[Title 40 CFR R]
[Code of Federal Regulations (annual edition) - July 1, 1996 Edition]
[Title 40 - PROTECTION OF ENVIRONMENT]
[Chapter I - ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)]
[Subchapter R - TOXIC SUBSTANCES CONTROL ACT--(Continued)]
[From the U.S. Government Publishing Office]
40
PROTECTION OF ENVIRONMENT
18
1996-07-01
1996-07-01
false
TOXIC SUBSTANCES CONTROL ACT--(Continued)
R
SUBCHAPTER R
PROTECTION OF ENVIRONMENT
ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
SUBCHAPTER R--TOXIC SUBSTANCES CONTROL ACT--(Continued)
PART 790--PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES--Table of Contents
Subpart A--General Provisions
Sec.
790.1 Scope, purpose, and authority.
790.2 Applicability.
790.3 Definitions.
790.5 Submission of information.
790.7 Confidentiality.
Subpart B--Procedures for Developing Consent Agreements and Test Rules
790.20 Recommendation and designation of testing candidates by the ITC.
790.22 Procedures for gathering information and negotiating consent
agreements on chemicals which the ITC has recommended for
testing with an intent to designate.
790.24 Criteria for determining whether a consensus exists concerning
the provisions of a draft consent agreement.
790.26 Initiation and completion of rulemaking proceedings on ITC-
designated chemicals.
790.28 Procedures for developing consent agreements and/or test rules
for chemicals that have not been designated or recommended
with intent to designate by the ITC.
Subpart C--Implementation, Enforcement, and Modification of Test Rules
790.40 Promulgation of test rules.
790.42 Persons subject to a test rule.
790.45 Submission of letter of intent to conduct testing or exemption
application.
790.48 Procedure if no one submits a letter of intent to conduct
testing.
790.50 Submission of study plans.
790.52 Phase II test rule.
790.55 Modification of test standards or schedules during conduct of
test.
790.59 Failure to comply with a test rule.
Subpart D--Implementation, Enforcement and Modification of Consent
Agreements
790.60 Contents of consent agreements.
790.62 Submission of study plans and conduct of testing.
790.65 Failure to comply with a consent agreement.
790.68 Modification of consent agreements.
Subpart E--Exemptions From Test Rules
Sec.
790.80 Submission of exemption applications.
790.82 Content of exemption application.
790.85 Submission of equivalence data.
790.87 Approval of exemption applications.
790.88 Denial of exemption application.
790.90 Appeal of denial of exemption application.
790.93 Termination of conditional exemption.
790.97 Hearing procedures.
790.99 Statement of financial responsibility.
Appendix A to Subpart E--Schedule for Developing Consent Agreements and
Test Rules
Authority: 15 U.S.C. 2603.
Subpart A--General Provisions
Sec. 790.1 Scope, purpose, and authority.
(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.
[[Page 6]]
(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.
[51 FR 23712, June 30, 1986]
Sec. 790.2 Applicability.
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.
[51 FR 23712, June 30, 1986]
Sec. 790.3 Definitions.
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:
Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.
Additive means a chemical substance that is intentionally added to
another chemical substance to improve its stability or impart some other
desirable quality.
Chemical means a chemical substance or mixture.
Consortium means an association of manufacturers and/or processors
who have made an agreement to jointly sponsor testing.
EPA means the U.S. Environmental Protection Agency.
Equivalence data means chemical data or biological test data
intended to show that two substances or mixtures are equivalent.
Equivalent means that a chemical substance or mixture is able to
represent or substitute for another in a test or series of tests, and
that the data from one substance can be used to make scientific and
regulatory decisions concerning the other substance.
Exemption means an exemption from a testing requirement of a test
rule promulgated under section 4 of the Act and part 799 of this
chapter.
Impurity means a chemical substance which is uninitentionally
present with another chemical substance.
Joint sponsor means a person who sponsors testing pursuant to
section 4(b)(3)(A) of the Act.
Joint sponsorship means the sponsorship of testing by two or more
persons in accordance with section
4(b)(3)(A) of the Act.
Person means an individual, partnership, corporation, association,
scientific or academic establishment, or organizational unit thereof,
and any other legal entity.
Principal sponsor means an individual sponsor or the joint sponsor
who assumes primary responsibility for the direction of a study and for
oral and written communication with EPA.
Protocol means the plan and procedures which are to be followed in
conducting a test.
Reimbursement period refers to a period that begins when the data
from the last non-duplicative test to be completed under a test rule are
submitted to EPA and ends after an amount of time equal to that which
had been required to develop data or after five years, whichever is
later.
Sponsor means the person or persons who design, direct and finance
the testing of a substance or mixture.
Test substance means the form of chemical substance or mixture that
is specified for use in testing.
[49 FR 39782, Oct. 10, 1984, as amended at 51 FR 23712, June 30, 1986]
Sec. 790.5 Submission of information.
(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
[[Page 7]]
Office (7407), Office of Pollution Prevention and Toxics, U.S.
Environmental Protection Agency, Room G-099, 401 M St., SW., Washington,
DC 20460, ATTN: TSCA Section 4.
[50 FR 20656, May 17, 1985, as amended at 51 FR 23712, June 30, 1986; 58
FR 34205, June 23, 1993; 60 FR 31922, June 19, 1995; 60 FR 34466, July
3, 1995]
Sec. 790.7 Confidentiality.
(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 Secs. 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.
[49 FR 39782, Oct. 10, 1984, as amended at 51 FR 23713, June 30, 1986]
Subpart B--Procedures for Developing Consent Agreements and Test Rules
Source: 51 FR 23713, June 30, 1986, unless otherwise noted.
Sec. 790.20 Recommendation and designation of testing candidates by the ITC.
(a) Recommendations with intent to designate. The ITC has advised
EPA that it will discharge its responsibilities under section 4(e) of
the Act in the following manner:
[[Page 8]]
(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) EPA consideration of ITC recommendations. (1) Where a substance
or mixture is designated for EPA action under section 4(e)(1)(B) of the
Act, the Agency will take either one of the following actions within 12
months after receiving the ITC designation:
(i) Initiate rulemaking proceedings under section 4(a) of the Act.
(ii) Publish a Federal Register notice explaining the Agency's
reasons for not initiating such rulemaking proceedings. EPA may conclude
that rulemaking proceedings under section 4(a) of the Act are
unnecessary if it determines that the findings specified in section 4(a)
of the Act cannot be made or if the Agency has entered into a consent
agreement requiring testing in accordance with the provisions of this
subpart.
(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 Federal Register notice explaining the Agency's
reasons for concluding that testing is unnecessary.
(iii) Entering into a consent agreement in accordance with this
subpart.
Sec. 790.22 Procedures for gathering information and negotiating consent agreements on chemicals which the ITC has recommended for testing with an intent to
designate.
(a) Preliminary EPA evaluation. Following receipt of an ITC report
containing a recommendation with an intent to designate, EPA will use
the following procedure for completing a preliminary evaluation of
testing needs. Appendix A\1\ to this part presents the schedule that EPA
intends to follow for this purpose.
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\1\Editorial Note: Appendix A appears at the end of subpart E.
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(1) EPA will publish the ITC report in the Federal Register and
announce that interested persons have 30 days to submit comments on the
ITC's testing recommendations.
(2) EPA will publish a Federal Register notice adding all ITC-
recommended chemicals to the automatic reporting provisions of its rules
under sections 8(a) and 8(d) of the Act (40 CFR parts 712 and 716).
(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.
[[Page 9]]
(6) EPA will hold a public meeting to announce its preliminary
testing determinations.
(b) Negotiation procedures for consent agreements. Where EPA
believes that testing is necessary, the Agency will explore whether a
consent agreement can be negotiated that satisfies the testing needs
identified by the Agency. EPA will use the following procedures for
negotiating, formulating and accepting consent agreements. Appendix A\1\
to this part presents the schedule that EPA intends to follow for this
purpose.
(1) In the Federal Register notice described in paragraph (a)(1) of
this section, EPA will explain its procedures and timetable for
negotiating consent agreements and invite persons interested in
participating in or monitoring negotiations to contact the Agency in
writing.
(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 Sec. 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
Federal Register notice that summarizes the agreement, describes the ITC
recommendations for the test substance, outlines the chemical's use and
exposure characteristics, and explains the background, objectives and
rationale of the testing to be conducted, and codifies in subpart C of
part 799 the name of the substance(s) to be tested and the citation to
the Federal Register notice of the agreement.
[[Page 10]]
Sec. 790.24 Criteria for determining whether a consensus exists concerning the provisions of a draft consent agreement.
(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 Sec. 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 Sec. 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.
Sec. 790.26 Initiation and completion of rulemaking proceedings on ITC-designated chemicals.
(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\1\ to this part.
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\1\Editorial Note: Appendix A appears at the end of subpart E.
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(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\1\ to this part.
Sec. 790.28 Procedures for developing consent agreements and/or test rules for chemicals that have not been designated or recommended with intent to designate
by the ITC.
(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 Federal
Register notice describing its tentative evaluation of testing needs,
announcing a date for a public course-setting meeting, and inviting
persons interested in participating in or monitoring negotiations to
[[Page 11]]
contact the Agency in writing. Any negotiations that EPA conducts will
conform to the procedures specified in Sec. 790.22(b) and, to the extent
feasible, will follow the schedules presented in appendix A\1\ to this
part.
(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
Sec. 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\1\ to this part.
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\1\Editorial Note: Appendix A appears at the end of subpart E.
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Subpart C--Implementation, Enforcement, and Modification of Test Rules
Source: 50 FR 20657, May 17, 1985, unless otherwise noted.
Redesignated at 51 FR 23713, June 30, 1986.
Sec. 790.40 Promulgation of test rules.
(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 Secs. 790.50 and 790.52.
[50 FR 20657, May 17, 1985. Redesignated and amended at 51 FR 23713,
June 30, 1986; 54 FR 36313, Sept. 1, 1989]
Sec. 790.42 Persons subject to a test rule.
(a) Each test rule described in Sec. 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
[[Page 12]]
Act and will indicate who will be required to submit letters of intent
to conduct testing.
(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 Sec. 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 Sec. 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 Sec. 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]
[50 FR 20657, May 17, 1985. Redesignated at 51 FR 23713, June 30, 1986,
and amended at 55 FR 18884, May 7, 1990]
Sec. 790.45 Submission of letter of intent to conduct testing or exemption application.
(a) No later than 30 days after the effective date of a test rule
described in Sec. 790.40, each person subject to that rule and required
to comply with the requirements of that rule as provided in
Sec. 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.
[[Page 13]]
(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
Sec. 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 Sec. 790.40 or by 30 days after
publication of the Federal Register notice described in
Sec. 790.48(b)(2) who, before the end of the reimbursement period,
processes the test chemical and who is required to comply with the
requirements of the rule must submit the letter of intent to test or an
exemption application required by Sec. 790.48(b)(3) of the date
processing begins.
(e) Manufacturers subject to a test rule described in Sec. 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 Sec. 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 Sec. 790.40 and
required to comply with the requirements of test rule pursuant to
Sec. 790.42(a)(2) or a Federal Register notice as described in
Sec. 790.48(b)(2) who do not submit to EPA either a letter of their
intent to conduct tests or a request for an exemption 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 Sec. 790.40 or 31 days after
publication of the Federal Register notice described in
Sec. 790.48(b)(2) or on the date processing begins as described in
paragraph (d) of this section, as appropriate.
Sec. 790.48 Procedure if no one submits a letter of intent to conduct testing.
(a) If only manufacturers are subject to the rule. (1) This
paragraph applies if testing is being required solely to allow
evaluation of risks associated with manufacturing and the test rule
described in Sec. 790.40 states that manufacturers only are responsible
for testing.
(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 Sec. 790.40, EPA
will notify all manufacturers, including those described in
Sec. 790.42(a)(4) and (a)(5), by certified mail or by publishing a
notice of this fact in the Federal Register specifying the tests for
which no letter of intent has been submitted and will give such
manufacturers an opportunity to take corrective action.
(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 Federal Register notice described in
paragraph (a)(2) of this section, all manufacturers subject to the rule
will be in violation of the test rule from the 31st day after receipt of
the certified letter or publication of the Federal Register notice
described in this paragraph.
(b) If manufacturers and processors are subject to the rule. (1)
This paragraph applies 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 the test
rule described in Sec. 790.40 states that manufacturers and processors
are responsible for testing.
(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
Sec. 790.40, EPA will publish a notice in the Federal Register of this
fact
[[Page 14]]
specifying the tests for which no letter of intent has been submitted.
(3) No later than 30 days after the date of publication of the
Federal Register notice described in paragraph (b)(2) of this section,
each person described in Sec. 790.40(a)(4) and (5) and each person
processing the subject chemical as of the effective date of the test
rule described in Sec. 790.40 or by 30 days after the date of
publication of the Federal Register notice described in paragraph (b)(2)
of this section must, for each test specified in the Federal Register
notice, 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.
(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 Federal
Register notice described in paragraph (b)(2) of this section, EPA will
notify all manufacturers and processors by certified letter or publish a
Federal Register notice of this fact specifying the tests for which no
letter of intent has been submitted. This letter or Federal Register
notice will give the manufacturers and processors an opportunity to take
corrective action.
(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 Federal Register notice
described in paragraph (b)(4) of this section, all manufacturers and
processors subject to the rule will be in violation of the test rule
from the 31st day after receipt of the certified letter or publication
of the Federal Register notice described in paragraph (b)(4) of this
section.
(c) Only processors are subject to the rule. (1) This paragraph
applies if testing is being required solely to allow evaluation of risks
associated with processing and the test rule described in Sec. 790.40
states that only processors are responsible for testing.
(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 Sec. 790.40, EPA will
notify all the processors by certified mail or publish a notice in the
Federal Register of this fact, specifying the tests for which no letter
of intent has been submitted and give the processors an opportunity to
take corrective action.
(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 Federal Register notice described in
paragraph (c)(2) of this section, all processors subject to the rule
will be in violation of the test rule from the 31st day after receipt of
the certified letter or publication of the Federal Register notice
described in this paragraph.
[50 FR 20657, May 17, 1985. Redesignated at 51 FR 23713, June 30, 1986,
and amended at 55 FR 18884, May 7, 1990]
Sec. 790.50 Submission of study plans.
(a) Who must submit study plans. (1) Persons who notify EPA of their
intent to conduct tests in compliance with the requirements of a single
phase test rule as described in Sec. 790.40(b)(1) must submit study
plans for those tests prior to the initiation of each of these tests,
unless directed by a particular test rule or consent agreement to submit
study plans at a specific time.
(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
Sec. 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 Sec. 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 Sec. 790.45(d), as
appropriate, to the address in Sec. 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
[[Page 15]]
required by the rule at any time, regardless of whether the person
previously submitted an application for exemption from testing for that
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 Sec. 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 Sec. 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 Sec. 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 Sec. 790.48(b)(2), or 60 days after the date
processing begins as described in Sec. 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) Extensions of time for submission of study plans. (1) EPA may
grant requests for additional time for the development of study plans on
a case-by-case basis. Requests for additional time for study plan
development must be made in writing to EPA at the address in
Sec. 790.5(b). Each extension request must state why EPA should grant
the extension.
(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 Sec. 790.40(b)(2); or for processors complying with the
notice described in Sec. 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 Sec. 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
Sec. 790.45(e) and (f).
(c) Content of study plans. (1) All study plans are required to
contain the following information:
(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) (1) The names and addresses of the testing facilities and the
names, addresses, and telephone numbers of the testing facilities'
administrative officials and project manager(s) responsible for the
testing.
(2) 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),
microbiologist(s), and laboratory assistants.
(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
[[Page 16]]
and contaminants and their concentrations; for in vitro test systems, a
description of culture medium and its source; and a summary of expected
spontaneous chronic diseases (including tumors), genealogy, and life
span.
(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) Incomplete study plans. (1) Upon receipt of a study plan, EPA
will review the study plan to determine whether it complies with
paragraph (c) of this section. If EPA determines that the study plan
does not comply with paragraph (c) of this section, EPA will notify the
submitter that the submission is incomplete and will identify the
deficiencies and the steps necessary to complete the submission.
(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 Sec. 790.45(e) and (f).
(e) Amendments to study plans. Test sponsors shall submit all
amendments to study plans to the Director, Office of Compliance
Monitoring at the address in Sec. 790.5(d).
[50 FR 20657, May 17, 1985. Redesignated and amended at 51 FR 23713,
June 30, 1986; 52 FR 36569, Sept. 30, 1987; 54 FR 36313, Sept. 1, 1989;
55 FR 18884, May 7, 1990; 58 FR 34205, June 23, 1993; 60 FR 34466, July
3, 1995]
Sec. 790.52 Phase II test rule.
(a) If EPA determines that the proposed study plan described in
Sec. 790.50(a)(2) complies with Sec. 790.50(c), EPA will publish a
proposed Phase II test rule in the Federal Register requesting comments
on the ability of the proposed study plan to ensure that data from the
test will be reliable and adequate.
(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 Sec. 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 Sec. 790.50(c)(1)(vi) of this chapter, as the
schedule for the required testing in a final Phase II test rule.
[50 FR 20657, May 17, 1985. Redesignated at 51 FR 23713, June 30, 1986,
and amended at 52 FR 36569, Sept. 30, 1987]
Sec. 790.55 Modification of test standards or schedules during conduct of test.
(a) Application. Any test sponsor who wishes to modify the test
schedule for the mandatory testing conditions or requirements (i.e.,
``shall statements'') in the test standard for any test required by a
test rule must submit an application in accordance with this paragraph.
Application for modification must be made in writing to EPA at the
address in Sec. 790.5(b), or by phone with written confirmation to
follow within 10 working days. Applications must include an appropriate
explanation and rationale for the modification. Where a test sponsor
requests EPA to provide guidance or to clarify a non-mandatory testing
requirement (i.e., ``should statements'') in a test standard, the test
sponsor should submit these requests to EPA at the address in
Sec. 790.5(b).
[[Page 17]]
(b) Adoption. (1) Where EPA concludes that the requested
modification of a test standard or schedule for a test required under a
test rule is appropriate, EPA will proceed in accordance with this
paragraph (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 Federal Register indicating the test standards or schedules for
tests required in test rules which have been modified under this
paragraph (b)(2) and describing the nature of the modifications. Until
the Federal Register notice is published, any modification approved by
EPA under this paragraph (b)(2) shall apply only to the test sponsor who
applied for the modification under this paragraph (a) of this section.
(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 Federal Register requesting comment on the
proposed modification. However, EPA will approve a requested
modification of a test standard under paragraph (b)(3) of this section
without first seeking public comment if EPA believes that an immediate
modification to the test standard is necessary to preserve the accuracy
or validity of an ongoing test. EPA may also modify a testing
requirement or test condition in a test standard if EPA determines that
the completion or achievement of this requirement or condition is not
technically feasible. EPA may approve a test schedule extension under
paragraph (b)(3) of this section without first seeking public comment if
EPA determines, on a case-by-case basis, that a delay of over 12 months
is not the fault of the test sponsor and is the result of unforeseen
circumstances such as a lack of laboratory availability, lack of
availability of suitable test substance (e.g., 14-C labelled test
substance), lack of availability of healthy test organisms, or the
unexpected failure of a long-term test. EPA will publish an annual
notice in the Federal Register announcing the approval of any test
standard modifications and test schedule extensions under paragraph
(b)(3) of this section and provide a brief rationale of why the
modification was granted.
(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) Disapproval. Where EPA concludes that the requested modification
of a test standard or schedule for a test required under a test rule is
not appropriate, EPA will so notify the test sponsor in writing.
(d) Timing. (1) Test sponsors should submit all applications for
test schedule modifications at least 60 days before the reporting
deadline for the test in question.
(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
[[Page 18]]
cannot be successfully completed according to the test standard
specified in the rule.
[50 FR 20657, May 17, 1985. Redesignated at 51 FR 23713, June 30, 1986,
and amended at 52 FR 36571, Sept. 30, 1987; 54 FR 36314, Sept. 1, 1989;
60 FR 34466, July 3, 1995]
Sec. 790.59 Failure to comply with a test rule.
(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 Sec. 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 Sec. 792.17 of this
chapter.
Subpart D--Implementation, Enforcement and Modification of Consent
Agreements
Source: 51 FR 23715, June 30, 1986, unless otherwise noted:
Sec. 790.60 Contents of consent agreements.
(a) Standard provisions. All consent agreements will contain the
following provisions:
(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 Sec. 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 Federal
Register the Administrator's reason for not initiating such a
proceeding.
(15) A statement that the Agency may conduct laboratory inspections
[[Page 19]]
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) Contents of standards for the development of data. The standards
for the development of the data included in consent agreements will be
based on the TSCA test guidelines in 40 CFR parts 796, 797, and 798, the
Organization for Economic Cooperation and Development (OECD) test
guidelines, the EPA pesticide assessment guidelines published by The
National Technical Information Service (NTIS), or other suitable test
methodologies. During the negotiation of consent agreements, EPA will
initially propose suitable test guidelines as the required test
standards; manufacturers and processors or other interested parties may
then suggest alternative methodologies or modifications to the Agency's
proposed guidelines. These alternative methodologies or modifications
will be adopted only where, in the judgment of EPA, they will develop at
least equally reliable and adequate data on the chemical substance or
mixture subject to the agreement.
(c) Statement of rationale for consent agreement. EPA will prepare a
written explanation of the basis for each consent agreement. This
document will summarize the agreement, describe any ITC testing
recommendations for the chemical involved, outline the chemical's use
and exposure characteristics, and explain the objectives of the testing
to be conducted and the rationale for the specific studies selected.
This document will be published in the Federal Register and, for ITC-
designated chemicals, will constitute the statement of EPA's reasons for
not initiating rulemaking required by section 4(e)(1)(B) of the Act.
[51 FR 23715, June 30, 1986, as amended at 54 FR 36314, Sept. 1, 1989]
Sec. 790.62 Submission of study plans and conduct of testing.
(a) Timing of submission. The principal sponsor of testing conducted
pursuant to a consent agreement shall submit a study plan no later than
45 days prior to the initiation of testing.
(b) Content of study plans. All study plans are required to contain
the following information:
(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],
microbiologist[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 in vitro test systems, a
description of culture medium and its source; and a summary of expected
spontaneous chronic diseases (including tumors), genealogy, and life
span.
[[Page 20]]
(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) Review and modification. (1) Upon receipt of a study plan, EPA
will review it to determine whether it complies with paragraph (b) of
this section. If EPA determines that the study plan does not comply with
paragraph (b) of this section, EPA will notify the submitter that the
plan is incomplete and will identify the deficiencies and the steps
necessary to complete the plan. It is the responsibility of the test
sponsor to review the study protocols to determine if they comply with
all the mandatory testing conditions and requirements in the test
standards (i.e., ``shall statements'').
(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 Sec. 790.65 (c) and (d).
(4) The test sponsor shall submit any amendments to study plans to
EPA at the address specified in Sec. 790.5(b).
(d) Functions of the principal test sponsor. When testing is being
conducted pursuant to a consent agreement, the principal test sponsor
will be responsible for submitting interim progress and final reports to
EPA, informing the Agency of any proposed changes in standards for the
development of data, study plans or testing schedules, and communicating
with the Agency about laboratory inspections and other matters affecting
the progress of testing.
[51 FR 23715, June 30, 1986, as amended at 54 FR 36314, Sept. 1, 1989;
60 FR 34466, July 3, 1995]
Sec. 790.65 Failure to comply with a consent agreement.
(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 Sec. 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.
Sec. 790.68 Modification of consent agreements.
(a) Changes in the scope of testing. (1) Manufacturers or processors
subject to a consent agreement, other persons or EPA may seek
modifications in the scope of testing performed under the consent
agreement. If, upon receiving a request for modification, EPA determines
that new issues have been raised that warrant reconsideration of the
scope of testing, or if EPA determines
[[Page 21]]
on its own that such reconsideration is appropriate, EPA will publish a
Federal Register notice describing the proposed modification and
soliciting public comment. If, based on the comments received, EPA
concludes that differences of opinion may exist about the proposed
modification, EPA will establish a schedule for conducting negotiations
and invite parties who wish to participate in or monitor these
negotiations to contact the Agency in writing. Any negotiations that EPA
conducts will conform to the procedures specified in Sec. 790.22(b).
(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 Sec. 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) Changes in test standards or schedules. (1) Any test sponsor who
wishes to modify the test schedule for any test required under a consent
order must submit an application in accordance with this paragraph.
Application for modification must be made in writing to EPA at the
address in Sec. 790.5(b), or by phone with written confirmation to
follow within 10 working days. Applications must include an appropriate
explanation and rationale for the modification. EPA will consider only
those applications that request modifications to mandatory testing
conditions or requirements (``shall statements'' in the consent order).
Where a test sponsor requests EPA to provide guidance or to clarify a
non-mandatory testing requirement (i.e., ``should statements''), the
test sponsor should submit these requests to EPA at the address in
section 790.5(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 Federal Register indicating the test standards or
schedules for test required in consent agreements which have been
modified under this paragraph (b)(2)(ii) and describing the nature of
the modifications.
(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 Federal Register requesting comment on the
proposed modification. However, EPA will approve a requested
modification of a test standard under paragraph (b)(2)(iii) of this
section without first seeking public comment if EPA believes that an
immediate modification to the test standard is necessary to preserve the
accuracy or validity of an ongoing test. EPA also may modify a testing
requirement or test condition in a test standard if EPA determines that
the completion or achievement of this requirement or condition is not
technically feasible. EPA may approve a requested modification of a test
schedule under paragraph (b)(2)(iii) of this section without first
seeking public comment if EPA determines, on a case-by-case basis, that
a delay of over 12 months is not the fault of the test sponsor and is
due
[[Page 22]]
to unforeseen circumstances such as a lack of laboratory availability,
lack of availability of suitable test substance (e.g., 14-C labelled
test substance), lack of availability of healthy test organisms, or the
unexpected failure of a long-term test. EPA will publish an annual
notice in the Federal Register announcing the approval of any test
standard modifications and test scheduled extensions under paragraph
(b)(2)(iii) of this section, and provide a brief rationale of why the
modification was granted.
(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) Timing. (1) Test sponsors should submit all applications for
test schedule modifications at least 60 days before the reporting
deadline for the test in question.
(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.
[51 FR 23715, June 30, 1986, as amended at 52 FR 36571, Sept. 30, 1987;
54 FR 36314, Sept. 1, 1989; 60 FR 34466, July 3, 1995]
Subpart E--Exemptions From Test Rules
Source: 50 FR 20660, May 17, 1985, unless otherwise noted.
Sec. 790.80 Submission of exemption applications.
(a) Who should file applications. (1) Any manufacturer or processor
subject to a test rule in part 799 of this chapter may submit an
application to EPA for an exemption from performing any or all of the
tests required under the test rule.
(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
Federal Register notice as described in Sec. 790.48(b)(2) under the
following circumstances:
(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) When applications must be filed. (1) Exemption applications must
be filed within 30 days after the effective date of the test rule
described in Sec. 790.40 or, if being submitted in compliance with the
Federal Register notice described in Sec. 790.48(b)(2), within 30 days
after the publication of that notice.
(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
Sec. 790.40 or by 30 days after the effective date of the test rule
described in Sec. 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
[[Page 23]]
intent to test or an exemption application.
(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 Sec. 790.40 or by 30 days after publication of the Federal
Register notice described in Sec. 790.48(b)(2) who, before the end of
the reimbursement period, processes the test substance and who is
subject to the requirement to submit either a letter of intent to test
or an exemption application.
(c) Scope of application. A person may apply for an exemption from
all, or one or more, specific testing requirements in a test rule in
part 799 of this chapter.
[50 FR 20660, May 17, 1985, as amended at 58 FR 34205, June 23, 1993]
Sec. 790.82 Content of exemption application.
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 Sec. 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 Sec. 790.85.
[50 FR 20660, May 17, 1985, as amended at 54 FR 36315, Sept. 1, 1989]
Sec. 790.85 Submission of equivalence data.
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.
Sec. 790.87 Approval of exemption applications.
(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
[[Page 24]]
required data have been or are being submitted in accordance with a test
rule; and
(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 Federal Register notice in single-phase
rulemaking, or a letter by certified mail will give exemption applicants
final notice that they have received a conditional exemption. All
conditional exemptions thus granted are contingent upon the test
sponsors' successful completion of testing according to the
specifications in the test rule.
Sec. 790.88 Denial of exemption application.
(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 Sec. 790.82; or
(3) The exemption applicant fails to submit any of the information
specified in Sec. 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 Sec. 790.55.
(b) EPA will notify the exemption applicant by certified mail or
Federal Register notice of EPA's determination that the exemption
application is denied.
Sec. 790.90 Appeal of denial of exemption application.
(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
Sec. 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 Federal
Register notice described in Sec. 790.88(b). Hearing requests must
provide reasons why a hearing is necessary.
(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.
[[Page 25]]
Sec. 790.93 Termination of conditional exemption.
(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
Sec. 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 Sec. 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 Federal
Register notice of EPA's intent to terminate that conditional exemption.
(c) Within 30 days after receipt of a letter of notification or
publication of a notice in the Federal Register that EPA intends to
terminate a conditional exemption, the exemption holder may submit
information to rebut EPA's preliminary decision or notify EPA by letter
of its intent to conduct the required test pursuant to the test standard
established in the final test rule. Such a letter of intent shall
contain all of the information required by Sec. 790.45(c).
(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 Sec. 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 Federal
Register notice described in paragraph (b) of this section.
(e) EPA will notify the exemption holder by certified letter or by
Federal Register notice of EPA's final decision concerning termination
of conditional exemptions and will give instructions as to what actions
the former exemption holder must take to avoid being found in violation
of the test rule.
Sec. 790.97 Hearing procedures.
(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.
Sec. 790.99 Statement of financial responsibility.
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.
Appendix A to Subpart E--Schedule for Developing Consent Agreements and
Test Rules
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.
------------------------------------------------------------------------
Week \1\ Event
------------------------------------------------------------------------
0............................. Receive ITC report, recommendation.
2............................. Publish ITC report, 8(a) and 8(d)
notices, and invitation for public
participation in negotiations.
[[Page 26]]
3-6........................... Comment period on ITC report.
6............................. Public focus meeting.
7-14.......................... 8(a) and 8(d) reporting period.
22............................ Public meeting on course-setting
decision and deadline for requests to
participate in negotiations.
22-30......................... Negotiations.
32............................ EPA decision point: consent agreement or
test rule.
------------------------------------------------------------------------
\1\ The dates contained in the left-hand column are calculated from the
date EPA receives the ITC report recommending a chemical for testing.
------------------------------------------------------------------------
Week Consent Agreement Week Test Rule
------------------------------------------------------------------------
36-40.......... Comment period on 32-60 Rule preparation,
consent agreement. agency review and
sign-off.
42............. Comment resolution 62 Publish proposed rule
meeting if necessary. in Federal
Register.\1\
48............. Sign-off consent 70-106 Agency reviews
agreement and Federal comments;
Register notice. preparation of final
rule or no-test
decision, agency
review and sign-
off.\1\
50............. Publish Federal 108 Publish final rule or
Register notice. no-test decision in
Federal Register.\1\
------------------------------------------------------------------------
\1\ As stated in Sec. 790.26, EPA may publish an Advance Notice of
Proposed Rulemaking (ANPR) where the testing recommendations of the
ITC raise unusually novel and complex issues that require additional
Agency review and opportunity for public comment. EPA intends to
publish such ANPRs by Week 62 following receipt of the initial ITC
report; to publish a proposed rule or decision-not-to-test by Week
108; and to publish a final rule or notice terminating the rulemaking
process by Week 154.
[51 FR 23717, June 30, 1986]
PART 791--DATA REIMBURSEMENT--Table of Contents
Subpart A--General Provisions
Sec.
791.1 Scope and authority.
791.2 Applicability.
791.3 Definitions.
Subpart B--Hearing Procedures
791.20 Initiation of reimbursement proceeding.
791.22 Consolidation of hearings.
791.27 Pre-hearing preparation.
791.29 Appointment of hearing officer.
791.30 Hearing procedures.
791.31 Expedited procedures.
791.34 Serving of notice.
791.37 The award.
791.39 Fees and expenses.
Subpart C--Basis for Proposed Order
791.40 Basis for the proposed order.
791.45 Processors.
791.48 Production volume.
791.50 Costs.
791.52 Multiple tests.
Subpart D--Review
791.60 Review.
Subpart E--Final Order
791.85 Availability of final Agency order.
Subpart F--Prohibited Acts
791.105 Prohibited acts.
Authority: 15 U.S.C. 2603 and 2607.
Source: 48 FR 31791, July 11, 1983, unless otherwise noted.
Subpart A--General Provisions
Sec. 791.1 Scope and authority.
(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)).
Sec. 791.2 Applicability.
(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.
[[Page 27]]
Sec. 791.3 Definitions.
Terms defined in the Act, and not explicitly defined herein, are
used with the meanings given in the Act.
(a) The Act refers to the Toxic Substances Control Act (TSCA) (15
U.S.C. 2601 et seq.).
(b) The Agency or EPA refers to the Environmental Protection Agency.
(c) Byproduct refers to a chemical substance produced without a
separate commercial intent during the manufacture, processing, use or
disposal of another chemical substance or mixture.
(d) Dispute refers to a present controversy between parties subject
to a test rule over the amount or method of reimbursement for the cost
of developing health and environmental data on the test chemical.
(e) Exemption holder refers to a manufacturer or processor, subject
to a test rule, that has received an exemption under sections 4(c)(1) or
4(c)(2) of TSCA from the requirement to conduct a test and submit data.
(f) Impurity refers to a chemical substance unintentionally present
with another chemical substance or mixture.
(g) A party refers to a person subject to a section 4 test rule,
who:
(1) Seeks reimbursement from another person under these rules, or
(2) From whom reimbursement is sought under these rules.
(h) Reimbursement period refers to a period that begins when the
data from the last non-duplicative test to be completed under a test
rule is submitted to EPA and ends after an amount of time equal to that
which had been required to develop that data or after 5 years, whichever
is later.
(i) Small business refers to a manufacturer or importer whose annual
sales, when combined with those of its parent company (if any) are less
than $30 million.
(j) Test rule refers to a regulation ordering the development of
data on health or environmental effects or chemical fate for a chemical
substance or mixture pursuant to TSCA section 4(a).
Subpart B--Hearing Procedures
Sec. 791.20 Initiation of reimbursement proceeding.
(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.
Sec. 791.22 Consolidation of hearings.
(a) Promptly upon receipt of the request for a hearing, the
Administrator will publish a notice in the Federal Register, advising
those subject to the test rule that a request for a hearing has been
made.
(b) Any other person wishing to participate in the hearing shall so
notify EPA within 45 days of the Federal Register notice. EPA will
promptly inform the regional office of the American Arbitration
Association where the request has been filed of the additional parties.
Sec. 791.27 Pre-hearing preparation.
(a) Responses to requests for hearings. After filing of the request
for hearing, if any other party desires to file an answer it shall be
made in writing and filed with the American Arbitration Association, and
a copy thereof shall
[[Page 28]]
be mailed to the other parties within a period of fourteen days from the
date of receiving the complete list of parties. After the hearing
officer is appointed, however, no new or different claim may be
submitted except with the hearing officer's consent.
(b) Pre-hearing conference. At the request of the parties or at the
discretion of the American Arbitration Association, a pre-hearing
conference with a representative of the American Arbitration Association
and the parties or their counsel will be scheduled in appropriate cases
to arrange for an exchange of information and the stipulation of
uncontested facts so as to expedite the proceedings.
(c) Fixing of locale. The parties may mutually agree on the locale
where the hearing is to be held. If the locale is not designated within
45 days from the time the complete list of parties is received, the
American Arbitration Association shall have power to determine the
locale. Its decision shall be final and binding. If any party requests,
and informs the other parties of its request, that the hearing be held
in a specific locale and the other parties file no objection thereto
within 14 days of the request, the locale shall be the one requested.
(d) Time and place. The hearing officer shall fix the time and place
for each hearing. The American Arbitration Association will mail notice
to each party at least 14 days in advance.
Sec. 791.29 Appointment of hearing officer.
(a) Qualifications of hearing officer. All hearing officers shall be
neutral, subject to disqualification for the reasons specified in
paragraph (f) of this section.
(b) Appointment from panel. Promptly after receiving the complete
list of parties at the close of the notice period described in
Sec. 791.22, the American Arbitration Association shall submit
simultaneously to each party to the dispute an identical list of names.
Each party to the dispute shall have thirty days from the mailing date
in which to cross off any names objected to, number the remaining names
to indicate the order of preference, and return the list to the American
Arbitration Association. If a party does not return the list within the
time specified, all persons named therein shall be deemed acceptable to
that party. From among the persons who have been approved on all lists,
and in accordance with the designated order of mutual preference, the
American Arbitration Association shall invite the acceptance of a
hearing officer to serve. If the parties fail to agree upon any of the
persons named, or if acceptable hearing officers are unable to act, or
if for any other reason the appointment cannot be made from the
submitted lists, the American Arbitration Association shall have the
power to make the appointment without the submission of any additional
list.
(c) Nationality of hearing officer in international dispute. If one
of the parties is a national or resident of a country other than the
United States, the hearing officer shall upon the request of any party,
be appointed from among the nationals of a country other than that of
the parties.
(d) Number of hearing officers. The dispute shall be heard and
determined by one hearing officer unless the American Arbitration
Association, in its discretion, directs that a greater number of hearing
officers be appointed.
(e) Notice of appointment. Notice of the appointment of the hearing
officer, together with a copy of these rules, and the signed acceptance
of the hearing officer shall be filed prior to the opening of the first
hearing.
(f) Disclosure and challenge procedure. A person appointed as
hearing officer shall disclose to the American Arbitration Association
any circumstances likely to affect impartiality, including any bias or
any financial or personal interest in the result of the hearing or any
past or present relationship with the parties or their counsel. Upon
receipt of such information from such hearing officer or other source,
the American Arbitration Association shall communicate such information
to the parties, and, if it deems it appropriate to do so, to the hearing
officer and others. Thereafter, the American Arbitration Association
shall determine whether the hearing officer should be disqualified and
shall inform the parties of its decision, which shall be conclusive.
[[Page 29]]
(g) Vacancies. If any hearing officer should resign, die, withdraw,
refuse, be disqualified or be unable to perform the duties of the
office, the American Arbitration Association may, on proof satisfactory
to it, declare the office vacant. Vacancies shall be filled in
accordance with the applicable provisions of these rules and the matter
shall be reheard unless the parties shall agree otherwise.
Sec. 791.30 Hearing procedures.
(a) Representation by counsel. Any party may be represented by
counsel. A party intending to be so represented shall notify the other
parties and the American Arbitration Association of the name and address
of counsel at least 5 days prior to the date set for the hearing at
which counsel is first to appear. When a hearing is initiated by
counsel, or where an attorney replies for the other party, such notice
is deemed to have been given.
(b) Stenographic record. The American Arbitration Association shall
make the necessary arrangements for the taking of a stenographic record.
The parties shall share the cost of such record.
(c) Attendance at hearings. The hearing officer shall have the power
to require the exclusion of anyone, including a party or other essential
person, during the testimony of any witness to protect confidential
business information. It shall be discretionary with the hearing officer
to determine the propriety of the attendance of any other person.
(d) Oaths. Hearing officers shall swear or affirm their neutrality
and their dedication to a fair and equitable resolution. Witnesses shall
swear or affirm that they are telling the truth.
(e) Order of proceedings. (1) A hearing shall be opened by the
filing of the oath of the hearing officer and by the recording of the
place, time and date of the hearing, the presence of the hearing officer
and parties, and counsel, if any, and by the receipt by the hearing
officer of the request for hearing and answer, if any.
(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) Hearing in the absence of a party. A hearing may proceed in the
absence of any party which, after due notice, fails to be present or
fails to obtain an adjournment. An award shall not be made solely on the
default of a party. The hearing officer shall require the parties who
are present to submit such evidence as the hearing officer may require
for the making of an award.
(g) Evidence. (1) The parties may offer such evidence as they desire
and shall produce such additional evidence as the hearing officer may
deem necessary to an understanding and determination of the dispute. The
hearing officer shall be the judge of the relevancy and materiality of
the evidence offered and conformity to legal rules of evidence shall not
be necessary. All evidence shall be taken in the presence of all the
hearing officers and of all the parties, except where any of the parties
is absent in default, has waived the right to be present, or has been
excluded by the hearing officer to protect confidential business
information.
(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) Evidence by affidavit and filing of documents. The hearing
officer shall receive and consider the evidence of witnesses by
affidavit, but shall give it only such weight as the hearing officer
[[Page 30]]
deems it entitled to after consideration of any objections made to its
admission.
(i) Closing of hearings. The hearing officer shall specifically
inquire of all parties whether they have any further proofs to offer or
witnesses to be heard. Upon receiving negative replies, the hearing
officer shall declare the hearings closed and record the time of closing
of the hearing. If briefs are to be filed, the hearings shall be
declared closed as of the final date set by the hearing officer for the
receipt of briefs. If documents are to be filed as provided for in
paragraph (g)(2) of this section and the date set for their receipt is
later than that set for the receipt of briefs, the later date shall be
the date of closing the hearings.
(j) Reopening of hearings. The hearings may be reopened on the
hearing officer's own motion, or upon application of a party at any time
before the award is made. If the reopening of the hearings would prevent
the making of the award within the specified time the matter may not be
reopened, unless the parties agree upon the extension of the time limit.
(k) Waiver of oral hearings. The parties may provide, by written
agreement, for the waiver of oral hearings. If the parties are unable to
agree as to the procedure, the American Arbitration Association shall
specify a fair and equitable procedure.
(l) Waiver of rules. Any party who proceeds with the hearing after
knowledge that any provision or requirement of these rules has not been
complied with and who fails to state objection thereto in writing, shall
be deemed to have waived the right to object.
(m) Extensions of time. The parties may modify any period of time by
mutual agreement. The American Arbitration Association for good cause
may extend any period of time established by these rules, except the
time for making the award. (Sec. 791.37(a)) The American Arbitration
Association shall notify the parties of any such extension of time and
its reason therefor.
(n) Communication with hearing officer. There shall be no direct
communication between the parties and a hearing officer other than at
oral hearings. Any other oral or written communications from the parties
to the hearing officer shall be directed to the American Arbitration
Association for transmittal to the hearing officer.
Sec. 791.31 Expedited procedures.
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) Application of rules. The expedited hearings will be conducted
according to the same procedures as the regular ones, except for those
specifically changed by the expedited rules in this section,
Sec. 791.31.
(b) Notice by telephone. The parties shall accept all notices from
the American Arbitration Association by telephone. Such notices by the
American Arbitration Association shall subsequently be confirmed in
writing to the parties. Notwithstanding the failure to confirm in
writing any notice or objection hereunder, the proceeding shall
nonetheless be valid if notice or obligation has, in fact, been given by
telephone.
(c) Appointment and qualifications of hearing officers. The American
Arbitration Association shall submit simultaneously to each party to the
dispute an identical list of five persons from which one hearing officer
shall be appointed. Each party shall have the right to strike two names
from the list on a peremptory basis. The list is returnable to the
American Arbitration Association within 10 days from the date of
mailing. If for any reasons the appointment cannot be made from the
list, the American Arbitration Association shall have the authority to
make the appointment without the submission of additional lists. Such
appointment shall be subject to disqualification for the reasons
specified in Sec. 791.29(f). The parties shall be given notice by
telephone by the American Arbitration Association of the appointment of
the hearing officer. The parties shall notify the American Arbitration
Association, by telephone, within 7 days of any objections to the
hearing
[[Page 31]]
officer(s) appointed. Any objection by a party to such hearing officer
shall be confirmed in writing to the American Arbitration Association
with a copy to the other parties.
(d) Time and place of hearing. The hearing officer shall fix the
date, time and place of the hearing. The American Arbitration
Association will notify the parties by telephone, 7 days in advance of
the hearing date. Formal notice of hearing will be sent by the American
Arbitration Association to the parties.
(e) The hearing. Generally, the hearing shall be completed within 1
day. The hearing officer, for good cause shown, may schedule an
additional hearing to be held within 5 days.
(f) Time of award. Unless otherwise agreed to by the parties, the
Award shall be rendered not later than 15 business days from the date of
the closing of the hearing.
Sec. 791.34 Serving of notice.
(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.
Sec. 791.37 The award.
(a) Time of award. The award shall be made promptly by the hearing
officer and, unless otherwise agreed by the parties, no later than 30
days from the date of closing the hearings, or if oral hearings have
been waived, from the date of transmitting the final statements and
proofs to the hearing officer.
(b) Form of award. The award shall be in writing and shall be signed
either by the sole hearing officer or by at least a majority if there is
more than one. It shall contain a concise statement of its basis and
rationale, and a timetable for payment of any ordered reimbursement.
(c) Delivery of award to parties. Parties shall accept as legal
delivery of the award the delivery of the award or a true copy thereof
by certified mail to the party at its last known address or to its
attorney, or by personal service.
Sec. 791.39 Fees and expenses.
(a) Administrative fees. (1) As a not-for-profit organization, the
American Arbitration Association shall prescribe an Administrative Fee
Schedule and a Refund Schedule to compensate it for the cost of
providing administrative services. The schedule in effect at the time of
filing or the time of refund shall be applicable.
(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) Expenses. Subject to paragraph (a)(3) of this section, all
expenses of the hearing, including the cost of recording (though not
transcribing) the hearing and required traveling and other expenses of
the hearing officer and of American Arbitration Association
representatives, and the expenses of any witness or the cost of any
proofs produced at the direct request of the hearing officer, shall be
borne equally by the parties, unless they agree otherwise, or unless the
hearing officer, in the award, assesses such expenses or any part
thereof against any specified party or parties.
(c) Hearing officer's fee. Hearing officers will normally serve
without a fee. In prolonged or special cases the American Arbitration
Association in consultation with the Administrator may
[[Page 32]]
determine that payment of a fee by the parties is appropriate and may
establish a reasonable amount, taking into account the extent of service
by the hearing officer and other relevant circumstances of the case. Any
arrangements for compensation shall be made through the American
Arbitration Association and not directly between the parties and the
hearing officer.
Subpart C--Basis for Proposed Order
Sec. 791.40 Basis for the proposed order.
(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:
Vx
Rx = C ---------
Vt
Where:
R=the reimbursement share owed by company X.
C=the total cost of the testing required by the test rule.
Vx=the volume of the test chemical produced or imported by company
X over the period defined by Sec. 791.48.
Vt=the total volume of the test chemical produced or imported over
the period defined by Sec. 791.48.
(c) The burden of proposing modifications to the formula shall lie
with the party requesting the modification.
Sec. 791.45 Processors.
(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 Federal Register notice
pertaining to a test rule expressly obligates processors as well as
manufacturers to assume direct testing and data reimbursement
responsibilities.
(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.
Sec. 791.48 Production volume.
(a) Production volume will be measured over a period that begins one
calendar year before publication of the final test rule in the Federal
Register and continues up to the latest data available upon resolution
of a dispute.
(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.
[[Page 33]]
(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.
Sec. 791.50 Costs.
(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.
Sec. 791.52 Multiple tests.
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.
Subpart D--Review
Sec. 791.60 Review.
(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).
Subpart E--Final Order
Sec. 791.85 Availablity of final Agency order.
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.
Subpart F--Prohibited Acts
Sec. 791.105 Prohibited acts.
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).
PART 792--GOOD LABORATORY PRACTICE STANDARDS--Table of Contents
Subpart A--General Provisions
Sec.
792.1 Scope.
792.3 Definitions.
792.10 Applicability to studies performed under grants and contracts.
792.12 Statement of compliance or non-compliance.
792.15 Inspection of a testing facility.
792.17 Effects of non-compliance.
Subpart B--Organization and Personnel
792.29 Personnel.
[[Page 34]]
792.31 Testing facility management.
792.33 Study director.
792.35 Quality assurance unit.
Subpart C--Facilities
792.41 General.
792.43 Test system care facilities.
792.45 Test system supply facilities.
792.47 Facilities for handling test, control, and reference substances.
792.49 Laboratory operation areas.
792.51 Specimen and data storage facilities.
Subpart D--Equipment
792.61 Equipment design.
792.63 Maintenance and calibration of equipment.
Subpart E--Testing Facilities Operation
792.81 Standard operating procedures.
792.83 Reagents and solutions.
792.90 Animal and other test system care.
Subpart F--Test, Control, and Reference Substances
792.105 Test, control, and reference substance characterization.
792.107 Test, control, and reference substance handling.
792.113 Mixtures of substances with carriers.
Subpart G--Protocol for and Conduct of A Study
792.120 Protocol.
792.130 Conduct of a study.
792.135 Physical and chemical characterization studies.
Subparts H-I--[Reserved]
Subpart J--Records and Reports
792.185 Reporting of study results.
792.190 Storage and retrieval of records and data.
792.195 Retention of records.
Authority: 15 U.S.C. 2603.
Source: 54 FR 34043, Aug. 17, 1989, unless otherwise noted.
Subpart A--General Provisions
Sec. 792.1 Scope.
(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 et seq.).
(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.
Sec. 792.3 Definitions.
As used in this part the following terms shall have the meanings
specified:
Batch means a specific quantity or lot of a test, control, or
reference substance that has been characterized according to
Sec. 792.105(a).
Carrier means any material, including but not limited to, feed,
water, soil, and nutrient media, with which the test substance is
combined for administration to a test system.
Control substance means any chemical substance or mixture, or any
other material other than a test substance, feed, or water, that is
administered to the test system in the course of a study for the purpose
of establishing a basis for comparison with the test substance for
chemical or biologicaI measurements.
EPA means the U.S. Environmental Protection Agency.
Experimental start date means the first date the test substance is
applied to the test system.
Experimental termination date means the last date on which data are
collected directly from the study.
FDA means the U.S. Food and Drug Administration.
Person includes an individual, partnership, corporation,
association, scientific or academic establishment, government agency, or
organizational unit thereof, and any other legal entity.
Quality assurance unit means any person or organizational element,
except
[[Page 35]]
the study director, designated by testing facility management to perform
the duties relating to quality assurance of the studies.
Raw data means any laboratory worksheets, records, memoranda, notes,
or exact copies thereof, that are the result of original observations
and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact
transcripts of raw data have been prepared (e.g., tapes which have been
transcribed verbatim, dated, and verified accurate by signature), the
exact copy or exact transcript may be substituted for the original
source as raw data. ``Raw data'' may include photographs, microfilm or
microfiche copies, computer printouts, magnetic media, including
dictated observations, and recorded data from automated instruments.
Reference substance means any chemical substance or mixture, or
analytical standard, or material other than a test substance, feed, or
water, that is administered to or used in analyzing the test system in
the course of a study for the purposes of establishing a basis for
comparison with the test substance for known chemical or biological
measurements.
Specimen means any material derived from a test system for
examination or analysis.
Sponsor means:
(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.
Study means any experiment at one or more test sites, in which a
test substance is studied in a test system under laboratory conditions
or in the environment to determine or help predict its effects,
metabolism, environmental and chemical fate, persistence, or other
characteristics in humans, other living organisms, or media. The term
``study'' does not include basic exploratory studies carried out to
determine whether a test substance or a test method has any potential
utility.
Study completion date means the date the final report is signed by
the study director.
Study director means the individual responsible for the overall
conduct of a study.
Study initiation date means the date the protocol is signed by the
study director.
Test substance means a substance or mixture administered or added to
a test system in a study, which substance or mixture is used to develop
data to meet the requirements of a TSCA section 4(a) test rule and/or is
developed under a TSCA section 4 testing consent agreement or section 5
rule or order to the extent the agreement, rule or order references this
part.
Test system means any animal, plant, microorganism, chemical or
physical matrix, including but not limited to, soil or water, or
components thereof, to which the test, control, or reference substance
is administered or added for study. ``Test system'' also includes
appropriate groups or components of the system not treated with the
test, control, or reference substance.
Testing facility means a person who actually conducts a study, i.e.,
actually uses the test substance in a test system. ``Testing facility''
encompasses only those operational units that are being or have been
used to conduct studies.
TSCA means the Toxic Substances Control Act (15 U.S.C, 2601 et seq.)
Vehicle means any agent which facilitates the mixture, dispersion,
or solubilization of a test substance with a carrier.
Sec. 792.10 Applicability to studies performed under grants and contracts.
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.
[[Page 36]]
Sec. 792.12 Statement of compliance or non-compliance.
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.
Sec. 792.15 Inspection of a testing facility.
(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.
Sec. 792.17 Effects of non-compliance.
(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 Sec. 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 Sec. 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.
[[Page 37]]
Subpart B--Organization and Personnel
Sec. 792.29 Personnel.
(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.
Sec. 792.31 Testing facility management.
For each study, testing facility management shall:
(a) Designate a study director as described in Sec. 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
Sec. 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.
Sec. 792.33 Study director.
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
Sec. 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.
Sec. 792.35 Quality assurance unit.
(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
[[Page 38]]
conformance with the regulations in this part. For any given study, the
quality assurance unit shall be entirely separate from and independent
of the personnel engaged in the direction and conduct of that study. The
quality assurance unit shall conduct inspections and maintain records
appropriate to the study.
(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.
Subpart C--Facilities
Sec. 792.41 General.
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.
Sec. 792.43 Test system care facilities.
(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
[[Page 39]]
same chamber, aquarium, or housing unit.
(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, photoperiod) 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.
Sec. 792.45 Test system supply facilities.
(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.
Sec. 792.47 Facilities for handling test, control, and reference substances.
(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.
Sec. 792.49 Laboratory operation areas.
Separate laboratory space and other space shall be provided, as
needed, for the performance of the routine and specialized procedures
required by studies.
[[Page 40]]
Sec. 792.51 Specimen and data storage facilities.
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.
Subpart D--Equipment
Sec. 792.61 Equipment design.
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.
Sec. 792.63 Maintenance and calibration of equipment.
(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
Sec. 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.
Subpart E--Testing Facilities Operation
Sec. 792.81 Standard operating procedures.
(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.
Sec. 792.83 Reagents and solutions.
All reagents and solutions in the laboratory areas shall be labeled
to indicate identity, titer or concentration,
[[Page 41]]
storage requirements, and expiration date. Deteriorated or outdated
reagents and solutions shall not be used.
Sec. 792.90 Animal and other test system care.
(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.
Subpart F--Test, Control, and Reference Substances
Sec. 792.105 Test, control, and reference substance characterization.
(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,
[[Page 42]]
or reference substance shall be documented by the sponsor or the testing
facility, and such location of documentation shall be specified.
(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 Sec. 792.195.
(e) The stability of test, control, and reference substances under
storage conditions at the test site shall be known for all studies.
Sec. 792.107 Test, control, and reference substance handling.
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.
Sec. 792.113 Mixtures of substances with carriers.
(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.
Subpart G--Protocol for and Conduct of A Study
Sec. 792.120 Protocol.
(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.
[[Page 43]]
(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.
Sec. 792.130 Conduct of a study.
(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
histopathologically.
(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.
Sec. 792.135 Physical and chemical characterization studies.
(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 biodegradation, 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:
Section 792.31 (c), (d), and (g)
Section 792.35 (b) and (c)
Section 792.43
Section 792.45
Section 792.47
Section 792.49
Section 792.81(b) (1), (2), (6) through (9), and (12)
Section 792.90
Section 792.105 (a) through (d)
[[Page 44]]
Section 792.113
Section 792.120(a) (5) through (12), and (15)
Section 792.185(a) (5) through (8), (10), (12), and (14)
Section 792.195 (c) and (d)
Subparts H-I--[Reserved]
Subpart J--Records and Reports
Sec. 792.185 Reporting of study results.
(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 Sec. 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.
Sec. 792.190 Storage and retrieval of records and data.
(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
[[Page 45]]
specimens in accordance with the requirements for the time period of
their retention and the nature of the documents of specimens. A testing
facility may contract with commercial archives to provide a repository
for all material to be retained. Raw data and specimens may be retained
elsewhere provided that the archives have specific reference to those
other locations.
(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.
Sec. 792.195 Retention of records.
(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 Sec. 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 Sec. 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 Sec. 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.
[[Page 46]]
PART 795--PROVISIONAL TEST GUIDELINES--Table of Contents
Subpart A--[Reserved]
Subpart B--Provisional Chemical Fate Guidelines
Sec.
795.70 Indirect photolysis screening test: Sunlight photolysis in
waters containing dissolved humic substances.
Subpart C--Provisional Environmental Effects Guidelines
795.120 Gammarid acute toxicity test.
Subpart D--Provisional Health Effects Guidelines
795.225 Dermal pharmacokinetics of DGBE and DGBA.
795.228 Oral/dermal pharmacokinetics.
795.231 Pharmacokinetics of isopropanal.
795.232 Inhalation and dermal pharmacokinetics of commercial hexane.
795.250 Developmental neurotoxicity screen.
Authority: 15 U.S.C. 2603.
Subpart A--[Reserved]
Subpart B--Provisional Chemical Fate Guidelines
Sec. 795.70 Indirect photolysis screening test: Sunlight photolysis in waters containing dissolved humic substances.
(a) Introduction. (1) Chemicals dissolved in natural waters are
subject to two types of photoreaction. In the first case, the chemical
of interest absorbs sunlight directly and is transformed to products
when unstable excited states of the molecule decompose. In the second
case, reaction of dissolved chemical is the result of chemical or
electronic excitation transfer from light-absorbing humic species in the
natural water. In contrast to direct photolysis, this photoreaction is
governed initially by the spectroscopic properties of the natural water.
(2) In general, both indirect and direct processes can proceed
simultaneously. Under favorable conditions the measurement of a
photoreaction rate constant in sunlight (KpE) in a natural water
body will yield a net value that is the sum of two first-order reaction
rate constants for the direct (kDE) and indirect (kIE)
pathways which can be expressed by the relationship
Equation 1
kpE=kDE+kIE.
This relationship is obtained when the reaction volume is optically thin
so that a negligible fraction of the incident light is absorbed and is
sufficiently dilute in test chemical; thus the direct and indirect
photoreaction processes become first-order.
(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 kpE in a
natural water and kDE in pure water, kIE can be calculated.
(4) Two protocols have been written that measure kDE in
sunlight or predict kDE in sunlight from laboratory measurements
with monochromatic light (USEPA (1984) under paragraph (f)(14) and (15)
of this section; Mill et al. (1981) under paragraph (f)(9) of this
section; Mill et al. (1982) under paragraph (f)(10) of this section;
Mill et al. (1983) under paragraphs (f)(11) of this section). As a
preface to the use of the present protocol, it is not necessary to know
kDE; it will be determined under conditions that definitively
establish whether kIE is significant with respect to kDE.
(5) This protocol provides a cost effective test method for
measuring kIE for test chemicals in a natural water (synthetic
humic water, SHW) derived from commercial humic material. It describes
the preparation and standardization of SHW. To implement the method, a
test chemical is exposed to sunlight in round tubes containing SHW and
tubes containing pure water for defined periods of time based on a
screening test.
(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 kDE, which, once measured, can be calculated
for different seasons and latitudes, kIE only
[[Page 47]]
applies to the season and latitude for which it is determined. This
condition exists because the solar action spectrum for indirect
photoreaction in humic-containing waters is not generally known and
would be expected to change for different test chemicals. For this
reason, kpE, which contains kIE, is likewise valid only for
the experimental data and latitude.
(8) The value of kpE represents an atypical quantity because
kIE will change somewhat from water body to water body as the
amount and quality of dissolved aquatic humic substances change. Studies
have shown, however, that for optically-matched natural waters, these
differences are usually within a factor of two (Zepp et al. (1981) under
paragraph (f)(17) of this section).
(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 kpE is calculated that is the sum
of kIE and kDE (Equation 1) (Winterle and Mill (1985) under
paragraph (f)(12) of this section).
(b) Phase 1--Preparation and standardization of synthetic natural
water--(1) Approach. (i) Recent studies have demonstrated that natural
waters can promote the indirect (or sensitized) photoreaction of
dissolved organic chemicals. This reactivity is imparted by dissolved
organic material (DOM) in the form of humic substances. These materials
absorb sunlight and produce reactive intermediates that include singlet
oxygen (102) (Zepp et al. (1977) under paragraph (f)(20) of
this section, Zepp et al. (1981) under paragraph (f)(17) of this
section, Zepp et al. (1981) under paragraph (f)(18) of this section,
Wolff et al. (1981) under paragraph (f)(16) of this section, Haag et al.
(1984) under paragraph (f)(6) of this section, Haag et al. (1984) under
paragraph (f)(7) of this section); peroxy radicals (RO2-) (Mill et
al. (1981) under paragraph (f)(9) of this section; Mill et al. (1983)
under paragraph (f)(8) of this section); hydroxyl radicals (HO-) (Mill
et al. (1981) under paragraph (f)(9) of this section, Draper and Crosby
(1981, 1984) under paragraphs (f)(3) and (4) of this section);
superoxide anion (02--) and hydroperoxy radicals (HO-).
(Cooper and Zika (1983) under paragraph (f)(1) of this section, Draper
and Crosby (1983) under paragraph (f)(2) of this section); and triplet
excited states of the humic substances (Zepp et al. (1981) under
paragraph (f)(17) of this section, Zepp et al. (1985) under paragraph
(f)(21) of this section). Synthetic humic waters, prepared by extracting
commercial humic or fulvic materials with water, photoreact similarly to
natural waters when optically matched (Zepp et al. (1981) under
paragraphs (f)(17) and (18) of this section).
(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
[[Page 48]]
standard mixture under defined, reproducible conditions.
(2) Procedure. (i) Twenty grams of Aldrich humic acid are added to a
clean 2-liter Pyrex Erlenmeyer flask. The flask is filled with 2 liters
of 0.1 percent NaOH solution. A stir bar is added to the flask, the
flask is capped, and the solution is stirred for 1 hour at room
temperature. At the end of this time the dark brown supernatant is
decanted off and either filtered through coarse filter paper or
centrifuged and then filtered through 0.4 )m microfilter. The pH is
adjusted to 7.0 with dilute H2SO4 and filter sterilized
through a 0.2 )m filter into a rigorously cleaned 2-liter Erlenmeyer
flask. This mixture contains roughly 60 ppm DOC and the absorbance (in a
1 cm path length cell) is approximately 1.7 at 313 nm and 0.7 at 370 nm.
(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 x 10-2 at 370 nm, and a dissolved organic
carbon of about 5 ppm. Such values are characteristic of many surface
fresh waters.
(3) Rationale. The foregoing procedure is designed to produce a
standard humic-containing solution that is pH controlled, and
sufficiently aged that its photobleaching first-order rate constant is
not time dependent. It has been demonstrated that after 7 days of winter
sunlight exposure, SHW solutions photobleached with a nearly constant
rate constant (Mill et al. (1983) under paragraph (f)(11) of this
section).
(c) Phase 2--Screening test--(1) Introduction and purpose. (i) Phase
2 measurements provide approximate solar photolysis rate constants and
half-lives of test chemicals in PW and SHW. If the photoreaction rate in
SHW is significantly larger than in PW (factor of > 2X) then the test
chemical is subject to indirect photoreaction and Phase 3 is necessary.
Phase 2 data are needed for more accurate Phase 3 measurements, which
require parallel solar irradiation of actinometer and test chemical
solutions. The actinometer composition is adjusted according to the
results of Phase 2 for each chemical, to equalize as much as possible
photoreaction rate constants of chemical in SHW and actinometer.
(ii) In Phase 2, sunlight photoreaction 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) Procedure. (i) Solutions of test chemicals should be prepared
using sterile, air-saturated, 0.010 M, pH 7.0 phosphate buffer and
reagent-grade (or purer) chemicals.\1\ Reaction mixtures should be
prepared with chemicals at concentrations at less than one-half their
solubility in pure water and at concentrations such that, at any
wavelengths above 290 nm, the absorbance in a standard quartz sample
cell with a 1-cm path length is less than 0.05. If the chemicals are too
insoluble in water to permit reasonable handling or analytical
procedures, 1-volume percent acetonitrile may be added to the buffer as
a cosolvent.
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\1\The water should be ASTM Type IIA, or an equivalent grade.
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(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 x 100 mm
quartz tubes with screw tops and tightly sealed with Mininert valves.\2\
Twenty four tubes are required for each chemical solution
[[Page 49]]
(12 samples and 12 dark controls), to give a total of 48 tubes.
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\2\ Mininert Teflon sampling vials are available from Alltech
Associates, Inc., 202 Campus Dr., Arlington Heights, IL 60004.
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(iii) The sample tubes are mounted in a photolysis rack with the
tops facing geographically north and inclined 30 deg. 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 (kp)SHW and (kp)W if the percent
conversions are J 20 percent but F 80 percent. The rate constants
(kp)SHW and (kp)W are calculated, respectively, from
Equations 2 and 3:
Equation 2
(kp)SHW=(1/t)Pn(Co/Ct)SHW (in d-1)
Equation 3
(kp)W=(1/t)Pn(Co/Ct)W (in d-1),
where the subscript identifies a reaction in SHW or PW; t is the
photolysis time in calendar days; Co is the initial molar
concentration; and Ct is the molar concentration in the irradiated
tube at t. In this case t=1 day.
(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.
(1) Expose tubes of chemical in SHW and PW to sunlight starting at
0900 hours and remove one tube and one control at 1, 2, 4, and 8 hours.
Analyze all tubes the next day.
(2) Extimate (kp)SHW for the first tube in which
photoreaction is J 20 percent but F 80 percent. If more than 80 percent
conversion occurs in the first SHW tube, report: ``The half-life is less
than one hour'' and end all testing. The chemical is ``photolabile.''
Phase 3 is not applicable.
(3) The rate constants (kp)SHW and (kp)W are
calculated from equations 2 and 3 but the time of irradiation must be
adjusted to reflect the fact that day-averaged rate constants are
approximately one-third of rate constants averaged over only 8 daylight
hours. For 1 hour of insolation enter t=0.125 day into equation 2. For
reaction times of 2, 4, and 8 hours enter 0.25, 0.50 and 1.0 days,
respectively. Proceed to Phase 3 testing.
(4) Once (kp)SHW and (kp)W are measured,
determine the ratio R from equation 4:
Equation 4
R=(kp)SHW/(kp)W.
The coefficient R, defined by Equation 4, is equal to
[(kI+kD)/kD]. If R is in the range 0 to 1, the
photoreaction is inhibited by the synthetic humic water and Phase 3 does
not apply. If R is in the range 1 to 2, the test chemical is marginally
susceptable to indirect photolysis. In this case, Phase 3 studies are
optional. If R is greater than 2, Phase 3 measurements are necessary to
measure kpE and to evaluate kIE.
(vii) Since the rate of photolysis in tubes is faster than the rate
in natural
[[Page 50]]
water bodies, values of near-surface photolysis rate constants in
natural and pure water bodies, kpE and kDE, respectively, can
be obtained from (kp)SHW and (kp)W from Equations 5
and 6:
Equation 5
kpE=0.45(kp)SHW
Equation 6
kDE=0.45(kp)W.
The factor 0.45 is an approximate geometric correction for scattered
light in tubes versus horizontal surfaces. A rough value of kIE,
the rate constant for indirect photolysis in natural waters or SHW, can
be estimated from the difference between kpE and kDE using
Equation 7:
Equation 7
kIE=kpE-kDE.
(3) Criteria for Phase 2. (i) If no loss of chemical is found in
dark control solutions compared with the analysis in tubes at zero time
(within experimental error), any loss of chemical in sunlight is assumed
to be due to photolysis, and the procedure provides a valid estimate of
kpE and kDE. Any loss of chemical in the dark-control
solutions may indicate the intervention of some other loss process such
as hydrolysis, microbial degradation, or volatilization. In this case,
more detailed experiments are needed to trace the problem and if
possible eliminate or minimize the source of loss.
(ii) Rate constants determined by the Phase 2 protocol depend upon
latitude, season, and weather conditions. Note that (kp)SHW
and kD values apply to round tubes and kpE and kDE values
apply to a natural water body. Because both (kp)SHW and
kD are measured under the same conditions the ratio
((kp)SHW/kD) is a valid measure of the susceptibility of
a chemical to indirect photolysis. However, since SHW is subject to
photobleaching, (kp)SHW will decrease with time because the
indirect rate will diminish. Therefore, R >2 is considered to be a
conservative limit because (kp)SHW will become systematically
smaller with time.
(4) Rationale. The Phase 2 protocol is a simple procedure for
evaluating direct and indirect sunlight photolysis rate constants of a
chemical at a specific time of year and latitude. It provides a rough
rate constant for the chemical in SHW that is necessary for Phase 3
testing. By comparison with the direct photoreaction rate constant, it
can be seen whether the chemical is subject to indirect photoreaction
and whether Phase 3 tests are necessary.
(5) Scope and limitations. (i) Phase 2 testing separates test
chemicals into three convenient categories: ``Photolabile'',
``photoinert'', and those chemicals having sunlight half-lives in round
tubes in the range of 1 hour to 50 days. Chemicals in the first two
categories fall outside the practical limits of the test, and cannot be
used in Phase 3. All other chemicals are suitable for Phase 3 testing.
(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 (kp)SHW estimate remains
valid.
(6) Illustrative Example. (i) Chemical A was dissolved in 0.010 M pH
7.0 buffer. The solution was filtered through a 0.2 )m filter, air
saturated, and analyzed. It contained 1.7 x 10 -5 M A, five-fold
less than its water solubility of 8.5 x 10 -5 M at 25 deg.C. A uv
spectrum (1-cm path length) versus buffer blank showed no absorbance
greater than 0.05 in the wavelength interval 290 to 825 nm, a condition
required for the Phase 2 protocol. The 180 mL mixture was diluted by the
addition of 20 mL of SHW stock solution.
(ii) The SHW solution of A was photolyzed in sealed quartz tubes
(12 x 100 mm) in the fall season starting on October 1. At the end of 1
and 2 days, respectively, the concentration of
[[Page 51]]
A was found to be 1.13 x 10 -5 M and 0.92 x 10 -5 M compared
to unchanged dark controls (1.53 x 10 -5 M).
(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:
(kp)SHW=(1/1d)Pn(1.53 x 10 -5/1.13 x 10 -5)
(kp)SHW=0.30 d-1.
(iv) From this value, kpE was found to be 0.14 d-1 using
equation 5 under paragraph (c)(2)(vii) of this section:
kpE=0.45(0.30 d-1)=0.14d-1.
(v) From measurements in pure water, kD for chemical A was
found to be 0.085 d-1. Because the ratio of (kp)SHW/
kD(=3.5) is greater than 2, Phase 3 experiments were started.
(d) Phase 3--Indirect photoreaction with actinometer: Calculation of
kIE and kpE--(1) Introduction and purpose.
(i) The purpose of Phase 3 is to measure k