Testing of Certain High Production Volume Chemicals:
Federal Register: January 7, 2011 (Volume 76, Number 5)
Rules and Regulations
Page 1067-1093
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr07ja11-4
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 9 and 799
EPA-HQ-OPPT-2007-0531; FRL-8846-9
RIN 2070-AD16
Testing of Certain High Production Volume Chemicals; Second Group of Chemicals
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: EPA is promulgating a final 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.
Page 1068
DATES: This final rule is effective February 7, 2011. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of February 7, 2011. For purposes of judicial review, this final rule shall be promulgated at 1 p.m. eastern daylight/standard time on January 24, 2011.
ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPPT-2007-0531. All documents in the docket are listed on the regulations.gov Web site. Although listed in the index, some information is not publicly available, i.e.,
Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket 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),
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 legal 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 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.
For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
-
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 Sec. 799.5087(j) of the regulatory text.
Any use of the term ``manufacture'' in this document will encompass
``import,'' unless otherwise stated. In addition, as described in Unit
VI., 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 19 subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.
Processors of one or more of the 19 subject chemical substances (NAICS 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 V.E. and consult
Sec. 799.5087(b) of the 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.
-
Background
-
What action is the agency taking?
EPA is promulgating a final test rule under TSCA section 4(a)(1)(B)
(15 U.S.C. 2603(a)(1)(B)) that requires manufacturers and processors of 19 chemical substances to conduct testing for environmental fate
(including 5 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 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 a Federal Register notice which published on December 26, 2000 (Ref. 1).
In the proposed rule for this final rule, published in the Federal
Register of July 24, 2008, EPA proposed Screening Information Data Set
(SIDS) testing for 19 HPV chemicals (Ref. 2). Comments were received on the proposed rule. In consideration of those comments, EPA changed some testing requirements for certain HPV chemicals, as explained in Unit
-
-
However, none of these changes resulted in dropping all testing proposed for any of the chemical substances, and EPA is still requiring testing for each of the 19 HPV chemicals originally proposed for testing in 2008.
This action also follows an earlier testing action for certain HPV chemicals (see the proposed and final rules entitled ``Testing of
Certain High Production Volume Chemicals; Proposed Rule'' (Ref. 3) and
``Testing of Certain High Production Volume Chemicals; Final Rule''
(Ref. 4)).
EPA has also proposed testing for a third group of HPV chemicals
(Ref. 5), and plans to propose testing for additional HPV chemicals as the Agency learns more about these chemical substances with respect to human exposure, release, and sufficiency of data and experience available on their potential hazards.
-
What is the agency's authority for taking this action?
This final rule is being promulgated under TSCA section 4(a) (15
U.S.C. 2603(a)), which directs EPA to require the development of data relevant to assessing whether activities associated with chemical substances and mixtures present an unreasonable risk of injury to health or the environment, when appropriate findings are made. Section 2(b)(1) of TSCA (15 U.S.C. 2603(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, EPA is promulgating this test rule under
TSCA section 4(a)(1)(B) (15 U.S.C. 2603(a)(1)(B)). Section 4(a) of TSCA mandates EPA require by rule that manufacturers and/or processors of
Page 1069
chemical substances and mixtures conduct testing if the EPA
Administrator finds that:
(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 EPA 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 EPA Administrator has made a finding under TSCA section 4(a)(1)(A) or TSCA section 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 TSCA section 4(a)(1)(B)(i) findings. This approach is explained in more detail in EPA's TSCA section 4(a)(1)(B) Final
Statement of Policy published in the Federal Register issue of May 14, 1993 (``B'' policy) (Ref. 6, pp. 28738).
In this final rule, EPA is using 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 Sec. 799.5087(j) of the regulatory text. Following consideration of the public comments received by EPA on the proposed rule (Ref. 2) and production volume information (i.e., 2006 Inventory Update Rule (IUR) data), EPA is making the following findings for the 19 chemical substances under TSCA section 4(a)(1)(B): 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.
-
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 chemical substances 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 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 first identified for this program through data reported under the 1990 IUR. The SIDS data set sought by the 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 being coordinated by 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. 7). This includes agreements to sponsor a U.S.
HPV chemical under either the OECD HPV SIDS Program (Ref. 8), including sponsorship by OECD member countries beyond the United States, or the international HPV Initiative that is being organized by the ICCA (Ref. 9).
Additional details regarding the voluntary HPV Challenge Program and these international efforts were provided in the prior HPV TSCA section 4 rules (Refs. 2-4).
As EPA stated in the first HPV test rule, U.S. data needs that remained unmet in the voluntary HPV Challenge Program or through international efforts could be addressed through TSCA section 4 rulemakings, such as the final test rule promulgated by EPA on March 16, 2006 (Ref. 4). This second final TSCA section 4 HPV SIDS rule addresses the unmet data needs for 19 chemical substances.
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 docket for the final rule identified under ADDRESSES. As appropriate, this information will be used to ensure a scientifically sound basis for risk assessment/management actions.
-
Why is EPA focusing on HPV chemicals and SIDS testing?
This final rule pertains to HPV chemicals, which EPA determined account for 95% of total chemical production in the United States (Ref. 10, p. 32296). EPA found that, of those HPV non-polymeric organic substances 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. 11). Of the over 2,800
U.S. HPV chemicals, 43% had no publicly available basic hazard data.
For the remaining chemical substances, 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 chemical substances that may be found in their environment, their homes, their workplaces, and the products they buy.
SIDS testing evaluates the following six testing endpoints (Ref. 8):
Acute toxicity.
Repeat dose toxicity.
Developmental and reproductive toxicity.
Genetic toxicity (gene mutations and chromosomal aberrations).
Ecotoxicity (studies in fish, Daphnia, and algae).
Page 1070
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 chemical substances and whether additional testing or assessment is necessary.
-
How would the data developed under this final rule be used?
EPA will use the data obtained from this final rule to support development of preliminary hazard and risk assessments for the 19 HPV chemicals subject to the rule. The data will also be used by EPA to set priorities for further testing that may produce hazard information on these chemicals that may be needed by EPA, other Federal agencies, the public, industry, and others, to support adequate risk assessments. As appropriate, this information will be used to ensure a scientifically sound basis for risk characterizations and risk management actions. As such, this effort will 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 actions as the risk management decisions and activities under TSCA, development of water quality criteria, Toxic Release Inventory (TRI) listings, and reduction of workplace exposures.
In addition, a key goal of the 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 HPV Challenge Program was that the public has a right to know about the hazards associated with chemical substances 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 chemical substances that they encounter in their daily lives.
-
-
Response to Public Comments
EPA received a number of comments in response to the proposed rule
(Ref. 2). A summary of those comments and EPA's response to each comment are presented in the document entitled ``Response to Public
Comments'' (Ref. 12). The comments and EPA's ``Response to Public
Comments'' document are available in the docket. The comments on the proposed rule were submitted by the Acetaldehyde Working Group (AWG) of the Vinyl Acetate Council; Albemarle Corporation (Albemarle); American
Chemistry Council (ACC); Chlorinated Paraffins Industry Association
(CPIA); Dyno Nobel, Inc. (Dyno Nobel); and Vertellus Specialties, Inc.
(Vertellus). Comments were also submitted by People for the Ethical
Treatment of Animals (PETA), the Physicians Committee for Responsible
Medicine (PCRM), the Alternatives Research Development Foundation
(ARDF), and the American Anti-Vivisection Society (AAVS). Additional comments submitted by PCRM were also on behalf of the Doris Day Animal
League (DDAL) and the Humane Society of the United States (HSUS). EPA also received comments from numerous private citizens. In response to these comments, EPA made the following changes to the regulatory text in the final rule: 1. The screening test for reproduction/developmental toxicity is not required for 2,4-hexadienoic acid, (E,E)- (Chemical Abstract
Service Registry Number (CASRN) 110-44-1), also known as sorbic acid.
This change is further discussed in Unit VII.A. and in the ``Response to Public Comments'' document (Ref. 12). 2. Screening testing for reproductive/developmental toxicity is not required for ethanedioic acid (CASRN 144-62-7). This change is further discussed in Unit VII.B. and in the ``Response to Public Comments'' document (Ref. 12). 3. Vapor pressure, water solubility, n-Octanol/Water Partition
Coefficient (log 10 basis) or ``log Kow,'' and aquatic toxicity testing are not required for castor oil, oxidized (CASRN 68187-84-8). EPA is also not requiring water solubility or log
Kowtesting for castor oil, sulfated, sodium salt (CASRN 68187-76-8). These changes are further discussed in Unit VII.C. and in the ``Response to Public Comments'' document (Ref. 12). In addition, for castor oil, oxidized (CASRN 68187-84-8), the acute mammalian toxicity test is not required. This change is further discussed in Unit
VII.D. and in the ``Response to Public Comments'' document (Ref. 12). 4. Boiling point is not required for benzenediamine, ar,ar-diethyl- ar-methyl--(CASRN 68479-98-1). This change is further discussed in Unit
VII.E. and in the ``Response to Public Comments'' document (Ref. 12). 5. Acute mammalian toxicity, repeated-dose toxicity, and in vitro mutagenicity tests are not required for alkenes, C12-24, chloro. These changes are further discussed in Unit VII.F. and in the
``Response to Public Comments'' document (Ref. 12).
-
Findings
-
What is the basis for EPA's final rule to test these chemical substances?
As indicated in Unit II.B., in order to promulgate a 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 requiring testing of the chemical substances included in this final test rule based on its findings under TSCA section 4(a)(1)(B)(i) relating to ``substantial'' production and ``substantial human exposure,'' as well as findings under TSCA section 4(a)(1)(B)(ii) and (iii) relating to sufficient data and the need for testing. The chemical substances included in this final rule are listed in Table 2 in Sec. 799.5087(j) of the regulatory text along with their CASRN.
``Substantial production'' of a chemical substance or mixture under
TSCA section 4(a)(1)(B)(i) is generally considered to be aggregate production (including import) volume equaling or exceeding 1 million lbs per year of that chemical substance or mixture and exposure of 1,000 workers or more on a routine or episodic basis to a chemical substance or mixture is considered to be ``substantial exposure.'' See
EPA's ``B'' policy (Ref. 6) for further discussion on how EPA generally evaluates chemical substances or mixtures under TSCA section 4(a)(1)(B)(i).
EPA finds that, under TSCA section 4(a)(1)(B)(i), each of the 19 chemical substances included in this final rule is produced in
``substantial'' quantities and that there is or may be ``substantial human exposure'' to each chemical substance (Ref. 13). Also, for three substances, EPA finds that, under TSCA section 4(a)(1)(B)(i), the substance enters or may reasonably be anticipated to enter the environment in substantial quantities (Ref. 13). In addition, under
TSCA section 4(a)(1)(B)(ii), EPA finds that there are insufficient data and experience to reasonably determine or predict the effects of the manufacture, processing, or use of these chemical
Page 1071
substances, or of any combination of such activities, on human health or the environment. EPA also finds that testing the 19 chemical substances identified in this final rule is necessary to develop such data (TSCA section 4(a)(1)(B)(iii)) (see Unit IV.F.). EPA has not identified any ``additional factors'' as discussed in the ``B'' policy
(Ref. 6) to cause the Agency to use decisionmaking criteria other than the general thresholds described in the ``B'' policy with respect to the chemical substances included in this final rule.
The chemical substances included in this final rule are listed in
Sec. 799.5087(j) of the regulatory text along with their CASRN. For a chemical-by-chemical summary of each of the findings, see Table 1 of this unit.
Table 1--Exposure-Based Findings
Meet exposure
Meet 2006 IUR
based criteria
Meet exposure- Meet exposure- substantial or NLM household
CASRN
production volume
for Mfg &
NOES (number based criteria based criteria significant
chemicals
(lbs)
industrial
of workers) for commercial for consumers
release
database workers
workers
criteria
75-07-0........................ > 100 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.......
X
1,257
Notes: CASRN--Chemical Abstract Service Registry Number, IUR--Inventory Update Rule, M--Million, Mfg--Manufacturing, NOES--National Occupational
Exposure Survey, NLM--National Library of Medicine.
-
Are these chemical substances produced and/or imported in substantial quantities?
EPA finds that each of the chemical substances included in this final rule is produced and/or imported in an amount equal to or greater than 1 million lbs per year (Ref. 13), based on information gathered pursuant to the 2006 IUR (40 CFR part 710), which is the most recently available compilation of TSCA Chemical Substance 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 Ref. 6, p. 28746). A discussion of
EPA's ``substantial production'' finding for each chemical substance included in this final rule is contained in a separate document (Ref. 13).
-
Are a substantial number of workers exposed to these chemical substances?
EPA finds that the manufacture, processing, and use of the 19 chemical substances included in this action result or may result in exposure of a substantial number of workers to the chemical substances.
These chemical substances are used in a wide variety of industrial applications which result in potential exposures to workers, as described in the exposure support document for this final rule (Ref. 13).
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 were required to provide information regarding the commercial and consumer uses of the chemical substance.
In accordance with the Agency's ``B'' policy (Ref. 6), EPA believes, as a general matter, 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 further 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. 6). EPA is not aware of any facts in this case that warrant departure from this policy, and finds that there is or may be substantial human exposure (workers) to these 19 chemical substances.
Besides the 2006 IUR data, EPA also reviewed National Occupational
Exposure Survey (NOES) data developed by the National Institute for
Occupational Safety and Health (NIOSH). The NOES data additionally support EPA's finding that more than 1,000 workers are exposed to each of the 19 chemical substances that are the subject of this final 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
Page 1072
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 chemical substances (Refs. 14-16). 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 final rule, only one chemical's (acetaldehyde, CASRN 75-07-0) production volume decreased from 1986 to 2006 (Ref. 13). 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 2006 IUR submissions can be found in ``Testing of Certain High Production Volume
Chemicals; Second Group of Chemicals (Exposure Findings Supporting
Information)'' (Ref. 13). Based on the nature of the IUR uses, EPA considers that chemical substances with reported commercial uses may result in potential exposure to 1,000 workers or more. The total number of workers reported under the 2006 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'' (CASRN 68647-60-9) and ``Oils, reclaimed'' (CASRN 69029-75-0)) from reporting certain processing and use data under the TSCA section 8(a) 2006 IUR. The exemption was not based on an assessment of the toxicity of the process streams but on the fact that the chemical substances are frequently processed, transported, and stored in vessels that minimize the potential for releases and exposure to workers (Refs. 17 and 18). 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 chemical substances, supporting the finding of substantial human exposure (Ref. 13).
-
Are a substantial number of consumers exposed to these chemical substances?
Based on 2006 IUR data, EPA finds 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. 13). EPA reviewed the consumer use information reported for the 2006 IUR and carefully considered the nature of those uses. Upon completion of the review, EPA concluded that the reported consumer uses for these 13 chemical substances may result in at least 10,000 potentially exposed consumers, thus meeting the exposure based finding for consumers.
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 (see Ref. 13).
The chemical substances reported in the 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 NLM Household Products Database is from a variety of publicly available sources including brand-specific labels and Material Safety
Data Sheets when available from manufacturers and manufacturers' Web sites.
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 further believes, based on experience gained through case-by-case analysis of existing chemical substances, 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. 6). Therefore, EPA finds that there is or may be substantial human exposure (consumers) to these chemical substances.
A discussion of EPA's ``substantial exposure'' finding for consumers is contained in a separate document (see Ref. 13).
-
Are substantial quantities of these chemical substances released to the environment?
EPA finds for three chemical substances in this final rule that there are substantial releases to the environment. One substance, acetaldehyde (CASRN 75-07-0) is included in TRI and has estimated environmental release in 2005 of 13,567,452 lbs (see Ref. 13). TRI contains information about releases of certain chemical substances and management of wastes at a wide variety of sources, including manufacturing operations, certain service businesses, and Federal facilities. Two additional chemical substances (ethanedioic acid (CASRN 144-62-7) and 1,3,5-triazine-1,3,5(2H,4H,6H)-triethanol (CASRN 4719-04- 4)) also meet the substantial release criteria based on the environmental releases from their reported 2006 IUR uses.
EPA believes that in general 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. 6).
A discussion of EPA's ``substantial release to the environment'' finding is contained in a separate document (see Ref. 13).
-
Do sufficient data exist for these chemical substances?
EPA has determined that for the 19 chemical substances for which testing is required under this final rule, there are either no data available on SIDS testing endpoints or these data are insufficient to reasonably determine or predict the effects on human health or the environment that may result from exposures to the chemical substances included in this final rule during the manufacturing, processing, or use of the subject chemical substances.
The finding for insufficient data is based on the results of searches for data on SIDS endpoints by EPA, including available data as summarized on its High Production Volume Information System (HPVIS)
(Refs. 2, 19, and 20). This finding is also based on the results of
EPA's review of studies/data identified by commenters in response to the proposal or identified by EPA after the publication of the proposal to this
Page 1073
final rule. The studies and data submitted or identified subsequent to the proposal were found to be sufficient for some proposed tests of certain chemical substances and those tests are not required for those chemical substances in this final rule (see Unit VII.).
EPA encouraged the submission of existing data on SIDS testing endpoints which are relevant to characterizing the hazard of those chemical substances for which testing was proposed. All such submitted information was carefully evaluated by EPA in the development of the final testing requirements in this rule. However, if persons required to test under this final rule become aware of additional relevant scientifically adequate existing data (including structure-activity relationships (SAR) information or a scientifically defensible category approach) and submit this information to EPA at any time before testing is initiated, the Agency would consider such data to determine if they satisfy the testing requirement and would take appropriate necessary action to ensure that the testing in this rule is no longer required.
In fact, they may submit such information as a requested modification to the testing requirements under 40 CFR 790.55 at anytime as long as the request is made at least 60 days before the reporting deadline for the test in question.
Section 799.5087(j) of the regulatory text lists each chemical substance and the SIDS tests for which adequate data are not currently available to the Agency. The Agency finds that the existing data for one or more of the SIDS testing endpoints for each of the chemical substances listed in Table 2 in Sec. 799.5087(j) of the 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.
-
Is testing necessary for these chemical substances?
As discussed in Unit II.D., data on SIDS testing endpoints, including acute toxicity, repeat dose toxicity, developmental and reproductive toxicity, genetic toxicity (gene mutations and chromosomal aberrations), ecotoxicity (tests in fish, Daphnia, and algae), and environmental fate (five tests for physical/chemical properties
melting point, boiling point, vapor pressure, n-octanol/water partition coefficient, and water solubility
and biodegradation), are necessary in ascertaining the health and environmental effects of the 19 chemical substances in this final rule. EPA knows of no other means to generate the SIDS data other than the testing described in this rule, and therefore 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. EPA also believes it is important to make these data available to satisfy the ``Right-to-Know'' principles included in the HPV Challenge Program goals.
-
-
Final Rule
-
What testing is being required in this action?
EPA is requiring specific testing and reporting requirements for the chemical substances specified in Sec. 799.5087(j) of the regulatory text. The testing requirements for each chemical are denoted by alphanumeric symbols in Table 2 in Sec. 799.5087(j) of the regulatory text. Table 3 in Sec. 799.5087(j) of the regulatory text provides the key to identify the tests denoted by the alphanumeric symbols and lists special conditions which might apply when conducting some of those tests. The test methods listed in Table 3 in Sec. 799.5087(j) of the regulatory text are grouped according to the endpoint that they address. The following endpoints and test standards are required under this final rule; also discussed in this unit are the special conditions which EPA has identified and is requiring for several of the required test standards. 1. Physical/Chemical Properties
Melting Point: American Society for Testing and Materials (ASTM)
E 324-99 (capillary tube) (Ref. 21). (If a Freezing Point: OECD102
(melting point/melting range) (Ref. 25)).
Boiling Point: ASTM E 1719-05 (ebulliometry) (Ref. 22).
Vapor Pressure: ASTM E 1782-08 (thermal analysis) (Ref. 23). n-Octanol/Water Partition Coefficient: Method A (40 CFR 799.6755--shake flask).
Method B (ASTM E 1147-92 (Reapproved 2005)--liquid chromatography) (Ref. 24).
Method C (40 CFR 799.6756--generator column).
Water Solubility: Method A (ASTM E 1148-02 (Reapproved 2008)-- 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 requiring, for those chemical substances for which melting points determinations are needed, that melting points be determined according to the method ASTM E 324-99. 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).
However, ASTM still makes the method available for informational purposes and it can still be purchased from ASTM at the address listed in Sec. 799.5087(h) of the regulatory text.
EPA concludes that ASTM's withdrawal of ASTM E 324-99 does not have negative implications on the validity of the method; therefore, EPA is requiring, for those chemical substances for which melting points determinations are needed, that melting points be determined according to the method ASTM E 324-99.
However, EPA received public comment about testing a substance that is a liquid at room temperature (Ref. 12). In its response, EPA notes that the melting point ideally is identical with the solidification or freezing point. Therefore, a measured freezing point would in this case meet the obligation to report the melting point. Since ASTM E 324-99
(capillary tube) does not specifically include instructions for determining freezing point, EPA is instead requiring, for substances which are liquid at room temperature, OECD 102 (melting point/melting range), which includes guidance for determining freezing point.
For the vapor pressure endpoint, ASTM has updated and revised its test method for vapor pressure (ASTM E 1782-08--thermal analysis) since the time of the proposed rule. Some material related to alternative test methods and some unnecessary descriptive material was omitted in the revision, but the test method itself is unchanged. The updated and revised method (ASTM E 1782-08) is listed as the required test method for the vapor pressure endpoint in this final rule. Note: ASTM issues its test methods under a fixed designation (e.g., E1719);
Page 1074
``the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon (e) indicates an editorial change since the last revision or reapproval'' (Ref. 22).
In addition, ASTM has updated its test method for Measurement of
Aqueous Solubility (ASTM E 1148-02). The test method was reapproved in 2008. There was a minor change in ``Referenced Documents,'' but the test method itself is unchanged. When required, the updated method
(ASTM E 1148-02 (Reapproved 2008)) is listed as the required test method for the ``Water Solubility'' endpoint in this final rule (Ref. 26).
For the log Kowand water solubility endpoints, EPA is requiring 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 Sec. 799.5087(j) of the regulatory text.
For the log Kowendpoint, EPA is requiring that an appropriate selection be made from among three alternative methods for measuring the chemical substance's log Kow. Prior to determining the appropriate standard to use, if any, to measure the n- octanol/water partition coefficient, EPA is recommending that the log
Kowbe 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 requiring that test sponsors must submit with the final study report the underlying rationale for the test standard selected for this endpoint. EPA is requiring this approach in recognition of the fact that depending on the chemical substance's log
Kow,one or more test methods may provide adequate information for determining the log Kow, but that in some instances one particular test method may be more appropriate. In general, EPA believes that the more hydrophobic a subject chemical substance is, Method B (ASTM E 1147-92 (Reapproved 2005)) and especially Method C (40 CFR 799.6756--generator column) become more suitable than Method A (40 CFR 799.6755--shake flask). The required 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 highly recommends that all required n-octanol/water partition coefficient tests be conducted at pH 7 to ensure environmental relevance. The required test standards and log
Kowranges 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 Physical/Chemical Properties
Test requirements
Testing category
and references
Special conditions
Physical/chemical properties n-Octanol/water
n-Octanol/water partition
partition coefficient (log 10 coefficient (log 10 basis) or log Kow: basis) or log Kow:
The appropriate log Which method is
Kow test, if any,
required, if any, would be selected
is determined by from those listed
the test in this column--see substance's
Special Conditions estimated log Kow in the adjacent
as follows: column
Method A: 40 CFR
log Kow 1-4: 2005) (liquid
Method A, B, or C. chromatography)
log Kow range > 4-6:
Method C: 40 CFR
Method B or C. 799.6756 (generator log Kow >6: Method column).
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.
Note: ASTM--American Society for Testing and Materials.
For the ``Water Solubility'' endpoint, EPA is requiring that the 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 requiring that test sponsors submit in the final study report the underlying rationale for the test standard selected for this endpoint.
The required 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 highly recommends that all required water solubility tests be conducted starting at pH 7 to ensure environmental relevance. The estimated water solubility ranges that EPA is requiring for use in this final rule to select the appropriate 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:
Water solubility:
Page 1075
The appropriate method to use, if any, Which method is required, if any, to test for water solubility would be would be determined by the test selected from those listed in this
substance's estimated water column--see Special Conditions in the solubility. Test sponsors must adjacent column.
provide in the final study report
Method A: ASTM E 1148-02 (Reapproved
the underlying rationale for the 2008) (shake flask).
method and pH selected. In order to
Method B: 40 CFR 799.6784 (shake
ensure environmental relevance, EPA flask).
highly recommends that the selected
Method C: 40 CFR 799.6784 (column
study be conducted starting at pH 7. elution).
Method D: 40 CFR 799.6786 (generator column).
...................................... > 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. 2production test) (Ref. 30).
Method B: International Organization for Standardization (ISO) 14593:1999(E) (CO2headspace test) (Ref. 31).
Method C: ISO 7827:1994(E) (Method by analysis of dissolved organic carbon (DOC)) (Ref. 32).
Method D: ISO 9408:1999(E) (Determination of oxygen demand in a closed respirometer) (Ref. 33).
Method E: ISO 9439:1999(E) (Carbon dioxide evolution test) (Ref. 34).
Method F: ISO 10707:1994(E) (Closed bottle test) (Ref. 35).
Method G: ISO 10708:1997(E) (Two-phase closed bottle test) (Ref. 36).
ASTM has updated its test method for Determining Ready, Ultimate,
Biodegradability of Organic Chemicals in a Sealed Vessel CO2
Production Test (ASTM E 1720-01). The test method was reapproved in 2008. There were minor changes, including the deletion of mention of specific apparatus brands in the ``Apparatus'' section; however the test method itself is unchanged. When required, the reapproved method
(ASTM E 1720-01 (Reapproved 2008)) is listed as the required test method for the ``Ready Biodegradation'' endpoint in this final rule
(Ref. 30).
For the ``Ready Biodegradation'' endpoint, EPA is requiring that the 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 E 1720-01 (Reapproved 2008)) and Method B (ISO 14593:1999(E)) 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 10634:1995(E) (Ref. 37), provides guidance for selection of the appropriate test method for a given test substance considering the substances physical and chemical properties. EPA is also requiring that test sponsors 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 (Reapproved 2007)) (Ref. 38), Acute toxicity to Daphnia (ASTM E 729-96
(Reapproved 2007)) (Ref. 38), and Toxicity to plants (algae) (ASTM E 1218-04\e1\) (Ref. 39).
Test Group 2: Chronic toxicity to Daphnia (ASTM E 1193-97
(Reapproved 2004)) (Ref. 40) and Toxicity to plants (algae) (ASTM E 1218-04\e1\) (Ref. 39).
ASTM has updated its test method for Conducting Acute Toxicity
Tests on Test Materials with Fishes, Macroinvertebrates, and Amphibians
(ASTM E 729-96 (Reapproved 2002)). The test method was reapproved in 2007. There were minor changes, for example, reference to ASTM Web site in place of Annual Book of ASTM Standards minor changes in references and dates, titles of ASTM documents changed to correspond to new titles, etc., however the test method itself is unchanged. When required, the updated method (ASTM E 729-96 (Reapproved 2007)) is listed as the required test method for the ``Aquatic Toxicity'' endpoints in this final rule (Ref. 38).
For the ``Aquatic Toxicity'' endpoint, the OECD HPV SIDS Program recognizes that, for certain chemical substances, acute toxicity studies are of limited value in assessing the substances' aquatic toxicity. This issue arises when considering chemical substances with high log Kowvalues. 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 requiring that the aquatic toxicity testing requirement be determined based on the test substance's measured log Kowas determined by using the approach outlined in Unit V.A.1., in the discussion of ``n-Octanol/Water
Coefficient,'' and in Table 3 in Sec. 799.5087(j) of the regulatory text. For test substances determined to have a log Kowof less than 4.2, one or more of the following tests (described as ``Test
Group 1'' in Table 3 in Sec. 799.5087(j) of the regulatory text) are required: Acute toxicity to fish (ASTM E 729-96 (Reapproved 2007));
Acute toxicity to Daphnia (ASTM E 729-96 (Reapproved 2007)); and
Toxicity to plants (algae) (ASTM E 1218-04\e1\). For test substances determined to have a log Kowthat is greater than or equal to 4.2, one or both of the following tests (described as ``Test Group 2'' in Table 3 in Sec. 799.5087(j) of the regulatory text) are required: Chronic toxicity to Daphnia (ASTM E 1193-97 (Reapproved 2004)) and Toxicity to plants (algae) (ASTM E 1218-04\e1\). As outlined in Table 3 in Sec. 799.5087(j) of the regulatory text, depending on the testing required 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 Kowof 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 substance in the surrounding environment (Ref. 42). For the purposes of this final rule,
EPA's use
Page 1076
of a log Kowequal 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 (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
Kow] value equal to or greater than 4.3 to help define the potential of a new chemical substance to cause significant adverse environmental effects (Ref. 44). EPA considers the difference between the log Kowof 4.3 cited in the 1989 Federal Register document (Ref. 44) and the log Kowvalue of 4.2 cited in this final TSCA section 4 test 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 Kowequal 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
Kowvalues greater than 4.2 and may still be acutely toxic to aquatic organisms. For any chemical substance listed in Table 3 in
Sec. 799.5087(j) of the regulatory text for which a test sponsor believes that an alternative to the log Kowthreshold 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. 4. Mammalian Toxicity--Acute
Acute Inhalation Toxicity (rat): Method A (40 CFR 799.9130).
Acute Oral Toxicity (rat): Method B (ASTM E 1163-98 (Reapproved 2002) (Ref. 45) or 40 CFR 799.9110(d)(1)(i)(A)).
For the ``Mammalian Toxicity--Acute'' endpoint, EPA is requiring 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 Sec. 799.5087(j) of the 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 requiring that, for test substances that are gases at room temperature
(25 [deg]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 Sec. 799.5087(j) of the 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 chemical substances (i.e., those that are either liquids or solids at room temperature), EPA is requiring that the acute toxicity testing be conducted via oral administration using an ``Up/Down'' test method
(described as Method B (ASTM E 1163-98 (Reapproved 2002) or 40 CFR 799.9110(d)(1)(i)(A)) in Table 3 in Sec. 799.5087(j) of the regulatory text). Consistent with the voluntary HPV Challenge Program, EPA is allowing 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 in Sec. 799.5087(j) of the regulatory text. A document developed by the
National Institutes of Environmental Health Sciences (NIEHS) provides guidance on how to use the NRU assay to estimate a starting dose for an acute oral toxicity test (Ref. 46). Recent versions of the standardized protocols for the NTU assay are available at the NIEHS/Interagency
Coordination Committee on the Validation of Alternative Methods
(ICCVAM) website (Refs. 47-49). 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 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 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/
Developmental Toxicity Screening Test: 40 CFR 799.9365.
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 requiring 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 submit to EPA a rationale for conducting these alternate tests in the final study reports.
In the proposal (Ref. 2) to this final rule, EPA stated that certain of the chemical substances for which mammalian toxicity-- repeated dose/reproduction/developmental toxicity testing is required may be used solely as ``closed system intermediates,'' and if that were the case, 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, reproduction, and developmental toxicity. EPA requested persons who believe that their chemical substance is used solely as a closed system intermediate to submit appropriate information along with their comments which substantiate this belief. If EPA agreed that the chemical substance is used solely as a closed system intermediate, EPA would defer repeated dose, reproduction, and developmental toxicity testing and address any needed developmental toxicity testing in subsequent rulemaking. In its comments on the proposal to this final rule, PETA (Ref. 50) claimed that the chemical substance phosphorochloridothioic acid, O,O-diethyl ester (CASRN 2524-
Page 1077
04-1) is a closed system intermediate; Albemarle further claimed that this chemical substance is no longer being manufactured (Ref. 51). EPA has not found, at this time, that these claims result in a change of the testing requirements for this substance. Albemarle is not the only producer of this chemical and existing production data indicate that this chemical is still an HPV chemical. Furthermore, EPA has not received any claims from a chemical manufacturer that this substance is used solely as a closed system intermediate. EPA's response to these claims is discussed in Unit E.12. of the ``Response to Public
Comments'' document (Ref. 12).
-
When will the testing imposed by this final rule begin?
Once this final rule is effective, which is 30 days after its publication in the Federal Register, the required testing must be initiated at a time sufficient to allow the required final report to be submitted by the deadline indicated in Sec. 799.5087(i) of the regulatory text.
-
How must the studies required under this test rule be conducted?
Persons required to comply with this final rule must conduct the necessary testing in accordance with the testing requirements listed in
Tables 2 and 3 in Sec. 799.5087(j) of the regulatory text, the reporting requirements described in Sec. 799.5087(i) of the regulatory text, and with 40 CFR Part 792--TSCA Good Laboratory Practice
Standards.
-
What form of test substances will be tested under this rule?
EPA is specifying two distinct approaches for identifying the specific substances that would be tested under this 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 Sec. 799.5087(j) of the regulatory text identifies the listed substances as either Class 1 or Class 2 substances.
The ``Class 1'' chemical substances listed in Table 2 in Sec. 799.5087(j) of the regulatory text (i.e., 14 of the 19 chemical substances included in this final rule) must be tested at a purity of at least 99%. In those instances in which the test sponsor(s) believes that a 99% level of purity is unattainable for a given chemical substance, the sponsor may request a modification under the procedures described in 40 CFR 790.55.
For the ``Class 2'' chemical substances listed in Table 2 in Sec. 799.5087(j) of the regulatory text (i.e., 5 of the 19 chemical substances included in this final rule), EPA is requiring that the substance to be tested be any representative form of the chemical substance.
In requiring a different approach for identifying the chemical substance to be tested with regard to Class 2 chemical substances, EPA recognizes two characteristics which further distinguish Class 1 from
Class 2 chemical substances. First, unlike for Class 1 chemical substances, knowledge of the composition of commercial Class 2 chemical substances can vary in quality and specificity from substance to substance.
The composition of the chemical species which comprise a Class 2 chemical 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-C14tert-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 chemical 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 substances that have similar combinations of different chemical species and/or that were prepared from similar feedstocks using similar production methods. By contrast, Class 1 substances generally represent a much narrower group of substances for which the only variables are their impurities. EPA believes that, for purposes of this final rule, the testing of any representative form of a subject Class 2 substance would provide the data necessary to support the development of preliminary or screening level hazard and risk characterizations for the subject Class 2 substance. However, EPA would encourage the selection of representative forms of test substances that meet industry or consensus standards, where they exist. In accordance with TSCA Good
Laboratory Practice Standards (GLPS) at 40 CFR part 792, the final study report would be required to include test substance identification information, including name, CASRN, strength, purity, and composition, or other appropriate characteristics (see 40 CFR 792.185). In future
TSCA section 4 test rules involving Class 2 substances, testing requirements relative to the number and specificity of the representative form of the substance may differ from the testing requirement in this final rule (i.e., testing of any representative form of the subject Class 2 substances). For example, EPA may require testing of more than one representative form of a Class 2 chemical substance or may specify the representative form to be tested and/or may specify equivalence data that must be submitted by exemption applicants (see 40 CFR 790.82).
-
Am I required to test under this rule? 1. Am I subject to this rule? You are subject to this final 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 final rule during the time period discussed in Unit V.E.2. However, if you do not know or cannot reasonably ascertain that you manufacture or process a chemical substance listed in this final rule (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 are not subject to this final rule for that listed substance. 2. When will my manufacture or processing (or my intent to do so) cause me to be subject to this final rule? You are subject to this final rule if you manufacture or process, or intend to manufacture or process, a chemical substance listed in Table 2 in Sec. 799.5087(j) of the regulatory text at any time from the effective date of the
Page 1078
final test rule to the end of the test cost reimbursement period. 3. Will I be required to test if I am subject to this final rule?
It depends on the nature of your activities. All persons who are subject to this final 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), 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) must 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 do not have to initially comply with the final rule) need not 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 V.E.3.f. 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 V.E.4. a. Who is in Tier 1 and 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
Tier 2 (Persons not initially comply)
required to comply)
Persons who manufacture (as defined at A. Persons who manufacture (as
TSCA section 3(7)), or intend to
defined at TSCA section 3(7)) manufacture, a test rule substance,
or intend to manufacture a and who are not listed under Tier 2.
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 R&D (as described at 40
CFR 790.42(a)(5)).
-
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)).
Note: kg--kilogram, R&D--research and development, TSCA--Toxic
Substances Control Act.
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 final rule, EPA has established certain requirements that differ from those under 40 CFR part 790.
In this final test rule, EPA has reconfigured the tiers in 40 CFR 790.42. In addition to processors, manufacturers of less than 500 kilograms (kgs) (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 final rule. EPA believes that those persons in Tier 1 who are required to conduct testing under this final rule are generally 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. 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 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 V.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 section 4(a)(1)(A)(ii) or TSCA section 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 substance subject to this final rule,
(e.g., manufacturers or processors of a substance as a trace contaminant who are not aware of and cannot reasonably ascertain these activities) are not be subject to the rule. See Unit V.E.1. and Sec. 799.5087(b)(2) of the regulatory text. b. Subdivision of Tier 2 entities. In this final rule the Agency has prioritized which persons in Tier 2 would be required to perform testing, if needed. Specifically, the Agency subdivided Tier 2 entities into: i. Tier 2A. Tier 2 manufacturers, i.e., those who manufacture, or intend to manufacture, a test rule chemical substance solely as one or more of the
Page 1079
following: A byproduct, an impurity, a naturally occurring substance, a non-isolated intermediate, a component of a Class 2 chemical 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 chemical substance (in any form). The terms
``process'' and ``processor'' are defined by TSCA section 3(10) and
TSCA section 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. 52). In addition, ``[t]here are [typically] so many processors [of a given test rule chemical substance] 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. 53). c. When is it appropriate for a person 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 relating to exemptions in 40 CFR 790.80 through 790.99, and Sec. 799.5087(c)(2), (c)(5), (c)(7), and (c)(11) of the regulatory text. In this final rule, EPA will not require the submission of equivalence data (i.e., data demonstrating that your substance is equivalent to the substance actually being tested) as a condition for approval of your exemption. Therefore, 40 CFR 790.82(e)(1) and 790.85 do not apply to this final rule. d. What will happen if I submit an exemption application? EPA believes that requiring the collection of duplicative data is unnecessarily burdensome. As a result, if EPA has received a letter of intent to test from another source or has received (or expects to receive) the test data that would be required under this rule, the
Agency would conditionally approve your exemption application under 40
CFR 790.87.
The Agency would terminate conditional exemptions if a problem occurs with the initiation, conduct, or completion of the required testing, or with the submission of the required data to EPA. EPA may then require you to submit a notice of intent to test or an exemption application. See 40 CFR 790.93 and Sec. 799.5087(c)(8) of the regulatory text. In addition, the Agency would terminate a conditional exemption if no letter of intent to test has been received by persons required to comply with the rule. See, e.g., Sec. 799.5087(c)(6) of the regulatory text. Note that the provisions at 40 CFR 790.48(b) have been incorporated into the regulatory text of this final rule; thus, persons subject to this final rule are not required to comply with 40
CFR 790.48 itself (see Sec. 799.5087(c)(4)-(c)(7) and Sec. 799.5087(d)(3) of the regulatory text). Note that persons who obtain exemptions or receive them automatically would nonetheless be subject to providing reimbursement to persons who do actually conduct the testing, as described in Unit V.E.4. e. What are my obligations if I am in Tier 2? If you are in Tier 2, you would be subject to the rule and you would be responsible for providing reimbursement to persons in Tier 1, as described in Unit
V.E.4. You are considered to have an automatic conditional exemption.
You do not need to submit a letter of intent to test or an exemption application unless you are notified by EPA that you are required to do so.
If a problem occurs with the initiation, conduct, or completion of the required testing, or with the submission of the required data to
EPA, the Agency may require you to submit a notice of intent to test or an exemption application. See 40 CFR 790.93 and Sec. 799.5087(c)(10) of the regulatory text.
In addition, you will 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; and
EPA has published a Federal Register document directing persons in Tier 2 to submit to EPA letters of intent to conduct testing or exemption applications.
See Sec. 799.5087(c)(4), (c)(5), (c)(6), and (c)(7) of the regulatory text. The Agency will 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 will happen if no one submits 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 this final rule. However, in the event it does not receive a letter of intent for one or more of the tests required for any of the chemical substances in this rule within 30 days after the publication of a Federal Register document notifying Tier 2 manufacturers and processors of the obligation to submit a letter of intent to conduct testing or to apply for an exemption from testing, EPA will notify all manufacturers and processors of the chemical substance of this fact by certified letter or by publishing a Federal Register document specifying the test(s) for which no letter of intent has been submitted. This letter or Federal Register document will additionally notify all manufacturers and processors that all exemption applications concerning the test(s) have been denied, and will 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 the Federal Register document, all manufacturers and processors subject to the rule with respect to that chemical substance who are not already in violation of the rule would be in violation of the 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(c). These procedures include: The opportunity for a hearing with the American Arbitration Association; publication by EPA of a document in the Federal Register concerning 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 final 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
Page 1080
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).
-
What are the reporting requirements under this final rule?
A final report must be submitted for each test for each chemical substance 13 months after the effective date of the final rule, i.e., by the deadline indicated in Sec. 799.5087(i) of the regulatory text.
EPA also requests that a robust summary of the final report for each specific test be submitted 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. 19). Persons who submit robust summaries are also encouraged to submit the robust summary electronically via 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.''
-
What would I need to do if I cannot complete the testing required by the final rule?
A company that submits a letter of intent to test under the final rule and that 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.
-
Will there be sufficient test facilities and personnel to undertake the testing required under this test rule?
EPA's most recent analysis of laboratory capacity (Ref. 54) indicates that available test facilities and personnel would adequately accommodate the testing specified in this rule.
-
-
Might EPA seek further testing of the chemical substances in this final test rule?
If EPA determines that it needs additional data regarding any of the chemical substances included in this final 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.
-
Export Notification
Any person who exports, or intends to export, one of the chemical substances contained in this final rule in any form (e.g., as byproducts, impurities, components of Class 2 substances, etc.) is subject to the export notification requirements in TSCA section 12(b)(1) and 40 CFR part 707, subpart D. 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 substance.
-
Decision Not To Require Testing for Certain Endpoints
For certain testing endpoints for certain chemicals listed in the proposed rule, EPA is not making the TSCA section 4(a)(1)(B)(ii) finding that ``* * * there are insufficient data and experience to reasonably determine or predict the effects of the manufacture, processing, or use of these chemical substances, or of any combination of such activities, on human health or the environment * * *'' and is not finalizing the proposed testing. Table 2 in Sec. 799.5087(j) of the regulatory text, which lists the chemical substances and testing requirements, has been revised to reflect this. Further discussion follows in Units VII.A. through VII.F.
-
Screening Reproduction/Developmental Toxicity of 2,4-Hexadienoic
Acid, (E,E)-
As discussed in Unit E.3. of the ``Response to Public Comments'' document (Ref. 12), EPA reviewed additional data, including studies submitted by the PETA (PETA submitted on behalf of themselves and other
Animal Welfare Organizations (AWOs)) for 2,4-hexadienoic acid, (E,E)-
(CASRN 110-44-1), also known as sorbic acid. After reviewing these data, EPA finds existing studies are adequate to evaluate reproduction/ developmental toxicity and is not finalizing the proposed testing for reproduction/developmental toxicity for sorbic acid.
-
Screening Reproduction/Developmental Toxicity of Ethanedioic Acid
As discussed in Unit E.4. of the ``Response to Public Comments'' document (Ref. 12), EPA reviewed additional data, including studies submitted by PETA (PETA submitted on behalf of themselves and other
AWOs) for ethanedioic acid (CASRN 144-62-7). After reviewing these data, EPA finds existing studies are adequate to evaluate reproduction/ developmental toxicity and is not finalizing the proposed testing for reproduction/developmental toxicity for ethanedioic acid. However, as further discussed in the ``Response to Public Comments'' document, EPA finds studies submitted for other endpoints inadequate and is still requiring the testing of ethanedioic acid for chromosomal damage, aquatic toxicity and chemical/physical endpoints as described in Table 2 in Sec. 799.5087(j) of the regulatory text.
-
Physical Chemical Properties and Aquatic Toxicity of Castor Oil,
Oxidized, and Physical Chemical Properties of Castor Oil, Sulfated,
Sodium Salt
As discussed in Unit E.7. of the ``Response to Public Comments'' document (Ref. 12), EPA reviewed data submitted by Vertellus on vapor pressure, water solubility, and Log Kow. Based on information provided by Vertellus, indicating the extremely low water solubility and vapor pressure, and extremely high Log Kowof this substance, EPA is not finalizing the proposed testing for these endpoints for castor oil, oxidized (CASRN 68187-84-8). In addition, EPA agrees with Vertellus that the extreme insolubility of this substance makes aquatic toxicity testing for this chemical substance not feasible. Therefore, EPA is not finalizing the proposed testing for aquatic toxicity testing for castor oil, oxidized. However, EPA is still requiring a ``melting point'' test be conducted for this substance. EPA acknowledges Vertellus' comment that the substance is a liquid at room temperature. In these cases the melting point determination would actually involve determination of a freezing point.
Since ASTM E 324-99 (capillary tube) does not specifically include instructions for determining a freezing point, for that particular endpoint EPA
Page 1081
is requiring OECD Guideline 102 (melting point/melting range) be used instead of ASTM E 324-99 for that test. Furthermore, as discussed in
Unit E.7. of the ``Response to Public Comments'' document, because of its structural similarity with castor oil, oxidized, EPA is also not requiring water solubility and log Kowfor castor oil, sulfated, sodium salt (CASRN 68187-76-8). However, because of its surfactant properties, EPA is still requiring aquatic toxicity testing for castor oil, sulfated, sodium salt.
-
Mammalian Toxicity--Acute, of Castor Oil, Oxidized
As discussed in Unit E.7. of the ``Response to Public Comments'' document (Ref. 12), EPA reviewed data submitted by Vertellus on acute toxicity of oxidized castor oil (CASRN 68187-84-8) and has concluded that these data are adequate. However, while EPA believes that data for certain endpoints, as just discussed, are adequate for castor oil, sulfated; and castor oil, oxidized; data are still needed on the other end-points listed for these chemical substances in Table 2 in Sec. 799.5087(j) of the regulatory text, including, for castor oil, sulfated, mammalian acute toxicity testing, for which EPA received no data contraindicating this testing need.
-
Boiling Point of Benzenediamine, Ar,Ar-Diethyl-Ar-Methyl-
Boiling point is not required for benzenediamine, ar,ar-diethyl-ar- methyl- (CASRN 68479-98-1), as discussed in Unit E.8. of the ``Response to Public Comments'' document (Ref. 12). Albemarle provided EPA with data which are adequate for this endpoint.
-
Acute Mammalian Toxicity, Repeated-Dose Toxicity, and Mutagenicity
Endpoints of Alkenes, C12 24, Chloro
As discussed in Unit E.9. of the ``Response to Public Comments'' document (Ref. 12), EPA reviewed additional data including studies submitted by AWOs and CPIA. In addition to data on this group of chemicals, comments focused on the potential acceptability of using analog data available for other similar classes of chlorinated paraffins. For certain proposed tests, EPA has accepted certain of these data, including analog data on similar substances. However, for other testing endpoints, EPA does not agree that the surrogate chemicals are acceptable analogs, or has found some of the submitted studies inadequate. Specifically, EPA finds that data are acceptable for the acute mammalian, repeated-dose, and mutagenicity endpoints. EPA continues to require testing on physical/chemical properties (all), biodegradation, aquatic toxicity testing (C1, Test Group 2), in vitro chromosomal aberrations, and reproductive and developmental toxicity.
-
-
Economic Impacts
EPA has prepared an economic assessment entitled ``Economic Impact
Analysis for the Final Section 4 Test Rule for High Production Volume
Chemicals'' (Ref. 55), a copy of which has been placed in the docket this final rule. This economic assessment evaluates the potential for significant economic impacts as a result of the testing required by this final rule. The analysis covers 19 chemical substances. The total social cost of providing test data on the 19 chemical substances that were evaluated in this economic analysis is estimated to be $4.19 million. (Ref. 55).
While legally subject to this test rule, processors of a subject chemical substance would be required to comply with the requirements of the rule only if they are directed to do so by EPA as described in
Sec. 799.5087(c)(5) and (c)(6) of the 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, or completion 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 final 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 EPA does not expect that processors will need to comply with the final rule, the economic assessment does not address processors.
To evaluate the potential for an adverse economic impact of testing on manufacturers of the chemical substances in this final rule, EPA employed a screening approach that estimated the impact of testing requirements as a percentage of each chemical substance's sale price.
This measure compares annual revenues from the sale of a chemical substance to the annualized compliance cost for that chemical substance to assess the percentage of testing costs that can be accommodated by the revenue stream generated by that chemical substance over a number of years. Compliance costs include costs of testing and administering the testing, as well as reporting costs. Annualized compliance costs divide testing expenditures into an equivalent, constant yearly expenditure over a longer period of time. To calculate the percent price impact, testing costs (including laboratory and administrative expenditures) are annualized over 15 years using a 7% discount rate.
Annualized testing costs are then divided by the estimated annual revenue of the chemical substance to derive the cost-to-sales ratio.
EPA estimates the total annualized compliance cost of testing for the 19 chemical substances evaluated in the economic analysis to be $1.48 million under the average cost scenario. In addition, the TSCA section 12(b) export notification requirements (included in the total and annualized cost estimates) that would be triggered by this final rule are expected to have a negligible impact on exporters. The estimated cost of the TSCA section 12(b) export notification requirements, which, under this final rule, would be required for the first export to a particular country of a chemical substance subject to the rule, is estimated to range from $25.56 per notice to $80.22 per notice (Ref. 55). The Agency's estimated total costs of testing (including both laboratory and administrative costs) annualized testing cost, and public reporting burden hours for this final rule are presented in the economic assessment.
Under a least cost scenario, 16 out of the 19 chemical substances
(84%) would have a price impact at less than the 1% level. Similarly, 15 out of the 19 chemical substances (79%) would be impacted at less than the 1% level under an average cost scenario. Thus, the potential for adverse economic impact due to this final test rule is low for at least 79% of the chemical substances in this rule. Approximately 4 chemical substances (21%) of the 19 chemical substances for which price data are available would have a price impact at a level greater than or equal to 1% under the least (average) cost scenario.
EPA believes, on the basis of these calculations, that the testing of the chemical substances in this final rule presents a low potential for adverse economic impact for the majority of chemical substances.
Because the subject chemical substances have relatively large production volumes, the annualized costs of testing, expressed as a percentage of annual revenue, are very small for most chemical substances. There are, however, some chemical substances for which the price impact is expected to exceed 1% of the revenue from that chemical substance. The potential for adverse economic impact is
Page 1082
expected to be higher for these chemical substances. In these cases, companies may choose to use revenue sources other than the profits from the individual chemical substances to pay for testing. Smaller businesses are less likely to have additional revenue sources to cover the compliance costs in this situation. Therefore, the Agency also compared the costs of compliance to company sales for small businesses.
EPA does not provide quantitative estimates of the benefits from these tests. Ideally, a discussion of benefits would focus on the additional benefits to be gained from new information relative to information that already exists. Such an approach could examine the value of new information provided as a result of the test rule where such information has not been publicly available. Because of constraints on information on the value of information, our evaluation of benefits is qualitative and does not address incremental benefits.
We believe, however, that the net benefits of the new information are positive.
-
Materials in the Docket
As indicated under ADDRESSES, a docket was established for this final rule under docket ID number EPA-HQ-OPPT-2007-0531. The following is a listing of the documents that have been placed in the docket for this final rule. The docket includes information considered by EPA in developing this final 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, consult either of the technical persons listed under FOR
FURTHER INFORMATION CONTACT. The docket is available for review as specified under ADDRESSES. 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; Second
Group of Chemicals. Proposed Rule. Federal Register (73 FR 43314, July 24, 2008) (FRL-8373-9). 3. EPA. Testing of Certain High Production Volume Chemicals.
Proposed Rule. Federal Register (65 FR 81658, December 26, 2000) (FRL- 6758-4). 4. EPA. Testing of Certain High Production Volume Chemicals. Final
Rule. Federal Register (71 FR 13707, March 16, 2006) (FRL-7335-2). 5. EPA. Testing of Certain High Production Volume Chemicals; Third
Group of Chemicals. Proposed Rule. Federal Register (75 FR 8575,
February 25, 2010) (FRL-8805-8). 6. EPA. TSCA Section 4(a)(1)(B) Final Statement of Policy; Criteria for Evaluating Substantial Production, Substantial Release, Substantial or Significant Human Exposure. Notice. Federal Register (58 FR 28736,
May 14, 1993). 7. EPA, Office of Pollution Prevention and Toxics (OPPT). HPV
Challenge Program Chemical List. Available on-line at: http:// www.epa.gov/oppt/chemrtk/pubs/update/hpvchmlt.htm. 8. OECD Secretariat. Manual for the Investigation of HPV Chemicals.
OECD Programme on the Co-Operative Investigation of High Production
Volume Chemicals. Paris, France. September 2004. Available on-line at: http://www.oecd.org/document/7/0,2340,en_2649_34379_1947463_1_1_ 1_1,00.htm. 9. ICCA. ICCA HPV Working List of Chemicals. October 2005.
Available on-line at: http://www.cefic.org/activities/hse/mgt/hpv/ hpvinit.htm and http://www.iccahpv.com/hpvchallenge/about.cfm. 10. EPA. TSCA Section 4(a)(1)(B) Proposed Statement of Policy.
Notice. Federal Register (56 FR 32294, July 15, 1991). 11. Chemical Manufacturing Association (CMA) now American Chemistry
Council (ACC). Comments on EPA's TSCA section 4(a)(1)(B) Proposed
Statement of Policy submitted to the TSCA Public Docket Office, EPA.
September 13, 1991. 12. EPA, OPPT, Chemical Information and Testing Branch (CITB).
Response to public comments regarding testing of certain high production volume chemicals. August 2010. 13. EPA, OPPT, Economics, Exposure and Technology Division (EETD).
Testing of Certain High Production Volume Chemicals-2 (Exposure
Findings Supporting Information). July 2010. 14. Department of Health and Human Services (DHHS), Centers for
Disease Control (CDC), NIOSH. National occupational exposure survey field guidelines. Vol. I. Seta, J.A.; Sundin, D.S.; and Pedersen, D.H., eds. Cincinnati, OH. DHHS (NIOSH) Publication No. 88-106. Available on- line at: http://www.cdc.gov/niosh/88-106.html. 1988. 15. DHHS, CDC, NIOSH. National occupational exposure survey analysis of management interview responses. Vol. III. Pedersen, D.H. and Sieber, W.K., eds. Cincinnati, OH. DHHS (NIOSH) Publication No. 89- 103. Available on-line at: http://www.cdc.gov/niosh/89-103.html. 1989. 16. DHHS, CDC, NIOSH. National occupational exposure survey sampling methodology. Vol. II. Sieber, W.K., ed. Cincinnati, OH. DHHS
(NIOSH) Publication No. 89-102. Available on-line at: http:// www.cdc.gov/niosh/89-102.html. 1989. 17. EPA. TSCA Inventory Update Rule Amendments. Final Rule. Federal
Register (68 FR 848, January 7, 2003) (FRL-6767-4). 18. EPA. TSCA Inventory Update Reporting Revisions. Final Rule.
Federal Register (70 FR 75059, December 19, 2005) (FRL-7743-9). 19. EPA, OPPT. Draft Guidance on Developing Robust Summaries.
October 22, 1999. Available on-line at: http://www.epa.gov/chemrtk/ pubs/general/robsumgd.htm. 20. EPA. OPPT. High Production Volume Chemical Data Information
System (HPVIS). Data from HVPIS on eighteen HPV chemicals. May 2008. 21. ASTM International. Standard Test Method for Relative Initial and Final Melting Points and the Melting Range of Organic Chemicals.
ASTM E 324-99. 1999. 22. ASTM International. Standard Test Method for Vapor Pressure of
Liquids by Ebulliometry. ASTM E 1719-05. 2005. 23. ASTM International. Standard Test Method for Determining Vapor
Pressure by Thermal Analysis. ASTM E 1782-08. 2008. 24. ASTM International. Standard Test Method for Partition
Coefficient (n-Octanol/Water) Estimation by Liquid Chromatography. ASTM
E 1147-92 (Reapproved 2005). 25. OECD. Guideline for the Testing of Chemicals: Melting Point/
Melting Range. OECD 102. July 27, 1995. 26. ASTM International. Standard Test Method for Measurements of
Aqueous Solubility. ASTM E 1148-02 (Reapproved 2008). 27. ASTM International. Question about ASTM E 324. E-mail from
Diane Rehiel, ASTM, to Greg Schweer, CITB, Chemical Control Division,
OPPT, EPA. September 15, 2004. 28. Meylan, W.M. and Howard, P.H. Atom/Fragment Contribution Method for Estimating Octanol-Water Partition Coefficients. Journal of
Pharmaceutical Sciences. 84(1):83-92. 1995.
Page 1083
29. Meylan, W.M.; Howard, P.H.; and Boethling, R.S. Improved Method for Estimating Water Solubility from Octanol/Water Partition
Coefficient. Environmental Toxicology and Chemistry. 15(2):100-106. 1996. 30. ASTM International. Standard Test Method for Determining Ready,
Ultimate, Biodegradability of Organic Chemicals in a Sealed Vessel
CO2Production Test. ASTM E 1720-01 (Reapproved 2008). 31. International Organization for Standardization (ISO). Water
Quality--Evaluation of Ultimate Aerobic Biodegradability of Organic
Compounds in Aqueous Medium--Method by Analysis of Inorganic Carbon in
Sealed Vessels (CO2Headspace Test). ISO 14593:1999(E). 32. ISO. Water Quality--Evaluation in an Aqueous Medium of the
``Ultimate'' Aerobic Biodegradability of Organic Compounds--Method by
Analysis of Dissolved Organic Carbon (DOC). ISO 7827:1994(E). 33. ISO. Water Quality--Evaluation of Ultimate Aerobic
Biodegradability of Organic Compounds in Aqueous Medium By
Determination Of Oxygen Demand in a Closed Respirometer. ISO 9408:1999(E). 34. ISO. Water Quality--Evaluation of Ultimate Aerobic
Biodegradability of Organic Compounds in Aqueous Medium--Carbon Dioxide
Evolution Test. ISO 9439:1999(E). 35. ISO. Water Quality--Evaluation in an Aqueous Medium of the
``Ultimate'' Aerobic Biodegradability of Organic Compounds--Method by
Analysis of Biochemical Oxygen Demand (Closed Bottle Test). ISO 10707:1994(E). 36. ISO. Water Quality--Evaluation in an Aqueous Medium of the
Ultimate Aerobic Biodegradability of Organic Compounds--Determination
Of Biochemical Oxygen Demand in a Two-Phase Closed Bottle Test
(available in English only). ISO 10708:1997(E). 37. ISO. Water Quality--Guidance for the Preparation and Treatment of Poorly Water-Soluble Organic Compounds for the Subsequent Evaluation of Their Biodegradability in an Aqueous Medium. ISO 10634:1995(E). 38. ASTM International. Standard Guide for Conducting Acute
Toxicity Tests on Test Materials with Fishes, Macroinvertebrates, and
Amphibians. ASTM E 729-96 (Reapproved 2007). 39. ASTM International. Standard Guide for Conducting Static
Toxicity Tests with Microalgae. ASTM E 1218-04\e1\. 2004. 40. ASTM International. Standard Guide for Conducting Daphnia magna
Life-Cycle Toxicity Tests. ASTM E 1193-97 (Reapproved 2004). 41. Veith, G.D. and Kosian, P. Estimating bioconcentration potential from octanol/water partition coefficients. Physical Behavior of PCB's in the Great Lakes. (MacKay, Paterson, Eisenreich, and
Simmons, eds.). Ann Arbor Science, Ann Arbor, MI. 1982. 42. Bintein, S.; DeVillers, J.; and Karcher, W. Nonlinear
Dependence of Fish Bioconcentration on n-Octanol/Water Partition
Coefficient. SAR and QSAR in Environmental Research, Vol. 1, pp. 29-39. 1993. 43. EPA. Document containing EPA's Policy Statement under TSCA section 5. 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. 44. EPA. Significant New Use Rules; General Provisions for New
Chemical Followup. Final Rule. Federal Register (54 FR 31298, July 27, 1989). 45. ASTM International. Standard Test Method for estimating Acute
Oral Toxicity in Rats. ASTM E 1163-98 (Reapproved 2002). 46. NIEHS 2001b. Guidance Document on Using In Vitro Data to
Estimate In Vivo Starting Doses for Acute Toxicity. NIH Publication No. 01-4500. August 2001. Available on-line at: http:// iccvam.niehs.nih.gov/methods/acutetox/inv_cyto_guide.htm. 47. NIEHS 2003a. Test Method Protocol for Solubility Determination,
In Vitro Cytotoxicity Validation Study--Phase III. National Toxicology
Program (NTP) Interagency Center for the Evaluation of Alternative
Toxicological Methods (NICEATM). September 24, 2003. Available on-line at: http://iccvam.niehs.nih.gov/methods/acutetox/invitrocyto/invcyt_ proto.htm. 48. NIEHS 2003b. Test Method Protocol for the BALB/c 3T3 Neutral
Red Uptake Cytotoxicity Test, a Test for Basal Cytotoxicity for an In
Vitro Validation Study--Phase III. NTP/NICEATM. November 4, 2003.
Available on-line at: http://iccvam.niehs.nih.gov/methods/acutetox/ invitrocyto/invcyt_proto.htm. 49. NIEHS 2003c. Test Method Protocol for the NHK Neutral Red
Uptake Cytotoxicity Test, a Test for Basal Cytotoxicity for an In Vitro
Validation Study--Phase III. NTP/NICEATM. November 4, 2003. Available on-line at: http://iccvam.niehs.nih.gov/methods/acutetox/invitrocyto/ invcyt_proto.htm. 50. PETA. Comments on EPA's Proposed Test Rule for Testing of
Certain High Production Volume Chemicals; Second Group of Chemicals submitted to the TSCA Public Docket Office, EPA. October 22, 2008. 51. Albemarle. Comments on EPA's Proposed Test Rule for Testing of
Certain High Production Volume Chemicals; Second Group of Chemicals submitted to the TSCA Public Docket Office, EPA. October 21, 2008. 52. EPA. Toxic Substances; Test Rule Development and Exemption
Procedures. Interim Final Rule. Federal Register (50 FR 20652, 20654,
May 17, 1985). 53. EPA. Toxic Substances Control Act; Data Reimbursement. Final
Rule. Federal Register (48 FR 31786, 31789, July 11, 1983). 54. EPA, Economics and Policy Analysis Branch (EPAB). Analysis of
Laboratory Capacity to Support U.S. EPA Chemical Testing Program
Initiatives. Washington, DC. August 2004. 55. EPA, OPPT. Economic Impact Analysis for the Final Section 4
Test Rule for High Production Volume Chemicals-2. Prepared by the OPPT
Economic and Policy Analysis Branch. July 2010. 56. EPA, OPPT. The Use of Structure-Activity Relationships (SAR) in the High Production Volume Chemicals Challenge Program. August 26, 1999. Available on-line at: http://www.epa.gov/chemrtk/pubs/general/ sarfinl1.htm. 57. EPA, OPPT, EETD, EPAB. Economic Analysis in Support of the TSCA 12(b) Information Collection Request. Washington, DC. October 30, 1998.
-
Statutory and Executive Order Reviews
-
Executive Order 12866
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), this rule is not a ``significant regulatory action'' subject to review by the Office of Management and
Budget (OMB) under Executive Order 12866, because it does not raise novel legal or policy issues arising out of legal mandates, the
President's priorities, or the principles set forth in section 3(f)(4) of the Executive Order. Accordingly, EPA did not submit this final rule to OMB for review under Executive Order 12866.
EPA has prepared an economic analysis of this action, which is contained in a document entitled Economic Impact Analysis for the Final
Section 4 Test Rule for High Production Volume Chemicals-2 (Ref. 55). A copy of the economic analysis is available in the docket for this final rule and is summarized in Unit VIII.
Page 1084
-
Paperwork Reduction Act
This final 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. 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 approved EPA ICR No. 0795. The Agency's estimated burden for this test rule is provided in the economic analysis (Ref. 55).
The information collection activities related to export notification under TSCA section 12(b)(1) are already approved under OMB control number 2070-0030 (EPA ICR No. 0795). This final rule does not impose any new or changes to the export notification requirements, and is not expected to result in any substantive changes in the burden estimates for EPA ICR No. 0795 that would require additional review and/or approval by OMB. Under PRA, an agency may not conduct or sponsor, and a person is not required to respond to, an information collection request unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40
CFR part 9 and included on the related collection instrument. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this final rule.
This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and
OMB's implementing regulations at 5 CFR part 1320. This ICR was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. In addition, EPA is correcting typographical errors in several listings which were introduced into the table by a final rule published in the Federal
Register issue of June 30, 2010 (75 FR 37722) (FRL-8833-7).
As a result, EPA finds that there is ``good cause'' under section 553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this table without further notice and comment.
The standard chemical testing program involves the submission of letters of intent to test (or exemption applications), study plans, semi-annual progress reports, test results, and some administrative costs. For this final rule, EPA estimates the public reporting burden for all 19 chemical substances is 9,008 hours, with an estimated burden per chemical substance of 474 hours (Ref. 55). The estimated burden of the information collection activities related to export notification is estimated to average 1 burden hour for each chemical substance/country combination for an initial notification and 0.5 hours for each subsequent notification (Ref. 55). In estimating the total burden hours approved for the information collection activities related to export notification, the Agency has included sufficient burden hours to accommodate any export notifications that may be required by the
Agency's issuance of final test rules for chemical substances. As such,
EPA does not expect to need to request an increase in the total burden hours approved by OMB for export notifications.
As defined by PRA and 5 CFR 1320.3(b), ``burden'' means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a
Federal agency. This includes the time needed to: Review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.
-
Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., after considering the potential economic impacts on small entities, the Agency hereby certifies that this final 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 final rule (Ref. 55), which is summarized in Unit VIII., and a copy of which is available in the docket for this final rule. The following is a brief summary of the factual basis for this certification.
Under RFA, small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of this final rule on small entities, small entity is defined in accordance with RFA as: 1. A small business as defined by the Small Business
Administration's (SBA) regulations at 13 CFR 121.201. 2. A small governmental jurisdiction that is a government of a city, county, town, school district, or special district with a population of less than 50,000. 3. A small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.
Based on the industry profile that EPA prepared as part of the economic analysis for this final rule (Ref. 55), EPA has determined that this final rule is not expected to impact any small not-for-profit organizations or small governmental jurisdictions. As such, the
Agency's analysis presents only the estimated potential impacts on small business.
Two factors are examined in EPA's small entity impact analysis
(Ref. 55) in order to characterize the potential small entity impacts of this final 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 final 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
Page 1085
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 final 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.
The SBA size standard is generally based on the number of employees an entity in a particular industrial sector may have. For example, in the chemical manufacturing industrial sector (i.e., NAICS code 325 and
NAICS code 324110), approximately 98% of the firms would be classified as small businesses under the default SBA definition. The SBA size standard for 75% of this industry sector is 500 employees, and the size standard for 23% of this industry sector is either 750; 1,000; or 1,500 employees. When assessing the potential impacts of test rules on chemical manufacturers, EPA believes that a standard based on total annual sales may provide a more appropriate means to judge the ability of a chemical manufacturing firm to support chemical testing without significant costs or burdens.
EPA is currently determining what level of annual sales would provide the most appropriate size cutoff with regard to various segments of the chemical industry usually impacted by TSCA section 4(a) test rules, but has not yet reached a determination. As stated above, therefore, the factual basis for the RFA determination for this final rule is based on an analysis using the default SBA size standards.
Although EPA is not currently proposing to establish an alternate definition for use in the analysis conducted for this final rule, the analysis for this final rule also presents the results of calculations using a standard based on total annual sales (40 CFR 704.3).
The SBA has developed 6-digit NAICS code-specific size standards based on employment thresholds. These size standards range from 500 to 1,500 employees for the various 6-digit NAICS codes that are potentially impacted (Ref. 55). For a conservative estimate of the number of small businesses affected by the HPV rule, the Agency chose an employment threshold of less than 1,500 employees for all businesses regardless of the NAIC-specific threshold to determine small business status.
For each manufacturer of the 19 chemical substances covered by this final rule, the parent company (ultimate corporate entity (UCE)) was identified and sales and employment data were obtained for companies where data was publicly available. The search determined that there were 48 affected UCEs. Sales and employment data could be found for 45 and 46 of these UCEs (88%), respectively.
Parent company sales data were collected to identify companies that qualified as a ``small business'' for purposes of RFA analysis. Based on the SBA size standard applied (1,500 employees or less), 20 companies were identified as small.
The potential significance of this final rule's impact on small businesses was analyzed by examining the number of small entities that experienced different levels of costs as a percentage of their sales.
Small businesses were placed in the following categories on the basis of cost-to-sales ratios: Less than 1%, greater than 1%, and greater than 3%. This analysis was conducted under both a least- and average- cost scenario.
Of the 20 small businesses analyzed for small business impacts, one company had no sales data available. Another 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. Of the 19 designated as small businesses, none had cost-to- sales ratios of greater than 1% under both the least- and average-cost scenarios. For the chemical substances where sales data were unavailable, EPA used the median sales value sales of all other small businesses equal to $15.4 million. The costs for the three companies were estimated to be well below 0.01% of this sales level. Given these results, the Agency has determined that there is not a significant economic impact on a substantial number of small entities as a result of this final rule.
The estimated cost of the TSCA section 12(b)(1) export notification, which, as a result of the final rule, would be required for the first export to a particular country of a chemical substance subject to the rule, is estimated to be $80.22 for the first time that an exporter must comply with TSCA section 12(b)(1) export notification requirements, and $25.56 for each subsequent export notification submitted by that exporter (Refs. 55-57). EPA has concluded that the costs of TSCA section 12(b)(1) export notification would have a negligible impact on exporters of the chemical substances in the final rule, regardless of the size of the exporter.
-
Unfunded Mandates Reform Act
Pursuant to Title II of the Unfunded Mandates Reform Act of 1995
(UMRA), Public Law 104-4, EPA has determined that this final 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 final rule, which are summarized in
Unit VIII., would be $4.19 million. The total annualized costs of this final rule are estimated to be $1.48 million. 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 this rule would apply directly to
State, local, or tribal governments, EPA has determined that this final rule would not significantly or uniquely affect small governments.
Accordingly, this final rule is not subject to the requirements of sections 202, 203, 204, and 205 of UMRA.
-
Executive Order 13132
Under Executive Order 13132, entitled Federalism (64 FR 43255,
August 10, 1999), EPA has determined that this final 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 final 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 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 final rule.
-
Executive Order 13175
Under Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has determined that this final 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
Page 1086
tribes, as specified in the 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 rule.
-
Executive Order 13045
This final 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 final 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 final rule present potential risks, allowing the Agency and others to take appropriate action to investigate and mitigate those risks.
-
Executive Order 13211
This final 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.
-
-
National Technology Transfer and Advancement Act
Section 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 inconsistent with 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 final rule involves technical standards that require the use of particular test methods. When 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 is required by this rule, EPA is requiring the use of voluntary consensus standards issued by ASTM and ISO which evaluate the same type of toxicity as the TSCA and OECD test methods, where applicable. Copies of the 18 ASTM, ISO, and OECD test methods referenced in Sec. 799.5087(h) of the regulatory text have been placed in the docket for this final rule. You may obtain copies of the ASTM standards from the American Society for Testing and Materials, 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 Gen[egrave]ve 20 Switzerland. EPA received the required approval from the Director of the Federal Register for the incorporation by reference of the ASTM and ISO standards used in this 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 test methods, 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 final rule are based.
-
Executive Order 12898
This final 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 final rule will assist EPA and others in determining the potential hazards and risks associated with the chemical substances covered by the rule. Although not directly impacting environmental justice-related concerns, this information will better enable the Agency to better protect human health and the environment, including in low-income and minority communities.
-
-
Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of the rule in the Federal Register.
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects 40 CFR Part 9
Environmental protection, Administrative practice and procedure,
Reporting and recordkeeping requirements. 40 CFR Part 799
Environmental protection, Chemicals, Hazardous substances,
Incorporation by reference, Laboratories, Reporting and recordkeeping requirements.
Dated: December 21, 2010.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention. 0
Therefore, 40 CFR chapter I is amended as follows:
PART 9--[AMENDED] 0 1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671, 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3
CFR 1971-1975, Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j- 2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048. 0 2. In Sec. [emsp14]9.1, in the table, revise the entries ``Part 725,
Part 749, Part 761, Part 790, and Part 799'' under the appropriate undesignated center heading indicated below to read as follows:
Page 10873
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
OMB control 40 CFR citation
No.
* * * * *
Reporting Requirements and Review Processes for Microorganisms
Part 725................................................
2070-0012
* * * * *
Water Treatment Chemicals
Part 749................................................
2070-0193
* * * * *
Polychlorinated Biphenyls (PCBs) Manufacturing, Processing, Distribution in Commerce, and Use Prohibitions
Part 761................................................
2070-0012
* * * * *
Procedures Governing Testing Consent Agreements and Test Rules
Part 790................................................
2070-0033
* * * * *
Identification of Specific Chemical Substance and Mixture Testing
Requirements
Part 799................................................
2070-0033
* * * * *
PART 799--[AMENDED] 0 3. The authority citation for part 799 continues to read as follows:
Authority: 15 U.S.C. 2603, 2611, 2625. 0 4. Add Sec. 799.5087 to subpart D to read as follows:
Sec. 799.5087 Chemical testing requirements for second group of high production volume chemicals (HPV2).
(
-
What substances will be tested under this section? Table 2 in paragraph (j) of this section identifies the chemical substances that must be tested under this section. For the chemical substances identified as ``Class 1'' chemical substances in Table 2 in paragraph
(j) of this section, the purity of each chemical substance must be 99% or greater, unless otherwise specified in this section. For the chemical substances identified as ``Class 2'' chemical substances in
Table 2 in paragraph (j), a representative form of each chemical substance must be tested. The representative form selected for a given
Class 2 chemical substance should meet industry or consensus standards where they exist.
(b) Am I subject to this section? (1) If you manufacture (including import) or intend to manufacture, or process or intend to process, any chemical substance listed in Table 2 in paragraph (j) of this section at any time from February 7, 2011 to the end of the test data reimbursement period as defined in 40 CFR 791.3(h), you are subject to this section with respect to that chemical substance.
(2) If you do not know or cannot reasonably ascertain that you manufacture or process a chemical substance listed in Table 2 in paragraph (j) of this section during the time period described in paragraph (b)(1) of this section (based on all information in your possession or control, as well as all information that a reasonable person similarly situated might be expected to possess, control, or know, or could obtain without unreasonable burden), you are not subject to this section with respect to that chemical substance.
(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.
Table 1--Persons Subject to the Rule: Persons in Tier 1 and Tier 2
Persons initially required to comply with this Persons not initially required to comply with this section section (Tier 1).
(Tier 2).
Persons not otherwise specified in column 2 of Tier 2A. Persons who manufacture (as defined at TSCA section this table that manufacture (as defined at
3(7)) or intend to manufacture a chemical substance included
TSCA section 3(7)) or intend to manufacture a in this section solely as one or more of the following: chemical substance included in this section.
--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 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)).
-
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)).
Note: kg--kilogram, TSCA--Toxic Substances Control Act.
(ii) Table 1 of paragraph (c)(1)(i) of this section expands the list of persons in Tier 2, that is, those persons specified in 40 CFR 790.42(a)(2), (a)(4), and (a)(5), who, while legally subject to this section, must comply with the requirements of this section only if directed to do so by EPA under the circumstances set forth in paragraphs (c)(4), (c)(5), (c)(6), (c)(7), and (c)(10) of this section.
(2) If you are in Tier 1 with respect to a chemical substance listed in Table 2 in paragraph (j) of this section, you must, for each test required under this section for that chemical substance, either submit to EPA a letter of intent to test or apply to EPA for an exemption from testing. The letter of intent to test or the exemption application must be received by EPA no later than February 7, 2011.
(3) If you are in Tier 2 with respect to a chemical substance listed in Table 2 in paragraph (j) of this section, you are considered to have an automatic conditional exemption and you will be required to comply with this section with regard to that chemical substance only if directed to do so by EPA under paragraphs (c)(5), (c)(7), or (c)(10) of this section.
Page 1088
(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 on or before February 7, 2011, EPA will publish a Federal Register document 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 February 7, 2011, or within 30 days after publication of the Federal Register document 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 the document 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 the Federal Register document described in paragraph (c)(4) of this section, EPA will publish another Federal Register document 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 February 7, 2011, or within 30 days after publication of the Federal Register document described in paragraph (c)(6) of this section, you must, for each test specified for that chemical substance in the document 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 the document 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 the Federal Register document 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 a Federal Register document specifying the test(s) for which no letter of intent has been submitted. This letter or Federal Register document 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 the Federal Register document 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 this section will be in violation of this section.
(10) If a problem occurs with the initiation, conduct, or completion of the required testing or the submission of the required data with respect to a chemical substance listed in Table 2 in paragraph (j) of this section, under the procedures in 40 CFR 790.93 and 790.97, EPA may initiate termination proceedings for all testing exemptions with respect to that chemical substance and may notify persons in Tier 1 and Tier 2 that they are required to submit letters of intent to test or exemption applications within a specified period of time.
(11) If you are required to comply with this section, but your manufacture or processing of, or intent to manufacture or process, a chemical substance listed in Table 2 in paragraph (j) of this section begins after the applicable compliance date referred to in paragraphs
(c)(2), (c)(5), or (c)(6) of this section, you must either submit a letter of intent to test or apply to EPA for an exemption. The letter of intent to test or the exemption application must be received by EPA no later than the day you begin manufacture or processing.
(d) What must I do to comply with this section? (1) To comply with this section you must either submit to EPA a letter of intent to test, or apply to and obtain from EPA an exemption from testing.
(2) For each test with respect to which you submit to EPA a letter of intent to test, you must conduct the testing specified in paragraph
(h) of this section and submit the test data to EPA.
(3) You must also comply with the procedures governing test rule requirements in 40 CFR part 790 (except for those requirements listed in this paragraph as not applicable to this section), including the submission of letters of intent to test or exemption applications, the conduct of testing, and the submission of data; 40 CFR Part 792--Good
Laboratory Practice Standards; and this section. The following provisions of 40 CFR part 790 do not apply to this section: Paragraphs
(a), (d), (e), and (f) of Sec. 790.45; paragraph (a)(2) and paragraph
(b) of Sec. 790.80; Sec. 790.82(e)(1); Sec. 790.85; and Sec. 790.48.
(e) If I do not comply with this section, when will I be considered in violation of it? You will be considered in violation of this section as of 1 day after the date by which you are required to comply with this section.
(f) How are EPA's data reimbursement procedures affected for purposes of this section? If persons subject to this section are unable to agree on the amount or method of reimbursement for test data development for one or more chemical substances included in this section, any person may request a hearing as described in 40 CFR part 791. In the determination of fair reimbursement shares under this section, if the hearing officer chooses to use a formula based on production volume, the total production volume amount will include amounts of a chemical substance produced as an impurity.
(g) Who must comply with the export notification requirements? Any person who exports, or intends to export, a chemical substance listed in Table 2 in paragraph (j) of this section is subject to 40 CFR part 707, subpart D.
(h) How must I conduct my testing? (1) The tests that are required for each chemical substance are indicated in Table 2 in paragraph (j) of this section. The test methods that must be followed are provided in
Table 3 in paragraph (j) of this section. You must proceed in accordance with these test methods as required according to Table 3 in paragraph (j) of this section, or as appropriate if more than one alternative is allowed according to Table 3 in paragraph (j) of this section. Included in Table 3 in paragraph (j) of this section
Page 1089
are the following 18 test methods which are incorporated by reference:
(i) Standard Test Method for Relative Initial and Final Melting
Points and the Melting Range of Organic Chemicals, ASTM E 324-99, approved September 10, 1999.
(ii) Standard Test Method for Partition Coefficient (N-Octanol/
Water) Estimation by Liquid Chromatography, ASTM E 1147-92 (Reapproved 2005), approved August 1, 2005.
(iii) Standard Guide for Conducting Acute Toxicity Tests on Test
Materials with Fishes, Macroinvertebrates, and Amphibians, ASTM E 729- 96 (Reapproved 2007), approved October 1, 2007.
(iv) Standard Test Method for Measurements of Aqueous Solubility,
ASTM E 1148-02 (Reapproved 2008), approved February 1, 2008.
(v) Standard Test Method for Estimating Acute Oral Toxicity in
Rats, ASTM E 1163-98 (Reapproved 2002), approved October 10, 2002.
(vi) Standard Guide for Conducting Daphnia Magna Life-Cycle
Toxicity Tests, ASTM E 1193-97 (Reapproved 2004), approved April 1, 2004.
(vii) Standard Guide for Conducting Static Toxicity Tests with
Microalgae, ASTM E 1218-04\e1\, approved April 1, 2004.
(viii) Standard Test Method for Vapor Pressure of Liquids by
Ebulliometry, ASTM E 1719-05, approved March 1, 2005.
(ix) Standard Test Method for Determining Ready, Ultimate,
Biodegradability of Organic Chemicals in a Sealed Vessel CO2
Production Test. ASTM E 1720-01 (Reapproved 2008), approved February 1, 2008.
(x) Standard Test Method for Determining Vapor Pressure by Thermal
Analysis, ASTM E 1782-08, approved March 1, 2008.
(xi) Water Quality--Evaluation of Ultimate Aerobic Biodegradability of Organic Compounds in Aqueous Medium--Method by Analysis of Inorganic
Carbon in Sealed Vessels (CO2Headspace Test). First
Edition, March 15, 1999. ISO 14593:1999(E).
(xii) Water Quality--Evaluation in an Aqueous Medium of the
``Ultimate'' Aerobic Biodegradability of Organic Compounds--Method by
Analysis of Dissolved Organic Carbon (DOC). Second Edition, September 15, 1994. ISO 7827:1994(E).
(xiii) Water Quality--Evaluation of Ultimate Aerobic
Biodegradability of Organic Compounds in Aqueous Medium by
Determination of Oxygen Demand in a Closed Respirometer. Second
Edition, August 1, 1999. ISO 9408:1999(E).
(xiv) Water Quality--Evaluation of Ultimate Aerobic
Biodegradability of Organic Compounds in Aqueous Medium--Carbon Dioxide
Evolution Test. Second Edition, March 1, 1999. ISO 9439:1999(E).
(xv) Water Quality--Evaluation in an Aqueous Medium of The
``Ultimate'' Aerobic Biodegradability of Organic Compounds--Method by
Analysis of Biochemical Oxygen Demand (Closed Bottle Test). First
Edition, October 15, 1994. ISO 10707:1994(E).
(xvi) Water Quality--Evaluation in an Aqueous Medium of the
Ultimate Aerobic Biodegradability of Organic Compounds--Determination of Biochemical Oxygen Demand in a Two-Phase Closed Bottle Test. First
Edition, February 1, 1997. ISO 10708:1997(E).
(xvii) Water Quality--Guidance for the Preparation and Treatment of
Poorly Water-Soluble Organic Compounds for the Subsequent Evaluation of
Their Biodegradability in an Aqueous Medium. First Edition, August 15, 1995. ISO 10634:1995(E).
(xviii) Guideline for the Testing of Chemicals: Melting Point/
Melting Range. OECD 102. July 27, 1995.
(2) The Director of the Federal Register approved this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies of the ASTM test methods from the
American Society for Testing and Materials, 100 Bar Harbor Dr., P.O.
Box C700, West Conshohocken, PA 19428-2959, telephone number: (610) 832-9585, web address: http://www.astm.org; copies of the ISO test methods from the International Organization for Standardization, 1, ch. de la Voie-Creuse, Case postale, 56 CH-1211 Geneve 20 Switzerland, telephone number: +41 22 749 01 11, web address: http://www.iso.org; and a copy of the OECD guideline from the Organization for Economic
Cooperation and Development, 2, rue Andr[eacute] Pascal,75775 Paris
Cedex 16 France, telephone number: +33 1 45 24 82 00, web address: http://www.oecd.org. You may inspect each test method and guideline at the EPA Docket Center, EPA West, Rm. B102, 1301 Constitution Ave., NW.,
Washington, DC 20004, telephone number: (202) 566-1744, or at the
National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.
(i) Reporting requirements. A final report for each specific test for each subject chemical substance must be received by EPA by March 7, 2012, unless an extension is granted in writing pursuant to 40 CFR 790.55. A robust summary of the final report for each specific test should be submitted 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'' which is available on-line: http:// www.epa.gov/chemrtk/pubs/general/robsumgd.htm.
(j) Designation of specific chemical substances and testing requirements. The chemical substances identified by chemical name,
Chemical Abstract Service Registry Number (CASRN), and class in Table 2 of this paragraph must be tested in accordance with the requirements designated in Tables 2 and 3 of this paragraph, and the requirements described in 40 CFR part 792--Good Laboratory Practice Standards:
Table 2--Chemical Substances and Testing Requirements
Required tests/
CASRN
Chemical name
Class
(See table 3 of this section)
75-07-0............... Acetaldehyde.....
1 C2, F2. 78-11-5............... 1,3-Propanediol,
1 C4. 2,2- bis[(nitrooxy)me thyl]-, dinitrate
(ester). 84-65-1............... 9,10-
1 C6.
Anthracenedione. 89-32-7............... 1H,3H-Benzo[1,2-
1 A3, A4, A5, B, c:4,5-c']difuran-
C1, D, E1, F1. 1,3,5,7-tetrone. 110-44-1.............. 2,4-Hexadienoic
1 C6. acid, (E,E)-. 118-82-1.............. Phenol, 4,4'-
1 C1. methylenebis[2,6- bis(1,1- dimethylethyl)-. 119-61-9.............. Methanone,
1 B, C2. diphenyl-.
Page 1090
144-62-7.............. Ethanedioic acid.
1 A1, A2, A3, A5,
B, C1, E2. 149-44-0.............. Methanesulfinic
1 E1. acid,. hydroxy-, monosodium salt. 2524-04-1............. Phosphorochlorido
1 A1, A2, A3, A4, thioic acid, O,O-
A5, B, C1, E1, diethyl ester.
E2, F2. 4719-04-4............. 1,3,5-Triazine-
1 C6. 1,3,5(2H,4H,6H)- triethanol. 6381-77-7............. D-erythro-hex-2-
1 A4, B, C1. enonic acid, gamma.-lactone, monosodium salt. 31138-65-5............ D-gluco-heptonic
1 A1, A2, A4, A5, acid, monosodium
B, C1, D, E1, salt, (2.xi.)-.
E2, F1. 66241-11-0............ C.I. Leuco
2 A1, A2, A3, A4,
Sulphur Black 1.
A5, B, C1, D,
E1, E2, F1. 68187-76-8............ Castor oil,
2 A1, A2, C1, D, sulfated, sodium
E1, E2, F1. salt. 68187-84-8............ Castor oil,
2 A1, A2, B, E1, oxidized.
E2, F1. 68479-98-1............ Benzenediamine,
1 A1, A3, A4, A5, ar,ar-diethyl-ar-
C1, E1, E2, F1. methyl-. 68527-02-6............ Alkenes, C12 24,
2 A1, A2, A3, A4, chloro.
A5, B, C1, E2,
F2. 68647-60-9............ Hydrocarbons, C >
2 A2, A3, A5, B, 4.
C1, D, E1, E2,
F1.
Note: CASRN = Chemical Abstract Service Registry Number.
Table 3--Key to the Test Requirements Denoted by Alphanumeric Symbols in Table 2 of this Paragraph
Note: The ASTM and ISO test methods and the OECD guideline required in this paragraph are incorporated by reference; see paragraph (h) of this section.
Test requirements and
Testing category
Test symbol
references
Special conditions
Physical/chemical properties....... A
1. Melting Point: American n-Octanol/water Partition
Society for Testing and
Coefficient (log 10 basis)
Materials (ASTM) E 324-99 or log KOW:
(capillary tube), if a
Which method is required,
Freezing Point:
if any, is determined by
Organization for Economic the test substance's
Cooperation and
estimated \i\ log KOW as
Development (OECD) 102
follows:
(melting point/melting
log KOW 1-4: Method 1782-08 (thermal analysis). A, B, or C. 4. n-Octanol/Water
log KOW range > 4-6: Method
Partition Coefficient (log B or C. 10 basis) or log KOW: (See log KOW > 6: Method C.
Special Conditions for the Test sponsors must provide log KOW test requirement
in the final study report and select the appropriate the underlying rationale method to use, if any,
for the method and pH from those listed in this selected. In order to column.).
ensure environmental
Method A: 40 CFR 799.6755 relevance, EPA highly
(shake flask).
recommends that the
Method B: ASTM E 1147-92
selected study be
(Reapproved 2005) (liquid conducted at pH 7. chromatography).
Water Solubility:
Method C: 40 CFR 799.6756 Which method is required,
(generator column).
if any, is determined by 5. Water Solubility: (See
the test substance's
Special Conditions for the estimated \ii\ water water solubility test
solubility. Test sponsors requirement and select the must provide in the final appropriate method to use, study report the if any, from those listed underlying rationale for in this column.).
the method and pH
Method A: ASTM E 1148-02
selected. In order to
(Reapproved 2008) (shake
ensure environmental flask).
relevance, EPA highly
Method B: 40 CFR 799.6784 recommends that the
(shake flask).
selected study be
Method C: 40 CFR 799.6784 conducted starting at pH
(column elution).
7.
Method D: 40 CFR 799.6786 > 5,000 milligram/Liter (mg/
(generator column).
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.
=
Test Group 2 for C1:....... 4.2: Test Group 2 is 1. Chronic Toxicity to
required
Daphnia: ASTM E 1193-97
(Reapproved 2004). 2. Toxicity to Plants
(Algae): ASTM E 1218--04
\e1\.
C2
For 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
(Reapproved 2007).
................. 2. Toxicity to Plants
(Algae): ASTM E 1218-04
\e1\.
................. Test Group 2 for C2:.......
................. 1. Chronic Toxicity to
Daphnia: ASTM E 1193-97
(Reapproved 2004).
................. 2. Toxicity to Plants
(Algae): ASTM E 1218-04
\e1\.
C3
For 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 (Reapproved 2007).
................. 2. Toxicity to Plants
(Algae): ASTM E 1218-04
\e1\.
................. Test Group 2 for C3:.......
................. 1. Chronic Toxicity to
Daphnia: ASTM E 1193-97
(Reapproved 2004).
................. 2. Toxicity to Plants
(Algae): ASTM E 1218-04
\e1\.
C4
For 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 (Reapproved 2007).
................. 2. Acute Toxicity to
Daphnia: ASTM E 729-96
(Reapproved 2007).
................. Test Group 2 for C4:.......
................. 1. Chronic Toxicity to
Daphnia: ASTM E 1193-97
(Reapproved 2004).
C5
For 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
(Reapproved 2007).
................. Test Group 2 for C5:.......
................. 1. Chronic Toxicity to
Daphnia: ASTM E 1193-97
(Reapproved 2004).
C6
Toxicity to Plants (Algae):
ASTM E 1218-04 \e1\.
C7
For 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 (Reapproved 2007).
................. Test Group 2 for C7:.......
................. 1. Chronic Toxicity to
Daphnia: ASTM E 1193-97
(Reapproved 2004).
Page 1092
Mammalian toxicity--acute.......... D
See special conditions for Which testing method is this test requirement and required is determined by select the method that
the test substance's must be used from those
physical state at room listed in this column..
temperature (25 [deg]C).
Method A: Acute Inhalation
For those test substances
Toxicity (rat): 40 CFR
that are gases at room 799.9130.
temperature, Method A is
Method B: EITHER:.......... required; otherwise, use 1. Acute (Up/Down) Oral
either of the two methods
Toxicity (rat): ASTM E
listed under Method B. 1163-98 (Reapproved 2002). In Method B, 40 CFR
OR........................ 799.9110(d)(1)(i)(A) 2. Acute (Up/Down) Oral
refers to the OECD 425 Up/
Toxicity (rat): 40 CFR
Down Procedure.\iv\ 799.9110(d)(1)(i)(A).
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.
Mammalian toxicity--genotoxicity... E1
Bacterial Reverse Mutation None
Test (in vitro): 40 CFR 799.9510.
E2
Conduct any one of the
Persons required to conduct following three tests for testing for chromosomal chromosomal damage: In
damage are encouraged to vitro Mammalian Chromosome use the in vitro Mammalian
Aberration Test: 40 CFR
Chromosome Aberration Test 799.9537.
(40 CFR 799.9537) to
OR........................ generate the needed data
Mammalian Bone Marrow
unless known chemical
Chromosomal Aberration
properties (e.g., physical/
Test (in vivo in rodents: chemical properties, mouse (preferred species), chemical class rat, or Chinese hamster): characteristics) preclude 40 CFR 799.9538.
its use. A subject person
OR........................ who uses one of the in
Mammalian Erythrocyte
vivo methods instead of
Micronucleus Test [sampled the in vitro method to in bone marrow] (in vivo
address a chromosomal in rodents: Mouse
damage test requirement
(preferred species), rat, must submit to EPA a or Chinese hamster): 40
rationale for conducting
CFR 799.9539.
that alternate test in the final study report.
Mammalian toxicity--repeated dose/ F1
Combined Repeated Dose
Where F1 is required, EPA reproduction/developmental.
Toxicity Study with the
recommends use of the
Reproduction/Developmental Combined Repeated Dose
Toxicity Screening Test:
Toxicity Study with the 40 CFR 799.9365.
Reproduction/Developmental
OR........................ Toxicity Screening Test
Reproduction/Developmental
Toxicity Screening Test:
However, there may be 40 CFR 799.9355.
valid reasons to test a
AND....................... particular chemical using
Repeated Dose 28-Day Oral
both 40 CFR 799.9355 and
Toxicity Study in rodents: 40 CFR 799.9305 to fill 40 CFR 799.9305.
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.
F2
Reproduction/Developmental
Toxicity Screening Test: 40 CFR 799.9355.
F3
Repeated Dose 28-Day Oral
Toxicity Study in rodents: 40 CFR 799.9305.
\i\ EPA recommends, but does not require, that log KOW be quantitatively estimated prior to initiating this study. One method, among many similar methods, for estimating log KOW is described in the article entitled
``Atom/Fragment Contribution Method for Estimating Octanol-Water Partition Coefficients'' by W.M. Meylan and
P.H. Howard in the Journal of Pharmaceutical Sciences. 84(1):83-92. January 1992. This reference is available in docket ID number EPA-HQ-OPPT-2007-0531 at the EPA Docket Center, Rm. 3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington, DC 20004, telephone number: (202) 566-1744, from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal holidays.
\ii\ EPA recommends, but does not require, that water solubility be quantitatively estimated prior to initiating this study. One method, among many similar methods, for estimating water solubility is described in the article entitled ``Improved Method for Estimating Water Solubility From Octanol/Water Partition Coefficient'' by W.M. Meylan, P.H. Howard, and R.S. Boethling in Environmental Toxicology and Chemistry. 15(2):100-106. 1996. This reference is available in docket ID number EPA-HQ-OPPT-2007-0531 at the EPA Docket Center, Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC 20004, telephone number: (202) 566-1744, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
\iii\ Chemical substances that are dispersible in water may have log KOW values greater than 4.2 and may still be acutely toxic to aquatic organisms. Test sponsors who wish to conduct Test Group 1 studies on such chemicals may request a modification to the test standard 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 be used for determining whether acute or chronic aquatic toxicity testing be performed for a specific substance.
\iv\ The OECD 425 Up/Down Procedure, revised by OECD in December 2001, is available in docket ID number EPA-HQ-
OPPT-2007-0531 at the EPA Docket Center, Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC 20004, telephone number: (202) 566-1744, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
Page 1093
\v\ The neutral red uptake basal cytotoxicity assay, which may be used to estimate the starting dose for the mammalian toxicity-acute endpoint, is available in docket ID number EPA-HQ-OPPT-2007-0531 at the EPA Docket
Center, Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC 20004, telephone number: (202) 566-1744, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
FR Doc. 2010-33313 Filed 1-6-11; 8:45 am
BILLING CODE 6560-50-P
-
