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The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further subdivided into parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year and issued on a quarterly basis approximately as follows:
Title 1 through Title 16
Title 17 through Title 27
Title 28 through Title 41
Title 42 through Title 50
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Title 40—
Chapter I—Environmental Protection Agency appears in all thirty-one volumes. An alphabetical Listing of Pesticide Chemicals Index appears in parts 150-189. Regulations issued by the Council on Environmental Quality appear in the volume containing part 790 to End. The OMB control numbers for title 40 appear in § 9.1 of this chapter.
For this volume, Ruth Green was Chief Editor. The Code of Federal Regulations publication program is under the direction of Frances D. McDonald, assisted by Alomha S. Morris.
(This book contains parts 700 to 789)
Nomenclature changes to chapter I appear at 65 FR 47324, 47325, Aug. 2, 2000; 66 FR 34375, 34376, June 28, 2001.
15 U.S.C. 2625 and 2665.
(a)
(b)
User fees relating to radon proficiency programs authorized under the Toxic Substances Control Act appear at 40 CFR part 195.
Definitions in section 3 of the Act (15 U.S.C. 2602), as well as definitions contained in §§ 704.3, 720.3, and 725.3 of this chapter, apply to this subpart unless otherwise specified in this section. In addition, the following definitions apply:
(a)
(b)
(1)
(2)
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(c)
(d)
(e)
(2) Each remittance shall be sent to the Environmental Protection Agency, HQ Accounting Operations Branch (PM-226), P.O. 360399M, Pittsburgh, PA 15251-6399, ATTN: TSCA User Fee.
(3) Persons who submit a section 5 notice shall place a unique identifying number, which must include the letters “TS” followed by a combination of 6 numbers (letters may be substituted for some numbers), on the front page of each section 5 notice submitted. The same identifying number and the submitter's name must appear on the corresponding fee remittance under this section. If a remittance applies to more than one section 5 notice, the person shall include the name of the submitter, the identifying number for each section 5 notice to which the remittance applies, and the amount of the remittance which applies to each notice. Any remittance not having the identifying name and number described above will be returned to the remitter.
(4)(i) Each person who remits the fee identified in paragraph (b)(1) of this section for a PMN, consolidated PMN, intermediate PMN, or significant new use notice shall write or type the words, “The company named in part 1, section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(b).” under “CERTIFICATION” on Page 2 of the Premanufacture Notice for New Chemical Substances (EPA Form 7710-25 (4-26-83)).
(ii) Each person who remits the fee identified in paragraph (b)(1) of this section for an exemption application under section 5(h)(2) of the Act shall include the words, “Each company identified in this application is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(b).” in the exemption application.
(iii) Each person who remits the fee identified in paragraph (b)(1) of this section for an exemption notice under § 723.175 of this chapter shall include the words, “Each company identified in this notice is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(b).” in the certification required in § 723.175(i)(1)(x) of this chapter.
(iv) Each person who remits the fee identified in paragraph (b)(1) of this section for a MCAN for a microorganism shall include the words, “The company identified in this notice is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(d),” in the certification required in § 725.25(b) of this chapter.
(5)(i) Each person who remits a fee identified in paragraph (b)(2) of this section for a PMN, consolidated PMN, intermediate PMN, or significant new use notice shall write or type the words, “The company named in part 1, section A has remitted the fee specified in 40 CFR 700.45(b).” under “CERTIFICATION” on page 2 of the Premanufacture Notice for New Chemical Substances (EPA Form 7710-25 (4-26-83)).
(ii) Each person who remits the fee identified in paragraph (b)(2) of this section for an exemption application under section (5)(h)(2) of the Act shall include the words, “Each company identified in this application has remitted a fee of $2,500 in accordance with 40 CFR 700.45(b).” in the exemption application.
(iii) Each person who remits the fee identified in paragraph (b)(2) of this section for an exemption notice under § 723.175 of this chapter shall include the words, “Each company identified in this notice has remitted a fee of $2,500 in accordance with 40 CFR 700.45(b).” in the certification required in § 723.175(i)(1)(x) of this chapter.
(iv) Each person who remits a fee identified in paragraph (b)(2) of this section for a MCAN for a microorganism shall include the words, “The company identified in this notice has remitted the fee specified in 40 CFR 700.45(b),” in the certification required in § 725.25(b) of this chapter.
(f)
(1) That the chemical substance that is the subject of a PMN, intermediate PMN, exemption application, or exemption notice is not a new chemical substance as of the date of submission of the notice.
(2) In the case of a significant new use notice, that the notice was not required.
(3) The notice is incomplete under either § 720.65(c) or 725.33, of this chapter.
(4) That as of the date of submission of the notice: the microorganism that is the subject of a MCAN is not a new microorganism; nor is the use involving the microorganism a significant new use.
EPA will not consider a section 5 notice to be complete unless the appropriate certification under § 700.45(e) is included and until the appropriate remittance under § 700.45(b) has been sent to EPA as provided in § 700.45(e) and received by EPA. EPA will notify the submitter that the section 5 notice is incomplete in accordance with §§ 720.65(c) and 725.33 of this chapter.
15 U.S.C. 2619.
Section 20 of the Toxic Substances Control Act (TSCA) authorizes any person to begin a civil action to compel performance by the Environmental Protection Agency (EPA) of TSCA non-discretionary acts or duties (section 20(a)(2)) or to restrain any violation of TSCA, or of any rule promulgated under sections 4, 5, or 6, or of any order issued under section 5 of TSCA (section 20(a)(1)). The purpose of this regulation is to prescribe procedures governing the giving of a notice of intent to file suit required by section 20(b) of TSCA as a prerequisite to beginning such civil actions.
(a)
(b)
(c)
(d)
(ii) If the alleged violator is a State or local government entity, notice of intent to file suit shall be served on the head of the agency. Notice shall also be served on the Administrator of the EPA, and a copy shall be sent to the Attorney General of the United States.
(iii) If the alleged violator is a Federal agency, notice of intent to file suit shall be served on the head of the agency. Notice shall also be served on the Administrator of the EPA, and a copy shall be sent to the Attorney General of the United States.
(2)
(3)
(a)
(1) The specific provision of TSCA or of the rule or order under TSCA alleged to have been violated.
(2) The activity alleged to constitute a violation.
(3) The person or persons responsible for the alleged violation.
(4) The location of the alleged violation.
(5) The date or dates of the alleged violation as closely as the citizen is able to specify them.
(6) The full name, address, and telephone number of the citizen giving notice.
(b)
(1) Identify the specific provision of TSCA which requires an act or creates a duty.
(2) Describe with reasonable specificity the action taken or not taken by the Administrator which is alleged to constitute a failure to perform the act or duty.
(3) State the full name, address, and telephone number of the citizen giving the notice.
(c)
15 U.S.C. 2607(a).
(a) This part specifies reporting and recordkeeping procedures under section 8(a) of the Toxic Substances Control Act (TSCA) for manufacturers, importers, and processors of chemical substances and mixtures (hereafter collectively referred to as substances) that are identified in subpart B of this part. The reporting and recordkeeping provisions in subpart A of this part apply throughout this part unless revised in any other subpart.
(b) Subpart B of this part sets out chemical-specific reporting and recordkeeping requirements under section 8(a) of TSCA.
All definitions as set forth in section 3 of TSCA apply in this part. In addition, the following definitions are provided for the purposes of this part.
(i) The person primarily liable for the payment of any duties on the merchandise, or
(ii) An authorized agent acting on his behalf (as defined in 19 CFR 1.11).
(2) Importer also includes, as appropriate:
(i) The consignee.
(ii) The importer of record.
(iii) The actual owner if an actual owner's declaration and superseding bond have been filed in accordance with 19 CFR 141.20.
(iv) The transferee, if the right to draw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR part 144.
(3) For the purposes of this definition, the customs territory of the United States consists of the 50 States, Puerto Rico, and the District of Columbia.
(i) For commercial distribution, including for test marketing.
(ii) For use by the manufacturer, including use for product research and development, or as an intermediate.
(2) Manufacture for commercial purposes also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including both byproducts that are separated from that other substance or mixture and impurities that remain in that substance or mixture. Such byproducts and impurities may, or may not, in themselves have commercial value. They are nonetheless produced for the purpose of obtaining a commercial advantage since they are part of the manufacture of a chemical product for a commercial purpose.
(1) In the person's own files including files maintained by employees of the person in the course of their employment.
(2) In commercially available data bases to which the person has purchased access.
(3) Maintained in the files in the course of employment by other agents of the person who are associated with research, development, test marketing, or commercial marketing of the chemical substance in question.
(1)
(2)
(3)
A person who is subject to reporting requirements for a substance identified in this part is exempt from those requirements to the extent that the person and that person's use of the substance is described in this section. This section is superseded by any TSCA section 8(a) rule that adds to, removes, or revises the exemptions described in this section.
(a)
(b)
(c)
(d)
(e)
(f)
(a) Any person submitting a notice under this rule may assert a business confidentiality claim covering all or any part of the notice. Any information covered by a claim will be disclosed by EPA only to the extent and by means of the procedures set forth in part 2 of this title.
(b) If no claim accompanies the notice at the time it is submitted to EPA, the notice will be placed in an open file available to the public without further notice to the respondent.
(c) To assert a claim of confidentiality for data contained in a notice, the respondent must submit two copies of the notice.
(1) One copy of the notice must be complete. In that copy the respondent must indicate what data, if any, are claimed as confidential by marking the specific information on each page with a label such as “confidential”, “proprietary”, or “trade secret”.
(2) If some data in the notice are claimed as confidential, the respondent must submit a second copy. The second copy must be complete except that all information claimed as confidential in the first copy must be deleted.
(3) The first copy of the notice will be for internal use by EPA. The second copy will be placed in an open file to be available to the public.
(4) Failure to furnish a second copy of the notice when information is claimed as confidential in the first copy will be considered a presumptive waiver of the claim of confidentiality. EPA will notify the respondent by certified mail that a finding of a presumptive waiver of the claim of confidentiality has been made. The respondent has 15 days from the date of receipt of notification to submit the required second copy. Failure to submit the second copy will cause EPA to place the first copy in the public file.
(d) In submitting a claim of confidentiality, a person attests to the truth of the following four statements concerning all information which is claimed confidential:
(1) My company has taken measures to protect the confidentiality of the information, and it intends to continue to take such measures.
(2) The information is not, and has not been, reasonably obtainable without our consent by other persons (other than government bodies) by use of legitimate means (other than discovery based on a showing of special need in a judicial or quasi-judicial proceeding).
(3) The information is not publicly available elsewhere.
(4) Disclosure of the information would cause substantial harm to our competitive position.
Reports must be submitted by certified mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, ATTN: 8(a) Reporting.
Each person who is subject to the reporting requirements of this part must retain the following records for 3 years following the creation or compilation of the record.
(a) A copy of each report submitted by the person in response to the requirements of this part.
(b) Materials and documentation sufficient to verify or reconstruct the values submitted in the report.
(c) A copy of each notice sent by the person, return receipt requested, to that person's customers for the purpose of notifying their customers of the customer's reporting obligations under this part.
(d) All return receipts signed by the person's customers who received the notice described in paragraph (c) of this section.
Violators of the requirements of this part may be subject to civil administrative penalties up to $25,000 per day of violation or criminal prosecution, as provided in sections 15 and 16 of TSCA. In addition, under section 17, EPA may seek judicial relief to compel submission of required information.
(a)
(2)
(3)
(4)
(5)
(6)
(7)
(i)
(ii)
(iii)
(8)
(b)
(1) Persons who manufacture or propose to manufacture 11-AA:
(i) For use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11-AA will be fully polymerized during the manufacturing process, or
(ii) For use as a component in photoprocessing solutions.
(2) Persons who import or propose to import 11-AA:
(i) For use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11-AA will be fully polymerized during the manufacturing process, or
(ii) For use as a component in photoprocessing solutions.
(3) Persons who process or propose to process 11-AA:
(i) For use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11-AA will be fully polymerized during the manufacturing process, or
(ii) For use as a component in photoprocessing solutions.
(c)
(1) Small manufacturers (includes importers) as described in § 704.3.
(2) Small processors.
(3) Persons described in § 704.5.
(4) Persons who, at any time during the 3-year period ending July 22, 1986, manufactured, imported, or processed 11-AA:
(i) For use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11-AA will be fully polymerized during the manufacturing process, or
(ii) For use as a component in photoprocessing solutions.
(d)
(e)
(2) Persons who initiated manufacturing, importing, or processing of 11-AA for use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11-AA will be fully polymerized during the manufacturing process, or for use as a component in photoprocessing solutions during the time period between July 22, 1986 and July 13, 1987 must notify EPA by August 10, 1987.
(f)
(g)
(a)
(2)
(3)
(4)
(i)
(ii)
(iii)
(b)
(1) Persons who manufactured, imported, or processed P-TBBA, P-TBT, and/or P-TBB for commercial purposes during the person's latest complete corporate fiscal year prior to June 25, 1986. For purposes of this provision, processors of P-TBBA, P-TBT, and/or P-TBB shall include only those persons who processed the substances other than as non-isolated intermediates.
(2) Persons who commence manufacture or importation of P-TBBA, P-TBT, and/or P-TBB for commercial purposes after June 25, 1986. This provision is applicable to persons who cease manufacture or importation of P-TBBA, P-TBT, and/or P-TBB after June 25, 1986 and then subsequently resume manufacture or importation of the substance(s).
(3) Persons who process P-TBBA, P-TBT, and/or P-TBB for commercial purposes in any way other than as a non-isolated intermediate after June 25, 1986.
(c)
(d)
(1) All manufacturers, importers, and processors specified in paragraph (b) of
(2) All manufacturers, importers, and processors specified in paragraph (b) of this section shall report the name, address, and office telephone number (including area code) of their principal technical contact.
(3) All manufacturers, importers, and processors specified in paragraph (b) of this section shall report the name and address of each site where P-TBBA, P-TBT, and/or P-TBB is manufactured, imported, or processed.
(4) All manufacturers, importers, and processors specified in paragraph (b)(1) of this section only shall report the information described in this paragraph (d)(4). Respondents to this paragraph (d)(4) shall report separately for each substance that they manufacture, import, or process, and for each site at which they do so. However, if the information to be reported in response to this paragraph (d)(4) is the same for different sites, the respondent need not report separately for each site but need only notify EPA that the information is the same for each site. The information to be reported under this paragraph (d)(4) shall cover the respondent's latest complete corporate fiscal year prior to June 25, 1986. Respondents to this paragraph (d)(4) shall report the following information:
(i) The total quantity (by weight) of P-TBBA, P-TBT, or P-TBB manufactured, imported, or processed for commercial purposes per site.
(ii) A narrative description of the manufacturing, importing, or processing operation(s) involving P-TBBA, P-TBT, or P-TBB at each site.
(iii) A narrative description of worker activities involving P-TBBA, P-TBT, or P-TBB at each site, including the number of workers potentially exposed to each substance and, if applicable, the number of workers potentially exposed to more than one substance.
(iv) The potential routes of worker exposure to P-TBBA, P-TBT, or P-TBB at each site (e.g., inhalation, ingestion, dermal absorption).
(v) Available monitoring data from employee breathing zones with potential exposure to P-TBBA, P-TBT, or P-TBB at each site, including a description of the method of monitoring, the number of samples taken, and the potential number of workers similarly exposed for each worker job category. Respondents to this paragraph (d)(4)(v) shall submit data showing a range of 8-hour time weighted averages (TWAs), provided that the data are available in that form. Respondents also shall submit a calculated geometric mean of these data, with an explanation of the method by which the mean was derived. However, if the monitoring data are not available in the form of 8-hour TWAs, respondents shall submit raw sample data results and the duration time of sampling for each job category.
(vi) A narrative description of any personal protective equipment and/or engineering controls used to prevent exposure to P-TBBA, P-TBT, or P-TBB at each site.
(vii) A listing of the estimated quantities of P-TBBA, P-TBT, or P-TBB released directly into air, water, or land from each site.
(viii) A narrative description of the times during the manufacturing, importing, or processing operations involving P-TBBA, P-TBT, or P-TBB when environmental release occurs at each site.
(ix) A narrative description of any engineering controls used to prevent environmental release of P-TBBA, P-TBT, or P-TBB at each site.
(x) A narrative description of all known end uses of any P-TBBA, P-TBT, or P-TBB that is manufactured, imported, or processed by the respondent. The narrative need not include customer identity.
(xi) A narrative description of the methods used at each site for disposing of wastes generated during the manufacture, importation, or processing of P-TBBA, P-TBT, or P-TBB, including the quantity and content of such wastes (per site), the method of disposal, and an identification of the disposal site(s).
(5) All manufactureres, importers, and processors specified in paragraph (b) of this section shall report the information described in this paragraph (d)(5). Respondents to this paragraph (d)(5) shall report separately for each substance that they intend to manufacture, import, or process during the first 2 years following the date on which
(i) An estimate of the total quantity (by weight) of P-TBBA, P-TBT, or P-TBB that the respondent intends to manufacture, import, or process for commercial purposes per site during each of the first 2 years following the date on which the respondent becomes subject to this rule.
(ii) A narrative description of the intended manufacturing, importing, or processing activities involving P-TBBA, P-TBT, or P-TBB at each site during the first 2 years following the date on which the respondent becomes subject to this rule. The description shall include a summary of the intended manufacturing, importing, or processing operation(s); a summary of intended worker activities involving the substances, including an estimate of the number of persons anticipated to be exposed annually to P-TBBA, P-TBT, or P-TBB (per site) during the 2-year period, the anticipated routes of worker exposure to the substances (e.g., inhalation, ingestion, dermal absorption); and a summary of any personal protective equipment and/or engineering controls that the respondent intends to use to prevent exposure to the substances.
(iii) A narrative description of anticipated environmental releases of P-TBBA, P-TBT, or P-TBB at each site from the manufacture, importation, or processing of these substances during the first 2 years following the date on which the respondent becomes subject to this rule. The narrative shall include the anticipated quantities of each substance released directly into air, water, or land, the anticipated routes of environmental release, and any intended engineering controls to be used to prevent environmental release of the substances.
(iv) A narrative description of all anticipated end uses or P-TBBA, P-TBT, or P-TBB resulting from the respondent's manufacture, importation, or processing of the substances during the first 2 years following the date on which the respondent becomes subject to this rule. The summary need not include customer identity.
(v) A narrative summary of the anticipated disposal of wastes generated from the manufacture, importation, or processing of P-TBBA, P-TBT, or P-TBB during the first 2 years following the date on which the respondent becomes subject to this rule. The summary shall include the anticipated quantity and content of such wastes (per site), the intended method of disposal, and an identification of intended disposal site(s).
(e)
(f)
(g)
(a)
(2)
(3)
(4)
(5)
(i) A manufacturer of a chemical substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $40 million. However, if the annual production volume of a particular chemical substance at any individual site owned or controlled by the manufacturer is greater than 45,400 kilograms (100,000 pounds), the manufacturer shall not qualify as small for purposes of reporting on the production of that chemical substance at that site, unless the manufacturer qualifies as small under paragraph (a)(5)(ii) of this section.
(ii) A manufacturer of a chemical substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $4 million, regardless of the quantity of the particular chemical substance produced by that manufacturer.
(iii) For imported mixtures containing a chemical substance identified in paragraph (b) of this section, the 45,400 kilograms (100,000 pounds) standard in paragraph (a)(5)(i) of this section applies only to the amount of the chemical substance in a mixture and not the other components of the mixture.
(6)
(b)
(c)
(2) Persons who propose to import a chemical substance identified in paragraph (b) of this section on or after October 8, 1984.
(3) Persons who manufacture a chemical substance identified in paragraph (b) of this section after October 8, 1984.
(4) A person is required to report only once for each chemical substance identified in paragraph (b) of this section.
(d)
(2) Persons described in § 704.5.
(e)
(1) Company name and address.
(2) Name, address, and telephone number of the principal technical contact.
(3) For chemical substances proposed to be imported, the proposed date of import.
(4) A description of the use(s) or intended use(s) for the chemical substance.
(5) A description of the isomeric ratio and extent of chlorination of the chemical substance and the impurity level of polychlorinated biphenyls.
(6) The quantity (by weight) manufactured or imported within 12 months prior to October 8, 1984, if any, and the estimated quantity (by weight) to be manufactured or imported for the first
(7) The number of persons exposed to the chemical substance during manufacture, import, processing, distribution in commerce, use, and disposal.
(8) If a manufacturer's waste contains one or more of the chemical substances identified in paragraph (b) of this section, the manufacturer must:
(i) Provide the quantity (by weight) of the chemical substances identified in paragraph (b) of this section present in the waste.
(ii) Identify the constituents of the waste and their concentrations,
(iii) State the rate of waste generation as a percentage of production volume,
(iv) Describe where in the manufacturing process the waste is generated, and
(v) Describe the method for disposal of the waste.
(f)
(2) Persons who propose to import a chemical substance identified in paragraph (b) of this section on or after October 8, 1984 must notify EPA by November 6, 1984, or 15 days after making the management decision described in § 704.3, whichever is later in time.
(3) Persons who manufacture a chemical substance identified in paragraph (b) of this section after October 8, 1984 must notify EPA within 30 days after the initial date of manufacture.
(a)
(2)
(3)
(4)
(5)
(i)
(ii)
(b)
(1) Persons who manufacture or propose to manufacture chlorinated terphenyl.
(2) Persons who import (importers) or propose to import chlorinated terphenyl as a chemical substance in bulk or as part of a mixture.
(c)
(1) Company name and address.
(2) Name, address, and telephone number of principal technical contact.
(3) A description of the use(s) or intended use(s) for chlorinated terphenyl.
(4) A description of the isomeric ratio and extent of chlorination of the chlorinated terphenyl and the impurity level of polychlorinated biphenyls.
(5) The quantity (by weight) manufactured or imported within 12 months prior to the effective date of the rule, if any, and the estimated quantity (by weight) to be manufactured or imported for the first three years following the date of the report or the date of the intended start of production, whichever occurs later.
(6) The proposed date for the initiation of manufacturing or importation of chlorinated terphenyl, if appropriate.
(d)
(a)
(b)
(1) Persons who manufacture or import any of the substances identified in paragraph (a) of this section.
(2) Persons who propose to manufacture or propose to import any of the substances identified in paragraph (a) of this section. For the purposes of importer reporting under this section, an import site is the operating unit within the person's organization which is directly responsible for importing the substance and which controls the import transaction; the import site may in some cases be the organization's headquarters office in the United States.
(c)
(1) Initial Report:
(i) Name and Chemical Abstracts Service Registry Number of the substance for which the report is submitted.
(ii) Company name and headquarters address.
(iii) Name, address, and telephone number of the principal technical contact.
(iv) The total quantity (by weight in pounds) of the substance manufactured or imported for the person's most recently completed corporate fiscal year.
(v) A description of the commercial uses of the substance during the person's most recently completed corporate fiscal year, including the production volume for each use.
(vi) The estimated quantity (by weight in pounds) of the substance proposed to be manufactured or imported in the person's current corporate fiscal year.
(vii) A description of the intended commercial uses of the substance during the person's current corporate fiscal year, including the estimated production volume for each use.
(2) Follow-up Report:
(i) Name and Chemical Abstracts Service Registry Number of the substance for which the report is submitted.
(ii) Company name and headquarters address.
(iii) Name, address, and telephone number of the principal technical contact.
(iv) The estimated quantity (by weight in pounds) of the substance proposed to be manufactured or imported in the person's current corporate fiscal year.
(v) A description of the intended commercial uses of the substance during the person's current corporate fiscal year, including the estimated production volume for each use.
(d)
(2) Persons specified in paragraph (b)(2) of this section must submit an initial report within 30 days after making the management decision described in § 704.3 or by January 3, 1989, whichever is later.
(3) Persons specified in paragraph (b) of this section, who submitted a report described in paragraph (c)(1) of this section, must submit a follow-up report described in paragraph (c)(2) of this section within 30 days of making the management decision, described at § 704.3, to do either of the following events:
(i) Manufacture or import the substance in a quantity 50 percent greater than the quantity reported in the most recently submitted report.
(ii) Manufacture or import the substance for a use not reported for that substance in any previous report.
(e)
(f)
(a)
(2)
(3)
(4)
(i) A business is small if its total annual sales, when combined with those of its parent (if any), are less than $40 million. However, if the annual manufacture, importation, or processing volume of a particular chemical substance at any individual site owned or controlled by the business is greater than 45,400 kilograms (100,000 pounds), the business shall not qualify as small for purposes of reporting on the manufacture, importation, or processing of that chemical substance at that site, unless the business qualifies as small under paragraph (a)(4)(ii) of this section.
(ii) A business is small if its total annual sales, when combined with those of its parent company (if any), are less than $4 million, regardless of the quantity of the particular chemical substance manufactured, imported, or processed by that business.
(iii) For imported and processed mixtures containing HEX-BCH, the 45,400 kilograms (100,000 pounds) standard in paragraph (a)(4)(i) of this section applies only to the amount of HEX-BCH in a mixture and not the other components of the mixture.
(5)
(6)
(b)
(i) Persons who are manufacturing, importing, or processing HEX-BCH for use as an intermediate in the production or isodrin or endrin on or after January 2, 1986; and
(ii) Persons who propose to manufacture, import, or process HEX-BCH for use as an intermediate in the production of isodrin or endrin, on or after January 2, 1986.
(2) Persons described in paragraph (b)(1) of this section who engage or propose to engage in more than one activity (i.e., manufacture and processing) must report the information required in paragraph (d) separately for each activity.
(c)
(2) Persons described in § 704.5(a) and (c).
(d)
(i) Company name and address.
(ii) Name, address, and telephone number of the principal contact.
(iii) Name and address of plant sites where HEX-BCH is or is proposed to be manufactured, imported, or processed, noting for each plant site which activity takes or would take place at each site.
(iv) If applicable, the intended date for initiating the manufacture, import, or processing of HEX-BCH.
(v) If applicable, the actual quantity (by weight) of HEX-BCH manufactured, imported, or processed during the most recently concluded year.
(vi) The estimated quantity (by weight) of HEX-BCH to be manufactured, imported, or processed each year during the first 3 years following the date of the report or the date of the intended start of manufacture, import, or processing, whichever occurs later.
(vii) For each year described in paragraphs (d)(1) (v) and (vi) of this section: the number or expected number of employees exposed to HEX-BCH during the manufacture, import, processing, distribution in commerce, use, and disposal; the routes of exposure; and the 8-hour time weighted average of exposure.
(viii) If employees are exposed or expected to be exposed to HEX-BCH, state for each reported route of exposure, whether personal protective equipment is used or expected to be used, and a description of the personal protective equipment.
(ix) The actual or anticipated quantity, content, method of disposal, and disposal site of any wastes generated or expected to be generated during the manufacture, importation, or processing of HEX-BCH.
(2) Subsequent reports must provide, to the extent known to or reasonably ascertainable by the person reporting, the information in paragraph (d)(1) of this section and a statement explaining why the subsequent report is required.
(e)
(2) Persons who propose to manufacture, import, or process HEX-BCH on or after January 2, 1986, must submit an initial report to EPA by February 3,
(3) Persons described in paragraph (b) of this section, who have submitted a report described in paragraph (d) of this section, must submit a subsequent report within 30 days of any of the following events. Based on the most recently submitted report:
(i) The manufacture, importation, or processing of HEX-BCH begins at a plant site different than that reported pursuant to paragraph (d)(1)(iii) of this section.
(ii) The actual quantity (by weight) of HEX-BCH manufactured, imported, or processed in a given year is greater than or equal to 200 percent of the estimated value for that year reported pursuant to paragraph (d)(1)(vi) of this section.
(iii) The total number of employees exposed to HEX-BCH is greater than 130 percent of the projected value reported pursuant to paragraph (d)(1)(vii) of this section.
(iv) The route of exposures to HEX-BCH differs from that reported pursuant to paragraph (d)(1)(vii) of this section.
(v) The actual 8-hour time weighted average exposure for any activity exceeds the projection reported pursuant to paragraph (d)(1)(vii) of this section by more than 100 percent.
(vi) The method of disposal or disposal site reported pursuant to paragraph (d)(1)(ix) of this section has changed.
(vii) Three years have passed since the most recent submission of a report and the person is still engaged in the manufacture, importation, or processing of HEX-BCH.
(f)
(g)
(1) Retain documentation of information contained in their reports. This documentation must be maintained for a period of 3 years from the date of the submission of the report; and
(2) Retain the certification required by paragraph (f) of this section for 3 years from the date of its creation.
(a)
(2) “Enclosed process” means a process that is designed and operated so that there is no intentional release of any substance present in the process. A process with fugitive, inadvertent, or emergency pressure relief releases remains an enclosed process so long as measures are taken to prevent worker exposure to and environmental contamination from the releases.
(3) “Small processor” means a processor that meets either the standard in paragraph (a)(3)(i) of this section or the standard in paragraph (a)(3)(ii) of this section.
(i)
(ii)
(iii)
(b)
(1) Persons who manufacture or propose to manufacture HFPO for use as an intermediate in the manufacture of fluorinated substances in an enclosed process.
(2) Persons who import or propose to import HFPO for use as an intermediate in the manufacture of fluorinated substances in an enclosed process.
(3) Persons who process or propose to process HFPO as an intermediate in the manufacture of fluorinated substances in an enclosed process.
(c)
(1) Small processors.
(2) Persons described in § 704.5 (a) through (d).
(3) Persons who have already submitted to EPA a completed copy of the Preliminary Assessment Information Manufacturer's Report (EPA Form 7710-35, as described at § 712.28 of this chapter) for HFPO are not required to report under this section with respect to activities previously reported on.
(d)
(e)
(2) Persons who propose to manufacture, import, or process HFPO for use as an intermediate in the manufacture of fluorinated substances in an enclosed process after December 10, 1987, must report within 30 days after making a firm management decision to commit financial resources for the manufacturing, importing, or processing of HFPO.
(f)
(g)
(a)
(b)
(1) Persons who propose to manufacture MBOCA in the United States on or after June 2, 1986.
(2) Persons who are manufacturing MBOCA in the United States as of June 2, 1986.
(3) Persons manufacturing MBOCA in the United States on or after June 2, 1986 who propose to change their manner or method of manufacturing the substance from a manner or method of manufacturing that previously was reported under this section.
(c)
(1) Persons who import MBOCA into the customs territory of the United States and do not otherwise manufacture the substance in the United States.
(2) Persons who complied with the requirements of this section prior to
(d)
(e)
(2) Persons specified in paragraph (b)(2) of this section must report by July 2, 1986.
(3) Persons specified in paragraph (b)(3) of this section must report within 30 days of making a firm management decision to commit financial resources to change their manner or method of manufacturing the substance from a manner or method of manufacturing that previously was reported under this section.
15 U.S.C. 2611(b) and 2612.
(a)
(2) In addition to this statement of policy, EPA will continue, as necessary, to address problems associated with imports in rulemaking and other actions under individual sections of TSCA, i.e., sections 4, 5, 6, 7, 8, and 12. Sections 5, 6, and 7 apply directly to imports subject to the section 13 requirements. Section 12 may apply to
(b)
(2)(i) The section 13 rule requires importers to sign the following statement for each import of chemical substances subject to TSCA: “I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am not offering a chemical substance for entry in violation of TSCA or any applicable rule or order under TSCA.” The certification will document that, in accordance with TSCA, the importer has taken the necessary steps to insure compliance.
(ii) The section 13 rule requires importers of chemicals not subject to TSCA (e.g., pesticides) to certify that compliance with TSCA is not required. Importers must certify this by signing the statement: “I certify that all chemicals in this shipment are not subject to TSCA.” This is appropriate when a chemical import is not clearly identified as a pesticide or other chemical not subject to TSCA.
(3) The United States is involved in a major effort toward international harmonization in the control of chemicals. At such time as international agreement is reached on this issue, EPA would be prepared to modify its policy if necessary. EPA believes that its international harmonization efforts in the control of chemicals will protect health and the environment while fulfilling its obligations under the Trade Agreements Act of 1979.
(c)
(ii) The certification applies to TSCA sections 5, 6, and 7.
(iii) EPA expects that this certification will be based upon actual knowledge of the importer in most cases. However, EPA realizes that sometimes importers may not have actual knowledge of the chemical composition of imported mixtures. In these cases, the importer should attempt to discover the chemical constituents of the shipment by contacting another party to the transaction (e.g., his principal or the foreign manufacturer). This person may be able to identify the components of the mixture, or at least state that the substances comply with TSCA. The greater the effort an importer makes to learn the identities of the imported substances and their compliance with TSCA, the smaller his chance of committing a violation by importing a noncomplying shipment. If a shipment is ultimately determined to have violated TSCA, the good faith efforts of the importer to verify compliance, as evidenced by documents contained in his files, may obviate or mitigate the assessment of a civil penalty under section 16 of TSCA.
(2)
(ii) When EPA determines that a shipment should be detained, EPA will identify the reasons for the detention and the necessary actions for an importer to bring the shipment into compliance with TSCA. If EPA has given this information to Customs before the district director issues the detention notice, the information will become part of the detention notice. The importer should contact one of the following EPA regional offices for guidance as to the proper procedures to correct any deficiencies in the shipment.
(iii) If Customs detains or refuses entry of a shipment (other than for failure to make the general certification) and the importer takes measures necessary to bring the shipment into conformity with the requirements of TSCA, EPA officials will reassess the shipment to determine its current compliance status. When a shipment is no longer in violation, EPA will notify the district director and the importer. The district director will then release the shipment. This notice will also serve as a determination to permit entry under 19 CFR 12.123(c) if a shipment is brought into compliance before the 19 CFR 12.123(c) decisionmaking process has been completed. If compliance is achieved after a 19 CFR 12.123(c) determination (adverse to the importer) has been made, the EPA notice to the district director will serve as a reversal of the decision to refuse entry.
(3)
(a) Section 12(b) of the Toxic Substances Control Act requires any person who exports or intends to export a
(1) Data are required under section 4 or 5(b),
(2) An order has been issued under section 5,
(3) A rule has been proposed or promulgated under section 5 or 6, or
(4) An action is pending, or relief has been granted under section 5 or 7.
(b) No notice of export will be required for articles, except PCB articles, unless the Agency so requires in the context of individual section 5, 6, or 7 actions.
(c) Any person who exports or intends to export polychlorinated biphenyls (PCBs) or PCB articles, for any purpose other than disposal, shall notify EPA of such intent or exportation under section 12(b). PCBs and PCB articles have the definitions published in § 761.3 of this title respectively.
(d) Any person who would be prohibited by a section 5 or 6 regulation from exporting a chemical substance or mixture, but who is granted an exemption by EPA to export that chemical substance or mixture, shall notify EPA under section 12(b) of such intent to export or exportation.
(e) Failure to comply with section 12(b) as set forth in these rules will be considered a violation of section 15(3) of the Toxic Substances Control Act, and will subject the exporter to the penalty, enforcement, and seizure provisions of sections 16 and 17 of the Toxic Substances Control Act.
The definitions set forth in the Toxic Substances Control Act, section 3, apply for this part. In addition, the following abbreviations and definitions are provided for purposes of this rule:
(a)
(b)
(c)
(d)
(a) Exporters must notify EPA of their export or intended export of each regulated chemical in accordance with the following:
(1) The notice must be in writing;
(2)(i) The notice must be for the first export or intended export to a particular country in a calendar year when data are required under section 5(b), an order has been issued under section 5, a rule has been proposed or promulgated under section 5 or 6, or an action is pending or relief has been granted under section 5 or 7.
(ii) The notice must be for the first export or intended export to a particular country when data are required under section 4.
(3) The notice must be postmarked within seven days of forming the intent to export or on the date of export, whichever is earlier. A notice of intent to export must be based on a definite contractual obligation, or an equivalent intra-company agreement, to export the regulated chemical.
(b) If the EPA action that prompts the notice is a proposed rule, the requirement to submit export notices to EPA shall begin thirty days after publication of the action in the
(c) You must submit TSCA section 12(b) notices by one of the following methods:
(1) Mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, ATTN: TSCA 12(b) Notice.
(2) Hand delivery to OPPT Document Control Office (DCO), EPA East, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC, ATTN: TSCA 12(b) Notice. The DCO is open from 8 a.m. to
The notice to EPA shall include:
(a) The name of the regulated chemical as it appears in the section 4, 5, 6, or 7 action. If a category is regulated, the name of the individual regulated chemical within that category, as well as the category, must be given. The name shall be that which appears in Volume I of the EPA Chemical Substance Inventory, or its supplements, if the chemical appears there.
(b) The name and address of the exporter.
(c) The country (countries) of import.
(d) The date(s) of export or intended export.
(e) The section (4, 5, 6, or 7) of TSCA under which EPA has taken action.
(a)(1) Notice by EPA to the importing country shall be sent no later than 5 working days after receipt by the TSCA Document Processing Center of the first annual notification for each regulated chemical when data are required under section 5(b), an order has been issued under section 5, a rule has been proposed or promulgated under section 5 or 6, or an action is pending or relief has been granted under section 5 or 7.
(2) Notice by EPA to the importing country shall be sent no later than 5 working days after receipt by the TSCA Document Processing Center of the first notification for each regulated chemical when data are required under section 4.
(b) Notices shall:
(1) Identify the regulated chemical.
(2) Summarize the regulatory action taken, or indicate the availability of data under section 4 or 5(b) of TSCA.
(3) Identify an EPA official to contact for further information.
(4) Include a copy of the pertinent
(c) Notices shall be sent to the country's ambassador in Washington, DC, or other official designated by the foreign government, and to the United States Department of State.
(a) The reporting requirements of subpart D of this part are terminated for certain specific chemical substances and mixtures as set forth in this paragraph.
(1) When data required under part 766 of this chapter have been submitted to EPA for a specific chemical substance produced by a specific process, and the data show no positive test result as defined in § 766.3 of this chapter, reporting is no longer required by persons who export or intend to export that substance produced by that process.
(2) [Reserved]
(b) [Reserved]
(a) A person may assert a claim of confidentiality for any information which is submitted to EPA in a notice.
(b) Any claim of confidentiality must accompany the information at the time it is submitted to EPA. In the notice, the submitter must clearly identify the information that is claimed confidential by marking the specific information on each page with a label such as “confidential business information”, “proprietary”, or “trade secret”.
(c) Notwithstanding any claim of confidentiality, information outlined in § 707.70 will be included in the EPA notice to the foreign government. With this exception, EPA will disclose information that is covered by a claim of confidentiality asserted in accordance with this section only to the extent permitted by, and in accordance with, the procedures set forth in TSCA and part 2 of this chapter.
(d) If a person does not assert a claim of confidentiality for information at the time a notice is submitted to EPA, the Agency may make the information
15 U.S.C. 2607(a).
(a) This part establishes regulations governing reporting and recordkeeping by certain persons who manufacture, import, or process chemical substances for commercial purposes under section 8(a) of the Toxic Substances Control Act (15 U.S.C. 2607(a)) (TSCA). Section 8(a) authorizes the Administrator to require reporting of information necessary for administration of the Act and requires EPA to issue regulations for the purpose of compiling and keeping current an inventory of chemical substances manufactured or processed for a commercial purpose, as required by section 8(b) of the Act. Following an initial reporting period, EPA published an initial inventory of chemical substances manufactured, processed, or imported for commercial purposes. In accordance with section 8(b), EPA periodically amends the inventory to include new chemical substances which are manufactured or imported for a commercial purpose and reported under section 5(a)(1) of the Act. EPA also revises the categories of chemical substances and makes other amendments as appropriate.
(b) The regulations in this part apply to the activities associated with the compilation of the TSCA Chemical Inventory and the update of information on a subset of the chemical substances included on the Inventory. The Inventory Update regulations were amended in 2002; however, these amendments apply to updates after 2002, not to the 2002 update. In order to prevent confusion as to which regulations apply to which update, EPA has preserved the provisions that apply to the 2002 update in subpart B. The new and revised requirements that apply to updates after 2002 appear in subpart C. Prior to January 1, 2003, the regulations in subpart B of this part are effective for purposes of Inventory update activities. As of January 1, 2003, subpart C is effective for purposes of Inventory update activities. The Agency intends to remove subpart B from the CFR once the 2002 update is complete.
(c) Section 15(3) of TSCA makes it unlawful for any person to fail or refuse to submit information required under these reporting regulations. In addition, section 15(3) makes it unlawful for any person to fail to keep, and permit access to, records required by these regulations. Section 16 provides that any person who violates a provision of section 15 is liable to the United States for a civil penalty and may be
(d) Each person who reports under these regulations must maintain records that document information reported under these regulations and, in accordance with the Act, permit access to, and the copying of, such records by EPA officials.
In addition to the definitions in § 704.3 of this chapter, the following definitions apply to this part:
(a) The following terms will have the meaning contained in the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321
(b) The term
(c) The following terms will have the meaning contained in the Atomic Energy Act of 1954, 42 U.S.C. 2014
(d) The following definitions also apply to this part:
An
(1) Which is formed to a specific shape or design during manufacture,
(2) Which has end use function(s) dependent in whole or in part upon its shape or design during end use, and
(3) Which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article and that may occur as described in § 710.4(d)(5); except that fluids and particles are not considered articles regardless of shape or design.
(1) Any mixture,
(2) Any pesticide when manufactured, processed, or distributed in commerce for use as a pesticide,
(3) Tobacco or any tobacco product, but not including any derivative products,
(4) Any source material, special nuclear material, or byproduct material,
(5) Any pistol, firearm, revolver, shells, and cartridges, and
(6) Any food, food additive, drug, cosmetic, or device, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device.
(1) Between a place in a State and any place outside of such State, or
(2) Which affects trade, traffic, transportation, or commerce described in paragraph (1) of this definition.
(1) The person primarily liable for the payment of any duties on the merchandise, or
(2) An authorized agent acting on his/her behalf (as defined in 19 CFR 1.11).
(1) Which is intentionally removed from the equipment in which it is manufactured, and
(2) Which either is consumed in whole or in part in chemical reaction(s) used for the intentional manufacture of other chemical substance(s) or mixture(s), or is intentionally present for the purpose of altering the rate of such chemical reaction(s).
The
(1) For commercial distribution, including for test marketing, or
(2) For use by the manufacturer, including use for product research and development, or as an intermediate.
(1) Any combination which occurs, in whole or in part, as a result of a chemical reaction if the combination could have been manufactured for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined and if, after the effective date or premanufacture notification requirements, none of the chemical substances comprising the combination is a new chemical substance, and
(2) Hydrates of a chemical substance or hydrated ions formed by association of a chemical substance with water.
(1) In the same form or physical state as, or in a different form or physical
(2) As part of a mixture or article containing the chemical substance or mixture.
(1) For distribution in commerce, including for test marketing purposes, or
(2) For use as an intermediate.
(1) Are no greater than reasonably necessary for such purposes, and
(2) After the publication of the revised inventory, are used by, or directly under the supervision of, a technically qualified individual(s).
Any chemical substances manufactured, imported, or processed in quantities less than 1,000 lbs. (454 kg) annually will be presumed to be manufactured, imported, or processed for research and development purposes. No person may report for the inventory any chemical substance in such quantities unless that person can certify that the substance was not manufactured, imported, or processed solely in small quantities for research and development, as defined in this section.
(1) Who because of his/her education, training, or experience, or a combination of these factors, is capable of appreciating the health and environmental risks associated with the chemical substance which is used under his/her supervision,
(2) Who is responsible for enforcing appropriate methods of conducting scientific experimentation, analysis, or chemical research in order to minimize such risks, and
(3) Who is responsible for the safety assessments and clearances related to the procurement, storage, use, and disposal of the chemical substance as may be appropriate or required within the scope of conducting the research and development activity. The responsibilities in this paragraph may be delegated to another individual, or other individuals, as long as each meets the criteria in paragraph (1) of this definition.
(a)
(b)
(1) Which is (i) unprocessed or (ii) processed only by manual, mechanical, or gravitational means; by dissolution
(2) Which is extracted from air by any means, will automatically be included in the inventory under the category “Naturally Occurring Chemical Substances.” Examples of such substances are: raw agricultural commodities; water, air, natural gas, and crude oil; and rocks, ores, and minerals.
(c)
(1) Any substance which is not considered a “chemical substance” as provided in subsection 3(2)(B) of the Act and in the definition of “chemical substance” in § 710.3(d);
(2) Any mixture as defined in § 710.3(d);
A chemical substance that is manufactured as part of a mixture is subject to these reporting regulations. This exclusion applies only to the mixture and not to the chemical substances of which the mixture is comprised. The term “mixture” includes alloys, inorganic glasses, ceramics, frits, and cements, including Portland cement.
(3) Any chemical substance which is manufactured, imported, or processed solely in small quantities for research and development, as defined in § 710.3(d); and
(4) Any chemical substance not manufactured, processed or imported for a commercial purpose since January 1, 1975.
(d)
In addition, chemical substances excluded here will not be subject to premanufacture notification under section 5 of the Act.
(1) Any impurity.
(2) Any byproduct which has no commercial purpose.
A byproduct which has commercial value only to municipal or private organizations who (i) burn it as a fuel, (ii) dispose of it as a waste, including in a landfill or for enriching soil, or (iii) extract component chemical substances which have commercial value, may be reported for the inventory, but will not be subject to premanufacture notification under section 5 of the Act if not included.
(3) Any chemical substance which results from a chemical reaction that occurs incidental to exposure of another chemical substance, mixture, or article to environmental factors such as air, moisture, microbial organisms, or sunlight.
(4) Any chemical substance which results from a chemical reaction that occurs incidental to storage of another chemical substance, mixture, or article.
(5) Any chemical substance which results from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles such as adhesives, paints, miscellaneous cleansers or other housekeeping products, fuels and fuel additives, water softening and treatment agents, photographic films, batteries, matches, and safety flares, and which is not itself manufactured for distribution in commerce or for use as an intermediate.
(6) Any chemical substance which results from a chemical reaction that occurs upon use of curable plastic or rubber molding compounds, inks, drying oils, metal finishing compounds, adhesives, or paints; or other chemical substances formed during manufacture of an article destined for the marketplace without further chemical change of the chemical substance except for those chemical changes that may occur as described elsewhere in this § 710.4(d).
(7) Any chemical substance which results from a chemical reaction that occurs when (i) a stabilizer, colorant, odorant, antioxidant, filler, solvent, carrier, surfactant, plasticizer, corrosion inhibitor, antifoamer or de-foamer, dispersant, precipitation inhibitor, binder, emulsifier, de-emulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH neutralizer, sequesterant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended or (ii) a chemical substance, solely intended to impart a specific physicochemical characteristic, functions as intended.
(8) Chemical substances which are not intentionally removed from the equipment in which they were manufactured.
See note to definition of “intermediate” at § 710.3(d) for explanation of “equipment in which it was manufactured.”
In addition to the definitions in § 704.3 of this chapter and § 710.3, the following definitions also apply to subpart B of this part.
Any chemical substance which is in the Master Inventory File at the beginning of a reporting period described in § 710.33, unless the chemical substance is specifically excluded by § 710.26.
The following categories of chemical substances are excluded from the reporting requirements of this subpart. However, a chemical substance described in paragraphs (a), (b), or (c) of this section is not excluded from the reporting requirements of this subpart if that substance is the subject of a rule proposed or promulgated under section 4, 5(a)(2), 5(b)(4), or 6 of the Act, or is the subject of an order issued under section 5(e) or 5(f) of the Act, or is the subject of relief that has been granted under a civil action under section 5 or 7 of the Act.
(a)
(b)
(2) Any chemical substance which is identified in the 1985 edition of the Inventory or the Master Inventory File as siloxane and silicone, silsesquioxane, a protein (albumin, casein, gelatin, gluten, hemoglobin), an enzyme, a polysaccharide (starch, cellulose, gum), rubber, or lignin. This exclusion, however, does not apply to a chemical substance which has been hydrolyzed, depolymerized, or chemically modified to the extent that the final product is no longer polymeric in structure.
(c)
(d)
Except as provided in §§ 710.29 and 710.30, the following persons are subject to the requirements of this subpart. Persons must determine whether they must report under this § 710.28 for each chemical substance that they manufacture at an individual site.
(a)
(b)
(c)
A person described in § 710.28 is not subject to the requirements of this subpart if that person qualifies as a small manufacturer as that term is defined in § 704.3 of this chapter. Notwithstanding this exclusion, a person who qualifies as a small manufacturer is subject to this subpart with respect to any chemical substance that is the subject of a rule proposed or promulgated under section 4, 5(b)(4), or 6 of the Act, or is the subject of an order in effect under section 5(e) of the Act, or is the subject of relief that has been granted under a civil action under section 5 or 7 of the Act.
A person described in § 710.28 is not subject to the requirements of this subpart with respect to any chemical substance described in § 710.25 that the person manufactured or imported under the following circumstances:
(a) The person manufactured or imported the chemical substance described in § 710.25 solely in small quantities for research and development,
(b) The person imported the chemical substance described in § 710.25 as part of an article,
(c) The person manufactured the chemical substance described in § 710.25 in a manner described in § 720.30(g) or (h) of this chapter.
Any person who must report under this part must submit the information prescribed in this section for each chemical substance described in § 710.25 that the person manufactured for commercial purposes in an amount of 10,000 pounds (4,540 kilograms) or more at a
(a)
(b)
(c)
(1) The name, company, address, city, State, Zip code, and telephone number of a person who will serve as technical contact for the respondent company, and will be able to answer questions about the information submitted by the company to EPA. Persons reporting by means of magnetic media must submit this information on the reporting form available from EPA at the address set forth in § 710.39.
(2) A certification statement signed and dated by an authorized official of the respondent company. Persons reporting by means of magnetic media must submit this information on the reporting form available from EPA at the address set forth in § 710.39.
(3) The specific chemical name and Chemical Abstracts Service (CAS) Registry Number of each chemical substance for which reporting is required under this subpart. A respondent to this subpart may use other chemical identification numbers in lieu of CAS Registry Numbers when a CAS Registry Number is not known to the respondent as provided in the instruction booklet identified in § 710.39(b), including EPA-designated Accession Numbers for confidential substances, EPA-assigned numbers for
(4) The name, street address, city, State, and Zip code of each site at which 10,000 pounds (4,540 kilograms) or more of a chemical substance for which reporting is required under this subpart is manufactured or imported. (The site for a person who imports a chemical substance is the site of the operating unit within the person's organization which is directly responsible for importing the substance and which controls the import transaction, and may in some cases be the organization's headquarters office in the U.S.) A respondent to this subpart must include the appropriate Dun and Bradstreet Number for each plant site reported.
(5) A statement for each substance for which information is being submitted indicating whether the substance is manufactured in the United States or imported into the United States.
(6) A statement for each substance for which information is being submitted indicating whether the substance is site-limited.
(7) The total volume (in pounds) of each subject chemical substance manufactured or imported at each site. This amount must be reported to two significant figures of accuracy provided that the reported figures are within ±10 percent of the actual volume.
All information reported to EPA in response to the requirements of this subpart must be submitted during an applicable reporting period. The following reporting periods are prescribed for this subpart.
(a)
(b)
(c)
(a)
(b)
Each person who is subject to the reporting requirements of this part must maintain records that document any information reported to EPA. For substances that are manufactured or imported at less than 10,000 pounds annually, volume records must be maintained as evidence to support a decision not to submit a report. Records relevant to reporting during a reporting period described in § 710.33 must be retained for a period of four years beginning with the effective date of that reporting period.
(a) Any person submitting information under this part may assert a business confidentiality claim for the information. The procedures for asserting confidentiality claims are described in the instruction booklet identified in § 710.39. Information claimed as confidential in accordance with this section and those instructions will be treated and disclosed in accordance with the procedures in part 2 of this chapter.
(b) A person may assert a claim of confidentiality for the chemical identity of a specific chemical substance only if the identity of that substance is treated as confidential in the Master Inventory File as of the time the report is submitted for that substance under this part.
(c) To assert a claim of confidentiality for the chemical identity of a specific chemical substance, the person must take the following steps:
(1) The person must submit with the report detailed written answers to the following questions signed and dated by an authorized official.
(i) What harmful effects to your competitive position, if any, do you think would result from the identity of the chemical substance being disclosed in connection with reporting under this part? How could a competitor use such information? Would the effects of disclosure be substantial? What is the causal relationship between the disclosure and the harmful effects?
(ii) How long should confidential treatment be given? Until a specific date, the occurrence of a specific event, or permanently? Why?
(iii) Has the chemical substance been patented? If so, have you granted licenses to others with respect to the patent as it applies to the chemical substance? If the chemical substance has been patented and therefore disclosed through the patent, why should it be treated as confidential?
(iv) Has the identity of the chemical substance been kept confidential to the extent that your competitors do not know it is being manufactured or imported for a commercial purpose by anyone?
(v) Is the fact that the chemical substance is being manufactured or imported for a commercial purpose available to the public, for example in technical journals, libraries, or State, local, or Federal agency public files?
(vi) What measures have you taken to prevent undesired disclosure of the fact that this chemical substance is being manufactured or imported for a commercial purpose?
(vii) To what extent has the fact that this chemical substance is manufactured or imported for commercial purposes been revealed to others? What precautions have been taken regarding these disclosures? Have there been public disclosures or disclosures to competitors?
(viii) Does this particular chemical substance leave the site of manufacture in any form, as product, effluent, emission, etc.? If so, what measures have you taken to guard against discovery of its identity?
(ix) If the chemical substance leaves the site in a product that is available to the public or your competitors, can the substance be identified by analysis of the product?
(x) For what purpose do you manufacture or import the substance?
(xi) Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality determinations regarding this chemical substance? If so, please attach copies of such determinations.
(2) If any of the information contained in the answers to the questions is asserted to contain confidential business information, the person must mark that information as “trade secret,” “confidential,” or other appropriate designation.
(d) If no claim of confidentiality accompanies information at the time it is submitted to EPA under this part or if substantiation required under paragraph (c) of this section is not submitted with the reporting form, EPA may make the information available to the public without further notice to the submitter.
(a)
(b)
(c)
(1)
(2)
(3)
(d)
In addition to the definitions in § 704.3 of this chapter and § 710.3, the following definitions also apply to subpart C of this part:
(1) Is the product commonly recognized (i.e., by a reasonable person) as being intended for children age 14 or younger?
(2) Does the manufacturer of the product state through product labeling or other written materials that the product is intended for or will be used by children age 14 or younger?
(3) Is the advertising, promotion, or marketing of the product aimed at children age 14 or younger?
Any chemical substance which is in the Master Inventory File at the beginning of a submission period described in § 710.53, unless the chemical substance is specifically excluded by § 710.46.
The following groups or categories of chemical substances are exempted from some or all of the reporting requirements of this subpart, with the following exception: A chemical substance described in paragraph (a)(1), (a)(2), or (a)(4), or (b) of this section is not exempted from any of the reporting requirements of this subpart if that substance is the subject of a rule proposed or promulgated under section 4, 5(a)(2), 5(b)(4), or 6 of the Act, or is the subject of an order issued under section 5(e) or 5(f) of the Act, or is the subject of relief that has been granted under a civil action under section 5 or 7 of the Act.
(a)
(1)
(ii) Any chemical substance which is identified in the Master Inventory File as siloxane and silicone, silsesquioxane, a protein (albumin, casein, gelatin, gluten, hemoglobin), an enzyme, a polysaccharide (starch, cellulose, gum), rubber, or lignin.
(iii) This exclusion does not apply to a polymeric substance that has been
(2)
(3)
(4)
(b)
(1)
(2)
(ii)
(A) Whether the chemical qualifies or has qualified in past IUR collections for the reporting of the information described in § 710.52(c)(4) (i.e., at least one site manufactures 300,000 pounds or more of the chemical).
(B) The chemical substance's chemical and physical properties or potential for persistence, bioaccumulation, health effects, or environmental effects (considered independently or together).
(C) The information needs of EPA, other federal agencies, tribes, states, and local governments, as well as members of the public.
(D) The availability of other complementary risk screening information.
(E) The availability of comparable processing and use information.
(F) Whether the potential risks of the chemical substance are adequately managed.
(iii)
(A) Any person may request that EPA amend the chemical list in paragraph (b)(2)(iv) of this section. Your request must be in writing and must be submitted to the address provided in § 710.59(d). Requests must identify the chemical in question, as well as its CAS number or other chemical identification number as identified in § 710.52(c)(3)(i), and must contain a written rationale for the request that provides sufficient specific information, addressing the considerations listed in § 710.46(b)(2)(ii), including cites and relevant documents, to demonstrate to EPA that the collection of the information in § 710.52(c)(4) for the chemical in question either is or is not of low current interest. If a request related to a particular chemical is resubmitted, any subsequent request must clearly identify new information contained in the request. EPA may request other information that it believes necessary to evaluate the request. EPA will issue a written response to each request within 120 days of receipt of the request, and will maintain copies of these responses in a public docket that will be established for each reporting cycle.
(B) As needed, the Agency will initiate rulemaking to make revisions to the list in paragraph (b)(2)(iv) of this section.
(C) To assist EPA in reaching a decision regarding a particular request prior to a given reporting year, requests must be submitted to EPA no later than 12 months prior to the start of the reporting year, i.e., by January 1, 2004, or by each January 1 at 5-year intervals thereafter.
(iv)
(3)
Except as provided in § § 710.49 and 710.50, the following persons are subject to the requirements of this subpart. Persons must determine whether they must report under this section for each chemical substance that they manufacture (including import) at an individual site.
(a)
(b)
A person described in § 710.48 is not subject to the requirements of this subpart if that person qualifies as a small manufacturer as that term is defined in § 704.3 of this chapter. Notwithstanding this exclusion, a person who qualifies as a small manufacturer is subject to this subpart with respect to any chemical substance that is the subject of a rule proposed or promulgated under section 4, 5(b)(4), or 6 of the Act, or is the subject of an order in effect under section 5(e) of the Act, or is the subject of relief that has been granted under a civil action under section 5 or 7 of the Act.
A person described in § 710.48 is not subject to the requirements of this subpart with respect to any chemical substance described in § 710.45 that the person solely manufactured or imported under the following circumstances:
(a) The person manufactured or imported the chemical substance described in § 710.45 solely in small quantities for research and development.
(b) The person imported the chemical substance described in § 710.45 as part of an article.
(c) The person manufactured the chemical substance described in § 710.45 in a manner described in § 720.30(g) or (h) of this chapter.
Any person who must report under this subpart, as described in § 710.48, must submit the information described in this section for each chemical substance described in § 710.45 that the person manufactured (including imported) for commercial purposes in an amount of 25,000 lbs. (11,340 kg) or more at any one site during calendar year 2005 or during the calendar year at 5-year intervals thereafter. (See § 710.48(b) for the “site” for importers). A separate form must be submitted for each chemical substance at each site for which the submitter is required to report. A submitter of information under this subpart must report information as described in paragraphs (c)(1), (c)(2), and (c)(3) of this section to the extent that such information is
(a)
(b)
(c)
(1)
(2)
(i) The name of a person who will serve as technical contact for the submitter company, and who will be able to answer questions about the information submitted by the company to EPA, the parent company name and Dun and Bradstreet Number, the contact person's full mailing address, the contact person's telephone number and the contact person's e-mail address.
(ii) The name and full street address of each site. A submitter under this subpart must include the appropriate Dun and Bradstreet Number for each plant site reported, and the county or parish (or other jurisdictional indicator) in which the plant site is located.
(3)
(i) The specific chemical name and CAS Number of each reportable chemical substance at each site. A submitter under this subpart may use an EPA-designated Accession Number for confidential substances, or a premanufacture notice (PMN) case number (see § 720.65 of this chapter) in lieu of a CAS Number when a CAS Number is not known to or reasonably ascertainable by the submitter. In addition to reporting the number itself, submitters must specify the type of number they are reporting by selecting from among the following codes:
(ii) A statement indicating, for each reportable chemical substance at each site, whether the substance is manufactured in the United States, imported into the United States, or both manufactured in the United States and imported into the United States.
(iii) A designation indicating, for each reportable chemical substance at each site, whether the substance is site-limited.
(iv) The total volume (in pounds) of each reportable chemical substance manufactured and imported at each site. The total manufactured volume (not including imported volume) and the total imported volume must be separately reported. This amount must be reported to two significant figures of accuracy provided that the reported figures are within ±10% of the actual volume.
(v) The total number of workers reasonably likely to be exposed to each reportable chemical substance at each site. For each reportable substance at each site, the submitter must select from among the ranges of workers listed in the following table and report the corresponding code (i.e., W1 through W8):
(vi) The maximum concentration, measured by percentage of weight, of each reportable chemical substance at the time it is sent off-site from each site. If the chemical is site-limited, you must report the maximum concentration, measured by percentage of weight, of the reportable chemical substance at the time it is reacted on-site to produce a different chemical substance. This information must be reported regardless of the physical form(s) in which the substance is sent off-site/reacted on-site. For each substance at each site, select the maximum concentration of the substance from among the ranges listed in the following table and report the corresponding code (i.e., M1 through M5):
(vii) The physical form(s) of the reportable chemical substance as it is sent off-site from each site. If the chemical is site-limited, you must report the physical form(s) of the reportable chemical substance at the time it is reacted on-site to produce a different chemical substance. For each substance at each site, the submitter must report as many physical forms as apply from among the physical forms listed below:
(A) Dry powder.
(B) Pellets or large crystals.
(C) Water- or solvent-wet solid.
(D) Other solid.
(E) Gas or vapor.
(F) Liquid.
(viii) Submitters must report the percentage, rounded off to the closest 10%, of total production volume of the reportable chemical substance, reported in response to paragraph (c)(3)(iv) of this section, that is associated with each physical form reported under paragraph (c)(3)(vii) of this section.
(4)
(i)
(B) The five-digit North American Industrial Classification System (NAICS) codes which best describe the industrial activities associated with each industrial processing or use operation reported under paragraph (c)(4)(i)(A) of this section. Information about how to find these codes is provided in the instruction booklet available from EPA at the address set forth in § 710.59. A particular NAICS code may need to be reported more than once, to the extent that a submitter reports more than one industrial function code (under paragraph (c)(4)(i)(C) of this section) that applies to a given NAICS code under this paragraph.
(C) For each NAICS code reported under paragraph (c)(4)(i)(B) of this section, code(s) from the following list must be selected to designate the industrial function category(ies) that best represents the specific manner in which the chemical substance is used. A particular industrial function category may need to be reported more than once, to the extent that a submitter reports more than one industrial processing or use operation/NAICS code combination (under paragraphs (c)(4)(i)(A) and (c)(4)(i)(B) of this section) that applies to a given industrial function category under this paragraph. If more than 10 unique combinations of industrial processing or use operations/NAICS codes/industrial function categories apply to a chemical substance, submitters need only report the 10 unique combinations for the chemical substance that cumulatively represent the largest percentage of the submitter's production volume for that chemical, measured by weight.
(D) The estimated percentage, rounded off to the closest 10%, of total production volume of the reportable chemical substance associated with each combination of industrial processing or use operation, NAICS code and industrial function category. Where a particular combination of industrial processing or use operation, NAICS code and industrial function category accounts for 5% or less of the submitter's site's total production volume of a reportable chemical substance, the percentage must not be rounded off to zero % if the production volume attributable to that industrial processing or
(E) For each combination of industrial processing or use operation, NAICS code and industrial function category, the submitter must estimate the number of sites at which each reportable chemical substance is processed or used. For each combination associated with each substance, the submitter must select from among the ranges of sites listed in the following table and report the corresponding code (i.e., S1 through S7):
(F) For each combination of industrial processing or use operation, NAICS code and industrial function category, the submitter must estimate the number of workers reasonably likely to be exposed to each reportable chemical substance. For each combination associated with each substance, the submitter must select from among the worker ranges listed in paragraph (c)(3)(vi) of this section and report the corresponding code (i.e., W1 though W8).
(ii)
(B) Submitters must determine, within each commercial and consumer product category reported under paragraph (c)(4)(ii)(A) of this section, whether any amount of each reportable chemical substance manufactured (including imported) by the submitter is present in (for example, a plasticizer chemical used to make pacifiers) or on (for example, as a component in the paint on a toy) any consumer products intended for use by children up to the age of 14, regardless of the concentration of the substance remaining in or on the product. Submitters must select from the following options: the chemical substance is used in or on any consumer products intended for use by children, the chemical substance is not used in or on any consumer products intended for use by children, or information as to whether the chemical substance is used in or on any consumer products intended for use by children is not readily obtainable.
(C) The estimated percentage, rounded off to the closest 10%, of the submitter's site's total production volume of the reportable chemical substance associated with each commercial and consumer product category. Where a particular commercial and consumer product category accounts for 5% or
(D) Where the reportable chemical substance is used in commercial or consumer products, the estimated typical maximum concentration, measured by weight, of the chemical substance in each commercial and consumer product category reported under paragraph (c)(4)(ii)(A) of this section. For each substance in each commercial and consumer product category reported under paragraph (c)(4)(ii)(A) of this section, submitters must select from among the ranges of concentrations listed in the table in paragraph (c)(3)(vii) of this section and report the corresponding code (i.e., M1 through M5).
All information reported to EPA in response to the requirements of this subpart must be submitted during an applicable submission period. The first submission period is from August 25, 2006, to December 23, 2006. Subsequent recurring submission periods are from June 1 to September 30 at 5-year intervals after the first submission period. Any person described in § 710.48(a) must report during each submission period for each chemical substance described in § 710.45 that the person manufactured (including imported) during the preceding calendar year (i.e., the “reporting year”).
(a)
(b)
Each person who is subject to the reporting requirements of this subpart must retain records that document any information reported to EPA. Records relevant to reporting during a submission period must be retained for a period of 5 years beginning on the last day of the submission period. Submitters are encouraged to retain their records longer than 5 years to ensure that past records are available as a reference when new submissions are being generated.
(a) Any person submitting information under this subpart may assert a business confidentiality claim for the information at the time it is submitted. These claims will apply only to the information submitted with the claim. New confidentiality claims, if necessary, must be asserted with regard to information submitted during the next submission period. Guidance for asserting confidentiality claims is provided in the instruction booklet identified in § 710.59. Information claimed as confidential in accordance with this section will be treated and
(b)
(1) The submitter must submit with the report detailed written answers to the following questions signed and dated by an authorized official.
(i) What harmful effects to your competitive position, if any, do you think would result from the identity of the chemical substance being disclosed in connection with reporting under this subpart? How could a competitor use such information? Would the effects of disclosure be substantial? What is the causal relationship between the disclosure and the harmful effects?
(ii) How long should confidential treatment be given? Until a specific date, the occurrence of a specific event, or permanently? Why?
(iii) Has the chemical substance been patented? If so, have you granted licenses to others with respect to the patent as it applies to the chemical substance? If the chemical substance has been patented and therefore disclosed through the patent, why should it be treated as confidential?
(iv) Has the identity of the chemical substance been kept confidential to the extent that your competitors do not know it is being manufactured or imported for a commercial purpose by anyone?
(v) Is the fact that the chemical substance is being manufactured (including imported) for a commercial purpose available to the public, for example in technical journals, libraries, or State, local, or Federal agency public files?
(vi) What measures have been taken to prevent undesired disclosure of the fact that the chemical substance is being manufactured (including imported) for a commercial purpose?
(vii) To what extent has the fact that this chemical substance is manufactured (including imported) for commercial purposes been revealed to others? What precautions have been taken regarding these disclosures? Have there been public disclosures or disclosures to competitors?
(viii) Does this particular chemical substance leave the site of manufacture (including import) in any form, e.g., as product, effluent, emission? If so, what measures have been taken to guard against the discovery of its identity?
(ix) If the chemical substance leaves the site in a product that is available to the public or your competitors, can the substance be identified by analysis of the product?
(x) For what purpose do you manufacture (including import) the substance?
(xi) Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality determinations regarding this chemical substance? If so, please attach copies of such determinations.
(2) If any of the information contained in the answers to the questions listed in paragraph (b)(1) of this section is asserted to contain confidential business information, the submitter must clearly identify the information that is claimed confidential by marking the specific information on each page with a label such as “confidential business information,” “proprietary,” or “trade secret.”
(c)
(1) The submitter must submit with the report detailed written answers to the following questions signed and dated by an authorized official:
(i) Has site information been linked with a chemical identity in any other Federal, state or local reporting scheme? For example, is the chemical identity linked to a facility in a filing under the Emergency Planning and Community Right-to-Know Act (EPCRA) section 311, namely through a Material Safety Data Sheet (MSDS)? If
(ii) What harmful effect, if any, to your competitive position do you think would result from the identity of the site and the chemical substance being disclosed in connection with reporting under this subpart? How could a competitor use such information? Would the effects of disclosure be substantial? What is the causal relationship between the disclosure and the harmful effects?
(2) If any of the information contained in the answers to the questions listed in paragraph (c)(1) of this section is asserted to contain confidential business information, the submitter must clearly identify the information that is claimed confidential by marking the specific information on each page with a label such as “confidential business information,” “proprietary,” or “trade secret.”
(d) If no claim of confidentiality is indicated on the reporting form submitted to EPA under this subpart, or if confidentiality claim substantiation required under paragraphs (b) and (c) of this section is not submitted with the reporting form, EPA may make the information available to the public without further notice to the submitter.
(a)
(b)
(c)
(1)
(2)
(3)
(4)
(d)
15 U.S.C. 2607(a).
(a) This part establishes procedures for chemical manufacturers and processors to report production, use, and exposure-related information on listed chemical substances. Subpart A establishes requirements that apply to all reporting under this part. Subpart B covers manufacturers' and processors' reporting.
(b) Chemical substances, mixtures, and categories of substances or mixtures which have been recommended by the Interagency Testing Committee for testing consideration by the Agency but not designated for Agency response within 12 months, will be added to § 712.30 using the procedure specified in § 712.30(c) only to the extent that the total number of designated and recommended chemicals has not exceeded 50 in any 1 year. Additional recommended but not designated chemicals may be added after proposal, and consideration of public comment.
The definitions in section 3 of TSCA, 15 U.S.C. 2602, apply for this part. In addition, the following definitions apply:
(a)
(b)
(c)
(d)
(1) The consignee.
(2) The importer of record.
(3) The actual owner if an actual owner's declaration and superseding bond has been filed in accordance with 19 CFR 141.20.
(4) The transferee, if the right to withdraw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR part 144. For the purposes of this definition, the customs territory of the U.S. consists of the 50 states, Puerto Rico, and the District of Columbia.
(e)
(f)
(g)
(h)
(1) For commercial distribution, including for test marketing.
(2) For use by the manufacturer, including use for product research and development, or as an intermediate. Manufacture for commercial purposes also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including byproducts and coproducts that are separated from that other substance or mixture, and impurities that remain in that substance or mixture. Byproducts and impurities may not in themselves have commercial value. They are nonetheless produced for the purpose of obtaining a commercial advantage since they are part of the manufacture of a chemical produced for a commercial purpose.
(i)
(j)
(k)
(l)
(m)
(n)
(o)
(p)
(a)
(b)
For example, persons who manufacture a chemical substance such as “sweetened naphtha, 64741-87-3,” but do not refine the naphtha to produce “hexane, 110-54-3” would not report on hexane. Only the production of “hexane” as an isolated product must be reported—not previous production of more crude, complex substances such as naphtha from which hexane is extracted. Thus, persons who produce crude oil, ores, and other crude natural materials, but do not carry them through further manufacturing steps that produce a listed chemical have no reporting responsibilities under this Part. Note, however, that any method of extraction, refinement, or purification of a listed chemical substance is considered to be manufacturing for the purposes of this rule.
(c)
(1) The chemical substance in aqueous solution.
(2) The chemical substance containing an additive (such as a stabilizer or other chemical) to maintain the integrity or physical form of the substance.
(3) The chemical substance in any grade of purity.
TSCA section 8(a) authorizes EPA to require persons to report information that is known to or reasonably ascertainable by them. For purposes of subpart B, however, a lesser standard applies. Companies must report information that is readily obtainable by management and supervisory employees responsible for manufacturing, processing, distributing, technical services, and marketing. Extensive file searches are not required.
(a) Any person submitting information under this part may assert business confidentiality claims for the information as described in the pertinent reporting form and its instructions. Any information covered by a claim will be disclosed by EPA only as provided in the procedures set forth at 40 CFR part 2.
(b) Persons must certify to the validity of a claim of confidentiality they make for information reported under this part, as specified on the reporting form.
(c) If no claim accompanies the information at the time it is submitted to EPA or if certification as to the claim is not made on the reporting form, EPA may place the information in an open file available to the public without further notice to the submitter.
Except as described in § 712.25, at the time a chemical substance is listed in § 712.3, the following persons must submit the “Manufacturer's Report—Preliminary Assessment Information” (as described in § 712.28) for each plant site at which they manufactured or imported the chemical substance during the reporting period specified in § 712.30:
(a) Persons who manufactured one or more of the chemical substances listed in § 712.30 for commercial purposes.
(b) Persons who imported in bulk form one or more of the chemical substances listed in § 712.30 for commercial purposes.
(a) Persons who manufactured or imported the chemical substance during the reporting period, solely for purposes of scientific experimentation, analysis, or research, including research or analysis for product development, are not subject to reporting under § 712.20.
(b) Persons who, during the reporting period, manufactured or imported fewer than 500 kilograms (1100 pounds) of the chemical substance at a single plant site are not subject to reporting for that site under § 712.20.
(c) Persons who qualify as small manufacturers or importers in respect to a specific chemical substance listed in § 712.30 are exempt. However, this exemption does not apply with respect to any chemical in § 712.30 designated by an asterisk. A manufacturer is qualified as small and is exempt from submitting a report under this subpart for a chemical substance manufactured at a particular plant site if both of the following criteria are met:
(1) Total annual sales taken together of all sites owned or controlled by the foreign or domestic parent company were below $30 million for the reporting period;
(2) Total production of the listed substance for the reporting period was below 45,400 kilograms (100,000 pounds) at the plant site.
(d) Persons are not subject to reporting under § 712.20 if they manufactured or imported the chemical substance during the reporting period only in the following forms:
(1) As a byproduct that was not used or sold or that was formed as described in 40 CFR 710.4(d) (3) through (7).
(2) As a non-isolated intermediate.
(3) As an impurity.
(a) Manufacturers and importers subject to this subpart must submit a single EPA Form No. 7710-35, “Manufacturer's Report—Preliminary Assessment Information,” for each plant site manufacturing or importing a chemical substance listed in § 712.30.
(b) Reporting companies may submit their reports through individual plant sites or company headquarters as they choose. A separate form must be submitted for each plant site manufacturing the chemical substance.
(c) Forms must be sent (preferably by certified mail) to the Document Control Office (7407), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Room G-099, 1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTN: 8(a) PAIR Reporting.
(d) Form 7710-35, Manufacturer's Report—Preliminary Assessment Information or PAIR form and instructions may be obtained by telephoning or writing the Environmental Assistance Division. The telephone number and the address of the Environmental Assistance Division is: Phone Number (202) 554-1404, TDD (202) 554-0551. Address: Environmental Assistance Division (7406), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
(a)(1) Persons subject to this subpart B must submit a Preliminary Assessment Information Manufacturer's Report for each chemical substance or mixture that is listed or designated in this section.
(2) Unless a respondent has already prepared a Manufacturer's Report in conformity with conditions set forth in paragraph (a)(3) of this section, the information in each Manufacturer's Report must cover the respondent's latest complete corporate fiscal year as of the effective date. The effective date will be 30 days after the
(3) Persons subject to this subpart B need not comply with the requirements of paragraph (a)(2) of this section if they meet either one of the following conditions:
(i) The respondent has previously and voluntarily provided EPA with a Manufacturer's Report on a chemical substance or mixture subject to this subpart B, which contains data for a one-year period ending no more than three years prior to the effective date described in paragraph (a)(2) of this section. Respondents meeting this condition must notify EPA by letter of their
(ii) The respondent has previously submitted a Manufacturer's Report on a chemical substance or mixture subject to this subpart B to the Interagency Testing Committee, but not to EPA, and that Report contained data for a one-year period ending less than three years prior to the effective date described in paragraph (a)(2) of this section. Respondents meeting this condition must submit a copy of the Manufacturer's Report to EPA, and must submit an accompanying letter notifying EPA of the respondent's intent that the submission be used in lieu of a current Manufacturer's Report. The notification letter must verify the completeness and current accuracy of the voluntarily submitted data. Such a letter must contain the following language: “I hereby certify that, to the best of my knowledge and belief, all information entered on this form is complete and accurate. I agree to permit access to, and the copying of records by, a duly authorized representative of the EPA Administrator, in accordance with the Toxic Substances Control Act, to document any information reported on the form.” The submission must be made prior to the reporting deadline.
(b) Except as provided in paragraph (c) of this section, chemical substances and designated mixtures will be added after a notice of proposed amendment of this subpart is published in the
(c) Chemical substances, mixtures, and categories of substances or mixtures that have been added by the Interagency Testing Committee, established under section 4(e) of TSCA, to the section 4(e) Priority List, for testing consideration by the Agency, will be added to this section 30 days after EPA issues for publication in the
(d) Manufacturers and importers of the substances listed below must submit a Preliminary Assessment Information Manufacturer's Report for each site at which they manufacture or import each substance by the reporting date shown in the table below. The substances are listed in Chemical Abstracts Service Registry Number order. Typically EPA lists the trivial or common name first, then, following the symbol “- -”, EPA lists the substance by its TSCA Chemical Substance Inventory name. Whenever EPA lists a single name, the name may be either the TSCA Chemical Substance Inventory name, a trivial name, or a common name. Generally, when a single
(e) Manufacturers and importers of the substances listed below by category must submit a Preliminary Assessment Information Manufacturers Report for each site at which they manufacture or import each substance by the reporting date shown in the table below. The categories are listed in alphabetic order with the chemical substances within each category listed by ascending numerical CAS number.
For
At 59 FR 14115, Mar. 25, 1994, in § 712.30 paragraph (x), the chemical substances under the category “propylene glycol ethers esters” and all related dates were stayed, effective March 25, 1994. At 60 FR 31921, June 19, 1995, § 712.30 was amended in part by redesignating paragraph (x) as paragraph (e).
15 U.S.C. 2607(d).
(a) This subpart sets forth requirements for the submission of lists and copies of health and safety studies on chemical substances and mixtures selected for priority consideration for testing rules under section 4(a) of the Toxic Substances Control Act (TSCA) and on other chemical substances and mixtures for which EPA requires health and safety information in fulfilling the purposes of TSCA.
(b) Section 15(3) of TSCA makes it unlawful for any person to fail or refuse to submit information required under this subpart. Section 16 provides that a violation of section 15 renders a person liable to the United States for a civil penalty and possible criminal prosecution. Under section 17, the district courts of the United States have jurisdiction to restrain any violation of section 15.
The definitions in section 3 of TSCA apply to this subpart. In addition, the following definitions are provided for the purposes of this subpart:
(1) It is intended that the term
(2) Examples are:
(i) Long- and short-term tests of mutagenicity, carcinogenicity, or teratogenicity; data on behavioral disorders; dermatoxicity; pharmacological effects; mammalian absorption, distribution, metabolism, and excretion; cumulative, additive, and synergistic effects; and acute, subchronic, and chronic effects.
(ii) Tests for ecological or other environmental effects on invertebrates, fish, or other animals, and plants, including: Acute toxicity tests, chronic toxicity tests, critical life-stage tests, behavioral tests, algal growth tests, seed germination tests, plant growth or damage tests, microbial function tests, bioconcentration or bioaccumulation tests, and model ecosystem (microcosm) studies.
(iii) Assessments of human and environmental exposure, including workplace exposure, and impacts of a particular chemical substance or mixture on the environment, including surveys, tests, and studies of: Biological, photochemical, and chemical degradation; structure/activity relationships; air, water, and soil transport; biomagnification and bioconcentration; and chemical and physical properties, e.g., boiling point, vapor pressure, evaporation rates from soil and water, octanol/water partition coefficient, and water solubility.
(iv) Monitoring data, when they have been aggregated and analyzed to measure the exposure of humans or the environment to a chemical substance or mixture.
(1) The consignee.
(2) The importer of record.
(3) The actual owner, if an actual owner's declaration and superseding bond has been filed in accordance with 19 CFR 141.20.
(4) The transferee, if the right to draw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR part 144. For the purpose of this definition, the customs territory of the United States consists of the 50 States, Puerto Rico, and the District of Columbia.
(i) For commercial distribution, including for test marketing.
(ii) For use by the manufacturer, including use for product research and development, or as an intermediate.
(2) Manufacture for commercial purposes also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including byproducts and impurities. Such byproducts and impurities may, or may not, in themselves have commercial value. They are nonetheless produced for the purpose of obtaining a commercial advantage since they are part of the manufacture of a chemical product for a commercial purpose.
(a) Except as provided in paragraphs (b) and (c) of this section, only those persons described in this section are required to report under this part. Persons who must report include manufacturers (including importers) who fall within the North American Industry Classification System (NAICS) (in effect as of January 1, 1997) Subsector 325 (chemical manufacturing and allied products) or Industry Group 32411 (petroleum refineries), who:
(1) In the 10 years preceding the effective date on which a substance or mixture is added to § 716.120, either had proposed to manufacture (including import), or had manufactured (including imported) the listed substance or listed mixture (including as a known byproduct), are required to report during the reporting period specified in § 716.65.
(2) As of the effective date on which a substance or mixture is added to § 716.120, and who propose to manufacture (including import), or who are manufacturing (including importing) the listed substance or listed mixture (including as a known byproduct), are required to report during the reporting period specified in § 716.65.
(3) After the effective date on which a substance or mixture is added to § 716.120, and who propose to manufacture (including import) the listed substance or listed mixture (including as a known byproduct), are required to report during the reporting period specified in § 716.65.
(b) A rule promulgated under the authority of 15 U.S.C. 2607(d) may require that any person who does not fall within NAICS (in effect as of January 1, 1997) Subsector 325 or Industry Group 32411, and who had proposed to manufacture (including import) or process, had manufactured (including imported) or processed, proposes to manufacture (including import) or process, or is manufacturing (including importing) or processing a substance or mixture listed in § 716.120 must report under this part.
(c) Processors and persons who propose to process a substance or mixture otherwise subject to the reporting requirements imposed by this part are not subject to this part unless EPA specifically states otherwise in a particular notice or rule promulgated under the authority of 15 U.S.C. 2607(d).
(a) In general, health and safety studies, as defined in § 716.3, on any substance or listed mixture listed in § 716.120, that are unpublished are reportable, i.e., must be submitted or listed. However, this requirement has limitations according to the nature of the material studied, so that:
(1) All studies of substances and listed mixtures are reportable. However, in the case of physical and chemical properties, only those studies listed in § 716.50 must be submitted.
(2) Studies of mixtures known to contain substances or listed mixtures listed in § 716.120 are reportable except for
(3) Studies of substances or listed mixtures that a person who is reporting has manufactured, imported, or processed or proposed to manufacture, import, or process only as impurities are not generally reportable under § 716.20(a)(9).
(4) Underlying data, such as medical or health records, individual files, lab notebooks, and daily monitoring records supporting studies do not have to be submitted initially. EPA may request underlying data later under § 716.40.
(b) [Reserved]
(a) Excluding paragraph (a)(3) of this section, the following types of studies are exempt from the copy and list submission requirements of §§ 716.30 and 716.35.
(1) Studies which have been published in the scientific literature.
(2) Studies previously submitted to the EPA Office of Pollution Prevention and Toxics. These studies are limited to section 8(e) submissions, studies submitted during section 4 proceedings, studies submitted with premanufacture notices or significant new use notices, and studies submitted “for your information” (FYI submissions) in support of EPA's TSCA Existing Chemicals Program. Studies which have been initiated pursuant to a TSCA section 4(a) test rule, for which the person has submitted a letter of intent to conduct testing in accordance with the provisions of § 790.25 of part 790 of this chapter, are exempt from the list submission requirements of § 716.35.
(3) Except for those studies described in paragraph (a)(2) of this section, studies previously submitted to any Federal agency with no claims of confidentiality are exempt only from the copy submission requirements of § 716.30, and must be listed in accordance with the provisions of § 716.35.
(4) Studies conducted or initiated by or for another person who is subject to, and who will report the studies under §§ 716.30 and 716.35.
(5) Studies of chemical substances which are not on the TSCA Chemical Substances Inventory. This exemption applies only to those substances within categories listed under § 716.120(c).
(6) The following types of studies when the subject of the study is a mixture known to contain a substance or listed mixture listed under § 716.120.
(i) Acute oral toxicity studies.
(ii) Acute dermal toxicity studies.
(iii) Acute inhalation toxicity studies.
(iv) Primary eye irritation studies.
(v) Primary dermal irritation studies.
(vi) Dermal sensitization studies.
(vii) Physical and chemical properties.
(7) Analyzed aggregations of monitoring data based on monitoring data acquired more than 5 years preceding the date the substance or listed mixture was added to the list under § 716.120.
(8) Analyzed aggregations of monitoring data on mixtures known to contain one or more substances or listed mixtures listed in § 716.120, when the monitoring data are not analyzed to determine the exposure or concentration levels of the substances or listed mixture listed under § 716.120.
(9) Studies on a substance or listed mixture listed under § 716.120 that the person who is reporting has manufactured, imported, or processed or proposed to manufacture, import, or process only as an impurity. When reporting of such studies is to be required, that reporting will be separately proposed in the
(10) Studies of chemical substances or listed mixtures previously submitted by trade associations in accordance with the provisions of § 716.30.
(b) The following types of studies on substances or listed mixtures listed under § 716.120 are exempt from the copy and list submission requirements of §§ 716.30 and 716.35.
(1) For the listed ureaformaldehyde resins (CAS Nos. 9011-05-6 and 68611-64-3), studies on agronomic plant growth or damage which demonstrate only that the resins stimulate plant growth
(2) For the specified chemicals in § 716.120(d) under the category “Siloxanes,” acute oral, dermal, and inhalation toxicity studies and primary eye and dermal irritation studies.
(3) For the listed chemicals under § 716.120(d) in the category “OSHA Chemicals in Need of Dermal Absorption Testing,” studies on ecological effects.
(4) For the chemicals listed at § 716.120 with a special exemption referencing this paragraph, studies on mixtures containing the listed substance at levels below 1 percent of the mixture, except when a purpose of the study includes the investigation of the effects of the listed substance at levels below 1 percent.
(5) Rulemaking proceedings that add substances and mixtures to § 716.120 will specify the types of health and/or environmental effects studies that must be reported and will specify the chemical grade/purity requirements that must be met or exceeded in individual studies. Chemical grade/purity requirements will be specified on a per chemical basis or for a category of chemicals for which reporting is required.
(a) Health and safety studies reportable under part 716 for the following chemical substances, mixtures, or categories of chemical substances, as listed in § 716.120, must be submitted or listed only as specified in this section:
(1) For 3H-1,2,4-triazole-3-thione, 5-amino-1,2-dihydro- and imidazo[4,5-d]imidazole-2,5-(1H,3H)-dione, tetrahydro-, all unpublished environmental effects studies and health effects studies on pharmacokinetics, genotoxicity, subchronic toxicity, immunotoxicity, carcinogenicity, reproductive effects, and developmental toxicity where the purity of 3H-1,2,4-triazole-3-thione, 5-amino-1,2-dihydro- or imidazo[4,5-d]imidazole-2,5-(1H,3H)-dione, tetrahydro- is greater than or equal to 90% of the test substance by weight must be submitted.
(2) For benzenamine, 3-chloro-2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)-, all unpublished environmental effects studies including bioconcentration, environmental fate studies on biodegradation, and health effects studies on pharmacokinetics, subchronic toxicity, mutagenicity, reproductive effects, and developmental toxicity, and carcinogenicity where the purity of benzenamine, 3-chloro-2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)- is greater than or equal to 90% of the test substance by weight must be submitted.
(3) For stannane, dimethylbis[(1-oxoneodecyl)oxy]-, all unpublished environmental effects studies including bioconcentration, environmental fate studies on hydrolysis and biodegradation and health effects studies on pharmacokinetics, subchronic toxicity, mutagenicity, neurotoxicity, reproductive effects, and developmental toxicity, and carcinogenicity where the purity of stannane, dimethylbis[(1-oxoneodecyl)oxy]- is greater than or equal to 90% of the test substance by weight must be submitted.
(4) For benzene, 1,3,5-tribromo-2-(2-propenyloxy)-, all unpublished environmental effects studies including bioconcentration, environmental fate studies on biodegradation and health effects studies on pharmacokinetics, subchronic toxicity, neurotoxicity, reproductive effects, and developmental toxicity, and carcinogenicity where the purity of benzene, 1,3,5-tribromo-2-(2-propenyloxy)- is greater than or equal to 90% of the test substance by weight must be submitted.
(5) For 1-triazene, 1,3-diphenyl-, all unpublished health effects studies on pharmacokinetics, genotoxicity, subchronic and chronic toxicity, reproductive effects, and developmental toxicity where the purity of 1-triazene, 1,3-diphenyl- is greater than or equal to 90% of the test substance by weight must be submitted.
(6) For the 9 chemicals in the indium compound category, all unpublished health effects studies on pharmacokinetics, genotoxicity, subchronic and chronic toxicity, reproductive effects, and developmental toxicity where the
(b) [Reserved]
The scope of a person's responsibility to search records is limited to records in the location(s) where the required information is typically kept, and to records kept by the person or the person's individual employee(s) who is/are responsible for keeping such records or advising the person on the health and environmental effects of chemicals. Persons are not required to search for reportable information dated before January 1, 1977, to comply with this subpart unless specifically required to do so in a rule.
(a)(1) Except as provided in §§ 716.5, 716.20, and 716.50, persons must send to EPA copies of any health and safety studies in their possession for the substances or mixtures listed in § 716.120. Persons are responsible for submitting copies on only the substances or listed mixtures which they: Have manufactured, imported, or processed or proposed to manufacture, import, or process (including as known byproducts) within the 10 years preceding the effective date for reporting on the substances or listed mixtures; manufacture, import, or process on the effective date for reporting on the substances or listed mixtures; and propose to manufacture, import, or process following the effective date for reporting on the substances or listed mixtures. Persons who list studies as ongoing or initiated under § 716.35(a) (1) and (2) must submit them when they are completed.
(2) [Reserved]
(b) Submissions under paragraph (a) of this section must be identified either on the face of the study or otherwise by the applicable chemical name and CAS number (if any) listed in § 716.120(a) (1) and (2), and must be accompanied by a cover letter containing the name, job title, address and telephone number of the submitting official, and the name and address of the manufacturing or processing establishment on whose behalf the submission is made. In the cover letter, submitters must identify any impurity or additive known to have been present in the substance or listed mixtures as studied unless its presence is specifically noted in the study itself. The cover letter accompanying a study submitted by a trade association must also state that the submission is to satisfy reporting requirements under this part.
(c) Copies of health and safety studies and the accompanying cover letters must be submitted, preferably by certified mail, to the Document Control Office (7407), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Room G-099, 1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTN: 8(d) Health and Safety Reporting Rule (Notification/Reporting).
(a) Except as provided in §§ 716.5, 716.20, and 716.50, persons subject to this rule must send lists of studies to EPA for each of the listed substances or listed mixtures (including as a known byproduct) in § 716.120 which they are manufacturing, importing, or processing, or which they propose to manufacture (including import) or process.
(1)
(2)
(3)
(4)
(b) Submission under paragraph (a) of this section must be identified either on the face of the study or otherwise by the applicable chemical name and CAS number (if any) listed in § 716.120(a) (1) and (2), and must be accompanied by a cover letter containing the name, job title, address and telephone numbers of the submitting official, and the name and address of the manufacturing or processing establishment on whose behalf the submission is made.
(c) Lists of health and safety studies should be submitted, preferably by certified mail, to the Document Control Office (7407), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Room G-099, 1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTN: 8(d) Health and Safety Reporting Rule (Notification Reporting).
EPA may, by letter, request a person to submit or make available for review the following information after the initial reporting under §§ 716.30 and 716.35. If the requested submissions are not made, EPA may subpoena them under section 11 of TSCA, 15 U.S.C. 2610.
(a) Submission of underlying data of the kind described in § 716.10(a)(4) by persons who submit copies of studies under § 716.30 or list studies under § 716.35(a)(1) or § 716.35(a)(2).
(b) Submission of preliminary reports of ongoing studies by persons who list the studies under § 716.35(a)(1) or § 716.35(a)(2).
(c) Submission of copies of studies by persons listed under § 716.35(a)(3) as possessing them.
Section 716.120 lists substances and mixtures, in order by Chemical Abstract Service Registry Number and by alphabetical order. Studies of listed substances and listed mixtures shall be reported as follows:
(a) When a substance is individually listed under § 716.120(a), studies of the substance and studies of mixtures known to contain the substance must be reported as studies of that substance.
(b) When two or more substances are listed as a mixture under § 716.120(b), studies of the listed mixture and studies of any mixture known to contain the listed mixture must be reported as studies of the listed mixture.
(c) Studies of the following preparations of a substance must be reported as studies of the substance itself, not as studies of mixtures known to contain the substance.
(1) The substance in aqueous solution.
(2) The substance containing a small amount of an additive, such as a stabilizer, emulsifier, or other chemical added for purposes of maintaining the integrity or physical form of the substance.
(3) The substance of the grade/purity specified in each rule promulgated under 15 U.S.C. 2607(d).
Studies of physical and chemical properties must be reported under this subpart if performed for the purpose of determining the environmental or biological fate of a substance, and only if they investigated one or more of the following properties:
(a) Water solubility.
(b) Adsorption/desorption on particulate surfaces, e.g., soil.
(c) Vapor pressure.
(d) Octanol/water partition coefficient.
(e) Density/relative density (specific gravity).
(f) Particle size distribution for insoluble solids.
(g) Dissociation constant.
(h) Degradation by photochemical mechanisms—aquatic and atmospheric.
(i) Degradation by chemical mechanisms—hydrolytic, reductive, and oxidative.
(j) Degradation by biological mechanisms—aerobic and anaerobic.
(a)(1) Section 14(b) of TSCA provides that EPA may not withhold from disclosure, on the grounds that they are confidential business information, health and safety studies of any substance or mixture that has been offered for commercial distribution (including for test marketing purposes and for use in research and development), any substance or mixture for which testing is required under TSCA section 4, or any substance for which notice is required under TSCA section 5, except to the extent that disclosure of data from such studies would reveal—
(i) Processes used in the manufacturing, importing, or processing of the substance or mixture, or
(ii) The portion of a mixture comprised by any of the substances in the mixture.
(2) Any respondent who wishes to assert a claim that part of a study should be withheld from disclosure because disclosure would reveal a confidential process or quantitative mixture composition should briefly state the basis of the claim, e.g., by saying “reveals confidential mixture proportion data,” and clearly identify the material subject to the claim.
(3) Any respondent may assert a confidentiality claim for company name or address, financial statistics, and product codes used by a company. This information will not be subject to the disclosure requirements of section 14(b) of TSCA.
(4) Information other than company name or address, financial statistics, and product codes used by a company, which is contained in a study, the disclosure of which would clearly be an unwarranted invasion of personal privacy (such as individual medical records), will be considered confidential by EPA as provided in Title 5, United States Code, section 552(b)(6).
(b) To assert a claim of confidentiality for data contained in a submitted document, the respondent must submit two copies of the document:
(1) One copy must be complete. In that copy, the respondent must indicate what data, if any, are claimed as confidential by bracketing or underlining the specific information. Each page containing data claimed as confidential must also contain a brief statement for the basis of the claim as well as a label such as “confidential,” “proprietary,” or “trade secret.”
(2) The second copy must be complete, except that all information claimed as confidential in the first copy must be deleted. The second copy will be immediately subject to public disclosure.
(3) Failure to furnish a second copy when information is claimed as confidential in the first copy will be considered a presumptive waiver of the claim of confidentiality. EPA will notify the respondent by certified mail that a finding of a presumptive waiver of the claim of confidentiality has been made. The respondent will be given 30
(c) If no claim of confidentiality accompanies a document at the time it is submitted to EPA, the document will be placed in an open file available to the public without further notice to the respondent.
(a)
(b)(1)
(2)
(c)
Unless otherwise required in a rule promulgated under 15 U.S.C. 2607(d) relating to a listed chemical substance or listed mixture [hereinafter “rule”], the reporting period for a listed chemical substance or listed mixture will terminate 60 days after the effective date on which the listed chemical substance or listed mixture is added to 40 CFR 716.120. EPA may require reporting for a listed chemical substance or listed mixture beyond the 60 day period in a rule promulgated under 15 U.S.C. 2607(d), however EPA will not extend any reporting period later than 2 years after the effective date on which a listed chemical substance or listed mixture is added to 40 CFR 716.120. After the applicable reporting period terminates, any person subject to the rule under 40 CFR 716.5 (a)(2) or (a)(3) and who has submitted to EPA lists of ongoing or initiated studies under 40 CFR 716.35 (a)(1) or (a)(2) must submit a copy of any such study within 30 days after its completion, regardless of the study's completion date.
The requirements of this subpart will be extended periodically to cover additional substances and mixtures. Two procedures will be used to add substances and mixtures.
(a) Except as provided in paragraph (b) of this section, substances and mixtures will be added to § 716.120 after publication in the
(b) Except as provided in paragraph (c) of this section, chemical substances, mixtures, and categories of chemical substances that have been added to the TSCA section 4(e) Priority
(c) Prior to the effective date of an amendment under paragraph (b) of this section, the Assistant Administrator for Prevention, Pesticides and Toxic Substances may for good cause withdraw a chemical substance, mixture, or category of chemical substances from § 716.120. Any information submitted showing why a chemical substance, mixture, or category of chemical substances should be withdrawn from the amendment must be received by EPA within 14 days after the date of publication of the notice under paragraph (b) of this section. If a chemical substance, mixture, or category of chemical substances is withdrawn, a
Substances listed in this section appear in order by Chemical Abstract Service Registry Number. Chemical mixtures and categories are listed separately and by alphabetical order. Chemical substances listed within a category are provided only as examples of the category, and are not included on the list of substances. When a chemical substance in the substance or category list had been listed previously by a trivial (or common) name, it appears first, followed by the Chemical Abstract Service (CAS) name appearing in the TSCA Chemical Substance Inventory.
(a)
(b) [Reserved]
(c)
(d)
At 59 FR 14115, Mar. 25, 1994, in § 716.120 paragraph (d), the chemical substances under the category “propylene glycol ethers and esters” and all related dates, was stayed effective March 25, 1994.
15 U.S.C. 2607(c).
Section 8 (c) of the Toxic Substances Control Act (TSCA) requires manufacturers, processors, and distributors of chemical substances and mixtures:
(a) To keep “records of significant adverse reactions to health or the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture.”
(b) To “permit inspection and submit copies of such records”, upon request of any designated representative of the Administrator. This rule implements section 8(c) of TSCA. It describes the records to be kept and prescribes the conditions under which certain firms must submit or make the records available to a duly designated representative of the Administrator.
The definitions set forth in section 3 of TSCA and the following definitions apply to this part:
(a)
(b)
(c)(1)
(i) Scientific articles or publications abstracted in standard reference sources.
(ii) The firm's product labeling or material safety data sheets (MSDS).
(2) However, an effect is not a “known human effect” if it:
(i) Was a significantly more severe toxic effect than previously described.
(ii) Was a manifestation of a toxic effect after a significantly shorter exposure period or lower exposure level than described.
(iii) Was a manifestation of a toxic effect by an exposure route different from that described.
(d)
(e)(1)
(i) For distribution in commerce, including for test marketing.
(ii) For use by the manufacturer, including use for product research and development, or as an intermediate.
(2)
(f)
(g)
(h)
(i)
(j)
(k)
(a)
(2) A manufacturer must collect:
(i) Any allegation identifying a chemical substance it manufactures and any allegation identifying the operations in the manufacture of any chemical substance it manufactures.
(ii) Any allegation identifying any of its own processing or distribution in commerce activities with respect to any chemical substance it manufactures.
(iii) Any allegation identifying emissions, effluents, or other discharges from activities described in this paragraph.
(iv) Any allegation identifying a substance produced coincidentally during processing, use, storage or disposal of a chemical substance it manufactures.
(3) For the purpose of this part, owned or controlled means ownership of 50 percent or more of a firm's voting stock or other equity rights, or the power to control the management and policies of that firm.
(b)
(2) As a processor subject to this part such person must collect:
(i) Any allegation identifying any mixture it produces and distributes in commerce and any allegation identifying any chemical substance or mixture it repackages and distributes in commerce.
(ii) Any allegation identifying any of its own further processing or distribution in commerce activities of the products described in paragraph (b)(2)(i) of this section.
(iii) Any allegation identifying emissions, effluents, or other discharges from activities described in this paragraph.
(iv) Any allegation identifying a substance produced coincidentally during the processing, use, storage or disposal of the products described in paragraph (b)(2)(i) of this section.
(c)
(a)
(2) A person is not subject to this part if the chemical substances that person causes to be produced are limited to:
(i) Chemical substances that result from chemical reactions that occur incidental to exposure of another chemical substance, mixture, or article to environmental factors such as air, moisture, microbial organisms, or sunlight.
(ii) Chemical substances that result from chemical reactions that occur incidental to storage or disposal of other chemical substances, mixtures, or articles.
(iii) Chemical substances that result from chemical reactions that occur upon end use of other chemical substances, mixtures, or articles such as adhesives, paints, miscellaneous cleaners or other housekeeping products, fuel additives, water softening and treatment agents, photographic films, batteries, matches, or safety flares, and that are not themselves manufactured or imported for distribution in commerce for use as chemical intermediates.
(iv) Chemical substances that result from chemical reactions that occur upon use of curable plastic or rubber molding compounds, inks, drying oils, metal finishing compounds, adhesives, or paints, or other chemical substance formed during the manufacture of an article destined for the marketplace without further chemical change of the chemical substance.
(v) Chemical substances that result from chemical reactions that occur when (A) a stabilizer, colorant, odorant, antioxidant, filler, solvent, carrier, surfactant, plasticizer, corrosion inhibitor, antifoamer or defoamer, dispersant, precipitation-inhibitor, binder, emulsifier, deemulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH adjuster, sequestrant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended, or (B) a chemical substance, which is intended solely to impart a specific physicochemical characteristic, functions as intended.
(b) [Reserved]
(c)
(d)
(a) Allegations subject to this part are those allegations received on or after November 21, 1983 by persons subject to this part.
(b) Allegations subject to this part are those that:
(1) Are submitted either in writing and are signed by the alleger, or are submitted orally. In the case of an oral allegation, the firm must transcribe the allegation into written form, or it must inform the alleger that such allegation may be subject to this part and request that the alleger submit such
(2) Implicate a substance that caused the stated significant adverse reaction by one of the following:
(i) Naming the specific substance.
(ii) Naming a mixture that contains a specific substance.
(iii) Naming an article that contains a specific substance.
(iv) Naming a company process or operation in which substances are involved.
(v) Identifying an effluent, emission, or other discharge from a site of manufacturing, processing or distribution of a substance.
(c) Allegations subject to this part may be made to a firm by any person, such as an employee of the firm, individual consumer, a neighbor of the firm's plant, another firm on behalf of its employees or an organization on behalf of its members.
(d) EPA intends that firms should, to the maximum practical extent, provide allegers with information regarding the ultimate disposition of their allegations. For example, firms could provide a brief notice to the alleger stating that a record was created under this part based upon their allegation, or that a record was not created and briefly explain the reasons why not.
(a) Except as provided in paragraph (b) of this section, significant adverse reactions to human health that must be recorded include but are not limited to:
(1) Long-lasting or irreversible damage, such as cancer or birth defects.
(2) Partial or complete impairment of bodily functions, such as reproductive disorders, neurological disorders or blood disorders.
(3) An impairment of normal activities experienced by all or most of the persons exposed at one time.
(4) An impairment of normal activities which is experienced each time an individual is exposed.
(b) Firms are not required to record significant adverse reactions that are known human effects as defined in § 717.3(c).
(c) Except as provided in paragraph (d) of this section, significant adverse reactions to the environment that must be recorded, even if restricted to the environs of a plant or disposal site, include but are not limited to:
(1) Gradual or sudden changes in the composition of animal life or plant life, including fungal or microbial organisms, in an area.
(2) Abnormal number of deaths of organisms (e.g., fish kills).
(3) Reduction of the reproductive success or the vigor of a species.
(4) Reduction in agricultural productivity, whether crops or livestock.
(5) Alterations in the behavior or distribution of a species.
(6) Long lasting or irreversible contamination of components of the physical environment, especially in the case of ground water, and surface water and soil resources that have limited self-cleansing capability.
(d) Firms are not required to record a significant adverse reaction to the environment if the alleged cause of that significant adverse reaction can be directly attributable to an accidental spill or other accidental discharge, emission exceeding permitted limits, or other incident of environmental contamination that has been reported to the Federal Government under any applicable authority.
(a)
(b)
(1) The original allegation as received.
(2) An abstract of the allegation and other pertinent information as follows:
(i) The name and address of the plant site which received the allegation.
(ii) The date the allegation was received at that site.
(iii) The implicated substance, mixture, article, company process or operation, or site discharge.
(iv) A description of the alleger (e.g., “company employee,” “individual consumer,” “plant neighbor”). If the allegation involves a health effect, the sex and year of birth of the individual should be recorded, if ascertainable.
(v) A description of the alleged health effect(s). The description must relate how the effect(s) became known and the route of exposure, if explained in the allegation.
(vi) A description of the nature of the alleged environmental effect(s), identifying the affected plant and/or animal species, or contaminated portion of the physical environment.
(3) The results of any self-initiated investigation with respect to an allegation. (EPA does not require persons subject to this part to investigate allegations received, and no provision of this part shall be construed to imply that EPA recommends, encourages or requires such investigation.)
(4) Copies of any further required records or reports relating to the allegation. For example, if an employee allegation results in a requirement for the firm to record the case on Occupational Safety and Health Form 101 or appropriate substitute (see 29 CFR part 1904 for requirements under the Occupational Safety and Health Act of 1970), a copy of that OSHA record must be included in the allegation record.
(c)
(1) A specific chemical identity.
(2) A mixture.
(3) An article.
(4) A company process or operation.
(5) A site emission, effluent or other discharge.
(d)
(e)
(2) If a firm ceases to do business and there is no successor to receive and keep the records for the prescribed period, these records must be transmitted to EPA. See § 717.17(c) for the address to which such records must be sent.
(a)
(b)
(c)
(a) Any person submitting copies of records may assert a business confidentiality claim covering all or part of the submitted information. Any information covered by a claim will be disclosed by EPA only as provided in procedures set forth at part 2 of this title.
(b) If no claim accompanies a document at the time it is submitted to EPA, the document will be placed in an open file available to the public without further notice to the respondent.
(c) To asset a claim of confidentiality for information contained in a submitted record, the respondent must submit two copies of the document.
(1) One copy must be complete. In that copy, the respondent must indicate what information, if any, is claimed as confidential by marking the specific information on each page with a label such as “confidential”, “proprietary”, or “trade secret” and briefly state the basis of the claim.
(2) If some information is claimed as confidential, the respondent must submit a second copy of the record. The second copy must be complete, except that all information claimed as confidential in the first copy must be deleted.
(3) The first copy will be for internal use by EPA. The second copy will be placed in an open file to be available to the public.
(4) Failure to furnish a second copy when information is claimed as confidential in the first copy will be considered a presumptive waiver of the claim of confidentiality. EPA will notify the respondent by certified mail that a finding of a presumptive waiver of the claim of confidentiality has been made. The respondent will be given 30 days from the date of receipt of notification to submit the required second copy. If the respondent fails to submit the second copy within the 30 days, EPA will place the first copy in the public file.
15 U.S.C. 2604, 2607, and 2613.
This part establishes procedures for the reporting of new chemical substances by manufacturers and importers under section 5 of the Toxic Substances Control Act, 15 U.S.C. 2604. This part applies to microorganisms only to the extent provided by part 725 of this chapter. The rule defines the persons and chemical substances subject to the reporting requirements, prescribes the contents of section 5 notices, and establishes procedures for submitting notices. The rule also establishes EPA policy regarding claims of confidentiality for, and public disclosure of, various categories of information submitted in connection with section 5 notices.
(a)(1) For the purposes of this part, the terms
(2) The term
(3) The terms
(b)
(c)
(d)
(e)
(1) Any mixture.
(2) Any pesticide when manufactured, processed, or distributed in commerce for use as a pesticide.
(3) Tobacco or any tobacco product.
(4) Any source material, special nuclear material, or byproduct material.
(5) Any pistol, firearm, revolver, shells, or cartridges.
(6) Any food, food additive, drug, cosmetic, or device, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device.
(f)
(g)
(h)
(i)
(j)
(k)
(1) Not only is information which arises as a result of a formal, disciplined study included, but other information relating to the effects of a chemical substance or mixture on health or the environment is also included. Any data that bear on the effects of a chemical substance on health or the environment would be included.
(2) Examples include:
(i) Long- and short-term tests of mutagenicity, carcinogenicity, or teratogenicity; data on behavioral disorders; dermatoxicity; pharmacological effects; mammalian absorption, distribution, metabolism, and excretion; cumulative, additive, and synergistic effects; acute, subchronic, and chronic effects; and structure/activity analyses.
(ii) Tests for ecological or other environmental effects on invertebrates, fish, or other animals, and plants, including: Acute toxicity tests, chronic toxicity tests, critical life stage tests, behavioral tests, algal growth tests, seed germination tests, plant growth or damage tests, microbial function tests, bioconcentration or bioaccumulation tests, and model ecosystem (microcosm) studies.
(iii) Assessments of human and environmental exposure, including workplace exposure, and impacts of a particular chemical substance or mixture on the environment, including surveys, tests, and studies of: Biological, photochemical, and chemical degradation; air, water, and soil transport; biomagnification and bioconcentration; and chemical and physical properties, e.g., boiling point, vapor pressure, evaporation rates from soil and water, octanol/water partition coefficient, and water solubility.
(iv) Monitoring data, when they have been aggregated and analyzed to measure the exposure of humans or the environment to a chemical substance or mixture.
(v) Any assessments of risk to health and the environment resulting from the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance.
(l)
(1) The consignee.
(2) The importer of record.
(3) The actual owner if an actual owner's declaration and superseding bond has been filed in accordance with 19 CFR 141.20; or
(4) The transferee, if the right to draw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR part 144. (See “principal importer.”)
(m)
(n)
(o)
(p)
(q)
(r)
(1) To import, produce, or manufacture with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer or importer, and includes, among other things, “manufacture” of any amount of a chemical substance or mixture:
(i) For commercial distribution, including for test marketing.
(ii) For use by the manufacturer, including use for product research and development or as an intermediate.
(2) The term also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including byproducts that are separated from that other substance or mixture and impurities that remain in that substance or mixture. Byproducts and impurities without separate commercial value are nonetheless produced for the purpose of obtaining a commercial advantage, since they are part of the manufacture of a chemical substance for commercial purposes.
(s)
(1) Distribution in commerce is limited to purposes of export or processing solely for export as defined in § 721.3 of this chapter.
(2) The manufacturer or importer, and any person to whom the substance is distributed for purposes of export or processing solely for export (as defined in § 721.3 of this chapter), may not use the substance except in small quantities solely for research and development in accordance with § 720.36.
(t)
(u)
(v)
(w)
(x)
(y)
(1) In files maintained by submitter's employees who are:
(i) Associated with research, development, test marketing, or commercial marketing of the chemical substance in question.
(ii) Reasonably likely to have such data.
(2) Maintained in the files of other agents of the submitter who are associated with research, development, test marketing, or commercial marketing of the chemical substance in question in the course of their employment as such agents.
(z)
(aa)
(bb)
(cc)
(dd)
(ee)
(ff)
(gg)
(hh)
(a)(1) Any person who intends to manufacture a new chemical substance in the United States for commercial purposes must submit a notice unless the substance is excluded under § 720.30.
(2) If a person contracts with a manufacturer to manufacture or produce a new chemical substance, and (i) the manufacturer manufactures or produces the substance exclusively for that person, and (ii) that person specifies the identity of the substance, and controls the total amount produced and the basic technology for the plant process, that person must submit the notice. If it is unclear who must report, EPA should be contacted to determine who must submit the notice.
(3) Only manufacturers that are incorporated, licensed, or doing business in the United States may submit a notice.
(b)(1) Any person who intends to import a new chemical substance into the United States for commercial purposes must submit a notice, unless the substance is excluded under § 720.30 or unless the substance is imported as part of an article.
(2) When several persons are involved in an import transaction, the notice must be submitted by the principal importer. If no one person fits the principal importer definition in a particular transaction, the importer should contact EPA to determine who must submit the notice for that transaction.
(a) A new chemical substance is any chemical substance that is not currently listed on the Inventory.
(b)(1) A chemical substance is listed in the public portion of the Inventory by a specific chemical name (either a Chemical Abstracts (CA) Index Name or a CA Preferred Name) and a Chemical Abstracts Service (CAS) Registry Number if its identity is not confidential. If its identity is confidential, it is listed in the public portion of the Inventory by a TSCA Accession Number and a generic chemical name that masks the specific substance identity. The confidential substance is listed by its specific chemical name only in the confidential portion of the Inventory, which is not available to the public. A person who intends to manufacture or import a chemical substance not listed by specific chemical name in the public portion of the Inventory may ask EPA whether the substance is included in the confidential Inventory. EPA will answer such an inquiry only if EPA determines that the person has a
(2) To establish a
(i) Except as provided in paragraphs (b)(3) (i) and (ii) of this section, the specific chemical identity of the substance that the person intends to manufacture or import, using the currently, correct CA name for the substance and the other correct chemical identity information in accordance with §§ 720.45(a) (1), (2), and (3).
(ii) A signed statement that the person intends to manufacture or import that chemical substance for commercial purposes.
(iii)(A) A brief description of the research and development activities conducted to date related to the substance, including the year in which the person first started to conduct research or development activity on the substance, and the general types of research and development activities conducted thus far (e.g., synthesis, substance isolation/purification, formulating, product development, process development, end-use application, toxicity testing, etc.). The person must also indicate whether any pilot plant or production-scale plant evaluations have been conducted involving the manufacture or processing of the substance.
(B) If an importer is unable to provide the information requested in paragraph (b)(2)(iii)(A) of this section from the foreign manufacturer or supplier, the following information shall be submitted:
(
(
(
(iv) A specific description of the major intended application or use of the substance.
(v) An infrared spectrum of the substance, or alternative spectra or other data which identify the substance if infrared analysis is not suitable for the substance or does not yield a reasonable amount of structural information. When using alternative spectra or instrumental analysis, the person must submit a spectrum or instrumental readout for the substance.
(vi) The estimated date (month/year) in which the person intends to submit a Premanufacture Notice (PMN) for this substance if EPA informs the notice submitter that the substance is not on the Inventory.
(vii) The address of the facility under the control of the submitter at which the manufacture or processing of the substance would most likely occur. For an imported substance, the facility under the control of the importer at which processing of the substance would likely occur, if any.
(viii)(A) For substances intended to be manufactured in the United States, a description of the most probable manufacturing process that would be used by the submitter to produce the substance for non-exempt commercial purposes.
(B) For substances intended to be imported, a brief description of how the submitter is most likely to process or use the substance for a commercial purpose. If the substance is not expected to be processed or used at any facility under the importer's control, a statement to this effect must be included along with a description of how the substance will be processed or used at sites controlled by others, if this information is known or reasonably ascertainable.
(3)(i) If an importer cannot provide the chemical identity information required by paragraph (b)(2) (i) and (v) of this section because it is claimed confidential by its foreign manufacturer or supplier, the foreign manufacturer or supplier must supply the required information directly to EPA in accordance with § 720.45(a) (1), (2), and (3) and reference the importer's notice. If the appropriate supporting document from the foreign party is not received within 30 days after EPA receives the importer's notice, the notice will be considered incomplete.
(ii) If a manufacturer cannot provide all of the required information in accordance with § 720.45(a) (1), (2), and (3) because the new chemical substance is manufactured using a reactant that has a specific chemical identity claimed as confidential by its supplier, the notice must contain chemical identity information that is as complete as known by the manufacturer. In addition, a letter of support for the notice must then be sent to EPA by the chemical supplier of the confidential reactant, providing the specific chemical identity of the proprietary reactant. The letter of support must reference the manufacturer's notice. If the appropriate supporting document from the supplier is not received within 30 days after EPA receives the manufacturer's notice, the notice will be considered incomplete.
(4) EPA will review the information submitted by the proposed manufacturer or importer under this paragraph to determine whether it has a
(5) If the proposed manufacturer or importer has shown a
(6) If the chemical substance is found on the confidential Inventory, EPA will notify the person(s) who originally reported the chemical substance that another person has demonstrated a
(7) A disclosure of a confidential chemical identity to a person with a
(8) EPA will answer an inquiry on whether a particular chemical substance is on the confidential Inventory within 30 days after receipt of a complete submission under paragraph (b)(2) of this section.
(9) If the required chemical identity information has not been reported correctly or completely in the notice (except as provided under paragraph (b)(3)(ii) of this section) or if any other required data or information has been omitted or is incomplete, EPA will consider the whole notice to be incomplete. As soon as an incomplete notice is identified as such by EPA, the Agency will immediately return the notice directly to the submitter. The submitter must then resubmit the whole, completed
The following substances are not subject to the notification requirements of this part:
(a) Any substance which is not a “chemical substance” as defined in § 720.3(e).
(b) Any mixture as defined in § 720.3(u).
(c) Any new chemical substance which will be manufactured or imported in small quantities solely for research and development under § 720.36.
(d) Any new chemical substance which will be manufactured or imported solely for test-marketing purposes under an exemption granted under § 720.38.
(e) Any new chemical substance manufactured solely for export if, when the substance is distributed in commerce:
(1) The substance is labeled in accordance with section 12(a)(1)(B) of the Act.
(2) The manufacturer knows that the person to whom the substance is being distributed intends to export it or process it solely for export as defined in § 721.3 of this chapter.
(f) Any new chemical substance which is manufactured or imported under the terms of a rule promulgated under section 5(h)(4) of the Act.
(g) Any byproduct if its only commercial purpose is for use by public or private organizations that (1) burn it as a fuel, (2) dispose of it as a waste, including in a landfill or for enriching soil, or (3) extract component chemical substances from it for commercial purposes. (This exclusion only applies to the byproduct; it does not apply to the component substances extracted from the byproduct.)
(h) The chemical substances described below: (Although they are manufactured for commercial purposes under the Act, they are not manufactured for distribution in commerce as chemical substances per se and have no commercial purpose separate from the substance, mixture, or article of which they are a part.)
(1) Any impurity.
(2) Any byproduct which is not used for commercial purposes.
(3) Any chemical substance which results from a chemical reaction that occurs incidental to exposure of another chemical substance, mixture, or article
(4) Any chemical substance which results from a chemical reaction that occurs incidental to storage or disposal of another chemical substance, mixture, or article.
(5) Any chemical substance which results from a chemical reaction that occurs upon end use of another chemical substance, mixture, or article such as an adhesive, paint, miscellaneous cleanser or other housekeeping product, fuel additive, water softening and treatment agent, photographic film, battery, match, or safety flare, and which is not itself manufactured or imported for distribution in commerce or for use as an intermediate.
(6) Any chemical substance which results from a chemical reaction that occurs upon use of curable plastic or rubber molding compounds, inks, drying oils, metal finishing compounds, adhesives, or paints, or any other chemical substance formed during the manufacture of an article destined for the marketplace without further chemical change of the chemical substance except for those chemical changes that occur as described elsewhere in this paragraph.
(7) Any chemical substance which results from a chemical reaction that occurs when (i) a stabilizer, colorant, odorant, antioxidant, filler, solvent, carrier, surfactant, plasticizer, corrosion inhibitor, antifoamer or defoamer, dispersant, precipitation inhibitor, binder, emulsifier, deemulsifier, dewater-ing agent, agglomerating agent, adhesion promoter, flow modifier, pH neutralizer, sequesterant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intented, or (ii) a chemical substance, which is intended solely to impart a specific physiochemical characteristic, functions as intended.
(8) Any nonisolated intermediate.
(i) Any chemical substance which is manufactured solely for non-commercial research and development purposes. Non-commercial research and development purposes include scientific experimentation, research, or analysis conducted by academic, government, or independent not-for-profit research organizations (e.g., universities, colleges, teaching hospitals, and research institutes), unless the activity is for eventual commercial purposes.
(a) This part does not apply to a chemical substance if the following conditions are met:
(1) The chemical substance is manufactured or imported only in small quantities solely for research and development.
(2) The manufacturer or importer notifies all persons in its employ or to whom it directly distributes the chemical substance, who are engaged in experimentation, research, or analysis on the chemical substance, including the manufacture, processing, use, transport, storage, and disposal of the substance associated with research and development activities, of any risk to health, identified under paragraph (b) of this section, which may be associated with the substance. The notification must be made in accordance with paragraph (c) of this section.
(3) The chemical substance is used by, or directly under the supervision of, a technically qualified individual.
(b)(1) To determine whether notification under paragraph (a)(2) of this section is required, the manufacturer or importer must review and evaluate the following information to determine whether there is reason to believe there is any potential risk to health which may be associated with the chemical substance:
(i) Information in its possession or control concerning any significant adverse reaction by persons exposed to the chemical substance which may reasonably be associated with such exposure.
(ii) Information provided to the manufacturer or importer by a supplier or any other person concerning a health risk believed to be associated with the substance.
(iii) Health and environmental effects data in its possession or control concerning the substance.
(iv) Information on health effects which accompanies any EPA rule or order issued under sections 4, 5, or 6 of the Act that applies to the substance and of which the manufacturer or importer has knowledge.
(2) When the research and development activity is conducted solely in a laboratory and exposure to the chemical substance is controlled through the implementation of prudent laboratory practices for handling chemical substances of unknown toxicity, and any distribution, except for purposes of disposal, is to other such laboratories for further research and development activity, the information specified in paragraph (b)(1) of this section need not be reviewed and evaluated. (For purposes of this paragraph, a laboratory is a contained research facility where relatively small quantities of chemical substances are used on a non-production basis, and where activities involve the use of containers for reactions, transfers, and other handling of substances designed to be easily manipulated by a single individual.)
(c)(1) The manufacturer or importer must notify the persons identified in paragraph (a)(2) of this section by means of a container labeling system, conspicuous placement of notices in areas where exposure may occur, written notification to each person potentially exposed, or any other method of notification which adequately informs persons of health risks which the manufacturer or importer has reason to believe may be associated with the substance, as determined under paragraph (b)(1) of this section.
(2) If the manufacturer or importer distributes a chemical substance manufactured or imported under this section to persons not in its employ, the manufacturer or importer must in written form:
(i) Notify those persons that the substance is to be used only for research and development purposes.
(ii) Provide the notice of health risks specified in paragraph (c)(1) of this section.
(3) The adequacy of any notification under this section is the responsibility of the manufacturer or importer.
(d) A chemical substance is not exempt from reporting under this part if any amount of the substance, including as part of a mixture, is processed, distributed in commerce, or used, for any commercial purpose other than research and development, except where the chemical substance is processed, distributed in commerce, or used only as an impurity or as part of an article.
(e) Quantities of the chemical substance, or of mixtures or articles containing the chemical substance, remaining after completion of research and development activities may be:
(1) Disposed of as a waste in accordance with applicable Federal, state, and local regulations, or
(2) Used for the following commercial purposes:
(i) Burning it as a fuel.
(ii) Reacting or otherwise processing it to form other chemical substances for commercial purposes, including extracting component chemical substances.
(f) Quantities of research and development substances existing solely as impurities in a product or incorporated into an article, in accordance with paragraph (d) of this section, and quantities of research and development substances used solely for commercial purposes listed in paragraph (e) of this section, are not subject to the requirements of paragraphs (a), (b), and (c) of this section, once research and development activities have been completed.
(g) A person who manufactures or imports a chemical substance in small quantities solely for research and development is not required to comply with the requirements of this section if the person's exclusive intention is to perform research and development activities solely for the purpose of determining whether the substance can be used as a pesticide.
(a) Any person may apply for an exemption to manufacture or import a new chemical substance for test marketing. EPA may grant the exemption if the person demonstrates that the chemical substance will not present an unreasonable risk to injury to health or the environment as a result of the test marketing.
(b) Persons applying for a test-marketing exemption should provide the following information:
(1) All existing data regarding health and environmental effects of the chemical substance, including physical/chemical properties or, in the absence of such data, a discussion of toxicity based on structure-activity relationships (SAR) and relevant data on chemical analogues.
(2) The maximum quantity of the chemical substance which the applicant will manufacture or import for test marketing.
(3) The maximum number of persons who may be provided the chemical substance during test marketing.
(4) The maximum number of persons who may be exposed to the chemical substance as a result of test marketing, including information regarding duration and route of such exposures.
(5) A description of the test-marketing activity, including its length and how it can be distinguished from full-scale commercial production and research and development.
(c) In accordance with section 5(h)(6) of the Act, after EPA receives an application for exemption under this section, the Agency will file with the Office of the Federal Register a notice containing a summary of the information provided in the application, to the extent it has not been claimed confidential.
(d) No later than 45 days after EPA receives an application, the Agency will either approve or deny the application. Thereafter, EPA will publish a notice in the
(e) In approving an application for exemption, EPA may impose any restrictions necessary to ensure that the substance will not present an unreasonable risk of injury to health and the environment as a result of test marketing.
(a)
(2) Information may be submitted on paper, or electronically, as follows:
(i) Information submitted on paper must be submitted in the form and manner set forth in EPA Form No. 7710-25, which is available from the Environmental Assistance Division (7408), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Information which is not submitted on the EPA Form No. 7710-25 or a photocopy thereof (e.g., on a form created by commercial form-making software) must be in a format pre-approved by the Agency.
(ii) Information may be submitted electronically (on magnetic or other media) pursuant to an EPA published format for electronic submissions. Such submissions must comply with this format and all other media specifications published by EPA. Persons submitting electronically must still complete and submit on paper the Certification and Submitter Identification sections of Form 7710-25.
(b)
(c)
(d)
(2) A person who submits a notice to EPA under this part must provide EPA with an original and two complete copies of the notice, including all test data and any other information attached to the notice form. If information is claimed as confidential pursuant to § 720.80, a sanitized copy must also be provided.
(e)
(2) A manufacturer or importer may authorize another person, (e.g., a foreign manufacturer or supplier, or a toll manufacturer) to report some of the information required in the notice to EPA on its behalf. If separate portions of a joint notice are not submitted together, the submitter should indicate which information will be supplied by another person and identify that person. The other person must submit the information on the appropriate part of the notice form. The manufacturer or importer and any other person supplying the information must sign the certification provided on their respective notice forms.
(3) If EPA receives a submission which does not include information required by this rule, which the submitter indicates that it has authorized another person to provide, the notice review period will not begin until EPA receives that information.
(f)
(g)
(2) If EPA has granted the submitter an exemption under section 4(c) of the Act from the requirement to conduct tests and submit data, the submitter may not submit a notice until EPA receives the test data.
(3) If EPA has granted the submitter an exemption under section 4(c) of the Act and if another person previously has submitted the test data to EPA, the exempted person may either submit the test data or provide the following information as part of the notice:
(i) The name, title, and address of the person who submitted the test data to EPA.
(ii) The date the test data were submitted to EPA.
(iii) A citation for the test rule.
(iv) A description of the exemption and a reference identifying it.
(h)
(2) Data submitted under paragraph (h)(1) of this section must be data which the person submitting the notice believes show that the manufacture, processing, distribution in commerce, use and disposal of the substance, or any combination of such activities, will not present an unreasonable risk of injury to health or the environment.
Each person who submits a notice must include the information specified in the notice form to the extent it is known to or reasonably ascertainable by the submitter. However, no person is required to include information which relates solely to exposure of human or ecological populations outside of the United States. The notice form requires the following information relating to the manufacture, processing, distribution in commerce, use, and disposal of the new chemical substance:
(a)(1) The specific chemical identity of the substance that the person intends to manufacture or import, which includes the following:
(i) The currently correct Chemical Abstracts (CA) name for the substance, based on the Ninth Collective Index (9CI) of CA nomenclature rules and conventions, and consistent with listings for similar substances in the Inventory. For each substance having a chemical composition that can be represented by a specific, complete chemical structure diagram (a Class 1 substance), a CA Index Name must be provided. For each chemical substance that cannot be fully represented by a complete, specific chemical structure diagram (a Class 2 substance), or if the substance is a polymer, a CA Index Name or CA Preferred Name must be provided (whichever is appropriate based on CA 9CI nomenclature rules and conventions). In addition, for a Class 2 substance, the notice must identify the immediate chemical precursors and reactants by specific chemical name and Chemical Abstracts Service Registry Number (CASRN), if the number is available. Tradenames or generic names of chemical precursors or reactants are not acceptable as substitutes for specific chemical names.
(ii) The currently correct CASRN for the substance if a CASRN already exists for the substance.
(iii) For a Class 1 substance and for any Class 2 substance for which a definite molecular formula is known or reasonably ascertainable, the correct molecular formula.
(iv) For a Class 1 substance, a complete, correct chemical structure diagram; for a Class 2 substance or polymer, a correct representative or partial chemical structure diagram, as complete as can be known, if one can be reasonably ascertained.
(2) For a polymer, the submitter must also report the following:
(i) The specific chemical name and CASRN, if the number is available, of each monomer and other reactant used, at any weight percent, to manufacture the polymer. Tradenames or generic names of chemical reactants or monomers are not acceptable as substitutes for specific chemical names.
(ii) The typical percent by weight of each monomer and other reactant in the polymer (weight of the monomer or other reactant expressed as a percentage of the weight of the polymeric chemical substance manufactured), and the maximum residual amount of each monomer present in the polymer.
(iii) For monomers and other reactants used at 2 weight percent or less (based on the dry weight of the polymer manufactured), indicate on the PMN form any such monomers and other reactants that should be included as part of the polymer description on the Inventory, where the weight percent is based on either (A) the weight of monomer or other reactant actually charged to the reaction vessel, or (B) the minimum weight of monomer or other reactant required in theory to account for the actual weight of monomer or other reactant molecules or fragments chemically incorporated (chemically combined) in the polymeric substance manufactured.
(iv) For a determination that 2 weight percent or less of a monomer or
(v) Measured or estimated values of the minimum number-average molecular weight of the polymer and the amount of low molecular weight species below 500 and below 1,000 molecular weight, with a description of how the measured or estimated values were obtained.
(3) The person must use one of the following two methods to develop or obtain the specified chemical identity information reported under paragraphs (a) (1) and (2) of this section and must identify the method used in the notice:
(i)
(ii)
(4) If an importer submitting the notice cannot provide all the information specified in paragraphs (a) (1) and (2) of this section because it is claimed as confidential by the foreign supplier of the substance, the importer must have the foreign supplier follow the procedures in paragraph (a)(3) of this section and provide the correct chemical identity information specified in paragraphs (a) (1) and (2) of this section directly to EPA in a joint submission or as a letter of support to the notice, which clearly references the importer's notice and PMN User Fee Identification Number. The statutory review process will commence upon receipt of both the notice and the complete, correct information.
(5) If a manufacturer cannot provide all the information specified in paragraphs (a) (1) and (2) of this section because the new chemical substance is manufactured using a reactant having a specific chemical identity claimed as confidential by its supplier, the manufacturer must submit a notice directly to EPA containing all the information known by the manufacturer about the chemical identity of the reported substance and its proprietary reactant. In addition, the manufacturer must ensure that the supplier of the confidential reactant submit a letter of support directly to EPA providing the specific chemical identity of the confidential reactant, including the CAS number, if available, and the appropriate PMN or exemption number, if applicable. The letter of support must reference the manufacturer's name and PMN User Fee Identification Number under § 700.45(c)(3) of this chapter. The statutory review period will commence upon receipt of both the notice and the letter of support.
(b) The impurities anticipated to be present in the substance by name, CAS Registry number, and weight percent of the total substance.
(c) Known synonyms or trade names of the new chemical substance.
(d) A description of the byproducts resulting from the manufacture, processing, use, and disposal of the new chemical substance.
(e) The estimated maximum amount to be manufactured or imported during the first year of production and the estimated maximum amount to be manufactured or imported during any 12-month period during the first three years of production.
(f) A description of intended categories of use by function and application, the estimated percent of production volume devoted to each category of use, and the percent of the new substance in the formulation for each commercial or consumer use.
(g) For sites controlled by the submitter:
(1) The identity of sites where the new substance will be manufactured, processed, or used.
(2) A process description of each manufacture, processing, and use operation which includes a diagram of the major unit operations and chemical conversions, the identity and entry point of all feedstocks, and the points of release of the new chemical substance.
(3) Worker exposure information, including worker activities, physical form of the new substance to which workers may be exposed, the number of workers, and the duration of activities.
(4) Information on release of the new substance to the environment, including the quantity and media of release and type of control technology used.
(h) For sites not controlled by the submitter, a description of each type of processing and use operation involving the new chemical substance, including identification of the estimated number of processing or use sites, situations in which worker exposure to and/or environmental release of the new chemical substance will occur, the number of workers exposed and the duration of exposure, and controls which limit worker exposure and environmental release.
(a)
(2) A full report or standard literature citation must be submitted for the following types of test data:
(i) Health effects data.
(ii) Ecological effects data.
(iii) Physical and chemical properties data.
(iv) Environmental fate characteristics.
(v) Monitoring data and other test data related to human exposure to or environmental release of the chemical substance.
(3)(i) If the data do not appear in the open scientific literature, the submitter must provide a full report. A full report includes the experimental methods and materials, results, discussion and data analysis, conclusions, references, and the name and address of the laboratory that developed the data.
(ii) If the data appear in the open scientific literature, the submitter need only provide a standard literature citation. A standard literature citation includes author, title, periodical name, date of publication, volume, and page numbers.
(4)(i) If a study, report, or test is incomplete when a person submits a notice, the submitter must identify the nature and purpose of the study; name and address of the laboratory developing the data; progress to date; types of data collected; significant preliminary results; and anticipated completion date.
(ii) If a test or experiment is completed before the notice review period ends, the person must submit the study, report, or test to the address listed on the notice form, as specified in paragraph (a)(3)(i) of this section, within ten days of receiving it, but no later than five days before the end of the review period. If the test or experiment is completed during the last five days of the review period, the submitter must immediately inform its EPA contact for that notice by telephone.
(5) For test data in the submitter's possession or control which are not listed in paragraph (a)(2) of this section, a person is not required to submit a complete report. The person must submit a summary of the data. If EPA so requests, the person must submit a full report within ten days of the request, but no later than five days before the end of the review period.
(6) All test data described by paragraph (a) are subject to these requirements, regardless of their age, quality, or results.
(b)
(i) Any data, other than test data, in the submitter's possession or control.
(ii) Any data, including test data, which are not in the submitter's possession or control, but which are known to or reasonably ascertainable by the submitter. For the purposes of this section, data are known to or reasonably ascertainable by the submitter if the data are known to any of its employees or other agents who are associated with the research and development, test marketing, or commercial marketing of the substance.
(2) Data that must be described include data concerning the new chemical substance in a pure, technical grade, or formulated form.
(3) The description of data reported under this paragraph must include:
(i) If the data appear in the open scientific literature, a standard literature citation, which includes the author, title, periodical name, date of publication, volume, and pages.
(ii) If the data are not contained in the open scientific literature, a description of the type of data and summary of the results, if available, and the names and addresses of persons the submitter believes may have possession or control of the data.
(4) All data described by this paragraph are subject to these requirements, regardless of their age, quality, or results; and regardless of whether they are complete at the time the notice is submitted.
(c) [Reserved]
(d)
(ii) For data previously submitted to EPA with a claim of confidentiality, the person must resubmit the data with the notice and any claim of confidentiality, under § 720.80.
(2)
(3)
(a) Except as otherwise provided in this section, the provisions of this subpart C apply to each person who submits a notice for a new chemcial substance which he or she intends to import for a commercial purpose. In addition, each importer must comply with this section.
(b) EPA will hold the principal importer, or the importer that EPA determines must submit the notice when there is no principal importer under § 720.22(b)(2), liable for complying with this part, for completing the notice form and for the completeness and truthfulness of all information which it submits.
This subpart establishes procedures that EPA will follow in reviewing notices.
When EPA receives a notice, EPA will review it to determine whether the chemical substance is subject to the requirements of this part. If EPA determines that the chemical substance is not subject to these requirements, EPA will notify the submitter that section 5 of the Act does not prevent the manufacture or import of the substance and that the submission is not a notice under this part.
(a)
(b)
(i) Failure to date the notice form.
(ii) Typographical errors that cause data to be misleading or answers to any questions to be unclear.
(iii) Contradictory information.
(iv) Ambiguous statements or information.
(2) In the request to correct the notice, EPA will explain the action which the submitter must take to correct the notice.
(3) If the submitter fails to correct the notice within 15 days of receipt of the request, EPA may extend the notice period under section (5)(c) of the Act, in accordance with § 720.75(c).
(c)
(i) The wrong person submits the notice form.
(ii) The submitter does not sign the notice form.
(iii) Some or all of the information in the notice or the attachments are not in English, except for published scientific literature.
(iv) The submitter does not use the notice form.
(v) The submitter does not provide information that is required by section 5(d)(1) (B) and (C) of the Act and § 720.50.
(vi) The submitter does not provide information required on the notice form and by § 720.45 or indicate that it is not known to or reasonably ascertainable by the submitter.
(vii) The submitter does not submit a second copy of the submission with all confidential information deleted for the public file, as required by § 720.80(b)(2).
(viii) The submitter does not include any information required by section 5(b)(1) of the Act and pursuant to a rule promulgated under section 4 of the Act, as required by § 720.40(g).
(ix) The submitter does not submit data which the submitter believes show that the chemical substance will not present an unreasonable risk of injury to health or the environment, if EPA has listed the chemical substance under section 5(b)(4) of the Act, as required in § 720.40(h).
(2)(i) If EPA receives an incomplete submission, the Director, or his or her delegate, will notify the submitter within 30 days of receipt that the submission is incomplete and that the notice review period will not begin until EPA receives a complete notice.
(ii) If EPA obtains additional information during the notice review period that indicates the original submission was incomplete, the Director, or his or her delegate, may declare the submission incomplete within 30 days after EPA obtains the additional information and so notify the submitter.
(3) The notification that a submission is incomplete under paragraph (c)(2) (i) or (ii) of this section will include:
(i) A statement of the basis of EPA's determination that the submission is incomplete.
(ii) The requirements for correcting the incomplete submission.
(iii) Information on procedures under paragraph (c)(4) of this section for filing objections to the determination or requesting modification of the requirements for completing the submission.
(4) Within ten days after receipt of notification by EPA that a submission is incomplete, the submitter may file written objections requesting that EPA accept the submission as a complete notice or modify the requirements necessary to complete the submission.
(5)(i) EPA will consider the objections filed by the submitter. The Director, or his or her delegate, will determine whether the submission was complete or incomplete, or whether to modify the requirements for completing the submission. EPA will notify the submitter in writing of EPA's response within ten days of receiving the objections.
(ii) If the Director, or his or her delegate, determines, in response to the objection, that the submission was complete, the notice review period will be deemed suspended on the date EPA declared the notice incomplete, and will resume on the date that the notice is declared complete. The submitter need not correct the notice as EPA originally requested. If EPA can complete its review within 90 days from the date of the original submission, the Director, or his or her delegate, may inform the submitter that the running of the review period will resume on the date EPA originally declared it incomplete.
(iii) If the Director, or his or her delegate, modifies the requirements for completing the submission or concurs with EPA's original determination, the notice review period will begin when EPA receives a complete notice.
(d)
(a)
(b)
(2) The categories of use of the new chemical substance will be published as reported in the notice unless this information is claimed confidential. If confidentiality is claimed, the generic information which is submitted under § 720.87(b) will be published.
(3) A list of data submitted in accordance with § 720.50(a) will be published. In addition, for test data submitted in accordance with § 720.40(g), a summary of the data will be published.
(4) The submitter's identity will be published, unless the submitter has claimed it confidential.
(a)
(b)
(2) A request for suspension may be made in writing to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. The suspension also may be made orally, including by telephone, to the submitter's EPA contact for that notice. EPA will send the submitter a written confirmation that the suspension has been granted.
(i) An oral request may be granted for 15 days only. To obtain a longer suspension, the Document Control Officer for the Office of Pollution Prevention and Toxics must receive written confirmation of the oral request. The notice review period is suspended as of the date of the oral request.
(ii) If the submitter has not made a previous oral request, the running of the notice review period is suspended as of the date of receipt of the written request by the Document Control Officer for the Office of Pollution Prevention and Toxics.
(c)
(2) If EPA makes such a determination, EPA will:
(i) Notify the submitter that EPA is extending the notice review period for a specified length of time, and state the reasons for the extension.
(ii) Issue a notice for publication in the
(3) The initial extension may be for a period of up to 90 days. If the initial extension is for less than 90 days, EPA may make additional extensions. However, the total period of extensions may not exceed 90 days for any notice.
(4) The following are examples of situations in which EPA may find that good cause exists for extending the notice review period:
(i) EPA has reviewed the notice and determined that there is a significant possibility that the chemical substance will be regulated under section 5(e) or section 5(f) of the Act, but EPA is unable to initiate regulatory action within the initial 90-day period.
(ii) EPA has reviewed the submission and is seeking additional information.
(iii) EPA has received significant additional information during the notice review period.
(iv) The submitter has failed to correct a notice after receiving EPA's request under § 720.65(b).
(d)
(e)
(2) If a manufacturer or importer which withdrew a notice later resubmits a notice for the same chemical substance, a new notice review period begins.
(a) Any person who submits a notice under this part must retain documentation of information in the notice,
(b)(1) Persons who manufacture or import a chemical substance under § 720.36 must retain the following records:
(i) Copies of, or citations to, information reviewed and evaluated under § 720.36(b)(1) to determine the need to make any notification of risk.
(ii) Documentation of the nature and method of notification under § 720.36(c)(1) including copies of any labels or written notices used.
(iii) Documentation of prudent laboratory practices used instead of notification and evaluation under § 720.36(b)(2).
(iv) The names and addresses of any persons other than the manfacturer or importer to whom the substance is distributed, the identity of the substance to the extent known, the amount distributed, and copies of the notifications required under § 720.36(c)(2). These records are not required when substances are distributed as impurities or incorporated into an article, in accordance with paragraph (d) of this section.
(2) A person who manufactures or imports a chemical substance under § 720.36 and who manufactures or imports the substance in quantities greater than 100 kilograms per year must retain records of the identity of the substance to the extent known, the production volume of the substance, and the person's disposition of the substance. The person is not required to maintain records of the disposition of products containing the substance as an impurity or of articles incorporating the substances.
(3) Records under this paragraph must be retained for 5 years after they are developed.
(c) Any person who obtains a test-marketing exemption under this part must retain documentation of information in the application and documentation of compliance with any restrictions imposed by EPA when it granted the application. This information must be retained for five years from the final date of manufacture or import under the exemption.
(a) A person may assert a claim of confidentiality for any information which he or she submits to EPA under this part.
(b) Any claim of confidentiality must accompany the information when it is submitted to EPA.
(1)(i) For information submitted on the notice form, the claim(s) must be asserted on the form in the manner prescribed on the notice form.
(ii) When a person submits information in an attachment, the claim(s) must be asserted in the attachment as described on the notice form.
(2) If any information is claimed as confidential, the person must submit, in addition to the copies specified by § 720.40, a sanitized copy of the notice form (or electronic submission) and any attachments.
(i) The original and two copies of the notice, specified at § 720.40 (or electronic submission) and attachments must be complete. The submitter must designate that information which is claimed as confidential in the manner prescribed on the notice form (or in EPA's electronic submission instructions).
(ii) The sanitized copy must be complete except that all information claimed as confidential in the original must be deleted. EPA will place this sanitized copy in the public file.
(iii) If the person does not provide the sanitized copy, or information in a health and safety study (except information claimed as confidential in accordance with § 720.90), the submission will be deemed incomplete and the notice review period will not begin until EPA receives the sanitized copy or the health and safety study information is included, in accordance with § 720.65(c)(1)(vii).
(c) EPA will disclose information that is subject to a claim of confidentiality asserted under this section only to the extent permitted by the Act, this subpart, and part 2 of this title.
(d) If a notice submitter does not assert a claim of confidentiality for information at the time it is submitted to EPA, EPA may make the information public and place it in the public file without further notice to the submitter.
(a)
(ii) If the notice includes a health and safety study concerning the new chemical substance and if the claim for confidentiality with respect to the chemical identity is denied in accordance with § 720.90(c), EPA will deny a claim asserted under this paragraph.
(2) Any person who asserts a claim of confidentiality for chemical identity under this paragraph must provide one of the following items at the time the notice is submitted:
(i) The generic name which was accepted by EPA in the prenotice consultation conducted under paragraph (a)(3) of this section.
(ii) One generic name that is only as generic as necessary to protect the confidential chemical identity of the particular chemical substance. The name should reveal the specific chemical identity to the maximum extent possible. The generic name will be subject to EPA review and approval at the time a notice of commencement is submitted.
(3)(i) Any person who intends to assert a claim of confidentiality for the chemical identity of a new chemical substance may seek a determination by EPA of an appropriate generic name for the substance before submitting a notice. For this purpose, the person should submit to EPA:
(A) The chemical identity of the substance.
(B) A proposed generic name(s) which in only as generic as necessary to protect the confidential chemical identity of the new chemical substance. The name(s) should reveal the chemical identity of the substance to the maximum extent possible.
(ii) Within 30 days, EPA will inform the submitter either that one of the proposed generic names is adequate or that none is adequate and further consultation is necessary.
(4) If a submitter claims chemical identity to be confidential under this paragraph, and if the submitter complies with paragraph (a)(2) of this section, EPA will issue for publication in the
(b)
(2)(i) A person who believes that public disclosure of the fact that anyone
(ii) If the notice includes a health and safety study concerning the new chemical substance, and if the claim for confidentiality with respect to the chemical identity is denied in accordance with § 720.90(c), EPA will deny a claim asserted under this paragraph.
(3) Any person who asserts a confidentiality claim for chemical identity must:
(i) Comply with the requirements of paragraph (a)(3) of this section regarding submission of a generic name.
(ii) Agree that EPA may disclose to a person with a
(iii) Have available for the particular chemical substance, and agree to furnish to EPA upon request:
(A) An elemental analysis.
(B) Either an X-ray diffraction pattern (for inorganic substances), a mass spectrum (for most other substances), or an infrared spectrum of the particular chemical substance, or if such data do not resolve uncertainties with respect to the identity of the chemical substance, additional or alternative spectra or other data to identify the chemical substance.
(iv) Provide a detailed written substantiation of the claim, by answering the following questions:
(A) What harmful effects to your competitive position, if any, do you think would result if EPA publishes on the Inventory the identity of the chemical substance? How could a competitor use such information given the fact that the identity of the substance otherwise would appear on the Inventory of chemical substances with no link between the substance and your company or industry? How substantial would the harmful effects of disclosure be? What is the casual relationship between the disclosure and the harmful effects?
(B) For what period of time should confidential treatment be given? Until a specific date, the occurrence of a specific event, or permanently? Why?
(C) Has the chemical substance been patented? If so, have you granted licenses to others with respect to the patent as it applies to the chemical substance? If the chemical substance has been patented and therefore disclosed through the patent, why should it be treated as confidential for purposes of the Inventory?
(D) Has the identity of the chemical substance been kept confidential to the extent that your competitors do not know it is being manufactured on imported for a commercial purpose by anyone?
(E) Is the fact that someone is manufacturing or importing this chemical substance for commercial purposes available to the public, e.g., in technical journals or other publications; in libraries; or in State, local, or Federal agency public files?
(F) What measures have you taken to prevent undesired disclosure of the fact that you are manufacturing or importing this substance for a commercial purpose?
(G) To what extent has the fact that you are manufacturing or importing this chemical substance for a commercial purpose been disclosed to others? What precautions have you taken in regard to these disclosures? Has this information been disclosed to the public or to competitors?
(H) In what form does this particular chemical substance leave the site of manufacture, e.g., as part of a product; in an effluent or emission stream? If so, what measures have you taken to guard against discovery of its identity?
(I) If the chemical substance leaves the site of manufacture in a product that is available to either the public or your competitors, can they identify the substance by analyzing the product?
(J) For what purpose do you manufacture or import the substance?
(K) Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality determinations regarding this chemical substance? If so, copies of such determinations must be included in the substantiation.
(L) If the notice includes a health and safety study concerning the new chemical substance, the submitter
(4) If the submitter does not meet the requirements of this paragraph, EPA will deny the claim of confidentiality.
(5)(i) EPA will publish a generic name on the public Inventory if:
(A) The submitter asserts a claim of confidentiality in accordance with this paragraph.
(B) No claim for confidentiality of the specific chemical identity as part of a health and safety study has been denied in accordance with part 2 of this title or § 720.90.
(ii) Publication of a generic name on the public Inventory does not create a category for purposes of the Inventory. Any person who has a
(iii) Upon receipt of a request described in § 720.25(b), EPA may require the submitter which originally asserted confidentiality for a chemical substance to submit to EPA the information listed in paragraph (b)(3)(iii) of this section.
(iv) Failure to submit any of the information required under paragraph (b)(3)(iii) of this section within ten days of a request by EPA under this paragraph is a waiver of the original submitter's confidentiality claim. In this event, EPA may place the specific chemical identity on the public Inventory without further notice to the original submitter.
(6) If a submitter asserts a claim of confidentiality under this paragraph, EPA will examine the generic chemical name proposed by the submitter.
(i) If EPA determines that the generic name proposed by the submitter is only as generic as necessary to protect the confidential identity of the particular chemical substance, EPA will place that generic name on the public Inventory.
(ii) If EPA determines that the generic name proposed by the submitter is more generic than necessary to protect the confidential identity, EPA will propose in writing, for review by the submitter, an alternative generic name that will reveal the chemical identity of the chemical substance to the maximum extent possible.
(iii) If the generic name proposed by EPA is acceptable to the submitter, EPA will place that generic name on the public Inventory.
(iv) If the generic name proposed by EPA is not acceptable to the submitter, the submitter must explain in detail why disclosure of that generic name would reveal confidential business information and propose another generic name which is only as generic as necessary to protect the confidential identity. If EPA does not receive a response from the submitter within 30 days after the submitter receives the proposed name, EPA will place EPA's chosen generic name on the public Inventory. If the submitter does provide the information requested, EPA will review the response. If the submitter's proposed generic name is acceptable, EPA will publish that generic name on the public Inventory. If the submitter's proposed generic name is not acceptable, EPA will notify the submitter of EPA's choice of a generic name. Thirty days after this notification, EPA will place the chosen generic name on the public Inventory.
(a) A person who submits information to EPA under this part on the categories or proposed categories of use of a new chemical substance may assert a claim of confidentiality for this information.
(b) A submitter that asserts such a claim must:
(1) Report the categories or proposed categories of use of the chemical substance.
(2) Provide, in nonconfidential form, a description of the uses that is only as generic as necessary to protect the confidential business information. The generic use description will be included in the
(c) The person must submit the information required by paragraph (b) of this section in the manner specified in the notice form.
(a)
(1) Processes used in the manufacture or processing of a chemical substance or mixture.
(2) In the case of a mixture, the portion of the mixture comprised by any of the chemical substances in the mixture.
(3) Information which is not in any way related to the effects of a substance on human health or the environment, such as the name of the submitting company, cost or other financial data, product development or marketing plans, and advertising plans, for which the person submits a claim of confidentiality in accordance with § 720.80.
(b)
(2)
(i) Would disclosure of the chemical identity disclose processes used in the manufacture or processing of a chemical substance or mixture? Describe how this would occur. In responding to the question in § 720.85(b)(3)(iv)(A), explain what harmful competitive effects would occur from disclosure of this process information.
(ii) Would disclosure of the chemical identity disclose the portion of a mixture comprised by any of the substances in the mixture? Describe how this would occur. In responding to the question in § 720.85(b)(3)(iv)(A), explain what harmful competitive effects would occur from disclosure of this information.
(iii) Do you assert that disclosure of the chemical identity is not necessary to interpret any of the health and safety studies you have submitted? If so, explain how a less specific identity would be sufficient to interpret the studies.
(c)
(1) The information would disclose processes used in the manufacture or processing of a chemical substance or mixture.
(2) In the case of a mixture, the information would disclose the portion of the mixture comprised by any of the substances in the mixture.
(3) The specific chemical identity is not necessary to interpret a health and safety study.
(d)
All information submitted with a notice, including any health and safety study and other supporting documentation, will become part of the public file for that notice, unless such materials are claimed confidential. In addition, EPA may add materials to the public file, subject to subpart E of this part. Any of the nonconfidential material described in this subpart will be available for public inspection in the Non-Confidential Information Center
(a)
(b)
(2) If manufacture or import for commercial purposes began or will begin before the effective date of this rule, the submitter must submit the notice by the effective date of this rule.
(c)
(i) The specific chemical identity of the PMN substance.
(ii) A generic chemical name (if the chemical identity is claimed as confidential by the submitter).
(iii) The premanufacture notice (PMN) number assigned by EPA.
(iv) The date of commencement for the submitter's manufacture or import for a non-exempt commercial purpose (indicating whether the substance was initially manufactured in the United States or imported). The date of commencement is the date of completion of non-exempt manufacture of the first amount (batch, drum, etc.) of new chemical substance identified in the submitter's PMN. For importers, the date of commencement is the date the new chemical substance clears United States customs.
(v) The name and address of the submitter.
(vi) The name of the authorized official.
(vii) The name and telephone number of a technical contact in the United States.
(viii) The address of the site where commencement of manufacture occurred.
(ix) Clear indications of whether the chemical identity, submitter identity, and/or other information are claimed as confidential by the submitter.
(2) If the submitter claims the chemical identity confidential, and wants the identity to be listed on the confidential portion of the Inventory, the claim must be reasserted and substantiated in accordance with § 720.85(b). Otherwise, EPA will list the specific chemical identity on the public Inventory. Submitters who did not claim the chemical identity, submitter identity, or other information to be confidential in the PMN cannot claim this information as confidential in the notice of commencement.
(d)
(a) Failure to comply with any provision of this part is a violation of section 15 of the Act (15 U.S.C 2614).
(b) A person who manufactures or imports a new chemical substance before a notice is submitted and the notice review period expires is in violation of section 15 of the Act even if that person was not requied to submit the notice under § 720.22.
(c) Using for commercial purposes a chemical substance or mixture which a person knew or had reason to know was manufactured, processed, or distributed in commerce in violation of section 5 of this rule is a violation of section 15 of the Act (15 U.S.C. 2614).
(d) Failure or refusal to establish and maintain records or to permit access to or copying of records, as required by the Act, is a violation of section 15 of the Act (15 U.S.C. 2614).
(e) Failure or refusal to permit entry or inspection as required by section 11 is a violation of section 15 of the Act (15 U.S.C. 2614).
(f) Violators may be subject to the civil and criminal penalties in section 16 of the Act (15 U.S.C. 2615) for each violation. Persons who submit materially misleading or false information in connection with the requirements of any provision of this rule may be subject to penalties calculated as if they never filed their notices.
(g) EPA may seek to enjoin the manufacture or processing of a chemical substance in violation of this rule or act to seize any chemical substance manufactured or processed in violation of this rule or take other actions under the authority of section 7 of this Act (15 U.S.C. 2606) or section 17 or this Act (15 U.S.C. 2616).
EPA will conduct inspections under section 11 of the Act to assure compliance with section 5 of the Act and this rule, to verify that information submitted to EPA under this rule is true and correct, and to audit data submitted to EPA under this rule.
15 U.S.C. 2604, 2607, and 2625(c).
(a) This part identifies uses of chemical substances, except for microorganisms regulated under part 725 of this chapter, which EPA has determined are significant new uses under the authority of section 5(a)(2) of the Toxic Substances Control Act. In addition, it specifies procedures for manufacturers, importers, and processors to report on those significant new uses. This subpart A contains general provisions applicable to this part. subpart B of this part identifies generic requirements for certain significant new uses cross referenced in specific provisions of subpart E of this part. subpart C of this part identifies generic reporting requirements for certain significant new uses cross referenced in specific provisions of subpart E of this part. subpart E of this part identifies chemical substances and their significant new uses.
(b) This subpart A contains provisions governing submission and review of notices for the chemical substances and significant new uses identified in subpart E of this part. The provisions of this subpart A apply to the chemical substances and significant new uses identified in subpart E of this part, except to the extent that they are specifically modified or supplanted by specific requirements in subpart E of this part. In the event of a conflict between the provisions of this subpart A and the provisions of subpart E of this part, the provisions of subpart E of this part shall govern.
(c) The provisions of part 720 of this chapter apply to this part 721. For purposes of this part 721, wherever the phrase “new chemical substance” appears in part 720 of this chapter, it shall mean the chemical substance subject to this part 721. In the event of a conflict between the provisions of part 720 of this chapter and the provisions of this part 721, the provisions of this part 721 shall govern.
The definitions in section 3 of the Act, 15 U.S.C. 2602, and § 720.3 of this chapter apply to this part. In addition, the following definitions apply to this part:
(1) At least 50 percent of the exposed mammalian test animals following oral administration of a single dose of the test substance at 25 milligrams or less per kilogram of body weight (LD
(2) At least 50 percent of the exposed mammalian test animals following dermal administration of a single dose of the test substance at 50 milligrams or less per kilogram of body weight (LD
(3) At least 50 percent of the exposed mammalian test animals following administration of the test substance for 8 hours or less by continuous inhalation at a steady concentration in air at 0.5 milligrams or less per liter of air (LC
(1) An acute aquatic EC
(2) An acute aquatic EC
(3) A Maximum Acceptable Toxicant Concentration (MATC) of less than or equal to 100 parts per billion (100 ppb).
(4) An acute aquatic EC
(a) The following persons must submit a significant new use notice as specified under the provisions of section 5(a)(1)(B) of the Act, part 720 of this chapter, and § 721.25:
(1) A person who intends to manufacture, import, or process for commercial purposes a chemical substance identified in a specific section in subpart E of this part, and intends to engage in a significant new use of the substance identified in that section.
(2) A person who intends to manufacture, import, or process for commercial purposes a chemical substance identified in a specific section in subpart E of this part, and intends to distribute the substance in commerce. A person described in this paragraph is not required to submit a significant new use notice if that person can document one or more of the following as to each recipient of the substance from that person:
(i) That the person has notified the recipient, in writing, of the specific section in subpart E of this part which identifies the substance and its designated significant new uses.
(ii) That the recipient has knowledge of the specific section in subpart E of this part which identifies the substance and its designated significant new uses.
(iii) That the recipient cannot undertake any significant new use described
(b) A person described in paragraph (a)(2) of this section must submit a significant new use notice if that person has knowledge at the time of commercial distribution of the substance identified in the specific section in subpart E of this part that a recipient intends to engage in a designated significant new use of that substance without submitting a notice under this part.
(c) A person who processes a chemical substance identified in a specific section in subpart E of this part for a significant new use of that substance is not required to submit a significant new use notice if that person can document each of the following:
(1) That the person does not know the specific chemical identity of the chemical substance being processed.
(2) That the person is processing the chemical substance without knowledge that the substance is identified in subpart E of this part.
(d)(1) If at any time after commencing distribution in commerce of a chemical substance identified in a specific section in subpart E of this part a person described in paragraph (a)(2) of this section has knowledge that a recipient of the substance is engaging in a significant new use of that substance designated in that section without submitting a notice under this part, the person is required to cease supplying the chemical substance to that recipient and to submit a significant new use notice for that chemical substance and significant new use, unless the person is able to document each of the following:
(i) That the person has notified the recipient and EPA enforcement authorities (at the address in paragraph (d)(1)(iii) of this section), in writing within 15 working days of the time the person develops knowledge that the recipient is engaging in a significant new use, that the recipient is engaging in a significant new use without submitting a significant new use notice.
(ii) That, within 15 working days of notifying the recipient as described in paragraph (d)(1)(i) of this section, the person received from the recipient, in writing, a statement of assurance that the recipient is aware of the terms of the applicable section in subpart E of this part and will not engage in the significant new use.
(iii) That the person has promptly provided EPA enforcement authorities with a copy of the recepient's statement of assurance described in paragraph (d)(1)(ii) of this section. The copy must be sent to the Office of Enforcement and Compliance Assurance, Office of Compliance (2224A), U.S. Environmental Protection Agency, Ariel Rios, 1200 Pennsylvania Ave., N.W., Washington, DC, 20044.
(2) If EPA notifies the manufacturer, importer, or processor that the recipient is engaging in a significant new use after providing the statement of assurance described in paragraph (d)(1)(ii) of this section and without submitting a notice under this part, the manufacturer, importer, or processor shall immediately cease distribution to that recipient until the manufacturer, importer, or processor or the recipient has submitted a significant new use notice under this part and the notice review period has ended.
(3) If, after receiving a statement of assurance from a recipient under paragraph (d)(1)(ii) of this section, a manufacturer, importer, or processor has knowledge that the recipient is engaging in a significant new use without submitting a notice under this part, the manufacturer, importer, or processor must immediately cease distributing the substance to that recipient and notify EPA enforcement authorities at the address identified in paragraph (d)(1)(iii) of this section. The manufacturer, importer, or processor may not resume distribution to that recipient until any one of the following has occurred:
(i) The manufacturer, importer, or processor has submitted a significant new use notice under this part and the notice review period has ended.
(ii) The recipient has submitted a significant new use notice under this part and the notice review period has ended.
(iii) The manufacturer, importer, or processor has received notice from EPA enforcement authorities that it may resume distribution to that recipient.
(e) Any significant new use notice relating to import of a substance must be submitted by the principal importer.
(a) A person who intends to manufacture, import, or process a chemical substance which is described by a generic chemical name is subpart E of this part may ask EPA whether the substance is subject to the requirements of this part. EPA will answer such an inquiry only if EPA determines that the person has a
(b) To establish a
(1) The specific chemical identity of the chemical substance that the person intends to manufacture, import, or process.
(2) A signed statement that the person intends to manufacture, import, or process the chemical substance for commercial purposes.
(3) A description of the research and development activities conducted to date, and the purpose for which the person will manufacture, import, or process the chemical substance.
(4) An elemental analysis.
(5) Either an X-ray diffraction pattern (for inorganic substances), a mass spectrum (for most other substances), or an infrared spectrum of the particular chemical substance, or, if such data do not resolve uncertainties with respect to the identity of the chemical substance, additional or alternative spectra or other data to identify the substance.
(c) If an importer or processor cannot provide all the information required in paragraph (b) of this section because it is claimed as confidential business information by the importer's or processor's manufacturer or supplier, the manufacturer or supplier may supply the information directly to EPA.
(d) EPA will review the information submitted by the manufacturer, importer, or processor under paragraph (b) of this section to determine whether than person has shown a
(e) If the manufacturer, importer, or processor has shown a
(f) A disclosure to a person with a
(g) EPA will answer an inquiry on whether a particular chemical substance is subject to this part within 30 days after receipt of a complete submission under paragraph (b) of this section.
Persons who intend to export a chemical substance identified in subpart E of this part, or in any proposed rule which would amend subpart E of this part, are subject to the export notification provisions of section 12(b) of the
(a) Each person who is required to submit a significant new use notice under this part must submit the notice at least 90 calendar days before commencing manufacture, import, or processing of a chemical substance identified in subpart E of this part for a significant new use. The submitter must comply with any applicable requirement of section 5(b) of the Act, and the notice must include the information and test data specified in section 5(d)(1) of the Act. The notice must be submitted on EPA Form 7710-25, and must comply with the requirements of part 720 of this chapter, except to the extent that they are inconsistent with this part 721.
(b) If two or more persons are required to submit a significant new use notice for the same chemical substance and significant new use identified in subpart E of this part, they may submit a joint notice to EPA. Persons submitting a joint notice must individually complete the certification section of part I of the required notification form. Persons who are required to submit individually, but elect to submit jointly, remain individually liable for the failure to submit required information which is known to or reasonably ascertainable by them and test data in their possession or control.
(c) EPA will process the notice in accordance with the procedures of part 720 of this chapter, expect to the extent they are inconsistent with this part 721.
(d) Any person submitting a significant new use notice in response to the requirements of this part 721 shall not manufacture, import, or process a chemical substance identified in subpart E of this part for a significant new use until the notice review period, including all extensions and suspensions, has expired.
(a) In certain sections of subpart E of this part, significant new uses for the identified substances are described as the failure to establish and implement programs providing for the use of either: specific measures to control worker exposure to or release of substances which are identified in such sections, or alternative measures to control worker exposure or environmental release which EPA has determined provide substantially the same degree of protection as the specified control measures. Persons who manufacture, import, or process a chemical substance identified in such sections and who intend to employ alternative measures to control worker exposure or environmental release must submit a request to EPA for a determination of equivalency before commencing manufacture, import, or processing involving the alternative control measures.
(b) A request for a determination of equivalency must be submitted in writing to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; ATTN: SNUR Equivalency Determination, and must contain:
(1) The name of the submitter.
(2) The specific chemical identity of the substance.
(3) The citation for the specific section in subpart E of this part which pertains to the substance for which the request is being submitted.
(4) A detailed description of the activities involved.
(5) The specifications of the alternative worker exposure control measures or environmental release control measures.
(6) An analysis justifying why such alternative control measures provide
(7) The data and information described in § 720.50 (a) and (b) of this chapter unless such data and information have already been submitted to the Office of Pollution Prevention and Toxics, EPA.
(c) Requests for determinations of equivalency will be reviewed by EPA within 45 days. Determinations under this paragraph will be made by the Director, Office of Pollution Prevention and Toxics, or designee. Notice of the results of such determinations will be mailed to the submitter.
(d) If EPA notifies the submitter under paragraph (c) of this section that EPA has determined that the alternative control measures provide substantially the same degree of protection as the specified control measures identified in the specified section of subpart E of this part which pertains to the substance for which the request is being submitted, the submitter may commence manufacture, import, or processing in accordance with the specifications for alternative worker exposure control measures or environmental release control measures identified in the submitter's request, and may alter any corresponding notification to workers to reflect such alternative controls. Deviations from the activities described in the EPA notification constitute a significant new use and are subject to the requirements of this part.
(a) Failure to comply with any provision of this part is a violation of section 15(1) of the Act (15 U.S.C. 2614).
(b) Using for commercial purposes a chemical substance which a person knew or had reason to know was manufactured, imported, or processed in violation of this part is a violation of section 15(2) of the Act (15 U.S.C. 2614).
(c) Failure or refusal to permit access to or copying of records, as required by section 11 of the Act, is a violation of section 15(3) of the Act (15 U.S.C. 2614).
(d) Failure or refusal to permit entry or inspection, as required by section 11 of the Act, is a violation of section 15(4) of the Act.
(e) Violators of the Act or of this part may be subject to the civil and criminal penalties in section 16 of the Act (15 U.S.C. 2615) for each violation. The submission of false or misleading information in connection with the requirement of any provision of this part may subject persons to penalties calculated as if they never filed a notice.
(f) Under the authority of sections 7 and 17 of the Act, EPA may:
(1) Seek to enjoin the manufacture, import, or processing of a chemical substance in violation of this part.
(2) Act to seize any chemical substance which is being manufactured, imported, or processed in violation of this part.
(3) Take any other appropriate action.
Any person subject to the requirements of this part must retain documentation of information contained in that person's significant new use notice. This documentation must be maintained for a period of 5 years from the date of the submission of the significant new use notice.
The persons identified in § 721.5 are not subject to the notification requirements of § 721.25 for a chemical substance identified in subpart E of this part, unless otherwise specified in a specific section in subpart E, if:
(a) The person has applied for and has been granted an exemption for test marketing the substance for a significant new use identified in subpart E of this part in accordance with section 5(h)(1) of the Act and § 720.38 of this chapter.
(b) The person manufactures, imports, or processes the substance for a significant new use identified in subpart E of this part in small quantities
(c) The person has applied for and been granted an exemption under section 5(h)(5) of the Act.
(d) The person manufactures, imports, or processes the substance only as an impurity.
(e) The person manufactures, imports, or processes the substance only as a byproduct which is used only by public or private organizations that (1) burn it as a fuel, (2) dispose of it as a waste, including in a landfill or for enriching soil, or (3) extract component chemical substances from it for commercial purposes.
(f) The person imports or processes the substance as part of an article.
(g) The person manufactures or processes the substance solely for export and, when distributing the substance in commerce, labels the substance in accordance with section 12(a)(1)(B) of the Act.
(h) The person submits a significant new use notice for the substance prior to the promulgation date of the section in subpart E of this part which identifies the substance, and the person receives written notification of compliance from EPA prior to the effective date of such section. The notice submitter must comply with any applicable requirement of section 5(b) of the Act. The notice must include the information and test data specified in section 5(d)(1) of the Act and must be submitted on the notice form in Appendix A to part 720 of this chapter. For purposes of this exemption, the specific section in subpart E of this part which identifies the substance and §§ 721.1, 721.3, 721.11, 721.35, and 721.40 apply; after the effective date of the section in subpart E of this part which identifies the substance, § 721.5 applies and § 721.20 continues to apply. EPA will provide the notice submitter with written notification of compliance only if one of the following occurs:
(1) EPA is unable to make the finding that the activities described in the significant new use notice will or may present an unreasonable risk of injury to health or the environment under reasonably foreseeable circumstances.
(2) EPA and the person negotiate a consent order under section 5(e) of the Act, such order to take effect on the effective date of the section in subpart E of this part which identifies the substance.
(i) The person is operating under the terms of a consent order issued under section 5(e) of the Act applicable to that person. If a provision of such section 5(e) order is inconsistent with a specific significant new use identified in subpart E of this part, abiding by the provision of the section 5(e) order exempts the person from submitting a significant new use notice for that specific significant new use.
(a) A person who manufactures, imports, or processes a chemical substance identifies in subpart E of this part for a significant new use identified in subpart E of this part is not subject to the notification requirements of § 721.25 if the following conditions are met:
(1) The person manufactures, imports, or processes the substance for the significant new use in small quantities solely for research and development.
(2) The manufacturer, importer, or processor notifies all persons in its employ or to whom it directly distributes the chemical substance, who are engaged in experimentation, research, or analysis on the chemical substance, including the manufacture, processing, use, transport, storage, and disposal of the substance associated with research and development activities, of any risk to health, identified under paragraph (b) of this section, which may be associated with the substance. The notification must be made in accordance with paragraph (c) of this section.
(3) The chemical substance is used by, or directly under the supervision of, a technically qualified individual.
(b)(1) To determine whether notification under paragraph (a)(2) of this section is required, the manufacturer, importer, or processor must review and evaluate the following information to determine whether there is reason to believe there is any risk to health which may be associated with the chemicals substance:
(i) Information in its possession or control concerning any significant adverse reaction by persons exposed to the chemical substance which may reasonably be associated with such exposure.
(ii) Information provided to the manufacturer, importer, or processor by a supplier or any other person concerning a health risk believed to be associated with the substance.
(iii) Health and environmental effects data in its possession or control concerning the substance.
(iv) Information on health effects which accompanies any EPA rule or order issued under section 4, 5, or 6 of the Act that applies to the substance and of which the manufacturer, importer, or processor has knowledge.
(2) When the research and development activity is conducted solely in a laboratory and exposure to the chemical substance is controlled through the implementation of prudent laboratory practices for handling chemical substances of unknown toxicity, and any distribution, except for purposes of disposal, is to other such laboratories for further research and development activity, the information specified in paragraph (b)(1) of this section need not be reviewed and evaluated. (For purposes of this paragraph (b)(2), a laboratory is defined as a contained research facility where relatively small quantities of chemical substances are used on a pro-production basis, and where activities involve the use of containers for reactions, transfers, and other handling of substances designed to be easily manipulated by a single individual).
(c)(1) The manufacturer, importer, or processor must notify the persons identified in paragraph (a)(2) of this section by means of a container labeling system, conspicuous placement of notices in areas where exposure may occur, written notification to each person potentially exposed, or any other method of notification which adequately informs persons of health risks which the manufacturer, importer, or processor has reason to believe may be associated with the substance, as determined under paragraph (b)(1) of this section.
(2) If the manufacturer, importer, or processor distributes a chemical substance manufactured, imported, or processed under this section to persons not in its employ, the manufacturer, importer, or processor must in written form:
(i) Notify those persons that the substance is to be used only for research and development purposes.
(ii) Provide the notice of health risks specified in paragraph (c)(1) of this section.
(3) The adequacy of any notification under this section is the responsibility of the manufacturer, importer, or processor.
(d) Quantities of the chemical substance, or of mixtures or articles containing the chemical substance, remaining after completion of research and development activities may be:
(1) Disposed of as a waste in accordance with applicable Federal, State, and local regulations, to the extent the disposal activity is not identified as a significant new use for the substance in subpart E of this part, or
(2) Used for a commercial purpose, to the extent the use is not identified as a significant new use of the substance in subpart E of this part.
(e)(1) Persons who manufacture, import, or process a chemical substance under this section must retain the following records:
(i) Copies of or citations to information reviewed and evaluated under paragraph (b)(1) of this section to determine the need to make any notification of risk.
(ii) Documentation of the nature and method of notification under paragraph (c)(1) of this section including copies of any labels or written notices used.
(iii) Documentation of prudent laboratory practices used instead of notification and evaluation under paragraph (b)(2) of this section.
(iv) The names and addresses of any persons other than the manufacturer, importer, or processor to whom the substance is distributed, the identity of the substance, the amount distributed, and copies of the notifications required under paragraph (c)(2) of this section.
(2) [Reserved]
This subpart B identifies certain significant new uses of chemical substances identified in subpart E of this part. The provisions of this subpart B apply only when referenced as applying to a chemical substance identified in subpart E of this part.
(a) Whenever a substance is identified in subpart E of this part as being subject to this section, a significant new use of the substance is any manner or method of manufacturing, importing, or processing associated with any use of the substance without establishing a program whereby:
(1) Each person who is reasonably likely to be dermally exposed in the work area to the chemical substance through direct handling of the substance or through contact with equipment on which the substance may exist, or because the substance becomes airborne in the form listed in paragraph (a)(6) of this section, and cited in subpart E of this part for the chemical substance, is provided with, and is required to wear, personal protective equipment that provides a barrier to prevent dermal exposure to the substance in the specific work area where it is selected for use. Each such item of personal protective equipment must be selected and used in accordance with 29 CFR 1910.132 and 1910.133.
(2) In addition to any other personal protective equipment selected in paragraph (a)(1) of this section, the following items are required:
(i) Gloves.
(ii) Full body chemical protective clothing.
(iii) Chemical goggles or equivalent eye protection.
(iv) Clothing which covers any other exposed areas of the arms, legs, and torso. Clothing provided under this paragraph need not be tested or evaluated under the requirements of paragraph (a)(3) of this section.
(3) The employer is able to demonstrate that each item of chemical protective clothing, including gloves, selected provides an impervious barrier to prevent dermal exposure during normal and expected duration and conditions of exposure within the work area by any one or a combination of the following:
(i) Testing the material used to make the chemical protective clothing and the construction of the clothing to establish that the protective clothing will be impervious for the expected duration and conditions of exposure. The testing must subject the chemical protective clothing to the expected conditions of exposure, including the likely combinations of chemical substances to which the clothing may be exposed in the work area.
(ii) Evaluating the specifications from the manufacturer or supplier of the chemical protective clothing, or of the material used in construction of the clothing, to establish that the chemical protective clothing will be impervious to the chemical substance alone and in likely combination with other chemical substances in the work area.
(4) Each person who is reasonably likely to be exposed to the chemical substance by inhalation in the work area in one or more of the forms listed in paragraph (a)(6) of this section and cited in subpart E of this part for the chemical substance, is provided with, and is required to wear, at a minimum, a NIOSH- approved respirator from one of the categories listed in paragraph (a)(5) of this section, and the respirator is used in accordance with 29 CFR 1910.134 and 30 CFR part 11.
(5) The following NIOSH approved respirators meet the minimum requirements for paragraph (a)(4) of this section:
(i) Category 19C Type C supplied-air respirator operated in pressure demand or other positive pressure mode and equipped with a full facepiece.
(ii) Category 19C Type C supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a tight-fitting facepiece.
(iii) Category 19C Type C supplied-air respirator operated in pressure demand or continuous flow mode and equipped
(iv) Category 21C air-purifying respirator equipped with a full facepiece and high efficiency particulate filters.
(v) Category 21C powered air-purifying respirator equipped with a tight-fitting facepiece and high efficiency particulate filters.
(vi) Category 21C powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate filters.
(vii) Category 21C air-purifying respirator equipped with a high efficiency particulate filter including disposable respirators.
(viii) Category 23C air-purifying respirator equipped with a full facepiece and combination cartridges approved for paints, lacquers, and enamels. (Approval label may preclude use for some paints, lacquers, or enamels.)
(ix) Category 23C powered air-purifying respirator equipped with a tight-fitting facepiece and combination cartridges approved for paints, lacquers, and enamels. (Approval label may preclude use for some paints, lacquers, or enamels.)
(x) Category 23C powered air-purifying respirator equipped with a loose-fitting hood or helmet and combination cartridges approved for paints, lacquers, and enamels. (Approval label may preclude use for some paints, lacquers, or enamels.)
(xi) Category 23C air-purifying respirator equipped with combination cartridges approved for paints, lacquers, and enamels, including disposable respirators. (Approval label may preclude use for some paints, lacquers, or enamels.)
(xii) Category 23C air-purifying respirator equipped with a full facepiece and organic gas/vapor cartridges.
(xiii) Category 23C powered air-purifying respirator equipped with a tight-fitting facepiece and organic gas/vapor cartridges.
(xiv) Category 23C powered air-purifying respirator equipped with a loose-fitting hood or helmet and organic gas/vapor cartridges.
(xv) Category 23C air-purifying respirator equipped with organic gas/vapor cartridges, including disposable respirators.
(6) When cited in subpart E of this part for a substance, the following airborne form(s) of the substance apply to paragraphs (a) (1) and (4) of this section:
(i) Dust.
(ii) Mist.
(iii) Fume.
(iv) Smoke.
(v) Vapor.
(vi) Gas.
(b) If a substance identified in subpart E of this part is present in the work area only as a mixture, an employer is exempt from the provisions of this section if the concentration of the substance in the mixture does not exceed a concentration set in subpart E of this part. The exemption does not apply if the employer has reason to believe that during intended use or processing in the work area, the substance in the mixture may be concentrated above the level set in subpart E of this part.
(c)(1) If at any time after commencing distribution in commerce of a chemical substance that is identified in subpart E of this part as subject to this section, the person has knowledge that a recipient of the substance is engaging in an activity that is not consistent with the implementation of a program specified in paragraph (a) of this section, the person is considered to have knowledge that the recipient is engaging in a significant new use and is required to follow the procedures in § 721.5(d) unless the person is able to document the following:
(i) That the person has notified the recipient in writing within 15 working days of the time the person first has knowledge that the recipient is engaging in an activity that is not consistent with the implementation of a program specified in paragraph (a) of this section, and that the person has knowledge of the failure of implementation.
(ii) That within 15 working days of notifying the recipient that the recipient is engaging in an activity that is not consistent with the implementation of a program specified in paragraph (a) of this section the person has received from the recipient, in writing,
(2) If, after receiving a statement of assurance from a recipient under paragraph (c)(1)(ii) of this section, a manufacturer, importer, or processor has knowledge that the recipient is engaging in an activity that is not consistent with the implementation of the program specified in paragraph (a) of this section, that person is considered to have knowledge that the person is engaging in a significant new use and is required to follow the procedures in § 721.5(d).
Whenever a substance is identified in subpart E of this part as being subject to this section, a significant new use of that substance is any manner or method of manufacture, import, or processing associated with any use of that substance without establishing a hazard communication program as described in this section.
(a)
(1) A list of each substance identified in subpart E of this part as subject to this section known to be present in the work area. The list must be maintained in the work area and must use the identity provided on the appropriate MSDS for each substance required under paragraph (c) of this section. The list may be compiled for the workplace or for individual work areas.
(2) The methods the employer will use to inform employees of the hazards of non-routine tasks involving the substance, for example, the cleaning of reactor vessels, and the hazards associated with the substance contained in unlabeled pipes in their work area.
(3) The methods the employer will use to inform contractors of the presence of the substance in the employer's workplace and of the provisions of this part applicable to the substance if employees of the contractor work in the employer's workplace and are reasonably likely to be exposed to the substance while in the employer's workplace.
(b)
(i) The label shall, at a minimum, contain the following information:
(A) A statement of health hazard(s) and precautionary measure(s) for the substance, if any, identified in subpart E of this part or by the employer.
(B) The identity by which the substance may be commonly recognized.
(C) A statement of environmental hazard(s) and precautionary measure(s) for the substance, if any, identified in subpart E of this part or by the employer.
(D) A statement of exposure and precautionary measure(s), if any, identified in subpart E of this part or by the employer.
(ii) The employer may use signs, placards, process sheets, batch tickets, operating procedures, or other such written materials in lieu of affixing labels to individual stationary process containers, as long as the alternative method identifies the containers to which it is applicable and conveys information specified by paragraph (b)(1)(i) of this section. Any written materials must be readily accessible to
(iii) The employer need not label portable containers into which the substance is transferred from labeled containers, and which are intended only for the immediate use of the employee who performs the transfer.
(iv) The employer shall not remove or deface an existing label on incoming containers of the substance unless the container is immediately relabeled with the information specified in paragraph (b)(1)(i) of this section.
(2) Each employer shall ensure that each container of the substance leaving its workplace for distribution in commerce is labeled in accordance with this paragraph.
(i) The label shall, at a minimum, contain the following information:
(A) The information required under paragraph (b)(1)(i) of this section.
(B) The name and address of the manufacturer or a responsible party who can provide additional information on the substance for hazard evaluation and any appropriate emergency procedures.
(ii) The label shall not conflict with the requirements of the Hazardous Materials Transportation Act (18 U.S.C. 1801 et. seq.) and regulations issued under that Act by the Department of Transportation.
(3) The label, or alternative forms of warning, shall be legible and prominently displayed.
(4) The label, or alternative forms of warning, shall be in English; however, the information may be repeated in other languages.
(5) If the label or alternative form of warning is to be applied to a mixture containing a substance identified in subpart E of this part as subject to this section in combination with another substance identified in subpart E of this part and/or a substance defined as a “hazardous chemical” under the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (29 CFR 1900.1200), the employer may prescribe on the label, MSDS, or alternative form of warning, the measures to control worker exposure or environmental release which the employer determines provide the greatest degree of protection. However, should these control measures differ from the applicable measures required under subpart E of this part, the employer must seek a determination of equivalency for such alternative control measures pursuant to § 721.30 before prescribing them under this paragraph.
(c)
(2) Each MSDS shall contain, at a minimum, the following information:
(i) The identity used on the container label of the substance under this section, and, if not claimed confidential, the chemical and common name of the substance. If the chemical and common name are claimed confidential, a generic chemical name must be used.
(ii) Physical and chemical characteristics of the substance known to the employer (such as vapor pressure, flash point).
(iii) The physical hazards of the substance known to the employer, including the potential for fire, explosion, and reactivity.
(iv) The potential human and environmental hazards as specified in subpart E of this part for the substance.
(v) Signs and symptoms of exposure, and any medical conditions which are expected to be aggravated by exposure to the substance known to the employer.
(vi) The primary routes of exposure to the substance.
(vii) Precautionary measures to control worker exposure and/or environmental release identified in subpart E of this part for the substance, or alternative control measures which EPA has determined under § 721.30 provide substantially the same degree of protection as the identified control measures.
(viii) Any generally applicable precautions for safe handling and use of the substance which are known to the employer, including appropriate hygienic practices, protective measures during repair and maintenance of contaminated equipment, and procedures for response to spills and leaks.
(ix) Any generally applicable control measures which are known to the employer, such as appropriate engineering
(x) Emergency first aid procedures known to the employer.
(xi) The date of preparation of the MSDS or of its last revision.
(xii) The name, address, and telephone number of the individual preparing or distributing the MSDS, or a responsible party who can provide additional information on the substance for hazard evaluation and any appropriate emergency procedures.
(3) If no relevant information is found or known for any given category on the MSDS, the employer must mark the MSDS to indicate that no applicable information was found.
(4) Where multiple mixtures containing the substance have similar compositions (i.e., the chemical ingredients are essentially the same, but the specific composition varies from mixture to mixture) and similar hazards, the employer may prepare one MSDS to apply to all of these multiple mixtures.
(5) If the employer becomes aware of any significant new information regarding the hazards of the substance or ways to protect against the hazards, this new information must be added to the MSDS within 3 months from the time the employer becomes aware of the new information. If the substance is not currently being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to the MSDS before the substance is reintroduced into the workplace.
(6) The employer must ensure that persons receiving the substance from the employer are provided an appropriate MSDS with their initial shipment and with the first shipment after an MSDS is revised. The employer may either provide the MSDS with the shipped containers or send it to the person prior to or at the time of shipment.
(7) The employer must maintain a copy of the MSDS in its workplace, and must ensure that it is readily accessible during each work shift to employees when they are in their work areas.
(8) The MSDS may be kept in any form, including as operating procedures, and may be designed to cover groups of substances in a work area where it may be more appropriate to address the potential hazards of a process rather than individual substances. However, in all cases, the required information must be provided for each substance and must be readily accessible during each work shift to employees when they are in their work areas.
(9) The MSDS must be printed in English; however, the information may be repeated in other languages.
(d)
(1) Information provided to employees under this paragraph shall include:
(i) The requirements of this section.
(ii) Any operations in the work area where the substance is present.
(iii) The location and availability of the written hazard communication program required under paragraph (a) of this section, including the list of substances identified in subpart E of this part as subject to this section, and MSDSs required by paragraph (c) of this section.
(2) Training provided to employees shall include:
(i) Methods and observations that may be used to detect the presence or release of the substance in or from an employee's work area (such as monitoring conducted by the employer, continuous monitoring devices, visual appearance, or odor of the substance when being released).
(ii) The potential human health and environmental hazards of the substance as specified in subpart E of this part.
(iii) The measures employees can take to protect themselves and the environment from the substance, including specific procedures the employer has implemented to protect employees and the environment from exposure to the substance, including appropriate work practices, emergency procedures,
(iv) The requirements of the hazard communication program developed by the employer under this section, including an explanation of the labeling system and the MSDS required by this section and guidance on obtaining and using appropriate hazard information.
(e)
(f)
(g)
(1) Human health hazard statements: This substance may cause:
(i) Skin irritation.
(ii) Respiratory complications.
(iii) Central nervous system effects.
(iv) Internal organ effects.
(v) Birth defects.
(vi) Reproductive effects.
(vii) Cancer.
(viii) Immune system effects.
(ix) Developmental effects.
(2) Human health hazard precautionary statements: When using this substance:
(i) Avoid skin contact.
(ii) Avoid breathing substance.
(iii) Avoid ingestion.
(iv) Use respiratory protection.
(v) Use skin protection.
(3) Environmental hazard statements: This substance may be:
(i) Toxic to fish.
(ii) Toxic to aquatic organisms.
(4) Environmental hazard precautionary statements: Notice to users:
(i) Disposal restrictions apply.
(ii) Spill clean-up restrictions apply.
(iii) Do not release to water.
(5) Each human health or environmental hazard precautionary statement identified in subpart E of this part for the label on the substance container must be followed by the statement, “See MSDS for details.”
(h)
(i)
(B) When using this substance, use skin protection.
(C) Use respiratory protection when there is a reasonable likelihood of exposure in the work area from dust, mist, or smoke from spray application.
(D) Chemicals similar in structure to this substance have been found to cause cancer in laboratory animals.
(ii)
(A) Skin irritation
(B) Respiratory complications
(C) Central nervous system effects
(D) Internal organ effects
(E) Birth defects
(F) Reproductive effects
(G) Cancer
(H) Immune system effects
(I) Developmental effects
(iii)
(A) Avoid skin contact
(B) Avoid breathing substance
(C) Avoid ingestion
(D) Use respiratory protection
(E) Use skin protection
(iv)
(A) Toxic to fish
(B) Toxic to aquatic organisms
(v)
(A) Disposal restrictions apply
(B) Spill clean-up restrictions apply
(C) Do not release to water.
(vi)
(2) Whenever referenced in subpart E of this part for a substance, the following human health, environmental hazard, exposure, and precautionary statements shall appear on each MSDS as specified in paragraph (c) of this section. Additional statements may be included as long as they are true and do not alter the meaning of the required statements.
(i)
(B) When using this substance, use skin protection.
(C) Use respiratory protection when there is a reasonable likelihood of exposure in the work area from dust, mist, or smoke from spray application.
(D) Chemicals similar in structure to this substance have been found to cause cancer in laboratory animals.
(ii)
(A) Skin irritation
(B) Respiratory complications
(C) Central nervous system effects
(D) Internal organ effects
(E) Birth defects
(F) Reproductive effects
(G) Cancer
(H) Immune system effects
(I) Developmental effects
(iii)
(A) Avoid skin contact
(B) Avoid breathing substance
(C) Avoid ingestion
(D) Use respiratory protection
(E) Use skin protection
(iv)
(A) Toxic to fish
(B) Toxic to aquatic organisms
(v)
(A) Disposal restrictions apply
(B) Spill clean-up restrictions apply
(C) Do not release to water.
Whenever a substance is identified in subpart E of this part as being subject to this section, a significant new use of the substance is:
(a) Use in non-enclosed processes.
(b) Any manner or method of manufacture in non-enclosed processes associated with any use.
(c) Any manner or method of processing in non-enclosed processes associated with any use.
(d) Use beyond the site of manufacture or import.
(e) Processing beyond the site of manufacture or import.
(f) Any manner or method of manufacture (excluding import) of the substance associated with any use.
(g) Use other than as an intermediate.
(h) Use other than as a site-limited intermediate.
(i) Use as an intermediate where the concentration of the intermediate substance in the product intended for distribution in commerce exceeds the concentration specified in subpart E of this part for the substance.
(j) Use other than as described in the premanufacture notice referenced in subpart E of this part for the substance.
(k) Use other than allowed by the section 5(e) consent order referenced in subpart E of this part for the substance.
(l) Non-industrial use.
(m) Commercial use.
(n) Non-commercial use.
(o) Use in a consumer product.
(p) Aggregate manufacture and importation volume for any use greater than that specified in subpart E of this part for the substance.
(q) Aggregate manufacture and importation volume for any use greater than that allowed by the section 5(e) consent order referenced in subpart E of this part for the substance.
(r) Aggregate manufacture and importation volume for any use greater than that specified in subpart E of this part for the substance unless the manufacturer or importer has submitted the results of the health or environmental effects studies identified in subpart E of this part for the substance and those studies comply with the procedures and criteria for developing and evaluating data identified in subpart E of this part for the substance.
(s) Annual manufacture and importation volume for any use greater than that specified in subpart E of this part for the substance.
(t) Annual manufacture and importation volume for any use greater than that allowed by the section 5(e) consent order referenced in subpart E of this part for the substance.
(u) Annual manufacture and importation volume for any use greater than that specified in subpart E of this part for the substance unless the manufacturer or importer has submitted the results of the health or environmental effects studies identified in subpart E of this part for the substance and those studies comply with the procedures and criteria for developing and evaluating data identified in subpart E of this part for the substance.
(v) Use in the form of:
(1) A powder.
(2) A solid.
(3) A liquid.
(4) A gas.
(w) Any manner or method of manufacture of the substance in the following form associated with any use:
(1) A powder.
(2) A solid.
(3) A liquid.
(4) A gas.
(x) Any manner or method of processing of the substance in the following form associated with any use:
(1) A powder.
(2) A solid.
(3) A liquid.
(4) A gas.
(y) Use involving an application method that generates:
(1) A vapor, mist, or aerosol.
(2) A dust.
Whenever a substance is identified in subpart E of this part as being subject to this section, a significant new use of the substance is any method of:
(a) Disposal of the process stream associated with any use of the substance or with any manner or method of manufacturing associated with any use of the substance other than by the following. This provision does not supercede any applicable Federal, State, or local laws and regulations.
(1) Incineration.
(2) Landfill.
(3) Deep well injection.
(b) Disposal of the process stream associated with any use or with any manner or method of processing associated with any use other than by the following. This provision does not supercede any applicable Federal, State, or local laws and regulations.
(1) Incineration.
(2) Landfill.
(3) Deep well injection.
(c) Disposal of the use stream associated with any use, other than by the following. This provision does not supercede any applicable Federal, State, or local laws and regulations.
(1) Incineration.
(2) Landfill.
(3) Deep well injection.
(d) Disposal of the substance associated with any use of the substance, or with any manner or method of manufacture or processing in association with any use. This provision does not supercede any applicable Federal, State, or local laws and regulations.
Whenever a substance is identified in subpart E of this part as being subject to this section, a significant new use of the substance is:
(a) Any predictable or purposeful release of a manufacturing stream associated with any use of the substance, from any site:
(1) Into the waters of the United States.
(2) Into the waters of the United States without application of one or more of the following treatment technologies as specified in subpart E of this part either by the discharger or, in the case of a release through publicly-owned treatment works, by a combination of treatment by the discharger and the publicly-owned treatment works:
(i) Chemical precipitation and settling.
(ii) Biological treatment (activated sludge or equivalent) plus clarification.
(iii) Steam stripping.
(iv) Resin or activated carbon adsorption.
(v) Chemical destruction or conversion.
(vi) Primary wastewater treatment.
(3) Into the waters of the United States without primary wastewater treatment, and secondary wastewater treatment as defined in 40 CFR part 133.
(4) Into the waters of the United States if the quotient from the following formula:
(b) Any predictable or purposeful release of a process stream containing the substance associated with any use of the substance from any site:
(1) Into the waters of the United States.
(2) Into the waters of the United States without application of one or more of the following treatment technologies as specified in subpart E of this part either by the discharger or, in the case of a release through publicly-owned treatment works, by a combination of treatment by the discharger and the publicly-owned treatment works:
(i) Chemical precipitation and settling.
(ii) Biological treatment (activated sludge or equivalent) plus clarification.
(iii) Steam stripping.
(iv) Resin or activated carbon adsorption.
(v) Chemical destruction or conversion.
(vi) Primary wastewater treatment.
(3) Into the waters of the United States without primary wastewater treatment, and secondary wastewater treatment as defined in 40 CFR part 133.
(4) Into the waters of the United States if the quotient from the following formula:
(c) Any predictable or purposeful release of a use stream containing the substance associated with any use of the substance from any site:
(1) Into the waters of the United States.
(2) Into the waters of the United States without application of one or more of the following treatment technologies as specified in subpart E of this part either by the discharger or, in the case of a release through publicly-owned treatment works, by a combination of treatment by the discharger and the publicly-owned treatment works:
(i) Chemical precipitation and settling.
(ii) Biological treatment (activated sludge or equivalent) plus clarification.
(iii) Steam stripping.
(iv) Resin or activated carbon adsorption.
(v) Chemical destruction or conversion.
(vi) Primary wastewater treatment.
(3) Into the waters of the United States without primary wastewater treatment, and secondary wastewater treatment as defined in 40 CFR part 133.
(4) Into the waters of the United States if the quotient from:
These instructions describe the use of the equation specified in § 721.90(a)(4) and (b)(4) to compute estimated surface water concentrations which will result from release of a substance identified in subpart E of this part. The equation shall be computed for each site using the stream flow rate appropriate for the site according to paragraph (b) of this section, and the highest number of kilograms calculated to be released for that site on a given day according to paragraph (a) of this section. Two variables shall be considered in computing the equation, the number of kilograms released, and receiving stream flow.
(a)
(2) Indicate on each diagram the entry point of all feedstocks (e.g., reactants, solvents, and catalysts) used in the operation. Identify each feedstock and specify its approximate weight regardless of whether the process is continuous or batch.
(3) Identify all release points from which the substance or wastes containing the substance will be released into air, land, or water. Indicate these release points on the diagram. Do not include accidental releases or fugitive emissions.
(4) For releases identified in the diagram that are destined for water, estimate the amount of substance that will be released before the substance enters control technology. The kilograms of
(i) The mass balance of the operation, i.e., totaling inputs and outputs, including wastes for each part of the process such that outputs equal inputs. The amount released to water may be the difference between the amount of the substance in the starting material (or formed in a reaction) minus the amount of waste material removed from each part of the process and not released to water and the amount of the substance in the final product.
(ii) Physical properties such as water solubility where a known volume of water being discharged is assumed to contain the substance at concentrations equal to its solubility in water. This approach is particularly useful where the waste stream results from separation of organic/water phases or filtration of the substance from an aqueous stream to be discharged.
(iii) Measurements of flow rates of the process/use stream and known concentrations of the substance in the stream.
(5) After releases of a substance to water are estimated for each operation on a site, total the releases of the substance to water from all operations at that site. The value (number of kilograms) specified in the numerator of the equation should reflect total kilograms of substance released to water per day from all operations at a single site.
(6) Use the highest expected daily release of the substance for each site.
(b)
(2) Receiving stream flow data may be available from the National Pollutant Discharge Elimination System (NPDES) permit for the site or the POTW releasing the substance to surface water, from the NPDES permit-writing authority for the site or the POTW, or from USGS publications, such as the water-data report series.
(3) If receiving stream flow data are not available for a stream, either the value of 10 MLD or the daily flow of wastewater from the site or the POTW releasing the substance must be used as an assumed minimum stream flow. Similarly, if stream flow data are not available because the location of the point of release of the substance to surface water is a lake, estuary, bay, or ocean, then the flow rate to be used must be the daily flow of wastewater from the site or the POTW releasing the substance to surface water. Wastewater flow data may be available from the NPDES permit or NPDES authority for the site or the POTW releasing the substance to water.
This subpart C identifies certain additional recordkeeping requirements applicable to manufacturers, importers, and processors of substances identified in subpart E of this part for each specific substance. The provisions of this subpart C apply only when referenced in subpart E of this part for a substance and significant new use identified in that subpart E. If the provisions in this subpart C conflict with general provisions of subpart A of this part, the provisions of this subpart C shall apply.
At the time EPA adds a substance to subpart E of this part, EPA will specify appropriate recordkeeping requirements which correspond to the significant new use designations for the substance selected from subpart B of this part. Each manufacturer, importer,
(a) Records documenting the manufacture and importation volume of the substance and the corresponding dates of manufacture and import.
(b) Records documenting volumes of the substance purchased in the United States by processors of the substance, names and addresses of suppliers, and corresponding dates of purchase.
(c) Records documenting the names and addresses (including shipment destination address, if different) of all persons outside the site of manufacture, importation, or processing to whom the manufacturer, importer, or processor directly sells or transfers the substance, the date of each sale or transfer, and the quantity of the substance sold or transferred on such date.
(d) Records documenting establishment and implementation of a program for the use of any applicable personal protective equipment required under § 721.63.
(e) Records documenting the determinations required by § 721.63(a)(3) that chemical protective clothing is impervious to the substance.
(f) Records documenting establishment and implementation of the hazard communication program required under § 721.72.
(g) Copies of labels required under § 721.72(b).
(h) Copies of material safety data sheets required under § 721.72(c).
(i) Records documenting compliance with any applicable industrial, commercial, and consumer use limitations under § 721.80.
(j) Records documenting compliance with any applicable disposal requirements under § 721.85, including the method of disposal, location of disposal sites, dates of disposal, and volume of the substance disposed. Where the estimated disposal volume is not known to or reasonably ascertainable by the manufacturer, importer, or processor, that person must maintain other records which demonstrate establishment and implementation of a program that ensures compliance with any applicable disposal requirements.
(k) Records documenting establishment and implementation of procedures that ensure compliance with any applicable water discharge limitations under § 721.90.
(a)
(2) If EPA determines that significant new use notification requirements are not needed for a substance that is subject to a final order issued under section 5(e) of the Act, except for an order that prohibits manufacture or import of the substance, EPA will issue a notice in the
(b)
(2) Significant new use requirements and other specific requirements designated under this section will be listed in subpart E of this part. For each substance, subpart E will identify:
(i) The chemical name.
(ii) The activities designated as significant new uses.
(iii) Other specific requirements applicable to the substance, including recordkeeping requirements or any other requirements included in the final section 5(e) order.
(c)
(2)
(i) The chemical identity of the substance or, if its specific identity is claimed confidential, an appropriate generic chemical name and an accession number assigned by EPA.
(ii) The premanufacture notice number.
(iii) The CAS number, where available and not claimed confidential.
(iv) A summary of EPA's findings under section 5(e)(1)(A) of the Act for the final order issued under section 5(e).
(v) Designation of the significant new uses subject to, or proposed to be subject to, notification and any other applicable requirements.
(vi) Any modifications of subpart A of this part applicable to the specific substance and significant new uses.
(vii) If the
(3)
(ii) The
(iii) If EPA, having considered any timely comments submitted in response to the proposal, decides to establish notification requirements under this section, EPA will issue a final rule adding the substance to subpart E of this part and designating the significant new uses subject to notification.
(4)
(ii) If EPA, having considered any timely comments, decides to establish notification requirements under this section, EPA will issue a final rule adding the substance to subpart E of this
(5)
(A) The significant new use rule will take effect on the date of publication.
(B) Persons will be given 30 days from the date of publication to submit comments.
(ii) Interim final rules issued under this section shall cease to be in effect 180 days after publication unless, within the 180-day period, EPA issues a final rule in the
(d)
(2) Unless EPA determines that a significant new use rule should not be issued under this section, EPA will issue a proposed rule, a direct final rule, or an interim final rule within 1 year of October 10, 1989, for any substance for which the valid notice of commencement under § 720.102 of this chapter was received before October 10, 1989.
(3) If EPA receives adverse or critical significant comments following publication of a proposed or interim final rule, EPA will either withdraw the rule or issue a final rule addressing the comments received.
(a)
(b)
(1)(i) The substance may cause carcinogenic effects because the substance:
(A) Has been shown by valid test data to cause carcinogenic effects in humans or in at least one species of laboratory animal.
(B) Has been shown to be a possible carcinogen based on the weight of the evidence in short-term tests indicative of the potential to cause carcinogenic effects.
(C) Is closely analogous, based on toxicologically relevant similarities in molecular structure and physical properties, to another substance that has been shown by test data to cause carcinogenic effects in humans or in at least one species of laboratory animal, provided that if there is more than one such analogue, the greatest weight will be given to the relevant data for the most appropriate analogues.
(D) Is known or can reasonably be anticipated, based on valid scientific data or established scientific principles, to be metabolized in humans or transformed in the environment to a substance which may have the potential to cause carcinogenic effects under the criteria in paragraphs (b)(1)(i) (A), (B), or (C) of this section.
(ii) No substance may be regulated based on a finding under paragraph
(2) The substance has been shown by valid test data to cause acutely toxic effects in at least one species of laboratory animal or is closely analogous, based on toxicologically relevant similarities in molecular structure and physical properties, to another substance that has been shown by valid test data to cause acutely toxic effects in at least one species of laboratory animal, provided that if there is more than one such analogue, the greatest weight will be given to the relevant data for the most appropriate analogues.
(3) The substance may cause serious chronic effects, serious acute effects, or developmentally toxic effects under reasonably anticipated conditions of exposure because the substance:
(i) Has been shown by valid test data to cause serious chronic effects, serious acute effects, or developmentally toxic effects in humans or in at least one species of laboratory animal at dose levels that could be of concern under reasonably anticipated conditions of exposure.
(ii) Is closely analogous, based on toxicologically relevant similarities in molecular structure and physical properties, to another chemical substance that has been shown by valid test data to cause serious chronic effects, serious acute effects, or developmentally toxic effects in humans or in at least one species of laboratory animal at dose levels that could be of concern under reasonably anticipated conditions of exposure, provided that if there is more than one such analogue, the greatest weight will be given to the relevant data for the most appropriate analogues.
(iii) Is known or can reasonably be anticipated, based on valid scientific data or established scientific principles, to be metabolized in humans or transformed in the environment to a substance which may have the potential to cause serious chronic effects, serious acute effects, or developmentally toxic effects under the criteria in paragraph (b)(3) (i) and (ii) of this section.
(iv) Has been shown to potentially cause developmentally toxic effects based on the weight of the evidence in short-term tests indicative of the potential to cause developmentally toxic effects.
(4) The substance may cause significant adverse environmental effects under reasonably anticipated conditions of release because the substance:
(i) Has been shown by valid test data to cause significant adverse environmental effects at dose levels that could be of concern under reasonably anticipated conditions of release.
(ii) Is closely analogous, based on toxicologically relevant similarities in molecular structure and physical properties, to another substance that has been shown by valid test data to cause significant adverse environmental effects at dose levels that could be of concern under reasonably anticipated conditions of release, provided that if there is more than one such analogue, the greatest weight will be given to the relevant data for the most appropriate analogues.
(iii) Has been determined, based on calculations using the substance's physical and chemical properties, to be potentially able to cause significant adverse environmental effects at dose levels that could be of concern under reasonably anticipated conditions of release.
(iv) Is known or can reasonably be anticipated, based on valid scientific data or established scientific principles, to be environmentally transformed to a substance which may have the potential to cause significant adverse environmental effects under the criteria in paragraph (b)(4) (i), (ii), and (iii) of this section.
(5) Concern exists about the health or environmental effects of one or more impurities or byproducts of the substance because the impurity or byproduct meets one or more of the criteria in paragraph (b) (1) through (4) of this section and either:
(i) The impurity or byproduct is a new chemical substance and may be present in concentrations that could cause adverse health or environmental effects under reasonably anticipated conditions of exposure or release.
(ii) Reasonably anticipated manufacture, processing, or use activities involving the substance for which a
(c)
(2) EPA may designate as a significant new use only those activities that (i) are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to the premanufacture notice, and (ii) may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified under paragraph (b) of this section.
(d)
(i) The chemical name.
(ii) The activities designated as significant new uses, which may include one or more of the activities described in paragraph (c) of this section.
(iii) Other specific requirements applicable to the substance.
(2) When EPA determines that a substance is a candidate for a significant new use rule under this section, it will notify the person that submitted the premanufacture notice for the substance no later than 7 calendar days before the expiration of the notice review period under § 720.75 of this chapter. In providing this notice, EPA will describe the health or environmental concerns identified under paragraph (b) of this section and the activities under consideration for designation as significant new uses. Such notice may be by telephone, but in this event will be confirmed in writing no later than 30 days after completion of the notice review period.
(3)
(i) The chemical identity of the substance or, if its specific identity is claimed confidential, an appropriate generic chemical name and an accession number assigned by EPA.
(ii) The premanufacture notice number.
(iii) The CAS number, where available and not claimed confidential.
(iv) A summary of the basis for action under this section.
(v) Designation of the significant new uses subject to, or proposed to be subject to, notification and any other applicable requirements.
(vi) Any modifications of subpart A of this part applicable to the specific substance and significant new uses.
(vii) If the
(4) EPA will issue significant new use rules under this section by one of the following three processes: direct final rulemaking, interim final rulemaking, or notice and comment rulemaking. EPA will use the direct final rulemaking process to issue significant new use rules unless it determines that, in a particular case, one of the other processes is more appropriate.
(i)(A) When EPA uses the direct final rulemaking procedure to issue a significant new use rule it will issue a direct final rule in the final rule section of the
(B) The
(C) If EPA, having considered any timely comments submitted in response to the proposal, decides to establish notification requirements under this section, EPA will issue a final rule adding the substance to subpart E of this part and designating the significant new uses subject to notification.
(ii)(A) When EPA uses a notice and comment procedure to issue a significant new use rule, EPA will issue a proposed rule in the
(B) If EPA, having considered any timely comments, decides to establish notification requirements under this section, EPA will issue a final rule adding the substance to subpart E of this part and designating the significant new uses subject to notification.
(iii)(A) When EPA uses the interim final rulemaking procedure to issue a significant new use rule, EPA will issue an interim final rule in the final rule section of the
(
(
(B) An interim final rule issued under this section shall cease to be in effect 180 days after publication unless, within the 180-day period, EPA issues a final rule in the
(e)
(2) If EPA receives adverse or critical comments within the designated comment period following publication of a proposed rule or an interim final rule, EPA will either withdraw the rule or issue a final rule addressing the comments received.
(a)
(1) Test data or other information obtained by EPA provide a reasonable basis for concluding that activities designated as significant new uses of the substance will not present an unreasonable risk of injury to human health or the environment.
(2) EPA has promulgated a rule under section 4 or 6 of the Act, or EPA or another agency has taken action under another law for the substance that eliminates the need for significant new use notification under section 5(a)(2) of the Act.
(3) EPA has received significant new use notices for some or all of the activities designated as significant new uses of the substance and, after reviewing such notices, concluded that there is no need to require additional notice from persons who propose to engage in identical or similar activities.
(4) EPA has examined new information, or has reexamined the test data or other information or analysis supporting its decision to add the substance to subpart E of this part under § 721.170 and has concluded that the substance does not meet the criteria under § 721.170(b).
(5) For a substance added to subpart E of this part under § 721.160, EPA has examined new information, or has reexamined the test data or other in-for-ma-tion or analysis supporting its finding under section 5(e)(1)(A)(ii)(I) of the Act, and has concluded that a rational basis no longer exists for the findings that activities involving the substance may present an unreasonable risk of injury to human health or the environment required under section 5(e)(1)(A) of the Act.
(6) For a substance added to subpart E of this part under § 721.160, certain activities involving the substance have been designated as significant new uses pending the completion of testing, and adequate test data developed in accordance with applicable procedures and criteria have been submitted to EPA.
(b)
(1) Any affected person may request modification or revocation of significant new use notification requirements for a substance that has been added to subpart E of this part using the procedures described in § 721.160 or § 721.170 by writing to the Director of the Office of Pollution Prevention and Toxics and stating the basis for such request. All requests should be sent to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. ATTN: Request to amend significant new use rule. The request must be accompanied by information sufficient to support the request.
(2) The Director of the Office of Pollution Prevention and Toxics will consider the request, make a determination whether to initiate rulemaking to modify the requirements, and notify the requester of that determination by certified letter. If the request is denied, the letter will explain why EPA has concluded that the significant new use notification requirements for that substance should remain in effect.
(3) If EPA concludes that significant new use notification requirements for a substance should be limited or revoked, EPA will propose the changes in the
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are: (i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are: (i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), (f), (g)(1)(i), (g)(1)(iii), (g)(1)(iv), (g)(1)(v), (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), and (g)(5).
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv) [Reserved]
(v)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(A) Each study required to be performed pursuant to this section must be scientifically valid.
(
(
(
(
(
(B) Before starting to conduct any of the studies in paragraph (a)(2)(i) of this section, the person must obtain approval of test protocols from EPA by submitting written protocols. EPA will respond to the person within 4 weeks of receiving the written protocols. Published test guidelines specified in paragraph (a)(2)(i) of this section (e.g., 40 CFR part 797 or part 798) provide general guidance for development of test protocols, but are not themselves acceptable protocols.
(C) The person shall:
(
(
(
(D)(
(
(
(
(E) The person is not required to conduct a study specified in paragraph (a)(2)(i) of this section if notified in writing by EPA that it is unnecessary to conduct that study.
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2)
(3) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new use is any use other than as.
(i) An intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11-aminoundecanoic acid will be fully polymerized during the manufacturing process, or
(ii) A component in photoprocessing solutions.
(b)
(1)
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a) Chemical substances and significant new uses subject to reporting. (1) The chemical substance benzenamine, 4,4′-[1,3-phenylenebis(1-methyl ethylidene)]bis[2,6-dimethyl- (CAS Registry Number 2716-12-3; PMN P-86-501) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(v)
(b)
(1)
(2)
(3)
(a)
(2) The significant new use for P-85-335 is: Manufacture, import, or processing in a quantity of 100,000 pounds per year, or greater, for any use.
(3) The significant new use for P-85-336 is: Any use.
(4) The significant new use for P-86-1153 is: Manufacture, import, or processing in a quantity of 225,000 pounds per year, or greater, for any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new use is: Any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a) Chemical substances and significant new uses subject to reporting. (1) The chemical substance benzenamine, 4,4′-[1,4-phenylenebis(1-methylethylidene)]bis- (CAS Registry Number 2716-10-1; PMN P-86-503) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i) Use in spray applications.
(ii) Manufacture or processing without establishing a program whereby:
(A) During all stages of manufacture and processing of the substance, and during response to emergencies and spills involving the substance, any person employed by or under the control of the manufacturer or processor who may potentially be dermally exposed to the substance wears:
(
(
(
(B) All workers described in paragraph (a)(ii)(A) of this section are informed in writing, or by presenting the information as part of a training program in a safety meeting where attendance is recorded, of the following: To avoid all contact with this substance; that structurally similar chemicals have been found to cause cancer, reproductive effects, kidney and liver effects in laboratory animals, and allergic reactions in humans; that this substance is a severe skin and eye irritant; and that the use of impervious gloves, face shields and other clothing to cover exposed areas of the arms, the legs, and the torso is required.
(C) A label is affixed to each container of the substance or of a formulation containing the substance which (in a print size no smaller than ten point type) contains, at a minimum, the following information:
(b)
(1)
(i) The names of persons informed, the date they are informed, and the means by which they are informed in accordance with paragraph (a)(2)(ii)(B) of this section.
(ii) The names of any transferee and the dates of any transfers of containers which are labeled in accordance with paragraph (a)(2)(ii)(C) of this section.
(iii) The method used to determine that the protective gloves are impervious to the substance and date and the results of that determination.
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are: (i)
(ii)
(iii)
(iv)
(A) The following forms of the substance - the substance as a commercial chemical product or manufacturing chemical intermediate; the substance as an off-specification commercial chemical product or manufacturing chemical intermediate; the substance as a residue remaining in a container or in an inner liner removed from a container that has held the substance, unless the container is empty as defined in 40 CFR 261.7(b)(3); any residue or contaminated soil, water, or other debris resulting from the cleanup of a spill into or on any land or water of the substance as a commercial chemical product or manufacturing chemical intermediate, or any residue or contaminated soil, water, or other debris resulting from the cleanup of a spill into or on any land or water, of the substance as an off-specification commercial chemical product or manufacturing chemical intermediate; and any waste stream containing greater than 1.0% of this substance and the substance identified in § 721.1240 combined - shall be disposed of as follows: Requirements as specified in § 721.85 (a)(1), (b)(1), (c)(1), (a)(2), (b)(2), and (c)(2); the landfill shall be operated in accordance with Subtitle C of the Resource Conservation and Recovery Act.
(B) Any forms of the substance other than those described in paragraph (a)(2)(iv)(A) of this section, including waste streams containing 1.0% or less of this substance and the substance identified in § 721.1240, shall be disposed of as follows: § 721.85 (a)(1), (b)(1), (c)(1), (a)(2), (b)(2), (c)(2), (a)(3), (b)(3), (c)(3), carbon adsorption followed by either physical destruction, or as specified in § 721.90; the landfill shall be operated in accordance with the Resource Conservation and Recovery Act.
(v)
(b)
(1)
(2)
(a)
(2) The significant new uses are: (i)
(ii)
(iii)
(iv)
(A) The following forms of the substance - the substance as a commercial chemical product or manufacturing chemical intermediate; the substance as an off-specification commercial chemical product or manufacturing chemical intermediate; the substance as a residue remaining in a container or in an inner liner removed from a container that has held the substance, unless the container is empty as defined in 40 CFR 261.7(b)(3); any residue or contaminated soil, water, or other debris resulting from the cleanup of a spill into or on any land or water of the substance as a commercial chemical product or manufacturing chemical intermediate, or any residue or contaminated soil, water, or other debris resulting from the cleanup of a spill into or on any land or water, of the substance as an off-specification commercial chemical product or manufacturing chemical intermediate; and any waste stream containing greater than 1.0% of this substance and the substance identified in § 721.1230 combined - shall be disposed of as follows: Requirements as specified in § 721.85 (a)(1), (b)(1), (c)(1), (a)(2), (b)(2), and (c)(2); the landfill shall be operated in accordance with Subtitle C of the Resource Conservation and Recovery Act.
(B) Any forms of the substance other than those described in paragraph (a)(2)(iv)(A) of this section, including waste streams containing 1.0% or less of this substance and the substance identified in § 721.1240, shall be disposed of as follows: § 721.85 (a)(1), (b)(1), (c)(1), (a)(2), (b)(2), (c)(2), (a)(3), (b)(3), (c)(3), carbon adsorption followed by either physical destruction, or as specified in § 721.90; the landfill shall be operated in accordance with the Resource Conservation and Recovery Act.
(v)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new use is: Any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new use is: Manufacture, import, or processing of 10,000 pounds or more per year per facility for any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new use is: Manufacture, import, or processing of 10,000 pounds or more per year per facility for any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new use is: Manufacture, import, or processing of 10,000 pounds or more per year per facility for any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i) Use other than for applications where the substance will be completely reacted (cured or used as a chemical intermediate).
(ii) Any method of disposal other than by landfill, incineration, or for wastewater from vent scrubbers, steam vacuum ejectors, pad washings, equipment washouts, and stormwater runoffs, wastewater treatment in permitted industrial wastewater treatment facilities. Each method of disposal must meet all applicable local, State, and Federal laws and regulations.
(iii) Any manner or method of manufacturing, importing, or processing without establishing a program whereby:
(A) Any person who may be exposed dermally to the substance wears:
(
(
(
(B) Any person who may be exposed to the substance through inhalation during manufacture, in addition to the dermal protective equipment described in paragraph (a)(2)(iii)(A) of this section, wears at a minimum, a National Institute for Occupational Safety and Health approved, category 23C respirator, organic vapor type. Use of the respirator must be according to 29 CFR 1910.134 and 30 CFR part 11. If a full-face type respirator is selected and worn, the chemical safety goggles requirement in paragraph (a)(2)(iii)(A)(
(C)(
WARNING: Avoid all contact. Chemicals similar in structure to [insert appropriate name] have been found to cause chronic organ and systemic effects and cancer in laboratory animals. To protect yourself, you must wear chemical safety goggles or equivalent eye protection, impervious gloves, and protective clothing while handling this material.
(
Respirators are required during clean-up or loading of bulk material.
(D) All persons that receive the PMN substance are notified by means of a Material Safety Data Sheet (“MSDS”) which includes, at a minimum, the language specified in paragraph (a)(2)(iii)(C)(
(E) Each container of the substance distributed in commerce has affixed to it a label which includes a Warning Statement which consists, at a minimum, of the language specified in paragraph (a)(2)(iii)(C)(
(iv) Manufacturing and importing the substance for any use at greater than
(b)
(1)
(ii) EPA will review this information to determine whether the person has a
(iii) A disclosure to a person with a
(2)
(i) Any determination that gloves are impervious to the substance.
(ii) Names of persons who have attended safety meetings in accordance with paragraph (a)(2)(iii)(C) of this section, the dates of such meetings, and copies of any written information provided in accordance with paragraph (a)(2)(iii)(C) of this section.
(iii) Copies of any MSDSs used.
(iv) Names and addresses of all persons to whom the substance is sold or transferred including shipment destination address if different, the date of each transfer, and the quantity of substance sold or transferred on such date.
(v) Copies of any labels used.
(vi) Any names used for the substance and the corresponding dates of use.
(vii) Quantities of the substance manufactured or imported, with the corresponding dates of manufacture or import.
(viii) Quantities of the substance purchased in the United States by processors of the substance, names and addresses of suppliers, and corresponding dates of purchase.
(ix) Information on disposal of the substance, including dates waste material is disposed of, location of disposal sites, volume of disposed solid material, estimated volume of any disposed liquid wastes containing the substance, and method of disposal.
(a)
(2) The significant new use is: Manufacture, import, or processing in powder or dry solid form.
(b) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new use is:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health, the employer must incorporate this new information, and any information on methods for protecting against such risk, into an MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported,
(B) The employer must ensure that persons who will receive this substance from the employer are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are any use other than as a reagent to test for hydrogen peroxide in milk; a reagent to test for hydrogen sulfate, hydrogen cyanide, and nicotine; a stain in microscopy; a reagent for detecting blood; an analytical standard; and also for Colour Index (C.I.) Direct Red 28 (Congo Red, CAS No. 573-58-0) as an indicator dye.
(b)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are: (i) Any use other than the use described in Premanufacture Notice P-82-438.
(ii) Any manner or method of manufacturing or processing the substance for the use described in Pre-man-u-fac-ture Notice P-82-438 different than the manner or method described in Premanufacture Notice P-82-438.
(b)
(1)
(ii) To establish a
(A) All materials and statements required under § 721.6.
(B) The specific use for which the person intends to manufacture, import, or process the chemical substance.
(iii) EPA will review the information submitted by the person under this paragraph to determine whether the person has a
(iv) If EPA determines that the person has a
(v) A disclosure to a person with a
(vi) EPA will answer an inquiry on whether a particular use is subject to this section within 30 days after receipt of a complete submission under paragraph (b)(1) of this section.
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for these substances, the employer becomes aware that these substances may present a risk of injury to the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into a MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If these substances are not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substances are reintroduced into the workplace.
(B) The employer must ensure that persons who will receive, or who have received these substances from the employer within 5 years from the date the employer becomes aware of the new information described in paragraph (a)(2)(i)(A) of this section, are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(i) The significant new use is: Any use.
(ii)
(A)
(B) [Reserved]
(2) The chemical substance identified as 1,1′-(Biphenyl, 4-bromo- (CAS No. 92-66-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2)(i) of this section.
(i) The significant new uses are:
(A)
(B)
(ii)
(A)
(B)
(C)
(b) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(v)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(B) The employer must ensure that persons who have received, or will receive, this substance from the employer are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(v)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new use is: Manufacture, import, or processing of 10,000 pounds or more per year per facility for any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new use is: Manufacture, import, or processing of 10,000 pounds or more per year per facility for any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) Each study required to be performed pursuant to this section must be scientifically valid.
(
(
(
(
(
(B) Before starting to conduct any of the studies in paragraph (a)(2)(i) of this section, the person must obtain approval of test protocols from EPA by submitting written protocols. EPA will respond to the person within 4 weeks of receiving the written protocols. Published test guidelines specified in paragraph (a)(2)(i) of this section (e.g., 40 CFR part 797 or part 798) provide general guidance for development of test protocols, but are not themselves acceptable protocols.
(C) The person shall:
(
(
(
(D)(
(
(
(
(E) The person is not required to conduct a study specified in paragraph (a)(2)(i) of this section if notified in writing by EPA that it is unnecessary to conduct that study.
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are: (i)
(ii)
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(q).
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new use is: Manufacture, import, or processing of 10,000 pounds or more per year per facility for any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new use is: Manufacture, import, or processing of 10,000 pounds or more per year per facility for any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i) Use other than as an intermediate.
(ii) Manufacture, import, or processing for use as an intermediate without establishing a program whereby:
(A) Persons employed by or under the control of the manufacturer, importer, or processor who may be exposed to the substance (including those persons involved in maintenance, packaging, and storage operations) wear protective gloves determined to be impervious to the substance by testing the gloves under the conditions of exposure or by evaluating the specifications provided by the manufacturer of the gloves, and
(B) Packages containing the substance (including those storing the substance between manufacturing or importing and processing stages) are labeled to indicate that the substance should be handled only while using gloves determined to be impervious to the substance.
(b)
(1)
(i) The results of any determination that gloves are impervious.
(ii) The names of persons required to wear gloves.
(iii) Copies of labels described in paragraph (a)(2)(ii)(B) of this section.
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(A) Each study required to be performed pursuant to this section must be scientifically valid.
(
(
(
(
(
(B) Before starting to conduct any of the studies in paragraph (a)(2)(iii) of this section, the person must obtain approval of test protocols from EPA by submitting written protocols. EPA will respond to the person within 4 weeks of receiving the written protocols. Published test guidelines specified in paragraph (a)(2)(iii) of this section (e.g., 40 CFR part 797 or part 798) provide general guidance for development of test protocols, but are not themselves acceptable protocols.
(C) The person shall:
(
(
(
(D)(
(
(
(
(E) The person is not required to conduct a study specified in paragraph (a)(2)(iii) of this section if notified in writing by EPA that it is unnecessary to conduct that study.
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new use is any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(v)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(v)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new use is any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new use is: Any use.
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(v)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(i) The significant new uses are:
(A)
(B)
(C)
(D)
(ii)
(A)
(B)
(C)
(2) The chemical substance identified as carboxylic acid glycidyl ester (PMN P-92-777) is subject to reporting under this section for the significant new uses described in this paragraph.
(i) The significant new uses are:
(A)
(B)
(C)
(D)
(ii)
(A)
(B)
(C)
(b) [Reserved]
(a)
(2) The significant new uses are:
(i) Any manufacture in the United States for commercial purposes.
(ii) Failure to require the use of gloves determined to be impervious to the substance, and/or failure to require the use of clothing to prevent dermal contact for any person involved in any processing or use operation where dermal contact may occur. (Gloves may be determined to be impervious to the substance either by testing the gloves under the conditions of use or by relying on the manufacturer's specifications.)
(iii) Distribution in commerce by any person, including importers, processors, and distributors, without affixing to each container of any formulation containing the substance a label that includes, in letters no smaller than 10 point type, the following statements:
WARNING! HARMFUL IF INHALED OR ABSORBED THROUGH THE SKIN. MAY CAUSE REPRODUCTIVE EFFECTS.
FIRST AID: In case of contact.
EYES: Immediately flush with water for at least 15 minutes.
SKIN: Promptly wash thoroughly with mild soap and water.
INHALATION: Remove to fresh air. If breathing is difficult, give oxygen.
INGESTION: If conscious, give water and induce vomiting.
(b)
(1)
(i) The names of persons required to wear protective clothing.
(ii) The name and address of each person to whom the substance is sold or transferred and the date of such sale or transfer.
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(A) If as a result of the test data required under the TSCA section 5(e) consent order for these substances, the employer becomes aware that these substances may present a risk of injury to human health or the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into an MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substances are reintroduced into the workplace.
(B) The employer must ensure that persons who will receive or who have received the substances from the employer within 5 years from the date the employer becomes aware of the new information described in paragraph (a)(2)(i)(A), are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) within 90 days from the time the employer becomes aware of the new information.
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to this section.
(a)
(2) The significant new uses are:
(i)
(ii)
(A) If as a result of the test data required under the TSCA section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health or the environment the employer must incorporate this new information, and any information on methods for protecting against such risk, into a MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substances are reintroduced into the workplace.
(B) The employer must ensure that persons who will receive, or who have received the substance from the employer within 5 years from the date the employer becomes aware of the new information described in paragraph (a)(2)(i)(A) of this section, are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health or the environment the employer must incorporate this new information, and any information on methods for protecting against such risk, into a material safety data sheet (MSDS) as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive, or who have received, this substance from the employer within 5 years from the date the employer becomes aware of the new information described in paragraph (a)(2)(i)(A) of this section, are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new use is: any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new use is any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new use is: Manufacture, import, or processing of 10,000 pounds or more per year per facility for any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new use is: Manufacture, import, or processing of 10,000 pounds or more per year per facility for any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(i) The significant new uses are:
(A)
(B)
(C)
(D)
(ii)
(A)
(B)
(C)
(2) The chemical substance haloalkyl substituted cyclic ether (PMN P-85-367) is subject to reporting under this section for the significant new uses described in this paragraph.
(i) The significant new uses are:
(A)
(B)
(C)
(D)
(ii)
(A)
(B)
(C)
(b) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are: (i) Manufacture or processing without requiring use of the following by persons employed by or under the control of the manufacturer or processor who are involved in, and in the immediate area of, any operation where dermal contact and/or inhalation of the substance may occur:
(A) A respirator, approved by the National Institute for Occupational Safety (NIOSH) to provide protection against dusts having an air contamination level not less than 0.05 mg per cubic meter of air and fitted according to procedures established by the Occupational Safety and Health Administration and Mine Safety and Health Administration regulations and set forth at 29 CFR 1910.134, and 30 CFR part 11, respectively, and
(B) Gloves which are determined to be impervious to the substance under the conditions of potential exposure (gloves must be determined to be impervious to the substance either by testing the gloves under the conditions of exposure, including the duration of exposure, or by evaluating the data and specifications supplied by the glove manufacturer or others, in the context of the conditions of exposure including the duration of exposure, associated chemical substances, chemical and mechanical stresses, and potential durations of exposures.
(ii) Manufacture or processing without requiring that any container of the substance or of a formulation containing the substance be:
(A) Packaged to prevent any leakage of the substance to the environment.
(B) Labeled on the package that the substance should be handled only while using NIOSH approved respirators and impervious gloves.
(b)
(1)
(i) The names of persons required to wear protective equipment in accordance with paragraph (a)(2) of this section.
(ii) The names and addresses of any person to whom the substance is sold or transferred and the dates of such sale or transfer.
(iii) Records of respirator fit tests for each person required to wear a respirator in accordance with paragraph (a)(2) of this section.
(iv) The method for determining that the gloves described in paragraph (a)(2) of this section are impervious to the substance, the date(s) of such determination, and the results of that determination.
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for these substances, the employer becomes aware that these substances may present a risk of injury to human health, the employer must incorporate this new information, and any information on methods for protecting against such risk, into an MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If these substances are not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substances are reintroduced into the workplace.
(B) The employer must ensure that persons who will receive, or who have received these substances from the employer within 5 years from the date the employer becomes aware of the new information described in paragraph (a)(2)(i)(A) of this section, are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new use is:
(i)
(ii) [Reserved].
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(i) The significant new uses are:
(A)
(B)
(C)
(ii)
(A)
(B)
(2) The chemical substance identified generically as disubstituted tetrafluoro alkene (PMN P-84-106) is subject to reporting under this section for the significant new uses described in paragraph (a)(2)(i) of this section.
(i) The significant new uses are:
(A)
(B)
(C)
(ii)
(A)
(B)
(3) The chemical substance identified generically as disubstituted tetrafluoro alkene (PMN P-84-107) is subject to reporting under this section for the significant new uses described in paragraph (a)(3)(i) of this section.
(i) The significant new uses are:
(A)
(B)
(C)
(ii)
(A)
(B)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) If, as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health or the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into a Material Safety Data Sheet (MSDS) as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive, or who have received this substance from the employer within 5 years from the date the
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(v)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health, the employer must incorporate this new information, and any information on methods for protecting against such risk, into an MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who have received, or will receive, this substance from the employer are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into an MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive this substance from the employer, or who have received this substance from the employer within 5 years from the date the employer becomes aware of this new information described in paragraph (a)(2)(i)(A) of this section, are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(A) If, as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health, the employer must incorporate this new information, and any information on methods for protecting against such risk, into a Material Safety Data Sheet (MSDS) as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who have received, or will receive, this substance from the employer are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health or the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into an MSDS as described at § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who have received, or will receive, this substance from the employer are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new use is: Manufacture, import, or processing of 10,000 pounds or more per year per facility for any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new use is: Use other than as an intermediate in the production of isodrin or endrin.
(b)
(1)
(i) “Endrin” means the pesticide 2,7:3,6-Dimethanonaphth[2,3-b]oxirene, 3,4,5,6,9,9-hexachloro-1a,2,2a,3,6,6a,7,7a-octahydro-, (1a alpha, 2
(ii) “Isodrin” means the pesticide 1,4:5,8-Dimethano-naphthalene,1,2,3,4,10,10-hexachloro-1,4,4a,5,8,8a-hexahydro-, (1
(2) [Reserved]
(a)
(2) The significant new use is: Manufacture, import, or processing of 10,000 pounds or more per year per facility for any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new use is any use other than as an intermediate in the manufacture of fluorinated substances in an enclosed process.
(b)
(1)
(i)
(ii) [Reserved]
(2) [Reserved]
(a)
(2) The significant new use is: Any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are: (i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(v)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set a 0.1 percent), (f), (g)(1)(vii), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(3), and (g)(5).
(iii)
(iv)
(A) Selling or transferring the substance to any person for use where the substance is released to surface waters without notifying in writing the parties listed in subparagraph (B) of the identities of all such persons. Such notification shall be sent within 15 days of the date of the first sale or transfer and shall contain the following information:
(
(
(
(
(
(
(
(B) The parties to be notified are as follows.
(
(
(
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a) Chemical substances and significant new uses subject to reporting.
(1) The chemical substances ethane, 2-chloro-1,1,1-trifluoro- (CAS Number 75-88-7) and ethane, 1,2-dichloro-1,1-difluoro- (CAS Number 1649-08-7) are subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(2) The significant new use is: Use other than as an intermediate.
(b) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health, the employer must incorporate this new information, and any information on methods for protecting against such risk, into an MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive this substance from the employer, or who have received the substance from the employer within 5 years from the date the employer becomes aware of the information described in paragraph (a)(2)(i)(A) of this section, are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(A) Each study required to be performed pursuant to this section must be scientifically valid.
(
(
(
(
(
(B) Before starting to conduct any of the studies in paragraph (a)(2)(iii) of this section, the person must obtain approval of test protocols from EPA by submitting written protocols. EPA will respond to the person within 4 weeks of receiving the written protocols. Published test guidelines specified in paragraph (a)(2)(iii) of this section (e.g., 40 CFR part 797 or part 798) provide general guidance for development of test protocols, but are not themselves acceptable protocols.
(C) The person shall:
(
(
(
(D)(
(
(
(
(E) The person is not required to conduct a study specified in paragraph (a)(2)(iii) of this section if notified in writing by EPA that it is unnecessary to conduct that study.
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new use is use in metalworking fluids.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are: (i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for these substances, the employer becomes aware that these substances may present a risk of injury to human health or the environment the employer must incorporate this new information, and any information on methods for protecting against such risk, into a Material Safety Data Sheet (MSDS) as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If these substances are not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substances are reintroduced into the workplace.
(B) The employer must ensure that persons who will receive, or who have received their substances from the employer within 5 years from the date the employer becomes aware of the new information described in paragraph (a)(2)(i)(A) of this section, are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are: (i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into an MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive this substance from the employer, or who have received this substance from the employer within 5 years from the date the employer becomes aware of the new information described under paragraph (a)(2)(i)(A) of this section, are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), (f) (g)(1)(ii), (g)(1)(vii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv).
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(B) The employer must ensure that persons who have received, or will receive, this substance from the employer are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new use is: Use as an ingredient in metalworking fluids (as defined in 40 CFR 721.3) containing amines.
(b) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new use is any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv) [Reserved]
(v)
(b)
(1)
(2)
(3)
(a)
(2) The significant new use is: Manufacture, import, or processing of 10,000 pounds or more per year per facility for any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(iii)
(iv)
(v)
(vi)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(v)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv) [Reserved]
(v)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are: (i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(v)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are: (i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new use is:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance
(B) The employer must ensure that persons who will receive this substance from the employer are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(1)(i)(A) within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new use is any manufacture, processing, or use of the
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(A) If as a result of the test data required under the TSCA section 5(e) consent order for these chemical substances, the employer becomes aware that these chemical substances may present a risk of injury to human health or the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into a Material Safety Data Sheet (MSDS) as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this chemical substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the chemical substances are reintroduced into the workplace.
(B) The employer must ensure that persons who will receive or who have received the chemical substances from the employer within 5 years from the date the employer becomes aware of the new information described in paragraph (a)(2)(i)(A) of this section, are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(v)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5).
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a) Chemical substance and significant new use subject to reporting. (1) The chemical substance phenacetin (CAS No. 62-442) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(2) The significant new use is: Manufacture, import, or processing of 10,000 pounds or more per year per facility for any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health, the employer must incorporate this new information, and any information on methods for protecting against such risk, into an MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive this substance from the employer are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(1)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are: (i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are: (i)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for these substances, the employer becomes aware that any of these substances may present a risk of injury to human health, the employer must incorporate this new information, and any information on methods for protecting against such risk, into an MSDS as described at § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If these substances are not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before these substances are reintroduced into the workplace.
(B) The employer must ensure that persons who have received, or will receive, these substances from the employer are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new use is: Any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health, the employer must incorporate this new information, and any information on methods for protecting against such risk, into an MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who have received, or will receive, this substance from the employer are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are: (i)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are: (i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health, the employer must incorporate this new information, and any information on methods for protecting against such risk, into an MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive, or who have received this substance from the employer within 5 years from the date the employer becomes aware of the new information described under paragraph (a)(2)(i)(A) of this section, are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new use is:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health, the employer must incorporate this new information, and any information on methods for protecting against such risk, into an MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons will receive this substance from the employer are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(i) The significant new uses are:
(A)
(B) [Reserved]
(ii)
(A)
(B)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new use is:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health, the employer must incorporate this new information, and any information on methods for protecting against such risk, into a Material Safety Data Sheet (MSDS) as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who have received, or will receive, this substance from the employer are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health, the employer must incorporate this new information, and any information on methods for protecting against such risk, into an MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who have received, or will receive, this substance from the employer are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health, the employer must incorporate this new information, and any information on methods for protecting against such risk, into a Material Safety Data Sheet (MSDS) as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who have received, or will receive, this substance from the employer are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(v)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health or the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into a Material Safety Data Sheet (MSDS) which includes a written listing of safety data for this substance within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who have received, or will receive, this substance from the employer are provided an MSDS containing a written listing of safety data for this chemical and the information required under paragraph (a)(2)(i)(A) within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iv), (a)(5)(v), (a)(6)(i), (a)(6)(ii), (b) (concentration set at 0.1 percent), and (c).
(ii) Hazard communication program. Requirements as specified in § 721.72 (a) through (f), (g)(1)(iv), (g)(1)(viii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), and (g)(5).
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health, the employer must incorporate this new information, and any information on methods for protecting against such risk, into a Material Safety Data Sheet (MSDS) as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who have received, or will receive, this substance from the employer are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(v)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(v)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly(oxy-1,2-ethanediyl),α-hydro-ω-(oxiranylmethoxy)-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1) (PMN P-88-2188) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(v)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly(oxy-1,2-ethanediyl), α,α′-[(1-methylethylidene) di-4,1-phenylene] bis [ω-(oxiranylmethoxy)- (PMN P-88-2181) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(v)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are: (i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly[oxy(methyl-1,2-ethanediyl)], α,α,′-(2,2-dimethyl-1,3-propanediyl)bis[ω-(oxiranymethoxy)- (PMN P-88-2180) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(v)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(4)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new use is: Use in a consumer product at concentrations greater than five percent by weight.
(b)
(1)
“Consumer” means any natural person who uses products for personal rather than business purposes.
“Consumer product” means any chemical substance which is directly, or as part of a mixture, sold or made available to consumers for their use in or around a permanent or temporary household or residence, in or around a school, or in recreation.
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are: (i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(i) The significant new uses are:
(A)
(B)
(C)
(D)
(ii)
(A)
(B)
(2) The chemical substances identified generically as halogenated pyridines (PMN P-85-216, P-85-1184) is subject to reporting under this section for the significant new uses described in paragraph (a)(4)(i) of this section.
(i) The significant new uses are:
(A)
(B)
(C)
(D)
(ii)
(A)
(B)
(b) [Reserved]
(a)
(i) The significant new uses are:
(A)
(B)
(C)
(D)
(ii)
(A)
(B)
(2) The chemical substance identified generically as halogenated alkyl pyridine (PMN P-83-1162) is subject to reporting under this section for the significant new uses described in paragraph (a)(2)(i) of this section.
(i) The significant new uses are:
(A)
(B)
(C)
(D)
(ii)
(A)
(B)
(b) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(i) The significant new uses are:
(A)
(B)
(C)
(D)
(ii)
(A)
(B)
(2) The chemical substances identified generically as substituted pyridines (PMNs P-85-236 and P-85-706) are subject to reporting under this section for the significant new uses described in paragraph (a)(2)(i) of this section.
(i) The significant new uses are:
(A)
(B)
(C)
(D)
(ii)
(A)
(B)
(3) The chemical substance identified generically as substituted pyridine (PMN P-85-36) is subject to reporting under this section for the significant new uses described in paragraph (a)(3)(i) of this section.
(i) The significant new uses are:
(A)
(B)
(C)
(D)
(ii)
(A)
(B)
(4) The chemical substance identified generically as substituted pyridine (PMN P-85-1184) is subject to reporting under this section for the significant new uses described in paragraph (a)(4)(i) of this section.
(i) The significant new uses are:
(A)
(B)
(C)
(D)
(ii)
(A)
(B)
(b) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses for P-83-49 and P-83-272 are manufacture or processing without:
(i) Requiring use of the following personal protective equipment for persons involved in any operation where dermal contact and/or inhalation of the substances may occur, and where local exhaust ventilation is present at the site of the operation:
(A) Chemical cartridge respirator, approved by the National Institute for Occupational Safety and Health for protection from organic vapors, and used and fitted according to 29 CFR 1910.134 and 30 CFR part 11.
(B) Chemical worker gloves and aprons or other equivalent personal protective clothing determined to be impervious to the particular substance in its conditions of use. (Equipment may be determined to be impervious either by testing under the conditions of use, including the duration of exposure, or by evaluating the specifications supplied by the supplier of the equipment.)
(ii) Requiring use of the following personal protective equipment for persons involved in and in the immediate area of any operation where dermal contact and/or inhalation of the substance may occur, and where local exhaust ventilation is not present at the site of the operation:
(A) Full facepiece, positive pressure air-supplied respirator, approved by the Bureau of Mines, Department of the Interior or by the National Institute of Occupational Safety and Health fitted according to procedures established at 29 CFR 1910.134.
(B) Chemical worker gloves and aprons, or other equivalent personal protective clothing determined to be impervious to the particular substance in its conditions of use. (Equipment may be determined to be impervious either by testing under the conditions of use, including the duration of exposure, or by evaluating the specifications supplied by the supplier of the equipment.)
(iii) Notifying in writing, each employee required to use protective equipment that these chemical substances may present a hazard of liver, kidney, and nervous system toxicity unless the specified protective equipment is used.
(3) The significant new uses for P-83-23, P-83-24, and P-83-75 are manufacture or processing without:
(i) Requiring the use of the following personal protective equipment for persons involved in any operation where dermal contact may occur:
(A) Chemical goggles.
(B) Chemical worker gloves and aprons, or other equivalent personal protective clothing determined to be impervious to the particular substance in its conditions of use. (Equipment may be determined to be impervious either by testing under the conditions of use, including the duration of exposure, or by evaluating the specifications supplied by the supplier of the equipment.)
(ii) Notifying in writing, each employee required to use protective equipment that these chemical substances may present a hazard of liver, kidney, and nervous system toxicity unless the specified protective equipment is used.
(b)
(1)
(i) The names of persons required to wear protective clothing and/or equipment.
(ii) Records of respirator fit tests for each person required to wear a respirator.
(iii) The names and addresses of persons to whom any of these substances are sold or transferred and the date of such sale or transfer.
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(v)
(b)
(1)
(2)
(3)
(a)
(2) The significant new use is: Manufacture, import, or processing of 10,000 pounds or more per year per facility for any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health, the employer must incorporate this new information, and any information on methods for protecting against such risk, into an MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who have received, or will receive, this substance from the employer are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health, the employer must incorporate this new information, and any information on methods for protecting against such risk, into an MSDS as described
(B) The employer must ensure that persons who will receive this substance from the employer are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health, the employer must incorporate this new information, and any information on methods for protectintg against such risk, into an MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive this substance, or who have received this substance from the employer within 5 years from the date the employer becomes aware of the new information described in section (a)(2)(i)(A) of this subparagraph, are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new use is: Manufacture, import, or processing of 10,000 pounds or more per year per facility for any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) If, as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health, or the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into the applicable Material Safety Data Sheet (MSDS) as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive, or who have received this substance from the employer within 5 years from the date the employer becomes aware of the new information described in paragraph (a)(2)(i)(A) of this section, are provided an MSDS as described in § 721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the Company becomes aware of the new information. Requirements as specified in § 721.72 (a), (b), (c), (d), (f), and (g)(4)(iii).
(ii)
(iii) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new use is: Manufacture, import, or processing of 10,000 pounds or more per year per facility for any use.
(b)
(1)
(2) [Reserved]
(a) Chemical substances and significant new uses subject to reporting.
(1) The chemical substances listed in Table 1 and Table 2 of this section are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Any manufacture or import for any use of any chemical listed in Table 1 of paragraph (a)(1) of this section on or after January 1, 2001.
(ii) Any manufacture or import for any use of any chemical listed in Table 2 of paragraph (a)(1) of this section on or after January 1, 2003, except as noted in paragraph (a)(3) of this section.
(3) Manufacture or import of any chemical listed in Table 2 of paragraph (a)(1) of this section for the following specific uses shall not be considered as a significant new use subject to reporting under this section:
(i) Use as an anti-erosion additive in fire-resistant phosphate ester aviation hydraulic fluids.
(ii) Use as a component of a photoresist substance, including a photo acid generator or surfactant, or as a component of an anti-reflective coating, used in a photomicrolithography process to produce semiconductors or similar components of electronic or other miniaturized devices.
(iii) Use in coatings for surface tension, static discharge, and adhesion control for analog and digital imaging films, papers, and printing plates, or as a surfactant in mixtures used to process imaging films.
(iv) Use as an intermediate only to produce other chemical substances to be used solely for the uses listed in paragraph (a)(3)(i), (ii), or (iii) of this section.
(b) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are: (i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new use is: Manufacture, import, or processing of 10,000 pounds or more per year per facility for any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are: (i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(A) Manufactured by other than the method described in premanufacture notice P-90-226.
(B) The bulk density measurements of the PMN substance in the pure form are less than 0.4 g/cm
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(i) The significant new uses are:
(A)
(B)
(C)
(D)
(E)
(ii) [Reserved]
(2) The chemical substance monosubstituted alkoxyaminotrazines (PMN P-86-1044) is subject to reporting under this section for the significant new uses described in paragraph (a)(2)(i) of this section.
(i) The significant new uses are:
(A)
(B)
(C)
(D)
(E)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(v)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(A) For conditions of exposure which are intermittent, gloves may be tested in accordance with the most current version of ASTM F1383 “Standard Test Method for Resistance of Protective Clothing Materials to Permeation by Liquids or Gases Under Conditions of Intermittent Contact,” provided the contact time in testing is greater than or equal to the expected duration of dermal contact, and the purge time used in the testing is less than or equal to the expected duration of non-contact during the intermittent cycle of dermal exposure in the workplace. If ASTM F1383 is used for testing, the company must submit to the Agency a description of worker activities involving the chemical substance which includes daily frequencies and durations of potential worker exposures.
(B) The results of all glove permeation testing must be reported in accordance with the most current version of (ASTM) F1194 “Guide for Documenting the Results of Chemical Permeation Testing of Protective Clothing Materials.” The company must submit all test data to the Agency and must receive written Agency approval for each type of glove tested prior to use of such gloves. Gloves must be discarded and replaced with such frequency as to ensure that they will reliably provide an impervious barrier to the chemical substances under normal and expected conditions of exposure within the work area. Gloves that have been damaged or are defective shall not be used. For PMNs P-94-1871 through P-94-1874, EPA has approved North Safety Butyl Rubber gloves (32 mils thick). For P-93-204 and P-94-1870, EPA has approved North Safety Butyl Rubber gloves (32 mils thick) only if used in combination with a chemical-resistant glove that has been demonstrated (EPA review not required) impermeable to the solvent, e.g., North Silvershield gloves and North 4H gloves.
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are: (i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(A) Each study required to be performed pursuant to this section must be scientifically valid.
(
(
(
(
(
(B) Before starting to conduct any of the studies in paragraph (a)(2)(i) of this section, the person must obtain approval of test protocols from EPA by submitting written protocols. EPA will respond to the person within 4 weeks of receiving the written protocols. Published test guidelines specified in paragraph (a)(2)(i) of this section (e.g., 40 CFR part 797 or part 798) provide general guidance for development of test protocols, but are not themselves acceptable protocols.
(C) The person shall:
(
(
(
(D)(
(
(
(
(E) The person is not required to conduct a study specified in paragraph (a)(2)(i) of this section if notified in writing by EPA that it is unnecessary to conduct that study.
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new use is: Any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new use is: Manufacture, import, or processing of 10,000 pounds or more per year per facility for any use.
(b)
(1)
(2) [Reserved]
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new use is manufacture or import for any use on or after January 1, 2005.
(b)
(1)
(2) [Reserved]
At 71 FR 34021, June 13, 2006, § 721.10000 was added, effective Aug. 14, 2006.
(a)
(2) The significant new use is domestic use in a consumer product or the manufacture or import of 2-methoxyethanol acetate at levels greater than 10,000 pounds per year.
(b)
(1)
(2) [Reserved]
15 U.S.C. 2604.
(a)
(i) Chemical substances manufactured in quantities of 10,000 kilograms or less per year.
(ii) Chemical substances with low environmental releases and human exposures.
(2) To manufacture a new chemical substance under the terms of this exemption a manufacturer must:
(i) Submit a notice of intent to manufacture 30 days before manufacture begins, as required under paragraph (e) of this section.
(ii) Comply with all other provisions of this section.
(3) This section does not apply to microorganisms subject to part 725 of this chapter.
(b)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(i) Any irreversible damage to biological, commercial, or agricultural resources of importance to society;
(ii) Any reversible damage to biological, commercial, or agricultural resources of importance to society if the damage persists beyond a single generation of the damaged resource or beyond a single year; or
(iii) Any known or reasonably anticipated loss of members of an endangered or threatened species. Endangered or threatened species are those species identified as such by the Secretary of the Interior in accordance with the Endangered Species Act, as amended (16 U.S.C. 1531).
(9)
(10) The terms
(c)
(1) Any manufacturer of a new chemical substance manufactured in quantities of 10,000 kilograms or less per
(2) Any manufacturer of a new chemical substance satisfying all of the following low environmental release and low human exposure eligibility criteria:
(i)
(A) No dermal exposure.
(B) No inhalation exposure (except as described in paragraph (c)(2)(iv) of this section.
(C) Exposure in drinking water no greater than a 1 milligram per year (estimated average dosage resulting from drinking water exposure in streams from the maximum allowable concentration level from ambient surface water releases established under paragraph (c)(2)(iii) of this section or a higher concentration authorized by EPA under paragraph (c)(2)(iii) of this section).
(ii)
(A) No dermal exposure (this criterion is met if adequate dermal exposure controls are used in accordance with applicable EPA guidance).
(B) No inhalation exposure (this criterion is considered to be met if adequate inhalation exposure controls are used in accordance with applicable EPA guidance).
(iii)
(iv)
(kg/day of release after treatment) multiplied by (number of release days per year) multiplied by (9.68 × 10
(v)
(d)
(1) Serious acute (lethal or sublethal) effects.
(2) Serious chronic (including carcinogenic and teratogenic) effects.
(3) Significant environmental effects.
(e)
(2) The notice shall contain the information described below, pursuant to the referenced provisions of §720.45.
(i) Manufacturer identity.
(ii) Chemical identity (§720.45(a)).
(iii) Impurities (§720.45(b)).
(iv) Known synonyms or trade names (§720.45(c)).
(v) Byproducts (§720.45(d)).
(vi) Production volume (§720.45(e)). (A) Manufacturers submitting an exemption application under paragraph (c)(1) of this section will be assumed to be manufacturing at an annual production volume of 10,000 kilograms. Manufacturers who intend to manufacture an exempted substance at annual volumes of less than 10,000 kilograms and wish EPA to conduct its risk assessment based upon such lesser annual production level rather than a 10,000-kilograms level, may so specify by writing the lesser annual production volume in the appropriate box on the PMN form and marking the adjacent binding option box. Manufacturers who opt to specify annual production levels below 10,000 kilograms and who mark the production volume binding option box shall not manufacture more than the specific annual amount of the exempted substance unless a new exemption notice for a higher (up to 10,000 kgs) manufacturing volume is submitted and approved pursuant to this section.
(B) Manufacturers submitting an exemption under paragraph (c)(2) of this section shall list the estimated maximum amount to be manufactured during the first year of production and the estimated maximum amount to be manufactured during any 12-month period during the first 3 years of production.
(vii) Description of intended categories of use (§720.45(f)).
(viii) For manufacturer-controlled sites, the manufacturer shall supply identity of manufacturing sites, process descriptions, and worker exposure and environmental release information (§720.45(g)); for sites not controlled by the manufacturer, processing and use operation descriptions, estimated number of processing and use sites, and worker exposure/environmental release information (§720.45(h)). A manufacturer applying for an exemption under paragraph (c)(1) of this section need not provide information on worker exposure and environmental release referenced in paragraphs (e)(2)(viii) of this section if such information is not known or not readily available to the manufacturer. To assist in reporting this information, manufacturers may obtain a copy of EPA's Guidance for Reporting Occupational Exposure and Environmental Release Information under 40 CFR 723.50, available from the Environmental Assistance Division at the address listed in paragraph (e)(1) of this section. Where worker exposure and environmental release information is not supplied by the manufacturer, EPA will generally apply “bounding estimates” (i.e., exposure estimates higher than those incurred by persons in the population with the highest exposure) to account for uncertainties in actual exposure and release scenarios.
(ix) Type and category of notice. The manufacturer must clearly indicate on the first page of the PMN form that the submission is a “TSCA section 5(h)(4) exemption notice,” and must indicate whether the notice is being submitted under paragraph (c)(1) or (c)(2) of this section. Manufacturers of chemical substances that qualify for an exemption under both paragraph (c)(1) and (c)(2) of this section may apply for either exemption, but not both.
(x) Test data (§720.50).
(xi) Certification. In addition to the certifications required in EPA form 7710-25, the following certifications shall be included in notices under this section. The manufacturer must certify that:
(A) The manufacturer intends to manufacture or import the new chemical substance for commercial purposes, other than in small quantities solely for research and development, under the terms of this section.
(B) The manufacturer is familiar with the terms of this section and will comply with those terms.
(C) The new chemical substance for which the notice is submitted meets all applicable exemption conditions.
(D) For substances manufactured under paragraph (c)(1) of this section, the manufacturer intends to commence manufacture of the exempted substance for commercial purposes within 1 year of the date of the expiration of the 30-day review period.
(xii) Sanitized copy of notice. (A) The manufacturer must make all claims of confidentiality in accordance with paragraph (l) of this section. If any information is claimed confidential, the manufacturer must submit a second copy of the notice, with all information claimed as confidential deleted, in accordance with paragraph (l)(3) of this section.
(B) If the manufacturer does not provide the second copy, the submission will be considered incomplete.
(3)
(f)
(2)(i) If EPA proposes to deny an exemption application for a substance for which another manufacturer currently holds an exemption, and that proposed denial is based exclusively on the cumulative human exposure or environmental release of the substance which precludes the EPA from determining that the subsequent applicant's activities will not present an unreasonable risk of injury to human health or the environment, the EPA will notify the first exemption holder that it must, within 21 days of its receipt of EPA's notice, either:
(A) Provide a new certification that it has commenced, or that it will commence, manufacture of the new chemical substance under this section within 1 year of the expiration of its exemption review period; or
(B) Withdraw its exemption for the new chemical substance.
(ii) If the first exemption holder does not respond to the EPA's notice under paragraph (f)(2)(i) of this section within the prescribed time period, EPA shall issue a notice of ineligibility to the first exemption holder under the provisions of paragraph (h)(2) of this section.
(g)
(2) Upon expiration of the 30-day review period, if EPA has taken no action, the manufacturer may consider its exemption approved and begin to manufacture the new chemical substance under the terms described in its notice and in this section.
(h)
(2)
(B) The manufacturer may continue to manufacture, process, distribute in commerce, and use the substance after receiving the notice under paragraph (h)(2)(i)(A) of this section if the manufacturer was manufacturing, processing, distributing in commerce, or using the substance at the time of the notification and if the manufacturer submits objections or an explanation under paragraph (h)(2)(ii) of this section. Manufacturers not manufacturing, processing, distributing in commerce, or using the substance at the time of the notification may not begin manufacture until EPA makes its final determination under paragraph (h)(2)(iii) of this section.
(ii) A manufacturer who has received notice under paragraph (h)(2)(i)(A) of this section may submit, within 15 days of receipt of written notification, detailed objections to the determination or an explanation of its diligence and good faith efforts in attempting to comply with the terms of this section.
(iii) The Assistant Administrator will consider any objections or explanation submitted under paragraph (h)(2)(ii) of this section and will make a final determination. The Assistant Administrator will notify the manufacturer of the final determination by telephone within 15 days of receipt of the objections or explanation, and subsequently by certified letter.
(iv) If the Assistant Administrator determines that manufacture of the new chemical substance meets the terms of this section, the manufacturer may continue or resume manufacture, processing, distribution in commerce, and use in accordance with the terms of this section.
(v) If the Assistant Administrator determines that manufacture of the new chemical substance does not meet the terms of this section and that the manufacturer did not act with due diligence and in good faith to meet the terms of this section, the manufacturer must cease any continuing manufacture, processing, distribution in commerce, and use of the new chemical substance within 7 days of the written notification under paragraph (h)(2)(iii) of this section. The manufacturer may not resume manufacture, processing, distribution in commerce, and use of the new chemical substance until it submits a notice under section 5(a)(1) of the Act and part 720 of this chapter and the notice review period has ended.
(vi) If the Assistant Administrator determines that manufacture of the new chemical substance does not meet the terms of this section and that the manufacturer acted with due diligence and in good faith to meet the terms of this section, the manufacturer may continue manufacture, processing, distribution in commerce, and use of the new chemical substance if:
(A) It was actually manufacturing, processing, distributing in commerce,
(B) It submits a notice on the new chemical substance under section 5(a)(1) of the Act and part 720 of this chapter within 15 days of receipt of the written notification under paragraph (h)(2)(iii) of this section. Such manufacture, processing, distribution in commerce, and use may continue unless EPA takes action under section 5(e) or 5(f) of the Act.
(3) Action under this paragraph does not preclude action under sections 7, 15, 16, or 17 of the Act.
(i)
(j)
(2) Where the manufacturer lists a specific physical form in which the new chemical substance will be manufactured, processed, and/or used, the manufacturer must continue manufacturing, processing, and/or using the new chemical substance in either the same physical form described in the notice under paragraph (e), or in a physical form which will not increase the human exposure to or environmental release of the new chemical substance over those exposures or releases resulting from the specified physical form (e.g., a manufacturer which specifies that the new chemical substance will be produced in a non-volatile liquid form generally may not change to a respirable powder form).
(3) The annual production volume of chemical substances manufactured under paragraph (c)(1) of this section for which the manufacturer designated a binding annual production volume pursuant to paragraph (e)(2)(vi) of this section must not exceed that designated volume.
(4) Any person who manufactures a new chemical substance under paragraph (c)(1) or (c)(2) of this section must comply with the provisions of this section, including submission of a new notice under paragraph (e) of this section, before:
(i) Manufacturing the new chemical substance at a site that was not approved in a previous exemption notice for the substance, except as provided in paragraph (j)(6) of this section.
(ii) Manufacturing the new chemical substance for a use that was not approved in a previous exemption notice for the substance.
(iii) Manufacturing the new chemical substance without employing the human exposure and environmental release controls approved in a previous exemption notice for the substance.
(iv) Manufacturing the new chemical substance in a physical form different than that physical form approved in a previous exemption notice for the substance and which form may increase the human exposure to, or environmental release of, the new chemical
(v) Manufacturing the chemical substance in annual production volumes above any volume designated by the manufacturer as binding under paragraph (e)(2)(vi) of this section in a previous exemption notice for the substance.
(5) In an exemption notice informing EPA of a change in site, use, or worker protection, or environmental release controls, the manufacturer is not required to provide all of the same information submitted to EPA in a previous exemption notice for that chemical substance. The new exemption notice, however, must indicate the identity of the new chemical substance; the manufacturer's name; the name and telephone number of a technical contact; and location of the new site, new worker protection or environmental release controls, and new use information. The notice must also include the EPA-designated exemption number assigned to the previous notice and a new certification by the manufacturer, as described in paragraph (e)(2)(xi) of this section.
(6)(i) A manufacturer may, without submitting a new notice, manufacture the new chemical substance at a site not listed in its exemption application under the following conditions:
(A) the magnitude, frequency, and duration of exposure of individual workers to the new chemical substance at the new manufacturing site is equal to, or less than, the magnitude, frequency, and duration of exposure of the individual workers to the new chemical substance at the manufacturing site for which the EPA performed its original risk-assessment pursuant to the original exemption notice; and
(B) Either (
(ii) The manufacturer shall notify EPA of any new manufacturing site no later than 30 days after the commencement of manufacture of the new chemical substance under the exemption at the new manufacturing site as follows:
(A) The notification must contain the EPA-designated exemption number to which the notification applies, manufacturer identity, the street address of the new manufacturing site, the date on which manufacture commenced at the new site, the name and telephone number of a technical contact at the new site, any claim of confidentiality, and a statement that the notification is an amendment to the original exemption application under the terms of this section.
(B) The notification may be submitted on EPA form 7710-56 “Notice of Commencement of Manufacture;” however, the manufacturer must add the statement required under paragraph (j)(6)(ii)(A) of this section that the notification is an amendment to the original exemption.
(C) The notification must contain an original signature of an authorized official of the manufacturer.
(k)
(2) A manufacturer of a new chemical substance described in paragraph (c)(2) of this section may distribute the chemical substance only to other persons who agree in writing to not further distribute the substance until it has been reacted, incorporated into an
(3) If the manufacturer learns that a direct or indirect customer is processing or using the new substance in violation of use restrictions or without imposing prescribed worker protection or environmental release controls, the manufacturer must cease distribution of the substance to the customer or the customer's supplier immediately unless the manufacturer is able to document each of the following:
(i) That the manufacturer has, within 5 working days, notified the customer in writing that the customer has failed to comply with the conditions specified in this section and the exemption notice under paragraph (e) of this section.
(ii) That, within 15 working days of notifying the customer of the noncompliance, the manufacturer received from the customer, in writing, a statement of assurance that the customer is aware of the terms of this section and the exemption notice and will comply with those terms.
(4) If, after receiving a statement of assurance from a customer under paragraph (k)(3)(ii) of this section, the manufacturer obtains knowledge that the customer has again failed to comply with any of the conditions specified in this section or the exemption notice, the manufacturer shall cease supplying the new chemical substance to that customer and shall report the failure to comply to EPA within 15 days of obtaining this knowledge. Within 30 days of its receipt of the report, EPA will notify the manufacturer whether, and under what conditions, distribution of the chemical substance to the customer may resume.
(l)
(2)(i) Any person who asserts a claim of confidentiality for chemical identity under this paragraph (l) must provide a generic chemical name that is only as generic as necessary to protect the confidential chemical identity of the particular chemical substance. The name should reveal the specific chemical identity to the maximum extent possible.
(ii) The generic name provided by the manufacturer will be subject to EPA review and approval in accordance with the procedures specified in §720.85(b)(6) of this chapter. The generic name provided by the submitter or an alternative selected by EPA under these procedures will be placed on a public list of substances exempt under this section.
(3) If any information is claimed confidential, the manufacturer must submit a second copy of the notice with all information claimed as confidential deleted. EPA will place the second copy in the public file.
(m)
(n)
(2) The records must include the following to demonstrate compliance with this section:
(i) Records of annual production volume and import volume.
(ii) Records documenting compliance with the applicable requirements and restrictions of paragraphs (c), (e), (f), (h), (i), (j), and (k) of this section.
(3) Any person who manufactures a new chemical substance under the terms of this section must, upon request of a duly designated representative of EPA, permit such person at all reasonable times to have access to and to copy records kept under paragraph (n)(2) of this section.
(4) The manufacturer must submit the records listed in paragraph (n)(2) of this section to EPA upon request. Manufacturers must provide these records within 15 working days of receipt of such request.
(o)
(2) Submitting materially misleading or false information in connection with the requirements of any provision of this section is a violation of this section and therefore a violation of section 15 of the Act (15 U.S.C. 2614).
(3) Violators may be subject to the civil and criminal penalties in section 16 of the Act (15 U.S.C. 2615) for each violation.
(4) EPA may seek to enjoin the manufacture or processing of a chemical substance in violation of this section, or act to seize any chemical substance manufactured or processed in violation of this section, or take other action under the authority of section 7 of the Act (15 U.S.C. 2606) or section 17 of the Act (15 U.S.C. 1616).
(a)
(2) To manufacture a new chemical substance under the terms of this exemption, a manufacturer of instant photographic or peel-apart film articles must:
(i) Submit an exemption notice when manufacture begins under paragraph (i) of this section.
(ii) Comply with certain requirements to limit exposure to the new chemical substance under paragraphs (e), (f), (g), and (h) of this section.
(iii) Comply with all recordkeeping requirements under paragraph (j) of this section.
(b)
(2) An
(3) The terms
(4) The term
(5) The terms
(6)
(7) The term
(8) The term
(9)
(10)
(11) The term
(12)
(13)
(14)
(i) Data from a formal or informal study, test, experiment, recorded observation, monitoring, or measurement.
(ii) Information concerning the objectives, experimental methods and materials, protocols, results, data analyses (including risk assessments), and conclusions from a study, test, experiment, recorded observation, monitoring, or measurement.
(15)
(16)
(c)
(d)
(1) Manufacture the new chemical substances used in or for the manufacture or processing of the instant photographic or peel-apart film articles.
(2) Limit manufacture and processing of a new chemical substance to the site(s) listed in the exemption notice for that new chemical substance submitted under paragraph (i) of this section.
(3) Comply with the requirements of paragraphs (e), (f), (g), (h), and (j) of this section.
(4) Do not distribute in commerce or use a peel-apart film article containing a new chemical substance until submission of a premanufacture notice under section 5(a)(1)(A) of the Act (15 U.S.C. 2604) and until the review period for the notice has ended without EPA action to prevent distribution or use.
(e)
(1)
(2)
(ii)
(iii)
(3)
(B) When suitable sampling and analytic methods do not exist, compliance with the exposure limits of paragraph (e)(1) and the requirements of paragraph (e)(10) of this section must be determined by an evaluation of monitoring data developed for a surrogate chemical substance possessing comparable physical-chemical properties under similar manufacturing and processing conditions.
(ii)
(iii)
(B) If the manufacturer demonstrates compliance with the exposure limits
(iv)
(4)
(5)
(ii)
(iii)
(6)
(7)
(8)
(9)
(ii) No label is required if the new chemical substance has been incorporated into a photographic article, or if it is contained in a sealed reaction vessel or pipeline, or if it has been incorporated into an instant photographic or peel-apart film article.
(10)
(f)
(1)
(2)
(ii)
(iii)
(3)
(g)
(h)
(2)
(3)
(i)
(1)
(i)
(ii)
(A)
(B)
(C)
(iii)
(iv)
(v)
(vi)
(vii)
(viii)
(ix)
(x)
(2)
(3)
(j)
(i)
(ii)
(iii)
(iv)
(2) The manufacturer must make the records listed in paragraph (j)(1) of this section available to EPA upon written request by the Director of the Office of Pollution Prevention and Toxics. The manufacturer must provide these records within 15 working days of receipt of this request.
(k)
(l)
(2) As required by section 5(h)(4) of the Act, EPA will amend or repeal the substantive terms of an exemption granted under this part only by the formal rulemaking procedures described in section 6(c)(2) and (3) of the Act (15 U.S.C. 2605(c)).
(m)
(n)
(2) Submitting materially misleading or false information in connection with the requirements of any provision of this part is a violation of this regulation and therefore a violation of section 15 of the Act (15 U.S.C. 2614).
(3) Violators may be subject to the civil and criminal penalties in section 16 of the Act (15 U.S.C. 2615) for each violation.
(4) EPA may seek to enjoin the manufacture of a new chemical substance in violation of this exemption or act to seize any chemical substances manufactured in violation of the exemption under the authority of section 17 of the Act (15 U.S.C. 2616).
(a)
(2) To manufacture a new chemical substance under the terms of this section, a manufacturer must:
(i) Determine that the substance meets the definition of polymer in paragraph (b) of this section.
(ii) Determine that the substance is not specifically excluded by paragraph (d) of this section.
(iii) Ensure that the substance meets the exemption criteria of paragraph (e) of this section.
(iv) Submit a report as required under paragraph (f) of this section.
(v) Comply with the recordkeeping requirements of paragraph (j) of this section.
(b)
(c)
(d)
(i) The polymer is a solid material that is not soluble or dispersible in water and will be used only in the solid phase (e.g., polymers that will be used as ion exchange beads), or
(ii) The combined (total) functional group equivalent weight of cationic groups in the polymer is equal to or greater than 5,000.
(2)
(ii) A polymer cannot be manufactured under this section if it contains as an integral part of its composition, except as impurities, any elements other than the following:
(A) The elements listed in paragraph (d)(2)(i) of this section.
(B) Sodium, magnesium, aluminum, potassium, calcium, chlorine, bromine, and iodine as the monatomic counterions Na
(C) Fluorine, chlorine, bromine, and iodine covalently bound to carbon.
(D) Less than 0.20 weight percent of any combination of the atomic elements lithium, boron, phosphorus, titanium, manganese, iron, nickel, copper, zinc, tin, and zirconium.
(3)
(4)
(5)
(e)
(1)
(ii) The polymer cannot contain reactive functional groups unless it meets one of the following criteria:
(A) The polymer contains only the following reactive functional groups: carboxylic acid groups, aliphatic hydroxyl groups, unconjugated olefinic groups that are considered “ordinary,”(i.e., not specially activated either by being part of a larger functional group, such as a vinyl ether, or by other activating influences, e.g., strongly electron-withdrawing sulfone group with which the olefinic groups interact), butenedioic acid groups, those conjugated olefinic groups contained in naturally-occurring fats, oils, and carboxylic acids, blocked isocyanates (including ketoxime-blocked isocyanates), thiols, unconjugated nitrile groups, and halogens (except that reactive halogen-containing groups such as benzylic or allylichalides cannot be included).
(B) The polymer has a combined (total) reactive group equivalent weight greater than or equal to 1,000 for the following reactive functional groups: acidhalides; acid anhydrides; aldehydes, hemiacetals; methylolamides,- amines or,- ureas; alkoxysilanes with alkoxy greater than C
(C) If any reactive functional groups not included in paragraph (e)(1)(ii)(A) and (B) of this section are present, the combined (total) reactive group equivalent weight, including any groups listed in paragraph (e)(1)(ii)(B), is greater than or equal to 5,000.
(2)
(3)
(f)
(1)
(2)
(g)
(1) A specific chemical name and CAS Registry Number (or EPA assigned Accession Number) for each “reactant,” as that term is defined in paragraph (b) of this section, used at any weight in the manufacture of the polymer. For purposes of determining chemical identity, the manufacturer may determine whether a reactant is used at greater than two weight percent according to either the weight of the reactant charged to the reaction vessel or the
(2) A representative structural diagram, if possible.
(h)
(1) The substance is manufactured or imported for a commercial purpose other than for research and development.
(2) All information in the certification is truthful.
(3) The new chemical substance meets the definition of a polymer, is not specifically excluded from the exemption in paragraph (d) of this section, and meets the conditions of the exemption in paragraph (e) of this section.
(i)
(j)
(2) The records must include the following to demonstrate compliance with the terms of this section:
(i) Chemical identity information as required in paragraph (g) of this section.
(ii) Information to demonstrate that the new polymer is not specifically excluded from the exemption.
(iii) Records of production volume for the first 3 years of manufacture and the date of commencement of manufacture.
(iv) Information to demonstrate that the new polymer meets the exemption criteria in paragraphs (e)(1), (e)(2), or (e)(3) of this section.
(v) Analytical data, or theoretical calculations (if it can be documented that an analytical determination cannot be made or is not necessary), to demonstrate that the polymer meets the number-average MW exemption criteria in paragraphs (e)(1) or (e)(2) of this section.The analytical tests may include gel permeation chromatography (GPC).vapor pressure osmometry (VPO), or other such tests which will demonstrate that the polymer meets the number-average MW criterion.
(vi) Analytical data, or theoretical calculations (if it can be documented that an analytical determination cannot be made or is not necessary), to demonstrate that the polymer meets the criteria in paragraphs (e)(1) or (e)(2) of this section, meets the low MW content criteria in paragraphs (e)(1) or (e)(2) of this section.
(vii) If applicable, analytical data, or theoretical calculations (if it can be documented that an analytical determination cannot be made or is not necessary) required in paragraph (g) of this section for determining monomers or reactants charged to the reaction vessel at greater than 2 weight percent but incorporated at 2 weight percent or less in the manufactured polymer.
(viii) The certification statements as required under paragraph (h) of this section.
(3) The manufacturer must submit the records listed in paragraph (j)(2) of this section to EPA upon written request by EPA. The manufacturer must
(k)
(l)
(2) Using for commercial purposes a chemical substance or mixture which a person knew or had reason to know was manufactured, processed, or distributed in commerce in violation of section 5 of the Act is a violation of section 15 of the Act (15 U.S.C. 2614).
(3) Failure or refusal to establish and maintain records or to permit access to or copying of records, as required by this section and section 11 of the Act, is a violation of section 15 of the Act (15 U.S.C. 2614).
(4) Failure or refusal to permit entry or inspection as required by section 11 of the Act is a violation of section 15 of the Act (15 U.S.C. 2614).
(5) Violators may be subject to the civil and criminal penalties in section 16 of the Act (15 U.S.C. 2615) for each violation. Persons who submit materially misleading or false information in connection with the requirements of any provision of this section may be subject to penalties calculated as if they never filed their notices.
(6) EPA may seek to enjoin the manufacture or processing of a chemical substance in violation of this section or act to seize any chemical substance manufactured or processed in violation of this section or take other actions under the authority of section 7 of the Act (15 U.S.C. 2606) or section 17 of the Act (15 U.S.C. 2616).
(m)
(n)
15 U.S.C. 2604, 2607, 2613, and 2625.
(a) This part establishes all reporting requirements under section 5 of TSCA for manufacturers, importers, and processors of microorganisms subject to TSCA jurisdiction for commercial purposes, including research and development for commercial purposes. New
(b) Any manufacturer, importer, or processor required to report under section 5 of TSCA (see § 725.100 for new microorganisms and § 725.900 for significant new uses) must file a Microbial Commercial Activity Notice (MCAN) with EPA, unless the activity is eligible for a specific exemption as described in this part. The general procedures for filing MCANs are described in subpart D of this part. The exemptions from the requirement to file a MCAN are for certain kinds of contained activities (see §§ 725.424 and 725.428), test marketing activities (see § 725.300), and research and development activities described in paragraph (c) of this section.
(c) Any manufacturer, importer, or processor required to file a MCAN for research and development (R&D) activities may instead file a TSCA Experimental Release Application (TERA) for a specific test (see § 725.250). A TERA is not required for certain R&D activities; however a TERA exemption does not extend beyond the research and development stage, to general commercial use of the microorganism, for which compliance with MCAN requirements is required. The TERA exemptions are for R&D activities subject to other Federal agencies or programs (see § 725.232), certain kinds of contained R&D activities (see § 725.234), and R&D activities using certain listed microorganisms (see § 725.238).
(d) New microorganisms will be added to the Inventory established under section 8 of TSCA once a MCAN has been received, the MCAN review period has expired, and EPA receives a Notice of Commencement (NOC) indicating that manufacture or importation has actually begun. New microorganisms approved for use under a TERA will not be added to the Inventory until a MCAN has been received, the MCAN review period has expired, and EPA has received an NOC.
Definitions in section 3 of the Act (15 U.S.C. 2602), as well as definitions contained in §§ 704.3, 720.3, and 721.3 of this chapter, apply to this part unless otherwise specified in this section. In addition, the following definitions apply to this part:
(1) It is intended that the term “health and safety study of a microorganism” be interpreted broadly. Not only is information which arises as a
(2) Examples include:
(i) Tests for ecological or other environmental effects on invertebrates, fish, or other animals, and plants, including: Acute toxicity tests, chronic toxicity tests, critical life stage tests, behavioral tests, algal growth tests, seed germination tests, plant growth or damage tests, microbial function tests, bioconcentration or bioaccumulation tests, and model ecosystem (microcosm) studies.
(ii) Long- and short-term tests of mutagenicity, carcinogenicity, or teratogenicity; dermatoxicity; cumulative, additive, and synergistic effects; and acute, subchronic, and chronic effects.
(iii) Assessments of human and environmental exposure, including workplace exposure, and impacts of a particular microorganism or microbial mixture on the environment, including surveys, tests, and studies of: Survival and transport in air, water, and soil; ability to exchange genetic material with other microorganisms, ability to colonize human or animal guts, and ability to colonize plants.
(iv) Monitoring data, when they have been aggregated and analyzed to measure the exposure of humans or the environment to a microorganism.
(v) Any assessments of risk to health and the environment resulting from the manufacture, processing, distribution in commerce, use, or disposal of the microorganism.
(1) The term “intergeneric microorganism” includes a microorganism which contains a mobile genetic element which was first identified in a microorganism in a genus different from the recipient microorganism.
(2) The term “intergeneric microorganism” does not include a microorganism which contains introduced genetic material consisting of only well-characterized, non-coding regulatory regions from another genus.
(1) To import, produce, manufacture, or process with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer, importer, or processor, and includes, among other things, “manufacture” or “processing” of any amount of a microorganism or microbial mixture:
(i) For commercial distribution, including for test marketing.
(ii) For use by the manufacturer, including use for product research and development or as an intermediate.
(2) The term also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another microorganism or microbial mixture, including byproducts that are separated from that other microorganism or microbial mixture and impurities that remain in that microorganism or microbial mixture. Byproducts and impurities without separate commercial value are nonetheless produced for the purpose of obtaining a commercial advantage, since they are part of the manufacture or processing of a microorganism for commercial purposes.
(1) The regulatory region and any inserted flanking nucleotides do not code for protein, peptide, or functional ribonucleic acid molecules.
(2) The regulatory region solely controls the activity of other regions that code for protein or peptide molecules or act as recognition sites for the initiation of nucleic acid or protein synthesis.
(1) Who, because of education, training, or experience, or a combination of these factors, is capable of understanding the health and environmental risks associated with the microorganism which is used under his or her supervision,
(2) Who is responsible for enforcing appropriate methods of conducting scientific experimentation, analysis, or microbiological research to minimize such risks, and
(3) Who is responsible for the safety assessments and clearances related to the procurement, storage, use, and disposal of the microorganism as may be appropriate or required within the scope of conducting a research and development activity.
(1) The function of all of the products expressed from the structural gene(s).
(2) The function of sequences that participate in the regulation of expression of the structural gene(s).
(3) The presence or absence of associated nucleotide sequences and their associated functions, where associated nucleotide sequences are those sequences needed to move genetic material including linkers, homopolymers, adaptors, transposons, insertion sequences, and restriction enzyme sites.
(a)
(b)
(c)
(1) Any microorganism which would be excluded from the definition of
(2) Any microbial mixture as defined in § 725.3. This exclusion applies only to a microbial mixture as a whole and not to any microorganisms and other chemical substances which are part of the microbial mixture.
(3) Any microorganism that is manufactured and processed solely for export if the following conditions are met:
(i) The microorganism is labeled in accordance with section 12(a)(1)(B) of the Act, when the microorganism is distributed in commerce.
(ii) The manufacturer and processor can document at the commencement of manufacturing or processing that the person to whom the microorganism will be distributed intends to export it or process it solely for export as defined in § 721.3 of this chapter.
To identify and list microorganisms on the Inventory, both taxonomic designations and supplemental information will be used. The supplemental information required in paragraph (b) of this section will be used to specifically describe an individual microorganism on the Inventory. Submitters must provide the supplemental information required by paragraph (b) of this section to the extent necessary to enable a microorganism to be accurately and unambiguously identified on the Inventory.
(a)
(b)
(1)
(2)
(a)
(1) Confidential identity or use. In some cases it may not be possible to directly determine if a specific microorganism is listed, because portions of that entry may contain generic information to protect confidential business information (CBI). If any portion of the microorganism's identity or use has been claimed as CBI, that portion does not appear on the public version of the Inventory, in § 725.239 or in subpart M of this part. Instead, it is contained in a confidential version held in EPA's Confidential Business Information Center (CBIC). The public versions contain generic information which masks the confidential business information. A person who intends to conduct an activity involving a microorganism or
(2) Uncertain microorganism identity. The current state of scientific knowledge leads to some imprecision in describing a microorganism. As the state of knowledge increases, EPA will be developing policies to determine whether one microorganism is equivalent to another. Persons intending to conduct activities involving microorganisms may inquire of EPA whether the microorganisms they intend to manufacture, import, or process are equivalent to specific microorganisms described on the Inventory, in § 725.239, or in subpart M of this part.
(b)
(2) To establish a
(i) Taxonomic designations and supplemental information required by § 725.12.
(ii) A signed statement certifying that the submitter intends to manufacture, import, or process the microorganism for commercial purposes.
(iii) A description of research and development activities conducted with the microorganism to date, demonstration of the submitter's ability to produce or obtain the microorganism from a foreign manufacturer, and the purpose for which the person will manufacture, import, or process the microorganism.
(iv) An indication of whether a related microorganism was previously reviewed by EPA to the extent known by the submitter.
(v) A specific description of the major intended application or use of the microorganism.
(c) If an importer or processor cannot provide all the information required by paragraph (b) of this section, because it is claimed as confidential business information by its foreign manufacturer or supplier, the foreign manufacturer or supplier may supply the information directly to EPA.
(d) EPA will review the information submitted by the manufacturer, importer, or processor under this paragraph to determine whether that person has shown a
(e) In order for EPA to make a conclusive determination of the microorganism's status, the proposed manufacturer, importer, or processor must show a
(f) If the microorganism is found on the confidential version of the Inventory, in § 725.239 or in subpart M of this part, EPA will notify the person(s) who originally reported the microorganism that another person (whose identity will remain confidential, if so requested) has demonstrated a
(g) A disclosure to a person with a
(h) EPA will answer an inquiry on whether a particular microorganism is
Persons may consult with EPA, either in writing or by telephone, about their obligations under this part. Written consultation is preferred. Written inquiries should be sent to the following address: Environmental Assistance Division (7408), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTN: Biotechnology Notice Consultation. Persons wishing to consult with EPA by telephone should call (202) 554-1404; hearing impaired TDD (202) 554-0551 or e-mail:
This subpart describes general administrative procedures applicable to all persons who submit MCANs and exemption requests to EPA under section 5 of the Act for microorganisms.
(a)
(2) In addition to specific information required, the submitter should submit all information known to or reasonably ascertainable by the submitter that would permit EPA to make a reasoned evaluation of the human health and environmental effects of the microorganism and any microbial mixture or article that may contain the microorganism.
(b)
I certify that to the best of my knowledge and belief: The company named in this submission intends to manufacture, import, or process for a commercial purpose, other than in small quantities solely for research and development, the microorganism identified in this submission. All information provided in this submission is complete and truthful as of the date of submission. I am including with this submission all test data in my possession or control and a description of all other data known to or reasonably ascertainable by me as required by 40 CFR 725.160 or 725.260.
(c)
(d)
(2) In accordance with § 725.160 or 725.260, as appropriate, the submission must also include any test data in the submitter's possession or control and descriptions of other data which are known to or reasonably ascertainable by the submitter and which concern the health and environmental effects of the microorganism.
(e)
(2) A manufacturer or importer may authorize another person (e.g., a foreign manufacturer or supplier, or a toll
(3) If EPA receives a submission which does not include the information required, which the submitter indicates that it has authorized another person to provide, the review period will not begin until EPA receives all of the required information.
(f)
(2) If EPA has granted the submitter an exemption under section 4(c) of the Act from the requirement to conduct tests and submit data, the person may not file a MCAN or TERA until EPA receives the test data.
(3) If EPA has granted the submitter an exemption under section 4(c) of the Act and if another person previously has submitted the test data to EPA, the exempted person may either submit the test data or provide the following information as part of the notice:
(i) The name, title, and address of the person who submitted the test data to EPA.
(ii) The date the test data were submitted to EPA.
(iii) A citation for the test rule.
(iv) A description of the exemption and a reference identifying it.
(g)
(i) Intends to manufacture or import a microorganism which is subject to the notification requirements of this part and which is subject to a rule issued under section 5(b)(4) of the Act; and
(ii) Is not required by a rule issued under section 4 of the Act to submit test data for the microorganism before the filing of a submission, the person must submit to EPA data described in paragraph (g)(2) of this section at the time the submission is filed.
(2) Data submitted under paragraph (g)(1) of this section must be data which the person submitting the notice believes show that the manufacture, processing, distribution in commerce, use, and disposal of the microorganism, or any combination of such activities, will not present an unreasonable risk of injury to health or the environment.
(h)
(1) Data previously submitted to EPA. (i) A person need not submit any data previously submitted to EPA with no claims of confidentiality if the new submission includes: the office or person to whom the data were submitted; the date of submission; and, if appropriate, a standard literature citation as specified in § 725.160(a)(3)(ii).
(ii) For data previously submitted to EPA with a claim of confidentiality, the person must resubmit the data with the new submission and any claim of confidentiality, under § 725.80.
(2) Efficacy data. This part does not require submission of any data related solely to product efficacy. However, including efficacy data will improve EPA's ability to assess the benefits of the use of the microorganism. This does not exempt a person from submitting any of the data specified in § 725.160 or 725.260.
(3) Non-U.S. exposure data. This part does not require submission of any data which relates only to exposure of humans or the environment outside the United States. This does not exclude
Each person who is required to submit information under this part must submit the information in the form and manner set forth in the appropriate subpart.
(a) Requirements specific to MCANs are described in §§ 725.150 through 725.160.
(b) Requirements specific to TERAs are described in §§ 725.250 through 725.260.
(c) Requirements specific to test marketing exemptions (TMEs) are described in §§ 725.350 and 725.355.
(d) Requirements specific to Tier I and Tier II exemptions for certain general commercial uses are described in §§ 725.424 through 725.470.
(e) Additional requirements specific to significant new uses for microorganisms are described at § 725.950.
When EPA receives a MCAN or exemption request, EPA will review it to determine whether the microorganism is subject to the requirements of this part. If EPA determines that the microorganism is not subject to these requirements, EPA will notify the submitter that section 5 of the Act does not prevent the manufacture, import, or processing of the microorganism and that the submission is not needed.
(a) EPA will acknowledge receipt of each submission by sending the submitter a letter that identifies the number assigned to each MCAN or exemption request and the date on which the review period begins. The review period will begin on the date the MCAN or exemption request is received by the Office of Pollution Prevention and Toxics Document Control Officer.
(b) The acknowledgement does not constitute a finding by EPA that the submission is in compliance with this part.
(a) Within 30 days of receipt of the submission, EPA may request that the submitter remedy errors in the submission. The following are examples of such errors:
(1) Failure to date the submission.
(2) Typographical errors that cause data to be misleading or answers to any questions to be unclear.
(3) Contradictory information.
(4) Ambiguous statements or information.
(b) In the request to correct the submission, EPA will explain the action which the submitter must take to correct the submission.
(c) If the submitter fails to correct the submission within 15 days of receipt of the request, EPA may extend the review period.
(a) A submission under this part is not complete, and the review period does not begin, if:
(1) The wrong person files the submission.
(2) The submitter does not attach and sign the certification statement as required by § 725.25(b).
(3) Some or all of the information in the submission or any attachments are not in English, except for published scientific literature.
(4) The submitter does not provide information that is required by sections 5(d)(1)(B) and (C) of the Act and § 725.160 or 725.260, as appropriate.
(5) The submitter does not provide information required by § 725.25, 725.155, 725.255, 725.355, or 725.455, as appropriate, or indicate that it is not known to or reasonably ascertainable by the submitter.
(6) The submitter has asserted confidentiality claims and has failed to:
(i) Submit a second copy of the submission with all confidential information deleted for the public file, as required by § 725.80(b)(2).
(ii) Comply with the substantiation requirements as described in § 725.94.
(7) The submitter does not include any information required by section 5(b)(1) of the Act and pursuant to a rule promulgated under section 4 of the Act, as required by § 725.25(f).
(8) The submitter does not submit data which the submitter believes show that the microorganism will not present an unreasonable risk of injury to health or the environment, if EPA has listed the microorganism under section 5(b)(4) of the Act, as required in § 725.25(g).
(9) For MCANs, the submitter does not remit the fees required by § 700.45(b)(1) or (b)(2)(vi) of this chapter.
(b)(1) If EPA receives an incomplete submission under this part, the Director, or a designee, will notify the submitter within 30 days of receipt that the submission is incomplete and that the review period will not begin until EPA receives a complete submission.
(2) If EPA obtains additional information during the review period for any submission that indicates the original submission was incomplete, the Director, or a designee, may declare the submission incomplete within 30 days after EPA obtains the additional information and so notify the submitter.
(c) The notification that a submission is incomplete under paragraph (b) of this section will include:
(1) A statement of the basis of EPA's determination that the submission is incomplete.
(2) The requirements for correcting the incomplete submission.
(3) Information on procedures under paragraph (d) of this section for filing objections to the determination or requesting modification of the requirements for completing the submission.
(d) Within 10 days after receipt of notification by EPA that a submission is incomplete, the submitter may file written objections requesting that EPA accept the submission as complete or modify the requirements necessary to complete the submission.
(e)(1) EPA will consider the objections filed by the submitter. The Director, or a designee, will determine whether the submission was complete or incomplete, or whether to modify the requirements for completing the submission. EPA will notify the submitter in writing of EPA's response within 10 days of receiving the objections.
(2) If the Director, or a designee, determines, in response to the objection, that the submission was complete, the review period will be deemed suspended on the date EPA declared the submission incomplete, and will resume on the date that the submission is declared complete. The submitter need not correct the submission as EPA originally requested. If EPA can complete its review within the review period beginning on the date of the submission, the Director, or a designee, may inform the submitter that the running of the review period will resume on the date EPA originally declared it incomplete.
(3) If the Director, or a designee, modifies the requirements for completing the submission or concurs with EPA's original determination, the review period will begin when EPA receives a complete submission.
(f) If EPA discovers at any time that a person submitted materially false or misleading statements in information submitted under this part, EPA may find that the submission was incomplete from the date it was submitted, and take any other appropriate action.
(a) During the review period, if a submitter possesses, controls, or knows of new information that materially adds to, changes, or otherwise makes significantly more complete the information included in the MCAN or exemption request, the submitter must send that information to the address listed in § 725.25(c) within 10 days of receiving the new information, but no later than 5 days before the end of the review period.
(b) The new submission must clearly identify the submitter, the MCAN or exemption request to which the new information is related, and the number assigned to that submission by EPA, if known to the submitter.
(c) If the new information becomes available during the last 5 days of the review period, the submitter must immediately inform the EPA contact for that submission by telephone of the new information.
(a)
(b)
(2) The categories of use of the microorganism will be published as reported in the submission unless this information is claimed confidential. If confidentiality is claimed, the generic information which is submitted under § 725.88 will be published.
(3) A list of information submitted in accordance with § 725.160(a), 725.255, 725.260, 725.355, or 725.455, as appropriate, will be published.
(4) The submitter's identity will be published, unless the submitter has claimed it confidential.
(c)
(a)
(b)
(1)
(2)
(3)
(a) A submitter may voluntarily suspend the running of the review period if the Director, or a designee, agrees. If the Director does not agree, the review period will continue to run, and EPA will notify the submitter. A submitter may request a suspension at any time during the review period. The suspension must be for a specified period of time.
(b) A request for suspension may be made in writing to the address listed in § 725.25(c). The suspension also may be made orally, including by telephone, to the submitter's EPA contact for that submission. EPA will send the submitter a written confirmation that the suspension has been granted.
(1) An oral request may be granted for no longer than 15 days. To obtain a longer suspension, the Document Control Officer for the Office of Pollution Prevention and Toxics must receive written confirmation of the oral request. The review period is suspended as of the date of the oral request.
(2) If the submitter has not made a previous oral request, the running of the review period is suspended as of the date of receipt of the written request by the Document Control Officer for the Office of Pollution Prevention and Toxics.
(a) At any time during the review period, EPA may unilaterally determine that good cause exists to extend the review period specified for MCANs, or the exemption requests.
(b) If EPA makes such a determination, EPA:
(1) Will notify the submitter that EPA is extending the review period for a specified length of time and state the reasons for the extension.
(2) For MCANs, EPA may issue a notice for publication in the
(c) The total period of the extension may be for a period of up to the same length of time as specified for each type of submission in § 725.50. If the initial extension is for less than the total time allowed, EPA may make additional extensions. However, the sum of the extensions may not exceed the total allowed.
(d) The following are examples of situations in which EPA may find that good cause exists for extending the review period:
(1) EPA has reviewed the submission and is seeking additional information.
(2) EPA has received significant additional information during the review period.
(3) The submitter has failed to correct a submission after receiving EPA's request under § 725.32.
(4) EPA has reviewed the submission and determined that there is a significant possibility that the microorganism will be regulated under section 5(e) or section 5(f) of the Act, but EPA is unable to initiate regulatory action within the initial review period.
(a) A submitter may withdraw a submission during the review period. A statement of withdrawal must be made in writing to the address listed in § 725.25(c). The withdrawal is effective upon receipt of the statement by the Document Control Officer.
(b) If a manufacturer, importer, or processor who withdrew a submission later resubmits a submission for the same microorganism, a new review period begins.
(a)
(i) Any data in the submitter's possession or control; and
(ii) Records of production volume for the first 3 years of manufacture, import, or processing.
(2) Any person who submits a notice under this part must retain documentation of the date of commencement of testing, manufacture, import, or processing.
(3) Any person who is exempt from some or all of the reporting requirements of this part must retain documentation that supports the exemption.
(4) All information required by this section must be retained for 3 years from the date of commencement of each activity for which records are required under this part.
(b)
(1) Additional recordkeeping requirements for activities conducted inside a structure are set forth in § 725.235(h).
(2) Additional recordkeeping requirements for TERAs are set forth in § 725.250(f).
(3) Additional recordkeeping requirements for TMEs are set forth in § 725.350(c).
(4) Additional recordkeeping requirements for Tier I exemptions under subpart G of this part are set forth in § 725.424(a)(5).
(5) Additional recordkeeping requirements for Tier II exemptions under subpart G of this part are set forth in § 725.450(d).
(6) Additional recordkeeping requirements for significant new uses of microorganisms reported under subpart L of this part are set forth in § 725.850. Recordkeeping requirements may also be included when a microorganism and significant new use are added to subpart M of this part.
(a)
(2)
(i) The effects of the new microorganism on health and the environment.
(ii) The magnitude of exposure of human beings and the environment to the new microorganism.
(iii) The benefits of the new microorganism for various uses and the availability of substitutes for such uses.
(iv) The reasonably ascertainable economic consequences of granting or denying the exemption, including effects on the national economy, small business, and technological innovation.
(3)
(i)
(ii)
(iii)
(A) Identification and classification of the microorganism using available genotypic and phenotypic information;
(B) Information to evaluate the relationship of the microorganism to any other closely related microorganisms which have a potential for adverse effects on health or the environment;
(C) A history of safe commercial use for the microorganism;
(D) Commercial uses indicating that the microorganism products might be subject to TSCA;
(E) Studies which indicate the potential for the microorganism to cause adverse effects to health or the environment; and
(F) Studies which indicate the survival characteristics of the microorganism in the environment.
(b)
(2)
(c)
(i) An unreasonable risk determination under the Act is an administrative judgment that requires balancing of the harm to health or the environment that a chemical substance may cause and the magnitude and severity of that harm, against the social and economic effects on society of EPA action to reduce that harm.
(ii) A determination of unreasonable risk under section 5(h)(4) of the Act will examine the reasonably ascertainable economic and social consequences of granting or denying the exemption after consideration of the effect on the national economy, small business, technological innovation, the environment, and public health.
(2)
(3)
(a) Failure to comply with any provision of this part is a violation of section 15 of the Act (15 U.S.C. 2614).
(b) A person who manufactures or imports a microorganism before a MCAN is submitted and the MCAN review period expires is in violation of section 15 of the Act even if that person was not required to submit the MCAN under § 725.105.
(c) Using a microorganism which a person knew or had reason to know was manufactured, processed, or distributed in commerce in violation of section 5 of the Act or this part is a violation of section 15 of the Act (15 U.S.C. 2614).
(d) Failure or refusal to establish and maintain records or to permit access to or copying of records, as required by the Act, is a violation of section 15 of the Act (15 U.S.C. 2614).
(e) Failure or refusal to permit entry or inspection as required by section 11 of the Act is a violation of section 15 of the Act (15 U.S.C. 2614).
(f) Violators may be subject to the civil and criminal penalties in section 16 of the Act (15 U.S.C. 2615) for each violation. Persons who submit materially misleading or false information in connection with the requirements of any provision of this part may be subject to penalties calculated as if they never filed their submissions.
(g) EPA may seek to enjoin the manufacture or processing of a microorganism in violation of this part or act to seize any microorganism manufactured or processed in violation of this part or take other actions under the authority of section 7 of the Act (15 U.S.C. 2606) or section 17 of the Act (15 U.S.C. 2616).
EPA will conduct inspections under section 11 of the Act to assure compliance with section 5 of the Act and this part, to verify that information required by EPA under this part is true and correct, and to audit data submitted to EPA under this part.
(a) A person may assert a claim of confidentiality for any information submitted to EPA under this part. However,
(1) Any person who asserts a claim of confidentiality for portions of the specific microorganism identity must provide the information as described in § 725.85.
(2) Any person who asserts a claim of confidentiality for a use of a microorganism must provide the information as described in § 725.88.
(3) Any person who asserts a claim of confidentiality for information contained in a health and safety study of a microorganism must provide the information described in § 725.92.
(b) Any claim of confidentiality must accompany the information when it is submitted to EPA.
(1) When a person submits any information under this part, including any attachments, for which claims of confidentiality are made, the claim(s) must be asserted by circling the specific information which is claimed and marking the page on which that information appears with an appropriate designation such as “trade secret,” “TSCA CBI,” or “confidential business information.”
(2) If any information is claimed confidential, the person must submit two copies of the document including the claimed information.
(i) One copy of the document must be complete. In that copy, the submitter must mark the information which is claimed as confidential in the manner prescribed in paragraph (b)(1) of this section.
(ii) The second copy must be complete except that all information claimed as confidential in the first copy must be deleted. EPA will place the second copy in the public file.
(iii) If the submitter does not provide the second copy, the submission is incomplete and the review period does not begin to run until EPA receives the
(iv) Any information contained within the copy submitted under paragraph (b)(2)(ii) of this section which has been in the public file for more than 30 days will be presumed to be in the public domain, notwithstanding any assertion of confidentiality made under this section.
(3) A person who submits information to EPA under this part must reassert a claim of confidentiality and substantiate the claim each time the information is submitted to EPA.
(c) Any person asserting a claim of confidentiality under this part must substantiate each claim in accordance with the requirements in § 725.94.
(d) EPA will disclose information that is subject to a claim of confidentiality asserted under this section only to the extent permitted by the Act, this subpart, and part 2 of this title.
(e) If a submitter does not assert a claim of confidentiality for information at the time it is submitted to EPA, EPA may make the information public and place it in the public file without further notice to the submitter.
(a)
(ii) A person who submits information to EPA under this part must reassert a claim of confidentiality and substantiate the claim each time the information is submitted to EPA. For example, if a person claims certain information confidential in a TERA submission and wishes the same information to remain confidential in a subsequent TERA or MCAN submission, the person must reassert and resubstantiate the claim in the subsequent submission.
(2)
(ii) If the submission includes a health and safety study concerning the microorganism and if the claim for confidentiality with respect to the specific identity is denied in accordance with § 725.92(c), EPA will deny a claim asserted under paragraph (a) of this section.
(3)
(i) The generic name which was accepted by EPA in the prenotice consultation conducted under paragraph (a)(4) of this section.
(ii) One generic name that is only as generic as necessary to protect the confidential identity of the particular microorganism. The name should reveal the specific identity to the maximum extent possible. The generic name will be subject to EPA review and approval.
(4)
(A) The specific identity of the microorganism.
(B) A proposed generic name(s) which is only as generic as necessary to protect the confidential identity of the new microorganism. The name(s) should reveal the specific identity of
(ii) Within 30 days, EPA will inform the submitter either that one of the proposed generic names is adequate or that none is adequate and further consultation is necessary.
(5)
(b)
(i) A submitter may not claim the microorganism identity confidential for the period after commencement of manufacture or import for general commercial use unless the submitter claimed the microorganism identity confidential under paragraph (a) of this section in the MCAN submitted for the microorganism.
(ii) A submitter may claim the microorganism identity confidential for the period after commencement of manufacture or import for general commercial use if the submitter did not claim the microorganism identity confidential under paragraph (a) of this section in any TERA submitted for the microorganism, but subsequently did claim microorganism identity confidential in the MCAN submitted for the microorganism.
(2)
(ii) If the notice includes a health and safety study concerning the new microorganism, and if the claim for confidentiality with respect to the microorganism identity is denied in accordance with § 725.92(c), EPA will deny a claim asserted under paragraph (b) of this section.
(3)
(i) Comply with the requirements of paragraph (a)(3) of this section regarding submission of a generic name.
(ii) Agree that EPA may disclose to a person with a
(iii) Have available and agree to furnish to EPA upon request the taxonomic designations and supplemental information required by § 725.12.
(iv) Provide a detailed written substantiation of the claim, in accordance with the requirements of § 725.94(b).
(4)
(5)
(A) The submitter asserts a claim of confidentiality in accordance with this paragraph.
(B) No claim for confidentiality of the microorganism identity as part of a health and safety study has been denied in accordance with part 2 of this title or § 725.92.
(ii) Publication of a generic name on the public Inventory does not create a category for purposes of the Inventory. Any person who has a
(iii) Upon receipt of a request described in § 725.15(b), EPA may require the submitter who originally asserted confidentiality for a microorganism to submit to EPA the information listed in paragraph (b)(3)(iii) of this section.
(iv) Failure to submit any of the information required under paragraph (b)(3)(iii) of this section within 10 calendar days of receipt of a request by EPA under paragraph (b) of this section will constitute a waiver of the original submitter's confidentiality claim. In this event, EPA may place the specific microorganism identity on the public Inventory without further notice to the original submitter.
(6)
(i) If EPA determines that the generic name proposed by the submitter is only as generic as necessary to protect the confidential identity of the particular microorganism, EPA will place that generic name on the public Inventory.
(ii) If EPA determines that the generic name proposed by the submitter is more generic than necessary to protect the confidential identity, EPA will propose in writing, for review by the submitter, an alternative generic name that will reveal the identity of the microorganism to the maximum extent possible.
(iii) If the generic name proposed by EPA is acceptable to the submitter, EPA will place that generic name on the public Inventory.
(iv) If the generic name proposed by EPA is not acceptable to the submitter, the submitter must explain in detail why disclosure of that generic name would reveal confidential business information and propose another generic name which is only as generic as necessary to protect the confidential identity of the microorganism. If EPA does not receive a response from the submitter within 30 days after the submitter receives the proposed name, EPA will place EPA's chosen generic name on the public Inventory. If the submitter does provide the information requested, EPA will review the response. If the submitter's proposed generic name is acceptable, EPA will publish that generic name on the public Inventory. If the submitter's proposed generic name is not acceptable, EPA will notify the submitter of EPA's choice of a generic name. Thirty days after this notification, EPA will place the chosen generic name on the public Inventory.
(a)
(b)
(1) Report the categories or proposed categories of use of the microorganism.
(2) Provide, in nonconfidential form, a description of the uses that is only as generic as necessary to protect the confidential business information. The generic use description will be included in the
(c)
(a)
(1) Processes used in the manufacture or processing of a microorganism.
(2) Information which is not in any way related to the effects of a microorganism on health or the environment, such as, the name of the submitting company, cost or other financial
(b)
(2)
(c)
(1) The information would disclose processes used in the manufacture or processing of a microorganism.
(2) The microorganism identity is not necessary to interpret a health and safety study.
(d)
(a)
(i) If any information in the submission is claimed as confidential business information, the submitter must substantiate each claim by submitting written answers to the questions in paragraphs (c), (d), and (e) of this section at the time the person submits the information.
(ii) If the submitter does not provide written substantiation as required in paragraph (a)(1)(i) of this section, the submission will be considered incomplete and the review period will not begin in accordance with § 725.33.
(2)
(b)
(2) The submitter must substantiate the claim for confidentiality of the microorganism identity by answering all of the questions in paragraphs (c), (d), and (e) in this section. In addition, the following questions must be answered:
(i) What harmful effects to the company's or institution's competitive position, if any, would result if EPA publishes on the Inventory the identity of the microorganism? How could a competitor use such information given the
(ii) Has the identity of the microorganism been kept confidential to the extent that competitors do not know it is being manufactured or imported for general commercial use by anyone?
(c)
(1) For what period of time is a claim of confidentiality being asserted? If the claim is to extend until a certain event or point in time, indicate that event or time period. Explain why the information should remain confidential until such point.
(2) Briefly describe any physical or procedural restrictions within the company or institution relating to the use and storage of the information claimed as confidential. What other steps, if any, apply to use or further disclosure of the information?
(3) Has the information claimed as confidential been disclosed to individuals outside of the company or institution? Will it be disclosed to such persons in the future? If so, what restrictions, if any, apply to use or further disclosure of the information?
(4) Does the information claimed as confidential appear, or is it referred to, in any of the following questions? If the answer is yes to any of these questions, indicate where the information appears and explain why it should nonetheless be treated as confidential.
(i) Advertising or promotional materials for the microorganism or the resulting end product?
(ii) Material safety data sheets or other similar materials for the microorganism or the resulting end product?
(iii) Professional or trade publications?
(iv) Any other media available to the public or to competitors?
(v) Patents?
(vi) Local, State, or Federal agency public files?
(5) Has EPA, another Federal agency, a Federal court, or a State made any confidentiality determination regarding the information claimed as confidential? If so, provide copies of such determinations.
(6) For each type of information claimed confidential, describe the harm to the company's or institution's competitive position that would result if this information were disclosed. Why would this harm be substantial? How could a competitor use such information? What is the causal connection between the disclosure and harm?
(7) If EPA disclosed to the public the information claimed as confidential, how difficult would it be for the competitor to enter the market for the resulting product? Consider such constraints as capital and marketing cost, specialized technical expertise, or unusual processes.
(d)
(1) Has the microorganism or method of production been patented in the U.S. or elsewhere? If so, why is confidentiality necessary?
(2) Does the microorganism leave the site of production or testing in a form which is accessible to the public or to competitors? What is the cost to a competitor, in time and money, to develop appropriate use conditions? What factors facilitate or impede product analysis?
(3) For each additional type of information claimed as confidential, explain what harm would result from disclosure of each type of information if the identity of the microorganism were to remain confidential.
(e)
(1) Would the disclosure of the information claimed confidential reveal: confidential process information, or information unrelated to the effects of the microorganism on health and the environment. Describe the causal connection between the disclosure and harm.
(2) Does the company or institution assert that disclosure of the microorganism identity is not necessary to interpret any health and safety studies which have been submitted? If so, explain how a less specific identity would be sufficient to interpret the studies.
All information submitted, including any health and safety study of a microorganism and other supporting documentation, will become part of the public file for that submission, unless such materials are claimed confidential. In addition, EPA may add materials to the public file, unless such materials are claimed confidential. Any of the nonconfidential material described in this subpart will be available for public inspection in the TSCA Public Docket Office, Rm. NE-B607, 401 M St., SW., Washington, DC, between the hours of noon to 4 p.m., Monday through Friday, excluding legal holidays.
(a) This subpart establishes procedures for submission of a notice to EPA under section 5(a) of the Act for persons who manufacture, import, or process microorganisms for commercial purposes. This notice is called a Microbial Commercial Activity Notice (MCAN). It is expected that MCANs will in general only be submitted for microorganisms intended for general commercial use. Persons who manufacture, import, or process a microorganism in small quantities solely for research and development as defined in § 725.3 are not required to submit a notice to EPA. Persons who manufacture, import, or process a microorganism for research and development activities that do not fit the definition of small quantities solely for research and development may nonetheless qualify for more limited reporting requirements in Subpart E, including the TERA which can be used for review of research and development involving environmental release.
(b) Persons subject to MCAN submission are described in § 725.105.
(c) Exclusions and exemptions specific to MCAN submissions are described in § 725.110.
(d) Submission requirements applicable specifically to MCANs are described at § 725.150.
(e) Data requirements for MCANs are set forth in §§ 725.155 and 725.160.
(f) EPA review procedures specific to MCANs are set forth in § 725.170.
(g) Subparts A through C of this part apply to any MCAN submitted under this subpart.
(a)
(2) If a person contracts with a manufacturer to produce or process a new microorganism and the manufacturer produces or processes the microorganism exclusively for that person, and that person specifies the identity of the microorganism, and controls the total amount produced and the basic technology for the plant process, then that person must submit the MCAN. If it is unclear who must report, EPA should be contacted to determine who must submit the MCAN.
(3) Only manufacturers that are incorporated, licensed, or doing business in the United States may submit a MCAN.
(b)
(2) When several persons are involved in an import transaction, the MCAN must be submitted by the principal importer. If no one person fits the principal importer definition in a particular transaction, the importer should contact EPA to determine who must submit the MCAN for that transaction.
(3) Except as otherwise provided in paragraph (b)(4) of this section, the provisions of this subpart D apply to each person who submits a MCAN for a
(4) EPA will hold the principal importer, or the importer that EPA determines must submit the MCAN when there is no principal importer under paragraph (b)(2) of this section, liable for complying with this part, for completing the MCAN, and for the completeness and truthfulness of all information which it submits.
(c)
Persons are not subject to the requirements of this subpart for the following activities:
(a) Manufacturing, importing, or processing solely for research and development microorganisms that meet the requirements for an exemption under subpart E of this part.
(b) Manufacturing, importing, or processing microorganisms for test marketing activities which have been granted an exemption under subpart F of this part.
(c) Manufacturing or importing new microorganisms under the conditions of a Tier I or Tier II exemption under subpart G of this part.
General requirements for all MCANs under this part are contained in subparts A through C of this part. In addition, the following requirements apply to MCANs submitted under this subpart:
(a)
(b)
(c)
(d)
(a) Each person who is required by this part to submit a MCAN must include the information specified in paragraphs (c) through (h) of this section, to the extent it is known to or reasonably ascertainable by that person. However, no person is required to include information which relates solely to exposure of humans or ecological populations outside of the United States.
(b) Each person should also submit, in writing, all other information known to or reasonably ascertainable by that person that would permit EPA to make a reasoned evaluation of the health and environmental effects of the microorganism, or any microbial mixture or article, including information on its effects on humans, animals, plants, and other microorganisms, and in the environment. The information to be submitted under this subpart includes the information listed in paragraphs (c) through (h) of this section relating to the manufacture, processing, distribution in commerce, use, and disposal of the new microorganism.
(c)
(2) The name, address, and office telephone number (including area code) of the principal technical contact representing the submitter.
(d)
(1)
(ii) Information on the morphological and physiological features of the new microorganism.
(iii) Other specific data by which the new microorganism may be uniquely identified for Inventory purposes.
(2)
(ii) Description of the traits for which the new microorganism has been selected or developed and other traits known to have been added or modified.
(iii) A detailed description of the genetic construction of the new microorganism, including the technique used to modify the microorganism (e.g., fusion of cells, injection of DNA, electroporation or chemical poration, or methods used for induced mutation and selection). The description should include, for example, a description of the introduced genetic material, including any regulatory sequences and structural genes and the products of those genes; how the introduced genetic material is expected to affect behavior of the recipient; expression, alteration, and stability of the introduced genetic material; methods for vector construction and introduction; and a description of the regulatory and structural genes that are components of the introduced genetic material, including genetic maps of the introduced sequences.
(3)
(ii) Survival and dissemination under relevant environmental conditions including a description of methods for detecting the new or recipient microorganism(s) in the environment and the sensitivity limit of detection for these techniques.
(iii) A description of anticipated biological interactions with and effects on target organisms and other organisms such as competitors, prey, hosts, symbionts, parasites, and pathogens; a description of host range; a description of pathogenicity, infectivity, toxicity, virulence, or action as a vector of pathogens; and capacity for genetic transfer under laboratory and relevant environmental conditions.
(iv) A description of anticipated involvement in biogeochemical or biological cycling processes, involvement in rate limiting steps in mineral or nutrient cycling, or involvement in inorganic compounds cycling (such as possible sequestration or transformation of heavy metals).
(e)
(f)
(g)
(h)
(i) The identity of sites where the new microorganism will be manufactured, processed, or used. For purposes of this section, the site for a person who imports a new microorganism is the site of the operating unit within the person's organization which is directly responsible for importing the new microorganism and which controls the import transaction. The import site may in some cases be the organization's headquarters office in the United States.
(ii) A process description of each manufacture, processing, and use operation, which includes a diagram of the major unit operations and conversions, the identity and entry point of all feedstocks, and the identity of any possible points of release of the new microorganism from the process, including a description of all controls, including engineering controls, used to prevent such releases.
(iii) Worker exposure information, including worker activities, physical form of process streams which contain the new microorganism to which workers may be exposed, the number of workers, and the duration of activities.
(iv) Information on release of the new microorganism to the environment, including the quantity and media of release and type of control technology used.
(v) A narrative description of the intended transport of the new microorganism, including the means of transport, containment methods to be used during transport, and emergency containment procedures to be followed in case of accidental release.
(vi) Procedures for disposal of any articles, waste, clothing, or other equipment involved in the activity, including procedures for inactivation of the new microorganism, containment, disinfection, and disposal of contaminated items.
(2) For sites not controlled by the submitter, a description of each type of processing and use operation involving the new microorganism, including identification of the estimated number of processing or use sites, situations in which worker exposure to and/or environmental release of the new microorganism will occur, the number of workers exposed and the duration of exposure; procedures for transport of the new microorganism and for disposal, including procedures for inactivation of the new microorganism; and control measures which limit worker exposure and environmental release.
(a)
(2) A full report or standard literature citation must be submitted for the following types of test data:
(i) Health effects data.
(ii) Ecological effects data.
(iii) Physical and chemical properties data.
(iv) Environmental fate characteristics.
(v) Monitoring data and other test data related to human exposure to or environmental release of the new microorganism.
(3)(i) If the data do not appear in the open scientific literature, the submitter must provide a full report. A full report includes the experimental methods and materials, results, discussion and data analysis, conclusions, references, and the name and address of the laboratory that developed the data.
(ii) If the data appear in the open scientific literature, the submitter need only provide a standard literature citation. A standard literature citation includes author, title, periodical name, date of publication, volume, and page numbers.
(4)(i) If a study, report, or test is incomplete when a person submits a MCAN, the submitter must identify the
(ii) If a test or experiment is completed before the MCAN review period ends, the person must submit the study, report, or test, as specified in paragraph (a)(3)(i) of this section, to the address listed in § 725.25(c) within 10 days of receiving it, but no later than 5 days before the end of the review period. If the test or experiment is completed during the last 5 days of the review period, the submitter must immediately inform its EPA contact for that submission by telephone.
(5) For test data in the submitter's possession or control which are not listed in paragraph (a)(2) of this section, a person is not required to submit a complete report. The person must submit a summary of the data. If EPA so requests, the person must submit a full report within 10 days of the request, but no later than 5 days before the end of the review period.
(6) All test data described under paragraph (a) of this section are subject to these requirements, regardless of their age, quality, or results.
(b)
(i) Any data, other than test data, in the submitter's possession or control.
(ii) Any data, including test data, which are not in the submitter's possession or control, but which are known to or reasonably ascertainable by the submitter. For the purposes of this section, data are known to or reasonably ascertainable by the submitter if the data are known to any of its employees or other agents who are associated with the research and development, test marketing, or commercial marketing of the microorganism.
(2) Data that must be described include data concerning the new microorganism in a pure culture or formulated form as used or as intended to be used in one of the activities listed in paragraph (b)(1) of this section.
(3) The description of data reported under paragraph (b) of this section must include:
(i) If the data appear in the open scientific literature, a standard literature citation, which includes the author, title, periodical name, date of publication, volume, and pages.
(ii) If the data are not available in the open scientific literature, a description of the type of data and summary of the results, if available, and the names and addresses of persons the submitter believes may have possession or control of the data.
(4) All data described in paragraph (b) of this section are subject to these requirements, regardless of their age, quality, or results; and regardless of whether they are complete at the time the MCAN is submitted.
General procedures for review of all submissions under this part are contained in §§ 725.28 through 725.60. In addition, the following procedures apply to EPA review of MCANs submitted under this subpart:
(a) Length of the review period. The MCAN review period specified in section 5(a) of the Act runs for 90 days from the date the Document Control Officer for the Office of Pollution Prevention and Toxics receives a complete MCAN, or the date EPA determines the MCAN is complete under § 725.33, unless the Agency extends the period under section 5(c) of the Act and § 725.56.
(b) Notice of expiration of MCAN review period. (1) EPA will notify the submitter that the MCAN review period has expired or that EPA has completed its review of the MCAN. Expiration of the review period does not constitute EPA approval or certification of the new microorganism, and does
(2) After expiration of the MCAN review period, in the absence of regulatory action by EPA under section 5(e), 5(f), or 6(a) of the Act, the submitter may manufacture or import the microorganism even if the submitter has not received notice of expiration.
(3) Early notification that EPA has completed its review does not permit commencement of manufacture or import prior to the expiration of the 90-day MCAN review period.
(c) No person submitting a MCAN in response to the requirements of this subpart may manufacture, import, or process a microorganism subject to this subpart until the review period, including all extensions and suspensions, has expired.
(a)
(b)
(2) If manufacture or import for nonexempt, commercial purposes began or will begin before May 27, 1997, the submitter must submit the NOC by May 27, 1997.
(3) Submission of an NOC prior to the commencement of manufacture or import is a violation of section 15 of the Act.
(c)
(d)
(a) This subpart describes exemptions from the reporting requirements under subpart D of this part for research and development activities involving microorganisms.
(b) In lieu of complying with subpart D of this part, persons described in § 725.205 may submit a TSCA Experimental Release Application (TERA) for research and development activities involving microorganisms or otherwise comply with this subpart.
(c) Exemptions from part 725 are provided at §§ 725.232, 725.234, and 725.238.
(d) Submission requirements specific for TERAs are described at § 725.250.
(e) Data requirements for TERAs are set forth in §§ 725.255 and 725.260.
(f) EPA review procedures specific for TERAs are set forth in §§ 725.270 and 725.288.
(g) Subparts A through C of this part apply to any submission under this subpart.
(a) Commercial research and development activities involving new microorganisms or significant new uses of microorganisms are subject to reporting under this part unless they qualify for an exemption under this part.
(b) Commercial purposes for research and development means that the activities are conducted with the purpose of obtaining an immediate or eventual commercial advantage for the researcher and would include:
(1) All research and development activities which are funded directly, in whole or in part, by a commercial entity regardless of who is actually conducting the research. Indications that the research and development activities are funded directly, in whole or in
(i) Situations in which a commercial entity contracts directly with a university or researcher; or
(ii) Situations in which a commercial entity gives a conditional grant where the commercial entity holds patent rights, or establishes a joint venture where the commercial entity holds patent or licensing rights; or
(iii) Any other situation in which the commercial entity intends to obtain an immediate or eventual commercial advantage for the commercial entity and/or the researcher.
(2) Research and development activities that are not funded directly by a commercial entity, if the researcher intends to obtain an immediate or eventual commercial advantage. Indications that the researcher intends to obtain an immediate or eventual commercial advantage may include, but are not limited to:
(i) The research is directed toward developing a commercially viable improvement of a product already on the market; or
(ii) The researcher has sought or is seeking commercial funding for the purpose of developing a commercial application; or
(iii) The researcher or university has sought or is seeking a patent to protect a commercial application which the research is developing; or
(iv) Other evidence that the researcher is aware of a commercial application for the research and has directed the research toward developing that application.
(c) Certain research and development activities involving microorganisms subject to jurisdiction under the Act are exempt from reporting under this part. A person conducting research and development activities which meet the conditions for the exemptions described in §§ 725.232, 725.234, or 725.238 is exempt from TERA reporting under this subpart.
(d) A microorganism is not exempt from reporting under subpart D of this part if any amount of the microorganism, including as part of a mixture, is processed, distributed in commerce, or used, for any commercial purpose other than research and development.
(e) Quantities of the inactivated microorganism, or mixtures or articles containing the inactivated microorganism, remaining after completion of research and development activities may be disposed of as a waste in accordance with applicable Federal, State, and local regulations.
(f) A person who manufactures, imports, or processes a microorganism solely for research and development is not required to comply with the requirements of this section if:
(1) The person is manufacturing a microbial pesticide identified in § 172.45(c), or
(2) The person is manufacturing a microbial pesticide for which an Experimental Use Permit is required, pursuant to § 172.3; or
(3) The person is manufacturing a microbial pesticide for which a notification or an Experimental Use Permit is not required to be submitted.
This part does not apply to any research and development activity that meets all of the following conditions.
(a) The microorganism is manufactured, imported, or processed solely for research and development activities.
(b) There is no intentional testing of a microorganism outside of a structure, as structure is defined in § 725.3.
(c)(1) The person receives research funds from another Federal agency, and the funds are awarded on the condition that the research will be conducted in accordance with the relevant portions of the NIH Guidelines, or
(2) A Federal agency or program otherwise imposes the legally binding requirement that the research is to be conducted in accordance with relevant portions of the NIH Guidelines.
A person who manufactures, imports, or processes a microorganism is not subject to the reporting requirements under subpart D of this part if all of the following conditions are met:
(a) The microorganism is manufactured, imported, or processed solely for research and development activities.
(b) The microorganism is used by, or directly under the supervision of, a technically qualified individual, as defined in § 725.3. The technically qualified individual must maintain documentation of the procedures selected to comply with paragraph (d) of this section and must ensure that the procedures are used.
(c) There is no intentional testing of a microorganism outside of a structure, as structure is defined in § 725.3.
(d) Containment and/or inactivation controls. (1) Selection and use of containment and/or inactivation controls inside a structure for a particular microorganism shall take into account the following:
(i) Factors relevant to the organism's ability to survive in the environment.
(ii) Potential routes of release in air, solids and liquids; in or on waste materials and equipment; in or on people, including maintenance and custodial personnel; and in or on other organisms, such as insects and rodents.
(iii) Procedures for transfer of materials between facilities.
(2) The technically qualified individual's selection of containment and/or inactivation controls shall be approved and certified by an authorized official (other than the TQI) of the institution that is conducting the test prior to the commencement of the test.
(3) Records shall be developed and maintained describing the selection and use of containment and/or inactivation controls, as specified in § 725.235(c). These records, which must be maintained at the location where the research and development activity is being conducted, shall be submitted to EPA upon written request and within the time frame specified in EPA's request.
(4) Subsequent to EPA review of records in accordance with paragraph (d)(3) of this section, changes to the containment/inactivation controls selected under paragraph (d)(1) of this section must be made upon EPA order. Failure to comply with EPA's order shall result in automatic loss of eligibility for an exemption under this section.
(e) The manufacturer, importer, or processor notifies all persons in its employ or to whom it directly distributes the microorganism, who are engaged in experimentation, research, or analysis on the microorganism, including the manufacture, processing, use, transport, storage, and disposal of the microorganism associated with research and development activities, of any risk to health, identified under § 725.235(a), which may be associated with the microorganism. The notification must be made in accordance with § 725.235(b).
(a)
(1) For research conducted in accordance with the NIH Guidelines, the manufacturer, importer, or processor must meet the conditions laid out at IV-B-4-d of the NIH Guidelines; or
(2) For all other research conducted in accordance with § 725.234, the manufacturer, importer, or processor must review and evaluate the following information to determine whether there is reason to believe there is any risk to health which may be associated with the microorganism:
(i) Information in its possession or control concerning any significant adverse reaction of persons exposed to the microorganism which may reasonably be associated with such exposure.
(ii) Information provided to the manufacturer, importer, or processor by a supplier or any other person concerning a health risk believed to be associated with the microorganism.
(iii) Health and environmental effects data in its possession or control concerning the microorganism.
(iv) Information on health effects which accompanies any EPA rule or order issued under TSCA section 4, 5, or 6 of the Act that applies to the microorganism and of which the manufacturer, importer, or processor has knowledge.
(b)
(2) If the manufacturer, importer, or processor distributes a microorganism manufactured, imported, or processed under this section to persons not in its employ, the manufacturer, importer, or processor must in written form:
(i) Notify those persons that the microorganism is to be used only for research and development purposes and the requirements of § 725.234 are to be met.
(ii) Provide the notice of health risks specified in paragraph (b)(1) of this section.
(3) The adequacy of any notification under this section is the responsibility of the manufacturer, importer, or processor.
(c)
(i) Documentation that the NIH Guidelines have been adhered to. Such documentation shall include:
(A) For experiments subject to Institutional Biosafety Committee review, or notification simultaneous with initiation of the experiment, the information submitted for review or notification, along with standard laboratory records, shall satisfy the recordkeeping requirements specified in § 725.234(d)(3).
(B) For experiments exempt from Institutional Biosafety Committee review or notification simultaneous with initiation of the experiment, documentation of the exemption, along with standard laboratory records, shall satisfy the recordkeeping requirement specified in § 725.234(d)(3).
(ii) Documentation of how the following requirements are satisfied under the NIH Guidelines:
(A) Copies or citations to information reviewed and evaluated to determine the need to make any notification of risk.
(B) Documentation of the nature and method of notification of risk, including copies of any labels or written notices used.
(C) The names and addresses of any persons other than the manufacturer, importer, or processor to whom the substance is distributed, the identity of the microorganism, the amount distributed, and copies of the notifications required.
(2) For all other research conducted in accordance with § 725.234, a person who manufacturers, imports, or processes a microorganism under this section, must maintain the following records:
(i) Records describing selection and use of containment and/or inactivation controls required by § 725.234(d)(3) and certification by an authorized official required by § 725.234(d)(2) for each microorganism.
(ii) Copies or citations to information reviewed and evaluated under paragraph (a) of this section to determine the need to make any notification of risk.
(iii) Documentation of the nature and method of notification under paragraph (b)(1) of this section, including copies of any labels or written notices used.
(iv) The names and addresses of any persons other than the manufacturer, importer, or processor to whom the substance is distributed, the identity of the microorganism, the amount distributed, and copies of the notifications required under paragraph (b)(2) of this section.
(a)
(2) The research and development activity involving a microorganism listed in § 725.239 must be conducted by, or directly under the supervision of, a technically qualified individual, as defined in § 725.3.
(b)
(1) Name, address, and telephone number of the manufacturer or importer.
(2) Location, estimated duration, and planned start date of the test.
(3) Certification of the following:
(i) Compliance with the conditions of the exemption specified for the microorganism in § 725.239.
(ii) If state and/or local authorities have been notified of the activity, evidence of notification.
(c)
(a)
(1)
(2)
(ii) The introduced genetic material must consist only of the following components:
(A) The structural gene(s) of interest, which have the following limitations:
(
(
(B) The regulatory sequences permitting the expression of solely the gene(s) of interest.
(C) Associated nucleotide sequences needed to move genetic material, including linkers, homopolymers, adaptors, transposons, insertion sequences, and restriction enzyme sites.
(D) The vector nucleotide sequences needed for vector transfer.
(E) The vector nucleotide sequences needed for vector maintenance.
(3)
(ii) The technically qualified individual must select appropriate methods to limit the dissemination of modified
(b)
(1)
(2)
(ii) The introduced genetic material must consist only of the following components:
(A) The structural gene(s) of interest, which have the following limitations:
(
(
(B) The regulatory sequences permitting the expression of solely the gene(s) of interest.
(C) Associated nucleotide sequences needed to move genetic material, including linkers, homopolymers, adaptors, transposons, insertion sequences, and restriction enzyme sites.
(D) The vector nucleotide sequences needed for vector transfer.
(E) The vector nucleotide sequences needed for vector maintenance.
(3)
(ii) The technically qualified individual must select appropriate methods to limit the dissemination of modified
General requirements for all submissions under this part are contained in subparts A through C of this part. In addition, the following requirements apply to TERAs submitted under this subpart:
(a) When to submit the TERA. Each person who is eligible to submit a TERA under this subpart must submit the TERA at least 60 calendar days before the person intends to initiate the proposed research and development activity.
(b) Contents of the TERA. Each person who submits a TERA under this subpart must provide the information and test data described in §§ 725.255 and 725.260. In addition, the submitter must supply sufficient information to enable EPA to evaluate the effects of all activities for which approval is requested.
(c) A person may submit a TERA for one or more microorganisms and one or more research and development activities, including a research program.
(d) EPA will either approve the TERA, with or without conditions, or disapprove it under procedures established in this subpart.
(e) The manufacturer, importer, or processor who receives a TERA approval must comply with all terms of the approval, as well as conditions described in the TERA, and remains liable for compliance with all terms and conditions, regardless of who conducts the research and development activity. Any person conducting the research and development activity approved under the TERA must comply with all terms of the TERA approval, as well as the conditions described in the TERA.
(f) Recordkeeping. Persons submitting a TERA must comply with the recordkeeping requirements of § 725.65. In addition, the following requirements apply to TERAs:
(1) Each person submitting a TERA under this part must retain documentation of information contained in the TERA for a period of 3 years from the date that the results of the study are submitted to the Agency.
(2) Summaries of all data, conclusions, and reports resulting from the conduct of the research and development activity under the TERA must be submitted to the EPA address identified in § 725.25(c) within 1 year of the termination of the activity.
(a) To review a TERA, EPA must have sufficient information to permit a reasoned evaluation of the health and environmental effects of the planned test in the environment. The person seeking EPA approval must submit all information known to or reasonably ascertainable by the submitter on the microorganism(s) and the research and development activity, including information not listed in paragraphs (c), (d), and (e) of this section that the person believes will be useful for EPA's risk assessment. The TERA must be in writing and must include at least the information described in the following paragraphs.
(b) When specific information is not submitted, an explanation of why such information is not available or not applicable must be included.
(c) Persons applying for a TERA, must include the submitter identification and microorganism identity information required for MCANs in § 725.155(c), (d)(1), and (d)(2).
(d) Persons applying for a TERA must submit phenotypic and ecological characteristics information required in § 725.155(d)(3) as it relates directly to the conditions of the proposed research and development activity.
(e) Persons applying for a TERA must also submit the following information about the proposed research and development activity:
(1)
(ii) Number of microorganisms released (including viability per volume if applicable) and the method(s) of application or release.
(iii) Characteristics of the test site(s), including location, geographical, physical, chemical, and biological features, proximity to human habitation or activity, and description of site characteristics that would influence dispersal or confinement.
(iv) Target organisms (if the microorganism(s) to be tested has an intended target), including identification of each target organism and anticipated mechanism and result of interaction.
(v) Planned start date and duration of each activity.
(vi) If State and/or local authorities have been notified of the activity, evidence of notification.
(2)
(ii) Mitigation and emergency procedures.
(iii) Measures to detect and control potential adverse effects.
(iv) Name of principal investigator and chief of site personnel responsible for emergency procedures.
(v) Personal protective equipment, engineering controls, and procedures to be followed to minimize dispersion of the microorganism(s) by people, machinery, or equipment.
(vi) Procedures for disposal of any articles, waste, clothing, machinery, or other equipment involved in the experimental release, including methods for inactivation of the microorganism(s), containment, disinfection, and disposal of contaminated items.
Each TERA must contain all available data concerning actual or potential effects on health or the environment of the new microorganism that are in the possession or control of the submitter and a description of other data known to or reasonably ascertainable by the submitter that will permit a reasoned evaluation of the planned test in the environment. The data must be reported in the manner described in § 725.160(a)(3) and (b)(3).
General procedures for review of all submissions under this part are contained in §§ 725.28 through 725.60. In addition, the following procedures apply to EPA review of applications submitted under this subpart:
(a)
(2) A submitter shall not proceed with the research and development activity described in the TERA unless and until EPA provides written approval of the TERA. A submitter may receive early approval if a review is completed in less than 60 days.
(b)
(2) If EPA determines that the proposed research and development activity for the microorganism does not present an unreasonable risk of injury to health or the environment, EPA will notify the submitter that the TERA is approved and that the submitter can proceed with the proposed research and development activity described in the TERA.
(3) EPA may include requirements and conditions in its approval of the TERA that would be stated in the TERA approval under paragraph (c) of this section.
(4) If EPA concludes that it cannot determine that the proposed research and development activity described in the TERA will not present an unreasonable risk of injury to health or the environment, EPA will deny the TERA and will provide reasons for the denial in writing.
(c)
(2) When EPA approves a TERA, the submitter must conduct the research and development activity only as described in the TERA and in accordance with any requirements and conditions prescribed by EPA in its approval of the TERA.
(3) Any person who fails to conduct the research and development activity as described in the TERA and in accordance with any requirements and conditions prescribed by EPA in its approval of the TERA under this section, shall be in violation of sections 5 and 15 of the Act and be subject to civil and criminal penalties under section 16 of the Act.
(a)
(2) The submitter may, within 10 days of receipt of EPA's notice, provide in writing additional information or arguments concerning the significance of the questions and whether EPA should modify or revoke the approval of the TERA.
(3) After considering any such information and arguments, EPA will decide whether to change its determination regarding approval of the TERA.
(i) If EPA determines that the activity will not present an unreasonable risk of injury to health or the environment, it will notify the submitter in writing. To make this finding, EPA may prescribe additional conditions which must be followed by the submitter.
(ii) If EPA determines that it can no longer conclude that the activity will not present an unreasonable risk of injury to health or the environment, it will notify the submitter in writing that EPA is revoking its approval and state its reasons. In that event, the submitter must terminate the research and development activity within 48 hours of receipt of the notice in accordance with directions provided by EPA in the notice.
(b)
(2) In the notice, EPA may prescribe additional safeguards to address or reduce the risk, or may instruct the submitter to suspend the research and development activities.
(3) Within 48 hours, the submitter must implement the instructions contained in the notice. The submitter may then submit additional information or arguments concerning the matters raised by EPA and whether EPA should modify or revoke the approval of the TERA in accordance with paragraph (a)(2) of this section.
(4) EPA will consider the information and arguments in accordance with paragraph (a)(3) of this section.
(5) Following consideration of the information and arguments under paragraph (a)(3) of this section, if EPA notifies the submitter that the R&D activity must be suspended or terminted, the submitter may resume the activity only upon written notice from EPA that EPA has approved resumption of the activity. In approving resumption of an activity, EPA may prescribe additional conditions which must be followed by the submitter.
(c)
(a) This subpart describes exemptions from the reporting requirements under
(b) In lieu of complying with subpart D of this part, persons described in § 725.305 may submit an application for a test marketing exemption (TME).
(c) Submission requirements specific for TME applications are described at § 725.350.
(d) Data requirements for TME applications are set forth in § 725.355.
(e) EPA review procedures specific for TMEs are set forth in § 725.370.
(f) Subparts A through C of this part apply to any submission under this subpart.
A person identified in this section may apply for a test marketing exemption. EPA may grant the exemption if the person demonstrates that the microorganism will not present an unreasonable risk of injury to health or the environment as a result of the test marketing. A person may apply under this subpart for the following test marketing activities:
(a) A person who intends to manufacture or import for commercial purposes a new microorganism.
(b) A person who intends to manufacture, import, or process for commercial purposes a microorganism identified in subpart M of this part for a significant new use.
General requirements for all submissions under this part are contained in subparts A through C of this part. In addition, the following requirements apply to applications submitted under this subpart:
(a)
(b)
(c)
(a) To review a TME application, EPA must have sufficient information to permit a reasoned evaluation of the health and environmental effects of the planned test marketing activity. The person seeking EPA approval must submit all information known to or reasonably ascertainable by the person on the microorganism and the test marketing activity, including information not listed in paragraphs (c), (d), and (e) of this section that the person believes will demonstrate that the microorganism will not present an unreasonable risk of injury to health or the environment as a result of the test marketing. The TME application must be in writing and must include at least the information described in paragraphs (b), (c), (d), and (e) of this section.
(b) When specific information is not submitted, an explanation of why such information is not available or not applicable must be included.
(c) Persons applying for a TME must submit the submitter identification and microorganism identity information required for MCANs in § 725.155(c), (d)(1), and (d)(2).
(d) Persons applying for a TME must submit phenotypic and ecological characteristics information required in § 725.155(d)(3) as it relates directly to the conditions of the proposed test marketing activity.
(e) Persons applying for a TME must also submit the following information about the proposed test marketing activity:
(1)
(ii) The maximum number of persons who may be provided the microorganism during test marketing.
(iii) The maximum number of persons who may be exposed to the microorganism as a result of test marketing, including information regarding duration and route of such exposures.
(iv) A description of the test marketing activity, including its duration and how it can be distinguished from full-scale commercial production and research and development activities.
(2)
General procedures for review of all submissions under this part are contained in §§ 725.28 through 725.60. In addition, the following procedures apply to EPA review of TME applications submitted under this subpart:
(a) No later than 45 days after EPA receives a TME, the Agency will either approve or deny the application.
(b) A submitter may only proceed with test marketing activities after receipt of EPA approval.
(c) In approving a TME application, EPA may impose any restrictions necessary to ensure that the microorganism will not present an unreasonable risk of injury to health and the environment as a result of test marketing.
(a) This subpart describes exemptions from reporting under subpart D of this part, and from review under this part altogether, for manufacturing and importing of certain new microorganisms for commercial purposes.
(b) Recipient microorganisms eligible for the tiered exemption from review under this part are listed in § 725.420.
(c) Criteria for the introduced genetic material contained in the new microorganisms are described in § 725.421.
(d) Physical containment and control technologies are described in § 725.422.
(e) The conditions for the Tier I exemption are listed in § 725.424.
(f) In lieu of complying with subpart D of this part, persons using recipient microorganisms eligible for the tiered exemption may submit a Tier II exemption request. The limited reporting requirements for the Tier II exemption, including data requirements, are described in §§ 725.450 and 725.455.
(g) EPA review procedures for the Tier II exemption are set forth in § 725.470.
(h) Subparts A through C of this part apply to any submission under this subpart.
The following recipient microorganisms are eligible for either exemption under this subpart:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
For a new microorganism to qualify for either exemption under this subpart, introduced genetic material must meet all of the criteria listed in this section.
(a)
(1) The structural gene(s) of interest.
(2) The regulatory sequences permitting the expression of solely the gene(s) of interest.
(3) Associated nucleotide sequences needed to move genetic material, including linkers, homopolymers, adaptors, transposons, insertion sequences, and restriction enzyme sites.
(4) The nucleotide sequences needed for vector transfer.
(5) The nucleotide sequences needed for vector maintenance.
(b)
(1) The function of all of the products expressed from the structural gene(s).
(2) The function of sequences that participate in the regulation of expression of the structural gene(s).
(3) The presence or absence of associated nucleotide sequences and their associated functions, where associated nucleotide sequences are those sequences needed to move genetic material including linkers, homopolymers, adaptors, transposons, insertion sequences, and restriction enzyme sites.
(c)
(d)
(i) For the purposes of this section, a functional portion of a toxin-encoding sequence means any sequence which codes for a polypeptide that has one of the following effects:
(A) It directly or indirectly contributes to toxic effects in humans. Directly contributes to toxic effects in humans means those sequences encoding polypeptides that have direct toxicity to target cells. An example of a sequence which directly contributes to toxic effects in humans is one which encodes the portion of diphtheria toxin, listed in paragraph (d)(2) of this section, capable of interacting with elongation factor 2, leading to inhibition of protein synthesis in target respiratory, heart, kidney, and nerve tissues. Indirectly contributes to toxic effects in humans means a sequence whose encoded polypeptide is not directly toxic to target cells, yet still adversely affects humans. An example of a sequence which indirectly contributes to toxic effects is the sequence which encodes the portion of the botulinum toxin, listed in paragraph (d)(3) of this section, capable of blocking the release of acetylcholine from gangliosides. Botulinum toxin affects neuromuscular junctions by its blockage of acetylcholine release, leading to irreversible relaxation of muscles and respiratory arrest.
(B) It binds a toxin or toxin precursor to target human cells.
(C) It facilitates intracellular transport of a toxin in target human cells.
(ii) While these toxins are listed (with synonyms in parentheses) in paragraphs (d)(2) through (d)(7) of this section according to the source organism, it is use of the nucleotide sequences that encode the toxins that is being restricted and not the use of the source organisms. The source organisms are listed to provide specificity in identification of sequences whose use is restricted. Although similar or identical sequences may be isolated from organisms other than those listed below in paragraphs (d)(2) through (d)(7) of this section, these comparable toxin sequences, regardless of the organism from which they are derived, must not be included in the introduced genetic material.
(2)
(3)
(4)
(5)
(6) Sequences that affect membrane integrity.
(7)
The manufacturer must meet all of the following criteria for physical containment and control technologies for any facility in which the new microorganism will be used for a Tier I exemption; these criteria also serve as guidance for a Tier II exemption.
(a) Use a structure that is designed and operated to contain the new microorganism.
(b) Control access to the structure.
(c) Provide written, published, and implemented procedures for the safety of personnel and control of hygiene.
(d) Use inactivation procedures demonstrated and documented to be effective against the new microorganism contained in liquid and solid wastes prior to disposal of the wastes. The inactivation procedures must reduce viable microbial populations by at least 6 logs in liquid and solid wastes.
(e) Use features known to be effective in minimizing viable microbial populations in aerosols and exhaust gases released from the structure, and document use of such features.
(f) Use systems for controlling dissemination of the new microorganism through other routes, and document use of such features.
(g) Have in place emergency clean-up procedures.
(a)
(1) The recipient microorganism is listed in and meets any requirements specified in § 725.420.
(2) The introduced genetic material meets the criteria under § 725.421.
(3) The physical containment and control technologies of any facility in which the microorganism will be manufactured, processed, or used meet the criteria under § 725.422.
(4) The manufacturer or importer submits a certification described in paragraph (b) of this section to EPA at least 10 days before commencing initial manufacture or import of a new microorganism derived from a recipient microorganism listed in § 725.420.
(5) The manufacturer or importer complies with the recordkeeping requirements of § 725.65 and maintains records for the initial and subsequent uses of the new microorganism that verify compliance with the following:
(i) The certifications made in paragraph (b) of this section.
(ii) All the eligibility criteria for the Tier I exemption including the criteria for the recipient microorganism, the introduced genetic material, the physical containment and control technologies.
(b)
(1) Name and address of manufacturer or importer.
(2) Date when manufacture or import is expected to begin.
(3) The identification (genus, species) of the recipient microorganism listed in § 725.420 which is being used to create the new microorganism which will be used under the conditions of the Tier I exemption.
(4) Certification of the following:
(i) Compliance with the introduced genetic material criteria described in § 725.421.
(ii) Compliance with the containment requirements described in § 725.422, including the provision in paragraph (a)(3) of this section.
(5) The site of waste disposal and the type of permits for disposal, the permit numbers and the institutions issuing the permits.
(6) The certification statement required in § 725.25(b). Certification of submission of test data is not required for the Tier I exemption.
The Tier I exemption under § 725.424 applies only to a manufacturer or importer of a new microorganism that certifies that the microorganism will be used in all cases in compliance with §§ 725.420, 725.421, and 725.422.
The manufacturer or importer of a new microorganism for commercial purposes may submit to EPA a Tier II exemption request in lieu of a MCAN under subpart D of this part if all of the following conditions are met:
(a) The recipient microorganism is listed in and meets any requirements specified in § 725.420.
(b) The introduced genetic material meets the criteria under § 725.421.
(c) Adequate physical containment and control technologies are used. The criteria listed under § 725.422 for physical containment and control technologies of facilities should be used as guidance to satisfy the Tier II exemption request data requirements listed at § 725.455(d). EPA will review proposed process and containment procedures as part of the submission for a Tier II exemption under this section.
General requirements for all submissions under this part are contained in § 725.25. In addition, the following requirements apply to requests submitted under this subpart:
(a)
(b)
(c)
(d)
(1) The certifications made in the request.
(2) All the eligibility criteria for the Tier II exemption request including the criteria for the recipient microorganism, the introduced genetic material, the physical containment and control technologies.
The submitter must indicate clearly that the submission is a Tier II exemption request for a microorganism instead of the MCAN under subpart D of this part and must submit the following information:
(a)
(2) The name, address, and office telephone number (including area code) of the principal technical contact representing the submitter.
(b)
(2) Type of genetic modification and the function of the introduced genetic material.
(3) Site of insertion.
(4) Certification of compliance with the introduced genetic material criteria described in § 725.421.
(c)
(d)
(i) Identity and location of the manufacturing site(s).
(ii) Process flow diagram illustrating the production process, including downstream separations, and indicating the containment envelope around the appropriate equipment.
(iii) Identities and quantities of feedstocks.
(iv) Sources and quantities of potential releases to both the workplace and environment, and a description of engineering controls, inactivation procedures, and other measures which will reduce worker exposure and environmental releases.
(v) A description of procedures which will be undertaken to prevent fugitive emissions, i.e. leak detection and repair program.
(vi) A description of procedures/safeguards to prevent and mitigate accidental releases to the workplace and the environment.
(2) Certification of those elements of the containment criteria described in § 725.422 with which the manufacturer is in compliance, including stating by number the elements with which the manufacturer is in full compliance.
(e) The site of waste disposal and the type of permits for disposal, the permit numbers and the institutions issuing the permits.
(f) The certification statement required in § 725.25(b). Certification of submission of test data is not required for the Tier II exemption.
General procedures for review of all submissions under this part are contained in §§ 725.28 through 725.60. In addition, the following procedures apply to EPA review of Tier II exemption requests submitted under this subpart:
(a)
(b)
(c)
(d)
(2) If the Agency makes this determination, the Administrator, or a designee will notify the manufacturer or importer by telephone, followed by a letter, that the request has been denied. The letter will explain reasons for the denial.
(3) If the request is denied, the manufacturer or importer may submit the information necessary to constitute a MCAN under subpart D of this part.
(e)
(2) In approving a request, EPA may impose any restrictions necessary to ensure that the microorganism will not present an unreasonable risk of injury to health and the environment as a result of general commercial use.
(f) EPA may seek to enjoin the manufacture or import of a microorganism in violation of this subpart, or act to seize any microorganism manufactured or imported in violation of this section or take other actions under the authority of sections 7 or 17 of the Act.
(g) A manufacturer or importer may only proceed after receipt of EPA approval.
(a) This subpart describes additional provisions governing submission of MCANs for microorganisms subject to significant new use rules identified in subpart M of this part.
(b) Manufacturers, importers, and processors described in § 725.105(c) must submit a MCAN under subpart D of this part for significant new uses of microorganisms described in subpart M of this part, unless they are excluded under §§ 725.910 or 725.912.
(c) Section 725.920 discusses exports and imports.
(d) Additional recordkeeping requirements specific to significant new uses of microorganisms are described in § 725.950.
(e) Section 725.975 describes how EPA will approve alternative means of complying with significant new use requirements designated in subpart M of this part.
(f) Expedited procedures for promulgating significant new use requirements under subpart M of this part for microorganisms subject to section 5(e) orders are discussed in §§ 725.980 and 725.984.
(g) This subpart L contains provisions governing submission and review of notices for the microorganisms and significant new uses identified in subpart M of this part. The provisions of this subpart L apply to the microorganisms and significant new uses identified in subpart M of this part, except to the extent that they are specifically modified or supplanted by specific requirements in subpart M of this part.
(h) The provisions of subparts A through F of this part also apply to subparts L and M of this part. For purposes of subparts L and M of this part, wherever the words “microorganism” or “new microorganism” appear in subparts A through F of this part, it shall mean the microorganism subject to subparts L and M of this part. In the event of a conflict between the provisions of subparts A through F and the provisions of subparts L and M of this part, the provisions of subparts L and M of this part shall govern.
(a) A person who intends to manufacture, import, or process a microorganism identified in subpart M of this part and who intends to distribute it in commerce is not required to submit a MCAN under subpart D of this part, if that person can document one or more of the following as to each recipient of the microorganism from that person:
(1) That the person has notified the recipient, in writing, of the specific section in subpart M of this part which identifies the microorganism and its designated significant new uses, or
(2) That the recipient has knowledge of the specific section in subpart M of this part which identifies the microorganism and its designated significant new uses, or
(3) That the recipient cannot undertake any significant new use described in the specific section in subpart M of this part.
(b) The manufacturer, importer, or processor described in paragraph (a) of this section must submit a MCAN under subpart D of this part, if such person has knowledge at the time of commercial distribution of the microorganism identified in the specific section in subpart M of this part that a recipient intends to engage in a designated significant new use of that microorganism without submitting a MCAN under this part.
(c) A person who processes a microorganism identified in a specific section in subpart M of this part for a significant new use of that microorganism is not required to submit a MCAN if that person can document each of the following:
(1) That the person does not know the specific microorganism identity of the microorganism being processed, and
(2) That the person is processing the microorganism without knowledge that the microorganism is identified in subpart M of this part.
(d)(1) If at any time after commencing distribution in commerce of a microorganism identified in a specific section in subpart M of this part, a person who manufactures, imports, or processes a microorganism described in subpart M of this part and distributes it in commerce has knowledge that a recipient of the microorganism is engaging in a significant new use of that microorganism designated in that section without submitting a MCAN under this part, the person is required to cease supplying the microorganism to that recipient and to submit a MCAN for that microorganism and significant new use, unless the person is able to document each of the following:
(i) That the person has notified the recipient and EPA enforcement authorities (at the address in paragraph (d)(1)(iii) of this section), in writing within 15 working days of the time the person develops knowledge that the recipient is engaging in a significant new use, that the recipient is engaging in a significant new use without submitting a MCAN.
(ii) That, within 15 working days of notifying the recipient as described in paragraph (d)(1)(i) of this section, the person received from the recipient, in writing, a statement of assurance that the recipient is aware of the terms of the applicable section in subpart M of this part and will not engage in the significant new use.
(iii) That the person has promptly provided EPA enforcement authorities with a copy of the recipient's statement of assurance described in paragraph (d)(1)(ii) of this section. The copy must be sent to the Director, Office of Compliance (2221A), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
(2) If EPA notifies the manufacturer, importer, or processor that the recipient is engaging in a significant new use after providing the statement of assurance described in paragraph (d)(1)(ii) of this section and without submitting a MCAN under this part, the manufacturer, importer, or processor shall immediately cease distribution to that recipient until the manufacturer, importer, or processor or the recipient has submitted a MCAN under this part and the MCAN review period has ended.
(3) If, after receiving a statement of assurance from a recipient under paragraph (d)(1)(ii) of this section, a manufacturer, importer, or processor has knowledge that the recipient is engaging in a significant new use without submitting a MCAN under this part, the manufacturer, importer, or processor must immediately cease distributing the microorganism to that recipient and notify EPA enforcement authorities at the address identified in paragraph (d)(1)(iii) of this section. The manufacturer, importer, or processor may not resume distribution to that recipient until any one of the following has occurred:
(i) The manufacturer, importer, or processor has submitted a MCAN under this part and the MCAN review period has ended.
(ii) The recipient has submitted a MCAN under this part and the MCAN review period has ended.
(iii) The manufacturer, importer, or processor has received notice from EPA enforcement authorities that it may resume distribution to that recipient.
Persons identified in § 725.105(c) are not required to submit a MCAN under subpart D of this part for a microorganism identified in subpart M of this part, unless otherwise specified in a specific section in subpart M, if:
(a) The person submits a MCAN for the microorganism prior to the promulgation date of the section in subpart M of this part which identifies the microorganism, and the person receives written notification of compliance from EPA prior to the effective date of such section. The MCAN submitter must comply with any applicable requirement of section 5(b) of the Act. The MCAN must include the information and test data specified in section 5(d)(1) of the Act. For purposes of this exemption, the specific section in subpart M of this part which identifies the microorganism and §§ 725.3, 725.15, 725.65, 725.70, 725.75, 725.100, and 725.900 apply; after the effective date of the section in subpart M of this part which identifies the microorganism, §§ 725.105 and 725.910 apply and § 725.920 continues to apply. EPA will provide the MCAN submitter with written notification of compliance only if one of the following occurs:
(1) EPA is unable to make the finding that the activities described in the MCAN will or may present an unreasonable risk of injury to health or the environment under reasonably foreseeable circumstances, or
(2) EPA and the person negotiate a consent order under section 5(e) of the Act, such order to take effect on the effective date of the section in subpart M of this part which identifies the microorganism.
(b) The person is operating under the terms of a consent order issued under section 5(e) of the Act applicable to that person. If a provision of such section 5(e) order is inconsistent with a specific significant new use identified in subpart M of this part, abiding by the provision of the section 5(e) order exempts the person from submitting a MCAN for that specific significant new use.
(a)
(b)
Persons submitting a MCAN for a significant new use of a microorganism must comply with the recordkeeping requirements of § 725.65. In addition, the following requirements apply:
(a) At the time EPA adds a microorganism to subpart M of this part, EPA may specify appropriate recordkeeping requirements. Each manufacturer, importer, and processor of the microorganism shall maintain the records for 3 years from the date of their creation.
(b) The records required to be maintained under this section may include the following:
(1) Records documenting the information contained in the MCAN submitted to EPA.
(2) Records documenting the manufacture and importation volume of the microorganism and the corresponding dates of manufacture and import.
(3) Records documenting volumes of the microorganism purchased domestically by processors of the microorganism, names and addresses of suppliers and corresponding dates of purchase.
(4) Records documenting the names and addresses (including shipment destination address, if different) of all persons outside the site of manufacture or import to whom the manufacturer, importer, or processor directly sells or transfers the microorganism, the date of each sale or transfer, and the quantity of the microorganism sold or transferred on such date.
(a) In certain sections of subpart M of this part, significant new uses for the identified microorganisms are described as the failure to establish and implement programs providing for the use of either: specific measures to control worker exposure to or release of microorganisms which are identified in such sections, or alternative measures to control worker exposure or environmental release which EPA has determined provide substantially the same degree of protection as the specified control measures. Persons who manufacture, import, or process a microorganism identified in such sections and who intend to employ alternative measures to control worker exposure or environmental release must submit a request to EPA for a determination of equivalency before commencing manufacture, import, or processing involving the alternative control measures.
(b) A request for a determination of equivalency must be submitted in writing to the Office of Pollution Prevention and Toxics, Document Control Officer, 7407, 1200 Pennsylvania Ave., NW., Washington, DC 20460: ATTN: SNUR Equivalency Determination, and must contain:
(1) The name of the submitter.
(2) The specific identity of the microorganism.
(3) The citation for the specific section in subpart M of this part which pertains to the microorganism for which the request is being submitted.
(4) A detailed description of the activities involved.
(5) The specifications of the alternative worker exposure control measures or environmental release control measures.
(6) A detailed analysis explaining why such alternative control measures provide substantially the same degree of protection as the specific control measures identified in the specific section in subpart M of this part which pertains to the microorganism for which the request is being submitted.
(7) The data and information described in §§ 725.155 and 725.160. If such data and information have already been submitted to EPA's Office of Pollution Prevention and Toxics, the submitter need only document that it was previously submitted, to whom, and the date it was submitted.
(c) Requests for determinations of equivalency will be reviewed by EPA within 45 days. Determinations under this paragraph will be made by the Director, or a designee. Notice of the results of such determinations will be mailed to the submitter.
(d) If EPA notifies the submitter under paragraph (c) of this section that EPA has determined that the alternative control measures provide substantially the same degree of protection as the specified control measures
(a)
(2) If EPA determines that significant new use notifications requirements are not needed for a microorganism that is subject to a final order issued under section 5(e) of the Act, EPA will issue a notice in the
(b)
(2) Significant new use requirements and other specific requirements designated under this section will be listed in subpart M of this part. For each microorganism, subpart M of this part will identify:
(i) The microorganism name.
(ii) The activities designated as significant new uses.
(iii) Other specific requirements applicable to the microorganism, including recordkeeping requirements or any other requirements included in the final section 5(e) order.
(c)
(2)
(i) The microorganism identity or, if its specific identity is claimed confidential, an appropriate generic microorganism name and an accession number assigned by EPA.
(ii) The MCAN number.
(iii) A summary of EPA's findings under section 5(e)(1)(A) of the Act for the final order issued under section 5(e).
(iv) Designation of the significant new uses subject to, or proposed to be subject to, notification and any other applicable requirements.
(v) Any modification of subpart L of this part applicable to the specific microorganism and significant new uses.
(vi) If the
(3)
(ii) The
(iii) If EPA, having considered any timely comments submitted in response to the proposal, decides to establish notification requirements under this section, EPA will issue a final rule adding the microorganism to subpart M of this part and designating the significant new uses subject to notification.
(4)
(A) The significant new use rule will take effect on the date of publication.
(B) Persons will be given 30 days from the date of publication to submit comments.
(ii) Interim final rules issued under this section shall cease to be in effect 180 days after publication unless, within the 180-day period, EPA issues a final rule in the
(5)
(ii) If EPA, having considered any timely comments, decides to establish notification requirements under this section, EPA will issue a final rule adding the microorganism to subpart M of this part and designating the significant new uses subject to notification.
(d)
(2) If EPA receives adverse or critical significant comments following publication of a proposed or interim final rule, EPA will either withdraw the rule or issue a final rule addressing the comments received.
(a)
(1) Test data or other information obtained by EPA provide a reasonable basis for concluding that activities designated as significant new uses of the microorganism will not present an unreasonable risk of injury to health or the environment.
(2) EPA has promulgated a rule under section 4 or 6 of the Act, or EPA or another agency has taken action under another law, for the microorganism that eliminates the need for significant new use notification under section 5(a)(2) of the Act.
(3) EPA has received MCANs for some or all of the activities designated as significant new uses of the microorganism and, after reviewing such MCANs, concluded that there is no need to require additional notice from persons who propose to engage in identical or similar activities.
(4) EPA has examined new information, or has reexamined the test data or other information supporting its finding under section 5(e)(1)(A)(ii)(I) of the Act and has concluded that a rational basis no longer exists for the findings that activities involving the microorganism may present an unreasonable risk of injury to health or the environment required under section 5(e)(1)(A) of the Act.
(5) Certain activities involving the microorganism have been designated as significant new uses pending the completion of testing, and adequate test data developed in accordance with applicable procedures and criteria have been submitted to EPA.
(b)
(1) Any affected person may request modification or revocation of significant new use notification requirements for a microorganism that has been added to subpart M of this part using the procedures described in § 725.980 by writing to the Director, or a designee, and stating the basis for such request. The request must be accompanied by information sufficient to support the request. All requests should be sent to the TSCA Document Processing Center (7407), Room L-100, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTN: Request to amend SNUR.
(2) The Director, or a designee, will consider the request, make a determination whether to initiate rulemaking to modify the requirements, and notify the requester of that determination by certified letter. If the request is denied, the letter will explain why EPA has concluded that the significant new use notification requirements for that microorganism should remain in effect.
(3) If EPA concludes that significant new use notification requirements for a microorganism should be limited or revoked, EPA will propose the changes in a notice in the
This subpart identifies uses of microorganisms which EPA has determined to be significant new uses under the authority of section 5(a)(2) of the Toxic Substances Control Act.
(a)
(2) The significant new use is any use other than research and development in the degradation of chemicals via injection into subsurface groundwater.
(b) [Reserved]
15 U.S.C. 2605, 2607, 2681-2692 and 42 U.S.C. 4852d.
(a) This subpart identifies lead-based paint hazards.
(b) The standards for lead-based paint hazards apply to target housing and child-occupied facilities.
(c) Nothing in this subpart requires the owner of property(ies) subject to these standards to evaluate the property(ies) for the presence of lead-based paint hazards or take any action to control these conditions if one or more of them is identified.
The following definitions apply to part 745.
(a)
(1) Any lead-based paint on a friction surface that is subject to abrasion and where the lead dust levels on the nearest horizontal surface underneath the friction surface (e.g., the window sill, or floor) are equal to or greater than the dust-lead hazard levels identified in paragraph (b) of this section.
(2) Any damaged or otherwise deteriorated lead-based paint on an impact surface that is caused by impact from a related building component (such as a door knob that knocks into a wall or a door that knocks against its door frame.
(3) Any chewable lead-based painted surface on which there is evidence of teeth marks.
(4) Any other deteriorated lead-based paint in any residential building or child-occupied facility or on the exterior of any residential building or child-occupied facility.
(b)
(c)
(d)
(1) Two square feet of deteriorated lead-based paint per room or equivalent,
(2) Twenty square feet of deteriorated paint on the exterior building, or
(3) Ten percent of the total surface area of deteriorated paint on an interior or exterior type of component with a small surface area.
This subpart contains regulations developed under Title IV (15 U.S.C. 2681-2692) of the Toxic Substances Control Act and applies to all renovations of target housing performed for compensation. The purpose of this subpart is to require each person who performs a renovation of target housing for compensation to provide a lead hazard information pamphlet to the owner and occupant of such housing prior to commencing the renovation.
The requirements in this subpart shall take effect on June 1, 1999.
(a) Except as provided in paragraph (b) of this section, this subpart applies to all renovations of target housing performed for compensation.
(b) This subpart does not apply to renovation activities that are limited to the following:
(1) Minor repair and maintenance activities (including minor electrical work and plumbing) that disrupt 2 square feet or less of painted surface per component.
(2) Emergency renovation operations.
(3) Renovations in target housing in which a written determination has been made by an inspector (certified pursuant to either Federal regulations at § 745.226 or a State or Tribal certification program authorized pursuant to § 745.324) that the components affected by the renovation are free of paint or other surface coatings that contain lead equal to or in excess of 1.0 milligram per square centimeter or 0.5 percent by weight, where the renovator has obtained a copy of the determination.
For purposes of this part, the definitions in § 745.103 as well as the following definitions apply:
(a) Those who assert a confidentiality claim for submitted information must provide EPA with two copies of their submission. The first copy must be complete and contain all information being claimed as confidential. The second copy must contain only information not claimed as confidential. EPA will place the second copy of the submission in the public file.
(b) EPA will disclose information subject to a claim of confidentiality only to the extent permitted by section 14 of TSCA and 40 CFR part 2, subpart B. If a person does not assert a claim of confidentiality for information at the time it is submitted to EPA, EPA may make the information public without further notice to that person.
(a)
(1) Provide the owner of the unit with the pamphlet, and comply with one of the following:
(i) Obtain, from the owner, a written acknowledgment that the owner has received the pamphlet.
(ii) Obtain a certificate of mailing at least 7 days prior to the renovation.
(2) In addition to the requirements in paragraph (a)(1) of this section, if the owner does not occupy the dwelling unit, provide an adult occupant of the unit with the pamphlet, and comply with one of the following:
(i) Obtain, from the adult occupant, a written acknowledgment that the occupant has received the pamphlet; or certify in writing that a pamphlet has been delivered to the dwelling and that the renovator has been unsuccessful in obtaining a written acknowledgment from an adult occupant. Such certification must include the address of the unit undergoing renovation, the date and method of delivery of the pamphlet, names of the persons delivering the pamphlet, reason for lack of acknowledgment (e.g., occupant refuses to sign, no adult occupant available), the signature of the renovator, and the date of signature.
(ii) Obtain a certificate of mailing at least 7 days prior to the renovation.
(b)
(1) Provide the owner with the pamphlet, and comply with one of the following:
(i) Obtain, from the owner, a written acknowledgment that the owner has received the pamphlet.
(ii) Obtain a certificate of mailing at least 7 days prior to the renovation.
(2) Notify in writing, or ensure written notification of, each unit of the multi-family housing and make the pamphlet available upon request prior to the start of renovation. Such notification shall be accomplished by distributing written notice to each affected unit. The notice shall describe the general nature and locations of the planned renovation activities; the expected starting and ending dates; and a statement of how the occupant can obtain the pamphlet, at no charge, from the renovator.
(3) Prepare, sign, and date a statement describing the steps performed to notify all occupants of the intended renovation activities and to provide the pamphlet.
(4) If the scope, locations, or expected starting and ending dates of the planned renovation activities change after the initial notification, the renovator shall provide further written notification to the owners and occupants providing revised information on the ongoing or planned activities. This subsequent notification must be provided before the renovator initiates work beyond that which was described in the original notice.
(c)
(1) Include a statement recording the owner or occupant's name and acknowledging receipt of the pamphlet
(2) Be either a separate sheet or part of any written contract or service agreement for the renovation.
(3) Be written in the same language as the text of the contract or agreement for the renovation or, in the case of non-owner occupied target housing, in the same language as the lease or rental agreement or the pamphlet.
(a) Renovators shall retain and, if requested, make available to EPA all records necessary to demonstrate compliance with this subpart for a period of 3 years following completion of the renovation activities in target housing. This 3-year retention requirement does not supersede longer obligations required by other provisions for retaining the same documentation, including any applicable State or Tribal laws or regulations.
(b) Records that must be retained pursuant to paragraph (a) of this section shall include (where applicable):
(1) Reports certifying that a determination had been made by an inspector (certified pursuant to either Federal regulations at § 745.226 or an EPA-authorized State or Tribal certification program) that lead-based paint is not present in the area affected by the renovation, as described in § 745.82(b)(vi).
(2) Signed and dated acknowledgments of receipt as described in § 745.85(a)(1)(i), (a)(2)(i), and (b)(1)(i).
(3) Certifications of attempted delivery as described in § 745.85(a)(2)(i).
(4) Certificates of mailing as described in § 745.85(a)(1)(ii), (a)(2)(ii), and (b)(1)(ii).
(5) Records of notification activities performed regarding common area renovations, as described in § 745.85(b) (3) and (4).
(a) Failure or refusal to comply with any provision of this subpart is a violation of TSCA section 409 (15 U.S.C. 2689).
(b) Failure or refusal to establish and maintain records or to make available or permit access to or copying of records, as required by this subpart, is a violation of TSCA sections 15 and 409 (15 U.S.C. 2614 and 2689).
(c) Failure or refusal to permit entry or inspection as required by 40 CFR 745.87 and TSCA section 11 (15 U.S.C. 2610) is a violation of sections 15 and 409 (15 U.S.C. 2614 and 2689).
(d) Violators may be subject to civil and criminal sanctions pursuant to TSCA section 16 (15 U.S.C. 2615) for each violation.
(e) EPA may conduct inspections and issue subpoenas pursuant to the provisions of TSCA section 11 (15 U.S.C. 2610) to ensure compliance with this subpart.
(a)(1)
(2)
(b)(1)
(2)
(i)
I certify that I have made a good faith effort to deliver the pamphlet,
(ii)
I certify that I have made a good faith effort to deliver the pamphlet,
This subpart implements the provisions of 42 U.S.C. 4852d, which impose certain requirements on the sale or lease of target housing. Under this subpart, a seller or lessor of target housing shall disclose to the purchaser or lessee the presence of any known lead-based paint and/or lead-based paint hazards; provide available records and reports; provide the purchaser or lessee with a lead hazard information pamphlet; give purchasers a 10-day opportunity to conduct a risk assessment or inspection; and attach specific disclosure and warning language to the sales or leasing contract before the purchaser or lessee is obligated under a contract to purchase or lease target housing.
This subpart applies to all transactions to sell or lease target housing, including subleases, with the exception of the following:
(a) Sales of target housing at foreclosure.
(b) Leases of target housing that have been found to be lead-based paint free by an inspector certified under the Federal certification program or under a federally accredited State or tribal certification program. Until a Federal certification program or federally accredited State certification program is in place within the State, inspectors shall be considered qualified to conduct an inspection for this purpose if they have received certification under any existing State or tribal inspector certification program. The lessor has the option of using the results of additional test(s) by a certified inspector to confirm or refute a prior finding.
(c) Short-term leases of 100 days or less, where no lease renewal or extension can occur.
(d) Renewals of existing leases in target housing in which the lessor has previously disclosed all information required under § 745.107 and where no new information described in § 745.107 has come into the possession of the lessor. For the purposes of this paragraph, renewal shall include both renegotiation of existing lease terms and/or ratification of a new lease.
The requirements in this subpart take effect in the following manner:
(a) For owners of more than four residential dwellings, the requirements shall take effect on September 6, 1996.
(b) For owners of one to four residential dwellings, the requirements shall take effect on December 6, 1996.
The following definitions apply to this subpart.
(1) A surface-by-surface investigation to determine the presence of lead-based paint as provided in section 302(c) of the Lead-Based Paint Poisoning and Prevention Act [42 U.S.C. 4822], and
(2) The provision of a report explaining the results of the investigation.
(1) A single-family dwelling, including attached structures such as porches and stoops; or
(2) A single-family dwelling unit in a structure that contains more than one separate residential dwelling unit, and in which each such unit is used or occupied, or intended to be used or occupied, in whole or in part, as the residence of one or more persons.
(1) Information gathering regarding the age and history of the housing and occupancy by children under age 6;
(2) Visual inspection;
(3) Limited wipe sampling or other environmental sampling techniques;
(4) Other activity as may be appropriate; and
(5) Provision of a report explaining the results of the investigation.
(1) An entity that transfers shares in a cooperatively owned project, in return for consideration; and
(2) An entity that transfers its interest in a leasehold, in jurisdictions or circumstances where it is legally permissible to separate the fee title from the title to the improvement, in return for consideration.
(a) The following activities shall be completed before the purchaser or lessee is obligated under any contract to purchase or lease target housing that is not otherwise an exempt transaction pursuant to § 745.101. Nothing in this section implies a positive obligation on the seller or lessor to conduct any evaluation or reduction activities.
(1) The seller or lessor shall provide the purchaser or lessee with an EPA-approved lead hazard information pamphlet. Such pamphlets include the EPA document entitled
(2) The seller or lessor shall disclose to the purchaser or lessee the presence of any known lead-based paint and/or lead-based paint hazards in the target housing being sold or leased. The seller or lessor shall also disclose any additional information available concerning the known lead-based paint and/or lead-based paint hazards, such as the basis for the determination that lead-based paint and/or lead-based paint hazards exist, the location of the lead-based paint and/or lead-based paint hazards, and the condition of the painted surfaces.
(3) The seller or lessor shall disclose to each agent the presence of any known lead-based paint and/or lead-based paint hazards in the target housing being sold or leased and the existence of any available records or reports pertaining to lead-based paint and/or lead-based paint hazards. The seller or lessor shall also disclose any additional information available concerning the known lead-based paint and/or lead-based paint hazards, such as the basis
(4) The seller or lessor shall provide the purchaser or lessee with any records or reports available to the seller or lessor pertaining to lead-based paint and/or lead-based paint hazards in the target housing being sold or leased. This requirement includes records or reports regarding common areas. This requirement also includes records or reports regarding other residential dwellings in multifamily target housing, provided that such information is part of an evaluation or reduction of lead-based paint and/or lead-based paint hazards in the target housing as a whole.
(b) If any of the disclosure activities identified in paragraph (a) of this section occurs after the purchaser or lessee has provided an offer to purchase or lease the housing, the seller or lessor shall complete the required disclosure activities prior to accepting the purchaser's or lessee's offer and allow the purchaser or lessee an opportunity to review the information and possibly amend the offer.
(a) Before a purchaser is obligated under any contract to purchase target housing, the seller shall permit the purchaser a 10-day period (unless the parties mutually agree, in writing, upon a different period of time) to conduct a risk assessment or inspection for the presence of lead-based paint and/or lead-based paint hazards.
(b) Not withstanding paragraph (a) of this section, a purchaser may waive the opportunity to conduct the risk assessment or inspection by so indicating in writing.
(a)
(1) A Lead Warning Statement consisting of the following language:
Every purchaser of any interest in residential real property on which a residential dwelling was built prior to 1978 is notified that such property may present exposure to lead from lead-based paint that may place young children at risk of developing lead poisoning. Lead poisoning in young children may produce permanent neurological damage, including learning disabilities, reduced intelligence quotient, behavioral problems, and impaired memory. Lead poisoning also poses a particular risk to pregnant women. The seller of any interest in residential real property is required to provide the buyer with any information on lead-based paint hazards from risk assessments or inspections in the seller's possession and notify the buyer of any known lead-based paint hazards. A risk assessment or inspection for possible lead-based paint hazards is recommended prior to purchase.
(2) A statement by the seller disclosing the presence of known lead-based paint and/or lead-based paint hazards in the target housing being sold or indicating no knowledge of the presence of lead-based paint and/or lead-based paint hazards. The seller shall also provide any additional information available concerning the known lead-based paint and/or lead-based paint hazards, such as the basis for the determination that lead-based paint and/or lead-based paint hazards exist, the location of the lead-based paint and/or lead-based paint hazards, and the condition of the painted surfaces.
(3) A list of any records or reports available to the seller pertaining to lead-based paint and/or lead-based paint hazards in the housing that have been provided to the purchaser. If no such records or reports are available, the seller shall so indicate.
(4) A statement by the purchaser affirming receipt of the information set out in paragraphs (a)(2) and (a)(3) of this section and the lead hazard information pamphlet required under 15 U.S.C. 2696.
(5) A statement by the purchaser that he/she has either:
(i) Received the opportunity to conduct the risk assessment or inspection required by § 745.110(a); or
(ii) Waived the opportunity.
(6) When one or more agents are involved in the transaction to sell target
(i) The agent has informed the seller of the seller's obligations under 42 U.S.C. 4852d; and
(ii) The agent is aware of his/her duty to ensure compliance with the requirements of this subpart.
(7) The signatures of the sellers, agents, and purchasers certifying to the accuracy of their statements to the best of their knowledge, along with the dates of signature.
(b)
(1) A Lead Warning Statement with the following language:
Housing built before 1978 may contain lead-based paint. Lead from paint, paint chips, and dust can pose health hazards if not managed properly. Lead exposure is especially harmful to young children and pregnant women. Before renting pre-1978 housing, lessors must disclose the presence of lead-based paint and/or lead-based paint hazards in the dwelling. Lessees must also receive a federally approved pamphlet on lead poisoning prevention.
(2) A statement by the lessor disclosing the presence of known lead-based paint and/or lead-based paint hazards in the target housing being leased or indicating no knowledge of the presence of lead-based paint and/or lead-based paint hazards. The lessor shall also disclose any additional information available concerning the known lead-based paint and/or lead-based paint hazards, such as the basis for the determination that lead-based paint and/or lead-based paint hazards exist, the location of the lead-based paint and/or lead-based paint hazards, and the condition of the painted surfaces.
(3) A list of any records or reports available to the lessor pertaining to lead-based paint and/or lead-based paint hazards in the housing that have been provided to the lessee. If no such records or reports are available, the lessor shall so indicate.
(4) A statement by the lessee affirming receipt of the information set out in paragraphs (b)(2) and (b)(3) of this section and the lead hazard information pamphlet required under 15 U.S.C. 2696.
(5) When one or more agents are involved in the transaction to lease target housing on behalf of the lessor, a statement that:
(i) The agent has informed the lessor of the lessor as obligations under 42 U.S.C. 4852d; and
(ii) The agent is aware of his/her duty to ensure compliance with the requirements of this subpart.
(6) The signatures of the lessors, agents, and lessees, certifying to the accuracy of their statements, to the best of their knowledge, along with the dates of signature.
(c)
(1) The seller, and any agent, shall retain a copy of the completed attachment required under paragraph (a) of this section for no less than 3 years from the completion date of the sale. The lessor, and any agent, shall retain a copy of the completed attachment or lease contract containing the information required under paragraph (b) of this section for no less than 3 years from the commencement of the leasing period.
(2) This recordkeeping requirement is not intended to place any limitations on civil suits under the Act, or to otherwise affect a lessee's or purchaser's rights under the civil penalty provisions of 42 U.S.C. 4852d(b)(3).
(d) The seller, lessor, or agent shall not be responsible for the failure of a purchaser's or lessee's legal representative (where such representative receives all compensation from the purchaser or lessee) to transmit disclosure materials to the purchaser or lessee, provided that all required parties have completed and signed the necessary certification and acknowledgment language required under paragraphs (a) and (b) of this section.
(a) Each agent shall ensure compliance with all requirements of this subpart. To ensure compliance, the agent shall:
(1) Inform the seller or lessor of his/her obligations under §§745.107, 745.110, and 745.113.
(2) Ensure that the seller or lessor has performed all activities required under §§ 745.107, 745.110, and 745.113, or personally ensure compliance with the requirements of §§ 745.107, 745.110, and 745.113.
(b) If the agent has complied with paragraph (a)(1) of this section, the agent shall not be liable for the failure to disclose to a purchaser or lessee the presence of lead-based paint and/or lead-based paint hazards known by a seller or lessor but not disclosed to the agent.
(a) Any person who knowingly fails to comply with any provision of this subpart shall be subject to civil monetary penalties in accordance with the provisions of 42 U.S.C. 3545 and 24 CFR part 30.
(b) The Secretary is authorized to take such action as may be necessary to enjoin any violation of this subpart in the appropriate Federal district court.
(c) Any person who knowingly violates the provisions of this subpart shall be jointly and severally liable to the purchaser or lessee in an amount equal to 3 times the amount of damages incurred by such individual.
(d) In any civil action brought for damages pursuant to 42 U.S.C. 4852d(b)(3), the appropriate court may award court costs to the party commencing such action, together with reasonable attorney fees and any expert witness fees, if that party prevails.
(e) Failure or refusal to comply with § 745.107 (disclosure requirements for sellers and lessors), § 745.110 (opportunity to conduct an evaluation), § 745.113 (certification and acknowledgment of disclosure), or § 745.115 (agent responsibilities) is a violation of 42 U.S.C. 4852d(b)(5) and of TSCA section 409 (15 U.S.C. 2689).
(f) Violators may be subject to civil and criminal sanctions pursuant to TSCA section 16 (15 U.S.C. 2615) for each violation. For purposes of enforcing this subpart, the penalty for each violation applicable under 15 U.S.C. 2615 shall not be more than $11,000 for all violations occuring after July 28, 1997; all violations occuring on or prior to that date are subject to a penalty not more than $10,000.
Nothing in this subpart shall relieve a seller, lessor, or agent from any responsibility for compliance with State or local laws, ordinances, codes, or regulations governing notice or disclosure of known lead-based paint or lead-based paint hazards. Neither HUD nor EPA assumes any responsibility for ensuring compliance with such State or local requirements.
(a) This subpart contains procedures and requirements for the accreditation of lead-based paint activities training programs, procedures and requirements for the certification of individuals and firms engaged in lead-based paint activities, and work practice standards for performing such activities. This subpart also requires that, except as discussed below, all lead-based paint activities, as defined in this subpart, be performed by certified individuals and firms.
(b) This subpart applies to all individuals and firms who are engaged in lead-based paint activities as defined in § 745.223, except persons who perform these activities within residential dwellings that they own, unless the residential dwelling is occupied by a person or persons other than the owner or the owner's immediate family while these activities are being performed, or a child residing in the building has been identified as having an elevated blood lead level. This subpart applies only in those States or Indian Country that do not have an authorized State or Tribal program pursuant to § 745.324 of subpart Q.
(c) Each department, agency, and instrumentality of the executive, legislative, and judicial branches of the Federal Government having jurisdiction over any property or facility, or engaged in any activity resulting, or which may result, in a lead-based paint hazard, and each officer, agent, or employee thereof shall be subject to, and comply with, all Federal, State, interstate, and local requirements, both substantive and procedural, including the requirements of this subpart regarding lead-based paint, lead-based paint activities, and lead-based paint hazards.
(d) While this subpart establishes specific requirements for performing lead-based paint activities should they be undertaken, nothing in this subpart requires that the owner or occupant undertake any particular lead-based paint activity.
The definitions in subpart A apply to this subpart. In addition, the following definitions apply.
(1) The removal of paint and dust, the permanent enclosure or encapsulation of lead-based paint, the replacement of painted surfaces or fixtures, or the removal or permanent covering of soil, when lead-based paint hazards are present in such paint, dust or soil; and
(2) All preparation, cleanup, disposal, and post-abatement clearance testing activities associated with such measures.
(3) Specifically, abatement includes, but is not limited to:
(i) Projects for which there is a written contract or other documentation, which provides that an individual or firm will be conducting activities in or to a residential dwelling or child-occupied facility that:
(A) Shall result in the permanent elimination of lead-based paint hazards; or
(B) Are designed to permanently eliminate lead-based paint hazards and are described in paragraphs (1) and (2) of this definition.
(ii) Projects resulting in the permanent elimination of lead-based paint hazards, conducted by firms or individuals certified in accordance with § 745.226, unless such projects are covered by paragraph (4) of this definition;
(iii) Projects resulting in the permanent elimination of lead-based paint hazards, conducted by firms or individuals who, through their company name or promotional literature, represent, advertise, or hold themselves out to be in the business of performing lead-based paint activities as identified and defined by this section, unless such projects are covered by paragraph (4) of this definition; or
(iv) Projects resulting in the permanent elimination of lead-based paint hazards, that are conducted in response to State or local abatement orders.
(4) Abatement does not include renovation, remodeling, landscaping or other activities, when such activities are not designed to permanently eliminate lead-based paint hazards, but, instead, are designed to repair, restore, or remodel a given structure or dwelling, even though these activities may incidentally result in a reduction or elimination of lead-based paint hazards. Furthermore, abatement does not include interim controls, operations and maintenance activities, or other measures and activities designed to temporarily, but not permanently, reduce lead-based paint hazards.
(a)
(2) Training programs may first apply to EPA for accreditation of their lead-based paint activities courses or refresher courses pursuant to this section on or after August 31, 1998.
(3) A training program shall not provide, offer, or claim to provide EPA-accredited lead-based paint activities courses without applying for and receiving accreditation from EPA as required under paragraph (b) of this section on or after March 1, 1999.
(b)
(1) A training program seeking accreditation shall submit a written application to EPA containing the following information:
(i) The training program's name, address, and telephone number.
(ii) A list of courses for which it is applying for accreditation.
(iii) A statement signed by the training program manager certifying that the training program meets the requirements established in paragraph (c) of this section. If a training program uses EPA-recommended model training materials, or training materials approved by a State or Indian Tribe that has been authorized by EPA under subpart Q of this part, the training program manager shall include a statement certifying that, as well.
(iv) If a training program does not use EPA-recommended model training materials or training materials approved by an authorized State or Indian Tribe, its application for accreditation shall also include:
(A) A copy of the student and instructor manuals, or other materials to be used for each course.
(B) A copy of the course agenda for each course.
(v) All training programs shall include in their application for accreditation the following:
(A) A description of the facilities and equipment to be used for lecture and hands-on training.
(B) A copy of the course test blueprint for each course.
(C) A description of the activities and procedures that will be used for conducting the assessment of hands-on skills for each course.
(D) A copy of the quality control plan as described in paragraph (c)(9) of this section.
(2) If a training program meets the requirements in paragraph (c) of this section, then EPA shall approve the application for accreditation no more than 180 days after receiving a complete application from the training program. In the case of approval, a certificate of accreditation shall be sent to the applicant. In the case of disapproval, a letter describing the reasons for disapproval shall be sent to the applicant. Prior to disapproval, EPA may, at its discretion, work with the applicant to address inadequacies in the application for accreditation. EPA may also request additional materials retained by the training program under paragraph (i) of this section. If a
(3) A training program may apply for accreditation to offer courses or refresher courses in as many disciplines as it chooses. A training program may seek accreditation for additional courses at any time as long as the program can demonstrate that it meets the requirements of this section.
(4) A training program applying for accreditation must submit the appropriate fees in accordance with § 745.238.
(c)
(1) The training program shall employ a training manager who has:
(i) At least 2 years of experience, education, or training in teaching workers or adults; or
(ii) A bachelor's or graduate degree in building construction technology, engineering, industrial hygiene, safety, public health, education, business administration or program management or a related field; or
(iii) Two years of experience in managing a training program specializing in environmental hazards; and
(iv) Demonstrated experience, education, or training in the construction industry including: lead or asbestos abatement, painting, carpentry, renovation, remodeling, occupational safety and health, or industrial hygiene.
(2) The training manager shall designate a qualified principal instructor for each course who has:
(i) Demonstrated experience, education, or training in teaching workers or adults; and
(ii) Successfully completed at least 16 hours of any EPA-accredited or EPA-authorized State or Tribal-accredited lead-specific training; and
(iii) Demonstrated experience, education, or training in lead or asbestos abatement, painting, carpentry, renovation, remodeling, occupational safety and health, or industrial hygiene.
(3) The principal instructor shall be responsible for the organization of the course and oversight of the teaching of all course material. The training manager may designate guest instructors as needed to provide instruction specific to the lecture, hands-on activities, or work practice components of a course.
(4) The following documents shall be recognized by EPA as evidence that training managers and principal instructors have the education, work experience, training requirements or demonstrated experience, specifically listed in paragraphs (c)(1) and (c)(2) of this section. This documentation need not be submitted with the accreditation application, but, if not submitted, shall be retained by the training program as required by the recordkeeping requirements contained in paragraph (i) of this section. Those documents include the following:
(i) Official academic transcripts or diploma as evidence of meeting the education requirements.
(ii) Resumes, letters of reference, or documentation of work experience, as evidence of meeting the work experience requirements.
(iii) Certificates from train-the-trainer courses and lead-specific training courses, as evidence of meeting the training requirements.
(5) The training program shall ensure the availability of, and provide adequate facilities for, the delivery of the lecture, course test, hands-on training, and assessment activities. This includes providing training equipment that reflects current work practices and maintaining or updating the equipment and facilities as needed.
(6) To become accredited in the following disciplines, the training program shall provide training courses that meet the following training hour requirements:
(i) The inspector course shall last a minimum of 24 training hours, with a minimum of 8 hours devoted to hands-on training activities. The minimum curriculum requirements for the inspector course are contained in paragraph (d)(1) of this section.
(ii) The risk assessor course shall last a minimum of 16 training hours, with a minimum of 4 hours devoted to hands-on training activities. The minimum curriculum requirements for the risk assessor course are contained in paragraph (d)(2) of this section.
(iii) The supervisor course shall last a minimum of 32 training hours, with a minimum of 8 hours devoted to hands-on activities. The minimum curriculum requirements for the supervisor course are contained in paragraph (d)(3) of this section.
(iv) The project designer course shall last a minimum of 8 training hours. The minimum curriculum requirements for the project designer course are contained in paragraph (d)(4) of this section.
(v) The abatement worker course shall last a minimum of 16 training hours, with a minimum of 8 hours devoted to hands-on training activities. The minimum curriculum requirements for the abatement worker course are contained in paragraph (d)(5) of this section.
(7) For each course offered, the training program shall conduct either a course test at the completion of the course, and if applicable, a hands-on skills assessment, or in the alternative, a proficiency test for that discipline. Each individual must successfully complete the hands-on skills assessment and receive a passing score on the course test to pass any course, or successfully complete a proficiency test.
(i) The training manager is responsible for maintaining the validity and integrity of the hands-on skills assessment or profiency test to ensure that it accurately evaluates the trainees' performance of the work practices and procedures associated with the course topics contained in paragraph (d) of this section.
(ii) The training manager is responsible for maintaining the validity and integrity of the course test to ensure that it accurately evaluates the trainees' knowledge and retention of the course topics.
(iii) The course test shall be developed in accordance with the test blueprint submitted with the training accreditation application.
(8) The training program shall issue unique course completion certificates to each individual who passes the training course. The course completion certificate shall include:
(i) The name, a unique identification number, and address of the individual.
(ii) The name of the particular course that the individual completed.
(iii) Dates of course completion/test passage.
(iv) Expiration date of interim certification, which shall be 6 months from the date of course completion.
(v) The name, address, and telephone number of the training program.
(9) The training manager shall develop and implement a quality control plan. The plan shall be used to maintain and improve the quality of the training program over time. This plan shall contain at least the following elements:
(i) Procedures for periodic revision of training materials and the course test to reflect innovations in the field.
(ii) Procedures for the training manager's annual review of principal instructor competency.
(10) The training program shall offer courses which teach the work practice standards for conducting lead-based paint activities contained in § 745.227, and other standards developed by EPA pursuant to Title IV of TSCA. These standards shall be taught in the appropriate courses to provide trainees with the knowledge needed to perform the lead-based paint activities they are responsible for conducting.
(11) The training manager shall be responsible for ensuring that the training program complies at all times with all of the requirements in this section.
(12) The training manager shall allow EPA to audit the training program to verify the contents of the application for accreditation as described in paragraph (b) of this section.
(13) The training manager must provide notification of lead-based paint activities courses offered.
(i) The training manager must provide EPA with notification of all lead-based paint activities courses offered. The original notification must be received by EPA at least 7 business days prior to the start date of any lead-based paint activities course.
(ii) The training manager must provide EPA updated notification when lead-based paint activities courses will begin on a date other than the start date specified in the original notification, as follows:
(A) For lead-based paint activities courses beginning prior to the start date provided to EPA, an updated notification must be received by EPA at least 7 business days before the new start date.
(B) For lead-based paint activities courses beginning after the start date provided to EPA, an updated notification must be received by EPA at least 2 business days before the start date provided to EPA.
(iii) The training manager must update EPA of any change in location of lead-based paint activities courses at least 7 business days prior to the start date provided to EPA.
(iv) The training manager must update EPA regarding any course cancellations, or any other change to the original notification. Updated notifications must be received by EPA at least 2 business days prior to the start date provided to EPA.
(v) Each notification, including updates, must include the following:
(A) Notification type (original, update, cancellation).
(B) Training program name, EPA accreditation number, address, and telephone number.
(C) Course discipline, type (initial/ refresher), and the language in which instruction will be given.
(D) Date(s) and time(s) of training.
(E) Training location(s) telephone number, and address.
(F) Principal instructor's name.
(G) Training manager's name and signature.
(vi) Notification must be accomplished using any of the following methods: Written notification, or electronically using the Agency's Central Data Exchange (CDX). Written notification of lead-based paint activities course schedules can be accomplished by using either the sample form titled “Lead-Based Paint Activities Training Course Schedule” or a similar form containing the information required in paragraph (c)(13)(v) of this section. All written notifications must be delivered by U.S. Postal Service, fax, commercial delivery service, or hand delivery (persons submitting notification by U.S. Postal Service are reminded that they should allow 3 additional business days for delivery in order to ensure that EPA receives the notification by the required date). Instructions and sample forms can be obtained from the NLIC at 1-800-424-LEAD(5323), or on the Internet at
(vii) Lead-based paint activities courses must not begin on a date, or at a location other than that specified in the original notification unless an updated notification identifying a new start date or location is submitted, in which case the course must begin on the new start date and/or location specified in the updated notification.
(viii) No training program shall provide lead-based paint activities courses without first notifying EPA of such activities in accordance with the requirements of this paragraph.
(14) The training manager must provide notification following completion of lead-based paint activities courses.
(i) The training manager must provide EPA notification after the completion of any lead-based paint activities course. This notice must be received by EPA no later than 10 business days following course completion.
(ii) The notification must include the following:
(A) Training program name, EPA accreditation number, address, and telephone number.
(B) Course discipline and type (initial/refresher).
(C) Date(s) of training.
(D) The following information for each student who took the course:
(
(
(
(
(
(E) Training manager's name and signature.
(iii) Notification must be accomplished using any of the following methods: Written notification, or electronically using the Agency's Central Data Exchange (CDX). Written notification following lead-based paint activities training courses can be accomplished by using either the sample form titled “Lead-Based Paint Activities Training Course Follow-up” or a similar form containing the information required in paragraph (c)(14)(ii) of this section. All written notifications must
(d)
(1)
(ii) Background information on lead and its adverse health effects.
(iii) Background information on Federal, State, and local regulations and guidance that pertains to lead-based paint and lead-based paint activities.
(iv) Lead-based paint inspection methods, including selection of rooms and components for sampling or testing.*
(v) Paint, dust, and soil sampling methodologies.*
(vi) Clearance standards and testing, including random sampling.*
(vii) Preparation of the final inspection report.*
(viii) Recordkeeping.
(2)
(ii) Collection of background information to perform a risk assessment.
(iii) Sources of environmental lead contamination such as paint, surface dust and soil, water, air, packaging, and food.
(iv) Visual inspection for the purposes of identifying potential sources of lead-based paint hazards.*
(v) Lead hazard screen protocol.
(vi) Sampling for other sources of lead exposure.*
(vii) Interpretation of lead-based paint and other lead sampling results, including all applicable State or Federal guidance or regulations pertaining to lead-based paint hazards.*
(viii) Development of hazard control options, the role of interim controls, and operations and maintenance activities to reduce lead-based paint hazards.
(ix) Preparation of a final risk assessment report.
(3)
(ii) Background information on lead and its adverse health effects.
(iii) Background information on Federal, State, and local regulations and guidance that pertain to lead-based paint abatement.
(iv) Liability and insurance issues relating to lead-based paint abatement.
(v) Risk assessment and inspection report interpretation.*
(vi) Development and implementation of an occupant protection plan and abatement report.
(vii) Lead-based paint hazard recognition and control.*
(viii) Lead-based paint abatement and lead-based paint hazard reduction methods, including restricted practices.*
(ix) Interior dust abatement/cleanup or lead-based paint hazard control and reduction methods.*
(x) Soil and exterior dust abatement or lead-based paint hazard control and reduction methods.*
(xi) Clearance standards and testing.
(xii) Cleanup and waste disposal.
(xiii) Recordkeeping.
(4)
(ii) Development and implementation of an occupant protection plan for large scale abatement projects.
(iii) Lead-based paint abatement and lead-based paint hazard reduction methods, including restricted practices for large-scale abatement projects.
(iv) Interior dust abatement/cleanup or lead hazard control and reduction methods for large-scale abatement projects.
(v) Clearance standards and testing for large scale abatement projects.
(vi) Integration of lead-based paint abatement methods with modernization and rehabilitation projects for large scale abatement projects.
(5)
(ii) Background information on lead and its adverse health effects.
(iii) Background information on Federal, State and local regulations and guidance that pertain to lead-based paint abatement.
(iv) Lead-based paint hazard recognition and control.*
(v) Lead-based paint abatement and lead-based paint hazard reduction methods, including restricted practices.*
(vi) Interior dust abatement methods/cleanup or lead-based paint hazard reduction.*
(vii) Soil and exterior dust abatement methods or lead-based paint hazard reduction.*
(e)
(1) Each refresher course shall review the curriculum topics of the full-length courses listed under paragraph (d) of this section, as appropriate. In addition, to become accredited to offer refresher training courses, training programs shall ensure that their courses of study include, at a minimum, the following:
(i) An overview of current safety practices relating to lead-based paint activities in general, as well as specific information pertaining to the appropriate discipline.
(ii) Current laws and regulations relating to lead-based paint activities in general, as well as specific information pertaining to the appropriate discipline.
(iii) Current technologies relating to lead-based paint activities in general, as well as specific information pertaining to the appropriate discipline.
(2) Each refresher course, except for the project designer course, shall last a minimum of 8 training hours. The project designer refresher course shall last a minimum of 4 training hours.
(3) For each course offered, the training program shall conduct a hands-on assessment (if applicable), and at the completion of the course, a course test.
(4) A training program may apply for accreditation of a refresher course concurrently with its application for accreditation of the corresponding training course as described in paragraph (b) of this section. If so, EPA shall use the approval procedure described in paragraph (b) of this section. In addition, the minimum requirements contained in paragraphs (c) (except for the requirements in paragraph (c)(6)), and (e)(1), (e)(2) and (e)(3) of this section shall also apply.
(5) A training program seeking accreditation to offer refresher training courses only shall submit a written application to EPA containing the following information:
(i) The refresher training program's name, address, and telephone number.
(ii) A list of courses for which it is applying for accreditation.
(iii) A statement signed by the training program manager certifying that the refresher training program meets the minimum requirements established in paragraph (c) of this section, except for the requirements in paragraph (c)(6) of this section. If a training program uses EPA-developed model training materials, or training materials approved by a State or Indian Tribe that has been authorized by EPA under § 745.324 to develop its refresher training course materials, the training manager shall include a statement certifying that, as well.
(iv) If the refresher training course materials are not based on EPA-developed model training materials or training materials approved by an authorized State or Indian Tribe, the training program's application for accreditation shall include:
(A) A copy of the student and instructor manuals to be used for each course.
(B) A copy of the course agenda for each course.
(v) All refresher training programs shall include in their application for accreditation the following:
(A) A description of the facilities and equipment to be used for lecture and hands-on training.
(B) A copy of the course test blueprint for each course.
(C) A description of the activities and procedures that will be used for conducting the assessment of hands-on skills for each course (if applicable).
(D) A copy of the quality control plan as described in paragraph (c)(9) of this section.
(vi) The requirements in paragraphs (c)(1) through (c)(5), and (c)(7) through (c)(14) of this section apply to refresher training providers.
(vii) If a refresher training program meets the requirements listed in this paragraph, then EPA shall approve the application for accreditation no more than 180 days after receiving a complete application from the refresher training program. In the case of approval, a certificate of accreditation shall be sent to the applicant. In the case of disapproval, a letter describing the reasons for disapproval shall be sent to the applicant. Prior to disapproval, EPA may, at its discretion, work with the applicant to address inadequacies in the application for accreditation. EPA may also request additional materials retained by the refresher training program under paragraph (i) of this section. If a refresher training program's application is disapproved, the program may reapply for accreditation at any time.
(f)
(2) A training program seeking re-accreditation shall submit an application to EPA no later than 180 days before its accreditation expires. If a training program does not submit its application for re-accreditation by that date, EPA cannot guarantee that the program will be re-accredited before the end of the accreditation period.
(3) The training program's application for re-accreditation shall contain:
(i) The training program's name, address, and telephone number.
(ii) A list of courses for which it is applying for re-accreditation.
(iii) A description of any changes to the training facility, equipment or course materials since its last application was approved that adversely affects the students ability to learn.
(iv) A statement signed by the program manager stating:
(A) That the training program complies at all times with all requirements in paragraphs (c) and (e) of this section, as applicable; and
(B) The recordkeeping and reporting requirements of paragraph (i) of this section shall be followed.
(v) A payment of appropriate fees in accordance with § 745.238.
(4) Upon request, the training program shall allow EPA to audit the training program to verify the contents of the application for re-accreditation as described in paragraph (f)(3) of this section.
(g)
(i) Misrepresented the contents of a training course to EPA and/or the student population.
(ii) Failed to submit required information or notifications in a timely manner.
(iii) Failed to maintain required records.
(iv) Falsified accreditation records, instructor qualifications, or other accreditation-related information or documentation.
(v) Failed to comply with the training standards and requirements in this section.
(vi) Failed to comply with Federal, State, or local lead-based paint statutes or regulations.
(vii) Made false or misleading statements to EPA in its application for accreditation or re-accreditation which EPA relied upon in approving the application.
(2) In addition to an administrative or judicial finding of violation, execution of a consent agreement in settlement of an enforcement action constitutes, for purposes of this section,
(h)
(i) The legal and factual basis for the suspension, revocation, or modification.
(ii) The anticipated commencement date and duration of the suspension, revocation, or modification.
(iii) Actions, if any, which the affected entity may take to avoid suspension, revocation, or modification, or to receive accreditation in the future.
(iv) The opportunity and method for requesting a hearing prior to final EPA action to suspend, revoke or modify accreditation.
(v) Any additional information, as appropriate, which EPA may provide.
(2) If a hearing is requested by the accredited training program, EPA shall:
(i) Provide the affected entity an opportunity to offer written statements in response to EPA's assertions of the legal and factual basis for its proposed action, and any other explanations, comments, and arguments it deems relevant to the proposed action.
(ii) Provide the affected entity such other procedural opportunities as EPA may deem appropriate to ensure a fair and impartial hearing.
(iii) Appoint an official of EPA as Presiding Officer to conduct the hearing. No person shall serve as Presiding Officer if he or she has had any prior connection with the specific matter.
(3) The Presiding Officer appointed pursuant to paragraph (h)(2) of this section shall:
(i) Conduct a fair, orderly, and impartial hearing within 90 days of the request for a hearing.
(ii) Consider all relevant evidence, explanation, comment, and argument submitted.
(iii) Notify the affected entity in writing within 90 days of completion of the hearing of his or her decision and order. Such an order is a final agency action which may be subject to judicial review.
(4) If EPA determines that the public health, interest, or welfare warrants immediate action to suspend the accreditation of any training program prior to the opportunity for a hearing, it shall:
(i) Notify the affected entity of its intent to immediately suspend training program accreditation for the reasons listed in paragraph (g)(1) of this section. If a suspension, revocation, or modification notice has not previously been issued pursuant to paragraph (g)(1) of this section, it shall be issued at the same time the emergency suspension notice is issued.
(ii) Notify the affected entity in writing of the grounds for the immediate suspension and why it is necessary to suspend the entity's accreditation before an opportunity for a suspension, revocation or modification hearing.
(iii) Notify the affected entity of the anticipated commencement date and duration of the immediate suspension.
(iv) Notify the affected entity of its right to request a hearing on the immediate suspension within 15 days of the suspension taking place and the procedures for the conduct of such a hearing.
(5) Any notice, decision, or order issued by EPA under this section, any transcripts or other verbatim record of oral testimony, and any documents filed by an accredited training program in a hearing under this section shall be available to the public, except as otherwise provided by section 14 of TSCA or by part 2 of this title. Any such hearing at which oral testimony is presented shall be open to the public, except that the Presiding Officer may exclude the public to the extent necessary to allow presentation of information which may be entitled to confidential treatment under section 14 of TSCA or part 2 of this title.
(6) The public shall be notified of the suspension, revocation, modification or reinstatement of a training program's accreditation through appropriate mechanisms.
(7) EPA shall maintain a list of parties whose accreditation has been suspended, revoked, modified or reinstated.
(i)
(i) All documents specified in paragraph (c)(4) of this section that demonstrate the qualifications listed in paragraphs (c)(1) and (c)(2) of this section of the training manager and principal instructors.
(ii) Current curriculum/course materials and documents reflecting any changes made to these materials.
(iii) The course test blueprint.
(iv) Information regarding how the hands-on assessment is conducted including, but not limited to:
(A) Who conducts the assessment.
(B) How the skills are graded.
(C) What facilities are used.
(D) The pass/fail rate.
(v) The quality control plan as described in paragraph (c)(9) of this section.
(vi) Results of the students' hands-on skills assessments and course tests, and a record of each student's course completion certificate.
(vii) Any other material not listed above in paragraphs (i)(1)(i) through (i)(1)(vi) of this section that was submitted to EPA as part of the program's application for accreditation.
(2) The training program shall retain these records at the address specified on the training program accreditation application (or as modified in accordance with paragraph (i)(3) of this section for a minimum of 3 years and 6 months.
(3) The training program shall notify EPA in writing within 30 days of changing the address specified on its training program accreditation application or transferring the records from that address.
(a)
(i) Submit to EPA an application demonstrating that they meet the requirements established in paragraphs (b) or (c) of this section for the particular discipline for which certification is sought; or
(ii) Submit to EPA an application with a copy of a valid lead-based paint activities certification (or equivalent) from a State or Tribal program that has been authorized by EPA pursuant to subpart Q of this part.
(2) Individuals may first apply to EPA for certification to engage in lead-based paint activities pursuant to this section on or after March 1, 1999.
(3) Following the submission of an application demonstrating that all the requirements of this section have been meet, EPA shall certify an applicant as an inspector, risk assessor, supervisor, project designer, or abatement worker, as appropriate.
(4) Upon receiving EPA certification, individuals conducting lead-based paint activities shall comply with the work practice standards for performing the appropriate lead-based paint activities as established in § 745.227.
(5) It shall be a violation of TSCA for an individual to conduct any of the lead-based paint activities described in § 745.227 after March 1, 2000, if that individual has not been certified by EPA pursuant to this section to do so.
(6) Individuals applying for certification must submit the appropriate fees in accordance with § 745.238.
(b)
(i) Successfully complete an accredited course in the appropriate discipline and receive a course completion certificate from an accredited training program.
(ii) Pass the certification exam in the appropriate discipline offered by EPA; and,
(iii) Meet or exceed the following experience and/or education requirements:
(A) Inspectors. (
(
(B) Risk assessors. (
(
(
(
(C) Supervisor: (
(
(2) The following documents shall be recognized by EPA as evidence of meeting the requirements listed in (b)(2)(iii) of this paragraph:
(i) Official academic transcripts or diploma, as evidence of meeting the education requirements.
(ii) Resumes, letters of reference, or documentation of work experience, as evidence of meeting the work experience requirements.
(iii) Course completion certificates from lead-specific or other related training courses, issued by accredited training programs, as evidence of meeting the training requirements.
(3) In order to take the certification examination for a particular discipline an individual must:
(i) Successfully complete an accredited course in the appropriate discipline and receive a course completion certificate from an accredited training program.
(ii) Meet or exceed the education and/or experience requirements in paragraph (b)(1)(iii) of this section.
(4) The course completion certificate shall serve as interim certification for an individual until the next available opportunity to take the certification exam. Such interim certification shall expire 6 months after issuance.
(5) After passing the appropriate certification exam and submitting an application demonstrating that he/she meets the appropriate training, education, and/or experience prerequisites described in paragraph (b)(1) of this section, an individual shall be issued a certificate by EPA. To maintain certification, an individual must be re-certified as described in paragraph (e) of this section.
(6) An individual may take the certification exam no more than three times within 6 months of receiving a course completion certificate.
(7) If an individual does not pass the certification exam and receive a certificate within 6 months of receiving his/her course completion certificate, the individual must retake the appropriate course from an accredited training program before reapplying for certification from EPA.
(c)
(i) Successfully complete an accredited course in the appropriate discipline and receive a course completion certificate from an accredited training program.
(ii) Meet or exceed the following additional experience and/or education requirements:
(A) Abatement workers. (
(
(B) Project designers. (
(
(
(2) The following documents shall be recognized by EPA as evidence of meeting the requirements listed in this paragraph:
(i) Official academic transcripts or diploma, as evidence of meeting the education requirements.
(ii) Resumes, letters of reference, or documentation of work experience, as evidence of meeting the work experience requirements.
(iii) Course completion certificates from lead-specific or other related training courses, issued by accredited training programs, as evidence of meeting the training requirements.
(3) The course completion certificate shall serve as an interim certification until certification from EPA is received, but shall be valid for no more than 6 months from the date of completion.
(4) After successfully completing the appropriate training courses and meeting any other qualifications described in paragraph (c)(1) of this section, an individual shall be issued a certificate from EPA. To maintain certification, an individual must be re-certified as described in paragraph (e) of this section.
(d)
(i) Applicants for certification as an inspector, risk assessor, or supervisor shall:
(A) Demonstrate that the applicant has successfully completed training or on-the-job training in the conduct of a lead-based paint activity.
(B) Demonstrate that the applicant meets or exceeds the education and/or experience requirements in paragraph (b)(1)(iii) of this section.
(C) Successfully complete an accredited refresher training course for the appropriate discipline.
(D) Pass a certification exam administered by EPA for the appropriate discipline.
(ii) Applicants for certification as an abatement worker or project designer shall:
(A) Demonstrate that the applicant has successfully completed training or on-the-job training in the conduct of a lead-based paint activity.
(B) Demonstrate that the applicant meets the education and/or experience requirements in paragraphs (c)(1) of this section; and
(C) Successfully complete an accredited refresher training course for the appropriate discipline.
(2) Individuals shall have until March 1, 2000, to apply to EPA for certification under the above procedures. After that date, all individuals wishing to obtain certification must do so through the procedures described in paragraph (a), and paragraph (b) or (c) of this section, according to the discipline for which certification is being sought.
(e)
(i) Every 3 years if the individual completed a training course with a course test and hands-on assessment; or
(ii) Every 5 years if the individual completed a training course with a proficiency test.
(2) An individual shall be re-certified if the individual successfully completes the appropriate accredited refresher training course and submits a valid copy of the appropriate refresher course completion certificate.
(3) Individuals applying for re-certification must submit the appropriate fees in accordance with § 745.238.
(f)
(2) A firm seeking certification shall submit to EPA a letter attesting that the firm shall only employ appropriately certified employees to conduct lead-based paint activities, and that the firm and its employees shall follow the work practice standards in § 745.227 for conducting lead-based paint activities.
(3) From the date of receiving the firm's letter requesting certification, EPA shall have 90 days to approve or disapprove the firm's request for certification. Within that time, EPA shall respond with either a certificate of approval or a letter describing the reasons for a disapproval.
(4) The firm shall maintain all records pursuant to the requirements in § 745.227.
(5) Firms may first apply to EPA for certification to engage in lead-based paint activities pursuant to this section on or after March 1, 1999.
(6) Firms applying for certification must submit the appropriate fees in accordance with § 745.238.
(7) To maintain certification a firm shall submit appropriate fees in accordance with § 745.238 every 3 years.
(g)
(i) Obtained training documentation through fraudulent means.
(ii) Gained admission to and completed an accredited training program through misrepresentation of admission requirements.
(iii) Obtained certification through misrepresentation of certification requirements or related documents dealing with education, training, professional registration, or experience.
(iv) Performed work requiring certification at a job site without having proof of certification.
(v) Permitted the duplication or use of the individual's own certificate by another.
(vi) Performed work for which certification is required, but for which appropriate certification has not been received.
(vii) Failed to comply with the appropriate work practice standards for lead-based paint activities at § 745.227.
(viii) Failed to comply with Federal, State, or local lead-based paint statutes or regulations.
(2) In addition to an administrative or judicial finding of violation, for purposes of this section only, execution of a consent agreement in settlement of an enforcement action constitutes evidence of a failure to comply with relevant statutes or regulations.
(h)
(i) Performed work requiring certification at a job site with individuals who are not certified.
(ii) Failed to comply with the work practice standards established in § 745.227.
(iii) Misrepresented facts in its letter of application for certification to EPA.
(iv) Failed to maintain required records.
(v) Failed to comply with Federal, State, or local lead-based paint statutes or regulations.
(2) In addition to an administrative or judicial finding of violation, for purposes of this section only, execution of a consent agreement in settlement of an enforcement action constitutes evidence of a failure to comply with relevant statutes or regulations.
(i)
(1) If EPA decides to suspend, revoke, or modify the certification of any individual or firm, it shall notify the affected entity in writing of the following:
(i) The legal and factual basis for the suspension, revocation, or modification.
(ii) The commencement date and duration of the suspension, revocation, or modification.
(iii) Actions, if any, which the affected entity may take to avoid suspension, revocation, or modification or to receive certification in the future.
(iv) The opportunity and method for requesting a hearing prior to final EPA action to suspend, revoke, or modify certification.
(v) Any additional information, as appropriate, which EPA may provide.
(2) If a hearing is requested by the certified individual or firm, EPA shall:
(i) Provide the affected entity an opportunity to offer written statements in response to EPA's assertion of the legal and factual basis and any other
(ii) Provide the affected entity such other procedural opportunities as EPA may deem appropriate to ensure a fair and impartial hearing.
(iii) Appoint an official of EPA as Presiding Officer to conduct the hearing. No person shall serve as Presiding Officer if he or she has had any prior connection with the specific matter.
(3) The Presiding Officer shall:
(i) Conduct a fair, orderly, and impartial hearing within 90 days of the request for a hearing;
(ii) Consider all relevant evidence, explanation, comment, and argument submitted; and
(iii) Notify the affected entity in writing within 90 days of completion of the hearing of his or her decision and order. Such an order is a final EPA action subject to judicial review.
(4) If EPA determines that the public health, interest, or welfare warrants immediate action to suspend the certification of any individual or firm prior to the opportunity for a hearing, it shall:
(i) Notify the affected entity of its intent to immediately suspend certification for the reasons listed in paragraph (h)(1) of this section. If a suspension, revocation, or modification notice has not previously been issued, it shall be issued at the same time the immediate suspension notice is issued.
(ii) Notify the affected entity in writing of the grounds upon which the immediate suspension is based and why it is necessary to suspend the entity's accreditation before an opportunity for a hearing to suspend, revoke, or modify the individual's or firm's certification.
(iii) Notify the affected entity of the commencement date and duration of the immediate suspension.
(iv) Notify the affected entity of its right to request a hearing on the immediate suspension within 15 days of the suspension taking place and the procedures for the conduct of such a hearing.
(5) Any notice, decision, or order issued by EPA under this section, transcript or other verbatim record of oral testimony, and any documents filed by a certified individual or firm in a hearing under this section shall be available to the public, except as otherwise provided by section 14 of TSCA or by part 2 of this title. Any such hearing at which oral testimony is presented shall be open to the public, except that the Presiding Officer may exclude the public to the extent necessary to allow presentation of information which may be entitled to confidential treatment under section 14 of TSCA or part 2 of this title.
(a)
(2) When performing any lead-based paint activity described by the certified individual as an inspection, lead-hazard screen, risk assessment or abatement, a certified individual must perform that activity in compliance with the appropriate requirements below.
(3) Documented methodologies that are appropriate for this section are found in the following: The U.S. Department of Housing and Urban Development (HUD) Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing; the EPA Guidance on Residential Lead-Based Paint, Lead-Contaminated Dust, and Lead-Contaminated Soil; the EPA Residential Sampling for Lead: Protocols for Dust and Soil Sampling (EPA report number 7474-R-95-001); Regulations, guidance, methods or protocols issued by States and Indian Tribes that have been authorized by EPA; and other equivalent methods and quidelines.
(4) Clearance levels are appropriate for the purposes of this section may be found in the EPA Guidance on Residential Lead-Based Paint, Lead-Contaminated Dust, and Lead Contaminiated Soil or other equivalent guidelines.
(b)
(2) When conducting an inspection, the following locations shall be selected according to documented methodologies and tested for the presence of lead-based paint:
(i) In a residential dwelling and child-occupied facility, each component with a distinct painting history and each exterior component with a distinct painting history shall be tested for lead-based paint, except those components that the inspector or risk assessor determines to have been replaced after 1978, or to not contain lead-based paint; and
(ii) In a multi-family dwelling or child-occupied facility, each component with a distinct painting history in every common area, except those components that the inspector or risk assessor determines to have been replaced after 1978, or to not contain lead-based paint.
(3) Paint shall be sampled in the following manner: (i) The analysis of paint to determine the presence of lead shall be conducted using documented methodologies which incorporate adequate quality control procedures; and/or
(ii) All collected paint chip samples shall be analyzed according to paragraph (f) of this section to determine if they contain detectable levels of lead that can be quantified numerically.
(4) The certified inspector or risk assessor shall prepare an inspection report which shall include the following information:
(i) Date of each inspection.
(ii) Address of building.
(iii) Date of construction.
(iv) Apartment numbers (if applicable).
(v) Name, address, and telephone number of the owner or owners of each residential dwelling or child-occupied facility.
(vi) Name, signature, and certification number of each certified inspector and/or risk assessor conducting testing.
(vii) Name, address, and telephone number of the certified firm employing each inspector and/or risk assessor, if applicable.
(viii) Each testing method and device and/or sampling procedure employed for paint analysis, including quality control data and, if used, the serial number of any x-ray fluorescence (XRF) device.
(ix) Specific locations of each painted component tested for the presence of lead-based paint.
(x) The results of the inspection expressed in terms appropriate to the sampling method used.
(c)
(2) If conducted, a lead hazard screen shall be conducted as follows:
(i) Background information regarding the physical characteristics of the residential dwelling or child-occupied facility and occupant use patterns that may cause lead-based paint exposure to one or more children age 6 years and under shall be collected.
(ii) A visual inspection of the residential dwelling or child-occupied facility shall be conducted to:
(A) Determine if any deteriorated paint is present, and
(B) Locate at least two dust sampling locations.
(iii) If deteriorated paint is present, each surface with deteriorated paint, which is determined, using documented methodologies, to be in poor condition and to have a distinct painting history, shall be tested for the presence of lead.
(iv) In residential dwellings, two composite dust samples shall be collected, one from the floors and the other from the windows, in rooms, hallways or stairwells where one or more children, age 6 and under, are most likely to come in contact with dust.
(v) In multi-family dwellings and child-occupied facilities, in addition to the floor and window samples required in paragraph (c)(1)(iii) of this section, the risk assessor shall also collect composite dust samples from common areas where one or more children, age 6 and under, are most likely to come into contact with dust.
(3) Dust samples shall be collected and analyzed in the following manner:
(i) All dust samples shall be taken using documented methodologies that incorporate adequate quality control procedures.
(ii) All collected dust samples shall be analyzed according to paragraph (f) of this section to determine if they contain detectable levels of lead that can be quantified numerically.
(4) Paint shall be sampled in the following manner: (i) The analysis of paint to determine the presence of lead shall be conducted using documented methodologies which incorporate adequate quality control procedures; and/or
(ii) All collected paint chip samples shall be analyzed according to paragraph (f) of this section to determine if they contain detectable levels of lead that can be quantified numerically.
(5) The risk assessor shall prepare a lead hazard screen report, which shall include the following information:
(i) The information required in a risk assessment report as specified in paragraph (d) of this section, including paragraphs (d)(11)(i) through (d)(11)(xiv), and excluding paragraphs (d)(11)(xv) through (d)(11)(xviii) of this section. Additionally, any background information collected pursuant to paragraph (c)(2)(i) of this section shall be included in the risk assessment report; and
(ii) Recommendations, if warranted, for a follow-up risk assessment, and as appropriate, any further actions.
(d)
(2) A visual inspection for risk assessment of the residential dwelling or child-occupied facility shall be undertaken to locate the existence of deteriorated paint, assess the extent and causes of the deterioration, and other potential lead-based paint hazards.
(3) Background information regarding the physical characteristics of the residential dwelling or child-occupied facility and occupant use patterns that may cause lead-based paint exposure to one or more children age 6 years and under shall be collected.
(4) The following surfaces which are determined, using documented methodologies, to have a distinct painting history, shall be tested for the presence of lead:
(i) Each friction surface or impact surface with visibly deteriorated paint; and
(ii) All other surfaces with visibly deteriorated paint.
(5) In residential dwellings, dust samples (either composite or single-surface samples) from the interior window sill(s) and floor shall be collected and analyzed for lead concentration in all living areas where one or more children, age 6 and under, are most likely to come into contact with dust.
(6) For multi-family dwellings and child-occupied facilities, the samples required in paragraph (d)(4) of this section shall be taken. In addition, interior window sill and floor dust samples (either composite or single-surface samples) shall be collected and analyzed for lead concentration in the following locations:
(i) Common areas adjacent to the sampled residential dwelling or child-occupied facility; and
(ii) Other common areas in the building where the risk assessor determines that one or more children, age 6 and under, are likely to come into contact with dust.
(7) For child-occupied facilities, interior window sill and floor dust samples (either composite or single-surface samples) shall be collected and analyzed for lead concentration in each room, hallway or stairwell utilized by one or more children, age 6 and under, and in other common areas in the child-occupied facility where one or more children, age 6 and under, are likely to come into contact with dust.
(8) Soil samples shall be collected and analyzed for lead concentrations in the following locations:
(i) Exterior play areas where bare soil is present; and
(ii) The rest of the yard (i.e., non-play areas) where bare soil is present.
(iii) Dripline/foundation areas where bare soil is present.
(9) Any paint, dust, or soil sampling or testing shall be conducted using documented methodologies that incorporate adequate quality control procedures.
(10) Any collected paint chip, dust, or soil samples shall be analyzed according to paragraph (f) of this section to determine if they contain detectable levels of lead that can be quantified numerically.
(11) The certified risk assessor shall prepare a risk assessment report which shall include the following information:
(i) Date of assessment.
(ii) Address of each building.
(iii) Date of construction of buildings.
(iv) Apartment number (if applicable).
(v) Name, address, and telephone number of each owner of each building.
(vi) Name, signature, and certification of the certified risk assessor conducting the assessment.
(vii) Name, address, and telephone number of the certified firm employing each certified risk assessor if applicable.
(viii) Name, address, and telephone number of each recognized laboratory conducting analysis of collected samples.
(ix) Results of the visual inspection.
(x) Testing method and sampling procedure for paint analysis employed.
(xi) Specific locations of each painted component tested for the presence of lead.
(xii) All data collected from on-site testing, including quality control data and, if used, the serial number of any XRF device.
(xiii) All results of laboratory analysis on collected paint, soil, and dust samples.
(xiv) Any other sampling results.
(xv) Any background information collected pursuant to paragraph (d)(3) of this section.
(xvi) To the extent that they are used as part of the lead-based paint hazard determination, the results of any previous inspections or analyses for the presence of lead-based paint, or other assessments of lead-based paint-related hazards.
(xvii) A description of the location, type, and severity of identified lead-based paint hazards and any other potential lead hazards.
(xviii) A description of interim controls and/or abatement options for each identified lead-based paint hazard and a suggested prioritization for addressing each hazard. If the use of an encapsulant or enclosure is recommended, the report shall recommend a maintenance and monitoring schedule for the encapsulant or enclosure.
(e)
(2) A certified supervisor is required for each abatement project and shall be onsite during all work site preparation and during the post-abatement cleanup of work areas. At all other times when abatement activities are being conducted, the certified supervisor shall be onsite or available by telephone, pager or answering service, and able to be present at the work site in no more than 2 hours.
(3) The certified supervisor and the certified firm employing that supervisor shall ensure that all abatement activities are conducted according to the requirements of this section and all other Federal, State and local requirements.
(4) A certified firm must notify EPA of lead-based paint abatement activities as follows:
(i) Except as provided in paragraph (e)(4)(ii) of this section, EPA must be notified prior to conducting lead-based paint abatement activities. The original notification must be received by EPA at least 5 business days before the start date of any lead-based paint abatement activities.
(ii) Notification for lead-based paint abatement activities required in response to an elevated blood lead level (EBL) determination, or Federal, State, Tribal, or local emergency abatement order should be received by EPA as early as possible before, but must be received no later than the start date of the lead-based paint abatement activities. Should the start date and/or location provided to EPA
(iii) Except as provided in paragraph (e)(4)(ii) of this section, updated notification must be provided to EPA for lead-based paint abatement activities that will begin on a date other than the start date specified in the original notification, as follows:
(A) For lead-based paint abatement activities beginning prior to the start date provided to EPA an updated notification must be received by EPA at least 5 business days before the new start date included in the notification.
(B) For lead-based paint abatement activities beginning after the start date provided to EPA an updated notification must be received by EPA on or before the start date provided to EPA.
(iv) Except as provided in paragraph (e)(4)(ii) of this section, updated notification must be provided to EPA for any change in location of lead-based paint abatement activities at least 5 business days prior to the start date provided to EPA.
(v) Updated notification must be provided to EPA when lead-based paint abatement activities are canceled, or when there are other significant changes including, but not limited to, when the square footage or acreage to be abated changes by more than 20%. This updated notification must be received by EPA on or before the start date provided to EPA, or if work has already begun, within 24 hours of the change.
(vi) The following must be included in each notification:
(A) Notification type (original, updated, cancellation).
(B) Date when lead-based paint abatement activities will start.
(C) Date when lead-based paint abatement activities will end (approximation using best professional judgement).
(D) Firm's name, EPA certification number, address, telephone number.
(E) Type of building (e.g., single family dwelling, multi-family dwelling, child-occupied facilities) on/in which abatement work will be performed.
(F) Property name (if applicable).
(G) Property address including apartment or unit number(s) (if applicable) for abatement work.
(H) Documentation showing evidence of an EBL determination or a copy of the Federal/State/Tribal/local emergency abatement order, if using the abbreviated time period as described in paragraph (e)(4)(ii) of this section.
(I) Name and EPA certification number of the project supervisor.
(J) Approximate square footage/acreage to be abated.
(K) Brief description of abatement activities to be performed.
(L) Name, title, and signature of the representative of the certified firm who prepared the notification.
(vii) Notification must be accomplished using any of the following methods: Written notification, or electronically using the Agency's Central Data Exchange (CDX). Written notification can be accomplished using either the sample form titled “Notification of Lead-Based Paint Abatement Activities” or similar form containing the information required in paragraph (e)(4)(vi) of this section. All written notifications must be delivered by U.S. Postal Service, fax, commercial delivery service, or hand delivery (persons submitting notification by U.S. Postal Service are reminded that they should allow 3 additional business days for delivery in order to ensure that EPA receives the notification by the required date). Instructions and sample forms can be obtained from the NLIC at 1-800-424-LEAD(5323), or on the Internet at
(viii) Lead-based paint abatement activities shall not begin on a date, or at a location other than that specified in either an original or updated notification, in the event of changes to the original notification.
(ix) No firm or individual shall engage in lead-based paint abatement activities, as defined in § 745.223, prior to notifying EPA of such activities according to the requirements of this paragraph.
(5) A written occupant protection plan shall be developed for all abatement projects and shall be prepared according to the following procedures:
(i) The occupant protection plan shall be unique to each residential dwelling or child-occupied facility and be developed prior to the abatement. The occupant protection plan shall describe the measures and management procedures that will be taken during the abatement to protect the building occupants from exposure to any lead-based paint hazards.
(ii) A certified supervisor or project designer shall prepare the occupant protection plan.
(6) The work practices listed below shall be restricted during an abatement as follows:
(i) Open-flame burning or torching of lead-based paint is prohibited;
(ii) Machine sanding or grinding or abrasive blasting or sandblasting of lead-based paint is prohibited unless used with High Efficiency Particulate Air (HEPA) exhaust control which removes particles of 0.3 microns or larger from the air at 99.97 percent or greater efficiency;
(iii) Dry scraping of lead-based paint is permitted only in conjunction with heat guns or around electrical outlets or when treating defective paint spots totaling no more than 2 square feet in any one room, hallway or stairwell or totaling no more than 20 square feet on exterior surfaces; and
(iv) Operating a heat gun on lead-based paint is permitted only at temperatures below 1100 degrees Fahrenheit.
(7) If conducted, soil abatement shall be conducted in one of the following ways:
(i) If the soil is removed:
(A) The soil shall be replaced by soil with a lead concentration as close to local background as practicable, but no greater than 400 ppm.
(B) The soil that is removed shall not be used as top soil at another residential property or child-occupied facility.
(ii) If soil is not removed, the soil shall be permanently covered, as defined in § 745.223.
(8) The following post-abatement clearance procedures shall be performed only by a certified inspector or risk assessor:
(i) Following an abatement, a visual inspection shall be performed to determine if deteriorated painted surfaces and/or visible amounts of dust, debris or residue are still present. If deteriorated painted surfaces or visible amounts of dust, debris or residue are present, these conditions must be eliminated prior to the continuation of the clearance procedures.
(ii) Following the visual inspection and any post-abatement cleanup required by paragraph (e)(8)(i) of this section, clearance sampling for lead in dust shall be conducted. Clearance sampling may be conducted by employing single-surface sampling or composite sampling techniques.
(iii) Dust samples for clearance purposes shall be taken using documented methodologies that incorporate adequate quality control procedures.
(iv) Dust samples for clearance purposes shall be taken a minimum of 1 hour after completion of final post-abatement cleanup activities.
(v) The following post-abatement clearance activities shall be conducted as appropriate based upon the extent or manner of abatement activities conducted in or to the residential dwelling or child-occupied facility:
(A) After conducting an abatement with containment between abated and unabated areas, one dust sample shall be taken from one interior window sill and from one window trough (if present) and one dust sample shall be taken from the floors of each of no less than four rooms, hallways or stairwells within the containment area. In addition, one dust sample shall be taken from the floor outside the containment area. If there are less than four rooms, hallways or stairwells within the containment area, then all rooms, hallways or stairwells shall be sampled.
(B) After conducting an abatement with no containment, two dust samples shall be taken from each of no less than four rooms, hallways or stairwells in the residential dwelling or child-occupied facility. One dust sample shall be taken from one interior window sill and window trough (if present) and one dust sample shall be taken from the floor of each room, hallway or stairwell
(C) Following an exterior paint abatement, a visible inspection shall be conducted. All horizontal surfaces in the outdoor living area closest to the abated surface shall be found to be cleaned of visible dust and debris. In addition, a visual inspection shall be conducted to determine the presence of paint chips on the dripline or next to the foundation below any exterior surface abated. If paint chips are present, they must be removed from the site and properly disposed of, according to all applicable Federal, State and local requirements.
(vi) The rooms, hallways or stairwells selected for sampling shall be selected according to documented methodologies.
(vii) The certified inspector or risk assessor shall compare the residual lead level (as determined by the laboratory analysis) from each single surface dust sample with clearance levels in paragraph (e)(8)(viii) of this section for lead in dust on floors, interior window sills, and window troughs or from each composite dust sample with the applicable clearance levels for lead in dust on floors, interior window sills, and window troughs divided by half the number of subsamples in the composite sample. If the residual lead level in a single surface dust sample equals or exceeds the applicable clearance level or if the residual lead level in a composite dust sample equals or exceeds the applicable clearance level divided by half the number of subsamples in the composite sample, the components represented by the failed sample shall be recleaned and retested.
(viii) The clearance levels for lead in dust are 40 µg/ft
(9) In a multi-family dwelling with similarly constructed and maintained residential dwellings, random sampling for the purposes of clearance may be conducted provided:
(i) The certified individuals who abate or clean the residential dwellings do not know which residential dwelling will be selected for the random sample.
(ii) A sufficient number of residential dwellings are selected for dust sampling to provide a 95 percent level of confidence that no more than 5 percent or 50 of the residential dwellings (whichever is smaller) in the randomly sampled population exceed the appropriate clearance levels.
(iii) The randomly selected residential dwellings shall be sampled and evaluated for clearance according to the procedures found in paragraph (e)(8) of this section.
(10) An abatement report shall be prepared by a certified supervisor or project designer. The abatement report shall include the following information:
(i) Start and completion dates of abatement.
(ii) The name and address of each certified firm conducting the abatement and the name of each supervisor assigned to the abatement project.
(iii) The occupant protection plan prepared pursuant to paragraph (e)(5) of this section.
(iv) The name, address, and signature of each certified risk assessor or inspector conducting clearance sampling and the date of clearance testing.
(v) The results of clearance testing and all soil analyses (if applicable) and the name of each recognized laboratory that conducted the analyses.
(vi) A detailed written description of the abatement, including abatement methods used, locations of rooms and/or components where abatement occurred, reason for selecting particular abatement methods for each component, and any suggested monitoring of encapsulants or enclosures.
(f)
(1) Collected by persons certified by EPA as an inspector or risk assessor; and
(2) Analyzed by a laboratory recognized by EPA pursuant to section 405(b) of TSCA as being capable of performing analyses for lead compounds in paint chip, dust, and soil samples.
(g)
(1) Composite dust samples shall consist of at least two subsamples;
(2) Every component that is being tested shall be included in the sampling; and
(3) Composite dust samples shall not consist of subsamples from more than one type of component.
(h)
(i) On any surface that is tested and found to contain lead equal to or in excess of 1.0 milligrams per square centimeter or equal to or in excess of 0.5% by weight; and
(ii) On any surface like a surface tested in the same room equivalent that has a similar painting history and that is found to be lead-based paint.
(2) A paint-lead hazard is present:
(i) On any friction surface that is subject to abrasion and where the lead dust levels on the nearest horizontal surface underneath the friction surface (e.g., the window sill or floor) are equal to or greater than the dust hazard levels identified in § 745.227(b);
(ii) On any chewable lead-based paint surface on which there is evidence of teeth marks;
(iii) Where there is any damaged or otherwise deteriorated lead-based paint on an impact surface that is cause by impact from a related building component (such as a door knob that knocks into a wall or a door that knocks against its door frame; and
(iv) If there is any other deteriorated lead-based paint in any residential building or child-occupied facility or on the exterior of any residential building or child-occupied facility.
(3) A dust-lead hazard is present in a residential dwelling or child occupied facility:
(i) In a residential dwelling on floors and interior window sills when the weighted arithmetic mean lead loading for all single surface or composite samples of floors and interior window sills are equal to or greater than 40 µg/ft
(ii) On floors or interior window sills in an unsampled residential dwelling in a multi-family dwelling, if a dust-lead hazard is present on floors or interior window sills, respectively, in at least one sampled residential unit on the property; and
(iii) On floors or interior window sills in an unsampled common area in a multi-family dwelling, if a dust-lead hazard is present on floors or interior window sills, respectively, in at least one sampled common area in the same common area group on the property.
(4) A soil-lead hazard is present:
(i) In a play area when the soil-lead concentration from a composite play area sample of bare soil is equal to or greater than 400 parts per million; or
(ii) In the rest of the yard when the arithmetic mean lead concentration from a composite sample (or arithmetic mean of composite samples) of bare soil from the rest of the yard (i.e., non-play areas) for each residential building on a property is equal to or greater than 1,200 parts per million.
(i)
Lead-based paint activities, as defined in this part, shall only be conducted according to the procedures and
(a) Failure or refusal to comply with any requirement of §§ 745.225, 745.226, 745.227, or 745.233 is a prohibited act under sections 15 and 409 of TSCA (15 U.S.C. 2614, 2689).
(b) Failure or refusal to establish, maintain, provide, copy, or permit access to records or reports as required by §§ 745.225, 745.226, or 745.227 is a prohibited act under sections 15 and 409 of TSCA (15 U.S.C. 2614, 2689).
(c) Failure or refusal to permit entry or inspection as required by § 745.237 and section 11 of TSCA (15 U.S.C. 2610) is a prohibited act under sections 15 and 409 of TSCA (15 U.S.C. 2614, 2689).
(d) In addition to the above, any individual or firm that performs any of the following acts shall be deemed to have committed a prohibited act under sections 15 and 409 of TSCA (15 U.S.C. 2614, 2689). These include the following:
(i) Obtaining certification through fraudulent representation;
(ii) Failing to obtain certification from EPA and performing work requiring certification at a job site; or
(iii) Fraudulently obtaining certification and engaging in any lead-based paint activities requiring certification.
(e) Violators are subject to civil and criminal sanctions pursuant to section 16 of TSCA (15 U.S.C. 2615) for each violation.
EPA may conduct reasonable inspections pursuant to the provisions of section 11 of TSCA (15 U.S.C. 2610) to ensure compliance with this subpart.
(a)
(b)
(1)
(ii)
(2)
(c)
(2)
(3)
(4)
(d)
(ii)
(2)
(3)
(e)
(i)
(ii)
(iii)
(2) Submit application and payment in the amount specified in paragraph (c)(4) of this section in accordance with the instructions provided with the application package.
(f)
(2) The fees will be evaluated based on the cost to administer and enforce the program, and the number of applicants. New fee schedules will be published in the
(g)
(2) EPA will not replace identification cards or certificates for any individual, firm, or training program which does not remit fees described in paragraph (c) of this section in accordance with the procedures specified in paragraph (e) of this section.
This subpart L shall apply in any State or Indian Country that does not have an authorized program under subpart Q, effective August 31, 1998. In such States or Indian Country:
(a) Training programs shall not provide, offer or claim to provide training or refresher training for certification without accreditation from EPA pursuant to § 745.225 on or after March 1, 1999.
(b) No individual or firm shall perform, offer, or claim to perform lead-based paint activities, as defined in this subpart, without certification from EPA to conduct such activities pursuant to § 745.226 on or after March 1, 2000.
(c) All lead-based paint activities shall be performed pursuant to the work practice standards contained in § 745.227 on or after March 1, 2000.
(a) This subpart establishes the requirements that State or Tribal programs must meet for authorization by the Administrator to administer and enforce the standards, regulations, or other requirements established under TSCA section 402 and/or section 406 and establishes the procedures EPA will follow in approving, revising, and withdrawing approval of State or Tribal programs.
(b) For State or Tribal lead-based paint training and certification programs, a State or Indian Tribe may seek authorization to administer and enforce §§ 745.225, 745.226, and 745.227. The provisions of §§ 745.220, 745.223, 745.233, 745.235, 745.237, and 745.239 shall be applicable for the purposes of such program authorization.
(c) For State or Tribal pre-renovation notification programs, a State or Indian Tribe may seek authorization to administer and enforce regulations developed pursuant to TSCA section 406.
(d) A State or Indian Tribe applying for program authorization may seek either interim approval or final approval of the compliance and enforcement portion of the State or Tribal lead-based paint program pursuant to the procedures at § 745.327(a).
(e) State or Tribal submissions for program authorization shall comply with the procedures set out in this subpart.
(f) Any State or Tribal program approved by the Administrator under this subpart shall at all times comply with the requirements of this subpart.
(g) In many cases States will lack authority to regulate activities in Indian
The definitions in subpart A apply to this subpart. In addition, the definitions in § 745.223 and the following definitions apply:
(a)
(2) Before developing an application for authorization, a State or Indian Tribe shall disseminate a public notice of intent to seek such authorization and provide an opportunity for a public hearing.
(3) A State or Tribal application shall include:
(i) A transmittal letter from the State Governor or Tribal Chairperson (or equivalent official) requesting program approval.
(ii) A summary of the State or Tribal program. This summary will be used to provide notice to residents of the State or Tribe.
(iii) A description of the State or Tribal program in accordance with paragraph (b) of this section.
(iv) An Attorney General's or Tribal Counsel's (or equivalent) statement in accordance with paragraph (c) of this section.
(v) Copies of all applicable State or Tribal statutes, regulations, standards, and other materials that provide the State or Indian Tribe with the authority to administer and enforce a lead-based paint program.
(4) After submitting an application, the Agency will publish a
(5) Within 60 days of submission of a State or Tribal application, EPA will, if requested, conduct a public hearing in each State or Indian Country seeking program authorization and will consider all comments submitted at that hearing during the review of the State or Tribal application.
(b)
(1)(i) The name of the State or Tribal agency that is or will be responsible for administering and enforcing the program, the name of the official in that agency designated as the point of contact with EPA, and addresses and phone numbers where this official can be contacted.
(ii) Where more than one agency is or will be responsible for administering and enforcing the program, the State or Indian Tribe must designate a primary agency to oversee and coordinate
(iii) In the event that more than one agency is or will be responsible for administering and enforcing the program, the application must also include a description of the functions to be performed by each agency. The desciption shall explain and how the program will be coordinated by the primary agency to ensure consistency and effective administration of the lead-based paint training accreditation and certification program within the State or Indian Tribe.
(2) To demonstrate that the State or Tribal program is at least as protective as the Federal program, fulfilling the criteria in paragraph (e)(2)(i) of this section, the State or Tribal application must include:
(i) A description of the program that demonstrates that the program contains all of the elements specified in § 745.325, § 745.326, or both; and
(ii) An analysis of the State or Tribal program that compares the program to the Federal program in subpart L of this part, regulations developed pursuant to TSCA section 406, or both. This analysis shall demonstrate how the program is, in the State's or Indian Tribe's assessment, at least as protective as the elements in the Federal program at subpart L of this part, regulations developed pursuant to TSCA section 406, or both. EPA will use this analysis to evaluate the protectiveness of the State or Tribal program in making its determination pursuant to paragraph (e)(2)(i) of this section.
(3) To demonstrate that the State or Tribal program provides adequate enforcement, fulfilling the criteria in paragraph (e)(2)(ii) of this section, the State or Tribal application must include a description of the State or Tribal lead-based paint compliance and enforcement program that demonstrates that the program contains all of the elements specified at § 745.327. This description shall include copies of all policies, certifications, plans, reports, and other materials that demonstrate that the State or Tribal program contains all of the elements specified at § 745.327.
(4)(i) The program description for an Indian Tribe shall also include a map, legal description, or other information sufficient to identify the geographical extent of the territory over which the Indian Tribe exercises jurisdiction.
(ii) The program description for an Indian Tribe shall also include a demonstration that the Indian Tribe:
(A) Is recognized by the Secretary of the Interior.
(B) has an existing government exercising substantial governmental duties and powers.
(C) has adequate civil regulatory jurisdiction (as shown in the Tribal legal certification in paragraph (c)(2) of this section) over the subject matter and entities regulated.
(D) is reasonably expected to be capable of administering the Federal program for which it is seeking authorization.
(iii) If the Administrator has previously determined that an Indian Tribe has met the prerequisites in paragraphs (b)(4)(ii)(A) and (B) of this section for another EPA program, the Indian Tribe need provide only that information unique to the lead-based paint program required by paragraphs (b)(4)(ii)(C) and (D) of this section.
(c)
(2) The Tribal legal certification (the equivalent to the Attorney General's statement) may also be submitted and signed by an independent attorney retained by the Indian Tribe for representation in matters before EPA or the courts pertaining to the Indian Tribe's program. The certification shall include an assertion that the attorney has the authority to represent the Indian Tribe with respect to the Indian Tribe's authorization application.
(3) If a State application seeks approval of its program to operate in Indian Country, the required legal certification shall include an analysis of the applicant's authority to implement its provisions in Indian Country. The applicant shall include a map delineating the area over which it seeks to operate the program.
(d)
(2) If this certification is contained in a State's application, the program shall be deemed to be authorized by EPA until such time as the Administrator disapproves the program application or withdraws the program authorization. A program shall not be deemed authorized pursuant to this subpart to the extent that jurisdiction is asserted over Indian Country, including non-member fee lands within an Indian reservation.
(3) If the application does not contain such certification, the State program will be authorized only after the Administrator authorizes the program in accordance with paragraph (e) of this section.
(4) This certification shall take the form of a letter from the Governor or the Attorney General to the Administrator. The certification shall reference the program analysis in paragraph (b)(3) of this section as the basis for concluding that the State program is at least as protective as the Federal program, and provides adequate enforcement.
(e)
(2) Within 180 days of receipt of a complete State or Tribal application, the Administrator shall either authorize the program or disapprove the application. The Administrator shall authorize the program, after notice and the opportunity for public comment and a public hearing, only if the Administrator finds that:
(i)(A) In the case of an application to authorize the State or Indian Tribe to administer and enforce the provisions of subpart L of this part, the State or Tribal program is at least as protective of human health and the environment as the corresponding Federal program under subpart L of this part; and/or
(B) In the case of an application to authorize the State or Indian Tribe to administer and enforce the regulations developed pursuant to TSCA section 406, the State or Tribal program is at least as protective of human health and the environment as the Federal regulations developed pursuant to TSCA section 406.
(ii) The State or Tribal program provides adequate enforcement.
(3) EPA shall notify in writing the State or Indian Tribe of the Administrator's decision to authorize the State or Tribal program or disapprove the State's or Indian Tribe's application.
(4) If the State or Indian Tribe applies for authorization of State or Tribal programs under both subpart L and regulations developed pursuant to TSCA section 406, EPA may, as appropriate, authorize one program and disapprove the other.
(f)
(2) If a State or Indian Tribe does not have an authorized program to administer and enforce regulations developed pursuant to TSCA section 406 in effect by August 31, 1998, the Administrator shall, by such date, establish and enforce the provisions of regulations developed pursuant to TSCA section 406 as the Federal program for that State or Indian Country.
(3) Upon authorization of a State or Tribal program, pursuant to paragraph (d) or (e) of this section, it shall be an unlawful act under sections 15 and 409 of TSCA for any person to fail or refuse to comply with any requirements of such program.
(g)
(h)
The report shall include the following information:
(1) Any significant changes in the content or administration of the State or Tribal program implemented since the previous reporting period; and
(2) All information regarding the lead-based paint enforcement and compliance activities listed at § 745.327(d) “Summary on Progress and Performance.”
(i)
(2) The Notice of Intent to Withdraw shall:
(i) Identify the program aspects that EPA believes are inadequate and provide a factual basis for such findings.
(ii) Include copies of relevant documents.
(iii) Provide an opportunity for the State or Indian Tribe to respond either in writing or at a meeting with appropriate EPA officials.
(3) EPA may request that an informal conference be held between representatives of the State or Indian Tribe and EPA officials.
(4) Prior to issuance of a withdrawal, a State or Indian Tribe may request that EPA hold a public hearing. At this hearing, EPA, the State or Indian Tribe, and the public may present facts bearing on whether the State's or Indian Tribe's authorization should be withdrawn.
(5) If EPA finds that deficiencies warranting withdrawal did not exist or were corrected by the State or Indian Tribe, EPA may rescind its Notice of Intent to Withdraw authorization.
(6) Where EPA finds that deficiencies in the State or Tribal program exist that warrant withdrawal, an agreement to correct the deficiencies shall be jointly prepared by the State or Indian Tribe and EPA. The agreement shall describe the deficiencies found in the program, specify the steps the State or Indian Tribe has taken or will take to remedy the deficiencies, and establish a schedule, no longer than 180 days, for each remedial action to be initiated.
(7) If the State or Indian Tribe does not respond within 60 days of issuance of the Notice of Intent to Withdraw or an agreement is not reached within 180 days after EPA determines that a State or Indian Tribe is not in compliance with the Federal program, the Agency shall issue an order withdrawing the State's or Indian Tribe's authorization.
(8) By the date of such order, the Administrator shall establish and enforce the provisions of subpart L of this part or regulations developed pursuant to TSCA section 406, or both, as the Federal program for that State or Indian Country.
(a)
(1) Procedures and requirements for the accreditation of lead-based paint activities training programs.
(2) Procedures and requirements for the certification of individuals engaged in lead-based paint activities.
(3) Work practice standards for the conduct of lead-based paint activities.
(4) Requirements that all lead-based paint activities be conducted by appropriately certified contractors.
(5) Development of the appropriate infrastructure or government capacity to effectively carry out a State or Tribal program.
(b)
(1) Procedures and requirements for the accreditation of training programs that establish:
(i) Requirements for the accreditation of training programs, including but not limited to:
(A) Training curriculum requirements.
(B) Training hour requirements.
(C) Hands-on training requirements.
(D) Trainee competency and proficiency requirements.
(E) Requirements for training program quality control.
(ii) Procedures for the re-accreditation of training programs.
(iii) Procedures for the oversight of training programs.
(iv) Procedures for the suspension, revocation, or modification of training program accreditations; or
(2) Procedures or regulations, for the purposes of certification, for the acceptance of training offered by an accredited training provider in a State or Tribe authorized by EPA.
(c)
(1) Ensure that certified individuals:
(i) Are trained by an accredited training program; and
(ii) Possess appropriate education or experience qualifications for certification.
(2) Establish procedures for re-certification.
(3) Require the conduct of lead-based paint activities in accordance with work practice standards established by the State or Indian Tribe.
(4) Establish procedures for the suspension, revocation, or modification of certifications.
(5) Establish requirements and procedures for the administration of a third-party certification exam.
(d)
(1) The work practice standards for the inspection for the presence of lead-based paint must require that:
(i) Inspections are conducted only by individuals certified by the appropriate State or Tribal authority to conduct inspections.
(ii) Inspections are conducted in a way that identifies the presence of lead-based paint on painted surfaces within the interior or on the exterior of a residential dwelling or child-occupied facility.
(iii) Inspections are conducted in a way that uses documented methodologies that incorporate adequate quality control procedures.
(iv) A report is developed that clearly documents the results of the inspection.
(v) Records are retained by the certified inspector or the firm.
(2) The work practice standards for risk assessment must require that:
(i) Risk assessments are conducted only by individuals certified by the appropriate State or Tribal authority to conduct risk assessments.
(ii) Risk assessments are conducted in a way that identifies and reports the presence of lead-based paint hazards.
(iii) Risk assessments consist of, at least:
(A) An assessment, including a visual inspection, of the physical characteristics of the residential dwelling or child-occupied facility;
(B) Environmental sampling for lead in paint, dust, and soil;
(C) Environmental sampling requirements for lead in paint, dust, and soil that allow for comparison to the standards for lead-based paint hazards established or revised by the State or Indian Tribe pursuant to paragraph (e) of this section; and
(D) A determination of the presence of lead-based paint hazards made by comparing the results of visual inspection and environmental sampling to the standards for lead-based paint hazards established or revised by the State or Indian Tribe pursuant to paragraph (e) of this section.
(iv) The program elements required in paragraph (d)(2)(iii)(C) and (d)(2)(iii)(D) of this section shall be adopted in accordance with the schedule for the demonstration required in paragraph (e) of this section.
(v) The risk assessor develops a report that clearly presents the results of the assessment and recommendations for the control or elimination of all identified hazards.
(vi) The certified risk assessor or the firm retains the appropriate records.
(3) The work practice standards for abatement must require that:
(i) Abatements are conducted only by individuals certified by the appropriate State or Tribal authority to conduct or supervise abatements.
(ii) Abatements permanently eliminate lead-based paint hazards and are conducted in a way that does not increase the hazards of lead-based paint to the occupants of the dwelling or child-occupied facility.
(iii) Abatements include post-abatement lead in dust clearance sampling and conformance with clearance levels established or adopted by the State or Indian Tribe.
(iv) The abatement contractor develops a report that describes areas of the residential dwelling or child-occupied facility abated and the techniques employed.
(v) The certified abatement contractor or the firm retains appropriate records.
(e) The State or Indian Tribe must demonstrate that it has standards for identifying lead-based paint hazards and clearance standards for dust, that are at least as protective as the standards in § 745.227 as amended on February 5, 2001. A State or Indian Tribe with such a section 402 program approved before February 5, 2003 shall make this demonstration no later than the first report submitted pursuant to § 745.324(h) on or after February 5, 2003. A State or Indian Tribe with such a program submitted but not approved before February 5, 2003 may make this demonstration by amending its application or in its first report submitted pursuant to § 745.324(h). A State or Indian Tribe submitting its program on or after February 5, 2003 shall make this demonstration in its application.
(a)
(1) Procedures and requirements for the distribution of lead hazard information to owners and occupants of target housing before renovations for compensation; and
(2) An approved lead hazard information pamphlet meeting the requirements of section 406 of TSCA, as determined by EPA. EPA will provide States or Tribes with guidance on what is necessary for a State or Tribal pamphlet approval application.
(b)
(1) Clear standards for identifying home improvement activities that trigger the pamphlet distribution requirements; and
(2) Procedures for distributing the lead hazard information to owners and occupants of the housing prior to renovation activities.
(c)
(1) Distribute the lead hazard information pamphlet developed by EPA under section 406(a) of TSCA, titled
(2) Distribute an alternate pamphlet or package of lead hazard information that has been submitted by the State or Tribe, reviewed by EPA, and approved by EPA for use in that State or Tribe. Such information must meet the content requirements prescribed by section 406(a) of TSCA, and be in a format that is readable to the diverse audience of housing owners and occupants in that State or Tribe.
(a)
(1)
(i) To be considered adequate for purposes of obtaining interim approval for the compliance and enforcement program portion of a State or Tribal lead-based paint program, a State or Indian Tribe must, in its application described at § 745.324(a):
(A) Demonstrate it has the legal authority and ability to immediately implement the elements in paragraph (b) of this section. This demonstration shall include a statement that the State or Indian Tribe, during the interim approval period, shall carry out a level of compliance monitoring and enforcement necessary to ensure that the State or Indian Tribe addresses any significant risks posed by noncompliance with lead-based paint activity requirements.
(B) Present a plan with time frames identified for implementing in the field each element in paragraph (c) of this section. All elements of paragraph (c) of this section must be fully implemented no later than 3 years from the date of EPA's interim approval of the compliance and enforcement program portion of a State or Tribal lead-based paint program. A statement of resources must be included in the State or Tribal plan which identifies what resources the State or Indian Tribe intends to devote to the administration of its lead-based paint compliance and enforcement program.
(C) Agree to submit to EPA the Summary on Progress and Performance of lead-based paint compliance and enforcement activities as described at paragraph (d) of this section.
(ii) Any interim approval granted by EPA for the compliance and enforcement program portion of a State or Tribal lead-based paint program will expire no later than 3 years from the date of EPA's interim approval. One hundred and eighty days prior to this expiration date, a State or Indian Tribe shall apply to EPA for final approval of the compliance and enforcement program portion of a State or Tribal lead-based paint program. Final approval shall be given to any State or Indian Tribe which has in place all of the elements of paragraphs (b), (c), and (d) of this section. If a State or Indian Tribe does not receive final approval for the compliance and enforcement program portion of a State or Tribal lead-based paint program by the date 3 years after the date of EPA's interim approval, the Administrator shall, by such date, initiate the process to withdraw the State or Indian Tribe's authorization pursuant to § 745.324(i).
(2)
(i) For the compliance and enforcement program to be considered adequate for final approval through the application described at § 745.324(a), a State or Indian Tribe must, in its application:
(A) Demonstrate it has the legal authority and ability to immediately implement the elements in paragraphs (b) and (c) of this section.
(B) Submit a statement of resources which identifies what resources the State or Indian Tribe intends to devote to the administration of its lead-based paint compliance and enforcement program.
(C) Agree to submit to EPA the Summary on Progress and Performance of lead-based paint compliance and enforcement activities as described at paragraph (d) of this section.
(ii) For States or Indian Tribes which previously received interim approval as described in paragraph (a)(1) of this section, in order for the State or Tribal compliance and enforcement program to be considered adequate for final approval through a separate application addressing only the compliance and enforcement program portion of a State or Tribal lead-based paint program, a State or Indian Tribe must, in its application:
(A) Demonstrate that it has the legal authority and ability to immediately implement the elements in paragraphs (b) and (c) of this section.
(B) Submit a statement which identifies the resources the State or Indian Tribe intends to devote to the administration of its lead-based paint compliance and enforcement program.
(C) Agree to submit to EPA the Summary on Progress and Performance of lead-based paint compliance and enforcement activities as described at paragraph (d) of this section.
(D) To the extent not previously submitted through the application described at § 745.324(a), submit copies of all applicable State or Tribal statutes, regulations, standards, and other material that provide the State or Indian Tribe with authority to administer and enforce the lead-based paint compliance and enforcement program, and copies of the policies, certifications, plans, reports, and any other documents that demonstrate that the program meets the requirements established in paragraphs (b) and (c) of this section.
(b)
(1)
(i) Accreditation of training programs as described at § 745.325(b).
(ii) Certification of individuals engaged in lead-based paint activities as described at § 745.325(c).
(iii) Standards for the conduct of lead-based paint activities as described at § 745.325(d); and, as appropriate,
(iv) Requirements that regulate the conduct of pre-renovation notification activities as described at § 745.326.
(2)
(i) State or Tribal officials must be able to enter premises or facilities where those engaged in training for lead-based paint activities conduct business.
(ii) For the purposes of enforcing a pre-renovation notification program, State or Tribal officials must be able to enter a renovator's place of business.
(iii) State or Tribal officials must have authority to take samples and review records as part of the lead-based paint activities inspection process.
(3)
(i) Warning letters, Notices of Noncompliance, Notices of Violation, or the equivalent;
(ii) Administrative or civil actions, including penalty authority (e.g., accreditation or certification suspension, revocation, or modification); and
(iii) Authority to apply criminal sanctions or other criminal authority using existing State or Tribal laws, as applicable.
(4)
(c)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(d)
(e)
(f)
States and Indian Tribes may seek authorization to administer and enforce subpart L pursuant to this subpart effective October 28, 1996.
15 U.S.C. 2604 and 2605.
This section identifies activities with respect to a chemical substance which are prohibited and requires that warnings and instructions accompany the substance when distributed in commerce.
(a)
(b)
(1) The terms
(2)
(3)
(4)
(i) Processing must be performed at sites under the control of the processor.
(ii) Distribution in commerce is limited to purposes of export.
(iii) The processor or distributor may not use the substance except in small quantities solely for research and development.
(c)
(2) Any person using as a metalworking fluid a product containing P-84-529 is prohibited from adding any nitrosating agent to the product.
(d)
(i) A letter that includes the following statements:
A substance, identified generically as mixed mono and diamides of an organic acid, contained in the product (
(ii) A copy of this § 747.115.
(2)(i) Any person who distributes in commerce a metalworking fluid containing P-84-529 must affix a label to each container containing the fluid.
(ii) The label shall contain a warning statement which shall consist only of the following language:
WARNING! Do Not Add Nitrites to This Metalworking Fluid under Penalty of Federal Law. Addition of nitrites leads to formation of a substance known to cause cancer. This product is designed to be used without nitrites.
(iii) The first work of the warning statement shall be capitalized, and the type size for the first word shall be no smaller than six point type for a label five square inches or less in area, ten point type for a label above five but below ten square inches in area, twelve point type for a label above ten but below fifteen square inches in area, fourteen point type for a label above fifteen but below thirty square inches in area, or eighteen point type for a label over thirty square inches in area. The type size of the remainder of the warning statement shall be no smaller than six point type. All required label text shall be of sufficient prominence, and shall be placed with such conspicuousness relative to other label text and
(e)
(2) Except for manufacturers and importers of P-84-529, no processor, distributor, or user of P-84-529 will be in violation of this section unless that person has received a letter specified in paragraph (d)(1) of this section or a container with the label specified in paragraph (d)(2) of this section.
(f)
(1) The person manufactures, imports, processes, distributes in commerce, or uses the substance only in small quantities solely for research and development and in accordance with section 5(h)(3) of the Act.
(2) The person manufactures, imports, processes, distributes in commerce, or uses the substance only as an impurity.
(3) The person imports, processes, distributes in commerce, or uses the substance only as part of an article.
(4) The person processes or distributes the substance in commerce solely for export and, when distributing in commerce, lables the substance in accordance with section 12(a)(1)(B) of the Act.
(g)
(2) Failure or refusal to permit access to or copying of records, as required under section 11 of the Act, is a violation of section 15 of the Act [15 U.S.C. 2614].
(3) Failure or refusal to permit entry or inspection, as required under section 11 of the Act, is a violation of section 15 of the Act [15 U.S.C. 2614].
(4) Violators may be subject to the civil and criminal penalties in section 16 of the Act [15 U.S.C. 2615] for each violation.
(5) EPA may seek to enjoin the processing, distribution in commerce, or use of a chemical substance in violation of this section; act to seize any chemical substance processed, distributed in commerce, or used in violation of this section; or take other actions under the authority of sections 7 and 17 of the Act [15 U.S.C. 2605 and 2616].
This section identifies activities with respect to a chemical substance which are prohibited and requires that warnings and instructions accompany the substance when distributed in commerce.
(a)
(b)
(1) The terms
(2)
(3)
(4)
(i) Processing must be performed at sites under the control of the processor.
(ii) Distribution in commerce is limited to purposes of export.
(iii) The processor or distributor may not use the substance except in small quantities solely for research and development.
(c)
(2) A person using as a metalworking fluid a product containing P-84-310 is prohibited from adding any nitrosating agent to the product.
(d)
(i) A letter that includes the following statements: A substance, identified generically as a triethanolamine salt of a substituted organic acid, contained in the product (
(ii) A copy of this § 747.195.
(2)(i) Any person who distributes in commerce a metalworking fluid containing P-84-310 must affix a label to each container containing the fluid.
(ii) The label shall contain a warning statement which shall consist only of the following language:
WARNING! Do Not Add Nitrites to This Metalworking Fluid under Penalty of Federal Law. Addition of nitrites leads to formation of a substance known to cause cancer. This product is designed to be used without nitrites.
(iii) The first word of the warning statement shall be capitalized, and the type size for the first word shall be no smaller than six point type for a label five square inches or less in area, ten point type for a label above five but below ten square inches in area, twelve point type for a label above ten but below fifteen square inches in area, fourteen point type for a label above fifteen but below thirty square inches in area, or eighteen point type for a label over thirty square inches in area. The type size of the remainder of the warning statement shall be no smaller than six point type. All required label text shall be of sufficient prominence, and shall be placed with such conspicuousness relative to other label text and graphic material, to insure that the warning statement is read and understood by the ordinary individual under customary conditions of purchase and use.
(e)
(2) Except for manufacturers and importers of P-84-310, no processor, distributor, or user of P-84-310 will be in violation of this section unless that
(f)
(1) The person manufactures, imports, processes, distributes in commerce, or uses the substance only in small quantities solely for research and development and in accordance with section 5(h)(3) of the Act.
(2) The person manufactures, imports, processes, distributes in commerce, or uses the substance only as an impurity.
(3) The person imports, processes, distributes in commerce, or uses the substance only as part of an article.
(4) The person processes or distributes the substance in commerce solely for export, and when distributing in commerce, labels the substance in accordance with section 12(a)(1)(B) of the Act.
(g)
(2) Failure or refusal to permit access to or copying of records, as required under section 11 of the Act, is a violation of section 15 of the Act (15 U.S.C. 2614).
(3) Failure or refusal to permit entry or inspection, as required under section 11 of the Act, is a violation of section 15 of the Act (15 U.S.C. 2614).
This section identifies activities with respect to two chemical substances which are prohibited and requires that warnings and instructions accompany the substances when distributed in commerce.
(a)
P-83-1005, triethanolamine salt of tricarboxylic acid; and
P-83-1062, tricarboxylic acid.
(b)
(1) The terms
(2)
(3)
(c)
(2) Any person using as metalworking fluid a product containing P-83-1005 is prohibited from adding any nitrosating agent to the product.
(d)
(i) A letter that includes the following statements:
A substance, identified generically as triethanolamine salt, of tricarboxylic acid, contained in the product (
(ii) A copy of this rule.
(2) Any person who distributes in commerce a metalworking fluid containing P-83-1005 must affix to each container containing the fluid a label that includes, in letters no smaller than ten point type, the following statement:
WARNING! Do Not Add Nitrites to This Metalworking Fluid under Penalty of Federal Law. Addition of nitrite leads to formation of a substance known to cause cancer. This product is designed to be used without nitrites.
(3) Any person who distributes in commerce P-83-1062 in any form in which it could be combined with water and triethanolamine to produce P-83-1005 must send to each recipient of P-83-1062, and confirm receipt prior to the first shipment to that person:
(i) A letter that includes the following statements:
A substance, identified generically as tricarboxylic acid, contained in the product (
(ii) A copy of this rule.
(e)
(2) Except for manufacturers and importers of P-83-1005 and P-83-1062, no processor, distributor, or user of P-83-1005 or P-83-1062 will be in violation of this section unless that person has received a letter specified in paragraph (d)(1) or (3) of this section or a container with the label specified in paragraph (d)(2) of this section.
(f)
(1) The substance is manufactured, imported, processed, distributed in commerce, and used only in small quantities solely for research and development, and if the substance is manufactured, imported, processed, distributed in commerce, and used in accordance with section 5(h)(3) of the Act.
(2) The substance is manufactured, imported, processed, distributed in commerce, or used only as an impurity.
(3) The substance is imported, processed, distributed in commerce, or used only as part of an article.
(4) The substance is manufactured solely for export.
(g)
(2) Failure or refusal to permit access to or copying of records, as required under section 11 of the Act, is a violation of a section 15 of the Act (15 U.S.C. 2614).
(3) Failure or refusal to permit entry or inspection, as required under section 11 of the Act, is a violation of section 15 of the Act (15 U.S.C. 2614).
(4) Violators may be subject to the civil and criminal penalties in section 16 of the Act (15 U.S.C 2615) for each violation.
(5) EPA may seek to enjoin the processing, distribution in commerce, or use of a chemical substance in violation of this section, act to seize any
15 U.S.C. 2605 and 2607.
(a)
(b)
(c)
(d)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
(15)
(16)
(e)
(2) All persons are prohibited from commercial use of hexavalent chromium-based water treatment chemicals in comfort cooling towers.
(3) Distribution in commerce of hexavalent chromium-based water treatment chemicals for use in, and commercial use of hexavalent chromium-based water treatment chemicals in, industrial cooling towers and closed cooling water systems are not prohibited.
(f)
(2) The prohibition described in paragraph (e)(2) of this section against using hexavalent chromium-based water treatment chemicals in comfort cooling towers is effective May 18, 1990.
(g)
WARNING: This product contains hexavalent chromium. Inhalation of hexavalent chromium air emissions increases the risk of lung cancer. Federal Law prohibits use of this substance in comfort cooling towers, which are towers that are open water recirculation devices and that are dedicated exclusively to, and are an integral part of, heating, ventilation, and air conditioning or refrigeration systems.
(2) The first word of the warning statement shall be capitalized, and the type size for the first word shall be no smaller than 10-point type for a label less than or equal to 10 square inches in area, 12-point type for a label above 10 but less than or equal to 15 square inches in area, 14-point type for a label above 15 but less than or equal to 30 square inches in area, or 18-point type for a label above 30 square inches in area. The type size of the remainder of the warning statement shall be no smaller than 6-point type. All required label text shall be in English and of sufficient prominence and shall be placed with such conspicuousness, relative to other label text and graphic material, to ensure that the warning statement is read and understood by the ordinary individual under customary conditions of purchase and use.
(h)
(i) The name, address, contact, and telephone number of the cooling system owners/operators to whom the chemicals were shipped.
(ii) The chemicals included in the shipment, the amount of each chemical shipped, and the location(s) at which the chemicals will be used.
(2) The information described in paragraph (h)(1) of this section shall be retained for 2 years from the date of shipment.
(i)
(i) For the headquarters, the distributor name, address, telephone number, and the name of a contact.
(ii) For the shipment offices through which hexavalent chromium-based water treatment chemicals are sold for use in cooling systems, the distributor name, address, telephone number, and the name of a contact.
(2) The report identified in paragraph (i)(1) of this section shall be updated as changes occur in the distributor headquarters or shipment office information. The updated report shall be submitted to the Regional Administrator and postmarked no later than 10 calendar days after the change occurs.
(3) A person may assert a claim of confidentiality for any information submitted to EPA in connection with this rule. Any claim of confidentiality must accompany the information when submitted to EPA. Persons claiming information as confidential should do so by circling, bracketing, or underlining it and marking it with “CONFIDENTIAL.” EPA will disclose information subject to a claim of confidentiality only to the extent permitted by section 14 of TSCA and 40 CFR part 2, subpart B. If a person does not assert a claim of confidentiality for information at the time it is submitted to EPA, EPA may make the information public without further notice to that person.
(j)
(2) Failure or refusal to establish and maintain records or to permit access to or copying of records, as required by the Act, is a violation of section 15 of the Act (15 U.S.C. 2614).
(3) Failure or refusal to permit entry or inspection as required by section 11 of the Act (15 U.S.C. 2610) is a violation of section 15 of the Act (15 U.S.C. 2614).
(4) Violators may be subject to the civil and criminal penalties in section 16 of the Act (15 U.S.C. 2615) for each violation.
(k)
15 U.S.C. 2605.
This part applies to all rulemakings under authority of section 6 of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2605.
(a) Each rulemaking becomes subject to this part with the publication of a Notice of Proposed Rulemaking in the
(b) Each such notice shall contain:
(1) A draft finding that there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use or disposal of the chemical substance(s) or mixture(s) at issue, or any combination of such activities, presents or will present an unreasonable risk of injury to health or the environment.
(2) A Notice of Proposed Rulemaking stating with particularity the reasons for the proposed rule together with a statement why the proposed rule protects adequately against the risk(s) involved using the least burdensome requirements authorized by TSCA.
(3) Either the draft text of the proposed rule (which may include alternative approaches among which a final choice has not yet been made) or a description of the approaches and provisions being considered for inclusion in the rule, or some combination of the above.
(4) Except for rules published under authority of section 6(e), a draft statement with respect to:
(i) The effects of the substance(s) or mixture(s) at issue on health and the magnitude of the exposure of human beings to such substance(s) or mixture(s);
(ii) The effects of the substace(s) or mixture(s) at issue on the environment and the magnitude of the exposure of the environment to such substance(s) or mixture(s).
(iii) The benefits of the substance(s) or mixture(s) at issue for various uses and the availability of substitutes for such uses; and
(iv) The reasonably ascertainable economic consequences of the rule, after consideration of the effect on the national economy, small business, technological innovation, the environment, and public health.
(v) Major impacts of alternatives to the proposed rule shall also be analyzed.
(5) In cases where the administrator, in his or her discretion, determines that a risk of injury to health or the environment could be eliminated or reduced to a sufficient extent by actions taken under a Federal law (or laws) other than TSCA administered in whole or in part by the Administrator, a finding that it is in the public interest to proceed against such risk under TSCA. Any such finding shall be accompanied by a brief statement discussing:
(i) All relevant aspects of the risk;
(ii) A comparison of the estimated costs of complying with actions taken under TSCA and under such other law (or laws); and
(iii) The relative efficiency of actions under TSCA and under such other law (or laws) to protect against risk of injury.
(c) In addition to the material required under paragraph (b) of this section, each notice of proposed rulemaking shall contain:
(1) A statement of the time and place at which the informal hearing required by section 6(c)(2)(C) of TSCA shall begin, or, to the extent these are not specified, a statement that they will be specified later in a separate
(2) A statement identifying the place at which the official record of the rulemaking is located, the hours during which it will be open for public inspection, the documents contained in it as of the date the notice of proposed rulemaking was issued, and a statement of the approximate times at which additional materials such as public comments, hearing transcripts, and agency studies in progress will be added to the record. If any material other than public comments or material generated by a hearing is added to the record after publication of the notice required by this section, and notice of its future addition was not given at the time of that initial publication, a separate
(3) The due date for public comments, which shall be at least two weeks prior to the informal hearing for main comments and no more than two weeks after the informal hearing for reply comments;
(4) The name, address and office telephone number of the Record and Hearing Clerk for the rulemaking in question; and
(5) A nonbinding target date for issuing the final rule.
(a) No later than the date of proposal of a rule subject to this part, a rulemaking record for that rule shall be established. It shall consist of a separate identified filing space containing:
(1) All documents required by § 750.2(b);
(2) All documents cited in the documents required by § 750.2(b);
(3) All public comments timely received;
(4) All public hearing transcripts;
(5) All material received during an informal hearing and accepted for the record of that hearing; and
(6) Any other information which the Administrator considers to be relevant to such rule and which the Administrator identified, on or before the date of the promulgation of the rule, in a notice published in the
(b) The Record and Hearing Clerk for each rulemaking shall be responsible for Agency compliance with the requirements of paragraph (a) of this section.
(a) Main comments shall be postmarked or received no later than the time specified in the Notice of Proposed Rulemaking and shall contain all comments on and criticisms of that
(b) Reply comments shall be postmarked or received no later than two weeks after the close of all informal hearings on the proposed rule and shall be restricted to comments on:
(1) Other comments;
(2) Material in the hearing record; and
(3) Material which was not and could not reasonably have been available to the commenting party a sufficient time before main comments were due.
(c) Extensions of the time for filing comments may be granted in writing by the Record and Hearing Clerk. Application for an extension shall be made in writing. Comments submitted after the comment period and all extensions of it have expired need not be added to the rulemaking record and need not be considered in decisions concerning the rule. Unless the Notice of Proposed Rulemaking states otherwise, four copies of all comments shall be submitted.
(a) Where necessary, subpoenas requiring the production of documentary material, the attendance of persons at the hearing, or responses to written questions may be issued. Subpoenas may be issued either upon request as provided in paragraph (b) of this section or by EPA on its own motion.
(b) All subpoena requests shall be in writing. Hearing participants may request the issuance of subpoenas as follows:
(1) Subpoenas for the attendance of persons, and for the production of documents or responses to questions at the legislative hearing may be requested at any time up to the deadline for filing main comments.
(2) Subpoenas for production of documents or answers to questions after the legislative hearing may be requested at any time between the beginning of the legislative hearing and the deadline for submitting reply comments.
(c) EPA will rule on all subpoena requests filed under paragraph (b)(1) of this section no later than the beginning of the legislative hearing. Such requests may be granted, denied, or deferred. EPA will rule on all subpoena requests filed under paragraph (b)(2) of this section and all deferred subpoena requests filed under paragraph (b)(1) of this section no later than the promulgation of the final rule. Such requests shall be either granted or denied.
(a) Each person or organization desiring to participate in the informal hearing required by section 6(c)(2)(C) of TSCA shall file a written request to so participate with the Record and Hearing Clerk which shall be postmarked or received no later than three weeks prior to the scheduled start of such hearing. The request shall include:
(1) A brief statement of the interest of the person or organization in the proceeding;
(2) A brief outline of the points to be addressed;
(3) An estimate of the time required; and
(4) If the request comes from an organization, a nonbinding list of the persons to take part in the presentation. Organizations are requested to bring with them, to the extent possible, employees with individual expertise in and responsibility for each of the areas to be addressed. No organization not filing main comments in the rulemaking will be allowed to participate at the hearing, unless a waiver of this requirement is granted in writing by the Record and Hearing Clerk or the organization is appearing at the request of EPA or under subpoena.
(b) No later than one week prior to the start of the hearing, the Record and Hearing Clerk shall make a hearing schedule publicly available and mail or deliver it to each of the persons who requested to appear at the hearing. This schedule shall be subject to change during the course of the hearing at the discretion of those presiding over it.
(c) Opening statements should be brief, and restricted either to points that could not have been made in main comments, or to emphasizing points which are made in main comments, but which the participant believes can be
(a) A panel of EPA employees shall preside at each hearing conducted under section 6(c)(2)(C) of TSCA. In appropriate cases other Executive Branch employees may also sit with and assist the panel. The membership of the panel may change as different topics arise during the hearing. In general, the panel membership will consist of agency employees with special responsibility for the final rule or special expertise in the topics under discussion. One member of the panel shall be named to chair the proceedings and shall attend throughout the hearing, unless unavoidably prevented by sickness or similar personal circumstances.
(b) The panel may question any individual or group participating in the hearing on any subject relating to the rulemaking. Cross-examination by others will normally not be permitted at this stage. It may be granted in compelling circumstances at the sole discretion of the hearing panel. However, persons in the hearing audience may submit questions in writing for the hearing panel to ask the participants, and the hearing panel may, at their discretion, ask these questions.
(c) Participants in the hearing may submit additional material for the hearing record and shall submit such additional material as the hearing panel may request. All such submissions shall become part of the record of the hearing. A verbatim transcript of the hearing shall be made.
(a) After the close of the legislative hearing conducted under § 750.7, any participant in that hearing may submit a written request for cross-examination. The request shall be received by EPA within one week after a full transcript of the legislative hearing becomes available and shall specify:
(1) The disputed issue(s) of material fact as to which cross-examination is requested. This shall include an explanation of why the questions at issue are “factual”, rather than of an analytical or policy nature, the extent to which they are in “dispute” in the light of the record made thus far, and the extent to which and why they can reasonably be considered “material” to the decision on the final rule; and
(2) The person(s) the participant desires to cross-examine, and an estimate of the time necessary. This shall include a statement by the cross-examination requested can be expected to result in “full and true disclosure” resolving the issue of material fact involved.
(b) Within one week after receipt of all requests for cross-examination under paragraph (a) of this section the hearing panel shall rule on them. The ruling shall be served by the Record and Hearing Clerk on all participants who have requested cross-examination and shall be inserted in the record. Written notice of the ruling shall be given to all persons requesting cross-examination and all persons to be cross-examined. The ruling shall specify:
(1) The issues as to which cross-examination is granted,
(2) The persons to be cross-examined on each issue,
(3) The persons to be allowed to conduct cross-examination, and
(4) Time limits for the examination of each witness by each cross-examiner.
(c) Within one week after the insertion into the record of the ruling under paragraph (b) of this section, the hearing at which the cross-examination will be conducted shall commence. One or more members of the original panel shall preside for the Agency. The panel shall have authority to conduct cross-examination on behalf of any participant, although as a general rule this right will not be exercised. The panel shall also have authority to modify the
(d)(1) No later than the time set for requesting cross-examination, a hearing participant may request that other alternative methods of clarifying the record (such as informal conferences or the submittal of additional information) be used. Such requests may be submitted either in lieu of cross-examination requests, or in conjunction with them.
(2) The panel in passing on a cross-examination request may as a precondition to ruling on its merits require that alternative means of clarifying the record be used whether or not that has been requested under paragraph (d)(1) of this section. In such a case the results of the use of such alternative means shall be made available to the person requesting cross-examination of a one-week comment period, and the panel shall make a final ruling on cross-examination within one week thereafter.
(e) Waivers or extensions of any deadline in this section applicable to persons other than EPA may be granted on the record of the hearing by the person chairing it or in writing by the Record and Hearing Clerk.
(a) As soon as feasible after the deadline for submittal of reply comments, the Agency shall issue a final rule. Final versions of the statements required by paragraph (b) of § 750.2 shall be published in the
(1) A list of all material added to the record (other than public comments and material from the hearng record) which has not previously been listed in a
(2) The effective date of the rule.
(b) [Reserved]
To assist in reading the regulations set forth above, this appendix sets forth the principal stages through which rules promulgated under section 6 of TSCA will pass.
The second column gives the relationship that one date bears to another whenever that relationship is specified in the regulations, and cites the governing provision. The third column contains estimates of the time that a typical rulemaking is likely to require to reach and complete each stage of these proceedings. In drawing up this third column, we have assumed that 60 days will be allowed for the submission of main comments; that the legislative phase of the informal hearing will take two weeks, and that cross-examination will take four days. Since these are only estimates, in any given rulemaking shorter or longer times may actually be required for each of these stages.
Sections 750.10-750.21 apply to all rulemakings under authority of section 6(e)(3)(B) of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2605(e)(3)(B) with respect to petitions filed pursuant to § 750.11(a) of this part.
(a)
(b)
(c)
(1) Name, address and telephone number of petitioner.
(2) Description of PCB ban exemption requested, including items to be manufactured and nature of manufacturing process—such as smelting.
(3) Location(s) of manufacturing sites requiring exemption.
(4) Length of time requested for exemption (maximum length of exemption is 1 year).
(5) Amount of PCB chemical substance or PCB mixture (by pounds and/or volume) to be manufactured or used during requested exemption period and the manner of release of PCB's into the environment associated with such manufacture or use.
(6) The basis for the petitioner's contention that under section 6(e)(3)(B)(i) of TSCA “an unreasonable risk of injury to health or environment would not result” from the granting of his petition for exemption.
(7) The basis for the petitioner's contention that he meets the criterion of section 6(e)(3)(B)(ii) of TSCA concerning substitutes for PCB's.
(8) Quantification of the reasonably ascertainable economic consequences of denial of the petition for exemption from the 1979 manufacturing ban and an explanation of the manner of computation.
(d)
(e)
(i) This letter must contain a certification by the petitioner that the type of activities, the procedures for handling the PCBs, the amount of PCBs handled, and any other aspect of the exemption have not changed from the original exemption petition request.
(ii) This letter must be received by EPA at least 6 months prior to the expiration of the existing exemption.
(iii) If a petitioner fails to make a submission or the submission is not timely under this section, the exemption will expire 1 year from the effective date of granting that exemption.
(iv) EPA will address a timely submission of a renewal request by rulemaking and either grant or deny the request.
(2) Any petitioner who has been granted an exemption on or after May 25, 1994, and who seeks to increase the amount of PCBs handled or to change the type of activities, the procedures for handling the PCBs, and any other aspect of their existing exemption must submit a new exemption petition to EPA. The existing exemption activity may continue until the new submission is addressed by rulemaking, provided the activity conforms to the terms of the current exemption approved by EPA, and the petitioner complies with the conditions of paragraph (e)(1) of this section.
(3) Any petitioner who has been granted a TSCA section 6(e)(3)(B) exemption in a rule prior to May 25, 1994, and who seeks to increase the amount of PCBs handled or to change the type of activities, the procedures for handling the PCBs, and any other aspect of their existing exemption must submit a new exemption petition to EPA. The existing exemption activity may continue until the new submission is addressed by rulemaking, provided the activity conforms to the terms of the original exemption approved by EPA.
All petitions received pursuant to § 750.11(a) will be consolidated into one
Rulemaking for PCB exemptions filed pursuant to § 750.11(a) shall begin with the publication of a notice of proposed rulemaking in the
The due date for public comments, which shall be (1) thirty days after publication of the notice of proposed rulemaking for main comments and (2) one week after the close of the informal hearing for reply comments.
Section 750.3 shall be applicable with the exception that the words “§ 750.11(c)” are substituted for “§ 750.2(b)” in § 750.3(a)(1) and (2).
Section 750.4 shall be applicable with the exception that the time period in § 750.4(b) is shortened to 1 week.
The Agency encourages the submission of nonconfidential information by petitioners and commenters. The Agency does not wish to have unnecessary restrictions on access to the rulemaking record. However, if a petitioner or commenter believes that he can only state his position through the use of information claimed to be confidential, he may submit it. Such information must be separately submitted for the rulemaking record and marked “confidential” by the submitter. For the information claimed to be confidential, the Agency will list only the date and the name and address of the petitioner or commenter in the public file, noting that the petitioner or commenter has requested confidential treatment. The information claimed to be confidential will be placed in a confidential file. A petitioner must also file a nonconfidential petition with a nonconfidential summary of the confidential information to be placed in the public file. Similarly, a commenter must supply a nonconfidential summary of the information claimed to be confidential to be placed in the public file. Any information not marked as confidential will be placed in the public file. Information marked confidential will be treated in accordance with the procedures in part 2, subpart B of this title.
Section 750.5 shall be applicable.
(a) Each person or organization desiring to participate in the informal hearing required by section 6(c)(2)(C) of TSCA shall file a written request to so participate with the record and hearing clerk which shall be received no later than 7 days prior to the scheduled start of the hearing. The hearing shall begin 7 days after the close of the 30-day comment period or as soon thereafter as practicable.
(b) With the exception of the first sentence in § 750.6(a), § 750.6 shall be applicable with the further exception that the time period in § 750.6(b) is shortened to no later than 3 days prior to the start of the hearing.
Section 750.7 shall be applicable with the addition of the following sentence at the end of § 750.7(c):
Participants shall be allowed to designate testimony from prior EPA informal rulemaking hearings concerning PCB's under TSCA. The hearing panel may reject repetitive testimony previously presented at such hearings.
Section 750.8 shall be applicable.
(a) As soon as feasible after the deadline for submittal of reply comments,
(1) A list of all material added to the record (other than public comments and material from the hearing record) which has not previously been listed in a
(2) The effective date of the rule.
(b) The Administrator hereby delegates final Agency authority to grant or deny petitions under section 6(e)(3)(B) of TSCA submitted pursuant to § 750.11 of these rules to the Assistant Administrator for Prevention, Pesticides and Toxic Substances. The Assistant Administrator shall act on such petitions subsequent to opportunity for an informal hearing pursuant to these rules.
(c) In determining whether to grant an exemption to the PCB ban, the Agency shall apply the two standards enunciated in section 6(e)(3)(B) of TSCA.
Sections 750.30-750.41 apply to all rulemakings under authority of section 6(e)(3)(B) of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2605(e)(3)(B) with respect to petitions for PCB processing and distribution in commerce exemptions filed pursuant to § 750.31(a) of this part.
(a)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(b)
(c)
(1) Name, address and telephone number of petitioner. See also paragraphs (a) (1) through (9) of this section for additional identification requirements applicable to certain consolidated petitions.
(2) Description of PCB processing or distribution in commerce exemption requested, including a description of the chemical substances, mixtures or items to be processed or distributed in commerce and, if processing is involved, the nature of the processing.
(3) For processing petitions, location(s) of sites requiring exemption.
(4) Length of time requested for exemption (maximum length of exemption is one year).
(5) Estimated amount of PCBs (by pound and/or volume) to be processed, distributed in commerce, or used during requested exemption period and the manner of release of PCBs into the environment associated with such processing, distribution in commerce, or use. Where the PCB concentration is less than 500 ppm, both the total liquid volume and the total PCB volume must be provided.
(6) The basis for the petitioner's contention that under section 6(e)(3)(B)(i) of TSCA “an unreasonable risk of injury to health or environment would not result” from the granting of the petition for exemption.
(7) The basis for the petitioner's contention that under section 6(e)(3)(B)(ii) “good faith efforts have been made to develop a chemical substance which does not present an unreasonable risk of injury to health or the environment and which may be substituted for” the PCB.
(8) Quantification of the reasonably ascertainable economic consequences of denying the petition for exemption and an explanation of the manner of computation.
(9) In addition to the information in paragraphs (c)(1) through (c)(8) of this section, certain petitions must contain additional information as follows:
(i) Persons who process or distribute in commerce dielectric fluids containing 50 ppm or greater PCB for use in PCB Transformers, railroad transformers, or PCB electromagnets must also state the expected number of PCB Transformers, railroad transformers,
(ii) Persons filing petitions under paragraph (a)(1) of this section (Processing and Distribution in Commerce of PCB-Contaminated Transformer Dielectric Fluid) must also provide the expected number of PCB-Contaminated Transformers to be serviced under the requested exemption and the expected method of disposal of waste dielectric fluid. In addition, a person must identify all the facilities which he owns or operates where he services PCB-Contaminated Transformers. This information, as well as the information required by paragraphs (c)(1), (c)(3), and (c)(5) of this section, must be provided for each person represented by the petition. All other information may be provided on a group basis.
(iii) Persons filing petitions under paragraphs (a)(2) (Contaminated Substances and Mixtures-Processing) and (a)(3) (Contaminated Substances and Mixtures-Distribution in Commerce) must also provide a justification for the class grouping selected and a description of the uses and the human and environmental exposure associated with each use of the PCB-contaminated chemical substance or mixture for which an exemption is sought. Information may be provided on a group basis, except that the information required by paragraphs (c)(1), (c)(3) and (c)(5) of this section, must be provided for each person represented by a petition under paragraph (a)(2) of this section.
(iv) Persons filing petitions under paragraph (a)(4) of this section (PCB Capacitor Distribution for Purposes of Repair) must also provide an estimate of the expected total number of PCB Capacitors to be distributed in commerce under the requested exemption. All information may be provided on a group basis.
(v) Persons filing petitions under paragraphs (a) (7) and (8) of this section (Processing of PCB Articles into PCB Equipment and Processing of PCB Equipment into Other PCB Equipment) must provide a description of each type of PCB Equipment (including the amount of PCBs by poundage and/or volume in the PCB Equipment) to be processed and/or distributed in commerce under the exemption, the number of each type of equipment expected to be processed and/or distributed in commerce, and the approximate number of distributors or further processors covered by the petition. All information may be provided on a group basis. However, in the case of a petition under paragraph (a)(7) of this section, the processor of PCB Articles into PCB Equipment must be identified in the petition. In the case of a petition under paragraph (a)(8) of this section, the processor of PCB Equipment who files the petition must be identified.
(vi) Persons filing petitions under paragraph (a)(9) of this section (Distribution of PCB Equipment) must provide a description of each type of PCB Equipment (including the amount of PCBs by poundage and/or volume in the PCB Equipment) to be distributed in commerce under the exemption, the number of each type of equipment to be distributed in commerce, and the approximate number of distributors covered by the petition. All information may be provided on a group basis.
(vii) Persons filing petitions under paragraphs (a) (5) and (6) of this section must provide the information required by paragraphs (c) (1) through (8) of this section for each petitioner named in the petition.
(d) EPA reserves the right to request further information as to each petition where necessary to determine whether the petition meets the statutory tests of section 6(e)(3)(B) of TSCA prior to or after publication of the notice of proposed rulemaking required by § 750.33 of these rules.
(e)
(i) This letter must contain a certification by the petitioner that the type
(ii) This letter must be received by EPA at least 6 months prior to the expiration of the existing exemption.
(iii) If a petitioner fails to make a submission or the submission is not timely under this section, the exemption will expire 1 year from the effective date of granting that exemption.
(iv) EPA will address a timely submission of a renewal request by rulemaking and either grant or deny the request.
(2) Any petitioner who has been granted an exemption on or after May 25, 1994, and who seeks to increase the amount of PCBs handled or to change the type of activities, the procedures for handling the PCBs, and any other aspect of their existing exemption must submit a new exemption petition to EPA. The existing exemption activity may continue until the new submission is addressed by rulemaking, provided the activity conforms to the terms of the current exemption approved by EPA, and the petitioner complies with the conditions of paragraph (e)(1) of this section.
(3) Any petitioner who has been granted a TSCA section 6(e)(3)(B) exemption in a rule prior to May 25, 1994, and who seeks to increase the amount of PCBs handled or to change the type of activities, the procedures for handling the PCBs, and any other aspect of their existing exemption must submit a new exemption petition to EPA. The existing exemption activity may continue until the new submission is addressed by rulemaking, provided the activity conforms to the terms of the original exemption approved by EPA.
All petitions received pursuant to § 750.31(a) will be consolidated into one rulemaking with one informal hearing held on all petitions.
Rulemaking for PCB processing and distribution in commerce exemptions filed pursuant to § 750.31(a) will begin with the publication of a Notice of Proposed Rulemaking in the
(a) A summary of the information required in §750.31(d);
(b) A statement of the time and place at which the informal hearing required by section 6(c)(2)(C) of TSCA shall begin, or, to the extent these are not specified, a statement that they will be specified later in a separate
(c) A statement identifying the place at which the official record of the rulemaking is located, the hours during which it will be open for public inspection, the documents contained in it as of the date the Notice of Proposed Rulemaking was issued, and a statement of the approximate times at which additional materials such as public comments, hearing transcripts, and Agency studies in progress will be added to the record. If any material other than public comments or material generated by a hearing is added to the record after publication of the notice required by this action, and notice of its future addition was not given at the time of that initial publication, a separate
(d) The due date for public comments, which will be (1) 30 days after publication of the notice of proposed rulemaking for main comments and (2) one week after the informal hearing for reply comments;
(e) The name, address, and office telephone number of the Record Clerk and the Hearing Clerk for the rulemaking in question; and
(f) A nonbinding target date for issuing the final rule.
(a) No later than the date of proposal of a rule subject to this subpart, a rulemaking record for that rule will be established. It will consist of a separate identified filing space containing:
(1) All documents required by § 750.31(d);
(2) All public comments timely received;
(3) All public hearing transcripts;
(4) All material received during an informal hearing and accepted for the record of that hearing; and
(5) Any other information that the Assistant Administrator for Prevention, Pesticides and Toxic Substances considers to be relevant to such rule and that the Assistant Administrator identified, on or before the date of the promulgation of the rule, in a notice published in the
(b) All material in the record will be appropriately indexed. Each record will be available for public inspection during normal EPA business hours. Appropriate arrangements allowing members of the public to copy record materials that do not risk the permanent loss of such materials will be made. All material required to be included in the record will be added to the record as soon as feasible after its receipt by EPA.
(c) The Record Clerk for each rulemaking will be responsible for EPA compliance with the requirements of paragraph (a) of this section.
(a) Main comments must be postmarked or received no later than the time specified in the Notice of Proposed Rulemaking and must contain all comments on and criticisms of that Notice by the commenting person, based on information which is or reasonably could have been available to that person at the time.
(b) Reply comments must be postmarked or received no later than one week after the close of all informal hearings on the proposed rule and must be restricted to comments on:
(1) Other comments;
(2) Material in the hearing record; and
(3) Material which was not and could not reasonably have been available to the commenting party a sufficient time before main comments were due.
(c) Extensions of the time for filing comments may be granted in writing by the Hearing Chairman. Application for an extension must be made in writing. Comments submitted after the comment period and all extensions of it have expired need not be added to the rulemaking record and need not be considered in decisions concerning the rule.
(d) Unless the Notice of Proposed Rulemaking states otherwise, four copies of all comments must be submitted.
EPA encourages the submission of non-confidential information by petitioners and commentors. EPA does not wish to have unnecessary restrictions on access to the rulemaking record. However, if a petitioner or commentor believes that he can only state his position through the use of information claimed to be confidential, he may submit it. Such information must be separately submitted for the rulemaking record and marked “confidential” by the submitter. For the information claimed to be confidential, EPA will list only the date and the name and address of the petitioner or commentor in the public file, noting that the petitioner or commentor has requested confidential treatment. The information claimed to be confidential will be placed in a confidential file. A petitioner must also file a non-confidential petition with a non-confidential summary of the confidential information to be placed in the public file. Similarly, a commentor must supply a non-confidential summary of the information claimed to be confidential to be placed in the public file. Any information not marked as confidential will be placed in the public file. Information marked confidential will be treated in accordance with the procedures in part 2, subpart B of this title.
(a) Where necessary, subpoenas requiring the production of documentary material, the attendance of persons at the hearing, or responses to written questions may be issued. Subpoenas may be issued either upon request as
(b) All subpoena requests must be in writing. Hearing participants may request the issuance of subpoenas as follows:
(1) Subpoenas for the attendance of persons or for the production of documents or responses to questions at the legislative hearing may be requested at any time up to the deadline for filing main comments.
(2) Subpoenas for production of documents or answers to questions after the legislative hearing may be requested at any time between the beginning of the legislative hearing and the deadline for submitting reply comments.
(c) EPA will rule on all subpoena requests filed under paragraph (b)(1) of this section no later than the beginning of the informal hearing. Such requests may be granted, denied, or deferred. EPA will rule on all subpoena requests filed under paragraph (b)(2) of this section and all deferred subpoena requests filed under paragraph (b)(1) of this section no later than the promulgation of the final rule. Such requests will be either granted or denied.
(a) Each person or organization desiring to participate in the informal hearing required by section 6(c)(2)(C) of TSCA must file a written request to participate with the Hearing Clerk. This request must be received no later than seven days prior to the scheduled start of the hearing. The hearing will begin seven days after the close of the thirty day comment period or as soon thereafter as practicable. The request must include:
(1) A brief statement of the interest of the person or organization in the proceeding;
(2) A brief outline of the points to be addressed;
(3) An estimate of the time required; and
(4) If the request comes from an organization, a nonbinding list of the persons to take part in the presentation. Organizations are requested to bring with them, to the extent possible, employees with individual expertise in and responsibility for each of the areas to be addressed. No organization not filing main comments in the rulemaking will be allowed to participate at the hearing, unless a waiver of this requirement is granted in writing by the Hearing Chairman or the organization is appearing at the request of EPA or under subpoena.
(b) No later than three days prior to the start of the hearing, the Hearing Clerk will make a hearing schedule publicly available and mail or deliver it to each of the persons who requested to appear at the hearing. This schedule will be subject to change during the course of the hearing at the discretion of those presiding over it.
(c) Opening statements should be brief, and restricted either to points that could not have been made in main comments or to emphasizing points which are made in main comments, but which the participant believes can be more forcefully urged in the hearing context.
(a) A panel of EPA employees shall preside at each hearing conducted under section 6(c)(2)(C) of TSCA. In appropriate cases, other Executive Branch employees may also sit with and assist the panel. The membership of the panel may change as different topics arise during the hearing. In general, the panel membership will consist of EPA employees with special responsibility for the final rule or special expertise in the topics under discussion. One member of the panel will be named to chair the proceedings and will attend throughout the hearing, unless unavoidably prevented by sickness or similar personal circumstances.
(b) The panel may question any individual or group participating in the hearing on any subject relating to the rulemaking. Cross-examination by others will normally not be permitted at this stage. It may be granted in compelling circumstances at the sole discretion of the hearing panel. However, persons in the hearing audience may submit questions in writing for the hearing panel to ask the participants, and the hearing panel may, at their discretion, ask these questions.
(c) Participants in the hearing may submit additional material for the
(a) After the close of the informal hearing conducted under § 750.39, any participant in that hearing may submit a written request for cross-examination. The request must be received by EPA within one week after a full transcript of the informal hearing becomes available and must specify:
(1) The disputed issue(s) of material fact as to which cross-examination is requested. This must include an explanation of why the questions at issue are “factual”, rather than of an analytical or policy nature, the extent to which they are in “dispute” in the light of the record made thus far, and the extent to which and why they can reasonably be considered “material” to the decision on the final rule; and
(2) The person(s) the participant desires to cross-examine, and an estimate of the time necessary. This must include a statement as to how the cross-examination requested can be expected to result in “full and true disclosure” resolving the issue of material fact involved.
(b) Within one week after receipt of all requests for cross-examination under paragraph (a), the hearing panel will rule on them. The ruling will be served by the Hearing Clerk on all participants who have requested cross-examination and will be inserted in the record. Written notice of the ruling will be given to all persons requesting cross-examination and all persons to be cross-examined. The ruling will specify:
(1) The issues as to which cross-examination is granted;
(2) The persons to be cross-examined on each issue;
(3) The persons to be allowed to conduct cross-examination; and
(4) Time limits for the examination of each witness by each cross-examiner.
(c) In issuing this ruling, the panel may determine that one or more participants who have requested cross-examination have the same or similar interests and should be required to choose a single representative for purposes of cross-examination by that single representative without identifying the representative further. Subpoenas for witnesses may be issued where necessary.
(d) Within one week after the insertion into the record of the ruling under paragraph (b) of this section, the hearing at which the cross-examination will be conducted will begin. One or more members of the original panel will preside for EPA. The panel will have authority to conduct cross-examination on behalf of any participant, although as a general rule this right will not be exercised. The panel will also have authority to modify the governing ruling in any respect and to make new rulings on group representation under section 6(c)(3)(C) of TSCA. A verbatim transcript of the hearing will be made.
(e)(1) No later than the time set for requesting cross-examination, a hearing participant may request that other alternative methods of clarifying the record (such as informal conferences or the submittal of additional information) be used. Such requests may be submitted either in lieu of cross-examination requests, or in conjunction with them.
(2) The panel in passing on a cross-examination request may, as a precondition to ruling on its merits, require that alternative means of clarifying the record be used whether or not that has been requested under paragraph (e)(1) of this section. In such a case, the results of the use of such alternative means will be made available to the person requesting cross-examination for a one-week comment period, and the panel will make a final ruling on cross-examination within one week thereafter.
(f) Waivers or extensions of any deadline in this section applicable to persons other than EPA may be granted
(a) As soon as feasible after the deadline for submittal of reply comments, EPA will issue a final rule. EPA will also publish at that time:
(1) A list of all material added to the record (other than public comments and material from the hearing record) which has not previously been listed in a
(2) The effective date of the rule.
(b) Pursuant to the delegation of authority made in the Preamble to the Final Regulation for the PCB Manufacturing, Processing, Distribution in Commerce and Use Prohibitions, the Assistant Administrator for Prevention, Pesticides and Toxic Substances will grant or deny petitions under section 6(e)(3)(B) of TSCA submitted pursuant to § 750.31. The Assistant Administrator will act on such petitions subsequent to opportunity for an informal hearing pursuant to this rule.
(c) In determining whether to grant an exemption to the PCB ban, EPA will apply the two standards enunciated in section 6(e)(3)(B) of TSCA.
15 U.S.C. 2605, 2607, 2611, 2614, and 2616.
(a) This part establishes prohibitions of, and requirements for, the manufacture, processing, distribution in commerce, use, disposal, storage, and marking of PCBs and PCB Items.
(b)(1) This part applies to all persons who manufacture, process, distribute in commerce, use, or dispose of PCBs or PCB Items. Substances that are regulated by this part include, but are not limited to: dielectric fluids; solvents; oils; waste oils; heat transfer fluids; hydraulic fluids; paints or coatings; sludges; slurries; sediments; dredge spoils; soils; materials containing PCBs as a result of spills; and other chemical substances or combinations of substances, including impurities and byproducts and any byproduct, intermediate, or impurity manufactured at any point in a process.
(2) Unless otherwise noted, PCB concentrations shall be determined on a weight-per-weight basis (e.g., milligrams per kilogram), or for liquids, on a weight-per-volume basis (e.g., milligrams per liter) if the density of the liquid is also reported. Unless otherwise provided, PCBs are quantified based on the formulation of PCBs present in the material analyzed. For example, measure Aroclor
(3) Most provisions in this part apply only if PCBs are present in concentrations above a specified level. Provisions that apply to PCBs at concentrations of < 50 ppm apply also to contaminated surfaces at PCB concentrations of ≤ 10 µg/100 cm
(4) PCBs can be found in liquid, non-liquid and multi-phasic (combinations of liquid and non-liquid) forms. A person should use the following criteria to determine PCB concentrations to determine which provisions of this part apply to such PCBs.
(i) Any person determining PCB concentrations for non-liquid PCBs must do so on a dry weight basis.
(ii) Any person determining PCB concentrations for liquid PCBs must do so on a wet weight basis. Liquid PCBs containing more than 0.5 percent by weight non-dissolved material shall be analyzed as multi-phasic non-liquid/liquid mixtures.
(iii) Any person determining the PCB concentration of samples containing PCBs and non-dissolved non-liquid materials ≥0.5 percent, must separate the non-dissolved materials into non-liquid PCBs and liquid PCBs. For multi-phasic non-liquid/liquid or liquid/liquid mixtures, the phases shall be separated before chemical analysis. Following phase separation, the PCB concentration in each non-liquid phase shall be determined on a dry weight basis and the PCB concentration in each liquid phase shall be determined separately on a wet weight basis.
(iv) Any person disposing of multi-phasic non-liquid/liquid or liquid/liquid
(5) No person may avoid any provision specifying a PCB concentration by diluting the PCBs, unless otherwise specifically provided.
(6) Unless otherwise specified, references to weights or volumes of PCBs in this part apply to the total weight or total volume of the material (oil, soil, debris, etc.) that contains regulated concentrations of PCBs, not the calculated weight or volume of only the PCB molecules contained in the material.
(c) Definitions of the terms used in these regulations are in subpart A. The basic requirements applicable to disposal and marking of PCBs and PCB Items are set forth in subpart D—Disposal of PCBs and PCB Items and in subpart C—Marking of PCBs and PCB Items. Prohibitions applicable to PCB activities are set forth in subpart B—Manufacture, Processing, Distribution in Commerce, and Use of PCBs and PCB Items. Subpart B also includes authorizations from the prohibitions. Subparts C and D set forth the specific requirements for disposal and marking of PCBs and PCB Items.
(d) Section 15 of the Toxic Substances Control Act (TSCA) states that failure to comply with these regulations is unlawful. Section 16 imposes liability for civil penalties upon any person who violates these regulations, and the Administrator can establish appropriate remedies for any violations subject to any limitations included in section 16 of TSCA. Section 16 also subjects a person to criminal prosecution for a violation which is knowing or willful. In addition, section 17 authorizes Federal district courts to enjoin activities prohibited by these regulations, compel the taking of actions required by these regulations, and issue orders to seize PCBs and PCB Items manufactured, processed or distributed in violation of these regulations.
(e) These regulations do not preempt other more stringent Federal statutes and regulations.
(f) Unless and until superseded by any new more stringent regulations issued under EPA authorities, or any permits or any pretreatment requirements issued by EPA, a state or local government that affect release of PCBs to any particular medium:
(1) Persons who inadvertently manufacture or import PCBs generated as unintentional impurities in excluded manufacturing processes, as defined in § 761.3, are exempt from the requirements of subpart B of this part, provided that such persons comply with subpart J of this part, as applicable.
(2) Persons who process, distribute in commerce, or use products containing PCBs generated in excluded manufacturing processes defined in § 761.3 are exempt from the requirements of subpart B provided that such persons comply with subpart J of this part, as applicable.
(3) Persons who process, distribute in commerce, or use products containing recycled PCBs defined in § 761.3, are exempt from the requirements of subpart B of this part, provided that such persons comply with subpart J of this part, as applicable.
(4) Except as provided in § 761.20 (d) and (e), persons who process, distribute in commerce, or use products containing excluded PCB products as defined in § 761.3, are exempt from the requirements of subpart B of this part.
(a)(1) Any person may assume that transformers with < 3 pounds (1.36 kilograms (kgs)) of fluid, circuit breakers, reclosers, oil-filled cable, and rectifiers whose PCB concentration is not established contain PCBs at < 50 ppm.
(2) Any person must assume that mineral oil-filled electrical equipment that was manufactured before July 2, 1979, and whose PCB concentration is not established is PCB-Contaminated
(3) Any person must assume that a transformer manufactured prior to July 2, 1979, that contains 1.36 kg (3 pounds) or more of fluid other than mineral oil and whose PCB concentration is not established, is a PCB Transformer (i.e., ≥ 500 ppm). If the date of manufacture and the type of dielectric fluid are unknown, any person must assume the transformer to be a PCB Transformer.
(4) Any person must assume that a capacitor manufactured prior to July 2, 1979, whose PCB concentration is not established contains ≥500 ppm PCBs. Any person may assume that a capacitor manufactured after July 2, 1979, is non-PCB (i.e., < 50 ppm PCBs). If the date of manufacture is unknown, any person must assume the capacitor contains ≥500 ppm PCBs. Any person may assume that a capacitor marked at the time of manufacture with the statement “No PCBs” in accordance with § 761.40(g) is non-PCB.
(b) PCB concentration may be established by:
(1) Testing the equipment; or
(2)(i) A permanent label, mark, or other documentation from the manufacturer of the equipment indicating its PCB concentration at the time of manufacture; and
(ii) Service records or other documentation indicating the PCB concentration of all fluids used in servicing the equipment since it was first manufactured.
For the purpose of this part:
(1)
(2)
(3)
Under civil and criminal penalties of law for the making or submission of false or fraudulent statements or representations (18 U.S.C. 1001 and 15 U.S.C. 2615), I certify that the information contained in or accompanying this document is true, accurate, and complete. As to the identified section(s) of this document for which I cannot personally verify truth and accuracy, I certify as the company official having supervisory responsibility for the persons who, acting under my direct instructions, made the verification that this information is true, accurate, and complete.
(2) Such term does not include: Any mixture; any pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a pesticide; tobacco or any tobacco product; any source material, special nuclear material, or byproduct material (as such terms are defined in the Atomic Energy Act of 1954 and regulations issued under such Act); any article the sale of which is subject to the tax imposed by section 4181 of the Internal Revenue Code of 1954 (determined without regard to any exemptions from such tax provided by section 4182 or section 4221 or any provisions of such Code); and any food, food additive, drug, cosmetic, or device (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act) when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device.
(1) Between a place in a State and any place outside of such State, or
(2) Which affects trade, traffic, transportation, or commerce described in paragraph (1) of this definition.
(1) The concentration of inadvertently generated PCBs in products leaving any manufacturing site or imported into the United States must have an annual average of less than 25 ppm, with a 50 ppm maximum.
(2) The concentration of inadvertently generated PCBs in the components of detergent bars leaving the manufacturing site or imported into the United States must be less than 5 ppm.
(3) The release of inadvertently generated PCBs at the point at which emissions are vented to ambient air must be less than 10 ppm.
(4) The amount of inadvertently generated PCBs added to water discharged from a manufacturing site must be less than 100 micrograms per resolvable gas chromatographic peak per liter of water discharged.
(5) Disposal of any other process wastes above concentrations of 50 ppm PCB must be in accordance with subpart D of this part.
(1) Non-Aroclor inadvertently generated PCBs as a byproduct or impurity resulting from a chemical manufacturing process.
(2) Products contaminated with Aroclor or other PCB materials from historic PCB uses (investment casting waxes are one example).
(3) Recycled fluids and/or equipment contaminated during use involving the products described in paragraphs (1) and (2) of this definition (heat transfer and hydraulic fluids and equipment and other electrical equipment components and fluids are examples).
(4) Used oils, provided that in the cases of paragraphs (1) through (4) of this definition:
(i) The products or source of the products containing < 50 ppm concentration PCBs were legally manufactured, processed, distributed in commerce, or used before October 1, 1984.
(ii) The products or source of the products containing < 50 ppm concentrations PCBs were legally manufactured, processed, distributed in commerce, or used, i.e., pursuant to authority granted by EPA regulation, by exemption petition, by settlement agreement, or pursuant to other Agency-approved programs;
(iii) The resulting PCB concentration (i.e. below 50 ppm) is not a result of dilution, or leaks and spills of PCBs in concentrations over 50 ppm.
(1) Control of combustion air to maintain adequate temperature for efficient combustion.
(2) Containment of the combustion reaction in an enclosed device to provide sufficient residence time and mixing for complete combustion.
(3) Control of emission of the gaseous combustion products.
(1) Non-liquid bulk wastes or debris from the demolition of buildings and other man-made structures manufactured, coated, or serviced with PCBs. PCB bulk product waste does not include debris from the demolition of
(2) PCB-containing wastes from the shredding of automobiles, household appliances, or industrial appliances.
(3) Plastics (such as plastic insulation from wire or cable; radio, television and computer casings; vehicle parts; or furniture laminates); preformed or molded rubber parts and components; applied dried paints, varnishes, waxes or other similar coatings or sealants; caulking; adhesives; paper; Galbestos; sound deadening or other types of insulation; and felt or fabric products such as gaskets.
(4) Fluorescent light ballasts containing PCBs in the potting material.
(1) Environmental media containing PCBs, such as soil and gravel; dredged materials, such as sediments, settled sediment fines, and aqueous decantate from sediment.
(2) Sewage sludge containing < 50 ppm PCBs and not in use according to § 761.20(a)(4); PCB sewage sludge; commercial or industrial sludge contaminated as the result of a spill of PCBs including sludges located in or removed from any pollution control device; aqueous decantate from an industrial sludge.
(3) Buildings and other man-made structures (such as concrete floors, wood floors, or walls contaminated from a leaking PCB or PCB-Contaminated Transformer), porous surfaces, and non-porous surfaces.
(1) In the same form or physical state as, or in a different form or physical state from, that in which it was received by the person so preparing such substance or mixture, or
(2) As part of an article containing the chemical substance or mixture.
(1) An incinerator approved under the provisions of § 761.70. Any level of PCB concentration can be destroyed in an incinerator approved under § 761.70.
(2) A high efficiency boiler which complies with the criteria of § 761.71(a)(1), and for which the operator has given written notice to the appropriate EPA Regional Administrator in accordance with the notification requirements for the burning of mineral oil dielectric fluid under § 761.71(a)(2).
(3) An incinerator approved under section 3005(c) of the Resource Conservation and Recovery Act (42 U.S.C. 6925(c)) (RCRA).
(4) Industrial furnaces and boilers which are identified in 40 CFR 260.10 and 40 CFR 279.61 (a)(1) and (2) when operating at their normal operating temperatures (this prohibits feeding fluids, above the level of detection, during either startup or shutdown operations).
(1) There are no detectable concentrations of PCBs in asphalt roofing material products leaving the processing site.
(2) The concentration of PCBs in paper products leaving any manufacturing site processing paper products, or in paper products imported into the United States, must have an annual average of less than 25 ppm with a 50 ppm maximum.
(3) The release of PCBs at the point at which emissions are vented to ambient air must be less than 10 ppm.
(4) The amount of Aroclor PCBs added to water discharged from an asphalt roofing processing site must at all times be less than 3 micrograms per liter (µg/L) for total Aroclors (roughly 3 parts per billion (3 ppb)). Water discharges from the processing of paper products must at all times be less than 3 micrograms per liter (µg/L) for total Aroclors (roughly 3 ppb), or comply with the equivalent mass-based limitation.
(5) Disposal of any other process wastes at concentrations of 50 ppm or greater must be in accordance with subpart D of this part.
(1) Whether the waste is amenable to the treatment process;
(2) What pretreatment (if any) is required;
(3) The optimal process conditions needed to achieve the desired treatment;
(4) The efficiency of a treatment process for the specific type of waste (i.e., soil, sludge, liquid, etc.); or,
(5) The characteristics and volumes of residuals from a particular treatment process. A “treatability study” is not a mechanism to commercially treat or dispose of PCB waste. Treatment is a form of disposal under this part.
(a) [Reserved]
(b)
Except as authorized in § 761.30, the activities listed in paragraphs (a) and (d) of this section are prohibited pursuant to section 6(e)(2) of TSCA. The requirements set forth in paragraph (c) of this section and subpart F of this part concerning export and import of PCBs and PCB Items for disposal are established pursuant to section 6(e)(1) of
(a) No persons may use any PCB, or any PCB Item regardless of concentration, in any manner other than in a totally enclosed manner within the United States unless authorized under § 761.30, except that:
(1) An authorization is not required to use those PCBs or PCB Items which consist of excluded PCB products as defined in § 761.3.
(2) An authorization is not required to use those PCBs or PCB Items resulting from an excluded manufacturing process or recycled PCBs as defined in § 761.3, provided all applicable conditions of § 761.1(f) are met.
(3) An authorization is not required to use those PCB Items which contain or whose surfaces have been in contact with excluded PCB products as defined in § 761.3.
(4) An authorization is not required to use sewage sludge where the uses are regulated at parts 257, 258, and 503 of this chapter. No person may blend or otherwise dilute PCBs regulated for disposal, including PCB sewage sludge and sewage sludge not used pursuant to parts 257, 258, and 503 of this chapter, for purposes of use or to avoid disposal requirements under this part. Except as explicitly provided in subpart D of this part, no person may dispose of regulated PCB wastes including, but not limited to, PCB remediation waste, PCB bulk product waste, PCBs, and PCB industrial sludges, into treatment works, as defined in § 503.9(aa) of this chapter.
(b) No person may manufacture PCBs for use within the United States or manufacture PCBs for export from the United States without an exemption, except that: an exemption is not required for PCBs manufactured in an excluded manufacturing process as defined in § 761.3, provided all applicable conditions of § 761.1(f) are met.
(c) No persons may process or distribute in commerce any PCB, or any PCB Item regardless of concentration, for use within the United States or for export from the United States without
(1) PCBs at concentrations of 50 ppm or greater, or PCB Items with PCB concentrations of 50 ppm or greater, sold before July 1, 1979 for purposes other than resale may be distributed in commerce only in a totally enclosed manner after that date.
(2) Any person may process and distribute in commerce for disposal PCBs at concentrations of ≥50 ppm, or PCB Items with PCB concentrations of ≥50 ppm, if they comply with the applicable provisions of this part.
(i) Processing activities which are primarily associated with and facilitate storage or transportation for disposal do not require a TSCA PCB storage or disposal approval.
(ii) Processing activities which are primarily associated with and facilitate treatment, as defined in § 260.10 of this chapter, or disposal require a TSCA PCB disposal approval unless they are part of an existing approval, are part of a self-implementing activity under § 761.61(a) or § 761.79 (b) or (c), or are otherwise specifically allowed under subpart D of this part.
(iii) With the exception of provisions in § 761.60 (a)(2) and (a)(3), in order to meet the intent of § 761.1(b), processing, diluting, or otherwise blending of waste prior to being introduced into a disposal unit for purposes of meeting a PCB concentration limit shall be done in accordance with a TSCA PCB disposal approval or comply with the requirements of § 761.79.
(iv) Where the rate of delivering liquids or non-liquids into a PCB disposal unit is an operating parameter, this rate shall be a condition of the TSCA PCB disposal approval for the unit when an approval is required.
(3) PCBs and PCB Items may be exported for disposal in accordance with the requirements of subpart F of this part.
(4) PCBs, at concentrations of less than 50 ppm, or PCB Items, with concentrations of less than 50 ppm, may be processed and distributed in commerce for purposes of disposal.
(5) Decontaminated materials. Any person may distribute in commerce equipment, structures, or other liquid or non-liquid materials that were contaminated with PCBs ≥50 ppm, including those not otherwise authorized for distribution in commerce under this part, provided that one of the following applies:
(i) The materials were decontaminated in accordance with a TSCA PCB disposal approval issued under subpart D of this part, with § 761.79, or with applicable EPA PCB spill cleanup policies in effect at the time of the decontamination.
(ii) If not previously decontaminated, the materials now meet an applicable decontamination standard in § 761.79(b).
(d) The use of waste oil that contains any detectable concentration of PCB as a sealant, coating, or dust control agent is prohibited. Prohibited uses include, but are not limited to, road oiling, general dust control, use as a pesticide or herbicide carrier, and use as a rust preventative on pipes.
(e) In addition to any applicable requirements under 40 CFR part 279, subparts G and H, marketers and burners of used oil who market (process or distribute in commerce) for energy recovery, used oil containing any quantifiable level of PCBs are subject to the following requirements:
(1)
(i) Qualified incinerators as defined in 40 CFR 761.3.
(ii) Marketers who market off-specification used oil for energy recovery only to other marketers who have notified EPA of their used oil management activities, and who have an EPA identification number where an identification number is required by 40 CFR 279.73. This would include persons who
(iii) Burners identified in 40 CFR 279.61(a)(1) and (2). Only burners in the automotive industry may burn used oil generated from automotive sources in used oil-fired space heaters provided the provisions of 40 CFR 279.23 are met. The Regional Administrator may grant a variance for a boiler that does not meet the 40 CFR 279.61(a)(1) and (2) criteria after considering the criteria listed in 40 CFR 260.32 (a) through (f). The applicant must address the relevant criteria contained in 40 CFR 260.32 (a) through (f) in an application to the Regional Administrator.
(2)
(i) The person who first claims that a used oil fuel does not contain quantifiable level (2 ppm) PCB must obtain analyses or other information to support that claim.
(ii) Testing to determine the PCB concentration in used oil may be conducted on individual samples, or in accordance with the testing procedures described in § 761.60(g)(2). However, for purposes of this part, if any PCBs at a concentration of 50 ppm or greater have been added to the container or equipment, then the total container contents must be considered as having a PCB concentration of 50 ppm or greater for purposes of complying with the disposal requirements of this part.
(iii) Other information documenting that the used oil fuel does not contain quantifiable levels (2 ppm) of PCBs may consist of either personal, special knowledge of the source and composition of the used oil, or a certification from the person generating the used oil claiming that the oil contains no detectable PCBs.
(3)
(ii) Before a burner accepts from a marketer the first shipment of used oil fuel containing detectable PCBs (2 ppm), the burner must provide the marketer a one-time written and signed notice certifying that:
(A) The burner has complied with any notification requirements applicable to “qualified incinerators” (§ 761.3) or to “burners” regulated under 40 CFR part 279, subpart G.
(B) The burner will burn the used oil only in a combustion facility identified in paragraph (e)(1) of this section and identify the class of burner he qualifies.
(4)
(i)
(ii)
The following non-totally enclosed PCB activities are authorized pursuant to section 6(e)(2)(B) of TSCA:
(a)
(1)
(ii) As of October 1, 1990, the use of network PCB Transformers with higher secondary voltages (secondary voltages equal to or greater than 480 volts, including 480/277 volt systems) in or near commercial buildings is prohibited. Network PCB Transformers with higher secondary voltages which are removed from service in accordance with this requirement must either be reclassified to PCB Contaminated or non PCB status, placed into storage for disposal, or disposed.
(iii) Except as otherwise provided, as of October 1, 1985, the installation of PCB Transformers, which have been placed into storage for reuse or which have been removed from another location, in or near commercial buildings is prohibited.
(A) Retrofilled mineral oil PCB Transformers may be installed for reclassification purposes indefinitely after October 1, 1990.
(B) Once a retrofilled transformer has been installed for reclassification purposes, it must be tested 3 months after installation to ascertain the concentration of PCBs. If the PCB concentration is below 50 ppm, the transformer can be reclassified as a non-PCB Transformer. If the PCB concentration is between 50 and 500 ppm, the transformer can be reclassified as a PCB-Contaminated transformer. If the PCB concentration remains at 500 ppm or greater, the entire process must either be repeated until the transformer has been reclassified to a non-PCB or PCB-Contaminated transformer in accordance with paragraph (a)(2)(v) of this section or the transformer must be removed from service.
(iv) As of October 1, 1990, all higher secondary voltage radial PCB Transformers, in use in or near commercial buildings, and lower secondary voltage network PCB Transformers not located in sidewalk vaults in or near commercial buildings (network transformers with secondary voltages below 480 volts) that have not been removed from service as provided in paragraph (a)(1)(iv)(B) of this section, must be equipped with electrical protection to avoid transformer ruptures caused by high current faults. As of February 25, 1991, all lower secondary voltage radial PCB Transformers, in use in or near commercial buildings, must be equipped with electrical protection to avoid transformer ruptures caused by high current faults.
(A) Current-limiting fuses or other equivalent technology must be used to detect sustained high current faults and provide for the complete deenergization of the transformer (within several hundredths of a second in the case of higher secondary voltage radial PCB Transformers and within tenths of a second in the case of lower secondary voltage network PCB Transformers), before transformer rupture occurs. Lower secondary voltage radial PCB Transformers must be equipped with electrical protection as provided in paragraph (a)(1)(iv)(E) of this section. The installation, setting, and maintenance of current-limiting fuses or other equivalent technology to avoid PCB Transformer ruptures from sustained high current faults must be completed in accordance with good engineering practices.
(B) All lower secondary voltage network PCB Transformers not located in sidewalk vaults (network transformers with secondary voltages below 480 volts), in use in or near commercial buildings, which have not been protected as specified in paragraph (a)(1)(iv)(A) of this section by October 1, 1990, must be removed from service by October 1, 1993.
(C) As of October 1, 1990, owners of lower secondary voltage network PCB Transformers, in use in or near commercial buildings which have not been protected as specified in paragraph
(
(
(
(D) As of October 1, 1993, all lower secondary voltage network PCB Transformers located in sidewalk vaults (network transformers with secondary voltages below 480 volts) in use near commercial buildings must be removed from service.
(E) As of February 25, 1991, all lower secondary voltage radial PCB Transformers must be equipped with electrical protection, such as current-limiting fuses or other equivalent technology, to detect sustained high current faults and provide for the complete deenergization of the transformer or complete deenergization of the faulted phase of the transformer within several hundredths of a second. The installation, setting, and maintenance of current-limiting fuses or other equivalent technology to avoid PCB Transformer ruptures from sustained high current faults must be completed in accordance with good engineering practices.
(v) As of October 1, 1990, all radial PCB Transformers with higher secondary voltages (480 volts and above, including 480/277 volt systems) in use in or near commercial buildings must, in addition to the requirements of paragraph (a)(1)(iv)(A) of this section, be equipped with protection to avoid transformer ruptures caused by sustained low current faults.
(A) Pressure and temperature sensors (or other equivalent technology which has been demonstrated to be effective in early detection of sustained low current faults) must be used in these transformers to detect sustained low current faults.
(B) Disconnect equipment must be provided to insure complete deenergization of the transformer in the event of a sensed abnormal condition (e.g., an overpressure or overtemperature condition in the transformer), caused by a sustained low current fault. The disconnect equipment must be configured to operate automatically within 30 seconds to 1 minute of the receipt of a signal indicating an abnormal condition from a sustained low current fault, or can be configured to allow for manual deenergization from a manned on-site control center upon the receipt of an audio or visual signal indicating an abnormal condition caused by a sustained low current fault. Manual deenergization from a manned on-site control center must occur within 1 minute of the receipt of the audio or visual signal indicating an abnormal condition caused by a sustained low current fault. If automatic operation is selected and a circuit breaker is utilized for disconnection, it must also have the capability to be manually opened if necessary.
(C) The enhanced electrical protective system required for the detection of sustained low current faults and the complete and rapid deenergization of transformers must be properly installed, maintained, and set sensitive enough (in accordance with good engineering practices) to detect sustained low current faults and allow for rapid and total deenergization prior to PCB Transformer rupture (either violent or non violent rupture) and release of PCBs.
(vi)(A) No later than December 28, 1998 all owners of PCB Transformers, including those in storage for reuse, must register their transformers with the Environmental Protection Agency, National Program Chemicals Division, Office of Pollution Prevention and Toxics (7404), 1200 Pennsylvania Ave., NW., Washington, DC 20460. This registration requirement is subject to the limitations in paragraph (a)(1) of this section.
(
(
(B) Any person submitting a registration under this section must include:
(
(
(
(
(
(
(C) A transformer owner must retain a record of each PCB Transformer's registration (e.g., a copy of the registration and the return receipt signed by EPA) with the inspection and maintenance records required for each PCB Transformer under paragraph (a)(1)(xii)(I) of this section.
(D) A transformer owner must comply with all requirements of paragraph (a)(1)(vi)(A) of this section to continue the PCB-Transformer's authorization for use, or storage for reuse, pursuant to this section and TSCA section 6(e)(2)(B).
(vii) As of December 1, 1985, PCB Transformers in use in or near commercial buildings must be registered with building owners. For PCB Transformers located in commercial buildings, PCB Transformer owners must register the transformers with the building owner of record. For PCB Transformers located near commercial buildings, PCB Transformer owners must register the transformers with all owners of buildings located within 30 meters of the PCB Transformer(s). Information required to be provided to building owners by PCB Transformer owners includes but is not limited to:
(A) The specific location of the PCB Transformer(s).
(B) The principal constituent of the dielectric fluid in the transformer(s) (e.g., PCBs, mineral oil, or silicone oil).
(C) The type of transformer installation (e.g., 208/120 volt network, 208/120 volt radial, 208 volt radial, 480 volt network, 480/277 volt network, 480 volt radial, 480/277 volt radial).
(viii) As of December 1, 1985, combustible materials, including, but not limited to paints, solvents, plastics, paper, and sawn wood must not be stored within a PCB Transformer enclosure (i.e., in a transformer vault or in a partitioned area housing a transformer); within 5 meters of a transformer enclosure, or, if unenclosed (unpartitioned), within 5 meters of a PCB Transformer.
(ix) A visual inspection of each PCB Transformer (as defined in the definition of “PCB Transformer” under § 761.3) in use or stored for reuse shall be performed at least once every 3 months. These inspections may take place any time during the 3-month periods: January-March, April-June, July-September, and October-December as long as there is a minimum of 30 days between inspections. The visual inspection must include investigation for any leak of dielectric fluid on or around the transformer. The extent of the visual inspections will depend on the physical constraints of each transformer installation and should not require an electrical shutdown of the transformer being inspected.
(x) If a PCB Transformer is found to have a leak which results in any quantity of PCBs running off or about to run off the external surface of the transformer, then the transformer must be repaired or replaced to eliminate the source of the leak. In all cases any leaking material must be cleaned up and properly disposed of according to disposal requirements of subpart D of this part. Cleanup of the released PCBs must be initiated as soon as possible, but in no case later than 48 hours of its discovery. Until appropriate action is completed, any active leak of PCBs must be contained to prevent exposure of humans or the environment
(xi) If a PCB Transformer is involved in a fire-related incident, the owner of the transformer must immediately report the incident to the National Response Center (toll-free 1-800-424-8802; in Washington, DC 202-426-2675). A fire-related incident is defined as any incident involving a PCB Transformer which involves the generation of sufficient heat and/or pressure (by any source) to result in the violent or non-violent rupture of a PCB Transformer and the release of PCBs. Information must be provided regarding the type of PCB Transformer installation involved in the fire-related incident (e.g., high or low secondary voltage network transformer, high or low secondary voltage simple radial system, expanded radial system, primary selective system, primary loop system, or secondary selective system or other systems) and the readily ascertainable cause of the fire-related incident (e.g., high current fault in the primary or secondary or low current fault in secondary). The owner of the PCB Transformer must also take measures as soon as practically and safely possible to contain and control any potential releases of PCBs and incomplete combustion products into water. These measures include, but are not limited to:
(A) The blocking of all floor drains in the vicinity of the transformer.
(B) The containment of water runoff.
(C) The control and treatment (prior to release) of any water used in subsequent cleanup operations.
(xii) Records of inspection and maintenance history shall be maintained at least 3 years after disposing of the transformer and shall be made available for inspection, upon request by EPA. Such records shall contain the following information for each PCB Transformer:
(A) Its location.
(B) The date of each visual inspection and the date that leak was discovered, if different from the inspection date.
(C) The person performing the inspection.
(D) The location of any leak(s).
(E) An estimate of the amount of dielectric fluid released from any leak.
(F) The date of any cleanup, containment, repair, or replacement.
(G) A description of any cleanup, containment, or repair performed.
(H) The results of any containment and daily inspection required for uncorrected active leaks.
(I) Record of the registration of PCB Transformer(s).
(J) Records of transfer of ownership in compliance with § 761.180(a)(2)(ix).
(xiii) A reduced visual inspection frequency of at least once every 12 months applies to PCB Transformers that utilize either of the following risk reduction measures. These inspections may take place any time during the calendar year as long as there is a minimum of 180 days between inspections.
(A) A PCB Transformer which has impervious, undrained, secondary containment capacity of at least 100 percent of the total dielectric fluid volume of all transformers so contained or
(B) A PCB Transformer which has been tested and found to contain less than 60,000 ppm PCBs (after 3 months of in service use if the transformer has been serviced for purposes of reducing the PCB concentration).
(xiv) An increased visual inspection frequency of at least once every week applies to any PCB Transformer in use or stored for reuse which poses an exposure risk to food or feed. The user of a PCB Transformer posing an exposure risk to food is responsible for the inspection, recordkeeping, and maintenance requirements under this section until the user notifies the owner that the transformer may pose an exposure risk to food or feed. Following such notification, it is the owner's ultimate responsibility to determine whether the PCB Transformer poses an exposure risk to food or feed.
(xv) In the event a mineral oil transformer, assumed to contain less than 500 ppm of PCBs as provided in § 761.2, is tested and found to be contaminated at 500 ppm or greater PCBs, it will be subject to all the requirements of this Part 761. In addition, efforts must be initiated immediately to bring the transformer into compliance in accordance with the following schedule:
(A) Report fire-related incidents, effective immediately after discovery.
(B) Mark the PCB transformer within 7 days after discovery.
(C) Mark the vault door, machinery room door, fence, hallway or other means of access to the PCB Transformer within 7 days after discovery.
(D) Register the PCB Transformer in writing with the building owner within 30 days of discovery.
(E) Install electrical protective equipment on a radial PCB Transformer and a non-sidewalk vault, lower secondary voltage network PCB Transformer in or near a commercial building within 18 months of discovery or by October 1, 1990, whichever is later.
(F) Remove a non-sidewalk vault, lower secondary voltage network PCB Transformer in or near a commercial building, if electrical protective equipment is not installed, within 18 months of discovery or by October 1, 1993, whichever is later.
(G) Remove a lower secondary voltage network PCB Transformer located in a sidewalk vault in or near a commercial building, within 18 months of discovery or by October 1, 1993, whichever is later.
(H) Retrofill and reclassify a radial PCB Transformer or a lower or higher secondary voltage network PCB Transformer, located in other than a sidewalk vault in or near a commercial building, within 18 months or by October 1, 1990, whichever is later. This is an option in lieu of installing electrical protective equipment on a radial or lower secondary voltage network PCB Transformer located in other than a sidewalk vault or of removing a higher secondary voltage network PCB Transformer or a lower secondary voltage network PCB Transformer, located in a sidewalk vault, from service.
(I) Retrofill and reclassify a lower secondary voltage network PCB Transformer, located in a sidewalk vault, in or near a commercial building within 18 months or by October 1, 1993, whichever is later. This is an option in lieu of installing electrical protective equipment or removing the transformer from service.
(J) Retrofill and reclassify a higher secondary voltage network PCB Transformer, located in a sidewalk vault, in or near a commercial building within 18 months or by October 1, 1990, whichever is later. This is an option in lieu of other requirements.
(2)
(ii) Any servicing (including rebuilding) of PCB Transformers (as defined in the definition of “PCB Transformer” under § 761.3) that requires the removal of the transformer coil from the transformer casing is prohibited. PCB Transformers may be serviced (including topping off) with dielectric fluid at any PCB concentration.
(iii) PCBs removed during any servicing activity must be captured and either reused as dielectric fluid or disposed of in accordance with the requirements of § 761.60. PCBs from PCB Transformers must not be mixed with or added to dielectric fluid from PCB-Contaminated Electrical Equipment.
(iv) Regardless of its PCB concentration, dielectric fluids containing less than 500 ppm PCB that are mixed with fluids that contain 500 ppm or greater PCB must not be used as dielectric fluid in any electrical equipment. The entire mixture of dielectric fluid must be considered to be greater than 500 ppm PCB and must be disposed of in an incinerator that meets the requirements in § 761.70.
(v) You may reclassify a PCB Transformer that has been tested and determined to have a concentration of ≥500 ppm PCBs to a PCB-Contaminated transformer (≥50 but < 500 ppm) or to a non-PCB transformer (< 50 ppm), and you may reclassify a PCB-Contaminated transformer that has been tested and determined to have a concentration of ≥50 ppm but < 500 ppm to a non-PCB transformer, as follows:
(A) Remove the free-flowing PCB dielectric fluid from the transformer. Flushing is not required. Either test the fluid or assume it contains ≥1,000 ppm PCBs. Retrofill the transformer with fluid containing known PCB levels according to the following table.
(B) If you discover that the PCB concentration of the fluid in a reclassified transformer has changed, causing the reclassified status to change, the transformer is regulated based on the actual concentration of the fluid. For example, a transformer that was reclassified to non-PCB status is regulated as a PCB-Contaminated transformer if you discover that the concentration of the fluid has increased to ≥50 but <500 ppm PCBs. If you discover that the PCB concentration of the fluid has risen to ≥500 ppm, the transformer is regulated as a PCB Transformer. Follow paragraphs (a)(1)(xv)(A) through (J) of this section to come into compliance with the regulations applicable to PCB Transformers. You also have the option of repeating the reclassification process.
(C) The Director, National Program Chemicals Division, may, without further rulemaking, grant approval on a case-by-case basis for the use of alternative methods to reclassify transformers. You may request an approval by writing to the Director, National Program Chemicals Division (7404), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Describe the equipment you plan to reclassify, the alternative reclassification method you plan to use, and test data or other evidence on the effectiveness of the method.
(D) You must keep records of the reclassification required by § 761.180(g).
(vi) Any dielectric fluid containing 50 ppm or greater PCB used for servicing transformers must be stored in accordance with the storage for disposal requirements of § 761.65.
(vii) Processing and distribution in commerce of PCBs for purposes of servicing transformers is permitted only for persons who are granted an exemption under TSCA 6(e)(3)(B).
(b)
(1)
(2)
(ii) After January 1, 1984, railroad transformers may only be serviced with dielectric fluid containing less than 1000 ppm PCB, except as provided in paragraph (b)(2)(i) of this section;
(iii) Dielectric fluid may be filtered through activated carbon or otherwise industrially processed for the purpose of reducing the PCB concentration in the fluid;
(iv) Any PCB dielectric fluid that is used to service PCB railroad transformers must be stored in accordance with the storage for disposal requirements of § 761.65;
(v) After July 1, 1979, processing and distribution in commerce of PCBs for purposes of servicing railroad transformers is permitted only for persons who are granted an exemption under TSCA section 6(e)(3)(B).
(vi) A PCB Transformer may be converted to a PCB-Contaminated Transformer or to a non-PCB Transformer by draining, refilling, and/or otherwise servicing the railroad transformer. In order to reclassify, the railroad transformer's dielectric fluid must contain less than 500 ppm (for conversion to PCB-Contaminated Transformer) or less than 50 ppm PCB (for conversion to a non-PCB Transformer) after a minimum of three months of inservice use subsequent to the last servicing conducted for the purpose of reducing the PCB concentration in the transformer.
(c)
(d)
(e)
(f)
(g) [Reserved]
(h)
(1)
(ii) Use and storage for reuse of voltage regulators which contain 1.36 kilograms (3 lbs) or more of dielectric fluid with a PCB concentration of ≥500 ppm are subject to the following provisions:
(A) The owner of the voltage regulator must mark its location in accordance with § 761.40.
(B) If a voltage regulator is involved in a fire-related incident, the owner must immediately report the incident to the National Response Center (Toll-free: 1-800-424-8802; in Washington, DC: 202-426-2675). A fire-related incident is defined as any incident that involves the generation of sufficient heat and/or pressure, by any source, to result in the violent or non-violent rupture of
(C) The owner of the voltage regulator must inspect it in accordance with the requirements of paragraphs (a)(1)(ix), (a)(1)(xiii), and (a)(1)(xiv) of this section that apply to PCB Transformers.
(D) The owner of the voltage regulator must comply with the recordkeeping and reporting requirements at § 761.180.
(iii) The owner of a voltage regulator that assumes it contains <500 ppm PCBs as provided in § 761.2, and discovers by testing that it is contaminated at ≥500 ppm PCBs, must comply with paragraph (h)(1)(ii)(A) of this section 7 days after the discovery, and paragraphs (h)(1)(ii)(B), (h)(1)(ii)(C), and (h)(1)(ii)(D) of this section immediately upon discovery.
(2)
(ii) Electromagnets, switches, and voltage regulators classified as PCB-Contaminated Electrical Equipment (as defined in the definition of “PCB-Contaminated Electrical Equipment” under § 761.3) may be serviced (including rebuilding) only with dielectric fluid containing less than 500 ppm PCB.
(iii) PCBs removed during any servicing activity must be captured and either reused as dielectric fluid or disposed of in accordance with the requirements of § 761.60. PCBs from electromagnets switches, and voltage regulators with a PCB concentration of at least 500 ppm must not be mixed with or added to dielectric fluid from PCB-Contaminated Electrical Equipment.
(iv) Regardless of its PCB concentration, dielectric fluids containing less than 500 ppm PCB that are mixed with fluids that contain 500 ppm or greater PCB must not be used as dielectric fluid in any electrical equipment. The entire mixture of dielectric fluid must be considered to be greater than 500 ppm PCB and must be disposed of in an incinerator that meets the requirements of § 761.70.
(v) You may reclassify an electromagnet, switch, or voltage regulator that has been tested and determined to have a concentration of ≥500 ppm PCBs to PCB-Contaminated status (≥50 but <500 ppm) or to non-PCB status (<50 ppm), and you may reclassify a PCB-Contaminated electromagnet, switch, or voltage regulator that has been tested and determined to have a concentration of ≥50 ppm but <500 ppm to a non-PCB status, as follows:
(A) Remove the free-flowing PCB dielectric fluid from the electromagnet, switch, or voltage regulator. Flushing is not required. Either test the fluid or assume it contains ≥1,000 ppm PCBs. Retrofill the electromagnet, switch, or voltage regulator with fluid containing known PCB levels according to the following table. Determine the electromagnet, switch, or voltage regulator's reclassified status according to the following table (if following this process does not result in the reclassified status you desire, you may repeat the process):
(B) If you discover that the PCB concentration of the fluid in a reclassified electromagnet, switch, or voltage regulator has changed, causing the reclassified status to change, the electromagnet, switch, or voltage regulator is regulated based on the actual concentration of the fluid. For example, an electromagnet, switch, or voltage regulator that was reclassified to non-PCB status is regulated as a PCB-Contaminated electromagnet, switch, or voltage regulator if you discover that the concentration of the fluid has increased to ≥50 but <500 ppm PCBs. If you discover that the PCB concentration of the fluid in a voltage regulator has risen to ≥500 ppm, follow paragraph (h)(1)(iii) of this section to come into compliance with the regulations applicable to voltage regulators containing ≥500 ppm PCBs. You also have the option of repeating the reclassification process.
(C) The Director, National Program Chemicals Division may, without further rulemaking, grant approval on a case-by-case basis for the use of alternative methods to reclassify electromagnets, switches or voltage regulators. You may request an approval by writing to the Director, National Program Chemicals Division (7404), Environmental Protection Agency,1200 Pennsylvania Ave., NW., Washington, DC 20460. Describe the equipment you plan to reclassify, the alternative reclassification method you plan to use, and test data or other evidence on the effectiveness of the method.
(D) You must keep records of the reclassification required by § 761.180(g).
(vi) Any dielectric fluid containing 50 ppm or greater PCB used for servicing electromagnets, switches, or voltage regulators must be stored in accordance with the storage for disposal requirements of § 761.65.
(vii) Processing and distribution in commerce of PCBs for purposes of servicing electromagnets, switches or voltage regulators is permitted only for persons who are granted an exemption under TSCA 6(e)(3)(B).
(i)
(ii) PCBs are authorized for use, at concentrations ≥50 ppm, in natural gas pipeline systems not owned or operated by a seller or distributor of natural gas.
(iii)(A) PCBs are authorized for use, at concentrations ≥50 ppm, in natural gas pipeline systems owned or operated by a seller or distributor of natural gas, if the owner or operator:
(
(
(
(
(
(
(B) Owners or operators of natural gas pipeline systems which do not include potential sources of PCB contamination as described in paragraph (i)(1)(iii)(A)(
(C) The owner or operator of a natural gas pipeline system must document in writing all data collected and actions taken, or not taken, pursuant to the authorization in paragraph (i)(1)(iii)(A) of this section. They must maintain the information for 3 years after the PCB concentration in the component or segment is reduced to <50 ppm, and make it available to EPA upon request.
(D) The Director, National Program Chemicals Division, after consulting with the appropriate EPA Region(s) may, based on a finding of no unreasonable risk, modify in writing the requirements of paragraph (i)(1)(iii)(A) of this section, including extending any compliance date, approving alternative formats for documentation, waiving one or more requirements for a segment or component, requiring sampling and analysis, and requiring implementation of engineering measures to reduce PCB concentrations. EPA will make such modifications based on the natural gas pipeline system size, configuration, and current operating conditions; nature, extent or source of contamination; proximity of contamination to end-users; or previous sampling, monitoring, remedial actions or documentation of activities taken regarding compliance with this authorization or other applicable Federal, State, or local laws and regulations. The Director, National Program Chemicals Division, may defer the authority described in this paragraph, upon request, to the appropriate EPA Region.
(E) The owner or operator of a natural gas pipeline system may use historical data to fulfill the requirements of paragraphs (i)(1)(iii)(A)(
(2) Any person may reuse PCB-Contaminated natural gas pipe and appurtenances in a natural gas pipeline system, provided all free-flowing liquids have been removed.
(3) Any person may use PCB-Contaminated natural gas pipe, drained of all free-flowing liquids, in the transport of liquids (e.g., bulk hydrocarbons, chemicals, petroleum products, or coal slurry), as casing to provide secondary containment or protection (e.g., protection for electrical cable), as industrial structural material (e.g., fence posts, sign posts, or bridge supports), as temporary flume at construction sites, as equipment skids, as culverts under transportation systems in intermittent flow situations, for sewage service with written consent of the Publicly Owned Treatment Works (POTW), for steam service, as irrigation systems (<20 inch diameter) of less than 200 miles in length, and in a totally enclosed compressed air system.
(4) Any person characterizing PCB contamination in natural gas pipe or natural gas pipeline systems must do so by analyzing organic liquids collected at existing condensate collection points in the pipe or pipeline system. The level of PCB contamination found at a collection point is assumed to extend to the next collection point downstream. Any person characterizing multi-phasic liquids must do so in accordance with § 761.1(b)(4); if no liquids are present, they must use standard wipe samples in accordance with subpart M of this part.
(5)(i) Any person disposing of liquids containing PCBs ≥50 ppm removed, spilled, or otherwise released from a natural gas pipeline system must do so in accordance with § 761.61(a)(5)(iv) based on the PCB concentration at the time of removal from the system. Any person disposing of materials contaminated by spills or other releases of PCBs ≥50 ppm from a natural gas pipeline systems, must do so in accordance with §§ 761.61 or 761.79, as applicable.
(ii) Any person who markets or burns for energy recovery liquids containing PCBs at concentrations <50 ppm PCBs at the time of removal from a natural gas pipeline system must do so in accordance with the provisions pertaining to used oil at § 761.20(e). No other use of liquid containing PCBs at concentrations above the quantifiable level/level of detection removed from a natural gas pipeline system is authorized.
(j)
(1) They obtain the PCBs and PCBs in analytical reference samples derived from waste materials from sources authorized under § 761.80 to manufacture, process, and distribute PCBs in commerce and the PCBs are packaged in
(2) They store all PCB wastes resulting from R&D activities (e.g., spent laboratory samples, residuals, contaminated media such as clothing, etc.) in compliance with § 761.65(b) and dispose of all PCB wastes in compliance with § 761.64.
(3) [Reserved]
(4) No person may manufacture, process, or distribute in commerce PCBs for research and development unless they have been granted an exemption to do so under TSCA section 6(e)(3)(B).
(k)
(l)
(1)
(ii) After October 1, 1988, the use of PCB Large High Voltage Capacitors and PCB Large Low Voltage Capacitors is prohibited unless the capacitor is used within a restricted-access electrical substation or in a contained and restricted-access indoor installation. A restricted-access electrical substation is an outdoor, fenced or walled-in facility that restricts public access and is used in the transmission or distribution of electric power. A contained and restricted-access indoor installation does not have public access and has an adequate roof, walls, and floor to contain any release of PCBs within the indoor location.
(2) [Reserved]
(m)
(1)
(ii) Any circuit breaker, recloser or cable found to contain at least 50 ppm PCBs may be serviced only in accordance with the conditions contained in 40 CFR 761.30(h)(2).
(2) [Reserved]
(n)-(o) [Reserved]
(p)
(i) The source of PCB contamination is removed or contained to prevent further release to porous surfaces.
(ii) If the porous surface is accessible to superficial surface cleaning:
(A) The double wash rinse procedure in subpart S of this part is conducted on the surface to remove surface PCBs.
(B) The treated surface is allowed to dry for 24 hours.
(iii) After accessible surfaces have been cleaned according to paragraph (p)(1)(ii) of this section and for all surfaces inaccessible to cleanup:
(A) The surface is completely covered to prevent release of PCBs with:
(
(
(B) The surface is marked with the M
(C) M
(2) Removal of a porous surface contaminated with PCBs from its location or current use is prohibited except for removal for disposal in accordance with §§ 761.61 or 761.79 for surfaces contaminated by spills, or § 761.62 for manufactured porous surfaces.
(q) [Reserved]
(r)
(s)
(2) Any person may use PCBs in air compressor systems (or components thereof) at concentrations ≥50 ppm provided that:
(i) All free-flowing liquids containing PCBs ≥50 ppm are removed from the air compressor crankcase and the crankcase is refilled with non-PCB liquid.
(ii) Other air compressor system components contaminated with PCBs ≥50 ppm, are decontaminated in accordance with § 761.79 or disposed of in accordance with subpart D of this part.
(iii) Air compressor piping with a nominal inside diameter of <2 inches is decontaminated by continuous flushing for 4 hours, at no <300 gallons per hour (§ 761.79 contains solvent requirements).
(3) The requirements in paragraph (s)(2) of this section must be completed by August 30, 1999 or within 1 year of the date of discovery of PCBs at ≥50 ppm in the air compressor system, whichever is later. The EPA Regional Administrator for the EPA Region in which an air compressor system is located may, at his/her discretion and in writing, extend this timeframe.
(t)
(2) PCBs are authorized for use at concentrations ≥50 ppm in intact and non-leaking gas or liquid transmission systems not owned or operated by a seller or distributor of the gas or liquid transmitted in the system.
(3) Any person may use PCBs at concentrations ≥50 ppm in intact and non-leaking gas or liquid transmission systems, with the written approval of the Director, National Program Chemicals Division, subject to the requirements applicable to natural gas pipeline systems at paragraphs (i)(1)(iii)(A), (i)(1)(iii)(C) through (i)(1)(iii)(E), and (i)(2) through (i)(5) of this section.
(u)
(i) The materials were decontaminated in accordance with:
(A) A TSCA PCB disposal approval issued under subpart D of this part;
(B) Section 761.79; or
(C) Applicable EPA PCB spill cleanup policies (e.g., TSCA, RCRA, CERCLA, EPA regional) in effect at the time of the decontamination; or
(ii) If not previously decontaminated, the materials now meet an applicable decontamination standard in § 761.79(b).
(2) No person shall use or reuse materials decontaminated in accordance with paragraph (u)(1)(i) of this section or meeting an applicable decontamination standard in paragraph (u)(1)(ii) of this section, in direct contact with food, feed, or drinking water unless otherwise allowed under this section or this part.
(3) Any person may use water containing PCBs at concentrations ≤0.5µg/L PCBs without restriction.
(4) Any person may use water containing PCBs at concentrations <200 µg/L (i.e., < 200 ppb PCBs) for non-contact use in a closed system where there are no releases (e.g., as a non-contact cooling water).
For
(a) The owner or operator of a PCB Article may store it for reuse in an area which is not designed, constructed, and operated in compliance with § 761.65(b), for no more than 5 years after the date the Article was originally removed from use (e.g., disconnected electrical equipment) or 5 years after August 28, 1998, whichever is later, if the owner or operator complies with the following conditions:
(1) Follows all use requirements at § 761.30 and marking requirements at subpart C of this part that are applicable to the PCB Article.
(2) Maintains records starting at the time the PCB Article is removed from use or August 28, 1998. The records must indicate:
(i) The date the PCB Article was removed from use or August 28, 1998, if the removal date is not known.
(ii) The projected location and the future use of the PCB Article.
(iii) If applicable, the date the PCB Article is scheduled for repair or servicing.
(b) The owner or operator of a PCB Article may store it for reuse in an area that does not comply with § 761.65(b) for a period longer than 5 years, provided that the owner or operator has received written approval from the EPA Regional Administrator for the Region in which the PCB Article is stored. An owner or operator of a PCB Article seeking approval to extend the 5-year period must submit a request for extension to the EPA Regional Administrator at least 6 months before the 5-year storage for reuse period expires and must include an item-by-item justification for the desired extension. The EPA Regional Administrator may include any conditions to such approval deemed necessary to protect health or the environment. The owner or operator of the PCB Article being stored for reuse must comply with the other applicable provisions of this part, including the record retention requirements at § 761.180(a).
(c) Any person may store a PCB Article for reuse indefinitely in:
(1) A unit in compliance with § 761.65(b).
(2) A unit permitted under section 3004 of RCRA to manage hazardous wastes in containers.
(3) A unit permitted by a State authorized under section 3006 of RCRA to manage hazardous waste.
(a) Each of the following items in existence on or after July 1, 1978 shall be marked as illustrated in Figure 1 in § 761.45(a): The mark illustrated in Figure 1 is referred to as M
(1) PCB Containers;
(2) PCB Transformers at the time of manufacture, at the time of distribution in commerce if not already marked, and at the time of removal from use if not already marked. [Marking of PCB-Contaminated Electrical Equipment is not required];
(3) PCB Large High Voltage Capacitors at the time of manufacture, at the time of distribution in commerce if not already marked, and at the time of removal from use if not already marked;
(4) Equipment containing a PCB Transformer or a PCB Large High Voltage Capacitor at the time of manufacture, at the time of distribution in commerce if not already marked, and at the time of removal of the equipment from use if not already marked;
(5) PCB Large Low Voltage Capacitors at the time of removal from use (see also paragraph (k) of this section).
(6) Electric motors using PCB coolants (See also paragraph (e) of this section).
(7) Hydraulic systems using PCB hydraulic fluid (See also paragraph (e) of this section);
(8) Heat transfer systems (other than PCB Transformers) using PCBs (See also paragraph (e) of this section);
(9) PCB Article Containers containing articles or equipment that must be marked under paragraphs (a) (1) through (8) of this section;
(10) Each storage area used to store PCBs and PCB Items for disposal.
(b) As of October 1, 1978, each transport vehicle loaded with PCB Containers that contain more than 45 kg (99.4 lbs.) of liquid PCBs at concentrations of ≥50 ppm or with one or more PCB Transformers shall be marked on each end and each side with the M
(c) As of January 1, 1979, the following PCB Articles shall be marked with mark M
(1) All PCB Transformers not marked under paragraph (a) of this section [marking of PCB-Contaminated Electrical Equipment is not required];
(2) All PCB Large High Voltage Capacitors not marked under paragraph (a) of this section
(i) Will be marked individually with mark M
(ii) If one or more PCB Large High Voltage Capacitors are installed in a protected location such as on a power pole, or structure, or behind a fence; the pole, structure, or fence shall be marked with mark M
(d) As of January 1, 1979, all PCB Equipment containing a PCB Small Capacitor shall be marked at the time of manufacture with the statement, “This equipment contains PCB Capacitor(s)”. The mark shall be of the same size as the mark M
(e) As of October 1, 1979, applicable PCB Items in paragraphs (a)(1), (a)(6), (a)(7), and (a)(8) of this section containing PCBs in concentrations of 50 to 500 ppm shall be marked with the M
(f) Where mark M
(g) Each large low voltage capacitor, each small capacitor normally used in alternating current circuits, and each fluorescent light ballast manufactured (“manufactured”, for purposes of this sentence, means built) between July 1, 1978 and July 1, 1998 that do not contain PCBs shall be marked by the manufacturer at the time of manufacture with the statement, “No PCBs”. The mark shall be of similar durability and readability as other marking that indicate electrical information, part numbers, or the manufacturer's name. For purposes of this paragraph marking requirement only is applicable to items built domestically or abroad after June 30, 1978.
(h) All marks required by this subpart must be placed in a position on the exterior of the PCB Items, storage units, or transport vehicles so that the marks can be easily read by any persons inspecting or servicing the marked PCB Items, storage units, or transport vehicles.
(i) Any chemical substance or mixture that is manufactured after the effective date of this rule and that contains less than 500 ppm PCB (0.05% on a dry weight basis), including PCB that is a byproduct or impurity, must be marked in accordance with any requirements contained in the exemption granted by EPA to permit such manufacture and is not subject to any other requirement in this subpart unless so specified in the exemption. This paragraph applies only to containers of chemical substances or mixtures. PCB articles and equipment into which the chemical substances or mixtures are processed, are subject to the marking requirements contained elsewhere in this subpart.
(j) PCB Transformer locations shall be marked as follows:
(1) Except as provided in paragraph (j)(2) of this section, as of December 1, 1985, the vault door, machinery room door, fence, hallway, or means of access, other than grates and manhole covers, to a PCB Transformer must be marked with the mark M
(2) A mark other than the M
(i) The program using such an alternative mark was initiated prior to August 15, 1985, and can be substantiated with documentation.
(ii) Prior to August 15, 1985, coordination between the transformer owner and the primary fire department occurred, and the primary fire department knows, accepts, and recognizes
(iii) The EPA Regional Administrator in the appropriate region is informed in writing of the use of the alternative mark by October 3, 1988 and is provided with documentation that the program began before August 15, 1985, and documentation that demonstrates that prior to that date the primary fire department knew, accepted and recognized the meaning of the mark, and included this information in firefighting training.
(iv) The Regional Administrator will either approve or disapprove in writing the use of an alternative mark within 30 days of receipt of the documentation of a program.
(3) Any mark placed in accordance with the requirements of this section must be placed in the locations described in paragraph (j)(1) of this section and in a manner that can be easily read by emergency response personnel fighting a fire involving this equipment.
(k) As of April 26, 1999 the following PCB Items shall be marked with the M
(1) All PCB Large Low Voltage Capacitors not marked under paragraph (a) of this section shall be marked individually, or if one or more PCB Large Low Voltage Capacitors are installed in a protected location such as on a power pole, or structure, or behind a fence, then the owner or operator shall mark the pole, structure, or fence with the M
(2) All equipment not marked under paragraph (a) of this section containing a PCB Transformer or a PCB Large High or Low Voltage Capacitor.
(l)(1) All voltage regulators which contain 1.36 kilograms (3 lbs.) or more of dielectric fluid with a PCB concentration of ≥ 500 ppm must be marked individually with the M
(2) Locations of voltage regulators which contain 1.36 kilograms (3 lbs.) or more of dielectric fluid with a PCB concentration of ≥ 500 ppm shall be marked as follows: The vault door, machinery room door, fence, hallway, or means of access, other than grates or manhole covers, must be marked with the M
The following formats shall be used for marking:
(a)
(b)
(a)
(1) No person may open burn PCBs. Combustion of PCBs approved under § 761.60 (a) or (e), or otherwise allowed under part 761, is not open burning.
(2) No person may process liquid PCBs into non-liquid forms to circumvent the high temperature incineration requirements of § 761.60(a).
(3) No person may discharge water containing PCBs to a treatment works (as defined § 503.9(aa) of this chapter) or to navigable waters unless the PCB concentration is <3 µg/L (approximately 3 ppb), or unless the discharge is in accordance with a PCB discharge limit included in a permit issued under section 307(b) or 402 of the Clean Water Act.
(4) Spills and other uncontrolled discharges of PCBs at concentrations of ≥50 ppm constitute the disposal of PCBs.
(5) Any person land disposing of non-liquid PCBs may avoid otherwise-applicable sampling requirements by presuming that the PCBs disposed of are ≥500 ppm (or ≥100 µg/100 cm
(6) Any person storing or disposing of PCBs is also responsible for determining and complying with all other applicable Federal, State, and local laws and regulations.
(b)
(2)
(i) Fluorescent light ballasts containing PCBs only in an intact and non-leaking PCB Small Capacitor are regulated for disposal under § 761.60(b)(2)(ii).
(ii) Fluorescent light ballasts containing PCBs in the potting material are regulated for disposal as PCB bulk product waste under § 761.62.
(3)
(i) Any person responsible for PCB waste at as-found concentrations ≥ 50 ppm that was either placed in a land disposal facility, spilled, or otherwise released into the environment prior to April 18, 1978, regardless of the concentration of the spill or release; or placed in a land disposal facility, spilled, or otherwise released into the environment on or after April 18, 1978, but prior to July 2, 1979, where the concentration of the spill or release was
(A) Sites containing these wastes are presumed not to present an unreasonable risk of injury to health or the environment from exposure to PCBs at the site. However, the EPA Regional Administrator may inform the owner or operator of the site that there is reason to believe that spills, leaks, or other uncontrolled releases or discharges, such as leaching, from the site constitute ongoing disposal that may present an unreasonable risk of injury to health or the environment from exposure to PCBs at the site, and may require the owner or operator to generate data necessary to characterize the risk. If after reviewing any such data, the EPA Regional Administrator makes a finding, that an unreasonable risk exists, then he or she may direct the owner or operator of the site to dispose of the PCB remediation waste in accordance with § 761.61 such that an unreasonable risk of injury no longer exists.
(B) Unless directed by the EPA Regional Administrator to dispose of PCB waste in accordance with paragraph (b)(3)(i)(A) of this section, any person responsible for PCB waste at as-found concentrations ≥ 50 ppm that was either placed in a land disposal facility, spilled, or otherwise released into the environment prior to April 18, 1978, regardless of the concentration of the spill or release; or placed in a land disposal facility, spilled, or otherwise released into the environment on or after April 18, 1978, but prior to July 2, 1979, where the concentration of the spill or release was ≥ 50 ppm but < 500 ppm, who unilaterally decides to dispose of that waste (for example, to obtain insurance or to sell the property), is not required to clean up in accordance with § 761.61. Disposal of the PCB remediation waste must comply with § 761.61. However, cleanup of those wastes that is not in complete compliance with § 761.61 will not afford the responsible party with relief from the applicable PCB regulations for that waste.
(ii) Any person responsible for PCB waste at as-found concentrations ≥ 50 ppm that was either placed in a land disposal facility, spilled, or otherwise released into the environment on or after April 18, 1978, but prior to July 2, 1979, where the concentration of the spill or release was ≥ 500 ppm; or placed in a land disposal facility, spilled, or otherwise released into the environment on or after July 2, 1979, where the concentration of the spill or release was ≥ 50 ppm, must dispose of it in accordance with either of the following:
(A) In accordance with the PCB Spill Cleanup Policy (Policy) at subpart G of this part, for those PCB remediation wastes that meet the criteria of the Policy. Consult the Policy for a description of the spills it covers and its notification and timing requirements.
(B) In accordance with § 761.61. Complete compliance with § 761.61 does not create a presumption against enforcement action for penalties for any unauthorized PCB disposal.
(iii) The owner or operator of a site containing PCB remediation waste has the burden of proving the date that the waste was placed in a land disposal facility, spilled, or otherwise released into the environment, and the concentration of the original spill.
(4)
(ii)
(5)
(6)
(7)
(ii) Any person disposing of PCB/radioactive waste must do so taking into account both its PCB concentration and its radioactive properties. If, taking into account only the properties of the PCBs in the waste (and not the radioactive properties of the waste), the waste meets the requirements for disposal in a facility permitted, licensed, or registered by a State as a municipal or non-municipal non-hazardous waste landfill (e.g., PCB bulk product waste under § 761.62(b)(1)), then the person may dispose of the PCB/radioactive waste, without regard to the PCB component of the waste, on the basis of its radioactive properties in accordance with all applicable requirements for the radioactive component of the waste.
(8)
(c)
(d)
(2)
(3)
(4)
(e)
(a)
(1) For mineral oil dielectric fluid, in a high efficiency boiler according to § 761.71(a).
(2) For liquids other than mineral oil dielectric fluid, in a high efficiency boiler according to § 761.71(b).
(3) For liquids from incidental sources, such as precipitation, condensation, leachate or load separation and are associated with PCB Articles or non-liquid PCB wastes, in a chemical waste landfill which complies with § 761.75 if:
(i) [Reserved]
(ii) Information is provided to or obtained by the owner or operator of the chemical waste landfill that shows that the liquids do not exceed 500 ppm PCB and are not an ignitable waste as described in § 761.75(b)(8)(iii).
(b)
(1)
(A) In an incinerator that complies with § 761.70; or
(B) In a chemical waste landfill approved under § 761.75; provided that all free-flowing liquid is removed from the transformer, the transformer is filled with a solvent, the transformer is allowed to stand for at least 18 continuous hours, and then the solvent is thoroughly removed. Any person disposing of PCB liquids that are removed from the transformer (including the dielectric fluid and all solvents used as a flush), shall do so in an incinerator that complies with § 761.70 of this part, or shall decontaminate them in accordance with § 761.79. Solvents may include kerosene, xylene, toluene, and other solvents in which PCBs are readily soluble. Any person disposing of these PCB liquids must ensure that the solvent flushing procedure is conducted in accordance with applicable safety and health standards as required by Federal or State regulations.
(ii) [Reserved]
(2)
(ii) Any person may dispose of PCB Small Capacitors as municipal solid waste, unless that person is subject to the requirements of paragraph (b)(2)(iv) of this section.
(iii) Any PCB Large High or Low Voltage Capacitor which contains 500 ppm or greater PCBs, owned by any person, shall be disposed of in accordance with either of the following:
(A) Disposal in an incinerator that complies with § 761.70; or
(B) Until March 1, 1981, disposal in a chemical waste landfill that complies with § 761.75.
(iv) Any person who manufactures or at any time manufactured PCB Capacitors or PCB Equipment, and acquired the PCB Capacitor in the course of such manufacturing, shall place the PCB Small Capacitors in a container meeting the DOT packaging requirements at 49 CFR parts 171 through 180 and dispose of them in accordance with either of the following:
(A) Disposal in an incinerator which complies with § 761.70; or
(B) Until March 1, 1981, disposal in a chemical waste landfill which complies with § 761.75.
(v) Notwithstanding the restrictions imposed by paragraph (b)(2)(iii)(B) or (b)(2)(iv)(B) of this section, PCB capacitors may be disposed of in PCB chemical waste landfills that comply with § 761.75 subsequent to March 1, 1981, if the Assistant Administrator for Prevention, Pesticides and Toxic Substances publishes a notice in the
(A) Adequate incineration capability for PCB capacitors is not available, or
(B) The incineration of PCB capacitors will significantly interfere with the incineration of liquid PCBs, or
(C) There is other good cause shown.
(vi) Any person disposing of large PCB capacitors or small PCB capacitors described in paragraph (b)(2)(iv) of this section in a chemical waste landfill approved under § 761.75, shall first place them in a container meeting the DOT packaging requirements at 49 CFR parts 171 through 180. In all cases, the person must fill the interstitial space in the container with sufficient absorbent material (such as soil) to absorb
(3)
(A) In accordance with § 761.79.
(B) In a facility which is permitted, licensed, or registered by a State to manage municipal solid waste subject to part 258 of this chapter or non-municipal non-hazardous waste subject to §§ 257.5 through 257.30 of this chapter, as applicable (excluding thermal treatment units).
(C) In a scrap metal recovery oven or smelter operating in compliance with § 761.72.
(D) In a disposal facility approved under this part.
(ii) All free-flowing liquid must be removed from each machine and the liquid must be disposed of in accordance with the provisions of paragraph (a) of this section. If the PCB liquid contains ≥1,000 ppm PCB, then the hydraulic machine must be decontaminated in accordance with § 761.79 or flushed prior to disposal with a solvent listed at paragraph (b)(1)(i)(B) of this section which contains <50 ppm PCB. The solvent must be disposed of in accordance with paragraph (a) of this section or § 761.79.
(4)
(5)
(i)
(A) Natural gas pipe having a nominal inside diameter of ≤4 inches, and containing PCBs at any concentration but no free-flowing liquids, may be abandoned in the place it was used to transport natural gas if each end is sealed closed and the pipe is either:
(
(
(B) PCB-Contaminated natural gas pipe of any diameter, where the PCB concentration was determined after the last transmission of gas through the pipe or at the time of abandonment, that contains no free-flowing liquids may be abandoned in the place it was used to transport natural gas if each end is sealed closed.
(C) Natural gas pipe of any diameter which contains PCBs at any concentration but no free-flowing liquids, may be abandoned in the place it was used to transport natural gas, if each end is sealed closed, and either:
(
(
(D) Natural gas pipe of any diameter which contains PCBs at any concentration may be abandoned in place after decontamination in accordance with
(ii)
(A) The following classifications of natural gas pipe containing no free-flowing liquids may be disposed of in a facility permitted, licensed, or registered by a State to manage municipal solid waste subject to part 258 of this chapter or non-municipal non-hazardous waste subject to §§ 257.5 through 257.30 of this chapter, as applicable (excluding thermal treatment units); a scrap metal recovery oven or smelter operating in compliance with the requirements of § 761.72; or a disposal facility approved under this part:
(
(
(B) Any component of a natural gas pipeline system may be disposed of under one of the following provisions:
(
(
(
(
(iii)
(B) PCB concentration of the organic phase of multi-phasic liquids shall be determined in accordance with § 761.1(b)(4).
(iv)
(B) Any person who markets or burns for energy recovery liquid containing PCBs at concentrations <50 ppm PCBs at the time of removal from a natural gas pipeline system must do so in accordance with the provisions pertaining to used oil at § 761.20(e). No other use of liquid containing PCBs at concentrations above the quantifiable level/level of detection removed from a natural gas pipeline system is authorized.
(6)
(A) In an incinerator that complies with § 761.70; or
(B) In a chemical waste landfill that complies with § 761.75, provided that all free-flowing liquid PCBs have been thoroughly drained from any articles before the articles are placed in the chemical waste landfill and that the drained liquids are disposed of in an incinerator that complies with § 761.70.
(ii)(A) Except as specifically provided in paragraphs (b)(1) through (b)(5) of this section, any person disposing of a PCB-Contaminated Article must do so by removing all free-flowing liquid from the article, disposing of the liquid in accordance with paragraph (a) of this section, and disposing of the PCB-Contaminated Article with no free-
(
(
(
(
(B) Storage for disposal of PCB-Contaminated Articles from which all free-flowing liquids have been removed is not regulated under subpart D of this part.
(C) Requirements in subparts J and K of this part do not apply to PCB-Contaminated Articles from which all free-flowing liquids have been removed.
(iii) Fluorescent light ballasts containing PCBs in their potting material must be disposed of in a TSCA-approved disposal facility, as bulk product waste under § 761.62, as household waste under § 761.63 (where applicable), or in accordance with the decontamination provisions of § 761.79.
(7)
(8) Persons disposing of PCB Articles must wear or use protective clothing or equipment to protect against dermal contact with or inhalation of PCBs or materials containing PCBs.
(c)
(i) In an incinerator which complies with § 761.70, or
(ii) In a chemical waste landfill that complies with § 761.75; provided that if there are PCBs in a liquid state, the PCB Container shall first be drained and the PCB liquid disposed of in accordance with paragraph (a) of this section.
(2) Any PCB Container used to contain only PCBs at a concentration less than 500 ppm shall be disposed of as municipal solid wastes; provided that if the PCBs are in a liquid state, the PCB Container shall first be drained and the PCB liquid shall be disposed of in accordance with paragraph (a) of this section.
(3) Prior to disposal, a PCB container with PCB concentrations at 50 ppm or greater shall be stored in a unit which complies with § 761.65.
(d) [Reserved]
(e) Any person who is required to incinerate any PCBs and PCB Items under this subpart and who can demonstrate that an alternative method of destroying PCBs and PCB Items exists and that this alternative method can achieve a level of performance equivalent to an incinerator approved under § 761.70 or a high efficiency boiler operating in compliance with § 761.71, must submit a written request to either the EPA Regional Administrator or the Director, National Program Chemicals Division, for a waiver from the incineration requirements of § 761.70 or § 761.71. Requests for approval of alternate methods that will be operated in more than one Region must be submitted to the Director, National Program Chemicals Division except for research and development activities involving less than 500 pounds of PCB material (see paragraph (i)(2) of this section). Requests for approval of alternate methods that will be operated in only one Region must be submitted to the appropriate EPA Regional Administrator. The applicant must show that his or her method of destroying PCBs will not present an unreasonable risk of injury to health or the environment. On the basis of such information and any available information, the EPA Regional Administrator or the Director, National Program Chemicals Division may, in his or her discretion, approve the use of the alternate method if he or she finds that the alternate disposal method provides PCB destruction equivalent to disposal in a § 761.70 incinerator or a § 761.71 high efficiency
(f)(1) Each operator of a chemical waste landfill, incinerator, or alternative to incineration approved under paragraph (e) of this section shall give the following written notices to the state and local governments within whose jurisdiction the disposal facility is located:
(i) Notice at least thirty (30) days before a facility is first used for disposal of PCBs required by these regulations; and
(ii) At the request of any state or local government, annual notice of the quantities and general description of PCBs disposed of during the year. This annual notice shall be given no more than thirty (30) days after the end of the year covered.
(iii) The Regional Administrator may reduce the notice period required by paragraph (f)(1)(i) of this section from thirty days to a period of no less than five days in order to expedite interim approval of the chemical waste landfill located in Sedgwick County, Kansas.
(2) [Reserved]
(g)
(i) Dielectric fluid removed from mineral oil dielectric fluid electrical equipment may be collected in a common container, provided that no other chemical substances or mixtures are added to the container. This common container option does not permit dilution of the collected oil. Mineral oil that is assumed or known to contain at least 50 ppm PCBs must not be mixed with mineral oil that is known or assumed to contain less than 50 ppm PCBs to reduce the concentration of PCBs in the common container. If dielectric fluid from untested, oil-filled circuit breakers, reclosers, or cable is collected in a common container with dielectric fluid from other oil-filled electrical equipment, the entire contents of the container must be treated as PCBs at a concentration of at least 50 ppm, unless all of the fluid from the other oil-filled electrical equipment has been tested and shown to contain less than 50 ppm PCBs.
(ii) For purposes of complying with the marking and disposal requirements, representative samples may be taken from either the common containers or the individual electrical equipment to determine the PCB concentration, except that if any PCBs at a concentration of 500 ppm or greater have been added to the container or equipment then the total container contents must be considered as having a PCB concentration of 500 ppm or greater for purposes of complying with the disposal requirements of this subpart. For purposes of this subparagraph, representative samples of mineral oil dielectric fluid are either samples taken in accordance with ASTM D 923-86 or ASTM D 923-89 or samples taken from a container that has been thoroughly mixed in a manner such that any PCBs in the container are uniformly distributed throughout the liquid in the container.
(iii) Unless otherwise specified in this part, any person conducting the chemical analysis of PCBs shall do so using gas chromatography. Any gas chromatographic method that is appropriate for the material being analyzed may be used, including EPA Method 608, “Organochlorine Pesticides and PCBs” at 40 CFR part 136, Appendix A;” EPA Method 8082, “Polychlorinated Biphenyls (PCBs) by Capillary Column Gas Chromatography” of SW-846, “OSW Test Methods for Evaluating Solid Waste,” which is available from NTIS; and ASTM Standard D-4059, “Standard Test Method for Analysis of Polychlorinated Biphenyls in Insulating Liquids by Gas Chromatography,” which is available from ASTM.
(2) Owners or users of waste oil may use the following procedures to determine the PCB concentration of waste oil:
(i) Waste oil from more than one source may be collected in a common container, provided that no other chemical substances or mixtures, such as non-waste oils, are added to the container.
(ii) For purposes of complying with the marking and disposal requirements, representative samples may be taken from either the common containers or the individual electrical equipment to determine the PCB concentration.
(iii) Unless otherwise specified in this part, any person conducting the chemical analysis of PCBs shall do so using gas chromatography. Any gas chromatographic method that is appropriate for the material being analyzed may be used, including those indicated in paragraph (g)(1)(iii) of this section.
(h) Requirements for export and import of PCBs and PCB Items for disposal are found in Subpart F of this part.
(i)
(2) Except for activity authorized under paragraph (j) of this section, research and development (R&D) for PCB disposal using a total of <500 pounds of PCB material (regardless of PCB concentration) will be reviewed and approved by the EPA Regional Administrator for the Region where the R&D will be conducted, and R&D for PCB disposal using 500 pounds or more of PCB material (regardless of PCB concentration) will be reviewed and approved by the Director, National Program Chemicals Division.
(j)
(i) File a notification and obtain an EPA identification number pursuant to subpart K of this part.
(ii) Notify in writing the EPA Regional Administrator, the State environmental protection agency, and local environmental protection agency, having jurisdiction where the R&D for PCB disposal activity will occur at least 30 days prior to the commencement of any R&D for PCB disposal activity conducted under this section. Each written notification shall include the EPA identification number of the site where the R&D for PCB disposal activities will be conducted, the quantity of PCBs to be treated, the type of R&D technology to be used, the general physical and chemical properties of material being treated, and an estimate of the duration of the PCB activity. The EPA Regional Administrator, the State environmental protection agency, and the local environmental protection agency may waive notification in writing prior to commencement of the research.
(iii) The amount of material containing PCBs treated annually by the facility during R&D for PCB disposal activities does not exceed 500 gallons or 70 cubic feet of liquid or non-liquid PCBs and does not exceed a maximum concentration of 10,000 ppm PCBs.
(iv) No more than 1 kilogram total of pure PCBs per year is disposed of in all
(v) Each R&D for PCB disposal activity under this section lasts no more than 1 calendar year.
(vi) Store all PCB wastes (treated and untreated PCB materials, testing samples, spent laboratory samples, residuals, untreated samples, contaminated media or instrumentation, clothing, etc.) in compliance with § 761.65(b) and dispose of them according to the undiluted PCB concentration prior to treatment. However, PCB materials not treated in the R&D for PCB disposal activity may be returned either to the physical location where the samples were collected or a location where other regulated PCBs from the physical location where the samples were collected are being stored for disposal.
(vii) Use manifests pursuant to subpart K of this part for all R&D PCB wastes being transported from the R&D facility to an approved PCB storage or disposal facility. However, §§ 761.207 through 761.218 do not apply if the residuals or treated samples are returned either to the physical location where the samples were collected or a location where other regulated PCBs from the physical location where the samples were collected are being stored for disposal.
(viii) Package and ship all PCB wastes pursuant to DOT requirements under 49 CFR parts 171 through 180.
(ix) Comply with the recordkeeping requirements of § 761.180.
(2) Do not exceed material limitations set out in paragraphs (j)(1) (iii) and (iv) of this section and the time limitation set out in paragraph (j)(1)(v) of this section without prior written approval from EPA. Requests for approval to exceed the material limitations for PCBs in R&D for PCB disposal activities as specified in this section must be submitted in writing to the EPA Regional Administrator for the Region in which the facility conducting R&D for PCB disposal activities is located. Each request shall specify the quantity or concentration requested or additional time needed for disposal and include a justification for each increase. For extensions to the duration of the R&D for PCB disposal activity, the request shall also include a report on the accomplishments and progress of the previously authorized R&D for PCB disposal activity for which the extension is sought. The EPA Regional Administrator may grant a waiver in writing for an increase in the volume of PCB material, the maximum concentration of PCBs, the total amount of pure PCBs, or the duration of the R&D activity. Approvals will state all requirements applicable to the R&D for PCB disposal activity.
(3) The EPA Regional Administrator for the Region in which an R&D for PCB disposal activity is conducted may determine, at any time, that an R&D PCB disposal approval is required under paragraphs (e) and (i)(2) of this section or § 761.70(d) to ensure that any R&D for PCB disposal activity does not present an unreasonable risk of injury to health or the environment.
For
This section provides cleanup and disposal options for PCB remediation waste. Any person cleaning up and disposing of PCBs managed under this section shall do so based on the concentration at which the PCBs are found. This section does not prohibit any person from implementing temporary emergency measures to prevent, treat, or contain further releases or mitigate migration to the environment of PCBs or PCB remediation waste.
(a)
(1)
(A) Surface or ground waters.
(B) Sediments in marine and freshwater ecosystems.
(C) Sewers or sewage treatment systems.
(D) Any private or public drinking water sources or distribution systems.
(E) Grazing lands.
(F) Vegetable gardens.
(ii) The self-implementing cleanup provisions shall not be binding upon cleanups conducted under other authorities, including but not limited to, actions conducted under section 104 or section 106 of CERCLA, or section 3004(u) and (v) or section 3008(h) of RCRA.
(2)
(3)
(A) The nature of the contamination, including kinds of materials contaminated.
(B) A summary of the procedures used to sample contaminated and adjacent areas and a table or cleanup site map showing PCB concentrations measured in all pre-cleanup characterization samples. The summary must include sample collection and analysis dates. The EPA Regional Administrator may require more detailed information including, but not limited to, additional characterization sampling or all sample identification numbers from all previous characterization activities at the cleanup site.
(C) The location and extent of the identified contaminated area, including topographic maps with sample collection sites cross referenced to the sample identification numbers in the data summary from paragraph (a)(3)(i)(B) of this section.
(D) A cleanup plan for the site, including schedule, disposal technology, and approach. This plan should contain options and contingencies to be used if unanticipated higher concentrations or wider distributions of PCB remediation waste are found or other obstacles force changes in the cleanup approach.
(E) A written certification, signed by the owner of the property where the cleanup site is located and the party conducting the cleanup, that all sampling plans, sample collection procedures, sample preparation procedures, extraction procedures, and instrumental/chemical analysis procedures used to assess or characterize the PCB contamination at the cleanup site, are on file at the location designated in the certificate, and are available for EPA inspection. Persons using alternate methods for chemical extraction and chemical analysis for site characterization must include in the certificate a statement that such a method will be used and that a comparison study which meets or exceeds the requirements of subpart Q of this part, and for which records are on file, has been completed prior to verification sampling.
(ii) Within 30 calendar days of receiving the notification, the EPA Regional Administrator will respond in writing approving of the self-implementing cleanup, disapproving of the self-implementing cleanup, or requiring additional information. If the EPA Regional Administrator does not respond within 30 calendar days of receiving the notice, the person submitting the notification may assume that it is complete and acceptable and proceed with the cleanup according to the information the person provided to the EPA
(iii) Any person conducting a cleanup activity may obtain a waiver of the 30-day notification requirement, if they receive a separate waiver, in writing, from each of the agencies they are required to notify under this section. The person must retain the original written waiver as required in paragraph (a)(9) of this section.
(4)
(i)
(A)
(B)
(
(
(ii)
(iii)
(iv)
(v)
(vi) The EPA Regional Administrator, as part of his or her response to a notification submitted in accordance with § 761.61(a)(3) of this part, may require cleanup of the site, or portions of it, to more stringent cleanup levels than are otherwise required in this section, based on the proximity to areas such as residential dwellings, hospitals,
(5)
(i)
(A) Any person cleaning up bulk PCB remediation waste on-site using a soil washing process may do so without EPA approval, subject to all of the following:
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(
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(
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(B) Bulk PCB remediation waste may be sent off-site for decontamination or disposal in accordance with this paragraph, provided the waste is either dewatered on-site or transported off-site in containers meeting the requirements of the DOT Hazardous Materials Regulations (HMR) at 49 CFR parts 171 through 180.
(
(
(
(
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(ii)
(A) For on-site disposal, non-porous surfaces shall be cleaned on-site or off-site to the levels in paragraph (a)(4)(ii) of this section using:
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(B) For off-site disposal, non-porous surfaces:
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(C) For use, non-porous surfaces shall be decontaminated on-site or off-site to the standards specified in § 761.79(b)(3) or in accordance with § 761.79(c).
(iii)
(iv)
(A) Decontaminate the waste to the levels specified in § 761.79(b)(1) or (b)(2).
(B) Dispose of the waste in accordance with paragraph (b) of this section or an approval issued under paragraph (c) of this section.
(v)
(A) Non-liquid cleaning materials and personal protective equipment waste at any concentration, including non-porous surfaces and other non-liquid materials such as rags, gloves, booties, other disposable personal protective equipment, and similar materials resulting from cleanup activities shall be either decontaminated in accordance with § 761.79(b) or (c), or disposed of in one of the following facilities, without regard to the requirements of subparts J and K of this part:
(
(
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(B) Cleaning solvents, abrasives, and equipment may be reused after decontamination in accordance with § 761.79.
(6)
(ii)
(B) Where sample analysis results in a measurement of PCBs greater than the levels specified in paragraph (a)(4) of this section, self-implementing cleanup of the sampled PCB remediation waste is not complete. The owner or operator of the site must either dispose of the sampled PCB remediation waste, or reclean the waste represented by the sample and reinitiate sampling and analysis in accordance with paragraph (a)(6)(i) of this section.
(7)
(8)
(i) Within 60 days of completion of a cleanup activity under this section, the owner of the property shall:
(A) Record, in accordance with State law, a notation on the deed to the property, or on some other instrument which is normally examined during a title search, that will in perpetuity notify any potential purchaser of the property:
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(B) Submit a certification, signed by the owner, that he/she has recorded the notation specified in paragraph (a)(8)(i)(A) of this section to the EPA Regional Administrator.
(ii) The owner of a site being cleaned up under this section may remove a fence or cap after conducting additional cleanup activities and achieving cleanup levels, specified in paragraph (a)(4) of this section, which do not require a cap or fence. The owner may remove the notice on the deed no earlier than 30 days after achieving the cleanup levels specified in this section which do not require a fence or cap.
(9)
(b)
(2) Any person disposing of non-liquid PCB remediation waste shall do so by one of the following methods:
(i) Dispose of it in a high temperature incinerator approved under § 761.70(b), an alternate disposal method approved under § 761.60(e), a chemical waste landfill approved under § 761.75, or in a facility with a coordinated approval issued under § 761.77.
(ii) Decontaminate it in accordance with § 761.79.
(3) Any person may manage or dispose of material containing <50 ppm PCBs that has been dredged or excavated from waters of the United States:
(i) In accordance with a permit that has been issued under section 404 of the Clean Water Act, or the equivalent of such a permit as provided for in regulations of the U.S. Army Corps of Engineers at 33 CFR part 320.
(ii) In accordance with a permit issued by the U.S. Army Corps of Engineers under section 103 of the Marine Protection, Research, and Sanctuaries Act, or the equivalent of such a permit as provided for in regulations of the U.S. Army Corps of Engineers at 33 CFR part 320.
(c)
(2) EPA will issue a written decision on each application for a risk-based method for PCB remediation wastes. EPA will approve such an application if it finds that the method will not pose an unreasonable risk of injury to health or the environment.
PCB bulk product waste shall be disposed of in accordance with paragraph (a), (b), or (c) of this section. Under some of these provisions, it may not be necessary to determine the PCB concentration or leaching characteristics of the PCB bulk product waste. When it is necessary to analyze the waste to make either of these determinations, use the applicable procedures in subpart R of this part to sample the waste for analysis, unless EPA approves another sampling plan under paragraph (c) of this section.
(a)
(1) In an incinerator approved under § 761.70.
(2) In a chemical waste landfill approved under § 761.75.
(3) In a hazardous waste landfill permitted by EPA under section 3004 of RCRA, or by a State authorized under section 3006 of RCRA.
(4) Under an alternate disposal approval under § 761.60(e).
(5) In accordance with the decontamination provisions of § 761.79.
(6) For metal surfaces in contact with PCBs, in accordance with the thermal decontamination provisions of § 761.79(c)(6).
(7) In accordance with a TSCA PCB Coordinated Approval issued under § 761.77.
(b)
(i) Plastics (such as plastic insulation from wire or cable; radio, television and computer casings; vehicle parts; or furniture laminates); preformed or molded rubber parts and components; applied dried paints, varnishes, waxes or other similar coatings or sealants; caulking; Galbestos; non-liquid building demolition debris; or non-liquid PCB bulk product waste from the shredding of automobiles or household appliances from which PCB small capacitors have been removed (shredder fluff).
(ii) Other PCB bulk product waste, sampled in accordance with the protocols set out in subpart R of this part, that leaches PCBs at <10 µg/L of water measured using a procedure used to simulate leachate generation.
(2) Any person may dispose of PCB bulk product waste other than those materials meeting the conditions of paragraph (b)(1) of this section, (e.g., paper or felt gaskets contaminated by liquid PCBs in a facility that is permitted, licensed, or registered by a State to manage municipal solid waste subject to part 258 of this chapter or non-municipal non-hazardous waste subject to §§ 257.5 through 257.30 of this chapter, as applicable, if:
(i) The PCB bulk product waste is segregated from organic liquids disposed of in the landfill unit.
(ii) Leachate is collected from the landfill unit and monitored for PCBs.
(3) Any release of PCBs (including but not limited to leachate) from the landfill unit shall be cleaned up in accordance with § 761.61.
(4)(i) Any person disposing off-site of PCB bulk product waste regulated under paragraph (b)(1) of this section at a waste management facility not having a commercial PCB storage or disposal approval must provide written notice to the facility a minimum of 15 days in advance of the first shipment from the same disposal waste stream. The notice shall state that the PCB bulk product waste may include components containing PCBs at ≥ 50 ppm based on analysis of the waste in the shipment or application of a general knowledge of the waste stream (or similar material) which is known to contain PCBs at those levels, and that the PCB bulk product waste is known or presumed to leach <10 µg/L PCBs.
(ii) Any person disposing off-site of PCB bulk product waste regulated under paragraph (b)(2) of this section at a waste management facility not having a commercial PCB storage or disposal approval must provide written notice to the facility a minimum of 15 days in advance of the first shipment from the same disposal waste stream and with each shipment thereafter. The notice shall state that the PCB bulk product waste may include components containing PCBs at ≥50 ppm based on analysis of the waste in the shipment or application of a general knowledge of the waste stream (or similar material) which is known to contain PCBs at those levels, and that the PCB bulk product waste is known or presumed to leach ≥10 µg/L PCBs.
(5) Any person disposing of PCB bulk product waste must maintain a written record of all sampling and analysis of PCBs or notifications made under this paragraph for 3 years from the date of the waste's generation. The records must be made available to EPA upon request.
(6) Requirements in subparts C, J, and K of this part do not apply to waste disposed of under paragraph (b) of this section.
(c)
(2) EPA will issue a written decision on each application for a risk-based sampling, disposal, or storage method for PCB bulk product wastes. EPA will approve such an application if it finds that the method will not pose an unreasonable risk of injury to health or the environment.
(d)
(1) As daily landfill cover as long as the daily cover remains in the landfill and is not released or dispersed by wind or other action; or
(2) Under asphalt as part of a road bed.
PCB household waste, as defined at § 761.3, managed in a facility permitted, licensed, or registered by a State to manage municipal or industrial solid waste, or in a facility with an approval to dispose of PCB bulk product waste under § 761.62(c), is not subject to any other requirements of part 761 of this chapter. PCB household waste stored in a unit regulated for storage of PCB waste must not be commingled with PCB waste.
This section provides disposal requirements for wastes generated during and as a result of research and development authorized under § 761.30(j). This section also provides disposal requirements for wastes generated during the chemical analysis of samples containing PCBs under part 761, including §§ 761.30, 761.60, 761.61, 761.62, and 761.79. For determining the presence of PCBs in samples, chemical analysis includes: sample preparation, sample extraction, extract cleanup, extract concentration,
(a) Portions of samples of a size designated in a chemical extraction and analysis method for PCBs and extracted for purposes of determining the presence of PCBs or concentration of PCBs are unregulated for PCB disposal under this part.
(b) All other wastes generated during these activities are regulated for disposal based on their concentration at the time of disposal as follows:
(1) Liquid wastes, including rinse solvents, must be disposed of according to § 761.61(a)(5)(iv).
(2) Non-liquid wastes must be disposed of in the same manner as non-liquid cleaning materials and personal protective equipment waste according to § 761.61(a)(5)(v)(A).
This section applies to the storage for disposal of PCBs at concentrations of 50 ppm or greater and PCB Items with PCB concentrations of 50 ppm or greater.
(a)(1)
(2)
(i) The notification is received by the EPA Regional Administrator at least 30 days before the initial 1-year time limit expires and the notice identifies the storer, the types, volumes, and locations of the waste and the reasons for failure to meet the initial 1-year time limit.
(ii) A written record documenting all continuing attempts to secure disposal is maintained until the waste is disposed of.
(iii) The written record required by paragraph (a)(2)(ii) of this section is available for inspection or submission if requested by EPA.
(iv) Continuing attempts to secure disposal were initiated within 270 days after the time the waste was first subject to the 1-year time limit requirement, as specified in paragraph (a)(1) of this section. Failure to initiate and continue attempts to secure disposal throughout the total time the waste is in storage shall automatically disqualify the notifier from receiving an automatic extension under this section.
(3)
(4)
(b) Except as provided in paragraphs (b)(2), (c)(1), (c)(7), (c)(9), and (c)(10) of this section, after July 1, 1978, owners or operators of any facilities used for the storage of PCBs and PCB Items designated for disposal shall comply with the following storage unit requirements:
(1) The facilities shall meet the following criteria:
(i) Adequate roof and walls to prevent rain water from reaching the stored PCBs and PCB Items;
(ii) An adequate floor that has continuous curbing with a minimum 6 inch high curb. The floor and curbing must provide a containment volume equal to at least two times the internal volume of the largest PCB Article or PCB Container or 25 percent of the total internal volume of all PCB Articles or PCB Containers stored there, whichever is greater. PCB/radioactive wastes are not required to be stored in an area with a minimum 6 inch high curbing. However, the floor and curbing must still provide a containment volume equal to at least two times the internal volume of the largest PCB Container or 25 percent of the total internal volume of all PCB Containers stored there, whichever is greater.
(iii) No drain valves, floor drains, expansion joints, sewer lines, or other openings that would permit liquids to flow from the curbed area;
(iv) Floors and curbing constructed of Portland cement, concrete, or a continuous, smooth, non-porous surface as defined at § 761.3, which prevents or minimizes penetration of PCBs.
(v) Not located at a site that is below the 100-year flood water elevation.
(2) No person may store PCBs and PCB Items designated for disposal in a storage unit other than one approved pursuant to paragraph (d) of this section or meeting the design requirements of paragraph (b) of this section, unless the unit meets one of the following conditions:
(i) Is permitted by EPA under section 3004 of RCRA to manage hazardous waste in containers, and spills of PCBs are cleaned up in accordance with subpart G of this part.
(ii) Qualifies for interim status under section 3005 of RCRA to manage hazardous waste in containers, meets the requirements for containment at § 264.175 of this chapter, and spills of PCBs are cleaned up in accordance with subpart G of this part.
(iii) Is permitted by a State authorized under section 3006 of RCRA to manage hazardous waste in containers, and spills of PCBs are cleaned up in accordance with subpart G of this part.
(iv) Is approved or otherwise regulated pursuant to a State PCB waste management program no less stringent in protection of health or the environment than the applicable TSCA requirements found in this part.
(v) Is subject to a TSCA Coordinated Approval, which includes provisions for storage of PCBs, issued pursuant to § 761.77.
(vi) Has a TSCA PCB waste management approval, which includes provisions for storage, issued pursuant to § 761.61(c) or § 761.62(c).
(c)(1) The following PCB Items may be stored temporarily in an area that does not comply with the requirements of paragraph (b) of this section for up to thirty days from the date of their removal from service, provided that a notation is attached to the PCB Item or a PCB Container (containing the item) indicating the date the item was removed from service:
(i) Non-leaking PCB Articles and PCB Equipment;
(ii) Leaking PCB Articles and PCB Equipment if the PCB Items are placed in a non-leaking PCB Container that contains sufficient sorbent materials to absorb any liquid PCBs remaining in the PCB Items;
(iii) PCB Containers containing non-liquid PCBs such as contaminated soil, rags, and debris; and
(iv) PCB containers containing liquid PCBs at concentrations of ≥50 ppm, provided a Spill Prevention, Control and Countermeasure Plan has been prepared for the temporary storage area in accordance with part 112 of this chapter and the liquid PCB waste is in packaging authorized in the DOT Hazardous Materials Regulations at 49 CFR parts 171 through 180 or stationary bulk storage tanks (including rolling stock such as, but not limited to, tanker trucks, as specified by DOT).
(2) Non-leaking and structurally undamaged PCB Large High Voltage Capacitors and PCB-Contaminated Electrical Equipment that have not been drained of free flowing dielectric fluid may be stored on pallets next to a storage facility that meets the requirements of paragraph (b) of this section. PCB-Contaminated Electrical Equipment that has been drained of free flowing dielectric fluid is not subject to the storage provisions of § 761.65. Storage under this subparagraph will be permitted only when the storage facility has immediately available unfilled storage space equal to 10 percent of the volume of capacitors and equipment stored outside the facility. The capacitors and equipment temporarily stored outside the facility shall be checked for leaks weekly.
(3) Any storage area subject to the requirements of paragraph (b) or paragraph (c)(1) of this section shall be marked as required in subpart C § 761.40(a)(10).
(4) No item of movable equipment that is used for handling PCBs and PCB Items in the storage units and that comes in direct contact with PCBs shall be removed from the storage unit area unless it has been decontaminated as specified in § 761.79.
(5) All PCB Items in storage shall be checked for leaks at least once every 30 days. Any leaking PCB Items and their contents shall be transferred immediately to properly marked non-leaking containers. Any spilled or leaked materials shall be immediately cleaned up and the materials and residues containing PCBs shall be disposed of in accordance with § 761.61. Records of inspections, maintenance, cleanup and disposal must be maintained in accordance with § 761.180(a) and (b).
(6) Except as provided in paragraphs (c)(6)(i) and (c)(6)(ii) of this section, any container used for the storage of liquid or non-liquid PCB waste shall be in accordance with the requirements set forth in the DOT Hazardous Materials Regulations (HMR) at 49 CFR parts 171 through 180. PCB waste not subject to the HMR (i.e., PCB wastes at concentrations of <20 ppm or <1 pound of PCBs regardless of concentration) must be packaged in accordance with Packaging Group III, unless other hazards associated with the PCB waste cause it to require packaging in accordance with Packaging Groups I or II. For purposes of describing PCB waste not subject to DOT's HMR on a manifest, one may use the term “Non-DOT Regulated PCBs.”
(i) Containers other than those meeting HMR performance standards may be used for storage of PCB/radioactive waste provided the following requirements are met:
(A) Containers used for storage of liquid PCB/radioactive wastes must be non-leaking.
(B) Containers used for storage of non-liquid PCB/ radioactive wastes must be designed to prevent the buildup of liquids if such containers are stored in an area meeting the containment requirements of paragraph (b)(1)(ii) of this section, as well as all other applicable State or Federal regulations or requirements for control of radioactive materials.
(C) Containers used to store both liquid and non-liquid PCB/radioactive wastes must meet all regulations and requirements pertaining to nuclear criticality safety. Acceptable container materials currently include polyethylene and stainless steel provided that the container material is chemically compatible with the wastes being stored. Other containers may be used
(ii) The following DOT specification containers that conform to the requirements of 49 CFR, chapter I, subchapter C in effect on September 30, 1991, may be used for storage and transportation activities that are not subject to DOT regulation, and may be used on a transitional basis as permitted at 49 CFR 171.14. For liquid PCBs: Specification 5 container without removable head, Specification 5B container without removable head, Specification 6D overpack with Specification 2S or 2SL polyethylene containers, or Specification 17E container. For non-liquid PCBs: Specification 5 container, Specification 5B container, or Specification 17C container.
(7) Stationary storage containers for liquid PCBs can be larger than the containers specified in paragraph (c)(6) of this section provided that:
(i) The containers are designed, constructed, and operated in compliance with Occupational Safety and Health Standards, 29 CFR 1910.106,
(ii) The owners or operators of any facility using containers described in paragraph (c)(7)(i) of this section, shall prepare and implement a Spill Prevention Control and Countermeasure (SPCC) Plan as described in part 112 of this title. In complying with 40 CFR part 112, the owner or operator shall read “oil(s)” as “PCB(s)” whenever it appears. The exemptions for storage capacity, 40 CFR 112.1(d)(2), and the amendment of SPCC plans by the Regional Administrator, 40 CFR 112.4, shall not apply unless some fraction of the liquids stored in the container are oils as defined by section 311 of the Clean Water Act.
(8) PCB Items shall be dated on the item when they are removed from service for disposal. The storage shall be managed so that the PCB Items can be located by this date. Storage containers provided in paragraph (c)(7) of this section, shall have a record that includes for each batch of PCBs the quantity of the batch and date the batch was added to the container. The record shall also include the date, quantity, and disposition of any batch of PCBs removed from the container.
(9) Bulk PCB remediation waste or PCB bulk product waste may be stored at the clean-up site or site of generation for 180 days subject to the following conditions:
(i) The waste is placed in a pile designed and operated to control dispersal of the waste by wind, where necessary, by means other than wetting.
(ii) The waste must not generate leachate through decomposition or other reactions.
(iii) The storage site must have:
(A) A liner that is designed, constructed, and installed to prevent any migration of wastes off or through the liner into the adjacent subsurface soil, ground water or surface water at any time during the active life (including the closure period) of the storage site. The liner may be constructed of materials that may allow waste to migrate into the liner. The liner must be:
(
(
(
(B) A cover that meets the requirements of paragraph (c)(9)(iii)(A) of this section, is installed to cover all of the stored waste likely to be contacted with precipitation, and is secured so as not to be functionally disabled by winds expected under normal seasonal meteorological conditions at the storage site.
(C) A run-on control system designed, constructed, operated, and maintained such that:
(
(
(iv) The provisions of this paragraph may be modified under § 761.61(c).
(10) Owners or operators of storage facilities shall establish and maintain records as provided in § 761.180.
(d)
(2) The Regional Administrator for the region in which the storage facility is located (or the Director, National Programs Chemical Division, if the commercial storage area is ancillary to a facility approved for disposal by the Director, National Programs Chemical Division) shall grant written, final approval to engage in the commercial storage of PCB waste upon a determination by the Regional Administrator or the Director, National Programs Chemical Division, that the criteria in paragraph (d)(2)(i) through (d)(2)(vii) of this section have been met by the applicant:
(i) The applicant, its principals, and its key employees responsible for the establishment or operation of the commercial storage facility are qualified to engage in the business of commercial storage of PCB waste.
(ii) The facility possesses the capacity to handle the quantity of PCB waste which the owner or operator of the facility has estimated will be the maximum quantity of PCB waste that will be handled at any one time at the facility.
(iii) The owner or operator of the unit has certified compliance with the storage facility standards in paragraphs (b) and (c)(7) of this section.
(iv) The owner or operator has developed a written closure plan for the facility that is deemed acceptable by the Regional Administrator (or the Director, National Programs Chemical Division, if the commercial storage is ancillary to a disposal facility permitted by the Director, National Programs Chemical Division) under the closure plan standards of paragraph (e) of this section.
(v) The owner or operator has included in the application for final approval a demonstration of financial responsibility for closure that meets the financial responsibility standards of paragraph (g) of this section.
(vi) The operation of the storage facility will not pose an unreasonable risk of injury to health or the environment.
(vii) The environmental compliance history of the applicant, its principals, and its key employees may be deemed to constitute a sufficient basis for denial of approval whenever in the judgment of the Regional Administrator (or Director, National Programs Chemical Division) that history of environmental civil violations or criminal convictions evidences a pattern or practice of noncompliance that demonstrates the applicant's unwillingness or inability to achieve and maintain compliance with the regulations.
(3) Applicants for storage approvals shall submit a written application that includes any relevant information bearing upon the qualifications of the facility's principals and key employees to engage in the business of commercial storage of PCB wastes. This information shall include, but is not limited to:
(i) The identification of the owner and the operator of the facility, including all general partners of a partnership, any limited partner of a partnership, any stockholder of a corporation or any participant in any other type of business organization or entity who owns or controls, directly or indirectly, more than 5 percent of each partnership, corporation, or other business organization and all officials of the facility who have direct management responsibility for the facility.
(ii) The identification of the person responsible for the overall operations of the facility (i.e., a plant manager, superintendent, or a person of similar responsibility) and the supervisory employees who are or will be responsible for the operation of the facility.
(iii) Information concerning the technical qualifications and experience of the persons responsible for the overall operation of the facility and the employees responsible for handling PCB waste or other wastes.
(iv) Information concerning any past State or Federal environmental violations involving the same business or another business with which the principals or supervisory employees were affiliated directly that occurred within 5 years preceding the date of submission and which relate directly to violations that resulted in either a civil penalty (irrespective of whether the matter was disposed of by an adjudication or by a without prejudice settlement) or judgment of conviction whether entered after trial or a plea, either of guilt or nolo contendere or civil injunctive relief and involved storage, disposal, transport, or other waste handling activities.
(v) A list of all companies currently owned or operated in the past by the principals or key employees identified in paragraphs (d)(3)(i) and (d)(3)(ii) of this section that are or were directly or indirectly involved with waste handling activities.
(vi) The owner's or operator's estimate of maximum PCB waste quantity to be handled at the facility.
(vii) A written statement certifying compliance with paragraph (b) or (c) of this section and containing a certification as defined in § 761.3.
(viii) A written closure plan for the facility, as described in paragraph (e) of this section.
(ix) The current closure cost estimate for the facility, as described in paragraph (f) of this section.
(x) A demonstration of financial responsibility to close the facility, as described in paragraph (g) of this section.
(4) The written approval issued by the Regional Administrator (or the Director, National Programs Chemical Division, if the commercial storage area is ancillary to a disposal facility approved by the Director, National Programs Chemical Division) shall include, but not be limited to, the following:
(i) The determination that the applicant has satisfied the requirements set forth in paragraph (d)(2) of this section, and a brief statement setting forth the basis for the determination.
(ii) Incorporation of the closure plan submitted by the facility owner or operator and approved by the Regional Administrator (or the Director, National Programs Chemical Division, if the commercial storage area is ancillary to a disposal facility approved by the Director, National Programs Chemical Division).
(iii) A condition imposing a maximum PCB storage capacity which the facility shall not exceed during its PCB waste storage operations. The maximum storage capacity imposed under this condition shall not be greater than the estimated maximum inventory of PCB waste included in the owner's or operator's application for final approval.
(iv) Such other conditions as deemed necessary by the Regional Administrator (or the Director, National Programs Chemical Division, if the commercial storage area is ancillary to a disposal facility approved by the Director, National Programs Chemical Division) to ensure that the operations of
(5) Storage areas at transfer facilities are exempt from the requirement to obtain approval as a commercial storer of PCB waste under this paragraph, unless the same PCB waste is stored at these facilities for a period of time greater than 10 consecutive days between destinations.
(6) Storage areas at RCRA-permitted facilities may be exempt from the separate TSCA storage approval requirements in this paragraph (d) upon a showing to the Regional Administrator's satisfaction that the facility's existing RCRA closure plan is substantially equivalent to this rule's closure plan standards, and that such facility's closure cost estimate and financial assurance demonstration account for maximum PCB waste inventories, and the requirements of paragraph (d)(3)(i) through (d)(3)(v) and (d)(3)(vii) of this section are met. A pay-in period of longer than 3 years after approval of the storage facility pursuant to this rule, will be acceptable to EPA if that pay-in period has already been established for a valid RCRA facility or previously approved TSCA facility.
(7) Storage areas ancillary to TSCA-approved disposal facilities may be exempt from a separate facility approval provided all of the following conditions are met:
(i) The current disposal approval contains an expiration date.
(ii) The current disposal approval's closure and financial responsibility conditions specifically extend to storage areas ancillary to disposal.
(iii) The current disposal approval's closure and financial responsibility conditions provide for annual adjustments for inflation, and for modification when changes in operation would affect closure costs.
(iv) The current disposal approval contains conditions on closure and financial responsibility that are at least as stringent as those in paragraphs (e) and (g) of this section. However, the provision for a 3-year closure trust pay-in period, as specified in paragraph (g)(1)(i) of this section, would be waived in a case in which an approved TSCA facility or RCRA facility that covers PCB storage has a longer pay-in period for the trust.
(v) The current disposal approval satisfies the requirements of paragraph (d)(3)(i) through (d)(3)(v) of this section.
(8) The approval of any existing TSCA-approved disposal facility ancillary to a commercial storage facility that is deficient in any of the conditions of paragraph (d)(7)(i) through (d)(7)(v) of this section shall be called in by the Regional Administrator or the Director, National Programs Chemical Division, if it was the Director, National Programs Chemical Division who issued it. The approval shall be modified to meet the requirements of paragraph (d)(7) of this section within 180 days of the effective date of this final rule, or a separate application for approval of the storage facility may be submitted to the Regional Administrator or the Director, National Programs Chemical Division, in the cases where the Director, National Programs Chemical Division issued the approval.
(e)
(i) A description of how the PCB storage areas of the facility will be closed in a manner that eliminates the potential for post-closure releases of PCBs into the environment.
(ii) An identification of the maximum extent of storage operations that will be open during the active life of the facility, including an identification of the extent of PCB storage operations at the facility relative to other wastes that will be handled at the facility.
(iii) An estimate of the maximum inventory of PCB wastes that could be handled at one time at the facility over its active life, and a detailed description of the methods or arrangements to be used during closure for removing, transporting, storing, or disposing of the facility's inventory of PCB waste,
(iv) A detailed description of the steps needed to remove or decontaminate PCB waste residues and contaminated containment system components, equipment, structures, and soils during closure in accordance with the levels specified in the PCB Spills Cleanup Policy in subpart G of this part, including a description of the methods for sampling and testing of surrounding soils, and the criteria for determining the extent of removal or decontamination.
(v) A detailed description of other activities necessary during the closure period to ensure that any post-closure releases of PCBs will not present unreasonable risks to human health or the environment. This includes activities such as ground-water monitoring, run-on and run-off control, and facility security.
(vi) A schedule for closure of each area of the facility where PCB waste is stored or handled, including the total time required to close each area of PCB waste storage or handling, and the time required for any intervening closure activities.
(vii) An estimate of the expected year of closure of the PCB waste storage areas, if a trust fund is opted for as the financial mechanism.
(2) A written closure plan determined to be acceptable by the Regional Administrator (or the Director, National Programs Chemical Division, if the commercial storage area is ancillary to a disposal facility approved by the Director, National Programs Chemical Division) under this section shall become a condition of any approval granted under paragraph (d) of this section.
(3) A separate and new closure plan need not be submitted in cases where a facility is currently covered by a TSCA approval or a RCRA permit, upon a showing to the satisfaction of the Regional Administrator (or the Director, National Programs Chemical Division, if the commercial storage area is ancillary to a disposal facility approved by the Director, National Programs Chemical Division) that the existing closure plan is substantially equivalent to closure plans required under paragraphs (d) through (g) of this section, and that the plan adequately accounts for PCB waste inventories.
(4) The commercial storer of PCB waste shall submit a written request to the Regional Administrator (or the Director, National Programs Chemical Division, if he approved the closure plan) for a modification to its storage approval to amend its closure plan, whenever:
(i) Changes in ownership, operating plans, or facility design affect the existing closure plan.
(ii) There is a change in the expected date of closure, if applicable.
(iii) In conducting closure activities, unexpected events require a modification of the approved closure plan.
(5) The Regional Administrator or the Director, National Programs Chemical Division, if he approved the closure plan, may modify the existing closure plan under the conditions described in paragraph (e)(4) of this section.
(6) Commercial storers of PCB waste shall comply with the following closure schedule:
(i) The commercial storer shall notify in writing the Regional Administrator or the Director, National Programs Chemical Division if he approved the closure plan, at least 60 days prior to the date on which final closure of its PCB storage facility is expected to begin.
(ii) The date when a commercial storer of PCB waste “expects to begin closure” shall be no later than 30 days after the date on which the storage facility received its final quantities of PCB waste. For good cause shown, the Regional Administrator or the Director, National Programs Chemical Division if he approved the closure plan, may extend the date for commencement of closure for an additional 30-day period.
(iii) Within 90 days after receiving the final quantity of PCB waste for storage, a commercial storer of PCB waste shall remove all PCB waste in storage at the facility from the facility in accordance with the approved closure plan. For good cause shown, the Regional Administrator or the Director, National Programs Chemical Division if he approved the closure plan,
(iv) A commercial storer of PCB waste shall complete closure activities in accordance with the approved closure plan and within 180 days after receiving the final quantity of PCB waste for storage at the facility. For good cause shown, the Regional Administrator or Director, National Programs Chemical Division if he approved the closure plan, may approve a reasonable extension to the closure period.
(7) During the closure period, all contaminated system component equipment, structures, and soils shall be disposed of in accordance with the disposal requirements of subpart D of this part, or, if applicable, decontaminated in accordance with the levels specified in the PCB Spills Cleanup Policy at subpart G of this part. When PCB waste is removed from the storage facility during closure, the owner or operator becomes a generator of PCB waste subject to the generator requirements of subpart J of this part.
(8) Within 60 days of completion of closure of each facility for the storage of PCB waste, the commercial storer of PCB waste shall submit to the Regional Administrator (or Director, National Programs Chemical Division if he approved the closure plan), by registered mail, a certification that the PCB storage facility has been closed in accordance with the approved closure plan. The certification shall be signed by the owner or operator and by an independent registered professional engineer.
(f)
(i) The closure cost estimate shall equal the cost of final closure at the point in the PCB storage facility's active life when the extent and manner of PCB storage operations would make closure the most expensive, as indicated by the facility's closure plan.
(ii) The closure cost estimate shall be based on the costs to the owner or operator of hiring a third party to close the facility, and the third party shall not be either a corporate parent or subsidiary of the owner or operator, or member in joint ownership of the facility.
(iii) The owner or operator shall include in the estimate the current market costs for off-site commercial disposal of the facility's maximum estimated inventory of PCB wastes, except that on-site disposal costs may be used if on-site disposal capacity will exist at the facility at all times over the life of the PCB storage facility.
(iv) The closure cost estimate may not incorporate any salvage value that may be realized with the sale of wastes, facility structures or equipment, land, or other assets associated with the facility at the time of closure.
(2) During the active life of the PCB storage facility, the commercial storer of PCB waste shall adjust annually for inflation the closure cost estimate within 60 days prior to the anniversary date of the establishment of the financial instruments used to demonstrate financial responsibility for closure, except that owners or operators who use the financial test or corporate guarantee shall adjust their closure cost estimates for inflation within 30 days after the close of the storer's fiscal year. The adjustment may be made by recalculating the maximum costs of closure in current dollars, or by using an inflation factor derived from the most recent Implicit Price Deflator for Gross National Product published by the U.S. Department of Commerce in its
(3) Where the Regional Administrator (or the Director, National Programs Chemical Division, if he approved the closure plan) approves a modification to the facility's closure plan, and that modification increases the cost of closure, the owner or operator shall revise the closure cost estimate no later than 30 days after the modification is approved. Any such revision shall also be adjusted for inflation in accordance with paragraph (f)(2) of this section.
(4) The owner or operator of the facility shall keep at the facility during its operating life the most recent closure cost estimate, including any adjustments resulting from inflation or from modifications to the closure plan.
(g)
(1) The “closure trust fund,” as specified in § 264.143(a) of this chapter, except for paragraph (a)(3) of § 264.143. For purposes of this paragraph, the following provisions also apply:
(i) Payments into the trust fund shall be made annually by the owner or operator over the remaining operating life of the facility as estimated in the closure plan, or over 3 years, whichever period is shorter. This period of time is hereafter referred to as the “pay-in period.” For an existing facility, the first payment must be made within 30 calendar days after EPA has notified the facility of its conditional approval. Interim approval to operate is canceled and the application is denied if EPA does not receive verification that the payment was made in that 30-day period.
(ii) For a new facility, the first payment into the closure trust fund shall be made before EPA grants final approval of the application and before the facility may accept the initial shipment of PCB waste for commercial storage. A receipt from the trustee shall be submitted by the owner or operator to the Regional Administrator (or the Director, National Programs Chemical Division, if the commercial storage area is ancillary to a disposal facility approved by the Director CMD) before this initial delivery of PCB waste. The first payment shall be at least equal to the current closure cost estimate, divided by the number of years in the pay-in period, except as provided in paragraph (g)(7) of this section for multiple mechanisms. Subsequent payments shall be made no later than 30 days after each anniversary date of the first payment. The amount of each subsequent payment shall be determined by subtracting the current value of the trust fund from the current closure cost estimate, and dividing this difference by the number of years remaining in the pay-in period.
(iii) If an owner or operator of a facility existing on the effective date of this paragraph establishes a trust fund to meet the financial assurance requirements of this paragraph, and the value of the trust fund is less than the current closure cost estimate when a final approval is granted for the facility, the amount of the current closure cost estimate still to be paid into the trust fund shall be paid in over the pay-in period as defined in paragraph (g)(1)(i) of this section. Payments shall continue to be made no later than 30 days after each anniversary date of the first payment made into the trust fund. The amount of each payment shall be determined by subtracting the current value of the trust fund from the current closure cost estimate, and dividing this difference by the number of years remaining in the pay-in period.
(iv) The submission of a trust agreement with the wording specified in § 264.151(a)(1) of this chapter, including any reference to hazardous waste management facilities, shall be deemed to be in compliance with the requirement to submit a trust agreement under this subpart.
(2) The “surety bond guaranteeing payment into a closure trust fund,” as specified in § 264.143(b) of this chapter, including the use of the surety bond instrument specified at § 264.151(b) of this chapter and the standby trust specified at § 264.143(b)(3) of this chapter. The use of the surety bonds, surety bond instruments, and standby trust agreements specified in § § 264.143(b) and 264.151(b) of
(3)(i) The “surety bond guaranteeing performance of closure,” as specified at § 264.143(c) of this chapter, except for paragraph (c)(5) of § 264.143 of this chapter. The submission and use of the surety bond instrument specified at § 264.151(c) of this chapter and the standby trust specified at § 264.143(c)(3) of this chapter shall be deemed to be in compliance with the requirements under this subpart relating to the use of surety bonds and standby trust funds.
(ii) For the purposes of this paragraph, and under the terms of the bond, the surety shall become liable on the bond obligation when the owner or operator fails to perform as guaranteed by the bond. Liability is established by a final administrative determination pursuant to section 16 of TSCA that the owner or operator has failed to perform final closure in accordance with the closure plan and other approval or regulatory requirements when required to do so.
(4)(i) The “closure letter of credit” specified in § 264.143(d) of this chapter, except for paragraph (d)(8). The submission and use of the irrevocable letter of credit instrument specified in § 264.151(d) of this chapter and the standby trust specified in § 264.143(d)(3) of this chapter shall be deemed to be in compliance with the requirements of this subpart relating to the use of letters of credit and standby trust funds.
(ii) For the purposes of this paragraph, the Regional Administrator (or the Director, National Programs Chemical Division, if the commercial storage area is ancillary to a disposal facility approved by the Director, National Programs Chemical Division) may draw on the letter of credit following a final administrative determination pursuant to section 16 of TSCA that the owner or operator has failed to perform final closure in accordance with the closure plan and other approval or regulatory requirements when required to do so.
(5) “Closure insurance,” as specified in § 264.143(e) of this chapter, utilizing the certificate of insurance for closure specified at § 264.151(e) of this chapter. The use of closure insurance as specified in § 264.143(e) of this chapter and the submission and use of the certificate of insurance specified in § 264.151(e) of this chapter shall be deemed to be in compliance with the requirements of this subpart relating to the use of closure insurance.
(6) The “financial test and corporate guarantee for closure,” as described in § 264.143(f) of this chapter, including a letter signed by the owner's or operator's chief financial officer as specified at § 264.151(f) of this chapter and, if applicable, the written corporate guarantee specified at § 264.151(h) of this chapter. The use of the financial test and corporate guarantee specified in § 264.143(f) of this chapter, the submission and use of the letter specified in § 264.151(f) of this chapter, and the submission and use of the written corporate guarantee specified at § 264.151(h) of this chapter shall be deemed to be in compliance with the requirements of this subpart relating to the use of financial tests and corporate guarantees.
(7) The corporate guarantee as specified in § 264.143(f)(10) of this chapter.
(8) The use of multiple financial mechanisms, as specified in § 264.143(g) of this chapter is permitted.
(9) A modification to a facility storing PCB waste that increases the maximum storage capacity indicated in the permit requires that a new financial assurance mechanism be established or an existing one be amended. When such a modification occurs, the Director of the Federal or State issuing authority must be notified in writing no later than 30 days from the completion of the modification. The new or revised financial assurance mechanism must be established and activated no later than 30 days after the Director of the Federal or State issuing authority is notified of the completion of the modification, but prior to the use of the modified portion of the facility.
(h)
(i)
(2) A laboratory sample is exempt from the manifesting requirements in § 761.208 when:
(i) The sample is being transported to a laboratory for the purpose of testing.
(ii) The sample is being transported back to the sample collector after testing.
(iii) The sample is being stored by the sample collector before transport to a laboratory for testing.
(iv) The sample is being stored in a laboratory before testing.
(v) The sample is being stored in a laboratory after testing but before it is returned to the sample collector.
(vi) The sample is being stored temporarily in the laboratory after testing for a specific purpose (for example, until conclusion of a court case or enforcement action where further testing of the sample may be necessary).
(3) In order to qualify for the exemption in paragraph (i)(2)(i) and (i)(2)(ii) of this section, a sample collector shipping samples to a laboratory and a laboratory returning samples to a sample collector must:
(i) Comply with applicable U.S. Department of Transportation (DOT) or U.S. Postal Service (USPS) shipping requirements, found respectively in 49 CFR 173.345 and U.S. Postal Regulations 652.2 and 652.3.
(ii) Assure that the following information accompanies the sample:
(A) The sample collector's name, mailing address, and telephone number.
(B) The laboratory's name, mailing address, and telephone number.
(C) The quantity of the sample.
(D) The date of shipment.
(E) A description of the sample.
(iii) Package the sample so that it does not leak, spill, or vaporize from its packaging.
(4) When the concentration of the PCB sample has been determined, and its use is terminated, the sample must be properly disposed. A laboratory must either manifest the PCB waste to a disposer or commercial storer, as required under § 761.208, retain a copy of each manifest, as required under § 761.209, and follow up on exception reporting, as required under § 761.215 (a) and (b), or return the sample to the sample collector who must then properly dispose of the sample. If the laboratory returns the sample to the sample collector, the laboratory must comply with the shipping requirements set forth in paragraph (i)(3)(i) through (i)(3)(iii) of this section.
(j)
(1) The transferee has established financial assurance for closure pursuant to paragraph (g) of this section using a mechanism effective as of the date of final approval so that there will be no lapse in financial assurance for the transferred facility.
(2) The transferor or transferee has resolved any deficiencies (e.g., technical operations, closure plans, cost estimates, etc.) the Agency has identified in the transferor's application.
(k)
This section applies to facilities used to incinerate PCBs required to be incinerated by this part.
(a)
(1) Combustion criteria shall be either of the following:
(i) Maintenance of the introduced liquids for a 2-second dwell time at 1200 °C (±100 °C) and 3 percent excess oxygen in the stack gas; or
(ii) Maintenance of the introduced liquids for a 1
(2) Combustion efficiency shall be at least 99.9 percent computed as follows:
(3) The rate and quantity of PCBs which are fed to the combustion system shall be measured and recorded at regular intervals of no longer than 15 minutes.
(4) The temperatures of the incineration process shall be continuously measured and recorded. The combustion temperature of the incineration process shall be based on either direct (pyrometer) or indirect (wall thermocouple-pyrometer correlation) temperature readings.
(5) The flow of PCBs to the incinerator shall stop automatically whenever the combustion temperature drops below the temperatures specified in paragraph (a)(1) of this section.
(6) Monitoring of stack emission products shall be conducted:
(i) When an incinerator is first used for the disposal of PCBs under the provisions of this regulation;
(ii) When an incinerator is first used for the disposal of PCBs after the incinerator has been modified in a manner which may affect the characteristics of the stack emission products; and
(iii) At a minimum such monitoring shall be conducted for the following parameters:
(
(7) At a minimum monitoring and recording of combustion products and incineration operations shall be conducted for the following parameters whenever the incinerator is incinerating PCBs:
(i) O
(8) The flow of PCBs to the incinerator shall stop automatically when any
(i) Failure of monitoring operations specified in paragraph (a)(7) of this section;
(ii) Failure of the PCB rate and quantity measuring and recording equipment specified in paragraph (a)(3) of this section; or
(iii) Excess oxygen falls below the percentage specified in paragraph (a)(1) of this section.
(9) Water scrubbers shall be used for HCl control during PCB incineration and shall meet any performance requirements specified by the appropriate EPA Regional Administrator or the Director, National Programs Chemical Division. Scrubber effluent shall be monitored and shall comply with applicable effluent or pretreatment standards, and any other State and Federal laws and regulations. An alternate method of HCl control may be used if the alternate method has been approved by the Regional Administrator or the Director, National Programs Chemical Division. (The HCl neutralizing capability of cement kilns is considered to be an alternate method.)
(b)
(1) The mass air emissions from the incinerator shall be no greater than 0.001g PCB/kg of the PCB introduced into the incinerator.
(2) The incinerator shall comply with the provisions of paragraphs (a)(2), (3), (4), (6), (7), (8)(i) and (ii), and (9) of this section.
(c)
(d)
(1)
(i) The location of the incinerator;
(ii) A detailed description of the incinerator including general site plans and design drawings of the incinerator;
(iii) Engineering reports or other information on the anticipated performance of the incinerator;
(iv) Sampling and monitoring equipment and facilities available;
(v) Waste volumes expected to be incinerated;
(vi) Any local, State, or Federal permits or approvals; and
(vii) Schedules and plans for complying with the approval requirements of this regulation.
(2)
(ii) If the Regional Administrator or the Director, National Programs Chemical Division determines that a trial burn must be held, the person who submitted the report described in paragraph (d)(1) of this section shall submit to the Regional Administrator or the Director, National Programs Chemical Division a detailed plan for conducting and monitoring the trial burn. At a minimum, the plan must include:
(A) Date trial burn is to be conducted;
(B) Quantity and type of PCBs and PCB Items to be incinerated;
(C) Parameters to be monitored and location of sampling points;
(D) Sampling frequency and methods and schedules for sample analyses; and
(E) Name, address, and qualifications of persons who will review analytical results and other pertinent data, and who will perform a technical evaluation of the effectiveness of the trial burn.
(iii) Following receipt of the plan described in paragraph (d)(2)(ii) of this section, the Regional Administrator or the Director, National Programs Chemical Division will approve the plan, require additions or modifications to the plan, or disapprove the plan. If the plan is disapproved, the Regional Administrator or the Director, National Programs Chemical Division will notify the person who submitted the plan of such disapproval, together with the reasons why it is disapproved. That person may thereafter submit a new plan in accordance with paragraph (d)(2)(ii) of this section. If the plan is approved (with any additions or modifications which the Regional Administrator or the Director, National Programs Chemical Division may prescribe), the Regional Administrator or the Director, National Programs Chemical Division will notify the person who submitted the plan of the approval. Thereafter, the trial burn shall take place at a date and time to be agreed upon between the Regional Administrator or the Director, National Programs Chemical Division and the person who submitted the plan.
(3)
The Regional Administrator will have available for review and inspection an Agency manual containing information on sampling methods and analytical procedures for the parameters required in § 761.70(a) (3), (4), (6), and (7) plus any other parameters he/she may determine to be appropriate. Owners or operators are encouraged to review this manual prior to submitting any report required in § 761.70.
(4)
(ii) In addition to the requirements of paragraphs (a) and/or (b) of this section, the Regional Administrator or the Director, National Programs Chemical Division may include in an approval any other requirements that the Regional Administrator or the Director, National Programs Chemical Division finds are necessary to ensure that operation of the incinerator does not present an unreasonable risk of injury to health or the environment from
(5)
(6)
(7)
(8)
(a) To burn mineral oil dielectric fluid containing a PCB concentration of ≥50 ppm, but <500 ppm:
(1) The boiler shall comply with the following criteria:
(i) The boiler is rated at a minimum of 50 million BTU hours.
(ii) If the boiler uses natural gas or oil as the primary fuel, the carbon monoxide concentration in the stack is ≤50 ppm and the excess oxygen is at least 3 percent when PCBs are being burned.
(iii) If the boiler uses coal as the primary fuel, the carbon monoxide concentration in the stack is ≤100 ppm and the excess oxygen is at least 3 percent when PCBs are being burned.
(iv) The mineral oil dielectric fluid does not comprise more than 10 percent (on a volume basis) of the total fuel feed rate.
(v) The mineral oil dielectric fluid is not fed into the boiler unless the boiler is operating at its normal operating temperature (this prohibits feeding these fluids during either start up or shut down operations).
(vi) The owner or operator of the boiler:
(A) Continuously monitors and records the carbon monoxide concentration and excess oxygen percentage in the stack gas while burning mineral oil dielectric fluid; or
(B) If the boiler will burn <30,000 gallons of mineral oil dielectric fluid per year, measures and records the carbon monoxide concentration and excess oxygen percentage in the stack gas at regular intervals of no longer than 60 minutes while burning mineral oil dielectric fluid.
(vii) The primary fuel feed rates, mineral oil dielectric fluid feed rates, and total quantities of both primary fuel and mineral oil dielectric fluid fed
(viii) The carbon monoxide concentration and the excess oxygen percentage are checked at least once every hour that mineral oil dielectric fluid is burned. If either measurement falls below the levels specified in this section, the flow of mineral oil dielectric fluid to the boiler shall be stopped immediately.
(2) Thirty days before any person burns mineral oil dielectric fluid in the boiler, the person gives written notice to the EPA Regional Administrator for the EPA Region in which the boiler is located and that the notice contains the following information:
(i) The name and address of the owner or operator of the boiler and the address of the boiler.
(ii) The boiler rating in units of BTU/hour.
(iii) The carbon monoxide concentration and the excess oxygen percentage in the stack of the boiler when it is operated in a manner similar to the manner in which it will be operated when mineral oil dielectric fluid is burned.
(iv) The type of equipment, apparatus, and procedures to be used to control the feed of mineral oil dielectric fluid to the boiler and to monitor and record the carbon monoxide concentration and excess oxygen percentage in the stack.
(3) When burning mineral oil dielectric fluid, the boiler must operate at a level of output no less than the output at which the measurements required under paragraph (a)(2)(iii) of this section were taken.
(4) Any person burning mineral oil dielectric fluid in a boiler obtains the following information and retains the information for 5 years at the boiler location:
(i) The data required to be collected under paragraphs (a)(1)(vi) and (vii) of this section.
(ii) The quantity of mineral oil dielectric fluid burned in the boiler each month.
(b) To burn liquids, other than mineral oil dielectric fluid, containing a PCB concentration of ≥50 ppm, but <500 ppm:
(1) The boiler shall comply with the following criteria:
(i) The boiler is rated at a minimum of 50 million BTU/hour.
(ii) If the boiler uses natural gas or oil as the primary fuel, the carbon monoxide concentration in the stack is ≤50 ppm and the excess oxygen is at least 3 percent when PCBs are being burned.
(iii) If the boiler uses coal as the primary fuel, the carbon monoxide concentration in the stack is ≤100 ppm and the excess oxygen is at least 3 percent when PCBs are being burned.
(iv) The waste does not comprise more than 10 percent (on a volume basis) of the total fuel feed rate.
(v) The waste is not fed into the boiler unless the boiler is operating at its normal operating temperature (this prohibits feeding these fluids during either start up or shut down operations).
(vi) The owner or operator of the boiler must:
(A) Continuously monitor and record the carbon monoxide concentration and excess oxygen percentage in the stack gas while burning waste fluid; or
(B) If the boiler will burn <30,000 gallons of waste fluid per year, measure and record the carbon monoxide concentration and excess oxygen percentage in the stack gas at regular intervals of no longer than 60 minutes while burning waste fluid.
(vii) The primary fuel feed rate, waste fluid feed rate, and total quantities of both primary fuel and waste fluid fed to the boiler must be measured and recorded at regular intervals of no longer than 15 minutes while burning waste fluid.
(viii) The carbon monoxide concentration and the excess oxygen percentage must be checked at least once every hour that the waste is burned. If either measurement falls below the levels specified in either (a)(1)(ii) or (a)(1)(iii) of this section, the flow of waste to the boiler shall be stopped immediately.
(2) Prior to any person burning these liquids in the boiler, approval must be obtained from the EPA Regional Administrator for the EPA Region in
(i) The name and address of the owner or operator of the boiler and the address of the boiler.
(ii) The boiler rating in units of BTU/hour.
(iii) The carbon monoxide concentration and the excess oxygen percentage in the stack of the boiler when it is operated in a manner similar to the manner in which it will be operated when low concentration PCB liquid is burned.
(iv) The type of equipment, apparatus, and procedures to be used to control the feed of mineral oil dielectric fluid to the boiler and to monitor and record the carbon monoxide concentration and excess oxygen percentage in the stack.
(v) The type of waste to be burned (e.g., hydraulic fluid, contaminated fuel oil, heat transfer fluid, etc.).
(vi) The concentration of PCBs and of any other chlorinated hydrocarbon in the waste and the results of analyses using the American Society of Testing and Materials (ASTM) methods as follows: Carbon and hydrogen content using ASTM D-3178-84, nitrogen content using ASTM E-258-67 (Reapproved 1987), sulfur content using ASTM D-2784-89, ASTM D-1266-87, or ASTM D-129-64, chlorine content using ASTM D-808-87, water and sediment content using either ASTM D-2709-88 or ASTM D-1796-83 (Reapproved 1990), ash content using ASTM D-482-87, calorific value using ASTM D-240-87, carbon residue using either ASTM D-2158-89 or ASTM D-524-88, and flash point using ASTM D-93-90.
(vii) The quantity of wastes estimated to be burned in a 30-day period.
(viii) An explanation of the procedures to be followed to ensure that burning the waste will not adversely affect the operation of the boiler such that combustion efficiency will decrease.
(3) On the basis of the information in paragraph (b)(2) of this section and any other available information, the Regional Administrator may, at his/her discretion, find that the alternate disposal method will not present an unreasonable risk of injury to health or the environment and approve the use of the boiler.
(4) When burning PCB wastes, the boiler must operate at a level of output no less than the output at which the measurements required under paragraph (b)(2)(iii) of this section were taken.
(5) Any person burning liquids in boilers approved as provided in paragraph (b)(3) of this section, must obtain the following information and retain the information for 5 years at the boiler location:
(i) The data required to be collected in paragraphs (b)(1)(vi) and (b)(1)(vii) of this section.
(ii) The quantity of low concentration PCB liquid burned in the boiler each month.
(iii) The analysis of the waste required by paragraph (b)(2)(vi) of this section taken once a month for each month during which low concentration PCB liquid is burned in the boiler.
Any person may dispose of residual PCBs associated with PCB-Contaminated articles regulated for disposal under § 761.60(b), metal surfaces in PCB remediation waste regulated under § 761.61, or metal surfaces in PCB bulk product waste regulated under §§ 761.62(a)(6) and 761.79(c)(6), from which all free-flowing liquids have been removed:
(a) In a scrap metal recovery oven:
(1) The oven shall have at least two enclosed (i.e., negative draft, no fugitive emissions) interconnected chambers.
(2) The equipment with all free-flowing liquid removed shall first be placed in the primary chamber at room temperature.
(3) The primary chamber shall operate at a temperature between 537 °C and 650 °C for a minimum of 2
(4) Heated gases from the primary chamber must feed directly into the
(5) Heating of the primary chamber shall not commence until the secondary chamber has reached a temperature of 1,200 ±100 °C (2,192 ° ±180 °F).
(6) Continuous emissions monitors and recorders for carbon dioxide, carbon monoxide, and excess oxygen in the secondary chamber and continuous temperature recorders in the primary and secondary chambers shall be installed and operated while the primary and secondary chambers are in operation to assure that the two chambers are within the operating parameters in paragraphs (a)(3) through (a)(5) of this section.
(7) Emissions from the secondary chamber must be vented through an exhaust gas stack in accordance with either:
(i) State or local air regulations or permits, or
(ii) The standards in paragraph (a)(8) of this section.
(8) Exhaust gas stack emissions shall be for: particulates <0.015 grains/dry standard cubic foot, sulfur dioxide <35 parts per million by volume (ppmv), nitrogen oxide <150 ppmv, carbon monoxide <35 ppmv, and hydrogen chloride <35 ppmv.
(9) A measurement of the temperature in the secondary chamber at the time the primary chamber starts heating must be taken, recorded and retained at the facility for 3 years from the date each charge is introduced into the primary chamber.
(b) By smelting:
(1) The operating temperature of the hearth must be at least 1,000 °C at the time it is charged with any PCB-Contaminated non-porous surface.
(2) Each charge containing a PCB-Contaminated item must be added into molten metal or a hearth at ≥1,000 °C.
(3) Successive charges may not be introduced into the hearth in less than 15-minute intervals.
(4) The smelter must operate in compliance with any applicable emissions standards in part 60 of this chapter.
(5) The smelter must have an operational device which accurately measures directly or indirectly, the temperature in the hearth.
(6) Take, record and retain at the disposal facility for 3 years from the date each charge is introduced, a reading of the temperature in the hearth at the time it is charged with a non-porous surface item.
(c)(1) Scrap metal recovery ovens and smelters must either have a final permit under RCRA (part 266, subpart H of this chapter and § 270.66 of this chapter) or be operating under a valid State air emissions permit which includes a standard for PCBs.
(2) Scrap metal recovery ovens and smelters disposing of PCBs must provide notification as disposers of PCBs, are not required to submit annual reports, and shall otherwise comply with all applicable provisions of subparts J and K of this part, as well as other applicable Federal, State, and local laws and regulations.
(3) In lieu of the requirements in paragraph (c)(1) of this section, upon written request by the owner or operator of a scrap metal recovery oven or smelter, the EPA Regional Administrator, for the Region where the oven or smelter is located, may make a finding in writing, based on a site-specific risk assessment, that the oven or smelter does not pose an unreasonable risk of injury to health or the environment because it is operating in compliance with the parameters and conditions listed in paragraph (a) or (b) of this section even though the oven or smelter does not have a RCRA or State air permit as required by paragraph (c)(1) of this section. The written request shall include a site-specific risk assessment.
(d) PCB liquids, other liquid waste qualifying as waste oils which may be used as provided for at § 761.20(e), or PCB remediation waste, other than PCB-Contaminated articles, may not be disposed of in a scrap metal recovery oven or smelter unless approved or
This section applies to facilities used to dispose of PCBs in accordance with the part.
(a)
(b)
(1)
(i) In-place soil thickness, 4 feet or compacted soil liner thickness, 3 feet;
(ii) Permeability (cm/sec), equal to or less than 1×10
(iii) Percent soil passing No. 200 Sieve, >30;
(iv) Liquid Limit, >30; and
(v) Plasticity Index >15.
(2)
(3)
(4)
(ii) If the landfill site is above the 100-year floodwater elevation, the operators shall provide diversion structures capable of diverting all of the surface water runoff from a 24-hour, 25-year storm.
(5)
(6)
(B) Any surface watercourse designated by the Regional Administrator using the authority provided in paragraph (c)(3)(ii) of this section shall be sampled at least monthly when the landfill is being used for disposal operations.
(C) Any surface watercourse designated by the Regional Administrator using the authority provided in paragraph (c)(3)(ii) of this section shall be sampled for a time period specified by the Regional Administrator on a frequency of no less than once every six months after final closure of the disposal area.
(ii)
(B) All monitor wells shall be cased and the annular space between the monitor zone (zone of saturation) and the surface shall be completely backfilled with Portland cement or an equivalent material and plugged with Portland cement to effectively prevent percolation of surface water into the well bore. The well opening at the surface shall have a removable cap to provide access and to prevent entrance of rainfall or stormwater runoff. The well shall be pumped to remove the volume of liquid initially contained in the well before obtaining a sample for analysis. The discharge shall be treated to meet applicable State or Federal discharge standards or recycled to the chemical waste landfill.
(iii)
(A) PCBs.
(B) pH.
(C) Specific conductance.
(D) Chlorinated organics.
(7)
(i)
(ii)
(iii)
(8)
(ii) An operation plan shall be developed and submitted to the Regional Administrator for approval as required in paragraph (c) of this section. This plan shall include detailed explanations of the procedures to be used for recordkeeping, surface water handling procedures, excavation and backfilling, waste segregation burial coordinates, vehicle and equipment movement, use of roadways, leachate collection systems, sampling and monitoring procedures, monitoring wells, environmental emergency contingency plans, and security measures to protect against vandalism and unauthorized waste placements. EPA guidelines entitled “Thermal Processing and Land Disposal of Solid Waste” (39 FR 29337, Aug. 14, 1974) are a useful reference in preparation of this plan. If the facility is to
(iii) Ignitable wastes shall not be disposed of in chemical waste landfills. Liquid ignitable wastes are wastes that have a flash point less than 60 degrees C (140 degrees F) as determined by the following method or an equivalent method: Flash point of liquids shall be determined by a Pensky-Martens Closed Cup Tester, using the protocol specified in ASTM D 93-90, or the Setaflash Closed Tester using the protocol specified in ASTM Standard D-3278-89.
(iv) Records shall be maintained for all PCB disposal operations and shall include information on the PCB concentration in liquid wastes and the three dimensional burial coordinates for PCBs and PCB Items. Additional records shall be developed and maintained as required in § 761.180.
(9)
(ii) Roads shall be maintained to and within the site which are adequate to support the operation and maintenance of the site without causing safety or nuisance problems or hazardous conditions.
(iii) The site shall be operated and maintained in a manner to prevent safety problems or hazardous conditions resulting from spilled liquids and windblown materials.
(c)
(1)
(i) The location of the landfill;
(ii) A detailed description of the landfill including general site plans and design drawings;
(iii) An engineering report describing the manner is which the landfill complies with the requirements for chemical waste landfills specified in paragraph (b) of this section;
(iv) Sampling and monitoring equipment and facilities available;
(v) Expected waste volumes of PCBs;
(vi) General description of waste materials other than PCBs that are expected to be disposed of in the landfill;
(vii) Landfill operations plan as required in paragraph (b) of this section;
(viii) Any local, State, or Federal permits or approvals; and
(ix) Any schedules or plans for complying with the approval requirements of these regulations.
(2)
(3)
(ii) In addition to the requirements of paragraph (b) of this section, the Regional Administrator may include in an approval any other requirements or provisions that the Regional Administrator finds are necessary to ensure that operation of the chemical waste landfill does not present an unreasonable risk of injury to health or the environment from PCBs. Such provisions may include a fixed period of time for which the approval is valid.
(4)
(5)
(6)
(7)
(a)
(1) Persons seeking a TSCA PCB Coordinated Approval shall submit a request for approval by certified mail, to the EPA Regional Administrator for the Region in which the activity will take place. Persons seeking a TSCA PCB Coordinated Approval for a new PCB activity shall submit the request for approval at the same time they
(i) The request for a TSCA PCB Coordinated Approval shall include a copy of the letter from EPA announcing or confirming the EPA identification number issued to the facility for conducting PCB activities; the name, organization, and telephone number of the person who is the contact point for the non-TSCA Federal or State waste management authority; a copy of the relevant permit or waste management document specified in paragraphs (b) and (c) of this section, including all requirements, conditions, and limitations, if the EPA Regional Administrator does not have a copy of the document, or a description of the waste management activities to be conducted if a permit or other relevant waste management document has not been issued; and a certification that the person who owns or operates the facility is aware of and will adhere to the TSCA PCB reporting and recordkeeping requirements at subparts J and K of this part.
(ii) The EPA Regional Administrator shall review the request for completeness, for compliance with the requirements of paragraphs (b) and (c) of this section, and to ensure that the PCB activity for which approval is requested will not present an unreasonable risk of injury to health or the environment. The EPA Regional Administrator shall either:
(A) Issue a written notice of deficiency explaining why the request for approval is deficient. If appropriate, the EPA Regional Administrator may either:
(
(
(B) Issue a letter granting or denying the TSCA PCB Coordinated Approval. If the EPA Regional Administrator grants the TSCA PCB Coordinated Approval, he or she may acknowledge the non-TSCA approval meets the regulatory requirements under TSCA as written, or require additional conditions the EPA Regional Administrator has determined are necessary to prevent unreasonable risk of injury to health or the environment.
(C) If the EPA Regional Administrator denies a request for a Coordinated Approval under paragraphs (a)(1)(ii)(A) or (a)(1)(ii)(B) of this section, the person who requested the TSCA PCB Coordinated Approval may submit an application for a TSCA Disposal Approval.
(2) The EPA Regional Administrator may issue a notice of deficiency, revoke the TSCA PCB Coordinated Approval, require the person to whom the TSCA PCB Coordinated Approval was issued to submit an application for a TSCA PCB approval, or bring an enforcement action under TSCA if he or she determines that:
(i) Conditions of the approval relating to PCB waste management activities are not met.
(ii) The PCB waste management process is being operated in a manner which may result in an unreasonable risk of injury to health or the environment.
(iii) The non-TSCA approval expires, is revoked, is suspended, or otherwise ceases to be in full effect.
(3) Any person with a TSCA PCB Coordinated Approval must notify the EPA Regional Administrator in writing within 5 calendar days of changes relating to PCB waste requirements in the non-TSCA waste management document which serves as the basis for a TSCA PCB Coordinated Approval. Changes in the ownership of a commercial storage facility which holds a TSCA PCB Coordinated Approval shall be handled pursuant to § 761.65(j).
(b) Any person who owns or operates a facility that he or she intends to use to landfill PCB wastes; incinerate PCB wastes; dispose of PCB wastes using an alternative disposal method that is equivalent to disposal in an incinerator approved under § 761.70 or a high efficiency boiler operating in compliance with § 761.71; or stores PCB wastes may apply for a TSCA PCB Coordinated Approval. The EPA Regional Administrator may approve the request if the EPA Regional Administrator determines that the activity will not pose an unreasonable risk of injury to health or the environment and the person:
(1)(i) Has a waste management permit or other decision or enforcement document which exercises control over PCB wastes, issued by EPA or an authorized State Director for a State program that has been approved by EPA and is no less stringent in protection of health or the environment than the applicable TSCA requirements found in this part; or
(ii) Has a PCB waste management permit or other decision or enforcement document issued by a State Director pursuant to a State PCB waste management program no less stringent in protection of health or the environment than the applicable TSCA requirements found in this part; or
(iii) Is subject to a waste management permit or other decision or enforcement document which is applicable to the disposal of PCBs and which was issued through the promulgation of a regulation published in Title 40 of the Code of Federal Regulations.
(2) Complies with the terms and conditions of the permit or other decision or enforcement document described in paragraph (b)(1) of this section.
(3) Unless otherwise waived or modified in writing by the EPA Regional Administrator, complies with § 761.75(b); § 761.70(a)(1) through (a)(9), (b)(1) and (b)(2), and (c); or the PCB storage requirements at §§ 761.65(a), (c), and (d)(2), as appropriate.
(4) Complies with the reporting and recordkeeping requirements in subparts J and K of this part.
(c) A person conducting research and development (R&D) into PCB disposal methods (regardless of PCB concentration), or conducting PCB remediation activities may apply for a TSCA PCB Coordinated Approval. The EPA Regional Administrator may approve the request if the EPA Regional Administrator determines that the activity will not pose an unreasonable risk of injury to health or the environment and the person:
(1)(i) Has a permit or other decision and enforcement document issued or otherwise agreed to by EPA, or permit or other decision and enforcement document issued by an authorized State Director for a State program that has been approved by EPA, which exercises control over the management of PCB wastes, and that person is in compliance with all terms and conditions of that document; or
(ii) Has a permit, which exercises control over the management of PCB wastes, issued by a State Director pursuant to a State PCB disposal program no less stringent than the requirements in this part.
(2) Complies with the terms and conditions of that permit or other decision and enforcement document.
(3) Complies with the reporting and recordkeeping requirements in subparts J and K of this part.
(a)
(1) Decontamination in accordance with this section does not require a disposal approval under subpart D of this part.
(2) Materials from which PCBs have been removed by decontamination in accordance with this section may be distributed in commerce in accordance with § 761.20(c)(5).
(3) Materials from which PCBs have been removed by decontamination in accordance with this section may be used or reused in accordance with § 761.30(u).
(4) Materials from which PCBs have been removed by decontamination in accordance with this section, not including decontamination waste and residuals under paragraph (g) of this section, are unregulated for disposal under subpart D of this part.
(5) Any person decontaminating porous surfaces other than concrete under paragraph (b)(4) of this section and non-porous surfaces covered with a porous surface, such as paint or coating on metal, under paragraph (b)(3) or (c)(6) of this section must obtain an alternative decontamination approval in
(6) Any person engaging in decontamination under this section is responsible for determining and complying with all other applicable Federal, State, and local laws and regulations.
(b)
(1) The decontamination standard for water containing PCBs is:
(i) Less than 200 µg/L (i.e., <200 ppb PCBs) for non-contact use in a closed system where there are no releases;
(ii) For water discharged to a treatment works (as defined in § 503.9(aa) of this chapter) or to navigable waters, <3 µg/L (approximately <3 ppb) or a PCB discharge limit included in a permit issued under section 307(b) or 402 of the Clean Water Act; or
(iii) Less than or equal to 0.5 µg/L (i.e., approximately ≤0.5 ppb PCBs) for unrestricted use.
(2) The decontamination standard for organic liquids and non-aqueous inorganic liquids containing PCBs is <2 milligrams per kilogram (i.e., <2 ppm PCBs).
(3) The decontamination standard for non-porous surfaces in contact with liquid and non-liquid PCBs is:
(i) For unrestricted use:
(A) For non-porous surfaces previously in contact with liquid PCBs at any concentration, where no free-flowing liquids are currently present, ≤10 micrograms PCBs per 100 square centimeters (≤10 µg/100 cm
(B) For non-porous surfaces in contact with non-liquid PCBs (including non-porous surfaces covered with a porous surface, such as paint or coating on metal), cleaning to Visual Standard No. 2, Near-White Blast Cleaned Surface Finish, of the National Association of Corrosion Engineers (NACE). A person shall verify compliance with standard No. 2 by visually inspecting all cleaned areas.
(ii) For disposal in a smelter operating in accordance with § 761.72(b):
(A) For non-porous surfaces previously in contact with liquid PCBs at any concentration, where no free-flowing liquids are currently present, <100 µg/100 cm
(B) For non-porous surfaces in contact with non-liquid PCBs (including non-porous surfaces covered with a porous surface, such as paint or coating on metal), cleaning to Visual Standard No. 3, Commercial Blast Cleaned Surface Finish, of the National Association of Corrosion Engineers (NACE). A person shall verify compliance with standard No. 3 by visually inspecting all cleaned areas.
(4) The decontamination standard for concrete is ≤10 µg/100 cm
(c)
(1) Any person decontaminating a PCB Container must do so by flushing the internal surfaces of the container three times with a solvent containing <50 ppm PCBs. Each rinse shall use a volume of the flushing solvent equal to approximately 10 percent of the PCB Container capacity.
(2) Any person decontaminating movable equipment contaminated by PCBs, tools, and sampling equipment may do so by:
(i) Swabbing surfaces that have contacted PCBs with a solvent;
(ii) A double wash/rinse as defined in subpart S of this part; or
(iii) Another applicable decontamination procedure in this section.
(3) Any person decontaminating a non-porous surface in contact with free-flowing mineral oil dielectric fluid (MODEF) at levels ≤10,000 ppm PCBs must do so as follows:
(i) Drain the free-flowing MODEF and allow the residual surfaces to drain for an additional 15 hours.
(ii) Dispose of drained MODEF according to paragraph (g) of this section.
(iii) Soak the surfaces to be decontaminated in a sufficient amount of clean (containing <2 ppm PCBs) performance-based organic decontamination fluid (PODF) such that there is a minimum of 800 ml of PODF for each 100 cm
(iv) Approved PODFs include:
(A) Kerosene.
(B) Diesel fuel.
(C) Terpene hydrocarbons.
(D) Mixtures of terpene hydrocarbons and terpene alcohols.
(v) Drain the PODF from the surfaces.
(vi) Dispose of the drained PODF in accordance with paragraph (g) of this section.
(4) Any person decontaminating a non-porous surface in contact with free-flowing MODEF containing >10,000 ppm PCB in MODEF or askarel PCB (up to 70 percent PCB in a mixture of trichlorobenzenes and tetrachlorobenzenes) must do so as follows:
(i) Drain the free-flowing MODEF or askarel and allow the residual surfaces to drain for an additional 15 hours.
(ii) Dispose of drained MODEF or askarel according to paragraph (g) of this section.
(iii) Soak the surfaces to be decontaminated in a sufficient amount of clean PODF (containing <2 ppm PCBs) such that there is a minimum of 800 ml of PODF for each 100 cm
(iv) Approved PODFs include:
(A) Kerosene.
(B) Diesel fuel.
(C) Terpene hydrocarbons.
(D) Mixtures of terpene hydrocarbons and terpene alcohols.
(v) Drain the PODF from the surfaces.
(vi) Dispose of the drained PODF in accordance with paragraph (g) of this section.
(vii) Resoak the surfaces to be decontaminated, pursuant to paragraph (c)(3)(iii) of this section, in a sufficient amount of clean PODF (containing <2 ppm PCBs) such that there is a minimum of 800 ml of PODF for each 100 cm
(viii) Drain the PODF from the surfaces.
(ix) Dispose of the drained PODF in accordance with paragraph (g) of this section.
(5) Any person decontaminating piping and air lines in an air compressor system must do so as follows:
(i) Before decontamination proceeds, disconnect or bypass the air compressors and air dryers from the piping and air lines and decontaminate the air compressors and air dryers separately in accordance with paragraphs (b), (c)(1) through (c)(4), or (c)(6) of this section. Dispose of filter media and desiccant in the air dyers based on their existing PCB concentration.
(ii) Test the connecting line and appurtenances of the system to assure that there is no leakage. Test by introducing air into the closed system at from 90 to 100 pounds per square inch (psi). Only if there is a pressure drop of <5 psi in 30 minutes may decontamination take place.
(iii) When there is no leakage, fill the piping and air lines with clean (containing <2 ppm PCBs) solvent. Solvents include PODF, aqueous potassium hydroxide at a pH between 9 and 12, or water containing 5 percent sodium hydroxide by weight.
(iv) Circulate the solvent to achieve turbulent flow through the piping and air lines in the air compressor system until the total volume of solvent circulated equals 10 times the total volume of the particular article being decontaminated, then drain the solvent. Calculate the total volume of solvent circulated by multiplying the pump rate by the time of pumping. Turbulent flow means a Reynolds number range from 20,000 to 43,000. Refill the system
(6) Any person using thermal processes to decontaminate metal surfaces in contact with PCBs, as required by § 761.62(a)(6), must use one of the following options:
(i) Surfaces in contact with liquid and non-liquid PCBs at concentrations <500 ppm may be decontaminated in a scrap metal recovery oven or smelter for purposes of disposal in accordance with § 761.72.
(ii) Surfaces in contact with liquid or non-liquid PCBs at concentrations ≥500 ppm may be smelted in a smelter operating in accordance with § 761.72(b), but must first be decontaminated in accordance with § 761.72(a) or to a surface concentration of <100 µg/100 cm
(d)
(2) The solvent may be reused for decontamination so long as its PCB concentration is <50 ppm.
(3) Solvent shall be disposed of under paragraph (g) of this section.
(4) Other than as allowed in paragraphs (c)(3) and (c)(4) of this section, solvents may be tested and validated for performance-based decontamination of non-porous surfaces contaminated with MODEF or other PCB liquids, in accordance with the self-implementing procedures found in subpart T of this part. Specific conditions for the performance-based testing from this validation are determined in the validation study.
(e)
(2) Persons participating in decontamination activities shall wear or use protective clothing or equipment to protect against dermal contact or inhalation of PCBs or materials containing PCBs.
(f)
(2) Confirmatory sampling is not required for self-implementing decontamination procedures under paragraph (c) of this section. Any person using these procedures must retain a written record documenting compliance with the procedures for 3 years after completion of the decontamination procedures (e.g., video recordings, photographs).
(g)
(1) Distillation bottoms or residues and filter media are regulated for disposal as PCB remediation waste.
(2) PCBs physically separated from regulated waste during decontamination (such as by chopping, shredding, scraping, abrading or oil/water separation, as opposed to solvent rinsing and soaking), other than wastes described in paragraph (g)(1) of this section, are regulated for disposal at their original concentration.
(3) Hydrocarbon solvent used or reused for decontamination under this section that contains <50 ppm PCB must be burned and marketed in accordance with the requirements for used oil in § 761.20(e), disposed of in accordance with § 761.60(a) or (e), or decontaminated pursuant to this section.
(4) Chlorinated solvent at any PCB concentration used for decontamination under this section shall be disposed of in an incinerator operating in compliance with § 761.70, or decontaminated pursuant to this section.
(5) Solvents ≥50 ppm other than those described in paragraphs (g)(3) and (g)(4) of this section shall be disposed of in accordance with § 761.60(a) or decontaminated pursuant to this section.
(6) Non-liquid cleaning materials and personal protective equipment waste at any concentration, including non-porous surfaces and other non-liquid materials such as rags, gloves, booties, other disposable personal protective equipment, and similar materials resulting from decontamination shall be disposed of in accordance with § 761.61(a)(5)(v).
(h)
(2) Any person wishing to decontaminate material described in paragraph (a) of this section using a self-implementing procedure other than prescribed in paragraph (c) of this section must apply in writing to the EPA Regional Administrator in the Region where the activity would take place, for decontamination activity occurring in a single EPA Region; or the Director of the National Program Chemicals Division, for decontamination activity occurring in more than one EPA Region. Each application must describe the material to be decontaminated and the proposed self-implementing decontamination method and must include a proposed validation study to confirm performance of the method.
(3) Any person wishing to sample decontaminated material in a manner other than prescribed in paragraph (f) of this section must apply in writing to the EPA Regional Administrator in the Region where the activity would take place, for decontamination activity occurring in a single EPA Region; or the Director of the National Program Chemicals Division, for decontamination activity occurring in more than one EPA Region. Each application must contain a description of the material to be decontaminated, the nature and PCB concentration of the contaminating material (if known), the decontamination method, the proposed sampling procedure, and a justification for how the proposed sampling is equivalent to or more comprehensive than the sampling procedure required under paragraph (f) of this section.
(4) EPA may request additional information that it believes necessary to evaluate the application.
(5) EPA will issue a written decision on each application for risk-based decontamination or sampling. No person may conduct decontamination or sampling under this paragraph prior to obtaining written approval from EPA. EPA will approve an application if it finds that the proposed decontamination or sampling method will not pose an unreasonable risk of injury to health or the environment.
(a) The Administrator grants the following petitioner(s) an exemption for 1 year to process and distribute in commerce PCBs for use as a mounting medium in microscopy:
(1) McCrone Accessories Components, Division of Walter C. McCrone Associates, Inc., 2820 South Michigan Avenue, Chicago, IL. 60616.
(2) [Reserved]
(b) The Administrator grants the following petitioner(s) an exemption for 1
(1) R.P. Cargille Laboratories, Inc., 55 Commerce Road, Cedar Grove, N.J. 07009.
(2) [Reserved]
(c) The Administrator grants the following petitioner(s) an exemption for 1 year to export PCBs for use in small quantities for research and development:
(1) Accu-Standard, New Haven, CT. 06503.
(2) ManTech, Research Triangle Park, NC 27709.
(d) The Administrator grants the following petitioner(s) an exemption for 1 year to import (manufacture) into the United States, small quantities of existing PCB fluids from electrical equipment for analysis:
(1) Unison Transformer Services, Inc., Tarrytown, N.Y. 10591, provided each of the following conditions are met:
(i) The samples must be shipped in 5.0 ml or less, hermetically sealed vials.
(ii) The exemption is limited to no more than 250 total samples per year.
(iii) Unison makes quarterly inspections of its laboratories to ensure that proper safety procedures are being followed.
(iv) Unison annually notifies and describes to EPA its attempts to have samples analyzed abroad.
(2) [Reserved]
(e) The Administrator grants a class exemption to all research and development (R&D) facilities for a period of 1 year to manufacture or import PCBs for use solely in the manufacturer or importer's own research for the development of PCB disposal technologies. Each person that wishes to be part of the exemption must meet the following conditions:
(1) A petition for an exemption from the PCB prohibition on manufacturing PCBs must be received by EPA 60 days prior to engaging in these activities.
(2) Requests for renewal must be filed pursuant to § 750.11 of this chapter. EPA will deem any properly filed request for the renewal of the exemption by any member of the class as a renewal request for the entire class.
(3) The quantity of the PCBs manufactured annually must not exceed 500 grams by total weight of pure PCBs. Any person who wishes to manufacture or import more than 500 grams of PCBs in 1 year must receive written approval from the Director, National Program Chemicals Division to exceed the limitations established by this provision. The Director, National Program Chemicals Division may grant approval without further rulemaking. Any increase granted will be in writing and will extend only for a maximum of the time remaining in a specific exemption year.
(4) The owner or operator of the facility must notify the EPA Regional Administrator in writing 30 days prior to the commencement of R&D activities that include the manufacture or import of PCBs under the exemption, unless the facility has obtained a PCB R&D approval from EPA pursuant to § 761.60(e), § 761.60(i)(2), § 761.70(a), or § 761.70(b) and the approval contains a provision allowing the manufacture of PCBs.
(5) Records are maintained of their PCB activities for a period of 3 years after ceasing operations. The records must include the sources and the annual amounts of PCBs received if imported and the type and annual amount of PCBs that were manufactured.
(6) All PCBs and materials containing PCBs, regardless of concentration, remaining from the disposal-related studies must be disposed of according to § 761.60(j)(1)(vi), or decontaminated pursuant to § 761.79, based on the original PCB concentration.
(f) The Administrator grants the following petitioner(s) an exemption for 1 year to manufacture PCBs for use in small quantities for research and development:
(1) California Bionuclear Corp., Sun Valley, CA 91352 (ME-13).
(2) Foxboro Co., North Haven, CT 06473 (ME-6).
(3) ULTRA-Scientific, Inc.,Hope, RI 02831 (ME-99.1).
(4) Midwest Research Institute, Kansas City, MO 64110 (ME-70.1).
(5) Pathfinder Laboratories, St. Louis, MO 63146 (A division of Sigma
(6) Radian Corp., Austin, TX 78766 (ME-81.2).
(7) Wellington Sciences USA, College Station, TX 77840 (ME-104.1).
(8) Accu-Standard, 25 Science Park, New Haven, CT. 06503.
(g) The Administrator grants a class exemption to all processors and distributors of PCBs in small quantities for research and development provided that the following conditions are met:
(1) All processors and distributors must maintain records of their PCB activities for a period of 5 years.
(2) Any person or company which expects to process or distribute in commerce 100 grams (.22 lb) or more PCBs in 1 year must report to EPA identifying the sites of PCB activities and the quantity of PCBs to be processed or distributed in commerce.
(h) The Administrator grants the following petitioners an exemption for 1 year to process and distribute in commerce PCBs for analytical reference samples derived from actual waste materials:
(1) R.T. Corporation, Laramie, WY 82070.
(2) [Reserved]
(i) The Administrator grants a class exemption to all persons who manufacture, import, process, distribute in commerce, or export PCBs, or analytical reference samples derived from PCB waste material, provided the PCBs are manufactured, imported, processed, distributed in commerce, or exported solely for the purpose of R&D and the following conditions are met:
(1) Notification in the form of a petition for an exemption from the PCB prohibitions on manufacture, import, processing, distribution in commerce, or export is received by EPA 60 days prior to engaging in these activities.
(2) Requests for renewal are filed pursuant to §§ 750.11 and 750.31 of this chapter. EPA will deem any properly filed request for the renewal of the exemption by any member of the class as a renewal request for the entire class.
(3) The PCBs are packaged in one or more hermetically sealed containers of a volume of no more than 5.0 ml each. Analytical reference samples derived from PCB waste material may be packaged in a container larger than 5.0 ml when packaged pursuant to applicable DOT performance standards.
(4) The quantity of PCBs manufactured, imported, processed, distributed in commerce, or exported annually must not exceed 500 grams by total weight of pure PCBs. Any person who expects to manufacture, import, process, distribute in commerce, or export more than 500 grams of PCBs in 1 year or to exceed the 5.0 ml packaging requirement must obtain a written approval from the Director, National Program Chemicals Division and must identify the sites of PCB activities and the quantity of PCBs to be manufactured, imported, processed, distributed in commerce, or exported. Each request must include a justification. The Director, National Program Chemicals Division, may grant approval without further rulemaking. Any increase granted will be in writing and will extend only for a maximum of the time remaining in a specific exemption year.
(5) All treated and untreated PCB regulated material and material coming into contact with regulated material must be stored and disposed of according to subpart D of this part, or decontaminated pursuant to § 761.79.
(6) All PCB materials must be distributed in DOT-authorized packaging.
(7) Records are maintained of their PCB activities for a period of 3 years after ceasing operations. The records must include the sources and the annual amounts of PCBs received if imported, the annual amount of PCBs that were manufactured, the annual amount of PCBs that were processed and/or distributed in commerce (to include export), and the persons to whom the PCBs were shipped.
(j)-(l) [Reserved]
(m) The Administrator grants the following petitioner(s) an exemption for 1 year to process and export small quantities of PCBs for research and development:
(1) Chem Service, Inc., West Chester, PA 19380 (PDE-41).
(2) Foxboro Co., North Haven, CT 06473 (ME-6).
(3) PolyScience Corp., Niles, IL 60648 (PDE-178).
(4) ULTRA-Scientific, Inc., Hope, RI 02831 (PDE-282.1).
(5) Supelco, Inc., Bellefonte, PA 16823-0048 (PDE-41.2).
(6) Radian Corp., Austin, TX 78766 (PDE-182.1).
(7) Restek Corporation, Bellefonte, PA
(n) The 1-year exemption granted to petitioners in paragraphs (a) through (c)(1), (d), (f), and (m)(1) through (m)(6) of this section shall be renewed automatically as long as there is no increase in the amount of PCBs to be processed and distributed, imported (manufactured), or exported, nor any change in the manner of processing and distributing, importing (manufacturing), or exporting of PCBs. If there is such a change, a new exemption petition must be submitted to EPA and it will be addressed through an exemption rulemaking. In such a case, the activities granted under the existing exemption may continue until the new petition is addressed by rulemaking, but must conform to the terms of the existing exemption approved by EPA. The 1-year exemption granted to petitioners in paragraphs (c)(2), (h) and (m)(7) of this section may be extended pursuant to 40 CFR 750.11(e) or 750.31(e).
(o) The 1-year class exemption granted to all processors and distributors of PCBs in small quantities for research and development in paragraph (g) of this section shall be renewed automatically unless information is submitted affecting EPA's conclusion that the class exemption, or the activities of any individual or company included in the exemption, will not pose an unreasonable risk of injury to health or the environment. EPA will evaluate the information, issue a proposed rule for public comment, and issue a final rule affecting the class exemption or individuals or companies included in the class exemption. Until EPA issues a final rule, individuals and companies included in the class exemption will be allowed to continue processing and distributing PCBs in small quantities for research and development.
This subpart establishes requirements under section 6 of TSCA applicable to the transboundary shipments of PCBs and PCB Items into and out of the United States for disposal. Nothing in this subpart is intended to obviate or otherwise alter obligations applicable to imported or exported PCBs and PCB Items under foreign laws, international agreements or arrangements, other United States statutes and regulations, other sections of TSCA (e.g., sections 13 and 14), or laws of the various States of the United States. No provision of this section shall be construed to affect or limit the applicability of any requirement applicable to transporters of PCB waste under regulations issued by the U.S. Department of Transportation (DOT) and set forth at 49 CFR parts 171-180.
(a)
(b) [Reserved]
(a) General provisions. No person may export PCBs or PCB Items for disposal without an exemption, except that:
(1) PCBs and PCB Items at concentrations <50 ppm (or <10 µg PCB/100 cm
(2) For the purposes of this section, PCBs and PCB Items of unknown concentrations shall be treated as if they contain ≥50 ppm.
(b) [Reserved]
For purposes of this subpart, the following transboundary shipments are not considered exports or imports:
(a) PCB waste generated in the United States, transported outside the Customs Territory of the United States (including any residuals resulting from cleanup of spills of such wastes in transit) through another country or its territorial waters, or through international waters, and returned to the United States for disposal.
(b) PCB waste in transit, including any residuals resulting from cleanup of spills during transit, through the United States (e.g., from Mexico to Canada, from Canada to Mexico).
(c) PCB waste transported from any State to any other State for disposal, regardless of whether the waste enters or leaves the customs territory of the United States, provided that the PCB waste or the PCBs from which the waste was derived were present in the United States on January 1, 1979, and have remained within the United States since that date.
(a)
(1) Existing spills (spills which occurred prior to May 4, 1987, are excluded from the scope of this policy for two reasons:
(i) For old spills which have already been discovered, this policy is not intended to require additional cleanup where a party has already cleaned a spill in accordance with requirements imposed by EPA through its regional offices, nor is this policy intended to interfere with ongoing litigation of enforcement actions which bring into issue PCB spills cleanup.
(ii) EPA recognizes that old spills which are discovered after the effective date of this policy will require site-by-site evaluation because of the likelihood that the site involves more pervasive PCB contamination than fresh spills and because old spills are generally more difficult to clean up than fresh spills (particularly on porous surfaces such as concrete). Therefore, spills which occurred before the effective date of this policy are to be decontaminated to requirements established at the discretion of EPA, usually through its regional offices.
(2) EPA expects most PCB spills subject to the TSCA PCB regulations to conform to the typical spill situations considered in developing this policy. This policy does, however, exclude from application of the final numerical cleanup standards certain spill situations from its scope: Spills directly into surface waters, drinking water, sewers, grazing lands, and vegetable gardens. These types of spills are subject to final cleanup standards to be established at the discretion of the regional office. These spills are, however, subject to the immediate notification requirements and measures to minimize further environmental contamination.
(3) For all other spills, EPA generally expects the decontamination standards of this policy to apply. Occasionally, some small percentage of spills covered by this policy may warrant more stringent cleanup requirements because of additional routes of exposure or significantly greater exposures than those assumed in developing the final cleanup standards of this policy. While the EPA regional offices have the authority to require additional cleanup in these circumstances, the Regional Administrator must first make a finding based on the specific facts of a spill that additional cleanup must occur to prevent unreasonable risk. In addition, before a final decision is made to require additional cleanup, the Regional Administrator must notify the Director, Office of Pollution Prevention and Toxics at Headquarters of his/her finding and the basis for the finding.
(4) There may also be exceptional spill situations that requires less stringent cleanup or a different approach to cleanup because of factors associated with the particular spill. These factors may mitigate expected exposures and risks or make cleanup to these requirements impracticable.
(b)
(1) For example, site-specific characteristics, such as short depth to ground water, type of soil, or the presence of a shallow well, may pose exceptionally high potential for ground water contamination by PCBs remaining after cleanup to the standards specified in this policy. Spills that pose such a high degree of potential for ground water contamination have not been excluded from the policy under paragraph (d) of this section because the presence of such potential may not be readily apparent. EPA feels that automatically excluding such spills from the scope of the policy could result in the delay of cleanup—a particularly undesirable outcome if potential ground water contamination is, in fact, a significant concern.
(2) In those situations, the Regional Administrator may require cleanup in addition to that required under § 761.125 (b) and (c). However, the Regional Administrator must first make a finding, based on the specific facts of a spill, that additional cleanup is necessary to prevent unreasonable risk. In addition, before making a final decision on additional cleanup, the Regional Administrator must notify the Director of the Office of Pollution Prevention and Toxics of his finding and the basis for the finding.
(c)
(d)
(2) For the spill situations in paragraphs (d)(2)(i) through (vi) of this section, the responsible party shall decontaminate the spill in accordance with site-specific requirements established by the EPA regional offices.
(i) Spills that result in the direct contamination of surface waters (surface waters include, but are not limited
(ii) Spills that result in the direct contamination of sewers or sewage treatment systems.
(iii) Spills that result in the direct contamination of any private or public drinking water sources or distribution systems.
(iv) Spills which migrate to and contaminate surface waters, sewers, or drinking water supplies before cleanup has been completed in accordance with this policy.
(v) Spills that contaminate animal grazing lands.
(vi) Spills that contaminate vegetable gradens.
(e)
(2) The Agency recognizes that the existence of this policy will inevitably result in attempts to apply the standards to situations within the scope of other statutory authorities. However, other statutes require the Agency to consider different or alternative factors in determining appropriate corrective actions. In addition, the types and magnitudes of exposures associated with sites requiring corrective action under other statutes often involve important differences from those expected of the typical, electrical equipment-type spills considered in developing this policy. Thus, cleanups under other statutes, such as RCRA corrective actions or remedial and response actions under SARA may result in different outcomes.
For purposes of this policy, certain words and phrases are used to denote specific materials, procedures, or circumstances. The following definitions are provided for purposes of clarity and are not to be taken as exhaustive lists of situations and materials covered by the policy.
(1) “Requirements” as used in this policy refers to both the procedural responses and numerical decontamination levels set forth in this policy as constituting adequate cleanup of PCBs.
(2) “Standards” refers to the numerical decontamination levels set forth in this policy.
(a)
(1)
(i) Where a spill directly contaminates surface water, sewers, or drinking water supplies, as discussed under § 761.120(d), the responsible party shall notify the appropriate EPA regional office (the Office of Prevention, Pesticides and Toxic Substances Branch) and obtain guidance for appropriate cleanup measures in the shortest possible time after discovery, but in no
(ii) Where a spill directly contaminates grazing lands or vegetable gardens, as discussed under § 761.120(d), the responsible party shall notify the appropriate EPA regional office (the Office of Prevention, Pesticides and Toxic Substances Branch) and proceed with the immediate requirements specified under paragraph (b) or (c) of this section, depending on the source of the spill, in the shortest possible time after discovery, but in no case later than 24 hours after discovery.
(iii) Where a spill exceeds 10 pounds of PCBs by weight and is not addressed in paragraph (a)(1) (i) or (ii) of this section, the responsible party will notify the appropriate EPA regional office (Pesticides and Toxic Substances Branch) and proceed to decontaminate the spill area in accordance with this TSCA policy in the shortest possible time after discovery, but in no case later than 24 hours after discovery.
(iv) Spills of 10 pounds or less, which are not addressed in paragraph (a)(1) (i) or (ii) of this section, must be cleaned up in accordance with this policy (in order to avoid EPA enforcement liability), but notification of EPA is not required.
(2)
(3)
(b)
(i) Solid surfaces must be double washed/rinsed (as defined under § 761.123); except that all indoor, residential surfaces other than vault areas must be cleaned to 10 micrograms per 100 square centimeters (10 µg/100 cm
(ii) All soil within the spill area (i.e., visible traces of soil and a buffer of 1 lateral foot around the visible traces) must be excavated, and the ground be restored to its original configuration by back-filling with clean soil (i.e., containing less than 1 ppm PCBs).
(iii) Requirements of paragraphs (b)(1) (i) and (ii) of this section must be completed within 48 hours after the responsible party was notified or became aware of the spill.
(2)
(3)
(i) Identification of the source of the spill (e.g., type of equipment).
(ii) Estimated or actual date and time of the spill occurrence.
(iii) The date and time cleanup was completed or terminated (if cleanup was delayed by emergency or adverse weather: the nature and duration of the delay).
(iv) A brief description of the spill location.
(v) Precleanup sampling data used to establish the spill boundaries if required because of insufficient visible traces, and a brief description of the sampling methodology used to establish the spill boundaries.
(vi) A brief description of the solid surfaces cleaned and of the double wash/rinse method used.
(vii) Approximate depth of soil excavation and the amount of soil removed.
(viii) A certification statement signed by the responsible party stating that the cleanup requirements have been met and that the information contained in the record is true to the best of his/her knowledge.
(ix) While not required for compliance with this policy, the following information would be useful if maintained in the records:
(A) Additional pre- or post-cleanup sampling.
(B) The estimated cost of the cleanup by man-hours, dollars, or both.
(c)
(1)
(i) The responsible party shall notify the EPA regional office and the NRC as required by § 761.125(a)(1) or by other applicable statutes.
(ii) The responsible party shall effectively cordon off or otherwise delineate and restrict an area encompassing any visible traces plus a 3-foot buffer and place clearly visible signs advising persons to avoid the area to minimize the spread of contamination as well as the potential for human exposure.
(iii) The responsible party shall record and document the area of visible contamination, noting the extent of the visible trace areas and the center of the visible trace area. If there are no visible traces, the responsible party shall record this fact and contact the regional office of the EPA for guidance in completing statistical sampling of the spill area to establish spill boundaries.
(iv) The responsible party shall initiate cleanup of all visible traces of the fluid on hard surfaces and initiate removal of all visible traces of the spill on soil and other media, such as gravel, sand, oyster shells, etc.
(v) If there has been a delay in reaching the site and there are insufficient visible traces of PCBs remaining at the spill site, the responsible party must estimate (based on the amount of material missing from the equipment or container) the area of the spill and immediately cordon off the area of suspect contamination. The responsible party must then utilize a statistically based sampling scheme to identify the boundaries of the spill area as soon as practicable.
(vi) Although this policy requires certain immediate actions, as described in paragraphs (c)(1)(i) through (iv) of this section, EPA is not placing a time limit on completion of the cleanup effort since the time required for completion will vary from case to case. However, EPA expects that decontamination will be achieved promptly in all cases and will consider promptness of completion in determining whether the responsible party
(2)
(i) Contaminated solid surfaces (both impervious and non-impervious) shall be cleaned to a PCB concentration of 100 micrograms (µg)/100 square centimeters (cm
(ii) At the option of the responsible party, soil contaminated by the spill will be cleaned either to 25 ppm PCBs by weight, or to 50 ppm PCBs by weight provided that a label or notice is visibly placed in the area. Upon demonstration by the responsible party that cleanup to 25 ppm or 50 ppm will jeopardize the integrity of the electrical equipment at the substation, the EPA regional office may establish an alternative cleanup method or level and place the responsible party on a reasonably timely schedule for completion of cleanup.
(3)
(i) High-contact solid surfaces, as defined under § 761.163 shall be cleaned to 10 µg/100 cm
(ii) Low-contact, indoor, impervious solid surfaces will be decontaminated to 10 µg/100 cm
(iii) At the option of the responsible party, low-contact, indoor, nonimpervious surfaces will be cleaned either to 10 µg/100 cm
(iv) Low-contact, outdoor surfaces (both impervious and nonimpervious) shall be cleaned to 100 µg/100 cm
(v) Soil contaminated by the spill will be cleaned to 25 ppm PCBs by weight.
(4)
(i) Furnishings, toys, and other easily replaceable household items shall be disposed of in accordance with the provisions of subpart D of this part and replaced by the responsible party.
(ii) Indoor solid surfaces and high-contact outdoor solid surfaces, defined as high contact residential/commercial surfaces under § 761.123, shall be cleaned to 10 µg/100 cm
(iii) Indoor vault areas and low-contact, outdoor, impervious solid surfaces shall be decontaminated to 10 µg/100 cm
(iv) At the option of the responsible party, low-contact, outdoor, nonimpervious solid surfaces shall be either cleaned to 10 µg/100 cm
(v) Soil contaminated by the spill will be decontaminated to 10 ppm PCBs by weight provided that soil is excavated to a minimum depth of 10 inches. The excavated soil will be replaced with clean soil, i.e., containing less than 1 ppm PCBs, and the spill site will be restored (e.g., replacement of turf).
(5)
(i) Identification of the source of the spill, e.g., type of equipment.
(ii) Estimated or actual date and time of the spill occurrence.
(iii) The date and time cleanup was completed or terminated (if cleanup was delayed by emergency or adverse weather: the nature and duration of the delay).
(iv) A brief description of the spill location and the nature of the materials contaminated. This information should include whether the spill occurred in an outdoor electrical substation, other restricted access location, or in a nonrestricted access area.
(v) Precleanup sampling data used to establish the spill boundaries if required because of insufficient visible traces and a brief description of the sampling methodology used to establish the spill boundaries.
(vi) A brief description of the solid surfaces cleaned.
(vii) Approximate depth of soil excavation and the amount of soil removed.
(viii) Postcleanup verification sampling data and, if not otherwise apparent from the documentation, a brief description of the sampling methodology and analytical technique used.
(ix) While not required for compliance with this policy, information on the estimated cost of cleanup (by man-hours, dollars, or both) would be useful if maintained in the records.
Postcleanup sampling is required to verify the level of cleanup under § 761.125(c) (2) through (4). The responsible party may use any statistically valid, reproducible, sampling scheme (either random samples or grid samples) provided that the requirements of paragraphs (a) and (b) of this section are satisfied.
(a) The sampling area is the greater of (1) an area equal to the area cleaned plus an additional 1-foot boundary, or (2) an area 20 percent larger than the original area of contamination.
(b) The sampling scheme must ensure 95 percent confidence against false positives.
(c) The number of samples must be sufficient to ensure that areas of contamination of a radius of 2 feet or more within the sampling area will be detected, except that the minimum number of samples is 3 and the maximum number of samples is 40.
(d) The sampling scheme must include calculation for expected variability due to analytical error.
(e) EPA recommends the use of a sampling scheme developed by the Midwest Research Institute (MRI) for use in EPA enforcement inspections: “Verification of PCB Spill Cleanup by Sampling and Analysis.” Guidance for the use of this sampling scheme is available in the MRI report “Field Manual for Grid Sampling of PCB Spill Sites to Verify Cleanup.” Both the MRI sampling scheme and the guidance document are available from the Director, Environmental Assistance Division (7408), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Room E-543B, 1200 Pennsylvania Ave., NW., Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202) 544-0551. The major advantage of this sampling scheme is that it is designed to characterize the degree of contamination within the entire sampling area with a high degree of confidence while using fewer samples
(f) EPA may, at its discretion, take samples from any spill site. If EPA's sampling indicates that the remaining concentration level exceeds the required level, EPA will require further cleanup. For this purpose, the numerical level of cleanup required for spills cleaned in accordance with § 761.125(b) is deemed to be the equivalent of numerical cleanup requirements required for cleanups under § 761.125(c) (2) through (4). Using its best engineering judgment, EPA may sample a statistically valid random or grid sampling technique, or both. When using engineering judgment or random “grab” samples, EPA will take into account that there are limits on the power of a grab sample to dispute statistically based sampling of the type required of the responsible party. EPA headquarters will provide guidance to the EPA regions on the degree of certainty associated with various grab sample results.
(a) Although a spill of material containing 50 ppm or greater PCBs is considered improper PCB disposal, this policy establishes requirements that EPA considers to be adequate cleanup of the spilled PCBs. Cleanup in accordance with this policy means compliance with the procedural as well as the numerical requirements of this policy. Compliance with this policy creates a presumption against both enforcement action for penalties and the need for further cleanup under TSCA. The Agency reserves the right, however, to initiate appropriate action to compel cleanup where, upon review of the records of cleanup or EPA sampling following cleanup, EPA finds that the decontamination levels in the policy have not been achieved. The Agency also reserves the right to seek penalties where the Agency believes that the responsible party has not made a good faith effort to comply with all provisions of this policy, such as prompt notification of EPA of a spill, recordkeeping, etc.
(b) EPA's exercise of enforcement discretion does not preclude enforcement action under other provisions of TSCA or any other Federal statute. This includes, even in cases where the numerical decontamination levels set forth in this policy have been met, civil or criminal action for penalties where EPA believes the spill to have been the result of gross negligence or knowing violation.
This section contains recordkeeping and reporting requirements that apply to PCBs, PCB Items, and PCB storage and disposal facilities that are subject to the requirements of the part.
(a)
(1) The annual records shall include the following:
(i) All signed manifests generated by the facility during the calendar year.
(ii) All Certificates of Disposal that have been received by the facility during the calendar year.
(iii) Records of inspections and cleanups performed in accordance with § 761.65(c)(5).
(2) The written annual document log shall include the following:
(i) The name, address, and EPA identification number of the facility covered by the annual document log and the calendar year covered by the annual document log.
(ii) The unique manifest number of every manifest generated by the facility during the calendar year, and from each manifest and for unmanifested waste that may be stored at the facility, the following information:
(A) For bulk PCB waste (
(B) The serial number (if available) or other means of identifying each PCB Article (
(C) A unique number identifying each PCB Container, a description of the contents of each PCB Container, such as liquid, soil, cleanup debris, etc., including the total weight of the material in kilograms in each PCB Container, the first date material placed in each PCB Container was removed from service for disposal, and the date each PCB Container was placed in transport for off-site storage or disposal, and the date of disposal (if known).
(D) A unique number identifying each PCB Article Container, a description of the contents of each PCB Article Container, such as pipes, capacitors, electric motors, pumps, etc., including the total weight in kilograms of the content of each PCB Article Container, the first date a PCB Article placed in each PCB Article Container was removed from service for disposal, and the date the PCB Article Container was placed in transport for off-site storage or disposal, and the date of disposal (if known.)
(iii) The total number by specific type of PCB Articles and the total weight in kilograms of PCBs in PCB Articles, the total number of PCB Article Containers and total weight in kilograms of the contents of PCB Article Containers, the total number of PCB Containers and the total weight in kilograms of the contents of PCB Containers, and the total weight in kilograms of bulk PCB waste that was placed into storage for disposal or disposed during the calendar year.
(iv) The total number of PCB Transformers and total weight in kilograms of PCBs contained in the transformers remaining in service at the end of the calendar year.
(v) The total number of Large High or Low Voltage PCB Capacitors remaining in service at the end of the calendar year.
(vi) The total weight in kilograms of any PCBs and PCB Items in PCB Containers, including the identification of container contents, remaining in service at the facility at the end of the calendar year.
(vii) For any PCBs or PCB item received from or shipped to another facility owned or operated by the same generator, the information required under paragraph (a)(2)(ii)(A) through (a)(2)(ii)(D) of this section.
(viii) A record of each telephone call, or other means of verification agreed upon by both parties, made to each designated commercial storer or designated disposer to confirm receipt of
(ix) Whenever a PCB Item, excluding small capacitors, with a concentration of ≥50 ppm is distributed in commerce for reuse pursuant to § 761.20(c)(1), the name, address, and telephone number of the person to whom the item was transferred, date of transfer, and the serial number of the item or the internal identification number, if a serial number is not available, must be recorded in the annual document log. The serial number or internal identification number shall be permanently marked on the equipment.
(3) [Reserved]
(4) For purposes of this paragraph, PCB Voltage Regulators shall be recorded as PCB Transformers.
(b)
(1) The annual records shall include the following:
(i) All signed manifests generated or received at the facility during the calendar year.
(ii) All Certificates of Disposal that have been generated or received by the facility during the calendar year.
(iii) Records of inspections and cleanups performed in accordance with § 761.65(c)(5).
(2) The written annual document log shall include the following:
(i) The name, address, and EPA identification number of the storage or disposal facility covered by the annual document log and the calendar year covered by the annual document log.
(ii) For each manifest generated or received by the facility during the calendar year, the unique manifest number and the name and address of the facility that generated the manifest and the following information:
(A) For bulk PCB waste (
(B) The serial number or other means of identifying each PCB Article, not in a PCB Container or PCB Article Container, the weight in kilograms of the
(C) The unique number assigned by the generator identifying each PCB Container, a description of the contents of each PCB Container, such as liquid, soil, cleanup debris, etc., including the total weight of the PCB waste in kilograms in each PCB Container, the first date PCB waste placed in each PCB Container was removed from service for disposal, the date it was received at the facility, the date each PCB Container was placed in transport for off-site storage or disposal (as applicable), and the date the PCB Container was disposed of (if known).
(D) The unique number assigned by the generator identifying each PCB Article Container, a description of the contents of each PCB Article Container, such as pipes, capacitors, electric motors, pumps, etc., including the total weight in kilograms of the PCB waste in each PCB Article Container, the first date a PCB Article placed in each PCB Article Container was removed from service for disposal, the date it was received at the facility, the date each PCB Article Container was placed in transport for off-site storage or disposal (as applicable), and the date the PCB Article Container was disposed of (if known).
(E) Disposers of PCB waste shall include the confirmed date of disposal for items in paragraphs (b)(2)(ii)(A) through (b)(2)(ii)(D) of this section.
(iii) For any PCB waste disposed at a facility that generated the PCB waste or any PCB waste that was not manifested to the facility, the information required under paragraph (b)(2)(ii)(A) through (b)(2)(ii)(E) of this section.
(3) The owner or operator of a PCB disposal facility (including an owner or operator who disposes of his/her own waste and does not receive or generate manifests) or a commercial storage facility shall submit an annual report, which briefly summarizes the records and annual document log required to be maintained and prepared under paragraphs (b)(1) and (b)(2) of this section to the EPA Regional Administrator of the Region in which the facility is located by July 15 of each year, beginning with July 15, 1991. The first annual report submitted on July 15, 1991, shall be for the period starting February 5, 1990, and ending December 31, 1990. The annual report shall contain no confidential business information. The annual report shall consist of the information listed in paragraphs (b)(3)(i) through (b)(3)(vi) of this section.
(i) The name, address, and EPA identification number of the facility covered by the annual report for the calendar year.
(ii) A list of the numbers of all signed manifests of PCB waste initiated or received by the facility during that year.
(iii) The total weight in kilograms of bulk PCB waste, PCB waste in PCB Transformers, PCB waste in PCB Large High or Low Voltage Capacitors, PCB waste in PCB Article Containers, and PCB waste in PCB Containers in storage at the facility at the beginning of the calendar year, received or generated at the facility, transferred to another facility, or disposed of at the facility during the calendar year. The information must be provided for each of these categories, as appropriate.
(iv) The total number of PCB Transformers, the total number of PCB Large High or Low Voltage Capacitors, the total number of PCB Article Containers, and the total number of PCB Containers in storage at the facility at the beginning of the calendar year, received or generated at the facility, transferred to another facility, or disposed of at the facility during the calendar year. The information must be provided for each of these categories, as appropriate.
(v) The total weight in kilograms of each of the following PCB categories: bulk PCB waste, PCB waste in PCB Transformers, PCB waste in PCB Large High or Low Voltage Capacitors, PCB waste in PCB Article Containers, and PCB waste in PCB Containers remaining in storage for disposal at the facility at the end of the calendar year.
(vi) The total number of PCB Transformers, the total number of PCB Large High or Low Voltage Capacitors,
(vii) The requirement to submit annual reports to the Regional Administrator continues until the submission of the annual report for the calendar year during which the facility ceases PCB storage or disposal operations. Storage operations have not ceased until all PCB waste, including any PCB waste generated during closure, has been removed from the facility.
(4) Whenever a commercial storer of PCB waste accepts PCBs or PCB Items at his storage facility and transfers the PCB waste off-site to another facility for storage or disposal, the commercial storer of PCB waste shall initiate a manifest under subpart K of this part for the transfer of PCBs or PCB Items to the next storage or disposal facility.
Any requirements for weights in kilograms of PCBs may be calculated values if the internal volume of PCBs in containers and transformers is known and included in the reports, together with any assumptions on the density of the PCBs contained in the containers or tranformers. If the internal volume of PCBs is not known, a best estimate may be used.
(5) For purposes of this paragraph, PCB Voltage Regulators shall be recorded and reported as PCB Transformers.
(c)
(1) When PCBs are being incinerated, the following continuous and short-interval data:
(i) Rate and quantity of PCBs fed to the combustion system as required in § 761.70(a)(3);
(ii) Temperature of the combustion process as required in § 761.70(a)(4); and
(iii) Stack emission product to include O
(2) When PCBs are being incinerated, data and records on the monitoring of stack emissions as required in § 761.70(a)(6).
(3) Total weight in kilograms of any solid residues generated by the incineration of PCBs and PCB Items during the calendar year, the total weight in kilograms of any solid residues disposed of by the facility in chemical waste landfills, and the total weight in kilograms of any solid residues remaining on the facility site.
(4) When PCBs and PCB Items are being incinerated, additional periodic data shall be collected and maintained as specified by the Regional Administrator pursuant to § 761.70(d)(4).
(5) Upon any suspension of the operation of any incinerator pursuant to § 761.70(a)(8), the owner or operator of such an incinerator shall prepare a document. The document shall, at a minimum, include the date and time of the suspension and an explanation of the circumstances causing the suspension of operation. The document shall be sent to the appropriate Regional Administrator within 30 days of any such suspension.
(d)
(1) Any water analysis obtained in compliance with § 761.75(b)(6)(iii); and
(2) Any operations records including burial coordinates of wastes obtained in compliance with § 761.75(b)(8)(ii).
(e)
(1) For each month PCBs are burned in the boiler the carbon monoxide and excess oxygen data required in § 761.71(a)(1)(viii) and § 761.71(b)(1)(viii);
(2) The quantity of PCBs burned each month as required in § 761.71(a)(1)(vii) and § 761.71(b)(1)(vii); and
(3) For each month PCBs (other than mineral oil dielectric fluid) are burned, chemical analysis data of the waste as required in § 761.71(b)(2)(vi).
(f)
(1) All documents, correspondence, and data that have been provided to the owner or operator of the facility by any State or local government agency and that pertain to the storage or disposal of PCBs and PCB Items at the facility.
(2) All documents, correspondence, and data that have been provided by the owner or operator of the facility to any State or local government agency and that pertain to the storage or disposal of PCBs and PCB Items at the facility.
(3) Any applications and related correspondence sent by the owner or operator of the facility to any local, State, or Federal authorities in regard to waste water discharge permits, solid waste permits, building permits, or other permits or authorizations such as those required by §§ 761.70(d) and 761.75(c).
(g)
(a) In addition to meeting the basic requirements of § 761.1(f) and the definition of excluded manufacturing processes at § 761.3, manufacturers with processes inadvertently generating PCBs and importers of products containing inadvertently generated PCBs must report to EPA any excluded manufacturing process or imports for which the concentration of PCBs in products leaving the manufacturing site or imported is greater than 2 micrograms per gram (2 µg/g, roughly 2 ppm) for any resolvable gas chromatographic peak. Such reports must be filed by October 1, 1984 or, if no processes or imports require reports at the time, within 90 days of having processes or imports for which such reports are required.
(b) Manufacturers required to report by paragraph (a) of this section must transmit a letter notifying EPA of the number, the type, and the location of excluded manufacturing processes in which PCBs are generated when the PCB level in products leaving any manufacturing site is greater than 2 µg/g for any resolvable gas chromatographic peak. Importers required to report by paragraph (a) of this section must transmit a letter notifying EPA of the concentration of PCBs in imported products when the PCB concentration of products being imported is greater than 2 µg/g for any resolvable gas chromatographic peak. Persons must also certify the following:
(1) Their compliance with all applicable requirements of § 761.1(f), including any applicable requirements for air and water releases and process waste disposal.
(2) Whether determinations of compliance are based on actual monitoring of PCB levels or on theoretical assessments.
(3) That such determinations of compliance are being maintained.
(4) If the determination of compliance is based on a theoretical assessment, the letter must also notify EPA of the estimated PCB concentration levels generated and released.
(c) Any person who reports pursuant to paragraph (a) of this section:
(1) Must have performed either a theoretical analysis or actual monitoring of PCB concentrations.
(2) Must maintain for a period of three years after ceasing process operations or importation, or for seven years, whichever is shorter, records containing the following information:
(i)
(ii)
(B) The results of the analysis, including data from the Quality Assurance Plan.
(C) Description of the sample matrix.
(D) The name of the analyst or analysts.
(E) The date and time of the analysis.
(F) Numbers for the lots from which the samples are taken.
(d) The certification required by paragraph (b) of this section must be signed by a responsible corporate officer. This certification must be maintained by each facility or importer for a period of three years after ceasing process operation or importation, or for seven years, whichever is shorter, and must be made available to EPA upon request. For the purpose of this section, a responsible corporate officer means:
(1) A president, secretary, treasurer, or vice-president of the corporation in charge of a principal business function, or any other person who performs similar policy or decision-making functions for the corporation.
(2) The manager of one or more manufacturing, production, or operating facilities employing more than 250 persons or having gross annual sales or expenditures exceeding $25,000,000 (in second quarter 1980 dollars), if authority to sign documents has been assigned or delegated to the manager in accordance with corporate procedures.
(e) Any person signing a document under paragraph (d) of this section shall also make the following certification:
I certify under penalty of law that this document and all attachments were prepared under my direction or supervision in accordance with a system designed to assure that qualified personnel properly gather and evaluate information. Based on my inquiry of the person or persons directly responsible for gathering information, the information is, to the best of my knowledge and belief, true, accurate, and complete. I am aware that there are significant penalties for falsifying information, including the possibility of fines and imprisonment for knowing violations.
(f) This report must be submitted to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, ATTN: PCB Notification. This report must be submitted by October 1, 1984 or within 90 days of starting up processes or commencing importation of PCBs.
(g) This certification process must be repeated whenever process conditions are significantly modified to make the previous certification no longer valid.
In addition to meeting the basic requirements of § 761.1(f) and the definition of excluded manufacturing process
(a) Data are reported to the EPA by the owner/operator or importer concerning the total quantity of PCBs in product from excluded manufacturing processes leaving any manufacturing site in any calendar year when such quantity exceeds 0.0025 percent of that site's rated capacity for such manufacturing processes as of October 1, 1984; or the total quantity of PCBs imported in any calendar year when such quantity exceeds 0.0025 percent of the average total quantity of such product containing PCBs imported by such importer during the years 1978, 1979, 1980, 1981 and 1982.
(b) Data are reported to the EPA by the owner/operator concerning the total quantity of inadvertently generated PCBs released to the air from excluded manufacturing processes at any manufacturing site in any calendar year when such quantity exceeds 10 pounds.
(c) Data are reported to the EPA by the owner/operator concerning the total quantity of inadvertently generated PCBs released to water from excluded manufacturing processes from any manufacturing site in any calendar year when such quantity exceeds 10 pounds.
(d) These reports must be submitted to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, ATTN: PCB Notification.
(a) Persons who import, manufacture, process, distribute in commerce, or use chemicals containing PCBs present as a result of inadvertent generation or recycling who perform any actual monitoring of PCB concentrations must maintain records of any such monitoring for a period of three years after a process ceases operation or importing ceases, or for seven years, whichever is shorter.
(b) Monitoring records maintained pursuant to paragraph (a) of this section must contain:
(1) The method of analysis.
(2) The results of the analysis, including data from the Quality Assurance Plan.
(3) Description of the sample matrix.
(4) The name of the analyst or analysts.
(5) The date and time of the analysis.
(6) Numbers for the lots from which the samples are taken.
(a)
(b)
(1) A generator of PCB waste shall not:
(i) Process, store, dispose of, transport, or offer for transportation PCB waste without having received an EPA identification number from the Agency. A generator of PCB waste who is exempted from notification under § 761.205(c)(1) or who notifies EPA in a timely manner under § 761.205(c)(2)(i), but has not yet received a unique identification number, shall be regarded as having received from EPA the identification number “40 CFR PART 761.”
(ii) Offer the PCB waste to transporters, disposers, or commercial storers of PCB waste who have not received an EPA identification number.
(2) A transporter of PCB waste shall not:
(i) Transport PCB waste without having received an EPA identification number from EPA.
(ii) Deliver PCB waste to transporters, disposers, or commercial storers of PCB waste that have not received an EPA identification number.
(3) A commercial storer of PCB waste shall not accept any PCB waste for storage without having received an EPA identification number from EPA.
(4) A disposer of PCB waste shall not accept any PCB waste for disposal without having received an EPA identification number from EPA. A disposer of PCB waste who owns more than one disposal facility or mobile treatment unit shall not accept waste unless the disposer has received an EPA identification number for each facility or mobile unit.
(c)
(d)
(a)(1) All commercial storers, transporters, and disposers of PCB waste who were engaged in PCB waste handling activities on or prior to February 5, 1990 shall notify EPA of their PCB waste activities by filing EPA Form 7710-53 with EPA by no later than April 4, 1990. Upon receiving the notification form, EPA will assign an EPA identification number to each entity that notifies.
(2) All generators (other than generators exempt from notification under paragraph (c)(1) of this section), commercial storers, transporters, and disposers of PCB waste who first engage in PCB waste handling activities after February 5, 1990, shall notify EPA of their PCB waste activities by filing EPA Form 7710-53 with EPA prior to engaging in PCB waste handling activities.
(3) Any person required to notify EPA under this section shall file with EPA Form 7710-53. Copies of EPA Form 7710-53 are available from the Operation Branch (7404), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 401 M St. SW., Washington, DC 20460. Descriptive information and instructions for filling in the form are included in paragraphs (a)(4) (i) through (vii) of this section.
(4) All of the following information shall be provided to EPA on Form 7710-53:
(i) The name of the facility, and the name of the owner or operator of the facility.
(ii) EPA identification number, if any, previously issued to the facility.
(iii) The facility's mailing address.
(iv) The location of the facility.
(v) The facility's installation contact and telephone number.
(vi) The type of PCB waste activity engaged in at the facility.
(vii) Signature of the signer of the certification statement, typed or printed name and official title of signer, and date signed.
(viii) EPA has determined that the information in paragraphs (a)(4)(i) through (a)(4)(vii) of this section shall not be treated as confidential business information. This information will be disclosed to the public without further notice to the submitter unless the submitter provides a written justification (submitted with the notification form) which demonstrates extraordinary reasons why the information should be entitled to confidential treatment.
(b) Generators (other than those generators exempt from notification under paragraph (c)(1) of this section), commercial storers, transporters, and disposers of PCB waste who have previously notified EPA or a State of hazardous waste activities under RCRA shall notify EPA of their PCB waste activities under this part by filing EPA Form 7710-53 with EPA by no later than April 4, 1990. The notification shall include the EPA identification number previously issued by EPA or the State and upon receipt of the notification, EPA shall verify and authorize the use of the previously issued identification number for PCB waste activities.
(c)(1) Generators of PCB waste need not notify EPA and receive unique EPA identification numbers under this section, unless their PCB waste activities are described in paragraph (c)(2) of this section. Generators exempted from notifying EPA under this paragraph shall use the generic identification number “40 CFR PART 761” on the manifests, records, and reports which they shall prepare under this subpart, unless such generators elect to use a unique EPA identification number previously assigned to them under RCRA by EPA or a State.
(2) Generators of PCB waste who use, own, service, or process PCBs or PCB Items shall notify EPA of their PCB waste activities only if they own or operate PCB storage facilities subject to the storage requirements of § 761.65 (b) or (c)(7). Such generators shall notify EPA in the following manner:
(i) Generators storing PCB waste subject to the storage requirements of § 761.65 (b) or (c)(7) shall notify EPA by filing EPA Form 7710-53 with EPA by no later than April 4, 1990.
(ii) Generators who desire to commence storage of PCB waste after February 5, 1990 shall notify EPA and receive an EPA identification number before they may commence storage of PCBs at their facilities established under § 761.65 (b) or (c)(7).
(iii) A separate notification shall be submitted to EPA for each PCB storage facility owned or operated by generators of PCB waste. Upon receiving these notifications, EPA will assign generators unique EPA identification numbers for each storage facility notifying EPA under this section.
(d) Persons required to notify under this section shall file EPA Form 7710-53 with EPA by mailing the form to the following address: Chief, Operation Branch (7404), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
(e) The requirements under this section to notify EPA and obtain EPA identification numbers shall in no case excuse compliance by any person subject to the 1-year limit on storage prior to disposal under § 761.65(a).
(f) When a facility has previously notified EPA of its PCB waste handling activities using EPA Form 7710-53 and those activities change, the facility must resubmit EPA Form 7710-53 to reflect those changes no later than 30 days from when a change is made. Examples of when a PCB waste handler must renotify the Agency include, but are not limited to the following: the company changes location of the facility; or the company had notified solely as engaging in a certain type of PCB waste handling activity and now wishes to engage in another PCB waste activity (e.g., previously only commercially stored PCB waste and now wishes to transport PCB waste).
(a) A generator who relinquishes control over PCB wastes by transporting, or offering for transport by his own vehicle or by a vehicle owned by another person, PCB waste for commercial off-site storage or off-site disposal shall prepare a manifest on EPA Form 8700-22, and if necessary, a continuation sheet. The generator shall specify:
(1) For each bulk load of PCBs, the identity of the PCB waste, the earliest date of removal from service for disposal, and the weight in kilograms of the PCB waste.
(2) For each PCB Article Container or PCB Container, the unique identifying number, type of PCB waste (
(3) For each PCB Article not in a PCB Container or PCB Article Container, the serial number if available, or other identification if there is no serial number, the date of removal from service for disposal, and weight in kilograms of the PCB waste in each PCB Article.
(b) EPA does not maintain supplies of printed copies of Form 8700-22 for public use, although printed copies of the manifest may be available from State offices. Camera-ready copies of the form are available for printing purposes from State offices, EPA Regional Offices, and EPA Headquarters.
(c) If the State to which the shipment is manifested (i.e., consignment State) supplies the manifest and requires its use, then the generator must use that manifest.
(d) If the consignment State does not supply the manifest, but the State in which the generator is located (i.e., generator State) supplies the manifest and requires its use, then the generator must use that State's manifest.
(e) If both the consignment State and the generator State supply manifests and require their use, the generator must use the consignment State's manifest.
(f) If neither the generator State nor the consignment State supplies the manifest, the generator may obtain the manifest from any source.
(g) A generator shall designate on the manifest one off-site commercial storage or disposal facility approved under this part for the commercial storage or disposal of the PCBs and PCB Items described on the manifest.
(h) If the transporter is unable to deliver the PCB waste to the designated disposer or commercial storer, the transporter must contact the generator of the PCB waste for instructions. The generator shall either designate another approved disposer or commercial storer, or instruct the transporter to return the PCB waste back to the generator.
(i) The manifest which accompanies the PCB waste shall consist of at a minimum the number of copies required to provide the generator, the initial transporter, each subsequent transporter, and the owner or operator of the designated commercial storage or disposal facility with one legible copy each for their records, and one additional copy to be returned to the generator by the owner or operator of the first designated commercial storage or disposal facility.
(j) The requirements of this section apply only to PCB wastes as defined in § 761.3. This includes PCB wastes with PCB concentrations below 50 ppm where the PCB concentration below 50 ppm was the result of dilution; these PCB wastes are required under § 761.1(b) to be managed as if they contained PCB concentrations of 50 ppm and above. An example of such a PCB waste is spill cleanup material containing <50 ppm PCBs when the spill involved material containing PCBs at a concentration of ≥50 ppm. However, there is no manifest requirement for material currently below 50 ppm which derives from pre-April 18, 1978, spills of any concentration, pre-July 2, 1979, spills of < 500 ppm PCBs, or materials decontaminated in accordance with § 761.79.
(a)(1) The generator of PCB waste shall:
(i) Sign the manifest certification by hand.
(ii) Obtain the handwritten signature of the initial transporter and date of acceptance on the manifest.
(iii) Retain one copy among its records in accordance with § 761.209(a).
(iv) Give to the transporter the remaining copies of the manifest that will accompany the shipment of PCB waste.
(2) For bulk shipments of PCB waste within the United States transported solely by water, the generator shall send three copies of the manifest dated and signed in accordance with this section directly to the owner or operator of the designated commercial storage or disposal facility. Copies of the manifest are not required for each transporter.
(3) For rail shipments of PCB waste within the United States which originate at the site of generation, the generator shall send at least three copies of the manifest dated and signed in accordance with this section to:
(i) The next non-rail transporter, if any.
(ii) The designated commercial storage or disposal facility if transported solely by rail.
(4) When a generator has employed an independent transporter to transport the PCB waste to a commercial storer or disposer, the generator shall confirm by telephone, or by other means of confirmation agreed to by both parties, that the commercial storer or disposer actually received the manifested waste. The generator shall confirm receipt of the waste by close of business the day after he receives the manifest hand-signed by the commercial storer or disposer, in accordance with paragraph (c)(1)(iv) of this section. If the generator has not received the hand-signed manifest within 35 days after the independent transporter accepted the PCB waste, the generator shall telephone, or communicate with by some other agreed-upon means, the disposer or commercial storer to determine whether the PCB waste has actually been received. If the PCB waste has not been received, the generator shall contact the independent transporter to determine the disposition of the PCB waste. If the generator has not received a hand-signed manifest from an EPA-approved facility within 10 days from the date of the telephone call or other agreed upon means of communication, to the independent transporter, the generator shall submit an exception report to the EPA Regional Administrator for the Region in which the generator is located, as specified in § 761.215. The generator shall retain a written record of all telephone or other confirmations to be included in the annual document log, in accordance with § 761.180.
(b)(1) A transporter shall not accept PCB waste from a generator unless it is accompanied by a manifest signed by the generator in accordance with paragraph (a)(1) of this section, except that a manifest is not required if any one of the following conditions exists:
(i) The shipment of PCB waste consists solely of PCB wastes with PCB concentrations below 50 ppm, unless the PCB concentration below 50 ppm was the result of dilution, in which case § 761.1(b) requires that the waste be managed as if it contained PCBs at the concentration prior to dilution.
(ii) The PCB waste is accepted by the transporter for transport only to a storage or disposal facility owned or operated by the generator of the PCB waste.
(2) Before transporting the PCB waste, the transporter shall sign and date the manifest acknowledging acceptance of the PCB waste from the generator. The transporter shall return a signed copy to the generator before leaving the generator's facility.
(3) The transporter shall ensure that the manifest accompanies the PCB waste.
(4) A transporter who delivers PCB waste to another transporter, or to the designated commercial storer or disposer of PCB waste, shall:
(i) Obtain the date of delivery and the handwritten signature of the subsequent transporter of PCB waste, or of the owner or operator of the designated commercial storage or disposal facility on the manifest.
(ii) Retain one copy of the manifest in accordance with § 761.209(b).
(iii) Give the remaining copies of the manifest to the accepting transporter of PCB waste, or to the designated commercial storage or disposal facility.
(5) The requirements of paragraphs (b) (3) and (4) of this section shall not apply to transporters of bulk shipments by water if all of the following conditions are met:
(i) The PCB waste is delivered by water (bulk shipment) to the designated commercial storage or disposal facility.
(ii) A shipping paper containing all the information required on the manifest (excluding EPA identification number, generator certification, and signatures) accompanies the PCB waste.
(iii) The transporter delivering the PCB waste obtains the date of delivery and handwritten signature of the owner or operator of the designated commercial storage or disposal facility on either the manifest or the shipping paper.
(iv) The person delivering the PCB waste to the initial water (bulk shipment) transporter obtains the date of delivery and signature of the water (bulk shipment) transporter on the manifest and forwards it to the designated facility.
(v) A copy of the shipping paper or manifest is retained by each water (bulk shipment) transporter in accordance with § 761.209(b).
(6) For shipments involving rail transportation, the requirements of paragraphs (b)(3) and (b)(4) of this section shall not apply. Instead, the requirements described at § 263.20(f) of this chapter for the rail transportation of hazardous waste apply to such shipments. The rail transporter shall retain one copy of the manifest or rail shipping paper in accordance with § 761.209(b).
(7) The transporter shall deliver the entire quantity of PCB waste accepted from a generator or transporter to either of the following destinations:
(i) The designated commercial storage or disposal facility listed on the manifest.
(ii) The next designated transporter of PCB waste.
(8) If the PCB waste cannot be delivered in accordance with paragraph (b)(7) of this section, the transporter shall contact the generator for further directions and shall revise the manifest and/or return the PCB waste according to the generator's instructions.
(9) No provision of this section shall be construed to affect or limit the applicability of any requirement applicable to transporters of PCB waste under regulations issued by the Department of Transportation (DOT) and set forth at 49 CFR part 171.
(c)(1) If a commercial storage or disposal facility receives an off-site shipment of PCB waste accompanied by a manifest, the owner or operator, or his agent, shall:
(i) Sign and date each copy of the manifest to certify that the PCB waste covered by the manifest was received.
(ii) Note any significant discrepancies in the manifest (as defined in § 761.210(a)(1)) on each copy of the manifest.
(iii) Immediately give the transporter at least one copy of the signed manifest.
(iv) Within 30 days after the delivery, send a copy of the manifest to the generator.
(v) Retain a copy of each manifest among the facility's records in accordance with § 761.209(d).
(2) If a commercial storage or disposal facility receives PCB waste from a rail or water (bulk shipment) transporter accompanied by a shipping paper containing all the information required on the manifest except the EPA identification numbers, generator's certification, and signatures, the owner or operator, or his agent, shall:
(i) Sign and date each copy of the manifest or shipping paper to certify that the PCB waste covered by the manifest or shipping paper was received.
(ii) Note any significant discrepancies in the manifest or shipping paper on each copy of the manifest or shipping paper.
(iii) Immediately give the rail or water transporter at least one copy of the manifest or shipping paper, if applicable.
(iv) Within 30 days after the delivery, send a copy of the signed and dated manifest to the generator; however, if the manifest has not been received within 30 days after delivery, the owner or operator shall send a copy of the
(v) Retain at the commercial storage or disposal facility a copy of the manifest and shipping paper, if signed in lieu of the manifest, in accordance with § 761.209(d).
(3) Whenever an off-site shipment of PCB waste is initiated from a commercial storage or disposal facility, the owner or operator of the commercial storage or disposal facility shall comply with the manifest requirements that apply to generators of PCB waste.
(a) A generator of PCB waste shall keep a copy of each manifest signed in accordance with § 761.208(a)(1) until the generator receives a signed copy from the designated commercial storage or disposal facility which received the PCB waste. The copy signed by the commercial storer or disposer shall be retained for at least 3 years from the date the PCB waste was accepted by the initial transporter. A generator subject to annual document requirements under § 761.180 shall retain copies of each manifest for the period required by § 761.180(a).
(b)(1) A transporter of PCB waste shall keep a copy of the manifest signed by the generator, transporter, and the next designated transporter, if applicable, or the owner or operator of the designated commercial storage or disposal facility. This copy shall be retained for a period of at least 3 years from the date the PCB waste was accepted by the initial transporter.
(2) For shipments of PCB waste delivered to the designated commercial storage or disposal facility by water (bulk shipment), each water (bulk shipment) transporter shall retain a copy of the shipping paper described in § 761.208(b)(5)(ii) for a period of at least 3 years from the date the PCB waste was accepted by the initial transporter.
(3) For shipments of PCB waste by rail within the United States:
(i) The initial rail transporter shall keep a copy of the manifest and the shipping paper required to accompany the PCB waste for a period of at least 3 years from the date the PCB waste was accepted by the initial transporter.
(ii) The final rail transporter shall keep a copy of the signed manifest, or the required shipping paper if signed by the designated facility in lieu of the manifest, for a period of at least 3 years from the date the PCB waste was accepted by the initial transporter.
(c) The owner or operator of a PCB commercial storage or disposal facility that receives off-site shipments of PCB waste shall retain at the facility for at least 3 years a copy of each manifest or shipping paper that the owner or operator signs in accordance with § 761.208 (c)(1) or (c)(3).
(d) The periods of record retention required by this section shall be extended automatically during the course of any outstanding enforcement action regarding the regulated activity.
(a) Manifest discrepancies are differences between the quantity or type of PCB waste designated on the manifest or shipping paper and the quantity or type of PCB waste actually delivered to and received by a designated facility.
(1) Significant discrepancies in quantity are:
(i) Variations greater than 10 percent in weight of PCB waste in containers.
(ii) Any variation in piece count, such as a discrepancy of one PCB Transformer or PCB Container or PCB Article Container in a truckload.
(2) Significant discrepancies in type of PCB waste are obvious differences which may be discovered by inspection or waste analysis, such as the substitution of solids for liquids or the substitution of high concentration PCBs (above 500 ppm) with lower concentration materials.
(b) Upon discovering a significant discrepancy, the owner or operator of the designated commercial storage or disposal facility shall attempt to reconcile the discrepancy with the waste generator or transporter. If the discrepancy is not resolved within 15 days after receiving the PCB waste, such owner or operator shall immediately submit to the Regional Administrator for the Region in which the designated facility is located a letter describing
(a) After April 4, 1990, if a PCB commercial storage or disposal facility receives any shipment of PCB waste from an off-site source without an accompanying manifest or shipping paper (where required in place of a manifest), and any part of the shipment consists of any PCB waste regulated for disposal, then the owner or operator of the commercial storage or disposal facility shall attempt to contact the generator, using information supplied by the transporter, to obtain a manifest or to return the PCB waste.
(b) If the owner or operator of the commercial storage or disposal facility cannot contact the generator of the PCB waste, he shall notify the Regional Administrator of the EPA region in which his facility is located of the unmanifested PCB waste so that the Regional Administrator can determine whether further actions are required before the owner or operator may store or dispose of the unmanifested PCB waste.
(c) Within 15 days after receiving the unmanifested PCB waste, the owner or operator shall prepare and submit a report to the Regional Administrator for the Region in which the commercial storage or disposal facility is located and to the Regional Administrator for the Region in which the PCB waste originated, if known. The report may be submitted on EPA Form 8700-13B, or by a written letter designated “Unmanifested Waste Report.” The report shall include the following information:
(1) The EPA identification number, name, and address of the PCB commercial storage or disposal facility.
(2) The date the commercial storage or disposal facility received the unmanifested PCB waste.
(3) The EPA identification number, name, and address of the generator and transporter, if available.
(4) A description of the type and quantity of the unmanifested PCB waste received at the facility.
(5) A brief explanation of why the waste was unmanifested, if known.
(6) The disposition made of the unmanifested waste by the commercial storage or disposal facility, including:
(i) If the waste was stored or disposed by that facility, was the generator identified and was a manifest subsequently supplied.
(ii) If the waste was sent back to the generator, why and when.
(a) A generator of PCB waste, who does not receive a copy of the manifest with the handwritten signature of the owner or operator of the designated PCB commercial storage or disposal facility within 35 days of the date the waste was accepted by the initial transporter, shall immediately contact the transporter and/or the owner or operator of the designated facility to determine the status of the PCB waste.
(b) A generator of PCB waste subject to the manifesting requirements shall submit an Exception Report to the EPA Regional Administrator for the Region in which the generator is located if the generator has not received a copy of the manifest with the hand written signature of the owner or operator of the designated facility within 45 days of the date the waste was accepted by the initial transporter. The exception report shall be submitted to EPA no later than 45 days from the date on which the generator should have received the manifest. The Exception Report shall include the following:
(1) A legible copy of the manifest for which the generator does not have confirmation of delivery.
(2) A cover letter signed by the generator or his authorized representative explaining the efforts taken to locate the PCB waste and the results of those efforts.
(c) A disposer of PCB waste shall submit a One-year Exception Report to the EPA Regional Administrator for the Region in which the disposal facility is located no later than 45 days from the end of the 1-year storage for disposal date when the following occurs:
(1) The disposal facility receives PCBs or PCB Items on a date more than 9 months from the date the PCBs or PCB Items were removed from service for disposal, as indicated on the manifest or continuation sheet; and
(2) Because of contractual commitments or other factors affecting the facility's disposal capacity, the disposer of PCB waste could not dispose of the affected PCBs or PCB Items within 1 year of the date of removal from service for disposal.
(d) A generator or commercial storer of PCB waste who manifests PCBs or PCB Items to a disposer of PCB waste shall submit a One-year Exception Report to the EPA Regional Administrator for the Region in which the generator or commercial storer is located no later than 45 days from the date the following occurs:
(1) The generator or commercial storer transferred the PCBs or PCB Items to the disposer of PCB waste on a date within 9 months from the date of removal from service for disposal of the affected PCBs or PCB Items, as indicated on the manifest or continuation sheet; and
(2) The generator or commercial storer either has not received within 13 months from the date of removal from service for disposal a Certificate of Disposal confirming the disposal of the affected PCBs or PCB Items, or the generator or commercial storer receives a Certificate of Disposal confirming disposal of the affected PCBs or PCB Items on a date more than 1 year after the date of removal from service.
(e) The One-year Exception Report shall include:
(1) A legible copy of any manifest or other written communication relevant to the transfer and disposal of the affected PCBs or PCB Items.
(2) A cover letter signed by the submitter or an authorized representative explaining:
(i) The date(s) when the PCBs or PCB Items were removed from service for disposal.
(ii) The date(s) when the PCBs or PCB Items were received by the submitter of the report, if applicable.
(iii) The date(s) when the affected PCBs or PCB Items were transferred to a designated disposal facility.
(iv) The identity of the transporters, commercial storers, or disposers known to be involved with the transaction.
(v) The reason, if known, for the delay in bringing about the disposal of the affected PCBs or PCB Items within 1 year from the date of removal from service for disposal.
(f) PCB/radioactive waste that is exempt from the 1-year storage for disposal time limit pursuant to § 761.65(a)(1) is also exempt from the exception reporting requirements of paragraphs (c), (d), and (e) of this section.
(a) For each shipment of manifested PCB waste that the owner or operator of a disposal facility accepts by signing the manifest, the owner or operator of the disposal facility shall prepare a Certificate of Disposal for the PCBs and PCB Items disposed of at the facility, which shall include:
(1) The identity of the disposal facility, by name, address, and EPA identification number.
(2) The identity of the PCB waste affected by the Certificate of Disposal including reference to the manifest number for the shipment.
(3) A statement certifying the fact of disposal of the identified PCB waste, including the date(s) of disposal, and identifying the disposal process used.
(4) A certification as defined in § 761.3.
(b) The owner or operator of the disposal facility shall send the Certificate of Disposal to the generator identified on the manifest which accompanied the shipment of PCB waste within 30 days of the date that disposal of each item of PCB waste identified on the manifest was completed unless the generator and the disposer contractually agree to another time frame.
(c) The disposal facility shall keep a copy of each Certificate of Disposal among the records that it retains under § 761.180(b).
(d)(1) Generators of PCB waste shall keep a copy of each Certificate of Disposal that they receive from disposers of PCB waste among the records they retain under § 761.180(a).
(2) Commercial storers of PCB waste shall keep a copy of each Certificate of Disposal that they receive from disposers of PCB waste among the records they retain under § 761.180(b).
(a) Use these procedures to select surface sampling sites for natural gas pipe to determine its PCB surface concentration for abandonment-in-place or removal and disposal off-site in accordance with § 761.60(b)(5).
(b) “Pipe segment” means a length of natural gas pipe that has been removed from the pipeline system to be disposed of or reused, and that is usually approximately 12.2 meters (40 feet) or shorter in length. Pipe segments are usually linear.
(c) “Pipeline section” means a length of natural gas pipe that has been cut or otherwise separated from the active pipeline, usually for purposes of abandonment, and that is usually longer than 12.2 meters in length. Pipeline sections may be branched.
(a) Collect a surface sample from a natural gas pipe segment or pipeline section using a standard wipe test as defined in § 761.123. Detailed guidance for the entire wipe sampling process appears in the document entitled “Wipe Sampling and Double Wash/Rinse Cleanup as Recommended by the Environmental Protection Agency PCB Spill Cleanup Policy,” dated June 23, 1987 and revised on April 18, 1991. This document is available from the TSCA Assistance Information Service, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
(b) Collect a surface sample from a minimum surface area of 100 cm
(a)
(2) Locate the proper position along the length of the pipe segment that you have selected for sampling, by following the directions in paragraph (c) of this section.
(3) Select the proper sampling position around the circumference of the pipe segment that you have selected for sampling, by following the directions in paragraph (d) of this section.
(4) Prior to removing pipe from the ground or lifting the pipe from its location during former operations, mark the top side of the pipe.
(5) Do not sample if there are free-flowing liquids in the pipe segment. Free-flowing liquids must be removed prior to sampling.
(b)
(1) Do not sample a pipe segment that is longer than 12.2 meters (40 feet). If a segment is longer than 12.2 meters in length, cut the segment so that all resulting segments are 12.2 meters or less in length.
(2) Determine which pipe segments to sample as follows:
(i) When a length of pipe having seven or fewer segments is removed for
(ii) When removing a length of pipe having multiple contiguous segments less than 3 miles in total length, take samples from a total of seven segments.
(A) Sample the first and last segments removed.
(B) Select the five additional segments according to one of the two following procedures:
(
(
(iii) When removing a length of pipe having multiple contiguous segments more than 3 miles in total length for purposes of disposal, take samples of each segment that is
(c)
(1) Take samples at the end upstream of the former gas flow of each segment removed.
(2) If the pipe segment is cut with a torch or other high temperature heat source, take the sample at least 15 cm (6 inches) inside the cut end of the pipe segment.
(3) If the pipe segment is cut with a saw or other mechanical device, take the sample at least 2 cm (1 inch) inside the end of the pipe segment.
(4) If the sample site location selected in the procedure at paragraph (c)(2) or (c)(3) of this section is a porous surface (for example, there is significant corrosion so that the wipe material will be shredded), then move the sample site further inside the pipe segment (away from the end of the pipe or pipe segment) until there is no such porous surface. For purposes of this subpart, natural gas pipe with a thin porous corrosion preventive coating is a non-porous surface.
(5) If there is not a non-porous surface accessible by paragraphs (c)(2) and (c)(3) of this section, use one of the following three options:
(i) Sample the downstream end of the pipe segment using the same sample site location procedure as for the upstream end.
(ii) Select another pipe segment using the random selection procedure described in paragraph (b) of this section.
(iii) If there is no other pipe segment in the population to be sampled and both ends of a pipe segment have porous surfaces at all possible sample collection sites, then assume that the pipe segment contains ≥50 ppm PCB but <500 ppm PCB.
(d)
This procedure is for the sample site selection for a pipeline section to be abandoned, in accordance with § 761.60(b)(5)(i)(B).
(a)
(2) Select the proper sampling position along the pipe by following the directions in § 761.247 (c) and (d).
(3) Assure, by visual inspection, the absence of free-flowing liquids in the pipe by affirming no liquids at all liquid collection points and all ends of the pipeline section to be abandoned.
(b)
(1) If the pipeline section to be abandoned is between the pressure side of one compressor station and the suction side of the next compressor station downstream of the former gas flow, at a minimum, sample all ends of the abandoned pipe.
(2) If the pipeline section to be abandoned is longer than the distance between the pressure side of one compressor station and the suction side of the next compressor station downstream of the former gas flow, divide the pipeline section, for purposes of sampling, into smaller pipeline sections no longer than the distance from the pressure side of one compressor station to the suction side of the next compressor station downstream of the former gas flow. Consider each of the smaller sections to be a separate abandonment and sample each one, at a minimum, at all ends.
(3) Use the following procedure to locate representative sample collection sites in pipeline sections at points other than the suction and pressure side of compressor stations, or the ends of the pipeline section to be abandoned.
(i) First, assign a unique identifying sequential number to each kilometer or fraction of a kilometer length of pipe within the entire pipeline section.
(ii) Use a random number table or a random number generator to select each representative sample collection site from a complete list of the sequential identification numbers.
(iii) Samples may be collected by removing any covering soil, cutting the pipe to gain access to the sampling location, and collecting the surface sample with the pipe in place, rather than completely removing the pipeline sections to collect the surface sample.
(a) Extract PCBs from the standard wipe sample collection medium and clean-up the extracted PCBs in accordance with either Method 3500B/3540C or Method 3500B/3550B from EPA's SW-846, Test Methods for Evaluating Solid Waste, or a method validated under subpart Q of this part. Use Method 8082 from SW-846, or a method validated under subpart Q of this part, to analyze these extracts for PCBs.
(b) Report all PCB sample concentrations in µg/100 cm
(a) For purposes of removal for disposal of a pipe segment that has been sampled, the sample results for that segment determines its PCB surface concentration. Determine the PCB surface concentration of a segment which was not sampled as follows:
(1) If the unsampled pipe segment is between two pipe segments which have been sampled, assume that the unsampled segment has the same PCB surface concentration as the nearest sampled pipe segment.
(2) If an unsampled pipe segment is equidistant between two pipe segments which have been sampled, assume the PCB surface concentration of the unsampled segment to be the arithmetic mean of the PCB surface concentrations measured in the two equidistant, sampled, pipe segments.
(b) For purposes of abandonment of a pipeline section, assume that the PCB surface concentration for an entire pipeline section is the arithmetic mean of the PCB surface concentrations measured at the ends of the pipeline section. If additional representative
(c) For purposes of removal for disposal under § 761.60(b)(5)(ii)(A)(
This subpart provides a method for collecting new data for characterizing a PCB remediation waste cleanup site or for assessing the sufficiency of existing site characterization data, as required by § 761.61(a)(2).
(a) Use a grid interval of 3 meters and the procedures in §§ 761.283 and 761.286 to sample bulk PCB remediation waste that is not in a container and porous surfaces.
(b) Use the following procedures to sample bulk PCB remediation waste that is in a single container.
(1) Use a core sampler to collect a minimum of one core sample for the entire depth of the waste at the center of the container. Collect a minimum of 50 cm
(2) If more than one core sample is taken, thoroughly mix all samples into a composite sample. Take a subsample of a minimum of 50 cm
(c) Use the following procedures to sample bulk PCB remediation waste that is in more than one container.
(1) Segregate the containers by type (for example, a 55-gallon drum and a roll-off container are types of containers).
(2) For fewer than three containers of the same type, sample all containers.
(3) For more than three containers of the same type, list the containers and assign each container an unique sequential number. Use a random number generator or table to select a minimum of 10 percent of the containers from the list, or select three containers, whichever is the larger.
(4) Sample the selected container(s) according to paragraph (b) of this section.
(a) Sample large, nearly flat, non-porous surfaces by dividing the surface into roughly square portions approximately 2 meters on each side. Follow the procedures in § 761.302(a).
(b) It is not necessary to sample small or irregularly shaped surfaces.
(a) If the liquid is single phase, collect and analyze one sample. There are no required procedures for collecting a sample.
(b) If the liquid is multi-phasic, separate the phases, and collect and analyze a sample from each liquid phase. There are no required procedures for collecting a sample from each single phase liquid.
(c) If the liquid has a non-liquid phase which is >0.5 percent by total weight of the waste, separate the non-liquid phase from the liquid phase and sample it separately as a non-liquid in accordance with § 761.265.
Use either Method 3500B/3540C or Method 3500B/3550B from EPA's SW-846, Test Methods for Evaluating Solid Waste, or a method validated under subpart Q of this part, for chemical extraction of PCBs from individual and composite samples of PCB remediation waste. Use Method 8082 from SW-846, or a method validated under subpart Q of
(a) Report all sample concentrations for non-liquid PCBs on a dry weight basis as micrograms of PCBs per gram of sample (ppm by weight). Report surface sampling results as µg/100 cm
(b) Report all sample concentrations for liquid PCBs on a wet weight basis as micrograms of PCBs per gram of sample (ppm by weight).
Follow the procedures in this subpart when sampling to verify completion of the cleanup for self-implementing, on-site disposal of bulk PCB remediation waste and porous surfaces consistent with the levels of § 761.61(a)(4)(i) and (iii). The objective of this subpart is not to search for new contamination. Confirmation of compliance with the cleanup levels in § 761.61(a)(4) is only verifiable for the area sampled in accordance with this subpart. Do not make conclusions or extrapolations about PCB concentrations outside of the area which has been cleaned up and verified based on the results of this verification sampling.
This section addresses how to determine the number of samples to collect and sample collection locations for bulk PCB remediation waste and porous surfaces destined to remain at a cleanup site after cleanup.
(a)
(2) This is an example of how to calculate the minimum number of required samples at a PCB remediation waste location. There are three distinct cleanup sites at this example location: a loading dock, a transformer storage lot, and a disposal pit. The minimum number of samples to take appears in parentheses after each type of waste for each cleanup site. The PCB remediation wastes present at the loading dock are concrete (three samples) and clay soil (three samples). The non-liquid PCB remediation wastes present at the transformer storage lot are oily soil (three samples), clay soil (three samples) and gravel (three samples). The PCB remediation wastes present at the disposal pit are sandy soil (three samples), clay soil (three samples), oily soil (three samples), industrial sludge (three samples), and gravel (three samples).
(b)
(ii) If the site is recleaned based on the results of cleanup verification conducted in accordance with § 761.61(a)(6), follow the procedures in paragraph (b) of this section for locating sampling points after the recleaning, but reorient the grid axes established in paragraph (b)(1)(i) of this section by moving the origin one meter in the direction of magnetic north and one meter in the direction east of magnetic north.
(2) Mark out a series of sampling points 1.5 meters apart oriented to the grid axes. The sampling points shall
(3) Collect a sample at each point if the grid falls in the cleanup area. Analyze all samples either individually or according to the compositing schemes provided in the procedures at § 761.289. So long as every sample collected at a grid point is analyzed as either an individual sample or as part of a composite sample, there are no other restrictions on how many samples are analyzed.
(c)
(1) Use a smaller square grid interval and the procedures in paragraph (b) of this section.
(2) Use the following coordinate-based random sampling scheme. If the site is recleaned based on the results of cleanup verification conducted in accordance with § 761.61(a)(6), follow the procedures in this section for locating sampling points after the recleaning, but select three new pairs of sampling coordinates.
(i) Beginning in the southwest corner (lower left when facing magnetic north) of the area to be sampled, measure in centimeters (or inches) the maximum magnetic north-south dimension of the area to be sampled. Next, beginning in the southwest corner, measure in centimeters (or inches) the maximum magnetic east-west dimension of the area to be sampled. Designate the north-south and east-west dimensions (describing the west and south boundaries, respectively, of the area to be sampled), as the reference axes of a square-based grid system.
(ii) Use a random number table or random number generator to select a pair of coordinates that will locate the sample within the area to be sampled. The first coordinate in the pair is the measurement on the north-south axis. The second coordinate in the pair is the measurement on the east-west axis. Collect the sample at the intersection of an east-west line drawn through the measured spot on the north-south axis, and a north-south line drawn through the measured spot on the east-west axis. If the cleanup site is irregularly shaped and this intersection falls outside the cleanup site, select a new pair of sampling coordinates. Continue to select pairs of sampling coordinates until three are selected for each type of bulk PCB remediation waste or porous surface at the cleanup site.
(d)
At each selected sampling location for bulk PCB remediation waste or porous surfaces, collect at least 20 milliliters of waste, or a portion of sufficient weight for the chemical analyst to measure the concentration of PCBs and still have sufficient analytical detection sensitivity to reproducibly measure PCBs at the levels designated in § 761.61(a)(4). Use a core sampler having a diameter ≥2 cm and ≤3 cm. Collect waste to a maximum depth of 7.5 cms.
Compositing is a method of combining several samples of a specific type of bulk PCB remediation waste or porous surface from nearby locations for a single chemical analysis. There are two procedures for compositing bulk PCB remediation waste samples. These procedures are based on the method for selecting sampling site locations in § 761.283(b) and (c). The single chemical analysis of a composite sample results in an averaging of the concentrations of its component samples.
(a)
(b)(1)
(i) The first procedure is for sites with multiple point sources of contamination (such as an old electrical equipment storage area, a scrap yard, or repair shop) or for unknown sources of contamination. Under this compositing scheme, composite a maximum of nine samples for each type of bulk PCB remediation waste or porous surface at the cleanup site. The maximum dimensions of the area enclosing a nine grid point composite is two grid intervals bounded by three collinear grid points (3.0 meters or approximately 10 feet long). Take all samples in the composite at the same depth. Assure that composite sample areas and individually analyzed samples completely overlay the cleanup site.
(ii) The second procedure is for a single point source of contamination, such as discharge into a large containment area (e.g., pit, waste lagoon, or evaporation pond), or a leak onto soil from a single drum or tank. Single point source contamination may be from a one-time or continuous contamination. Composites come from two stages: an initial compositing area centered in the area to be sampled, and subsequent compositing areas forming concentric square zones around the initial compositing area. The center of the initial compositing area and each of the subsequent compositing areas is the origin of the grid axes.
(A)
(B)
(C)
(
(2)
(i)
(ii)
Use either Method 3500B/3540C or Method 3500B/3550B from EPA's SW-846, Test Methods for Evaluating Solid Waste, or a method validated under subpart Q of this part, for chemical extraction of PCBs from individual and composite samples of PCB remediation waste. Use Method 8082 from SW-846, or a method validated under subpart Q of this part, to analyze these extracts for PCBs.
(a) Report all sample concentrations for bulk PCB remediation waste and porous surfaces on a dry weight basis and as micrograms of PCBs per gram of sample (ppm by weight).
(b) Record and keep on file for 3 years the PCB concentration for each sample or composite sample.
(a) For grid samples which are chemically analyzed individually, the PCB concentration applies to the area of inference as described in § 761.283(d).
(b) For grid samples analyzed as part of a composite sample, the PCB concentration applies to the area of inference of the composite sample as described in § 761.283(d) (i.e., the area of inference is the total of the areas of the individual samples included in the composite).
(c) For coordinate pair samples analyzed as part of a composite sample, in accordance with §§ 761.283(c)(2) and 761.289(b)(2)(ii), the PCB concentration applies to the entire cleanup site.
This subpart provides sample site selection procedures for large, nearly flat non-porous surfaces, and for small or irregularly shaped non-porous surfaces. This subpart also provides procedures for analyzing the samples and interpreting the results of the sampling. Any person verifying completion of self-implementing cleanup and on-site disposal of non-porous surfaces under § 761.61(a)(6), or verifying that decontamination standards under § 761.79(b)(3) are met, must use these procedures.
(a)
(1) For large nearly flat surfaces contaminated by a single source of PCBs with a uniform concentration, assign each 1 meter square surface a unique sequential number.
(i) For three or fewer 1 meter square areas, sample all of the areas.
(ii) For four or more 1 meter square areas, use a random number generator or table to select a minimum of 10 percent of the areas from the list, or to select three areas, whichever is more.
(2) For other large nearly flat surfaces, sample all of the one meter square areas.
(b)
(c)
(a) For 1 square meter non-porous surface areas having the same size and shape, it is permissible to sample the same 10 cm by 10 cm location or position in each identical 1 square meter area. This location or position is determined in accordance with § 761.306 or § 761.308.
(b) If some 1 square meter surfaces for a larger non-porous surface area have different sizes and shapes, separately select the 10 cm by 10 cm sampling position for each different 1 square meter surface in accordance with § 761.308.
(c) If non-porous surfaces have been cleaned and the cleaned surfaces do not meet the applicable standards or levels, surfaces may be recleaned and resampled. When resampling surfaces previously sampled to verify cleanup levels, use the sampling procedures in §§ 761.306 through 761.316 to resample the surfaces. If any sample site selected coincides with a previous sampling site, restart the sample selection process until all resampling sites are different from any previous sampling sites.
(a) Divide each 1 meter square portion where it is necessary to collect a surface wipe test sample into two equal (or as nearly equal as possible) halves. For example, divide the area into top and bottom halves or left and right halves. Choose the top/bottom or left/right division that produces halves having as close to the shape of a circle as possible. For example, a square is closer to the shape of a circle than is a rectangle and a rectangle having a length to width ratio of 2:1 is closer to the shape of a circle than a rectangle having a length to width ratio of 3:1.
(b) Assign a unique identifier to each half and then select one of the halves for further sampling with a random number generator or other device (i.e., by flipping a coin).
(c) Continue selecting progressively smaller halves by dividing the previously selected half, in accordance with paragraphs (a) and (b) of this section, until the final selected half is larger than or equal to 100 cm
(d) Perform a standard PCB wipe test on the final selected halves from each 1 meter square portion.
(e) The following is an example of applying sampling by halves. Assume that the area to sample is a 1 meter square surface area (a square that has sides 1 meter long). Assign each half to one face of a coin. After flipping the coin, the half assigned to the face of the coin that is showing is the half selected.
(1) Selecting the first half:
(i) For a square shape the top/bottom halves have the same shape as the left/right halves when compared to a circle, i.e., regardless of which way the surface is divided, each half is 1 half meter wide by 1 meter long. Therefore, divide the area either top/bottom or left/right. For selecting the first half, this example will select from left/right halves.
(ii) A coin flip selects the left half. The dimensions of this selected surface area are 1 meter high and
(2) Selecting the second half:
(i) If the next selection of halves was left/right, the halves would be rectangles four times as long as they are wide (
(ii) A coin flip selects the top half. The dimensions of this selected surface area are
(3) Selecting the third half:
(i) Just as for the selection of the first half, which divided the original square area, both the left/right and the top/bottom halves have the same shape when compared to a circle (both are rectangles having the same dimensions). Therefore, choose either left/right or top/bottom halves. This example will select from left/right halves.
(ii) A coin flip selects the right half. The dimensions of this selected surface are
(4) Selecting the fourth half:
(i) If the next selection of halves was left/right, the halves would be rectangles four times as long as they are wide (
(ii) A coin flip selects the bottom half. The dimensions of this selected surface area are
(5) Selecting the fifth half:
(i) Just as for the selection of the first and third halves, both the left/right and the top/bottom halves have the same shape when compared to a circle (both are rectangles having the same dimensions). Therefore, choose either left/right or top/bottom halves. This example will select from left/right halves.
(ii) A coin flip selects the right half. The dimensions of the selected surface are
(6) Selecting the sixth half:
(i) If the next selection of halves was left/right, the halves would be rectangles four times as long as they are wide (
(ii) A coin flip selects the top half. The dimensions of this selected surface are
(7) Collect a standard wipe test sample in the sixth half. Since the dimensions of half of the sixth half would be 12.5 cm by 6.25 cm, the area (approximately 78 cm
(a) Divide the surface area of the non-porous surface into rectangular or square areas having a maximum area of 1 square meter and a minimum dimension of 10 centimeters.
(b) Measure the length and width, in centimeters, of each area created in paragraph (a) of this section. Round off the number of centimeters in the length and the width measurements to the nearest centimeter.
(c) For each 1 square meter area created in accordance with paragraph (a) of this section, select two random numbers: one each for the length and width borders measured in paragraph (b) of this section. An eligible random number can be from zero up to the total width, minus 10 centimeters.
(d) Locate the 10 centimeter by 10 centimeter sample.
(1) Orient the 1 square meter surface area so that, when you are facing the area, the length is left to right and the width is top to bottom. The origin, or reference point for measuring selected random numbers of centimeters to the sampling area, is on the lower left corner when facing the surface.
(2) Mark the random number selected for the length distance, in centimeters, from the origin to the right (at the bottom of the area away from the origin).
(3) From the marked length distance on the bottom of the area, move perpendicularly up from the bottom of the area into the area for the distance randomly selected for the width.
(4) Use the point determined in paragraph (d)(3) of this section as the lower left corner of the 10 centimeter by 10 centimeter sample.
Use the standard wipe test as defined in § 761.123 to sample one 10 centimeter by 10 centimeter square (100 cm
For a surface originally contaminated by a single source of PCBs with a uniform concentration, it is permissible to composite surface wipe test samples and to use the composite measurement to represent the PCB concentration of the entire surface. Composite samples consist of more than one sample gauze extracted and chemically analyzed together resulting in a single measurement. The composite measurement represents an arithmetic mean of the composited samples.
(a)
(b)
(2) For large nearly flat surfaces, composite a maximum of 10 adjacent samples.
Perform the chemical analysis of standard wipe test samples in accordance with § 761.272. Report sample results in micrograms per 100 cm
(a) For an individual sample taken from an approximately 1 meter square portion of the entire surface area and not composited with other samples, the status of the portion is based on the surface concentration measured in that sample. If the sample surface concentration is not equal to or lower than the cleanup level, by inference the entire 1 meter area, and not just the immediate area where the sample was taken, is not equal to or lower than the cleanup level.
(b) For areas represented by the measurement results from compositing more than one 10 centimeter by 10 centimeter sample, the measurement for the composite is the measurement for the entire area. For example, when there is a composite of 10 standard wipe test samples representing 9.5 square meters of surface area and the result of the analysis of the composite is 20 µg/100 cm
(c) For small surfaces having irregular contours, where the entire surface was sampled, measure the surface area. Divide 100 cm
This subpart describes self-implementing comparison testing requirements for chemical extraction and chemical analysis methods used as an alternative to the methods required in §§ 761.272 or 761.292. Any person conducting comparison testing under this
(a) The comparison study requires analysis of a minimum of 10 samples weighing at least 300 grams each. Samples of PCB remediation waste used in the comparison study must meet the following three requirements.
(1) The samples must either be taken from the PCB remediation waste at the cleanup site, or must be the same kind of material as that waste. For example, if the waste at the cleanup site is sandy soil, you must use the same kind of sandy soil in the comparison study. Do not use unrelated materials such as clay soil or dredged sediments in place of sandy soil.
(2) PCB remediation waste may contain interferences which confound or hamper sample extraction and chemical analysis. These interferences may be from chemicals or other attributes preexisting in the waste material, resulting from the PCB contamination source, or resulting from treatment to remove or destroy PCBs. Comparison study samples must also contain these interfering materials to demonstrate successful analysis in their presence. For example, a PCB remediation waste may have been co-disposed with chlorobenzene solvents or chlorinated pesticides. These chlorinated compounds would have to be present in the comparison study compounds at the same levels found, or at the highest levels expected to be found, in the PCB remediation waste. As another example, for PCB remediation waste which had been solvent washed with liquid amines to remove PCBs, comparison study samples would have to contain concentrations of these amines at the same levels found, or at the highest levels expected to be found, in the PCB remediation waste.
(b) Prior to initiating the comparison study, confirm the following PCB concentrations in the comparison study samples using the methods specified in § 761.292. All samples of non-liquid PCB remediation waste must have PCB concentrations between 0.1 and 150 ppm.
(1) A minimum of three comparison study samples must have PCB concentrations above the cleanup level specified for the site in § 761.61(a)(4) and a minimum of three comparison study samples must have PCB concentrations below the specified cleanup level.
(2) At least one comparison study sample must have a PCB concentration ≥90 percent and ≤100 percent of the cleanup level.
(3) At least one comparison study sample must have a PCB concentration ≥100 percent and ≤110 percent of the cleanup level.
(c) If the comparison study samples do not have the concentrations or concentration ranges required by paragraph (b) of this section, for purposes of use in this chemical extraction and chemical analysis comparison study, a person may adjust PCB concentrations by dilution. Any excess material resulting from the preparation of these samples, which is not used as an analytical sample, is regulated as the PCB concentration in the component having the highest PCB concentration of the component materials in the sample.
Extract or analyze the comparison study samples using the alternative method. For an alternative extraction method or alternative analytical method to be comparable to the methods required in § 761.292, all of the following conditions must be met.
(a) All samples having PCB concentrations greater than or equal to the level of concern, as measured by the methods required in § 761.292, are found to be greater than or equal to the level of concern as measured by the alternative method (no false negatives).
(b) Only one sample which contains PCBs at a level less than the level of concern, as measured by the methods required in § 761.292, is found to have a PCB concentration greater than the level of concern as measured by the alternative method (false positive); and all other samples which contain PCBs at levels less than the level of concern, as measured by the methods required
Use the procedures specified in this subpart to sample the following types of waste when it is necessary to analyze the waste to determine PCB concentration or leaching characteristics for storage or disposal.
(a) Existing accumulations of non-liquid, non-metal PCB bulk product waste.
(b) Non-liquid, non-metal PCB bulk product waste from processes that continuously generate new waste.
(c) Non-liquid PCB remediation waste from processes that continuously generate new waste, that will be sent off-site for disposal.
PCB bulk product waste and PCB remediation waste destined for off-site disposal must be in the form of either flattened or roughly conical piles. This subpart also contains a procedure for contemporaneous sampling of waste as it is being generated.
To select a sample of the waste and prepare it for chemical extraction and analysis, there are three required levels of random sampling.
(a) First, select a single 19-liter (5 gallon) portion from a composite accumulated either contemporaneously with the generation of the waste or by sampling an existing pile of waste. Collection procedures for the first level of sampling from existing piles of waste are in § 761.347. Collection procedures for the first level of sampling from a contemporaneous generation of waste are in § 761.348. Compositing requirements and requirements for the subsampling of composite samples to result in a single 19-liter sample are in § 761.350. Send the 19-liter sample to the laboratory for the second and third levels of sampling, including particle size reduction for leach testing and drying as required by § 761.1(b)(4).
(b) Second, at the laboratory, select one quarter of the 19-liter sample. Procedures the laboratory must use for this second level of sample selection appear in § 761.353.
(c) Third, select a 100 gram subsample from the second level subsample. Procedures the laboratory must use for this third level of sample selection appear in § 761.355.
(a)
(b)
(1) Divide the pile into quarters.
(2) Divide each of the quarter sections into quarters (i.e., into sixteenths of the original pile).
(3) Select two sixteenths from each of the four quarters, according to one of the two following options:
(i) Randomly select the two sixteenths from one quarter and sample
(ii) Randomly select two sixteenths from each of the four quarters (i.e., perform a random selection four different times).
(4) At this point the eight selected sixteenths undergo further division and sample selection. Divide each of the eight selected sixteenths into four equal parts. Using a random number generator or random number table, select one of the four equal parts from each of the eight equal areas. If each of the four equal parts has a volume >76 liters when projected downwards 30 cm, continue to divide each selected area into four equal parts, and select one of the parts, until each selected area has a volume of <76 liters but ≥19 liters. When projected to a depth of 30 cm, a square having a 25 cm side or a circle having a diameter of approximately 28.5 cm equals a volume of approximately 19 liters. The volume of 76 liters is equal to the volume enclosed by a square having a side of 50 cm (or other shape having an area of 250 cm
(5) Take one sample of approximately 19 unsorted liters of waste from each of the eight selected areas. Place each sample into a separate 19-liter container, allowing only sufficient space at the top of the container to secure the lid.
(6) Composite the eight 19-liter samples in accordance with § 761.350.
(c)
(1)
(2)
(3)
(i) Determine the radial component (r) of the location for each sample.
(A) Tie to a stake or otherwise fasten one of the strings at “b,” the bottom of the pile, as a reference point for finding
(B) Measure the circumference “c,” the distance around the bottom of the pile. Determine
(
(
(C) Locate
(D) Fasten the second string at the selected distance. The second string marks the first parameter
(ii) Determine the second parameter s of the location for each sample.
(A) Measure the distance,
(
(
(B) Mark, for example by placing a piece of tape on the string positioned according to paragraph (c)(3)(i)(D) of this section, the distance
(iii) Determine the third and final parameter
(A) Mark and number 1 cm intervals from one end of a rigid device, for example a rod, dowel, stake, or broom handle, for measuring the distance from the top of the pile to the bottom at the point
(B) Take the measuring device, constructed according to paragraph (c)(3)(iii)(A) of this section, and at position s, push the end of the device marked with zero straight down into the pile until it reaches the bottom of the pile or ground level. The vertical distance “v” is the number of centimeters from the surface of the pile at point s on the string to the bottom of the pile or ground level. Read the distance
(
(
(iv) Dig a hole straight down into the pile for
(v) At depth
(A) For a depth of 30 cm.
(B) Until the container is full.
(C) Until the ground level is reached.
(d)
Contemporaneous sampling is possible when there is active generation of waste and it is possible to sample the waste stream as it is generated. Collect eight 19-liter samples as follows.
(a) Collect each sample by filling a 19-liter (5 gallon) container at a location where the PCB bulk product waste is released from the waste generator
(b) Determine a sample collection start time using a random number generator or a random number table to select a number between 1 and 60. Collect the first sample at the randomly selected time in minutes after start up of the waste output, or if the waste is currently being generated, after the random time is selected. For example, if the randomly selected time is 35, begin collection 35 minutes after the start up of waste generation. Similarly, if waste output is ongoing and the random start determination occurred at 8:35 a.m., collect the first sample at 9:10 a.m. (35 minutes after the random start determination).
(c) Collect seven more samples, one every 60 minutes after the initial sample is collected. If the waste output process stops, stop the 60-minute interval time clock. When the process restarts, restart the 60-minute interval time clock and complete the incomplete 60-minute interval.
(d) Composite the eight 19-liter samples and subsample in accordance with § 761.350.
(a)
(1)
(2)
(b)
(1) From 19-liter sized piles, use a random number generator or random number table to select one of the piles.
(2) From one large pile, flatten the pile to a depth of 30 cm and divide it into 4 quarters of equal size. Use a random number generator or random number table to select one quarter of the pile. Further divide the selected quarter pile into 19-liter portions and use a random number generator or random number table to select one 19-liter portion. A square having a 25 cm side or a circle having a diameter of approximately 28.5 cm when projected downwards 30 cm equals approximately 19 liters.
(c)
The second level of sample selection reduces the size of the 19-liter subsample that was collected according to either § 761.347 or § 761.348 and subsampled according to § 761.350. The purpose of the sample size reduction is to limit the amount of time required to manually cut up larger particles of the waste to pass through a 9.5 millimeter (mm) screen.
(a)
(b)
(c) Drying the reduced particle size waste. Dry all of the waste portion resulting from conducting the procedures in paragraph (b) of this section, from 10 to 15 hours in a drying oven at 100 °C. Allow the dried waste to cool to room temperature.
(d)
(1)
(2)
The third level of sample selection further reduces the size of the subsample to 100 grams which is suitable for the chemical extraction and analysis procedure.
(a) Divide the subsample resulting from conducting the procedures in § 761.353 of this part into 100 gram portions.
(b) Use a random number generator or random number table to select one 100 gram size portion as a sample for a procedure used to simulate leachate generation.
(c) Dry the 100 gram sample, selected after conducting the procedure in paragraph (b) of this section, for 10 to 15 hours in a drying oven at 100 °C and cool it to the analytical laboratory room temperature before analysis using a procedure used to simulate leachate generation. This sample was dried previously in the larger quantity sample at the second level of sampling (§ 761.353(c)) and is dried a second time here (in the third level of sample selection). This dried and cooled sample must weigh at least 50 grams.
(d) If the dried and cooled sample weighs <50 grams, select additional 100 gram portions of sample one at a time by repeating the directions in paragraph (b) and (c) of this section, and add each additional 100 gram portion of sample to the first 100 gram portion until at least 50 grams of dried material is in the sample to be analyzed using a procedure used to simulate leachate generation.
No method is specified as a procedure used to simulate leachate generation.
Report the results of the procedure used to simulate leachate generation as micrograms PCBs per liter of extract from a 100 gram sample of dry bulk product waste. Divide 100 grams by the grams in the sample and multiply this quotient by the number of micrograms PCBs per liter of extract to obtain the equivalent measurement from a 100 gram sample.
Use either Method 3500B/3540C or Method 3500B/3550B from EPA's SW-846, Test Methods for Evaluating Solid Waste, or a method validated under subpart Q of this part, for chemical extraction of PCBs from individual and composite samples of PCB bulk product waste. Use Method 8082 from SW-846, or a method validated under subpart Q of this part, to analyze these extracts for PCBs.
Report all sample concentrations as ppm by weight on a dry weight basis.
The double wash/rinse procedure is used to quickly and effectively remove PCBs on surfaces. It is important to select and use the proper cleanup equipment, to conduct the procedure correctly so as not to redistribute PCBs, and to comply with disposal requirements for all cleanup materials.
The double wash/rinse procedure includes two washing steps and two rinsing steps. The two washing and rinsing steps are slightly different depending on whether a contaminated surface was relatively clean before the spill (see § 761.372), or whether the surface was coated or covered with dust, dirt, grime, grease or another absorbent material (see § 761.375).
(a) Use scrubbers and absorbent pads that are not dissolved by the solvents or cleaners used, and that do not shred, crumble, or leave visible fragments on the surface. Scrubbers and absorbent pads used to wash contaminated surfaces must not be reused. Scrubbers and absorbent pads for rinsing must not contain ≥2 ppm PCBs. Scrubbers and absorbent pads used in the second rinse of contaminated surfaces may be reused to wash contaminated surfaces.
(b) Capture and contain all solvents and cleaners for reuse, decontamination, or disposal. Clean organic solvents contain <2 ppm PCBs. Clean water contains <3 ppb PCBs.
If visible PCB-containing liquid is present on the surface to be cleaned, thoroughly wipe or mop the entire surface with absorbent paper or cloth until no liquid is visible on the surface.
For surfaces that do not appear dusty or grimy before a spill, such as glass, automobile surfaces, newly-poured concrete, and desk tops, use the double wash/rinse procedures in this section.
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
This subpart provides self-implementing criteria for validating the conditions for use in performance-based decontamination of solvents other than those listed in § 761.79(c)(3) and (c)(4). Any person may use this subpart for validating either a chemical formulation or a product with a trade name whether or not the constituents of the product are proprietary.
Use the self-implementing decontamination procedure only on smooth, non-porous surfaces that were once in contact with liquid PCBs. Decontamination procedures under this subpart shall exactly parallel § 761.79(c)(3) and (c)(4), except that the procedures described in § 761.79(c)(3)(iii) and (c)(3)(iv) and (c)(4)(iii), (c)(4)(iv) and (c)(4)(vii) may be revised to contain parameters validated in accordance with this subpart.
The following experimental conditions apply for any solvent:
(a)
(b)
(c)
(d)
(e)
(f)
There are no restrictions on the variable testing parameters described in this section which may be used in the validation study. The conditions demonstrated in the validation study for these variables shall become the required conditions for decontamination using the solvent being validated and shall replace the comparable conditions in § 761.79(b)(3) through (b)(6). There are limited potential options for varying a single requirement in this section. If you change one of these variable requirements, change it only in the way listed in this section and do not change any other validated conditions. If you desire to change more than one of the requirements in this section, you must conduct a new study to validate the decontamination under the desired conditions.
(a) The study apparatus is not standardized. Critical components of the study are the PCB material (for example MODEF or some other spiking solution), the volume of the soaking solvent, and the area of the contaminated surface. The EPA study used beakers and shallow dishes as the experimental vessels to contain the surface and solvent during the soaking process. In order to minimize surface-to-volume ratios, it is convenient to utilize flat contaminated surfaces and shallow solvent containers. During the validation study, use the same ratio of contaminated surface area to soak solvent volume as would be used during actual decontamination. It is also permissible to use a smaller surface area to soaking solvent volume than used in the validation study, so long as all other required parameters are used as validated in the confirmation required in § 761.386 (a) through (f), and paragraphs (a) through (c) of this section. Do not use a larger surface-area-to-solvent-volumes ratio or different kind of solvent based on the results of the validation study.
(b) Except for the minimum soak time of 1 hour (as required in § 761.386(c)), the length of soak time is not otherwise restricted in the validation study. The soak time used in the validation study, however, is a use requirement for subsequent decontamination using the solvent being validated. It is permissible to use longer soak times for decontamination than the soak time used in the validation study, if all other parameters required in § 761.386, and paragraphs (a) and (c) of this section are used.
(c) There is no restriction on the kind of material containing PCBs to use to create the surface contamination for the validation study. There is also no restriction on the level of starting PCB surface concentration. It is permissible to use lower concentrations of PCB than the concentration used in the validation study, if all other parameters required in § 761.386 (a) through (f), and paragraphs (a) through (c) of this section are used.
(a)(1) To validate a procedure to decontaminate a surface contaminated with a spill from liquid of a known concentration, contaminate (spike) the surface to be used in the validation study as follows:
(i) Use a spiking solution made of PCBs mixed with a solvent to contaminate clean surfaces. Clean surfaces are surfaces having PCB surface concentrations <1 µg/100 cm
(ii) Prior to contaminating a surface for the validation study, mark the surface sampling area to assure that it is completely covered with the spiking solution.
(iii) Deliver the spiking solution onto the surface, covering all of the sampling area. Contain any liquids which spill or flow off the surface. Allow the spiking solution to drip drain off into a
(iv) As a quality control step, test at least one contaminated surface to determine the PCB concentration to verify that there are measurable surface levels of PCBs resulting from the contamination before soaking the surface in the decontamination solvent. The surface levels of PCBs on the contaminated surfaces must be ≥20 µg/100 cm
(2) To validate a procedure to decontaminate a specified surface concentrations of PCBs as measured by a standard wipe sample, contaminate a minimum of 10 surfaces. Contaminate all the surfaces identically following the procedures in paragraph (a)(1) of this section and measure the PCB surface concentrations of at least three of the surfaces using a standard wipe test to establish a surface concentration to be included in the standard operating procedure. The surface levels of PCBs on the contaminated surfaces must be ≥20 µg/100 cm
(b) [Reserved]
(a) Decontaminate the following prepared sample surfaces using the selected testing parameters and experimental conditions. Take a standard wipe sample of the decontaminated surface.
(1) At least one uncontaminated surface. The surface levels of PCBs on the uncontaminated surface must be <1 µg/100 cm
(2) At least seven contaminated surfaces.
(b)(1) Use SW-846, Test Methods for Evaluating Solid Waste methods for sample extraction and chemical analysis as follows: Use Method 3500B/3540C or Method 3500B/3550B for the extraction and cleanup of the extract and Method 8082 for the chemical analysis, or methods validated under subpart Q of this part.
(2) Report all validation study surface sample concentrations on the basis of micrograms of PCBs per 100 cm
(c) Following completion of the validation study, measurements from the contaminated surfaces must have an arithmetic mean of ≤10 µg/100 cm
(a) Submit validation study results to the Director, National Program Chemicals Division (NPCD), (7404), Office of Pollution Prevention and Toxics, 1200 Pennsylvania Ave., NW., Washington, DC, prior to the first use of a new solvent for alternate decontamination under § 761.79(d)(4). The use of a new solvent is not TSCA Confidential Business Information (CBI). From time to time, the Director of NPCD will confirm the use of validated new decontamination solvents and publish the new solvents and validated decontamination procedures in the
(b) Any person may begin to use solvent validated in accordance with this subpart at the time results are submitted to EPA.
(c) Record all testing parameters and experimental conditions from the successful validation study into a standard operating procedure (SOP) for reference whenever the decontamination procedure is used. Include in the SOP the identity of the soaking solvent, the length of time of the soak, and the ratio of the soak solvent to contaminated surface area during the soaking process. Also include in the SOP the maximum concentration of PCBs in the spilled material and the identity of the spilled material, and/or the measured maximum surface concentration of the contaminated surface used in the validation study. Record and keep the results of the validation study as an appendix to the SOP. Include in this appendix, the solvent used to make the spiking solution, the PCB concentration of the spiking solution used to contaminate the surfaces in the validation study, and all of the validation study testing parameters and experimental conditions.
15 U.S.C. 2605, 2607(c), 2643, and 2646.
(a) This rule requires local education agencies to identify friable and nonfriable asbestos-containing material (ACM) in public and private elementary and secondary schools by visually inspecting school buildings for such materials, sampling such materials if they are not assumed to be ACM, and having samples analyzed by appropriate techniques referred to in this rule. The rule requires local education agencies to submit management plans to the Governor of their State by October 12, 1988, begin to implement the plans by July 9, 1989, and complete implementation of the plans in a timely fashion. In addition, local education agencies are required to use persons who have been accredited to conduct inspections, reinspections, develop management plans, or perform response actions. The rule also includes recordkeeping requirements. Local education agencies may contractually delegate their duties under this rule, but they remain responsible for the proper performance of those duties. Local education agencies are encouraged to consult with EPA Regional Asbestos Coordinators, or if applicable, a State's lead agency designated by the State Governor, for assistance in complying with this rule.
(b) Local education agencies must provide for the transportation and disposal of asbestos in accordance with EPA's “Asbestos Waste Management Guidance.” For convenience, applicable sections of this guidance are reprinted as Appendix D of this subpart. There are regulations in place, however, that
For purposes of this subpart:
(1) Any local educational agency as defined in section 198 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 3381).
(2) The owner of any nonpublic, nonprofit elementary, or secondary school building.
(3) The governing authority of any school operated under the defense dependent's education system provided for under the Defense Dependents' Education Act of 1978 (20 U.S.C. 921, et seq.).
(1) Friable ACBM is in an area regularly used by building occupants, including maintenance personnel, in the course of their normal activities.
(2) There are indications that there is a reasonable likelihood that the material or its covering will become damaged, deteriorated, or delaminated due to factors such as changes in building use, changes in operations and maintenance practices, changes in occupancy, or recurrent damage.
(1) Friable ACBM is in an area regularly used by building occupants, including maintenance personnel, in the course of their normal activities.
(2) There are indications that there is a reasonable likelihood that the material or its covering will become significantly damaged, deteriorated, or delaminated due to factors such as changes in building use, changes in operations and maintenance practices, changes in occupancy, or recurrent damage.
(3) The material is subject to major or continuing disturbance, due to factors including, but not limited to, accessibility or, under certain circumstances, vibration or air erosion.
(1) Any structure suitable for use as a classroom, including a school facility such as a laboratory, library, school eating facility, or facility used for the preparation of food.
(2) Any gymnasium or other facility which is specially designed for athletic or recreational activities for an academic course in physical education.
(3) Any other facility used for the instruction or housing of students or for the administration of educational or research programs.
(4) Any maintenance, storage, or utility facility, including any hallway, essential to the operation of any facility described in this definition of “school building” under paragraphs (1), (2), or (3).
(5) Any portico or covered exterior hallway or walkway.
(6) Any exterior portion of a mechanical system used to condition interior space.
Each local education agency shall:
(a) Ensure that the activities of any persons who perform inspections, reinspections, and periodic surveillance, develop and update management plans, and develop and implement response actions, including operations and maintenance, are carried out in accordance with subpart E of this part.
(b) Ensure that all custodial and maintenance employees are properly trained as required by this subpart E and other applicable Federal and/or State regulations (e.g., the Occupational Safety and Health Administration asbestos standard for construction, the EPA worker protection rule, or applicable State regulations).
(c) Ensure that workers and building occupants, or their legal guardians, are informed at least once each school year about inspections, response actions, and post-response action activities, including periodic reinspection and surveillance activities that are planned or in progress.
(d) Ensure that short-term workers (e.g., telephone repair workers, utility workers, or exterminators) who may come in contact with asbestos in a school are provided information regarding the locations of ACBM and suspected ACBM assumed to be ACM.
(e) Ensure that warning labels are posted in accordance with § 763.95.
(f) Ensure that management plans are available for inspection and notification of such availability has been provided as specified in the management plan under § 763.93(g).
(g)(1) Designate a person to ensure that requirements under this section are properly implemented.
(2) Ensure that the designated person receives adequate training to perform duties assigned under this section. Such training shall provide, as necessary, basic knowledge of:
(i) Health effects of asbestos.
(ii) Detection, identification, and assessment of ACM.
(iii) Options for controlling ACBM.
(iv) Asbestos management programs.
(v) Relevant Federal and State regulations concerning asbestos, including those in this subpart E and those of the Occupational Safety and Health Administration, U.S. Department of Labor, the U.S. Department of Transportation and the U.S. Environmental Protection Agency.
(h) Consider whether any conflict of interest may arise from the interrelationship among accredited personnel and whether that should influence the selection of accredited personnel to perform activities under this subpart.
(a)
(2) Any building leased or acquired on or after October 12, 1988, that is to be used as a school building shall be inspected as described under paragraphs (a) (3) and (4) of this section prior to use as a school building. In the event that emergency use of an uninspected building as a school building is necessitated, such buildings shall be inspected within 30 days after commencement of such use.
(3) Each inspection shall be made by an accredited inspector.
(4) For each area of a school building, except as excluded under § 763.99, each person performing an inspection shall:
(i) Visually inspect the area to identify the locations of all suspected ACBM.
(ii) Touch all suspected ACBM to determine whether they are friable.
(iii) Identify all homogeneous areas of friable suspected ACBM and all homogeneous areas of nonfriable suspected ACBM.
(iv) Assume that some or all of the homogeneous areas are ACM, and, for each homogeneous area that is not assumed to be ACM, collect and submit for analysis bulk samples under §§ 763.86 and 763.87.
(v) Assess, under § 763.88, friable material in areas where samples are collected, friable material in areas that are assumed to be ACBM, and friable ACBM identified during a previous inspection.
(vi) Record the following and submit to the person designated under § 763.84 a copy of such record for inclusion in the management plan within 30 days of the inspection:
(A) An inspection report with the date of the inspection signed by each accredited person making the inspection, State of accreditation, and if applicable, his or her accreditation number.
(B) An inventory of the locations of the homogeneous areas where samples are collected, exact location where each bulk sample is collected, dates that samples are collected, homogeneous areas where friable suspected ACBM is assumed to be ACM, and homogeneous areas where nonfriable suspected ACBM is assumed to be ACM.
(C) A description of the manner used to determine sampling locations, the name and signature of each accredited inspector who collected the samples, State of accreditation, and, if applicable, his or her accreditation number.
(D) A list of whether the homogeneous areas identified under paragraph (a)(4)(vi)(B) of this section, are surfacing material, thermal system insulation, or miscellaneous material.
(E) Assessments made of friable material, the name and signature of each accredited inspector making the assessment, State of accreditation, and if applicable, his or her accreditation number.
(b)
(2) Each inspection shall be made by an accredited inspector.
(3) For each area of a school building, each person performing a reinspection shall:
(i) Visually reinspect, and reassess, under § 763.88, the condition of all friable known or assumed ACBM.
(ii) Visually inspect material that was previously considered nonfriable ACBM and touch the material to determine whether it has become friable since the last inspection or reinspection.
(iii) Identify any homogeneous areas with material that has become friable since the last inspection or reinspection.
(iv) For each homogeneous area of newly friable material that is already assumed to be ACBM, bulk samples may be collected and submitted for analysis in accordance with §§ 763.86 and 763.87.
(v) Assess, under § 763.88, the condition of the newly friable material in areas where samples are collected, and newly friable materials in areas that are assumed to be ACBM.
(vi) Reassess, under § 763.88, the condition of friable known or assumed ACBM previously identified.
(vii) Record the following and submit to the person designated under § 763.84 a copy of such record for inclusion in the management plan within 30 days of the reinspection:
(A) The date of the reinspection, the name and signature of the person making the reinspection, State of accreditation, and if applicable, his or her accreditation number, and any changes in the condition of known or assumed ACBM.
(B) The exact locations where samples are collected during the reinspection, a description of the manner used to determine sampling locations, the name and signature of each accredited inspector who collected the samples, State of accreditation, and, if applicable, his or her accreditation number.
(C) Any assessments or reassessments made of friable material, the name and signature of the accredited inspector making the assessments, State of accreditation, and if applicable, his or her accreditation number.
(c)
(a)
(1) At least three bulk samples shall be collected from each homogeneous area that is 1,000 ft
(2) At least five bulk samples shall be collected from each homogeneous area that is greater than 1,000 ft
(3) At least seven bulk samples shall be collected from each homogeneous area that is greater than 5,000 ft
(b)
(2) Collect at least one bulk sample from each homogeneous area of patched thermal system insulation that is not assumed to be ACM if the patched section is less than 6 linear or square feet.
(3) In a manner sufficient to determine whether the material is ACM or not ACM, collect bulk samples from each insulated mechanical system that
(4) Bulk samples are not required to be collected from any homogeneous area where the accredited inspector has determined that the thermal system insulation is fiberglass, foam glass, rubber, or other non-ACBM.
(c)
(d)
(a) Local education agencies shall have bulk samples, collected under § 763.86 and submitted for analysis, analyzed for asbestos using laboratories accredited by the National Bureau of Standards (NBS). Local education agencies shall use laboratories which have received interim accreditation for polarized light microscopy (PLM) analysis under the EPA Interim Asbestos Bulk Sample Analysis Quality Assurance Program until the NBS PLM laboratory accreditation program for PLM is operational.
(b) Bulk samples shall not be composited for analysis and shall be analyzed for asbestos content by PLM, using the “Interim Method for the Determination of Asbestos in Bulk Insulation Samples” found at appendix E to subpart E of this part.
(c)(1) A homogeneous area is considered not to contain ACM only if the results of all samples required to be collected from the area show asbestos in amounts of 1 percent or less.
(2) A homogeneous area shall be determined to contain ACM based on a finding that the results of at least one sample collected from that area shows that asbestos is present in an amount greater than 1 percent.
(d) The name and address of each laboratory performing an analysis, the date of analysis, and the name and signature of the person performing the analysis shall be submitted to the person designated under § 763.84 for inclusion into the management plan within 30 days of the analysis.
(a)(1) For each inspection and reinspection conducted under § 763.85 (a) and (c) and previous inspections specified under § 763.99, the local education agency shall have an accredited inspector provide a written assessment of all friable known or assumed ACBM in the school building.
(2) Each accredited inspector providing a written assessment shall sign and date the assessment, provide his or her State of accreditation, and if applicable, accreditation number, and submit a copy of the assessment to the person designated under § 763.84 for inclusion in the management plan within 30 days of the assessment.
(b) The inspector shall classify and give reasons in the written assessment for classifying the ACBM and suspected ACBM assumed to be ACM in the school building into one of the following categories:
(1) Damaged or significantly damaged thermal system insulation ACM.
(2) Damaged friable surfacing ACM.
(3) Significantly damaged friable surfacing ACM.
(4) Damaged or significantly damaged friable miscellaneous ACM.
(5) ACBM with potential for damage.
(6) ACBM with potential for significant damage.
(7) Any remaining friable ACBM or friable suspected ACBM.
(c) Assessment may include the following considerations:
(1) Location and the amount of the material, both in total quantity and as a percentage of the functional space.
(2) Condition of the material, specifying:
(i) Type of damage or significant damage (e.g., flaking, blistering, water
(ii) Severity of damage (e.g., major flaking, severely torn jackets, as opposed to occasional flaking, minor tears to jackets).
(iii) Extent or spread of damage over large areas or large percentages of the homogeneous area.
(3) Whether the material is accessible.
(4) The material's potential for disturbance.
(5) Known or suspected causes of damage or significant damage (e.g., air erosion, vandalism, vibration, water).
(6) Preventive measures which might eliminate the reasonable likelihood of undamaged ACM from becoming significantly damaged.
(d) The local education agency shall select a person accredited to develop management plans to review the results of each inspection, reinspection, and assessment for the school building and to conduct any other necessary activities in order to recommend in writing to the local education agency appropriate response actions. The accredited person shall sign and date the recommendation, provide his or her State of accreditation, and, if applicable, provide his or her accreditation number, and submit a copy of the recommendation to the person designated under § 763.84 for inclusion in the management plan.
(a) The local education agency shall select and implement in a timely manner the appropriate response actions in this section consistent with the assessment conducted in § 763.88. The response actions selected shall be sufficient to protect human health and the environment. The local education agency may then select, from the response actions which protect human health and the environment, that action which is the least burdensome method. Nothing in this section shall be construed to prohibit removal of ACBM from a school building at any time, should removal be the preferred response action of the local education agency.
(b) If damaged or significantly damaged thermal system insulation ACM is present in a building, the local education agency shall:
(1) At least repair the damaged area.
(2) Remove the damaged material if it is not feasible, due to technological factors, to repair the damage.
(3) Maintain all thermal system insulation ACM and its covering in an intact state and undamaged condition.
(c)(1) If damaged friable surfacing ACM or damaged friable miscellaneous ACM is present in a building, the local education agency shall select from among the following response actions: encapsulation, enclosure, removal, or repair of the damaged material.
(2) In selecting the response action from among those which meet the definitional standards in § 763.83, the local education agency shall determine which of these response actions protects human health and the environment. For purposes of determining which of these response actions are the least burdensome, the local education agency may then consider local circumstances, including occupancy and use patterns within the school building, and its economic concerns, including short- and long-term costs.
(d) If significantly damaged friable surfacing ACM or significantly damaged friable miscellaneous ACM is present in a building the local education agency shall:
(1) Immediately isolate the functional space and restrict access, unless isolation is not necessary to protect human health and the environment.
(2) Remove the material in the functional space or, depending upon whether enclosure or encapsulation would be sufficient to protect human health and the environment, enclose or encapsulate.
(e) If any friable surfacing ACM, thermal system insulation ACM, or friable miscellaneous ACM that has potential for damage is present in a building, the local education agency shall at least implement an operations and maintenance (O&M) program, as described under § 763.91.
(f) If any friable surfacing ACM, thermal system insulation ACM, or friable miscellaneous ACM that has potential for significant damage is present in a building, the local education agency shall:
(1) Implement an O&M program, as described under § 763.91.
(2) Institute preventive measures appropriate to eliminate the reasonable likelihood that the ACM or its covering will become significantly damaged, deteriorated, or delaminated.
(3) Remove the material as soon as possible if appropriate preventive measures cannot be effectively implemented, or unless other response actions are determined to protect human health and the environment. Immediately isolate the area and restrict access if necessary to avoid an imminent and substantial endangerment to human health or the environment.
(g) Response actions including removal, encapsulation, enclosure, or repair, other than small-scale, short-duration repairs, shall be designed and conducted by persons accredited to design and conduct response actions.
(h) The requirements of this subpart E in no way supersede the worker protection and work practice requirements under 29 CFR 1926.58 (Occupational Safety and Health Administration (OSHA) asbestos worker protection standards for construction), 40 CFR part 763, subpart G (EPA asbestos worker protection standards for public employees), and 40 CFR part 61, subpart M (National Emission Standards for Hazardous Air Pollutants—Asbestos).
(i) Completion of response actions. (1) At the conclusion of any action to remove, encapsulate, or enclose ACBM or material assumed to be ACBM, a person designated by the local education agency shall visually inspect each functional space where such action was conducted to determine whether the action has been properly completed.
(2)(i) A person designated by the local education agency shall collect air samples using aggressive sampling as described in appendix A to this subpart E to monitor air for clearance after each removal, encapsulation, and enclosure project involving ACBM, except for projects that are of small-scale, short-duration.
(ii) Local education agencies shall have air samples collected under this section analyzed for asbestos using laboratories accredited by the National Bureau of Standards to conduct such analysis using transmission electron microscopy (TEM) or, under circumstances permitted in this section, laboratories enrolled in the American Industrial Hygiene Association Proficiency Analytical Testing Program for phase contrast microscopy (PCM).
(iii) Until the National Bureau of Standards TEM laboratory accreditation program is operational, local educational agencies shall use laboratories that use the protocol described in appendix A to subpart E of this part.
(3) Except as provided in paragraphs (i)(4), and (i)(5), of this section, an action to remove, encapsulate, or enclose ACBM shall be considered complete when the average concentration of asbestos of five air samples collected within the affected functional space and analyzed by the TEM method in appendix A of this subpart E, is not statistically significantly different, as determined by the Z-test calculation found in appendix A of this subpart E, from the average asbestos concentration of five air samples collected at the same time outside the affected functional space and analyzed in the same manner, and the average asbestos concentration of the three field blanks described in appendix A of this subpart E is below the filter background level, as defined in appendix A of this subpart E, of 70 structures per square millimeter (70 s/mm
(4) An action may also be considered complete if the volume of air drawn for each of the five samples collected within the affected functional space is equal to or greater than 1,199 L of air for a 25 mm filter or equal to or greater than 2,799 L of air for a 37 mm filter, and the average concentration of asbestos as analyzed by the TEM method in appendix A of this subpart E, for the five air samples does not exceed the filter background level, as defined in appendix A, of 70 structures per square millimeter (70 s/mm
(5) At any time, a local education agency may analyze air monitoring samples collected for clearance purposes by phase contrast microscopy (PCM) to confirm completion of removal, encapsulation, or enclosure of ACBM that is greater than small-scale, short-duration and less than or equal to 160 square feet or 260 linear feet. The action shall be considered complete when the results of samples collected in the affected functional space and analyzed by phase contrast microscopy using the National Institute for Occupational Safety and Health (NIOSH) Method 7400 entitled “Fibers” published in the NIOSH Manual of Analytical Methods, 3rd Edition, Second Supplement, August 1987, show that the concentration of fibers for each of the five samples is less than or equal to a limit of quantitation for PCM (0.01 fibers per cubic centimeter (0.01 f/cm
(6) To determine the amount of ACBM affected under paragraph (i)(5) of this section, the local education agency shall add the total square or linear footage of ACBM within the containment barriers used to isolate the functional space for the action to remove, encapsulate, or enclose the ACBM. Contiguous portions of material subject to such action conducted concurrently or at approximately the same time within the same school building shall not be separated to qualify under paragraph (i)(5), of this section.
(a)
(b)
(c)
(i) HEPA-vacuum or steam-clean all carpets.
(ii) HEPA-vacuum or wet-clean all other floors and all other horizontal surfaces.
(iii) Dispose of all debris, filters, mopheads, and cloths in sealed, leak-tight containers.
(2)
(d)
(1) Restrict entry into the area by persons other than those necessary to perform the maintenance project, either by physically isolating the area or by scheduling.
(2) Post signs to prevent entry by unauthorized persons.
(3) Shut off or temporarily modify the air-handling system and restrict other sources of air movement.
(4) Use work practices or other controls, such as, wet methods, protective clothing, HEPA-vacuums, mini-enclosures, glove bags, as necessary to inhibit the spread of any released fibers.
(5) Clean all fixtures or other components in the immediate work area.
(6) Place the asbestos debris and other cleaning materials in a sealed, leak-tight container.
(e)
(f)
(i) Thoroughly saturate the debris using wet methods.
(ii) Clean the area, as described in paragraph (e) of this section.
(iii) Place the asbestos debris in a sealed, leak-tight container.
(iv) Repair the area of damaged ACM with materials such as asbestos-free spackling, plaster, cement, or insulation, or seal with latex paint or an encapsulant, or immediately have the appropriate response action implemented as required by § 763.90.
(2)
(i) Restrict entry into the area and post signs to prevent entry into the area by persons other than those necessary to perform the response action.
(ii) Shut off or temporarily modify the air-handling system to prevent the distribution of fibers to other areas in the building.
(iii) The response action for any major fiber release episode must be designed by persons accredited to design response actions and conducted by persons accredited to conduct response actions.
(a)
(i) Information regarding asbestos and its various uses and forms.
(ii) Information on the health effects associated with asbestos exposure.
(iii) Locations of ACBM identified throughout each school building in which they work.
(iv) Recognition of damage, deterioration, and delamination of ACBM.
(v) Name and telephone number of the person designated to carry out general local education agency responsibilities under § 763.84 and the availability and location of the management plan.
(2) The local education agency shall ensure that all members of its maintenance and custodial staff who conduct any activities that will result in the disturbance of ACBM shall receive training described in paragraph (a)(1) of this section and 14 hours of additional training. Additional training shall include, but not be limited to:
(i) Descriptions of the proper methods of handling ACBM.
(ii) Information on the use of respiratory protection as contained in the EPA/NIOSH
(iii) The provisions of this section and § 763.91, Appendices A, C, and D of this subpart E of this part, EPA regulations contained in 40 CFR part 763, subpart G, and in 40 CFR part 61, subpart M, and OSHA regulations contained in 29 CFR 1926.58.
(iv) Hands-on training in the use of respiratory protection, other personal protection measures, and good work practices.
(3) Local education agency maintenance and custodial staff who have attended EPA-approved asbestos training or received equivalent training for O&M and periodic surveillance activities involving asbestos shall be considered trained for the purposes of this section.
(b)
(2) Each person performing periodic surveillance shall:
(i) Visually inspect all areas that are identified in the management plan as ACBM or assumed ACBM.
(ii) Record the date of the surveillance, his or her name, and any changes in the condition of the materials.
(iii) Submit to the person designated to carry out general local education agency responsibilities under § 763.84 a copy of such record for inclusion in the management plan.
(a)(1) On or before October 12, 1988, each local education agency shall develop an asbestos management plan for each school, including all buildings that they lease, own, or otherwise use as school buildings, and submit the plan to an Agency designated by the Governor of the State in which the local education agency is located. The plan may be submitted in stages that cover a portion of the school buildings under the authority of the local education agency.
(2) If a building to be used as part of a school is leased or otherwise acquired after October 12, 1988, the local education agency shall include the new building in the management plan for the school prior to its use as a school building. The revised portions of the management plan shall be submitted to the Agency designated by the Governor.
(3) If a local education agency begins to use a building as a school after October 12, 1988, the local education agency shall submit a management plan for the school to the Agency designated by the Governor prior to its use as a school.
(b) On or before October 17, 1987, the Governor of each State shall notify local education agencies in the State regarding where to submit their management plans. States may establish administrative procedures for reviewing management plans. If the Governor does not disapprove a management plan within 90 days after receipt of the plan, the local education agency shall implement the plan.
(c) Each local education agency must begin implementation of its management plan on or before July 9, 1989, and complete implementation in a timely fashion.
(d) Each local education agency shall maintain and update its management plan to keep it current with ongoing operations and maintenance, periodic surveillance, inspection, reinspection, and response action activities. All provisions required to be included in the management plan under this section shall be retained as part of the management plan, as well as any information that has been revised to bring the plan up-to-date.
(e) The management plan shall be developed by an accredited management planner and shall include:
(1) A list of the name and address of each school building and whether the school building contains friable ACBM, nonfriable ACBM, and friable and nonfriable suspected ACBM assumed to be ACM.
(2) For each inspection conducted before the December 14, 1987:
(i) The date of the inspection.
(ii) A blueprint, diagram, or written description of each school building that identifies clearly each location and approximate square or linear footage of any homogeneous or sampling area where material was sampled for ACM, and, if possible, the exact locations where bulk samples were collected, and the dates of collection.
(iii) A copy of the analyses of any bulk samples, dates of analyses, and a copy of any other laboratory reports pertaining to the analyses.
(iv) A description of any response actions or preventive measures taken to reduce asbestos exposure, including if possible, the names and addresses of all contractors involved, start and completion dates of the work, and results of any air samples analyzed during and upon completion of the work.
(v) A description of assessments, required to be made under § 763.88, of material that was identified before December 14, 1987, as friable ACBM or friable suspected ACBM assumed to be ACM, and the name and signature, State of accreditation, and if applicable, accreditation number of each accredited person making the assessments.
(3) For each inspection and reinspection conducted under § 763.85:
(i) The date of the inspection or reinspection and the name and signature, State of accreditation and, if applicable, the accreditation number of each accredited inspector performing the inspection or reinspection.
(ii) A blueprint, diagram, or written description of each school building that identifies clearly each location and approximate square or linear footage of homogeneous areas where material was sampled for ACM, the exact location where each bulk sample was collected, date of collection, homogeneous areas where friable suspected ACBM is assumed to be ACM, and where nonfriable suspected ACBM is assumed to be ACM.
(iii) A description of the manner used to determine sampling locations, and the name and signature of each accredited inspector collecting samples, the State of accreditation, and if applicable, his or her accreditation number.
(iv) A copy of the analyses of any bulk samples collected and analyzed, the name and address of any laboratory that analyzed bulk samples, a statement that the laboratory meets the applicable requirements of § 763.87(a) the date of analysis, and the name and signature of the person performing the analysis.
(v) A description of assessments, required to be made under § 763.88, of all ACBM and suspected ACBM assumed to be ACM, and the name, signature, State of accreditation, and if applicable, accreditation number of each accredited person making the assessments.
(4) The name, address, and telephone number of the person designated under § 763.84 to ensure that the duties of the local education agency are carried out, and the course name, and dates and hours of training taken by that person to carry out the duties.
(5) The recommendations made to the local education agency regarding response actions, under § 763.88(d), the name, signature, State of accreditation of each person making the recommendations, and if applicable, his or her accreditation number.
(6) A detailed description of preventive measures and response actions to be taken, including methods to be used, for any friable ACBM, the locations where such measures and action will be taken, reasons for selecting the response action or preventive measure,
(7) With respect to the person or persons who inspected for ACBM and who will design or carry out response actions, except for operations and maintenance, with respect to the ACBM, one of the following statements:
(i) If the State has adopted a contractor accreditation program under section 206(b) of Title II of the Act, a statement that the person(s) is accredited under such plan.
(ii) A statement that the local education agency used (or will use) persons who have been accredited by another State which has adopted a contractor accreditation plan under section 206(b) of Title II of the Act or is accredited by an EPA-approved course under section 206(c) of Title II of the Act.
(8) A detailed description in the form of a blueprint, diagram, or in writing of any ACBM or suspected ACBM assumed to be ACM which remains in the school once response actions are undertaken pursuant to § 763.90. This description shall be updated as response actions are completed.
(9) A plan for reinspection under § 763.85, a plan for operations and maintenance activities under § 763.91, and a plan for periodic surveillance under § 763.92, a description of the recommendation made by the management planner regarding additional cleaning under § 763.91(c)(2) as part of an operations and maintenance program, and the response of the local education agency to that recommendation.
(10) A description of steps taken to inform workers and building occupants, or their legal guardians, about inspections, reinspections, response actions, and post-response action activities, including periodic reinspection and surveillance activities that are planned or in progress.
(11) An evaluation of the resources needed to complete response actions successfully and carry out reinspection, operations and maintenance activities, periodic surveillance and training.
(12) With respect to each consultant who contributed to the management plan, the name of the consultant and one of the following statements:
(i) If the State has adopted a contractor accreditation plan under section 206(b) of Title II of the Act, a statement that the consultant is accredited under such plan.
(ii) A statement that the contractor is accredited by another State which has adopted a contractor accreditation plan under section 206(b) of Title II of the Act, or is accredited by an EPA-approved course developed under section 206(c) of Title II of the Act.
(f) A local education agency may require each management plan to contain a statement signed by an accredited management plan developer that such person has prepared or assisted in the preparation of such plan or has reviewed such plan, and that such plan is in compliance with this subpart E. Such statement may not be signed by a person who, in addition to preparing or assisting in preparing the management plan, also implements (or will implement) the management plan.
(g)(1) Upon submission of a management plan to the Governor for review, a local education agency shall keep a copy of the plan in its administrative office. The management plans shall be available, without cost or restriction, for inspection by representatives of EPA and the State, the public, including teachers, other school personnel and their representatives, and parents. The local education agency may charge a reasonable cost to make copies of management plans.
(2) Each local education agency shall maintain in its administrative office a complete, updated copy of a management plan for each school under its administrative control or direction. The management plans shall be available, during normal business hours, without cost or restriction, for inspection by representatives of EPA and the State, the public, including teachers, other school personnel and their representatives, and parents. The local education agency may charge a reasonable cost to make copies of management plans.
(3) Each school shall maintain in its administrative office a complete, updated copy of the management plan for that school. Management plans shall be available for inspection, without cost
(4) Upon submission of its management plan to the Governor and at least once each school year, the local education agency shall notify in writing parent, teacher, and employee organizations of the availability of management plans and shall include in the management plan a description of the steps taken to notify such organizations, and a dated copy of the notification. In the absence of any such organizations for parents, teachers, or employees, the local education agency shall provide written notice to that relevant group of the availability of management plans and shall include in the management plan a description of the steps taken to notify such groups, and a dated copy of the notification.
(h) Records required under § 763.94 shall be made by local education agencies and maintained as part of the management plan.
(i) Each management plan must contain a true and correct statement, signed by the individual designated by the local education agency under § 763.84, which certifies that the general, local education agency responsibilities, as stipulated by § 763.84, have been met or will be met.
(a) Records required under this section shall be maintained in a centralized location in the administrative office of both the school and the local education agency as part of the management plan. For each homogeneous area where all ACBM has been removed, the local education agency shall ensure that such records are retained for 3 years after the next reinspection required under § 763.85(b)(1), or for an equivalent period.
(b) For each preventive measure and response action taken for friable and nonfriable ACBM and friable and nonfriable suspected ACBM assumed to be ACM, the local education agency shall provide:
(1) A detailed written description of the measure or action, including methods used, the location where the measure or action was taken, reasons for selecting the measure or action, start and completion dates of the work, names and addresses of all contractors involved, and if applicable, their State of accreditation, and accreditation numbers, and if ACBM is removed, the name and location of storage or disposal site of the ACM.
(2) The name and signature of any person collecting any air sample required to be collected at the completion of certain response actions specified by § 763.90(i), the locations where samples were collected, date of collection, the name and address of the laboratory analyzing the samples, the date of analysis, the results of the analysis, the method of analysis, the name and signature of the person performing the analysis, and a statement that the laboratory meets the applicable requirements of § 763.90(i)(2)(ii).
(c) For each person required to be trained under § 763.92(a) (1) and (2), the local education agency shall provide the person's name and job title, the date that training was completed by that person, the location of the training, and the number of hours completed in such training.
(d) For each time that periodic surveillance under § 763.92(b) is performed, the local education agency shall record the name of each person performing the surveillance, the date of the surveillance, and any changes in the conditions of the materials.
(e) For each time that cleaning under § 763.91(c) is performed, the local education agency shall record the name of each person performing the cleaning, the date of such cleaning, the locations cleaned, and the methods used to perform such cleaning.
(f) For each time that operations and maintenance activities under § 763.91(d) are performed, the local education agency shall record the name of each person performing the activity, the
(g) For each time that major asbestos activity under § 763.91(e) is performed, the local education agency shall provide the name and signature, State of accreditation, and if applicable, the accreditation number of each person performing the activity, the start and completion dates of the activity, the locations where such activity occurred, a description of the activity including preventive measures used, and if ACBM is removed, the name and location of storage or disposal site of the ACM.
(h) For each fiber release episode under § 763.91(f), the local education agency shall provide the date and location of the episode, the method of repair, preventive measures or response action taken, the name of each person performing the work, and if ACBM is removed, the name and location of storage or disposal site of the ACM.
(a) The local education agency shall attach a warning label immediately adjacent to any friable and nonfriable ACBM and suspected ACBM assumed to be ACM located in routine maintenance areas (such as boiler rooms) at each school building. This shall include:
(1) Friable ACBM that was responded to by a means other than removal.
(2) ACBM for which no response action was carried out.
(b) All labels shall be prominently displayed in readily visible locations and shall remain posted until the ACBM that is labeled is removed.
(c) The warning label shall read, in print which is readily visible because of large size or bright color, as follows:
(a)
(i) Fail to conduct inspections pursuant to section 203(b) of Title II of the Act, including failure to follow procedures and failure to use accredited personnel and laboratories.
(ii) Knowingly submit false information to the Governor regarding any inspection pursuant to regulations under section 203(i) of Title II of the Act.
(iii) Fail to develop a management plan pursuant to regulations under section 203(i) of Title II of the Act.
(2) Section 207(a) of Title II of the Act (15 U.S.C. 2647) also provides that any local education agency which violates any provision of section 207 shall be liable for a civil penalty of not more than $5,000 for each day during which the violation continues. For the purposes of this subpart, a “violation” means a failure to comply with respect to a single school building.
(b)
(2) Section 15(3) of Title I of the Act (15 U.S.C. 2614) makes it unlawful for any person to fail or refuse to establish or maintain records, submit reports, notices or other information, or permit access to or copying of records, as required by this Act or a rule thereunder.
(3) Section 15(4) (15 U.S.C. 2614) of Title I of the Act makes it unlawful for any person to fail or refuse to permit entry or inspection as required by section 11 of Title I of the Act.
(4) Section 16(a) of Title I of the Act (15 U.S.C. 2615) provides that any person who violates any provision of section 15 of Title I of the Act shall be liable to the United States for a civil penalty in an amount not to exceed $25,000 for each such violation. Each day such a violation continues shall, for purposes of this paragraph, constitute a separate violation of section 15. A local
(c)
(d)
(e)
(f)
(a)
(2) A waiver from any requirement of this subpart E shall apply only to the specific provision for which a waiver has been granted under this section. All requirements of this subpart E shall apply until a waiver is granted under this section.
(b)
(1) A copy of the State provisions or proposed provisions relating to its program of asbestos inspection and management in schools for which the request is made.
(2)(i) The name of the State agency that is or will be responsible for administering and enforcing the requirements for which a waiver is requested, the names and job titles of responsible officials in that agency, and phone numbers where the officials can be contacted.
(ii) In the event that more than one agency is or will be responsible for administering and enforcing the requirements for which a waiver is requested, a description of the functions to be performed by each agency, how the program will be coordinated by the lead agency to ensure consistency and effective administration in the asbestos inspection and management program within the State, the names and job titles of responsible officials in the agencies, and phone numbers where the officials can be contacted. The lead agency will serve as the central contact point for the EPA.
(3) Detailed reasons, supporting papers, and the rationale for concluding that the state's asbestos inspection and management program provisions for which the request is made are at least as stringent as the requirements of Subpart E of this part, and that, if the state chooses to receive electronic documents, the state program includes, at a minimum, the requirements of 40 CFR part 3—(Electronic reporting).
(4) A discussion of any special situations, problems, and needs pertaining to the waiver request accompanied by an explanation of how the State intends to handle them.
(5) A statement of the resources that the State intends to devote to the administration and enforcement of the provisions relating to the waiver request.
(6) Copies of any specific or enabling State laws (enacted and pending enactment) and regulations (promulgated and pending promulgation) relating to the request, including provisions for assessing criminal and/or civil penalties.
(7) Assurance from the Governor, the Attorney General, or the legal counsel of the lead agency that the lead agency or other cooperating agencies have the legal authority necessary to carry out the requirements relating to the request.
(c)
(2) Within 30 days after EPA determines that a request is complete, EPA will issue for publication in the
(3) If, during the comment period, EPA receives a written objection to a Governor's request and a request for a public hearing detailing specific objections to the granting of a waiver, EPA will schedule a public hearing to be held in the affected State after the close of the comment period and will announce the public hearing date in the
(d)
(1) The State's lead agency and other cooperating agencies have the legal authority necessary to carry out the provisions of asbestos inspection and management in schools relating to the waiver request.
(2) The State's program of asbestos inspection and management in schools relating to the waiver request and implementation of the program are or will be at least as stringent as the requirements of this subpart E.
(3) The state has an enforcement mechanism to allow it to implement the program described in the waiver request and any electronic reporting requirements are at least as stringent as 40 CFR part 3—(Electronic reporting).
(4) The lead agency and any cooperating agencies have or will have qualified personnel to carry out the provisions relating to the waiver request.
(5) The State will devote adequate resources to the administration and enforcement of the asbestos inspection and management provisions relating to the waiver request.
(6) When specified by EPA, the State gives satisfactory assurances that necessary steps, including specific actions it proposes to take and a time schedule for their accomplishment, will be taken within a reasonable time to conform with applicable criteria under paragraphs (d) (2) through (4) of this section.
(e)
(f)
(g)
(1) A summary of the State's implementation and enforcement activities during the last reporting period relating to provisions waived under this section, including enforcement actions taken.
(2) Any changes in the administration or enforcement of the State program implemented during the last reporting period.
(3) Other reports as may be required by EPA to carry out effective oversight of any requirement of this subpart E that was waived under this section.
(h)
(i)
(i) Substantially comply with the terms of any provision that was waived under this section.
(ii) Meet the criteria under paragraph (d) of this section, including the failure to carry out enforcement activities or act on violations of the State program.
(2) EPA will:
(i) Specify to the State those aspects of the State's program believed to be inadequate.
(ii) Specify to the State the facts that underlie the belief of inadequacy.
(3) If EPA finds, on the basis of information submitted by the State at the conference, that deficiencies did not exist or were corrected by the State, no further action is required.
(4) Where EPA finds that deficiencies in the State program exist, a plan to correct the deficiencies shall be negotiated between the State and EPA. The plan shall detail the deficiencies found in the State program, specify the steps the State has taken or will take to remedy the deficiencies, and establish a schedule for each remedial action to be initiated.
(j)
(2) EPA will issue for publication in the
(a) A local education agency shall not be required to perform an inspection under § 763.85(a) in any sampling area as defined in 40 CFR 763.103 or homogeneous area of a school building where:
(1) An accredited inspector has determined that, based on sampling records, friable ACBM was identified in that homogeneous or sampling area during an inspection conducted before December 14, 1987. The inspector shall sign and date a statement to that effect with his or her State of accreditation and if applicable, accreditation number and, within 30 days after such determination, submit a copy of the statement to the person designated under § 763.84 for inclusion in the management plan. However, an accredited inspector shall assess the friable ACBM under § 763.88.
(2) An accredited inspector has determined that, based on sampling records, nonfriable ACBM was identified in that homogeneous or sampling area during an inspection conducted before December 14, 1987. The inspector shall sign and date a statement to that effect with his or her State of accreditation and if applicable, accreditation number and, within 30 days after such determination, submit a copy of the statement to the person designated under § 763.84 for inclusion in the management plan. However, an accredited inspector shall identify whether material that was nonfriable has become friable
(3) Based on sampling records and inspection records, an accredited inspector has determined that no ACBM is present in the homogeneous or sampling area and the records show that the area was sampled, before December 14, 1987 in substantial compliance with § 763.85(a), which for purposes of this section means in a random manner and with a sufficient number of samples to reasonably ensure that the area is not ACBM.
(i) The accredited inspector shall sign and date a statement, with his or her State of accreditation and if applicable, accreditation number that the homogeneous or sampling area determined not to be ACBM was sampled in substantial compliance with § 763.85(a).
(ii) Within 30 days after the inspector's determination, the local education agency shall submit a copy of the inspector's statement to the EPA Regional Office and shall include the statement in the management plan for that school.
(4) The lead agency responsible for asbestos inspection in a State that has been granted a waiver from § 763.85(a) has determined that, based on sampling records and inspection records, no ACBM is present in the homogeneous or sampling area and the records show that the area was sampled before December 14, 1987, in substantial compliance with § 763.85(a). Such determination shall be included in the management plan for that school.
(5) An accredited inspector has determined that, based on records of an inspection conducted before December 14, 1987, suspected ACBM identified in that homogeneous or sampling area is assumed to be ACM. The inspector shall sign and date a statement to that effect, with his or her State of accreditation and if applicable, accreditation number and, within 30 days of such determination, submit a copy of the statement to the person designated under § 763.84 for inclusion in the management plan. However, an accredited inspector shall identify whether material that was nonfriable suspected ACBM assumed to be ACM has become friable since the previous inspection and shall assess the newly friable material and previously identified friable suspected ACBM assumed to be ACM under § 763.88.
(6) Based on inspection records and contractor and clearance records, an accredited inspector has determined that no ACBM is present in the homogeneous or sampling area where asbestos removal operations have been conducted before December 14, 1987, and shall sign and date a statement to that effect and include his or her State of accreditation and, if applicable, accreditation number. The local education agency shall submit a copy of the statement to the EPA Regional Office and shall include the statement in the management plan for that school.
(7) An architect or project engineer responsible for the construction of a new school building built after October 12, 1988, or an accredited inspector signs a statement that no ACBM was specified as a building material in any construction document for the building, or, to the best of his or her knowledge, no ACBM was used as a building material in the building. The local education agency shall submit a copy of the signed statement of the architect, project engineer, or accredited inspector to the EPA Regional Office and shall include the statement in the management plan for that school.
(b) The exclusion, under paragraphs (a) (1) through (4) of this section, from conducting the inspection under § 763.85(a) shall apply only to homogeneous or sampling areas of a school building that were inspected and sampled before October 17, 1987. The local education agency shall conduct an inspection under § 763.85(a) of all areas inspected before October 17, 1987, that were not sampled or were not assumed to be ACM.
(c) If ACBM is subsequently found in a homogeneous or sampling area of a local education agency that had been identified as receiving an exclusion by an accredited inspector under paragraphs (a) (3), (4), (5) of this section, or an architect, project engineer or accredited inspector under paragraph
The following appendix contains three units. The first unit is the mandatory transmission electron microscopy (TEM) method which all laboratories must follow; it is the minimum requirement for analysis of air samples for asbestos by TEM. The mandatory method contains the essential elements of the TEM method. The second unit contains the complete non-mandatory method. The non-mandatory method supplements the mandatory method by including additional steps to improve the analysis. EPA recommends that the non-mandatory method be employed for analyzing air filters; however, the laboratory may choose to employ the mandatory method. The non-mandatory method contains the same minimum requirements as are outlined in the mandatory method. Hence, laboratories may choose either of the two methods for analyzing air samples by TEM.
The final unit of this Appendix A to subpart E defines the steps which must be taken to determine completion of response actions. This unit is mandatory.
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1. The sampling agency must have written quality control procedures and documents which verify compliance.
2. Sampling operations must be performed by qualified individuals completely independent of the abatement contractor to avoid possible conflict of interest (References 1, 2, 3, and 5 of Unit II.J.).
3. Sampling for airborne asbestos following an abatement action must use commercially available cassettes.
4. Prescreen the loaded cassette collection filters to assure that they do not contain concentrations of asbestos which may interfere with the analysis of the sample. A filter blank average of less than 18 s/mm
5. Use sample collection filters which are either polycarbonate having a pore size less than or equal to 0.4 µm or mixed cellulose ester having a pore size less than or equal to 0.45 µm.
6. Place these filters in series with a 5.0 µm backup filter (to serve as a diffuser) and a support pad. See the following Figure 1:
7. Reloading of used cassettes is not permitted.
8. Orient the cassette downward at approximately 45 degrees from the horizontal.
9. Maintain a log of all pertinent sampling information.
10. Calibrate sampling pumps and their flow indicators over the range of their intended use with a recognized standard. Assemble the sampling system with a representative filter (not the filter which will be used in sampling) before and after the sampling operation.
11. Record all calibration information.
12. Ensure that the mechanical vibrations from the pump will be minimized to prevent transferral of vibration to the cassette.
13. Ensure that a continuous smooth flow of negative pressure is delivered by the pump by damping out any pump action fluctuations if necessary.
14. The final plastic barrier around the abatement area remains in place for the sampling period.
15. After the area has passed a thorough visual inspection, use aggressive sampling conditions to dislodge any remaining dust. (See suggested protocol in Unit III.B.7.d.)
16. Select an appropriate flow rate equal to or greater than 1 liter per minute (L/min) or less than 10 L/min for 25 mm cassettes. Larger filters may be operated at proportionally higher flow rates.
17. A minimum of 13 samples are to be collected for each testing site consisting of the following:
a. A minimum of five samples per abatement area.
b. A minimum of five samples per ambient area positioned at locations representative of the air entering the abatement site.
c. Two field blanks are to be taken by removing the cap for not more than 30 seconds and replacing it at the time of sampling before sampling is initiated at the following places:
i. Near the entrance to each abatement area.
ii. At one of the ambient sites. (DO NOT leave the field blanks open during the sampling period.)
d. A sealed blank is to be carried with each sample set. This representative cassette is not to be opened in the field.
18. Perform a leak check of the sampling system at each indoor and outdoor sampling site by activating the pump with the closed sampling cassette in line. Any flow indicates a leak which must be eliminated before initiating the sampling operation.
19. The following Table I specifies volume ranges to be used:
20. Ensure that the sampler is turned upright before interrupting the pump flow.
21. Check that all samples are clearly labeled and that all pertinent information has been enclosed before transfer of the samples to the laboratory.
22. Ensure that the samples are stored in a secure and representative location.
23. Do not change containers if portions of these filters are taken for other purposes.
24. A summary of Sample Data Quality Objectives is shown in the following Table II:
Ship bulk samples to the analytical laboratory in a separate container from air samples.
1. Designate one individual as sample coordinator at the laboratory. While that individual will normally be available to receive samples, the coordinator may train and supervise others in receiving procedures for those times when he/she is not available.
2. Bulk samples and air samples delivered to the analytical laboratory in the same container shall be rejected.
1. All sample preparation and analysis shall be performed by a laboratory independent of the abatement contractor.
2. Wet-wipe the exterior of the cassettes to minimize contamination possibilities before taking them into the clean room facility.
3. Perform sample preparation in a well-equipped clean facility.
The clean area is required to have the following minimum characteristics. The area or hood must be capable of maintaining a positive pressure with make-up air being HEPA-filtered. The cumulative analytical blank concentration must average less than 18 s/mm
4. Preparation areas for air samples must not only be separated from preparation areas for bulk samples, but they must be prepared in separate rooms.
5. Direct preparation techniques are required. The object is to produce an intact film containing the particulates of the filter surface which is sufficiently clear for TEM analysis.
a. TEM Grid Opening Area measurement must be done as follows:
i. The filter portion being used for sample preparation must have the surface collapsed using an acetone vapor technique.
ii. Measure 20 grid openings on each of 20 random 200-mesh copper grids by placing a grid on a glass and examining it under the PCM. Use a calibrated graticule to measure the average field diameters. From the data, calculate the field area for an average grid opening.
iii. Measurements can also be made on the TEM at a properly calibrated low magnification or on an optical microscope at a magnification of approximately 400X by using an eyepiece fitted with a scale that has been calibrated against a stage micrometer. Optical microscopy utilizing manual or automated procedures may be used providing instrument calibration can be verified.
b. TEM specimen preparation from polycarbonate (PC) filters. Procedures as described in Unit III.G. or other equivalent methods may be used.
c. TEM specimen preparation from mixed cellulose ester (MCE) filters.
i. Filter portion being used for sample preparation must have the surface collapsed using an acetone vapor technique or the Burdette procedure (Ref. 7 of Unit II.J.)
ii. Plasma etching of the collapsed filter is required. The microscope slide to which the collapsed filter pieces are attached is placed in a plasma asher. Because plasma ashers vary greatly in their performance, both from unit to unit and between different positions in the asher chamber, it is difficult to specify the conditions that should be used. Insufficient etching will result in a failure to expose embedded filters, and too much etching may result in loss of particulate from the surface. As an interim measure, it is recommended that the time for ashing of a
iii. Procedures as described in Unit III. or other equivalent methods may be used to prepare samples.
1. An 80-120 kV TEM capable of performing electron diffraction with a fluorescent screen inscribed with calibrated gradations is required. If the TEM is equipped with EDXA it must either have a STEM attachment or be capable of producing a spot less than 250 nm in diameter at crossover. The microscope shall be calibrated routinely for magnification and camera constant.
2.
3.
4. While not required on every microscope in the laboratory, the laboratory must have either one microscope equipped with energy dispersive X-ray analysis or access to an equivalent system on a TEM in another laboratory.
5. Microscope settings: 80-120 kV, grid assessment 250-1,000X, then 15,000-20,000X screen magnification for analysis.
6. Approximately one-half (0.5) of the predetermined sample area to be analyzed shall be performed on one sample grid preparation and the remaining half on a second sample grid preparation.
7. Individual grid openings with greater than 5 percent openings (holes) or covered with greater than 25 percent particulate matter or obviously having nonuniform loading must not be analyzed.
8. Reject the grid if:
a. Less than 50 percent of the grid openings covered by the replica are intact.
b. The replica is doubled or folded.
c. The replica is too dark because of incomplete dissolution of the filter.
9.
a. Any continuous grouping of particles in which an asbestos fiber with an aspect ratio greater than or equal to 5:1 and a length greater than or equal to 0.5 µm is detected shall be recorded on the count sheet. These will be designated asbestos structures and will be classified as fibers, bundles, clusters, or matrices. Record as individual fibers any contiguous grouping having 0, 1, or 2 definable intersections. Groupings having more than 2 intersections are to be described as cluster or matrix. An intersection is a nonparallel touching or crossing of fibers, with the projection having an aspect ratio of 5:1 or greater. See the following Figure 2:
i.
ii.
iii.
iv.
b. Separate categories will be maintained for fibers less than 5 µm and for fibers equal to or greater than 5 µm in length.
c. Record NSD when no structures are detected in the field.
d. Visual identification of electron diffraction (ED) patterns is required for each asbestos structure counted which would cause the
e. The micrograph number of the recorded diffraction patterns must be reported to the client and maintained in the laboratory's quality assurance records. In the event that examination of the pattern by a qualified individual indicates that the pattern has been misidentified visually, the client shall be contacted.
f. Energy Dispersive X-ray Analysis (EDXA) is required of all amphiboles which would cause the analysis results to exceed the 70 s/mm
g. If the number of fibers in the nonasbestos class would cause the analysis to exceed the 70 s/mm
h. Fibers classified as chrysotile must be identified by diffraction or X-ray analysis and recorded on a count sheet. X-ray analysis alone can be used only after 70 s/mm
i. Fibers classified as amphiboles must be identified by X-ray analysis and electron diffraction and recorded on the count sheet. (X-ray analysis alone can be used only after 70 s/mm
j. If a diffraction pattern was recorded on film, record the micrograph number on the count sheet.
k. If an electron diffraction was attempted but no pattern was observed, record N on the count sheet.
l. If an EDXA spectrum was attempted but not observed, record N on the count sheet.
m. If an X-ray analysis spectrum is stored, record the file and disk number on the count sheet.
10. Classification Rules.
a.
b.
c.
d.
11. After finishing with a grid, remove it from the microscope, and replace it in the appropriate grid holder. Sample grids must be stored for a minimum of 1 year from the date of the analysis; the sample cassette must be retained for a minimum of 30 days by the laboratory or returned at the client's request.
1. Under the present sampling requirements a minimum of 13 samples is to be collected for the clearance testing of an abatement site. These include five abatement area samples, five ambient samples, two field blanks, and one sealed blank.
2. Carry out visual inspection of work site prior to air monitoring.
3. Collect a minimum of 5 air samples inside the work site and 5 samples outside the work site. The indoor and outdoor samples shall be taken during the same time period.
4. Remaining steps in the analytical sequence are contained in Unit IV of this Appendix.
1. The following information must be reported to the client for each sample analyzed:
a. Concentration in structures per square millimeter and structures per cubic centimeter.
b. Analytical sensitivity used for the analysis.
c. Number of asbestos structures.
d. Area analyzed.
e. Volume of air sampled (which must be initially supplied to lab by client).
f. Copy of the count sheet must be included with the report.
g. Signature of laboratory official to indicate that the laboratory met specifications of the method.
h. Report form must contain official laboratory identification (e.g., letterhead).
i. Type of asbestos.
Monitoring the environment for airborne asbestos requires the use of sensitive sampling and analysis procedures. Because the test is sensitive, it may be influenced by a variety of factors. These include the supplies used in the sampling operation, the performance of the sampling, the preparation of the grid from the filter and the actual examination of this grid in the microscope. Each of these unit operations must produce a product of defined quality if the analytical result is to be a reliable and meaningful test result. Accordingly, a series of control checks and reference standards are to be performed along with the sample analysis as indicators that the materials used are adequate and the
1. When the samples arrive at the laboratory, check the samples and documentation for completeness and requirements before initiating the analysis.
2. Check all laboratory reagents and supplies for acceptable asbestos background levels.
3. Conduct all sample preparation in a clean room environment monitored by laboratory blanks. Testing with blanks must also be done after cleaning or servicing the room.
4. Prepare multiple grids of each sample.
5. Provide laboratory blanks with each sample batch. Maintain a cumulative average of these results. If there are more than 53 fibers/mm
6. Perform a system check on the transmission electron microscope daily.
7. Make periodic performance checks of magnification, electron diffraction and energy dispersive X-ray systems as set forth in Table III under Unit II.I.
8. Ensure qualified operator performance by evaluation of replicate analysis and standard sample comparisons as set forth in Table III under Unit II.I.
9. Validate all data entries.
10. Recalculate a percentage of all computations and automatic data reduction steps as specified in Table III under Unit II.I.
11. Record an electron diffraction pattern of one asbestos structure from every five samples that contain asbestos. Verify the identification of the pattern by measurement or comparison of the pattern with patterns collected from standards under the same conditions. The records must also demonstrate that the identification of the pattern has been verified by a qualified individual and that the operator who made the identification is maintaining at least an 80 percent correct visual identification based on his measured patterns.
12. Appropriate logs or records must be maintained by the analytical laboratory verifying that it is in compliance with the mandatory quality assurance procedures.
For additional background information on this method, the following references should be consulted.
1. “Guidance for Controlling Asbestos-Containing Materials in Buildings,” EPA 560/5-85-024, June 1985.
2. “Measuring Airborne Asbestos Following an Abatement Action,” USEPA, Office of Pollution Prevention and Toxics, EPA 600/4-85-049, 1985.
3. Small, John and E. Steel. Asbestos Standards: Materials and Analytical Methods. N.B.S. Special Publication 619, 1982.
4. Campbell, W.J., R.L. Blake, L.L. Brown, E.E. Cather, and J.J. Sjoberg. Selected Silicate Minerals and Their Asbestiform Varieties. Information Circular 8751, U.S. Bureau of Mines, 1977.
5. Quality Assurance Handbook for Air Pollution Measurement System. Ambient Air Methods, EPA 600/4-77-027a, USEPA, Office of Research and Development, 1977.
6. Method 2A: Direct Measurement of Gas Volume through Pipes and Small Ducts. 40 CFR Part 60 Appendix A.
7. Burdette, G.J., Health & Safety Exec. Research & Lab. Services Div., London, “Proposed Analytical Method for Determination of Asbestos in Air.”
8. Chatfield, E.J., Chatfield Tech. Cons., Ltd., Clark, T., PEI Assoc., “Standard Operating Procedure for Determination of Airborne Asbestos Fibers by Transmission Electron Microscopy Using Polycarbonate Membrane Filters,” WERL SOP 87-1, March 5, 1987.
9. NIOSH Method 7402 for Asbestos Fibers, 12-11-86 Draft.
10. Yamate, G., Agarwall, S.C., Gibbons, R.D., IIT Research Institute, “Methodology for the Measurement of Airborne Asbestos by Electron Microscopy,” Draft report, USEPA Contract 68-02-3266, July 1984.
11. “Guidance to the Preparation of Quality Assurance Project Plans,” USEPA, Office of Pollution Prevention and Toxics, 1984.
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1. Sampling operations must be performed by qualified individuals completely independent of the abatement contractor to avoid possible conflict of interest (See References 1, 2, and 5 of Unit III.L.) Special precautions should be taken to avoid contamination of the sample. For example, materials that have not been prescreened for their asbestos background content should not be used; also, sample handling procedures which do not take cross contamination possibilities into account should not be used.
2. Material and supply checks for asbestos contamination should be made on all critical supplies, reagents, and procedures before their use in a monitoring study.
3. Quality control and quality assurance steps are needed to identify problem areas and isolate the cause of the contamination (see Reference 5 of Unit III.L.). Control checks shall be permanently recorded to document the quality of the information produced. The sampling firm must have written quality control procedures and documents which verify compliance. Independent audits by a qualified consultant or firm should be performed once a year. All documentation of compliance should be retained indefinitely to provide a guarantee of quality. A summary of Sample Data Quality Objectives is shown in Table II of Unit II.B.
4. Sampling materials.
a. Sample for airborne asbestos following an abatement action using commercially available cassettes.
b. Use either a cowling or a filter-retaining middle piece. Conductive material may reduce the potential for particulates to adhere to the walls of the cowl.
c. Cassettes must be verified as “clean” prior to use in the field. If packaged filters are used for loading or preloaded cassettes are purchased from the manufacturer or a distributor, the manufacturer's name and lot number should be entered on all field data sheets provided to the laboratory, and are required to be listed on all reports from the laboratory.
d. Assemble the cassettes in a clean facility (See definition of clean area under Unit III.A.).
e. Reloading of used cassettes is not permitted.
f. Use sample collection filters which are either polycarbonate having a pore size of less than or equal to 0.4 µm or mixed cellulose ester having a pore size of less than or equal to 0.45 µm.
g. Place these filters in series with a backup filter with a pore size of 5.0 µm (to serve as a diffuser) and a support pad. See the following Figure 1:
h. When polycarbonate filters are used, position the highly reflective face such that the incoming particulate is received on this surface.
i. Seal the cassettes to prevent leakage around the filter edges or between cassette part joints. A mechanical press may be useful to achieve a reproducible leak-free seal.
j. Use wrinkle-free loaded cassettes in the sampling operation.
5. Pump setup.
a. Calibrate the sampling pump over the range of flow rates and loads anticipated for the monitoring period with this flow measuring device in series. Perform this calibration using guidance from EPA Method 2A each time the unit is sent to the field (See Reference 6 of Unit III.L.).
b. Configure the sampling system to preclude pump vibrations from being transmitted to the cassette by using a sampling stand separate from the pump station and making connections with flexible tubing.
c. Maintain continuous smooth flow conditions by damping out any pump action fluctuations if necessary.
d. Check the sampling system for leaks with the end cap still in place and the pump operating before initiating sample collection. Trace and stop the source of any flow indicated by the flowmeter under these conditions.
e. Select an appropriate flow rate equal to or greater than 1 L/min or less than 10 L/min for 25 mm cassettes. Larger filters may be operated at proportionally higher flow rates.
f. Orient the cassette downward at approximately 45 degrees from the horizontal.
g. Maintain a log of all pertinent sampling information, such as pump identification number, calibration data, sample location, date, sample identification number, flow rates at the beginning, middle, and end, start and stop times, and other useful information or comments. Use of a sampling log form is recommended. See the following Figure 2:
h. Initiate a chain of custody procedure at the start of each sampling, if this is requested by the client.
i. Maintain a close check of all aspects of the sampling operation on a regular basis.
j. Continue sampling until at least the minimum volume is collected, as specified in the following Table I:
k. At the conclusion of sampling, turn the cassette upward before stopping the flow to minimize possible particle loss. If the sampling is resumed, restart the flow before reorienting the cassette downward. Note the condition of the filter at the conclusion of sampling.
l. Double check to see that all information has been recorded on the data collection forms and that the cassette is securely closed and appropriately identified using a waterproof label. Protect cassettes in individual clean resealed polyethylene bags. Bags are to be used for storing cassette caps when they are removed for sampling purposes. Caps and plugs should only be removed or replaced using clean hands or clean disposable plastic gloves.
m. Do not change containers if portions of these filters are taken for other purposes.
6. Minimum sample number per site. A minimum of 13 samples are to be collected for each testing consisting of the following:
a. A minimum of five samples per abatement area.
b. A minimum of five samples per ambient area positioned at locations representative of the air entering the abatement site.
c. Two field blanks are to be taken by removing the cap for not more than 30 sec and replacing it at the time of sampling before sampling is initiated at the following places:
i. Near the entrance to each ambient area.
ii. At one of the ambient sites.
Do not leave the blank open during the sampling period.)
d. A sealed blank is to be carried with each sample set. This representative cassette is not to be opened in the field.
7. Abatement area sampling.
a. Conduct final clearance sampling only after the primary containment barriers have been removed; the abatement area has been thoroughly dried; and, it has passed visual inspection tests by qualified personnel. (See Reference 1 of Unit III.L.)
b. Containment barriers over windows, doors, and air passageways must remain in place until the TEM clearance sampling and analysis is completed and results meet clearance test criteria. The final plastic barrier remains in place for the sampling period.
c. Select sampling sites in the abatement area on a random basis to provide unbiased and representative samples.
d. After the area has passed a thorough visual inspection, use aggressive sampling conditions to dislodge any remaining dust.
i. Equipment used in aggressive sampling such as a leaf blower and/or fan should be properly cleaned and decontaminated before use.
ii. Air filtration units shall remain on during the air monitoring period.
iii. Prior to air monitoring, floors, ceiling and walls shall be swept with the exhaust of a minimum one (1) horsepower leaf blower.
iv. Stationary fans are placed in locations which will not interfere with air monitoring equipment. Fan air is directed toward the ceiling. One fan shall be used for each 10,000 ft
v. Monitoring of an abatement work area with high-volume pumps and the use of circulating fans will require electrical power. Electrical outlets in the abatement area may be used if available. If no such outlets are available, the equipment must be supplied with electricity by the use of extension cords and strip plug units. All electrical power supply equipment of this type must be approved Underwriter Laboratory equipment that has not been modified. All wiring must be grounded. Ground fault interrupters should be used. Extreme care must be taken to clean up any residual water and ensure that electrical equipment does not become wet while operational.
vi. Low volume pumps may be carefully wrapped in 6-mil polyethylene to insulate the pump from the air. High volume pumps cannot be sealed in this manner since the heat of the motor may melt the plastic. The pump exhausts should be kept free.
vii. If recleaning is necessary, removal of this equipment from the work area must be handled with care. It is not possible to completely decontaminate the pump motor and parts since these areas cannot be wetted. To minimize any problems in this area, all equipment such as fans and pumps should be carefully wet wiped prior to removal from the abatement area. Wrapping and sealing low volume pumps in 6-mil polyethylene will provide easier decontamination of this equipment. Use of clean water and disposable wipes should be available for this purpose.
e. Pump flow rate equal to or greater than 1 L/min or less than 10 L/min may be used for 25 mm cassettes. The larger cassette diameters may have comparably increased flow.
f. Sample a volume of air sufficient to ensure the minimum quantitation limits. (See Table I of Unit III.B.5.j.)
8. Ambient sampling.
a. Position ambient samplers at locations representative of the air entering the abatement site. If makeup air entering the abatement site is drawn from another area of the building which is outside of the abatement area, place the pumps in the building, pumps should be placed out of doors located near the building and away from any obstructions that may influence wind patterns. If construction is in progress immediately outside the enclosure, it may be necessary to select another ambient site. Samples should be representative of any air entering the work site.
b. Locate the ambient samplers at least 3 ft apart and protect them from adverse weather conditions.
c. Sample same volume of air as samples taken inside the abatement site.
1. Ship bulk samples in a separate container from air samples. Bulk samples and air samples delivered to the analytical laboratory in the same container shall be rejected.
2. Select a rigid shipping container and pack the cassettes upright in a noncontaminating nonfibrous medium such as a bubble pack. The use of resealable polyethylene bags may help to prevent jostling of individual cassettes.
3. Avoid using expanded polystyrene because of its static charge potential. Also avoid using particle-based packaging materials because of possible contamination.
4. Include a shipping bill and a detailed listing of samples shipped, their descriptions
5. Hand-carry samples to the laboratory in an upright position if possible; otherwise choose that mode of transportation least likely to jar the samples in transit.
6. Address the package to the laboratory sample coordinator by name when known and alert him or her of the package description, shipment mode, and anticipated arrival as part of the chain of custody and sample tracking procedures. This will also help the laboratory schedule timely analysis for the samples when they are received.
Monitoring the environment for airborne asbestos requires the use of sensitive sampling and analysis procedures. Because the test is sensitive, it may be influenced by a variety of factors. These include the supplies used in the sampling operation, the performance of the sampling, the preparation of the grid from the filter and the actual examination of this grid in the microscope. Each of these unit operations must produce a product of defined quality if the analytical result is to be a reliable and meaningful test result. Accordingly, a series of control checks and reference standards is performed along with the sample analysis as indicators that the materials used are adequate and the operations are within acceptable limits. In this way, the quality of the data is defined, and the results are of known value. These checks and tests also provide timely and specific warning of any problems which might develop within the sampling and analysis operations. A description of these quality control/quality assurance procedures is summarized in the text below.
1. Prescreen the loaded cassette collection filters to assure that they do not contain concentrations of asbestos which may interfere with the analysis of the sample. A filter blank average of less than 18 s/mm
2. Calibrate sampling pumps and their flow indicators over the range of their intended use with a recognized standard. Assemble the sampling system with a representative filter—not the filter which will be used in sampling—before and after the sampling operation.
3. Record all calibration information with the data to be used on a standard sampling form.
4. Ensure that the samples are stored in a secure and representative location.
5. Ensure that mechanical calibrations from the pump will be minimized to prevent transferral of vibration to the cassette.
6. Ensure that a continuous smooth flow of negative pressure is delivered by the pump by installing a damping chamber if necessary.
7. Open a loaded cassette momentarily at one of the indoor sampling sites when sampling is initiated. This sample will serve as an indoor field blank.
8. Open a loaded cassette momentarily at one of the outdoor sampling sites when sampling is initiated. This sample will serve as an outdoor field blank.
9. Carry a sealed blank into the field with each sample series. Do not open this cassette in the field.
10. Perform a leak check of the sampling system at each indoor and outdoor sampling site by activating the pump with the closed sampling cassette in line. Any flow indicates a leak which must be eliminated before initiating the sampling operation.
11. Ensure that the sampler is turned upright before interrupting the pump flow.
12. Check that all samples are clearly labeled and that all pertinent information has been enclosed before transfer of the samples to the laboratory.
1. Designate one individual as sample coordinator at the laboratory. While that individual will normally be available to receive samples, the coordinator may train and supervise others in receiving procedures for those times when he/she is not available.
2. Adhere to the following procedures to ensure both the continued chain-of-custody and the accountability of all samples passing through the laboratory:
a. Note the condition of the shipping package and data written on it upon receipt.
b. Retain all bills of lading or shipping slips to document the shipper and delivery time.
c. Examine the chain-of-custody seal, if any, and the package for its integrity.
d. If there has been a break in the seal or substantive damage to the package, the sample coordinator shall immediately notify the shipper and a responsible laboratory manager before any action is taken to unpack the shipment.
e. Packages with significant damage shall be accepted only by the responsible laboratory manager after discussions with the client.
3. Unwrap the shipment in a clean, uncluttered facility. The sample coordinator or his or her designee will record the contents, including a description of each item and all identifying numbers or marks. A
The person breaking the chain-of-custody seal and itemizing the contents assumes responsibility for the shipment and signs documents accordingly.
4. Assign a laboratory number and schedule an analysis sequence.
5. Manage all chain-of-custody samples within the laboratory such that their integrity can be ensured and documented.
1. Personnel not affiliated with the Abatement Contractor shall be used to prepare samples and conduct TEM analysis. Wet-wipe the exterior of the cassettes to minimize contamination possibilities before taking them to the clean sample preparation facility.
2. Perform sample preparation in a well-equipped clean facility.
The clean area is required to have the following minimum characteristics. The area or hood must be capable of maintaining a positive pressure with make-up air being HEPA filtered. The cumulative analytical blank concentration must average less than 18 s/mm
3. Preparation areas for air samples must be separated from preparation areas for bulk samples. Personnel must not prepare air samples if they have previously been preparing bulk samples without performing appropriate personal hygiene procedures, i.e., clothing change, showering, etc.
4.
a. Use only TEM grids that have had grid opening areas measured according to directions in Unit III.J.
b. Remove the inlet and outlet plugs prior to opening the cassette to minimize any pressure differential that may be present.
c. Examples of techniques used to prepare polycarbonate filters are described in Unit III.F.7.
d. Examples of techniques used to prepare mixed cellulose ester filters are described in Unit III.F.8.
e. Prepare multiple grids for each sample.
f. Store the three grids to be measured in appropriately labeled grid holders or polyethylene capsules.
5. Equipment.
a. Clean area.
b. Tweezers. Fine-point tweezers for handling of filters and TEM grids.
c. Scalpel Holder and Curved No. 10 Surgical Blades.
d. Microscope slides.
e. Double-coated adhesive tape.
f. Gummed page reinforcements.
g. Micro-pipet with disposal tips 10 to 100 µL variable volume.
h. Vacuum coating unit with facilities for evaporation of carbon. Use of a liquid nitrogen cold trap above the diffusion pump will minimize the possibility of contamination of the filter surface by oil from the pumping system. The vacuum-coating unit can also be used for deposition of a thin film of gold.
i.
j.
k.
l.
m. Stainless steel mesh.
n. Lens tissue.
o. Copper 200-mesh TEM grids, 3 mm in diameter, or equivalent.
p. Gold 200-mesh TEM grids, 3 mm in diameter, or equivalent.
q. Condensation washer.
r. Carbon-coated, 200-mesh TEM grids, or equivalent.
s. Analytical balance, 0.1 mg sensitivity.
t. Filter paper, 9 cm in diameter.
u. Oven or slide warmer. Must be capable of maintaining a temperature of 65-70 °C.
v. Polyurethane foam, 6 mm thickness.
w. Gold wire for evaporation.
6. Reagents.
a.
b. Polycarbonate preparation method—chloroform.
c. Mixed Cellulose Ester (MCE) preparation method—acetone or the Burdette procedure (Ref. 7 of Unit III.L.).
7. TEM specimen preparation from polycarbonate filters.
a.
b. Cleaning of sample cassettes. Upon receipt at the analytical laboratory and before they are taken into the clean facility or laminar flow hood, the sample cassettes must be cleaned of any contamination adhering to the outside surfaces.
c. Preparation of the carbon evaporator. If the polycarbonate filter has already been carbon-coated prior to receipt, the carbon coating step will be omitted, unless the analyst believes the carbon film is too thin. If there is a need to apply more carbon, the filter will be treated in the same way as an uncoated filter. Carbon coating must be performed with a high-vacuum coating unit. Units that are based on evaporation of carbon filaments in a vacuum generated only by an oil rotary pump have not been evaluated for this application, and must not be used. The carbon rods should be sharpened by a carbon rod sharpener to necks of about 4 mm long and 1 mm in diameter. The rods are installed in the evaporator in such a manner that the points are approximately 10 to 12 cm from the surface of a microscope slide held in the rotating and tilting device.
d. Selection of filter area for carbon coating. Before preparation of the filters, a 75 mm×50 mm microscope slide is washed and dried. This slide is used to support strips of filter during the carbon evaporation. Two parallel strips of double-sided adhesive tape are applied along the length of the slide. Polycarbonate filters are easily stretched during handling, and cutting of areas for further preparation must be performed with great care. The filter and the MCE backing filter are removed together from the cassette and placed on a cleaned glass microscope slide. The filter can be cut with a curved scalpel blade by rocking the blade from the point placed in contact with the filter. The process can be repeated to cut a strip approximately 3 mm wide across the diameter of the filter. The strip of polycarbonate filter is separated from the corresponding strip of backing filter and carefully placed so that it bridges the gap between the adhesive tape strips on the microscope slide. The filter strip can be held with fine-point tweezers and supported underneath by the scalpel blade during placement on the microscope slide. The analyst can place several such strips on the same microscope slide, taking care to rinse and wet-wipe the scalpel blade and tweezers before handling a new sample. The filter strips should be identified by etching the glass slide or marking the slide using a marker insoluble in water and solvents. After the filter strip has been cut from each filter, the residual parts of the filter must be returned to the cassette and held in position by reassembly of the cassette. The cassette will then be archived for a period of 30 days or returned to the client upon request.
e. Carbon coating of filter strips. The glass slide holding the filter strips is placed on the rotation-tilting device, and the evaporator chamber is evacuated. The evaporation must be performed in very short bursts, separated by some seconds to allow the electrodes to cool. If evaporation is too rapid, the strips of polycarbonate filter will begin to curl, which will lead to cross-linking of the surface material and make it relatively insoluble in chloroform. An experienced analyst can judge the thickness of carbon film to be applied, and some test should be made first on unused filters. If the film is too thin, large particles will be lost from the TEM specimen, and there will be few complete and undamaged grid openings on the specimen. If the coating is too thick, the filter will tend to curl when exposed to chloroform vapor and the carbon film may not adhere to the support mesh. Too thick a carbon film will also lead to a TEM image that is lacking in contrast, and the ability to obtain ED patterns will be compromised. The carbon film should be as thin as possible and remain intact on most of the grid openings of the TEM specimen intact.
f. Preparation of the Jaffe washer. The precise design of the Jaffe washer is not considered important, so any one of the published designs may be used. A washer consisting of a simple stainless steel bridge is recommended. Several pieces of lens tissue approximately 1.0 cm×0.5 cm are placed on the stainless steel bridge, and the washer is filled with chloroform to a level where the meniscus contacts the underside of the mesh, which results in saturation of the lens tissue. See References 8 and 10 of Unit III.L.
g. Placing of specimens into the Jaffe washer. The TEM grids are first placed on a piece of lens tissue so that individual grids can be picked up with tweezers. Using a curved scalpel blade, the analyst excises three 3 mm square pieces of the carbon-coated polycarbonate filter from the filter strip. The three squares are selected from the center of the strip and from two points between the outer periphery of the active surface and the center. The piece of filter is placed on a TEM specimen grid with the shiny side of the TEM grid facing upwards, and the whole assembly is placed boldly onto the saturated lens tissue in the Jaffe washer. If carbon-coated grids are used, the filter should be
h.
8. TEM specimen preparation from MCE filters.
a. This method of preparing TEM specimens from MCE filters is similar to that specified in NIOSH Method 7402. See References 7, 8, and 9 of Unit III.L.
b. Upon receipt at the analytical laboratory, the sample cassettes must be cleaned of any contamination adhering to the outside surfaces before entering the clean sample preparation area.
c. Remove a section from any quadrant of the sample and blank filters.
d. Place the section on a clean microscope slide. Affix the filter section to the slide with a gummed paged reinforcement or other suitable means. Label the slide with a water and solvent-proof marking pen.
e. Place the slide in a petri dish which contains several paper filters soaked with 2 to 3 mL acetone. Cover the dish. Wait 2 to 4 minutes for the sample filter to fuse and clear.
f. Plasma etching of the collapsed filter is required.
i. The microscope slide to which the collapsed filter pieces are attached is placed in a plasma asher. Because plasma ashers vary greatly in their performance, both from unit to unit and between different positions in the asher chamber, it is difficult to specify the conditions that should be used. This is one area of the method that requires further evaluation. Insufficient etching will result in a failure to expose embedded filters, and too much etching may result in loss of particulate from the surface. As an interim measure, it is recommended that the time for ashing of a known weight of a collapsed filter be established and that the etching rate be calculated in terms of micrometers per second. The actual etching time used for a particular asher and operating conditions will then be set such that a 1-2 µm (10 percent) layer of collapsed surface will be removed.
ii. Place the slide containing the collapsed filters into a low-temperature plasma asher, and etch the filter.
g. Transfer the slide to a rotating stage inside the bell jar of a vacuum evaporator. Evaporate a 1 mm×5 mm section of graphite rod onto the cleared filter. Remove the slide to a clean, dry, covered petri dish.
h. Prepare a second petri dish as a Jaffe washer with the wicking substrate prepared from filter or lens paper placed on top of a 6 mm thick disk of clean spongy polyurethane foam. Cut a V-notch on the edge of the foam and filter paper. Use the V-notch as a reservoir for adding solvent. The wicking substrate should be thin enough to fit into the petri dish without touching the lid.
i. Place carbon-coated TEM grids face up on the filter or lens paper. Label the grids by marking with a pencil on the filter paper or by putting registration marks on the petri dish lid and marking with a waterproof marker on the dish lid. In a fume hood, fill the dish with acetone until the wicking substrate is saturated. The level of acetone should be just high enough to saturate the filter paper without creating puddles.
j. Remove about a quarter section of the carbon-coated filter samples from the glass slides using a surgical knife and tweezers. Carefully place the section of the filter, carbon side down, on the appropriately labeled grid in the acetone-saturated petri dish. When all filter sections have been transferred, slowly add more solvent to the wedge-shaped trough to bring the acetone level up to the highest possible level without disturbing the sample preparations. Cover the petri dish. Elevate one side of the petri dish by placing a slide under it. This allows drops of condensed solvent vapors to form near the edge rather than in the center where they would drip onto the grid preparation.
1.
a. Use an 80-120 kV TEM capable of performing electron diffraction with a fluorescent screen inscribed with calibrated gradations. If the TEM is equipped with EDXA it must either have a STEM attachment or be capable of producing a spot less than 250 nm
b. While not required on every microscope in the laboratory, the laboratory must have either one microscope equipped with energy dispersive X-ray analysis or access to an equivalent system on a TEM in another laboratory. This must be an Energy Dispersive X-ray Detector mounted on TEM column and associated hardware/software to collect, save, and read out spectral information. Calibration of Multi-Channel Analyzer shall be checked regularly for A1 at 1.48 KeV and Cu at 8.04 KeV, as well as the manufacturer's procedures.
i. Standard replica grating may be used to determine magnification (e.g., 2160 lines/mm).
ii. Gold standard may be used to determine camera constant.
c. Use a specimen holder with single tilt and/or double tilt capabilities.
2. Procedure.
a. Start a new Count Sheet for each sample to be analyzed. Record on count sheet: analyst's initials and date; lab sample number; client sample number microscope identification; magnification for analysis; number of predetermined grid openings to be analyzed; and grid identification. See the following Figure 4:
b. Check that the microscope is properly aligned and calibrated according to the manufacturer's specifications and instructions.
c. Microscope settings: 80-120 kV, grid assessment 250-1000X, then 15,000-20,000X screen magnification for analysis.
d. Approximately one-half (0.5) of the predetermined sample area to be analyzed shall be performed on one sample grid preparation and the remaining half on a second sample grid preparation.
e. Determine the suitability of the grid.
i. Individual grid openings with greater than 5 percent openings (holes) or covered with greater than 25 percent particulate matter or obviously having nonuniform loading shall not be analyzed.
ii. Examine the grid at low magnification (<1000X) to determine its suitability for detailed study at higher magnifications.
iii. Reject the grid if:
(1) Less than 50 percent of the grid openings covered by the replica are intact.
(2) It is doubled or folded.
(3) It is too dark because of incomplete dissolution of the filter.
iv. If the grid is rejected, load the next sample grid.
v. If the grid is acceptable, continue on to Step 6 if mapping is to be used; otherwise proceed to Step 7.
f. Grid Map (Optional).
i. Set the TEM to the low magnification mode.
ii. Use flat edge or finder grids for mapping.
iii. Index the grid openings (fields) to be counted by marking the acceptable fields for one-half (0.5) of the area needed for analysis on each of the two grids to be analyzed. These may be marked just before examining each grid opening (field), if desired.
iv. Draw in any details which will allow the grid to be properly oriented if it is reloaded into the microscope and a particular field is to be reliably identified.
g. Scan the grid.
i. Select a field to start the examination.
ii. Choose the appropriate magnification (15,000 to 20,000X screen magnification).
iii. Scan the grid as follows.
(1) At the selected magnification, make a series of parallel traverses across the field. On reaching the end of one traverse, move the image one window and reverse the traverse.
A slight overlap should be used so as not to miss any part of the grid opening (field).
(2) Make parallel traverses until the entire grid opening (field) has been scanned.
h. Identify each structure for appearance and size.
i. Appearance and size: Any continuous grouping of particles in which an asbestos fiber within aspect ratio greater than or equal to 5:1 and a length greater than or equal to 0.5 µm is detected shall be recorded on the count sheet. These will be designated asbestos structures and will be classified as fibers, bundles, clusters, or matrices. Record as individual fibers any contiguous grouping having 0, 1, or 2 definable intersections. Groupings having more than 2 intersections are to be described as cluster or matrix. See the following Figure 5:
(1)
(2)
(3)
(4)
(5)
(6)
ii. Structure Measurement.
(1) Recognize the structure that is to be sized.
(2) Memorize its location in the “window” relative to the sides, inscribed square and to other particulates in the field so this exact location can be found again when scanning is resumed.
(3) Measure the structure using the scale on the screen.
(4) Record the length category and structure type classification on the count sheet after the field number and fiber number.
(5) Return the fiber to its original location in the window and scan the rest of the field for other fibers; if the direction of travel is not remembered, return to the right side of the field and begin the traverse again.
i. Visual identification of Electron Diffraction (ED) patterns is required for each asbestos structure counted which would cause the analysis to exceed the 70 s/mm
i. Center the structure, focus, and obtain an ED pattern. (See Microscope Instruction Manual for more detailed instructions.)
ii. From a visual examination of the ED pattern, obtained with a short camera length, classify the observed structure as belonging to one of the following classifications: chrysotile, amphibole, or nonasbestos.
(1) Chrysotile: The chrysotile asbestos pattern has characteristic streaks on the layer lines other than the central line and some streaking also on the central line. There will be spots of normal sharpness on the central layer line and on alternate lines (2nd, 4th, etc.). The repeat distance between layer lines is 0.53 nm and the center doublet is at 0.73 nm. The pattern should display (002), (110), (130) diffraction maxima; distances and geometry should match a chrysotile pattern and be measured semiquantitatively.
(2) Amphibole Group [includes grunerite (amosite), crocidolite, anthophyllite, tremolite, and actinolite]: Amphibole asbestos fiber patterns show layer lines formed by very closely spaced dots, and the repeat distance between layer lines is also about 0.53 nm. Streaking in layer lines is occasionally present due to crystal structure defects.
(3) Nonasbestos: Incomplete or unobtainable ED patterns, a nonasbestos EDXA, or a nonasbestos morphology.
iii. The micrograph number of the recorded diffraction patterns must be reported to the client and maintained in the laboratory's quality assurance records. The records must also demonstrate that the identification of the pattern has been verified by a qualified individual and that the operator who made the identification is maintaining at least an 80 percent correct visual identification based on his measured patterns. In the event that examination of the pattern by the qualified individual indicates that the pattern had been misidentified visually, the client shall be contacted. If the pattern is a suspected chrysotile, take a photograph of the diffraction pattern at 0 degrees tilt. If the structure is suspected to be amphibole, the sample may have to be tilted to obtain a simple geometric array of spots.
j. Energy Dispersive X-Ray Analysis (EDXA).
i. Required of all amphiboles which would cause the analysis results to exceed the 70 s/mm
ii. Can be used alone to confirm chrysotile after the 70 s/mm
iii. Can be used alone to confirm all nonasbestos.
iv. Compare spectrum profiles with profiles obtained from asbestos standards. The closest match identifies and categorizes the structure.
v. If the EDXA is used for confirmation, record the properly labeled spectrum on a computer disk, or if a hard copy, file with analysis data.
vi. If the number of fibers in the nonasbestos class would cause the analysis to exceed the 70 s/mm
k. Stopping Rules.
i. If more than 50 asbestiform structures are counted in a particular grid opening, the analysis may be terminated.
ii. After having counted 50 asbestiform structures in a minimum of 4 grid openings, the analysis may be terminated. The grid opening in which the 50th fiber was counted must be completed.
iii. For blank samples, the analysis is always continued until 10 grid openings have been analyzed.
iv. In all other samples the analysis shall be continued until an analytical sensitivity of 0.005 s/cm
l. Recording Rules. The count sheet should contain the following information:
i. Field (grid opening): List field number.
ii. Record “NSD” if no structures are detected.
iii. Structure information.
(1) If fibers, bundles, clusters, and/or matrices are found, list them in consecutive numerical order, starting over with each field.
(2) Length. Record length category of asbestos fibers examined. Indicate if less than 5 µm or greater than or equal to 5 µm.
(3) Structure Type. Positive identification of asbestos fibers is required by the method. At least one diffraction pattern of each fiber type from every five samples must be recorded and compared with a standard diffraction pattern. For each asbestos fiber reported, both a morphological descriptor and an identification descriptor shall be specified on the count sheet.
(4) Fibers classified as chrysotile must be identified by diffraction and/or X-ray analysis and recorded on the count sheet. X-ray analysis alone can be used as sole identification only after 70s/mm
(5) Fibers classified as amphiboles must be identified by X-ray analysis and electron diffraction and recorded on the count sheet. (X-ray analysis alone can be used as sole identification only after 70s/mm
(6) If a diffraction pattern was recorded on film, the micrograph number must be indicated on the count sheet.
(7) If an electron diffraction was attempted and an appropriate spectra is not observed, N should be recorded on the count sheet.
(8) If an X-ray analysis is attempted but not observed, N should be recorded on the count sheet.
(9) If an X-ray analysis spectrum is stored, the file and disk number must be recorded on the count sheet.
m. Classification Rules.
i.
ii.
iii.
iv.
v.
n. After all necessary analyses of a particle structure have been completed, return the goniometer stage to 0 degrees, and return the structure to its original location by recall of the original location.
o. Continue scanning until all the structures are identified, classified and sized in the field.
p. Select additional fields (grid openings) at low magnification; scan at a chosen magnification (15,000 to 20,000X screen magnification); and analyze until the stopping rule becomes applicable.
q. Carefully record all data as they are being collected, and check for accuracy.
r. After finishing with a grid, remove it from the microscope, and replace it in the appropriate grid hold. Sample grids must be stored for a minimum of 1 year from the date of the analysis; the sample cassette must be retained for a minimum of 30 days by the laboratory or returned at the client's request.
1. Carry out visual inspection of work site prior to air monitoring.
2. Collect a minimum of five air samples inside the work site and five samples outside the work site. The indoor and outdoor samples shall be taken during the same time period.
3. Analyze the abatement area samples according to this protocol. The analysis must meet the 0.005 s/cm
4. Remaining steps in the analytical sequence are contained in Unit IV. of this Appendix.
The following information must be reported to the client. See the following Table II:
1. Concentration in structures per square millimeter and structures per cubic centimeter.
2. Analytical sensitivity used for the analysis.
3. Number of asbestos structures.
4. Area analyzed.
5. Volume of air samples (which was initially provided by client).
6. Average grid size opening.
7. Number of grids analyzed.
8. Copy of the count sheet must be included with the report.
9. Signature of laboratory official to indicate that the laboratory met specifications of the AHERA method.
10. Report form must contain official laboratory identification (e.g., letterhead).
11. Type of asbestos.
Appropriate implementation of the method requires a person knowledgeable in electron diffraction and mineral identification by ED and EDXA. Those inexperienced laboratories wishing to develop capabilities may acquire necessary knowledge through analysis of appropriate standards and by following detailed methods as described in References 8 and 10 of Unit III.L.
1.
a.
b. Determination of the TEM magnification on the fluorescent screen.
i. Define a field of view on the fluorescent screen either by markings or physical boundaries. The field of view must be measurable or previously inscribed with a scale or concentric circles (all scales should be metric).
ii. Insert a diffraction grating replica (for example a grating containing 2,160 lines/mm) into the specimen holder and place into the microscope. Orient the replica so that the grating lines fall perpendicular to the scale on the TEM fluorescent screen. Ensure that the goniometer stage tilt is 0 degrees.
iii. Adjust microscope magnification to 10,000X or 20,000X. Measure the distance (mm) between two widely separated lines on the grating replica. Note the number of spaces between the lines. Take care to measure between the same relative positions on the lines (e.g., between left edges of lines).
The more spaces included in the measurement, the more accurate the final calculation. On most microscopes, however, the magnification is substantially constant only within the central 8-10 cm diameter region of the fluorescent screen.
iv. Calculate the true magnification (M) on the fluorescent screen:
c. Calibration of the EDXA System. Initially, the EDXA system must be calibrated by using two reference elements to calibrate the energy scale of the instrument. When this has been completed in accordance with the manufacturer's instructions, calibration in terms of the different types of asbestos can proceed. The EDXA detectors vary in both solid angle of detection and in window thickness. Therefore, at a particular accelerating voltage in use on the TEM, the count rate obtained from specific dimensions of fiber will vary both in absolute X-ray count rate and in the relative X-ray peak heights for different elements. Only a few minerals are relevant for asbestos abatement work, and in this procedure the calibration is specified in terms of a “fingerprint” technique. The EDXA spectra must be recorded from individual fibers of the relevant minerals, and identifications are made on the basis of semiquantitative comparisons with these reference spectra.
d. Calibration of Grid Openings.
i. Measure 20 grid openings on each of 20 random 200-mesh copper grids by placing a grid on a glass slide and examining it under the PCM. Use a calibrated graticule to measure the average field diameter and use this number to calculate the field area for an average grid opening. Grids are to be randomly selected from batches up to 1,000.
A grid opening is considered as one field.
ii. The mean grid opening area must be measured for the type of specimen grids in use. This can be accomplished on the TEM at a properly calibrated low magnification or on an optical microscope at a magnification of approximately 400X by using an eyepiece fitted with a scale that has been calibrated against a stage micrometer. Optical microscopy utilizing manual or automated procedures may be used providing instrument calibration can be verified.
e. Determination of Camera Constant and ED Pattern Analysis.
i. The camera length of the TEM in ED operating mode must be calibrated before ED patterns on unknown samples are observed. This can be achieved by using a carbon-coated grid on which a thin film of gold has been
ii. In practice, it is desirable to optimize the thickness of the gold film so that only one or two sharp rings are obtained on the superimposed ED pattern. Thicker gold film would normally give multiple gold rings, but it will tend to mask weaker diffraction spots from the unknown fibrous particulates. Since the unknown d-spacings of most interest in asbestos analysis are those which lie closest to the transmitted beam, multiple gold rings are unnecessary on zone-axis ED patterns. An average camera constant using multiple gold rings can be determined. The camera constant is one-half the diameter, D, of the rings times the interplanar spacing, d, of the ring being measured.
Monitoring the environment for airborne asbestos requires the use of sensitive sampling and analysis procedures. Because the test is sensitive, it may be influenced by a variety of factors. These include the supplies used in the sampling operation, the performance of the sampling, the preparation of the grid from the filter and the actual examination of this grid in the microscope. Each of these unit operations must produce a product of defined quality if the analytical result is to be a reliable and meaningful test result. Accordingly, a series of control checks and reference standards is performed along with the sample analysis as indicators that the materials used are adequate and the operations are within acceptable limits. In this way, the quality of the data is defined and the results are of known value. These checks and tests also provide timely and specific warning of any problems which might develop within the sampling and analysis operations. A description of these quality control/quality assurance procedures is summarized in the following Table III:
1. When the samples arrive at the laboratory, check the samples and documentation for completeness and requirements before initiating the analysis.
2. Check all laboratory reagents and supplies for acceptable asbestos background levels.
3. Conduct all sample preparation in a clean room environment monitored by laboratory blanks and special testing after cleaning or servicing the room.
4. Prepare multiple grids of each sample.
5. Provide laboratory blanks with each sample batch. Maintain a cumulative average of these results. If this average is greater than 53 f/mm
6. Check for recovery of asbestos from cellulose ester filters submitted to plasma asher.
7. Check for asbestos carryover in the plasma asher by including a blank alongside the positive control sample.
8. Perform a systems check on the transmission electron microscope daily.
9. Make periodic performance checks of magnification, electron diffraction and energy dispersive X-ray systems as set forth in Table III of Unit III.K.
10. Ensure qualified operator performance by evaluation of replicate counting, duplicate analysis, and standard sample comparisons as set forth in Table III of Unit III.K.
11. Validate all data entries.
12. Recalculate a percentage of all computations and automatic data reduction steps as specified in Table III.
13. Record an electron diffraction pattern of one asbestos structure from every five samples that contain asbestos. Verify the identification of the pattern by measurement or comparison of the pattern with patterns collected from standards under the same conditions.
For additional background information on this method the following references should be consulted.
1. “Guidelines for Controlling Asbestos-Containing Materials in Buildings,” EPA 560/5-85-024, June 1985.
2. “Measuring Airborne Asbestos Following an Abatement Action,” USEP/Office of Pollution Prevention and Toxics, EPA 600/4-85-049, 1985.
3. Small, John and E. Steel. Asbestos Standards: Materials and Analytical Methods. N.B.S. Special Publication 619, 1982.
4. Campbell, W.J., R.L. Blake, L.L. Brown, E.E. Cather, and J.J. Sjoberg. Selected Silicate Minerals and Their Asbestiform Varieties. Information Circular 8751, U.S. Bureau of Mines, 1977.
5. Quality Assurance Handbook for Air Pollution Measurement System. Ambient Air Methods, EPA 600/4-77-027a, USEPA, Office of Research and Development, 1977.
6. Method 2A: Direct Measurement of Gas Volume Through Pipes and Small Ducts. 40 CFR Part 60 Appendix A.
7. Burdette, G.J. Health & Safety Exec., Research & Lab. Services Div., London, “Proposed Analytical Method for Determination of Asbestos in Air.”
8. Chatfield, E.J., Chatfield Tech. Cons., Ltd., Clark, T., PEI Assoc. “Standard Operating Procedure for Determination of Airborne Asbestos Fibers by Transmission Electron Microscopy Using Polycarbonate Membrane Filters.” WERL SOP 87-1, March 5, 1987.
9. NIOSH. Method 7402 for Asbestos Fibers, December 11, 1986 Draft.
10. Yamate, G., S.C. Agarwall, R.D. Gibbons, IIT Research Institute, “Methodology for the Measurement of Airborne Asbestos by Electron Microscopy.” Draft report, USEPA Contract 68-02-3266, July 1984.
11. Guidance to the Preparation of Quality Assurance Project Plans. USEPA, Office of Pollution Prevention and Toxics, 1984.
A response action is determined to be completed by TEM when the abatement area has been cleaned and the airborne asbestos concentration inside the abatement area is no higher than concentrations at locations outside the abatement area. “Outside” means outside the abatement area, but not necessarily outside the building. EPA reasons that an asbestos removal contractor cannot be expected to clean an abatement area to an airborne asbestos concentration that is lower than the concentration of air entering the abatement area from outdoors or from other parts of the building. After the abatement area has passed a thorough visual inspection, and before the outer containment barrier is removed, a minimum of five air samples inside the abatement area and a minimum of five air samples outside the abatement area must be collected. Hence, the response action is determined to be completed when the average airborne asbestos concentration measured inside the abatement area is not statistically different from the average airborne asbestos concentration measured outside the abatement area.
The inside and outside concentrations are compared by the Z-test, a statistical test that takes into account the variability in the measurement process. A minimum of five samples inside the abatement area and five samples outside the abatement area are required to control the false negative error rate, i.e., the probability of declaring the removal complete when, in fact, the air concentration inside the abatement area is significantly higher than outside the abatement area. Additional quality control is provided by requiring three blanks (filters through which no air has been drawn) to be analyzed to check for unusually high filter contamination that would distort the test results.
When volumes greater than or equal to 1,199 L for a 25 mm filter and 2,799 L for a 37 mm filter have been collected and the average number of asbestos structures on samples inside the abatement area is no greater than 70 s/mm
The initial screening test is expressed in structures per square millimeter of filter because filter background levels come from sources other than the air being sampled and cannot be meaningfully expressed as a concentration per cubic centimeter of air. The value of 70 s/mm
1. A minimum of 13 samples is required: five samples collected inside the abatement area, five samples collected outside the abatement area, two field blanks, and one sealed blank.
2. Sampling and TEM analysis must be done according to either the mandatory or nonmandatory protocols in Appendix A. At least 0.057 mm
1. The response action shall be considered complete if either:
a. Each sample collected inside the abatement area consists of at least 1,199 L of air for a 25 mm filter, or 2,799 L of air for a 37 mm filter, and the arithmetic mean of their asbestos structure concentrations per square millimeter of filter is less than or equal to 70 s/mm
b. The three blank samples have an arithmetic mean of the asbestos structure concentration on the blank filters that is less than or equal to 70 s/mm
When no fibers are counted, the calculated detection limit for that analysis is inserted for the concentration.
2. If the abatement site does not satisfy either (1) or (2) of this Section C, the site must be recleaned and a new set of samples collected.
It is possible to determine completion of the response action without analyzing all samples. Also, at any point in the process, a decision may be made to terminate the analysis of existing samples, reclean the abatement site, and collect a new set of samples. The following sequence is outlined to minimize the number of analyses needed to reach a decision.
1. Analyze the inside samples.
2. If at least 1,199 L of air for a 25 mm filter or 2,799 L of air for a 37 mm filter is collected for each inside sample and the arithmetic mean concentration of structures per square millimeter of filter is less than or equal to 70 s/mm
3. If less than 1,199 L of air for a 25 mm filter or 2,799 L of air for a 37 mm filter is collected for any of the inside samples, or the arithmetic mean concentration of structures per square millimeter of filter is greater than 70 s/mm
4. If the arithmetic mean concentration of structures per square millimeter on the blank filters is greater than 70 s/mm
5. If the arithmetic mean concentration of structures per square millimeter on the blank filters is less than or equal to 70 s/mm
6. If the Z-statistic is less than or equal to 1.65, the response action is complete. If the Z-statistic is greater than 1.65, reclean the abatement site and collect a new set of samples.
The Asbestos Model Accreditation Plan (MAP) for States has eight components:
(A) Definitions
(B) Initial Training
(C) Examinations
(D) Continuing Education
(E) Qualifications
(F) Recordkeeping Requirements for Training Providers
(G) Deaccreditation
(H) Reciprocity
(I) Electronic reporting
For purposes of Appendix C:
1. “Friable asbestos-containing material (ACM)” means any material containing more than one percent asbestos which has been applied on ceilings, walls, structural members, piping, duct work, or any other part of a building, which when dry, may be crumbled, pulverized, or reduced to powder by hand pressure. The term includes non-friable asbestos-containing material after such previously non-friable material becomes damaged to the extent that when dry it may be crumbled, pulverized, or reduced to powder by hand pressure.
2. “Friable asbestos-containing building material (ACBM)” means any friable ACM that is in or on interior structural members or other parts of a school or public and commercial building.
3. “Inspection” means an activity undertaken in a school building, or a public and commercial building, to determine the presence or location, or to assess the condition of, friable or non-friable asbestos-containing building material (ACBM) or suspected ACBM, whether by visual or physical examination, or by collecting samples of such material. This term includes reinspections of friable and non-friable known or assumed ACBM which has been previously identified. The term does not include the following:
a. Periodic surveillance of the type described in 40 CFR 763.92(b) solely for the purpose of recording or reporting a change in the condition of known or assumed ACBM;
b. Inspections performed by employees or agents of Federal, State, or local government solely for the purpose of determining compliance with applicable statutes or regulations; or
c. visual inspections of the type described in 40 CFR 763.90(i) solely for the purpose of determining completion of response actions.
4. “Major fiber release episode” means any uncontrolled or unintentional disturbance of ACBM, resulting in a visible emission, which involves the falling or dislodging of more than 3 square or linear feet of friable ACBM.
5. “Minor fiber release episode” means any uncontrolled or unintentional disturbance of ACBM, resulting in a visible emission, which involves the falling or dislodging of 3 square or linear feet or less of friable ACBM.
6. “Public and commercial building” means the interior space of any building which is not a school building, except that the term does not include any residential apartment building of fewer than 10 units or detached single-family homes. The term includes, but is not limited to: industrial and office buildings, residential apartment buildings and condominiums of 10 or more dwelling units, government-owned buildings, colleges, museums, airports, hospitals, churches, preschools, stores, warehouses and factories. Interior space includes exterior hallways connecting buildings, porticos, and mechanical systems used to condition interior space.
7. “Response action” means a method, including removal, encapsulation, enclosure, repair, and operation and maintenance, that protects human health and the environment from friable ACBM.
8. “Small-scale, short-duration activities (SSSD)” are tasks such as, but not limited to:
a. Removal of asbestos-containing insulation on pipes.
b. Removal of small quantities of asbestos-containing insulation on beams or above ceilings.
c. Replacement of an asbestos-containing gasket on a valve.
d. Installation or removal of a small section of drywall.
e. Installation of electrical conduits through or proximate to asbestos-containing materials.
SSSD can be further defined by the following considerations:
f. Removal of small quantities of ACM only if required in the performance of another maintenance activity not intended as asbestos abatement.
g. Removal of asbestos-containing thermal system insulation not to exceed amounts greater than those which can be contained in a single glove bag.
h. Minor repairs to damaged thermal system insulation which do not require removal.
i. Repairs to a piece of asbestos-containing wallboard.
j. Repairs, involving encapsulation, enclosure, or removal, to small amounts of friable ACM only if required in the performance of emergency or routine maintenance activity and not intended solely as asbestos abatement. Such work may not exceed amounts greater than those which can be contained in a single prefabricated mini-enclosure. Such an enclosure shall conform spatially and geometrically to the localized work area, in order to perform its intended containment function.
Training requirements for purposes of accreditation are specified both in terms of required subjects of instruction and in terms of length of training. Each initial training course has a prescribed curriculum and number of days of training. One day of training equals 8 hours, including breaks and lunch. Course instruction must be provided by EPA or State-approved instructors. EPA or State instructor approval shall be based upon a review of the instructor's academic credentials and/or field experience in asbestos abatement.
Beyond the initial training requirements, individual States may wish to consider requiring additional days of training for purposes of supplementing hands-on activities or for reviewing relevant state regulations. States also may wish to consider the relative merits of a worker apprenticeship program. Further, they might consider more stringent minimum qualification standards for the approval of training instructors. EPA recommends that the enrollment in any given course be limited to 25 students so that adequate opportunities exist for individual hands-on experience.
States have the option to provide initial training directly or approve other entities to offer training. The following requirements are for the initial training of persons required to have accreditation under TSCA Title II.
Training requirements for each of the five accredited disciplines are outlined below. Persons in each discipline perform a different job function and distinct role. Inspectors identify and assess the condition of ACBM, or suspect ACBM. Management planners use data gathered by inspectors to assess the degree of hazard posed by ACBM in schools to determine the scope and timing of appropriate response actions needed for schools. Project designers determine how asbestos abatement work should be conducted. Lastly, workers and contractor/supervisors carry out and oversee abatement work. In addition, a recommended training curriculum is also presented for a sixth discipline, which is not federally-accredited, that of “Project Monitor.” Each accredited discipline and training curriculum is separate and distinct from the others. A person seeking accreditation in any of the five accredited MAP disciplines cannot attend two or more courses concurrently, but may attend such courses sequentially.
In several instances, initial training courses for a specific discipline (e.g., workers, inspectors) require hands-on training. For asbestos abatement contractor/supervisors and workers, hands-on training should include working with asbestos-substitute materials, fitting and using respirators, use of glovebags, donning protective clothing, and constructing a decontamination unit as well as other abatement work activities.
A person must be accredited as a worker to carry out any of the following activities with respect to friable ACBM in a school or public and commercial building: (1) A response action other than a SSSD activity, (2) a maintenance activity that disturbs friable ACBM other than a SSSD activity, or (3) a response action for a major fiber release episode. All persons seeking accreditation as asbestos abatement workers shall complete at least a 4-day training course as outlined below. The 4-day worker training course shall include lectures, demonstrations, at least 14 hours of hands-on training, individual respirator fit testing, course review, and an examination. Hands-on training must permit workers to have actual experience performing tasks associated with asbestos abatement. A person who is otherwise accredited as a contractor/supervisor may perform in the role of a worker without possessing separate accreditation as a worker.
Because of cultural diversity associated with the asbestos workforce, EPA recommends that States adopt specific standards for the approval of foreign language courses for abatement workers. EPA further recommends the use of audio-visual materials to complement lectures, where appropriate.
The training course shall adequately address the following topics:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
A person must be accredited as a contractor/supervisor to supervise any of the following activities with respect to friable ACBM in a school or public and commercial building: (1) A response action other than a SSSD activity, (2) a maintenance activity that disturbs friable ACBM other than a SSSD activity, or (3) a response action for a major fiber release episode. All persons seeking accreditation as asbestos abatement contractor/supervisors shall complete at least a 5-day training course as outlined below. The training course must include lectures, demonstrations, at least 14 hours of hands-on training, individual respirator fit testing, course review, and a written examination. Hands-on training must permit supervisors to have actual experience performing tasks associated with asbestos abatement.
EPA recommends the use of audiovisual materials to complement lectures, where appropriate.
Asbestos abatement supervisors include those persons who provide supervision and direction to workers performing response actions. Supervisors may include those individuals with the position title of foreman, working foreman, or leadman pursuant to collective bargaining agreements. At least one supervisor is required to be at the worksite at all times while response actions are being conducted. Asbestos workers must have access to accredited supervisors throughout the duration of the project.
The contractor/supervisor training course shall adequately address the following topics:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
EPA recommends that transmission electron microscopy (TEM) be used for analysis of final air clearance samples, and that sample analyses be performed by laboratories accredited by the National Institute of Standards and Technology's (NIST) National Voluntary Laboratory Accreditation Program (NVLAP).
(i)
(i) Requirements of TSCA Title II.
(ii) National Emission Standards for Hazardous Air Pollutants (40 CFR part 61), Subparts A (General Provisions) and M (National Emission Standard for Asbestos).
(iii) OSHA standards for permissible exposure to airborne concentrations of asbestos fibers and respiratory protection (29 CFR 1910.134).
(iv) OSHA Asbestos Construction Standard (29 CFR 1926.58). (v)EPA Worker Protection Rule, (40 CFR part 763, Subpart G).
(j)
(k)
(l)
(m)
(n)
(o)
All persons who inspect for ACBM in schools or public and commercial buildings must be accredited. All persons seeking accreditation as an inspector shall complete at least a 3-day training course as outlined below. The course shall include lectures, demonstrations, 4 hours of hands-on training, individual respirator fit-testing, course review, and a written examination.
EPA recommends the use of audiovisual materials to complement lectures, where appropriate. Hands-on training should include conducting a simulated building walk-through inspection and respirator fit testing. The inspector training course shall adequately address the following topics:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
All persons who prepare management plans for schools must be accredited. All persons seeking accreditation as management planners shall complete a 3-day inspector training course as outlined above and a 2-day
EPA recommends the use of audiovisual materials to complement lectures, where appropriate.
TSCA Title II does not require accreditation for persons performing the management planner role in public and commercial buildings. Nevertheless, such persons may find this training and accreditation helpful in preparing them to design or administer asbestos operations and maintenance programs for public and commercial buildings.
The management planner training course shall adequately address the following topics:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
A person must be accredited as a project designer to design any of the following activities with respect to friable ACBM in a school or public and commercial building: (1) A response action other than a SSSD maintenance activity, (2) a maintenance activity that disturbs friable ACBM other than a SSSD maintenance activity, or (3) a response action for a major fiber release episode. All persons seeking accreditation as a project designer shall complete at least a minimum
EPA recommends the use of audiovisual materials to complement lectures, where appropriate.
The abatement project designer training course shall adequately address the following topics:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
EPA recommends the use of TEM for analysis of final air clearance samples. These samples should be analyzed by laboratories accredited under the NIST NVLAP.
(k)
(l)
(m)
(n)
(o)
(p)
(q)
(r)
(s)
(i) Requirements of TSCA Title II.
(ii) National Emission Standards for Hazardous Air Pollutants, (40 CFR part 61) subparts A (General Provisions) and M (National Emission Standard for Asbestos).
(iii) OSHA Respirator Standard found at 29 CFR 1910.134.
(iv) EPA Worker Protection Rule found at 40 CFR part 763, subpart G.
(v) OSHA Asbestos Construction Standard found at 29 CFR 1926.58.
(vi) OSHA Hazard Communication Standard found at 29 CFR 1926.59.
(t)
EPA recommends that States adopt training and accreditation requirements for persons seeking to perform work as project monitors. Project monitors observe abatement activities performed by contractors and generally serve as a building owner's representative to ensure that abatement work is completed according to specification and in compliance with all relevant statutes and regulations. They may also perform the vital role of air monitoring for purposes of determining final clearance. EPA recommends that a State seeking to accredit individuals as project monitors consider adopting a minimum 5-day training course covering the topics outlined below. The course outlined below consists of lectures and demonstrations, at least 6 hours of hands-on training, course review, and a written examination. The hands-on training component might be satisfied by having the student simulate participation in or performance of any of the relevant job functions or activities (or by incorporation of the workshop component described in item “n” below of this unit).
EPA recommends that the project monitor training course adequately address the following topics:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
Air monitoring strategies/asbestos abatement equipment: This workshop could consist of simulated abatement sites for which sampling strategies would have to be developed (i.e., occupied buildings, industrial situations). Through demonstrations and exhibition, the project monitor may also be able to gain a better understanding of the function of various pieces of equipment used on abatement projects (air filtration units, water filtration units, negative pressure monitoring devices, sampling pump calibration devices, etc.).
Conducting visual inspections: This workshop could consist, ideally, of an interactive video in which a participant is “taken through” a work area and asked to make notes of what is seen. A series of questions will be asked which are designed to stimulate a person's recall of the area. This workshop could consist of a series of two or three videos with different site conditions and different degrees of cleanliness.
1. Each State shall administer a closed book examination or designate other entities such as State-approved providers of training courses to administer the closed-book examination to persons seeking accreditation who have completed an initial training course. Demonstration testing may also be included as part of the examination. A person seeking initial accreditation in a specific discipline must pass the examination for that discipline in order to receive accreditation. For example, a person seeking accreditation as an abatement project designer must pass the State's examination for abatement project designer.
States may develop their own examinations, have providers of training courses develop examinations, or use standardized examinations developed for purposes of accreditation under TSCA Title II. In addition, States may supplement standardized examinations with questions about State regulations. States may obtain commercially developed standardized examinations, develop standardized examinations independently, or do so in cooperation with other States, or with commercial or non-profit providers on a regional or national basis. EPA recommends the use of standardized, scientifically-validated testing instruments, which may be beneficial in terms of both promoting competency and in fostering accreditation reciprocity between States.
Each examination shall adequately cover the topics included in the training course for that discipline. Each person who completes a
a. A unique certificate number
b. Name of accredited person
c. Discipline of the training course completed.
d. Dates of the training course.
e. Date of the examination.
f. An expiration date of 1 year after the date upon which the person successfully completed the course and examination.
g. The name, address, and telephone number of the training provider that issued the certificate.
h. A statement that the person receiving the certificate has completed the requisite training for asbestos accreditation under TSCA Title II.
States or training providers who reaccredit persons based upon completion of required refresher training must also provide accreditation certificates with all of the above information, except the examination date may be omitted if a State does not require a refresher examination for reaccreditation.
Where a State licenses accredited persons but has authorized training providers to issue accreditation certificates, the State may issue licenses in the form of photo-identification cards. Where this applies, EPA recommends that the State licenses should include all of the same information required for the accreditation certificates. A State may also choose to issue photo-identification cards in addition to the required accreditation certificates.
Accredited persons must have their initial and current accreditation certificates at the location where they are conducting work.
2. The following are the requirements for examination in each discipline:
a. Worker:
i. 50 multiple-choice questions
ii. Passing score: 70 percent correct
b. Contractor/Supervisor:
i. 100 multiple-choice questions
ii. Passing score: 70 percent correct
c. Inspector:
i. 50 Multiple-choice questions
ii. Passing score: 70 percent correct
d. Management Planner:
i. 50 Multiple-choice questions
ii. Passing score: 70 percent correct
e. Project Designer:
i. 100 multiple-choice questions
ii. Passing score: 70 percent correct
For all disciplines, a State's accreditation program shall include annual refresher training as a requirement for reaccreditation as indicated below:
1. Workers: One full day of refresher training.
2. Contractor/Supervisors: One full day of refresher training.
3. Inspectors: One half-day of refresher training.
4. Management Planners: One half-day of inspector refresher training and one half-day of refresher training for management planners.
5. Project Designers: One full day of refresher training.
The refresher courses shall be specific to each discipline. Refresher courses shall be conducted as separate and distinct courses and not combined with any other training during the period of the refresher course. For each discipline, the refresher course shall review and discuss changes in Federal, State, and local regulations, developments in state-of-the-art procedures, and a review of key aspects of the initial training course as determined by the State. After completing the annual refresher course, persons shall have their accreditation extended for an additional year from the date of the refresher course. A State may consider requiring persons to pass reaccreditation examinations at specific intervals (for example, every 3 years).
EPA recommends that States formally establish a 12-month grace period to enable formerly accredited persons with expired certificates to complete refresher training and have their accreditation status reinstated without having to re-take the initial training course.
In addition to requiring training and an examination, a State may require candidates for accreditation to meet other qualification and/or experience standards that the State considers appropriate for some or all disciplines. States may choose to consider requiring qualifications similar to the examples outlined below for inspectors, management planners and project designers. States may modify these examples as appropriate. In addition, States may want to include some requirements based on experience in performing a task directly as a part of a job or in an apprenticeship role. They may also wish to consider additional criteria for the approval of training course instructors beyond those prescribed by EPA.
1. Inspectors: Qualifications - possess a high school diploma. States may want to require an Associate's Degree in specific fields (e.g., environmental or physical sciences).
2. Management Planners: Qualifications - Registered architect, engineer, or certified industrial hygienist or related scientific field.
3. Project Designers: Qualifications - registered architect, engineer, or certified industrial hygienist.
4. Asbestos Training Course Instructor: Qualifications - academic credentials and/or field experience in asbestos abatement.
EPA recommends that States prescribe minimum qualification standards for training instructors employed by training providers.
All approved providers of accredited asbestos training courses must comply with the following minimum recordkeeping requirements.
1. Training course materials. A training provider must retain copies of all instructional materials used in the delivery of the classroom training such as student manuals, instructor notebooks and handouts.
2. Instructor qualifications. A training provider must retain copies of all instructors' resumes, and the documents approving each instructor issued by either EPA or a State. Instructors must be approved by either EPA or a State before teaching courses for accreditation purposes. A training provider must notify EPA or the State, as appropriate, in advance whenever it changes course instructors. Records must accurately identify the instructors that taught each particular course for each date that a course is offered.
3. Examinations. A training provider must document that each person who receives an accreditation certificate for an initial training course has achieved a passing score on the examination. These records must clearly indicate the date upon which the exam was administered, the training course and discipline for which the exam was given, the name of the person who proctored the exam, a copy of the exam, and the name and test score of each person taking the exam. The topic and dates of the training course must correspond to those listed on that person's accreditation certificate. States may choose to apply these same requirements to examinations for refresher training courses.
4. Accreditation certificates. The training providers or States, whichever issues the accreditation certificate, shall maintain records that document the names of all persons who have been awarded certificates, their certificate numbers, the disciplines for which accreditation was conferred, training and expiration dates, and the training location. The training provider or State shall maintain the records in a manner that allows verification by telephone of the required information.
5. Verification of certificate information. EPA recommends that training providers of refresher training courses confirm that their students possess valid accreditation before granting course admission. EPA further recommends that training providers offering the initial management planner training course verify that students have met the prerequisite of possessing valid inspector accreditation at the time of course admission.
6. Records retention and access. (a) The training provider shall maintain all required records for a minimum of 3 years. The training provider, however, may find it advantageous to retain these records for a longer period of time.
(b) The training provider must allow reasonable access to all of the records required by the MAP, and to any other records which may be required by States for the approval of asbestos training providers or the accreditation of asbestos training courses, to both EPA and to State Agencies, on request. EPA encourages training providers to make this information equally accessible to the general public.
(c) If a training provider ceases to conduct training, the training provider shall notify the approving government body (EPA or the State) and give it the opportunity to take possession of that providers asbestos training records.
1. States must establish criteria and procedures for deaccrediting persons accredited as workers, contractor/supervisors, inspectors, management planners, and project designers. States must follow their own administrative procedures in pursuing deaccreditation actions. At a minimum, the criteria shall include:
(a) Performing work requiring accreditation at a job site without being in physical possession of initial and current accreditation certificates;
(b) Permitting the duplication or use of one's own accreditation certificate by another;
(c) Performing work for which accreditation has not been received; or
(d) Obtaining accreditation from a training provider that does not have approval to offer training for the particular discipline from either EPA or from a State that has a contractor accreditation plan at least as stringent as the EPA MAP.
EPA may directly pursue deaccreditation actions without reliance on State deaccreditation or enforcement authority or actions. In addition to the above-listed situations, the Administrator may suspend or revoke the accreditation of persons who have been subject to a final order imposing a civil penalty or convicted under section 16 of TSCA, 15 U.S.C. 2615 or 2647, for violations of 40 CFR part 763, or section 113 of the Clean
2. Any person who performs asbestos work requiring accreditation under section 206(a) of TSCA, 15 U.S.C. 2646(a), without such accreditation is in violation of TSCA. The following persons are not accredited for purposes of section 206(a) of TSCA:
(a) Any person who obtains accreditation through fraudulent representation of training or examination documents;
(b) Any person who obtains training documentation through fraudulent means;
(c) Any person who gains admission to and completes refresher training through fraudulent representation of initial or previous refresher training documentation; or
(d) Any person who obtains accreditation through fraudulent representation of accreditation requirements such as education, training, professional registration, or experience.
EPA recommends that each State establish reciprocal arrangements with other States that have established accreditation programs that meet or exceed the requirements of the MAP. Such arrangements might address cooperation in licensing determinations, the review and approval of training programs and/or instructors, candidate testing and exam administration, curriculum development, policy formulation, compliance monitoring, and the exchange of information and data. The benefits to be derived from these arrangements include a potential cost-savings from the reduction of duplicative activity and the attainment of a more professional accredited workforce as States are able to refine and improve the effectiveness of their programs based upon the experience and methods of other States.
States that choose to receive electronic documents must include, at a minimum, the requirements of 40 CFR Part 3—(Electronic reporting) in their programs.
A. States may seek approval for a single discipline or all disciplines as specified in the MAP. For example, a State that currently only requires worker accreditation may receive EPA approval for that discipline alone. EPA encourages States that currently do not have accreditation requirements for all disciplines required under section 206(b)(2) of TSCA, 15 U.S.C. 2646(b)(2), to seek EPA approval for those disciplines the State does accredit. As States establish accreditation requirements for the remaining disciplines, the requested information outlined below should be submitted to EPA as soon as possible. Any State that had an accreditation program approved by EPA under an earlier version of the MAP may follow the same procedures to obtain EPA approval of their accreditation program under this MAP.
B. Partial approval of a State Program for the accreditation of one or more disciplines does not mean that the State is in full compliance with TSCA where the deadline for that State to have adopted a State Plan no less stringent than the MAP has already passed. State Programs which are at least as stringent as the MAP for one or more of the accredited disciplines may, however, accredit persons in those disciplines only.
C. States seeking EPA approval or reapproval of accreditation programs shall submit the following information to the Regional Asbestos Coordinator at their EPA Regional office:
1. A copy of the legislation establishing or upgrading the State's accreditation program (if applicable).
2. A copy of the State's accreditation regulations or revised regulations.
3. A letter to the Regional Asbestos Coordinator that clearly indicates how the State meets the program requirements of this MAP. Addresses for each of the Regional Asbestos Coordinators are shown below:
EPA maintains a listing of all those States that have applied for and received EPA approval for having accreditation requirements that are at least as stringent as the MAP for one or more disciplines. Any training courses
Individuals or groups wishing to sponsor training courses for disciplines required to be accredited under section 206(b)(1)(A) of TSCA, 15 U.S.C. 2646(b)(1)(A), may apply for approval from States that have accreditation program requirements that are at least as stringent as this MAP. For a course to receive approval, it must meet the requirements for the course as outlined in this MAP, and any other requirements imposed by the State from which approval is being sought. Courses that have been approved by a State with an accreditation program at least as stringent as this MAP are approved under section 206(a) of TSCA, 15 U.S.C. 2646(a), for that particular State, and also for any other State that does not have an accreditation program as stringent as this MAP.
A training provider must submit the following minimum information to a State as part of its application for the approval of each training course:
1. The course provider's name, address, and telephone number.
2. A list of any other States that currently approve the training course.
3. The course curriculum.
4. A letter from the provider of the training course that clearly indicates how the course meets the MAP requirements for:
a. Length of training in days.
b. Amount and type of hands-on training.
c. Examination (length, format, and passing score).
d. Topics covered in the course.
5. A copy of all course materials (student manuals, instructor notebooks, handouts, etc.).
6. A detailed statement about the development of the examination used in the course.
7. Names and qualifications of all course instructors. Instructors must have academic and/or field experience in asbestos abatement.
8. A description of and an example of the numbered certificates issued to students who attend the course and pass the examination.
The following minimum information is required for approval of refresher training courses by States:
1. The length of training in half-days or days.
2. The topics covered in the course.
3. A copy of all course materials (student manuals, instructor notebooks, handouts, etc.).
4. The names and qualifications of all course instructors. Instructors must have academic and/or field experience in asbestos abatement.
5. A description of and an example of the numbered certificates issued to students who complete the refresher course and pass the examination, if required.
States must establish criteria and procedures for suspending or withdrawing approval from accredited training programs. States should follow their own administrative procedures in pursuing actions for suspension or withdrawal of approval of training programs. At a minimum, the criteria shall include:
(1) Misrepresentation of the extent of a training course's approval by a State or EPA;
(2) Failure to submit required information or notifications in a timely manner;
(3) Failure to maintain requisite records;
(4) Falsification of accreditation records, instructor qualifications, or other accreditation information; or
(5) Failure to adhere to the training standards and requirements of the EPA MAP or State Accreditation Program, as appropriate.
In addition to the criteria listed above, EPA may also suspend or withdraw a training course's approval where an approved training course instructor, or other person with supervisory authority over the delivery of training has been found in violation of other asbestos regulations administered by EPA. An administrative or judicial finding of violation, or execution of a consent agreement and order under 40 CFR 22.18, constitutes evidence of a failure to comply with relevant statutes or regulations. States may wish to adopt this criterion modified to include their own asbestos statutes or regulations. EPA may also suspend or withdraw approval of training programs where a training provider has submitted false information as a part of the self-certification required under Unit V.B. of the revised MAP.
Training course providers shall permit representatives of EPA or the State which approved their training courses to attend, evaluate, and monitor any training course without charge. EPA or State compliance inspection staff are not required to give advance notice of their inspections. EPA may suspend or withdraw State or EPA approval of a training course based upon the criteria specified in this Unit III.C.
A. If the Administrator decides to suspend or revoke the accreditation of any person or
1. The grounds upon which the suspension, revocation, or withdrawal is based.
2. The time period during which the suspension, revocation, or withdrawal is effective, whether permanent or otherwise.
3. The conditions, if any, under which the affected entity may receive accreditation or approval in the future.
4. Any additional conditions which the Administrator may impose.
5. The opportunity to request a hearing prior to final Agency action to suspend or revoke accreditation or suspend or withdraw approval.
B. If a hearing is requested by the accredited person or training course provider pursuant to the preceding paragraph, the Administrator will:
1. Notify the affected entity of those assertions of law and fact upon which the action to suspend, revoke, or withdraw is based.
2. Provide the affected entity an opportunity to offer written statements of facts, explanations, comments, and arguments relevant to the proposed action.
3. Provide the affected entity such other procedural opportunities as the Administrator may deem appropriate to ensure a fair and impartial hearing.
4. Appoint an EPA attorney as Presiding Officer to conduct the hearing. No person shall serve as Presiding Officer if he or she has had any prior connection with the specific case.
C. The Presiding Officer appointed pursuant to the preceding paragraph shall:
1. Conduct a fair, orderly, and impartial hearing, without unnecessary delay.
2. Consider all relevant evidence, explanation, comment, and argument submitted pursuant to the preceding paragraph.
3. Promptly notify the affected entity of his or her decision and order. Such an order is a final Agency action.
D. If the Administrator determines that the public health, interest, or welfare warrants immediate action to suspend the accreditation of any person or the approval of any training course provider, the Administrator will:
1. Notify the affected entity of the grounds upon which the emergency suspension is based;
2. Notify the affected entity of the time period during which the emergency suspension is effective.
3. Notify the affected entity of the Administrator's intent to suspend or revoke accreditation or suspend or withdraw training course approval, as appropriate, in accordance with Unit IV.A. above. If such suspension, revocation, or withdrawal notice has not previously been issued, it will be issued at the same time the emergency suspension notice is issued.
E. Any notice, decision, or order issued by the Administrator under this section, and any documents filed by an accredited person or approved training course provider in a hearing under this section, shall be available to the public except as otherwise provided by section 14 of TSCA or by 40 CFR part 2. Any such hearing at which oral testimony is presented shall be open to the public, except that the Presiding Officer may exclude the public to the extent necessary to allow presentation of information which may be entitled to confidential treatment under section 14 of TSCA or 40 CFR part 2.
The various requirements of this MAP become effective in accordance with the following schedules:
1. Each State shall adopt an accreditation plan that is at least as stringent as this MAP within 180 days after the commencement of the first regular session of the legislature of the State that is convened on or after April 4, 1994.
2. If a State has adopted an accreditation plan at least as stringent as this MAP as of April 4, 1994, the State may continue to:
a. Conduct TSCA training pursuant to this MAP.
b. Approve training course providers to conduct training and to issue accreditation that satisfies the requirements for TSCA accreditation under this MAP.
c. Issue accreditation that satisfies the requirements for TSCA accreditation under this MAP.
3. A State that had complied with an earlier version of the MAP, but has not adopted an accreditation plan at least as stringent as this MAP by April 4, 1994, may:
a. Conduct TSCA training which remains in compliance with the requirements of Unit V.B. of this MAP. After such training has been self-certified in accordance with Unit V.B. of this MAP, the State may issue accreditation that satisfies the requirement for TSCA accreditation under this MAP.
b. Sustain its approval for any training course providers to conduct training and issue TSCA accreditation that the State had approved before April 4, 1994, and that remain in compliance with Unit V.B. of this MAP.
c. Issue accreditation pursuant to an earlier version of the MAP that provisionally satisfies the requirement for TSCA accreditation until October 4, 1994.
Such a State may not approve new TSCA training course providers to conduct training or to issue TSCA accreditation that satisfies
4. A State that had complied with an earlier version of the MAP, but fails to adopt a plan as stringent as this MAP by the deadline established in Unit V.A.1., is subject to the following after that deadline date:
a. The State loses any status it may have held as an EPA-approved State for accreditation purposes under section 206 of TSCA, 15 U.S.C. 2646.
b. All training course providers approved by the State lose State approval to conduct training and issue accreditation that satisfies the requirements for TSCA accreditation under this MAP.
c. The State may not:
i. Conduct training for accreditation purposes under section 206 of TSCA, 15 U.S.C. 2646.
ii. Approve training course providers to conduct training or issue accreditation that satisfies the requirements for TSCA accreditation; or
iii. Issue accreditation that satisfies the requirement for TSCA accreditation.
EPA will extend EPA-approval to any training course provider that loses State approval because the State does not comply with the deadline, so long as the provider is in compliance with Unit V.B. of this MAP, and the provider is approved by a State that had complied with an earlier version of the MAP as of the day before the State loses its EPA approval.
5. A State that does not have an accreditation program that satisfies the requirements for TSCA accreditation under either an earlier version of the MAP or this MAP, may not:
a. Conduct training for accreditation purposes under section 206 of TSCA, 15 U.S.C. 2646;
b. Approve training course providers to conduct training or issue accreditation that satisfies the requirements for TSCA accreditation; or
c. Issue accreditation that satisfies the requirement for TSCA accreditation.
As of October 4, 1994, an approved training provider must certify to EPA and to any State that has approved the provider for TSCA accreditation, that each of the provider's training courses complies with the requirements of this MAP. The written submission must document in specific detail the changes made to each training course in order to comply with the requirements of this MAP and clearly state that the provider is also in compliance with all other requirements of this MAP, including the new recordkeeping and certificate provisions. Each submission must include the following statement signed by an authorized representative of the training provider: “Under civil and criminal penalties of law for the making or submission of false or fraudulent statements or representations (18 U.S.C. 1001 and 15 U.S.C. 2615), I certify that the training described in this submission complies with all applicable requirements of Title II of TSCA, 40 CFR part 763, Appendix C to Subpart E, as revised, and any other applicable Federal, state, or local requirements.” A consolidated self-certification submission from each training provider that addresses all of its approved training courses is permissible and encouraged.
The self-certification must be sent via registered mail, to EPA Headquarters at the following address: Attn. Self-Certification Program, Field Programs Branch, Chemical Management Division (7404), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. A duplicate copy of the complete submission must also be sent to any States from which approval had been obtained.
The timely receipt of a complete self-certification by EPA and all approving States shall have the effect of extending approval under this MAP to the training courses offered by the submitting provider. If a self-certification is not received by the approving government bodies on or before the due date, the affected training course is not approved under this MAP. Such training providers must then reapply for approval of these training courses pursuant to the procedures outlined in Unit III.
Persons accredited by a State with an accreditation program no less stringent than an earlier version of the MAP or by an EPA-approved training provider as of April 3, 1994, are accredited in accordance with the requirements of this MAP, and are not required to retake initial training. They must continue to comply with the requirements for annual refresher training in Unit I.D. of the revised MAP.
In order to perform work requiring accreditation under TSCA Title II, persons who are not accredited by a State with an accreditation program no less stringent than an earlier version of the MAP or by an EPA-approved training provider as of April 3, 1994, must comply with the upgraded training requirements of this MAP by no later than October 4, 1994. Non-accredited persons may obtain initial accreditation on a provisional basis by successfully completing any of the training programs approved under an earlier
For the purposes of this appendix, transport is defined as all activities from receipt of the containerized asbestos waste at the generation site until it has been unloaded at the disposal site. Current EPA regulations state that there must be no visible emissions to the outside air during waste transport. However, recognizing the potential hazards and subsequent liabilities associated with exposure, the following additional precautions are recommended.
Asbestos NESHAPs Contact, Air Management Division, USEPA, Region I, JFK Federal Building, Boston, MA 02203, (617) 223-3266.
Asbestos NESHAPs Contact, Air & Waste Management Division, USEPA, Region II, 26 Federal Plaza, New York, NY 10007, (212) 264-6770.
Asbestos NESHAPs Contact, Air Management Division, USEPA, Region III, 841 Chestnut Street, Philadelphia, PA 19107, (215) 597-9325.
Asbestos NESHAPs Contact, Air, Pesticide & Toxic Management, USEPA, Region IV, 345 Courtland Street, NE., Atlanta, GA 30365, (404) 347-4298.
Asbestos NESHAPs Contact, Air Management Division, USEPA, Region V, 77 West Jackson Boulevard, Chicago, IL 60604, (312) 353-6793.
Asbestos NESHAPs Contact, Air & Waste Management Division, USEPA, Region VI, 1445 Ross Avenue, Dallas, TX 75202, (214) 655-7229.
Asbestos NESHAPs Contact, Air & Waste Management Division, USEPA, Region VII, 726 Minnesota Avenue, Kansas City, KS 66101, (913) 236-2896.
Asbestos NESHAPs Contact, Air & Waste Management Division, USEPA, Region VIII, 999 18th Street, Suite 500, Denver, CO 80202, (303) 293-1814.
Asbestos NESHAPs Contact, Air Management Division, USEPA, Region IX, 215 Fremont Street, San Francisco, CA 94105, (415) 974-7633.
Asbestos NESHAPs Contact, Air & Toxics Management Division, USEPA, Region X, 1200 Sixth Avenue, Seattle, WA 98101, (206) 442-2724.
Once the transporter is satisfied with the condition of the asbestos waste and agrees to handle it, the containers should be loaded into the transport vehicle in a careful manner to prevent breaking of the containers. Similarly, at the disposal site, the asbestos waste containers should be transferred carefully to avoid fiber release.
Disposal involves the isolation of asbestos waste material in order to prevent fiber release to air or water. Landfilling is recommended as an environmentally sound isolation method because asbestos fibers are virtually immobile in soil. Other disposal techniques such as incineration or chemical treatment are not feasible due to the unique properties of asbestos. EPA has established asbestos disposal requirements for active and inactive disposal sites under NESHAPs (40 CFR Part 61, subpart M) and specifies general requirements for solid waste disposal under RCRA (40 CFR Part 257). Advance EPA notification of the intended disposal site is required by NESHAPs.
• Designate a separate area for asbestos waste disposal. Provide a record for future landowners that asbestos waste has been buried there and that it would be hazardous to attempt to excavate that area. (Future regulations may require property deeds to identify the location of any asbestos wastes and warn against excavation.)
• Prepare a separate trench to receive asbestos wastes. The size of the trench will depend upon the quantity and frequency of asbestos waste delivered to the disposal site. The trenching technique allows application of soil cover without disturbing the asbestos waste containers. The trench should be ramped to allow the transport vehicle to back into it, and the trench should be as narrow as possible to reduce the amount of cover required. If possible, the trench should be aligned perpendicular to prevailing winds.
• Place the asbestos waste containers into the trench carefully to avoid breaking them. Be particularly careful with plastic bags because when they break under pressure asbestos particles can be emitted.
• Completely cover the containerized waste within 24 hours with a minimum of 6 inches of nonasbestos material. Improperly containerized waste is a violation of the NESHAPs and EPA should be notified.
However, if improperly containerized waste is received at the disposal site, it should be covered immediately after unloading. Only after the wastes, including properly containerized wastes, are completely covered, can the wastes be compacted or other heavy equipment run over it. During compacting, avoid exposing wastes to the air or tracking asbestos material away from the trench.
• For final closure of an area containing asbestos waste, cover with at least an additional 30 inches of compacted nonasbestos material to provide a 36-inch final cover. To control erosion of the final cover, it should be properly graded and vegetated. In areas of the United States where excessive soil erosion may occur or the frost line exceeds 3 feet, additional final cover is recommended. In desert areas where vegetation would be difficult to maintain, 3-6 inches of well graded crushed rock is recommended for placement on top of the final cover.
Bulk samples of building materials taken for asbestos identification are first examined for homogeneity and preliminary fiber identification at low magnification. Positive identification of suspect fibers is made by analysis of subsamples with the polarized light microscope.
The principles of optical mineralogy are well established.
Quantitative analysis involves the use of point counting. Point counting is a standard technique in petrography for determining the relative areas occupied by separate minerals in thin sections of rock. Background information on the use of point counting
This method is applicable to all bulk samples of friable insulation materials submitted for identification and quantitation of asbestos components.
The point counting method may be used for analysis of samples containing from 0 to 100 percent asbestos. The upper detection limit is 100 percent. The lower detection limit is less than 1 percent.
Fibrous organic and inorganic constituents of bulk samples may interfere with the identification and quantitation of the asbestos mineral content. Spray-on binder materials may coat fibers and affect color or obscure optical characteristics to the extent of masking fiber identity. Fine particles of other materials may also adhere to fibers to an extent sufficient to cause confusion in identification. Procedures that may be used for the removal of interferences are presented in Section 1.7.2.2.
Adequate data for measuring the accuracy and precision of the method for samples with various matrices are not currently available. Data obtained for samples containing a single asbestos type in a simple matrix are available in the EPA report
A low-power binocular microscope, preferably stereoscopic, is used to examine the bulk insulation sample as received.
Compound microscope requirements: A polarized light microscope complete with polarizer, analyzer, port for wave retardation plate, 360° graduated rotating stage, substage condenser, lamp, and lamp iris.
Sample preparation apparatus requirements will depend upon the type of insulation sample under consideration. Various physical and/or chemical means may be employed for an adequate sample assessment.
Exposure to airborne asbestos fibers is a health hazard. Bulk samples submitted for analysis are usually friable and may release fibers during handling or matrix reduction steps. All sample and slide preparations should be carried out in a ventilated hood or glove box with continuous airflow (negative pressure). Handling of samples without these precautions may result in exposure of the analyst and contamination of samples by airborne fibers.
Samples for analysis of asbestos content shall be taken in the manner prescribed in Reference 5 and information on design of sampling and analysis programs may be found in Reference 6. If there are any questions about the representative nature of the sample, another sample should be requested before proceeding with the analysis.
Bulk samples of building materials taken for the identification and quantitation of asbestos are first examined for homogeneity at low magnification with the aid of a stereomicroscope. The core sample may be examined in its container or carefully removed from the container onto a glassine transfer paper or clean glass plate. If possible, note is made of the top and bottom orientation. When discrete strata are identified, each is treated as a separate material so that fibers are first identified and quantified in that layer only, and then the results for each layer are combined to yield an estimate of asbestos content for the whole sample.
Bulk materials submitted for asbestos analysis involve a wide variety of matrix materials. Representative subsamples may not be readily obtainable by simple means in heterogeneous materials, and various steps may be required to alleviate the difficulties encountered. In most cases, however, the best preparation is made by using forceps to sample at several places from the bulk material. Forcep samples are immersed in a refractive index liquid on a microscope slide, teased apart, covered with a cover glass, and observed with the polarized light microscope.
Alternatively, attempts may be made to homogenize the sample or eliminate interferences before further characterization. The selection of appropriate procedures is dependent upon the samples encountered and personal preference. The following are presented as possible sample preparation steps.
A mortar and pestle can sometimes be used in the size reduction of soft or loosely bound materials though this may cause matting of some samples. Such samples may be reduced in a Wylie mill. Apparatus should be clean and extreme care exercised to avoid cross-contamination of samples. Periodic checks of the particle sizes should be made during the grinding operation so as to preserve any fiber bundles present in an identifiable form. These procedures are not recommended for samples that contain amphibole minerals or
Acid treatment may occasionally be required to eliminate interferences. Calcium carbonate, gypsum, and bassanite (plaster) are frequently present in sprayed or trowelled insulations. These materials may be removed by treatment with warm dilute acetic acid. Warm dilute hydrochloric acid may also be used to remove the above materials. If acid treatment is required, wash the sample at least twice with distilled water, being careful not to lose the particulates during decanting steps. Centrifugation or filtration of the suspension will prevent significant fiber loss. The pore size of the filter should be 0.45 micron or less. Caution: prolonged acid contact with the sample may alter the optical characteristics of chrysotile fibers and should be avoided.
Coatings and binding materials adhering to fiber surfaces may also be removed by treatment with sodium metaphosphate.
In samples with a large portion of cellulosic or other organic fibers, it may be useful to ash part of the sample and view the residue. Ashing should be performed in a low temperature asher. Ashing may also be performed in a muffle furnace at temperatures of 500 °C or lower. Temperatures of 550 °C or higher will cause dehydroxylation of the asbestos minerals, resulting in changes of the refractive index and other key parameters. If a muffle furnace is to be used, the furnace thermostat should be checked and calibrated to ensure that samples will not be heated at temperatures greater than 550 °C.
Ashing and acid treatment of samples should not be used as standard procedures. In order to monitor possible changes in fiber characteristics, the material should be viewed microscopically before and after any sample preparation procedure. Use of these procedures on samples to be used for quantitation requires a correction for percent weight loss.
Positive identification of asbestos requires the determination of the following optical properties.
Asbestos quantitation is performed by a point-counting procedure or an equivalent estimation method. An ocular reticle (cross-hair or point array) is used to visually superimpose a point or points on the microscope field of view. Record the number of points positioned directly above each kind of particle or fiber of interest. Score only points directly over asbestos fibers or nonasbestos matrix material. Do not score empty points for the closest particle. If an asbestos fiber and a matrix particle overlap so that a point is superimposed on their visual intersection, a point is scored for both categories. Point counting provides a determination of the area percent asbestos. Reliable conversion of area percent to percent of dry weight is not currently feasible unless the specific gravities and relative volumes of the materials are known.
For the purpose of this method, “asbestos fibers” are defined as having an aspect ratio greater than 3:1 and being positively identified as one of the minerals in Table 1-1.
A total of 400 points superimposed on either asbestos fibers or nonasbestos matrix material must be counted over at least eight different preparations of representative subsamples. Take eight forcep samples and mount each separately with the appropriate refractive index liquid. The preparation should not be heavily loaded. The sample should be uniformly dispersed to avoid overlapping particles and allow 25-50 percent empty area within the fields of view. Count 50 nonempty points on each preparation, using either
The percent asbestos is calculated as follows:
If a=0, report “No asbestos detected.” If 0< a≤3, report “<1% asbestos”.
The value reported should be rounded to the nearest percent.
1. Paul F. Kerr,
2. E. M. Chamot and C. W. Mason,
3. F. Chayes,
4. E. P. Brantly, Jr., K. W. Gold, L. E. Myers, and D. E. Lentzen,
5. U.S. Environmental Protection Agency,
6. D. Lucas, T. Hartwell, and A. V. Rao,
7. D. H. Taylor and J. S. Bloom, Hexametaphosphate pretreatment of insulation samples for identification of fibrous constituents,
8. W. J. Campbell, R. L. Blake, L. L. Brown, E. E. Cather, and J. J. Sjoberg.
9. Walter C. McCrone,
The principle of X-ray powder diffraction (XRD) analysis is well established.
Unlike optical methods of analysis, however, XRD cannot determine crystal morphology. Therefore, in asbestos analysis, XRD does not distinguish between fibrous and nonfibrous forms of the serpentine and amphibole minerals (Table 2-1). However, when used in conjunction with optical methods such as polarized light microscopy (PLM), XRD techniques can provide a reliable analytical method for the identification and characterization of asbestiform minerals in bulk materials.
For
Accurate
This XRD method is applicable as a confirmatory method for identification and quantitation of asbestos in bulk material samples that have undergone prior analysis by PLM or other optical methods.
The range of the method has not been determined.
The sensitivity of the method has not been determined. It will be variable and dependent upon many factors, including matrix effects (absoprtion and interferences), diagnostic reflections selected, and their relative intensities.
Since the fibrous and nonfibrous forms of the serpentine and amphibole minerals (Table 2-1) are indistinguishable by XRD techniques unless special sample preparation techniques and instrumentation are used,
The use of XRD for identification and quantitation of asbestiform minerals in bulk samples may also be limited by the presence of other interfering materials in the sample. For naturally occurring materials the commonly associated asbestos-related mineral interferences can usually be anticipated. However, for fabricated materials the nature of the interferences may vary greatly (Table 2-3) and present more serious problems in identification and quantitation.
Chrysotile
“Amosite”
Crocidolite
*Rock wool
*Slag wool
*Fiber glass
Gypsum (CaSO
Vermiculite (micas)
*Perlite
Clays (kaolin)
*Wood pulp
*Paper fibers (talc, clay, carbonate fillers)
Calcium silicates (synthetic)
Opaques (chromite, magnetite inclusions in serpentine)
Hematite (inclusions in “amosite”)
Magnesite
*Diatomaceous earth
Bassanite
Carbonate minerals (calcite, dolomite, vaterite)
Talc
Tremolite
Anthophyllite
Serpentine (including chrysotile)
Amosite
Crocidolite
*Mineral wool
*Rock wool
*Slag wool
*Fiber glass
Clays (kaolin)
Micas
Chlorite
Gypsum (CaSO
Quartz
*Organic binders and thickeners
Hyrdomagnesite
Wollastonite
Opaques (chromite, magnetite inclusions in serpentine)
Hematite (inclusions in “amosite”)
*Amorphous materials__contribute only to overall scattered radiation and increased background radiation.
The problem of intraspecies and matrix interferences is further aggravated by the variability of the silicate mineral powder diffraction patterns themselves, which often makes definitive identification of the asbestos minerals by comparison with standard reference diffraction patterns difficult. This variability results from alterations in the crystal lattice associated with differences in isomorphous substitution and degree of crystallinity. This is especially true for the amphiboles. These minerals exhibit a wide variety of very similar chemical compositions, with the result being that their diffraction patterns are chracterized by having major (110) reflections of the monoclinic amphiboles and (210) reflections of the orthorhombic anthophyllite separated by less than 0.2 A
If a copper X-ray source is used, the presence of iron at high concentrations in a sample will result in significant X-ray fluorescence, leading to loss of peak intensity along with increased background intensity and an overall decrease in sensitivity. This situation may be corrected by choosing an X-ray source other than copper; however, this is often accompanied both by loss of intensity and by decreased resolution of closely spaced reflections. Alternatively, use of a diffracted beam monochromator will reduce background fluorescent raditation, enabling weaker diffraction peaks to be detected.
X-ray absorption by the sample matrix will result in overall attenuation of the diffracted beam and may seriously interfere with quantitative analysis. Absorption effects may be minimized by using sufficiently “thin” samples for analysis.
Because the intensity of diffracted X-radiation is particle-size dependent, it is essential for accurate quantitative analysis that both sample and standard reference materials have similar particle size distributions. The optimum particle size range for quantitative analysis of asbestos by XRD has been reported to be 1 to 10 µm.
Preferred orientation of asbestiform minerals during sample preparation often poses a serious problem in quantitative analysis by XRD. A number of techniques have been developed for reducing preferred orientation effects in “thick layer” samples.
The problem of obtaining and characterizing suitable reference materials for asbestos analysis is clearly recognized. NIOSH has
In addition, the problem of ensuring the comparability of standard reference and sample materials, particularly regarding crystallite size, particle size distribution, and degree of crystallinity, has yet to be adequately addressed. For example, Langer et al.
Precision of the method has not been determined.
Accuracy of the method has not been determined.
Sample preparation apparatus requirements will depend upon the sample type under consideration and the kind of XRD analysis to be performed.
Sample analysis requirements include an X-ray diffraction unit, equipped with:
The reference materials listed below are intended to serve as a guide. Every attempt should be made to acquire pure reference materials that are comparable to sample materials being analyzed.
Tape, petroleum jelly, etc. (for attaching silver membrane filters to sample holders).
1 percent aerosol OT aqueous solution or equivalent.
ACS Reagent Grade.
Samples for analysis of asbestos content shall be collected as specified in EPA Guidance Document #C0090,
All samples must be analyzed initially for asbestos content by PLM. XRD should be used as an auxiliary method when a second, independent analysis is requested.
Asbestos is a toxic substance. All handling of dry materials should be performed in an operating fume hood.
The method of sample preparation required for XRD analysis will depend on: (1) The condition of the sample received (sample size, homogeneity, particle size distribution, and overall composition as determined by PLM); and (2) the type of XRD analysis to be performed (qualitative, quantitative, thin layer or bulk).
Bulk materials are usually received as inhomogeneous mixtures of complex composition with very wide particle size distributions. Preparation of a homogeneous, representative sample from asbestos-containing materials is particularly difficult because the fibrous nature of the asbestos minerals inhibits mechanical mixing and stirring, and because milling procedures may cause adverse lattice alterations.
A discussion of specific matrix reduction procedures is given below. Complete methods of sample preparation are detailed in Sections 2.7.2.2 and 2.7.2.3.
All samples should be examined microscopically before and after each matrix reduction step to monitor changes in sample particle size, composition, and crystallinity, and to ensure sample representativeness and homogeneity for analysis.
2.7.2.1.1
For
For accurate, reproducible
Final particle size distributions should always be verified by optical microscopy or another suitable method.
2.7.2.1.2
2.7.2.1.3
2.7.2.2.1
1. Grind and mix the sample with a mortar and pestle (or equivalent method, see Section 2.7.2.1.1.) to a final particle size sufficiently small (∼100 µm) to allow adequate packing into the sample holder.
2. Pack the sample into a standard bulk sample holder. Care should be taken to ensure that a representative portion of the milled sample is selected for analysis. Particular care should be taken to avoid possible size segregation of the sample. (Note: Use of a back-packing method
3. Mount the sample on the diffractometer and scan over the diagnostic peak regions for
4. Submit all samples that exhibit diffraction peaks in the diagnostic regions for asbestiform minerals to a full qualitative XRD scan (5°-60° 2
5. Compare the sample XRD pattern with standard reference powder diffraction patterns (i.e., JCPDS powder diffraction data
2.7.2.2.2
The proposed method for quantitation of asbestos in bulk samples is a modification of the NIOSH-recommended thin-layer method for chrysotile in air.
For quantitative analysis by thin-layer methods, the following procedure is recommended:
1. Mill and size all or a substantial representative portion of the sample as outlined in Section 2.7.2.1.1.
2. Dry at 100 °C for 2 hr; cool in a desiccator.
3. Weigh accurately to the nearest 0.01 mg.
4. Samples shown by PLM to contain large amounts of cellulosic or other organic materials, gypsum, or carbonates, should be submitted to appropriate matrix reduction procedures described in Sections 2.7.2.1.2 and 2.7.2.1.3. After ashing and/or acid treatment, repeat the drying and weighing procedures described above, and determine the percent weight loss; L.
5. Quantitatively transfer an accurately weighed amount (50-100 mg) of the sample to a 1-L volumetric flask with approximately 200 mL isopropanol to which 3 to 4 drops of surfactant have been added.
6. Ultrasonicate for 10 min at a power density of approximately 0.1 W/mL, to disperse the sample material.
7. Dilute to volume with isopropanol.
8. Place flask on a magnetic stirring plate. Stir.
9. Place a silver membrane filter on the filtration apparatus, apply a vacuum, and attach the reservoir. Release the vacuum and add several milliliters of isopropanol to the reservoir. Vigorously hand shake the asbestos suspension and immediately withdraw an aliquot from the center of the suspension so that total sample weight, W
10. Attach the filter to a flat holder with a suitable adhesive and place on the diffractometer. Use of a sample spinner is recommended.
11. For each asbestos mineral to be quantitated select a reflection (or reflections) that has been shown to be free from interferences by prior PLM or qualitative XRD analysis and that can be used unambiguously as an index of the amount of material present in the sample (see Table 2-2).
12. Analyze the selected diagnostic reflection(s) by step scanning in increments of 0.02° 2
13. Determine the net count, I
14. Normalize all raw, net intensities (to correct for instrument instabilities) by referencing them to an external standard (e.g., the 3.34 A
1. Mill and size standard asbestos materials according to the procedure outlined in Section 2.7.2.1.1.
2. Dry at 100 °C for 2 hr; cool in a desiccator.
3. Prepare two suspensions of each standard in isopropanol by weighing approximately 10 and 50 mg of the dry material to the nearest 0.01 mg. Quantitatively transfer each to a 1-L volumetric flask with approximately 200 mL isopropanol to which a few drops of surfactant have been added.
4. Ultrasonicate for 10 min at a power density of approximately 0.1 W/mL, to disperse the asbestos material.
5. Dilute to volume with isopropanol.
6. Place the flask on a magnetic stirring plate. Stir.
7. Prepare, in triplicate, a series of at least five standard filters to cover the desired analytical range, using appropriate aliquots of the 10 and 50 mg/L suspensions and the following procedure.
Mount a silver membrane filter on the filtration apparatus. Place a few milliliters of isopropanol in the reservoir. Vigorously hand shake the asbestos suspension and immediately withdraw an aliquot from the center of the suspension. Do not adjust the volume in the pipet by expelling part of the suspension; if more than the desired aliquot is withdrawn, discard the aliquot and resume the procedure with a clean pipet. Transfer the aliquot to the reservoir. Keep the tip of the pipet near the surface of the isopropanol. Filter rapidly under vacuum. Do not wash the sides of the reservoir. Leave the vacuum on for a time sufficient to dry the filter. Release the vacuum and remove the filter with forceps.
1. Mount each filter on a flat holder. Perform step scans on selected diagnostic reflections of the standards and reference specimen using the procedure outlined in Section 2.7.2.3, step 12, and the same conditions as those used for the samples.
2. Determine the normalized intensity for each peak measured, Î
For each asbestos reference material, calculate the exact weight deposited on each standard filter from the concentrations of the standard suspensions and aliquot volumes. Record the weight, w, of each standard. Prepare a calibration curve by regressing Î2
Determine the slope, m, of the calibration curve in counts/microgram. The intercept, b, of the line with the Î
Using the normalized intensity, Î
Determine the correction factor, f(T), for each sample according to the formula:
Calculate the weight, W
Calculate the percent composition, P
1. H. P. Klug and L. E. Alexander,
2. L. V. Azaroff and M. J. Buerger,
3.
4. W. J. Campbell, C. W. Huggins, and A. G. Wylie,
5. B. A. Lange and J. C. Haartz, Determination of microgram quantities of asbestos by X-ray diffraction: Chrysotile in thin dust layers of matrix material,
6.
7. H. Dunn and J. H. Stewart, Jr., Quantitative determination of chrysotile in building materials,
8. M. Taylor, Methods for the quantitative determination of asbestos and quartz in bulk samples using X-ray diffraction,
9. L. Birks, M. Fatemi, J. V. Gilfrich, and E. T. Johnson,
10. U.S. Environmental Protection Agency,
11. J. B. Krause and W. H. Ashton, Misidentification of asbestos in talc, pp. 339-353, in:
12. H. D. Stanley, The detection and identification of asbestos and asbesti-form minerals in talc, pp. 325-337,
13. A. L. Rickards, Estimation of trace amounts of chrysotile asbestos by X-ray diffraction,
14. P. M. Cook, P. L. Smith, and D. G. Wilson, Amphibole fiber concentration and determination for a series of community air samples: use of X-ray diffraction to supplement electron microscope analysis, in:
15. A. N. Rohl and A. M. Langer, Identification and quantitation of asbestos in talc,
16. J. L. Graf, P. K. Ase, and R. G. Draftz,
17. J. C. Haartz, B. A. Lange, R. G. Draftz, and R. F. Scholl, Selection and characterization of fibrous and nonfibrous amphiboles for analytical methods development, pp. 295-312, in:
18. Personal communication, A. M. Langer, Environmental Sciences Laboratory, Mount
19. A. M. Langer, M. S. Wolff, A. N. Rohl, and I. J. Selikoff, Variation of properties of chrysotile asbestos subjected to milling,
20. A. M. Langer, A. D. Mackler, and F. D. Pooley, Electron microscopical investigation of asbestos fibers,
21. E. Occella and G. Maddalon, X-ray diffraction characteristics of some types of asbestos in relation to different techniques of comminution,
22. K. R. Spurny, W. Stöber, H. Opiela, and G. Weiss, On the problem of milling and ultrasonic treatment of asbestos and glass fibers in biological and analytical applications,
23. L. G. Berry and B. Mason,
24. J. P. Schelz, The detection of chrysotile asbestos at low levels in talc by differential thermal analysis,
25. Reference 1, pp. 372-374.
26. J. Leroux,
27. J. A. Leroux, B. C. Davey, and A. Paillard,
This subpart protects certain State and local government employees who are not protected by the Asbestos Standards of the Occupational Safety and Health Administration (OSHA). This subpart applies the OSHA Asbestos Standards in 29 CFR 1910.1001 and 29 CFR 1926.1101 to these employees.
If you are a State or local government employer and you are not subject to a State asbestos standard that OSHA has approved under section 18 of the Occupational Safety and Health Act or a State asbestos plan that EPA has exempted from the requirements of this subpart under § 763.123, you must follow the requirements of this subpart to protect your employees from occupational exposure to asbestos.
If you are a State or local government employer whose employees perform:
(a) Construction activities identified in 29 CFR 1926.1101(a), you must:
(1) Comply with the OSHA standards in 29 CFR 1926.1101.
(2) Submit notifications required for alternative control methods to the Director, National Program Chemicals Division (7404), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
(b) Custodial activities not associated with the construction activities identified in 29 CFR 1926.1101(a), you must comply with the OSHA standards in 29 CFR 1910.1001.
(c) Repair, cleaning, or replacement of asbestos-containing clutch plates and brake pads, shoes, and linings, or removal of asbestos-containing residue from brake drums or clutch housings, you must comply with the OSHA standards in 29 CFR 1910.1001.
This section describes the process under which a State may be exempted from the requirements of this subpart.
(a)
(1)
(2)
(i) If EPA's preliminary determination is that your State's plan does meet the requirements of TSCA section 18, EPA will initiate a rulemaking, including an opportunity for public comment, to exempt your State from the requirements of this subpart. After considering any comments, EPA will issue a final rule granting or denying the exemption.
(ii) If EPA's preliminary determination is that the State plan does not meet the requirements of TSCA section 18, EPA will notify your State in writing and will give your State a reasonable opportunity to respond to that determination.
(iii) If EPA does not grant your State an exemption, then the State and local government employers in your State are subject to the requirements of this subpart.
(b)
(1)
(2)
(i) If EPA determines that the updated State plan does meet the requirements of TSCA section 18, EPA will issue your State an amended exemption.
(ii) If EPA determines that the updated State plan does not meet the requirements of TSCA section 18, EPA will notify your State in writing and will give your State a reasonable opportunity to respond to that determination.
(iii) If EPA does not grant your State an amended exemption, or if your State does not submit a timely request for amended exemption, then the State and local government employers in your State are subject to the requirements of this subpart.
This subpart prohibits the manufacture, importation, processing, and distribution in commerce of the asbestos-containing products identified and at the dates indicated in §§ 763.165, 763.167, and 763.169. This subpart requires that products subject to this rule's bans, but not yet subject to a ban on distribution in commerce, be labeled. This subpart also includes general exemptions and procedures for requesting exemptions from the provisions of this subpart.
For purposes of this subpart:
(1) The consignee.
(2) The importer of record.
(3) The actual owner if an actual owner's declaration and superseding bond has been filed in accordance with 19 CFR 141.20.
(4) The transferee, if the right to withdraw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR part 144.
(a) After August 27, 1990, no person shall manufacture or import the following asbestos-containing products, either for use in the United States or for export: flooring felt and new uses of asbestos.
(b) After August 26, 1996, no person shall manufacture or import the following asbestos-containing products, either for use in the United States or for export: commercial paper, corrugated paper, rollboard, and specialty paper.
(c) The import prohibitions of this subpart do not prohibit:
(1) The import into the customs territory of the United States of products imported solely for shipment outside the customs territory of the United States, unless further repackaging or processing of the product is performed in the United States; or
(2) Activities involving purchases or acquisitions of small quantities of products made outside the customs territory of the United States for personal use in the United States.
(a) After August 27, 1990, no person shall process for any use, either in the United States or for export, any of the asbestos-containing products listed at § 763.165(a).
(b) After August 26, 1996, no person shall process for any use, either in the United States or for export, any of the asbestos-containing products listed at § 763.165(b).
(a) After August 25, 1992, no person shall distribute in commerce, either for use in the United States or for export, any of the asbestos-containing products listed at § 763.165(a).
(b) After August 25, 1997, no person shall distribute in commerce, either for use in the United States or for export, any of the asbestos-containing products listed at § 763.165(b).
(c) A manufacturer, importer, processor, or any other person who is subject to a ban on distribution in commerce in paragraph (a) or (b) of this section must, within 6 months of the effective date of the ban of a specific asbestos-containing product from distribution in commerce, dispose of all their remaining stock-on-hand of that product, by means that are in compliance with applicable local, State, and Federal restrictions which are current at that time.
(a) After August 27, 1990, manufacturers, importers, and processors of all asbestos-containing products that are identified in § 763.165(a) shall label the products as specified in this subpart at the time of manufacture, import, or processing. This requirement includes labeling all manufacturers', importers', and processors' stock-on-hand as of August 27, 1990.
(b) After August 25, 1995, manufacturers, importers, and processors of all asbestos-containing products that are identified in § 763.165(b), shall label the products as specified in this subpart at the time of manufacture, import, or processing. This requirement includes
(c) The label shall be placed directly on the visible exterior of the wrappings and packaging in which the product is placed for sale, shipment, or storage. If the product has more than one layer of external wrapping or packaging, the label must be attached to the innermost layer adjacent to the product. If the innermost layer of product wrapping or packaging does not have a visible exterior surface larger than 5 square inches, either a tag meeting the requirements of paragraph (d) of this section must be securely attached to the product's innermost layer of product wrapping or packaging, or a label must be attached to the next outer layer of product packaging or wrapping. Any products that are distributed in commerce to someone other than the end user, shipped, or stored without packaging or wrapping must be labeled or tagged directly on a visible exterior surface of the product as described in paragraph (d) of this section.
(d)(1) Labels must be either printed directly on product packaging or in the form of a sticker or tag made of plastic, paper, metal, or other durable substances. Labels must be attached in such a manner that they cannot be removed without defacing or destroying them. Product labels shall appear as in paragraph (d)(2) of this section and consist of block letters and numerals of color that contrasts with the background of the label or tag. Labels shall be sufficiently durable to equal or exceed the life, including storage and disposal, of the product packaging or wrapping. The size of the label or tag must be at least 15.25 cm (6 inches) on each side. If the product packaging is too small to accommodate a label of this size, the label may be reduced in size proportionately to the size of the product packaging or wrapping down to a minimum 2.5 cm (1 inch) on each side if the product wrapping or packaging has a visible exterior surface larger than 5 square inches.
(2) Products subject to this subpart shall be labeled in English as follows:
This product contains
(e) No one may intentionally remove, deface, cover, or otherwise obscure or tamper with a label or sticker that has been applied in compliance with this section, except when the product is used or disposed of.
(a) Persons who are subject to the prohibitions imposed by §§ 763.165, 763.167, or 763.169 may file an application for an exemption. Persons whose exemption applications are approved by the Agency may manufacture, import, process, or distribute in commerce the banned product as specified in the Agency's approval of the application. No applicant for an exemption may continue the banned activity that is the subject of an exemption application after the effective date of the ban unless the Agency has granted the exemption or the applicant receives an extension under paragraph (b)(4) or (5) of this section.
(b) Application filing dates. (1) Applications for products affected by the prohibitions under §§ 763.165(a) and 763.167(a) may be submitted at any time and will be either granted or denied by EPA as soon as is feasible.
(2) Applications for products affected by the ban under § 763.169(a) may be submitted at any time and will be either granted or denied by EPA as soon as is feasible.
(3) Applications for products affected by the ban under §§ 763.165(b) and 763.167(b) may not be submitted prior to February 27, 1995. Complete applications received after that date, but before August 25, 1995, will be either granted or denied by the Agency prior to the effective date of the ban for the product. Applications received after August 25, 1995, will be either granted or denied by EPA as soon as is feasible.
(4) Applications for products affected by the ban under § 763.169(b) may not be submitted prior to February 26, 1996. Complete applications received after that date, but before August 26, 1996, will be either granted or denied by the Agency prior to the effective date of the ban for the product. Applications received after August 26, 1996, will be either granted or denied by EPA as soon as is feasible.
(5) The Agency will consider an application for an exemption from a ban under § 763.169 for a product at the same time the applicant submits an application for an exemption from a ban under § 763.165 or § 763.167 for that product. EPA will grant an exemption at that time from a ban under § 763.169 if the Agency determines it appropriate to do so.
(6) If the Agency denies an application less than 30 days before the effective date of a ban for a product, the applicant can continue the activity for 30 days after receipt of the denial from the Agency.
(7) If the Agency fails to meet the deadlines stated in paragraphs (b)(3) and (b)(4) of this section for granting or denying a complete application in instances in which the deadline is before the effective date of the ban to which the application applies, the applicant will be granted an extension of 1 year from the Agency's deadline date. During this extension period the applicant may continue the activity that is the subject of the exemption application. The Agency will either grant or deny the application during the extension period. The extension period will terminate either on the date the Agency grants the application or 30 days after the applicant receives the Agency's denial of the application. However, no extension will be granted if the Agency is scheduled to grant or deny an application at some date after the effective date of the ban, pursuant to the deadlines stated in paragraphs (b)(3) and (b)(4) of this section.
(c) Where to file. All applications must be submitted to the following location: TSCA Docket Receipts Office (7407), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Rm E-G99, 1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTENTION: Asbestos Exemption. For information regarding the submission of exemptions containing information claimed as confidential business information (CBI), see § 763.179.
(d) Content of application and criteria for decisionmaking.
(1) Content of application. Each application must contain the following:
(i) Name, address, and telephone number of the applicant.
(ii) Description of the manufacturing, import, processing, and/or distribution in commerce activity for which an exemption is requested, including a description of the asbestos-containing product to be manufactured, imported, processed, or distributed in commerce.
(iii) Identification of locations at which the exempted activity would take place.
(iv) Length of time requested for exemption (maximum length of an exemption is 4 years).
(v) Estimated amount of asbestos to be used in the activity that is the subject of the exemption application.
(vi) Data demonstrating the exposure level over the life cycle of the product that is the subject of the application.
(vii) Data concerning:
(A) The extent to which non-asbestos substitutes for the product that is the subject of the application fall significantly short in performance under necessary product standards or requirements, including laws or ordinances mandating product safety standards.
(B) The costs of non-asbestos substitutes relative to the costs of the asbestos-containing product and, in the case in which the product is a component of another product, the effect on the cost of the end use product of using the substitute component.
(C) The extent to which the product or use serves a high-valued use.
(viii) Evidence of demonstrable good faith attempts by the applicant to develop and use a non-asbestos substance or product which may be substituted for the asbestos-containing product or the asbestos in the product or use that is the subject to the application.
(ix) Evidence, in addition to that provided in the other information required with the application, showing that the continued manufacture, importation,
(2) Criteria for decision (existing products). After considering all the information provided by an applicant under paragraphs (d)(1) and (e) of this section, and any other information available to EPA, EPA will grant an exemption from the prohibitions in §§ 763.165, 763.167, or 763.169 for an applicant's asbestos-containing product only if EPA determines both of the following:
(i) The applicant has made good faith attempts to develop and use a non-asbestos substance or product which may be substituted for the asbestos-containing product or the asbestos in the product or use, and those attempts have failed to produce a substitute or a substitute that results in a product that can be economically produced.
(ii) Continued manufacturing, processing, distribution in commerce, and use, as applicable, of the product will not present an unreasonable risk of injury to human health.
(3) Criteria for decision (new products). Requests to develop and use an asbestos substance or product will be treated as a petition pursuant to section 21 of TSCA.
(e) The Agency reserves the right to request further information from an exemption applicant if necessary to complete the Agency's evaluation of an application.
(f) Upon receipt of a complete application, the Agency will issue a notice in the
(g) If the application does not include all of the information required in paragraph (d) of this section, the Agency will return it to the applicant as incomplete and any resubmission of the application will be considered a new application for purposes of the availability of any extension period. If the application is substantially inadequate to allow the Agency to make a reasoned judgment on any of the information required in paragraph (d) of this section and the Agency chooses to request additional information from the applicant, the Agency may also determine that an extension period provided for in paragraph (b)(5) of this section is unavailable to the applicant.
(h) When denying an application, the Agency will notify the applicant by registered mail of its decision and rationale. Whenever possible, the Agency will send this letter prior to the appropriate ban. This letter will be considered a final Agency action for purposes of judicial review. A notice announcing the Agency's denial of the application will be published in the
(i) If the Agency proposes to approve an exemption, it will issue a notice in the
(j) The length of an exemption period will be specified by the agency when it approves the exemption. To extend an exemption period beyond the period stipulated by EPA, applicants must submit a new application to the Agency, following the application procedures described in this section. Applications may not be submitted prior to 15 months before the expiration of the exemption period, unless stated otherwise in the notice granting the exemption. Applications received between 15 months and 1 year before the end of the exemption period will be either granted or denied by the Agency before the end of the exemption period. Applications received after the date 1 year prior to the end of the exemption period will be either granted or denied by the Agency as soon as is feasible. Applicants may not continue the activity that is the subject of the renewal application after the date of the end of the exemption period.
(a) Failure to comply with any provision of this subpart is a violation of section 15 of the Act (15 U.S.C. 2614).
(b) Failure or refusal to establish and maintain records, or to permit access
(c) Failure or refusal to permit entry or inspection as required by section 11 of the Act (15 U.S.C. 2610) is a violation of section 15 of the Act (15 U.S.C. 2614).
(d) Violators may be subject to the civil and criminal penalties in section 16 of the Act (15 U.S.C. 2615) for each violation.
(e) The Agency may seek to enjoin the manufacture, import, processing, or distribution in commerce of asbestos-containing products in violation of this subpart, or act to seize any asbestos-containing products manufactured, imported, processed, or distributed in commerce in violation of this subpart, or take any other actions under the authority of section 7 or 17 of the Act (15 U.S.C. 2606 or 2616) that are appropriate.
The Agency will conduct inspections under section 11 of the Act (15 U.S.C. 2610) to ensure compliance with this subpart.
(a)
(2) The inventory shall be in writing and shall include the type of product, the number of product units currently in the stock-on-hand of the person performing the inventory, and the location of the stock.
(3) Results of the inventory for a banned product must be maintained by the person for 3 years after the effective date of the § 763.165 or § 763.167 ban on the product.
(b)
(2) Each person who is subject to the requirements of § 763.171 must, for each product required to be labeled, maintain a copy of the label used in compliance with § 763.171. These records must be maintained for 3 years after the effective date of the ban on distribution in commerce for the product for which the § 763.171 requirements apply.
(a) Applicants for exemptions under § 763.173 may assert a Confidential Business Information (CBI) claim for information in an exemption application or supplement submitted to the Agency under this subpart only if the claim is asserted in accordance with this section, and release of the information would reveal trade secrets or confidential commercial or financial information, as provided in section 14(a) of the Act. Information covered by a CBI claim will be treated in accordance with the procedures set forth in 40 CFR part 2, subpart B. The Agency will place all information not claimed as CBI in the manner described in this section in a public file without further notice to the applicant.
(b) Applicants may assert CBI claims only at the time they submit a completed exemption application and only in the specified manner. If no such claim accompanies the information when it is received by the Agency, the information may be made available to the public without further notice to the applicant. Submitters that claim information as business confidential must do so by writing the word “Confidential” at the top of the page on which the information appears and by underlining, circling, or placing brackets ([ ]) around the information claimed CBI.
(c) Applicants who assert a CBI claim for submitted information must provide the Agency with two copies of their exemption application. The first copy must be complete and contain all
(d) Applicants must substantiate all claims of CBI at the time the applicant asserts the claim, i.e., when the exemption application or supplement is submitted, by responding to the questions in paragraph (e) of this section. Failure to provide substantiation of a claim at the time the applicant submits the application will result in a waiver of the CBI claim, and the information may be disclosed to the public without further notice to the applicant.
(e) Applicants who assert any CBI claims must substantiate all claims by providing detailed responses to the following:
(1) Is this information subject to a patent or patent application in the United States or elsewhere? If so, why is confidentiality necessary?
(2) For what period do you assert a claim of confidentiality? If the claim is to extend until a certain event or point in time, please indicate that event or time period. Explain why such information should remain confidential until such point.
(3) Has the information that you are claiming as confidential been disclosed to persons outside of your company? Will it be disclosed to such persons in the future? If so, what restrictions, if any, apply to use or further disclosure of the information?
(4) Briefly describe measures taken by your company to guard against undesired disclosure of the information you are claiming as confidential to others.
(5) Does the information claimed as confidential appear or is it referred to in advertising or promotional materials for the product or the resulting end product, safety data sheets or other similar materials for the product or the resulting end product, professional or trade publications, or any other media available to the public or to your competitors? If you answered yes, indicate where the information appears.
(6) If the Agency disclosed the information you are claiming as confidential to the public, how difficult would it be for the competitor to enter the market for your product? Consider in your answer such constraints as capital and marketing cost, specialized technical expertise, or unusual processes.
(7) Has the Agency, another Federal agency, or a Federal court made any confidentiality determination regarding this information? If so, provide copies of such determinations.
(8) How would your company's competitive position be harmed if the Agency disclosed this information? Why should such harm be considered substantial? Describe the causal relationship between the disclosure and harm.
(9) In light of section 14(b) of TSCA, if you have claimed information from a health and safety study as confidential, do you assert that disclosure of this information would disclose a process used in the manufacturing or processing of a product or information unrelated to the effects of asbestos on human health and the environment? If your answer is yes, explain.
15 U.S.C. 2603 and 2607.
(a) This part identifies requirements for testing under section 4 of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2603, to ascertain whether certain specified chemical substances may be contaminated with halogenated dibenzodioxins (HDDs)/dibenzofurans (HDFs) as defined in § 766.3, and requirements for reporting under section 8 of TSCA, 15 U.S.C. 2607.
(b) Section 766.35(b) requires manufacturers and processors of chemical substances identified in § 766.25 to submit to EPA:
(1) Any existing test data showing analysis of the chemical substances for concentrations of HDDs/HDFs, applicable protocols, and the results of the analysis for HDDs/HDFs, (2) allegations of significant adverse reactions to HDDs/HDFs, compiled in accordance with part 717 of this chapter, and (3) health and safety studies on the HDDs/HDFs, in accordance with applicable provisions of part 716 of this chapter.
(c) Section 766.35(a) requires manufacturers and, under certain circumstances, processors of chemical substances identified in § 766.25 to submit letters of intent to test and protocols for the analysis of the chemical substances for the presence of HDDs/HDFs. Section 766.20 requires these manufacturers and processors to test their chemical substances for the presence of HDDs/HDFs. Any submissions must be in accordance with the EPA Procedures Governing Testing Consent Agreements and Test Rules contained in part 790 of this chapter and any modifications to such procedures contained in this part.
(d) Section 766.32 specifies conditions under which persons required to test may request an exclusion or waiver from testing.
(e) Deadlines for submission to EPA of protocols, reports, studies, and test results are specified in part 790, subpart C and § 766.35.
(f) Sections 766.10, 766.12, 766.14, 766.16, and 766.18 prescribe analytical methods required; § 766.27 prescribes target levels of quantitation (LOQ) for each congener for which quantitation is required.
(g) If results of existing tests or tests performed under this part indicate the presence of HDDs/HDFs in the identified chemical substance above the LOQ specified in § 766.27, § 766.35(c) requires the following additional reporting on the specified chemicals: production, process, use, exposure and disposal data under section 8(a) of TSCA; health and safety studies under section 8(d) of TSCA; and reports of allegations of significant adverse reactions under section 8(c) of TSCA. In some cases, additional reporting may be required of manufacturers reporting no contamination of the identified chemical substances under § 766.35(c)(2).
(h) Section 766.38 requires manufacturers of chemical substances produced from chemical substances identified as possible precursors to HDD/HDF formation, to report on chemical substances produced from such precursors.
(a)
(2) The duration of this part for any testing requirement for any chemical substance is the period commencing with the effective date of this part to the end of the reimbursement period, as defined in § 766.3, for each chemical substance. All reporting requirements for any chemical substance listed under § 766.25 shall be in effect for the
(b)
(2) The requirement for precursor reporting under § 766.38 shall be in effect until three years after the effective date of this part.
(3) Small manufacturers are exempt from reporting process and reaction condition data on chemical substances made from precursor chemical substances listed under § 766.38.
The definitions in section 3 of TSCA and the definitions of §§ 704.3, 716.3, 717.3, and 790.3 of this chapter also apply to this part.
tetra-, T (4 atoms)
penta-, Pe (5 atoms)
hexa-, Hx (6 atoms)
hepta-, Hp (7 atoms)
Any person who fails or refuses to comply with any aspect of this part is in violation of section 15 of TSCA. Section 15(1) makes it unlawful for any person to fail or refuse to comply with any rule or order issued under section 4. Section 15(3) makes it unlawful for any person to fail or refuse to submit information required under this part. Section 16 provides that a violation of section 15 renders a person liable to the United States for a civil penalty and possible criminal prosecution. Under section 17 of TSCA, the district courts of the United States have jurisdiction to restrain any violation of section 15.
All information (including letters of intent, protocols, data, forms, studies, and allegations) submitted to EPA under this part must bear the applicable Code of Federal Regulations (CFR) section number (e.g., § 766.20) and must be addressed to: Document Control Office, (7407), Information Management Division, Office of Polution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTN: Dioxin/Furan Report.
Testing required under subpart B of this part must be performed using the protocols submitted to and reviewed by the EPA expert panel established under § 766.28. All new data, documentation, records, protocols, specimens, and reports generated as a result of testing under subpart B of this part must be fully developed and retained in accordance with part 792 of this chapter. These items must be made available during an inspection or submitted to EPA upon request by EPA or its authorized representative. Laboratories conducting testing for submission to EPA in response to a test rule promulgated under section 4 of TSCA must adhere to the TSCA Good Laboratory Practices (GLPs) published in part 792 of this chapter. Sponsors must notify the laboratory that the testing is being conducted pursuant to TSCA section 4. Sponsors are also responsible for ensuring that laboratories conducting the testing abide by the TSCA GLP standards. At the time test data are submitted, manufacturers must submit a certification to EPA that the laboratory performing the testing adhered to the TSCA GLPs.
Analytical test methods must be developed using methods equivalent to those described or reviewed in
Protocols should include all parts of the
Because of the matrix differences of the chemicals listed for testing, no one method for sample selection, preparation, extraction and clean up is prescribed. For analysis, High Resolution Gas Chromatography (HRGC) with High Resolution Mass Spectrometry (HRMS) is the method of choice, but other methods may be used if they can be demonstrated to reach the target LOQs as well as HRGC/HRMS.
(a)
(b)
(c)
(d)
The target level of quantitation required under § 766.27 for each HDD/HDF congener is the level which must be attempted for each resolved HRGC peak for that congener. For at least one product sample, at least two analyses of the same isotopically labeled HDD/HDF internal calibration standards spiked to a final product concentration equal to the LOQ for that congener must be reproducibly extracted, cleaned up, and quantified to within ±20 percent of each other. For each spiked product sample, the signal to noise ratio for the calibration standard peaks after complete extraction and cleanup must be 10:1 or greater. The recovery of the internal calibration standards in the extracted and cleaned up product samples must be within 50 to 150 percent of the amount spiked, and the results must be corrected for recovery.
(a) Any person who manufactures, imports, or processes a chemical substance listed in § 766.25 must test that chemical substance and must submit appropriate information to EPA according to the schedules described in § 766.35. Chemical substances manufactured, imported or processed between January 1, 1984 and the date of promulgation of this part are subject to testing upon the effective date of this part. All other chemical substances are subject to testing immediately upon manufacture, import or processing. EPA expects that only manufacturers and importers will perform testing, and that the cost of testing will be passed on to processors through the pricing mechanism, thereby enabling them to share in the cost of testing. However, processors will be called upon to sponsor testing should manufacturers and importers fail to do so. A processor may apply for an exemption from testing upon certification to EPA that a manufacturer or importer is testing the chemical substance which that person processes.
(b) If no manufacturer or importer described in § 766.20 submits a letter of intent to perform testing within the period described under § 766.35(a), or an exemption application under § 790.45(a), or a request for an exclusion or waiver under § 766.32, EPA will issue a notice in the
(c) If no manufacturer, importer or processor submits a letter of intent to perform testing of a specific chemical substance produced by a specific process, EPA will notify all manufacturers, importers, and processors, either by notice in the
(d) Manufacturers, importers, and processors who are subject to this part must comply with the test rule development and exemption procedures in part 790 of this chapter, except as modified in this part.
(a)
For purposes of guidance only, EPA lists the chemical substances subject to testing under this part in two classes—those known to be manufactured or imported between January 1, 1984, and promulgation of this part, and those not known to be manufactured or imported at the time of promulgation of this part.
(1)
(2)
(b)
Quantitation at the target LOQ shown for each of the following HDDs/HDFs which may be present in the chemical substances is required for the chemical substances listed under § 766.25. Analysis must take place for either chlorinated or brominated dibenzodioxins or dibenzofurans, whichever is predominantly expected to occur in the chemical substance to be tested. Only chlorinated and brominated congeners need be quantified; for chemical substances containing predominantly chlorine atoms, only congeners totally chlorinated at the numbered positions need be quantified; for chemical substances containing predominantly bromine atoms, only congeners totally brominated at the numbered positions need be quantified.
EPA will gather a panel of experts in analysis of chemical matrices for HDDs/HDFs to review the protocols for testing submitted to EPA. The panel members will be employees of EPA and/or of other U.S. Government agencies who have had experience in analysis of chemical matrices and/or chemical wastes for HDDs/HDFs. The panel will recommend to the Director, EPA Office of Pollution Prevention and Toxics, whether the protocol submitted is likely to allow analysis down to the target LOQs, or if not, whether the protocol represents a good faith effort on the part of the tester to achieve the lowest possible LOQs. The final determination to accept or reject the protocol will be made by the Director, Office of Pollution Prevention and Toxics. EPA will review the submitted protocols as rapidly as possible and will complete the review within 90 days after receipt. EPA may require submission of revised protocols. Comments and recommendations will be transmitted to the submitter, and if revisions are required, a final protocol must be submitted to EPA within 90 days after EPA transmits such recommendations.
(a)
(1)
(ii) Process and reaction conditions of the chemical substance such that no HDDs/HDFs could be produced under those conditions;
(2)
(ii) In the judgement of EPA, the cost of testing would drive the chemical substance off the market, or prevent
(iii) Waivers may be appropriately conditioned with respect to such factors as time and conditions of manufacture or use. The grade of decabromodiphenyl oxide produced by Dow Chemical Company (Dow) for the National Toxicology Program (NTP) bioassay on that chemical is excluded from the testing requirement under this part. Provided, however, that this exclusion will not apply if Dow fails to supply to EPA within 60 days of the effective date of this section evidence showing which grade was used for the NTP bioassay.
(b)
(c)
(d)
(a)
(ii) Persons who commence manufacture, import or processing of a chemical substance listed under § 766.25 that has not been manufactured, imported or processed between January 1, 1984 and the effective date of this part must submit under § 790.45 of this chapter, within 60 days after the commencement of manufacture, import, or processing of the chemical substance, a letter of intent to test or an exemption application.
(iii) Persons who commence manufacture, import or processing of a chemical substance listed under § 766.25 between the effective date of this part and the end of the reimbursement period for that particular chemical substance produced by a specific process must submit under § 790.45 of this chapter, within 60 days after the commencement of manufacture, import or processing of the chemical substance, a letter of intent to test or an exemption application.
(2)
(A) The protocols for each chlorinated chemical substance produced by each process to be tested must be submitted to EPA no later than 12 months after the effective date of this part.
(B) The protocol for each brominated chemical substance produced by each process to be tested must be submitted to EPA no later than 24 months after the effective date of this part except for the following chemicals.
(
(
(
(
(ii) For chemical substances produced by a specific process not manufactured or processed as of the effective date of this part, a person who begins manufacture and submits a notice of intent to test must submit protocols for the test as follows:
(A) Except as noted for the submitter and substance specified in the following table, protocols for testing must be submitted 12 months after manufacture or importation begins for chlorinated chemical substances.
(B) Protocols for testing must be submitted 24 months after manufacture begins for brominated chemical substances.
(iii) For persons who have been granted exemptions, waivers or exclusions from testing, protocols must be submitted 12 months after expiration of the exemption, waiver or exclusion for chlorinated chemical substances, and 24 months after expiration of the exemption, waiver or exclusion for brominated chemical substances.
(b)
(2) Any manufacturer or importer of a chemical substance listed in § 766.25 in possession of unpublished health and safety studies on HDDs/HDFs is required to submit copies of such studies to EPA no later than October 5, 1987 or 90 days after the person first manufactures or imports the chemical substance, whichever is later. The following provisions of part 716 of this chapter apply to submission of these studies: §§ 716.3, 716.10(a) (1) and (4); 716.20(a) (1), (2), (3), (4), (7), (8) and (10); 716.25; 716.30; 716.35(a) (1), (2), and (4) [if applicable]; 716.35 (b) and (c); 716.40 (a) and (b); 716.50; 716.55; and 716.60(a)(2).
(3) No later than October 5, 1987 or 90 days after the person first manufactures or imports the substance listed in § 766.25, any manufacturer or importer of a chemical substance listed in § 766.25 must submit records required to be held under part 717 of this chapter on any HDDs/HDFs.
(4)
(ii) For purposes of reporting test results to EPA, and for further reporting triggered by a positive test result under § 766.35(c), a positive test result is defined at § 766.3.
(iii) Reporting of test results must follow procedures set out in part 790 of this chapter, except as modified in this part.
(c)
(i) A completed form (EPA 7710-51) for that chemical substance. The form and instructions are available from the Environmental Assistance Division (7408), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. One form must be submitted for each chemical substance for which a positive test result has been submitted.
(ii) Health and safety studies for the chemical substance for which a positive test result has been reported. The following provisions of part 716 of this chapter apply to submission of these studies: §§ 716.3; 716.10 (a) (1), (2), (3) and (4); 716.20; 716.25; 716.30; 716.35(a) (1), (2), and (4), [if applicable]; 716.35 (b) and (c); 716.40 (a) and (b); 716.50; 716.55; 716.60(a)(2).
(iii) Copies of records on the chemical substances required to be held under part 717 of this chapter.
(2) If a positive test result on a chemical substance is received from one person but not from others, EPA may issue a notice in the
(d)-(e) [Reserved]
(f)
(2) The effective date for paragraph (a)(2)(i)(B) introductory text, (a)(2)(i)(B)(
(3) The guidelines and other test methods cited in this rule are referenced as they exist on the effective date of the final rule.
(a)
(b)
(c)
A list of CFR titles, subtitles, chapters, subchapters and parts and an alphabetical list of agencies publishing in the CFR are included in the CFR Index and Finding Aids volume to the Code of Federal Regulations which is published separately and revised annually.
Material Approved for Incorporation by Reference
Table of CFR Titles and Chapters
Alphabetical List of Agencies Appearing in the CFR
List of CFR Sections Affected
The Director of the Federal Register has approved under 5 U.S.C. 552(a) and 1 CFR Part 51 the incorporation by reference of the following publications. This list contains only those incorporations by reference effective as of the revision date of this volume. Incorporations by reference found within a regulation are effective upon the effective date of that regulation. For more information on incorporation by reference, see the preliminary pages of this volume.
All changes in this volume of the Code of Federal Regulations that were made by documents published in the
Title 40 was established at 36 FR 12213, June 29, 1971. For the period before January 1, 2001, see the “List of CFR Sections Affected, 1964-1972, 1973-1985, and 1986-2000” published in ten separate volumes.