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Thursday, 

July 24, 2008 

Part III 

Environmental 

Protection Agency 

40 CFR Part 799 

Testing of Certain High Production 

Volume Chemicals; Second Group of 

Chemicals; Proposed Rule 

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ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 799 

[EPA–HQ–OPPT–2007–0531; FRL–8373–9] 

RIN 2070–AD16 

Testing of Certain High Production 

Volume Chemicals; Second Group of 

Chemicals 

AGENCY: Environmental Protection 


Agency (EPA). 


ACTION: Proposed rule. 


SUMMARY: EPA is proposing a test rule 

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

Substances Control Act (TSCA) to 

require manufacturers, importers, and 

processors of certain high production 

volume (HPV) chemical substances to 

conduct testing to obtain screening level 

data for health and environmental 

effects and chemical fate. EPA has 

preliminarily determined that: Each of 

the 19 chemical substances included in 

this proposed rule is produced in 

substantial quantities and that there is 

or may be substantial human exposure 

to each of them; there are insufficient 

data to reasonably determine or predict 

the effects on health or the environment 

of the manufacture, distribution in 

commerce, processing, use, or disposal 

of the chemicals, or of any combination 

of these activities; and the testing 

program proposed here is necessary to 

develop such data. Data developed 

under this proposed rule will provide 

critical information about the 

environmental fate and potential 

hazards associated with these chemicals 

which, when combined with 

information about exposure and uses, 

will allow the Agency and others to 

evaluate potential health and 

environmental risks and to take 

appropriate follow-up action. Persons 

who export or intend to export any 

chemical substance included in the final 

rule would be subject to the export 

notification requirements in TSCA 

section 12(b)(1) and at 40 CFR part 707, 

subpart D. EPA has also taken steps, as 

described in this document, to consider 

animal welfare and to provide 

instructions on ways to reduce or in 

some cases eliminate animal testing, 

while at the same time ensuring that the 

public health is protected. 

DATES: Comments must be received on 

or before October 22, 2008. 

Written requests to present oral 

comments must be received on or before 

October 22, 2008. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2007–0531, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001. 

• Hand Delivery: OPPT Document 

Control Office (DCO), EPA East Bldg., 

Rm. 6428, 1201 Constitution Ave., NW., 

Washington, DC. Attention: Docket ID 

Number EPA–HQ–OPPT–2007–0531. 

The DCO is open from 8 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

DCO is (202) 564–8930. Such deliveries 

are only accepted during the DCO’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPPT– 

2007–0531. EPA’s policy is that all 

comments received will be included in 

the docket without change and may be 

made available on-line at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or email. The regulations.gov website is an 

‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through 

regulations.gov, your e-mail address 

will be automatically captured and 

included as part of the comment that is 

placed in the docket and made available 

on the Internet. If you submit an 

electronic comment, EPA recommends 

that you include your name and other 

contact information in the body of your 

comment and with any disk or CD-ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. For additional information 

about EPA’s public docket, visit the EPA 

Docket Center homepage at http:// 

www.epa.gov/epahome/dockets.htm. 

Docket: All documents in the docket 

are listed in the docket index available 

at http://www.regulations.gov. Follow 

the on-line instructions to view the 

docket index or access available 

documents. Although listed in the 

index, some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, will be publicly 

available only in hard copy. Publicly 

available docket materials are available 

electronically at http:// 

www.regulations.gov, or, if only 

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

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

3334, EPA West Bldg., 1301 

Constitution Ave., NW., Washington, 

DC. The EPA/DC Public Reading Room 

hours of operation are 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

Federal holidays. The telephone number 

of the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

FOR FURTHER INFORMATION CONTACT: For 

general information contact: Colby 

Lintner, Regulatory Coordinator, 

Environmental Assistance Division 

(7408M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 554–1404; e-mail address: 

TSCA-Hotline@epa.gov. 

For technical information contact: 

Paul Campanella or John Schaeffer, 

Chemical Control Division (7405M), 

Office of Pollution Prevention and 

Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

numbers: (202) 564–8091 or (202) 564– 

8173; e-mail addresses: 

campanella.paul@epa.gov or 

schaeffer.john@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you manufacture (defined 

by statute to include import) or process 

any of the chemical substances that are 

listed in § 799.5087(j) of the proposed 

regulatory text. Any use of the term 

‘‘manufacture’’ in this document will 

encompass ‘‘import,’’ unless otherwise 

stated. In addition, as described in Unit 

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V., once the Agency issues a final rule, 

any person who exports, or intends to 

export, any of the chemical substances 

included in the final rule will be subject 

to the export notification requirements 

in TSCA section 12(b)(1) and at 40 CFR 

part 707, subpart D. Potentially affected 

entities may include, but are not limited 

to: 

• Manufacturers (defined by statute to 

include importers) of one or more of the 

19 subject chemical substances (NAIC 

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

manufacturing and petroleum refineries. 

• Processors of one or more of the 19 

subject chemical substances (NAIC 

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

manufacturing and petroleum refineries. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

Unit IV.E. and consult § 799.5087(b) of 

the proposed regulatory text. If you have 

any questions regarding the 

applicability of this action to a 

particular entity, consult either of the 

technical persons listed under FOR 

FURTHER INFORMATION CONTACT. 

B. What Should I Consider as I Prepare 

My Comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or e-mail. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD-ROM that 

you mail to EPA, mark the outside of the 

disk or CD-ROM that you mail to EPA, 

mark the outside of the disk or CD-ROM 

as CBI and then identify electronically 

within the disk or CD-ROM the specific 

information that is claimed as CBI. In 

addition to one complete version of the 

comment that includes information 

claimed as CBI, a copy of the comment 

that does not contain the information 

claimed as CBI must be submitted for 

inclusion in the public docket. 

Information so marked will not be 

disclosed except in accordance with 

procedures set forth in 40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

C. Can I Request an Opportunity to 

Present Oral Comments to the Agency? 

You may submit a request for an 

opportunity to present oral comments. 

This request must be made in writing. 

If such a request is received on or before 

October 22, 2008, EPA will hold a 

public meeting on this proposed rule in 

Washington, DC. This written request 

must be submitted to the mailing or 

hand delivery addresses provided under 

ADDRESSES. If such a request is received, 

EPA will announce the scheduling of 

the public meeting in a subsequent 

document in the Federal Register. If a 

public meeting is announced, and if you 

are interested in attending or presenting 

oral and/or written comments at the 

public meeting, you should follow the 

instructions provided in the subsequent 

Federal Register document announcing 

the public meeting. 

II. Background 

A. What Action is the Agency Taking? 

EPA is proposing to issue a test rule 

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

U.S.C. 2603(a)(1)(B)) that would require 

manufacturers and processors of 19 

chemical substances to conduct testing 

for environmental fate (including five 

tests for physical/chemical properties 

and biodegradation), ecotoxicity (in fish, 

Daphnia, and algae), acute toxicity, 

genetic toxicity (gene mutations and 

chromosomal aberrations), repeat dose 

toxicity, and developmental and 

reproductive toxicity. The chemicals are 

HPV chemicals, i.e., chemicals with a 

production/import volume equal to or 

greater than 1 million pounds (lbs.) per 

year. A detailed discussion regarding 

efforts to enhance the availability of 

screening level hazard and 

environmental fate information about 

HPV chemicals can be found in a 

Federal Register notice which 

published on December 26, 2000 (Ref. 

1). 

The tests are screening level tests 

which are part of the Screening 

Information Data Set (SIDS) (see Unit 

II.D.). Some or all of these tests are being 

proposed as required tests for a 

particular chemical substance, 

depending upon what data are already 

available for that substance. 

This action also follows an earlier 

testing action for certain HPV chemicals 

(see ‘‘Testing of Certain High Production 

Volume Chemicals; Proposed Rule’’ 

(Ref. 2) and ‘‘Testing of Certain High 

Production Volume Chemicals; Final 

Rule’’ (Ref. 3). 

At a future date, EPA plans to propose 

testing for additional HPV chemicals as 

the Agency learns more about the 

chemicals with respect to human 

exposure, release, and sufficiency of 

data and experience available on the 

potential hazards. 

B. What is the Agency’s Authority for 

Taking this Action? 

EPA is proposing this test rule under 

section 4(a)(1)(B) of TSCA (15 U.S.C. 

2603(a)(1)(B)). 

Section 2(b)(1) of TSCA (15 U.S.C. 

2601(b)(1)) states that it is the policy of 

the United States that ‘‘adequate data 

should be developed with respect to the 

effect of chemical substances and 

mixtures on health and the environment 

and that the development of such data 

should be the responsibility of those 

who manufacture [which is defined by 

statute to include import] and those 

who process such chemical substances 

and mixtures[.]’’ To implement this 

policy, TSCA section 4(a)(1) mandates 

that EPA require by rule that 

manufacturers and/or processors of 

chemical substances and mixtures 

conduct testing if the Administrator 

finds that: 

(1)(A)(i) the manufacture, distribution in 

commerce, processing, use, or disposal of a 

chemical substance or mixture, or that any 

combination of such activities, may present 

an unreasonable risk of injury to health or the 

environment, 

(ii) there are insufficient data and 

experience upon which the effects of such 

manufacture, distribution in commerce, 

processing, use, or disposal of such substance 

or mixture or of any combination of such 

activities on health or the environment can 

reasonably be determined or predicted, and 

(iii) testing of such substance or mixture 

with respect to such effects is necessary to 

develop such data; or 

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(B)(i) a chemical substance or mixture is or 

will be produced in substantial quantities, 

and (I) it enters or may reasonably be 

anticipated to enter the environment in 

substantial quantities or (II) there is or may 

be significant or substantial human exposure 

to such substance or mixture, 

(ii) there are insufficient data and 

experience upon which the effects of the 

manufacture, distribution in commerce, 

processing, use, or disposal of such substance 

or mixture or of any combination of such 

activities on health or the environment can 

reasonably be determined or predicted, and 

(iii) testing of such substance or mixture 

with respect to such effects is necessary to 

develop such data [.] 

If EPA makes these findings for a 

chemical substance or mixture, the 

Administrator shall require by rule that 

testing be conducted on that chemical 

substance or mixture to develop data 

about health or environmental effects 

for which there is an insufficiency of 

data and experience, and which are 

relevant to a determination that the 

manufacture, distribution in commerce, 

processing, use, or disposal of the 

chemical substance or mixture, or any 

combination of such activities, does or 

does not present an unreasonable risk of 

injury to health or the environment. 

TSCA section 4(a)(1). 

Once the Administrator has made a 

finding under TSCA section 4(a)(1)(A) 

or 4(a)(1)(B), EPA may require any type 

of health or environmental effects 

testing necessary to address unanswered 

questions about the effects of the 

chemical substance or mixture that are 

relevant to whether the manufacture, 

distribution in commerce, processing, 

use, or disposal of the chemical 

substance or mixture, or any 

combination of such activities, presents 

an unreasonable risk of injury to health 

or the environment. EPA need not limit 

the scope of testing required to the 

factual basis for the TSCA section 

4(a)(1)(A)(i) or (B)(i) findings. This 

approach is explained in more detail in 

EPA’s TSCA section 4(a)(1)(B) Final 

Statement of Policy (‘‘B’’ policy) (Ref. 4, 

pp. 28738–28739). 

In this proposed rule, EPA would use 

its broad TSCA section 4(a) authority to 

obtain data necessary to support the 

development of preliminary or 

‘‘screening level’’ hazard and risk 

characterizations for certain HPV 

chemical substances specified in Table 

2 in § 799.5087(j) of the proposed 

regulatory text. EPA has made 

preliminary findings for these chemical 

substances under TSCA section 

4(a)(1)(B) that: They are produced in 

substantial quantities; there is or may be 

substantial human exposure to them; 

existing data are insufficient to 

determine or predict their health and 

environmental effects; and testing is 

necessary to develop such data. 

C. Why is EPA Taking this Action? 

On April 21, 1998, EPA initiated a 

national effort to empower citizens by 

providing them with knowledge about 

the most widespread chemicals in 

commerce. A major objective of this 

effort is to make certain basic 

information about the environmental 

fate and potential health and 

environmental hazards associated with 

HPV chemicals available to the public. 

Mechanisms to collect or, where 

necessary, develop needed data on U.S. 

HPV chemicals include the voluntary 

HPV Challenge Program, certain 

international efforts, and TSCA section 

4 rules. 

1. Voluntary HPV Challenge Program. 

The voluntary HPV Challenge Program, 

officially launched in late 1998, was 

created to ensure that a baseline set of 

data on approximately 2,800 HPV 

chemicals would be made available to 

EPA and the public. HPV chemicals are 

manufactured or imported in amounts 

equal to or greater than 1 million lbs. 

per year and were identified for this 

program through data reported under 

the TSCA Inventory Update Rule (IUR) 

during 1990. 

The data set sought by the voluntary 

HPV Challenge Program is known as the 

Screening Information Data Set (SIDS) 

that was developed by the Organization 

for Economic Cooperation and 

Development (OECD), of which the 

United States is a member. SIDS 

provides an internationally agreed upon 

set of test data for screening high 

production volume chemicals for 

human and environmental hazards, and 

will assist the Agency and others to 

make an informed, preliminary 

judgment about the hazards of HPV 

chemicals. 

Since the Program’s inception in 

1998, industry chemical manufacturers 

and importers have participated in the 

Challenge by sponsoring 2,250 

chemicals. More than 350 companies 

and 100 consortia have sponsored 

chemicals directly in the Program while 

additional companies/consortia have 

sponsored chemicals indirectly in an 

international counterpart to the 

voluntary HPV Challenge Program, the 

International Council of Chemical 

Associations (ICCA) HPV Initiative. 

HPV chemicals that are not sponsored 

in the Program may be subject to a test 

rule under TSCA section 4 where, 

among other things, these chemicals 

lack needed testing. The voluntary HPV 

Challenge Program is further described 

in a Federal Register document which 

published on December 26, 2000 (Ref. 1) 

and on the voluntary HPV Challenge 

Program website (http://www.epa.gov/ 

chemrtk). 

Under the voluntary HPV Challenge 

Program, alternatives to the testing 

proposed under this proposed rule were 

available. For example, under the OECD 

HPV SIDS Program, some instances 

have been identified where, using 

chemical category approaches, less than 

a full set of SIDS tests for every 

chemical in the category has been 

judged sufficient for screening purposes. 

In addition, the OECD HPV SIDS 

Program allows some use of structure 

activity relationship (SAR) analysis for 

individual chemicals. These strategies 

have the potential to reduce the time 

required to complete the program, the 

number of tests actually conducted, and 

the number of test animals needed. 

EPA advocated the use of categories 

or SAR approaches in the voluntary 

HPV Challenge Program and provided 

support for their use by developing 

guidance documents to assist industry 

and others in constructing scientifically 

defensible categories (Ref. 45) and SAR 

(Ref. 48). While EPA encouraged the use 

of scientifically appropriate categories 

of related chemicals and SAR under the 

voluntary HPV Challenge Program, 

these approaches are not included in 

this proposed rule. EPA has not 

identified any chemicals in this 

proposal for which category and SAR 

approaches would be appropriate. In 

addition, EPA believes that the 

incorporation of such elements in a test 

rule would require complex, time 

consuming, and intensive procedural 

steps, such as multi-phase rulemaking, 

without a corresponding benefit. 

In the proposed test rule (Ref. 2) for 

the final HPV SIDS test rule (Ref. 3), 

EPA specifically solicited comments 

and suggestions on procedures that 

would allow inclusion of such 

approaches in TSCA section 4 HPV 

SIDS rulemaking. The procedures 

suggested by commenters on that 

proposed rule would have required 

complex, time consuming, and resourceintensive procedural steps, such as 

multi-phase rulemaking. As a result, 

EPA did not incorporate these 

suggestions into the final rule. In 

addition, EPA did not identify, nor did 

the commenters bring to EPA’s 

attention, any possibilities that would 

have allowed inclusion of a category or 

SAR approach within the final test rule 

for any specific chemicals included in 

the final test rule (Ref. 19). 

Although the Agency believes that 

none of the chemicals included in this 

proposed rule appear to be candidates 

for category or SAR approaches, persons 

who believe that a chemical under this 

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proposed rule can be dealt with using a 

category or SAR approach are 

encouraged to submit appropriate 

information, along with their rationale 

which substantiates this belief, during 

the comment period on this proposed 

rule. If, based on submitted information 

and other information available to EPA, 

the Agency determines that a chemical 

is appropriate for consideration under a 

category or SAR approach, and that 

practicable measures are available at the 

time to modify the proposed testing 

requirement, EPA will take such 

measures as are necessary to avoid 

unnecessary testing in the final rule. 

2. Certain international efforts. The 

voluntary HPV Challenge Program is 

designed to make maximum use of 

scientifically adequate existing test data 

and to avoid unnecessary and 

duplicative testing of U.S. HPV 

chemicals. Therefore, EPA is continuing 

to participate in the voluntary 

international efforts, complementary to 

the voluntary HPV Challenge Program, 

that are being coordinated by the OECD 

to secure basic hazard information on 

HPV chemicals in use worldwide, 

including some of those on the U.S. 

(1990) HPV chemicals list (Ref. 5). This 

includes agreements to sponsor a U.S. 

HPV chemical under either the OECD 

HPV SIDS Program (Ref. 6), including 

sponsorship by OECD member countries 

beyond the United States, or the 

international HPV Initiative that is being 

organized by the ICCA (Ref. 7). 

The OECD HPV SIDS Program seeks 

the development of test data, if such 

data are not already available, related to 

6 health and environmental effects 

endpoints for international HPV 

chemicals (see Unit II.D.). The SIDS data 

set has been internationally agreed upon 

by the 29 member countries of the 

OECD as providing the minimum data 

set required to make an informed 

preliminary judgment about the hazards 

of a given HPV chemical. 

The ICCA consists of representatives 

of chemical industry trade associations 

from the United States, Europe, Japan, 

Australia, Canada, Mexico, Brazil, New 

Zealand, and Argentina. The intended 

goal of the ICCA HPV Initiative was to 

complete screening-level hazard 

assessments on 1,000 ‘‘high priority’’ 

chemicals. Most of the chemicals on the 

ICCA working list (Ref. 7) are also U.S. 

HPV chemicals. The ICCA testing/ 

assessment work is tied directly to that 

under the OECD HPV SIDS Program. 

Any U.S. HPV chemicals that are 

handled under the OECD HPV SIDS 

Program or the ICCA HPV Initiative are 

considered by EPA to be ‘‘sponsored’’ 

and are not anticipated to be addressed 

in the voluntary HPV Challenge 

Program unless the international 

commitments are not met. Nor does EPA 

intend to evaluate these chemicals for 

possible TSCA section 4 HPV SIDS 

rulemaking unless the international 

commitments are not met. 

The OECD HPV SIDS Program and the 

ICCA HPV Initiative are further 

described in the Federal Register 

document announcing the voluntary 

HPV Challenge Program (Ref. 1) and on 

the OECD website (Ref. 6) and ICCA 

website (Ref. 7). 

3. TSCA rulemaking. U.S. data needs 

which remain unmet in the voluntary 

HPV Challenge Program or through 

international efforts may be addressed 

through TSCA section 4 rulemakings, 

such as the final test rule promulgated 

by EPA on March 16, 2006 (Ref. 3). This 

proposed rule is the second TSCA 

section 4 HPV SIDS rule, and addresses 

the unmet data needs of 19 chemicals. 

Data collected and/or developed 

under a final rule based on this proposal 

and the voluntary HPV Challenge 

Program, when combined with 

information about exposure and uses, 

will allow the Agency and others to 

better assess the potential risk to health 

and the environment from these 

chemicals. EPA intends to make the 

information collected under the final 

rule available to the public, other 

Federal agencies, and any other 

interested parties on its website (http:// 

www.epa.gov/chemrtk) and in the 

public docket for the final rule. As 

appropriate, this information will be 

used to ensure a scientifically sound 

basis for risk assessment/management 

actions. This effort will serve to further 

the Agency’s goal of identifying and 

controlling human and environmental 

risks as well as providing greater 

protection and knowledge to the public. 

By using the same approach to testing 

as that of the OECD HPV SIDS Program, 

EPA is assuring that the data developed 

under this proposed rulemaking activity 

and the voluntary HPV Challenge 

Program will be comparable to the data 

being developed in other countries, 

thereby enabling an international 

sharing of data and the prevention of 

unnecessary and duplicative testing. See 

Refs.1 and 2, pp. 81662–81664, for 

further information about the voluntary 

HPV Challenge Program and 

international efforts. 

D. Why is this Proposal Focusing on 

HPV Chemicals and SIDS Testing? 

This proposal pertains to HPV 

chemicals, which are manufactured or 

imported in amounts equal to or greater 

than 1 million lbs. per year. Although 

those chemicals cover only about 11% 

of the chemical substances on the TSCA 

Inventory (see TSCA sections 8(a) and 

8(b)), using TSCA Inventory information 

available in 1988 (Ref. 8, p. 32296), that 

small percentage of the TSCA Inventory 

accounted for 95% of total chemical 

production in the United States. 

Testing under this proposal pertains 

to SIDS testing because SIDS is a battery 

of tests agreed upon by the international 

community through OECD, of which the 

United States is a member country, as 

appropriate for screening HPV chemical 

substances for toxicity and produces 

information relevant to understanding 

the basic health and environmental 

hazards and fate of HPV chemicals. The 

content of SIDS was agreed upon at the 

13th Joint Meeting of the OECD 

Chemicals Group and Management 

Committee of the Special Programme on 

the Control of Chemicals (Refs. 9 and 

10). The United States believes these are 

the right tests for basic screening of U.S. 

HPV chemicals for health and 

environmental effects and 

environmental fate. 

• SIDS testing evaluates the following 

six testing endpoints (Ref. 6): 

• Acute toxicity. 

• Repeat dose toxicity. 

• Developmental and reproductive 

toxicity. 

• Genetic toxicity (gene mutations and 

chromosomal aberrations). 

• Ecotoxicity (studies in fish, 

Daphnia, and algae). 

• Environmental fate (including 

physical/chemical properties (melting 

point, boiling point, vapor pressure, noctanol/water partition coefficient, and 

water solubility), photolysis, hydrolysis, 

transport/distribution, and 

biodegradation). 

While data on the six SIDS endpoints do 

not fully characterize a chemical’s 

toxicity and fate, they provide a 

consistent minimum set of information 

that can be used to help assess the 

relative risks of chemicals and whether 

additional testing or assessment is 

necessary. 

E. How Does EPA’s HPV Work Relate to 

that of OECD? 

As noted in Unit II.C.2., the OECD 

HPV SIDS Program is complementary to 

the voluntary HPV Challenge Program. 

However, EPA’s definition of an HPV 

chemical differs from that of the OECD. 

EPA defines an HPV chemical as having 

an annual production or importation 

volume of 1 million lbs. or more. OECD 

defines an HPV chemical as having an 

annual production volume of 2.2 

million lbs. (equivalent to 1 million 

kilograms (kg)) reported in any member 

country. 

The presence of a chemical on the 

OECD’s list of HPV chemicals was and 

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continues to be accepted by OECD 

member countries as providing a 

sufficient indicator of potential 

exposure to warrant testing at the SIDS 

level (Ref. 11). EPA, however, does not 

believe that a production volume 

threshold which is chosen for an 

international program on existing 

chemicals and which is the only trigger 

for entry into that program should be 

determinative of the threshold chosen 

for ‘‘substantial production’’ under 

TSCA section 4(a)(1)(B)(i). See EPA’s 

‘‘B’’ policy (Ref. 4). Among the reasons 

is that the TSCA section 4(a)(1)(B)(i) 

finding of substantial production is not 

the sole finding EPA must make to 

require testing based on TSCA section 

4(a)(1)(B). EPA must also find that there 

is substantial release, or substantial or 

significant human exposure under 

TSCA sections 4(a)(1)(B)(i)(I) and (II). In 

addition, EPA must find that data are 

insufficient and testing is necessary 

under TSCA sections 4(a)(1)(B)(ii) and 

(iii). Accordingly, a finding that a 

chemical is produced in substantial 

quantities alone is not a sufficient basis 

to require testing under TSCA section 4. 

In response to EPA’s proposed ‘‘B’’ 

policy (Ref. 8), both the American 

Chemistry Council (ACC), formerly the 

Chemical Manufacturers Association 

(CMA) and the Society of the Plastics 

Industry, Inc., commented that EPA’s 

proposed annual production-volume 

threshold of 1 million lbs. is a 

reasonable interpretation of ‘‘substantial 

production’’ under TSCA (Refs. 12 and 

13). Additionally, they indicated that 

the OECD’s 2.2 million lb. threshold 

would be preferable to achieve 

consistency between EPA’s activities 

under TSCA section 4 and the OECD 

HPV SIDS Program. Although the 

United States and OECD differ in their 

definition of an HPV chemical and what 

should trigger basic screening tests of an 

HPV chemical, both the U.S. and OECD 

HPV SIDS Programs are alike in their 

information needs for an HPV chemical. 

Both the U.S. and OECD HPV SIDS 

Programs have identified the SIDS 

battery of tests as the basic screening 

tests needed to provide enough 

information to support a screening level 

assessment of the health and 

environmental effects of a chemical. 

F. Why is EPA Pursuing Hazard 

Information on HPV Chemicals? 

In 1998 EPA found that, of those nonpolymeric organic substances produced 

or imported in amounts equal to or 

greater than 1 million lbs. per year 

based on 1990 IUR reporting, only 7% 

had a full set of publicly available and 

internationally recognized basic 

screening test data for health and 

environmental effects (Ref. 14). Of the 

over 2,800 U.S. HPV chemicals based on 

1990 IUR data, 43% had no publicly 

available basic hazard data. For the 

remaining chemicals, limited amounts 

of the data were available. This lack of 

available hazard data compromises 

EPA’s and others’ ability to determine 

whether these HPV chemicals pose 

potential risks to human health or the 

environment, as well as the public’s 

ability to know about the hazards of 

chemicals that may be found in their 

environment, their homes, their 

workplaces, and the products they buy. 

G. What is the Role of this Proposed 

Rule and Any Future TSCA Section 4 

HPV SIDS Rulemaking with Regard to 

the Voluntary HPV Challenge Program? 

As indicated in the December 26, 

2000 Federal Register document 

describing the voluntary HPV Challenge 

Program (Ref. 1), EPA intends to use 

rulemaking under TSCA, where 

appropriate, to help fill data gaps not 

addressed as part of the voluntary HPV 

Challenge Program or international 

efforts. EPA does not intend at this time 

to evaluate U.S. HPV chemicals that 

have been or are being handled through 

the OECD HPV SIDS Program or under 

a complementary program being 

coordinated by the ICCA (Ref. 7) for 

screening level testing under TSCA 

section 4 HPV SIDS rulemaking, 

although the Agency may revisit this 

question if commitments under those 

international programs are not met. See 

Unit III.G. of Ref. 1 for more information 

on these programs. EPA is evaluating 

the extent to which additional nonsponsored HPV chemicals meet the 

threshold criteria for rulemaking under 

TSCA section 4. 

H. How Would the Data Developed 

Under this Test Rule Be Used? 

Hazard data are used in risk 

assessment and risk management, and 

ultimately to inform the public and 

promote the pollution prevention ethic. 

Activities to ensure the availability of 

basic hazard information on HPV 

chemicals support EPA’s objectives. 

EPA would use the data obtained 

from this proposed rule to support 

development of preliminary hazard and 

risk assessments for the 19 chemical 

substances subject to the rule. The data 

would also be used by EPA to set 

priorities for further testing that may 

produce hazard information on these 

chemical substances that may be needed 

by EPA, other Federal agencies, the 

public, industry, and others, to support 

adequate risk assessments. As 

appropriate, this information would be 

used to ensure a scientifically sound 

basis for risk characterizations and risk 

management actions. As such, this effort 

would serve to further the Agency’s goal 

of identifying and controlling human 

and environmental risks as well as 

providing greater knowledge and 

protection to the public. In the past, 

EPA has used data from test rules to 

support such activities as the 

development of water quality criteria, 

Toxic Release Inventory (TRI) listings, 

chemical advisories, and reduction of 

workplace exposures. 

Under the Security and Prosperity 

Partnership of North America (SPP), a 

trilateral effort to encourage greater 

cooperation and information sharing 

among the United States, Canada, and 

Mexico (http://www.spp.gov), the 

United States committed in August 2007 

to assess and initiate needed action by 

the end of 2012 on the approximately 

6,750 chemicals produced above 25,000 

lbs. per year in the United States. 

(http://www.spp.gov/pdf/ 

spp_reg_coop_chemicals.pdf). To fulfill 

these SPP commitments, EPA 

established the Chemical Assessment 

and Management Program (ChAMP). 

Under ChAMP, EPA is developing 

screening-level documents that 

summarize basic hazard and exposure 

information on HPV chemicals, identify 

potential risks, note scientific issues and 

uncertainties, and indicate the initial 

priority being assigned by the Agency 

for potential future appropriate action. 

These screening-level documents are 

based primarily on hazard, use, and 

exposure data available to the Agency 

through the voluntary HPV Challenge 

Program and on EPA’s examination of 

chemical use and exposure information 

collected from the 2006 IUR as well as 

data from readily available sources of 

hazard and exposure information. 

Information on ChAMP and the riskbased prioritization process for HPV 

chemicals is available on the EPA’s 

ChAMP website (http://www.epa.gov/ 

champ) and on the related risk-based 

prioritization page (http://www.epa.gov/ 

hpv/hpvis/aboutrbd.htm). 

The data obtained from a final test 

rule based on this proposal would 

furnish the basic hazard information 

integral to this ChAMP process for the 

19 chemical substances subject to the 

rule. 

Finally, because the SIDS data would 

be comparable to the type of data agreed 

to as being appropriate and being 

developed by the OECD HPV SIDS 

Program, the development of these data 

would enable an international sharing of 

data. As conceived by the OECD, the 

SIDS battery of tests can be used by 

governments and others worldwide to 

conduct an initial assessment of the 

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hazards and risks posed by HPV 

chemicals and prioritize HPV chemicals 

to identify those in need of additional, 

more in-depth testing and assessment, 

as well as those of lesser concern. Not 

only could the data contribute to the 

international effort, but also 

international SIDS testing and 

assessments can be used to fill the data 

gaps identified as part of the voluntary 

HPV Challenge Program. Additional 

detailed information is available on the 

SIDS website (http://cs3-hq.oecd.org/ 

scripts/hpv) and EPA’s voluntary HPV 

Challenge Program website (http:// 

www.epa.gov/chemrtk). 

Data collected or developed for each 

sponsored chemical in the voluntary 

HPV Challenge Program are provided in 

the format of a ‘‘robust’’ (i.e., detailed) 

summary. A robust summary contains 

the technical information necessary to 

adequately describe an experiment or 

study and includes the objectives, 

methods, results, and conclusions of the 

full study report, which can either be an 

experiment or in some cases an 

estimation or prediction method. (See 

Ref. 15; also at http://www.epa.gov/ 

HPV/pubs/general/robsumgd.htm). A 

robust summary provides information 

that would assist a technically qualified 

person in making an independent 

assessment of a given study, and thereby 

facilitates the evaluation of existing data 

and the identification of additional data 

needs. EPA requests that existing data 

relevant to the testing in this proposed 

rule be submitted to the Agency in 

robust summary format. For any data 

developed under that final rule, EPA 

will request that a robust summary of 

the final report for each specific test be 

submitted in addition to the required 

final report itself (see § 799.5087(i) of 

the proposed regulatory text). Persons 

who respond to this request to submit 

robust summaries are also encouraged to 

submit the robust summary 

electronically via the High Production 

Volume Information System (HPVIS) to 

allow for its ready incorporation into 

HPVIS. Directions for electronic 

submission of robust summary 

information into HPVIS are provided at 

https://iaspub.epa.gov/oppthpv/ 

metadata.html. This link will direct you 

to the ‘‘HPVIS Quick Start and User’s 

Guide.’’ 

I. How are Animal Welfare Issues Being 

Considered in the HPV Initiative? 

EPA recognizes the concerns that 

have been expressed about the use of 

test procedures that require the use of 

animals. As discussed in Unit II.E. of 

Ref. 1, EPA is making every effort to 

ensure that as the HPV Initiative is 

implemented (including TSCA section 4 

HPV SIDS test rules), unnecessary or 

duplicative testing is avoided and the 

use of animals is minimized. As a 

general matter, EPA does not require 

that tests on animals be conducted if an 

alternative scientifically validated 

method is found acceptable and 

practically available for use. Where 

testing must be conducted to develop 

adequate data, the Agency is committed 

to reducing the number of animals used 

for testing, to replacing test methods 

requiring animals with alternative test 

methods when acceptable alternative 

methods are available, and to refining 

existing test methods to optimize animal 

use when there is no substitute for 

animal testing. EPA believes that these 

reduction, replacement, and refinement 

objectives are all important elements in 

the overall consideration of alternative 

testing methods. 

The governmental and nongovernmental scientific community is 

working to design, validate, and employ 

new methods of toxicity testing that are 

more accurate, less costly, and that 

reduce the need to use live animals. 

Over the years, significant research has 

been pursued to develop and validate 

non-animal test methods. U.S. scientists 

in academia, government, and industry 

have participated in both domestic and 

international efforts to develop 

alternative, non-animal tests. As part of 

the enterprise, the National Institute of 

Environmental Health Sciences (NIEHS) 

established a Federal Interagency 

Committee, the Interagency 

Coordinating Committee on Validation 

of Alternative Methods (ICCVAM), to 

review the status and validation of 

toxicological test methods including 

those that are performed in vitro. EPA 

scientists have contributed significantly 

to this body of knowledge and are 

continuing to play an important role in 

the development of alternative test 

methods for consideration. 

In addition, as part of the voluntary 

HPV Challenge Program, EPA asked 

participants in that program to observe 

certain testing principles, which are laid 

out in an October 14, 1999 letter (Ref. 

16). In this same letter, the Agency also 

indicated its intention that related 

TSCA rulemaking proceed in a manner 

consistent with these principles. This 

letter is available in the public docket 

for this proposed rulemaking, as well as 

on EPA’s ChemRTK website. In the 

letter, EPA requested that participants 

conduct a thoughtful, qualitative 

analysis of existing data before testing. 

This proposed rule reflects many of the 

principles presented in the referenced 

voluntary HPV Challenge Program 

letter. Certain components of these 

principles, however, are not pertinent to 

this proposed rule. For example, this 

proposed rule does not require any 

dermal toxicity testing or any terrestrial 

toxicity testing. 

III. EPA Proposed Findings 

A. What is the Basis for EPA’s Proposal 

to Test These Chemical Substances? 

As indicated in Unit II.B., in order to 

develop a rulemaking under TSCA 

section 4(a) requiring the testing of 

chemical substances or mixtures, EPA 

must, among other things, make certain 

findings regarding either risk (TSCA 

section 4(a)(1)(A)(i)) or production 

combined with either chemical release 

or human exposure (TSCA section 

4(a)(1)(B)(i)), with regard to those 

chemicals. EPA is proposing to require 

testing of the chemical substances 

included in this proposed test rule 

based on its preliminary findings under 

TSCA section 4(a)(1)(B)(i) relating to 

‘‘substantial’’ production and 

‘‘substantial human exposure,’’ as well 

as findings under TSCA sections 

4(a)(1)(B)(ii) and (iii) relating to 

sufficient data and the need for testing. 

The chemical substances included in 

this proposed rule are listed in Table 2 

in § 799.5087(j) of the proposed 

regulatory text along with their 

Chemical Abstract Service (CAS) 

registry numbers. 

In EPA’s ‘‘B’’ policy (see Unit II.E.), 

‘‘substantial production’’ of a chemical 

substance or mixture is generally 

considered to be aggregate production 

(including import) volume equaling or 

exceeding 1 million lbs. per year of that 

chemical substance or mixture (Ref. 4, 

p. 28747). The ‘‘B’’ policy also provides 

guidelines that are generally considered 

by EPA in evaluating whether there is 

‘‘substantial human exposure’’ of 

workers, consumers, and the general 

population to a chemical substance or 

mixture. Refer to EPA’s ‘‘B’’ policy for 

further discussion on how EPA 

generally evaluates chemicals or 

mixtures under TSCA section 

4(a)(1)(B)(i). For the reasons set out in 

the ‘‘B’’ policy, EPA believes that the 

guidance included in the ‘‘B’’ policy is 

appropriate for consideration in this 

proposed rule and EPA sees no reason 

not to act consistently with the 

guidelines with respect to the chemicals 

included in this proposed rule. 

EPA has found preliminarily that, 

under TSCA section 4(a)(1)(B)(i), each of 

the 19 chemical substances included in 

this proposed rule is produced in 

‘‘substantial’’ quantities (see Unit III.B.) 

and that there is or may be ‘‘substantial 

human exposure’’ to each chemical 

substance (see Units III.C. and III.D.). 

Also, for one substance, EPA has found 

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preliminarily that, under TSCA section 

4(a)(1)(B)(i), the substance enters or may 

reasonably be anticipated to enter the 

environment in substantial quantities 

(see Unit III.E.). In addition, under 

TSCA section 4(a)(1)(B)(ii), EPA has 

preliminarily determined 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 (see 

Unit III.F.). EPA has also found 

preliminarily that testing the 19 

chemical substances identified in this 

proposed rule is necessary to develop 

such data (TSCA section 4(a)(1)(B)(iii)) 

(see Unit III.F.). EPA has not identified 

any ‘‘additional factors’’ as discussed in 

the ‘‘B’’ policy (Ref. 4, p. 28746) to 

cause the Agency to use decisionmaking 

criteria other than those described in the 

policy. 

The chemical substances included in 

this proposed rule are listed in 

§ 799.5087(j) of the proposed regulatory 

text along with their CAS numbers. 

B. Are These Chemical Substances 

Produced and/or Imported in 

Substantial Quantities? 

EPA has made preliminary findings 

that each of the chemical substances 

included in this proposal is produced 

and/or imported in an amount equal to 

or greater than 1 million lbs. per year 

(Ref. 18), based on information gathered 

pursuant to the 2006 IUR which is the 

most recently available compilation of 

TSCA Inventory data. EPA believes that 

these annual production and/or 

importation volumes are ‘‘substantial’’ 

as that term is used with reference to 

production in TSCA section 

4(a)(1)(B)(i). (See also Ref. 4, p. 28746). 

A discussion of EPA’s preliminary 

‘‘substantial production’’ finding for 

each chemical substance included in 

this proposed rule is contained in a 

separate document (See Ref. 18). 

C. Are a Substantial Number of Workers 

Exposed to These Chemicals? 

EPA has made preliminary findings 

that the manufacture, processing, and 

use of the 19 chemical substances (Table 

1.–Exposure Based Findings– 

Substantial Human Exposure, Unit 

III.D.) included in this action result or 

may result in exposure of a substantial 

number of workers to the chemical 

substances. 

This finding is based, in large part, on 

information submitted in accordance 

with the 2006 IUR. For chemicals whose 

total production volume (manufactured 

and imported) exceeded 300,000 lbs. at 

a site during calendar year 2005, 

manufacturers and importers were 

required to report the number of 

potentially exposed workers during 

industrial processing and use to the 

extent the information was readily 

obtainable. In addition, the submitters 

are required to provide information 

regarding the commercial and consumer 

uses of the chemical substance. 

EPA believes that an exposure of over 

1,000 workers to a chemical substance 

is ‘‘substantial’’ as that term is used 

with reference to ‘‘human exposure’’ in 

TSCA section 4(a)(1)(B)(i). EPA believes, 

based on experience gained through 

case-by-case analysis of existing 

chemicals, that an exposure of 1,000 

workers or more to a chemical substance 

is a reasonable interpretation of the 

phrase ‘‘substantial human exposure’’ in 

TSCA section 4(a)(1)(B)(i); see Ref. 4). 

Therefore, EPA’s preliminary finding is 

that there is or may be substantial 

human exposure (workers) to these 19 

chemical substances. 

In addition to the 2006 IUR data, EPA 

also reviewed National Occupational 

Exposure Survey (NOES) data 

developed by the National Institute for 

Occupational Safety and Health 

(NIOSH). Based on the NOES data, EPA 

found that more than 1,000 workers 

were exposed to each of the 19 chemical 

substances that are the subject of this 

proposed rule. The NOES was a 

nationwide data gathering project 

conducted by NIOSH, which was 

designed to develop national estimates 

for the number of workers potentially 

exposed to various chemical, physical 

and biological agents and describe the 

distribution of these potential 

exposures. Begun in 1980 and 

completed in 1983, the survey involved 

a walk-through investigation by trained 

surveyors of 4,490 facilities in 523 

different types of industries. Surveyors 

recorded potential exposures when a 

chemical agent was likely to enter or 

contact the worker’s body for a 

minimum duration. These potential 

exposures could be observed or inferred. 

Information from these representative 

facilities was extrapolated to generate 

national estimates of potentially 

exposed workers for more than 10,000 

different chemicals (Refs. 20, 57, and 

58). EPA also compared production 

volumes from the 1986 IUR data 

collection to the production volumes for 

the 2006 IUR data collection. Of the 19 

chemical substances in this proposed 

rule, only one chemical’s production 

volume decreased from 1986 to 2006. 

The 2006 IUR production volume data 

are consistent with NOES results, as the 

production volumes for the remaining 

chemical substances either stayed the 

same or increased since 1986, thereby 

indicating that the usage of these 

chemical substances is no less than 

when NOES data were gathered. 

EPA has performed a chemical-bychemical analysis for all 19 chemical 

substances and carefully considered the 

industrial process and use information 

along with the commercial and 

consumer use information from the 

2006 IUR submissions. Commercial uses 

are defined as ‘‘The use of a chemical 

substance or mixture in a commercial 

enterprise providing saleable goods or 

services (e.g., dry cleaning 

establishment, painting contractor)’’; 40 

CFR 710.43. Detailed information from 

the IUR submissions can be found in 

‘‘Testing of Certain High Production 

Volume Chemicals; Second Group of 

Chemicals (Exposure Findings 

Supporting Information)’’ (Ref. 18). 

Based on the nature of the IUR uses, 

EPA considers that chemicals with 

reported commercial uses may result in 

potential exposure to 1,000 workers or 

more. The total number of workers 

reported under the IUR is the sum of 

information on both industrial workers 

plus commercial use workers. 

In 2003, EPA partially exempted 

certain petroleum process streams 

(including ‘‘Hydrocarbons, C>4’’ (CAS 

No. 68647–60–9) and ‘‘Oils, reclaimed’’ 

(CAS No. 69029–75–0)) from reporting 

certain processing and use data under 

the TSCA section 8(a) IUR. The 

exemption was not based on an 

assessment of the toxicity of the process 

streams but on the fact that the 

chemicals are frequently processed, 

transported, and stored in vessels that 

minimize the potential for releases and 

exposure to workers. (Federal Register 

issue of January 7, 2003 (68 FR 848) 

(FRL–6767–4) and Federal Register 

issue of December 19, 2005 (71 FR 

75059) (FRL–7743–9); available on-line 

at: http://www.epa.gov/fedrgstr). Despite 

the fact that the degree of exposure is 

expected to be diminished to particular 

workers because of the chemical 

processing and handling practices used, 

available data indicate that more than 

1,000 workers are potentially exposed to 

these chemicals, supporting the 

preliminary finding of substantial 

human exposure (Ref. 18). 

D. Are a Substantial Number of 

Consumers Exposed to These 

Chemicals? 

Based on 2006 IUR data, EPA has 

made preliminary findings that the uses 

of 13 of the chemical substances 

included in this action result or may 

result in exposure to a substantial 

number of consumers (Ref. 18). EPA 

reviewed the consumer use information 

reported for the 2006 IUR and carefully 

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considered the nature of those uses. 

Upon completion of the review, EPA 

concluded that the reported consumer 

uses for the chemicals in this action 

may result in at least 10,000 potentially 

exposed consumers, thus meeting the 

exposure based finding for consumers. 

In addition to findings made based on 

the 2006 IUR data, EPA has also made 

consumer exposure based findings 

based on the National Library of 

Medicine (NLM) Household Products 

Database (Ref. 18). The chemical 

substances reported in the National 

Library of Medicine (NLM) Household 

Products Database are present in 

multiple household products subject to 

TSCA including hobby/craft products, 

personal care products, home cleaning 

products, home maintenance products, 

and automotive products. The NLM 

Household Products Database provides 

information on the chemical ingredients 

and their percentage in specific brands 

of household products. Information in 

the database is from a variety of publicly 

available sources including brandspecific labels and Material Safety Data 

Sheets when available from 

manufacturers and manufacturers’ 

websites. Publicly available information 

from the database is available on-line at: 

http://householdproducts.nlm.nih.gov. 

EPA believes that use of the consumer 

products identified in the NLM 

Household Products Database may 

expose a substantial number of 

consumers (i.e., greater than 10,000) to 

these chemical substances. EPA believes 

that an exposure of over 10,000 

consumers to a chemical substance is 

‘‘substantial’’ as that term is used with 

reference to ‘‘human exposure’’ in TSCA 

section 4(a)(1)(B)(i). EPA believes, based 

on experience gained through case-bycase analysis of existing chemicals, that 

an exposure of 10,000 consumers or 

more to a chemical substance is a 

reasonable interpretation of the phrase 

‘‘substantial human exposure’’ in TSCA 

section 4(a)(1)(B)(i). (See Ref. 4.) 

Therefore, EPA’s preliminary finding is 

that there is or may be substantial 

human exposure (consumers) to these 

chemical substances. 

A discussion of EPA’s preliminary 

‘‘substantial exposure’’ finding for 

consumers is contained in a separate 

document (see Ref. 18). The Agency 

solicits comment regarding additional 

information pertaining to numbers of 

consumers potentially exposed to the 

chemical substances identified in this 

proposed rule. 

TABLE 1.—EXPOSURE BASED FINDINGS—SUBSTANTIAL HUMAN EXPOSURE 

CAS No. 

2006 IUR 

Production Volume 

Meet Exposure 

Based CriteriaFor 

Mfg & Industrial 

Workers 

NOES (number of workers) 

Meet Exposure Based 

Criteria for 

Commercial 

Workers 

Meet Exposure Based 

Criteria for 

Consumers 

Meet Substantial or 

Significant 

Release Criteria 

NLM Household Chemicals 

Database 

75–07–0 > 100 million 

(M)–500 M 

X 216,533 X X X 

78–11–5 > 1 M–10 M X 2,650 X 

84–65–1 > 10 M–50 M X 6,187 X X 

89–32–7 > 1 M–10 M X 1,926 

110–44–1 > 1 M–10 M X 69,243 X X X 

118–82–1 > 1 M–10 M X 120,009 X X 

119–61–9 > 1 M–10 M X 41,516 X X X 

144–62–7 > 1 M–10 M X 142,000 X X X X 

149–44–0 > 1 M–10 M X 239,465 X X 

2524–04–1 > 10 M–50 M X 1,088 

4719–04–4 > 10 M–50 M X 225,251 X X X X 

6381–77–7 > 1 M–10 M X 19,468 

31138–65–5 > 1 M–10 M X 74,165 X X 

66241–11–0 > 1 M–10 M X 38,555 X X 

68187–76–8 > 1 M–10 M X 11,164 X X 

68187–84–8 > 1 M–10 M X 36,381 X X X 

68479–98–1 > 10 M–50 M X 4,121 

68527–02–6 > 1 M–10 M X 84,192 

68647–60–9 > 1 Billion lbs. X 1,257 

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E. Are Substantial Quantities of These 

Chemicals Released to the 

Environment? 

EPA does not have readily available 

data on environmental releases for most 

of the 19 chemical substances in this 

proposed rule. However, one substance, 

acetaldehyde (CAS No. 75–07–0) is 

included in TRI and has estimated 

environmental release in 2005 of 

13,567,452 lbs. (Ref. 18). TRI contains 

information about releases of certain 

chemicals and management of wastes at 

a wide variety of sources, including 

manufacturing operations, certain 

service businesses, and Federal 

facilities. Publicly available information 

from the 2005 TRI reporting cycle is 

available on-line at: http:// 

www.epa.gov/triexplorer. Two 

additional chemicals (ethanedioic acid 

and 1,3,5-triazine-1,3,5(2H,4H,6H)-

triethanol) also meet the substantial 

release criteria based on the 

environmental releases from their 

reported IUR uses. 

EPA believes that an environmental 

release of a chemical substance in an 

amount equal to or greater than 1 

million lbs. per year or greater than 10% 

of the reported production volume is 

‘‘substantial’’ as that term is used with 

reference to ‘‘enter the environment in 

substantial quantities’’ in TSCA section 

4(a)(1)(B)(i). (See Ref. 4). 

The Agency solicits comment 

regarding additional information 

pertaining to the amount of 

environmental release of the chemical 

substances identified in this proposed 

rule. 

F. Do Sufficient Data Exist for These 

Chemical Substances? 

In developing the testing 

requirements for chemicals contained in 

this proposed rule, available 

information on chemical/physical 

properties, environmental fate, 

ecotoxicity, and human health effects 

was searched using the data sources 

outlined in the OECD guidelines found 

in section 3.1 (Reliability, Relevance 

and Adequacy) of the ‘‘Manual for the 

Investigation of HPV Chemicals’’ (Ref. 6) 

such as: Beilstein Database, CRC 

Handbook of Chemistry and Physics, 

Hawley’s Condensed Chemical 

Dictionary, Illustrated Handbooks of 

Physical-Chemical Properties and 

Environmental Fate for Organic 

Chemicals, Merck Index, Hazardous 

Substances Data Bank (HSDB), 

Toxicology Literature Online 

(TOXLINE), and the National Technical 

Information Service (NTIS). EPA also 

searched for available data as 

summarized in its HPV Information 

System (Ref. 56). For one HPV chemical, 

data available from an EPA 

reassessment of its use as an inert in 

pesticides formulations were examined 

(Ref. 21). When appropriate, the Federal 

Research In Progress (FEDRIP) database 

was also searched. Any information that 

was obtained from these searches was 

evaluated for data acceptability using 

the guidelines described on EPA’s 

voluntary HPV Challenge Program 

website (http://www.epa.gov/chemrtk/ 

pubs/general/guidocs.htm): ‘‘Guidance 

for Meeting the SIDS Requirements (The 

SIDS Guide)’’ and ‘‘Guidance for 

Assessing the Adequacy of Existing 

Data.’’ Furthermore, data adequacy and 

reliability were evaluated using the 

OECD guidelines which can be found in 

section 3.1 of the OECD ‘‘Manual for the 

Investigation of HPV Chemicals’’ (Ref. 

6). 

It is worth noting that additional 

testing is being proposed for five 

chemicals that had been included in the 

final TSCA section 4 HPV SIDS 

rulemaking issued on March 16, 2006 

(Ref. 3). EPA noted in the proposed (Ref. 

2) and final rule (Ref. 3) for that first 

HPV SIDS rulemaking that, for 

chemicals for which some data were 

available on one or more SIDS 

endpoints, EPA was not requiring 

testing at that time for those endpoints. 

However, EPA stated at that time that no 

definitive determination had been made 

as to the adequacy of those existing data 

for an initial assessment of a chemical’s 

hazards or risks to health or the 

environment. Consequently, in that final 

rule, EPA stated that if EPA determines 

that it needs additional data regarding 

any of the chemical substances included 

in the final rule, the Agency might seek 

further health and/or environmental 

effects testing for those chemical 

substances. EPA has now completed its 

assessment of the adequacy of the 

available data for those endpoints that 

were not included for these chemicals 

in the first HPV SIDS rulemaking. In 

some instances, EPA has made a 

preliminary finding that, for some of the 

SIDS endpoints, the existing data and 

experience are not sufficient to enable 

the effects of these substances on health 

or the environment to reasonably be 

determined or predicted. Therefore, 

EPA has also proposed testing for those 

endpoints in this proposed rule. 

Section 799.5087(j) of the proposed 

regulatory text lists each chemical and 

the SIDS tests for which adequate data 

are not currently available to the 

Agency. The Agency preliminarily finds 

that the existing data for one or more of 

the SIDS testing endpoints for each of 

the chemical substances listed in Table 

2 of the proposed regulatory text 

(including environmental fate 

(comprising five tests for physical/ 

chemical properties [melting point, 

boiling point, vapor pressure, n-octanol/ 

water partition coefficient, and water 

solubility] and biodegradation); 

ecotoxicity (tests in fish, Daphnia, and 

algae); acute toxicity; genetic toxicity 

(gene mutations and chromosomal 

aberrations); repeat dose toxicity; and 

developmental and reproductive 

toxicity) are insufficient to enable EPA 

to reasonably determine or predict the 

human health and environmental effects 

resulting from manufacture, processing, 

and use of these chemical substances. 

EPA solicits comment concerning the 

availability of existing studies on the 

SIDS endpoints proposed in this 

document on these chemical substances. 

To the extent that additional studies 

relevant to the testing proposed in this 

rulemaking are known to exist, EPA 

strongly encourages the submission of 

this information as comments to the 

proposed rule, including full citations 

for publications and full copies of 

unpublished studies. If EPA judges such 

data to be sufficient, corresponding 

testing will not be included in the final 

rule. Commenters are also encouraged to 

prepare a robust summary (Ref. 15) for 

each such study to facilitate EPA’s 

review of the full study report or 

publication. Persons who respond to 

this request to submit robust summaries 

are also encouraged to submit the robust 

summary electronically via the High 

Production Volume Information System 

(HPVIS) to allow for its ready 

incorporation into HPVIS. Directions for 

electronic submission of robust 

summary information into HPVIS are 

provided at https://iaspub.epa.gov/ 

oppthpv/metadata.html. This link will 

direct you to the ‘‘HPVIS Quick Start 

and User’s Guide.’’ 

As noted in Unit II.C.1., persons who 

believe that adequate information 

regarding a chemical subject to this 

proposed rule can be developed using a 

category or SAR approach are 

encouraged to submit appropriate 

information, along with their rationale 

which substantiates this belief, during 

the comment period on this proposed 

rule. If, based on submitted information 

and other information available to EPA, 

the Agency agrees; EPA will take such 

measures as are needed to avoid 

unnecessary testing in the final rule. 

G. Is Testing Necessary for These 

Chemical Substances? 

EPA would use the data obtained 

from this proposed testing to support 

development of preliminary hazard and 

risk characterizations for these HPV 

chemicals as part of the ChAMP process 

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fulfilling the U.S. commitments under 

the SPP to set initial priorities for 

potential future appropriate action, 

including possible further testing that 

would produce more definitive hazard 

information where needed on such 

chemical substances. Such additional 

information is needed by EPA, other 

Federal agencies, the public, industry, 

and others to ensure that adequate 

hazard and risk assessments can be 

conducted on these chemical 

substances. EPA has used data from test 

rules to support such activities as the 

development of water quality criteria, 

TRI listings, chemical advisories, and 

input for actions resulting in reduction 

of workplace exposures. 

EPA preliminarily believes that 

conducting the needed SIDS testing 

identified for the 19 subject chemical 

substances is necessary to provide data 

relevant to a determination of whether 

the manufacture, processing, and use of 

the chemical substances does or does 

not present an unreasonable risk of 

injury to human health and the 

environment. 

IV. Proposed Testing 

A. What Testing is Being Proposed in 

this Action? 

EPA is proposing specific testing and 

reporting requirements for the chemical 

substances specified in § 799.5087(j) of 

the proposed regulatory text. 

All of the proposed testing 

requirements are listed in Table 2 in 

§ 799.5087(j) of the proposed regulatory 

text and consist of a series of test 

methods covering many of the 

endpoints in the OECD HPV SIDS 

testing battery. EPA, however, requires 

that the American Society for Testing 

and Materials (ASTM) or the TSCA test 

guidelines at 40 CFR part 799 (TSCA 

799 guidelines) be used because the 

language in the TSCA 799 guidelines 

makes clear which steps are mandatory 

and which steps are only recommended. 

EPA’s TSCA 799 guidelines, however, 

have been harmonized with the OECD 

guidelines. Accordingly, in order to 

comply with this test rule, testing must 

be conducted in accordance with the 

specified mandatory and enforceable 

requirements in the ASTM or TSCA 799 

guidelines. Most of the proposed testing 

requirements for a particular endpoint 

are specified in one test standard. In the 

case of certain endpoints, however, any 

of multiple listed methods could be 

used. For several of the proposed test 

standards, EPA has identified and is 

proposing certain ‘‘Special Conditions’’ 

as discussed in this unit. The following 

endpoints and proposed test standards 

would be required under this proposed 

rule. 

1. Physical/chemical properties. 

Melting Point: American Society for 

Testing and Materials (ASTM) E 324–99 

(Capillary tube) (Ref. 22). 

Boiling Point: ASTM E 1719–05 

(Ebulliometry) (Ref. 23). 

Vapor Pressure: ASTM E 1782–03 

(Thermal analysis) (Ref. 24). 

n-Octanol/Water Partition 

Coefficient: 

Method A (40 CFR 799.6755— 

shake flask) 

Method B (ASTM E 1147– 

92(2005)—liquid chromatography) (Ref. 

25). 

Method C (40 CFR 799.6756— 

generator column). 

Water Solubility: 

Method A: (ASTM E 1148–02— 

shake flask) (Ref. 26). 

Method B (40 CFR 799.6784— 

shake flask). 

Method C (40 CFR 799.6784— 

column elution). 

Method D (40 CFR 799.6786— 

generator column). 

EPA is proposing, for those chemicals 

for which melting points determinations 

are needed, that melting points be 

determined according to the method 

ASTM E 324–99. Although ASTM 

indicates on its website, http:// 

www.astm.org/cgi-bin/SoftCart.exe/ 

STORE/ 

filtrexx40.cgi?U+mystore+lien2117+-

L+E324+/usr6/htdocs/astm.org/ 

DATABASE.CART/WITHDRAWN/ 

E324.htm that ASTM E 324–99 has been 

withdrawn, ASTM has explained that 

ASTM E 324–99 was withdrawn 

because: 

The standard utilizes old, well-developed 

technology; it is highly unlikely that any 

additional [changes] and/or modifications 

will ever be pursued by the E15 [committee]. 

The time and effort needed to maintain these 

documents detract from the time available to 

develop new standards which use modern 

technology. 

(Ref. 27) 

Withdrawal of the method by ASTM 

means only that ASTM no longer 

continues to develop and improve the 

method. It does not mean that ASTM no 

longer considers the method to be valid. 

ASTM still makes the method available 

for informational purposes and it can 

still be purchased from ASTM at the 

address listed in § 799.5087(h) of the 

proposed regulatory text. EPA 

concludes that ASTM’s withdrawal of E 

324–99 does not have negative 

implications on the validity of the 

method; therefore, EPA is proposing, for 

those chemicals for which melting 

points determinations are needed, that 

melting points be determined according 

to the method ASTM E 324–99. 

For the n-octanol/water partition 

coefficient and water solubility 

endpoints, EPA is proposing that certain 

‘‘Special Conditions’’ be considered by 

test sponsors in determining the 

appropriate test method that would be 

used from among those included for 

these endpoints in Table 3 in 

§ 799.5087(j) of the proposed regulatory 

text. 

For the ‘‘n-Octanol/Water Partition 

Coefficient (log 10 basis)’’ endpoint, also 

known as log Kow, EPA proposes that an 

appropriate selection be made from 

among three alternative methods for 

measuring the substance’s n-octanol/ 

water partition coefficient. Prior to 

determining the appropriate standard to 

use, if any, to measure the n-octanol/ 

water partition coefficient, EPA is 

recommending that the log 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 

proposing that test sponsors must 

submit with the final study report the 

underlying rationale for the test 

standard selected for this endpoint. EPA 

is proposing this approach in 

recognition of the fact that depending 

on the chemical substance’s log 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 is, the less well Method A 

(§ 799.6755—shake flask) will work and 

Method B (ASTM E 1147–92(2005)) and 

Method C (§ 799.6756—generator 

column) become more suitable, 

especially Method C. The proposed test 

methodologies have been developed to 

meet a wide variety of needs and, as 

such, are silent on experimental 

conditions related to pH. Therefore, 

EPA proposes that all required noctanol/water partition coefficient tests 

be conducted at pH 7 to ensure 

environmental relevance. The proposed 

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. 

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TABLE 2.—TEST REQUIREMENTS FOR THE N-OCTANOL/WATER PARTITION COEFFICIENT ENDPOINT 

Testing Category Test Requirements and References Special Conditions 

Physical/chemical 

properties 

n-Octanol/water partition coefficient (log 10 basis) 

or log Kow: 

The appropriate log Kow test, if any, would be selected from those listed in this column—see Special Conditions in the adjacent column. 

Method A: 40 CFR 799.6755 (shake flask) 

Method B: ASTM E 1147–92(2005) (liquid chromatography) 

Method C: 40 CFR 799.6756 (generator column) 

n-Octanol/water partition coefficient or log 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 or 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. 

For the ‘‘Water Solubility’’ endpoint, Estimating Water Solubility from conditions related to pH. Therefore, 

EPA proposes an appropriate selection Octanol/Water Partition Coefficient’’ EPA proposes that all required water 

be made from among four alternative (Ref. 29). EPA is also proposing that test solubility tests be conducted starting at methods for measuring that endpoint. sponsors be required to submit in the pH 7 to ensure environmental relevance. The test method used, if any, would be final study report the underlying The estimated water solubility ranges determined by first quantitatively rationale for the test standard selected that EPA is proposing for use in estimating the test substance’s water for this endpoint. The proposed test selecting an appropriate proposed test solubility. One recommended method methodologies have been developed to standard are shown in Table 3 of this for estimating water solubility is meet a wide variety of needs and, as unit. described in ‘‘Improved Method for such, are silent on experimental 

TABLE 3.—TEST REQUIREMENTS FOR THE WATER SOLUBILITY ENDPOINT 

Testing Category Test Requirements and References Special Conditions 

Physical/chemical Water solubility: Water solubility: 

properties The appropriate method to use, if any, to test for Which method is required, if any, would be determined by the test 

water solubility would be selected from those list- substance’s estimated water solubility. Test sponsors must proed in this column—see Special Conditions in the vide in the final study report the underlying rationale for the methadjacent column. od and pH selected. In order to ensure environmental relevance, 

Method A: ASTM E 1148–02 (shake flask) EPA highly recommends that the selected study be conducted 

Method B: 40 CFR 799.6784 (shake flask) starting at pH 7. 


Method C: 40 CFR 799.6784 (column elution) 
 > 5,000 milligram/Liter (mg/L): Method A or B. 

Method D: 40 CFR 799.6786 (generator column) > 10 mg/L—5,000 mg/L: Method A, B, C, or D. 

> 0.001 mg/L—10 mg/L: Method C or D. 

≤ 0.001 mg/L: No testing required. 

2. Environmental fate and pathways. 

Ready Biodegradation: 

Method A: ASTM E1720–01 

(Sealed vessel CO2 production test) (Ref. 

30). 

Method B: ISO 14593 (CO2 

headspace test) (Ref. 31). 

Method C: ISO 7827 (Method by 

analysis of dissolved organic carbon 

(DOC)) (Ref. 32). 

Method D: ISO 9408 

(Determination of oxygen demand in a 

closed respirometer) (Ref. 33). 

Method E: ISO 9439 (Carbon 

dioxide evolution test) (Ref. 34). 

Method F: ISO 10707 (Closed 

bottle test) (Ref 35). 

Method G: ISO 10708 (Two-phase 

closed bottle test) (Ref. 36). 

For the ‘‘Ready Biodegradation’’ 

endpoint, EPA proposes an appropriate 

selection be made from among seven 

alternative methods for measuring the 

substance’s ready biodegradability. For 

most test substances, EPA considers 

Method A (ASTM E1720–01) and 

Method B (ISO 14593) to be generally 

applicable, cost effective, and widely 

accepted internationally. However, the 

test method used, if any, will depend on 

the physical and chemical properties of 

the test substance, including its water 

solubility. An additional document, ISO 

10634 (Ref. 37), provides guidance for 

selection of an appropriate test method 

for a given test substance considering 

the substances physical and chemical 

properties. EPA is also proposing that 

test sponsors be required to submit in 

the final study report the underlying 

rationale for the test standard selected 

for this endpoint. 

3. Aquatic toxicity. 

Test Group 1: 

Acute toxicity to fish (ASTM E 

729–96(2002)) (Ref. 38). 

Acute toxicity to Daphnia (ASTM 

E 729–96(2002)) (Ref. 38). 

Toxicity to plants (algae) (ASTM 

E 1218–04e1) (Ref. 39). 

Test Group 2: 

Chronic toxicity to Daphnia 

(ASTM E 1193–97(2004)) (Ref. 40). 

Toxicity to plants (algae) (ASTM 

E 1218–04e1) (Ref. 39). 

For the ‘‘Aquatic Toxicity’’ endpoint, 

the OECD HPV SIDS Program recognizes 

that, for certain chemicals, acute 

toxicity studies are of limited value in 

assessing the substances’ aquatic 

toxicity. This issue arises when 

considering chemical substances with 

high log 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 substances to reach steady state or 

toxic concentrations in the test 

organism. For such situations, the OECD 

HPV SIDS Program recommends use of 

chronic toxicity testing in Daphnia in 

place of acute toxicity testing in fish and 

Daphnia. EPA is proposing that the 

aquatic toxicity testing requirement be 

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determined based on the test 

substance’s measured log Kow as 

determined by using the approach 

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

discussion of ‘‘n-Octanol/Water 

Coefficient,’’ and in Table 3 in 

§ 799.5087(j) of the proposed regulatory 

text. For test substances determined to 

have a log Kow of less than 4.2, one or 

more of the following tests (described as 

‘‘Test Group 1’’ in Table 3 in 

§ 799.5087(j) of the proposed regulatory 

text) are proposed: Acute toxicity to fish 

(ASTM E 729–96 (2002)); Acute toxicity 

to Daphnia (ASTM E 729–96(2002)); and 

Toxicity to plants (algae) (ASTM E 

1218–04e1). For test substances 

determined to have a log 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 § 799.5087(j) of 

the proposed regulatory text) are 

proposed: Chronic toxicity to Daphnia 

(ASTM E 1193–97(2004)) and Toxicity 

to plants (algae) (ASTM E 1218–04e1). 

As outlined in Table 3 in § 799.5087(j) 

of the proposed regulatory text, 

depending on the testing proposed in 

Test Group 1, the Test Group 2 chronic 

Daphnia test may substitute for either or 

both the acute fish toxicity test and the 

acute Daphnia test. 

Using SAR, a log Kow of 4.2 

corresponds with a fish 

bioconcentration factor (BCF) of about 

1,000 (Refs. 29, 41, and 42). A chemical 

substance with a fish BCF value of 1,000 

or more is characterized as having a 

tendency to accumulate in living 

organisms relative to the concentration 

of the chemical in the surrounding 

environment (Ref. 42). For the purposes 

of this proposed rulemaking, EPA’s use 

of a log Kow equal to or greater than 4.2 

(which corresponds with a fish BCF 

value of 1,000) is consistent with the 

approach taken in the Agency’s Final 

Policy Statement under TSCA section 5 

entitled Category for Persistent, 

Bioaccumulative, and Toxic New 

Chemical Substances (Ref. 43). EPA has 

also used a measured BCF that is equal 

to or greater than 1,000 or, in the 

absence of bioconcentration data, a log 

P [same as log 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 (Significant New Use Rules; 

General Provisions For New Chemical 

Follow-Up (Ref. 44) (See also 40 CFR 

721.3.)). EPA considers the difference 

between the log Kow of 4.3 cited in the 

1989 Federal Register document and 

the log Kow value of 4.2 cited in this 

proposed rule to be negligible. 

EPA recognizes that in some 

circumstances, acute aquatic toxicity 

testing (Test Group 1) may be relevant 

for certain chemical substances having a 

log 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 § 799.5087(j) of the 

proposed 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 the final rule as described 

in 40 CFR 790.55. Based upon the 

supporting rationale provided by the 

test sponsor, EPA may allow an 

alternative threshold or method to be 

used for determining whether acute or 

chronic aquatic toxicity testing must be 

performed for a specific substance. EPA 

is soliciting public comment on this 

approach as well as other alternative 

approaches in this area. 

4. Mammalian toxicity—acute. 

Acute Inhalation Toxicity (rat): 

Method A (40 CFR 799.9130). 

Acute Oral Toxicity (rat): Method B 

(ASTM E 1163–98(2002) (Ref. 59) or 40 

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

For the ‘‘Mammalian Toxicity— 

Acute’’ endpoint, EPA is proposing that 

certain ‘‘Special Conditions’’ in the form 

of the chemical substance’s physical/ 

chemical properties or physical state be 

considered in determining the 

appropriate test method that would be 

used from among those included for this 

endpoint in Table 3 in § 799.5087(j) of 

the proposed regulatory text. The OECD 

HPV SIDS Program recognizes that, for 

most chemical substances, the oral route 

of administration will suffice for this 

endpoint. However, consistent with the 

approach taken under the voluntary 

HPV Challenge Program, EPA is 

proposing that, for test substances that 

are gases at room temperature (25° C), 

the acute mammalian toxicity study be 

conducted using inhalation as the 

exposure route (described as Method A 

(40 CFR 799.9130) in Table 3 in 

§ 799.5087(j) of the proposed regulatory 

text). In the case of a potentially 

explosive test substance, care must be 

taken to avoid the generation of 

explosive concentrations. For all other 

chemicals (i.e., those that are either 

liquids or solids at room temperature), 

EPA is proposing that the acute toxicity 

testing be conducted via oral 

administration using an ‘‘Up/Down’’ 

test method (described as Method B 

(ASTM E 1163–98(2002) or 40 CFR 

799.9110(d)(1)(i)(A)) in Table 3 in 

§ 799.5087(j) of the proposed regulatory 

text). Consistent with the voluntary HPV 

Challenge Program, EPA is proposing to 

allow the use of the Neutral Red Uptake 

(NRU) basal cytotoxicity assay to select 

the starting dose for the acute oral 

toxicity test. This test is included as a 

special condition in Table 3 of the 

proposed regulatory text. A document 

developed by NIH/NIEHS provides 

guidance on how to use the NRU assay 

to estimate a starting dose for an acute 

oral toxicity test (Ref. 50). Recent 

versions of the standardized protocols 

for the NRU assay are available at the 

NIEHS/ICCVAM website, http:// 

iccvam.niehs.nih.gov/methods/ 

acutetox/invitrocyto/invcyt_proto.htm 

(Refs. 51–53). 

Dermal toxicity testing is not 

proposed in this rulemaking, and the 

Agency does not intend to include any 

dermal toxicity testing in any TSCA 

section 4 HPV SIDS rulemakings. 

5. Mammalian toxicity—genotoxicity. 

Gene mutations: 

Bacterial Reverse Mutation Test 

(in vitro): 40 CFR 799.9510. 

Chromosomal damage: 

In Vitro Mammalian Chromosome 

Aberration Test (40 CFR 799.9537), or 

the In Vivo Mammalian Bone Marrow 

Chromosomal Aberration Test (rodents: 

mouse (preferred species), rat, or 

Chinese hamster) (40 CFR 799.9538), or 

the In Vivo Mammalian Erythrocyte 

Micronucleus Test (sampled in bone 

marrow) (rodents: mouse (preferred 

species), rat, or Chinese hamster) (40 

CFR 799.9539). 

Persons who would be required to 

conduct testing for chromosomal 

damage are encouraged to use in vitro 

genetic toxicity testing (i.e., the 

Mammalian Chromosome Aberration 

Test) to generate the needed genetic 

toxicity screening data, unless known 

chemical properties preclude its use. 

These could include, for example, 

physical chemical properties or 

chemical class characteristics. A 

primary focus of both the voluntary 

HPV Challenge Program and this 

proposed rule is to implement this 

program in a manner consistent with the 

OECD HPV SIDS Program and as part of 

a larger international activity with 

global involvement. This proposed 

approach provides the same degree of 

flexibility as that which currently exists 

under the OECD HPV SIDS testing 

program (Ref. 6). A subject person who 

uses one of the in vivo methods instead 

of the in vitro method to address this 

end-point would be required to submit 

to EPA a rationale for conducting that 

alternate test in the final study report. 

6. Mammalian toxicity—repeated 

dose/reproduction/developmental. 

Combined Repeated Dose Toxicity 

Study with the Reproduction/ 

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43326 Federal Register / Vol. 73, No. 143 / Thursday, July 24, 2008 / Proposed Rules 

Developmental Toxicity Screening Test: 

40 CFR 799.9365. 

Reproduction/Developmental 

Toxicity Screening Test: 40 CFR 

799.9355. 

Repeated Dose 28–Day Oral 

Toxicity Study: 40 CFR 799.9305. 

For the ‘‘Mammalian Toxicity— 

Repeated Dose/Reproduction/ 

Developmental’’ endpoint, EPA 

recommends the use of the Combined 

Repeated Dose Toxicity Study with the 

Reproduction/Developmental Toxicity 

Screening Test (40 CFR 799.9365) as the 

test of choice. EPA recognizes, however, 

that there may be reasons to test a 

particular chemical substance using 

both the Reproduction/Developmental 

Toxicity Screening Test (40 CFR 

799.9355) and the Repeated Dose 28– 

Day Oral Toxicity Study (40 CFR 

799.9305) instead of the Combined 

Repeated Dose Toxicity Study with the 

Reproduction/Developmental Toxicity 

Screening Test (40 CFR 799.9365). With 

regard to such cases, EPA is proposing 

that a subject person who uses the 

combination of the Reproduction/ 

Developmental Toxicity Screening Test 

and the Repeated Dose 28–Day Oral 

Toxicity Study in place of the Combined 

Repeated Dose Toxicity Study with 

Reproduction/Developmental Toxicity 

Screen would be required to submit to 

EPA a rationale for conducting these 

alternate tests in the final study reports. 

Certain of the chemical substances for 

which Mammalian Toxicity—Repeated 

Dose/Reproduction/Developmental 

testing is proposed may be used solely 

as ‘‘closed system intermediates,’’ as 

described in the EPA guidance 

document developed for the voluntary 

HPV Challenge Program (Ref. 46). As 

described in that guidance, such 

chemical substances may be eligible for 

a reduced testing battery which 

substitutes a developmental toxicity 

study for the SIDS requirement to 

address repeated dose (e.g., subchronic), 

reproductive, and developmental 

toxicity. In other words, since only the 

developmental toxicity study would be 

conducted for those chemical 

substances that qualify for a reduced 

testing battery, repeated dose (e.g., 

subchronic) and reproductive studies 

would not be conducted. At the present 

time, EPA does not have sufficient 

information to know with any degree of 

certainty which if any of the chemical 

substances that are listed in the 

proposed regulatory text are solely 

closed system intermediates as defined 

in the voluntary HPV Challenge 

Program guidance document (Ref. 46). 

Persons who believe that a chemical 

substance fully satisfies the terms 

outlined in the guidance document are 

encouraged to submit appropriate 

information along with their comments 

on this proposed rule which 

substantiate this belief. If, based on 

submitted information and other 

information available to EPA, the 

Agency believes that a chemical 

substance is considered likely to meet 

the requirements for use solely as a 

closed system intermediate, EPA would 

not address any developmental toxicity 

testing needs in this proposed 

rulemaking. In those cases in which the 

Agency can determine that chemicals 

are solely closed system intermediates, 

it plans to handle them in accordance 

with the existing OECD procedures. 

B. When Would Any Testing Imposed by 

this Proposed Rulemaking Begin? 

The testing requirements contained in 

this proposed rule are not effective until 

and unless the Agency issues a final 

rule. Based on the effective date of the 

final rule, which is typically 30 days 

after the publication of a final rule in 

the Federal Register, the test sponsor 

may plan the initiation of any required 

testing as appropriate to submit the 

required final report by the deadline 

indicated as the number of months after 

the effective date that would be shown 

in § 799.5087(j) of the proposed 

regulatory text. 

C. How Would the Studies Proposed 

Under this Test Rule be Conducted? 

Persons required to comply with the 

final rule would have to conduct the 

necessary testing in accordance with the 

testing and reporting requirements 

established in the regulatory text of the 

final rule, and with the TSCA Good 

Laboratory Practice Standards (GLPS) 

(40 CFR part 792). 

D. What Form of Test Substances Would 

be Tested Under this Rule? 

EPA is proposing two distinct 

approaches for identifying the specific 

substances that would be tested under 

this proposed rule, the application of 

which would depend on whether the 

substance is considered to be a ‘‘Class 

1’’ or a ‘‘Class 2’’ substance. First 

introduced when EPA compiled the 

TSCA Chemical Substance Inventory, 

the term Class 1 substance refers to a 

chemical substance having a chemical 

composition that consists of a single 

chemical species (not including 

impurities) that can be represented by a 

specific, complete structure diagram. By 

contrast, the term Class 2 substance 

refers to a chemical substance having a 

composition that cannot be represented 

by a specific, complete chemical 

structure diagram, because such a 

substance generally contains two or 

more different chemical species (not 

including impurities). Table 2 in 

§ 799.5087(j) of the proposed regulatory 

text identifies the listed chemical 

substances as either Class 1 or Class 2 

substances. 

EPA is proposing that, for the Class 1 

substances that are listed in the 

proposed rule, the test substance have a 

purity of 99% or greater. EPA has 

generally applied this standard of purity 

to the testing of Class 1 substances in 

the past under TSCA section 4(a) testing 

actions, except for substances where it 

has been shown that such purity is 

unattainable. EPA is soliciting comment 

on whether a purity level of 99% or 

greater cannot be attained for any of the 

Class 1 substances listed in this 

proposed rule. For the Class 2 

substances that are listed in the 

proposed rule, EPA is proposing that the 

test substance be any representative 

form of the chemical substance, to be 

defined by the test sponsor(s). 

In proposing a different approach for 

identifying the substance to be tested 

with regard to Class 2 substances, EPA 

recognizes two characteristics which 

further distinguish Class 1 from Class 2 

substances. First, unlike for Class 1 

substances, knowledge of the 

composition of commercial Class 2 

substances can vary in quality and 

specificity from substance to substance. 

The composition of the chemical 

species which comprise a Class 2 

substance may be: 

• Well-characterized in terms of 

molecular formulae, structural 

diagrams, and compositional 

percentages of all species present (for 

example, methyl phenol); 

• Less well-characterized, for 

example, characterized only by 

molecular formulae, non-specific 

structural diagrams, and/or by 

incomplete or unknown compositional 

percentages of the species present (for 

example, C12–C14 tert-alkyl amines); or 

• Poorly characterized because all that 

is known is the identity of only some of 

the chemical species present and their 

percentages of composition, or of only 

the feedstocks and method of 

manufacture used to manufacture the 

substance (for example, nut shell liquor 

of cashew). 

Secondly, the composition of some 

Class 2 substances may vary from one 

manufacturer to another, or, for a single 

manufacturer, from production run to 

production run, because of small 

variations in feedstocks, manufacturing 

methods, or other production variables. 

A ‘‘Class 2’’ designation most frequently 

represents a group of chemical 

substances comprising substances that 

have similar combinations of different 

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chemical species and/or that were 

prepared from similar feedstocks using 

similar production methods. By 

contrast, Class 1 substances generally 

represent a much narrower group of 

substances for which the only variables 

are their impurities. EPA believes that, 

for purposes of this proposed rule, the 

testing of any representative form of a 

subject Class 2 substance would provide 

the data necessary to support the 

development of preliminary or 

screening level hazard and risk 

characterizations for the subject Class 2 

substance. However, EPA would 

encourage the selection of 

representative forms of test substances 

that meet industry or consensus 

standards, where they exist. In 

accordance with TSCA GLPS at 40 CFR 

part 792, the final study report would be 

required to include test substance 

identification information, including 

name, CAS number, strength, purity, 

and composition, or other appropriate 

characteristics. (See 40 CFR 792.185). 

As an alternative to requiring the 

testing of a representative form of a 

Class 2 substance designated by a 

person subject to the final rule, EPA is 

considering whether the Agency should 

specify the particular form of each 

chemical substance that must be tested, 

and, if so, what criteria EPA should use 

to identify the particular representative 

form that would be tested. EPA might 

specify, for example, a form of a 

substance that meets an industry or 

consensus specification, if one exists, or 

the form with the highest production 

volume, which could potentially be 

identified via information reported 

under a TSCA section 8(a) rule, or by 

other means. 

Under both of the approaches 

described in this unit, manufacturers 

and processors of each chemical 

substance listed in this proposed rule 

would be jointly responsible for the 

testing of a representative form of each 

Class 2 substance. 

To facilitate EPA’s review of 

exemption applications under this 

alternative, the Agency would require 

the submission of certain chemical 

substance-identifying data, including 

characteristics and properties of the 

exemption applicant’s substance, such 

as boiling point, melting point, chemical 

analysis, additives (if any), and spectral 

data information. 

EPA solicits comment on the 

proposed alternative approaches to the 

testing of Class 2 substances included in 

this proposed rule. 

E. Would I Be Required to Test Under 

this Rule? 

Under TSCA section 4(a)(1)(B)(ii), 

EPA has made preliminary findings that 

there are insufficient data and 

experience to reasonably determine or 

predict health and environmental effects 

resulting from the manufacture, 

processing, or use of the chemical 

substances listed in this proposed 

rulemaking. As a result, under TSCA 

section 4(b)(3)(B), manufacturers and 

processors of these chemical substances, 

and those who intend to manufacture or 

process them, would be subject to the 

rule with regard to those listed chemical 

substances which they manufacture or 

process. 

1. Would I be subject to this rule? You 

would be subject to this rule and may 

be required to test if you manufacture 

(which is defined by statute to include 

import) or process, or intend to 

manufacture or process, one or more 

chemical substances listed in this 

proposed rule during the time period 

discussed in Unit IV.E.2. However, if 

you do not know or cannot reasonably 

ascertain that you manufacture or 

process a listed test rule substance 

(based on all information in your 

possession or control, as well as all 

information that a reasonable person 

similarly situated might be expected to 

possess, control, or know, or could 

obtain without unreasonable burden), 

you would not be subject to the rule for 

that listed substance. 

2. When would my manufacture or 

processing (or my intent to do so) cause 

me to be subject to this rule? You would 

be subject to this rule if you 

manufacture or process, or intend to 

manufacture or process, a chemical 

substance listed in this proposed rule at 

any time from the effective date of the 

final test rule to the end of the test data 

reimbursement period. The term 

‘‘reimbursement period’’ is defined at 40 

CFR 791.3(h) and may vary in length for 

each substance to be tested under a final 

TSCA section 4(a) test rule, depending 

on what testing is required and when 

testing is completed. See Unit IV.E.4. 

3. Would I be required to test if I were 

subject to the rule? It depends on the 

nature of your activities. All persons 

who would be subject to this TSCA 

section 4(a) test rule, which, unless 

otherwise noted in the regulatory text, 

incorporates EPA’s generic procedures 

applicable to TSCA section 4(a) test 

rules (contained within 40 CFR part 

790), would fall into one of two groups, 

designated here as Tier 1 and Tier 2. 

Persons in Tier 1 (those who would 

have to initially comply with the final 

rule) would either: 

• Submit to EPA letters of intent to 

conduct testing, conduct this testing, 

and submit the test data to EPA, or 

• Apply to and obtain from EPA 

exemptions from testing. 

Persons in Tier 2 (those who would 

not have to initially comply with the 

final rule) would not need to take any 

action unless they are notified by EPA 

that they are required to do so (because, 

for example, no person in Tier 1 had 

submitted a letter of intent to conduct 

testing), as described in Unit IV.E.3.d. 

Note that both persons in Tier 1 who 

obtain exemptions and persons in Tier 

2 would nonetheless be subject to 

providing reimbursement to persons 

who actually conduct the testing, as 

described in Unit IV.E.4. 

a. Who would be in Tier 1 and Tier 

2? All persons who would be subject to 

the final rule are considered to be in 

Tier 1 unless they fall within Tier 2. 

Table 4 of this unit describes who is in 

Tier 1 and Tier 2. 

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TABLE 4.—PERSONS SUBJECT TO THE RULE: PERSONS IN TIER 1 AND TIER 2 

Tier 1 (Persons initially required to comply) Tier 2 (Persons not initially required to comply) 

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

or intend to manufacture, a test rule substance, and who are manufacture a test rule substance solely as one or more of the following: 

not listed under Tier 2 —As a byproduct (as defined at 40 CFR 791.3(c)); 

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

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

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

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

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

—In amounts of less than 500 kg (1,100 lbs.) annually (as described at 40 

CFR 790.42(a)(4)); or 

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

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

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

Under 40 CFR 790.2, EPA may 

establish procedures applying to 

specific test rules that differ from the 

generic procedures governing TSCA 

section 4(a) test rules in 40 CFR part 

790. For purposes of this proposed rule, 

EPA is proposing to establish certain 

requirements that differ from those 

under 40 CFR part 790. 

In this proposed test rule, EPA has 

reconfigured the tiers in 40 CFR 790.42. 

In addition to processors, manufacturers 

of less than 500 kg (1,100 lbs.) per year 

(‘‘small-volume manufacturers’’), and 

manufacturers of small quantities for 

research and development (‘‘R&D 

manufacturers’’), EPA has added the 

following persons to Tier 2: Byproduct 

manufacturers, impurity manufacturers, 

manufacturers of naturally occurring 

substances, manufacturers of nonisolated intermediates, and 

manufacturers of components of Class 2 

substances. The Agency took 

administrative burden and complexity 

into account in determining who was to 

be in Tier 1 in this proposed rule. EPA 

believes that those persons in Tier 1 

who would conduct testing under this 

rule, when finalized, would generally be 

large chemical manufacturers who, in 

the experience of the Agency, have 

traditionally conducted testing or 

participated in testing consortia under 

previous TSCA section 4(a) test rules. 

The Agency also believes that 

byproduct manufacturers, impurity 

manufacturers, manufacturers of 

naturally occurring substances, 

manufacturers of non-isolated 

intermediates, and manufacturers of 

components of Class 2 substances 

historically have not themselves 

participated in testing or contributed to 

reimbursement of those persons who 

have conducted testing. EPA 

understands that these manufacturers 

may include persons for whom the 

marginal transaction costs involved in 

negotiating and administering testing 

arrangements are deemed likely to raise 

the expense and burden of testing to a 

level that is disproportional to the 

additional benefits of including these 

persons in Tier 1. Therefore, EPA does 

not believe that the likelihood of the 

persons proposed to be added to Tier 2 

actually conducting the testing is 

sufficiently high to justify burdening 

these persons with Tier 1 requirements 

(e.g., submitting requests for 

exemptions). Nevertheless, these 

persons, along with all other persons in 

Tier 2, would be subject to 

reimbursement obligations to persons 

who actually conduct the testing, as 

described in Unit IV.E.4. 

TSCA section 4(b)(3)(B) requires all 

manufacturers and/or processors of a 

chemical substance to test that chemical 

substance if EPA has made findings 

under TSCA sections 4(a)(1)(A)(ii) or 

4(a)(1)(B)(ii) for that chemical 

substance, and issued a TSCA section 

4(a) test rule requiring testing. However, 

practicality must be a factor in 

determining who is subject to a 

particular test rule. Thus, persons who 

do not know or cannot reasonably 

ascertain that they are manufacturing or 

processing a chemical substance subject 

to this proposed rule, e.g., 

manufacturers or processors of a 

chemical substance as a trace 

contaminant who are not aware of and 

cannot reasonably ascertain these 

activities, would not be subject to the 

rule. See Unit IV.E.1. and 

§ 799.5087(b)(2) of the proposed 

regulatory text. 

b. Subdivision of Tier 2 entities. The 

Agency is proposing to prioritize which 

persons in Tier 2 would be required to 

perform testing, if needed. Specifically, 

the Agency is proposing that Tier 2 

entities be subdivided into: 

i. Tier 2A. Tier 2 manufacturers, i.e., 

those who manufacture, or intend to 

manufacture, a test rule substance solely 

as one or more of the following: A 

byproduct, an impurity, a naturally 

occurring substance, a non-isolated 

intermediate, a component of a Class 2 

substance, in amounts less than 1,100 

lbs. annually, or in small quantities 

solely for research and development. 

ii. Tier 2B. Tier 2 processors, i.e., 

those who process, or intend to process, 

a test rule substance (in any form). The 

terms ‘‘process’’ and ‘‘processor’’ are 

defined by TSCA sections 3(10) and 

3(11), respectively. 

If the Agency needs testing from 

persons in Tier 2, EPA would seek 

testing from persons in Tier 2A before 

proceeding to Tier 2B. It is appropriate 

to require manufacturers in Tier 2A to 

submit letters of intent to test or 

exemption applications before 

processors are called upon because the 

Agency believes that testing costs are 

traditionally passed by manufacturers 

along to processors, enabling them to 

share in the costs of testing (Ref. 54). In 

addition, ‘‘[t]here are [typically] so 

many processors [of a given test rule 

chemical] that it would be difficult to 

include them all in the technical 

decisions about the tests and in the 

financial decisions about how to 

allocate the costs’’ (Ref. 55). 

c. When would it be appropriate for a 

person who would be required to 

comply with the rule to apply for an 

exemption rather than to submit a letter 

of intent to conduct testing? You may 

apply for an exemption if you believe 

that the required testing will be 

performed by another person (or a 

consortium of persons formed under 

TSCA section 4(b)(3)(A)). You can find 

procedures relating to exemptions in 40 

CFR 790.80 through 790.99, and 

§ 799.5087(c)(2), (c)(5), (c)(7), and (c)(11) 

of the proposed regulatory text. In this 

rule, EPA would not require the 

submission of equivalence data (i.e., 

data demonstrating that your substance 

is equivalent to the substance actually 

being tested) as a condition for approval 

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of your exemption. Therefore, 40 CFR 

790.82(e)(1) and 40 CFR 790.85 would 

not apply to this test rule. 

d. What would happen if I submitted 

an exemption application? EPA believes 

that requiring the collection of 

duplicative data is unnecessarily 

burdensome. As a result, if EPA has 

received a letter of intent to test from 

another source or has received (or 

expects to receive) the test data that 

would be required under this rule, the 

Agency would conditionally approve 

your exemption application under 40 

CFR 790.87. 

The Agency would terminate 

conditional exemptions if a problem 

occurs with the initiation, conduct, or 

completion of the required testing, or 

with the submission of the required data 

to EPA. EPA may then require you to 

submit a notice of intent to test or an 

exemption application. See 40 CFR 

790.93 and § 799.5087(c)(8) of the 

proposed regulatory text. In addition, 

the Agency would terminate a 

conditional exemption if no letter of 

intent to test has been received by 

persons required to comply with the 

rule. See, e.g., § 799.5087(c)(6) of the 

proposed regulatory text. Note that the 

provisions at 40 CFR 790.48(b) have 

been incorporated into the regulatory 

text of this rule; thus, persons subject to 

this rule are not required to comply 

with 40 CFR 790.48 itself (see 

§ 799.5087(c)(4)–(c)(7) and 

§ 799.5087(d)(3) of the proposed 

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 IV.E.4. 

e. What would my obligations be if I 

were in Tier 2? If you are in Tier 2, you 

would be subject to the rule and you 

would be responsible for providing 

reimbursement to persons in Tier 1, as 

described in Unit IV.E.4. You are 

considered to have an automatic 

conditional exemption. You would not 

need to submit a letter of intent to test 

or an exemption application unless you 

are notified by EPA that you are 

required to do so. 

If a problem occurs with the 

initiation, conduct, or completion of the 

required testing, or with the submission 

of the required data to EPA, the Agency 

may require you to submit a notice of 

intent to test or an exemption 

application. See 40 CFR 790.93 and 

§ 799.5087(c)(10) of the proposed 

regulatory text. 

In addition, you would need to 

submit a notice of intent to test or an 

exemption application if: 

• No manufacturer in Tier 1 has 

notified EPA of its intent to conduct 

testing; and 

• EPA has published a Federal 

Register document directing persons in 

Tier 2 to submit to EPA letters of intent 

to conduct testing or exemption 

applications. See § 799.5087(c)(4), (c)(5), 

(c)(6), and (c)(7) of the proposed 

regulatory text. The Agency would 

conditionally approve an exemption 

application under 40 CFR 790.87, if EPA 

has received a letter of intent to test or 

has received (or expects to receive) the 

test data required under this rule. EPA 

is not aware of any circumstances in 

which test rule Tier 1 entities have 

sought reimbursement from Tier 2 

entities either through private 

agreements or by soliciting the 

involvement of the Agency under the 

reimbursement regulations at 40 CFR 

part 791. 

f. What would happen if no one 

submitted a letter of intent to conduct 

testing? EPA anticipates that it will 

receive letters of intent to conduct 

testing for all of the tests specified and 

chemical substances included in the 

final rule. However, in the event it does 

not receive a letter of intent for one or 

more of the tests required by the final 

rule for any of the chemical substances 

in the rule within 30 days after the 

publication of a Federal Register 

document notifying Tier 2 processors of 

the obligation to submit a letter of intent 

to conduct testing or to apply for an 

exemption from testing, EPA would 

notify all manufacturers and processors 

of the chemical substance of this fact by 

certified letter or by publishing a 

Federal Register document specifying 

the test(s) for which no letter of intent 

has been submitted. This letter or 

Federal Register document would 

additionally notify all manufacturers 

and processors that all exemption 

applications concerning the test(s) have 

been denied, and would give them an 

opportunity to take corrective action. If 

no one has notified EPA of its intent to 

conduct the required testing of the 

chemical substance within 30 days after 

receipt of the certified letter or 

publication of the Federal Register 

document, all manufacturers and 

processors subject to the rule with 

respect to that chemical substance who 

are not already in violation of the rule 

would be in violation of the rule. 

4. How do the reimbursement 

procedures work? In the past, persons 

subject to test rules have independently 

worked out among themselves their 

respective financial contributions to 

those persons who have actually 

conducted the testing. However, if 

persons are unable to agree privately on 

reimbursement, they may take 

advantage of EPA’s reimbursement 

procedures at 40 CFR part 791, 

promulgated under the authority of 

TSCA section 4(c). These procedures 

include: The opportunity for a hearing 

with the American Arbitration 

Association; publication by EPA of a 

document in the Federal Register 

concerning the request for a hearing; 

and the appointment of a hearing officer 

to propose an order for fair and 

equitable reimbursement. The hearing 

officer may base his or her proposed 

order on the production volume formula 

set out at 40 CFR 791.48, but is not 

obligated to do so. Under this proposed 

rule, amounts manufactured as 

impurities would be included in 

production volume (40 CFR 791.48(b)), 

subject to the discretion of the hearing 

officer (40 CFR 791.40(a)). The hearing 

officer’s proposed order may become the 

Agency’s final order, which is 

reviewable in Federal court (40 CFR 

791.60). 

F. What Reporting Requirements are 

Proposed Under this Test Rule? 

You would be required to submit a 

final report for a specific test by the 

deadline indicated as the number of 

months after the effective date of the 

final rule, which would be shown in 

§ 799.5087(j) of the proposed regulatory 

text. A robust summary of the final 

report for each specific test should be 

submitted in addition to and at the same 

time as the final report. The term 

‘‘robust summary’’ is used to describe 

the technical information necessary to 

adequately describe an experiment or 

study and includes the objectives, 

methods, results, and conclusions of the 

full study report which can be either an 

experiment or in some cases an 

estimation or prediction method. 

Guidance for the compilation of robust 

summaries is described in a document 

entitled Draft Guidance on Developing 

Robust Summaries (Ref. 15) which is 

available at: http://www.epa.gov/HPV/ 

pubs/general/robsumgd.htm. Persons 

who respond to this request to submit 

robust summaries are also encouraged to 

submit the robust summary 

electronically via the High Production 

Volume Information System (HPVIS) to 

allow for its ready incorporation into 

HPVIS. Directions for electronic 

submission of robust summary 

information into HPVIS are provided at 

https://iaspub.epa.gov/oppthpv/ 

metadata.html. This link will direct you 

to the ‘‘HPVIS Quick Start and User’s 

Guide.’’ 

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G. What Would I Need to Do if I Cannot 

Complete the Testing Required by the 

Final Rule? 

A company who submits a letter of 

intent to test under the final rule and 

who subsequently anticipates 

difficulties in completing the testing by 

the deadline set forth in the final rule 

may submit a modification request to 

the Agency, pursuant to 40 CFR 790.55. 

EPA will determine whether 

modification of the test schedule is 

appropriate, and may first seek public 

comment on the modification. 

H. Would There Be Sufficient Test 

Facilities and Personnel to Undertake 

the Testing Proposed Under this Test 

Rule? 

EPA’s most recent analysis of 

laboratory capacity (Ref. 47) indicates 

that available test facilities and 

personnel would adequately 

accommodate the testing proposed in 

this rule. 

I. Might EPA Seek Further Testing of the 

Chemicals in this Proposed Test Rule? 

If EPA determines that it needs 

additional data regarding any of the 

chemical substances included in this 

proposed rule, the Agency would seek 

further health and/or environmental 

effects testing for these chemical 

substances. Should the Agency decide 

to seek such additional testing via a test 

rule, EPA would initiate a separate 

action for this purpose. 

V. Export Notification 

Any person who exports, or intends to 

export, one of the chemical substances 

contained in this proposed rule in any 

form (e.g., as byproducts, impurities, 

components of Class 2 substances, etc.) 

will be subject to the export notification 

requirements in TSCA section 12(b)(1) 

and at 40 CFR part 707, subpart D, but 

only after the final rule is issued and 

only if the chemical is contained in the 

final rule. Export notification is 

generally not required for articles, as 

provided by 40 CFR 707.60(b). Section 

12(b) of TSCA states, in part, that any 

person who exports or intends to export 

to a foreign country a chemical 

substance or mixture for which the 

submission of data is required under 

section 4 must notify the EPA 

Administrator of such export or intent 

to export. The Administrator in turn 

will notify the government of the 

importing country of EPA’s regulatory 

action with respect to the chemical 

substance. 

VI. Economic Impacts 

In addition, EPA has prepared an 

economic assessment entitled Economic 

Analysis for the Proposed Section 4 Test 

Rule for High Production Volume 

Chemicals; Final Report (Ref. 17), a 

copy of which has been placed in the 

public docket for this proposed 

rulemaking. This economic assessment 

evaluates the potential for significant 

economic impacts as a result of the 

testing that would be required by this 

proposal. The analysis covers 19 

chemical substances. The total social 

cost of providing test data on the 19 

chemical substances that were evaluated 

in this economic analysis is estimated to 

be $4.4 million (Ref. 17). 

While legally subject to this test rule, 

processors of a subject chemical would 

be required to comply with the 

requirements of the rule only if they are 

directed to do so by EPA as described 

in § 799.5087(c)(5) and (c)(6) of the 

proposed regulatory text. EPA would 

only require processors to test if no 

person in Tier 1 has submitted a notice 

of its intent to conduct testing, or if 

under 40 CFR 790.93, a problem occurs 

with the initiation, conduct, 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, the Agency assumes that, for 

each chemical substance in this 

proposed rule, at least one such person 

will submit a letter of intent to conduct 

the required testing and that person will 

conduct such testing and will submit 

the test data to EPA. Because processors 

would not need to comply with the 

proposed rule initially, the economic 

assessment does not address processors. 

To evaluate the potential for an 

adverse economic impact of testing on 

manufacturers of the chemical 

substances in this proposed 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 to assess the percentage of 

testing costs that can be accommodated 

by the revenue stream generated by that 

chemical over a number of years. 

Compliance costs include costs of 

testing and administering the testing, as 

well as reporting costs. Annualized 

compliance costs divide testing 

expenditures into an equivalent, 

constant yearly expenditure over a 

longer period of time. To calculate the 

percent price impact, testing costs 

(including laboratory and administrative 

expenditures) are annualized over 15 

years using a 7% discount rate. 

Annualized testing costs are then 

divided by the estimated annual 

revenue of the chemical substance to 

derive the cost-to-sales ratio. EPA 

estimates the total annualized 

compliance cost of testing for the 19 

chemical substances evaluated in the 

economic analysis to be $1.68 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 the 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 the final 

rule, would be required for the first 

export to a particular country of a 

chemical subject to the rule, is 

estimated to range from $25.56 per 

notice to $80.22 per notice (Ref.17). The 

Agency’s estimated total costs of testing 

(including both laboratory and 

administrative costs) annualized testing 

cost, and public reporting burden hours 

for this proposed rule are presented in 

the economic assessment. 

Under a least cost scenario, 16 out of 

the 19 chemical substances (84%) 

would have a price impact at less than 

the 1% level. Similarly, 15 out of the 19 

chemical substances (79%) would be 

impacted at less than the 1% level 

under an average cost scenario. Thus, 

the potential for adverse economic 

impact due to the proposed test rule is 

low for at least 79% of the chemical 

substances in this proposed rule. 

Approximately 4 chemicals (21%) of the 

19 chemical substances for which price 

data are available would have a price 

impact at a level greater than or equal 

to 1% under the least (average) cost 

scenario. 

EPA believes, on the basis of these 

calculations, that the proposed testing of 

the chemical substances presents a low 

potential for adverse economic impact 

for the majority 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 most of the chemicals. There 

are, however, some chemical substances 

for which the price impact is expected 

to exceed 1% of the revenue from that 

chemical. 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 chemicals 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. 

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EPA does not provide quantitative 

estimates of the benefits from these 

tests. Ideally, a discussion of benefits 

would focus on the additional benefits 

to be gained from new information 

relative to information that already 

exists. Such an approach could examine 

the value of new information provided 

as a result of the test rule where such 

information has not been publicly 

available. Because of constraints on 

information on the value of information, 

our evaluation of benefits is qualitative 

and does not address incremental 

benefits. We believe, however, that the 

net benefits of the new information are 

positive. 

VII. Public Comment 

As discussed in Units III.D. and III.E., 

the Agency solicits comment regarding 

additional information pertaining to 

potential exposure of workers and 

consumers, respectively, to the chemical 

substances identified in this proposed 

rule. Also, as discussed in Units III.F., 

the Agency solicits comment regarding 

additional information pertaining to 

environmental releases of the chemical 

substances identified in this proposed 

rule. 

As discussed in Unit III.F., EPA is 

soliciting comments which identify 

existing data that may meet the 

requirements of studies under this 

proposed rule. To the extent that data 

relevant to the testing specified in this 

proposed rule are known to exist, EPA 

strongly encourages the submission of 

this information as comments to the 

proposed rule. Data submitted to EPA to 

meet the requirements of testing under 

this proposed rule must be in the form 

of full copies of unpublished studies or 

full citations of published studies, and 

may be accompanied by a robust 

summary (Ref. 15). To the extent that 

studies required under this proposed 

rule are currently available, and the data 

are judged sufficient by EPA, testing for 

the endpoint/chemical combination will 

not be required in the final rule based 

on this proposed rule. 

EPA also solicits public comment on 

the test methods proposed and the 

analysis detailing the burdens and costs 

for the regulatory impacts resulting from 

this rule. 

In addition, EPA solicits comment on 

the proposed and alternative approaches 

to the testing of Class 2 substances, 

whether the proposed approach for 

testing Class 1 substances (i.e., that each 

Class 1 substance be tested at a purity 

of 99% or more) should be applied to 

any Class 2 substances, and whether the 

proposed or alternative approaches for 

the testing of Class 2 substances (i.e., 

that a representative sample of each 

Class 2 substance be tested) should be 

applied to any Class 1 substances. 

VIII. Materials in the Docket 

As indicated under ADDRESSES, a 

docket has been established for this 

proposed rulemaking under docket ID 

number EPA–HQ–OPPT–2007–0531. 

The following is a listing of the 

documents that have been placed in the 

public docket for this proposed rule. 

The docket includes information 

considered by EPA in developing this 

proposed rule, including the documents 

listed in this unit, which are physically 

located in the docket. In addition, 

interested parties should consult 

documents that are referenced in the 

documents that EPA has placed in the 

public docket, regardless of whether 

these referenced documents are 

physically located in the public docket. 

For assistance in locating documents 

that are referenced in documents that 

EPA has placed in the public docket, 

but that are not physically located in the 

docket, please consult the technical 

contact listed under FOR FURTHER 

INFORMATION CONTACT. The public 

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. Proposed Test Rule for the 

Testing of Certain High Production 

Volume Chemicals. Proposed Rule. 

Federal Register (65 FR 81658, 

December 26, 2000) (FRL–6758–4). 

3. EPA. Final Test Rule for the Testing 

of Certain High Production Volume 

Chemicals. Final Rule. 40 CFR part 799. 

Federal Register (71 FR 13708, March 

16, 2006) (FRL–7335–2). 

4. EPA. TSCA Section 4(a)(1)(B) Final 

Statement of Policy. Notice. Federal 

Register (58 FR 28736, May 14, 1993). 

5. EPA, OPPT. HPV Challenge 

Program Chemical List. This list is 

updated periodically, and is available 

on-line at: http://www.epa.gov/oppt/ 

chemrtk/pubs/update/hpvchmlt.htm. 

6. OECD Secretariat. Manual for the 

Investigation of HPV Chemicals. OECD 

Programme on the Co-Operative 

Investigation of High Production 

Volume Chemicals. Paris, France. 

September 2004. Available on-line at: 

http://www.oecd.org/document/7/ 

0,2340,en_2649_34379_1947463_ 

1_1_1_1,00.htm. 

7. International Council of Chemical 

Associations (ICCA). ICCA HPV 

Working List of Chemicals. October 

2005. This list is updated periodically, 

and is available on-line at: http:// 

www.cefic.org/activities/hse/mgt/hpv/ 

hpvinit.htm. 

8. EPA. TSCA section 4(a)(1)(B) 

Proposed Statement of Policy. Notice. 

Federal Register (56 FR 32294, July 15, 

1991). 

9. OECD Secretariat. Summary Record 

of the 13th Joint Meeting of the OECD 

Chemicals Group and Management 

Committee of the Special Programme on 

the Control of Chemicals, November 8– 

10, 1989. ENV/CHEM/CM/89.2. 

February 1990. 

10. OECD Secretariat. Proposal for 

Further Work on the Investigation of 

High Production Volume Chemicals. 

OECD Chemicals Group and 

Management Committee of the Special 

Programme on the Control of Chemicals. 

ENV/CHEM/CM/89.14. October 1989. 

11. OECD. Decision-Recommendation 

on the Co-Operative Investigation and 

Risk Reduction of Existing Chemicals– 

C(90)163/FINAL. January 31, 1991. 

12. CMA (ACC). Comments on EPA’s 

TSCA section 4(a)(1)(B) Proposed 

Statement of Policy submitted to the 

TSCA Public Docket Office, EPA. 

September 13, 1991. 

13. Epoxy Resin Systems Task Group 

of the Society of the Plastics Industry, 

Inc. Comments on EPA’s TSCA section 

4(a)(1)(B) Proposed Statement of Policy 

submitted to the TSCA Public Docket 

Office, EPA. September 13, 1991. 

14. EPA, Office of Pollution 

Prevention and Toxics (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. 

15. EPA, OPPT. Draft Guidance on 

Developing Robust Summaries. October, 

22, 1999. Available on-line at: http:// 

www.epa.gov/HPV/pubs/general/ 

robsumgd.htm. 

16. EPA, Office of Prevention, 

Pesticides and Toxic Substances 

(OPPTS). Letter from Susan H. Wayland, 

Deputy Assistant Administrator, to 

participants in the voluntary HPV 

Challenge Program. October 14, 1999. 

Available on-line at http:// 

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

ceoltr2.htm. 

17. EPA, OPPT, Economics, Exposure 

and Technology Division (EETD), 

Economic and Policy Analysis Branch 

(EPAB). Economic Analysis for the 

Proposed Section 4 Test Rule for High 

Production Volume Chemicals; Final 

Report. February 2008. 

18. EPA, OPPT, EETD. Testing of 

Certain High Production Volume 

Chemicals; Second Group of Chemicals 

(Exposure Findings Supporting 

Information). July 2008. 

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19. EPA. OPPT. Chemical Information 

and Testing Branch (CITB). Response to 

public comments regarding testing of 

certain high production volume 

chemicals. May 31, 2005. 

20. NIOSH. National occupational 

exposure survey field guidelines. Vol. I. 

Seta JA, Sundin DS, Pedersen DH, eds. 

Cincinnati, OH: U.S. Department of 

Health and Human Services, Centers for 

Disease Control, National Institute for 

Occupational Safety and Health, DHHS 

(NIOSH) Publication No. 88–106. 1988. 

Available on-line at: http:// 

www.cdc.gov/niosh/88-106.html. 

21. EPA. Inert Reassessment—Oxalic 

Acid (CAS Reg. No. 144–62–7). Action 

Memorandum. From: Pauline Wagner, 

Chief, Inert Ingredient Assessment 

Branch, To: Lois A. Rossi, Director, 

Registration Division. September 6, 

2005. 

22. American Society for Testing and 

Materials International (ASTM 

International). Standard Test Method for 

Relative Initial and Final Melting Points 

and the Melting Range of Organic 

Chemicals. ASTM. E 324–99. 1999. 

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 

1782–03. 2003. 

25. ASTM International. Standard 

Test Method for Partition Coefficient (nOctanol/Water) Estimation by Liquid 

Chromatography. ASTM. E 1147– 

92(2005). 2005. 

26. ASTM International. Standard 

Test Method for Measurements of 

Aqueous Solubility. ASTM. E 1148–02. 

2002. 

27. 49. ASTM International. Question 

about ASTM E 324. E-mail from Diane 

Rehiel, ASTM, to Greg Schweer, CITB, 

CCD, 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. 

2001. 

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. 

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. 

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. 

34. ISO. Water quality—Evaluation of 

ultimate aerobic biodegradability of 

organic compounds in aqueous 

medium—Carbon dioxide evolution 

test. ISO 9439. 1999. 

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. 

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. 

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. 

38. ASTM International. Standard 

Guide for Conducting Acute Toxicity 

Tests on Test Materials with Fishes, 

Macroinvertebrates, and Amphibians. 

ASTM. E 729–96(2002). 2002. 

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(2004). 2004. 

41. Veith, G.D. and Kosian, P. 

Estimating bioconcentration potential 

from octanol/water partition 

coefficients, in Physical Behavior of 

PCB’s in the Great Lakes (MacKay, 

Paterson, Eisenreich, and Simmons, 

eds.), Ann Arbor Science, Ann Arbor, 

MI. 1982. 

42. Bintein, S.; DeVillers, J.; and 

Karcher, W. Nonlinear dependence of 

fish bioconcentration on n-octanol/ 

water partition coefficient. SAR and 

QSAR in Environmental Research, 1:29– 

39. 1993. 

43. EPA. Document containing EPA’s 

Policy Statement under TSCA section 5 

entitled Category for Persistent, 

Bioaccumulative, and Toxic New 

Chemical Substances. Notice. Federal 

Register (64 FR 60194, November 4, 

1999) (FRL–6097–7). Available on-line 

at: http://www.epa.gov/oppt/newchems/ 

pubs/pbtpolcy.htm. 

44. EPA. Significant New Use Rules; 

General Provisions for New Chemical 

Follow-Up. Final Rule. Federal Register 

(54 FR 31307, July 27, 1989). 

45. EPA, OPPT. Development of 

Chemical Categories in the HPV 

Challenge Program (Draft). August 25, 

1999. Available on-line at: http:// 

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

categuid.htm. 

46. EPA, OPPT. Guidance for Testing 

Closed System Intermediates for the 

HPV Challenge Program (Draft). March 

17, 1999. Available on-line at: http:// 

www.epa.gov/oppt/chemrtk/pubs/ 

general/closed9.htm. 

47. EPA, OPPT, EETD, EPAB. 

Analysis of Laboratory Capacity to 

Support U.S. EPA Chemical Testing 

Program Initiatives. August 2004. 

48. EPA, OPPT. The Use of StructureActivity Relationships (SAR) in the 

High Production Volume Chemicals 

Challenge Program. August 26, 1999. 

Available on-line at: http:// 

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

sarfinl1.htm. 

49. EPA, OPPT, EETD, EPAB. 

Economic Analysis in Support of the 

TSCA 12(b) Information Collection 

Request. October 30, 1998. 

50. NIEHS 2001b. Guidance 

Document on Using In Vitro Data to 

Estimate In Vivo Starting Doses for 

Acute Toxicity. NIH Publication No. 01– 

4500. August 2001. Available on-line at: 

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

acutetox/inv_cyto_guide.htm. 

51. NIEHS 2003a. Test Method 

Protocol for Solubility Determination, in 

vitro Cytotoxicity Validation Study— 

Phase III. National Toxicology Program 

(NTP) Interagency Center for the 

Evaluation of Alternative Toxicological 

Methods (NICEATM). September 24, 

2003. Available on-line at: http:// 

iccvam.niehs.nih.gov/methods/ 

acutetox/invitrocyto/invcyt_proto.htm. 

52. 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. National 

Toxicology Program (NTP) Interagency 

Center for the Evaluation of Alternative 

Toxicological Methods (NICEATM). 

November 4, 2003. Available on-line at: 

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

acutetox/invitrocyto/invcyt_proto.htm. 

53. NIEHS 2003c. Test Method 

Protocol for the NHK Neutral Red 

Uptake Cytotoxicity Test, a Test for 

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Basal Cytotoxicity for an in vitro 

Validation Study—Phase III. National 

Toxicology Program (NTP) Interagency 

Center for the Evaluation of Alternative 

Toxicological Methods (NICEATM). 

November 4, 2003. Available on-line at: 

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

acutetox/invitrocyto/invcyt_proto.htm. 

54. EPA. Toxic Substances; Test Rule 

Development and Exemption 

Procedures. Interim Final Rule. 40 CFR 

part 790. Federal Register (50 FR 20652, 

May 17, 1985). 

55. EPA. Toxic Substances Control 

Act; Data Reimbursement. Final Rule. 

40 CFR part 791. Federal Register (48 

FR 31786, July 11, 1983). 

56. EPA. OPPT. High Production 

Volume Chemical Data Information 

System (HPVIS). Data from HVPIS on 18 

HPV chemicals. May 2008. 

57. NIOSH. National occupational 

exposure survey analysis of 

management interview responses. Vol. 

III. Pedersen DH, Sieber WK, eds. 

Cincinnati, OH: U.S. Department of 

Health and Human Services, Centers for 

Disease Control, National Institute for 

Occupational Safety and Health, DHHS 

(NIOSH) Publication No. 89–103. 1989. 

Available on-line at: http:// 

www.cdc.gov/niosh/89-103.html. 

58. NIOSH. National occupational 

exposure survey sampling methodology. 

Vol. II. Sieber WK, ed. Cincinnati, OH: 

U.S. Department of Health and Human 

Services, Centers for Disease Control, 

National Institute for Occupational 

Safety and Health, DHHS (NIOSH) 

Publication No. 89–102. 1989. Available 

on-line at: http://www.cdc.gov/niosh/89-

102.html. 

59. ASTM International. Standard 

Test Method for estimating Acute Oral 

Toxicity in Rats. ASTM E 1163– 

98(2002). 2002. 

IX. 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 proposed 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 proposed 

rulemaking to OMB for review under 

Executive Order 12866. 

EPA has prepared an economic 

analysis of this proposed action, which 

is contained in a document entitled 

Economic Analysis for the Proposed 

Section 4 Test Rule for High Production 

Volume Chemicals; Final Report (Ref. 

17). A copy of the economic analysis is 

available in the docket for this proposed 

rule and is summarized in Unit VI. 

B. Paperwork Reduction Act 

This proposed rule does not impose 

any new or amended paperwork 

collection requirements that would 

require additional review and/or 

approval by OMB under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq. Although the activities are 

approved, OMB has specified that the 

additional burden associated with a new 

test rule is not covered by the ICR until 

the final rule is effective. The 

information collection requirements 

contained in TSCA section 4 test rules 

have already been approved by OMB 

under PRA, and have been assigned 

OMB control number 2070–0033 (EPA 

ICR No. 1139). In the context of 

developing a new test rule, the Agency 

must determine whether the total 

annual burden covered by the approved 

ICR needs to be amended to 

accommodate the burden associated 

with the new test rule. If so the Agency 

must submit an Information Correction 

Worksheet (ICW) to OMB and obtain 

OMB approval of an increase in the total 

approved annual burden in the OMB 

inventory. The Agency’s estimated 

burden for this test rule is provided in 

the economic analysis (Ref. 17). 

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 

rulemaking does not propose any new 

or changes to the export notification 

requirements, and is not expected to 

result in any substantive changes in the 

burden estimates for EPA ICR No. 0795 

that would require additional review 

and/or approval by OMB. 

Under PRA, an agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information that is subject to approval 

under PRA, unless it displays a 

currently valid OMB control number. 

The OMB control numbers for the EPA 

regulations codified in title 40 of the 

CFR, after appearing in the preamble of 

the final rule, are listed in 40 CFR part 

9, displayed either by publication in the 

Federal Register or by other appropriate 

means, such as on the related collection 

instrument or form, if applicable. The 

display of OMB control numbers in 

certain EPA regulations is consolidated 

in 40 CFR part 9. 

The 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 proposed 

rule, EPA estimates the public reporting 

burden for all 19 chemicals is 9,008 

hours, with an estimated burden per 

chemical of 474 hours (Ref. 17). The 

estimated burden of the information 

collection activities related to export 

notification is estimated to average 1 

burden hour for each chemical/country 

combination for an initial notification 

and 0.5 hours for each subsequent 

notification (Ref. 17). 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 chemical test rules. As 

such, EPA does not expect to need to 

request an increase in the total burden 

hours approved by OMB for export 

notifications. 

As defined by PRA and 5 CFR 

1320.3(b), ‘‘burden’’ means the total 

time, effort, or financial resources 

expended by persons to generate, 

maintain, retain, or disclose or provide 

information to or for a Federal agency. 

This includes the time needed to: 

Review instructions; develop, acquire, 

install, and utilize technology and 

systems for the purposes of collecting, 

validating, and verifying information, 

processing and maintaining 

information, and disclosing and 

providing information; adjust the 

existing ways to comply with any 

previously applicable instructions and 

requirements; train personnel to be able 

to respond to a collection of 

information; search data sources; 

complete and review the collection of 

information; and transmit or otherwise 

disclose the information. 

Comments are requested on the 

Agency’s need for this information, the 

accuracy of the provided burden 

estimates, and any suggested methods 

for minimizing respondent burden, 

including through the use of automated 

collection techniques. Send comments 

to EPA as part of your overall comments 

on this proposed action in the manner 

specified under ADDRESSES. In 

developing the final rule, the Agency 

will address any comments received 

regarding the information collection 

requirements contained in this proposal. 

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 of this 

proposed rule on small entities, the 

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Agency hereby certifies that this 

proposed rule would not have a 

significant adverse economic impact on 

a substantial number of small entities. 

The factual basis for the Agency’s 

determination is presented in the small 

entity impact analysis prepared as part 

of the economic analysis for this 

proposed rule (Ref. 17), which is 

summarized in Unit VI., and a copy of 

which is available in the docket for this 

proposed rulemaking. 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 proposed rule on small entities, 

small entity is defined in accordance 

with the 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 

proposed rulemaking (Ref. 17), EPA has 

determined that this proposed rule is 

not expected to impact any small notfor-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. 17) in 

order to characterize the potential small 

entity impacts of this proposed rule on 

small business: 

1. The size of the adverse economic 

impact (measured as the ratio of the cost 

to sales or revenue). 

2. The total number of small entities 

that experience the adverse economic 

impact. 

Section 601(3) of RFA establishes as 

the default definition of ‘‘small 

business’’ the definition used in section 

3 of the Small Business Act, 15 U.S.C. 

632, under which SBA establishes small 

business size standards (13 CFR 

121.201). For this proposed rulemaking, 

EPA has analyzed the potential small 

business impacts using the size 

standards established under this default 

definition. The SBA size standards, 

which are primarily intended to 

determine whether a business entity is 

eligible for government programs and 

preferences reserved for small 

businesses (13 CFR 121.101), ‘‘seek to 

ensure that a concern that meets a 

specific size standard is not dominant in 

its field of operation.’’ (13 CFR 

121.102(b)). See section 632(a)(1) of the 

Small Business Act. In analyzing 

potential impacts, RFA recognizes that 

it may be appropriate at times to use an 

alternate definition of small business. 

As such, section 601(3) of RFA provides 

that an agency may establish a different 

definition of small business after 

consultation with the SBA Office of 

Advocacy and after notice and an 

opportunity for public comment. Even 

though the Agency has used the default 

SBA definition of small business to 

conduct its analysis of potential small 

business impacts for this proposed rule, 

EPA does not believe that the SBA size 

standards are generally the best size 

standards to use in assessing potential 

small entity impacts with regard to 

TSCA section 4(a) test rules. 

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 codes 325 and 324110), 

approximately 98% of the firms would 

be classified as small businesses under 

the default SBA definition. The SBA 

size standard for 75% of this industry 

sector is 500 employees, and the size 

standard for 23% of this industry sector 

is either 750; 1,000; or 1,500 employees. 

When assessing the potential impacts of 

test rules on chemical manufacturers, 

EPA believes that a standard based on 

total annual sales may provide a more 

appropriate means to judge the ability of 

a chemical manufacturing firm to 

support chemical testing without 

significant costs or burdens. 

EPA is currently determining what 

level of annual sales would provide the 

most appropriate size cutoff with regard 

to various segments of the chemical 

industry usually impacted by TSCA 

section 4(a) test rules, but has not yet 

reached a determination. As stated in 

this unit, therefore, the factual basis for 

RFA determination for this proposed 

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 

proposed rule, the analysis for this 

proposed rule also presents the results 

of calculations using a standard based 

on total annual sales (40 CFR 704.3). 

EPA is interested in receiving comments 

on whether the Agency should consider 

establishing an alternate definition for 

small business to use in the small entity 

impact analyses for future TSCA section 

4(a) test rules, and what size cutoff may 

be appropriate. 

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. 

17). For a conservative estimate of the 

number of small businesses affected by 

this proposed rule, the Agency chose an 

employment threshold of less than 

1,500 employees for all businesses 

regardless of the NAICS-specific 

threshold to determine small business 

status. 

For each manufacturer of the 19 

chemicals covered by this proposed 

rule, the parent company (ultimate 

corporate entity, or UCE) was identified 

and sales and employment data were 

obtained for companies where data was 

publicly available. The search 

determined that there were 48 affected 

UCEs. Sales and employment data could 

be found for 45 and 46 of these UCEs 

(88%), respectively. 

Parent company sales data were 

collected to identify companies that 

qualified as a ‘‘small business’’ for 

purposes of the RFA analysis. Based on 

the SBA size standard applied (1,500 

employees or less), 20 companies were 

identified as small. 

The potential significance of this 

proposed rule’s impact on small 

businesses was analyzed by examining 

the number of small entities that 

experienced different levels of costs as 

a percentage of their sales. Small 

businesses were placed in the following 

categories on the basis of cost-to sales 

ratios: less than 1%, greater than 1%, 

and greater than 3%. This analysis was 

conducted under both a least and 

average cost scenario. 

Of the 20 small businesses analyzed 

for small business impacts, one 

company had no sales data available. 

Another two companies could not be 

classified as small or large because there 

were no employment data available, but 

were still included in the small business 

impact analysis. Of the 19 designated as 

small businesses, none had cost-to-sales 

ratios of greater than 1% under both the 

least and average cost scenarios. For the 

chemicals where sales data were 

unavailable, EPA used the median sales 

value sales of all other small businesses 

equal to $15.4 million. The costs for the 

three companies were estimated to be 

well below 0.01% of this sales level. 

Given these results, the Agency has 

determined that there is not a significant 

economic impact on a substantial 

number of small entities as a result of 

this proposed rule, if finalized. 

The estimated cost of the TSCA 

section 12(b)(1) export notification, 

which, as a result of the final rule, 

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would be required for the first export to 

a particular country of a chemical 

subject to the rule, is estimated to be 

$80.22 for the first time that an exporter 

must comply with TSCA section 

12(b)(1) export notification 

requirements, and $25.56 for each 

subsequent export notification 

submitted by that exporter (Refs. 17, 48, 

and 49). EPA has concluded that the 

costs of TSCA section 12(b)(1) export 

notification would have a negligible 

impact on exporters of the chemicals in 

the final rule, regardless of the size of 

the exporter. 

Any comments regarding the impacts 

that this action may impose on small 

entities, or regarding whether the 

Agency should consider establishing an 

alternate definition of small business to 

be used for analytical purposes for 

future test rules and what size cutoff 

may be appropriate, should be 

submitted to the Agency in the manner 

specified under ADDRESSES. 

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 proposed rulemaking does not 

contain a Federal mandate that may 

result in expenditures of $100 million or 

more for State, local, and tribal 

governments, in the aggregate, or the 

private sector in any 1 year. It is 

estimated that the total aggregate costs 

of this proposed rule, which are 

summarized in Unit VI., would be $4.4 

million. The total annualized costs of 

this proposed rule are estimated to be 

$1.68 million. In addition, since EPA 

does not have any information to 

indicate that any State, local, or tribal 

government manufactures or processes 

the chemicals covered by this action 

such that this rule would apply directly 

to State, local, or tribal governments, 

EPA has determined that this proposed 

rule would not significantly or uniquely 

affect small governments. Accordingly, 

this proposed rule is not subject to the 

requirements of sections 202, 203, 204, 

and 205 of UMRA. 

E. Executive Order 13132 

Under Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999), EPA has determined 

that this proposed rule does not have 

‘‘federalism implications’’ because it 

will not have substantial direct effects 

on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government, as 

specified in the Executive Order. This 

proposed rule would establish testing 

and recordkeeping requirements that 

apply to manufacturers (including 

importers) and processors of certain 

chemicals. Because EPA has no 

information to indicate that any State or 

local government manufactures or 

processes the chemical substances 

covered by this action, this proposed 

rule does not apply directly to States 

and localities and will not affect State 

and local governments. Thus, Executive 

Order 13132 does not apply to this 

proposed rule. 

F. Executive Order 13175 

Under Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000), EPA has 

determined that this proposed rule does 

not have tribal implications because it 

will not have any affect on tribal 

governments, on the relationship 

between the Federal Government and 

the Indian tribes, or on the distribution 

of power and responsibilities between 

the Federal Government and Indian 

tribes, as specified in the Executive 

Order. As indicated previously, EPA has 

no information to indicate that any 

tribal government manufactures or 

processes the chemical substances 

covered by this action. Thus, Executive 

Order 13175 does not apply to this 

proposed rule. 

G. Executive Order 13045 

This proposed rule is not subject to 

Executive Order 13045, entitled 

Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997), 

because it does not establish an 

environmental standard intended to 

mitigate health or safety risks, will not 

have an annual effect on the economy 

of $100 million or more, nor does it 

otherwise have a disproportionate effect 

on children. This proposed rule would 

establish testing and recordkeeping 

requirements that apply to 

manufacturers (including importers) 

and processors of certain chemicals, and 

would result in the development of data 

about those chemicals that can 

subsequently be used to assist the 

Agency and others in determining 

whether the chemicals in this proposed 

rule present potential risks, allowing the 

Agency and others to take appropriate 

action to investigate and mitigate those 

risks. 

H. Executive Order 13211 

This proposed rule is not subject to 

Executive Order 13211, entitled Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001), because it is unlikely to have 

any significant adverse effect on the 

supply, distribution, or use of energy. 

I. National Technology Transfer and 

Advancement 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 proposed rule involves technical 

standards because it proposes to require 

the use of particular test methods. If the 

Agency makes findings under TSCA 

section 4(a), EPA is required by TSCA 

section 4(b) to include specific 

standards or test methods that are to be 

used for the development of the data 

required in the test rules issued under 

TSCA section 4. For some of the testing 

that would be required by this rule, EPA 

is proposing the use of voluntary 

consensus standards issued by ASTM 

and ISO which evaluate the same type 

of toxicity as the TSCA and OECD test 

guidelines, where applicable. Copies of 

the 17 ASTM and ISO standards 

referenced in the proposed regulatory 

text at § 799.5087(h) have been placed 

in the docket for this proposed 

rulemaking. You may obtain copies of 

the ASTM standards from the American 

Society for Testing and Materials, 100 

Bar Harbor Dr., West Conshohocken, PA 

19428–2959, and copies of the ISO 

standards from the International 

Organization for Standardization, Case 

Postale, 56 CH-1211 Gene`ve 20 

Switzerland. In the final rule, EPA 

intends to seek approval from the 

Director of the Federal Register for the 

incorporation by reference of the ASTM 

and ISO standards used in the final rule 

in accordance with 5 U.S.C. 552(a) and 

1 CFR part 51. 

EPA is not aware of any potentially 

applicable voluntary consensus 

standards which evaluate partition 

coefficient (n-octanol/water) generator 

column, water solubility (column 

elution and generator column), acute 

inhalation toxicity, bacterial reverse 

mutations, in vivo mammalian bone 

marrow chromosomal aberrations, 

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combined repeated dose with 

reproductive/developmental toxicity 

screen, repeated dose 28–day oral 

toxicity screen, or the reproductive 

developmental toxicity screen which 

could be considered in lieu of the TSCA 

guidelines, 40 CFR 799.6756, 799.6784, 

799.6786, 799.9130, 799.9510, 799.9538, 

799.9365, 799.9305, and 799.9355, 

respectively, upon which the test 

standards in this proposed rule are 

based. The Agency invites comment on 

the potential use of voluntary consensus 

standards in this proposed rulemaking, 

and, specifically, invites the public to 

identify potentially applicable 

consensus standard(s) and to explain 

why such standard(s) should be used 

here. 

J. Executive Order 12898 

This proposed rule does not have an 

adverse impact on the environmental 

and health conditions in low-income 

and minority communities that require 

special consideration by the Agency 

under Executive Order 12898, entitled 

Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). The Agency believes that the 

information collected under this 

proposed rule, if finalized, will assist 

EPA and others in determining the 

potential hazards and risks associated 

with the chemicals covered by the rule. 

Although not directly impacting 

environmental justice-related concerns, 

this information will better enable the 

Agency to better protect human health 

and the environment, including in lowincome and minority communities. 

List of Subjects in 40 CFR Part 799 

Environmental protection, Chemicals, 

Hazardous substances, Laboratories, 

Reporting and recordkeeping 

requirements. 

Dated: July 17, 2008. 

James B. Gulliford, 

Assistant Administrator, Office of Prevention, 

Pesticides and Toxic Substances. 

Therefore, it is proposed that 40 CFR 

chapter I be amended as follows: 

1. The authority citation for part 799 

would continue to read as follows: 

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

2. By adding § 799.5087 to subpart D 

of part 799 that would read as follows: 

§ 799.5087 Chemical testing requirements 

for certain high production volume 

chemicals; second group of chemicals. 

(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’’ 

substances in Table 2 in paragraph (j) of 

this section, the purity of each 

substance must be 99% or greater, 

unless otherwise specified in this 

section. For the chemical substances 

identified as ‘‘Class 2’’ substances in 

Table 2 in paragraph (j), a representative 

form of each substance must be tested. 

The representative form selected for a 

given Class 2 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 the 

effective date of the final rule 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 

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

Persons not otherwise specified in column 2 of this table that 

manufacture (as defined at TSCA section 3(7)) or intend to 

manufacture a chemical substance included in this section. 

Tier 2A. Persons who manufacture (as defined at TSCA section 3(7)) or intend 

to manufacture a chemical substance included in this section solely as one 

or more of the following: 

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

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

—As a naturally occurring substance (as defined at 40 CFR 710.4(b)); 

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

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

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

—In amounts of less than 500 kilogram (kg) (1,100 lbs.) annually (as described 

at 40 CFR 790.42(a)(4)); or 

—For research and development (as described at 40 CFR 790.42(a)(5)). 

B. Persons who process (as defined at TSCA section 3(10)) or intend to process a chemical substance included in this section (see 40 CFR 

790.42(a)(2)). 

(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 § 790.42(a)(2), (a)(4) and (a)(5) of this 

chapter, who, while legally subject to 

this section, must comply with the 

requirements of this section only if 

directed to do so by EPA under the 

circumstances set forth in paragraphs 

(c)(4), (c)(5), (c)(6), (c)(7), and (c)(10) of 

this section. 

(2) If you are in Tier 1 with respect 

to a chemical substance listed in Table 

2 in paragraph (j) of this section, you 

must, for each test required under this 

section for that chemical substance, 

either submit to EPA a letter of intent 

to test or apply to EPA for an exemption 

from testing. The letter of intent to test 

or the exemption application must be 

received by EPA no later than 30 days 

after the effective date of the final rule. 

(3) If you are in Tier 2 with respect 

to a chemical substance listed in Table 

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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 within 

30 days after the effective date of the 

final rule, EPA will publish a Federal 

Register document that would specify 

the test(s) and the chemical substance(s) 

for which no letter of intent has been 

submitted and notify manufacturers in 

Tier 2A of their obligation to submit a 

letter of intent to test or to apply for an 

exemption from testing. 

(5) If you are in Tier 2A (as specified 

in Table 1 in paragraph (c) of this 

section) with respect to a chemical 

substance listed in Table 2 in paragraph 

(j) of this section, and if you 

manufacture, or intend to manufacture, 

this chemical substance as of [date 30 

days after date of publication of the 

final rule in the Federal Register], 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 intentto 

conduct one or more of the tests 

required by this section on any chemical 

substance listed in Table 2 in paragraph 

(j) of this section within 30 days after 

the publication of the Federal Register 

document described in paragraph (c)(4) 

of this section, EPA will publish another 

Federal Register document that would 

specify the test(s) and the chemical 

substance(s) for which no letter of intent 

has been submitted, and notify 

processors in Tier 2B of their obligation 

to submit a letter of intent to test or to 

apply for an exemption from testing. 

(7) If you are in Tier 2B (as specified 

in Table 1 in paragraph (c) of this 

section) with respect to a chemical 

substance listed in Table 2 in paragraph 

(j) of this section, and if you process, or 

intend to process, this chemical 

substance as of [date 30 days after date 

of publication of the final rule in the 

Federal Register], or within 30 days 

after publication of the Federal Register 

document described in paragraph (c)(6) 

of this section, you must, for each test 

specified for that chemical substance in 

the document described in paragraph 

(c)(6) of this section, either submit to 

EPA a letter of intent to test or apply to 

EPA for an exemption from testing. The 

letter of intent to test or the exemption 

application must be received by EPA no 

later than 30 days after publication of 

the document described in paragraph 

(c)(6) of this section. 

(8) If no manufacturer or processor 

has notified EPA of its intent to conduct 

one or more of the tests required by this 

section for any of the chemical 

substances listed in Table 2 in 

paragraph (j) of this section within 30 

days after the publication of the Federal 

Register document described in 

paragraph (c)(6) of this section, EPA will 

notify all manufacturers and processors 

of those chemical substances of this fact 

by certified letter or by publishing a 

Federal Register document specifying 

the test(s) for which no letter of intent 

has been submitted. This letter or 

Federal Register document will 

additionally notify all manufacturers 

and processors that all exemption 

applications concerning the test(s) have 

been denied, and will give the 

manufacturers and processors of the 

chemical substance(s) an opportunity to 

take corrective action. 

(9) If no manufacturer or processor 

has notified EPA of its intent to conduct 

one or more of the tests required by this 

section for any of the chemical 

substances listed in Table 2 in 

paragraph (j) of this section within 30 

days after receipt of the certified letter 

or publication of the Federal Register 

document described in paragraph (c)(8) 

of this section, all manufacturers and 

processors subject to this section with 

respect to that chemical substance who 

are not already in violation of this 

section will be in violation of this 

section. 

(10) If a problem occurs with the 

initiation, conduct, or completion of the 

required testing or the submission of the 

required data with respect to a chemical 

substance listed in Table 2 in paragraph 

(j) of this section, under the procedures 

in §§ 790.93 and 790.97 of this chapter, 

EPA may initiate termination 

proceedings for all testing exemptions 

with respect to that chemical substance 

and may notify persons in Tier 1 and 

Tier 2 that they are required to submit 

letters of intent to test or exemption 

applications within a specified period of 

time. 

(11) If you are required to comply 

with this section, but your manufacture 

or processing of, or intent to 

manufacture or process, a chemical 

substance listed in Table 2 in paragraph 

(j) of this section begins after the 

applicable compliance date referred to 

in paragraphs (c)(2), (c)(5) or (c)(6) of 

this section, you must either submit a 

letter of intent to test or apply to EPA 

for an exemption. The letter of intent to 

test or the exemption application must 

be received by EPA no later than the day 

you begin manufacture or processing. 

(d) What must I do to comply with 

this section? (1) To comply with this 

section you must either submit to EPA 

a letter of intent to test, or apply to and 

obtain from EPA an exemption from 

testing. 

(2) For each test with respect to which 

you submit to EPA a letter of intent to 

test, you must conduct the testing 

specified in paragraph (h) of this section 

and submit the test data to EPA. 

(3) You must also comply with the 

procedures governing test rule 

requirements in part 790 of this chapter, 

as modified by this section, including 

the submission of letters of intent to test 

or exemption applications, the conduct 

of testing, and the submission of data; 

Part 792—Good Laboratory Practice 

Standards of this chapter; 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; paragraph (a)(2) and 

paragraph (b) of §§ 790.80, 790.82(e)(1), 

790.85, and 790.48. 

(e) If I do not comply with this section, 

when will I be considered in violation of 

it? You will be considered in violation 

of this section as of one day after the 

date by which you are required to 

comply with this section. 

(f) How are EPA’s data reimbursement 

procedures affected for purposes of this 

section? If persons subject to this section 

are unable to agree on the amount or 

method of reimbursement for test data 

development for one or more chemical 

substances included in this section, any 

person may request a hearing as 

described in 40 CFR part 791. In the 

determination of fair reimbursement 

shares under this section, if the hearing 

officer chooses to use a formula based 

on production volume, the total 

production volume amount will include 

amounts of a chemical substance 

produced as an impurity. 

(g) Who must comply with the export 

notification requirements? Any person 

who exports, or intends to export, a 

chemical substance listed in Table 2 in 

paragraph (j) of this section is subject to 

part 707, subpart D, of this chapter. 

(h) How must I conduct my testing? 

(1) The tests that are required for each 

chemical substance are indicated in 

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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. 

(i) Reporting requirements. A final 

report for each specific test for each 

subject chemical substance must be 

received by EPA by [date 13 months 

after the effective date of the final rule] 

unless an extension is granted in writing 

pursuant to 40 CFR 790.55. A robust 

summary of the final report for each 

specific test should be submitted in 

addition to and at the same time as the 

final report. The term ‘‘robust 

summary’’ is used to describe the 

technical information necessary to 

adequately describe an experiment or 

study and includes the objectives, 

methods, results, and conclusions of the 

full study report which can be either an 

experiment or in some cases an 

estimation or prediction method. 

Guidance for the compilation of robust 

summaries is described in a document 

entitled Draft Guidance on Developing 

Robust Summaries which is available at: 

http://www.epa.gov/HPV/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 (CAS No.), 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 

CAS No. Chemical Name Class Required Tests/ (See Table 3 of this paragraph) 

75–07–0 Acetaldehyde 1 C2, F2 

78–11–5 1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-, 

dinitrate (ester) 

1 C4 

84–65–1 9,10-Anthracenedione 1 C6 

89–32–7 1H,3H-Benzo[1,2-c:4,5-c’]difuran-1,3,5,7-tetrone 1 A3, A4, A5, B, C1, D, E1, F1 

110–44–1 2,4-Hexadienoic acid, (E,E)- 1 C6, F2 

118–82–1 Phenol, 4,4’-methylenebis[2,6-bis(1,1-

dimethylethyl)-

1 C1 

119–61–9 Methanone, diphenyl- 1 B, C2 

144–62–7 Ethanedioic acid 1 A1, A2, A3, A5, B, C1, E2, F2 

149–44–0 Methanesulfinic acid, hydroxy-, monosodium 

salt 

1 E1 

2524–04–1 Phosphorochloridothioic acid, O,O-diethyl ester 1 A1, A2, A3, A4, A5, B, C1, E1, E2, F2 

4719–04–4 1,3,5-Triazine-1,3,5(2H,4H,6H)-triethanol 1 C6 

6381–77–7 D-erythro-Hex-2-enonic acid, g-lactone, monosodium salt 1 A4, B, C1 

31138–65–5 D-gluco-Heptonic acid, monosodium salt, (2.xi.)- 1 A1, A2, A4, A5, B, C1, D, E1, E2, F1 

66241–11–0 C.I. Leuco Sulphur Black 1 2 A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1 

68187–76–8 Castor oil, sulfated, sodium salt 2 A1, A2, A4, A5, C1, D, E1, E2, F1 

68187–84–8 Castor oil, oxidized 2 A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1 

68479–98–1 Benzenediamine, ar,ar-diethyl-ar-methyl- 1 A1, A2, A3, A4, A5, C1, E1, E2, F1 

68527–02–6 Alkenes, C12–24, chloro 2 A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1 

68647–60–9 Hydrocarbons, C > 4 2 A2, A3, A5, B, C1, D, E1, E2, F1 

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

Testing Category Test Test Requirements and References Special Conditions 

Physical/Chemical A 1. Melting Point: ASTM E 324–99 (capillary n-Octanol/water Partition Coefficient or log Kow: 


Properties 
 tube) Which method is required, if any, is determined by the test 

2. Boiling Point: ASTM E 1719–05 substance’s estimated i log Kow as follows: 

(ebulliometry) log Kow < 0: no testing required. 

3. Vapor Pressure: ASTM E 1782–03 (ther­ log Kow range 0–1: Method A or B. 

mal analysis) log Kow range > 1–4: Method A or B or C. 

4. n-Octanol/Water Partition Coefficient (log log Kow range > 4–6: Method B or C. 

10 basis) or log Kow: (See Special Condi­ log Kow > 6: Method C. 

tions for the log Kow test requirement and Test sponsors must provide in the final study report the unselect the appropriate method to use, if derlying rationale for the method and pH selected. In 

any, from those listed in this column.) order to ensure environmental relevance, EPA highly recMethod A: 40 CFR 799.6755 (shake ommends that the selected study be conducted at pH 7. 

flask) Water Solubility: 

Method B: ASTM E 1147–92(2005) (liq- Which method is required, if any, is determined by the test 

uid chromatography) substance’s estimated ii water solubility. Test sponsors 

Method C: 40 CFR 799.6756 (generator must provide in the final study report the underlying racolumn) tionale for the method and pH selected. In order to en5. Water Solubility: (See special conditions sure environmental relevance, EPA highly recommends 

for the water solubility test requirement that the selected study be conducted starting at pH 7. 

and select the appropriate method to use, > 5,000 mg/L: Method A or B. 

if any, from those listed in this column.) > 10 mg/L—5,000 mg/L: Method A, B, C, or D. 

Method A: ASTM E 1148-02 (shake > 0.001 mg/L—10 mg/L: Method C or D. 

flask) ≤ 0.001 mg/L: no testing required. 

Method B: 40 CFR 799.6784 (shake 

flask) 

Method C: 40 CFR 799.6784 (column 

elution) 

Method D: 40 CFR 799.6786 (generator 

column) 

Environmental Fate B For B, consult ISO 10634 for guidance, and Which method is required, if any, is determined by the test 

and Pathways— choose one of the methods listed in this substance’s physical and chemical properties, including 

Ready Biodegrada­ column: its water solubility. ISO 10634 provides guidance for setion 1. ASTM 1720–01 (sealed vessel CO2 pro­ lection of an appropriate test method for a given test subduction test) stance. Test sponsors must provide in the final study reOR port the underlying rationale for the method selected. 

2. ISO 14593 (CO2 headspace test) 

OR 

3. ISO 7827 (analysis of DOC) 


OR 


4. ISO 9408 (determination of oxygen demand in a closed respirometer) 

OR 

5. ISO 9439 (CO2 evolution test) 


OR 


6. ISO 10707 (closed bottle test) 


OR 


7. ISO 10708 (two-phase closed bottle test) 

Aquatic Toxicity C1 For C1, Test Group 1 or Test Group 2 listed The following are the special conditions for C1, C2, C3, C4, 

in this column must be used to fulfill the C5, and C7 testing; there are no special conditions for 

testing requirements—See Special Condi­ C6. Which test group is required is determined by the test 

tions. substance’s measured log KOW as obtained under Test 

Test Group 1 for C1: Category A, or using an existing measured log KOW. iii 

1. Acute Toxicity To Fish: ASTM E 729– If log Kow < 4.2: Test Group 1 is required. 

96(2002) If log Kow ≤ 4.2: Test Group 2 is required, 

2. Acute Toxicity To Daphnia: ASTM E 729– 

96(2002) 

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

04e1 


Test Group 2 for C1: 


1. Chronic Toxicity To Daphnia: ASTM E 

1193–97(2004) 

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

04e1 

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


Continued 


Testing Category Test Test Requirements and References Special Conditions 

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 (2002) 

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

04e1 

Test Group 2 for C2: 

1. Chronic Toxicity To Daphnia: ASTM E 

1193–97(2004) 

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

04e1 

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 

(2002) 

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

04e1 

Test Group 2 for C3: 

1. Chronic Toxicity To Daphnia: ASTM E 

1193–97(2004) 

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

04e1 

C4 For C4, Test Group 1 or Test Group 2 listed 

in this column must be used to fulfill the 

testing requirements—See special conditions. 

Test Group 1 for C4: 

1. Acute Toxicity To Fish: ASTM E 729–96 

(2002) 

2. Acute Toxicity To Daphnia: ASTM E 729– 

96 (2002) 

Test Group 2 for C4: 

1. Chronic Toxicity To Daphnia: ASTM E 

1193–97 (2004) 

2. [Reserved] 

C5 For C5, Test Group 1 or Test Group 2 listed 

in this column must be used to fulfill the 

testing requirements—See special conditions. 

Test Group 1 for C5: 

1. Acute Toxicity To Daphnia: ASTM E 729– 

96 (2002) 

2. [Reserved] 

Test Group 2 for C5: 

1. Chronic Toxicity To Daphnia: ASTM E 

1193–97 (2004) 

2. [Reserved] 

C6 Toxicity To Plants (Algae): ASTM E 1218– 

04e1 

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


Continued 


Testing Category Test Test Requirements and References Special Conditions 

C7 For C7, Test Group 1 or Test Group 2 listed 

in this column must be used to fulfill the 

testing requirements—See special conditions. 

Test Group 1 for C7: 

1. Acute Toxicity To Fish: ASTM E 729–96 

(2002) 

2. [Reserved] 

Test Group 2 for C7: 

1. Chronic Toxicity To Daphnia: ASTM E 

1193–97 (2004) 

2. [Reserved] 

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 (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 

F3 Repeated Dose 28–Day Oral Toxicity Study 

in rodents: 40 CFR 799.9305 

i. EPA recommends, but does not require, that log KOW be quantitatively estimated prior to initiating this study. One method, among many 

similar methods, for estimating log KOW is described in the article entitled Atom/Fragment Contribution Method for Estimating Octanol-Water Partition Coefficients by W.M. Meylan and P.H. Howard in the Journal of Pharmaceutical Sciences. 84(1):83–92. January 1992. This reference is 

available under docket ID number EPA–HQ–OPPT–2007–0531 at the EPA Docket Center, Rm. 3334 in the EPA West Bldg. located at 1301 

Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. 

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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 under docket ID number EPA–HQ–OPPT–2007–0531 at the EPA Docket Center, Rm. 3334 in the EPA West 

Bldg. located at 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. 

iii. Chemical substances that are dispersible in water may have log Kow values greater than 4.2 and may still be acutely toxic to aquatic organisms. Test sponsors who wish to conduct Test Group 1 studies on such chemicals may request a modification to the test standard as described 

in 40 CFR 790.55. Based upon the supporting rationale provided by the test sponsor, EPA may allow an alternative threshold or method be used 

for determining whether acute or chronic aquatic toxicity testing be performed for a specific substance. 

iv. The OECD 425 Up/Down Procedure, revised by OECD in December 2001, is available under docket ID number EPA–HQ–OPPT–2007– 

0531 at the EPA Docket Center, Rm. 3334 in the EPA West Bldg. located at 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 

4:30 p.m., Monday through Friday, excluding legal holidays. 

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 under docket ID number EPA–HQ–OPPT–2007–0531 at the EPA Docket Center, Rm. 3334 in the EPA West Bldg. located at 1301 

Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. 

(k) Effective date. This section is publication of the final rule in the 

effective on [date 30 days after date of Federal Register]. 

[FR Doc. E8–16992 Filed 7–23–08; 8:45am] 

BILLING CODE 6560–50–S