Source: http://www.regulations.gov/?_escaped_fragment_=documentDetail;D=EPA-HQ-OPPT-2009-0112-0001
Timestamp: 2016-07-30 20:48:29
Document Index: 672104885

Matched Legal Cases: ['§ 799', 'art 707', '§ 799', 'art 2', 'art 710', '§ 799', '§ 799', '§ 799', '§ 799', '§ 799', '§ 799', '§ 799', '§ 799', '§ 799', 'art 790', '§ 790', '§ 790', '§ 790', '§ 790', '§ 790', 'art 792', '§ 799', 'art 790', '§ 799', 'art 791', 'art 791', '§ 799', 'art 707', '§ 799', 'art 9', 'art 9', '§ 799', 'art 51', 'art 799', 'art 799', 'art 799', '§ 799', 'art 799']

Skip Navigation HomeHelpResourcesContact Us Advanced Search Start of Main Content Testing of Certain High Production Volume Chemicals: Third Group of Chemicals This Proposed Rule document was issued by the Environmental Protection Agency (EPA) For related information, Open Docket Folder Show agency attachment(s) ENVIRONMENTAL PROTECTION AGENCY
SummaryEPA is proposing a test rule under section 4(a)(1)(B) of the Toxic Substances Control Act (TSCA) that would require manufacturers, importers, and processors of certain high production volume (HPV) chemicals to conduct testing to obtain screening level data for health and environmental effects and chemical fate.
DatesComments must be received on or before May 26, 2010.
AddressesSubmit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2009-0112, by one of the following methods:
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-2009-0112. 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 specialarrangements should be made for deliveries of boxed information. Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2009-0112. 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. 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.
Supplementary InformationI. General InformationA. 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 § 799.5089(j) of the proposed regulatory text. Any use of the term “manufacture” in this proposed rule will encompass “import,” unless otherwise stated. In addition, as described in Unit V., once the Agency issues a final rule, any person who exports, or intends to export, any of the chemical substances included in the final rule will be subject to the export notification requirements in 40 CFR part 707, subpart D. Potentially affected entities may include, but are not limited to: Manufacturers (defined by statute to include importers) of one or more of the 29 subject chemical substances (NAIC codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.
Processors of one or more of the 29 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 § 799.5089(b) of the proposed regulatory text. If you have any questions regarding the applicability of this action to a particular entity, consult either technical person listed underFOR 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 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.
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 May 26, 2010, 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 underADDRESSES. If such a request is received, EPA will announce the scheduling of the public meeting in a subsequent document in theFederal 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 subsequentFederal Registerdocument announcing the public meeting.II. BackgroundA. 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 the 29 chemical substances listed in this proposed rule 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), repeated dose toxicity, and developmental and reproductive toxicity. The chemical substances are HPV chemicals, i.e., chemical substances 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 aFederal Registernotice which published on December 26, 2000 (Ref. 1).
Of the 207 chemical substances, 159 no longer meet the HPV criterion; 3 already have data that meets needs identified in this proposed rule; and 16, while meeting the production volume criterion for HPV, appear to lack the exposure data necessary to support TSCA section 4(a)(1)(B) findings. Therefore, these 178 chemical substances are not being considered for testing by EPA at this time. The remaining 29 chemical substances are addressed in this proposed TSCA section 4(a) test rule. These conclusions are based primarily on information reported in the 2006 TSCA Inventory Update Rule (IUR) (40 CFR part 710) and a 2006 TSCA Preliminary Assessment Information Reporting (PAIR) rule issued for the HPV orphan chemicals (Ref. 10). EPA also sought and considered, when available, information from other data sources (e.g., the Toxics Release Inventory (TRI), the National Occupational Exposure Survey (NOES)).B. What is the Agency’s Authority for Taking this Action?EPA is proposing this test rule under TSCA section 4(a)(1)(B) (15 U.S.C. 2603(a)(1)(B)), which directs EPA to require by rule that manufacturers and/or processors of chemical substances and mixtures conduct testing, if the EPA Administrator finds that:
In this proposed test 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 chemicals specified in Table 2 in § 799.5089(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?In April 1998, EPA initiated a national effort to make certain basic information about the environmental fate and potential health and environmental hazards associated with the most widespread chemicals in commerce 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 (the Organization for Economic Cooperation and Development (OECD) HPV Screening Information Data Sets (SIDS) Program; and the International Council of Chemical Associations (ICCA) HPV Initiative), and TSCA section 4 test rules. The voluntary HPV Challenge Program 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 the voluntary HPV Challenge Program through data reported under the IUR during 1990. The SIDS data set sought by the voluntary HPV Challenge Program was developed by OECD, of which the United States is a member. The SIDS provides an internationally agreed upon set of test data for screening HPV chemicals for human and environmental hazards, and assists the Agency and others in making an informed, preliminary judgment about the hazards of HPV chemicals.
The voluntary HPV Challenge Program was 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 beingcoordinated by the OECD to secure basic hazard information on HPV chemicals in use worldwide, including some of those on the 1990 U.S. 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).
After EPA publishes the final rule based on the proposed rule, EPA intends to make the information collected under the final rule available to the public, other Federal agencies, and any other interested parties. This information will be on its website (http://www.epa.gov/chemrtk) and in the docket for the final rule identified underADDRESSES. As appropriate, this information will be used to ensure a scientifically sound basis for risk assessment/management actions.D. Why is this Proposed Rule Focusing on HPV Chemicals and SIDS Testing?This proposed rule pertains to HPV chemicals, which are manufactured or imported in amounts equal to or greater than 1 million lbs. per year, which EPA determined account for 95% of total chemical production in the United States (Ref. 8, p. 32296). 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. 12). Of the over 2,800 U.S. HPV chemicals 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.
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).Data on the six SIDS endpoints 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 Would the Data Developed Under this Test Rule Be Used?EPA would use the data obtained from the rule proposed in this document to support development of preliminary hazard and risk assessments for the 29 HPV chemicals 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 HPV chemicals 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. EPA uses data from test rules to support such activities as the development of water quality criteria, TRI listings, chemical advisories, and reduction of workplace exposures.
In addition, a key goal of the voluntary HPV Challenge Program was making basic health and environmental effects data for HPV chemicals available to the public as part of EPA's “Right to Know” Initiative. A basic premise of the voluntary HPV Challenge Program is that the public has a right to know about the hazards associated with chemicals in their environment. Everyone—including industry, environmental protection groups, animal welfare organizations, government groups, and the general public, among others—can use the data provided through the HPV Challenge Program, and also data collected on HPV chemicals through other means, including TSCA section 4 testing, to make informed decisions related to the human and the environmental hazards of chemicals that they encounter in their daily lives.F. 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 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.III. EPA Proposed FindingsA. What is the Basis for EPA’s Proposed Rule to Test These Chemical Substances?As indicated in Unit II.B., in order to promulgate a final rule 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 chemical substances. EPA is proposing to require testing of the chemical substances included in this proposed rule based on its preliminary findings under TSCA section 4(a)(1)(B)(i) relating to “substantial” production and “substantial human exposure,” and/or “substantial release to the environment,” 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 inthis proposed rule are listed in Table 2 in § 799.5089(j) of the proposed regulatory text along with their Chemical Abstract Service (CAS) Registry numbers.
The chemical substances included in this proposed rule are listed in § 799.5089(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 proposed rule is produced and/or imported in an amount equal to or greater than 1 million lbs. per year (Ref. 15). These findings are based on:
2. A TSCA section 8(a) PAIR rule (Ref. 10), issued for those HPV orphan chemicals which had been added to the ITC Priority Testing List (Ref. 9). 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. 15).C. Are a Substantial Number of Workers Exposed to These Chemicals?EPA has made preliminary findings that the manufacture, processing, and use of 27 of the 29 chemical substances (Table 1. of Unit III.D.) included in this action result or may result in exposure of a substantial number of workers to the chemical substances.
EPA has performed a chemical-by-chemical analysis for all 29 chemical substances and carefully considered the industrial process and use information along with the commercial and consumer use information from the 2006 IUR and PAIR submissions. Commercial uses are defined as: “Theuse 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 the “Testing of Certain High Production Volume Chemicals-3 (Exposure Findings Supporting Information)” (Ref. 15). Based on the descriptions provided for the IUR uses, EPA has preliminarily concluded that chemical substances with certain reported commercial uses, such as painting contractor, etc., 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. EPA’s exposure findings document (Ref. 15) discusses the basis of EPA’s preliminary “substantial exposure” finding for workers. The Agency also solicits comment regarding the number of workers potentially exposed to the chemical substances identified in this proposed rule.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 20 of the chemical substances included in this action result or may result in exposure to a substantial number of consumers (Ref. 15). EPA reviewed the consumer use information reported for the 2006 IUR and carefully considered the nature of those uses. As stated in EPA’s B Policy, the Agency believes, based on experience gained through case-by-case analysis of other chemical substances, that an exposure of 10,000 or more consumers to a chemical substance is a reasonable interpretation of the phrase “substantial human exposure” in TSCA section 4(a)(1)(B)(i) (Ref. 4). Upon completion of the review, EPA has preliminarily concluded that the reported consumer uses for certain of the chemical substances in this action may result in exposures to at least 10,000 consumers, so there is substantial human exposure to these chemical substances.
CAS No.Production Volume2006 IURPAIRMeet Exposure Based Criteria ForManufacturing & Industrial WorkersNOES(number of workers)Meet Exposure Based Criteria for Commercial WorkersMeet Exposure Based Criteria for ConsumersMeet Substantial or Significant Release Criteria (PAIR)2006 IUR or PAIRcommercial/consumer use
83-41-0< 1 million (M)> 10M-50MX
96-22-0> 10M-50M> 10M-50MXX
98-09-9> 1M-10M> 1M-10MX851XXX
98-56-6> 1M-10M> 1M-10MXXXX
111-44-4> 1M-10M< 1MXXXX
127-68-4> 1M-10M< 1MX9,386X
506-51-4< 1M> 1M-10MX1,281X
506-52-5< 1M> 1M-10MX1,565X
515-40-2> 1M-10M> 1M-10MXXXX
2494-89-5> 1M-10M> 1M-10MXXXX
5026-74-4> 1M-10M> 1M-10MX952X
22527-63-5> 1M-10M> 1M-10MXXXX
24615-84-7> 1M-10M< 1MXXXX
25321-41-9> 1M-10M< 1MX2,843X
25646-71-3> 1M-10M< 1MXXXX
52556-42-0> 1M-10M> 1M-10MXXXX
61788-76-9> 10M-50M> 1M-10MX176,314XXX
65996-79-4> 10M-50M> 1M-10MXXXX
65996-82-9> 100M-1 billion (B)> 100M-1BXXXX
65996-89-6> 1B> 1BX761XXXX
65996-92-1> 100M-1B> 100M-1BXXXX
68082-78-0> 1M-10M> 1M-10MX41,153X
68187-57-5> 100M-1B> 100M-1BXXXX
68442-60-4> 1M-10M> 1M-10MXXXX
68610-90-2> 1M-10M> 1M-10MXX
68988-22-7> 10M-50M> 10M-50MX
70693-50-4> 1M-10M> 1M-10MXXXX
72162-15-3> 1M-10M< 1MX64,227X
73665-18-6> 50M-100M> 100M-1BXXXX
E. Are Substantial Quantities of These Chemicals Released to the Environment?EPA has made preliminary findings that three chemical substances, benzene, 1,2-dimethyl-3-nitro-acetaldehyde (CAS No. 83-41-0); tar oils, coal (CAS No. 65996-89-6); and 1,4-benzenedicarboxylic acid, 1,4-dimethyl ester, manuf. of, by-products from (CAS No. 68988-22-7) enter or may reasonably be anticipated to enter the environment in substantial quantities. These findings are based upon their reported PAIR data.
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. 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), TOXLINE, and National Technical Information Service (NTIS). EPA also searched for available data as summarized in its HPV Information System (Ref. 50). 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 HPV Challenge Program website (http://www.epa.gov/chemrtk): “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).
Section 799.5089(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 chemicals 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); repeated 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.G. Can Other Data Meet the Requirements for the Testing Proposed in this Action?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. 13) for each such study to facilitate EPA’s review of the full study report or publication. Persons who respond tothis 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.’’
Persons who believe that adequate information regarding a chemical subject to this proposed rule can be developed using a category or the Structure-Activity Relationships (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.H. Is Testing Necessary for These Chemical Substances?EPA knows of no other means to generate the SIDS data other than the testing proposed in this document, and therefore believes that conducting the needed SIDS testing identified for the 29 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. EPA also believes it’s important to make these data available to satisfy the “Right-to-Know” principles included in the HPV Challenge Program goals.IV. Proposed TestingA. What Testing is Being Proposed in this Action?EPA is proposing specific testing and reporting requirements for the chemical substances specified in § 799.5089(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 chemical substance’s n-Octanol/Water Partition Coefficient (log 10 basis; “log K ow”). 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. 23) 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 recognizing 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 (40 CFR 799.6755—shake flask) will work and Method B (ASTM E 1147-92(2005)) and Method C (40 CFR 799.6756—generator column) become more suitable, especially Method C. The proposed test methodologies have been developed to meet a wide variety ofneeds; 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.
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.
Physical/chemical propertiesWater 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.
For the “Aquatic Toxicity” endpoint, the OECD HPV SIDS Program recognizes that, for certain chemical substances, acute toxicity studies are of limitedvalue 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 determined based on the test substance’s measured log K 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 § 799.5089(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 § 799.5089(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 § 799.5089(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 § 799.5089(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. 24, 36, and 37). A chemical 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 substance in the surrounding environment (Ref. 37). For the purposes of this proposed rule, 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. 38). 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” under TSCA sections 5 and 26(c) (Ref. 39; see also 40 CFR 721.3)). EPA considers the difference between the log K ow of 4.3 cited in the 1989Federal Registerdocument (Ref. 39) and the log K ow value of 4.2 cited in this proposed TSCA section 4 test rule to be negligible.
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 knownchemical 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). 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.
Certain of the chemicals 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. 40). As described in that guidance, such chemicals 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 chemicals 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 chemicals that are listed in the proposed regulatory text are solely closed system intermediates as defined in the voluntary HPV Challenge Program guidance document (Ref. 40). Persons who believe that a chemical 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 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 rule.B. When Would any Testing Imposed by this Proposed Rule 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 theFederal 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 § 799.5089(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, with 40 CFR Part 790—Procedures Governing Testing Consent Agreements and Test Rules (except for paragraphs (a), (d), (e), and (f) of § 790.45; § 790.48; paragraph (a)(2) and paragraph (b) of § 790.80; paragraph (e)(1) of § 790.82; and § 790.85), and with 40 CFR Part 792—Good Laboratory Practice Standards.D. What Forms 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” chemical substance. First introduced when EPA compiled the TSCA Chemical Substance Inventory, the term Class 1 chemical 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 chemical 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 § 799.5089(j) of the proposed regulatory text identifies the listed substances as either Class 1 or Class 2 chemical substances.
EPA solicits comment on the proposed alternative approaches to thetesting of Class 2 chemical 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 rule. 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 chemicals which they manufacture or process.
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. 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.
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 2A. 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 kilograms (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)).
The Agency also believes that byproduct manufacturers, impurity manufacturers, manufacturers of naturally occurring chemical substances, manufacturers of non-isolated intermediates, and manufacturers of components of Class 2 chemical 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 forwhom 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.
In addition, you would need to submit a notice of intent to test or an exemption application if: No manufacturer in Tier 1 has notified EPA of its intent to conduct testing.
EPA has published aFederal Registerdocument directing persons in Tier 2 to submit to EPA letters of intent to conduct testing or exemption applications. See § 799.5089(c)(4), (c)(5), (c)(6), and (c)(7) of the proposed regulatory text. The Agency would conditionally approve an exemption application under 40 CFR 790.87, if EPA has received a letter of intent to test or has received (or expects to receive) the test data required under this rule. EPA is not aware of any circumstances in which test rule Tier 1 entities have sought reimbursement from Tier 2 entities either through private agreements or by soliciting the involvement of the Agency under the reimbursement regulations at 40 CFR part 791.f. What would happen if no one submitted a letter of intent to conduct testing? EPA anticipates that it will receive letters of intent to conduct testing for all of the tests specified and chemical substances included in thefinal rule. However, in the event it does not receive a letter of intent for one or more of the tests required by the final rule for any of the chemical substances in the final rule within 30 days after the publication of aFederal Registerdocument notifying Tier 2 processors of the obligation to submit a letter of intent to conduct testing or to apply for an exemption from testing, EPA would notify all manufacturers and processors of the chemical substance of this fact by certified letter or by publishing aFederal Registerdocument specifying the test(s) for which no letter of intent has been submitted. This letter orFederal Registerdocument would additionally notify all manufacturers and processors that all exemption applications concerning the test(s) have been denied, and would give them an opportunity to take corrective action. If no one has notified EPA of its intent to conduct the required testing of the chemical substance within 30 days after receipt of the certified letter or publication of theFederal Registerdocument, all manufacturers and processors subject to the final rule with respect to that chemical substance who are not already in violation of the final rule would be in violation of the final rule.
4. How do the reimbursement procedures work? In the past, persons subject to test rules have independently worked out among themselves their respective financial contributions to those persons who have actually conducted the testing. However, if persons are unable to agree privately on reimbursement, they may take advantage of EPA’s reimbursement procedures at 40 CFR part 791, promulgated under the authority of TSCA section 4(a). These procedures include: The opportunity for a hearing with the American Arbitration Association; publication by EPA of a document in theFederal Registerconcerning the request for a hearing; and the appointment of a hearing officer to propose an order for fair and equitable reimbursement. The hearing officer may base his or her proposed order on the production volume formula set out at 40 CFR 791.48, but is not obligated to do so. Under this proposed rule, amounts manufactured as impurities would be included in production volume (40 CFR 791.48(b)), subject to the discretion of the hearing officer (40 CFR 791.40(a)). The hearing officer’s proposed order may become the Agency’s final order, which is reviewable in Federal court (40 CFR 791.60).F. What Reporting Requirements are Proposed Under this Test Rule?You would be required to submit a final report for a specific test by the deadline indicated as the number of months after the effective date of the final rule, which would be shown in § 799.5089(j) of the proposed regulatory text. EPA is also proposing that a robust summary of the final report for each specific test would be required to be submitted electronically in addition to and at the same time as the final report. The term “robust summary” is used to describe 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 be either an experiment or in some cases an estimation or prediction method. Guidance for the compilation of robust summaries is described in a document entitled “Draft Guidance on Developing Robust Summaries” (Ref. 13). Persons who respond to this request to submit robust summaries are also encouraged to submit the robust summary electronically via the 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.’’ EPA is soliciting comment on this proposed reporting requirement.G. What Would I Need to Do if I Cannot Complete the Testing Required by the Final Rule?A company who submits a letter of intent to test under the final rule and who subsequently anticipates difficulties in completing the testing by the deadline set forth in the final rule may submit a modification request to the Agency, pursuant to 40 CFR 790.55. EPA will determine whether modification of the test schedule is appropriate, and may first seek public comment on the modification.H. Would There be Sufficient Test Facilities and Personnel to Undertake the Testing Proposed Under this Test Rule?EPA’s most recent analysis of laboratory capacity (Ref. 41) indicates that available test facilities and personnel would adequately accommodate the testing proposed in this rule.I. Might EPA Seek Further Testing of the Chemicals in this Proposed Test Rule?If EPA determines that it needs additional data regarding any of the chemical substances included in this proposed rule, the Agency would seek further health and/or environmental effects testing for these chemical substances. Should the Agency decide to seek such additional testing via a test rule, EPA would initiate a separate action for this purpose.V. Export NotificationAny person who exports, or intends to export, one of the chemical substances contained in this proposed rule in any form (e.g., as byproducts, impurities, components of Class 2 chemical substances, etc.) will be subject to the export notification requirements in TSCA section 12(b)(1) and at 40 CFR part 707, subpart D, but only after the final rule is issued and only if the chemical substance is contained in the final rule. Export notification is generally not required for articles, as provided by 40 CFR 707.60(b). Section 12(b) of TSCA states, in part, that any person who exports or intends to export to a foreign country a chemical substance or mixture for which the submission of data is required under TSCA section 4 must notify the EPA Administrator of such export or intent to export. The EPA Administrator in turn will notify the government of the importing country of EPA’s regulatory action with respect to the chemical substance.VI. Economic ImpactsEPA has prepared an economic assessment entitled “Economic Impact Analysis for the Proposed Section 4 Test Rule for High Production Volume Chemicals-3” (Ref. 14), a copy of which has been placed in the docket for this proposed rule. This economic assessment evaluates the potential for significant economic impacts as a result of the testing that would be required by this proposed rule. The analysis covers 29 chemical substances. The total social cost of providing test data on the 29 chemical substances that were evaluated in this economic analysis is estimated to be $10.30 million assuming an average cost scenario. Total costs of compliance to industry are estimated at $10.21 million (Ref. 14).
While legally subject to this test rule, processors of a subject chemical would be required to comply with the requirements of the final rule only if they are directed to do so by EPA as described in § 799.5089(c)(5) and (c)(6) of the proposed regulatory text. EPA would only require processors to test if no person in Tier 1 has submitted a notice of its intent to conduct testing, or if under 40 CFR 790.93, a problem occurs with the initiation, conduct, orcompletion of the required testing or the submission of the required data to EPA. Because EPA has identified at least one manufacturer in Tier 1 for each subject chemical substance, the Agency assumes that, for each chemical substance in this proposed rule, at least one such person will submit a letter of intent to conduct the required testing and that person will conduct such testing and will submit the test data to EPA. Because processors would not need to comply with the proposed rule initially, the economic assessment does not address processors.
The benefits resulting from this proposed test rule are discussed qualitatively in “Economic Impact Analysis for the Proposed Section 4 Test rule for High Production Volume Chemicals-3” (Ref. 14). EPA believes that the net benefits of this proposed rule are positive, but quantification of the benefits of the proposed rule would require more specific information about use patterns and preferences than is available.VII. Public CommentAs discussed in Units III.C. and III.D., the Agency solicits comment regarding additional information pertaining to potential exposure of workers and consumers, respectively, to the chemical substances identified in this proposed rule. Also, as discussed in Unit III.E., the Agency solicits comment regarding additional information pertaining to environmental releases of the chemical substances identified in this proposed rule.
In addition, EPA solicits comment on the proposed and alternative approaches to the testing of Class 2 chemical substances, whether the proposed approach for testing Class 1 chemical substances (i.e., that each Class 1 chemical substance be tested at a purity of 99% or more) should be applied to any Class 2 chemical substances, and whether the proposed or alternative approaches for the testing of Class 2 chemical substances (i.e., that a representative sample of each Class 2 substance be tested) should be applied to any Class 1 chemical substances.VIII. Materials in the DocketAs indicated underADDRESSES, a docket has been established for this proposed rule under docket ID number EPA-HQ-OPPT-2009-0112. The following is a listing of the documents that have been placed in the docket for this proposed rule. The docket includes information considered by EPA in developing this proposed rule, including the documents listed in this unit, which are physically located in the docket. In addition, interested parties should consult documents that are referenced in the documents that EPA has placed in the docket, regardless of whether these referenced documents are physically located in the docket. For assistance in locating documents that are referenced in documents that EPA has placed in the docket, but that are not physically located in the docket, please consult either technical person listed underFOR FURTHER INFORMATION CONTACT. The docket is available for review as specified underADDRESSES.
1. EPA. Data Collection and Development on High Production Volume (HPV) Chemicals; Notice.Federal Register(65 FR 81686, December 26, 2000) (FRL-6754-6).
2. EPA. Testing of Certain High Production Volume Chemicals; Proposed Rule.Federal Register(65 FR 81658, December 26, 2000) (FRL-6758-4).
3. EPA. Testing of Certain High Production Volume Chemicals; Final Rule.Federal Register(71 FR 13708, March 16, 2006) (FRL-7335-2).
4. EPA. TSCA Section 4(a)(1)(B) Final Statement of Policy; Criteria for Evaluating Substantial Production, Substantial Release, and Substantial or Significant Human Exposure; Notice.Federal Register(58 FR 28736, May 14, 1993).
8. EPA. TSCA Section 4(a)(1)(B) Proposed Statement of Policy; Notice.Federal Register(56 FR 32294, July 15, 1991).
9. EPA. Sixty-Third Report of the TSCA Interagency Testing Committee to the Administrator of the Environmental Protection Agency; Receipt of Report and Request for Comments; Notice.Federal Register(73 FR 65486, November 3, 2008) (FRL-8387-6).
10. EPA. Preliminary Assessment Information Reporting; Addition of Certain Chemicals. Final Rule and Technical Corrections.Federal Register(71 FR 47122, August 16, 2006) (FRL-7764-9).
11. EPA. Testing of Certain High Production Volume Chemicals; Second Group of Chemicals; Proposed Rule.Federal Register(73 FR 43314, July 24, 2008) (FRL-8373-9).
38. EPA. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances; Notice.Federal Register(64 FR 60194, November 4, 1999) (FRL-6097-7). Available on-line at: http://www.epa.gov/oppt/newchems/pubs/pbtpolcy.htm.
39. EPA. Significant New Use Rules; General Provisions for New ChemicalFollow-Up; Final Rule.Federal Register(54 FR 31298, July 27, 1989).
48. EPA. Toxic Substances; Test Rule Development and Exemption Procedures; Interim Final Rule.Federal Register(50 FR 20652, May 17, 1985).
49. EPA. Toxic Substances Control Act; Data Reimbursement; Final Rule.Federal Register(48 FR 31786, July 11, 1983).
53. ASTM International. Standard Test Method for estimating Acute Oral Toxicity in Rats. ASTM E 1163-98(2002). 2002.IX. Statutory and Executive Order ReviewsA. Executive Order 12866Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), this proposed rule is not a “significant regulatory action” subject to review by the Office of Management and Budget (OMB) under Executive Order 12866.
EPA has prepared an economic analysis of this proposed action, which is contained in a document entitled “Economic Impact Analysis for the Proposed Section 4 Test Rule for High Production Volume Chemicals-3” (Ref. 14). A copy of the economic analysis is available in the docket for this proposed rule and is summarized in Unit VI.B. Paperwork Reduction ActThis proposed rule does not impose any new or amended paperwork collection requirements that would require additional review and/or approval by OMB under the Paperwork Reduction Act (PRA) 44 U.S.C. 3501 et seq. Although the activities are approved, OMB has specified that the additional burden associated with a new test rule is not covered by the ICR until the final rule is effective. The information collection requirements contained in TSCA section 4 test rules have already been approved by OMB under PRA, and have been assigned OMB control number 2070-0033 (EPA ICR No. 1139). In the context of developing a new test rule, the Agency must determine whether the total annual burden covered by the approved ICR needs to be amended to accommodate the burden associated with the new test rule. If so, the Agency must submit an Information Correction Worksheet (ICW) to OMB and obtain OMB approval of an increase in the total approved annual burden in the OMB inventory. The Agency’s estimated burden for this proposed test rule is provided in the economic analysis (Ref. 14).
Under PRA, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information that is subject to approval under PRA, unless it displays a currently valid OMB control number. The OMB control numbers for the EPA regulations codified in chapter 40 of the CFR, after appearing in the preamble of the final rule, are listed in 40 CFR part 9, displayed either by publication in theFederal Registeror by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers in certain EPA regulations is consolidated in 40 CFR part 9.
The estimated burden of the information collection activities related to export notification is estimated to average 1 burden hour for each chemical/country combination for an initial notification and 0.5 hours for each subsequent notification (Ref. 14). In estimating the total burden hours approved for the information collection activities related to export notification, the Agency has included sufficientburden hours to accommodate any export notifications that may be required by the Agency’s issuance of final chemical test rules. As such, EPA does not expect to need to request an increase in the total burden hours approved by OMB for export notifications.
Comments are requested on the Agency’s need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques. Send comments to EPA as part of your overall comments on this proposed rule in the manner specified underADDRESSES. In developing the final rule, the Agency will address any comments received regarding the information collection requirements contained in this proposed rule.C. Regulatory Flexibility ActPursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., after considering the potential economic impacts of this proposed rule on small entities, the Agency hereby certifies that this proposed rule would not have a significant adverse economic impact on a substantial number of small entities. The factual basis for the Agency’s determination is presented in the small entity impact analysis prepared as part of the economic analysis for this proposed rule (Ref. 14), which is summarized in Unit VI., and a copy of which is available in the docket for this proposed rule. The following is a brief summary of the factual basis for this certification.
Two factors are examined in EPA’s small entity impact analysis (Ref. 14) in order to characterize the potential small entity impacts of this proposed rule on small business: The size of the adverse economic impact (measured as the ratio of the cost to sales or revenue).
The total number of small entities that experience the adverse economic impact.Section 601(3) of RFA establishes as the default definition of “small business” the definition used in section 3 of the Small Business Act, 15 U.S.C. 632, under which SBA establishes small business size standards (13 CFR 121.201). For this proposed rule, EPA has analyzed the potential small business impacts using the size standards established under this default definition. The SBA size standards, which are primarily intended to determine whether a business entity is eligible for government programs and preferences reserved for small businesses (13 CFR 121.101), “seek to ensure that a concern that meets a specific size standard is not dominant in its field of operation.” (13 CFR 121.102(b)). See section 632(a)(1) of the Small Business Act. In analyzing potential impacts, RFA recognizes that it may be appropriate at times to use an alternate definition of small business. As such, section 601(3) of RFA provides that an agency may establish a different definition of small business after consultation with the SBA Office of Advocacy and after notice and an opportunity for public comment. Even though the Agency has used the default SBA definition of small business to conduct its analysis of potential small business impacts for this proposed rule, EPA does not believe that the SBA size standards are generally the best size standards to use in assessing potential small entity impacts with regard to TSCA section 4(a) test rules.
For each manufacturer of the 29 chemical substances covered by thisproposed rule, the parent company (ultimate corporate entity or UCE) was identified and sales and employment data were obtained for companies where data was publicly available. The search determined that there were 54 affected UCEs. Sales and employment data could be found for 52 of these UCEs (96%). Two companies could not be classified as small or large because there were no employment data available, but were still included in the small business impact analysis.
Any comments regarding the impacts that this action may impose on small entities, or regarding whether the Agency should consider establishing an alternate definition of small business to be used for analytical purposes for future test rules and what size cutoff may be appropriate, should be submitted to the Agency in the manner specified underADDRESSES.D. Unfunded Mandates Reform ActPursuant to Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, EPA has determined that this proposed rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any 1 year. It is estimated that the total aggregate costs of this proposed rule to the private sector, which are summarized in Unit VI., would be $10.21 million. The total annualized costs of this proposed rule to the private sector are estimated to be $3.61 and 3.89 million using a 3% and 7% discount rate over 3 years (average cost scenario). In addition, since EPA does not have any information to indicate that any State, local, or tribal government manufactures or processes the chemical substances covered by this action such that the final rule would apply directly to State, local, or tribal governments, EPA has determined that this proposed rule would not significantly or uniquely affect small governments. Accordingly, this proposed rule is not subject to the requirements of sections 202, 203, 204, and 205 of UMRA.E. Executive Order 13132Under Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), EPA has determined that this proposed rule does not have “federalism implications” because it will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in the Executive Order. This proposed rule would establish testing and recordkeeping requirements that apply to manufacturers (including importers) and processors of certain chemical substances. Because EPA has no information to indicate that any State or local government manufactures or processes the chemical substances covered by this action, this proposed rule does not apply directly to States and localities and will not affect State and local governments. Thus, Executive Order 13132 does not apply to this proposed rule.F. Executive Order 13175Under Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has determined that this proposed rule does not have tribal implications because it will not have any affect on tribal governments, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in the Executive Order. As indicated previously, EPA has no information to indicate that any tribal government manufactures or processes the chemical substances covered by this action. Thus, Executive Order 13175 does not apply to this proposed rule.G. Executive Order 13045This proposed rule is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because it does not establish an environmental standard intended to mitigate health or safety risks, will not have an annual effect on the economy of $100 million or more, nor does it otherwise have a disproportionate effect on children. This proposed rule would establish testing and recordkeeping requirements that apply to manufacturers (including importers) and processors of certain chemical substances, and would result in the development of data about those chemical substances that can subsequently be used to assist the Agency and others in determining whether the chemical substances in this proposed rule present potential risks, allowing the Agency and others to take appropriate action to investigate and mitigate those risks.H. Executive Order 13211This proposed rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because it is unlikely to have any significant adverse effect on the supply, distribution, or use of energy.I. National Technology Transfer and Advancement ActSection 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note), directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistentwith applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.
This proposed rule involves technical standards because it proposes to require the use of particular test methods. If the Agency makes findings under TSCA section 4(a), EPA is required by TSCA section 4(b) to include specific standards or test methods that are to be used for the development of the data required in the test rules issued under TSCA section 4. For some of the testing that would be required by the final rule, EPA is proposing the use of voluntary consensus standards issued by ASTM International and ISO which evaluate the same type of toxicity as the TSCA 799 test guidelines and OECD test guidelines, where applicable. Copies of the 17 ASTM International and ISO standards referenced in the proposed regulatory text at § 799.5089(h) have been placed in the docket for this proposed rule. You may obtain copies of the ASTM International standards from the American Society for Testing and Materials International, 100 Bar Harbor Dr., West Conshohocken, PA 19428-2959, and copies of the ISO standards from the International Organization for Standardization, Case Postale, 56 CH-1211 Genève 20 Switzerland. In the final rule, EPA intends to seek approval from the Director of theFederal Registerfor the incorporation by reference of the ASTM International and ISO standards used in the final rule in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
EPA is not aware of any potentially applicable voluntary consensus standards which evaluate partition coefficient (n-octanol/water) generator column, water solubility (column elution and generator column), acute inhalation toxicity, bacterial reverse mutations, in vivo mammalian bone marrow chromosomal aberrations, combined repeated dose with reproductive/developmental toxicity screen, repeated dose 28-day oral toxicity screen, or the reproductive developmental toxicity screen which could be considered in lieu of the TSCA 799 test guidelines, 40 CFR 799.6756, 799.6784, 799.6786, 799.9130, 799.9510, 799.9538, 799.9365, 799.9305, and 799.9355, respectively, upon which the test standards in this proposed rule are based. The Agency invites comment on the potential use of voluntary consensus standards in this proposed rule, and, specifically, invites the public to identify potentially applicable consensus standard(s) and to explain why such standard(s) should be used here.J. Executive Order 12898This proposed rule does not have an adverse impact on the environmental and health conditions in low-income and minority communities that require special consideration by the Agency under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). The Agency believes that the information collected under this proposed rule, if finalized, will assist EPA and others in determining the potential hazards and risks associated with the chemical substances covered by this proposed rule. Although not directly impacting environmental justice-related concerns, this information will enable the Agency to better protect human health and the environment, including in low-income and minority communities.
List of Subjects in 40 CFR Part 799Environmental protection, Chemicals, Hazardous substances, Laboratories, Reporting and recordkeeping requirements.
Therefore, it is proposed that 40 CFR chapter I be amended as follows:Part 799 Identification of Specific Chemical Substance and Mixture Testing Requirements1. The authority citation for part 799 continues to read as follows:
§ 799.5089
Chemical testing requirements for certain high production volume chemicals; third group of chemicals.
(c) If I am subject to this section, when must I comply with it? (1) (i) Persons subject to this section are divided into two groups, as set forth in Table 1 of this paragraph: Tier 1 (persons initially required to comply) and Tier 2 (persons not initially required to comply). If you are subject to this section, you must determine if you fall within Tier 1 or Tier 2, based on Table 1 of this paragraph.
Tier 1 (Persons initially required to comply with this section)Tier 2 (Persons not initially required to comply with this section)
Persons not otherwise specified in column 2 of this table that manufacture (as defined at TSCA section 3(7)) or intend to manufacture a chemical substance included in this section.Tier 2A. Persons who manufacture (as defined at TSCA section 3(7)) or intend to manufacture a chemical substance included in this section 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 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 kilogram (kg) (1,100 lbs.) annually (as described at 40 CFR 790.42(a)(4)); or—For research and development (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 chemical substance included in this section (see 40 CFR 790.42(a)(2)).
(4) If no person in Tier 1 has notified EPA of its intent to conduct one or more of the tests required by this section on any chemical substance listed in Table 2 in paragraph (j) of this section within 30 days after the effective date of the final rule, EPA will publish aFederal Registerdocument that would specify the test(s) and the chemical substance(s) for which no letter of intent has been submitted and notify manufacturers in Tier 2A of their obligation to submit a letter of intent to test or to apply for an exemption from testing.
(5) If you are in Tier 2A (as specified in Table 1 in paragraph (c) of this section) with respect to a chemical substance listed in Table 2 in paragraph (j) of this section, and if you manufacture, or intend to manufacture, this chemical substance as of [30 days after date of publication of the final rule in the Federal Register], or within 30 days after publication of theFederal Registerdocument described in paragraph (c)(4) of this section, you must, for each test specified for that chemical substance in the document described in paragraph (c)(4) of this section, either submit to EPA a letter of intent to test or apply to EPA for an exemption from testing. The letter of intent to test or the exemption application must be received by EPA no later than 30 days after publication of theFederal Registerdocument described in paragraph (c)(4) of this section.
(6) If no manufacturer in Tier 1 or Tier 2A has notified EPA of its intent to conduct one or more of the tests required by this section on any chemical substance listed in Table 2 in paragraph (j) of this section within 30 days after the publication of theFederal Registerdocument described in paragraph (c)(4) of this section, EPA will publish anotherFederal Registerdocument that would specify the test(s) and the chemical substance(s) for which no letter of intent has been submitted, and notify processors in Tier 2B of their obligation to submit a letter of intent to test or to apply for an exemption from testing.
(7) If you are in Tier 2B (as specified in Table 1 in paragraph (c) of this section) with respect to a chemical substance listed in Table 2 in paragraph (j) of this section, and if you process, or intend to process, this chemical substance as of [30 days after date of publication of the final rule in the Federal Register], or within 30 days after publication of theFederal Registerdocument described in paragraph (c)(6) of this section, you must, for each test specified for that chemical substance in theFederal Registerdocument described in paragraph (c)(6) of this section, either submit to EPA a letter of intent to test or apply to EPA for an exemption from testing. The letter of intent to test or the exemption application must be received by EPA no later than 30 days after publication of theFederal Registerdocument described in paragraph (c)(6) of this section.
(8) If no manufacturer or processor has notified EPA of its intent to conduct one or more of the tests required by this section for any of the chemical substances listed in Table 2 in paragraph (j) of this section within 30 days after the publication of theFederal Registerdocument described in paragraph (c)(6) of this section, EPA will notify all manufacturers and processors of those chemical substances of this fact by certified letter or by publishing aFederal Registerdocument specifying the test(s) for which no letter of intent has been submitted. This letter orFederal Registerdocument will additionally notify all manufacturers and processors that all exemption applications concerning the test(s) have been denied, and will give the manufacturers and processors of the chemical substance(s) an opportunity to take corrective action.
(9) If no manufacturer or processor has notified EPA of its intent to conduct one or more of the tests required by this section for any of the chemical substances listed in Table 2 in paragraph (j) of this section within 30 days after receipt of the certified letter or publication of theFederal Registerdocument described in paragraph (c)(8) of this section, all manufacturers and processors subject to this section with respect to that chemical substance who are not already in violation of thissection will be in violation of this section.
83-41-0Benzene, 1,2-dimethyl-3-nitro-1A1, A2, A3, A4, A5, D, E2, F1
96-22-03-Pentanone1E1, F2
98-56-6Benzene, 1-chloro-4-(trifluoromethyl)-1A4, B, C1, F2
111-44-4'Ethane, 1,1'-oxybis[2-chloro-1C6, F1
506-51-41-Tetracosanol1A2, A3, A4, A5, B, C1, D, E1, E2, F1
506-52-51-Hexacosanol1A2, A3, A4, A5, C1, D, E1, E2, F1
24615-84-72-Propenoic acid, 2-carboxyethyl ester1A1, A2, A3, A4, A5, B, C1, E1, E2, F1
25321-41-9Benzenesulfonic acid, dimethyl-1A2, A3, A4, A5, B, C1, D, E1, E2, F1
25646-71-3Methanesulfonamide, N-[2-[(4-amino-3-methylphenyl)ethylamino]ethyl]-, sulfate (2:3)1A1, A2, A3, A4, A5, B, C1, F1
52556-42-01-Propanesulfonic acid, 2-hydroxy-3-(2-propenyloxy)-, sodium salt (1:1)1A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1
61788-76-9Alkanes, chloro2A2, A3, A4, A5, B,
65996-79-4Solvent naphtha (coal)2A3, A4, A5, B, C1, D, E1, E2, F1
65996-82-9Tar oils, coal2A3, A4, A5, B, C1, D, E1, E2, F1
65996-89-6Tar, coal, high-temperature2A4, A5, B, C1, D, E1, E2, F1
65996-92-1Distillates (coal tar)2A3, A4, A5, B, C1, D, E1, E2, F2
68187-57-5Pitch, coal tar-petroleum2A4, A5, B, C6, D, E1, E2, F1
68988-22-71,4-Benzenedicarboxylic acid, 1,4-dimethyl ester, manuf. of, by-products from2A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1
73665-18-6Extract residues (coal), tar oil alk., naphthalene distn. residues2A2, A3, A4, A5, B, C1, D, E1, E2, F1
Testing CategoryTestTest Requirements and ReferencesSpecial Conditions
Physical/Chemical PropertiesA1. Melting Point: ASTM E 324-99 (capillary tube)2. Boiling Point: ASTM E 1719-05 (ebulliometry)3. Vapor Pressure: ASTM E 1782-03 (thermal analysis)4. n-Octanol/Water Partition Coefficient (log 10 basis) or log K ow: (See Special Conditions for the log K ow test requirement and select the appropriate method to use, if any, from those listed in this 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)5. Water Solubility: (See Special Conditions for the water solubility test requirement and select the appropriate method to use, if any, from those listed in this 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) n-Octanol/Water Partition Coefficient or log K ow:Which method is required, if any, is determined by the test substance's estimated i 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. Water Solubility:Which method is required, if any, is determined by the test substance's estimated ii 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 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.
Environmental Fate and Pathways—Ready BiodegradationBFor B, consult ISO 10634 for guidance, and choose one of the methods listed in this column:1. ASTM 1720-01 (sealed vessel CO 2 production test)OR2. ISO 14593 (CO 2 headspace test)OR3. ISO 7827 (analysis of DOC)OR4. ISO 9408 (determination of oxygen demand in a closed respirometer)OR5. ISO 9439 (CO 2 evolution test)OR6. ISO 10707 (closed bottle test)OR7. ISO 10708 (two-phase closed bottle test)Which method is required, if any, is determined by the test substance's physical and chemical properties, including its water solubility. ISO 10634 provides guidance for selection of an appropriate test method for a given test substance. Test sponsors must provide in the final study report the underlying rationale for the method selected.
Aquatic ToxicityC1For C1, Test Group 1 or Test Group 2 listed in this column must be used to fulfill the testing requirements—see Special Conditions. Test Group 1 for C1:1. Acute Toxicity To Fish: ASTM E 729-96(2002)2. Acute Toxicity To Daphnia: ASTM E 729-96(2002)3. Toxicity To Plants (Algae): ASTM E 1218-04e1 Test Group 2 for C1:1. Chronic Toxicity To Daphnia: ASTM E 1193-97(2004)2. Toxicity To Plants (Algae): ASTM E 1218-04e1The following are the Special Conditions for C1, C2, C3, C4, C5, and C7 testing; there are no Special Conditions for C6.Which test group is required is determined by the test substance's measured log K OW as obtained under Test Category A, or using an existing measured log K OW. iii If log K ow< 4.2: Test Group 1 is required.If log K ow≥ 4.2: Test Group 2 is required.
C2For C2, Test Group 1 or Test Group 2 listed in this column must be used to fulfill the testing requirements—see Special Conditions. Test Group 1 for C2:1. Acute Toxicity To Daphnia: ASTM E 729-96(2002)2. Toxicity To Plants (Algae): ASTM E 1218-04e1 Test Group 2 for C2:1. Chronic Toxicity To Daphnia: ASTM E 1193-97(2004)2. Toxicity To Plants (Algae): ASTM E 1218-04e1
C3For C3, Test Group 1 or Test Group 2 listed in this column must be used to fulfill the testing requirements—see Special Conditions. Test Group 1 for C3:1. Acute Toxicity To Fish: ASTM E 729-96(2002)2. Toxicity To Plants (Algae): ASTM E 1218-04e1 Test Group 2 for C3:1. Chronic Toxicity To Daphnia: ASTM E 1193-97(2004)2. Toxicity To Plants (Algae): ASTM E 1218-04e1
C4For C4, Test Group 1 or Test Group 2 listed in this column must be used to fulfill the testing requirements—see Special Conditions. Test Group 1 for C4:1. Acute Toxicity To Fish: ASTM E 729-96(2002)2. Acute Toxicity To Daphnia: ASTM E 729-96(2002) Test Group 2 for C4:1. Chronic Toxicity To Daphnia: ASTM E 1193-97(2004)2. [Reserved]
C5For C5, Test Group 1 or Test Group 2 listed in this column must be used to fulfill the testing requirements—see Special Conditions. Test Group 1 for C5:1. Acute Toxicity To Daphnia: ASTM E 729-96(2002)2. [Reserved] Test Group 2 for C5:1. Chronic Toxicity To Daphnia: ASTM E 1193-97(2004)2. [Reserved]
C6Toxicity To Plants (Algae): ASTM E 1218-04e1
C7For C7, Test Group 1 or Test Group 2 listed in this column must be used to fulfill the testing requirements—see Special Conditions. Test Group 1 for C7:1. Acute Toxicity To Fish: ASTM E 729-96(2002)2. [Reserved] Test Group 2 for C7:1. Chronic Toxicity To Daphnia: ASTM E 1193-97(2004)2. [Reserved]
Mammalian Toxicity—AcuteDSee Special Conditions for this test requirement and select the method that must be used from those listed in this column. Method A: Acute Inhalation Toxicity (rat): 40 CFR 799.9130 Method B: EITHER:1. Acute (Up/Down) Oral Toxicity (rat): ASTM E 1163-98(2002)OR2. Acute (Up/Down) Oral Toxicity (rat): 40 CFR 799.9110(d)(1)(i)(A)Which testing method is required is determined by the test substance's physical state at room temperature (25°C). For those test substances that are gases at room temperature, Method A is required; otherwise, use either of the two methods listed under Method B.In Method B, 40 CFR 799.9110(d)(1)(i)(A) refers to the OECD 425 Up/Down Procedure. iv Estimating starting dose for Method B: Data from the neutral red uptake basal cytotoxicity assay v using normal human keratinocytes or mouse BALB/c 3T3 cells may be used to estimate the starting dose.
E2Conduct any one of the following three tests for chromosomal damage: In vitro Mammalian Chromosome Aberration Test: 40 CFR 799.9537ORMammalian Bone Marrow Chromosomal Aberration Test (in vivo in rodents: mouse (preferred species), rat, or Chinese hamster): 40 CFR 799.9538ORMammalian Erythrocyte Micronucleus Test [sampled in bone marrow] (in vivo in rodents: mouse (preferred species), rat, or Chinese hamster): 40 CFR 799.9539Persons required to conduct testing for chromosomal damage are encouraged to use the in vitro Mammalian Chromosome Aberration Test (40 CFR 799.9537) to generate the needed data unless known chemical properties (e.g., physical/chemical properties, chemical class characteristics) preclude its use. A subject person who uses one of the in vivo methods instead of the in vitro method to address a chromosomal damage test requirement must submit to EPA a rationale for conducting that alternate test in the final study report.
Mammalian Toxicity—Repeated Dose/Reproduction/DevelopmentalF1Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test: 40 CFR 799.9365ORReproduction/Developmental Toxicity Screening Test: 40 CFR 799.9355ANDRepeated Dose 28-Day Oral Toxicity Study in rodents: 40 CFR 799.9305Where F1 is required, EPA recommends use of the Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (40 CFR 799.9365). However, there may be valid reasons to test a particular chemical using both 40 CFR 799.9355 and 40 CFR 799.9305 to fill Mammalian Toxicity—Repeated Dose/Reproduction/Developmental data needs. A subject person who uses the combination of 40 CFR 799.9355 and 40 CFR 799.9305 in place of 40 CFR 799.9365 must submit to EPA a rationale for conducting these alternate tests in the final study reports. Where F2 or F3 is required, no rationale for conducting the required test need be provided in the final study report.
F2Reproduction/Developmental Toxicity Screening Test: 40 CFR 799.9355
F3Repeated Dose 28-Day Oral Toxicity Study in rodents: 40 CFR 799.9305
(k) Effective date. This section is effective on [30 days after date of publication of the final rule in the Federal Register].
[FR Doc. 2010-3734 Filed 2-24-10; 8:45 am]BILLING CODE 6560-50-S
Attachments View All (0) View document: No documents available. Attachments View All (0) Comment Now! Comment Period Closed May 26 2010, at 11:59 PM ET ID: EPA-HQ-OPPT-2009-0112-0001 Tracking Number: View original printed format: Document Information Date Posted: Feb 25, 2010RIN: 2070-AJ86CFR: 40 CFR Part 799Federal Register Number: 2010-03734 Show More Details Submitter Information Comments24 Comments Received* Comment View Comment See attached file(s) View Comment See attached file(s) View Comment Docket Information This document is contained in EPA-HQ-OPPT-2009-0112 Related Dockets: NoneRelated RINs: NoneRelated Documents: Toxic Substances Control Act Chemical Testing; Receipt of...Toxic Substances Control Act Chemical Testing; Receipt of...Toxic Substances Control Act Chemical Testing; Test Data Related Comments: View all * This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document. Document text and images courtesy of the Federal Register Home Search Advanced Search Browse By Category Learn About Us eRulemaking Program Media Toolkit Agencies Awards & Recognition Enhancements & Fixes Resources Site Data Regulatory Agenda Agency Reports Required by Statute API Overview Developers Help How to use Regulations.gov FAQs Glossary Connect With Contact Us Privacy and Security Notice User Notice Accessibility Statement Partner Sites We the People Federal Register Reginfo Congress.gov USA.gov E-Gov Opengov Participate Today!