Federal Register / Vol. 75, No. 37 / Thursday, February 25, 2010 / Proposed Rules 8575 

February 4, 2010) contains updated 

emissions inventory projections for both 

the Paducah and Owensboro Areas. 

Dated: February 12, 2010. 

J. Scott Gordon, 

Acting Regional Administrator, Region 4. 

[FR Doc. 2010–3838 Filed 2–24–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R03–OAR–2009–0871; FRL–9116–2] 

Approval and Promulgation of Air 

Quality Implementation Plans; Virginia; 

Revisions to the Definition of Volatile 

Organic Compound and Other Terms 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA proposes to approve the 

State Implementation Plan (SIP) 

revision submitted by the 

Commonwealth of Virginia consisting of 

the amended wording of 22 definitions, 

including the definition of Volatile 

Organic Compound (VOC). In the Final 

Rules section of this Federal Register, 

EPA is approving Virginia’s SIP 

submittal as a direct final rule without 

prior proposal because the Agency 

views this as a noncontroversial 

submittal and anticipates no adverse 

comments. A detailed rationale for the 

approval is set forth in the direct final 

rule. If no adverse comments are 

received in response to this action, no 

further activity is contemplated. If EPA 

receives adverse comments, the direct 

final rule will be withdrawn and all 

public comments received will be 

addressed in a subsequent final rule 

based on this proposed rule. EPA will 

not institute a second comment period. 

Any parties interested in commenting 

on this action should do so at this time. 

DATES: Comments must be received in 

writing by March 29, 2010. 

ADDRESSES: Submit your comments, 

identified by Docket ID Number EPA– 

R03–OAR–2009–0871 by one of the 

following methods: 

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

the on-line instructions for submitting 

comments. 

B. E-mail: frankford.harold@epa.gov. 

C. Mail: EPA–R03–OAR–2009–0871, 

Harold A. Frankford, Air Protection 

Division, Mailcode 3AP00, U.S. 

Environmental Protection Agency, 

Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

D. Hand Delivery: At the previouslylisted EPA Region III address. Such 

deliveries are only accepted during the 

Docket’s normal hours of operation, and 

special arrangements should be made 

for deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID No. EPA–R03–OAR–2009– 

0871. EPA’s policy is that all comments 

received will be included in the public 

docket without change, and may be 

made available online 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 http:// 

www.regulations.gov or e-mail. The 

http://www.regulations.gov Web site 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 http:// 

www.regulations.gov, your e-mail 

address will be automatically captured 

and included as part of the comment 

that is placed in the public 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. 

Docket: All documents in the 

electronic docket are listed in the 

http://www.regulations.gov index. 

Although listed in the index, some 

information is not publicly available, 

i.e., CBI or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically in http:// 

www.regulations.gov or in hard copy 

during normal business hours at the Air 

Protection Division, U.S. Environmental 

Protection Agency, Region III, 1650 

Arch Street, Philadelphia, Pennsylvania 

19103. Copies of the State submittal are 

available at the Virginia Department of 

Environmental Quality, 629 East Main 

Street, Richmond, Virginia 23219. 

FOR FURTHER INFORMATION CONTACT: 

Harold A. Frankford, (215) 814–2108, or 

by e-mail at frankford.harold@epa.gov. 

SUPPLEMENTARY INFORMATION: For 

further information, please see the 

information provided in the direct final 

action, with the same title, that is 

located in the ‘‘Rules and Regulations’’ 

section of this Federal Register 

publication. 

Dated: February 1, 2010. 

William C. Early, 

Acting Regional Administrator, Region III. 

[FR Doc. 2010–3510 Filed 2–24–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 799 

[EPA–HQ–OPPT–2009–0112; FRL–8805–8] 

RIN 2070–AD16 

Testing of Certain High Production 

Volume Chemicals; Third 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) that 

would require manufacturers, importers, 

and processors of certain high 

production volume (HPV) chemicals to 

conduct testing to obtain screening level 

data for health and environmental 

effects and chemical fate. 

DATES: Comments must be received on 

or before May 26, 2010. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2009–0112, 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–2009–0112. 

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

Monday through Friday, excluding legal 

holidays. The telephone number for the 

DCO is (202) 564–8930. Such deliveries 

are only accepted during the DCO’s 

normal hours of operation, and special 


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arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPPT– 

2009–0112. EPA’s policy is that all 

comments received will be included in 

the docket without change and may be 

made available on-line at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or 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. 

Docket: All documents in the docket 

are listed in the docket index available 

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

listed in the index, some information is 

not publicly available, e.g., 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 

legal holidays. The telephone number of 

the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

FOR FURTHER INFORMATION CONTACT: For 

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 

number: (202) 564–8091 or (202) 564– 

8173; e-mail address: 

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 § 799.5089(j) of the proposed 

regulatory text. Any use of the term 

‘‘manufacture’’ in this proposed rule will 

encompass ‘‘import,’’ unless otherwise 

stated. In addition, as described in Unit 

V., once the Agency issues a final rule, 

any person who exports, or intends to 

export, any of the chemical substances 

included in the final rule will be subject 

to the export notification requirements 

in 40 CFR part 707, subpart D. 

Potentially affected entities may 

include, but are not limited to: 

• Manufacturers (defined by statute to 

include importers) of one or more of the 

29 subject chemical substances (NAIC 

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

manufacturing and petroleum refineries. 

• Processors of one or more of the 29 

subject chemical substances (NAIC 

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

manufacturing and petroleum refineries. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

Unit IV.E. and consult § 799.5089(b) of 

the proposed regulatory text. If you have 

any questions regarding the 

applicability of this action to a 

particular entity, consult either 

technical person listed 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 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. 


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If such a request is received on or before 

May 26, 2010, EPA will hold a public 

meeting on this proposed rule in 

Washington, DC. This written request 

must be submitted to the mailing or 

hand delivery addresses provided 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 the 29 

chemical substances listed in this 

proposed rule to conduct testing for 

environmental fate (including five tests 

for physical/chemical properties and 

biodegradation), ecotoxicity (in fish, 

Daphnia, and algae), acute toxicity, 

genetic toxicity (gene mutations and 

chromosomal aberrations), repeated 

dose toxicity, and developmental and 

reproductive toxicity. The chemical 

substances are HPV chemicals, i.e., 

chemical substances with a production/ 

import volume equal to or greater than 

1 million pounds (lbs.) per year. A 

detailed discussion regarding efforts to 

enhance the availability of screening 

level hazard and environmental fate 

information about HPV chemicals can 

be found in a Federal Register notice 

which published on December 26, 2000 

(Ref. 1). 

This proposed rule follows earlier 

testing actions for certain HPV 

chemicals (see Refs. 2, 3, and 11). 

This proposed TSCA section 4(a) test 

rule addresses some of the 207 

remaining ‘‘orphan’’ HPV chemicals that 

were placed on the Priority Testing List 

by the Interagency Testing Committee 

(ITC). For a summary, see: ‘‘Sixty-Third 

Report of the TSCA Interagency Testing 

Committee to the Administrator of the 

Environmental Protection Agency; 

Receipt of Report and Request for 

Comments; Notice’’ (Ref. 9). ‘‘Orphan’’ 

chemical substances are those HPV 

chemicals that were not sponsored for 

testing under the voluntary HPV 

Challenge Program or under certain 

international efforts (see Unit II.C.). 

Of the 207 chemical substances, 159 

no longer meet the HPV criterion; 3 

already have data that meets needs 

identified in this proposed rule; and 16, 

while meeting the production volume 

criterion for HPV, appear to lack the 

exposure data necessary to support 

TSCA section 4(a)(1)(B) findings. 

Therefore, these 178 chemical 

substances are not being considered for 

testing by EPA at this time. The 

remaining 29 chemical substances are 

addressed in this proposed TSCA 

section 4(a) test rule. These conclusions 

are based primarily on information 

reported in the 2006 TSCA Inventory 

Update Rule (IUR) (40 CFR part 710) 

and a 2006 TSCA Preliminary 

Assessment Information Reporting 

(PAIR) rule issued for the HPV orphan 

chemicals (Ref. 10). EPA also sought 

and considered, when available, 

information from other data sources 

(e.g., the Toxics Release Inventory (TRI), 

the National Occupational Exposure 

Survey (NOES)). 

B. What is the Agency’s Authority for 

Taking this Action? 

EPA is proposing this test rule under 

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

2603(a)(1)(B)), which directs EPA to 

require by rule that manufacturers and/ 

or processors of chemical substances 

and mixtures conduct testing, if the EPA 

Administrator finds that: 

(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 [.] 

Once the EPA Administrator has 

made a finding under TSCA section 

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

health or environmental effects testing 

necessary to address unanswered 

questions about the effects of the 

chemical substance or mixture that are 

relevant to whether the manufacture, 

distribution in commerce, processing, 

use, or disposal of the chemical 

substance or mixture, or any 

combination of such activities, presents 

an unreasonable risk of injury to health 

or the environment. EPA need not limit 

the scope of testing required to the 

factual basis for the TSCA section 

4(a)(1)(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 test rule, EPA would 

use its broad TSCA section 4(a) 

authority to obtain data necessary to 

support the development of preliminary 

or ‘‘screening level’’ hazard and risk 

characterizations for certain HPV 

chemicals specified in Table 2 in 

§ 799.5089(j) of the proposed regulatory 

text. EPA has made preliminary findings 

for these chemical substances under 

TSCA section 4(a)(1)(B) that: They are 

produced in substantial quantities; there 

is or may be substantial human 

exposure to them; existing data are 

insufficient to determine or predict their 

health and environmental effects; and 

testing is necessary to develop such 

data. 

C. Why is EPA Taking this Action? 

In April 1998, EPA initiated a 

national effort to make certain basic 

information about the environmental 

fate and potential health and 

environmental hazards associated with 

the most widespread chemicals in 

commerce available to the public. 

Mechanisms to collect or, where 

necessary, develop needed data on U.S. 

HPV chemicals include the voluntary 

HPV Challenge Program, certain 

international efforts (the Organization 

for Economic Cooperation and 

Development (OECD) HPV Screening 

Information Data Sets (SIDS) Program; 

and the International Council of 

Chemical Associations (ICCA) HPV 

Initiative), and TSCA section 4 test 

rules. The voluntary HPV Challenge 

Program was created to ensure that a 

baseline set of data on approximately 

2,800 HPV chemicals would be made 

available to EPA and the public. HPV 

chemicals are manufactured or imported 

in amounts equal to or greater than 1 

million lbs. per year and were identified 

for the voluntary HPV Challenge 

Program through data reported under 

the IUR during 1990. The SIDS data set 

sought by the voluntary HPV Challenge 

Program was developed by OECD, of 

which the United States is a member. 

The SIDS provides an internationally 

agreed upon set of test data for 

screening HPV chemicals for human 

and environmental hazards, and assists 

the Agency and others in making an 

informed, preliminary judgment about 

the hazards of HPV chemicals. 

The voluntary HPV Challenge 

Program was designed to make 

maximum use of scientifically adequate 

existing test data and to avoid 

unnecessary and duplicative testing of 

U.S. HPV chemicals. Therefore, EPA is 

continuing to participate in the 

voluntary international efforts, 

complementary to the voluntary HPV 

Challenge Program, that are being 


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coordinated by the OECD to secure basic 

hazard information on HPV chemicals 

in use worldwide, including some of 

those on the 1990 U.S. HPV chemicals 

list (Ref. 5). This includes agreements to 

sponsor a U.S. HPV chemical under 

either the OECD HPV SIDS Program 

(Ref. 6), including sponsorship by OECD 

member countries beyond the United 

States, or the international HPV 

Initiative that is being organized by the 

ICCA (Ref. 7). 

Additional details regarding the 

voluntary HPV Challenge Program and 

these international efforts were 

provided in the prior HPV TSCA section 

4 rules (Refs. 2, 3, and 11). It was EPA’s 

position that U.S. data needs that 

remained unmet in the voluntary HPV 

Challenge Program or through 

international efforts could be addressed 

through TSCA section 4 rulemakings, 

such as the final test rule published by 

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

proposed rule is the third TSCA section 

4 HPV SIDS rule, and addresses the 

unmet data needs of 29 chemical 

substances. 

After EPA publishes the final rule 

based on the proposed rule, EPA 

intends to make the information 

collected under the final rule available 

to the public, other Federal agencies, 

and any other interested parties. This 

information will be on its website 

(http://www.epa.gov/chemrtk) and in 

the docket for the final rule identified 

under ADDRESSES. As appropriate, this 

information will be used to ensure a 

scientifically sound basis for risk 

assessment/management actions. 

D. Why is this Proposed Rule Focusing 

on HPV Chemicals and SIDS Testing? 

This proposed rule pertains to HPV 

chemicals, which are manufactured or 

imported in amounts equal to or greater 

than 1 million lbs. per year, which EPA 

determined account for 95% of total 

chemical production in the United 

States (Ref. 8, p. 32296). EPA found that, 

of those non-polymeric organic 

substances produced or imported in 

amounts equal to or greater than 1 

million lbs. per year based on 1990 IUR 

reporting, only 7% had a full set of 

publicly available and internationally 

recognized basic screening test data for 

health and environmental effects (Ref. 

12). Of the over 2,800 U.S. HPV 

chemicals 43% had no publicly 

available basic hazard data. For the 

remaining chemicals, limited amounts 

of the data were available. This lack of 

available hazard data compromises 

EPA’s and others’ ability to determine 

whether these HPV chemicals pose 

potential risks to human health or the 

environment, as well as the public’s 

ability to know about the hazards of 

chemicals that may be found in their 

environment, their homes, their 

workplaces, and the products they buy. 

SIDS testing evaluates the following 

six testing endpoints (Ref. 6): 

• Acute toxicity. 

• Repeated dose toxicity. 

• Developmental and reproductive 

toxicity. 

• Genetic toxicity (gene mutations 

and chromosomal aberrations). 

• Ecotoxicity (studies in fish, 

Daphnia, and algae). 

• Environmental fate (including 

physical/chemical properties (melting 

point, boiling point, vapor pressure, nOctanol/Water Partition Coefficient, and 

water solubility), photolysis, hydrolysis, 

transport/distribution, and 

biodegradation). 

Data on the six SIDS endpoints 

provide a consistent minimum set of 

information that can be used to help 

assess the relative risks of chemicals 

and whether additional testing or 

assessment is necessary. 

E. How Would the Data Developed 

Under this Test Rule Be Used? 

EPA would use the data obtained 

from the rule proposed in this document 

to support development of preliminary 

hazard and risk assessments for the 29 

HPV chemicals subject to the rule. The 

data would also be used by EPA to set 

priorities for further testing that may 

produce hazard information on these 

HPV chemicals that may be needed by 

EPA, other Federal agencies, the public, 

industry, and others, to support 

adequate risk assessments. As 

appropriate, this information would be 

used to ensure a scientifically sound 

basis for risk characterizations and risk 

management actions. As such, this effort 

would serve to further the Agency’s goal 

of identifying and controlling human 

and environmental risks as well as 

providing greater knowledge and 

protection to the public. EPA uses data 

from test rules to support such activities 

as the development of water quality 

criteria, TRI listings, chemical 

advisories, and reduction of workplace 

exposures. 

In addition, a key goal of the 

voluntary HPV Challenge Program was 

making basic health and environmental 

effects data for HPV chemicals available 

to the public as part of EPA’s ‘‘Right to 

Know’’ Initiative. A basic premise of the 

voluntary HPV Challenge Program is 

that the public has a right to know about 

the hazards associated with chemicals 

in their environment. Everyone— 

including industry, environmental 

protection groups, animal welfare 

organizations, government groups, and 

the general public, among others—can 

use the data provided through the HPV 

Challenge Program, and also data 

collected on HPV chemicals through 

other means, including TSCA section 4 

testing, to make informed decisions 

related to the human and the 

environmental hazards of chemicals that 

they encounter in their daily lives. 

F. How are Animal Welfare Issues Being 

Considered in the HPV Initiative? 

EPA recognizes the concerns that 

have been expressed about the use of 

test procedures that require the use of 

animals. As discussed in Unit II.E. of 

Ref. 1, EPA is making every effort to 

ensure that as the HPV Initiative is 

implemented (including TSCA section 4 

HPV test rules), unnecessary or 

duplicative testing is avoided and the 

use of animals is minimized. As a 

general matter, EPA does not require 

that tests on animals be conducted if an 

alternative scientifically validated 

method is found acceptable and 

practically available for use. Where 

testing must be conducted to develop 

adequate data, the Agency is committed 

to reducing the number of animals used 

for testing, to replacing test methods 

requiring animals with alternative test 

methods when acceptable alternative 

methods are available, and to refining 

existing test methods to optimize animal 

use when there is no substitute for 

animal testing. EPA believes that these 

reduction, replacement, and refinement 

objectives are all important elements in 

the overall consideration of alternative 

testing methods. 

III. EPA Proposed Findings 

A. What is the Basis for EPA’s Proposed 

Rule to Test These Chemical 

Substances? 

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

promulgate a final rule under TSCA 

section 4(a) requiring the testing of 

chemical substances or mixtures, EPA 

must, among other things, make certain 

findings regarding either risk (TSCA 

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

combined with either chemical release 

or human exposure (TSCA section 

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

chemical substances. EPA is proposing 

to require testing of the chemical 

substances included in this proposed 

rule based on its preliminary findings 

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

to ‘‘substantial’’ production and 

‘‘substantial human exposure,’’ and/or 

‘‘substantial release to the environment,’’ 

as well as findings under TSCA sections 

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

sufficient data and the need for testing. 

The chemical substances included in 


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this proposed rule are listed in Table 2 

in § 799.5089(j) of the proposed 

regulatory text along with their 

Chemical Abstract Service (CAS) 

Registry numbers. 

In EPA’s B Policy (see Unit III.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). EPA’s B Policy also provides 

guidelines that are generally considered 

by EPA in evaluating whether there is 

or may be ‘‘substantial human exposure’’ 

of workers, consumers, and the general 

population to a chemical substance or 

mixture or whether a chemical 

substance enters or may reasonably be 

anticipated to enter the environment in 

substantial quantities. Refer to EPA’s B 

Policy for further discussion on how 

EPA generally evaluates chemical 

substances or mixtures under TSCA 

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

out in EPA’s 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 that 

guidance with respect to the chemical 

substances included in this proposed 

rule. 

EPA has found preliminarily that, 

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

the 29 chemical substances included in 

this proposed rule is produced in 

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

and, for 27 chemical substances, that 

there is or may be ‘‘substantial human 

exposure’’ to each chemical substance 

(see Units III.C. and III.D.). Also, for 3 

chemical substances (including the 2 for 

which EPA is not able to make a 

preliminary finding regarding 

substantial human exposure), EPA has 

found preliminarily that, under TSCA 

section 4(a)(1)(B)(i), the chemical 

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 29 

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 

B Policy. 

The chemical substances included in 

this proposed rule are listed in 

§ 799.5089(j) of the proposed regulatory 

text along with their CAS numbers. 

B. Are These Chemical Substances 

Produced and/or Imported in 

Substantial Quantities? 

EPA has made preliminary findings 

that each of the chemical substances 

included in this proposed rule is 

produced and/or imported in an amount 

equal to or greater than 1 million lbs. 

per year (Ref. 15). These findings are 

based on: 

1. Information gathered in the 2006 

IUR (40 CFR part 710), which is the 

most recently available compilation of 

TSCA Inventory data. 

2. A TSCA section 8(a) PAIR rule (Ref. 

10), issued for those HPV orphan 

chemicals which had been added to the 

ITC Priority Testing List (Ref. 9). EPA 

believes that these annual production 

and/or importation volumes are 

‘‘substantial’’ as that term is used with 

reference to production in TSCA section 

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

A discussion of EPA’s preliminary 

‘‘substantial production’’ finding for 

each chemical substance included in 

this proposed rule is contained in a 

separate document (see Ref. 15). 

C. Are a Substantial Number of Workers 

Exposed to These Chemicals? 

EPA has made preliminary findings 

that the manufacture, processing, and 

use of 27 of the 29 chemical substances 

(Table 1. of Unit III.D.) included in this 

action result or may result in exposure 

of a substantial number of workers to 

the chemical substances. 

This finding is based, in large part, on 

information submitted in accordance 

with the 2006 IUR (40 CFR part 710) 

and the 2006 PAIR rule (Ref. 10). 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-bycase 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) (Ref. 4). Therefore, EPA’s 

preliminary finding is that there is or 

may be substantial human exposure 

(workers) to 27 of these 29 chemical 

substances. 

In addition to the 2006 IUR and the 

2006 PAIR data collected on the HPV 

orphan chemicals, EPA also reviewed 

NOES data developed by the National 

Institute for Occupational Safety and 

Health (NIOSH) (Ref. 16). The NOES 

data indicates that more than 1,000 

workers were exposed to 7 of the 29 

chemical substances that are the subject 

of this 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. 16, 51, and 

52). For the 29 chemical substances in 

this proposed rule, EPA compared 

production volumes from the 1986 IUR 

data collection to the production 

volumes for the 2006 IUR and PAIR data 

collections. For the 29 chemical 

substances in this proposed rule, there 

was no decrease in production volume 

from 1986 to 2006. For the 7 chemical 

substances for which EPA has NOES 

data indicating substantial worker 

exposure, the 2006 IUR and 2006 PAIR 

production volume data are consistent 

with the 1980’s NOES results, in that 

production volumes for these chemical 

substances either stayed the same or 

increased since 1986, thereby suggesting 

that the usage of these chemical 

substances is no less than when NOES 

data were gathered. 

EPA has performed a chemical–by– 

chemical analysis for all 29 chemical 

substances and carefully considered the 

industrial process and use information 

along with the commercial and 

consumer use information from the 

2006 IUR and PAIR submissions. 

Commercial uses are defined as: ‘‘The 


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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 the ‘‘Testing of Certain 

High Production Volume Chemicals-3 

(Exposure Findings Supporting 

Information)’’ (Ref. 15). Based on the 

descriptions provided for the IUR uses, 

EPA has preliminarily concluded that 

chemical substances with certain 

reported commercial uses, such as 

painting contractor, etc., may result in 

potential exposure to 1,000 workers or 

more. The total number of workers 

reported under the IUR is the sum of 

information on both industrial workers 

plus commercial use workers. EPA’s 

exposure findings document (Ref. 15) 

discusses the basis of EPA’s preliminary 

‘‘substantial exposure’’ finding for 

workers. The Agency also solicits 

comment regarding the number of 

workers potentially exposed to the 

chemical substances identified in this 

proposed rule. 

D. Are a Substantial Number of 

Consumers Exposed to These 

Chemicals? 

Based on 2006 IUR data, EPA has 

made preliminary findings that the uses 

of 20 of the chemical substances 

included in this action result or may 

result in exposure to a substantial 

number of consumers (Ref. 15). EPA 

reviewed the consumer use information 

reported for the 2006 IUR and carefully 

considered the nature of those uses. As 

stated in EPA’s B Policy, the Agency 

believes, based on experience gained 

through case-by-case analysis of other 

chemical substances, that an exposure 

of 10,000 or more consumers to a 

chemical substance is a reasonable 

interpretation of the phrase ‘‘substantial 

human exposure’’ in TSCA section 

4(a)(1)(B)(i) (Ref. 4). Upon completion of 

the review, EPA has preliminarily 

concluded that the reported consumer 

uses for certain of the chemical 

substances in this action may result in 

exposures to at least 10,000 consumers, 

so there is substantial human exposure 

to these chemical substances. 

A discussion of the basis for EPA’s 

preliminary ‘‘substantial exposure’’ 

finding for consumers is contained in a 

separate document (Ref. 15). The 

Agency solicits comment regarding the 

number of consumers potentially 

exposed to the chemical substances 

identified in this proposed rule, 

particularly on assumptions that are 

based on EPA’s experience with other 

chemical substances that there is or may 

be ‘‘substantial human exposure’’ to a 

chemical substance when that chemical 

substance is used in certain consumer– 

use products, and is produced at high 

production volume. 

TABLE 1.—EXPOSURE BASED FINDINGS—SUBSTANTIAL HUMAN EXPOSURE

CAS No. 

Production Volume Meet Exposure Based 

Criteria For 

Manufacturing & 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 (PAIR) 

2006 IUR or 

PAIR 

commercial/ 

consumer 

use 

2006 IUR PAIR 

83–41–0 < 1 million (M) > 10M–50M X 

96–22–0 > 10M–50M > 10M–50M X X 

98–09–9 > 1M–10M > 1M–10M X 851 X X X 

98–56–6 > 1M–10M > 1M–10M X X X X 

111–44–4 > 1M–10M < 1M X X X X 

127–68–4 > 1M–10M < 1M X 9,386 X 

506–51–4 < 1M > 1M–10M X 1,281 X 

506–52–5 < 1M > 1M–10M X 1,565 X 

515–40–2 > 1M–10M > 1M–10M X X X X 

2494–89–5 > 1M–10M > 1M–10M X X X X 

5026–74–4 > 1M–10M > 1M–10M X 952 X 

22527–63–5 > 1M–10M > 1M–10M X X X X 

24615–84–7 > 1M–10M < 1M X X X X 

25321–41–9 > 1M–10M < 1M X 2,843 X 

25646–71–3 > 1M–10M < 1M X X X X 

52556–42–0 > 1M–10M > 1M–10M X X X X 

61788–76–9 > 10M–50M > 1M–10M X 176,314 X X X 

65996–79–4 > 10M–50M > 1M–10M X X X X 

65996–82–9 > 100M–1 billion (B) > 100M–1B X X X X 


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TABLE 1.—EXPOSURE BASED FINDINGS—SUBSTANTIAL HUMAN EXPOSURE—Continued 

CAS No. 

Production Volume Meet Exposure Based 

Criteria For 

Manufacturing & 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 (PAIR) 

2006 IUR or 

PAIR 

commercial/ 

consumer 

use 

2006 IUR PAIR 

65996–89–6 > 1B > 1B X 761 X X X X 

65996–92–1 > 100M–1B > 100M–1B X X X X 

68082–78–0 > 1M–10M > 1M–10M X 41,153 X 

68187–57–5 > 100M–1B > 100M–1B X X X X 

68442–60–4 > 1M–10M > 1M–10M X X X X 

68610–90–2 > 1M–10M > 1M–10M X X 

68988–22–7 > 10M–50M > 10M–50M X 

70693–50–4 > 1M–10M > 1M–10M X X X X 

72162–15–3 > 1M–10M < 1M X 64,227 X 

73665–18–6 > 50M–100M > 100M–1B X X X X 

E. Are Substantial Quantities of These 

Chemicals Released to the 

Environment? 

EPA has made preliminary findings 

that three chemical substances, benzene, 

1,2–dimethyl–3–nitro–acetaldehyde 

(CAS No. 83–41–0); tar oils, coal (CAS 

No. 65996–89–6); and 1,4– 

benzenedicarboxylic acid, 1,4–dimethyl 

ester, manuf. of, by-products from (CAS 

No. 68988–22–7) enter or may 

reasonably be anticipated to enter the 

environment in substantial quantities. 

These findings are based upon their 

reported PAIR data. 

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, pp. 28736, 

28746). 

The Agency solicits comment 

regarding additional information 

pertaining to the amount of 

environmental release of the chemical 

substances identified in this proposed 

rule. 

F. Do Sufficient Data Exist for These 

Chemical Substances? 

In developing the testing 

requirements for chemicals contained in 

this proposed rule, available 

information on chemical/physical 

properties, environmental fate, 

ecotoxicity and human health effects 

was searched using the data sources 

outlined in the OECD guidelines found 

in section 3.1 (Reliability, Relevance 

and Adequacy) of the ‘‘Manual for the 

Investigation of HPV Chemicals’’ (Ref. 6) 

such as: Beilstein Database, CRC 

Handbook of Chemistry and Physics, 

Hawley’s Condensed Chemical 

Dictionary, Illustrated Handbooks of 

Physical–Chemical Properties and 

Environmental Fate for Organic 

Chemicals, Merck Index, Hazardous 

Substances Data Bank (HSDB), 

TOXLINE, and National Technical 

Information Service (NTIS). EPA also 

searched for available data as 

summarized in its HPV Information 

System (Ref. 50). When appropriate, the 

Federal Research In Progress (FEDRIP) 

database was also searched. Any 

information that was obtained from 

these searches was evaluated for data 

acceptability using the guidelines 

described on EPA’s HPV Challenge 

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

chemrtk): ‘‘Guidance for Meeting the 

SIDS Requirements (the SIDS Guide)’’ 

and ‘‘Guidance for Assessing the 

Adequacy of Existing Data.’’ 

Furthermore, data adequacy and 

reliability were evaluated using the 

OECD guidelines which can be found in 

section 3.1 of the OECD ‘‘Manual for the 

Investigation of HPV Chemicals’’ (Ref. 

6). 

Section 799.5089(j) of the proposed 

regulatory text lists each chemical and 

the SIDS tests for which adequate data 

are not currently available to the 

Agency. The Agency preliminarily finds 

that the existing data for one or more of 

the SIDS testing endpoints for each of 

the chemicals listed in Table 2 of the 

proposed regulatory text (including 

environmental fate (comprising five 

tests for physical/chemical properties 

[melting point, boiling point, vapor 

pressure, n-Octanol/Water Partition 

Coefficient, and water solubility] and 

biodegradation); ecotoxicity (tests in 

fish, Daphnia, and algae); acute toxicity; 

genetic toxicity (gene mutations and 

chromosomal aberrations); repeated 

dose toxicity; and developmental and 

reproductive toxicity) are insufficient to 

enable EPA to reasonably determine or 

predict the human health and 

environmental effects resulting from 

manufacture, processing, and use of 

these chemical substances. 

G. Can Other Data Meet the 

Requirements for the Testing Proposed 

in this Action? 

EPA solicits comment concerning the 

availability of existing studies on the 

SIDS endpoints proposed in this 

document on these chemical substances. 

To the extent that additional studies 

relevant to the testing proposed in this 

rulemaking are known to exist, EPA 

strongly encourages the submission of 

this information as comments to the 

proposed rule, including full citations 

for publications and full copies of 

unpublished studies. If EPA judges such 

data to be sufficient, corresponding 

testing will not be included in the final 

rule. Commenters are also encouraged to 

prepare a robust summary (Ref. 13) for 

each such study to facilitate EPA’s 

review of the full study report or 

publication. Persons who respond to 


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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.’’ 

Persons who believe that adequate 

information regarding a chemical 

subject to this proposed rule can be 

developed using a category or the 

Structure–Activity Relationships (SAR) 

approach are encouraged to submit 

appropriate information, along with 

their rationale which substantiates this 

belief, during the comment period on 

this proposed rule. If, based on 

submitted information and other 

information available to EPA, the 

Agency agrees EPA will take such 

measures as are needed to avoid 

unnecessary testing in the final rule. 

H. Is Testing Necessary for These 

Chemical Substances? 

EPA knows of no other means to 

generate the SIDS data other than the 

testing proposed in this document, and 

therefore believes that conducting the 

needed SIDS testing identified for the 29 

subject chemical substances is necessary 

to provide data relevant to a 

determination of whether the 

manufacture, processing, and use of the 

chemical substances does or does not 

present an unreasonable risk of injury to 

human health and the environment. 

EPA also believes it’s important to make 

these data available to satisfy the ‘‘Rightto-Know’’ principles included in the 

HPV Challenge Program goals. 

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 § 799.5089(j) of 

the proposed regulatory text. 

All of the proposed testing 

requirements are listed in Table 2 in 

§ 799.5089(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’s TSCA 799 test 

guidelines (40 CFR part 799, subparts E 

and H) have been harmonized with the 

OECD test guidelines. However, EPA is 

specifying that the American Society for 

Testing and Materials International 

(ASTM International) or the TSCA 799 

test guidelines be used rather than 

OECD test guidelines because the 

language in the ASTM International 

standards and the TSCA 799 test 

guidelines makes clear which steps are 

mandatory and which steps are only 

recommended. Accordingly, in order to 

comply with the testing proposed, EPA 

is proposing that testing must be 

conducted in accordance with ASTM 

International or TSCA 799 test 

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: ASTM E 324–99 

(capillary tube) (Ref. 17). 

Boiling Point: ASTM E 1719–05 

(ebulliometry) (Ref. 18). 

Vapor Pressure: ASTM E 1782–03 

(thermal analysis) (Ref. 19). 

n-Octanol/Water Partition Coefficient: 

Method A (40 CFR 799.6755—shake 

flask). 

Method B (ASTM E 1147–92(2005)— 

liquid chromatography) (Ref. 20). 

Method C (40 CFR 799.6756— 

generator column). 

Water Solubility: 

Method A: (ASTM E 1148–02—shake 

flask) (Ref. 21). 

Method B (40 CFR 799.6784—shake 

flask). 

Method C (40 CFR 799.6784—column 

elution). 

Method D (40 CFR 799.6786— 

generator column). 

For those chemical substances 

needing melting points determinations, 

EPA is proposing that melting points be 

determined according to ASTM method 

E 324–99. Although ASTM International 

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 International’s 

withdrawal of the method means only 

that ASTM International no longer 

continues to develop and improve the 

method. It does not mean that ASTM 

International no longer considers the 

method to be valid. ASTM International 

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. 22) 

ASTM International still makes the 

method available for informational 

purposes and it can still be purchased 

from ASTM International at the address 

listed in § 799.5089(h) of the proposed 

regulatory text. 

EPA concludes that ASTM 

International’s withdrawal of ASTM E 

324–99 does not have negative 

implications on the validity of the 

method, and EPA is proposing that 

melting points be determined according 

to ASTM E 324–99. 

For the ‘‘n-Octanol/Water Partition 

Coefficient (log 10 basis)’’ 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 § 799.5089(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 chemical substance’s nOctanol/Water Partition Coefficient (log 

10 basis; ‘‘log Kow’’). Prior to determining 

the appropriate standard to use, if any, 

to measure the n-Octanol/Water 

Partition Coefficient, EPA is 

recommending that the log Kow be 

quantitatively estimated. EPA 

recommends that the method described 

in ‘‘Atom/Fragment Contribution 

Method for Estimating Octanol-Water 

Partition Coefficients’’ (Ref. 23) be used 

in making such estimation. EPA is 

proposing that test sponsors must 

submit with the final study report the 

underlying rationale for the test 

standard selected for this endpoint. EPA 

is proposing this approach recognizing 

that, depending on the chemical 

substance’s log 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 (40 

CFR 799.6755—shake flask) will work 

and Method B (ASTM E 1147–92(2005)) 

and Method C (40 CFR 799.6756— 

generator column) become more 

suitable, especially Method C. The 

proposed test methodologies have been 

developed to meet a wide variety of 


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needs; and, as such, are silent on 

experimental conditions related to pH. 

Therefore, EPA proposes that all 

required n-Octanol/Water Partition 

Coefficient tests be conducted at pH 7 

to ensure environmental relevance. The 

proposed test standards and log Kow

ranges that would determine which tests 

must be conducted for this endpoint are 

shown in Table 2 of this unit. 

TABLE 2.—TEST REQUIREMENTS FOR THE 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, 

EPA proposes an appropriate selection 

be made from among four alternative 

methods for measuring that endpoint. 

The test method used, if any, would be 

determined by first quantitatively 

estimating the test substance’s water 

solubility. One recommended method 

for estimating water solubility is 

described in ‘‘Improved Method for 

Estimating Water Solubility From 

Octanol/Water Partition Coefficient’’ 

(Ref. 24). EPA is also proposing that test 

sponsors be required to submit in the 

final study report the underlying 

rationale for the test standard selected 

for this endpoint. The proposed test 

methodologies have been developed to 

meet a wide variety of needs and, as 

such, are silent on experimental 

conditions related to pH. Therefore, 

EPA proposes that all required water 

solubility tests be conducted starting at 

pH 7 to ensure environmental relevance. 

The estimated water solubility ranges 

that EPA is proposing for use in 

selecting an appropriate proposed test 

standard are shown in Table 3 of this 

unit. 

TABLE 3.—TEST REQUIREMENTS FOR THE WATER SOLUBILITY ENDPOINT

Testing Category Test Requirements and References Special Conditions 

Physical/chemical 

properties 

Water solubility: 

The appropriate method to use, if any, to test for 

water solubility would be selected from those listed in this column—see Special Conditions in the 

adjacent column. 

Method A: ASTM E 1148–02 (shake flask) 

Method B: 40 CFR 799.6784 (shake flask) 

Method C: 40 CFR 799.6784 (column elution) 

Method D: 40 CFR 799.6786 (generator column) 

Water solubility: 

Which method is required, if any, would be determined by the test 

substance’s estimated water solubility. Test sponsors must provide in the final study report the underlying rationale for the method and pH selected. In order to ensure environmental relevance, 

EPA highly recommends that the selected study be conducted 

starting at pH 7. 

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

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

> 0.001 mg/L—10 mg/L: Method C or D. 

≤ 0.001 mg/L: No testing required. 

2. Environmental Fate and Pathways. 

Ready Biodegradation: 

Method A: ASTM E 1720–01 (Sealed 

vessel CO2 production test) (Ref. 25). 

Method B: International Organization 

for Standardization (ISO) 14593 (CO2

headspace test) (Ref. 26). 

Method C: ISO 7827 (Method by 

analysis of dissolved organic carbon 

(DOC)) (Ref. 27). 

Method D: ISO 9408 (Determination 

of oxygen demand in a closed 

respirometer) (Ref. 28). 

Method E: ISO 9439 (Carbon dioxide 

evolution test) (Ref. 29). 

Method F: ISO 10707 (Closed bottle 

test) (Ref. 30). 

Method G: ISO 10708 (Two-phase 

closed bottle test) (Ref. 31). 

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 E 1720–01) 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. 32), 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. 33), 

Acute toxicity to Daphnia (ASTM E 

729–96(2002)) (Ref. 33), and 

Toxicity to plants (algae) (ASTM E 

1218–04e1) (Ref. 34). 

Test Group 2: 

Chronic toxicity to Daphnia (ASTM E 

1193–97(2004)) (Ref. 35) and 

Toxicity to plants (algae) (ASTM E 

1218–04e1) (Ref. 34). 

For the ‘‘Aquatic Toxicity’’ endpoint, 

the OECD HPV SIDS Program recognizes 

that, for certain chemical substances, 

acute toxicity studies are of limited 


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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 

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 

§ 799.5089(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 

§ 799.5089(j) of the proposed regulatory 

text) are proposed: Acute toxicity to fish 

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

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

Toxicity to plants (algae) (ASTM E 

1218–04e1). For test substances 

determined to have a log Kow that is 

greater than or equal to 4.2, one or both 

of the following tests (described as ‘‘Test 

Group 2’’ in Table 3 in § 799.5089(j) of 

the proposed regulatory text) are 

proposed: Chronic toxicity to Daphnia 

(ASTM E 1193–97(2004)) and Toxicity 

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

As outlined in Table 3 in § 799.5089(j) 

of the proposed regulatory text, 

depending on the testing proposed in 

Test Group 1, the Test Group 2 chronic 

Daphnia test may substitute for either or 

both the acute fish toxicity test and the 

acute Daphnia test. 

Using SAR, a log Kow of 4.2 

corresponds with a fish 

bioconcentration factor (BCF) of about 

1,000 (Refs. 24, 36, and 37). A chemical 

with a fish BCF value of 1,000 or more 

is characterized as having a tendency to 

accumulate in living organisms relative 

to the concentration of the chemical 

substance in the surrounding 

environment (Ref. 37). For the purposes 

of this proposed rule, EPA’s use of a log 

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. 38). EPA has 

also used a measured BCF that is equal 

to or greater than 1,000 or, in the 

absence of bioconcentration data, a log 

P [same as log 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’’ under TSCA sections 5 and 

26(c) (Ref. 39; see also 40 CFR 721.3)). 

EPA considers the difference between 

the log Kow of 4.3 cited in the 1989 

Federal Register document (Ref. 39) and 

the log Kow value of 4.2 cited in this 

proposed TSCA section 4 test rule to be 

negligible. 

EPA recognizes that in some 

circumstances, acute aquatic toxicity 

testing (Test Group 1) may be relevant 

for certain chemical substances having a 

log Kow equal to or greater than 4.2. 

Chemical substances that are dispersible 

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

aliphatic amines, and cationic dyes) 

may have log Kow values greater than 4.2 

and may still be acutely toxic to aquatic 

organisms. For any chemical substance 

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

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 test 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. 53) 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 § 799.5089(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 

§ 799.5089(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 

§ 799.5089(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 (Ref. 52). This test is 

included as a Special Condition in 

Table 3 of the proposed regulatory text. 

A document developed by National 

Institutes of Health/National Insitute of 

Environmental Health Sciences (NIH/ 

NIEHS) provides guidance on how to 

use the NRU assay to estimate a starting 

dose for an acute oral toxicity test (Ref. 

44). Recent versions of the standardized 

protocols for the NRU assay are 

available at the NIEHS/Interagency 

Coordinating Committee on the 

Validation of Alternative Methods 

(ICCVAM) website, http:// 

iccvam.niehs.nih.gov/methods/ 

acutetox/invitrocyto/invcyt_proto.htm 

(Refs. 45–47). 

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 


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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/ 

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 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 chemicals for which 

Mammalian Toxicity—Repeated Dose/ 

Reproduction/Developmental testing is 

proposed may be used solely as ‘‘closed 

system intermediates,’’ as described in 

the EPA guidance document developed 

for the voluntary HPV Challenge 

Program (Ref. 40). As described in that 

guidance, such chemicals may be 

eligible for a reduced testing battery 

which substitutes a developmental 

toxicity study for the SIDS requirement 

to address repeated dose (e.g., 

subchronic), reproductive, and 

developmental toxicity. In other words, 

since only the developmental toxicity 

study would be conducted for those 

chemicals that qualify for a reduced 

testing battery, repeated dose (e.g., 

subchronic) and reproductive studies 

would not be conducted. At the present 

time, EPA does not have sufficient 

information to know with any degree of 

certainty which if any of the chemicals 

that are listed in the proposed 

regulatory text are solely closed system 

intermediates as defined in the 

voluntary HPV Challenge Program 

guidance document (Ref. 40). Persons 

who believe that a chemical fully 

satisfies the terms outlined in the 

guidance document are encouraged to 

submit appropriate information along 

with their comments on this proposed 

rule which substantiate this belief. If, 

based on submitted information and 

other information available to EPA, the 

Agency believes that a chemical is 

considered likely to meet the 

requirements for use solely as a closed 

system intermediate; EPA would not 

address any developmental toxicity 

testing needs in this proposed rule. 

B. When Would any Testing Imposed by 

this Proposed Rule Begin? 

The testing requirements contained in 

this proposed rule are not effective until 

and unless the Agency issues a final 

rule. Based on the effective date of the 

final rule, which is typically 30 days 

after the publication of a final rule in 

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 § 799.5089(j) of the proposed 

regulatory text. 

C. How Would the Studies Proposed 

under this Test Rule be Conducted? 

Persons required to comply with the 

final rule would have to conduct the 

necessary testing in accordance with the 

testing and reporting requirements 

established in the regulatory text of the 

final rule, with 40 CFR Part 790— 

Procedures Governing Testing Consent 

Agreements and Test Rules (except for 

paragraphs (a), (d), (e), and (f) of 

§ 790.45; § 790.48; paragraph (a)(2) and 

paragraph (b) of § 790.80; paragraph 

(e)(1) of § 790.82; and § 790.85), and 

with 40 CFR Part 792—Good Laboratory 

Practice Standards. 

D. What Forms of Test Substances 

Would be Tested Under this Rule? 

EPA is proposing two distinct 

approaches for identifying the specific 

substances that would be tested under 

this proposed rule, the application of 

which would depend on whether the 

substance is considered to be a ‘‘Class 1’’ 

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

introduced when EPA compiled the 

TSCA Chemical Substance Inventory, 

the term Class 1 chemical substance 

refers to a chemical substance having a 

chemical composition that consists of a 

single chemical species (not including 

impurities) that can be represented by a 

specific, complete structure diagram. By 

contrast, the term Class 2 chemical 

substance refers to a chemical substance 

having a composition that cannot be 

represented by a specific, complete 

chemical structure diagram, because 

such a substance generally contains two 

or more different chemical species (not 

including impurities). Table 2 in 

§ 799.5089(j) of the proposed regulatory 

text identifies the listed substances as 

either Class 1 or Class 2 chemical 

substances. 

EPA is proposing that, for the Class 1 

chemical 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 chemical 

substances in the past under TSCA 

section 4(a) testing actions, except for 

chemical 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 

chemical substances listed in this 

proposed rule. For the Class 2 chemical 

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). 

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 chemical 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 


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testing of Class 2 chemical substances 

included in this proposed rule. 

E. Would I Be Required to Test Under 

this Rule? 

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

EPA has made preliminary findings that 

there are insufficient data and 

experience to reasonably determine or 

predict health and environmental effects 

resulting from the manufacture, 

processing, or use of the chemical 

substances listed in this proposed rule. 

As a result, under TSCA section 

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

of these chemical substances, and those 

who intend to manufacture or process 

them, would be subject to the rule with 

regard to those listed chemicals which 

they manufacture or process. 

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 chemical 

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 chemical 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 the 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. 

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

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

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

or intend to manufacture, a test rule substance, and who are 

not listed under Tier 2 

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

manufacture a test rule substance solely as one or more of the following: 

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

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

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

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

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

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

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

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

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

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

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 

configured the tiers in 40 CFR 790.42 as 

in previous HPV test rules (Refs. 3 and 

7). 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 chemical 

substances, manufacturers of nonisolated intermediates, and 

manufacturers of components of Class 2 

chemical 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 

proposed 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 chemical 

substances, manufacturers of nonisolated intermediates, and 

manufacturers of components of Class 2 

chemical substances historically have 

not themselves participated in testing or 

contributed to reimbursement of those 

persons who have conducted testing. 

EPA understands that these 

manufacturers may include persons for 


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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 

§ 799.5089b)(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–manufacturers, i.e., those 

who manufacture, or intend to 

manufacture, a test rule chemical 

substance solely as one or more of the 

following: A byproduct, an impurity, a 

naturally occurring chemical substance, 

a non-isolated intermediate, a 

component of a Class 2 chemical 

substance, in amounts less than 1,100 

lbs. annually, or in small quantities 

solely for research and development. 

ii. Tier 2B–processors, i.e., those who 

process, or intend to process, a test rule 

chemical substance (in any form). The 

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

defined by TSCA 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. 48). 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. 49). 

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 

§ 799.5089(c)(2), (c)(5), (c)(7), and (c)(11) 

of the proposed regulatory text. In this 

proposed rule, EPA would not require 

the submission of equivalence data (i.e., 

data demonstrating that your chemical 

substance is equivalent to the chemical 

substance actually being tested) as a 

condition for approval of your 

exemption. Therefore, 40 CFR 

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

not apply to this proposed 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 § 799.5089(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., § 799.5089(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 proposed rule; thus, persons 

subject to this rule are not required to 

comply with 40 CFR 790.48 itself (see 

§ 799.5089(c)(4)–(c)(7) and 

§ 799.5089(d)(3) of the proposed 

regulatory text). 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. There is no 

difference whether you are in Tier 2A or 

Tier 2B as regards reimbursement. 

Concerning testing, if you are in Tier 2, 

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. As previously noted, 

Tier 2A manufacturers would be 

notified to test before Tier 2B processors 

(Unit IV.E.3.ii.). 

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 

§ 799.5089(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. 

• 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 § 799.5089(c)(4), (c)(5), 

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

regulatory text. The Agency would 

conditionally approve an exemption 

application under 40 CFR 790.87, if EPA 

has received a letter of intent to test or 

has received (or expects to receive) the 

test data required under this rule. EPA 

is not aware of any circumstances in 

which test rule Tier 1 entities have 

sought reimbursement from Tier 2 

entities either through private 

agreements or by soliciting the 

involvement of the Agency under the 

reimbursement regulations at 40 CFR 

part 791. 

f. What would happen if no one 

submitted a letter of intent to conduct 

testing? EPA anticipates that it will 

receive letters of intent to conduct 

testing for all of the tests specified and 

chemical substances included in the 


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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 final 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 final rule with 

respect to that chemical substance who 

are not already in violation of the final 

rule would be in violation of the final 

rule. 

4. How do the reimbursement 

procedures work? In the past, persons 

subject to test rules have independently 

worked out among themselves their 

respective financial contributions to 

those persons who have actually 

conducted the testing. However, if 

persons are unable to agree privately on 

reimbursement, they may take 

advantage of EPA’s reimbursement 

procedures at 40 CFR part 791, 

promulgated under the authority of 

TSCA section 4(a). These procedures 

include: The opportunity for a hearing 

with the American Arbitration 

Association; publication by EPA of a 

document in 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 

§ 799.5089(j) of the proposed regulatory 

text. EPA is also proposing that a robust 

summary of the final report for each 

specific test would be required to be 

submitted electronically in addition to 

and at the same time as the final report. 

The term ‘‘robust summary’’ is used to 

describe the technical information 

necessary to adequately describe an 

experiment or study and includes the 

objectives, methods, results, and 

conclusions of the full study report 

which can be either an experiment or in 

some cases an estimation or prediction 

method. Guidance for the compilation 

of robust summaries is described in a 

document entitled ‘‘Draft Guidance on 

Developing Robust Summaries’’ (Ref. 

13). Persons who respond to this request 

to submit robust summaries are also 

encouraged to submit the robust 

summary electronically via the HPVIS 

to allow for its ready incorporation into 

HPVIS. Directions for electronic 

submission of robust summary 

information into HPVIS are provided at 

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

metadata.html. This link will direct you 

to the ‘‘HPVIS Quick Start and User’s 

Guide.’’ EPA is soliciting comment on 

this proposed reporting requirement. 

G. What Would I Need to Do if I Cannot 

Complete the Testing Required by the 

Final Rule? 

A company who submits a letter of 

intent to test under the final rule and 

who subsequently anticipates 

difficulties in completing the testing by 

the deadline set forth in the final rule 

may submit a modification request to 

the Agency, pursuant to 40 CFR 790.55. 

EPA will determine whether 

modification of the test schedule is 

appropriate, and may first seek public 

comment on the modification. 

H. Would There be Sufficient Test 

Facilities and Personnel to Undertake 

the Testing Proposed Under this Test 

Rule? 

EPA’s most recent analysis of 

laboratory capacity (Ref. 41) indicates 

that available test facilities and 

personnel would adequately 

accommodate the testing proposed in 

this rule. 

I. Might EPA Seek Further Testing of the 

Chemicals in this Proposed Test Rule? 

If EPA determines that it needs 

additional data regarding any of the 

chemical substances included in this 

proposed rule, the Agency would seek 

further health and/or environmental 

effects testing for these chemical 

substances. Should the Agency decide 

to seek such additional testing via a test 

rule, EPA would initiate a separate 

action for this purpose. 

V. Export 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 chemical 

substances, etc.) will be subject to the 

export notification requirements in 

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

part 707, subpart D, but only after the 

final rule is issued and only if the 

chemical substance is contained in the 

final rule. Export notification is 

generally not required for articles, as 

provided by 40 CFR 707.60(b). Section 

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

person who exports or intends to export 

to a foreign country a chemical 

substance or mixture for which the 

submission of data is required under 

TSCA section 4 must notify the EPA 

Administrator of such export or intent 

to export. The EPA Administrator in 

turn will notify the government of the 

importing country of EPA’s regulatory 

action with respect to the chemical 

substance. 

VI. Economic Impacts 

EPA has prepared an economic 

assessment entitled ‘‘Economic Impact 

Analysis for the Proposed Section 4 Test 

Rule for High Production Volume 

Chemicals-3’’ (Ref. 14), a copy of which 

has been placed in the docket for this 

proposed rule. This economic 

assessment evaluates the potential for 

significant economic impacts as a result 

of the testing that would be required by 

this proposed rule. The analysis covers 

29 chemical substances. The total social 

cost of providing test data on the 29 

chemical substances that were evaluated 

in this economic analysis is estimated to 

be $10.30 million assuming an average 

cost scenario. Total costs of compliance 

to industry are estimated at $10.21 

million (Ref. 14). 

While legally subject to this test rule, 

processors of a subject chemical would 

be required to comply with the 

requirements of the final rule only if 

they are directed to do so by EPA as 

described in § 799.5089(c)(5) and (c)(6) 

of the proposed regulatory text. EPA 

would only require processors to test if 

no person in Tier 1 has submitted a 

notice of its intent to conduct testing, or 

if under 40 CFR 790.93, a problem 

occurs with the initiation, conduct, or 


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completion of the required testing or the 

submission of the required data to EPA. 

Because EPA has identified at least one 

manufacturer in Tier 1 for each subject 

chemical substance, the Agency 

assumes that, for each chemical 

substance in this 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 an initial screening approach 

that estimated the impact of testing 

requirements as a percentage of each 

chemical substance’s sale price. This 

measure compares annual revenues 

from the sale of a chemical substance to 

the annualized compliance cost for that 

chemical substance to assess the 

percentage of testing costs that can be 

accommodated by the revenue stream 

generated by that chemical substance 

over a number of years. Compliance 

costs include costs of testing and 

administering the testing, as well as 

reporting costs. In addition, they 

include 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 substance subject to the final 

rule, estimated to range from $26.86 per 

notice to $85.70 per notice (Ref.14). 

These 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. 

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. 

These annualized testing costs are 

then divided by the estimated annual 

revenue of the chemical substance to 

derive a cost-to-sales ratio. 

The screening results suggest that 

under a least cost scenario, 17 out of the 

29 chemical substances (59%) would 

have a price impact at less than the 1% 

level. Similarly, 16 out of the 29 

chemical substances (55%) would be 

impacted at less than the 1% level 

under an 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 chemical substances. 

Because the subject chemical substances 

have relatively large production 

volumes, the annualized costs of testing, 

expressed as a percentage of annual 

revenue, are very small for most 

chemical substances. There are, 

however, some chemical substances for 

which the price impact is expected to 

exceed 1% of the revenue from that 

chemical substance. The potential for 

adverse economic impact is expected to 

be higher for these chemical substances. 

EPA, therefore, compared the 

annualized costs of testing to company 

revenue for those chemical substances 

because in these cases, companies may 

choose to use revenue sources other 

than the profits from the individual 

chemical substances to pay for testing. 

EPA estimates that the costs of testing 

will exceed 1% of company revenue for 

one of the affected companies. 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. 

The benefits resulting from this 

proposed test rule are discussed 

qualitatively in ‘‘Economic Impact 

Analysis for the Proposed Section 4 Test 

rule for High Production Volume 

Chemicals-3’’ (Ref. 14). EPA believes 

that the net benefits of this proposed 

rule are positive, but quantification of 

the benefits of the proposed rule would 

require more specific information about 

use patterns and preferences than is 

available. 

VII. Public Comment 

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

the Agency solicits comment regarding 

additional information pertaining to 

potential exposure of workers and 

consumers, respectively, to the chemical 

substances identified in this proposed 

rule. Also, as discussed in Unit III.E., 

the Agency solicits comment regarding 

additional information pertaining to 

environmental releases of the chemical 

substances identified in this proposed 

rule. 

As discussed in Unit III.G., 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. 13). 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 is also soliciting public comment 

on the proposed requirement for 

submission of robust summaries, the 

test methods proposed, and the analysis 

detailing the burdens and costs for the 

regulatory impacts resulting from this 

proposed rule. 

In addition, EPA solicits comment on 

the proposed and alternative approaches 

to the testing of Class 2 chemical 

substances, whether the proposed 

approach for testing Class 1 chemical 

substances (i.e., that each Class 1 

chemical substance be tested at a purity 

of 99% or more) should be applied to 

any Class 2 chemical substances, and 

whether the proposed or alternative 

approaches for the testing of Class 2 

chemical substances (i.e., that a 

representative sample of each Class 2 

substance be tested) should be applied 

to any Class 1 chemical substances. 

VIII. Materials in the Docket 

As indicated under ADDRESSES, a 

docket has been established for this 

proposed rule under docket ID number 

EPA–HQ–OPPT–2009–0112. The 

following is a listing of the documents 

that have been placed in the docket for 

this proposed rule. The docket includes 

information considered by EPA in 

developing this proposed rule, 

including the documents listed in this 

unit, which are physically located in the 

docket. In addition, interested parties 

should consult documents that are 

referenced in the documents that EPA 

has placed in the docket, regardless of 

whether these referenced documents are 

physically located in the docket. For 

assistance in locating documents that 

are referenced in documents that EPA 

has placed in the docket, but that are 

not physically located in the docket, 

please consult either technical person 

listed under FOR FURTHER INFORMATION

CONTACT. The docket is available for 

review as specified under ADDRESSES. 

1. EPA. Data Collection and 

Development on High Production 

Volume (HPV) Chemicals; Notice. 

Federal Register (65 FR 81686, 

December 26, 2000) (FRL–6754–6). 

2. EPA. Testing of Certain High 

Production Volume Chemicals; 

Proposed Rule. Federal Register (65 FR 

81658, December 26, 2000) (FRL–6758– 

4). 


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3. EPA. Testing of Certain High 

Production Volume Chemicals; Final 

Rule. Federal Register (71 FR 13708, 

March 16, 2006) (FRL–7335–2). 

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

Statement of Policy; Criteria for 

Evaluating Substantial Production, 

Substantial Release, and Substantial or 

Significant Human Exposure; Notice. 

Federal Register (58 FR 28736, May 14, 

1993). 

5. EPA. OPPT. HPV Challenge 

Program Chemical List. This list 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. 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. EPA. Sixty-Third Report of the 

TSCA Interagency Testing Committee to 

the Administrator of the Environmental 

Protection Agency; Receipt of Report 

and Request for Comments; Notice. 

Federal Register (73 FR 65486, 

November 3, 2008) (FRL–8387–6). 

10. EPA. Preliminary Assessment 

Information Reporting; Addition of 

Certain Chemicals. Final Rule and 

Technical Corrections. Federal Register 

(71 FR 47122, August 16, 2006) (FRL– 

7764–9). 

11. EPA. Testing of Certain High 

Production Volume Chemicals; Second 

Group of Chemicals; Proposed Rule. 

Federal Register (73 FR 43314, July 24, 

2008) (FRL–8373–9). 

12. 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. 

13. EPA. OPPT. Draft Guidance on 

Developing Robust Summaries. October, 

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

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

robsumgd.htm. 

14. EPA. OPPT. Economic Impact 

Analysis for the Proposed Section 4 Test 

Rule for High Production Volume 

Chemicals-3. Prepared by the OPPT 

Economic and Policy Analysis Branch. 

December 2009. 

15. EPA. OPPT. Testing of Certain 

High Production Volume Chemicals-3 

(Exposure Findings Supporting 

Information). Prepared by OPPT 

Economics, Exposure and Technology 

Division. September 2009. 

16. 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. 

Available on-line at: http:// 

www.cdc.gov/niosh/88-106.html. 1988. 

17. ASTM International. Standard 

Test Method for Relative Initial and 

Final Melting Points and the Melting 

Range of Organic Chemicals. ASTM E 

324–99. 1999. 

18. ASTM International. Standard 

Test Method for Vapor Pressure of 

Liquids by Ebulliometry. ASTM E 1719– 

05. 2005. 

19. ASTM International. Standard 

Test Method for Determining Vapor 

Pressure by Thermal Analysis. ASTM. E 

1782–03. 2003. 

20. ASTM International. Standard 

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

Chromatography. ASTM E 1147– 

92(2005). 2005. 

21. ASTM International. Standard 

Test Method for Measurements of 

Aqueous Solubility. ASTM E 1148–02. 

2002. 

22. ASTM International. Question 

about ASTM E 324. E-mail from Diane 

Rehiel, ASTM, to Greg Schweer, CITB, 

CCD, OPPT, EPA. September 15, 2004. 

23. Meylan, W.M. and Howard, P.H. 

Atom/Fragment Contribution Method 

for Estimating Octanol-Water Partition 

Coefficients. Journal of Pharmaceutical 

Sciences. Vol. 84(1):83–92. 1995. 

24. 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. Vol. 15(2):100–106. 1996. 

25. 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. 

26. 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. 

27. 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. 

28. 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. 

29. ISO. Water quality — Evaluation 

of ultimate aerobic biodegradability of 

organic compounds in aqueous medium 

— Carbon dioxide evolution test. ISO 

9439. 1999. 

30. 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. 

31. 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. 

32. 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. 

33. ASTM International. Standard 

Guide for Conducting Acute Toxicity 

Tests on Test Materials with Fishes, 

Macroinvertebrates, and Amphibians. 

ASTM E 729–96(2002). 2002. 

34. ASTM International. Standard 

Guide for Conducting Static Toxicity 

Tests with Microalgae. ASTM E 1218– 

04e1. 2004. 

35. ASTM International. Standard 

Guide for Conducting Daphnia magna 

Life-Cycle Toxicity Tests. ASTM E 

1193–97(2004). 2004. 

36. 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. 

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

Karcher, W. Nonlinear dependence of 

fish bioconcentration on n-Octanol/ 

Water Partition Coefficient. SAR and 

QSAR in Environmental Research. Vol. 

1, pp. 29–39. 1993. 

38. EPA. Category for Persistent, 

Bioaccumulative, and Toxic New 

Chemical Substances; Notice. Federal 

Register (64 FR 60194, November 4, 

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

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

pubs/pbtpolcy.htm. 

39. EPA. Significant New Use Rules; 

General Provisions for New Chemical 


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Follow-Up; Final Rule. Federal Register 

(54 FR 31298, July 27, 1989). 

40. 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. 

41. EPA. Analysis of Laboratory 

Capacity to Support U.S. EPA Chemical 

Testing Program Initiatives. Economic 

and Policy Analysis Branch. 

Washington, DC. August 2004. 

42. 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. 

43. EPA. Economic Analysis in 

Support of the TSCA 12(b) Information 

Collection Request, OPPT/EETD/EPAB. 

Washington, DC. October 30, 1998. 

44. 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. 

45. 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. 

46. NIEHS 2003b. Test Method 

Protocol for the BALB/c 3T3 Neutral 

Red Uptake Cytotoxicity Test, a Test for 

Basal Cytotoxicity for an in vitro 

Validation Study—Phase III. NTP/ 

NICEATM. November 4, 2003. Available 

on-line at: http://iccvam.niehs.nih.gov/ 

methods/acutetox/invitrocyto/ 

invcyt_proto.htm. 

47. NIEHS 2003c. Test Method 

Protocol for the NHK Neutral Red 

Uptake Cytotoxicity Test, a Test for 

Basal Cytotoxicity for an in vitro 

Validation Study—Phase III. NTP/ 

NICEATM. November 4, 2003. Available 

on-line at: http://iccvam.niehs.nih.gov/ 

methods/acutetox/invitrocyto/ 

invcyt_proto.htm. 

48. EPA. Toxic Substances; Test Rule 

Development and Exemption 

Procedures; Interim Final Rule. Federal 

Register (50 FR 20652, May 17, 1985). 

49. EPA. Toxic Substances Control 

Act; Data Reimbursement; Final Rule. 

Federal Register (48 FR 31786, July 11, 

1983). 

50. EPA. OPPT. High Production 

Volume Chemical Data Information 

System (HPVIS). Data from HVPIS on 29 

HPV chemicals. December 2009. 

51. NIOSH. National occupational 

exposure survey analysis of 

management interview responses. Vol. 

III. Pedersen, D.H. and Sieber, W.K., 

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. 

Available on-line at: http:// 

www.cdc.gov/niosh/89-103.html. 1989. 

52. NIOSH. National occupational 

exposure survey sampling methodology. 

Vol. II. Sieber, W.K., 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. Available online at: http://www.cdc.gov/niosh/89- 

102.html. 1989. 

53. 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. 

EPA has prepared an economic 

analysis of this proposed action, which 

is contained in a document entitled 

‘‘Economic Impact Analysis for the 

Proposed Section 4 Test Rule for High 

Production Volume Chemicals-3’’ (Ref. 

14). A copy of the economic analysis is 

available in the docket for this proposed 

rule and is summarized in Unit VI. 

B. Paperwork Reduction 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 proposed test rule is 

provided in the economic analysis (Ref. 

14). 

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 

proposed rule 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 chapter 40 of the 

CFR, after appearing in the preamble of 

the final rule, are listed in 40 CFR part 

9, displayed either by publication in 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 29 chemical substances is 

52,184 hours (average cost scenario). 

EPA assumes that industry will form a 

‘‘task force’’ or panel to coordinate 

testing where appropriate. A panel may 

often represent groups of chemical 

substances. EPA estimates 16 panels for 

the proposed rule; with an estimated 

burden per panel of 3,262 hours 

(average cost scenario) (Ref.14). 

The estimated burden of the 

information collection activities related 

to export notification is estimated to 

average 1 burden hour for each 

chemical/country combination for an 

initial notification and 0.5 hours for 

each subsequent notification (Ref. 14). 

In estimating the total burden hours 

approved for the information collection 

activities related to export notification, 

the Agency has included sufficient 


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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 rule 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 proposed 

rule. 

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 

Agency hereby certifies that this 

proposed rule would not have a 

significant adverse economic impact on 

a substantial number of small entities. 

The factual basis for the Agency’s 

determination is presented in the small 

entity impact analysis prepared as part 

of the economic analysis for this 

proposed rule (Ref. 14), which is 

summarized in Unit VI., and a copy of 

which is available in the docket for this 

proposed rule. The following is a brief 

summary of the factual basis for this 

certification. 

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 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 rule (Ref. 14), 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. 14) in 

order to characterize the potential small 

entity impacts of this proposed rule on 

small business: 

• The size of the adverse economic 

impact (measured as the ratio of the cost 

to sales or revenue). 

• The total number of small entities 

that experience the adverse economic 

impact. 

Section 601(3) of RFA establishes as 

the default definition of ‘‘small 

business’’ the definition used in section 

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

632, under which SBA establishes small 

business size standards (13 CFR 

121.201). For this proposed rule, EPA 

has analyzed the potential small 

business impacts using the size 

standards established under this default 

definition. The SBA size standards, 

which are primarily intended to 

determine whether a business entity is 

eligible for government programs and 

preferences reserved for small 

businesses (13 CFR 121.101), ‘‘seek to 

ensure that a concern that meets a 

specific size standard is not dominant in 

its field of operation.’’ (13 CFR 

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

Small Business Act. In analyzing 

potential impacts, RFA recognizes that 

it may be appropriate at times to use an 

alternate definition of small business. 

As such, section 601(3) of RFA provides 

that an agency may establish a different 

definition of small business after 

consultation with the SBA Office of 

Advocacy and after notice and an 

opportunity for public comment. Even 

though the Agency has used the default 

SBA definition of small business to 

conduct its analysis of potential small 

business impacts for this proposed rule, 

EPA does not believe that the SBA size 

standards are generally the best size 

standards to use in assessing potential 

small entity impacts with regard to 

TSCA section 4(a) test rules. 

The SBA size standard is generally 

based on the number of employees an 

entity in a particular industrial sector 

may have. For example, in the chemical 

manufacturing industrial sector (i.e., 

NAICS code 325 and NAICS code 

324110), approximately 98% of the 

firms would be classified as small 

businesses under the default SBA 

definition. The SBA size standard for 

75% of this industry sector is 500 

employees, and the size standard for 

23% of this industry sector is either 750, 

1,000, or 1,500 employees. When 

assessing the potential impacts of test 

rules on chemical manufacturers, EPA 

believes that a standard based on total 

annual sales may provide a more 

appropriate means to judge the ability of 

a chemical manufacturing firm to 

support chemical testing without 

significant costs or burdens. 

EPA is currently determining what 

level of annual sales would provide the 

most appropriate size cutoff with regard 

to various segments of the chemical 

industry usually impacted by TSCA 

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

reached a determination. As stated in 

this unit, therefore, the factual basis for 

the 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. 

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 

affected (Ref. 14). For a conservative 

estimate of the number of small 

businesses affected by the HPV rules, 

the Agency uses an employment 

threshold of less than 1,500 employees 

for all businesses regardless of the 

NAIC-specific threshold to determine 

small business status. 

For each manufacturer of the 29 

chemical substances covered by this 


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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 54 affected 

UCEs. Sales and employment data could 

be found for 52 of these UCEs (96%). 

Two companies could not be classified 

as small or large because there were no 

employment data available, but were 

still included in the small business 

impact analysis. 

Parent company sales data were 

collected to identify companies that 

qualified as a ‘‘small business’’ for 

purposes of RFA analysis. Based on the 

SBA size standard applied (1,500 

employees or less), 21 companies (39%) 

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 21 businesses designated as 

small business, none had cost-to-sales 

ratios of greater than 1% and 3% under 

both the least and average cost 

scenarios. For the chemical substances 

where sales data were unavailable, EPA 

used the median sales value sales of all 

other small businesses equal to $24.7 

million. The costs for the two 

companies were estimated to be well 

below 1% of this sales level. Given 

these results, the Agency has 

determined that there is not a significant 

economic impact on a substantial 

number of small entities as a result of 

this proposed rule, if finalized. 

The estimated cost of the TSCA 

section 12(b)(1) export notification, 

which, as a result of the final rule, 

would be required for the first export to 

a particular country of a chemical 

substance subject to the final rule, is 

estimated to be $85.70 for the first time 

that an exporter must comply with 

TSCA section 12(b)(1) export 

notification requirements, and $26.86 

for each subsequent export notification 

submitted by that exporter (Refs. 14, 42, 

and 43). EPA has concluded that the 

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

notification would have a negligible 

impact on exporters of the chemical 

substances in the final rule, regardless 

of the size of the exporter. 

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 rule does not contain 

a Federal mandate that may result in 

expenditures of $100 million or more 

for State, local, and tribal governments, 

in the aggregate, or the private sector in 

any 1 year. It is estimated that the total 

aggregate costs of this proposed rule to 

the private sector, which are 

summarized in Unit VI., would be 

$10.21 million. The total annualized 

costs of this proposed rule to the private 

sector are estimated to be $3.61 and 3.89 

million using a 3% and 7% discount 

rate over 3 years (average cost scenario). 

In addition, since EPA does not have 

any information to indicate that any 

State, local, or tribal government 

manufactures or processes the chemical 

substances covered by this action such 

that the final rule would apply directly 

to State, local, or tribal governments, 

EPA has determined that this proposed 

rule would not significantly or uniquely 

affect small governments. Accordingly, 

this proposed rule is not subject to the 

requirements of sections 202, 203, 204, 

and 205 of UMRA. 

E. Executive Order 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 chemical 

substances. Because EPA has no 

information to indicate that any State or 

local government manufactures or 

processes the chemical substances 

covered by this action, this proposed 

rule does not apply directly to States 

and localities and will not affect State 

and local governments. Thus, Executive 

Order 13132 does not apply to this 

proposed rule. 

F. Executive Order 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 chemical 

substances, and would result in the 

development of data about those 

chemical substances that can 

subsequently be used to assist the 

Agency and others in determining 

whether the chemical substances in this 

proposed rule present potential risks, 

allowing the Agency and others to take 

appropriate action to investigate and 

mitigate those risks. 

H. Executive Order 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 


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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 the final rule, 

EPA is proposing the use of voluntary 

consensus standards issued by ASTM 

International and ISO which evaluate 

the same type of toxicity as the TSCA 

799 test guidelines and OECD test 

guidelines, where applicable. Copies of 

the 17 ASTM International and ISO 

standards referenced in the proposed 

regulatory text at § 799.5089(h) have 

been placed in the docket for this 

proposed rule. You may obtain copies of 

the ASTM International standards from 

the American Society for Testing and 

Materials International, 100 Bar Harbor 

Dr., West Conshohocken, PA 19428– 

2959, and copies of the ISO standards 

from the International Organization for 

Standardization, Case Postale, 56 CH1211 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 International and ISO standards 

used in the final rule in accordance with 

5 U.S.C. 552(a) and 1 CFR part 51. 

EPA is not aware of any potentially 

applicable voluntary consensus 

standards which evaluate partition 

coefficient (n-octanol/water) generator 

column, water solubility (column 

elution and generator column), acute 

inhalation toxicity, bacterial reverse 

mutations, in vivo mammalian bone 

marrow chromosomal aberrations, 

combined repeated dose with 

reproductive/developmental toxicity 

screen, repeated dose 28–day oral 

toxicity screen, or the reproductive 

developmental toxicity screen which 

could be considered in lieu of the TSCA 

799 test guidelines, 40 CFR 799.6756, 

799.6784, 799.6786, 799.9130, 799.9510, 

799.9538, 799.9365, 799.9305, and 

799.9355, respectively, upon which the 

test standards in this proposed rule are 

based. The Agency invites comment on 

the potential use of voluntary consensus 

standards in this proposed rule, and, 

specifically, invites the public to 

identify potentially applicable 

consensus standard(s) and to explain 

why such standard(s) should be used 

here. 

J. Executive Order 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 chemical substances covered 

by this proposed rule. Although not 

directly impacting environmental 

justice-related concerns, this 

information will enable the Agency to 

better protect human health and the 

environment, including in low-income 

and minority communities. 

List of Subjects in 40 CFR Part 799 

Environmental protection, Chemicals, 

Hazardous substances, Laboratories, 

Reporting and recordkeeping 

requirements. 

Dated: February 17, 2010. 

James Jones, 

Acting Assistant Administrator, Office of 

Prevention, Pesticides and Toxic Substances. 

Therefore, it is proposed that 40 CFR 

chapter I be amended as follows: 

PART 799— IDENTIFICATION OF 

SPECIFIC CHEMICAL SUBSTANCE 

AND MIXTURE TESTING 

REQUIREMENTS 

1. The authority citation for part 799 

continues to read as follows: 

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

2. Add § 799.5089 to subpart D of part 

799 to read as follows: 

§ 799.5089 Chemical testing requirements 

for certain high production volume 

chemicals; third 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’’ 

chemical substances in Table 2 in 

paragraph (j) of this section, the purity 

of each chemical substance must be 

99% or greater, unless otherwise 

specified in this section. For the 

chemical substances identified as ‘‘Class 

2’’ chemical substances in Table 2 in 

paragraph (j), a representative form of 

each chemical substance must be tested. 

The representative form selected for a 

given Class 2 chemical substance should 

meet industry or consensus standards 

where they exist. 

(b) Am I subject to this section? (1) If 

you manufacture (including import) or 

intend to manufacture, or process or 

intend to process, any chemical 

substance listed in Table 2 in paragraph 

(j) of this section at any time from 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. 


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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 

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 [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 Federal Register document 

described in paragraph (c)(4) of this 

section. 

(6) If no manufacturer in Tier 1 or Tier 

2A has notified EPA of its intent to 

conduct one or more of the tests 

required by this section on any chemical 

substance listed in Table 2 in paragraph 

(j) of this section within 30 days after 

the publication of the Federal Register 

document described in paragraph (c)(4) 

of this section, EPA will publish another 

Federal Register document that would 

specify the test(s) and the chemical 

substance(s) for which no letter of intent 

has been submitted, and notify 

processors in Tier 2B of their obligation 

to submit a letter of intent to test or to 

apply for an exemption from testing. 

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

in Table 1 in paragraph (c) of this 

section) with respect to a chemical 

substance listed in Table 2 in paragraph 

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

intend to process, this chemical 

substance as of [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 Federal Register 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 Federal Register 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 


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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 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 

submission of study plans prior to 

testing, 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; § 790.48; 

paragraph (a)(2) and paragraph (b) of 

§ 790.80; paragraph (e)(1) of § 790.82; 

and § 790.85. 

(e) If I do not comply with this 

section, when will I be considered in 

violation of it? You will be considered 

in violation of this section as of 1 day 

after the date by which you are required 

to comply with this section. 

(f) How are EPA’s data 

reimbursement procedures affected for 

purposes of this section? If persons 

subject to this section are unable to 

agree on the amount or method of 

reimbursement for test data 

development for one or more chemical 

substances included in this section, any 

person may request a hearing as 

described in 40 CFR part 791. In the 

determination of fair reimbursement 

shares under this section, if the hearing 

officer chooses to use a formula based 

on production volume, the total 

production volume amount will include 

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? 

The tests that are required for each 

chemical substance are indicated in 

Table 2 in paragraph (j) of this section. 

The test methods that must be followed 

are provided in Table 3 in paragraph (j) 

of this section. You must proceed in 

accordance with these test methods as 

required according to Table 3 in 

paragraph (j) of this section, or as 

appropriate if more than one alternative 

is allowed according to Table 3 in 

paragraph (j) of this section. 

(i) Reporting requirements. A final 

report for each specific test for each 

subject chemical substance must be 

received by EPA by [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 

shall be submitted electronically in 

addition to and at the same time as the 

final report. The term ‘‘robust summary’’ 

is used to describe the technical 

information necessary to adequately 

describe an experiment or study and 

includes the objectives, methods, 

results, and conclusions of the full 

study report which can be either an 

experiment or in some cases an 

estimation or prediction method. 

Guidance for the compilation of robust 

summaries is described in a document 

entitled ‘‘Draft Guidance on Developing 

Robust Summaries’’ which is available 

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

pubs/general/robsumgd.htm. 

(j) Designation of specific chemical 

substances and testing requirements. 

The chemical substances identified by 

chemical name, Chemical Abstract 

Service Registry number (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 section) 

83–41–0 Benzene, 1,2-dimethyl-3-nitro- 1 A1, A2, A3, A4, A5, D, E2, F1 

96–22–0 3-Pentanone 1 E1, F2 

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

98–56–6 Benzene, 1-chloro-4-(trifluoromethyl)- 1 A4, B, C1, F2 

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

127–68–4 Benzenesulfonic acid, 3-nitro-, sodium salt 

(1:1) 

1 A3, F2 

506–51–4 1-Tetracosanol 1 A2, A3, A4, A5, B, C1, D, E1, E2, F1 

506–52–5 1-Hexacosanol 1 A2, A3, A4, A5, C1, D, E1, E2, F1 

515–40–2 Benzene, (2-chloro-1,1-dimethylethyl)- 1 A1, A3, A4, A5, B, C1, D, E1, E2, F1 


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TABLE 2.—CHEMICAL SUBSTANCES AND TESTING REQUIREMENTS—Continued 

CAS No. Chemical Name Class Required Tests 

(See Table 3 of this section) 

2494–89–5 Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate) 1 A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1 

5026–74–4 2-Oxiranemethanamine, N-[4-(2- 

oxiranylmethoxy)phenyl]-N-(2- 

oxiranylmethyl)- 

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

22527–63–5 Propanoic acid, 2-methyl-, 3-(benzoyloxy)- 

2,2,4-trimethylpentyl ester 

1 A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1 

24615–84–7 2-Propenoic acid, 2-carboxyethyl ester 1 A1, A2, A3, A4, A5, B, C1, E1, E2, F1 

25321–41–9 Benzenesulfonic acid, dimethyl- 1 A2, A3, A4, A5, B, C1, D, E1, E2, F1 

25646–71–3 Methanesulfonamide, N-[2-[(4-amino-3- 

methylphenyl)ethylamino]ethyl]-, sulfate 

(2:3) 

1 A1, A2, A3, A4, A5, B, C1, F1 

52556–42–0 1-Propanesulfonic acid, 2-hydroxy-3-(2- 

propenyloxy)-, sodium salt (1:1) 

1 A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1 

61788–76–9 Alkanes, chloro 2 A2, A3, A4, A5, B, 

65996–79–4 Solvent naphtha (coal) 2 A3, A4, A5, B, C1, D, E1, E2, F1 

65996–82–9 Tar oils, coal 2 A3, A4, A5, B, C1, D, E1, E2, F1 

65996–89–6 Tar, coal, high-temperature 2 A4, A5, B, C1, D, E1, E2, F1 

65996–92–1 Distillates (coal tar) 2 A3, A4, A5, B, C1, D, E1, E2, F2 

68082–78–0 Lard, oil, Me esters 2 A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1 

68187–57–5 Pitch, coal tar-petroleum 2 A4, A5, B, C6, D, E1, E2, F1 

68442–60–4 Acetaldehyde, reaction products with formaldehyde, by-products from 2 A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1 

68610–90–2 2-Butenedioic acid (2E)-, di-C8–18-alkyl 

esters 

2 A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1 

68988–22–7 1,4-Benzenedicarboxylic acid, 1,4-dimethyl 

ester, manuf. of, by-products from 

2 A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1 

70693–50–4 Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2- 

(2-nitrophenyl)diazenyl]- 

1 A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1 

72162–15–3 1-Decene, sulfurized 2 A2, A3, A4, A5, B, C1, D, E1, E2, F1 

73665–18–6 Extract residues (coal), tar oil alk., naphthalene distn. residues 2 A2, A3, A4, 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 

Properties 

A 1. Melting Point: ASTM E 324–99 (capillary 

tube) 

2. Boiling Point: ASTM E 1719–05 

(ebulliometry) 

3. Vapor Pressure: ASTM E 1782–03 (thermal analysis) 

4. n-Octanol/Water Partition Coefficient (log 

10 basis) or log Kow: (See Special Conditions for the log Kow test requirement and 

select the appropriate method to use, if 

any, from those listed in this column.) 

Method A: 40 CFR 799.6755 (shake 

flask) 

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

Method C: 40 CFR 799.6756 (generator 

column) 

5. Water Solubility: (See Special Conditions 

for the water solubility test requirement 

and select the appropriate method to use, 

if any, from those listed in this column.) 

Method A: ASTM E 1148-02 (shake 

flask) 

Method B: 40 CFR 799.6784 (shake 

flask) 

Method C: 40 CFR 799.6784 (column 

elution) 

Method D: 40 CFR 799.6786 (generator 

column) 

n-Octanol/Water Partition Coefficient or log Kow: 

Which method is required, if any, is determined by the test 

substance’s estimated i log Kow as follows: 

log Kow < 0: no testing required. 

log Kow range 0–1: Method A or B. 

log Kow range > 1–4: Method A 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. 

Water Solubility: 

Which method is required, if any, is determined by the test 

substance’s estimated ii water solubility. Test sponsors 

must provide in the final study report the underlying rationale for the method and pH selected. In order to ensure environmental relevance, EPA highly recommends 

that the selected study be conducted starting at pH 7. 

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

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

> 0.001 mg/L—10 mg/L: Method C or D. 

≤ 0.001 mg/L: no testing required. 

Environmental Fate 

and Pathways— 

Ready Biodegradation 

B For B, consult ISO 10634 for guidance, and 

choose one of the methods listed in this 

column: 

1. ASTM 1720–01 (sealed vessel CO2 production test) 

OR 

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) 

Which method is required, if any, is determined by the test 

substance’s physical and chemical properties, including 

its water solubility. ISO 10634 provides guidance for selection of an appropriate test method for a given test substance. Test sponsors must provide in the final study report the underlying rationale for the method selected. 

Aquatic Toxicity C1 For C1, Test Group 1 or Test Group 2 listed 

in this column must be used to fulfill the 

testing requirements—see Special Conditions. 

Test Group 1 for C1: 

1. Acute Toxicity To Fish: ASTM E 729– 

96(2002) 

2. Acute Toxicity To Daphnia: ASTM E 729– 

96(2002) 

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

04e1 

Test Group 2 for C1: 

1. Chronic Toxicity To Daphnia: ASTM E 

1193–97(2004) 

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

04e1 

The following are the Special Conditions for C1, C2, C3, 

C4, C5, and C7 testing; there are no Special Conditions 

for C6. Which test group is required is determined by the 

test substance’s measured log KOW as obtained under 

Test Category A, or using an existing measured log KOW. iii

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

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


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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 chemical substances may request a modification to the test standard 

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

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

iv. The OECD 425 Up/Down Procedure, revised by OECD test guidelines 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 

effective on [30 days after date of 

publication of the final rule in the 

Federal Register]. 

[FR Doc. 2010–3734 Filed 2–24–10; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 17 

[Docket No. FWS–R2–ES–2008–0059; MO 

92210–0–0008] 

Endangered and Threatened Wildlife 

and Plants; 12-Month Finding on a 

Petition To List the Sonoran Desert 

Population of the Bald Eagle as a 

Threatened or Endangered Distinct 

Population Segment 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: 12-month petition finding. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service (Service), announce a 

12-month finding on a petition to list 

the Sonoran Desert Area population of 

the bald eagle (Haliaeetus 

leucocephalus) as a distinct population 

segment (DPS). In the petition, we were 

asked that the DPS be recognized, listed 

as endangered, and that critical habitat 

be designated under the Endangered 

Species Act of 1973, as amended (Act). 

After review of all available scientific 

and commercial information, we find 

that the Sonoran Desert Area population 

of the bald eagle does not meet the 

definition of a DPS and, therefore, is not 

a listable entity under the Act. As a 

result, listing is not warranted, and we 

intend to publish a separate notice to 

remove this population from the List of 

Threatened and Endangered Wildlife 

once the District Court for the District of 

Arizona has been notified. We ask the 

public to continue to submit to us any 

new information that becomes available 

concerning the taxonomy, biology, 

ecology, and status of this population of 

the bald eagle and to support 

cooperative conservation of the bald 

eagle within the Sonoran Desert Area. 

DATES: The finding announced in this 

document was made on February 25, 

2010. 

ADDRESSES: This finding is available on 

the Internet at http:// 

www.regulations.gov at Docket Number 

[FWS–R2–ES–2008–0044]. Supporting 

documentation for this finding is 

available for inspection, by 

appointment, during normal business 

hours at the Arizona Ecological Services 

Office, 2321 West Royal Palm Road, 

Suite 103, Phoenix, AZ 85021–4951. 

Please submit any new information, 

materials, comments, or questions 

concerning this species or this finding 

to the above address, Attention: Sonoran 

Desert Area bald eagle. 

FOR FURTHER INFORMATION CONTACT: 

Steve Spangle, Field Supervisor, 

Arizona Ecological Services Office (see 

ADDRESSES); telephone, 602–242–0210; 

facsimile, 602–242–2513. If you use a 

telecommunications device for the deaf 

(TDD), call the Federal Information 

Relay Service (FIRS) at 800–877–8339. 

SUPPLEMENTARY INFORMATION: 

Background 

Section 4(b)(3)(B) of the Act (16 

U.S.C. 1531 et seq.) requires that, for 

any petition to revise the Lists of 

Endangered and Threatened Wildlife 

and Plants that contains substantial 

scientific or commercial information 

that listing may be warranted, we make 

a finding within 12 months of the date 

of our receipt of the petition on whether 

the petitioned action is: (a) Not 

warranted, (b) warranted, or (c) 

warranted, but the immediate proposal 

of regulation implementing the 

petitioned action is precluded by other 

pending proposals to determine whether 

species are threatened or endangered, 

and expeditious progress is being made 

to add or remove qualified species from 

the List of Endangered and Threatened 

Wildlife and Plants. Section 4(b)(3)(C) of 

the Act requires that we treat a petition 

for which the requested action is found 

to be warranted but precluded as though 

resubmitted on the date of such finding, 

that is, requiring that we make a 

subsequent finding within 12 months. 

Such 12-month findings must be 

published in the Federal Register. 

This notice constitutes our 12-month 

finding on a petition to list the Sonoran 

Desert Area bald eagle. In this 

document, the Sonoran Desert Area 

population is the name given to the 

entity under evaluation for designation 

as a DPS. For the purposes of this 

assessment, the Sonoran Desert Area 

population includes all bald eagle 

territories within Arizona, the Copper 

Basin breeding area in California near 

the Colorado River, and the territories of 

interior Sonora, Mexico, that occur 

within the Sonoran Desert or adjacent, 

transitional communities. For more 

detail on the boundary of the DPS, see 

the discussion below under 

Determination of the Area for Analysis. 

Previous Federal Action 

Bald eagles gained protection under 

the Bald Eagle Protection Act (16 U.S.C. 

668–668d) in 1940 and the Migratory 

Bird Treaty Act (MBTA) (16 U.S.C. 703– 

712) in 1972. A 1962 amendment to the 

Bald Eagle Protection Act added 

protection for the golden eagle and the 

amended statute became known as the 

Bald and Golden Eagle Protection Act 

(BGEPA). On March 11, 1967 (32 FR 

4001), the Secretary of the Interior listed 

bald eagles south of 40 north latitude as 

endangered under the Endangered 

Species Preservation Act of 1966 (Pub. 

L. 89–699, 80 Stat. 926) due to a 

population decline caused by dichlorodiphenyltrichloroethane (DDT) and 

other factors. On February 14, 1978, the 

Service listed the bald eagle as an 

endangered species under the Act (16 

U.S.C. 1531 et seq.) in 43 of the 

contiguous States, and as a threatened 

species in the States of Michigan, 

Minnesota, Wisconsin, Oregon, and 

Washington (43 FR 6230). Sub-specific 

designations for northern and southern 

eagles were removed. 


sroberts on DSKD5P82C1PROD with PROPOSALS