).
(c) If an action falls within the provisions of paragraph (a) of this section the potential lead agencies shall determine by letter or memorandum which agency shall be the lead agency and which shall be cooperating agencies. The agencies shall resolve the lead agency question so as not to cause delay. If there is disagreement among the agencies, the following factors (which are listed in order of descending importance) shall determine lead agency designation:
(1) Magnitude of agency's involvement.
(2) Project approval/disapproval authority.
(3) Expertise concerning the action's environmental effects.
(4) Duration of agency's involvement.
(5) Sequence of agency's involvement.
(d) Any Federal agency, or any State or local agency or private person substantially affected by the absence of lead agency designation, may make a written request to the potential lead agencies that a lead agency be designated.
(e) If Federal agencies are unable to agree on which agency will be the lead agency or if the procedure described in paragraph (c) of this section has not resulted within 45 days in a lead agency designation, any of the agencies or persons concerned may file a request with the Council asking it to determine which Federal agency shall be the lead agency.
(1) A precise description of the nature and extent of the proposed action.
(2) A detailed statement of why each potential lead agency should or should not be the lead agency under the criteria specified in paragraph (c) of this section.
(f) A response may be filed by any potential lead agency concerned within 20 days after a request is filed with the Council. The Council shall determine as soon as possible but not later than 20 days after receiving the request and all responses to it which Federal agency shall be the lead agency and which other Federal agencies shall be cooperating agencies.
The purpose of this section is to emphasize agency cooperation early in the NEPA process. Upon request of the lead agency, any other Federal agency which has jurisdiction by law shall be a cooperating agency. In addition any other Federal agency which has special expertise with respect to any environmental issue, which should be addressed in the statement may be a cooperating agency upon request of the lead agency. An agency may request the lead agency to designate it a cooperating agency.
(a) The lead agency shall:
(1) Request the participation of each cooperating agency in the NEPA process at the earliest possible time.
(2) Use the environmental analysis and proposals of cooperating agencies with jurisdiction by law or special expertise, to the maximum extent possible consistent with its responsibility as lead agency.
(3) Meet with a cooperating agency at the latter's request.
(b) Each cooperating agency shall:
(1) Participate in the NEPA process at the earliest possible time.
(2) Participate in the scoping process (described below in § 1501.7).
(3) Assume on request of the lead agency responsibility for developing information and preparing environmental analyses including portions of the environmental impact statement concerning which the cooperating agency has special expertise.
(4) Make available staff support at the lead agency's request to enhance the latter's interdisciplinary capability.
(5) Normally use its own funds. The lead agency shall, to the extent available funds permit, fund those major activities or analyses it requests from cooperating agencies. Potential lead agencies shall include such funding requirements in their budget requests.
(c) A cooperating agency may in response to a lead agency's request for assistance in preparing the environmental impact statement (described in paragraph (b)(3), (4), or (5) of this section) reply that other program commitments preclude any involvement or the degree of involvement requested in the action that is the subject of the environmental impact statement. A copy of this reply shall be submitted to the Council.
There shall be an early and open process for determining the scope of issues to be addressed and for identifying the significant issues related to a proposed action. This process shall be termed scoping. As soon as practicable after its decision to prepare an environmental impact statement and before the scoping process the lead agency shall publish a notice of intent (§ 1508.22) in the
(a) As part of the scoping process the lead agency shall:
(1) Invite the participation of affected Federal, State, and local agencies, any affected Indian tribe, the proponent of the action, and other interested persons (including those who might not be in accord with the action on environmental grounds), unless there is a limited exception under § 1507.3(c). An agency may give notice in accordance with § 1506.6.
(2) Determine the scope (§ 1508.25) and the significant issues to be analyzed in depth in the environmental impact statement.
(3) Identify and eliminate from detailed study the issues which are not significant or which have been covered by prior environmental review (§ 1506.3), narrowing the discussion of these issues in the statement to a brief presentation of why they will not have a significant effect on the human environment or providing a reference to their coverage elsewhere.
(4) Allocate assignments for preparation of the environmental impact statement among the lead and cooperating agencies, with the lead agency retaining responsibility for the statement.
(5) Indicate any public environmental assessments and other environmental impact statements which are being or will be prepared that are related to but are not part of the scope of the impact statement under consideration.
(6) Identify other environmental review and consultation requirements so the lead and cooperating agencies may prepare other required analyses and studies concurrently with, and integrated with, the environmental impact statement as provided in § 1502.25.
(7) Indicate the relationship between the timing of the preparation of environmental analyses and the agency's tentative planning and decisionmaking schedule.
(b) As part of the scoping process the lead agency may:
(1) Set page limits on environmental documents (§ 1502.7).
(2) Set time limits (§ 1501.8).
(3) Adopt procedures under § 1507.3 to combine its environmental assessment process with its scoping process.
(4) Hold an early scoping meeting or meetings which may be integrated with any other early planning meeting the agency has. Such a scoping meeting will often be appropriate when the impacts of a particular action are confined to specific sites.
(c) An agency shall revise the determinations made under paragraphs (a) and (b) of this section if substantial changes are made later in the proposed
Although the Council has decided that prescribed universal time limits for the entire NEPA process are too inflexible, Federal agencies are encouraged to set time limits appropriate to individual actions (consistent with the time intervals required by § 1506.10). When multiple agencies are involved the reference to agency below means lead agency.
(a) The agency shall set time limits if an applicant for the proposed action requests them:
(b) The agency may:
(1) Consider the following factors in determining time limits:
(i) Potential for environmental harm.
(ii) Size of the proposed action.
(iii) State of the art of analytic techniques.
(iv) Degree of public need for the proposed action, including the consequences of delay.
(v) Number of persons and agencies affected.
(vi) Degree to which relevant information is known and if not known the time required for obtaining it.
(vii) Degree to which the action is controversial.
(viii) Other time limits imposed on the agency by law, regulations, or executive order.
(2) Set overall time limits or limits for each constituent part of the NEPA process, which may include:
(i) Decision on whether to prepare an environmental impact statement (if not already decided).
(ii) Determination of the scope of the environmental impact statement.
(iii) Preparation of the draft environmental impact statement.
(iv) Review of any comments on the draft environmental impact statement from the public and agencies.
(v) Preparation of the final environmental impact statement.
(vi) Review of any comments on the final environmental impact statement.
(vii) Decision on the action based in part on the environmental impact statement.
(3) Designate a person (such as the project manager or a person in the agency's office with NEPA responsibilities) to expedite the NEPA process.
(c) State or local agencies or members of the public may request a Federal Agency to set time limits.
NEPA, the Environmental Quality Improvement Act of 1970, as amended (42 U.S.C. 4371
The primary purpose of an environmental impact statement is to serve as an action-forcing device to insure that the policies and goals defined in -the
To achieve the purposes set forth in § 1502.1 agencies shall prepare environmental impact statements in the following manner:
(a) Environmental impact statements shall be analytic rather than encyclopedic.
(b) Impacts shall be discussed in proportion to their significance. There shall be only brief discussion of other than significant issues. As in a finding of no significant impact, there should be only enough discussion to show why more study is not warranted.
(c) Environmental impact statements shall be kept concise and shall be no longer than absolutely necessary to comply with NEPA and with these regulations. Length should vary first with potential environmental problems and then with project size.
(d) Environmental impact statements shall state how alternatives considered in it and decisions based on it will or will not achieve the requirements of sections 101 and 102(1) of the Act and other environmental laws and policies.
(e) The range of alternatives discussed in environmental impact statements shall encompass those to be considered by the ultimate agency decisionmaker.
(f) Agencies shall not commit resources prejudicing selection of alternatives before making a final decision (§ 1506.1).
(g) Environmental impact statements shall serve as the means of assessing the environmental impact of proposed agency actions, rather than justifying decisions already made.
As required by sec. 102(2)(C) of NEPA environmental impact statements (§ 1508.11) are to be included in every recommendation or report.
On proposals (§ 1508.23).
For legislation and (§ 1508.17).
Other major Federal actions (§ 1508.18).
Significantly (§ 1508.27).
Affecting (§§ 1508.3, 1508.8).
The quality of the human environment (§ 1508.14).
(a) Agencies shall make sure the proposal which is the subject of an environmental impact statement is properly defined. Agencies shall use the criteria for scope (§ 1508.25) to determine which proposal(s) shall be the subject of a particular statement. Proposals or parts of proposals which are related to each other closely enough to be, in effect, a single course of action shall be evaluated in a single impact statement.
(b) Environmental impact statements may be prepared, and are sometimes required, for broad Federal actions such as the adoption of new agency programs or regulations (§ 1508.18). Agencies shall prepare statements on broad actions so that they are relevant to policy and are timed to coincide with meaningful points in agency planning and decisionmaking.
(c) When preparing statements on broad actions (including proposals by more than one agency), agencies may find it useful to evaluate the proposal(s) in one of the following ways:
(1) Geographically, including actions occurring in the same general location, such as body of water, region, or metropolitan area.
(2) Generically, including actions which have relevant similarities, such
(3) By stage of technological development including federal or federally assisted research, development or demonstration programs for new technologies which, if applied, could significantly affect the quality of the human environment. Statements shall be prepared on such programs and shall be available before the program has reached a stage of investment or commitment to implementation likely to determine subsequent development or restrict later alternatives.
(d) Agencies shall as appropriate employ scoping (§ 1501.7), tiering (§ 1502.20), and other methods listed in §§ 1500.4 and 1500.5 to relate broad and narrow actions and to avoid duplication and delay.
An agency shall commence preparation of an environmental impact statement as close as possible to the time the agency is developing or is presented with a proposal (§ 1508.23) so that preparation can be completed in time for the final statement to be included in any recommendation or report on the proposal. The statement shall be prepared early enough so that it can serve practically as an important contribution to the decisionmaking process and will not be used to rationalize or justify decisions already made (§§ 1500.2(c), 1501.2, and 1502.2). For instance:
(a) For projects directly undertaken by Federal agencies the environmental impact statement shall be prepared at the feasibility analysis (go-no go) stage and may be supplemented at a later stage if necessary.
(b) For applications to the agency appropriate environmental assessments or statements shall be commenced no later than immediately after the application is received. Federal agencies are encouraged to begin preparation of such assessments or statements earlier, preferably jointly with applicable State or local agencies.
(c) For adjudication, the final environmental impact statement shall normally precede the final staff recommendation and that portion of the public hearing related to the impact study. In appropriate circumstances the statement may follow preliminary hearings designed to gather information for use in the statements.
(d) For informal rulemaking the draft environmental impact statement shall normally accompany the proposed rule.
Environmental impact statements shall be prepared using an inter-disciplinary approach which will insure the integrated use of the natural and social sciences and the environmental design arts (section 102(2)(A) of the Act). The disciplines of the preparers shall be appropriate to the scope and issues identified in the scoping process (§ 1501.7).
The text of final environmental impact statements (e.g., paragraphs (d) through (g) of § 1502.10) shall normally be less than 150 pages and for proposals of unusual scope or complexity shall normally be less than 300 pages.
Environmental impact statements shall be written in plain language and may use appropriate graphics so that decisionmakers and the public can readily understand them. Agencies should employ writers of clear prose or editors to write, review, or edit statements, which will be based upon the analysis and supporting data from the natural and social sciences and the environmental design arts.
Except for proposals for legislation as provided in § 1506.8 environmental impact statements shall be prepared in two stages and may be supplemented.
(a) Draft environmental impact statements shall be prepared in accordance with the scope decided upon in the scoping process. The lead agency shall work with the cooperating agencies and shall obtain comments as required in part 1503 of this chapter. The draft statement must fulfill and satisfy to the fullest extent possible the requirements established for final statements
(b) Final environmental impact statements shall respond to comments as required in part 1503 of this chapter. The agency shall discuss at appropriate points in the final statement any responsible opposing view which was not adequately discussed in the draft statement and shall indicate the agency's response to the issues raised.
(c) Agencies:
(1) Shall prepare supplements to either draft or final environmental impact statements if:
(i) The agency makes substantial changes in the proposed action that are relevant to environmental concerns; or
(ii) There are significant new circumstances or information relevant to environmental concerns and bearing on the proposed action or its impacts.
(2) May also prepare supplements when the agency determines that the purposes of the Act will be furthered by doing so.
(3) Shall adopt procedures for introducing a supplement into its formal administrative record, if such a record exists.
(4) Shall prepare, circulate, and file a supplement to a statement in the same fashion (exclusive of scoping) as a draft and final statement unless alternative procedures are approved by the Council.
Agencies shall use a format for environmental impact statements which will encourage good analysis and clear presentation of the alternatives including the proposed action. The following standard format for environmental impact statements should be followed unless the agency determines that there is a compelling reason to do otherwise:
(a) Cover sheet.
(b) Summary.
(c) Table of contents.
(d) Purpose of and need for action.
(e) Alternatives including proposed action (sections 102(2)(C)(iii) and 102(2)(E) of the Act).
(f) Affected environment.
(g) Environmental consequences (especially sections 102(2)(C)(i), (ii), (iv), and (v) of the Act).
(h) List of preparers.
(i) List of Agencies, Organizations, and persons to whom copies of the statement are sent.
(j) Index.
(k) Appendices (if any).
The cover sheet shall not exceed one page. It shall include:
(a) A list of the responsible agencies including the lead agency and any cooperating agencies.
(b) The title of the proposed action that is the subject of the statement (and if appropriate the titles of related cooperating agency actions), together with the State(s) and county(ies) (or other jurisdiction if applicable) where the action is located.
(c) The name, address, and telephone number of the person at the agency who can supply further information.
(d) A designation of the statement as a draft, final, or draft or final supplement.
(e) A one paragraph abstract of the statement.
(f) The date by which comments must be received (computed in cooperation with EPA under § 1506.10).
Each environmental impact statement shall contain a summary which adequately and accurately summarizes the statement. The summary shall stress the major conclusions, areas of controversy (including issues raised by agencies and the public), and the issues to be resolved (including the choice
The statement shall briefly specify the underlying purpose and need to which the agency is responding in proposing the alternatives including the proposed action.
This section is the heart of the environmental impact statement. Based on the information and analysis presented in the sections on the Affected Environment (§ 1502.15) and the Environmental Consequences (§ 1502.16), it should present the environmental impacts of the proposal and the alternatives in comparative form, thus sharply defining the issues and providing a clear basis for choice among options by the decisionmaker and the public. In this section agencies shall:
(a) Rigorously explore and objectively evaluate all reasonable alternatives, and for alternatives which were eliminated from detailed study, briefly discuss the reasons for their having been eliminated.
(b) Devote substantial treatment to each alternative considered in detail including the proposed action so that reviewers may evaluate their comparative merits.
(c) Include reasonable alternatives not within the jurisdiction of the lead agency.
(d) Include the alternative of no action.
(e) Identify the agency's preferred alternative or alternatives, if one or more exists, in the draft statement and identify such alternative in the final statement unless another law prohibits the expression of such a preference.
(f) Include appropriate mitigation measures not already included in the proposed action or alternatives.
The environmental impact statement shall succinctly describe the environment of the area(s) to be affected or created by the alternatives under consideration. The descriptions shall be no longer than is necessary to understand the effects of the alternatives. Data and analyses in a statement shall be commensurate with the importance of the impact, with less important material summarized, consolidated, or simply referenced. Agencies shall avoid useless bulk in statements and shall concentrate effort and attention on important issues. Verbose descriptions of the affected environment are themselves no measure of the adequacy of an environmental impact statement.
This section forms the scientific and analytic basis for the comparisons under § 1502.14. It shall consolidate the discussions of those elements required by sections 102(2)(C)(i), (ii), (iv), and (v) of NEPA which are within the scope of the statement and as much of section 102(2)(C)(iii) as is necessary to support the comparisons. The discussion will include the environmental impacts of the alternatives including the proposed action, any adverse environmental effects which cannot be avoided should the proposal be implemented, the relationship between short-term uses of man's environment and the maintenance and enhancement of long-term productivity, and any irreversible or irretrievable commitments of resources which would be involved in the proposal should it be implemented. This section should not duplicate discussions in § 1502.14. It shall include discussions of:
(a) Direct effects and their significance (§ 1508.8).
(b) Indirect effects and their significance (§ 1508.8).
(c) Possible conflicts between the proposed action and the objectives of Federal, regional, State, and local (and in the case of a reservation, Indian tribe) land use plans, policies and controls for the area concerned. (See § 1506.2(d).)
(d) The environmental effects of alternatives including the proposed action. The comparisons under § 1502.14 will be based on this discussion.
(e) Energy requirements and conservation potential of various alternatives and mitigation measures.
(f) Natural or depletable resource requirements and conservation potential of various alternatives and mitigation measures.
(g) Urban quality, historic and cultural resources, and the design of the built environment, including the reuse and conservation potential of various alternatives and mitigation measures.
(h) Means to mitigate adverse environmental impacts (if not fully covered under § 1502.14(f)).
The environmental impact statement shall list the names, together with their qualifications (expertise, experience, professional disciplines), of the persons who were primarily responsible for preparing the environmental impact statement or significant background papers, including basic components of the statement (§§ 1502.6 and 1502.8). Where possible the persons who are responsible for a particular analysis, including analyses in background papers, shall be identified. Normally the list will not exceed two pages.
If an agency prepares an appendix to an environmental impact statement the appendix shall:
(a) Consist of material prepared in connection with an environmental impact statement (as distinct from material which is not so prepared and which is incorporated by reference (§ 1502.21)).
(b) Normally consist of material which substantiates any analysis fundamental to the impact statement.
(c) Normally be analytic and relevant to the decision to be made.
(d) Be circulated with the environmental impact statement or be readily available on request.
Agencies shall circulate the entire draft and final environmental impact statements except for certain appendices as provided in § 1502.18(d) and unchanged statements as provided in § 1503.4(c). However, if the statement is unusually long, the agency may circulate the summary instead, except that the entire statement shall be furnished to:
(a) Any Federal agency which has jurisdiction by law or special expertise with respect to any environmental impact involved and any appropriate Federal, State or local agency authorized to develop and enforce environmental standards.
(b) The applicant, if any.
(c) Any person, organization, or agency requesting the entire environmental impact statement.
(d) In the case of a final environmental impact statement any person, organization, or agency which submitted substantive comments on the draft.
Agencies are encouraged to tier their environmental impact statements to eliminate repetitive discussions of the same issues and to focus on the actual issues ripe for decision at each level of environmental review (§ 1508.28). Whenever a broad environmental impact statement has been prepared (such as a program or policy statement) and a subsequent statement or environmental assessment is then prepared on an action included within the entire program or policy (such as a site specific action) the subsequent statement or environmental assessment need only summarize the issues discussed in the broader statement and incorporate discussions from the broader statement by reference and shall concentrate on the issues specific to the subsequent action. The subsequent document shall state where the earlier document is available. Tiering may also be appropriate for different stages of actions. (Section 1508.28).
Agencies shall incorporate material into an environmental impact statement by reference when the effect will be to cut down on bulk without impeding agency and public review of the action. The incorporated material shall be cited in the statement and its content briefly described. No material
When an agency is evaluating reasonably foreseeable significant adverse effects on the human environment in an environmental impact statement and there is incomplete or unavailable information, the agency shall always make clear that such information is lacking.
(a) If the incomplete information relevant to reasonably foreseeable significant adverse impacts is essential to a reasoned choice among alternatives and the overall costs of obtaining it are not exorbitant, the agency shall include the information in the environmental impact statement.
(b) If the information relevant to reasonably foreseeable significant adverse impacts cannot be obtained because the overall costs of obtaining it are exorbitant or the means to obtain it are not known, the agency shall include within the environmental impact statement:
(1) A statement that such information is incomplete or unavailable; (2) a statement of the relevance of the incomplete or unavailable information to evaluating reasonably foreseeable significant adverse impacts on the human environment; (3) a summary of existing credible scientific evidence which is relevant to evaluating the reasonably foreseeable significant adverse impacts on the human environment, and (4) the agency's evaluation of such impacts based upon theoretical approaches or research methods generally accepted in the scientific community. For the purposes of this section, “reasonably foreseeable” includes impacts which have catastrophic consequences, even if their probability of occurrence is low, provided that the analysis of the impacts is supported by credible scientific evidence, is not based on pure conjecture, and is within the rule of reason.
(c) The amended regulation will be applicable to all environmental impact statements for which a Notice of Intent (40 CFR 1508.22) is published in the
If a cost-benefit analysis relevant to the choice among environmentally different alternatives is being considered for the proposed action, it shall be incorporated by reference or appended to the statement as an aid in evaluating the environmental consequences. To assess the adequacy of compliance with section 102(2)(B) of the Act the statement shall, when a cost-benefit analysis is prepared, discuss the relationship between that analysis and any analyses of unquantified environmental impacts, values, and amenities. For purposes of complying with the Act, the weighing of the merits and drawbacks of the various alternatives need not be displayed in a monetary cost-benefit analysis and should not be when there are important qualitative considerations. In any event, an environmental impact statement should at least indicate those considerations, including factors not related to environmental quality, which are likely to be relevant and important to a decision.
Agencies shall insure the professional integrity, including scientific integrity, of the discussions and analyses in environmental impact statements. They shall identify any methodologies used and shall make explicit reference by footnote to the scientific and other sources relied upon for conclusions in the statement. An agency may place discussion of methodology in an appendix.
(a) To the fullest extent possible, agencies shall prepare draft environmental impact statements concurrently with and integrated with environmental impact analyses and related surveys and studies required by the Fish and Wildlife Coordination Act (16 U.S.C. 661
(b) The draft environmental impact statement shall list all Federal permits, licenses, and other entitlements which must be obtained in implementing the proposal. If it is uncertain whether a Federal permit, license, or other entitlement is necessary, the draft environmental impact statement shall so indicate.
NEPA, the Environmental Quality Improvement Act of 1970, as amended (42 U.S.C. 4371
(a) After preparing a draft environmental impact statement and before preparing a final environmental impact statement the agency shall:
(1) Obtain the comments of any Federal agency which has jurisdiction by law or special expertise with respect to any environmental impact involved or which is authorized to develop and enforce environmental standards.
(2) Request the comments of:
(i) Appropriate State and local agencies which are authorized to develop and enforce environmental standards;
(ii) Indian tribes, when the effects may be on a reservation; and
(iii) Any agency which has requested that it receive statements on actions of the kind proposed.
(3) Request comments from the applicant, if any.
(4) Request comments from the public, affirmatively soliciting comments from those persons or organizations who may be interested or affected.
(b) An agency may request comments on a final environmental impact statement before the decision is finally made. In any case other agencies or persons may make comments before the final decision unless a different time is provided under § 1506.10.
Federal agencies with jurisdiction by law or special expertise with respect to any environmental impact involved and agencies which are authorized to develop and enforce environmental standards shall comment on statements within their jurisdiction, expertise, or authority. Agencies shall comment within the time period specified for comment in § 1506.10. A Federal agency may reply that it has no comment. If a cooperating agency is satisfied that its views are adequately reflected in the environmental impact statement, it should reply that it has no comment.
(a) Comments on an environmental impact statement or on a proposed action shall be as specific as possible and may address either the adequacy of the statement or the merits of the alternatives discussed or both.
(b) When a commenting agency criticizes a lead agency's predictive methodology, the commenting agency should describe the alternative methodology which it prefers and why.
(c) A cooperating agency shall specify in its comments whether it needs additional information to fulfill other applicable environmental reviews or consultation requirements and what information it needs. In particular, it shall specify any additional information it needs to comment adequately on the draft statement's analysis of significant site-specific effects associated with the granting or approving by that cooperating agency of necessary Federal permits, licenses, or entitlements.
(d) When a cooperating agency with jurisdiction by law objects to or expresses reservations about the proposal on grounds of environmental impacts, the agency expressing the objection or reservation shall specify the mitigation measures it considers necessary to allow the agency to grant or approve applicable permit, license, or related requirements or concurrences.
(a) An agency preparing a final environmental impact statement shall assess and consider comments both individually and collectively, and shall respond by one or more of the means listed below, stating its response in the final statement. Possible responses are to:
(1) Modify alternatives including the proposed action.
(2) Develop and evaluate alternatives not previously given serious consideration by the agency.
(3) Supplement, improve, or modify its analyses.
(4) Make factual corrections.
(5) Explain why the comments do not warrant further agency response, citing the sources, authorities, or reasons which support the agency's position and, if appropriate, indicate those circumstances which would trigger agency reappraisal or further response.
(b) All substantive comments received on the draft statement (or summaries thereof where the response has been exceptionally voluminous), should be attached to the final statement whether or not the comment is thought to merit individual discussion by the agency in the text of the statement.
(c) If changes in response to comments are minor and are confined to the responses described in paragraphs (a)(4) and (5) of this section, agencies may write them on errata sheets and attach them to the statement instead of rewriting the draft statement. In such cases only the comments, the responses, and the changes and not the final statement need be circulated (§ 1502.19). The entire document with a new cover sheet shall be filed as the final statement (§ 1506.9).
NEPA, the Environmental Quality Improvement Act of 1970, as amended (42 U.S.C. 4371
(a) This part establishes procedures for referring to the Council Federal interagency disagreements concerning proposed major Federal actions that might cause unsatisfactory environmental effects. It provides means for early resolution of such disagreements.
(b) Under section 309 of the Clean Air Act (42 U.S.C. 7609), the Administrator of the Environmental Protection Agency is directed to review and comment publicly on the environmental impacts of Federal activities, including actions for which environmental impact statements are prepared. If after this review the Administrator determines that the matter is “unsatisfactory from the standpoint of public health or welfare or environmental quality,” section 309 directs that the matter be referred to the Council (hereafter “environmental referrals”).
(c) Under section 102(2)(C) of the Act other Federal agencies may make similar reviews of environmental impact statements, including judgments on the acceptability of anticipated environmental impacts. These reviews
Environmental referrals should be made to the Council only after concerted, timely (as early as possible in the process), but unsuccessful attempts to resolve differences with the lead agency. In determining what environmental objections to the matter are appropriate to refer to the Council, an agency should weigh potential adverse environmental impacts, considering:
(a) Possible violation of national environmental standards or policies.
(b) Severity.
(c) Geographical scope.
(d) Duration.
(e) Importance as precedents.
(f) Availability of environmentally preferable alternatives.
(a) A Federal agency making the referral to the Council shall:
(1) Advise the lead agency at the earliest possible time that it intends to refer a matter to the Council unless a satisfactory agreement is reached.
(2) Include such advice in the referring agency's comments on the draft environmental impact statement, except when the statement does not contain adequate information to permit an assessment of the matter's environmental acceptability.
(3) Identify any essential information that is lacking and request that it be made available at the earliest possible time.
(4) Send copies of such advice to the Council.
(b) The referring agency shall deliver its referral to the Council not later than twenty-five (25) days after the final environmental impact statement has been made available to the Environmental Protection Agency, commenting agencies, and the public. Except when an extension of this period has been granted by the lead agency, the Council will not accept a referral after that date.
(c) The referral shall consist of:
(1) A copy of the letter signed by the head of the referring agency and delivered to the lead agency informing the lead agency of the referral and the reasons for it, and requesting that no action be taken to implement the matter until the Council acts upon the referral. The letter shall include a copy of the statement referred to in (c)(2) of this section.
(2) A statement supported by factual evidence leading to the conclusion that the matter is unsatisfactory from the standpoint of public health or welfare or environmental quality. The statement shall:
(i) Identify any material facts in controversy and incorporate (by reference if appropriate) agreed upon facts,
(ii) Identify any existing environmental requirements or policies which would be violated by the matter,
(iii) Present the reasons why the referring agency believes the matter is environmentally unsatisfactory,
(iv) Contain a finding by the agency whether the issue raised is of national importance because of the threat to national environmental resources or policies or for some other reason,
(v) Review the steps taken by the referring agency to bring its concerns to the attention of the lead agency at the earliest possible time, and
(vi) Give the referring agency's recommendations as to what mitigation alternative, further study, or other course of action (including abandonment of the matter) are necessary to remedy the situation.
(d) Not later than twenty-five (25) days after the referral to the Council the lead agency may deliver a response to the Council, and the referring agency. If the lead agency requests more time and gives assurance that the matter will not go forward in the interim, the Council may grant an extension. The response shall:
(1) Address fully the issues raised in the referral.
(2) Be supported by evidence.
(3) Give the lead agency's response to the referring agency's recommendations.
(e) Interested persons (including the applicant) may deliver their views in writing to the Council. Views in support of the referral should be delivered
(f) Not later than twenty-five (25) days after receipt of both the referral and any response or upon being informed that there will be no response (unless the lead agency agrees to a longer time), the Council may take one or more of the following actions:
(1) Conclude that the process of referral and response has successfully resolved the problem.
(2) Initiate discussions with the agencies with the objective of mediation with referring and lead agencies.
(3) Hold public meetings or hearings to obtain additional views and information.
(4) Determine that the issue is not one of national importance and request the referring and lead agencies to pursue their decision process.
(5) Determine that the issue should be further negotiated by the referring and lead agencies and is not appropriate for Council consideration until one or more heads of agencies report to the Council that the agencies' disagreements are irreconcilable.
(6) Publish its findings and recommendations (including where appropriate a finding that the submitted evidence does not support the position of an agency).
(7) When appropriate, submit the referral and the response together with the Council's recommendation to the President for action.
(g) The Council shall take no longer than 60 days to complete the actions specified in paragraph (f)(2), (3), or (5) of this section.
(h) When the referral involves an action required by statute to be determined on the record after opportunity for agency hearing, the referral shall be conducted in a manner consistent with 5 U.S.C. 557(d) (Administrative Procedure Act).
NEPA, the Environmental Quality Improvement Act of 1970, as amended (42 U.S.C. 4371
Agencies shall adopt procedures (§ 1507.3) to ensure that decisions are made in accordance with the policies and purposes of the Act. Such procedures shall include but not be limited to:
(a) Implementing procedures under section 102(2) to achieve the requirements of sections 101 and 102(1).
(b) Designating the major decision points for the agency's principal programs likely to have a significant effect on the human environment and assuring that the NEPA process corresponds with them.
(c) Requiring that relevant environmental documents, comments, and responses be part of the record in formal rulemaking or adjudicatory proceedings.
(d) Requiring that relevant environmental documents, comments, and responses accompany the proposal through existing agency review processes so that agency officials use the statement in making decisions.
(e) Requiring that the alternatives considered by the decisionmaker are encompassed by the range of alternatives discussed in the relevant environmental documents and that the decisionmaker consider the alternatives described in the environmental impact statement. If another decision document accompanies the relevant environmental documents to the decisionmaker, agencies are encouraged to make available to the public before the decision is made any part of that document that relates to the comparison of alternatives.
At the time of its decision (§ 1506.10) or, if appropriate, its recommendation to Congress, each agency shall prepare a concise public record of decision. The record, which may be integrated into any other record prepared by the agency, including that required by OMB Circular A-95 (Revised), part I, sections 6(c) and (d), and part II, section 5(b)(4), shall:
(a) State what the decision was.
(b) Identify all alternatives considered by the agency in reaching its decision, specifying the alternative or alternatives which were considered to be environmentally preferable. An agency may discuss preferences among alternatives based on relevant factors including economic and technical considerations and agency statutory missions. An agency shall identify and discuss all such factors including any essential considerations of national policy which were balanced by the agency in making its decision and state how those considerations entered into its decision.
(c) State whether all practicable means to avoid or minimize environmental harm from the alternative selected have been adopted, and if not, why they were not. A monitoring and enforcement program shall be adopted and summarized where applicable for any mitigation.
Agencies may provide for monitoring to assure that their decisions are carried out and should do so in important cases. Mitigation (§ 1505.2(c)) and other conditions established in the environmental impact statement or during its review and committed as part of the decision shall be implemented by the lead agency or other appropriate consenting agency. The lead agency shall:
(a) Include appropriate conditions in grants, permits or other approvals.
(b) Condition funding of actions on mitigation.
(c) Upon request, inform cooperating or commenting agencies on progress in carrying out mitigation measures which they have proposed and which were adopted by the agency making the decision.
(d) Upon request, make available to the public the results of relevant monitoring.
NEPA, the Environmental Quality Improvement Act of 1970, as amended (42 U.S.C. 4371
(a) Until an agency issues a record of decision as provided in § 1505.2 (except as provided in paragraph (c) of this section), no action concerning the proposal shall be taken which would:
(1) Have an adverse environmental impact; or
(2) Limit the choice of reasonable alternatives.
(b) If any agency is considering an application from a non-Federal entity, and is aware that the applicant is about to take an action within the agency's jurisdiction that would meet either of the criteria in paragraph (a) of this section, then the agency shall promptly notify the applicant that the agency will take appropriate action to insure that the objectives and procedures of NEPA are achieved.
(c) While work on a required program environmental impact statement is in progress and the action is not covered by an existing program statement,
(1) Is justified independently of the program;
(2) Is itself accompanied by an adequate environmental impact statement; and
(3) Will not prejudice the ultimate decision on the program. Interim action prejudices the ultimate decision on the program when it tends to determine subsequent development or limit alternatives.
(d) This section does not preclude development by applicants of plans or designs or performance of other work necessary to support an application for Federal, State or local permits or assistance. Nothing in this section shall preclude Rural Electrification Administration approval of minimal expenditures not affecting the environment (
(a) Agencies authorized by law to cooperate with State agencies of statewide jurisdiction pursuant to section 102(2)(D) of the Act may do so.
(b) Agencies shall cooperate with State and local agencies to the fullest extent possible to reduce duplication between NEPA and State and local requirements, unless the agencies are specifically barred from doing so by some other law. Except for cases covered by paragraph (a) of this section, such cooperation shall to the fullest extent possible include:
(1) Joint planning processes.
(2) Joint environmental research and studies.
(3) Joint public hearings (except where otherwise provided by statute).
(4) Joint environmental assessments.
(c) Agencies shall cooperate with State and local agencies to the fullest extent possible to reduce duplication between NEPA and comparable State and local requirements, unless the agencies are specifically barred from doing so by some other law. Except for cases covered by paragraph (a) of this section, such cooperation shall to the fullest extent possible include joint environmental impact statements. In such cases one or more Federal agencies and one or more State or local agencies shall be joint lead agencies. Where State laws or local ordinances have environmental impact statement requirements in addition to but not in conflict with those in NEPA, Federal agencies shall cooperate in fulfilling these requirements as well as those of Federal laws so that one document will comply with all applicable laws.
(d) To better integrate environmental impact statements into State or local planning processes, statements shall discuss any inconsistency of a proposed action with any approved State or local plan and laws (whether or not federally sanctioned). Where an inconsistency exists, the statement should describe the extent to which the agency would reconcile its proposed action with the plan or law.
(a) An agency may adopt a Federal draft or final environmental impact statement or portion thereof provided that the statement or portion thereof meets the standards for an adequate statement under these regulations.
(b) If the actions covered by the original environmental impact statement and the proposed action are substantially the same, the agency adopting another agency's statement is not required to recirculate it except as a final statement. Otherwise the adopting agency shall treat the statement as a draft and recirculate it (except as provided in paragraph (c) of this section).
(c) A cooperating agency may adopt without recirculating the environmental impact statement of a lead agency when, after an independent review of the statement, the cooperating agency concludes that its comments and suggestions have been satisfied.
(d) When an agency adopts a statement which is not final within the agency that prepared it, or when the action it assesses is the subject of a referral under part 1504, or when the statement's adequacy is the subject of
Any environmental document in compliance with NEPA may be combined with any other agency document to reduce duplication and paperwork.
(a)
(b)
(c)
Agencies shall:
(a) Make diligent efforts to involve the public in preparing and implementing their NEPA procedures.
(b) Provide public notice of NEPA-related hearings, public meetings, and the availability of environmental documents so as to inform those persons and agencies who may be interested or affected.
(1) In all cases the agency shall mail notice to those who have requested it on an individual action.
(2) In the case of an action with effects of national concern notice shall include publication in the
(3) In the case of an action with effects primarily of local concern the notice may include:
(i) Notice to State and areawide clearinghouses pursuant to OMB Circular A-95 (Revised).
(ii) Notice to Indian tribes when effects may occur on reservations.
(iii) Following the affected State's public notice procedures for comparable actions.
(iv) Publication in local newspapers (in papers of general circulation rather than legal papers).
(v) Notice through other local media.
(vi) Notice to potentially interested community organizations including small business associations.
(vii) Publication in newsletters that may be expected to reach potentially interested persons.
(viii) Direct mailing to owners and occupants of nearby or affected property.
(ix) Posting of notice on and off site in the area where the action is to be located.
(c) Hold or sponsor public hearings or public meetings whenever appropriate or in accordance with statutory requirements applicable to the agency. Criteria shall include whether there is:
(1) Substantial environmental controversy concerning the proposed action or substantial interest in holding the hearing.
(2) A request for a hearing by another agency with jurisdiction over the action supported by reasons why a hearing will be helpful. If a draft environmental impact statement is to be considered at a public hearing, the agency should make the statement available to the public at least 15 days in advance (unless the purpose of the hearing is to provide information for the draft environmental impact statement).
(d) Solicit appropriate information from the public.
(e) Explain in its procedures where interested persons can get information or status reports on environmental impact statements and other elements of the NEPA process.
(f) Make environmental impact statements, the comments received, and any underlying documents available to the public pursuant to the provisions of the Freedom of Information Act (5 U.S.C. 552), without regard to the exclusion for interagency memoranda where such memoranda transmit comments of Federal agencies on the environmental impact of the proposed action. Materials to be made available to the public shall be provided to the public without charge to the extent practicable, or at a fee which is not more than the actual costs of reproducing copies required to be sent to other Federal agencies, including the Council.
The Council may provide further guidance concerning NEPA and its procedures including:
(a) A handbook which the Council may supplement from time to time, which shall in plain language provide guidance and instructions concerning the application of NEPA and these regulations.
(b) Publication of the Council's Memoranda to Heads of Agencies.
(c) In conjunction with the Environmental Protection Agency and the publication of the 102 Monitor, notice of:
(1) Research activities;
(2) Meetings and conferences related to NEPA; and
(3) Successful and innovative procedures used by agencies to implement NEPA.
(a) The NEPA process for proposals for legislation (§ 1508.17) significantly affecting the quality of the human environment shall be integrated with the legislative process of the Congress. A legislative environmental impact statement is the detailed statement required by law to be included in a recommendation or report on a legislative proposal to Congress. A legislative environmental impact statement shall be considered part of the formal transmittal of a legislative proposal to Congress; however, it may be transmitted to Congress up to 30 days later in order to allow time for completion of an accurate statement which can serve as the basis for public and Congressional debate. The statement must be available in time for Congressional hearings and deliberations.
(b) Preparation of a legislative environmental impact statement shall conform to the requirements of these regulations except as follows:
(1) There need not be a scoping process.
(2) The legislative statement shall be prepared in the same manner as a draft statement, but shall be considered the “detailed statement” required by statute;
(i) A Congressional Committee with jurisdiction over the proposal has a
(ii) The proposal results from a study process required by statute (such as those required by the Wild and Scenic Rivers Act (16 U.S.C. 1271
(iii) Legislative approval is sought for Federal or federally assisted construction or other projects which the agency recommends be located at specific geographic locations. For proposals requiring an environmental impact statement for the acquisition of space by the General Services Administration, a draft statement shall accompany the Prospectus or the 11(b) Report of Building Project Surveys to the Congress, and a final statement shall be completed before site acquisition.
(iv) The agency decides to prepare draft and final statements.
(c) Comments on the legislative statement shall be given to the lead agency which shall forward them along with its own responses to the Congressional committees with jurisdiction.
Environmental impact statements together with comments and responses shall be filed with the Environmental Protection Agency, attention Office of Federal Activities (A-104),1200 Pennsylvania Ave., NW., Washington, DC 20460. Statements shall be filed with EPA no earlier than they are also transmitted to commenting agencies and made available to the public. EPA shall deliver one copy of each statement to the Council, which shall satisfy the requirement of availability to the President. EPA may issue guidelines to agencies to implement its responsibilities under this section and § 1506.10.
(a) The Environmental Protection Agency shall publish a notice in the
(b) No decision on the proposed action shall be made or recorded under § 1505.2 by a Federal agency until the later of the following dates:
(1) Ninety (90) days after publication of the notice described above in paragraph (a) of this section for a draft environmental impact statement.
(2) Thirty (30) days after publication of the notice described above in paragraph (a) of this section for a final environmental impact statement.
(c) If the final environmental impact statement is filed within ninety (90) days after a draft environmental impact statement is filed with the Environmental Protection Agency, the minimum thirty (30) day period and the minimum ninety (90) day period may run concurrently. However, subject to paragraph (d) of this section agencies shall allow not less than 45 days for comments on draft statements.
(d) The lead agency may extend prescribed periods. The Environmental Protection Agency may upon a showing by the lead agency of compelling reasons of national policy reduce the prescribed periods and may upon a
Where emergency circumstances make it necessary to take an action with significant environmental impact without observing the provisions of these regulations, the Federal agency taking the action should consult with the Council about alternative arrangements. Agencies and the Council will limit such arrangements to actions necessary to control the immediate impacts of the emergency. Other actions remain subject to NEPA review.
The effective date of these regulations is July 30, 1979, except that for agencies that administer programs that qualify under section 102(2)(D) of the Act or under section 104(h) of the Housing and Community Development Act of 1974 an additional four months shall be allowed for the State or local agencies to adopt their implementing procedures.
(a) These regulations shall apply to the fullest extent practicable to ongoing activities and environmental documents begun before the effective date. These regulations do not apply to an environmental impact statement or supplement if the draft statement was filed before the effective date of these regulations. No completed environmental documents need be redone by reasons of these regulations. Until these regulations are applicable, the Council's guidelines published in the
(b) NEPA shall continue to be applicable to actions begun before January 1, 1970, to the fullest extent possible.
NEPA, the Environmental Quality Improvement Act of 1970, as amended (42 U.S.C. 4371
All agencies of the Federal Government shall comply with these regulations. It is the intent of these regulations to allow each agency flexibility in adapting its implementing procedures authorized by § 1507.3 to the requirements of other applicable laws.
Each agency shall be capable (in terms of personnel and other resources) of complying with the requirements enumerated below. Such compliance may include use of other's resources, but the using agency shall itself have sufficient capability to evaluate what others do for it. Agencies shall:
(a) Fulfill the requirements of section 102(2)(A) of the Act to utilize a systematic, interdisciplinary approach which will insure the integrated use of the natural and social sciences and the environmental design arts in planning and in decisionmaking which may have an impact on the human environment. Agencies shall designate a person to be responsible for overall review of agency NEPA compliance.
(b) Identify methods and procedures required by section 102(2)(B) to insure that presently unquantified environmental amenities and values may be given appropriate consideration.
(c) Prepare adequate environmental impact statements pursuant to section 102(2)(C) and comment on statements
(d) Study, develop, and describe alternatives to recommended courses of action in any proposal which involves unresolved conflicts concerning alternative uses of available resources. This requirement of section 102(2)(E) extends to all such proposals, not just the more limited scope of section 102(2)(C)(iii) where the discussion of alternatives is confined to impact statements.
(e) Comply with the requirements of section 102(2)(H) that the agency initiate and utilize ecological information in the planning and development of resource-oriented projects.
(f) Fulfill the requirements of sections 102(2)(F), 102(2)(G), and 102(2)(I), of the Act and of Executive Order 11514, Protection and Enhancement of Environmental Quality, Sec. 2.
(a) Not later than eight months after publication of these regulations as finally adopted in the
(b) Agency procedures shall comply with these regulations except where compliance would be inconsistent with statutory requirements and shall include:
(1) Those procedures required by §§ 1501.2(d), 1502.9(c)(3), 1505.1, 1506.6(e), and 1508.4.
(2) Specific criteria for and identification of those typical classes of action:
(i) Which normally do require environmental impact statements.
(ii) Which normally do not require either an environmental impact statement or an environmental assessment (categorical exclusions (§ 1508.4)).
(iii) Which normally require environmental assessments but not necessarily environmental impact statements.
(c) Agency procedures may include specific criteria for providing limited exceptions to the provisions of these regulations for classified proposals. They are proposed actions which are specifically authorized under criteria established by an Executive Order or statute to be kept secret in the interest of national defense or foreign policy and are in fact properly classified pursuant to such Executive Order or statute. Environmental assessments and environmental impact statements which address classified proposals may be safeguarded and restricted from public dissemination in accordance with agencies' own regulations applicable to classified information. These documents may be organized so that classified portions can be included as annexes, in order that the unclassified portions can be made available to the public.
(d) Agency procedures may provide for periods of time other than those presented in § 1506.10 when necessary to comply with other specific statutory requirements.
(e) Agency procedures may provide that where there is a lengthy period between the agency's decision to prepare an environmental impact statement
NEPA, the Environmental Quality Improvement Act of 1970, as amended (42 U.S.C. 4371
The terminology of this part shall be uniform throughout the Federal Government.
(a) Direct effects, which are caused by the action and occur at the same time and place.
(b) Indirect effects, which are caused by the action and are later in time or farther removed in distance, but are still reasonably foreseeable. Indirect effects may include growth inducing effects and other effects related to induced changes in the pattern of land use, population density or growth rate, and related effects on air and water and other natural systems, including ecosystems.
(a) Means a concise public document for which a Federal agency is responsible that serves to:
(1) Briefly provide sufficient evidence and analysis for determining whether to prepare an environmental impact statement or a finding of no significant impact.
(2) Aid an agency's compliance with the Act when no environmental impact statement is necessary.
(3) Facilitate preparation of a statement when one is necessary.
(b) Shall include brief discussions of the need for the proposal, of alternatives as required by section 102(2)(E), of the environmental impacts of the proposed action and alternatives, and a listing of agencies and persons consulted.
(a) Actions include new and continuing activities, including projects and programs entirely or partly financed, assisted, conducted, regulated, or approved by federal agencies; new or revised agency rules, regulations, plans, policies, or procedures; and legislative proposals (§§ 1506.8, 1508.17). Actions do not include funding assistance solely in the form of general revenue sharing funds, distributed under the State and Local Fiscal Assistance Act of 1972, 31 U.S.C. 1221
(b) Federal actions tend to fall within one of the following categories:
(1) Adoption of official policy, such as rules, regulations, and interpretations adopted pursuant to the Administrative Procedure Act, 5 U.S.C. 551
(2) Adoption of formal plans, such as official documents prepared or approved by federal agencies which guide or prescribe alternative uses of Federal resources, upon which future agency actions will be based.
(3) Adoption of programs, such as a group of concerted actions to implement a specific policy or plan; systematic and connected agency decisions allocating agency resources to implement a specific statutory program or executive directive.
(4) Approval of specific projects, such as construction or management activities located in a defined geographic area. Projects include actions approved by permit or other regulatory decision as well as federal and federally assisted activities.
(a) With respect to the Environmental Protection Agency, any proposed legislation, project, action or regulation as those terms are used in section 309(a) of the Clean Air Act (42 U.S.C. 7609).
(b) With respect to all other agencies, any proposed major federal action to which section 102(2)(C) of NEPA applies.
(a) Avoiding the impact altogether by not taking a certain action or parts of an action.
(b) Minimizing impacts by limiting the degree or magnitude of the action and its implementation.
(c) Rectifying the impact by repairing, rehabilitating, or restoring the affected environment.
(d) Reducing or eliminating the impact over time by preservation and maintenance operations during the life of the action.
(e) Compensating for the impact by replacing or providing substitute resources or environments.
(a) Describe the proposed action and possible alternatives.
(b) Describe the agency's proposed scoping process including whether, when, and where any scoping meeting will be held.
(c) State the name and address of a person within the agency who can answer questions about the proposed action and the environmental impact statement.
(a) Actions (other than unconnected single actions) which may be:
(1) Connected actions, which means that they are closely related and therefore should be discussed in the same impact statement. Actions are connected if they:
(i) Automatically trigger other actions which may require environmental impact statements.
(ii) Cannot or will not proceed unless other actions are taken previously or simultaneously.
(iii) Are interdependent parts of a larger action and depend on the larger action for their justification.
(2) Cumulative actions, which when viewed with other proposed actions have cumulatively significant impacts and should therefore be discussed in the same impact statement.
(3) Similar actions, which when viewed with other reasonably foreseeable or proposed agency actions, have similarities that provide a basis for evaluating their environmental consequencies together, such as common timing or geography. An agency may wish to analyze these actions in the same impact statement. It should do so when the best way to assess adequately the combined impacts of similar actions or reasonable alternatives to such actions is to treat them in a single impact statement.
(b) Alternatives, which include:
(1) No action alternative.
(2) Other reasonable courses of actions.
(3) Mitigation measures (not in the proposed action).
(c) Impacts, which may be: (1) Direct; (2) indirect; (3) cumulative.
(a)
(b)
(1) Impacts that may be both beneficial and adverse. A significant effect may exist even if the Federal agency believes that on balance the effect will be beneficial.
(2) The degree to which the proposed action affects public health or safety.
(3) Unique characteristics of the geographic area such as proximity to historic or cultural resources, park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologically critical areas.
(4) The degree to which the effects on the quality of the human environment are likely to be highly controversial.
(5) The degree to which the possible effects on the human environment are highly uncertain or involve unique or unknown risks.
(6) The degree to which the action may establish a precedent for future actions with significant effects or represents a decision in principle about a future consideration.
(7) Whether the action is related to other actions with individually insignificant but cumulatively significant impacts. Significance exists if it is reasonable to anticipate a cumulatively significant impact on the environment. Significance cannot be avoided by terming an action temporary or by breaking it down into small component parts.
(8) The degree to which the action may adversely affect districts, sites, highways, structures, or objects listed in or eligible for listing in the National Register of Historic Places or may cause loss or destruction of significant scientific, cultural, or historical resources.
(9) The degree to which the action may adversely affect an endangered or threatened species or its habitat that has been determined to be critical under the Endangered Species Act of 1973.
(10) Whether the action threatens a violation of Federal, State, or local law or requirements imposed for the protection of the environment.
(a) From a program, plan, or policy environmental impact statement to a program, plan, or policy statement or analysis of lesser scope or to a site-specific statement or analysis.
(b) From an environmental impact statement on a specific action at an early stage (such as need and site selection) to a supplement (which is preferred) or a subsequent statement or analysis at a later stage (such as environmental mitigation). Tiering in such cases is appropriate when it helps the lead agency to focus on the issues which are ripe for decision and exclude from consideration issues already decided or not yet ripe.
This listing is provided for information purposes only. It is compiled and kept up-to-date by the Council on Environmental Quality, and is revised through July 1, 2004.
5 U.S.C. 552, as amended by Pub. L. 93-502.
The Freedom of Information Act (5 U.S.C. 552, commonly known as FOIA) is a law which creates a procedure for
(a) The Council on Environmental Quality (“CEQ” or “the Council”) was created by the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321 through 4347). The Council's authority is derived from that Act, the Environmental Quality Improvement Act of 1970, as amended (42 U.S.C. 4371-4374), Reorganization Plan No. 1 of 1977 (July 15, 1977), and Executive Order 11514, Protection and Enhancement of Environmental Quality, March 5, 1970, as amended by Executive Order 11991, May 24, 1977.
(b) The Council's primary responsibilities include the following:
(1) To review and evaluate the programs and activities of the Federal Government to determine how they are contributing to the attainment of the national environmental policy;
(2) To assist Federal agencies and departments in appraising the effectiveness of their existing and proposed facilities, programs, policies, and activities affecting environmental quality;
(3) To develop and recommend to the President policies to improve environmental quality to meet the conservation, social, economic, health, and other requirements and goals of the Nation;
(4) To advise and assist the President in achieving international cooperation for dealing with environmental problems;
(5) To assist in coordinating among Federal agencies and departments those programs which affect, protect, and improve environmental quality, including Federal compliance with the environmental impact statement process, and to seek resolution of significant environmental issues;
(6) To foster research relating to environmental quality and the impacts of new or changing technologies; and
(7) To analyze long and short term environmental problems and trends and assist in preparing an annual Environmental Quality Report to the President and the Congress.
(c) The Council maintains a “Quarterly Index” which lists its current policies and procedures, as required by section 552(a)(2) of the Freedom of Information Act. This index is updated and published in the
(a) The Council is made up of three members appointed by the President and subject to approval by the Senate. One member is designated as chairman by the President. All three serve in a full-time capacity.
(b) The National Environmental Policy Act and the Environmental Quality Improvement Act give the Council the authority to hire any officers and staff that may be necessary to carry out responsibilities and functions specified in these two Acts. Also, the use of consultants and experts is permitted.
(c) In addition to the three members, the Council has program and legal staff.
(d) The Council has no field or regional offices.
(e) The Council has a public affairs office which is responsible for providing information to the general public, the Congress, and the press. If you are interested in general information about the Council or have questions about the Council's recent activities or policy positions, you should call this
The CEQ public affairs office can respond fully and promptly to most questions you may have; the Council suggests that the Freedom of Information Act procedures be used when you are seeking a specific document and have had difficulty obtaining it.
(f) The Council is located at 722 Jackson Place NW., Washington, DC 20006. Office hours are 9-5:30, Monday through Friday, except legal holidays. If you wish to meet with any of the staff, please write or phone ahead for an appointment. The main number is 202-633-7027.
(a) The Chairman has appointed a Freedom of Information Officer who will be responsible for overseeing the Council's administration of the Freedom of Information Act and for receiving, routing, and overseeing the processing of all Freedom of Information requests. The Chairman has also appointed an Appeals Officer who is responsible for processing any appeals.
(b)
(2) You can make a Freedom of Information Act request by writing a letter which states that you are making a Freedom of Information Act request. Address your letter to:
(3) In your request you should identify the desired record or reasonably describe it. The request should be as specific as possible so that the item can be readily found. You should not make blanket requests, such as requests for “the entire file of” or “all materials relating to” a specified subject.
(4) The Council will make a reasonable effort to assist you in defining the request to eliminate extraneous and unwanted materials and to keep search and copying fees to a minimum. If you have budgetary constraints and anticipate that your request might be costly you may wish to indicate the maximum fee you are prepared to pay for acquiring the information. (See § 1515.15(c) also.)
(5) The 10 day period for making a determination on a request will begin when the records reqested are specified or reasonably identifiable.
(6) Despite its name, the Freedom of Information Act does not require a government agency to create or research information that you would like or that you may think the agency should have. The Act only requres that existing records be made available to the public.
(c)
(2) If it is appropriate to grant the request, the staff member will immediately collect the requested materials in order to accompany, wherever possible, the Freedom of Information Officer's letter notifying you of the decision.
(3) If your request is denied, in part or in full, the letter notifying you of the decision will be signed by the Freedom of Information Officer, and will include the names of any other individuals who participated in the decision. The letter will include the reasons for any denial and the procedure for filing an appeal.
(d)
(2) You can make an appeal by writing a letter to:
(3) Your letter should specify the records being requested and ask the Appeals Officer to review the determination made by the Freedom of Information Officer. The letter should explain the basis for the appeal.
(4) The Appeals Officer shall decide the appeal—or “make a final determination”—within 20 working days from the date the Officer receives the appeal. The Appeals Officer (or designee) will send you a letter informing you of the decision as soon as it is made. If the Appeals Officer denies your request, in part or in whole, the letter will also notify you of the provisions for judicial review and the names of any persons who participated in the final determination of the appeal.
(e)
(i) The need to search for and collect the requested records from * * * establishments that are separate from the office processing the request;
(ii) The need to search for, collect, and appropriately examine a voluminous amount of separate and distinct records which are demanded in a single request; or
(iii) The need for consultation, which shall be conducted with all practicable speed, with another agency having a substantial interest in the determination of the request or among two or more components of the agency having substantial subject-matter interest therein.
(a) When a request for information has been approved, in whole or in part, you may make an appointment to inspect or copy the materials requested during regular business hours by writing or telephoning the Freedom of Information Officer at the address or phone number given in § 1515.3(f). You may be charged reasonable fees for copying materials, as explained by § 1515.15. The Council on Environmental Quality will permit copying of any available material but will reserve the right to limit the number of copies made with the Council's copying facilities.
(b) In general, all records of the Council are available to the public, as required by the Freedom of Information Act. The Council claims the right, where it is applicable, to withhold material under the provisions specified in the Freedom of Information Act as amended (5 U.S.C. 552(b)).
(c) The legislative history of the establishment of the Council states that the Congress intended the Council to be a confidential advisor to the President on matters of environmental policy. Therefore, members of the public should presume that communications between the Council and the President (and their staffs) are confidential and ordinarily will not be released; they will usually fall, at a minimum, within Exemption 5 of the Act. The Freedom of Information Officer shall review each request, however, to determine whether the record is exclusively factual or may have factual portions which may be reasonably segregated and made available to the requester. Furthermore, on the recommendation of the FOIA Officer or Appeals Officer, the Council will consider the release of an entire record, even if it comes within an exemption or contains policy advice, if its disclosure would not impair Executive policymaking processes or
(a) Following is the schedule of fees you may be charged for the search and reproduction of information available under the Freedom of Information Act, 5 U.S.C. 552, as amended.
(1)
(2)
(3)
(b) If the Council anticipates that the fees chargeable under this section will amount to more than $25, or the maximum amount specified in your request, you shall be promptly notified of the amount of the anticipated fee or the closest estimate of the amount. In such instances you will be advised of your option to consult with Council personnel in order to reformulate the request in a manner which will reduce the fees, yet still meet your needs. A reformulated request shall be considered a new request, thus beginning a new 10 working day period for processing.
(c) Fees must be paid in full prior to issuance of the requested copies. In the event you owe money for previous request, copies of records will not be provided for any subsequent request until the debt has been paid in full.
(d) Search costs are due and payable even if the record which was requested cannot be located after all reasonable efforts have been made, or if the FOI Officer determines that a record which has been requested is exempt under the Freedom of Information Act as amended and is to be withheld.
(e) Payment shall be in the form either of a personal check or bank draft drawn on a bank in the United States, or a postal money order. Checks shall be made payable to General Services Administration. You should mail or deliver any payment for services to the Administrative Office, Council on Environmental Quality, 722 Jackson Place NW., Washington, DC 20006.
(f) A receipt for fees paid will be given upon request. Refunds of fees paid for services actually rendered will not be made.
(g) The Council may waive all or part of any fee provided for in this section when the Freedom of Information Officer (or designee) deems it to be in either the Council's interest or in the general public's interest.
5 U.S.C. 552a; Pub. L. 93-579.
The purposes of these regulations are to:
(a) Establish a procedure by which an individual can determine if the Council on Environmental Quality (hereafter known as the Council) maintains a system of records which includes a record pertaining to the individual; and
(b) Establish a procedure by which an individual can gain access to a record pertaining to him or her for the purpose of review, amendment and/or correction.
For the purpose of these regulations:
(a) The term
(b) The term
(c) The term
(d) The term
(e) The term
An individual shall submit a written request to the Administrative Officer of the Council to determine if a system of records named by the individual contains a record pertaining to the individual. The individual shall submit a written request to the Administrative Officer of the Council which states the individual's desire to review his or her record. The Administrative Officer of the Council is available to answer questions regarding these regulations and to provide assistance in locating records in the Council's system of records.
An individual making a request to the Administrative Officer of the Council pursuant to § 1516.3 shall present the request at the Council's office, 722 Jackson Place NW., Washington, DC 20006, on any business day between the hours of 9 a.m. and 5 p.m. and should be prepared to identify himself by signature. Requests will also be accepted in writing if mailed to the Council's offices and signed by the requester.
Upon verification of identity, the Council shall disclose to the individual the information contained in the record which pertains to that individual.
(a) The individual may be accompanied for this purpose by a person of his choosing.
(b) Upon request of the individual to whom the record pertains, all information in the accounting of disclosures will be made available.
The individual may submit a request to the Administrative Officer of the Council which states the individual's desire to correct or to amend his or her record. This request must be made in accordance with the procedures of § 1516.4 and shall describe in detail the change which is requested.
Within ten working days of the receipt of a request to correct or to amend a record, the Administrative Officer of the Council will acknowledge
(a) Make any correction or amendment of any portion thereof which the individual believes is not accurate, relevant, timely, or complete; or
(b) Inform the individual of his or her refusal to correct or amend the record in accordance with the request, the reason for the refusal, and the procedure established by the Council for the individual to request a review of that refusal.
An individual may appeal refusal by the Administrative Officer of the Council to correct or to amend his or her record by submitting a request for a review of such refusal to the General Counsel, Council on Environmental Quality, 722 Jackson Place NW., Washington, DC 20006. The General Counsel shall, not later than thirty working days from the date on which the individual requests such a review, complete such review and make a final determination unless, for good cause shown, the General Counsel extends such thirty day period. If, after his or her review, the General Counsel also refuses to correct or to amend the record in accordance with the request, the individual may file with the Council a concise statement setting forth the reasons for his or her disagreement with the General Counsel's decision and may seek judicial relief under 5 U.S.C. 552a(g)(1)(A).
The Council will not disclose a record to any individual other than to the individual to whom the record pertains without receiving the prior written consent of the individual to whom the record pertains, unless the disclosure either has been listed as a “routine use” in the Council's notices of its systems of records or falls within the special conditions of disclosure set forth in section 3 of the Privacy Act of 1974.
If an individual requests copies of his or her record, he or she shall be charged ten cents per page, excluding the cost of any search for the record, in advance of receipt of the pages.
5 U.S.C. 552b(g); Pub. L. 94-409.
Consistent with the policy that the public is entitled to the fullest information regarding the decisionmaking processes of the Federal Government, it is the purpose of this part to open the meetings of the Council on Environmental Quality to public observation while protecting the rights of individuals and the ability of the Council to carry out its primary responsibility of providing advice to the President. Actions taken by the Chairman acting as Director of the Office of Environmental Quality and Council actions involving advice to the President when such advice is not formulated collegially during a meeting are outside the scope of this part. In addition to conducting the meetings required by this part, it is the Council's policy to conduct, open to public observation, periodic meetings involving Council discussions of Council business, including where appropriate, matters outside the scope of this part. This part does not affect the procedures set forth in part 1515 pursuant to which records of the Council are made available to the public for inspection and copying, except that the exemptions set forth in § 1517.4(a) shall govern in the case of any request made to copy or inspect
For the purpose of this part:
(a) The term
(b) The term
(c)
(a) Every portion of every meeting of the Council is open to public observation subject to the exemptions provided in § 1517.4. Members of the Council may not jointly conduct or dispose of the business of the Council other than in accordance with this part.
(b) The Council will conduct open to public observation periodic meetings involving Council discussions of Council business including where appropriate matters outside the scope of this part. Such meetings will be noticed pursuant to § 1517.6.
(c) Members of the public may attend open meetings of the Council for the sole purpose of observation and may not participate in or photograph any meeting without prior permission of the Council. Members of the public who desire to participate in or photograph an open meeting of the Council may request permission to do so from the General Counsel of the Council before such meeting. Members of the public may record open meetings of the Council by means of any mechanical or electronic device unless the Council determines such recording would disrupt the orderly conduct of such meeting.
(a) A meeting or portion thereof may be closed to public observation, and information pertaining to such meeting or portion thereof may be withheld from the public, if the Council determines that such meeting or portion thereof or disclosure of such information is likely to:
(1) Disclose matters that are (i) specifically authorized under criteria established by an Executive order to be kept secret in the interest of national defense or foreign policy and (ii) in fact properly classified pursuant to that Executive order;
(2) Relate solely to the internal personnel rules and practices of the Council;
(3) Disclose matters specifically exempted from disclosure by statute (other than the Freedom of Information Act, 5 U.S.C. 552), provided that the statute: (i) Requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue, or (ii) establishes particular criteria for withholding or refers to particular types of matters to be withheld;
(4) Disclose the trade secrets and commercial or financial information obtained from a person and privileged or confidential;
(5) Involve accusing any person of a crime, or formally censuring any person;
(6) Disclose information of a personal nature if disclosure would constitute a clearly unwarranted invasion of personal privacy;
(7) Disclose investigatory records compiled for law enforcement purposes, or information which if written would be contained in such records, but only to the extent that the production of those records or information would:
(i) Interfere with enforcement proceedings,
(ii) Deprive a person of a right to a fair trial or an impartial adjudication,
(iii) Constitute an unwarranted invasion of personal privacy,
(iv) Disclose the identity of a confidential source and, in the case of a record compiled by a criminal law enforcement authority in the course of a criminal investigation, or by an agency conducting a lawful national security intelligence investigation, confidential information furnished only by the confidential source,
(v) Disclose investigative techniques and procedures, or,
(vi) Endanger the life or physical safety of law enforcement personnel;
(8) Disclose information contained in or related to examination, operating, or condition reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions;
(9) Disclose information the premature disclosure of which would be likely to significantly frustrate implementation of a proposed action of the Council. This exception shall not apply in any instance where the Council has already disclosed to the public the content or nature of the proposed action, or where the Council is required by law to make such disclosure on its own initiative prior to taking final action on the proposal; or
(10) Specifically concern the issuance of a subpoena by the Council, or the participation of the Council in a civil action or proceeding, an action in a foreign court or international tribunal, or an arbitration, or the initiation, conduct, or disposition by the Council of a particular case of formal adjudication pursuant to the procedures in 5 U.S.C. 554 or otherwise involving a determination on the record after opportunity for a hearing.
(b) Before a meeting is closed to public observation the Council shall determine whether or not the public interest requires that the meeting be open. The Council may open a meeting to public observation which could be closed under paragraph (a) of this section, if the Council finds it to be in the public interest to do so.
(a) A majority of the entire membership of the Council may vote to close to public observation a meeting or a portion or portions thereof, or to withhold information pertaining to such meeting. A separate vote of the members of the Council shall be taken with respect to each meeting of the Council, a portion or portions of which are proposed to be closed to the observation of the public or with respect to any information concerning such meetings or portion thereof. A single vote may be taken with respect to a series of meetings, a portion or portions of which are proposed to be closed to the public, or with respect to information concerning such series of meetings, so long as each meeting in such series involves the same particular matters and is scheduled to be held no more than thirty days after the initial meeting in such series. The vote of each member of the Council participating in a vote shall be recorded and no proxies shall be allowed.
(b) Whenever any person whose interest may be directly affected by a portion of a meeting requests that the Council close that portion to public observation for any of the reasons referred to in § 1517.4(a) the Council, upon request of any of the members of the Council, shall decide by recorded vote whether to close that portion of the meeting.
(c) For every meeting or portion thereof closed under this part, the General Counsel of the Council before such meeting is closed shall publicly certify that, in his or her opinion, the meeting may properly be closed to the public stating each relevant exemptive provision. The Council shall retain a copy of the General Counsel's certification, together with a statement from the presiding officer of the meeting setting forth the time and place of the meeting and listing the persons present.
(d) Within one day of any vote taken on a proposal to close a meeting, the Council shall make publicly available a record reflecting the vote of each member on the question. In addition, within one day of any vote which closes a portion or portions of a meeting to the public, the Council shall make publicly
(e) Following any announcement that the Council intends to close a meeting or portion thereof, any person may make a request that the meeting or portion thereof be opened. Such request shall be made of the Chairman of the Council who shall ensure that the request is circulated to all members of the Council on the same business day on which it is received. The request shall set forth the reasons why the requestor believes the meeting should be open. The Council upon the request of any member or its General Counsel, shall vote on the request.
(a) Except as otherwise provided in this section, the Council shall make a public announcement at least one week before a meeting, to include the following:
(1) Time, place, and subject matter of the meeting;
(2) Whether the meeting is to be open or closed; and
(3) Name and telephone number of the official who will respond to requests for information about the meeting.
(b) A majority of the members of the Council may determine by recorded vote that the business of the Council requires a meeting to be called with less than one week's notice. At the earliest practicable time, the Council shall publicly announce the time, place and subject matter of the meeting, and whether or not it is to be open or closed to the public.
(c) If announcement of the subject matter of a closed meeting would reveal the information that the meeting itself was closed to protect, the subject matter shall not be announced.
(d) Following the public announcement required by paragraph (a) or (b) of this section:
(1) A majority of the members of the Council may change the time or place of a meeting. At the earliest practicable time, the Council shall publicly announce the change.
(2) A majority of the entire membership of the Council may change the subject matter of a meeting, or the determination to open or close a meeting to the public, if it determines by a recorded vote that the change is required by the business of the Council and that no earlier announcement of the change was possible. At the earliest practicable time, the Council shall publicly announce the change, and the vote of each member upon the change.
(e) Individuals or organizations having a special interest in activities of the Council may request the Council to place them on a mailing list for receipt of information available under this section.
(f) Following public announcement of a meeting, the time or place of a meeting may be changed only if the change is announced publicly at the earliest practicable time. The subject matter of a meeting or the determination to open or close a meeting may be changed following public announcement of a meeting only if both of the following conditions are met:
(1) There must be a recorded vote of a majority of the Council that the business of the Council requires the change and that no earlier announcement of such change was possible; and
(2) There must be a public announcement of the change and of the individual Council members' votes at the earliest practicable time.
(g) Immediately following each public announcement required by this section, the following information, as applicable, shall be submitted for publication in the
(1) Notice of the time, place, and subject matter of a meeting;
(2) Whether the meeting is open or closed;
(3) Any change in one of the preceding; and
(4) The name and telephone number of the official who will respond to requests for information about the meeting.
(a) A record of each meeting or portion thereof which is closed to the public shall be made and retained for two
(b) If minutes are produced, such minutes shall fully and clearly describe all matters discussed, provide a full and accurate summary of any actions taken and the reasons expressed therefor, and include a description of each of the views expressed on any item. The minutes shall also reflect the vote of each member of the Council on any roll call vote taken during the proceedings and identify all documents produced at the meeting.
(c) The following documents shall be retained by the Council as part of the transcript, recording, or minutes of the meeting:
(1) Certification by the General Counsel that the meeting may properly be closed; and
(2) Statement from the presiding officer of the meeting setting forth the date, time, and place of the meeting and listing the persons present.
(d) The Council shall make promptly available to the public at its offices at 722 Jackson Place, NW., Washington, DC the transcript, electronic recording, or minutes maintained as a record of a closed meeting, except for such information as may be withheld under one of the provisions of § 1517.5. Copies of such transcript, minutes, or transcription of an electronic recording, disclosing the identity of each speaker, shall be furnished to any person at the actual cost of duplication or transcription.
(e) [Reserved]
(f) Requests to review or obtain copies of records other than transcripts, electronic recordings or minutes of a meeting will be processed under the Freedom of Information Act (5 U.S.C. 552) or, where applicable, the Privacy Act of 1974. (5 U.S.C. 552a). Nothing in these regulations authorizes the Council to withhold from any individual any record, including the transcripts or electronic recordings described in § 1517.8, to which the individual may have access under the Privacy Act of 1974 (5 U.S.C. 552a).
42 U.S.C. 4375(c).
The purpose of the OEQ Management Fund is to finance:
(a) Study contracts that are jointly sponsored by OEQ and one or more other Federal agency; and
(b) Federal interagency environmental projects (including task forces) in which OEQ participates.
(a)
(b)
(c)
(d)
(e)
(f)
(a) All studies and projects financed through the OEQ Management Fund shall be consistent with the purposes and goals of the National Environmental Policy Act and/or the Environmental Quality Improvement Act.
(b) Agency funds accepted by the Director for transfer into the OEQ Management Fund shall specify the purposes permissible under the source appropriation and any restrictions relating thereto.
(c) The Director may authorize expenditures to support OEQ Management Fund studies and projects, including:
(1) Leasing office space and providing utilities;
(2) Leasing or purchasing equipment;
(3) Funding travel;
(4) Contracting for goods and services; and
(5) Funding consultants and personnel costs for task force employees.
(d) In carrying out the purposes of the OEQ Management Fund, the Director is authorized to contract with public or private agencies, institutions, organizations and individuals, by negotiation, without regard to 31 U.S.C. 3324(a) and (b) 41 U.S.C. 5, and 42 U.S.C. 4372(e). All such contracting activities shall be accomplished through the Office of Administration, Executive Office of the President. The Director may, by interagency agreement with another federal agency or agencies and with the concurrence of the Office of Administration's Financial Management Division, obtain specific administrative services (including contracting activities) in support of OEQ Management Fund studies or projects.
(e) Task forces and projects funded by the OEQ Management Fund are permitted to make expenditures for all project and study activities, except for compensation or benefits for full-time OEQ employees or to reimburse OEQ or CEQ for ordinarily appropriated expenses, such as salaries, benefits, rent, telephone and supplies.
(a)
(2) The charter must clearly state the relation of the study or project to the goals and purposes of the Office of Environmental Quality and the National Environmental Policy Act; describe the study or project; identify the participating agency or agencies; provide the names, titles and phone numbers of the Project Officer and administrative contact.
(3) Charters may be amended by preparing a formal amendment, which sets forth the new language to be incorporated in the existing charter.
(4) The Director shall approve all Management Fund charters and amendments in writing.
(5) Copies of each charter and charter amendment approved by the Director shall be provided to the Contracts Branch and the Financial Management Division of the Office of Administration, Executive Office of the President.
(b)
(2) An operating budget for each project or study shall be submitted to the Financial Management Division of the Office of Administration, Executive Office of the President.
(3) All contributions from other agencies to the OEQ Management Fund for a joint study or project shall be accomplished by interagency agreements, which shall provide for full payment of funds on an advance basis. 42 U.S.C. 4375(a).
(4) All contributions by the Office of Environmental Quality or the Council on Environmental Quality to the OEQ Management Fund for a joint study or project shall be accomplished by a letter of transmittal which specifies the particular study or project to be funded. A copy of this transmittal letter shall be provided to the Financial Management Division of the Office of Administration, Executive Office of the President.
(5) The OEQ Management Fund is a no-year appropriations account, which can accept one-year or multiple-year funds, and is available until the objectives for which the authority was made available are attained. Funds transferred into the Management Fund are individually accounted for and expire under the terms of their appropriation.
(6) Any agency, including the Office of Environmental Quality and the Council on Environmental Quality, may provide technical expertise, physical resources, facilities, equipment, or other assets; perform support or administrative services; or assign detailees or agency representatives to an OEQ Management Fund project or study. These contributions may be in addition to funding.
(7) Subaccounts shall be established within OEQ Management Fund for each project or study. All expenditures for a particular project or study must be matched with the source contribution and approved by the Director or the Project Officer.
(8) The Director may transfer Management Fund resources for any study or project to other federal accounts or other OEQ subaccounts provided that the transfer:
(i) Is approved in writing by the source agency that provided the portion of the funds being transferred;
(ii) Promotes the statutory mission of OEQ; and
(iii) Is justified by the Director as being in the best interests of the government.
(9) Financial transactions shall be classified under each Management Funds subaccount in sufficient detail to satisfy management planning, control requirements and financial audit requirements.
(10) All fund expenditures must comport with the purposes of the Management Fund and follow CEQ approval procedures. Any fund expenditures pursuant to interagency agreement for the provision of administrative services shall comport with the CEQ approval procedures specified in the interagency agreement.
5 U.S.C. 301, 552(a)(1); 42 U.S.C. 7412(r)(6)(N).
This part describes the organization, functions, and operation of the Chemical Safety and Hazard Investigation Board (CSB). The CSB is an independent agency of the United States created by the Clean Air Act Amendments of 1990 [Pub. L. 101-549, 104 Stat. 2399, codified at 42 U.S.C. 7412(r)(6)
(a) The CSB's Board consists of five Members appointed by the President with the advice and consent of the Senate. The President designates one of the Members as Chairperson with the advice and consent of the Senate. The Members exercise various functions, powers, and duties set forth in the Clean Air Act Amendments of 1990 (42 U.S.C. 7412(r)(6)
(b) The CSB's staff is comprised of the following administrative units:
(1) The Office of the Chief Operating Officer;
(2) The Office of Investigations and Safety Programs;
(3) The Office of the General Counsel;
(4) The Office of Financial Operations;
(5) The Office of Management Operations; and
(6) The Office of Equal Employment Opportunity.
(a) The CSB investigates chemical accidents and hazards, recommending actions to protect workers, the public, and the environment. The CSB is responsible for the investigation and determination of the facts, conditions, and circumstances and the cause or probable cause or causes of any accidental release resulting in a fatality, serious injury, or substantial property damages.
(b) The CSB makes safety recommendations to Federal, State, and local agencies, including the Environmental Protection Agency and the Occupational Safety and Health Administration and private organizations to reduce the likelihood of recurrences of chemical incidents. It initiates and conducts safety studies and special investigations on matters pertaining to chemical safety.
(c) The CSB issues reports pursuant to its duties to determine the cause or probable cause or causes of chemical incidents and to report the facts, conditions, and circumstances relating to such incidents; and issues and makes available to the public safety recommendations, safety studies, and reports of special investigations.
In exercising its functions, duties, and responsibilities, the CSB utilizes:
(a) The CSB's staff, consisting of specialized offices performing investigative, administrative, legal, and financial work for the Board.
(b) Rules published in the
(c) Meetings of the Board Members conducted pursuant to the Government in the Sunshine Act and part 1603 of this title (CSB Rules Implementing the Government in the Sunshine Act) or voting by notation as provided in § 1600.5(b).
(d) Public hearings in connection with incident or hazard investigations.
(a)
(b)
The principal offices of the Chemical Safety and Hazard Investigation Board are located at 2175 K Street NW, Washington, DC 20037.
5 U.S.C. 552, 553; 42 U.S.C. 7412
This part contains the regulations of the United States Chemical Safety and Hazard Investigation Board (“CSB” or “Board” or “agency”) implementing the Freedom of Information Act (“FOIA”). These regulations provide procedures by which members of the public may obtain access to records compiled, created, and maintained by the CSB, along with procedures it must follow in response to such requests for records.
(a)
(b)
(a) Except as authorized by this part or as otherwise necessary in performing official duties, no employee shall in any manner disclose or permit disclosure of any document or information in the possession of the CSB that is confidential or otherwise of a nonpublic nature, including that regarding the CSB, the Environmental Protection Agency or the Occupational Safety and Health Administration.
(b) No person may, without permission, remove from the place where it is made available any record made available to him for inspection or copying. Stealing, altering, mutilating, obliterating, or destroying, in whole or in part, such a record shall be deemed a crime.
The CSB will preserve all correspondence pertaining to the requests that it receives under this part, as well as copies of all requested records, until disposition or destruction is authorized by Title 44 of the United States Code or the National Archives and Records Administration's General Records Schedule 14. Records will not be disposed of while they are the subject of a pending request, appeal, or lawsuit under the FOIA.
(a) The CSB maintains a public reading room that contains the records that the FOIA requires to be made regularly available for public inspection and copying as well as a current subject-matter index of its reading room records.
(b) Because of the lack of requests to date for material required to be indexed, the CSB has determined that it is unnecessary and impracticable to publish quarterly, or more frequently, and distribute (by sale or otherwise) copies of each index and supplements thereto, as provided in 5 U.S.C. 552(a)(2). However, the CSB will provide a copy of such indexes to a member of the public upon request, at a cost not to exceed the direct cost of duplication and mailing, if sending records by other than ordinary mail.
(c) The CSB maintains a public reading room at its headquarters: 2175 K Street, NW, Suite 400, Washington, DC 20037-1809.
(d)
(e) The CSB also makes reading room records available electronically through the agency's World Wide Web site (which can be found at http://www.csb.gov). This includes the index of its reading room records, indicating which records are available electronically.
(a)
(b)
(1) Whenever possible, a request should include specific information about each record sought, such as the date, title or name, author, recipient, and subject matter of the record.
(2) If the FOIA Officer determines that a request does not reasonably describe the records sought, he or she will either advise the requester what additional information is needed to locate the record or otherwise state why the request is insufficient. The FOIA Officer will also extend to the requester an opportunity to confer with CSB personnel with the objective of reformulating the request in a manner which will meet the requirements of this section.
(c)
(d)
(1) Compile or create records solely for the purpose of satisfying a request for records;
(2) Provide records not yet in existence, even if such records may be expected to come into existence at some future time; or
(3) Restore records destroyed or otherwise disposed of, except that the FOIA Officer must notify the requester that the requested records have been destroyed or otherwise disposed of.
(a)
(b)
(c)
(d)
(a)
(b)
(1) The name and title or position of the person making the denial;
(2) A brief statement of the reason or reasons for the denial, including the FOIA exemption or exemptions which the FOIA Officer has relied upon in denying the request; and
(3) A statement that the denial may be appealed under § 1601.23 and a description of the requirements of that section.
(a)
(b)
(c)
(d)
(a)
(b)
(2) The agency may provide requesters in its slower track with an opportunity to limit the scope of their requests in order to qualify for faster processing within the specified limits of the agency's faster track. If it does so, the agency will contact the requester either by telephone or by letter, whichever is most efficient in each case.
(c)
(2) Where the CSB reasonably believes that multiple requests submitted by a requester, or by a group of requesters acting in concert, constitute a single request that would otherwise involve unusual circumstances, and the requests involve clearly related matters, they may be aggregated. Multiple
(d)
(i) Circumstances in which the lack of expedited treatment could reasonably be expected to pose an imminent threat to the life or physical safety of an individual;
(ii) An urgency to inform the public about an actual or alleged Federal government activity, if made by a person primarily engaged in disseminating information;
(iii) The loss of substantial due process rights; or
(iv) A matter of widespread and exceptional media interest in which there exists possible questions about the government's integrity which affect public confidence.
(2) A request for expedited processing may be made at the time of the initial request for records or at any later time.
(3) A requester who seeks expedited processing must submit a statement, certified to be true and correct to the best of that person's knowledge and belief, explaining in detail the basis for requesting expedited processing. For example, a requester within the category in paragraph (d)(1)(ii) of this section, if not a full-time member of the news media, must establish that he or she is a person whose main professional activity or occupation is information dissemination, though it need not be his or her sole occupation. A requester within the category in paragraph (d)(1)(ii) of this section also must establish a particular urgency to inform the public about the government activity involved in the request, beyond the public's right to know about government activity generally. The formality of certification may be waived as a matter of administrative discretion.
(4) Within ten calendar days of its receipt of a request for expedited processing, the CSB shall decide whether to grant it and shall notify the requester of the decision. If a request for expedited treatment is granted, the request shall be given priority and shall be processed as soon as practicable. If a request for expedited processing is denied, any appeal of that decision shall be acted on expeditiously.
(e)
(1) Search for and collect the requested records from facilities that are separate from the office processing the request;
(2) Search for, collect, and appropriately examine a voluminous amount of separate and distinct records which are demanded in a single request; or
(3) Consult with another agency having a substantial interest in the determination of the request, or consult with various offices within the CSB that have a substantial interest in the records requested.
(f) When a determination cannot be mailed within the applicable time limit, the appeal will nevertheless be processed. In such case, upon the expiration of the time limit, the requester will be informed of the reason for the delay, of the date on which a determination may be expected to be mailed, and of that person's right to seek judicial review. The requester may be asked to forego judicial review until determination of the appeal.
(a) The FOIA Officer shall make requested records available to the public to the greatest extent possible in keeping with the FOIA, except that the following records are exempt from the disclosure requirements:
(1) Records specifically authorized under criteria established by an Executive Order to be kept secret in the interest of national defense or foreign policy and which are, in fact, properly classified pursuant to such Executive Order;
(2) Records related solely to the internal personnel rules and practices of the CSB;
(3) Records specifically exempted from disclosure by statute (other than 5 U.S.C. 552(b)) provided that such statute requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue or that the statute establishes particular criteria for withholding information or refers to particular types of matters to be withheld;
(4) Records containing trade secrets and commercial or financial information obtained from a person and privileged or confidential;
(5) Interagency or intra-agency memoranda or letters which would not be available by law to a party other than an agency in litigation with the CSB;
(6) Personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy;
(7) Records or information compiled for law enforcement purposes, but only to the extent that the production of such law enforcement records or information:
(i) Could reasonably be expected to interfere with enforcement proceedings;
(ii) Would deprive a person of a right to a fair trial or an impartial adjudication;
(iii) Could reasonably be expected to constitute an unwarranted invasion of personal privacy;
(iv) Could reasonably be expected to disclose the identity of a confidential source, including a State, local or foreign agency or authority or any private institution which furnished information on a confidential basis, and in the case of a record or information compiled by criminal law enforcement authority in the course of a criminal investigation or by an agency conducting a lawful national security intelligence investigation, information furnished by a confidential source;
(v) Would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law; or
(vi) Could reasonably be expected to endanger the life or physical safety of any individual.
(8) Records contained in or related to examination, operating, or condition reports prepared by, or on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions;
(9) Geological or geophysical information and data, including maps, concerning wells.
(b) If a requested record contains exempted material along with nonexempted material, all reasonably segregable nonexempt material shall be disclosed.
(c) Even if an exemption described in paragraph (a) of this section may be reasonably applicable to a requested record, or portion thereof, the CSB may elect under the circumstances of any particular request not to apply the exemption to such requested record, or portion thereof, subject to the provisions in § 1601.26 for confidential business information. The fact that the exemption is not applied by the CSB to any requested record, or portion thereof, has no precedential significance as to the application or non-application of the exemption to any other requested record, or portion thereof, no matter when the request is received.
(a)
(b)
(c)
(2) Whenever the FOIA Officer provides a business submitter with the notice set forth in this paragraph, the FOIA Officer shall notify the requester that the request includes information that may arguably be exempt from disclosure under Exemption 4 of the FOIA and that the person or entity who submitted the information to the CSB has been given the opportunity to comment on the proposed disclosure of information.
(d)
(1) The business submitter has in good faith designated the information as business information deemed protected from disclosure under 5 U.S.C. 552(b)(4); or
(2) The CSB has reason to believe that the request seeks business information the disclosure of which may result in substantial commercial or financial injury to the business submitter.
(e)
(f)
(i) A statement of the reasons for which the business submitter's disclosure objections were not sustained,
(ii) A description of the confidential commercial information to be disclosed, and
(iii) A specified disclosure date.
(2) Such notice of intent to disclose likewise shall be forwarded to the requester at least 10 working days prior to the specified disclosure date.
(g)
(h)
(1) The FOIA Officer determines that the information should not be disclosed;
(2) The information lawfully has been published or has been officially made available to the public;
(3) Disclosure of the information is required by law (other than 5 U.S.C. 552); or
(4) The designation made by the submitter in accordance with paragraph (b) of this section appears obviously frivolous; except that, in such a case, the FOIA Officer will provide the submitter with written notice of any final decision to disclose confidential business information within a reasonable number of days prior to a specified disclosure date.
(a)
(b)
(1)
(i)
(ii)
(iii)
(2)
(3)
(4)
(a)
(b)
(c)
(d)
(e)
(f) For purposes of the exceptions contained in this section on assessment of fees, the word
(g) For purposes of paragraph (e) of this section, the term
(a)
(b)
(c)
(i)
(ii)
(iii)
(iv)
(2) In order to determine whether the second fee waiver requirement is met, i.e., that disclosure of the requested information is not primarily in the commercial interest of the requester, the CSB shall consider the following two factors in sequence:
(i)
(ii)
(3) Where only a portion of the requested record satisfies the requirements for a waiver or reduction of fees under this paragraph, a waiver or reduction shall be granted only as to that portion.
(4) A request for a waiver or reduction of fees must accompany the request for disclosure of records and should include:
(i) A clear statement of the requester's interest in the records;
(ii) The proposed use of the records and whether the requester will derive income or other benefit from such use;
(iii) A statement of how the public will benefit from release of the requested records; and
(iv) If specialized use of the documents is contemplated, a statement of the requester's qualifications that are relevant to the specialized use.
(5) A requester may appeal the denial of a request for a waiver or reduction of fees in accordance with the provisions of § 1601.23.
(a)
(b)
(c)
(i) The CSB estimates or determines that the fees are likely to exceed $250. If it appears that the fees will exceed $250, the CSB will notify the requester of the likely cost and obtain satisfactory assurance of full payment where the requester has a history of prompt payment of FOIA fees. In the case of requesters with no history of payment, the CSB may require an advance payment of fees in an amount up to the full estimated charge that will be incurred; or
(ii) The requester has previously failed to pay a fee in a timely fashion,
(2) A request for an advance deposit shall ordinarily include an offer to the requester to confer with identified CSB personnel to attempt to reformulate the request in a manner which will meet the needs of the requester at a lower cost.
(3) When the CSB requests an advance payment of fees, the administrative time limits described in 5 U.S.C. 552(a)(6) begin only after the CSB has received the advance payment.
(d)
(e) Whenever a total fee calculated under paragraph (d) of this section is $14.00 or less for any request, no fee will be charged.
5 U.S.C. 552a, 553; 42 U.S.C. 7412
(a)
(b)
(a)
(b)
(c)
(d)
(e)
(1) The identity of the individual who is the subject of the record, by stating the name, current address, date and place of birth, and, at your option, the social security number of the individual;
(2) Your own identity, as required in paragraph (d) of this section;
(3) That you are the parent or guardian of that individual, which you may prove by providing a copy of the individual's birth certificate showing your parentage or by providing a court order establishing your guardianship; and
(4) That you are acting on behalf of that individual in making the request.
(a)
(b)
(c)
(1) Respond to the request regarding that record, after consulting with the agency best able to determine whether the record is exempt from access and with any other agency that has a substantial interest in it; or
(2) Refer the responsibility for responding to the request regarding that record to another agency that originated the record (but only if that agency is subject to the Privacy Act). Ordinarily, the agency that originated a record will be presumed to be best able to determine whether it is exempt from access.
(d)
(e)
(a)
(b)
(c)
(1) The name and title or position of the person responsible for the denial;
(2) A brief statement of the reason(s) for the denial, including any Privacy Act exemption(s) applied by the CSB in denying the request; and
(3) A statement that the denial may be appealed under § 1602.5(a) and a description of the requirements of § 1602.5(a).
(a)
(b)
(c)
(a)
(b)
(1) The reason(s) for the denial; and
(2) The procedure for appeal of the denial under paragraph (c) of this section, including the name and business address of the official who will act on your appeal.
(c)
(d)
(e)
(a)
(b)
(c)
The CSB will preserve all correspondence pertaining to the requests that it receives under this part, as well as copies of all requested records, until disposition or destruction is authorized by Title 44 of the United States Code or the National Archives and Records Administration's General Records Schedule 14. Records will not be disposed of while they are the subject of a pending request, appeal, or lawsuit under the Privacy Act.
The CSB will charge fees for duplication of records under the Privacy Act in the same way in which it charges duplication fees under the FOIA (see part 1601, subpart D of this chapter). No search or review fee will be charged for any record.
(a)
(b)
5 U.S.C. 552b; 42 U.S.C. 7412(r)(6)(N).
(a) This part implements the provisions of the Government in the Sunshine Act, 5 U.S.C. 552b. These procedures apply to meetings, as defined herein, of the Members of the Chemical Safety and Hazard Investigation Board (“CSB” or “Board”).
(b) This part does not affect the procedures by which CSB records are made available to the public, which continue to be governed by part 1601 of this chapter pursuant to the Freedom of Information Act, 5 U.S.C. 552, except that the exemptions set forth in § 1603.7 shall govern in the case of any requests made for the transcripts, recordings, and minutes described in § 1603.11.
It is the policy of the CSB to provide the public with the fullest practicable information regarding the decisionmaking processes of the Board, while protecting the rights of individuals and the ability of the Board to discharge its statutory functions and responsibilities. The public is invited to attend but not to participate in open meetings. For any open meeting, the Board,
As used in this part:
(a)
(b)
(c)
(1) Notation voting or similar consideration of business, whether by circulation of material to the Members individually in writing or by a polling of the Members individually by telephone.
(2) Action by at least a quorum of Members to:
(i) Open or to close a meeting or to release or to withhold information pursuant to § 1603.7;
(ii) Set an agenda for a proposed meeting(s);
(iii) Call a meeting on less than seven days' notice as permitted by § 1603.9(b); or
(iv) Change the subject matter or the determination to open or to close a publicly announced meeting under § 1603.10(b).
(3) A session attended by at least a quorum of Members for the purpose of having the Board's staff or expert consultants to the Board brief or otherwise provide information to the Board concerning any matters within the purview of the Board under its authorizing statute, provided that the Board does not engage in deliberations that determine or result in the joint conduct or disposition of official CSB business on such matters.
(4) A session attended by at least a quorum of Members for the purpose of having the Environmental Protection Agency or Occupational Safety and Health Administration (including contractors of those agencies) or other persons or organizations brief or otherwise provide information to the Board concerning any matters within the purview of the Board under its authorizing statute, provided that the Board does not engage in deliberations that determine or result in the joint conduct or disposition of official CSB business on such matters.
(5) A gathering of Members for the purpose of holding informal preliminary discussions or exchange of views which do not effectively predetermine official action.
(d)
(e)
(f)
Any meetings of the Board, as defined in § 1603.3, shall be conducted in accordance with this part. Except as provided in § 1603.7, the Board's meetings, or portions thereof, shall be open to public observation.
(a) The General Counsel or another attorney designated by the General Counsel will attend and monitor all briefings described in § 1603.3(c)(3) and (c)(4) and all informal preliminary discussions described in § 1603.3(c)(5), to assure that those gatherings do not proceed to the point of becoming deliberations and meetings for Sunshine Act purposes.
(b) The General Counsel or the designated attorney will inform the Board Members if developing discussions at a briefing or gathering should be deferred until a notice of an open or closed meeting can be published in the
(c) For each briefing described in § 1603.3(c)(3) or (c)(4) and each informal preliminary discussion described in
The Board may, by majority vote of its Members, determine that particular items or classes of Board business cannot be accomplished by notation voting, but must instead be decided by a recorded vote at a meeting, as defined in § 1603.3(c).
Except in a case where the Board finds that the public interest requires otherwise, a meeting may be closed and information pertinent to such meeting otherwise required by §§ 1603.8, 1603.9, and 1603.10 to be disclosed to the public may be withheld if the Board properly determines that such meeting or portion thereof or the disclosure of such information is likely to:
(a) Disclose matters that are:
(1) Specifically authorized under criteria established by an Executive Order to be kept secret in the interests of national defense or foreign policy; and
(2) In fact, properly classified pursuant to such Executive Order. In making the determination that this exemption applies, the Board shall rely upon the classification assigned to a document by the Environmental Protection Agency, Occupational Safety and Health Administration, or other originating agency;
(b) Relate solely to the internal personnel rules and practices of the CSB;
(c) Disclose matters specifically exempted from disclosure by statute (other than 5 U.S.C. 552), provided that such statute:
(1) Requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue; or
(2) Establishes particular criteria for withholding or refers to particular types of matters to be withheld;
(d) Disclose trade secrets and commercial or financial information obtained from a person and privileged or confidential;
(e) Involve accusing any person of a crime, or formally censuring any person;
(f) Disclose information of a personal nature where disclosure would constitute a clearly unwarranted invasion of personal privacy;
(g) Disclose investigatory records compiled for law enforcement purposes, or information which if written would be contained in such records, but only to the extent that the production of such records or information would:
(1) Interfere with enforcement proceedings;
(2) Deprive a person of a right to a fair trial or an impartial adjudication;
(3) Constitute an unwarranted invasion of personal privacy;
(4) Disclose the identity of a confidential source and, in the case of a record compiled by a criminal law enforcement authority in the course of a criminal investigation or by an agency conducting a lawful national security intelligence investigation, confidential information furnished only by the confidential source;
(5) Disclose investigative techniques and procedures; or
(6) Endanger the life or physical safety of law enforcement personnel;
(h) Disclose information the premature disclosure of which would be likely to significantly frustrate implementation of a proposed action of the CSB, except that this paragraph shall not apply in any instance where the
(i) Specifically concern the Board's issuance of a subpoena, or the CSB's participation in a civil action or proceeding, an action in a foreign court or international tribunal, or an arbitration, or the initiation, conduct, or disposition by the CSB of a particular case of formal agency adjudication pursuant to the procedures in 5 U.S.C. 554 or otherwise involving a determination on the record after opportunity for a hearing; or
(j) Disclose other information for which the Government in the Sunshine Act provides an exemption to the open meeting requirements of that Act.
(a) A meeting shall not be closed, or information pertaining thereto withheld, unless a majority of all Members votes to take such action. A majority of the Board may act by taking a single vote with respect to any action under § 1603.7. A single vote is permitted with respect to a series of meetings, a portion or portions of which are proposed to be closed to the public, or with respect to any information concerning such series of meetings, so long as each meeting in such series involves the same particular subject matters and is scheduled to be held no more than thirty days after the initial meeting in such series. Each Member's vote under this paragraph shall be recorded and proxies are not permitted.
(b) Any person whose interest may be directly affected if a portion of a meeting is open may request the Board to close that portion on any of the grounds referred to in § 1603.7(e) through (g). Requests, with reasons in support thereof, should be submitted in writing, no later than two days before the meeting in question, to the General Counsel, Chemical Safety and Hazard Investigation Board, 2175 K Street, NW., Suite 400, Washington, DC 20037. In motion of any Member, the Board shall determine by recorded vote whether to grant the request.
(c) Within one working day of any vote taken pursuant to this section, the CSB shall make available a written copy of such vote reflecting the vote of each Member on the question and, if a portion of a meeting is to be closed to the public, a full written explanation of its action closing the meeting and a list of all persons expected to attend and their affiliation.
(d) Before every closed meeting, the General Counsel of the CSB shall publicly certify that, in his/her opinion, the meeting may be closed to the public and shall state each relevant exemption provision. If the General Counsel invokes the exemption for classified or sensitive unclassified information under § 1603.7(a), he/shall rely upon the classification or designation assigned to the document containing such information by the Environmental Protection Agency, Occupational Safety and Health Administration, or other originating agency. A copy of such certification, together with a statement setting forth the time and place of the meeting and the persons present, shall be retained by the Board as part of the transcript, recording, or minutes required by § 1603.11.
(a) For each meeting, the CSB shall make public announcement, at least one week before the meeting, of:
(1) The time of the meeting;
(2) The place of the meeting;
(3) The subject matter of the meeting;
(4) Whether the meeting is to be open or closed; and
(5) The name and business telephone number of the offical designated by the CSB to respond to requests for information about the meeting.
(b) The one week advance notice required by paragraph (a) of this section may be reduced only if:
(1) A majority of all Members determines by recorded vote that CSB business requires that such meeting be scheduled in less than seven days; and
(2) The public announcement required by paragraph (a) of this section
(c) Immediately following each public announcement required by this section, or by § 1603.10, the CSB shall submit a notice of public announcement for publication in the
(a) The time or place of a meeting may be changed following the public announcement only if the CSB publicly announces such change at the earliest practicable time. Members need not approve such change.
(b) A meeting may be cancelled, or the subject matter of a meeting or the determination of the Board to open or to close a meeting, or a portion thereof, to the public may be changed following public announcement only if:
(1) A majority of all Members determines by recorded vote that CSB business so requires and that no earlier announcement of the cancellation or change was possible; and
(2) The CSB publicly announces such cancellation or change and the vote of each Member thereon at the earliest practicable time.
(c) The deletion of any subject matter announced for a meeting is not a change requiring the approval of the Board under paragraph (b) of this section.
(a) Along with the General Counsel's certification referred to in § 1603.8(d), the CSB shall maintain a complete transcript or electronic recording adequate to record fully the proceedings of each meeting, or a portion thereof, closed to the public. The CSB may maintain a set of minutes in lieu of such transcript or recording for meetings closed pursuant to § 1603.7(i). Such minutes shall fully and clearly describe all matters discussed and shall provide a full and accurate summary of any actions taken, and the reasons therefor, including a description of each of the views expressed on any item and the record of any rollcall vote. All documents considered in connection with any actions shall be identified in such minutes.
(b) The CSB shall maintain a complete verbatim copy of the transcript, a complete copy of the minutes, or a complete electronic recording of each meeting, or a portion thereof, closed to the public for at least two years after such meeting, or until one year after the conclusion of any CSB proceeding with respect to which the meeting, or a portion thereof, was held, whichever occurs later.
The CSB shall make promptly available to the public the transcript, electronic recording, or minutes of the discussion of any item on the agenda or of any testimony received at a meeting, except for such item, or items, of discussion or testimony as determined by the CSB to contain matters which may be withheld under the exemptive provisions of § 1603.7. Copies of the nonexempt portions of the transcript or minutes, or transcription of such recordings disclosing the identity of each speaker, shall be furnished to any person at the actual cost of transcription or duplication. Requests for transcripts, recordings, or minutes shall be made in writing to the General Counsel of the CSB, 2175 K Street, NW., Suite 400, Washington, DC 20037.
The CSB General Counsel shall annually report to the Congress regarding the Board's compliance with the Government in the Sunshine Act, including a tabulation of the total number of open meetings, the total number of closed meetings, the reasons for closing such meetings and a description of any litigation brought against the Board pursuant to the Government in the Sunshine Act, including any cost assessed against the Board in such litigation (whether or not paid by the Board).
If any provision of this part or the application of such provision to any person or circumstances, is held invalid, the remainder of this part or the
42 U.S.C. 7412(r)(6)(C)(i), 7412(r)(6)(L), 7412(r)(6)(N).
Section 1610.4 also issued under 5 U.S.C. 555.
(a)
(1) Counsel for a witness may advise the witness with respect to any question asked where it is claimed that the testimony or other evidence sought from a witness is outside the scope of the investigation, or that the witness is privileged to refuse to answer a question or to produce other evidence. For these allowable objections, the witness or counsel for the witness may object on the record to the question or requirement and may state briefly and precisely the ground therefor. If the witness refuses to answer a question, then counsel may briefly state on the record that counsel has advised the witness not to answer the question and the legal grounds for such refusal. The witness and his or her counsel shall not otherwise object to or refuse to answer any question, and they shall not otherwise interrupt the oral examination.
(2) Any objections made will be treated as continuing objections and preserved throughout the further course of the deposition without the necessity for repeating them as to any similar line of inquiry. Cumulative objections are unnecessary. Repetition of the grounds for any objection will not be allowed.
(3) Counsel for a witness may not, for any purpose or to any extent not allowed by paragraphs (a)(1) and (2) of this section, interrupt the examination of the witness by making any objections or statements on the record.
(4) Following completion of the examination of a witness, counsel for the witness may on the record request the person conducting the deposition to permit the witness to clarify any of his or her answers. The grant or denial of such request shall be within the sole discretion of the person conducting the deposition.
(5) The person conducting the deposition shall take all necessary action to regulate the course of the deposition, to avoid delay, and to prevent or restrain disorderly, dilatory, obstructionist, or contumacious conduct, or contemptuous language. Such person shall, for reasons stated on the record, immediately report to the Board any instances where an attorney has allegedly refused to comply with his or her directions, or has allegedly engaged in disorderly, dilatory, obstructionist, or contumacious conduct, or contemptuous language in the course of the deposition. The Board may thereupon take such further action, if any, as the circumstances warrant, including exclusion of that attorney from further participation in the particular investigation.
(b)
(a) If an attorney who has been sanctioned by the Board for disorderly, dilatory, obstructionist, or contumacious conduct, or contemptuous language in the course of a deposition under § 1610.1(a)(5) is sanctioned again by the Board in a subsequent deposition or investigation, the Board, after offering the attorney an opportunity to be heard, may reprimand, censure the attorney, or suspend the attorney from further practice before the Board for such period of time as the Board deems advisable.
(b) A reprimand or a censure shall be ordered with grounds stated on the record of the proceeding. A suspension shall be in writing, shall state the grounds on which it is based, and shall advise the person suspended of the right to appeal.
(c) An attorney suspended pursuant to this section may within ten (10) days after issuance of the order file an appeal with the Board. The appeal shall be in writing and state concisely, with supporting argument, why the appellant believes the order was erroneous, either as a matter of fact or law. If necessary for a full and fair consideration of the facts, the Board as a whole may conduct further evidentiary hearings, or may refer the matter to another presiding officer for development of a record. Such presiding officer may be an attorney who is a Member of the Board or is employed in the Office of General Counsel, or an administrative law judge detailed from another agency pursuant to 5 U.S.C. 3344. If the Board refers the matter to a presiding officer, unless the Board provides specific directions to the presiding officer, that officer shall determine the procedure to be followed and who shall present evidence, subject to applicable provisions of law. Such hearing shall commence as soon as possible. If no appeal is taken of a suspension, or, if the suspension is upheld at the conclusion of the appeal, the presiding officer, or the Board, as appropriate, shall notify the state bar(s) to which the attorney is admitted. Such notification shall include copies of the order of suspension, and, if an appeal was taken, briefs of the parties, and the decision of the Board.
(a) All witnesses compelled by subpoena to submit to CSB depositions shall be sequestered unless the official conducting the depositions permits otherwise.
(b) Any witness compelled by subpoena to appear at a deposition during a CSB investigation may be accompanied, represented, and advised by an attorney in good standing of his or her choice, pursuant to § 1610.1. However, when the CSB official conducting the investigation determines, after consultation with the Office of General Counsel, that the CSB has concrete evidence that the presence of an attorney representing multiple interests would obstruct and impede the investigation or inspection, the CSB official may prohibit that counsel from being present during the deposition.
(c) The deposing official is to provide a witness whose counsel has been excluded under paragraph (b) of this section, and the witness' counsel, a written statement of the reasons supporting the decision to exclude. This statement, which must be provided no later than five working days after exclusion, must explain the basis for the counsel's exclusion. This statement must also advise the witness of the witness' right to appeal the exclusion decision and obtain an automatic stay of the effectiveness of the subpoena by filing a motion to quash the subpoena with the Board within five days of receipt of this written statement.
(d) Within five days after receipt of the written notification required in paragraph (c) of this section, a witness whose counsel has been excluded may appeal the exclusion decision by filing a motion to quash the subpoena with the Board. The filing of the motion to quash will stay the effectiveness of the subpoena pending the Board's decision on the motion.
(e) If a witness' counsel is excluded under paragraph (b) of this section, the deposition may, at the witness' request, either proceed without counsel or be delayed for a reasonable period of time to permit the retention of new counsel. The deposition may also be rescheduled to a subsequent date established by the CSB, although the deposition shall not be rescheduled by the CSB to a date that precedes the expiration of the time provided in paragraph (d) of this section for appeal of the exclusion of counsel, unless the witness consents to an earlier date.
(a) Transcripts of depositions of witnesses compelled by subpoena to appear during a Board investigation, shall be recorded solely by an official reporter designated by the person conducting the deposition.
(b) Such a witness, after completing the compelled testimony, may file a petition with the Board's General Counsel to procure a copy of the official transcript of such testimony. The General Counsel shall rule on the petition, and may deny it for good cause. Whether or not such a petition is filed, the witness (and his or her attorney), upon proper identification, shall have the right to inspect the official transcript of the witness' own testimony. If such a petition is denied by the General Counsel, he shall inform the petitioner of the right to inspect the transcript.
(c) Good cause for denying a witness' petition to procure a transcript of his or her testimony may include, but shall not be limited to, the protection of: trade secrets and confidential business information contained in the testimony, security-sensitive operational and vulnerability information, and the integrity of Board investigations.
5 U.S.C. 301, 42 U.S.C. 7412(r)(6)(G).
(a) This part prescribes policies and procedures regarding the testimony of employees of the Chemical Safety and Hazard Investigation Board (CSB) in suits or actions for damages and criminal proceedings arising out of chemical incidents when such testimony is in an official capacity and arises out of or is related to an incident investigation. The purpose of this part is to ensure that the time of CSB employees is used only for official purposes, to avoid embroiling the CSB in controversial issues that are not related to its duties, to avoid spending public funds for non-CSB purposes, to preserve the impartiality of the CSB, and to prohibit the discovery of opinion testimony.
(b) This part does not apply to:
(1) Congressional requests or subpoenas for testimony or records;
(2) Federal court civil proceedings in which the United States is a party;
(3) Federal administrative proceedings;
(4) Employees who voluntarily testify, while on their own time or in approved leave status, as private citizens as to facts or events that are not related to the official business of the CSB. The employee must state for the record that the testimony represents the employee's own views and is not necessarily the official position of the CSB.
(c) This part only provides guidance for the internal operations of the CSB, and neither creates nor is intended to
(a) The statute creating the CSB, 42 U.S.C. 7412(r)(6)(G), precludes the use or admission into evidence of CSB investigative reports in any suit or action for damages arising from such incidents. This provision would be undermined if expert opinion testimony of CSB employees, which may be reflected in the views of the CSB expressed in its reports, were admitted in evidence or used in litigation arising out of an incident. The CSB relies heavily upon its investigators' opinions in its deliberations. Furthermore, the use of CSB employees as experts to give opinion testimony would impose a significant administrative burden on the CSB's investigative staff.
(b) For the reasons stated in paragraph (a) of this section and § 1611.1, CSB employees may only testify as to the factual information they obtained during the course of an investigation. However, they shall decline to testify regarding matters beyond the scope of their investigation, and they shall not give any expert or opinion testimony.
(c) CSB employees may testify about the firsthand information they obtained during an investigation that is not reasonably available elsewhere, including their own factual observations. Consistent with the principles cited in § 1611.1 and this section, current CSB employees are not authorized to testify regarding other employee's observations or reports, or other types of CSB documents, including but not limited to safety recommendations, safety studies, safety proposals, safety accomplishments, reports labeled studies, and analysis reports, as they contain staff analysis and/or CSB conclusions.
(d) Consistent with 42 U.S.C. 7412(r)(6)(G), a CSB employee may not use the CSB's investigation report for any purpose during his testimony.
(e) No employee may testify in any matter absent advance approval by the General Counsel as provided in this part.
(a) Testimony of CSB employees with unique, firsthand information may be made available for use in civil actions or civil suits for damages arising out of incidents through depositions or written interrogatories. CSB employees are not permitted to appear and testify in court in such actions.
(b) Normally, depositions will be taken and interrogatories answered at the CSB's headquarters in Washington, DC, and at a time arranged with the employee reasonably fixed to avoid substantial interference with the performance of his or her duties.
(c) CSB employees are authorized to testify only once in connection with any investigation they have made of an incident. Consequently, when more than one civil lawsuit arises as a result of an incident, it shall be the duty of counsel seeking the employee's deposition to ascertain the identity of all parties to the multiple lawsuits and their counsel, and to advise them of the fact that a deposition has been granted, so that all interested parties may be afforded the opportunity to participate therein.
(d) Upon completion of the deposition of a CSB employee, the original of the transcript will be provided to the deponent for signature and correction, which the CSB does not waive. A copy of the transcript of the testimony and any videotape shall be furnished, at the expense of the party requesting the deposition, to the CSB's General Counsel at Washington, DC headquarters for the CSB's files.
(e) If CSB employees are required to travel to testify, under the relevant substantive and procedural laws and regulations the party requesting the testimony must pay for the costs, including travel expenses. Costs must be paid by check or money order payable to the Chemical Safety and Hazard Investigation Board.
(a) A written request for testimony by deposition or interrogatories of a CSB employee relating to an incident shall be addressed to the General Counsel, who may approve or deny the request consistent with this part. Such request shall set forth the title of the civil case, the court, the date and place of the incident, the reasons for desiring the testimony, and a showing that the information desired is not reasonably available from other sources.
(b) Where testimony is sought in connection with civil litigation, the General Counsel shall not approve it until the CSB's investigation report is issued.
(c) The General Counsel shall attach to the approval of any deposition such reasonable conditions as may be deemed appropriate in order that the testimony will be consistent with § 1611.1, will be limited to the matters delineated in § 1611.3, will not interfere with the performance of the duties of the employee as set forth in § 1611.4, and will otherwise conform to the policies of this part.
(d) A subpoena shall not be served upon a CSB employee in connection with the taking of a deposition in civil litigation.
(a) It is not necessary to request CSB approval for testimony of a former CSB employee, nor is such testimony limited to depositions. However, the scope of permissible testimony continues to be constrained by all the limitations set forth in § 1611.3 and § 1611.4.
(b) Any former employee who is served with a subpoena to appear and testify in connection with civil litigation that relates to his or her work with the CSB, shall immediately notify the CSB General Counsel and provide all information requested by the General Counsel.
Any testimony regarding any incident within the CSB's jurisdiction, or any expert testimony arising from employment prior to CSB service is prohibited absent approval by the General Counsel. Approval shall only be given if testimony will not violate § 1611.1 and § 1611.3, and is subject to whatever conditions the General Counsel finds necessary to promote the purposes of this part as set forth in § 1611.1 and § 1611.3.
(a) If the CSB employee has received a subpoena to appear and testify in connection with civil litigation, a request for his deposition shall not be approved until the subpoena has been withdrawn.
(b) Upon receipt of a subpoena, the employee shall immediately notify the General Counsel and provide all information requested by the General Counsel.
(c) The General Counsel shall determine the course of action to be taken and will so advise the employee.
(a) As with civil litigation, the CSB prefers that testimony be taken by deposition if court rules permit, and that testimony await the issuance of
(b) In any case, CSB employees are prohibited from testifying in any civil, criminal, or other matter, either in person or by deposition or interrogatories, absent advance approval of the General Counsel.
(c) If permission to testify by deposition or in person is granted, testimony shall be limited as set forth in § 1611.3. Only factual testimony is authorized; no expert or opinion testimony shall be given.
It is the responsibility of the individual requesting testimony to obtain desired documents. There are a number of ways to obtain CSB investigation reports, and accompanying investigation docket files. The rules at part 1612 of this chapter explain CSB procedures for production of records in legal proceedings, and the CSB's Freedom of Information Act rules at part 1601 of this chapter explain CSB procedures for producing documents more generally. See also the information available on the CSB web site, at www.csb.gov. You may also call the CSB Office of General Counsel, at (202) 261-7600. Documents will not be supplied by witnesses at depositions, nor will copying services be provided by deponents.
5 U.S.C. 301, 42 U.S.C. 7412(r)(6)(G).
(a) This part sets forth procedures to be followed when requesting material for use in legal proceedings (including administrative proceedings) in which the Chemical Safety and Hazard Investigation Board (CSB) is not a party, and procedures to be followed by the employee upon receipt of a subpoena, order, or other demand (collectively referred to here as a demand) for such material by a court or other competent authority or by a private litigant.
(b) The purposes of this part are to:
(1) Conserve the time of employees for conducting official business;
(2) Minimize the possibility of involving the CSB in controversial issues not related to its mission;
(3) Maintain the impartiality of the CSB among private litigants;
(4) Avoid spending the time and money of the United States for private purposes; and
(5) To protect confidential, sensitive information, and the deliberative processes of the CSB.
This part applies to requests to produce material concerning information acquired in the course of performing official duties or because of the employee's official status. Specifically, this part applies to requests for: material contained in CSB files; and any information or material acquired by an employee of the CSB in the performance of official duties or as a result of the employee's status. Two sets of procedures are here established, dependent on the type of material sought. Rules governing requests for employee testimony, as opposed to material production, can be found at part 1611 of this chapter. Document production shall not accompany employee testimony, absent compliance with this part and General Counsel approval.
(a) Demands for published investigation reports should be directed to the Office of Congressional and Public Affairs, U.S. Chemical Safety and Hazard Investigation Board, 2175 K Street, NW, Suite 400, Washington, DC 20037. Demands for material contained in the CSB's official public docket files of its incident investigations shall be submitted, in writing, to CSB Records Officer, U.S. Chemical Safety and Hazard Investigation Board, 2175 K Street, NW, Suite 400, Washington, DC 20037. For information regarding the types of documents routinely issued by the CSB, see part 1601 of this chapter.
(b) No subpoena shall be issued to obtain materials subject to this section, and any subpoena issued shall be required to be withdrawn prior to release of the requested information. Payment of reproduction fees may be required in advance.
The CSB may authenticate or certify records to facilitate their use as evidence. Requests for certified copies should be made to the General Counsel at least 30 days before the date they will be needed. The CSB may charge a certification fee of $5.00 per document.
(a)
(b)
(1) All demands for material shall be submitted to the General Counsel at CSB headquarters, 2175 K Street, NW., Suite 400, Washington, DC 20037. If an employee receives a demand, he shall forward it immediately to the General Counsel.
(2) Each demand must contain an affidavit by the party seeking the material or his attorney setting forth the material sought and its relevance to the proceeding, and containing a certification, with support, that the information is not available from other sources, including CSB materials described in § 1612.3 and part 1601 of this chapter.
(3) In the absence of General Counsel approval of a demand, the employee is not authorized to comply with the demand.
(4) The General Counsel shall advise the requester of approval or denial of the demand, and may attach whatever conditions to approval considered appropriate or necessary to promote the purposes of this part. The General Counsel may also permit exceptions to any requirement in this part when necessary to prevent a miscarriage of justice, or when the exception is in the best interests of the CSB and/or the United States.
33 U.S.C. 1322, 1361.
(a) This part applies to the owners and operators of Armed Forces vessels, except where the Secretary of Defense finds that compliance with this part is not in the interest of the national security of the United States. This part does not apply to vessels while they are under construction, vessels in drydock, amphibious vehicles, or vessels under the jurisdiction of the Department of Transportation other than those of the Coast Guard.
(b) This part also applies to States and political subdivisions of States.
(a) This part identifies those discharges, other than sewage, incidental to the normal operation of Armed Forces vessels that require control within the navigable waters of the United States and the waters of the contiguous zone, and those discharges that do not require control. Discharges requiring control are identified in § 1700.4. Discharges not requiring control are identified in § 1700.5. Federal standards of performance for each required Marine Pollution Control Device are listed in § 1700.14. This part is not applicable beyond the contiguous zone.
(b) This part prohibits States and their political subdivisions from adopting or enforcing State or local statutes or regulations controlling the discharges from Armed Forces vessels listed in §§ 1700.4 and 1700.5 according to the timing provisions in § 1700.6, except to establish a no-discharge zone by State prohibition in accordance with § 1700.9, or to apply for a no-discharge zone by EPA prohibition in accordance with § 1700.10. This part also provides a mechanism for States to petition the Administrator and the Secretary to review a determination of whether a discharge requires control, or to review a Federal standard of performance for a Marine Pollution Control Device, in accordance with §§ 1700.11 through 1700.13.
(1) Sewage;
(2) A discharge of rubbish, trash, or garbage;
(3) A discharge of air emissions resulting from the operation of a vessel propulsion system, motor driven equipment, or incinerator;
(4) A discharge that requires a National Pollutant Discharge Elimination System (NPDES) permit under the Clean Water Act; or
(5) A discharge containing source, special nuclear, or byproduct materials regulated by the Atomic Energy Act.
For the following discharges incidental to the normal operation of Armed Forces vessels, the Administrator and the Secretary have determined that it is reasonable and practicable to require use of a Marine Pollution Control Device for at least one class of vessel to mitigate adverse impacts on the marine environment:
(a) Aqueous Film-Forming Foam: the firefighting foam and seawater mixture discharged during training, testing, or maintenance operations.
(b) Catapult Water Brake Tank & Post-Launch Retraction Exhaust: the oily water skimmed from the water tank used to stop the forward motion of an aircraft carrier catapult, and the condensed steam discharged when the catapult is retracted.
(c) Chain Locker Effluent: the accumulated precipitation and seawater that is emptied from the compartment used to store the vessel's anchor chain.
(d) Clean Ballast: the seawater taken into, and discharged from, dedicated ballast tanks to maintain the stability of the vessel and to adjust the buoyancy of submarines.
(e) Compensated Fuel Ballast: the seawater taken into, and discharged from, ballast tanks designed to hold both ballast water and fuel to maintain the stability of the vessel.
(f) Controllable Pitch Propeller Hydraulic Fluid: the hydraulic fluid that discharges into the surrounding seawater from propeller seals as part of normal operation, and the hydraulic fluid released during routine maintenance of the propellers.
(g) Deck Runoff: the precipitation, washdowns, and seawater falling on the weather deck of a vessel and discharged overboard through deck openings.
(h) Dirty Ballast: the seawater taken into, and discharged from, empty fuel tanks to maintain the stability of the vessel.
(i) Distillation and Reverse Osmosis Brine: the concentrated seawater (brine) produced as a byproduct of the processes used to generate freshwater from seawater.
(j) Elevator Pit Effluent: the liquid that accumulates in, and is discharged from, the sumps of elevator wells on vessels.
(k) Firemain Systems: the seawater pumped through the firemain system for firemain testing, maintenance, and training, and to supply water for the operation of certain vessel systems.
(l) Gas Turbine Water Wash: the water released from washing gas turbine components.
(m) Graywater: galley, bath, and shower water, as well as wastewater from lavatory sinks, laundry, interior deck drains, water fountains, and shop sinks.
(n) Hull Coating Leachate: the constituents that leach, dissolve, ablate, or erode from the paint on the hull into the surrounding seawater.
(o) Motor Gasoline and Compensating Discharge: the seawater taken into, and discharged from, motor gasoline tanks to eliminate free space where vapors could accumulate.
(p) Non-Oily machinery wastewater: the combined wastewater from the operation of distilling plants, water chillers, valve packings, water piping, low- and high-pressure air compressors, and propulsion engine jacket coolers.
(q) Photographic Laboratory Drains: the laboratory wastewater resulting from processing of photographic film.
(r) Seawater Cooling Overboard Discharge: the discharge of seawater from a dedicated system that provides noncontact cooling water for other vessel systems.
(s) Seawater Piping Biofouling Prevention: the discharge of seawater containing additives used to prevent the growth and attachment of biofouling organisms in dedicated seawater cooling systems on selected vessels.
(t) Small Boat Engine Wet Exhaust: the seawater that is mixed and discharged with small boat propulsion engine exhaust to cool the exhaust and quiet the engine.
(u) Sonar Dome Discharge: the leaching of antifoulant materials into the surrounding seawater and the release of seawater or freshwater retained within the sonar dome.
(v) Submarine Bilgewater: the wastewater from a variety of sources that accumulates in the lowest part of the submarine (i.e., bilge).
(w) Surface Vessel Bilgewater/Oil-Water Separator Effluent: the wastewater from a variety of sources that accumulates in the lowest part of the vessel (the bilge), and the effluent produced when the wastewater is processed by an oil water separator.
(x) Underwater Ship Husbandry: the materials discharged during the inspection, maintenance, cleaning, and repair of hulls performed while the vessel is waterborne.
(y) Welldeck Discharges: the water that accumulates from seawater flooding of the docking well (welldeck) of a vessel used to transport, load, and unload amphibious vessels, and from maintenance and freshwater washings of the welldeck and equipment and vessels stored in the welldeck.
For the following discharges incidental to the normal operation of Armed Forces vessels, the Administrator and the Secretary have determined that it is not reasonable or practicable to require use of a Marine Pollution Control Device to mitigate adverse impacts on the marine environment:
(a) Boiler Blowdown: the water and steam discharged when a steam boiler is blown down, or when a steam safety valve is tested.
(b) Catapult Wet Accumulator Discharge: the water discharged from a catapult wet accumulator, which stores a steam/water mixture for launching aircraft from an aircraft carrier.
(c) Cathodic Protection: the constituents released into surrounding water from sacrificial anode or impressed
(d) Freshwater Lay-up: the potable water that is discharged from the seawater cooling system while the vessel is in port, and the cooling system is in lay-up mode (a standby mode where seawater in the system is replaced with potable water for corrosion protection).
(e) Mine Countermeasures Equipment Lubrication: the constituents released into the surrounding seawater by erosion or dissolution from lubricated mine countermeasures equipment when the equipment is deployed and towed.
(f) Portable Damage Control Drain Pump Discharge: the seawater pumped through the portable damage control drain pump and discharged overboard during testing, maintenance, and training activities.
(g) Portable Damage Control Drain Pump Wet Exhaust: the seawater mixed and discharged with portable damage control drain pump exhaust to cool the exhaust and quiet the engine.
(h) Refrigeration and Air Conditioning Condensate: the drainage of condensed moisture from air conditioning units, refrigerators, freezers, and refrigerated spaces.
(i) Rudder Bearing Lubrication: the oil or grease released by the erosion or dissolution from lubricated bearings that support the rudder and allow it to turn freely.
(j) Steam Condensate: the condensed steam discharged from a vessel in port, where the steam originates from port facilities.
(k) Stern Tube Seals and Underwater Bearing Lubrication: the seawater pumped through stern tube seals and underwater bearings to lubricate and cool them during normal operation.
(l) Submarine Acoustic Countermeasures Launcher Discharge: the seawater that is mixed with acoustic countermeasure device propulsion gas following a countermeasure launch that is then exchanged with surrounding seawater, or partially drained when the launch assembly is removed from the submarine for maintenance.
(m) Submarine Emergency Diesel Engine Wet Exhaust: the seawater that is mixed and discharged with submarine emergency diesel engine exhaust to cool the exhaust and quiet the engine.
(n) Submarine Outboard Equipment Grease and External Hydraulics: the grease released into the surrounding seawater by erosion or dissolution from submarine equipment exposed to seawater.
(a) After the effective date of a final rule determining that it is not reasonable and practicable to require use of a Marine Pollution Control Device regarding a particular discharge incidental to the normal operation of an Armed Forces vessel, States or political subdivisions of States may not adopt or enforce any State or local statute or regulation, including issuance or enforcement of permits under the National Pollutant Discharge Elimination System, controlling that discharge, except that States may establish a no-discharge zone by State prohibition (as provided in § 1700.9), or apply for a no-discharge zone by EPA prohibition (as provided in § 1700.10).
(b)(1) After the effective date of a final rule determining that it is reasonable and practicable to require use of a Marine Pollution Control Device regarding a particular discharge incidental to the normal operation of an Armed Forces vessel, States may apply for a no-discharge zone by EPA prohibition (as provided in § 1700.10) for that discharge.
(2) After the effective date of a final rule promulgated by the Secretary governing the design, construction, installation, and use of a Marine Pollution Control Device for a discharge listed in § 1700.4, States or political subdivisions of States may not adopt or enforce any State or local statute or regulation, including issuance or enforcement of permits under the National Pollutant Discharge Elimination System, controlling that discharge except that States may establish a no-discharge zone by State prohibition (as provided in § 1700.9), or apply for a no-discharge zone by EPA prohibition (as provided in § 1700.10).
(c) The Governor of any State may submit a petition requesting that the
For this part, a no-discharge zone is a waterbody, or portion thereof, where one or more discharges incidental to the normal operation of Armed Forces vessels, whether treated or not, are prohibited. A no-discharge zone is established either by State prohibition using the procedures in § 1700.9, or by EPA prohibition, upon application of a State, using the procedures in § 1700.10.
(a) A no-discharge zone may be established by State prohibition for any discharge listed in § 1700.4 or § 1700.5 following the procedures in § 1700.9. A no-discharge zone established by a State using these procedures may apply only to those discharges that have been preempted from other State or local regulation pursuant to § 1700.6.
(b) A no-discharge zone may be established by EPA prohibition for any discharge listed in § 1700.4 or § 1700.5 following the procedures in § 1700.10.
(a) A State seeking to establish a no-discharge zone by State prohibition must send to the Administrator the following information:
(1) The discharge from § 1700.4 or § 1700.5 to be prohibited within the no-discharge zone.
(2) A detailed description of the waterbody, or portions thereof, to be included in the prohibition. The description must include a map, preferably a USGS topographic quadrant map, clearly marking the zone boundaries by latitude and longitude.
(3) A determination that the protection and enhancement of the waters described in paragraph (a)(2) of this section require greater environmental protection than provided by existing Federal standards.
(4) A complete description of the facilities reasonably available for collecting the discharge including:
(i) A map showing their location(s) and a written location description.
(ii) A demonstration that the facilities have the capacity and capability to provide safe and sanitary removal of the volume of discharge being prohibited in terms of both vessel berthing and discharge reception.
(iii) The schedule of operating hours of the facilities.
(iv) The draft requirements of the vessel(s) that will be required to use the facilities and the available water depth at the facilities.
(v) Information showing that handling of the discharge at the facilities is in conformance with Federal law.
(5) Information on whether vessels other than those of the Armed Forces are subject to the same type of prohibition. If the State is not applying the prohibition to all vessels in the area, the State must demonstrate the technical or environmental basis for applying the prohibition only to Armed Forces vessels. The following information must be included in the technical or environmental basis for treating Armed Forces vessels differently:
(i) An analysis showing the relative contributions of the discharge from Armed Forces and non-Armed Forces vessels.
(ii) A description of State efforts to control the discharge from non-Armed Forces vessels.
(b) The information provided under paragraph (a) of this section must be sufficient to enable EPA to make the two determinations listed below. Prior to making these determinations, EPA will consult with the Secretary on the adequacy of the facilities and the operational impact of any prohibition on Armed Forces vessels.
(1) Adequate facilities for the safe and sanitary removal of the discharge are reasonably available for the specified waters.
(2) The prohibition will not have the effect of discriminating against vessels of the Armed Forces by reason of the ownership or operation by the Federal
(c) EPA will notify the State in writing of the result of the determinations under paragraph (b) of this section, and will provide a written explanation of any negative determinations. A no-discharge zone established by State prohibition will not go into effect until EPA determines that the conditions of paragraph (b) of this section have been met.
(a) A State requesting EPA to establish a no-discharge zone must send to the Administrator an application containing the following information:
(1) The discharge from § 1700.4 or § 1700.5 to be prohibited within the no-discharge zone.
(2) A detailed description of the waterbody, or portions thereof, to be included in the prohibition. The description must include a map, preferably a USGS topographic quadrant map, clearly marking the zone boundaries by latitude and longitude.
(3) A technical analysis showing why protection and enhancement of the waters described in paragraph (a)(2) of this section require a prohibition of the discharge. The analysis must provide specific information on why the discharge adversely impacts the zone and how prohibition will protect the zone. In addition, the analysis should characterize any sensitive areas, such as aquatic sanctuaries, fish-spawning and nursery areas, pristine areas, areas not meeting water quality standards, drinking water intakes, and recreational areas.
(4) A complete description of the facilities reasonably available for collecting the discharge including:
(i) A map showing their location(s) and a written location description.
(ii) A demonstration that the facilities have the capacity and capability to provide safe and sanitary removal of the volume of discharge being prohibited in terms of both vessel berthing and discharge reception.
(iii) The schedule of operating hours of the facilities.
(iv) The draft requirements of the vessel(s) that will be required to use the facilities and the available water depth at the facilities.
(v) Information showing that handling of the discharge at the facilities is in conformance with Federal law.
(5) Information on whether vessels other than those of the Armed Forces are subject to the same type of prohibition. If the State is not applying a prohibition to other vessels in the area, the State must demonstrate the technical or environmental basis for applying a prohibition only to Armed Forces vessels. The following information must be included in the technical or environmental basis for treating Armed Forces vessels differently:
(i) An analysis showing the relative contributions of the discharge from Armed Forces and non-Armed Forces vessels.
(ii) A description of State efforts to control the discharge from non-Armed Forces vessels.
(b) The information provided under paragraph (a) of this section must be sufficient to enable EPA to make the three determinations listed below. Prior to making these determinations, EPA will consult with the Secretary on the adequacy of the facilities and the operational impact of the prohibition on Armed Forces vessels.
(1) The protection and enhancement of the specified waters require a prohibition of the discharge.
(2) Adequate facilities for the safe and sanitary removal of the discharge are reasonably available for the specified waters.
(3) The prohibition will not have the effect of discriminating against vessels of the Armed Forces by reason of the ownership or operation by the Federal Government, or the military function, or the vessels.
(c) If the three conditions in paragraph (b) of this section are met, EPA will by regulation establish the no-discharge zone. If the conditions in paragraphs (b) (1) and (3) of this section are met, but the condition in paragraph (b)(2) of this section is not met, EPA may establish the no-discharge zone if it determines that the significance of the waters and the potential impact of the discharge are of sufficient magnitude to warrant any resulting constraints on Armed Forces vessels.
(d) EPA will notify the State of its decision on the no-discharge zone application in writing. If EPA approves the no-discharge zone application, EPA will by regulation establish the no-discharge zone by modification to this part. A no-discharge zone established by EPA prohibition will not go into effect until the effective date of the regulation.
The Governor of any State may submit a petition requesting that the Administrator and Secretary review a determination of whether a Marine Pollution Control Device is required for any discharge listed in § 1700.4 or § 1700.5, or review a Federal standard of performance for a Marine Pollution Control Device. A State may submit a petition only where there is new, significant information not considered previously by the Administrator and Secretary.
A petition for review of a determination or standard must include:
(a) The discharge from § 1700.4 or § 1700.5 for which a change in determination is requested, or the performance standard from § 1700.14 for which review is requested.
(b) The scientific and technical information on which the petition is based.
(c) A detailed explanation of why the State believes that consideration of the new information should result in a change to the determination or the standard on a nationwide basis, and an explanation of how the new information is relevant to one or more of the following factors:
(1) The nature of the discharge.
(2) The environmental effects of the discharge.
(3) The practicability of using a Marine Pollution Control Device.
(4) The effect that installation or use of the Marine Pollution Control Device would have on the operation or operational capability of the vessel.
(5) Applicable United States law.
(6) Applicable international standards.
(7) The economic costs of the installation and use of the Marine Pollution Control Device.
The Administrator and the Secretary will evaluate the petition and grant or deny the petition no later than two years after the date of receipt of the petition. If the Administrator and Secretary grant the petition, they will undertake rulemaking to amend this part. If the Administrator and Secretary deny the petition, they will provide the State with a written explanation of why they denied it.
A list of CFR titles, subtitles, chapters, subchapters and parts and an alphabetical list of agencies publishing in the CFR are included in the CFR Index and Finding Aids volume to the Code of Federal Regulations which is published separately and revised annually.
Material Approved for Incorporation by Reference
Table of CFR Titles and Chapters
Alphabetical List of Agencies Appearing in the CFR
List of CFR Sections Affected
The Director of the Federal Register has approved under 5 U.S.C. 552(a) and 1 CFR Part 51 the incorporation by reference of the following publications. This list contains only those incorporations by reference effective as of the revision date of this volume. Incorporations by reference found within a regulation are effective upon the effective date of that regulation. For more information on incorporation by reference, see the preliminary pages of this volume.
All changes in this volume of the Code of Federal Regulations which were made by documents published in the
Title 40 was established at 36 FR 12213, June 29, 1971. For the period before January 1, 2001, see the “List of CFR Sections Affected, 1964-1972, 1973-1985, and 1986-2000”, published in ten separate volumes.