Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Rules and Regulations 65385 

EPA to provide Congress, through OMB, 

explanations when the Agency decides 

not to use available and applicable 

voluntary consensus standards. 

This final rule involves a technical 

standard. EPA is adopting an ASTM 

standard as described in Unit II.A of the 

SUPPLEMENTARY INFORMATION section of 

this document. The technical standard 

included in today’s rule is a standard 

developed by ASTM, a voluntary 

consensus standards body, and thus 

raises no issues under the NTTAA. The 

ASTM standard in today’s action may 

be obtained from ASTM International at 

100 Barr Harbor Drive, PO Box C700, 

West Conshohocken, PA 19428–2959, 

610–832–9585 (phone), 610–832–9555 

(fax), or service@astm.org (e-mail); or 

through the ASTM Web site (http:// 

www.astm.org). 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice and Minority Populations and 

Low-Income Populations 

Executive Order (EO) 12898 (59 FR 

7629 (Feb. 16, 1994)) establishes federal 

executive policy on environmental 

justice. Its main provision directs 

federal agencies, to the greatest extent 

practicable and permitted by law, to 

make environmental justice part of their 

mission by identifying and addressing, 

as appropriate, disproportionately high 

and adverse human health or 

environmental effects of their programs, 

policies, and activities on minority 

populations and low-income 

populations in the United States. 

EPA has determined that this final 

rule will not have disproportionately 

high and adverse human health or 

environmental effects on minority or 

low-income populations because it does 

not affect the level of protection 

provided to human health or the 

environment. The allowance of ASTM 

D6500–05 will provide additional 

flexibility to the regulated community 

in meeting olefins in gasoline testing 

requirements. This final rule 

amendment does not relax control 

measures on sources regulated by the 

rule and therefore will not cause 

emission increases from these sources. 

K. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of 

Congress and to 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. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). This rule 

will be effective November 21, 2011. 

IV. Statutory Provisions and Legal 

Authority 

Statutory authority for today’s final 

rule comes from sections 211(c) and 

211(k) of the CAA (42 U.S.C. 7545(c) 

and (k)). Section 211(c) allows EPA to 

regulate fuels that contribute to air 

pollution which endangers public 

health or welfare, or which impairs 

emission control equipment. Section 

211(k) prescribes requirements for RFG 

and CG and requires EPA to promulgate 

regulations establishing these 

requirements. Additional support for 

the fuels controls in today’s final rule 

comes from sections 114(a) and 301(a) 

of the CAA. 

List of Subjects in 40 CFR Part 80 

Environmental protection, Air 

pollution control, Fuel additives, 

Gasoline, Diesel, Imports, Incorporation 

by reference, Motor vehicle pollution, 

Reporting and recordkeeping 

requirements. 

Dated: October 13, 2011. 

Lisa P. Jackson, 

Administrator. 

For the reasons set forth in the 

preamble, part 80 of title 40, chapter I 

of the Code of Federal Regulations is 

amended as follows: 

PART 80—REGULATION OF FUELS 

AND FUEL ADDITIVES 

■ 1. The authority citation for part 80 

continues to reads as follows: 

Authority: 42 U.S.C. 7414, 7521(l), 7545 

and 7601(a). 

Subpart D—[Amended] 

■ 2. Section 80.46 is amended by adding 

paragraphs (b)(2) and (h)(1)(iii) to read 

as follows: 

§ 80.46 Measurement of reformulated 

gasoline fuel parameters. 

* * * * * 

(b) * * * 

(2)(i) Any refiner or importer may 

determine olefin content using ASTM 

standard method ASTM D6550 

(incorporated by reference, see 

paragraph (h) of this section) for 

purposes of meeting any testing 

requirement involving olefin content; 

provided that 

(ii) The refiner or importer test result 

is correlated with the method specified 

in paragraph (b)(1) of this section on a 

site-specific basis, in order to achieve an 

unbiased prediction of the result in 

volume percent, for the method 

specified in paragraph (b)(1) of this 

section. 

* * * * * 

(h) * * * 

(1) * * * 

(iii) ASTM standard method D6550– 

05 (‘‘ASTM D6550’’), Standard Test 

Method for Determination of Olefin 

Content of Gasolines by SupercriticalFluid Chromatography, approved 

November 1, 2005. 

* * * * * 

[FR Doc. 2011–27219 Filed 10–20–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 799 

[EPA–HQ–OPPT–2009–0112; FRL–8885–5] 

RIN 2070–AJ86 

Testing of Certain High Production 

Volume Chemicals; Third Group of 

Chemicals 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is promulgating this final 

rule under section 4(a)(1)(B) of the 

Toxic Substances Control Act (TSCA) to 

require manufacturers, importers, and 

processors to conduct testing to obtain 

screening level data for health and 

environmental effects and chemical fate 

for 15 high production volume (HPV) 

chemical substances listed in this final 

rule. This test data is needed in order to 

help EPA to determine whether these 15 

HPV chemical substances pose a risk to 

human health and/or environmental 

safety. Based on comments received by 

EPA on the proposed rule for this final 

rule, EPA has determined that only 15 

of the 29 HPV chemical substances 

proposed for testing meet the criteria for 

testing at this time. 

DATES: This final rule is effective 

November 21, 2011. 

The incorporation by reference of 

certain publications listed in this final 

rule is approved by the Director of the 

Federal Register as of November 21, 

2011. 

For purposes of judicial review, this 

final rule shall be promulgated at 1 p.m. 

eastern daylight/standard time on 

November 7, 2011. 


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ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPPT–2009–0112. 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 Office of 

Pollution Prevention and Toxics (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. 

Submission of Information: See Unit 

V.E.3. of the SUPPLEMENTARY

INFORMATION for additional instructions 

for submission of information (e.g., 

letters-of-intent-to-test, exemption 

requests, study plans, final study 

reports). 

Submission of information containing 

CBI and/or non-CBI material may be 

submitted by one of the following 

methods: 

• Mail: Document Control Office 

(DCO) (7407M), Office of Pollution 

Prevention and Toxics (OPPT), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001, Attn: 40 CFR 799.5089; 

Docket ID Number EPA–HQ–OPPT– 

2009–0112. 

• Hand delivery: OPPT Document 

Control Office (DCO), EPA East Bldg., 

Rm. E6428 ((202) 564–8930), 

Environmental Protection Agency, 1201 

Constitution Ave., NW., Washington, 

DC 20004, Attn: 40 CFR 799.5089; 

Docket ID Number EPA–HQ–OPPT– 

2009–0112. 

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: 

I. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture (defined 

by statute to include import) or process 

any of the chemical substances that are 

listed in § 799.5089(j) of the regulatory 

text. Any use of the term ‘‘manufacture’’ 

in this final rule will encompass 

‘‘import,’’ unless otherwise stated. In 

addition, as described in Unit VI., any 

person who exports, or intends to 

export, any of the chemical substances 

included in this 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 

15 HPV chemical substances (NAICS 

codes 325 and 324110), e.g., chemical 

manufacturing and petroleum refineries. 

• Processors of one or more of the 15 

HPV 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 § 799.5089(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. 

II. Background 

A. What action is the agency taking? 

EPA is promulgating this final rule 

under TSCA section 4(a)(1)(B) (15 

U.S.C. 2603(a)(1)(B)) that requires 

manufacturers and processors of 15 HPV 

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 (lb) per year). A 

detailed discussion regarding efforts to 

enhance the availability of screening 

level hazard and environmental fate 

information about HPV chemical 

substances 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 issue 

of February 25, 2010, EPA proposed 

Screening Information Data Set (SIDS) 

testing for 29 HPV chemical substances 

(Ref. 2). EPA received comments on the 

proposed rule. In consideration of those 

comments, EPA changed some testing 

requirements for certain HPV chemical 

substances and is not including certain 

other HPV chemical substances in this 

final rule, as explained in Unit III. On 

the basis that adequate data are 

available for certain proposed testing 

endpoints, EPA reduced the number of 

tests required for two chemical 

substances; for another chemical 

substance, EPA dropped all testing 

requirements and is not including that 

chemical substance in this final rule. In 

addition, EPA is not including 12 of the 

proposed chemical substances in this 

final rule because data provided to EPA 

after the proposed rule was published 

indicate that these chemical substances 

are no longer HPV, no longer have 

substantial human exposure, or no 

longer have substantial environmental 

release. Furthermore, EPA is deferring 

final action for one chemical substance, 

as explained in Unit VIII. This final rule 

requires testing for 15 of the 29 HPV 

chemical substances originally proposed 

for testing in 2010. 

This action follows earlier testing 

actions for certain HPV chemical 

substances (see the proposed and final 

rules entitled: ‘‘Testing of Certain High 

Production Volume Chemicals; 

Proposed Rule’’ (Ref. 3); ‘‘Testing of 

Certain High Production Volume 

Chemicals; Final Rule’’ (Ref. 4); 


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Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Rules and Regulations 65387 

‘‘Testing of Certain High Production 

Volume Chemicals; Second Group of 

Chemicals; Proposed Rule’’ (Ref. 5); and 

‘‘Testing of Certain High Production 

Volume Chemicals; Second Group of 

Chemicals; Final Rule’’ (Ref. 6)). 

EPA also intends to propose testing 

for additional HPV chemical substances 

in a proposed rule scheduled for 

publication in 2011. 

B. 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. This is 

the policy of the United States, which 

is articulated in TSCA section 2(b)(1) 

(15 U.S.C. 2603(b)(1)), which states: 

* * * 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 final 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 

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. 7, 

p. 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 15 HPV chemical 

substances specified in Table 2 in 

§ 799.5089(j) of the regulatory text. 

Following consideration of the public 

comments on the proposed rule (Ref. 2), 

EPA is making the following findings 

for the 15 HPV 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. 

C. Why is EPA taking this action? 

In April 1998, EPA initiated a 

national effort to make available to the 

public certain basic information about 

the environmental fate and potential 

health and environmental hazards 

associated with the most widespread 

chemical substances in commerce. 

Mechanisms to collect or, where 

necessary, develop needed data on U.S. 

HPV chemical substances include the 

HPV Challenge Program, certain 

international efforts (the Organization 

for Economic Cooperation and 

Development (OECD) HPV SIDS 

Program, the International Council of 

Chemical Associations (ICCA) HPV 

Initiative), and TSCA section 4 test 

rules. HPV chemical substances are 

manufactured or imported in amounts 

equal to or greater than 1 million lb per 

year and were first identified for the 

HPV Challenge Program through data 

reported under the 1990 Inventory 

Update Reporting (IUR) rule. The HPV 

Challenge Program is a voluntary testing 

program created by the United States to 

ensure that a baseline set of data on 

approximately 2,800 HPV chemical 

substances would be made available to 

EPA and the public. 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 

chemical substances for human and 

environmental hazards, and assists the 

Agency and others in making an 

informed, preliminary judgment about 

the hazards of HPV chemical 

substances. 

The 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 

chemical substances. Therefore, EPA 

continues to participate in the voluntary 

international efforts, complementary to 

the HPV Challenge Program, that OECD 

is coordinating to secure basic hazard 

information on HPV chemical 

substances in use worldwide, including 

some of those on the 1990 U.S. HPV 

chemical substances list (Ref. 8). This 

includes agreements to sponsor a U.S. 

HPV chemical substance under either 

the OECD HPV SIDS Program (Ref. 9), 

including sponsorship by OECD 

member countries beyond the United 

States, or the international HPV 

Initiative that is being organized by 

ICCA (Ref. 10). 

As EPA stated in the first TSCA 

section 4 HPV test rule, U.S. data needs 

that remained unmet in the HPV 

Challenge Program or through 

international efforts could be addressed 

through TSCA section 4 rulemakings, 

such as the final rule promulgated by 

EPA on March 16, 2006 (Ref. 4) and the 

final rule promulgated by EPA on 

January 7, 2011 (Ref. 6). This is the third 

TSCA section 4 HPV test rule; it 

addresses unmet data needs for 15 HPV 

chemical substances. 

EPA intends to make the information 

collected under this final rule available 

to the public, other Federal agencies, 

and any other interested parties on its 

Web site (http://www.epa.gov/chemrtk) 

and in the docket for this final rule 

identified under ADDRESSES. As 

appropriate, this information will be 

used to ensure a scientifically sound 

basis for risk assessments and risk 

management actions. 


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D. Why is EPA focusing on HPV 

chemical substances and SIDS testing? 

This final rule pertains to HPV 

chemical substances, which EPA has 

determined account for 95% of total 

chemical production in the United 

States (Ref. 11, p. 32296). Based on 1990 

IUR reports, EPA found that only 7% of 

non-polymeric organic HPV chemical 

substances had a full set of publicly 

available and internationally recognized 

basic screening test data for health and 

environmental effects (Ref. 12). Of the 

over 2,800 U.S. HPV chemical 

substances, 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 

chemical substances pose 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. 9): 

• Acute toxicity. 

• Repeat dose toxicity. 

• Developmental and reproductive 

toxicity. 

• Genetic toxicity (gene mutations 

and chromosomal aberrations). 

• Ecotoxicity (studies in fish, 

Daphnia, and algae). 

• Environmental fate (including 

physical/chemical properties (melting 

point, boiling point, vapor pressure, noctanol/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 help to assess the 

relative risks of chemical substances 

and whether additional testing or 

assessment is necessary. 

E. How will 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 15 HPV chemical substances 

subject to this final rule. The data will 

also be used by EPA to set priorities for 

further testing that may produce hazard 

information which may be needed by 

EPA, other Federal agencies, the public, 

industry, and others, to support 

adequate risk assessments. EPA uses 

data from TSCA section 4 test rules to 

support such actions as the risk 

management decisions and activities 

under TSCA, development of water 

quality criteria, Toxics Release 

Inventory (TRI) listings, and reduction 

of workplace exposures. 

As appropriate, this information will 

be used to ensure a scientifically sound 

basis for risk assessments 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. 

In addition, a key goal of the HPV 

Challenge Program was making basic 

health and environmental effects data 

for HPV chemical substances 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—can use the data provided 

through the HPV Challenge Program, 

and also data collected on HPV 

chemical substances 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. 

III. Response to Public Comments 

EPA received a number of comments, 

which are available in the docket, 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 

regarding testing of certain high 

production volume chemicals’’ 

(Response to Public Comments) (Ref. 

13). The comments on the proposed rule 

were submitted by the American Coke 

and Coal Chemicals Institute; Dover 

Chemical Corporation; the Society of 

Chemical Manufacturers and Affiliates 

on behalf of Bimax, Inc. and Rhodia, 

Inc.; Eastman Chemical Company; 

Nease Corporation; the International 

Imaging Industry Association; Special 

Materials Company; BASF Corporation; 

the American Chemistry Council; Sasol 

North America, Inc.; the Chlorinated 

Paraffins Industry Association; INVISTA 

S.a`.r.l.; Greenwich Chemical Consulting, 

Inc., on behalf of Brenntag North 

America, Inc.; Kowa American 

Corporation, Miami Chemical, Inc., and 

Univar U.S.A., Inc.; GE Water and 

Process Technologies; and Special 

Materials Company. Comments were 

also submitted by People for the Ethical 

Treatment of Animals (PETA); the 

Physicians Committee for Responsible 

Medicine; the Alternatives Research 

Development Foundation; and the 

American Anti-Vivisection Society. EPA 

also received comments from a private 

citizen. In response to these comments, 

EPA made the following changes to the 

regulatory text in this final rule: 

1. EPA is no longer requiring testing 

for the following 13 chemical 

substances: 

• Benzene, 1,2-dimethyl-3-nitro- 

(Chemical Abstract Service Registry 

Number (CASRN) 83–41–0). 

• 3-Pentanone (CASRN 96–22–0). 

• 1-Tetracosanol (CASRN 506–51–4). 

• 1-Hexacosanol (CASRN 506–52–5). 

• 2-Propenoic acid, 2-carboxyethyl 

ester (CASRN 24615–84–7). 

• Methanesulfonamide, N-[2-[(4- 

amino-3- 

methylphenyl)ethylamino]ethyl]-, 

sulfate (2:3) (CASRN 25646–71–3). 

• Solvent naphtha (coal) (CASRN 

65996–79–4). 

• Tar oils, coal (CASRN 65996–82–9). 

• Tar, coal, high temperature (CASRN 

65996–89–6). 

• Distillates (coal tar) (CASRN 65996– 

92–1). 

• Pitch, coal tar-petroleum (CASRN 

68187–57–5). 

• 1,4-Benzenedicarboxylic acid, 1,4- 

dimethyl ester, manuf. of, by-products 

from (CASRN 68988–22–7). 

• Extract residues (coal), tar oil alk., 

naphthalene distn. residues (CASRN 

73665–18–6). 

These changes are further discussed 

in Unit VII.A. and in the ‘‘Response to 

Public Comments’’ document (Ref. 13). 

2. N-octanol/water partition 

coefficient, log 10 basis (log Kow); and 

reproductive/developmental toxicity 

testing are not required for benzene, 1- 

chloro-4-(trifluoromethyl)- (CASRN 98– 

56–6). The aquatic toxicity testing 

requirement for this chemical substance 

has also been reduced. These changes 

are further discussed in Unit VII.B. and 

in the ‘‘Response to Public Comments’’ 

document (Ref. 13). 

3. Water solubility, ready 

biodegradation, aquatic toxicity, acute 

mammalian toxicity, combined 

repeated-dose/reproductive/ 

developmental toxicity, and in vitro 

mutagenicity tests are not required for 

benzenesulfonic acid, dimethyl (CASRN 

25321–41–9). These changes are further 

discussed in Unit VII.B. and in the 

‘‘Response to Public Comments’’ 

document (Ref. 13). 


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Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Rules and Regulations 65389 

IV. Findings 

A. What is the basis for EPA’s final rule 

to test these chemical substances? 

As described 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 make 

certain findings of 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)), in addition to findings 

(discussed in this unit) regarding the 

sufficiency of existing data (TSCA 

section 4(a)(l)(A)(ii) or TSCA section 

4(a)(1)(B)(ii)) and the need for testing 

(TSCA section 4(a)(1)(A)(iii) or TSCA 

section 4(a)(1)(B)(iii)). EPA is requiring 

testing of the chemical substances 

included in this final 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 § 799.5089(j) of the regulatory 

text, along with their CASRNs. 

EPA generally considers ‘‘substantial 

production’’ and ‘‘substantial exposure’’ 

of a chemical substance or mixture 

under TSCA section 4(a)(1)(B)(i) to be 

aggregate production (including import) 

volume equaling or exceeding 1 million 

lb per year of that chemical substance or 

mixture, and exposure of 1,000 workers 

or more, or 10,000 consumers or more, 

or 100,000 members of the general 

population or more to a chemical 

substance or mixture. See EPA’s B 

Policy (Ref. 7) 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 15 HPV 

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. 14). 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 substances, or 

of any combination of such activities, on 

human health or the environment. EPA 

also finds that testing the 15 HPV 

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. 7) 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 § 799.5089(j) 

of the regulatory text along with their 

CASRNs. For a chemical-by-chemical 

summary of each of the findings, see 

Table 1 of this unit. Table 1 of this unit 

summarizes EPA’s findings with respect 

to worker and consumer exposure, and 

includes the production volume, 

number of workers and broad use 

categories reported under IUR and 

Preliminary Assessment Information 

Reporting (PAIR) rules, and from the 

National Occupational Exposure Survey 

(NOES). For more details, see the 

discussion which follows the table and 

also the Exposure Findings Supporting 

Information document (Ref. 14). 

TABLE 1—EXPOSURE BASED FINDINGS

CASRN 2006 IUR production 

(million lb) 

2006 IUR substantial human 

exposure met 

(≥ 1,000 

workers) 

NOES 

(number of 

workers) 

2006 IUR or 

PAIR commercial/consumer 

use 

Meet exposure 

based criteria for 

commercial 

workers 

Meet exposure 

based criteria for 

consumers 

98–09–9 .................... 1 to <10 .................... ............................ ............................ X X X 

98–56–6 .................... 10 to <50 .................. ............................ ............................ X X X 

111–44–4 .................. 1 to <10 .................... ............................ ............................ X X X 

127–68–4 .................. 1 to <10 .................... ............................ 9,386 ............................ X ............................

515–40–2 .................. 1 to <10 .................... ............................ ............................ X X X 

2494–89–5 ................ 1 to <10 .................... ............................ ............................ X X X 

5026–74–4 ................ 1 to <10 .................... X ............................ ............................ X ............................

22527–63–5 .............. 1 to <10 .................... ............................ ............................ X X X 

25321–41–9 .............. 1 to <10 .................... ............................ 2,843 ............................ X ............................

52556–42–0 .............. 1 to <10 .................... X ............................ X X X 

68082–78–0 .............. 1 to <10 .................... ............................ 41,153 ............................ X ............................

68442–60–4 .............. 1 to <10 .................... ............................ ............................ X X X 

68610–90–2 .............. 1 to <10 .................... ............................ ............................ X ............................ X 

70693–50–4 .............. 1 to <10 .................... ............................ ............................ X X X 

72162–15–3 .............. 1 to <10 .................... ............................ 64,227 ............................ X ............................

Note: CASRN—Chemical Abstract Service Registry Number, IUR—Inventory Update Reporting, PAIR—Preliminary Assessment Information 

Reporting, NOES—National Occupational Exposure Survey. 

B. 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 or imported in an amount 

equal to or greater than 1 million lb per 

year (Ref. 14); this finding is based on 

information gathered pursuant to the 

2006 IUR submissions (see 2006 CFR 

edition for 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. 7, 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. 14). 

C. Are a substantial number of workers 

exposed to these chemical substances? 

EPA finds that the manufacture, 

processing, and use of 14 of the 15 HPV 

chemical substances included in this 

action results 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 


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document for this final rule (Ref. 14). 

(Note: For the single chemical substance 

for which EPA has not found substantial 

worker exposure, EPA finds that there is 

substantial consumer exposure; see 

Table 1 and Ref. 14.) 

This finding is based, in large part, on 

information submitted in accordance 

with the 2006 IUR submissions (see 

2006 CFR edition for 40 CFR part 710) 

and the 2006 PAIR (Ref. 15). For 

chemical substances whose total 

production volume (manufactured and 

imported) exceeded 300,000 lb 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, 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. 7), EPA believes, as a 

general matter, that an exposure of 1,000 

workers or more to a chemical substance 

is ‘‘substantial’’ as that term is used 

with reference to ‘‘human exposure’’ in 

TSCA section 4(a)(1)(B)(i) (Ref. 7). EPA 

is not aware of any facts in this case that 

warrant departure from that policy and 

finds that there is or may be substantial 

human exposure (workers) to 14 of these 

15 HPV chemical substances. 

Besides the 2006 IUR and 2006 PAIR 

data, EPA also reviewed NOES data 

developed by the National Institute for 

Occupational Safety and Health 

(NIOSH). NOES was a nationwide data 

gathering project conducted by NIOSH, 

which was designed to develop national 

estimates for the number of workers 

potentially exposed to various chemical, 

physical, and biological agents and 

describe the distribution of these 

potential exposures. Begun in 1980 and 

completed in 1983, the survey involved 

a walk-through investigation by trained 

surveyors of 4,490 facilities in 523 

different types of industries. Surveyors 

recorded potential exposures when a 

chemical agent was likely to enter or 

contact the worker’s body for a 

minimum duration. These potential 

exposures could be observed or inferred. 

Information from these representative 

facilities was extrapolated to generate 

national estimates of potentially 

exposed workers for more than 10,000 

different chemical substances (Refs. 16– 

18). For 4 of the 15 HPV chemical 

substances, the NOES data also supports 

EPA’s finding that 1,000 or more 

workers are exposed to these chemical 

substances. 

EPA also compared production 

volumes from the 1986 IUR data to the 

production volumes for the 2006 IUR 

data. For the 15 HPV chemical 

substances in this final rule, there was 

no decrease in production volume from 

1986 to 2006 (Ref. 14). For the chemical 

substances for which EPA has NOES 

data, the 2006 IUR production volume 

data are consistent with NOES results, 

as the production volumes for these 

seven 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, 

and, by inference (without contradictory 

data) that worker exposure is also likely 

to have stayed the same or increased. 

EPA carefully considered the 

industrial and commercial processing 

and use information reported for each of 

these 15 HPV chemical substances in 

2006 IUR and PAIR 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)’’ (see 2006 edition of the 

CFR for 40 CFR 710.43). Detailed 

information from the 2006 IUR 

submissions can be found in: ‘‘Testing 

of Certain High Production Volume 

Chemicals-3 (Exposure Findings 

Supporting Information)’’ (Ref. 14). 

Based on the nature of the reported 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 data is the sum of information 

on industrial workers plus commercial 

use workers. 

D. Are a substantial number of 

consumers exposed to these chemical 

substances? 

Based on 2006 IUR data, EPA finds 

that the uses of 9 of the 15 HPV 

chemical substances included in this 

action result or may result in exposure 

to a substantial number of consumers 

(Ref. 14). EPA reviewed the consumer 

use information reported for the 2006 

IUR data and carefully considered the 

nature of those uses. Upon completion 

of the review, EPA concluded that the 

reported consumer uses for these 

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 for 

one additional chemical substance 

based on the National Library of 

Medicine (NLM) Household Products 

Database (HPD) (see Ref. 13). The 

chemical substances reported in the 

HPD are present in multiple household 

products including hobby/craft 

products, personal care products, home 

cleaning products, home maintenance 

products, and automotive products. The 

HPD provides information on the 

chemical ingredients and their 

percentage in specific brands of 

household products. Information in the 

HPD is from a variety of publicly 

available sources including brandspecific labels and Material Safety Data 

Sheets, when available from 

manufacturers and manufacturers’ Web 

sites. 

EPA finds that consumers’ use of the 

products identified in the HPD may 

expose a substantial number of 

consumers (i.e., 10,000 or more) to the 

chemical substances in those products. 

EPA believes that an exposure of 10,000 

or more 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) 

(Ref. 7). Therefore, EPA finds that there 

is or may be substantial human 

exposure (consumers) to 10 of these 15 

HPV chemical substances. 

A discussion of EPA’s ‘‘substantial 

exposure’’ finding for consumers is 

contained in a separate document (Ref. 

14). 

E. Does sufficient data exist for these 

chemical substances? 

EPA has determined that for the 15 

HPV 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 during the manufacturing, 

processing, distribution in commerce, 

use, or disposal of the subject chemical 

substances. 

The finding of 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. 1, 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 proposed rule or identified by EPA 

after the publication of the proposed 

rule to this final rule. The studies and 

data submitted or identified subsequent 

to the proposed rule 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.). 


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EPA encouraged the submission of 

existing data on SIDS testing endpoints 

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 

final rule. However, if persons required 

to test under this final rule become 

aware of additional relevant and 

scientifically adequate existing data 

(including structure-activity 

relationships (SAR) information or a 

scientifically defensible category 

approach) and submit this information 

to EPA before testing is initiated, the 

Agency will consider such data to 

determine if they satisfy the testing 

requirement and will take appropriate 

necessary action to ensure that the 

testing in this final rule is no longer 

required. Persons may submit such 

information as a requested modification 

to the testing requirements under 40 

CFR 790.55 at any time at least 60 days 

before the reporting deadline for the test 

in question. 

F. 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 to ascertain the health and 

environmental effects of the 15 HPV 

chemical substances in this final rule. 

EPA knows of no other means to 

generate the SIDS data other than the 

testing described in this final rule, and 

therefore believes that conducting the 

SIDS testing identified for the 15 HPV 

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. 

V. Final Rule 

A. What testing is required by this final 

rule? 

EPA is requiring specific testing and 

reporting requirements for the chemical 

substances specified in § 799.5089(j) of 

the regulatory text. The testing 

requirements for each chemical are 

denoted by alphanumeric symbols in 

Table 2 in § 799.5089(j) of the regulatory 

text. Table 3 in § 799.5089(j) of the 

regulatory text provides the key to 

identify the tests denoted by the 

alphanumeric symbols and also lists 

special conditions that might apply 

when conducting some of those tests. 

Test methods listed in Table 3 in 

§ 799.5089(j) of the regulatory text are 

grouped according to the endpoint that 

they address. The endpoints and test 

standards required under this final rule 

are listed in this unit. 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—a. 

Melting Point: ASTM International 

(ASTM) E 324–99 (capillary tube) (Ref. 

21) (or, for substances liquid at room 

temperature, Freezing Point: OECD102 

(melting point/melting range) (Ref. 22)). 

b. Boiling Point: ASTM E 1719–05 

(ebulliometry) (Ref. 23). 

c. Vapor Pressure: ASTM E 1782–08 

(thermal analysis) (Ref. 24). 

d. n-Octanol/Water Partition 

Coefficient: Method A (40 CFR 

799.6755—shake flask). 

e. Method B (ASTM E 1147–92 

(Reapproved 2005)—liquid 

chromatography) (Ref. 25). 

f. Method C (40 CFR 799.6756— 

generator column). 

g. Water Solubility: Method A (ASTM 

E 1148–02 (Reapproved 2008)—shake 

flask) (Ref. 26). 

h. Method B (40 CFR 799.6784—shake 

flask). 

i. Method C (40 CFR 799.6784— 

column elution). 

j. 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. Though ASTM 

has withdrawn this method, ASTM still 

makes the method available for 

informational purposes and it can still 

be purchased from ASTM at the address 

listed in § 799.5089(h) of the regulatory 

text. 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) 

EPA concludes, therefore, that 

ASTM’s withdrawal of ASTM E 324–99 

does not have negative implications on 

the validity of the method. 

However, where the chemical 

substance is a liquid at room 

temperature a measured freezing point 

would meet the obligation to report the 

melting point. However, ASTM E 324– 

99 (capillary tube) does not specifically 

include instructions for determining 

freezing point. Therefore, EPA is instead 

requiring OECD 102 (melting point/ 

melting range), which includes 

guidance for determining freezing point 

for substances that are liquid at room 

temperature. 

ASTM has updated and revised its 

test method for vapor pressure (ASTM 

E 1782–08—thermal analysis) since the 

proposed rule was published. 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—thermal 

analysis) is 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., E 1719): 

‘‘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. 23). 

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 Kow and 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 

§ 799.5089(j) of the regulatory text. 

For the log Kow endpoint, EPA is 

requiring that an appropriate selection 

be made from among three alternative 


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methods for measuring the chemical 

substance’s log Kow. Prior to 

determining the appropriate standard to 

use to measure the n-octanol/water 

partition coefficient, EPA is 

recommending that the log Kow be 

quantitatively estimated. EPA 

recommends that the method described 

in ‘‘Atom/Fragment Contribution 

Method for Estimating Octanol-Water 

Partition Coefficients’’ (Ref. 28) be used 

in making such estimation. EPA is 

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 the more suitable 

Method B (ASTM E 1147–92 

(Reapproved 2005)), and especially 

Method C (40 CFR 799.6756—generator 

column), and the less suitable Method A 

(40 CFR 799.6755—shake flask), 

become. 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 Kow

ranges that would determine which tests 

must be conducted for this endpoint are 

shown in Table 2 of this unit. 

TABLE 2—TEST REQUIREMENTS FOR THE PHYSICAL/CHEMICAL PROPERTIES

Testing category Test requirements and references Special conditions 

Physical/chemical properties .............................. n-Octanol/water partition coefficient (log 10 

basis) or log Kow: 

Select from those listed in this column—see 

Special Conditions in the adjacent column. 

Method A: 40 CFR 799.6755 (shake flask) 

Method B: ASTM E 1147–92 (Reapproved 

2005) (liquid chromatography) 

Method C: 40 CFR 799.6756 (generator column) 

n-Octanol/water partition coefficient (log 10 

basis) or log Kow: 

Which method is required, if any, is determined by the test substance’s estimated log 

Kow as follows: 

log Kow < 0: no testing required. 

log Kow range 0–1: Method A or B. 

log Kow range > 1–4: Method A, B, or C. 

log Kow range > 4–6: Method B or C. 

log Kow > 6: Method C. 

Test sponsors must provide in the final study 

report the underlying rationale for the method and pH selected. In order to ensure environmental relevance, EPA highly recommends that the selected study be conducted at pH 7. 

Note: ASTM—ASTM International. 

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 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. 

EPA also highly recommends that all 

required water solubility tests be 

conducted starting at pH 7 to ensure 

environmental relevance. Table 3 of this 

unit shows the estimated water 

solubility ranges that EPA is requiring 

for use in this final rule to select the 

appropriate test standard. 

TABLE 3—TEST REQUIREMENTS FOR THE WATER SOLUBILITY ENDPOINT

Testing category Test requirements and references Special conditions 

Physical/chemical properties .............................. Water solubility: 

The appropriate method to use, if any, to test 

for water solubility would be selected from 

those listed in this column—see Special 

Conditions in the adjacent column. 

Method A: ASTM E 1148–02 (Reapproved 

2008) (shake flask) 

Method B: 40 CFR 799.6784 (shake flask) 

Method C: 40 CFR 799.6784 (column elution) 

Method D: 40 CFR 799.6786 (generator column)..

Water solubility: 

Which method is required would be determined by the test substance’s estimated 

water solubility. Test sponsors must provide 

in the final study report the underlying rationale for the method and pH selected. In 

order to ensure environmental relevance, 

EPA highly recommends that the selected 

study be conducted starting at pH 7. 

> 5,000 mg/L: Method A or B. 

> 10 mg/L–5,000 mg/L: Method A, B, C, or D. 

> 0.001 mg/L–10 mg/L: Method C or D. 

≤ 0.001 mg/L: No testing required. 

Note: ASTM—ASTM International, mg/L—milligram/liter. 

2. Environmental Fate and 

Pathways—a. Ready Biodegradation: 

Method A: ASTM E 1720–01 

(Reapproved 2008) (sealed vessel CO2

production test) (Ref. 30). 

b. Method B: International 

Organization for Standardization (ISO) 


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14593:1999(E) (CO2 headspace test) (Ref. 

31). 

c. Method C: ISO 7827:1994(E) 

(method by analysis of dissolved 

organic carbon (DOC)) (Ref. 32). 

d. Method D: ISO 9408:1999(E) 

(determination of oxygen demand in a 

closed respirometer) (Ref. 33). 

e. Method E: ISO 9439:1999(E) 

(carbon dioxide evolution test) (Ref. 34). 

f. Method F: ISO 10707:1994(E) 

(closed bottle test) (Ref. 35). 

g. Method G: ISO 10708:1997(E) (twophase 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 test 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 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 test substance’s 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—a. Test Group 1: 

i. Acute toxicity to fish (ASTM E 729– 

96 (Reapproved 2007)) (Ref. 38). 

ii. Acute toxicity to Daphnia (ASTM 

E 729–96 (Reapproved 2007)) (Ref. 38). 

iii. Toxicity to plants (algae) (ASTM E 

1218–04 ε1) (Ref. 39). 

b. Test Group 2: 

i. Chronic toxicity to Daphnia (ASTM 

E 1193–97 (Reapproved 2004)) (Ref. 40). 

ii. Toxicity to plants (algae) (ASTM E 

1218–04 ε1) (Ref. 39). 

ASTM has updated ASTM E 729–96 

(Reapproved 2002), its test method for 

Conducting Acute Toxicity Tests on 

Test Materials with Fishes, 

Macroinvertebrates, and Amphibians. 

ASTM reapproved this test method in 

2007. There were minor changes (for 

example, reference to the ASTM Web 

site in place of the ‘‘Annual Book of 

ASTM Standards,’’ minor changes in 

references and dates, titles of ASTM 

documents changed to correspond to 

new titles, etc.) but the test method 

itself is unchanged. 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 chemical 

substances’ aquatic toxicity. This issue 

arises when considering chemical 

substances with high log Kow values. In 

such cases, toxicity is unlikely to be 

observed over the duration of acute 

toxicity studies because of reduced 

uptake and the extended amount of time 

required for such chemical 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 Kow as 

determined by using the approach 

outlined in Unit V.A.1., in the 

discussion of ‘‘n-Octanol/Water 

Coefficient,’’ and in Table 3 in 

§ 799.5089(j) of the regulatory text. For 

test substances determined to have a log 

Kow of less than 4.2, one or more of the 

following tests (described as ‘‘Test 

Group 1’’ in Table 3 in § 799.5089(j) of 

the 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 ε1). 

For test substances determined to 

have a log Kow that is greater than or 

equal to 4.2, one or both of the following 

tests (described as ‘‘Test Group 2’’ in 

Table 3 in § 799.5089(j) of the regulatory 

text) are required: Chronic toxicity to 

Daphnia (ASTM E 1193–97 

(Reapproved 2004)) and/or Toxicity to 

plants (algae) (ASTM E 1218–04 ε1). As 

outlined in Table 3 in § 799.5089(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. 

For the purposes of this final rule, 

EPA’s use of a log Kow equal to or greater 

than 4.2 is consistent with the approach 

taken in the Agency’s final policy 

statement under TSCA section 5, 

‘‘Category for Persistent, 

Bioaccumulative, and Toxic New 

Chemical Substances’’ (Ref. 41). Using 

SAR, a log Kow of 4.2 corresponds with 

a fish bioconcentration factor (BCF) of 

about 1,000 (Refs. 29, 42, and 43). 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. 

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 Kow of 4.3 

cited in the 1989 Federal Register 

document (Ref. 46) and the log Kow

value 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 Kow equal to or greater than 4.2. 

Chemical substances that are dispersible 

in water (e.g., surfactants, detergents, 

aliphatic amines, and cationic dyes) 

may have log Kow values greater than 4.2 

and may still be acutely toxic to aquatic 

organisms. For any chemical substance 

listed in Table 3 in § 799.5089(j) of the 

regulatory text for which a test sponsor 

believes that an alternative to the log 

Kow threshold of 4.2 is appropriate, the 

test sponsor may request a modification 

of the test standard in this 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—a. 

Acute Inhalation Toxicity (rat): Method 

A (40 CFR 799.9130). 

b. 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,’’ such as the 

chemical substance’s physical/chemical 

properties or physical state, be 

considered in determining the 

appropriate test method from among 


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those included for this endpoint in 

Table 3 in § 799.5089(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 HPV 

Challenge Program, EPA is requiring 

that, for test substances that are gases at 

room temperature (25 °C), the acute 

mammalian toxicity study be conducted 

using inhalation as the exposure route 

(described as Method A (40 CFR 

799.9130) in Table 3 in § 799.5089(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 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 

§ 799.5089(j) of the regulatory text). 

Consistent with the 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 § 799.5089(j) of the regulatory 

text. 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 NRU assay are 

available at the NIEHS/Interagency 

Coordination Committee on the 

Validation of Alternative Methods Web 

site (Refs. 47–49). 

5. Mammalian Toxicity— 

Genotoxicity—a. Gene Mutations: 

Bacterial Reverse Mutation Test (in 

vitro): 40 CFR 799.9510. 

b. 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 test sponsor who uses 

one of the in vivo methods instead of the 

in vitro method to address this endpoint would be required to submit to 

EPA in the final study report a rationale 

for conducting that alternate test. 

6. Mammalian Toxicity—Repeated 

Dose/Reproduction/Developmental—a. 

Combined Repeated Dose Toxicity 

Study with the Reproduction/ 

Developmental Toxicity Screening Test: 

40 CFR 799.9365. 

b. Reproduction/Developmental 

Toxicity Screening Test: 40 CFR 

799.9355. 

c. 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 test sponsor 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 in the final study 

report a rationale for conducting these 

alternate tests. 

In the proposed rule (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’’ (e.g., 

stored in controlled on-site facilities; or 

with controlled transport, i.e., to a 

limited number of locations within the 

same company or second parties which 

use the chemical in a controlled way as 

an intermediate with a well-known 

technology). A chemical substance that 

is intended to undergo a further 

deliberate reaction to produce another 

industrial substance is considered an 

intermediate. Intermediates which are 

contained in closed systems and 

therefore have a limited potential for 

exposure may be eligible for a reduced 

testing battery. In these situations, such 

chemical substances may be eligible for 

a reduced testing battery that substitutes 

a developmental toxicity study for the 

SIDS requirement to address repeated 

dose, reproduction, and developmental 

toxicity. EPA requested that 

commenters who believe their chemical 

substance is used solely as a closed 

system intermediate submit appropriate 

information along with their comments 

which substantiate this belief, but EPA 

did not receive any comments from 

potential test sponsors that their 

chemical substance was a closed system 

intermediate. 

B. When will the testing imposed by this 

final rule begin? 

This final rule is effective 30 days 

after its publication in the Federal 

Register. Once it is effective, the 

required testing must be initiated in 

time to allow the required final report 

to be submitted within 13 months of the 

effective date of this final rule (see 

§ 799.5089(i) of the regulatory text). 

C. How must the studies required under 

this final 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 

§ 799.5089(j) of the regulatory text, the 

reporting requirements described in 

§ 799.5089(i) of the regulatory text, and 

with Good Laboratory Practice 

Standards (GLPS) at 40 CFR part 792. 

D. What form of test substances will be 

tested under this final rule? 

EPA is specifying two distinct 

approaches for identifying the specific 

chemical substances that would be 

tested under this final rule, the 

application of which would depend on 

whether the chemical 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 singlechemical species (not including 

impurities) that can be represented by a 

specific, complete structure diagram. By 

contrast, a Class 2 chemical substance 

has a composition that cannot be 

represented by a specific, complete 

chemical structure diagram, because 

such a chemical substance generally 

contains two or more different chemical 

species (not including impurities). A 

‘‘Class 2’’ designation most frequently 

represents a group of chemical 


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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 chemical substances generally 

represent a much narrower group of 

chemical substances for which the only 

variables are their impurities. Table 2 in 

§ 799.5089(j) of the regulatory text 

identifies the listed chemical substances 

as either Class 1 or Class 2 chemical 

substances. 

The ‘‘Class 1’’ chemical substances 

listed in Table 2 in § 799.5089(j) of the 

regulatory text (i.e., 11 of the 15 HPV 

chemical substances included in this 

final rule) must be tested at a purity of 

at least 99%. In 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 § 799.5089(j) of the 

regulatory text (i.e., 4 of the 15 HPV 

chemical substances included in this 

final rule), EPA is requiring that the 

chemical substance 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 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–C14 tert-alkyl amines); or 

• Poorly characterized because all 

that is known is the identity of only 

some of the chemical species present 

and their percentages of composition, or 

of only the feedstocks and method of 

manufacture used to manufacture the 

substance (for example, nut shell liquor 

of cashew). 

Secondly, the composition of some 

Class 2 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. 

EPA believes that, for purposes of this 

final rule, the testing of any 

representative form of a subject Class 2 

chemical substance would provide the 

data necessary to support the 

development of preliminary or 

screening level hazard and risk 

characterizations for the subject Class 2 

chemical substance. However, EPA 

encourages the selection of 

representative forms of test substances 

that meet industry or consensus 

standards, where they exist. In 

accordance with TSCA 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). 

E. Am I required to test under this final 

rule? 

1. Am I subject to this final rule? You 

are subject to this final rule and may be 

required to test if you manufacture 

(including import) or process, or intend 

to manufacture or process, one or more 

chemical substances listed in this final 

rule during the time period described 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 chemical substance (See 

§ 799.5089(b)(2) of the regulatory text). 

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 

§ 799.5089(j) of the regulatory text at 

any time from the effective date of this 

final 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 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 must initially 

comply with this final rule. To comply, 

they must either: 

• Submit to EPA letters-of-intent-toconduct-testing, conduct this testing, 

and submit the test data to EPA, or 

• Apply to and obtain from EPA 

exemptions from testing. 

See 40 CFR 790.5 (‘‘Submission of 

information’’) and 40 CFR 790.45 

(‘‘Submission of letter-of-intent-toconduct-testing or exemption 

application’’) for details. (Note: In 

addition to the identifying information 

specified in § 790.5, EPA also requests 

that the docket ID number EPA–HQ– 

OPPT–2009–0112 be included on the 

submission). For all submissions under 

this part, six copies must be provided to 

EPA. All submissions for this final rule, 

except those containing CBI, will be 

entered into the docket under 

‘‘Supporting and Related Material.’’ 

Addresses of the OPPT Document 

Control Office, where this information 

should be sent, are found in this final 

rule under ‘‘Submission of 

Information.’’ 

Persons in Tier 2: 

• Do not have to initially comply 

with this final rule. 

• Are not required to take any action 

unless EPA notifies them to the contrary 

(because, for example, no person in Tier 

1 had submitted a letter-of-intent-toconduct-testing), as described in Unit 

V.E.3.f. 

a. Who is in Tier 1 and Tier 2? Table 

4 of this unit describes who is in Tier 

1 and Tier 2. 


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TABLE 4—PERSONS SUBJECT TO THIS FINAL RULE: TIER 1 AND TIER 2 

Tier 1 

(persons initially required to comply) 

Tier 2 

(persons not initially required to comply) 

Persons who manufacture (as defined at TSCA section 3(7)), or intend 

to manufacture, a test rule substance, and who are not listed under 

Tier 2.

A. Persons who manufacture (as defined at TSCA section 3(7)) or intend to manufacture a test rule substance solely as one or more of 

the following: 

—As a byproduct (as defined at 40 CFR 791.3(c)); 

—As an impurity (as defined at 40 CFR 790.3); 

—As a naturally occurring chemical substance (as defined at 40 

CFR 710.4(b)); 

—As a non-isolated intermediate (as defined at 40 CFR 704.3); 

—As a component of a Class 2 substance (as described at 40 

CFR 720.45(a)(1)(i)); 

—In amounts of less than 500 kgs (1,100 lb) annually (as described at 40 CFR 790.42(a)(4)); or 

—In small quantities solely for research and development (as described at 40 CFR 790.42(a)(5)). 

B. Persons who process (as defined at TSCA section 3(10)) or intend 

to process a test rule substance (see 40 CFR 790.42(a)(2)). 

Note: kgs—kilograms, TSCA—Toxic Substances Control Act. 

Under 40 CFR 790.2, EPA may 

establish procedures for 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 rule, EPA has 

reconfigured the tiers in 40 CFR 790.42. 

The Agency took administrative burden 

and complexity into account in 

determining who was to be in Tier 1 in 

this final rule. 

Tier 1 includes: 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. 

Tier 2 includes: 

• Processors, manufacturers of less 

than 500 kilograms (kgs) (1,100 lb) per 

year (small-volume manufacturers). 

• Manufacturers of small quantities 

for research and development (R&D). 

• Byproduct manufacturers. 

• Impurity manufacturers. 

• Manufacturers of naturally 

occurring substances. 

• Manufacturers of non-isolated 

intermediates. 

• Manufacturers of components of 

Class 2 chemical substances. 

Byproduct manufacturers, impurity 

manufacturers, manufacturers of 

naturally occurring chemical 

substances, manufacturers of nonisolated intermediates, and 

manufacturers of components of Class 2 

chemical substances historically have 

not participated in testing or 

contributed to reimbursement of those 

persons who have conducted testing. 

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. 

EPA understands that for some 

manufacturers the marginal transaction 

costs involved in negotiating and 

administering testing arrangements may 

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 included in 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. 

b. Subdivision of Tier 2 entities. In 

this final rule the Agency has further 

subdivided which persons in Tier 2 

would be required to perform testing, if 

needed. 

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 

following: A byproduct, an impurity, a 

naturally occurring substance, a nonisolated intermediate, a component of a 

Class 2 chemical substance, in amounts 

less than 1,100 lb annually, or in small 

quantities solely for R&D. 

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 persons in Tier 2B. It is 

appropriate to call upon manufacturers 

before processors 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. 50). 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. 51). 

c. When is it appropriate for a person 

required to comply with this final rule 

to apply for an exemption rather than to 

submit a letter-of-intent-to-conducttesting? 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)). Procedures relating to 

exemptions are in 40 CFR 790.80 

through 790.99, and § 799.5089(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 the 

chemical substance is equivalent to the 

chemical 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 


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Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Rules and Regulations 65397 

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 final 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 § 799.5089(c)(8) of the 

regulatory text for details on submitting 

this notice. In addition, the Agency will 

terminate a conditional exemption if no 

letter-of-intent-to-test has been received 

from persons required to comply with 

this final rule. See, e.g., § 799.5089(c)(6) 

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 are 

subject to this final rule and you are 

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. 

The Agency may require you 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 

make the required submissions (see 

§ 799.5089(c)(4), (c)(5), (c)(6), and (c)(7) 

of the regulatory text), or if a problem 

occurs with the initiation, conduct, or 

completion of the required testing, or 

with the submission of the required data 

to EPA (see 40 CFR 790.93 and 

§ 799.5089(c)(10) of the regulatory text). 

f. What will happen if no one submits 

a letter-of-intent-to-conduct-testing? If 

no one in Tier 1 submits a letter-ofintent-to-test within 30 days of the 

effective date of this final rule, EPA will 

notify in a separate Federal Register 

document persons in Tier 2A first, and 

then persons in Tier 2B of their 

obligation to submit a letter-of-intent-totest, or an exemption application (see 

§ 799.5089(c)(4) and (6) of the regulatory 

text). Persons in Tier 2A will have 30 

days from the date the document 

published in the Federal Register to 

submit the required notice or exemption 

application. If no one in Tier 2A makes 

the required notification, EPA will 

follow the same procedure to notify 

persons in Tier 2B. 

In the event that EPA does not receive 

a letter-of-intent for one or more of the 

tests required for any of the chemical 

substances in this final rule within 30 

days after the publication of a Federal 

Register document notifying persons in 

Tier 2B 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 letterof-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 this final rule with 

respect to that chemical substance who 

are not already in violation of this final 

rule would be in violation of this final 

rule and would be subject to potential 

enforcement actions by EPA. 

4. What are the reimbursement 

procedures? 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 

CFR 791.40(a)). The hearing officer’s 

proposed order may become the 

Agency’s final order, which is 

reviewable in Federal court (40 CFR 

791.60). 

F. What are the reporting requirements 

under this final rule? 

Study plans must be submitted for 

each test for each chemical substance 90 

days after the effective date of this final 

rule, unless an extension is granted in 

writing pursuant to 40 CFR 790.55. See 

40 CFR 790.50 (submission of study 

plans) for what information the study 

plan must contain. A final report must 

be submitted for each test for each 

chemical substance 13 months after the 

effective date of this final rule; i.e., by 

the deadline indicated in § 799.5089(i) 

of the regulatory text. Addresses of the 

OPPT Document Control Office, where 

this information should be sent, are 

found in this final rule under 

‘‘Submission of Information.’’ 

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 a robust 

summary are also encouraged to submit 

it 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.’’ 

G. What would I need to do if I cannot 

complete the testing required by this 

final rule? 

A company that submits a letter-ofintent-to-test under this 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. 

H. Will there be sufficient test facilities 

and personnel to undertake the testing 

required under this final rule? 

EPA’s most recent analysis of 

laboratory capacity (Ref. 52) indicates 


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that available test facilities and 

personnel would adequately 

accommodate the testing specified in 

this final rule. 

I. Might EPA seek further testing of the 

chemical substances in this final 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 that purpose. 

VI. 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 chemical 

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 chemical 

substance. 

VII. Decision Not To Require Testing 

for Certain Chemical Substances 

A. TSCA Section 4(a)(1)(B)(i) Finding 

Not Made 

Based on comments received on the 

proposed rule and findings, the 

information before EPA at this point 

does not provide a basis to make the 

findings of substantial production, 

release to the environment in 

substantial quantities, and/or 

substantial human exposure for 12 of 

the chemical substances included in the 

proposed rule. Comments indicated that 

11 of the chemical substances were not 

or are no longer produced or imported 

in amounts equal to or greater than 1 

million lb per year. Comments also 

indicated that the proposed finding of 

‘‘enters or can be reasonably anticipated 

to enter the environment in substantial 

quantities’’ cannot be made for an 

additional chemical substance. Because 

the data provided show manufacture, 

human exposure, and/or environmental 

release are below the B Policy 

thresholds (discussed in Unit IV.A.) 

under TSCA section 4(a)(1)(B)(i), and 

because EPA has not identified any 

additional factors as discussed in the B 

Policy (Ref. 7) to cause the Agency to 

use decisionmaking criteria other than 

the general thresholds described in the 

B Policy for these chemical substances, 

EPA is not including these chemical 

substances in this final rule. In the event 

new Chemical Data Reporting (CDR) 

data or other data provide new or 

additional support for the TSCA section 

4(a)(1)(B)(i) finding for any of these 

chemical substances, EPA will take 

appropriate steps to proceed with a test 

rule for the chemical substance(s). 

Based on public comment, EPA no 

longer has the basis to find that six 

chemical substances are produced or 

imported in amounts equal to or greater 

than 1 million pounds per year. 

Therefore, these six chemical substances 

are no longer included in this final rule: 

Benzene, 1,2-dimethyl-3-nitro- (CASRN 

83–41–0); 1-tetracosanol (CASRN 506– 

51–4); 1-hexacosanol (CASRN 506–52– 

5); 2-propenoic acid, 2-carboxyethyl 

ester (CASRN 24615–84–7); 

methanesulfonamide, N-[2-[(4-amino-3- 

methylphenyl)ethylamino]ethyl]-, 

sulfate (2:3) (CASRN 25646–71–3); and 

tar, coal, high-temp. (CASRN 65996–89– 

6). 

Based on public comment, EPA no 

longer has the basis to find for an 

additional six chemical substances that 

they have substantial human exposure 

or substantial environmental release and 

so are also not included in this final 

rule. These chemical substances are: 

Solvent naphtha (coal) (CASRN 65996– 

79–4); tar oils, coal (CASRN 65996–82– 

9); distillates (coal tar) (CASRN 65996– 

92–1); pitch, coal tar-petroleum (CASRN 

68187–57–5); 1,4-benzenedicarboxylic 

acid, 1,4-dimethyl ester, manuf. of, byproducts from (CARN 68988–22–7); and 

extract residues (coal), tar oil alk., 

naphthalene distn. residues (CASRN 

73665–18–6). 

B. TSCA Section 4(a)(1)(B)(ii) Finding 

Not Made 

For certain testing endpoints for 

certain chemical substances 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 § 799.5089(j) of the regulatory text, 

which lists the chemical substances and 

testing requirements, has been revised 

to reflect this. For one chemical 

substance no testing is required; for two 

others, a more limited set of testing is 

being required than was originally 

proposed. Further discussion follows in 

Units VII.B.1.–3. 

1. Mutagenicity endpoints and 

screening reproduction/developmental 

toxicity of 3-pentanone (CASRN 96–22– 

0). As discussed in Unit E.2. of the 

‘‘Response to Public Comments’’ 

document (Ref. 13), EPA reviewed 

additional data, including studies 

submitted by PETA (PETA submitted 

these data on behalf of themselves and 

other Animal Welfare Organizations 

(AWOs)) for 3-pentanone (CASRN 96– 

22–0). After reviewing these data, EPA 

finds existing studies are adequate to 

evaluate mutagenicity and 

reproduction/developmental toxicity 

and is not finalizing the proposed 

testing for mutagenicity and 

reproduction/developmental toxicity. 

Therefore, 3-pentanone is not included 

in this final rule. 

2. Log Kow, ready biodegradation, 

aquatic toxicity, and screening 

reproduction/developmental toxicity of 

benzene, 1-chloro-4-(trifluoromethyl)- 

(CASRN 98–56–6). As discussed in Unit 

E.3. of the ‘‘Response to Public 

Comments’’ document (Ref. 13), EPA 

reviewed additional data, including 

studies submitted by the Greenwich 

Chemical Consulting, Inc. (GCC) for 

benzene, 1-chloro-4-(trifluoromethyl)-. 

After reviewing these data, EPA finds 

existing studies are adequate to evaluate 

log Kow and screening reproduction/ 

developmental toxicity and is not 

finalizing the proposed testing for these 

endpoints. In addition, EPA has 

reviewed the biodegradation studies and 

aquatic toxicity studies. EPA considers 

the biodegradation studies to be 

inadequate, so that test is required. 

While EPA considers the acute fish and 

invertebrate testing to no longer be 

necessary, EPA is still requiring an algal 

toxicity study. 

3. Physical/chemical properties, ready 

biodegradation, aquatic toxicity, acute 

mammalian toxicity, combined 

repeated-dose/screening reproduction/ 

developmental toxicity, and 

mutagenicity endpoints of 

benzenesulfonic acid, dimethyl (CASRN 

25321–41–9). As discussed in Unit E.7. 

of the ‘‘Response to Public Comments’’ 

document (Ref. 13), EPA reviewed 

additional data, including studies 

submitted by Nease Corporation 

providing data for several analogue 

chemical substances for 

benzenesulfonic acid, dimethyl. EPA 

finds these data acceptable to fulfill all 

of the proposed testing endpoints with 


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the exception of these three physical/ 

chemical (p-chem) properties: Boiling 

point, vapor pressure and log Kow. 

VIII. Decision to Defer Final Action for 

Chloroalkanes 

EPA is deferring final action for 

chlorinated paraffins: Alkanes, chloro 

(CASRN 61788–76–9). In addition to the 

proposed test rule (Ref. 2), EPA 

published an Action Plan for ShortChain Chlorinated Paraffins (SCCPs) 

and Other Chlorinated Paraffins (Ref. 

53). There is currently an unresolved 

issue regarding whether all the 

production previously reported to the 

Agency under CASRN 61788–76–9 

should in fact be covered by that listing. 

Pending resolution of this issue, EPA 

will defer making a final decision 

regarding test rule requirements for 

CASRN 61788–76–9, and will 

reevaluate the testing needs for CASRN 

61788–76–9 based on future CDR 

reports. 

IX. Economic Impacts 

EPA has prepared an economic 

assessment entitled ‘‘Economic Impact 

Analysis for the Final Section 4 Test 

Rule for High Production Volume 

Chemicals; Third Group of Chemicals’’ 

(Ref. 53), a copy of which has been 

placed in the docket for 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 15 HPV chemical substances. 

The total cost of providing test data on 

the 15 HPV chemical substances that 

were evaluated in this economic 

analysis is estimated to be $5.13 million 

(Ref. 54). 

While legally subject to this final rule, 

processors of a subject chemical 

substance would be required to comply 

with the requirements of this final rule 

only if they are directed to do so by EPA 

as described in § 799.5089(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-ofintent 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 

this 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 15 

HPV chemical substances evaluated in 

the economic analysis to be $0.56 

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 this final rule, is estimated to range 

from $27.49 per notice to $86.99 per 

notice (Ref. 54). 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, 7 out of 

the 15 HPV chemical substances (47%) 

would have a price impact at less than 

the 1% level. Similarly, 5 out of the 15 

HPV chemical substances (33%) 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 rule is low for 

at least 33% of the chemical substances 

in this final rule. Approximately 10 

chemical substances (67%) of the 15 

HPV chemical substances for which 

price data are available would have a 

price impact at a level greater than or 

equal to 1% under the average cost 

scenario. 

EPA believes that the testing of the 

chemical substances in this final rule 

presents a low potential for adverse 

economic impact for a reasonable 

number of the 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 nearly half 

of the 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 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. In that 

analysis, EPA found that the costs of 

testing requirements in this final rule for 

chemical substances produced by a 

specific company exceed 1% of 

company revenues for only one of the 

affected companies. 

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 this final rule where such 

information has not been publicly 

available. Because of constraints on 

information on the value of information, 

EPA’s evaluation of benefits is 

qualitative and does not address 

incremental benefits. EPA believes, 

however, that the net benefits of the 

new information are positive. 

X. Materials in the Docket 

As indicated under ADDRESSES, a 

docket was established for this final rule 

under docket ID number EPA–HQ– 

OPPT–2009–0112. The following is a 

listing of the documents that have been 

placed in the docket for this 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, 


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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; Third Group of 

Chemicals. Proposed Rule. Federal 

Register (75 FR 8575, February 25, 2010) 

(FRL–8805–8). 

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 13708, March 16, 2006) 

(FRL–7335–2). 

5. 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). 

6. EPA. Testing of Certain High Production 

Volume Chemicals; Second Group of 

Chemicals. Final Rule. Federal Register 

(76 FR 1067, January 7, 2011) (FRL– 

8846–9). 

7. 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). 

8. EPA, OPPT. HPV Challenge Program 

Chemical List. Available online at: 

http://www.epa./oppt/chemrtk/pubs/ 

update/hpvchmlt.htm. 

9. OECD Secretariat. OECD Programme on 

the Co-Operative Investigation of High 

Production Volume Chemicals. Manual 

for the Assessment of Chemicals. Paris, 

France. September 2004. Available 

online at: http://www.oecd.org/

document/7/0,2340,en_2649_34379_

1947463_1_1_1_1,00.htm. 

10. ICCA. ICCA HPV Working List of 

Chemicals. October 2005. Available 

online at: http://www.icca-chem.org/

Home/ICCA-initiatives/High-productionvolume-chemicals-initiative-HPV. 

11. EPA. TSCA Section 4(a)(1)(B) Proposed 

Statement of Policy. Notice. Federal 

Register (56 FR 32294, July 15, 1991). 

12. EPA, OPPT. Chemical Hazard Data 

Availability Study: What Do We Really 

Know About the Safety of High 

Production Volume Chemicals? April 

1998. Available online at: http://

www.epa.gov/chemrtk/pubs/general/ 

hazchem.htm. 

13. EPA, OPPT, Chemical Information and 

Testing Branch (CITB). Response to 

public comments regarding testing of 

certain high production volume 

chemicals. August 2010. 

14. EPA, OPPT, Economics, Exposure and 

Technology Division (EETD). Testing of 

Certain High Production Volume 

Chemicals-3 (Exposure Findings 

Supporting Information). March 2011. 

15. EPA. Preliminary Assessment 

Information Reporting; Addition of 

Certain Chemicals. Final Rule and 

Technical Corrections. Federal Register 

(71 FR 47122, August 16, 2006) (FRL– 

7764–9). 

16. 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. 1988. Available online at: http://

www.cdc.gov/niosh/88–106.html. 

17. 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. 1989. Available 

online at: http://www.cdc.gov/niosh/89- 

103.html. 

18. DHHS, CDC, NIOSH. National 

occupational exposure survey sampling 

methodology. Vol. II. Sieber, W.K., ed. 

Cincinnati, OH. DHHS (NIOSH) 

Publication No. 89–102. 1989. Available 

online at: http://www.cdc.gov/niosh/89- 

102.html. 

19. EPA, OPPT. Draft Guidance on 

Developing Robust Summaries. October 

22, 1999. Available online 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. OECD. Guideline for the Testing of 

Chemicals: Melting Point/Melting Range. 

OECD 102. July 27, 1995. 

23. ASTM International. Standard Test 

Method for Vapor Pressure of Liquids by 

Ebulliometry. ASTM E 1719–05. 2005. 

24. ASTM International. Standard Test 

Method for Determining Vapor Pressure 

by Thermal Analysis. ASTM E 1782–08. 

2008. 

25. ASTM International. Standard Test 

Method for Partition Coefficient (NOctanol/Water) Estimation by Liquid 

Chromatography. ASTM E 1147–92 

(Reapproved 2005). 

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. 

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 CO2

Production 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 (CO2 Headspace 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 TwoPhase 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 1218–04e1. 2004. 

40. ASTM International. Standard Guide for 

Conducting Daphnia magna Life-Cycle 

Toxicity Tests. ASTM E 1193–97 

(Reapproved 2004). 


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41. 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 online at: http://www.epa.gov/ 

oppt/newchems/pubs/pbtpolcy.htm. 

42. 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. 

43. 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. 

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 online 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 online 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 online 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 online at: 

http://iccvam.niehs.nih.gov/methods/ 

acutetox/invitrocyto/invcyt_proto.htm. 

50. EPA. Toxic Substances; Test Rule 

Development and Exemption 

Procedures. Interim Final Rule. Federal 

Register (50 FR 20652, 20654, May 17, 

1985). 

51. EPA. Toxic Substances Control Act; Data 

Reimbursement. Final Rule. Federal 

Register (48 FR 31786, July 11, 1983). 

52. EPA, Economics and Policy Analysis 

Branch (EPAB). Analysis of Laboratory 

Capacity to Support U.S. EPA Chemical 

Testing Program Initiatives. Washington, 

DC. October 28, 2010. 

53. EPA, OPPT. Short-Chain Chlorinated 

Paraffins (SCCPs) and Other Chlorinated 

Paraffins. Action Plan. December 30, 

2009. Available online at: http:// 

www.epa.gov/opptintr/ 

existingchemicals/pubs/actionplans/ 

sccps_ap_2009_1230_final.pdf. 

54. EPA, OPPT, EPAB. Economic Impact 

Analysis for the Final Section 4 Test 

Rule for High Production Volume 

Chemicals; Third Group of Chemicals. 

April 14, 2011. 

55. EPA, OPPT. The Use of Structure-Activity 

Relationships (SAR) in the High 

Production Volume Chemicals Challenge 

Program. August 26, 1999. Available 

online at: http://www.epa.gov/chemrtk/ 

pubs/general/sarfinl1.htm. 

56. EPA, OPPT, EETD, EPAB. Economic 

Analysis in Support of the TSCA 12(b) 

Information Collection Request. 

Washington, DC. October 30, 1998. 

XI. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

Under Executive Order 12866, 

entitled ‘‘Regulatory Planning and 

Review’’ (58 FR 51735, October 4, 1993), 

this final 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; Third 

Group of Chemicals’’ (Ref. 54). A copy 

of the economic analysis is available in 

the docket for this final rule and is 

summarized in Unit IX. 

B. 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 final 

rule is provided in the economic 

analysis (Ref. 54). 

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 

requirements 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. 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 15 HPV chemical 

substances is 25,226 hours, with an 

estimated burden per chemical 

substance of 1,682 hours (Ref. 54). 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. 54). 

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 


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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. 

C. 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 will not have a significant 

adverse economic impact on a 

substantial number of small entities. 

The factual basis for this determination 

is presented in the small entity impact 

analysis prepared as part of the 

economic analysis for this final rule 

(Ref. 54), which is summarized in Unit 

IX., 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. 54), 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. 54) 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 

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 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 

previously, 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. 

54). For a conservative estimate of the 

number of small businesses affected by 

this final 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 15 HPV 

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 31 affected 

UCEs. Sales and employment data could 

be found for 30 of these UCEs (97%). 

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), 13 companies (38%) 

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 13 small businesses included 

in the analysis, 1 company (8%) had 

cost-to-sales ratios of greater than 1% 

under both the least and average cost 

scenarios. For the single business where 

sales and employment data were 

unavailable, EPA conducted an analysis 

to evaluate the potential impact on this 

company using the median sales value 

sales of all other small businesses equal 

to $24.3 million. The costs for the 

company were estimated to be well 

below 1% 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. 


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The estimated cost of the TSCA 

section 12(b)(1) export notification, 

which, as a result of this final rule, 

would be required for the first export to 

a particular country of a chemical 

substance subject to this final rule, is 

estimated to be $86.99 for the first time 

that an exporter must comply with 

TSCA section 12(b)(1) export 

notification requirements, and $27.49 

for each subsequent export notification 

submitted by that exporter (Refs. 54–56). 

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 this final rule, regardless 

of the size of the exporter. 

D. 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 IX., would be 

$5.08 million. The total annualized 

costs of this final rule are estimated to 

be $1.81 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 final 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. 

E. 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 establishes 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 final 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. 

F. 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 effect on Tribal 

governments, on the relationship 

between the Federal Government and 

the Indian Tribes, or on the distribution 

of power and responsibilities between 

the Federal Government and Indian 

Tribes, as specified in the 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 final rule. 

G. 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 establishes 

testing and recordkeeping requirements 

that apply to manufacturers (including 

importers) and processors of certain 

chemical substances, and that will 

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. 

H. 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. 

I. 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 final rule, EPA 

is requiring the use of voluntary 

consensus standards issued by ASTM 

and ISO, and a OECD guideline, which 

evaluate the same type of toxicity as the 

TSCA and OECD test methods, where 

applicable. Copies of the 17 ASTM and 

ISO standards and 1 OECD guideline, 

referenced in § 799.5089(h) of the 

regulatory text, have been placed in the 

docket for this final rule and may also 

be obtained by contacting the 

organizations that produced these 

materials. The addresses for these 

organizations are listed in the regulatory 

text of § 799.5089(h). EPA received the 

required approval from the Director of 

the Federal Register for the 

incorporation by reference of the ASTM 

and ISO standards and OECD guideline 

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 TSCA test 

methods, 40 CFR 799.6756, 799.6784, 

799.6786, 799.9130, 799.9510, 799.9538, 

799.9365, 799.9305, and 799.9355. 


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J. 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 this final 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 lowincome and minority communities. 

XII. 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 in 40 CFR Part 799 

Environmental protection, Chemicals, 

Hazardous substances, Incorporation by 

reference, Laboratories, Reporting and 

recordkeeping requirements. 

Dated: October 13, 2011. 

Stephen A. Owens, 

Assistant Administrator, Office of Chemical 

Safety and Pollution Prevention. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 799—[AMENDED] 

■ 3. The authority citation for part 799 

continues to read as follows: 

Authority: 15 U.S.C. 2603, 2611, 2625. 

■ 4. Add new § 799.5089 to subpart D to 

read as follows: 

§ 799.5089 Chemical testing requirements 

for third group of high production volume 

chemicals (HPV3). 

(a) 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 

November 21, 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 section (Tier 1) Persons not initially required to comply with this section (Tier 2) 

Persons not otherwise specified in column 2 of this table that manufacture (as defined at TSCA section 3(7)) or intend to manufacture a 

chemical substance included in this section.

A. Persons who manufacture (as defined at TSCA section 3(7)) or intend to manufacture a chemical substance included in this section 

solely as one or more of the following: 

—As a byproduct (as defined at 40 CFR 791.3(c)); 

— As an impurity (as defined at 40 CFR 790.3); 

—As a naturally occurring substance (as defined at 40 CFR 

710.4(b)); 

—As a non-isolated intermediate (as defined at 40 CFR 704.3); 

—As a component of a Class 2 substance (as described at 40 

CFR 720.45(a)(1)(i)); 

—In amounts of less than 500 kg (1,100 lb) annually (as described at 40 CFR 790.42(a)(4)); or 

—For research and development (as described at 40 CFR 

790.42(a)(5)). 

B. Persons who process (as defined at TSCA section 3(10)) or intend 

to process a chemical substance included in this section (see 40 

CFR 790.42(a)(2)). 

Note: kgs—kilograms, 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 


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Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Rules and Regulations 65405 

must, for each test required under this 

section for that chemical substance, 

either submit to EPA a letter-of-intentto-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 December 

20, 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. 

(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 December 20, 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-totest 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 November 

21, 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-ofintent 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 November 21, 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-ofintent-to-test or apply to EPA for an 

exemption from testing. The letter-ofintent-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-intentto-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-totest 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-totest, you must submit a study plan and 

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, submission of study plans, 

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 § 790.45; § 790.48; 

paragraphs (a)(2) and (b) of § 790.80; 

paragraph (e)(1) of § 790.82; and 

§ 790.85. 

(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 


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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 

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 

1218–04e1, 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 (CO2 Headspace 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 WaterSoluble 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 standards 

from ASTM International, 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 standards from the International 

Organization for Standardization, 1, ch. 

de la Voie-Creuse, CP 56, CH–1211 

Geneve 20, Switzerland, telephone 

number: +41–22–749–01–11, Web 

address: http://www.iso.org; and copies 

of the OECD guideline from the 

Organization for Economic Cooperation 

and Development, 2, rue Andre ́ Pascal, 

75775 Paris Cedex 16, France, telephone 

number: +33–1–45–24–82–00, Web 

address: http://www.oecd.org. You may 

inspect each standard and guideline at 

the EPA Docket Center (EPA/DC), Rm. 

3334, EPA West Bldg., 1301 

Constitution Ave., NW., Washington, 

DC, from 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. The 

materials are also available for 

inspection 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 study 

plan for each specific test for each 

subject chemical substance must be 

received by EPA by February 20, 2012 

unless an extension is granted in writing 

pursuant to 40 CFR 790.55. A final 

report for each specific test for each 

subject chemical substance must be 

received by EPA by December 21, 2012 

unless an extension is granted in writing 

pursuant to 40 CFR 790.55. EPA is also 

requesting 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’’ which is available 

online at 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

CASRN Chemical name Class Required tests 

(see Table 3 of this section) 

98–09–9 ..................... Benzenesulfonyl chloride ........................................................................ 1 C2, E1, E2, F1 

98–56–6 ..................... Benzene, 1-chloro-4-(trifluoromethyl)- .................................................... 1 B, C6 


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TABLE 2—CHEMICAL SUBSTANCES AND TESTING REQUIREMENTS—Continued 

CASRN Chemical name Class Required tests 

(see Table 3 of this section) 

111–44–4 ................... Ethane, 1,1′-oxybis[2-chloro- .................................................................. 1 C6, F1 

127–68–4 ................... Benzenesulfonic acid, 3-nitro-, sodium salt (1:1) ................................... 1 A3, F2 

515–40–2 ................... Benzene, (2-chloro-1,1-dimethylethyl)- .................................................. 1 A1, A3, A4, A5, B, C1, D, E1, E2, 

F1 

2494–89–5 ................. Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate) .................. 1 A1, A2, A3, A4, A5, B, C1, D, E1, 

E2, F1 

5026–74–4 ................. 2-Oxiranemethanamine, N-[4-(2-oxiranylmethoxy)phenyl]-N-(2- 

oxiranylmethyl)- 

1 A1, A2, A3, A4, A5, B, C2, F1 

22527–63–5 ............... Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester .. 1 A1, A2, A3, A4, A5, B, C1, D, E1, 

E2, F1 

25321–41–9 ............... Benzenesulfonic acid, dimethyl- ............................................................. 1 A2, A3, A4 

52556–42–0 ............... 1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt 

(1:1).

1 A1, A2, A3, A4, A5, B, C1, D, E1, 

E2, F1 

68082–78–0 ............... Lard, oil, Me esters ................................................................................. 2 A1, A2, A3, A4, A5, B, C1, D, E1, 

E2, F1 

68442–60–4 ............... Acetaldehyde, reaction products with formaldehyde, by-products from 2 A1, A2, A3, A4, A5, B, C1, D, E1, 

E2, F1 

68610–90–2 ............... 2-Butenedioic acid (2E)-, di-C8-18-alkyl esters ..................................... 2 A1, A2, A3, A4, A5, B, C1, D, E1, 

E2, F1 

70693–50–4 ............... Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-nitrophenyl)diazenyl]- .. 1 A1, A2, A3, A4, A5, B, C1, D, E1, 

E2, F1 

72162–15–3 ............... 1-Decene, sulfurized ............................................................................... 2 A2, A3, A4, A5, B, C1, D, E1, E2, 

F1 

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] 

Testing category Test 

symbol Test requirements and references Special conditions 

Physical/chemical properties.A 1. Melting Point: ASTM International (ASTM) E 

324–99 (capillary tube), if a Freezing Point: Organization for Economic Cooperation and Development (OECD) 102 (melting point/melting range). 

2. Boiling Point: ASTM E 1719–05 (ebulliometry). 

3. Vapor Pressure: ASTM E 1782–08 (thermal 

analysis). 

4. n-Octanol/Water Partition Coefficient (log 10 

basis) or log Kow: (See Special Conditions for the 

log Kow test requirement and select the appropriate method to use, if any, from those listed in 

this column.) 

Method A: 40 CFR 799.6755 (shake flask). 

Method B: ASTM E 1147–92 (Reapproved 2005) 

(liquid chromatography). 

Method C: 40 CFR 799.6756 (generator column). 

5. Water Solubility: (See Special Conditions for the 

water solubility test requirement and select the 

appropriate method to use, if any, from those listed in this column.) 

Method A: ASTM E 1148–02 (Reapproved 2008) 

(shake flask). 

Method B: 40 CFR 799.6784 (shake flask). 

Method C: 40 CFR 799.6784 (column elution). 

Method D: 40 CFR 799.6786 (generator column). 

n-Octanol/water Partition Coefficient (log 10 basis) 

or_log Kow: 

Which method is required, if any, is determined by 

the test substance’s estimated i log Kow as follows: 

log Kow < 0: no testing required. 

log Kow range 0–1: Method A or B. 

log Kow range > 1–4: Method A, B, or C. 

log Kow range > 4–6: Method B or C. 

log Kow > 6: Method C. 

Test sponsors must provide in the final study report 

the underlying rationale for the method and pH 

selected. In order to ensure environmental relevance, EPA highly recommends that the selected study be conducted at pH 7. 

Water Solubility: 

Which method is required, if any, is determined by 

the test substance’s estimated ii water solubility. 

Test sponsors must provide in the final study report the underlying rationale for the method and 

pH selected. In order to ensure environmental 

relevance, EPA highly recommends that the selected study be conducted starting at pH 7. 

> 5,000 milligram/Liter (mg/L): Method A or B. 

> 10 mg/L–5,000 mg/L: Method A, B, C, or D. 

> 0.001 mg/L–10 mg/L: Method C or D. 

≤ 0.001 mg/L: No testing required. 


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TABLE 3—KEY TO THE TEST REQUIREMENTS DENOTED BY ALPHANUMERIC SYMBOLS IN TABLE 2 OF THIS PARAGRAPH— 

Continued 

[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] 

Testing category Test 

symbol Test requirements and references Special conditions 

Environmental fate and 

pathways—ready biodegradation.

B For B, consult International Organization for Standardization (ISO) 10634:1995(E) for guidance, and 

choose one of the methods listed in this column: 

1. ASTM E 1720–01 (Reapproved 2008) 

(sealed vessel CO2 production test) OR 

2. ISO 14593:1999(E) (CO2 headspace test) 

OR 

3. ISO 7827:1994(E) (analysis of DOC) OR 

4. ISO 9408:1999(E) (determination of oxygen 

demand in a closed respirometer) OR 

5. ISO 9439:1999(E) (CO2 evolution test) OR 

6. ISO 10707:1994(E) (closed bottle test) OR 

7. ISO 10708:1997(E) (two-phase closed bottle 

test). 

Which method is required, if any, is determined by 

the test substance’s physical and chemical properties, including its water solubility. ISO 

10634:1995(E) provides guidance for selection of 

an appropriate test method for a given test substance. Test sponsors must provide in the final 

study report the underlying rationale for the method selected. 

Aquatic toxicity .................. C1 For C1, Test Group 1 or Test Group 2 listed in this 

column must be used to fulfill the testing requirements—See Special Conditions. 

Test Group 1 for C1: 

1. Acute Toxicity to Fish: ASTM E 729–96 (Reapproved 2007). 

2. Acute Toxicity to Daphnia: ASTM E 729–96 

(Reapproved 2007). 

3. Toxicity to Plants (Algae): ASTM E 1218– 

04 ε1. 

Test Group 2 for C1: 

1. Chronic Toxicity to Daphnia: ASTM E 1193– 

97 (Reapproved 2004). 

2. Toxicity to Plants (Algae): ASTM E 1218– 

04 ε1. 

The following are the special conditions for C1, C2, 

C3, C4, C5, and C7 testing; there are no special 

conditions for C6. 

Which test group is required is determined by the 

test substance’s measured log Kow as obtained 

under Test Category A, or using an existing 

measured log Kow.iii

If log Kow < 4.2: Test Group 1 is required. 

If log Kow ≥ 4.2: Test Group 2 is required. 

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 ε1. 

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 ε1. 

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 ε1. 

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 ε1. 

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: Chronic Toxicity to Daphnia: 

ASTM E 1193–97 (Reapproved 2004). 


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TABLE 3—KEY TO THE TEST REQUIREMENTS DENOTED BY ALPHANUMERIC SYMBOLS IN TABLE 2 OF THIS PARAGRAPH— 

Continued 

[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] 

Testing category Test 

symbol Test requirements and references Special conditions 

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: Acute Toxicity to Daphnia: 

ASTM E 729–96 (Reapproved 2007). 

Test Group 2 for C5: Chronic Toxicity to Daphnia: 

ASTM E 1193–97 (Reapproved 2004). 

C6 Toxicity to Plants (Algae): ASTM E 1218–04 ε1. 

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: Acute Toxicity to Fish: ASTM 

E 729–96 (Reapproved 2007). 

Test Group 2 for C7: Chronic Toxicity to Daphnia: 

ASTM E 1193–97 (Reapproved 2004). 

Mammalian toxicity—acute D See special conditions for this test requirement and 

select the method that must be used from those 

listed in this column. 

Method A: Acute Inhalation Toxicity (rat): 40 CFR 

799.9130 

Method B: EITHER: 

1. Acute (Up/Down) Oral Toxicity (rat): ASTM 

E 1163–98 (Reapproved 2002) 

OR 

2. Acute (Up/Down) Oral Toxicity (rat): 40 CFR 

799.9110(d)(1)(i)(A). 

Which testing method is required is determined by 

the test substance’s physical state at room temperature (25 °C). For those test substances that 

are gases at room temperature, Method A is required; otherwise, use either of the two methods 

listed under Method B. 

In Method B, 40 CFR 799.9110(d)(1)(i)(A) refers to 

the OECD 425 Up/Down Procedure.iv

Estimating starting dose for Method B: Data from 

the neutral red uptake basal cytotoxicity assay v

using normal human keratinocytes or mouse 

BALB/c 3T3 cells may be used to estimate the 

starting dose. 

Mammalian toxicity— 

genotoxicity.

E1 Bacterial Reverse Mutation Test (in vitro): 40 CFR 

799.9510.

None. 

E2 Conduct any one of the following three tests for 

chromosomal damage: 

In vitro Mammalian Chromosome Aberration 

Test: 40 CFR 799.9537. 

OR 

Mammalian Bone Marrow Chromosomal Aberration Test (in vivo in rodents: mouse (preferred species), rat, or Chinese hamster): 40 

CFR 799.9538 

OR 

Mammalian Erythrocyte Micronucleus Test 

[sampled in bone marrow] (in vivo in rodents: 

Mouse (preferred species), rat, or Chinese 

hamster): 40 CFR 799.9539. 

Persons required to conduct testing for chromosomal damage are encouraged to use the in vitro 

Mammalian Chromosome Aberration Test (40 

CFR 799.9537) to generate the needed data unless known chemical properties (e.g., physical/ 

chemical properties, chemical class characteristics) preclude its use. A subject person who uses 

one of the in vivo methods instead of the in vitro 

method to address a chromosomal damage test 

requirement must submit to EPA a rationale for 

conducting that alternate test in the final study report. 

Mammalian toxicity—repeated dose/reproduction/developmental.F1 Combined Repeated Dose Toxicity Study with the 

Reproduction/Developmental Toxicity Screening 

Test: 40 CFR 799.9365 

OR 

Reproduction/Developmental Toxicity Screening Test: 40 CFR 799.9355 

AND 

Repeated Dose 28-Day Oral Toxicity Study in 

rodents: 40 CFR 799.9305. 

Where F1 is required, EPA recommends use of the 

Combined Repeated Dose Toxicity Study with 

the Reproduction/Developmental Toxicity Screening Test (40 CFR 799.9365). However, there may 

be valid reasons to test a particular chemical 

using both 40 CFR 799.9355 and 40 CFR 

799.9305 to fill Mammalian Toxicity—Repeated 

Dose/Reproduction/Developmental data needs. A 

subject person who uses the combination of 40 

CFR 799.9355 and 40 CFR 799.9305 in place of 

40 CFR 799.9365 must submit to EPA a rationale for conducting these alternate tests in the 

final study reports. Where F2 or F3 is required, 

no rationale for conducting the required test need 

be provided in the final study report. 

F2 Reproduction/Developmental Toxicity Screening 

Test: 40 CFR 799.9355. 


emcdonald on DSK5VPTVN1PROD with RULES
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TABLE 3—KEY TO THE TEST REQUIREMENTS DENOTED BY ALPHANUMERIC SYMBOLS IN TABLE 2 OF THIS PARAGRAPH— 

Continued 

[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] 

Testing category Test 

symbol Test requirements and references Special conditions 

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. 1995. This reference is available in 

docket ID number EPA–HQ–OPPT–2009–0112 at the EPA Docket Center (EPA/DC), Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., 

Washington, DC, from 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. 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–2009–0112 at the EPA Docket Center (EPA/DC), Rm. 3334, EPA 

West Bldg., 1301 Constitution Ave., NW., Washington, DC, from 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. 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 chemical substances 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 chemical 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 (EPA/DC), Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC, from 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. 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–2009–0112 at the EPA Docket Center (EPA/DC), Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC, from 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. 

[FR Doc. 2011–27227 Filed 10–20–11; 8:45 am] 

BILLING CODE 6560–50–P 


emcdonald on DSK5VPTVN1PROD with RULES