# 73 FR 43314: Testing of Certain High Production Volume Chemicals; Second Group of Chemicals

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/FR_PRORULE_E8-16992

## Section

- **Citation:** 73 FR 43314
- **Heading:** Testing of Certain High Production Volume Chemicals; Second Group of Chemicals
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Federal Register / Vol. 73 / 73 FR 43314

## Text

ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 799 [EPA-HQ-OPPT-2007-0531; FRL-8373-9] RIN 2070-AD16 Testing of Certain High Production Volume Chemicals; Second Group of Chemicals AGENCY:
Environmental Protection Agency (EPA).

ACTION:
Proposed rule.

SUMMARY:
EPA is proposing a test rule under section 4(a)(1)(B) of the Toxic Substances Control Act (TSCA) to require manufacturers, importers, and processors of certain high production volume (HPV) chemical substances to conduct testing to obtain screening level data for health and environmental effects and chemical fate. EPA has preliminarily determined that: Each of the 19 chemical substances included in this proposed rule is produced in substantial quantities and that there is or may be substantial human exposure to each of them; there are insufficient data to reasonably determine or predict the effects on health or the environment of the manufacture, distribution in commerce, processing, use, or disposal of the chemicals, or of any combination of these activities; and the testing program proposed here is necessary to develop such data. Data developed under this proposed rule will provide critical information about the environmental fate and potential hazards associated with these chemicals which, when combined with information about exposure and uses, will allow the Agency and others to evaluate potential health and environmental risks and to take appropriate follow-up action. Persons who export or intend to export any chemical substance included in the final rule would be subject to the export notification requirements in TSCA section 12(b)(1) and at 40 CFR part 707, subpart D. EPA has also taken steps, as described in this document, to consider animal welfare and to provide instructions on ways to reduce or in some cases eliminate animal testing, while at the same time ensuring that the public health is protected.

DATES:
Comments must be received on or before October 22, 2008
ort notification requirements in TSCA section 12(b)(1) and at 40 CFR part 707, subpart D. EPA has also taken steps, as described in this document, to consider animal welfare and to provide instructions on ways to reduce or in some cases eliminate animal testing, while at the same time ensuring that the public health is protected.

DATES:
Comments must be received on or before October 22, 2008.
Written requests to present oral comments must be received on or before October 22, 2008.

ADDRESSES:
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2007-0531, by one of the following methods:
• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line instructions for submitting comments.
• Mail : Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Hand Delivery : OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA-HQ-OPPT-2007-0531. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564-8930. Such deliveries are only accepted during the DCO’s normal hours of operation, and special arrangements should be made for deliveries of boxed information.
Instructions : Direct your comments to docket ID number EPA-HQ-OPPT-2007-0531. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail
ocket without change and may be made available on-line at http://www.regulations.gov , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA’s public docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm .
Docket : All documents in the docket are listed in the docket index available at http://www.regulations.gov . Follow the on-line instructions to view the docket index or access available documents. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at http://www.regulations.gov , or, if only available in hard copy, at the OPPT Docket
information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at http://www.regulations.gov , or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT:
For general information contact : Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov .
For technical information contact : Paul Campanella or John Schaeffer, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone numbers: (202) 564-8091 or (202) 564-8173; e-mail addresses : campanella.paul@epa.gov or schaeffer.john@epa.gov .

SUPPLEMENTARY INFORMATION:
I. General Information
A
on contact : Paul Campanella or John Schaeffer, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone numbers: (202) 564-8091 or (202) 564-8173; e-mail addresses : campanella.paul@epa.gov or schaeffer.john@epa.gov .

SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture (defined by statute to include import) or process any of the chemical substances that are listed in § 799.5087(j) of the proposed regulatory text. Any use of the term “manufacture” in this document will encompass “import,” unless otherwise stated. In addition, as described in Unit
• Manufacturers (defined by statute to include importers) of one or more of the 19 subject chemical substances (NAIC codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.
• Processors of one or more of the 19 subject chemical substances (NAIC codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in Unit IV.E. and consult § 799.5087(b) of the proposed regulatory text. If you have any questions regarding the applicability of this action to a particular entity, consult either of the technical persons listed under FOR FURTHER INFORMATION CONTACT .
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI
ction, you should carefully examine the applicability provisions in Unit IV.E. and consult § 799.5087(b) of the proposed regulatory text. If you have any questions regarding the applicability of this action to a particular entity, consult either of the technical persons listed under FOR FURTHER INFORMATION CONTACT .
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI . Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments . When submitting comments, remember to:
i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii
st alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
C. Can I Request an Opportunity to Present Oral Comments to the Agency?
You may submit a request for an opportunity to present oral comments. This request must be made in writing. If such a request is received on or before October 22, 2008, EPA will hold a public meeting on this proposed rule in Washington, DC. This written request must be submitted to the mailing or hand delivery addresses provided under ADDRESSES . If such a request is received, EPA will announce the scheduling of the public meeting in a subsequent document in the Federal Register . If a public meeting is announced, and if you are interested in attending or presenting oral and/or written comments at the public meeting, you should follow the instructions provided in the subsequent Federal Register document announcing the public meeting.
II. Background
A. What Action is the Agency Taking?
EPA is proposing to issue a test rule under TSCA section 4(a)(1)(B) (15 U.S.C. 2603(a)(1)(B)) that would require manufacturers and processors of 19 chemical substances to conduct testing for environmental fate (including five tests for physical/chemical properties and biodegradation), ecotoxicity (in fish, Daphnia, and algae), acute toxicity, genetic toxicity (gene mutations and chromosomal aberrations), repeat dose toxicity, and developmental and reproductive toxicity
.S.C. 2603(a)(1)(B)) that would require manufacturers and processors of 19 chemical substances to conduct testing for environmental fate (including five tests for physical/chemical properties and biodegradation), ecotoxicity (in fish, Daphnia, and algae), acute toxicity, genetic toxicity (gene mutations and chromosomal aberrations), repeat dose toxicity, and developmental and reproductive toxicity. The chemicals are HPV chemicals, i.e., chemicals with a production/import volume equal to or greater than 1 million pounds (lbs.) per year. A detailed discussion regarding efforts to enhance the availability of screening level hazard and environmental fate information about HPV chemicals can be found in a Federal Register notice which published on December 26, 2000 (Ref. 1).
The tests are screening level tests which are part of the Screening Information Data Set (SIDS) (see Unit II.D.). Some or all of these tests are being proposed as required tests for a particular chemical substance, depending upon what data are already available for that substance.
This action also follows an earlier testing action for certain HPV chemicals (see “Testing of Certain High Production Volume Chemicals; Proposed Rule” (Ref. 2) and “Testing of Certain High Production Volume Chemicals; Final Rule” (Ref. 3).
At a future date, EPA plans to propose testing for additional HPV chemicals as the Agency learns more about the chemicals with respect to human exposure, release, and sufficiency of data and experience available on the potential hazards.
B. What is the Agency's Authority for Taking this Action?
EPA is proposing this test rule under section 4(a)(1)(B) of TSCA (15 U.S.C. 2603(a)(1)(B)).
Section 2(b)(1) of TSCA (15 U.S.C
to propose testing for additional HPV chemicals as the Agency learns more about the chemicals with respect to human exposure, release, and sufficiency of data and experience available on the potential hazards.
B. What is the Agency's Authority for Taking this Action?
EPA is proposing this test rule under section 4(a)(1)(B) of TSCA (15 U.S.C. 2603(a)(1)(B)).
Section 2(b)(1) of TSCA (15 U.S.C. 2601(b)(1)) states that it is the policy of the United States that “adequate data should be developed with respect to the effect of chemical substances and mixtures on health and the environment and that the development of such data should be the responsibility of those who manufacture [which is defined by statute to include import] and those who process such chemical substances and mixtures[.]” To implement this policy, TSCA section 4(a)(1) mandates that EPA require by rule that manufacturers and/or processors of chemical substances and mixtures conduct testing if the Administrator finds that:
(1)(A)(i) the manufacture, distribution in commerce, processing, use, or disposal of a chemical substance or mixture, or that any combination of such activities, may present an unreasonable risk of injury to health or the environment,
(ii) there are insufficient data and experience upon which the effects of such manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any combination of such activities on health or the environment can reasonably be determined or predicted, and
(iii) testing of such substance or mixture with respect to such effects is necessary to develop such data; or
(B)(i) a chemical substance or mixture is or will be produced in substantial quantities, and (I) it enters or may reasonably be anticipated to enter the environment in substantial quantities or (II) there is or may be significant or substantial human exposure to such substance or mixture,
ii) testing of such substance or mixture with respect to such effects is necessary to develop such data; or
(B)(i) a chemical substance or mixture is or will be produced in substantial quantities, and (I) it enters or may reasonably be anticipated to enter the environment in substantial quantities or (II) there is or may be significant or substantial human exposure to such substance or mixture,
(ii) there are insufficient data and experience upon which the effects of the manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any combination of such activities on health or the environment can reasonably be determined or predicted, and
(iii) testing of such substance or mixture with respect to such effects is necessary to develop such data [.]
If EPA makes these findings for a chemical substance or mixture, the Administrator shall require by rule that testing be conducted on that chemical substance or mixture to develop data about health or environmental effects for which there is an insufficiency of data and experience, and which are relevant to a determination that the manufacture, distribution in commerce, processing, use, or disposal of the chemical substance or mixture, or any combination of such activities, does or does not present an unreasonable risk of injury to health or the environment. TSCA section 4(a)(1).
Once the Administrator has made a finding under TSCA section 4(a)(1)(A) or 4(a)(1)(B), EPA may require any type of health or environmental effects testing necessary to address unanswered questions about the effects of the chemical substance or mixture that are relevant to whether the manufacture, distribution in commerce, processing, use, or disposal of the chemical substance or mixture, or any combination of such activities, presents an unreasonable risk of injury to health or the environment. EPA need not limit the scope of testing required to the factual basis for the TSCA section 4(a)(1)(A)(i) or (B)(i) findings
hemical substance or mixture that are relevant to whether the manufacture, distribution in commerce, processing, use, or disposal of the chemical substance or mixture, or any combination of such activities, presents an unreasonable risk of injury to health or the environment. EPA need not limit the scope of testing required to the factual basis for the TSCA section 4(a)(1)(A)(i) or (B)(i) findings. This approach is explained in more detail in EPA’s TSCA section 4(a)(1)(B) Final Statement of Policy (“B” policy) (Ref. 4, pp. 28738-28739).
In this proposed rule, EPA would use its broad TSCA section 4(a) authority to obtain data necessary to support the development of preliminary or “screening level” hazard and risk characterizations for certain HPV chemical substances specified in Table 2 in § 799.5087(j) of the proposed regulatory text. EPA has made preliminary findings for these chemical substances under TSCA section 4(a)(1)(B) that: They are produced in substantial quantities; there is or may be substantial human exposure to them; existing data are insufficient to determine or predict their health and environmental effects; and testing is necessary to develop such data.
C. Why is EPA Taking this Action?
On April 21, 1998, EPA initiated a national effort to empower citizens by providing them with knowledge about the most widespread chemicals in commerce. A major objective of this effort is to make certain basic information about the environmental fate and potential health and environmental hazards associated with HPV chemicals available to the public. Mechanisms to collect or, where necessary, develop needed data on U.S. HPV chemicals include the voluntary HPV Challenge Program, certain international efforts, and TSCA section 4 rules.
1. Voluntary HPV Challenge Program . The voluntary HPV Challenge Program, officially launched in late 1998, was created to ensure that a baseline set of data on approximately 2,800 HPV chemicals would be made available to EPA and the public
re necessary, develop needed data on U.S. HPV chemicals include the voluntary HPV Challenge Program, certain international efforts, and TSCA section 4 rules.
1. Voluntary HPV Challenge Program . The voluntary HPV Challenge Program, officially launched in late 1998, was created to ensure that a baseline set of data on approximately 2,800 HPV chemicals would be made available to EPA and the public. HPV chemicals are manufactured or imported in amounts equal to or greater than 1 million lbs. per year and were identified for this program through data reported under the TSCA Inventory Update Rule (IUR) during 1990.
The data set sought by the voluntary HPV Challenge Program is known as the Screening Information Data Set (SIDS) that was developed by the Organization for Economic Cooperation and Development (OECD), of which the United States is a member. SIDS provides an internationally agreed upon set of test data for screening high production volume chemicals for human and environmental hazards, and will assist the Agency and others to make an informed, preliminary judgment about the hazards of HPV chemicals.
Since the Program’s inception in 1998, industry chemical manufacturers and importers have participated in the Challenge by sponsoring 2,250 chemicals. More than 350 companies and 100 consortia have sponsored chemicals directly in the Program while additional companies/consortia have sponsored chemicals indirectly in an international counterpart to the voluntary HPV Challenge Program, the International Council of Chemical Associations (ICCA) HPV Initiative. HPV chemicals that are not sponsored in the Program may be subject to a test rule under TSCA section 4 where, among other things, these chemicals lack needed testing. The voluntary HPV Challenge Program is further described in a Federal Register document which published on December 26, 2000 (Ref. 1) and on the voluntary HPV Challenge Program website ( http://www.epa.gov/chemrtk )
) HPV Initiative. HPV chemicals that are not sponsored in the Program may be subject to a test rule under TSCA section 4 where, among other things, these chemicals lack needed testing. The voluntary HPV Challenge Program is further described in a Federal Register document which published on December 26, 2000 (Ref. 1) and on the voluntary HPV Challenge Program website ( http://www.epa.gov/chemrtk ).
Under the voluntary HPV Challenge Program, alternatives to the testing proposed under this proposed rule were available. For example, under the OECD HPV SIDS Program, some instances have been identified where, using chemical category approaches, less than a full set of SIDS tests for every chemical in the category has been judged sufficient for screening purposes. In addition, the OECD HPV SIDS Program allows some use of structure activity relationship (SAR) analysis for individual chemicals. These strategies have the potential to reduce the time required to complete the program, the number of tests actually conducted, and the number of test animals needed.
EPA advocated the use of categories or SAR approaches in the voluntary HPV Challenge Program and provided support for their use by developing guidance documents to assist industry and others in constructing scientifically defensible categories (Ref. 45) and SAR (Ref. 48). While EPA encouraged the use of scientifically appropriate categories of related chemicals and SAR under the voluntary HPV Challenge Program, these approaches are not included in this proposed rule. EPA has not identified any chemicals in this proposal for which category and SAR approaches would be appropriate. In addition, EPA believes that the incorporation of such elements in a test rule would require complex, time consuming, and intensive procedural steps, such as multi-phase rulemaking, without a corresponding benefit.
In the proposed test rule (Ref. 2) for the final HPV SIDS test rule (Ref
as not identified any chemicals in this proposal for which category and SAR approaches would be appropriate. In addition, EPA believes that the incorporation of such elements in a test rule would require complex, time consuming, and intensive procedural steps, such as multi-phase rulemaking, without a corresponding benefit.
In the proposed test rule (Ref. 2) for the final HPV SIDS test rule (Ref. 3), EPA specifically solicited comments and suggestions on procedures that would allow inclusion of such approaches in TSCA section 4 HPV SIDS rulemaking. The procedures suggested by commenters on that proposed rule would have required complex, time consuming, and resource-intensive procedural steps, such as multi-phase rulemaking. As a result, EPA did not incorporate these suggestions into the final rule. In addition, EPA did not identify, nor did the commenters bring to EPA’s attention, any possibilities that would have allowed inclusion of a category or SAR approach within the final test rule for any specific chemicals included in the final test rule (Ref. 19).
Although the Agency believes that none of the chemicals included in this proposed rule appear to be candidates for category or SAR approaches, persons who believe that a chemical under this
2. Certain international efforts . The voluntary HPV Challenge Program is designed to make maximum use of scientifically adequate existing test data and to avoid unnecessary and duplicative testing of U.S. HPV chemicals. Therefore, EPA is continuing to participate in the voluntary international efforts, complementary to the voluntary HPV Challenge Program, that are being coordinated by the OECD to secure basic hazard information on HPV chemicals in use worldwide, including some of those on the U.S. (1990) HPV chemicals list (Ref. 5). This includes agreements to sponsor a U.S. HPV chemical under either the OECD HPV SIDS Program (Ref
continuing to participate in the voluntary international efforts, complementary to the voluntary HPV Challenge Program, that are being coordinated by the OECD to secure basic hazard information on HPV chemicals in use worldwide, including some of those on the U.S. (1990) HPV chemicals list (Ref. 5). This includes agreements to sponsor a U.S. HPV chemical under either the OECD HPV SIDS Program (Ref. 6), including sponsorship by OECD member countries beyond the United States, or the international HPV Initiative that is being organized by the ICCA (Ref. 7).
The OECD HPV SIDS Program seeks the development of test data, if such data are not already available, related to 6 health and environmental effects endpoints for international HPV chemicals (see Unit II.D.). The SIDS data set has been internationally agreed upon by the 29 member countries of the OECD as providing the minimum data set required to make an informed preliminary judgment about the hazards of a given HPV chemical.
The ICCA consists of representatives of chemical industry trade associations from the United States, Europe, Japan, Australia, Canada, Mexico, Brazil, New Zealand, and Argentina. The intended goal of the ICCA HPV Initiative was to complete screening-level hazard assessments on 1,000 “high priority” chemicals. Most of the chemicals on the ICCA working list (Ref. 7) are also U.S. HPV chemicals. The ICCA testing/assessment work is tied directly to that under the OECD HPV SIDS Program.
Any U.S. HPV chemicals that are handled under the OECD HPV SIDS Program or the ICCA HPV Initiative are considered by EPA to be “sponsored” and are not anticipated to be addressed in the voluntary HPV Challenge Program unless the international commitments are not met. Nor does EPA intend to evaluate these chemicals for possible TSCA section 4 HPV SIDS rulemaking unless the international commitments are not met
chemicals that are handled under the OECD HPV SIDS Program or the ICCA HPV Initiative are considered by EPA to be “sponsored” and are not anticipated to be addressed in the voluntary HPV Challenge Program unless the international commitments are not met. Nor does EPA intend to evaluate these chemicals for possible TSCA section 4 HPV SIDS rulemaking unless the international commitments are not met.
The OECD HPV SIDS Program and the ICCA HPV Initiative are further described in the Federal Register document announcing the voluntary HPV Challenge Program (Ref. 1) and on the OECD website (Ref. 6) and ICCA website (Ref. 7).
3. TSCA rulemaking . U.S. data needs which remain unmet in the voluntary HPV Challenge Program or through international efforts may be addressed through TSCA section 4 rulemakings, such as the final test rule promulgated by EPA on March 16, 2006 (Ref. 3). This proposed rule is the second TSCA section 4 HPV SIDS rule, and addresses the unmet data needs of 19 chemicals.
Data collected and/or developed under a final rule based on this proposal and the voluntary HPV Challenge Program, when combined with information about exposure and uses, will allow the Agency and others to better assess the potential risk to health and the environment from these chemicals. EPA intends to make the information collected under the final rule available to the public, other Federal agencies, and any other interested parties on its website ( http://www.epa.gov/chemrtk ) and in the public docket for the final rule. As appropriate, this information will be used to ensure a scientifically sound basis for risk assessment/management actions. This effort will serve to further the Agency’s goal of identifying and controlling human and environmental risks as well as providing greater protection and knowledge to the public
ies on its website ( http://www.epa.gov/chemrtk ) and in the public docket for the final rule. As appropriate, this information will be used to ensure a scientifically sound basis for risk assessment/management actions. This effort will serve to further the Agency’s goal of identifying and controlling human and environmental risks as well as providing greater protection and knowledge to the public. By using the same approach to testing as that of the OECD HPV SIDS Program, EPA is assuring that the data developed under this proposed rulemaking activity and the voluntary HPV Challenge Program will be comparable to the data being developed in other countries, thereby enabling an international sharing of data and the prevention of unnecessary and duplicative testing. See Refs.1 and 2, pp. 81662-81664, for further information about the voluntary HPV Challenge Program and international efforts.
D. Why is this Proposal Focusing on HPV Chemicals and SIDS Testing?
This proposal pertains to HPV chemicals, which are manufactured or imported in amounts equal to or greater than 1 million lbs. per year. Although those chemicals cover only about 11% of the chemical substances on the TSCA Inventory (see TSCA sections 8(a) and 8(b)), using TSCA Inventory information available in 1988 (Ref. 8, p. 32296), that small percentage of the TSCA Inventory accounted for 95% of total chemical production in the United States.
Testing under this proposal pertains to SIDS testing because SIDS is a battery of tests agreed upon by the international community through OECD, of which the United States is a member country, as appropriate for screening HPV chemical substances for toxicity and produces information relevant to understanding the basic health and environmental hazards and fate of HPV chemicals. The content of SIDS was agreed upon at the 13 th Joint Meeting of the OECD Chemicals Group and Management Committee of the Special Programme on the Control of Chemicals (Refs. 9 and 10)
States is a member country, as appropriate for screening HPV chemical substances for toxicity and produces information relevant to understanding the basic health and environmental hazards and fate of HPV chemicals. The content of SIDS was agreed upon at the 13 th Joint Meeting of the OECD Chemicals Group and Management Committee of the Special Programme on the Control of Chemicals (Refs. 9 and 10). The United States believes these are the right tests for basic screening of U.S. HPV chemicals for health and environmental effects and environmental fate.
• SIDS testing evaluates the following six testing endpoints (Ref. 6):
• Acute toxicity.
• Repeat dose toxicity.
• Developmental and reproductive toxicity.
• Genetic toxicity (gene mutations and chromosomal aberrations).
• Ecotoxicity (studies in fish, Daphnia, and algae).
• Environmental fate (including physical/chemical properties (melting point, boiling point, vapor pressure, n -octanol/water partition coefficient, and water solubility), photolysis, hydrolysis, transport/distribution, and biodegradation).
While data on the six SIDS endpoints do not fully characterize a chemical’s toxicity and fate, they provide a consistent minimum set of information that can be used to help assess the relative risks of chemicals and whether additional testing or assessment is necessary. E. How Does EPA's HPV Work Relate to that of OECD?
As noted in Unit II.C.2., the OECD HPV SIDS Program is complementary to the voluntary HPV Challenge Program. However, EPA’s definition of an HPV chemical differs from that of the OECD. EPA defines an HPV chemical as having an annual production or importation volume of 1 million lbs. or more. OECD defines an HPV chemical as having an annual production volume of 2.2 million lbs. (equivalent to 1 million kilograms (kg)) reported in any member country.
The presence of a chemical on the OECD's list of HPV chemicals was and
In response to EPA’s proposed “B” policy (Ref
f the OECD. EPA defines an HPV chemical as having an annual production or importation volume of 1 million lbs. or more. OECD defines an HPV chemical as having an annual production volume of 2.2 million lbs. (equivalent to 1 million kilograms (kg)) reported in any member country.
The presence of a chemical on the OECD's list of HPV chemicals was and
In response to EPA’s proposed “B” policy (Ref. 8), both the American Chemistry Council (ACC), formerly the Chemical Manufacturers Association (CMA) and the Society of the Plastics Industry, Inc., commented that EPA’s proposed annual production-volume threshold of 1 million lbs. is a reasonable interpretation of “substantial production” under TSCA (Refs. 12 and 13). Additionally, they indicated that the OECD's 2.2 million lb. threshold would be preferable to achieve consistency between EPA’s activities under TSCA section 4 and the OECD HPV SIDS Program. Although the United States and OECD differ in their definition of an HPV chemical and what should trigger basic screening tests of an HPV chemical, both the U.S. and OECD HPV SIDS Programs are alike in their information needs for an HPV chemical. Both the U.S. and OECD HPV SIDS Programs have identified the SIDS battery of tests as the basic screening tests needed to provide enough information to support a screening level assessment of the health and environmental effects of a chemical.
F. Why is EPA Pursuing Hazard Information on HPV Chemicals?
In 1998 EPA found that, of those non-polymeric organic substances produced or imported in amounts equal to or greater than 1 million lbs. per year based on 1990 IUR reporting, only 7% had a full set of publicly available and internationally recognized basic screening test data for health and environmental effects (Ref. 14). Of the over 2,800 U.S. HPV chemicals based on 1990 IUR data, 43% had no publicly available basic hazard data. For the remaining chemicals, limited amounts of the data were available
or greater than 1 million lbs. per year based on 1990 IUR reporting, only 7% had a full set of publicly available and internationally recognized basic screening test data for health and environmental effects (Ref. 14). Of the over 2,800 U.S. HPV chemicals based on 1990 IUR data, 43% had no publicly available basic hazard data. For the remaining chemicals, limited amounts of the data were available. This lack of available hazard data compromises EPA’s and others’ ability to determine whether these HPV chemicals pose potential risks to human health or the environment, as well as the public’s ability to know about the hazards of chemicals that may be found in their environment, their homes, their workplaces, and the products they buy.
G. What is the Role of this Proposed Rule and Any Future TSCA Section 4 HPV SIDS Rulemaking with Regard to the Voluntary HPV Challenge Program?
As indicated in the December 26, 2000 Federal Register document describing the voluntary HPV Challenge Program (Ref. 1), EPA intends to use rulemaking under TSCA, where appropriate, to help fill data gaps not addressed as part of the voluntary HPV Challenge Program or international efforts. EPA does not intend at this time to evaluate U.S. HPV chemicals that have been or are being handled through the OECD HPV SIDS Program or under a complementary program being coordinated by the ICCA (Ref. 7) for screening level testing under TSCA section 4 HPV SIDS rulemaking, although the Agency may revisit this question if commitments under those international programs are not met. See Unit III.G. of Ref. 1 for more information on these programs. EPA is evaluating the extent to which additional non-sponsored HPV chemicals meet the threshold criteria for rulemaking under TSCA section 4.
H. How Would the Data Developed Under this Test Rule Be Used?
Hazard data are used in risk assessment and risk management, and ultimately to inform the public and promote the pollution prevention ethic
G. of Ref. 1 for more information on these programs. EPA is evaluating the extent to which additional non-sponsored HPV chemicals meet the threshold criteria for rulemaking under TSCA section 4.
H. How Would the Data Developed Under this Test Rule Be Used?
Hazard data are used in risk assessment and risk management, and ultimately to inform the public and promote the pollution prevention ethic. Activities to ensure the availability of basic hazard information on HPV chemicals support EPA’s objectives.
EPA would use the data obtained from this proposed rule to support development of preliminary hazard and risk assessments for the 19 chemical substances subject to the rule. The data would also be used by EPA to set priorities for further testing that may produce hazard information on these chemical substances that may be needed by EPA, other Federal agencies, the public, industry, and others, to support adequate risk assessments. As appropriate, this information would be used to ensure a scientifically sound basis for risk characterizations and risk management actions. As such, this effort would serve to further the Agency’s goal of identifying and controlling human and environmental risks as well as providing greater knowledge and protection to the public. In the past, EPA has used data from test rules to support such activities as the development of water quality criteria, Toxic Release Inventory (TRI) listings, chemical advisories, and reduction of workplace exposures.
Under the Security and Prosperity Partnership of North America (SPP), a trilateral effort to encourage greater cooperation and information sharing among the United States, Canada, and Mexico ( http://www.spp.gov ), the United States committed in August 2007 to assess and initiate needed action by the end of 2012 on the approximately 6,750 chemicals produced above 25,000 lbs. per year in the United States. ( http://www.spp.gov/pdf/spp_reg_coop_chemicals.pdf )
(SPP), a trilateral effort to encourage greater cooperation and information sharing among the United States, Canada, and Mexico ( http://www.spp.gov ), the United States committed in August 2007 to assess and initiate needed action by the end of 2012 on the approximately 6,750 chemicals produced above 25,000 lbs. per year in the United States. ( http://www.spp.gov/pdf/spp_reg_coop_chemicals.pdf ). To fulfill these SPP commitments, EPA established the Chemical Assessment and Management Program (ChAMP). Under ChAMP, EPA is developing screening-level documents that summarize basic hazard and exposure information on HPV chemicals, identify potential risks, note scientific issues and uncertainties, and indicate the initial priority being assigned by the Agency for potential future appropriate action. These screening-level documents are based primarily on hazard, use, and exposure data available to the Agency through the voluntary HPV Challenge Program and on EPA's examination of chemical use and exposure information collected from the 2006 IUR as well as data from readily available sources of hazard and exposure information. Information on ChAMP and the risk-based prioritization process for HPV chemicals is available on the EPA’s ChAMP website ( http://www.epa.gov/champ ) and on the related risk-based prioritization page ( http://www.epa.gov/hpv/hpvis/aboutrbd.htm ).
The data obtained from a final test rule based on this proposal would furnish the basic hazard information integral to this ChAMP process for the 19 chemical substances subject to the rule.
Finally, because the SIDS data would be comparable to the type of data agreed to as being appropriate and being developed by the OECD HPV SIDS Program, the development of these data would enable an international sharing of data
rom a final test rule based on this proposal would furnish the basic hazard information integral to this ChAMP process for the 19 chemical substances subject to the rule.
Finally, because the SIDS data would be comparable to the type of data agreed to as being appropriate and being developed by the OECD HPV SIDS Program, the development of these data would enable an international sharing of data. As conceived by the OECD, the SIDS battery of tests can be used by governments and others worldwide to conduct an initial assessment of the http://cs3-hq.oecd.org/scripts/hpv ) and EPA’s voluntary HPV Challenge Program website ( http://www.epa.gov/chemrtk ).
Data collected or developed for each sponsored chemical in the voluntary HPV Challenge Program are provided in the format of a “robust” (i.e., detailed) summary. A robust summary contains the technical information necessary to adequately describe an experiment or study and includes the objectives, methods, results, and conclusions of the full study report, which can either be an experiment or in some cases an estimation or prediction method. (See Ref. 15; also at http://www.epa.gov/HPV/pubs/general/robsumgd.htm ). A robust summary provides information that would assist a technically qualified person in making an independent assessment of a given study, and thereby facilitates the evaluation of existing data and the identification of additional data needs. EPA requests that existing data relevant to the testing in this proposed rule be submitted to the Agency in robust summary format. For any data developed under that final rule, EPA will request that a robust summary of the final report for each specific test be submitted in addition to the required final report itself (see § 799.5087(i) of the proposed regulatory text). Persons who respond to this request to submit robust summaries are also encouraged to submit the robust summary electronically via the High Production Volume Information System (HPVIS) to allow for its ready incorporation into HPVIS
st summary of the final report for each specific test be submitted in addition to the required final report itself (see § 799.5087(i) of the proposed regulatory text). Persons who respond to this request to submit robust summaries are also encouraged to submit the robust summary electronically via the High Production Volume Information System (HPVIS) to allow for its ready incorporation into HPVIS. Directions for electronic submission of robust summary information into HPVIS are provided at https://iaspub.epa.gov/oppthpv/metadata.html . This link will direct you to the ‘‘HPVIS Quick Start and User’s Guide.’’
I. How are Animal Welfare Issues Being Considered in the HPV Initiative?
EPA recognizes the concerns that have been expressed about the use of test procedures that require the use of animals. As discussed in Unit II.E. of Ref. 1, EPA is making every effort to ensure that as the HPV Initiative is implemented (including TSCA section 4 HPV SIDS test rules), unnecessary or duplicative testing is avoided and the use of animals is minimized. As a general matter, EPA does not require that tests on animals be conducted if an alternative scientifically validated method is found acceptable and practically available for use. Where testing must be conducted to develop adequate data, the Agency is committed to reducing the number of animals used for testing, to replacing test methods requiring animals with alternative test methods when acceptable alternative methods are available, and to refining existing test methods to optimize animal use when there is no substitute for animal testing. EPA believes that these reduction, replacement, and refinement objectives are all important elements in the overall consideration of alternative testing methods.
The governmental and non-governmental scientific community is working to design, validate, and employ new methods of toxicity testing that are more accurate, less costly, and that reduce the need to use live animals
for animal testing. EPA believes that these reduction, replacement, and refinement objectives are all important elements in the overall consideration of alternative testing methods.
The governmental and non-governmental scientific community is working to design, validate, and employ new methods of toxicity testing that are more accurate, less costly, and that reduce the need to use live animals. Over the years, significant research has been pursued to develop and validate non-animal test methods. U.S. scientists in academia, government, and industry have participated in both domestic and international efforts to develop alternative, non-animal tests. As part of the enterprise, the National Institute of Environmental Health Sciences (NIEHS) established a Federal Interagency Committee, the Interagency Coordinating Committee on Validation of Alternative Methods (ICCVAM), to review the status and validation of toxicological test methods including those that are performed in vitro . EPA scientists have contributed significantly to this body of knowledge and are continuing to play an important role in the development of alternative test methods for consideration.
In addition, as part of the voluntary HPV Challenge Program, EPA asked participants in that program to observe certain testing principles, which are laid out in an October 14, 1999 letter (Ref. 16). In this same letter, the Agency also indicated its intention that related TSCA rulemaking proceed in a manner consistent with these principles. This letter is available in the public docket for this proposed rulemaking, as well as on EPA’s ChemRTK website. In the letter, EPA requested that participants conduct a thoughtful, qualitative analysis of existing data before testing. This proposed rule reflects many of the principles presented in the referenced voluntary HPV Challenge Program letter. Certain components of these principles, however, are not pertinent to this proposed rule
et for this proposed rulemaking, as well as on EPA’s ChemRTK website. In the letter, EPA requested that participants conduct a thoughtful, qualitative analysis of existing data before testing. This proposed rule reflects many of the principles presented in the referenced voluntary HPV Challenge Program letter. Certain components of these principles, however, are not pertinent to this proposed rule. For example, this proposed rule does not require any dermal toxicity testing or any terrestrial toxicity testing.
III. EPA Proposed Findings
A. What is the Basis for EPA’s Proposal to Test These Chemical Substances?
As indicated in Unit II.B., in order to develop a rulemaking under TSCA section 4(a) requiring the testing of chemical substances or mixtures, EPA must, among other things, make certain findings regarding either risk (TSCA section 4(a)(1)(A)(i)) or production combined with either chemical release or human exposure (TSCA section 4(a)(1)(B)(i)), with regard to those chemicals. EPA is proposing to require testing of the chemical substances included in this proposed test rule based on its preliminary findings under TSCA section 4(a)(1)(B)(i) relating to “substantial” production and “substantial human exposure,” as well as findings under TSCA sections 4(a)(1)(B)(ii) and (iii) relating to sufficient data and the need for testing. The chemical substances included in this proposed rule are listed in Table 2 in § 799.5087(j) of the proposed regulatory text along with their Chemical Abstract Service (CAS) registry numbers.
In EPA’s “B” policy (see Unit II.E.), “substantial production” of a chemical substance or mixture is generally considered to be aggregate production (including import) volume equaling or exceeding 1 million lbs. per year of that chemical substance or mixture (Ref. 4, p. 28747)
le 2 in § 799.5087(j) of the proposed regulatory text along with their Chemical Abstract Service (CAS) registry numbers.
In EPA’s “B” policy (see Unit II.E.), “substantial production” of a chemical substance or mixture is generally considered to be aggregate production (including import) volume equaling or exceeding 1 million lbs. per year of that chemical substance or mixture (Ref. 4, p. 28747). The “B” policy also provides guidelines that are generally considered by EPA in evaluating whether there is “substantial human exposure” of workers, consumers, and the general population to a chemical substance or mixture. Refer to EPA’s “B” policy for further discussion on how EPA generally evaluates chemicals or mixtures under TSCA section 4(a)(1)(B)(i). For the reasons set out in the “B” policy, EPA believes that the guidance included in the “B” policy is appropriate for consideration in this proposed rule and EPA sees no reason not to act consistently with the guidelines with respect to the chemicals included in this proposed rule.
EPA has found preliminarily that, under TSCA section 4(a)(1)(B)(i), each of the 19 chemical substances included in this proposed rule is produced in “substantial” quantities (see Unit III.B.) and that there is or may be “substantial human exposure” to each chemical substance (see Units III.C. and III.D.). Also, for one substance, EPA has found
The chemical substances included in this proposed rule are listed in § 799.5087(j) of the proposed regulatory text along with their CAS numbers.
B. Are These Chemical Substances Produced and/or Imported in Substantial Quantities?
EPA has made preliminary findings that each of the chemical substances included in this proposal is produced and/or imported in an amount equal to or greater than 1 million lbs. per year (Ref. 18), based on information gathered pursuant to the 2006 IUR which is the most recently available compilation of TSCA Inventory data
e Chemical Substances Produced and/or Imported in Substantial Quantities?
EPA has made preliminary findings that each of the chemical substances included in this proposal is produced and/or imported in an amount equal to or greater than 1 million lbs. per year (Ref. 18), based on information gathered pursuant to the 2006 IUR which is the most recently available compilation of TSCA Inventory data. EPA believes that these annual production and/or importation volumes are “substantial” as that term is used with reference to production in TSCA section 4(a)(1)(B)(i). (See also Ref. 4, p. 28746). A discussion of EPA’s preliminary “substantial production” finding for each chemical substance included in this proposed rule is contained in a separate document (See Ref. 18).
C. Are a Substantial Number of Workers Exposed to These Chemicals?
EPA has made preliminary findings that the manufacture, processing, and use of the 19 chemical substances (Table 1.-Exposure Based Findings-Substantial Human Exposure, Unit III.D.) included in this action result or may result in exposure of a substantial number of workers to the chemical substances.
This finding is based, in large part, on information submitted in accordance with the 2006 IUR. For chemicals whose total production volume (manufactured and imported) exceeded 300,000 lbs. at a site during calendar year 2005, manufacturers and importers were required to report the number of potentially exposed workers during industrial processing and use to the extent the information was readily obtainable. In addition, the submitters are required to provide information regarding the commercial and consumer uses of the chemical substance.
EPA believes that an exposure of over 1,000 workers to a chemical substance is “substantial” as that term is used with reference to “human exposure” in TSCA section 4(a)(1)(B)(i)
g industrial processing and use to the extent the information was readily obtainable. In addition, the submitters are required to provide information regarding the commercial and consumer uses of the chemical substance.
EPA believes that an exposure of over 1,000 workers to a chemical substance is “substantial” as that term is used with reference to “human exposure” in TSCA section 4(a)(1)(B)(i). EPA believes, based on experience gained through case-by-case analysis of existing chemicals, that an exposure of 1,000 workers or more to a chemical substance is a reasonable interpretation of the phrase “substantial human exposure” in TSCA section 4(a)(1)(B)(i); see Ref. 4). Therefore, EPA’s preliminary finding is that there is or may be substantial human exposure (workers) to these 19 chemical substances.
In addition to the 2006 IUR data, EPA also reviewed National Occupational Exposure Survey (NOES) data developed by the National Institute for Occupational Safety and Health (NIOSH). Based on the NOES data, EPA found that more than 1,000 workers were exposed to each of the 19 chemical substances that are the subject of this proposed rule. The NOES was a nationwide data gathering project conducted by NIOSH, which was designed to develop national estimates for the number of workers potentially exposed to various chemical, physical and biological agents and describe the distribution of these potential exposures. Begun in 1980 and completed in 1983, the survey involved a walk-through investigation by trained surveyors of 4,490 facilities in 523 different types of industries. Surveyors recorded potential exposures when a chemical agent was likely to enter or contact the worker’s body for a minimum duration. These potential exposures could be observed or inferred. Information from these representative facilities was extrapolated to generate national estimates of potentially exposed workers for more than 10,000 different chemicals (Refs. 20, 57, and 58)
es of industries. Surveyors recorded potential exposures when a chemical agent was likely to enter or contact the worker’s body for a minimum duration. These potential exposures could be observed or inferred. Information from these representative facilities was extrapolated to generate national estimates of potentially exposed workers for more than 10,000 different chemicals (Refs. 20, 57, and 58). EPA also compared production volumes from the 1986 IUR data collection to the production volumes for the 2006 IUR data collection. Of the 19 chemical substances in this proposed rule, only one chemical’s production volume decreased from 1986 to 2006. The 2006 IUR production volume data are consistent with NOES results, as the production volumes for the remaining chemical substances either stayed the same or increased since 1986, thereby indicating that the usage of these chemical substances is no less than when NOES data were gathered.
EPA has performed a chemical-by-chemical analysis for all 19 chemical substances and carefully considered the industrial process and use information along with the commercial and consumer use information from the 2006 IUR submissions. Commercial uses are defined as “The use of a chemical substance or mixture in a commercial enterprise providing saleable goods or services (e.g., dry cleaning establishment, painting contractor)”; 40 CFR 710.43. Detailed information from the IUR submissions can be found in “Testing of Certain High Production Volume Chemicals; Second Group of Chemicals (Exposure Findings Supporting Information)” (Ref. 18). Based on the nature of the IUR uses, EPA considers that chemicals with reported commercial uses may result in potential exposure to 1,000 workers or more. The total number of workers reported under the IUR is the sum of information on both industrial workers plus commercial use workers.
In 2003, EPA partially exempted certain petroleum process streams (including “Hydrocarbons, C>4” (CAS No. 68647-60-9) and “Oils, reclaimed” (CAS No
EPA considers that chemicals with reported commercial uses may result in potential exposure to 1,000 workers or more. The total number of workers reported under the IUR is the sum of information on both industrial workers plus commercial use workers.
In 2003, EPA partially exempted certain petroleum process streams (including “Hydrocarbons, C>4” (CAS No. 68647-60-9) and “Oils, reclaimed” (CAS No. 69029-75-0)) from reporting certain processing and use data under the TSCA section 8(a) IUR. The exemption was not based on an assessment of the toxicity of the process streams but on the fact that the chemicals are frequently processed, transported, and stored in vessels that minimize the potential for releases and exposure to workers. ( Federal Register issue of January 7, 2003 (68 FR 848) (FRL-6767-4) and Federal Register issue of December 19, 2005 (71 FR 75059) (FRL-7743-9); available on-line at: http://www.epa.gov/fedrgstr ). Despite the fact that the degree of exposure is expected to be diminished to particular workers because of the chemical processing and handling practices used, available data indicate that more than 1,000 workers are potentially exposed to these chemicals, supporting the preliminary finding of substantial human exposure (Ref. 18).
D. Are a Substantial Number of Consumers Exposed to These Chemicals?
Based on 2006 IUR data, EPA has made preliminary findings that the uses of 13 of the chemical substances included in this action result or may result in exposure to a substantial number of consumers (Ref. 18). EPA reviewed the consumer use information reported for the 2006 IUR and carefully
In addition to findings made based on the 2006 IUR data, EPA has also made consumer exposure based findings based on the National Library of Medicine (NLM) Household Products Database (Ref. 18)
emical substances included in this action result or may result in exposure to a substantial number of consumers (Ref. 18). EPA reviewed the consumer use information reported for the 2006 IUR and carefully
In addition to findings made based on the 2006 IUR data, EPA has also made consumer exposure based findings based on the National Library of Medicine (NLM) Household Products Database (Ref. 18). The chemical substances reported in the National Library of Medicine (NLM) Household Products Database are present in multiple household products subject to TSCA including hobby/craft products, personal care products, home cleaning products, home maintenance products, and automotive products. The NLM Household Products Database provides information on the chemical ingredients and their percentage in specific brands of household products. Information in the database is from a variety of publicly available sources including brand-specific labels and Material Safety Data Sheets when available from manufacturers and manufacturers' websites. Publicly available information from the database is available on-line at: http://householdproducts.nlm.nih.gov .
EPA believes that use of the consumer products identified in the NLM Household Products Database may expose a substantial number of consumers (i.e., greater than 10,000) to these chemical substances. EPA believes that an exposure of over 10,000 consumers to a chemical substance is “substantial” as that term is used with reference to “human exposure” in TSCA section 4(a)(1)(B)(i). EPA believes, based on experience gained through case-by-case analysis of existing chemicals, that an exposure of 10,000 consumers or more to a chemical substance is a reasonable interpretation of the phrase “substantial human exposure” in TSCA section 4(a)(1)(B)(i). (See Ref. 4.) Therefore, EPA’s preliminary finding is that there is or may be substantial human exposure (consumers) to these chemical substances
based on experience gained through case-by-case analysis of existing chemicals, that an exposure of 10,000 consumers or more to a chemical substance is a reasonable interpretation of the phrase “substantial human exposure” in TSCA section 4(a)(1)(B)(i). (See Ref. 4.) Therefore, EPA’s preliminary finding is that there is or may be substantial human exposure (consumers) to these chemical substances.
A discussion of EPA’s preliminary “substantial exposure” finding for consumers is contained in a separate document (see Ref. 18). The Agency solicits comment regarding additional information pertaining to numbers of consumers potentially exposed to the chemical substances identified in this proposed rule.
Table 1.—Exposure Based Findings—Substantial Human Exposure CAS No. 2006 IUR Production Volume Meet Exposure Based CriteriaFor Mfg & Industrial Workers NOES (number of workers) Meet Exposure Based Criteria for Commercial Workers Meet Exposure Based Criteria for Consumers Meet Substantial or Significant Release Criteria NLM Household Chemicals Database 75-07-0 > 100 million (M)-500 M X 216,533 X X X 78-11-5 > 1 M-10 M X 2,650 X 84-65-1 > 10 M-50 M X 6,187 X X 89-32-7 > 1 M-10 M X 1,926 110-44-1 > 1 M-10 M X 69,243 X X X 118-82-1 > 1 M-10 M X 120,009 X X 119-61-9 > 1 M-10 M X 41,516 X X X 144-62-7 > 1 M-10 M X 142,000 X X X X 149-44-0 > 1 M-10 M X 239,465 X X 2524-04-1 > 10 M-50 M X 1,088 4719-04-4 > 10 M-50 M X 225,251 X X X X 6381-77-7 > 1 M-10 M X 19,468 31138-65-5 > 1 M-10 M X 74,165 X X 66241-11-0 > 1 M-10 M X 38,555 X X 68187-76-8 > 1 M-10 M X 11,164 X X 68187-84-8 > 1 M-10 M X 36,381 X X X 68479-98-1 > 10 M-50 M X 4,121 68527-02-6 > 1 M-10 M X 84,192 68647-60-9 > 1 Billion lbs. X 1,257 E. Are Substantial Quantities of These Chemicals Released to the Environment?
EPA does not have readily available data on environmental releases for most of the 19 chemical substances in this proposed rule. However, one substance, acetaldehyde (CAS No
11,164 X X 68187-84-8 > 1 M-10 M X 36,381 X X X 68479-98-1 > 10 M-50 M X 4,121 68527-02-6 > 1 M-10 M X 84,192 68647-60-9 > 1 Billion lbs. X 1,257 E. Are Substantial Quantities of These Chemicals Released to the Environment?
EPA does not have readily available data on environmental releases for most of the 19 chemical substances in this proposed rule. However, one substance, acetaldehyde (CAS No. 75-07-0) is included in TRI and has estimated environmental release in 2005 of 13,567,452 lbs. (Ref. 18). TRI contains information about releases of certain chemicals and management of wastes at a wide variety of sources, including manufacturing operations, certain service businesses, and Federal facilities. Publicly available information from the 2005 TRI reporting cycle is available on-line at: http://www.epa.gov/triexplorer . Two additional chemicals (ethanedioic acid and 1,3,5-triazine-1,3,5(2H,4H,6H)-triethanol) also meet the substantial release criteria based on the environmental releases from their reported IUR uses.
EPA believes that an environmental release of a chemical substance in an amount equal to or greater than 1 million lbs. per year or greater than 10% of the reported production volume is “substantial” as that term is used with reference to “enter the environment in substantial quantities” in TSCA section 4(a)(1)(B)(i). (See Ref. 4).
The Agency solicits comment regarding additional information pertaining to the amount of environmental release of the chemical substances identified in this proposed rule.
F. Do Sufficient Data Exist for These Chemical Substances?
In developing the testing requirements for chemicals contained in this proposed rule, available information on chemical/physical properties, environmental fate, ecotoxicity, and human health effects was searched using the data sources outlined in the OECD guidelines found in section 3.1 (Reliability, Relevance and Adequacy) of the “Manual for the Investigation of HPV Chemicals” (Ref
Substances?
In developing the testing requirements for chemicals contained in this proposed rule, available information on chemical/physical properties, environmental fate, ecotoxicity, and human health effects was searched using the data sources outlined in the OECD guidelines found in section 3.1 (Reliability, Relevance and Adequacy) of the “Manual for the Investigation of HPV Chemicals” (Ref. 6) such as: Beilstein Database, CRC Handbook of Chemistry and Physics, Hawley’s Condensed Chemical Dictionary, Illustrated Handbooks of Physical-Chemical Properties and Environmental Fate for Organic Chemicals, Merck Index, Hazardous Substances Data Bank (HSDB), Toxicology Literature Online (TOXLINE), and the National Technical Information Service (NTIS). EPA also searched for available data as summarized in its HPV Information System (Ref. 56). For one HPV chemical, data available from an EPA reassessment of its use as an inert in pesticides formulations were examined (Ref. 21). When appropriate, the Federal Research In Progress (FEDRIP) database was also searched. Any information that was obtained from these searches was evaluated for data acceptability using the guidelines described on EPA's voluntary HPV Challenge Program website ( http://www.epa.gov/chemrtk/pubs/general/guidocs.htm ): “Guidance for Meeting the SIDS Requirements (The SIDS Guide)” and “Guidance for Assessing the Adequacy of Existing Data.” Furthermore, data adequacy and reliability were evaluated using the OECD guidelines which can be found in section 3.1 of the OECD “Manual for the Investigation of HPV Chemicals” (Ref. 6).
It is worth noting that additional testing is being proposed for five chemicals that had been included in the final TSCA section 4 HPV SIDS rulemaking issued on March 16, 2006 (Ref. 3). EPA noted in the proposed (Ref. 2) and final rule (Ref. 3) for that first HPV SIDS rulemaking that, for chemicals for which some data were available on one or more SIDS endpoints, EPA was not requiring testing at that time for those endpoints
tional testing is being proposed for five chemicals that had been included in the final TSCA section 4 HPV SIDS rulemaking issued on March 16, 2006 (Ref. 3). EPA noted in the proposed (Ref. 2) and final rule (Ref. 3) for that first HPV SIDS rulemaking that, for chemicals for which some data were available on one or more SIDS endpoints, EPA was not requiring testing at that time for those endpoints. However, EPA stated at that time that no definitive determination had been made as to the adequacy of those existing data for an initial assessment of a chemical’s hazards or risks to health or the environment. Consequently, in that final rule, EPA stated that if EPA determines that it needs additional data regarding any of the chemical substances included in the final rule, the Agency might seek further health and/or environmental effects testing for those chemical substances. EPA has now completed its assessment of the adequacy of the available data for those endpoints that were not included for these chemicals in the first HPV SIDS rulemaking. In some instances, EPA has made a preliminary finding that, for some of the SIDS endpoints, the existing data and experience are not sufficient to enable the effects of these substances on health or the environment to reasonably be determined or predicted. Therefore, EPA has also proposed testing for those endpoints in this proposed rule.
Section 799.5087(j) of the proposed regulatory text lists each chemical and the SIDS tests for which adequate data are not currently available to the Agency
sting data and experience are not sufficient to enable the effects of these substances on health or the environment to reasonably be determined or predicted. Therefore, EPA has also proposed testing for those endpoints in this proposed rule.
Section 799.5087(j) of the proposed regulatory text lists each chemical and the SIDS tests for which adequate data are not currently available to the Agency. The Agency preliminarily finds that the existing data for one or more of the SIDS testing endpoints for each of the chemical substances listed in Table 2 of the proposed regulatory text (including environmental fate (comprising five tests for physical/chemical properties [melting point, boiling point, vapor pressure, n -octanol/water partition coefficient, and water solubility] and biodegradation); ecotoxicity (tests in fish, Daphnia, and algae); acute toxicity; genetic toxicity (gene mutations and chromosomal aberrations); repeat dose toxicity; and developmental and reproductive toxicity) are insufficient to enable EPA to reasonably determine or predict the human health and environmental effects resulting from manufacture, processing, and use of these chemical substances.
EPA solicits comment concerning the availability of existing studies on the SIDS endpoints proposed in this document on these chemical substances. To the extent that additional studies relevant to the testing proposed in this rulemaking are known to exist, EPA strongly encourages the submission of this information as comments to the proposed rule, including full citations for publications and full copies of unpublished studies. If EPA judges such data to be sufficient, corresponding testing will not be included in the final rule. Commenters are also encouraged to prepare a robust summary (Ref. 15) for each such study to facilitate EPA’s review of the full study report or publication
sion of this information as comments to the proposed rule, including full citations for publications and full copies of unpublished studies. If EPA judges such data to be sufficient, corresponding testing will not be included in the final rule. Commenters are also encouraged to prepare a robust summary (Ref. 15) for each such study to facilitate EPA’s review of the full study report or publication. Persons who respond to this request to submit robust summaries are also encouraged to submit the robust summary electronically via the High Production Volume Information System (HPVIS) to allow for its ready incorporation into HPVIS. Directions for electronic submission of robust summary information into HPVIS are provided at https://iaspub.epa.gov/oppthpv/metadata.html . This link will direct you to the ‘‘HPVIS Quick Start and User’s Guide.’’
As noted in Unit II.C.1., persons who believe that adequate information regarding a chemical subject to this proposed rule can be developed using a category or SAR approach are encouraged to submit appropriate information, along with their rationale which substantiates this belief, during the comment period on this proposed rule. If, based on submitted information and other information available to EPA, the Agency agrees; EPA will take such measures as are needed to avoid unnecessary testing in the final rule.
G. Is Testing Necessary for These Chemical Substances?
EPA would use the data obtained from this proposed testing to support development of preliminary hazard and risk characterizations for these HPV chemicals as part of the ChAMP process
EPA preliminarily believes that conducting the needed SIDS testing identified for the 19 subject chemical substances is necessary to provide data relevant to a determination of whether the manufacture, processing, and use of the chemical substances does or does not present an unreasonable risk of injury to human health and the environment.
IV. Proposed Testing
A
as part of the ChAMP process
EPA preliminarily believes that conducting the needed SIDS testing identified for the 19 subject chemical substances is necessary to provide data relevant to a determination of whether the manufacture, processing, and use of the chemical substances does or does not present an unreasonable risk of injury to human health and the environment.
IV. Proposed Testing
A. What Testing is Being Proposed in this Action?
EPA is proposing specific testing and reporting requirements for the chemical substances specified in § 799.5087(j) of the proposed regulatory text.
All of the proposed testing requirements are listed in Table 2 in § 799.5087(j) of the proposed regulatory text and consist of a series of test methods covering many of the endpoints in the OECD HPV SIDS testing battery. EPA, however, requires that the American Society for Testing and Materials (ASTM) or the TSCA test guidelines at 40 CFR part 799 (TSCA 799 guidelines) be used because the language in the TSCA 799 guidelines makes clear which steps are mandatory and which steps are only recommended. EPA's TSCA 799 guidelines, however, have been harmonized with the OECD guidelines. Accordingly, in order to comply with this test rule, testing must be conducted in accordance with the specified mandatory and enforceable requirements in the ASTM or TSCA 799 guidelines. Most of the proposed testing requirements for a particular endpoint are specified in one test standard. In the case of certain endpoints, however, any of multiple listed methods could be used. For several of the proposed test standards, EPA has identified and is proposing certain “Special Conditions” as discussed in this unit. The following endpoints and proposed test standards would be required under this proposed rule.
1. Physical/chemical properties .
Melting Point: American Society for Testing and Materials (ASTM) E 324-99 (Capillary tube) (Ref. 22).
Boiling Point: ASTM E 1719-05 (Ebulliometry) (Ref. 23)
test standards, EPA has identified and is proposing certain “Special Conditions” as discussed in this unit. The following endpoints and proposed test standards would be required under this proposed rule.
1. Physical/chemical properties .
Melting Point: American Society for Testing and Materials (ASTM) E 324-99 (Capillary tube) (Ref. 22).
Boiling Point: ASTM E 1719-05 (Ebulliometry) (Ref. 23).
Vapor Pressure: ASTM E 1782-03 (Thermal analysis) (Ref. 24).
n -Octanol/Water Partition Coefficient:
Method A (40 CFR 799.6755—shake flask)
Method B (ASTM E 1147-92(2005)—liquid chromatography) (Ref. 25).
Method C (40 CFR 799.6756—generator column).
Water Solubility:
Method A: (ASTM E 1148-02—shake flask) (Ref. 26).
Method B (40 CFR 799.6784—shake flask).
Method C (40 CFR 799.6784—column elution).
Method D (40 CFR 799.6786—generator column).
EPA is proposing, for those chemicals for which melting points determinations are needed, that melting points be determined according to the method ASTM E 324-99. Although ASTM indicates on its website, http://www.astm.org/cgi-bin/SoftCart.exe/STORE/filtrexx40.cgi?U+mystore+lien2117+-L+E324+/usr6/htdocs/astm.org/DATABASE.CART/WITHDRAWN/E324.htm that ASTM E 324-99 has been withdrawn, ASTM has explained that ASTM E 324-99 was withdrawn because:
The standard utilizes old, well-developed technology; it is highly unlikely that any additional [changes] and/or modifications will ever be pursued by the E15 [committee]. The time and effort needed to maintain these documents detract from the time available to develop new standards which use modern technology.
(Ref. 27) Withdrawal of the method by ASTM means only that ASTM no longer continues to develop and improve the method. It does not mean that ASTM no longer considers the method to be valid. ASTM still makes the method available for informational purposes and it can still be purchased from ASTM at the address listed in § 799.5087(h) of the proposed regulatory text
rds which use modern technology.
(Ref. 27) Withdrawal of the method by ASTM means only that ASTM no longer continues to develop and improve the method. It does not mean that ASTM no longer considers the method to be valid. ASTM still makes the method available for informational purposes and it can still be purchased from ASTM at the address listed in § 799.5087(h) of the proposed regulatory text. EPA concludes that ASTM’s withdrawal of E 324-99 does not have negative implications on the validity of the method; therefore, EPA is proposing, for those chemicals for which melting points determinations are needed, that melting points be determined according to the method ASTM E 324-99. For the n -octanol/water partition coefficient and water solubility endpoints, EPA is proposing that certain “Special Conditions” be considered by test sponsors in determining the appropriate test method that would be used from among those included for these endpoints in Table 3 in § 799.5087(j) of the proposed regulatory text.
For the “ n -Octanol/Water Partition Coefficient (log 10 basis)” endpoint, also known as log K ow , EPA proposes that an appropriate selection be made from among three alternative methods for measuring the substance’s n -octanol/water partition coefficient. Prior to determining the appropriate standard to use, if any, to measure the n -octanol/water partition coefficient, EPA is recommending that the log K ow be quantitatively estimated. EPA recommends that the method described in “Atom/Fragment Contribution Method for Estimating Octanol-Water Partition Coefficients” (Ref. 28) be used in making such estimation. EPA is proposing that test sponsors must submit with the final study report the underlying rationale for the test standard selected for this endpoint
cient, EPA is recommending that the log K ow be quantitatively estimated. EPA recommends that the method described in “Atom/Fragment Contribution Method for Estimating Octanol-Water Partition Coefficients” (Ref. 28) be used in making such estimation. EPA is proposing that test sponsors must submit with the final study report the underlying rationale for the test standard selected for this endpoint. EPA is proposing this approach in recognition of the fact that depending on the chemical substance’s log K ow , one or more test methods may provide adequate information for determining the log K ow , but that in some instances one particular test method may be more appropriate In general, EPA believes that the more hydrophobic a subject chemical is, the less well Method A (§ 799.6755—shake flask) will work and Method B (ASTM E 1147-92(2005)) and Method C (§ 799.6756—generator column) become more suitable, especially Method C. The proposed test methodologies have been developed to meet a wide variety of needs and, as such, are silent on experimental conditions related to pH. Therefore, EPA proposes that all required n -octanol/water partition coefficient tests be conducted at pH 7 to ensure environmental relevance. The proposed test standards and log K ow ranges that would determine which tests must be conducted for this endpoint are shown in Table 2 of this unit.
Table 2.—Test Requirements for the n-Octanol/water Partition Coefficient Endpoint Testing Category Test Requirements and References Special Conditions Physical/chemical properties n -Octanol/water partition coefficient (log 10 basis) or log K ow : The appropriate log K ow test, if any, would be selected from those listed in this column—see Special Conditions in the adjacent column
of this unit.
Table 2.—Test Requirements for the n-Octanol/water Partition Coefficient Endpoint Testing Category Test Requirements and References Special Conditions Physical/chemical properties n -Octanol/water partition coefficient (log 10 basis) or log K ow : The appropriate log K ow test, if any, would be selected from those listed in this column—see Special Conditions in the adjacent column. Method A: 40 CFR 799.6755 (shake flask) Method B: ASTM E 1147-92(2005) (liquid chromatography) Method C: 40 CFR 799.6756 (generator column) n -Octanol/water partition coefficient or log K ow : Which method is required, if any, is determined by the test substance's estimated log K ow as follows: log K ow < 0: no testing required. log K ow range 0-1: Method A or B. log K ow range > 1-4: Method A or B or C. log K ow range > 4-6: Method B or C. log K ow > 6: Method C. Test sponsors must provide in the final study report the underlying rationale for the method and pH selected. In order to ensure environmental relevance, EPA highly recommends that the selected study be conducted at pH 7. For the “Water Solubility” endpoint, EPA proposes an appropriate selection be made from among four alternative methods for measuring that endpoint. The test method used, if any, would be determined by first quantitatively estimating the test substance’s water solubility. One recommended method for estimating water solubility is described in “Improved Method for Estimating Water Solubility from Octanol/Water Partition Coefficient” (Ref. 29). EPA is also proposing that test sponsors be required to submit in the final study report the underlying rationale for the test standard selected for this endpoint. The proposed test methodologies have been developed to meet a wide variety of needs and, as such, are silent on experimental conditions related to pH. Therefore, EPA proposes that all required water solubility tests be conducted starting at pH 7 to ensure environmental relevance
required to submit in the final study report the underlying rationale for the test standard selected for this endpoint. The proposed test methodologies have been developed to meet a wide variety of needs and, as such, are silent on experimental conditions related to pH. Therefore, EPA proposes that all required water solubility tests be conducted starting at pH 7 to ensure environmental relevance. The estimated water solubility ranges that EPA is proposing for use in selecting an appropriate proposed test standard are shown in Table 3 of this unit.
Table 3.—Test Requirements for the Water Solubility Endpoint Testing Category Test Requirements and References Special Conditions Physical/chemical properties Water solubility: The appropriate method to use, if any, to test for water solubility would be selected from those listed in this column—see Special Conditions in the adjacent column. Method A: ASTM E 1148-02 (shake flask) Method B: 40 CFR 799.6784 (shake flask) Method C: 40 CFR 799.6784 (column elution) Method D: 40 CFR 799.6786 (generator column) Water solubility: Which method is required, if any, would be determined by the test substance's estimated water solubility. Test sponsors must provide in the final study report the underlying rationale for the method and pH selected. In order to ensure environmental relevance, EPA highly recommends that the selected study be conducted starting at pH 7. > 5,000 milligram/Liter (mg/L): Method A or B. > 10 mg/L—5,000 mg/L: Method A, B, C, or D. > 0.001 mg/L—10 mg/L: Method C or D. ≤ 0.001 mg/L: No testing required. 2. Environmental fate and pathways .
Ready Biodegradation:
Method A: ASTM E1720-01 (Sealed vessel CO 2 production test) (Ref. 30).
Method B: ISO 14593 (CO 2 headspace test) (Ref. 31).
Method C: ISO 7827 (Method by analysis of dissolved organic carbon (DOC)) (Ref. 32).
Method D: ISO 9408 (Determination of oxygen demand in a closed respirometer) (Ref. 33).
Method E: ISO 9439 (Carbon dioxide evolution test) (Ref. 34)
hways .
Ready Biodegradation:
Method A: ASTM E1720-01 (Sealed vessel CO 2 production test) (Ref. 30).
Method B: ISO 14593 (CO 2 headspace test) (Ref. 31).
Method C: ISO 7827 (Method by analysis of dissolved organic carbon (DOC)) (Ref. 32).
Method D: ISO 9408 (Determination of oxygen demand in a closed respirometer) (Ref. 33).
Method E: ISO 9439 (Carbon dioxide evolution test) (Ref. 34).
Method F: ISO 10707 (Closed bottle test) (Ref 35).
Method G: ISO 10708 (Two-phase closed bottle test) (Ref. 36).
For the “Ready Biodegradation” endpoint, EPA proposes an appropriate selection be made from among seven alternative methods for measuring the substance’s ready biodegradability. For most test substances, EPA considers Method A (ASTM E1720-01) and Method B (ISO 14593) to be generally applicable, cost effective, and widely accepted internationally. However, the test method used, if any, will depend on the physical and chemical properties of the test substance, including its water solubility. An additional document, ISO 10634 (Ref. 37), provides guidance for selection of an appropriate test method for a given test substance considering the substances physical and chemical properties. EPA is also proposing that test sponsors be required to submit in the final study report the underlying rationale for the test standard selected for this endpoint.
3. Aquatic toxicity .
Test Group 1:
Acute toxicity to fish (ASTM E 729-96(2002)) (Ref. 38).
Acute toxicity to Daphnia (ASTM E 729-96(2002)) (Ref. 38).
Toxicity to plants (algae) (ASTM E 1218-04e1) (Ref. 39).
Test Group 2:
Chronic toxicity to Daphnia (ASTM E 1193-97(2004)) (Ref. 40).
Toxicity to plants (algae) (ASTM E 1218-04e1) (Ref. 39).
For the “Aquatic Toxicity” endpoint, the OECD HPV SIDS Program recognizes that, for certain chemicals, acute toxicity studies are of limited value in assessing the substances’ aquatic toxicity. This issue arises when considering chemical substances with high log K ow values
Chronic toxicity to Daphnia (ASTM E 1193-97(2004)) (Ref. 40).
Toxicity to plants (algae) (ASTM E 1218-04e1) (Ref. 39).
For the “Aquatic Toxicity” endpoint, the OECD HPV SIDS Program recognizes that, for certain chemicals, acute toxicity studies are of limited value in assessing the substances’ aquatic toxicity. This issue arises when considering chemical substances with high log K ow values. In such cases, toxicity is unlikely to be observed over the duration of acute toxicity studies because of reduced uptake and the extended amount of time required for such substances to reach steady state or toxic concentrations in the test organism. For such situations, the OECD HPV SIDS Program recommends use of chronic toxicity testing in Daphnia in place of acute toxicity testing in fish and Daphnia. EPA is proposing that the aquatic toxicity testing requirement be ow as determined by using the approach outlined in Unit IV.A.1., in the discussion of “ n -Octanol/Water Coefficient,” and in Table 3 in § 799.5087(j) of the proposed regulatory text. For test substances determined to have a log K ow of less than 4.2, one or more of the following tests (described as “Test Group 1” in Table 3 in § 799.5087(j) of the proposed regulatory text) are proposed: Acute toxicity to fish (ASTM E 729-96 (2002)); Acute toxicity to Daphnia (ASTM E 729-96(2002)); and Toxicity to plants (algae) (ASTM E 1218-04e1). For test substances determined to have a log K ow that is greater than or equal to 4.2, one or both of the following tests (described as “Test Group 2” in Table 3 in § 799.5087(j) of the proposed regulatory text) are proposed: Chronic toxicity to Daphnia (ASTM E 1193-97(2004)) and Toxicity to plants (algae) (ASTM E 1218-04e1). As outlined in Table 3 in § 799.5087(j) of the proposed regulatory text, depending on the testing proposed in Test Group 1, the Test Group 2 chronic Daphnia test may substitute for either or both the acute fish toxicity test and the acute Daphnia test
of the proposed regulatory text) are proposed: Chronic toxicity to Daphnia (ASTM E 1193-97(2004)) and Toxicity to plants (algae) (ASTM E 1218-04e1). As outlined in Table 3 in § 799.5087(j) of the proposed regulatory text, depending on the testing proposed in Test Group 1, the Test Group 2 chronic Daphnia test may substitute for either or both the acute fish toxicity test and the acute Daphnia test.
Using SAR, a log K ow of 4.2 corresponds with a fish bioconcentration factor (BCF) of about 1,000 (Refs. 29, 41, and 42). A chemical substance with a fish BCF value of 1,000 or more is characterized as having a tendency to accumulate in living organisms relative to the concentration of the chemical in the surrounding environment (Ref. 42). For the purposes of this proposed rulemaking, EPA’s use of a log K ow equal to or greater than 4.2 (which corresponds with a fish BCF value of 1,000) is consistent with the approach taken in the Agency's Final Policy Statement under TSCA section 5 entitled Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances (Ref. 43). EPA has also used a measured BCF that is equal to or greater than 1,000 or, in the absence of bioconcentration data, a log P [same as log K ow ] value equal to or greater than 4.3 to help define the potential of a new chemical substance to cause significant adverse environmental effects (Significant New Use Rules; General Provisions For New Chemical Follow-Up (Ref. 44) (See also 40 CFR 721.3.)). EPA considers the difference between the log K ow of 4.3 cited in the 1989 Federal Register document and the log K ow value of 4.2 cited in this proposed rule to be negligible.
EPA recognizes that in some circumstances, acute aquatic toxicity testing (Test Group 1) may be relevant for certain chemical substances having a log K ow equal to or greater than 4.2
(Ref. 44) (See also 40 CFR 721.3.)). EPA considers the difference between the log K ow of 4.3 cited in the 1989 Federal Register document and the log K ow value of 4.2 cited in this proposed rule to be negligible.
EPA recognizes that in some circumstances, acute aquatic toxicity testing (Test Group 1) may be relevant for certain chemical substances having a log K ow equal to or greater than 4.2. chemical substances that are dispersible in water (e.g., surfactants, detergents, aliphatic amines, and cationic dyes) may have log K ow values greater than 4.2 and may still be acutely toxic to aquatic organisms. For any chemical substance listed in Table 3 in § 799.5087(j) of the proposed regulatory text for which a test sponsor believes that an alternative to the log K ow threshold of 4.2 is appropriate, the test sponsor may request a modification of the test standard in the final rule as described in 40 CFR 790.55. Based upon the supporting rationale provided by the test sponsor, EPA may allow an alternative threshold or method to be used for determining whether acute or chronic aquatic toxicity testing must be performed for a specific substance. EPA is soliciting public comment on this approach as well as other alternative approaches in this area.
4. Mammalian toxicity—acute .
Acute Inhalation Toxicity (rat): Method A (40 CFR 799.9130).
Acute Oral Toxicity (rat): Method B (ASTM E 1163-98(2002) (Ref. 59) or 40 CFR 799.9110(d)(1)(i)(A)).
For the “Mammalian Toxicity—Acute” endpoint, EPA is proposing that certain “Special Conditions” in the form of the chemical substance’s physical/chemical properties or physical state be considered in determining the appropriate test method that would be used from among those included for this endpoint in Table 3 in § 799.5087(j) of the proposed regulatory text. The OECD HPV SIDS Program recognizes that, for most chemical substances, the oral route of administration will suffice for this endpoint
he form of the chemical substance’s physical/chemical properties or physical state be considered in determining the appropriate test method that would be used from among those included for this endpoint in Table 3 in § 799.5087(j) of the proposed regulatory text. The OECD HPV SIDS Program recognizes that, for most chemical substances, the oral route of administration will suffice for this endpoint. However, consistent with the approach taken under the voluntary HPV Challenge Program, EPA is proposing that, for test substances that are gases at room temperature (25° C), the acute mammalian toxicity study be conducted using inhalation as the exposure route (described as Method A (40 CFR 799.9130) in Table 3 in § 799.5087(j) of the proposed regulatory text). In the case of a potentially explosive test substance, care must be taken to avoid the generation of explosive concentrations. For all other chemicals (i.e., those that are either liquids or solids at room temperature), EPA is proposing that the acute toxicity testing be conducted via oral administration using an “Up/Down” test method (described as Method B (ASTM E 1163-98(2002) or 40 CFR 799.9110(d)(1)(i)(A)) in Table 3 in § 799.5087(j) of the proposed regulatory text). Consistent with the voluntary HPV Challenge Program, EPA is proposing to allow the use of the Neutral Red Uptake (NRU) basal cytotoxicity assay to select the starting dose for the acute oral toxicity test. This test is included as a special condition in Table 3 of the proposed regulatory text. A document developed by NIH/NIEHS provides guidance on how to use the NRU assay to estimate a starting dose for an acute oral toxicity test (Ref. 50). Recent versions of the standardized protocols for the NRU assay are available at the NIEHS/ICCVAM website, http://iccvam.niehs.nih.gov/methods/acutetox/invitrocyto/invcyt_proto.htm (Refs. 51-53)
condition in Table 3 of the proposed regulatory text. A document developed by NIH/NIEHS provides guidance on how to use the NRU assay to estimate a starting dose for an acute oral toxicity test (Ref. 50). Recent versions of the standardized protocols for the NRU assay are available at the NIEHS/ICCVAM website, http://iccvam.niehs.nih.gov/methods/acutetox/invitrocyto/invcyt_proto.htm (Refs. 51-53).
Dermal toxicity testing is not proposed in this rulemaking, and the Agency does not intend to include any dermal toxicity testing in any TSCA section 4 HPV SIDS rulemakings.
5. Mammalian toxicity—genotoxicity .
Gene mutations:
Bacterial Reverse Mutation Test ( in vitro ): 40 CFR 799.9510.
Chromosomal damage:
In Vitro Mammalian Chromosome Aberration Test (40 CFR 799.9537), or the In Vivo Mammalian Bone Marrow Chromosomal Aberration Test (rodents: mouse (preferred species), rat, or Chinese hamster) (40 CFR 799.9538), or the In Vivo Mammalian Erythrocyte Micronucleus Test (sampled in bone marrow) (rodents: mouse (preferred species), rat, or Chinese hamster) (40 CFR 799.9539).
Persons who would be required to conduct testing for chromosomal damage are encouraged to use in vitro genetic toxicity testing (i.e., the Mammalian Chromosome Aberration Test) to generate the needed genetic toxicity screening data, unless known chemical properties preclude its use. These could include, for example, physical chemical properties or chemical class characteristics. A primary focus of both the voluntary HPV Challenge Program and this proposed rule is to implement this program in a manner consistent with the OECD HPV SIDS Program and as part of a larger international activity with global involvement. This proposed approach provides the same degree of flexibility as that which currently exists under the OECD HPV SIDS testing program (Ref. 6)
ss characteristics. A primary focus of both the voluntary HPV Challenge Program and this proposed rule is to implement this program in a manner consistent with the OECD HPV SIDS Program and as part of a larger international activity with global involvement. This proposed approach provides the same degree of flexibility as that which currently exists under the OECD HPV SIDS testing program (Ref. 6). A subject person who uses one of the in vivo methods instead of the in vitro method to address this end-point would be required to submit to EPA a rationale for conducting that alternate test in the final study report.
6. Mammalian toxicity—repeated dose/reproduction/developmental .
Combined Repeated Dose Toxicity Study with the Reproduction/
Reproduction/Developmental Toxicity Screening Test: 40 CFR 799.9355.
Repeated Dose 28-Day Oral Toxicity Study: 40 CFR 799.9305.
For the “Mammalian Toxicity—Repeated Dose/Reproduction/Developmental” endpoint, EPA recommends the use of the Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (40 CFR 799.9365) as the test of choice. EPA recognizes, however, that there may be reasons to test a particular chemical substance using both the Reproduction/Developmental Toxicity Screening Test (40 CFR 799.9355) and the Repeated Dose 28-Day Oral Toxicity Study (40 CFR 799.9305) instead of the Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (40 CFR 799.9365). With regard to such cases, EPA is proposing that a subject person who uses the combination of the Reproduction/Developmental Toxicity Screening Test and the Repeated Dose 28-Day Oral Toxicity Study in place of the Combined Repeated Dose Toxicity Study with Reproduction/Developmental Toxicity Screen would be required to submit to EPA a rationale for conducting these alternate tests in the final study reports
d to such cases, EPA is proposing that a subject person who uses the combination of the Reproduction/Developmental Toxicity Screening Test and the Repeated Dose 28-Day Oral Toxicity Study in place of the Combined Repeated Dose Toxicity Study with Reproduction/Developmental Toxicity Screen would be required to submit to EPA a rationale for conducting these alternate tests in the final study reports.
Certain of the chemical substances for which Mammalian Toxicity—Repeated Dose/Reproduction/Developmental testing is proposed may be used solely as “closed system intermediates,” as described in the EPA guidance document developed for the voluntary HPV Challenge Program (Ref. 46). As described in that guidance, such chemical substances may be eligible for a reduced testing battery which substitutes a developmental toxicity study for the SIDS requirement to address repeated dose (e.g., subchronic), reproductive, and developmental toxicity. In other words, since only the developmental toxicity study would be conducted for those chemical substances that qualify for a reduced testing battery, repeated dose (e.g., subchronic) and reproductive studies would not be conducted. At the present time, EPA does not have sufficient information to know with any degree of certainty which if any of the chemical substances that are listed in the proposed regulatory text are solely closed system intermediates as defined in the voluntary HPV Challenge Program guidance document (Ref. 46). Persons who believe that a chemical substance fully satisfies the terms outlined in the guidance document are encouraged to submit appropriate information along with their comments on this proposed rule which substantiate this belief. If, based on submitted information and other information available to EPA, the Agency believes that a chemical substance is considered likely to meet the requirements for use solely as a closed system intermediate, EPA would not address any developmental toxicity testing needs in this proposed rulemaking
te information along with their comments on this proposed rule which substantiate this belief. If, based on submitted information and other information available to EPA, the Agency believes that a chemical substance is considered likely to meet the requirements for use solely as a closed system intermediate, EPA would not address any developmental toxicity testing needs in this proposed rulemaking. In those cases in which the Agency can determine that chemicals are solely closed system intermediates, it plans to handle them in accordance with the existing OECD procedures.
B. When Would Any Testing Imposed by this Proposed Rulemaking Begin?
The testing requirements contained in this proposed rule are not effective until and unless the Agency issues a final rule. Based on the effective date of the final rule, which is typically 30 days after the publication of a final rule in the Federal Register , the test sponsor may plan the initiation of any required testing as appropriate to submit the required final report by the deadline indicated as the number of months after the effective date that would be shown in § 799.5087(j) of the proposed regulatory text.
C. How Would the Studies Proposed Under this Test Rule be Conducted?
Persons required to comply with the final rule would have to conduct the necessary testing in accordance with the testing and reporting requirements established in the regulatory text of the final rule, and with the TSCA Good Laboratory Practice Standards (GLPS) (40 CFR part 792).
D. What Form of Test Substances Would be Tested Under this Rule?
EPA is proposing two distinct approaches for identifying the specific substances that would be tested under this proposed rule, the application of which would depend on whether the substance is considered to be a “Class 1” or a “Class 2” substance
ule, and with the TSCA Good Laboratory Practice Standards (GLPS) (40 CFR part 792).
D. What Form of Test Substances Would be Tested Under this Rule?
EPA is proposing two distinct approaches for identifying the specific substances that would be tested under this proposed rule, the application of which would depend on whether the substance is considered to be a “Class 1” or a “Class 2” substance. First introduced when EPA compiled the TSCA Chemical Substance Inventory, the term Class 1 substance refers to a chemical substance having a chemical composition that consists of a single chemical species (not including impurities) that can be represented by a specific, complete structure diagram. By contrast, the term Class 2 substance refers to a chemical substance having a composition that cannot be represented by a specific, complete chemical structure diagram, because such a substance generally contains two or more different chemical species (not including impurities). Table 2 in § 799.5087(j) of the proposed regulatory text identifies the listed chemical substances as either Class 1 or Class 2 substances.
EPA is proposing that, for the Class 1 substances that are listed in the proposed rule, the test substance have a purity of 99% or greater. EPA has generally applied this standard of purity to the testing of Class 1 substances in the past under TSCA section 4(a) testing actions, except for substances where it has been shown that such purity is unattainable. EPA is soliciting comment on whether a purity level of 99% or greater cannot be attained for any of the Class 1 substances listed in this proposed rule. For the Class 2 substances that are listed in the proposed rule, EPA is proposing that the test substance be any representative form of the chemical substance, to be defined by the test sponsor(s).
In proposing a different approach for identifying the substance to be tested with regard to Class 2 substances, EPA recognizes two characteristics which further distinguish Class 1 from Class 2 substances
the Class 2 substances that are listed in the proposed rule, EPA is proposing that the test substance be any representative form of the chemical substance, to be defined by the test sponsor(s).
In proposing a different approach for identifying the substance to be tested with regard to Class 2 substances, EPA recognizes two characteristics which further distinguish Class 1 from Class 2 substances. First, unlike for Class 1 substances, knowledge of the composition of commercial Class 2 substances can vary in quality and specificity from substance to substance.
The composition of the chemical species which comprise a Class 2 substance may be:
• Well-characterized in terms of molecular formulae, structural diagrams, and compositional percentages of all species present (for example, methyl phenol);
• Less well-characterized, for example, characterized only by molecular formulae, non-specific structural diagrams, and/or by incomplete or unknown compositional percentages of the species present (for example, C12-C14 tert-alkyl amines); or
• Poorly characterized because all that is known is the identity of only some of the chemical species present and their percentages of composition, or of only the feedstocks and method of manufacture used to manufacture the substance (for example, nut shell liquor of cashew).
Secondly, the composition of some Class 2 substances may vary from one manufacturer to another, or, for a single manufacturer, from production run to production run, because of small variations in feedstocks, manufacturing methods, or other production variables
sition, or of only the feedstocks and method of manufacture used to manufacture the substance (for example, nut shell liquor of cashew).
Secondly, the composition of some Class 2 substances may vary from one manufacturer to another, or, for a single manufacturer, from production run to production run, because of small variations in feedstocks, manufacturing methods, or other production variables. A “Class 2” designation most frequently represents a group of chemical substances comprising substances that have similar combinations of different
As an alternative to requiring the testing of a representative form of a Class 2 substance designated by a person subject to the final rule, EPA is considering whether the Agency should specify the particular form of each chemical substance that must be tested, and, if so, what criteria EPA should use to identify the particular representative form that would be tested. EPA might specify, for example, a form of a substance that meets an industry or consensus specification, if one exists, or the form with the highest production volume, which could potentially be identified via information reported under a TSCA section 8(a) rule, or by other means.
Under both of the approaches described in this unit, manufacturers and processors of each chemical substance listed in this proposed rule would be jointly responsible for the testing of a representative form of each Class 2 substance.
To facilitate EPA’s review of exemption applications under this alternative, the Agency would require the submission of certain chemical substance-identifying data, including characteristics and properties of the exemption applicant’s substance, such as boiling point, melting point, chemical analysis, additives (if any), and spectral data information.
EPA solicits comment on the proposed alternative approaches to the testing of Class 2 substances included in this proposed rule.
E
would require the submission of certain chemical substance-identifying data, including characteristics and properties of the exemption applicant’s substance, such as boiling point, melting point, chemical analysis, additives (if any), and spectral data information.
EPA solicits comment on the proposed alternative approaches to the testing of Class 2 substances included in this proposed rule.
E. Would I Be Required to Test Under this Rule?
Under TSCA section 4(a)(1)(B)(ii), EPA has made preliminary findings that there are insufficient data and experience to reasonably determine or predict health and environmental effects resulting from the manufacture, processing, or use of the chemical substances listed in this proposed rulemaking. As a result, under TSCA section 4(b)(3)(B), manufacturers and processors of these chemical substances, and those who intend to manufacture or process them, would be subject to the rule with regard to those listed chemical substances which they manufacture or process.
1. Would I be subject to this rule? You would be subject to this rule and may be required to test if you manufacture (which is defined by statute to include import) or process, or intend to manufacture or process, one or more chemical substances listed in this proposed rule during the time period discussed in Unit IV.E.2. However, if you do not know or cannot reasonably ascertain that you manufacture or process a listed test rule substance (based on all information in your possession or control, as well as all information that a reasonable person similarly situated might be expected to possess, control, or know, or could obtain without unreasonable burden), you would not be subject to the rule for that listed substance.
2
if you do not know or cannot reasonably ascertain that you manufacture or process a listed test rule substance (based on all information in your possession or control, as well as all information that a reasonable person similarly situated might be expected to possess, control, or know, or could obtain without unreasonable burden), you would not be subject to the rule for that listed substance.
2. When would my manufacture or processing (or my intent to do so) cause me to be subject to this rule? You would be subject to this rule if you manufacture or process, or intend to manufacture or process, a chemical substance listed in this proposed rule at any time from the effective date of the final test rule to the end of the test data reimbursement period. The term “reimbursement period” is defined at 40 CFR 791.3(h) and may vary in length for each substance to be tested under a final TSCA section 4(a) test rule, depending on what testing is required and when testing is completed. See Unit IV.E.4.
3. Would I be required to test if I were subject to the rule? It depends on the nature of your activities. All persons who would be subject to this TSCA section 4(a) test rule, which, unless otherwise noted in the regulatory text, incorporates EPA’s generic procedures applicable to TSCA section 4(a) test rules (contained within 40 CFR part 790), would fall into one of two groups, designated here as Tier 1 and Tier 2. Persons in Tier 1 (those who would have to initially comply with the final rule) would either:
• Submit to EPA letters of intent to conduct testing, conduct this testing, and submit the test data to EPA, or
• Apply to and obtain from EPA exemptions from testing.
Persons in Tier 2 (those who would not have to initially comply with the final rule) would not need to take any action unless they are notified by EPA that they are required to do so (because, for example, no person in Tier 1 had submitted a letter of intent to conduct testing), as described in Unit IV.E.3.d
ubmit the test data to EPA, or
• Apply to and obtain from EPA exemptions from testing.
Persons in Tier 2 (those who would not have to initially comply with the final rule) would not need to take any action unless they are notified by EPA that they are required to do so (because, for example, no person in Tier 1 had submitted a letter of intent to conduct testing), as described in Unit IV.E.3.d. Note that both persons in Tier 1 who obtain exemptions and persons in Tier 2 would nonetheless be subject to providing reimbursement to persons who actually conduct the testing, as described in Unit IV.E.4.
a. Who would be in Tier 1 and Tier 2? All persons who would be subject to the final rule are considered to be in Tier 1 unless they fall within Tier 2. Table 4 of this unit describes who is in Tier 1 and Tier 2.
Table 4.—Persons Subject to the Rule: Persons in Tier 1 and Tier 2 Tier 1 (Persons initially required to comply) Tier 2 (Persons not initially required to comply) Persons who manufacture (as defined at TSCA section 3(7)), or intend to manufacture, a test rule substance, and who are not listed under Tier 2 A. Persons who manufacture (as defined at TSCA section 3(7)) or intend to manufacture a test rule substance solely as one or more of the following: —As a byproduct (as defined at 40 CFR 791.3(c)); —As an impurity (as defined at 40 CFR 790.3); —As a naturally occurring chemical substance (as defined at 40 CFR 710.4(b));—As a non-isolated intermediate (as defined at 40 CFR 704.3); —As a component of a Class 2 substance (as described at 40 CFR 720.45(a)(1)(i)); —In amounts of less than 500 kg (1,100 lbs.) annually (as described at 40 CFR 790.42(a)(4)); or —In small quantities solely for research and development (R and D) (as described at 40 CFR 790.42(a)(5)). B. Persons who process (as defined at TSCA section 3(10)) or intend to process a test rule substance (see 40 CFR 790.42(a)(2))
ponent of a Class 2 substance (as described at 40 CFR 720.45(a)(1)(i)); —In amounts of less than 500 kg (1,100 lbs.) annually (as described at 40 CFR 790.42(a)(4)); or —In small quantities solely for research and development (R and D) (as described at 40 CFR 790.42(a)(5)). B. Persons who process (as defined at TSCA section 3(10)) or intend to process a test rule substance (see 40 CFR 790.42(a)(2)). Under 40 CFR 790.2, EPA may establish procedures applying to specific test rules that differ from the generic procedures governing TSCA section 4(a) test rules in 40 CFR part 790. For purposes of this proposed rule, EPA is proposing to establish certain requirements that differ from those under 40 CFR part 790.
In this proposed test rule, EPA has reconfigured the tiers in 40 CFR 790.42. In addition to processors, manufacturers of less than 500 kg (1,100 lbs.) per year (“small-volume manufacturers”), and manufacturers of small quantities for research and development (“R&D manufacturers”), EPA has added the following persons to Tier 2: Byproduct manufacturers, impurity manufacturers, manufacturers of naturally occurring substances, manufacturers of non-isolated intermediates, and manufacturers of components of Class 2 substances. The Agency took administrative burden and complexity into account in determining who was to be in Tier 1 in this proposed rule. EPA believes that those persons in Tier 1 who would conduct testing under this rule, when finalized, would generally be large chemical manufacturers who, in the experience of the Agency, have traditionally conducted testing or participated in testing consortia under previous TSCA section 4(a) test rules.
The Agency also believes that byproduct manufacturers, impurity manufacturers, manufacturers of naturally occurring substances, manufacturers of non-isolated intermediates, and manufacturers of components of Class 2 substances historically have not themselves participated in testing or contributed to reimbursement of those persons who have conducted testing
previous TSCA section 4(a) test rules.
The Agency also believes that byproduct manufacturers, impurity manufacturers, manufacturers of naturally occurring substances, manufacturers of non-isolated intermediates, and manufacturers of components of Class 2 substances historically have not themselves participated in testing or contributed to reimbursement of those persons who have conducted testing. EPA understands that these manufacturers may include persons for whom the marginal transaction costs involved in negotiating and administering testing arrangements are deemed likely to raise the expense and burden of testing to a level that is disproportional to the additional benefits of including these persons in Tier 1. Therefore, EPA does not believe that the likelihood of the persons proposed to be added to Tier 2 actually conducting the testing is sufficiently high to justify burdening these persons with Tier 1 requirements (e.g., submitting requests for exemptions). Nevertheless, these persons, along with all other persons in Tier 2, would be subject to reimbursement obligations to persons who actually conduct the testing, as described in Unit IV.E.4.
TSCA section 4(b)(3)(B) requires all manufacturers and/or processors of a chemical substance to test that chemical substance if EPA has made findings under TSCA sections 4(a)(1)(A)(ii) or 4(a)(1)(B)(ii) for that chemical substance, and issued a TSCA section 4(a) test rule requiring testing. However, practicality must be a factor in determining who is subject to a particular test rule. Thus, persons who do not know or cannot reasonably ascertain that they are manufacturing or processing a chemical substance subject to this proposed rule, e.g., manufacturers or processors of a chemical substance as a trace contaminant who are not aware of and cannot reasonably ascertain these activities, would not be subject to the rule. See Unit IV.E.1. and § 799.5087(b)(2) of the proposed regulatory text.
b. Subdivision of Tier 2 entities
ly ascertain that they are manufacturing or processing a chemical substance subject to this proposed rule, e.g., manufacturers or processors of a chemical substance as a trace contaminant who are not aware of and cannot reasonably ascertain these activities, would not be subject to the rule. See Unit IV.E.1. and § 799.5087(b)(2) of the proposed regulatory text.
b. Subdivision of Tier 2 entities . The Agency is proposing to prioritize which persons in Tier 2 would be required to perform testing, if needed. Specifically, the Agency is proposing that Tier 2 entities be subdivided into:
i. Tier 2A . Tier 2 manufacturers, i.e., those who manufacture, or intend to manufacture, a test rule substance solely as one or more of the following: A byproduct, an impurity, a naturally occurring substance, a non-isolated intermediate, a component of a Class 2 substance, in amounts less than 1,100 lbs. annually, or in small quantities solely for research and development.
ii. Tier 2B . Tier 2 processors, i.e., those who process, or intend to process, a test rule substance (in any form). The terms ‘‘process’’ and ‘‘processor’’ are defined by TSCA sections 3(10) and 3(11), respectively.
If the Agency needs testing from persons in Tier 2, EPA would seek testing from persons in Tier 2A before proceeding to Tier 2B. It is appropriate to require manufacturers in Tier 2A to submit letters of intent to test or exemption applications before processors are called upon because the Agency believes that testing costs are traditionally passed by manufacturers along to processors, enabling them to share in the costs of testing (Ref. 54). In addition, ‘‘[t]here are [typically] so many processors [of a given test rule chemical] that it would be difficult to include them all in the technical decisions about the tests and in the financial decisions about how to allocate the costs’’ (Ref. 55).
c
that testing costs are traditionally passed by manufacturers along to processors, enabling them to share in the costs of testing (Ref. 54). In addition, ‘‘[t]here are [typically] so many processors [of a given test rule chemical] that it would be difficult to include them all in the technical decisions about the tests and in the financial decisions about how to allocate the costs’’ (Ref. 55).
c. When would it be appropriate for a person who would be required to comply with the rule to apply for an exemption rather than to submit a letter of intent to conduct testing ? You may apply for an exemption if you believe that the required testing will be performed by another person (or a consortium of persons formed under TSCA section 4(b)(3)(A)). You can find procedures

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/FR_PRORULE_E8-16992. Check the current official text before relying on it. Not legal advice.