65580 Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Proposed Rules 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 721 and 799 

[EPA–HQ–OPPT–2010–0520; FRL–8876–6] 

RIN 2070–AJ66 

Certain High Production Volume 

Chemicals; Test Rule and Significant 

New Use Rule; Fourth Group of 

Chemicals 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to issue a 

test rule under Toxic Substances 

Control Act (TSCA) section 4(a)(1)(B) to 

require manufacturers and processors of 

23 high production volume (HPV) 

chemical substances to develop 

screening-level health, environmental, 

and fate data based on the potential for 

substantial exposures of workers and 

consumers to these chemicals. EPA is 

also proposing to issue simultaneously 

a significant new use rule (SNUR) for 

another 22 HPV chemical substances 

under TSCA section 5(a)(2). The SNUR 

would require persons to file a 

significant new use notice (SNUN) with 

EPA prior to manufacturing, importing, 

or processing any of these chemical 

substances for use in a consumer 

product or for any use, or combination 

of uses, that is reasonably likely to 

expose 1,000 or more workers at a single 

corporate entity. The required 

notification would provide EPA with 

the opportunity to evaluate the intended 

use and, if necessary, to prohibit or limit 

that activity before it occurs. EPA is also 

soliciting comment on a number of 

issues with regard to both the test rule 

and the SNUR. 

DATES: Comments must be received on 

or before January 19, 2012. 

You may submit a request for an 

opportunity to present oral comments. 

This request must be made in writing. 

If such a request is received on or before 

January 19, 2012, EPA will hold a 

public meeting on this proposed rule in 

Washington, DC. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2010–0520, 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–2010–0520. 

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

Monday through Friday, excluding legal 

holidays. The telephone number for the 

DCO is (202) 564–8930. Such deliveries 

are only accepted during the DCO’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPPT– 

2010–0520. 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 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 

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. 

Submission of requests: You may 

submit a request for an opportunity to 

present oral comments. This request 

must be made in writing and submitted 

to the mailing or hand delivery 

addresses provided in this unit. If such 

a request is received, EPA will 

announce the scheduling of the public 

meeting in a subsequent document in 

the Federal Register. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Robert 

Jones (test rule) or Amy Breedlove 

(SNUR), Chemical Control Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–8161 or (202) 564– 

9823; e-mail address: 

jones.robert@epa.gov or 

breedlove.amy@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; e-mail address: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

these actions if you manufacture 

(defined by statute to include import) or 

process any of the chemical substances 

that are listed in Tables A. or B. in Unit 

III. Potentially affected entities may 

include, but are not limited to: 

• Manufacturers (defined by statute to 

include importers) of one or more of the 

subject chemical substances (NAICS 

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

manufacturing and petroleum refineries. 

• Processors of one or more of the 

subject chemical substances (NAICS 

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

manufacturing and petroleum refineries. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 


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Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Proposed Rules 65581 

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. 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. 

This action may also affect certain 

entities through pre-existing import 

certification and export notification 

rules under TSCA. See Unit VI. for 

export notification requirements. 

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. 

If such a request is received on or before 

January 19, 2012, 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 and 

why? 

Congress gave EPA (also referred to as 

‘‘Agency’’) broad authority to require 

testing of chemical substances when 

EPA can establish a minimum level of 

risk concern for a chemical substance 

(hazard and exposure are considered), 

and/or when EPA can establish that 

there is or may be substantial 

production and release or exposure of a 

chemical substance (production volume 

and exposure are considered). HPV 

chemical substances often have either 

significant release or human exposure 

scenarios that would stimulate EPA 

interest and support an EPA decision to 

require testing or to require notification 

before additional exposures occur. EPA 

is proposing to regulate 45 HPV 

chemical substances with either a test 

rule or a SNUR. EPA is proposing a test 

rule under TSCA section 4(a)(1)(B) for 

23 of these 45 HPV chemical substances 

and a SNUR under TSCA section 5(a)(2) 

for the other 22 HPV chemical 

substances (see Tables A. and B. in Unit 

III.). 

These 45 HPV chemical substances 

are among the chemical substances that 

were included in EPA’s HPV Challenge 

Program (hereafter HPV Challenge) 

initiated in 1998. Of the 2,782 chemical 

substances originally included in the 

HPV Challenge, 1,858 were officially 

sponsored either directly in the HPV 

Challenge or indirectly through 

international efforts, although 5 were 

later withdrawn. Another 416 of the 

2,782 chemical substances were 

removed from the scope of the HPV 

Challenge for a variety of reasons (e.g., 

polymers, inorganics, etc.). The 

remaining 508 of the 2,782 chemical 

substances were termed ‘‘orphans’’ 

because they were not sponsored and 

there were no other factors that removed 

the chemical substances from the scope 

of the HPV Challenge. Of the 508 

orphans, 405 are no longer produced at 

HPV levels. Of the remaining 103 

chemical substances, 63 have been 

included in one of three test rules, or 

EPA has otherwise received data 

adequate to meet its needs. The 

remaining 40, plus the 5 chemical 

substances whose HPV Challenge 

sponsorships were withdrawn, are the 

subject of this proposed test rule and 

SNUR. For more information on the 

HPV Challenge go to http:// 

www.epa.gov/hpv/ or see the Federal 

Register of March 16, 2008 (71 FR 

13708) (FRL–7335–2). This action 

contains the fourth and final test rule in 

the series and includes the last 

unsponsored/orphan chemical 

substances in the HPV Challenge. 

The data that EPA seeks through the 

HPV Challenge is the Screening 

Information Data Set (SIDS) developed 

by the Organisation for Economic Cooperation and Development (OECD), of 

which the United States is a member. 

SIDS consists of tests for six endpoints 

(Ref. 1), including acute toxicity, 

repeated dose toxicity, developmental 

and reproductive toxicity, genetic 

toxicity, ecotoxicity, and environmental 

fate. The six SIDS endpoints provide a 

minimum, internationally-agreed-upon 

set of test data for screening HPV 

chemical substances for human and 

environmental hazards, and assist EPA 

and others in making an informed, 

preliminary judgment about the hazards 

of HPV chemical substances. 

B. What is the agency’s authority for 

taking these actions? 

1. Test rule. EPA is proposing this test 

rule under TSCA section 4(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: 

i. A chemical substance or mixture is 

or will be produced in substantial 

quantities, and (1) it enters or may 

reasonably be anticipated to enter the 

environment in substantial quantities or 

(2) 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 


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65582 Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Proposed Rules 

substance or mixture or of any 

combination of such activities on health 

or the environment can reasonably be 

determined or predicted. 

iii. Testing of such substance or 

mixture with respect to such effects is 

necessary to develop such data. 

2. SNUR. Section 5(a)(2) of TSCA 

authorizes EPA to determine that a use 

of a chemical substance is a ‘‘significant 

new use.’’ EPA must make this 

determination by rule after considering 

all relevant factors, including those 

listed in TSCA section 5(a)(2). Once 

EPA determines that a use of a chemical 

substance is a significant new use, 

TSCA section 5(a)(1)(B) requires persons 

to submit a SNUN to EPA at least 90 

days before they manufacture, import, 

or process the chemical substance for 

that use. 

C. Applicability of General Provisions 

1. Test rule. General provisions for 

test rules appear under 40 CFR part 790 

(subparts A, B, C, and E), 40 CFR part 

791, 40 CFR part 792, and 40 CFR part 

799 (subpart A). 40 CFR part 790, 

subpart A, describes the scope, purpose, 

and authority for test rules and consent 

agreements, provisions for submitting 

information to the Agency, and the 

treatment of confidential business 

information. 40 CFR part 790, subpart B 

covers the procedures for developing 

consent agreements and test rules. 40 

CFR part 790, subpart C covers the 

implementation, enforcement, and 

modification of test rules. This subpart 

includes information about persons 

subject to testing and required to submit 

letters-of-intent to conduct testing and 

persons who must submit testing 

exemption applications, and includes 

information about the submission of 

study plans and how to modify test 

standards and schedules if necessary. 

Subpart E of 40 CFR part 790 provides 

detailed information about exemptions 

from test rules. 40 CFR parts 791 and 

792 respectively cover provisions for 

data reimbursement and required good 

laboratory practice standards. 40 CFR 

part 799, subpart A, provides additional 

information on the scope and purpose of 

the rule, the applicability of the rule, 

submitting information, test standards, 

the availability of test guidelines, 

distinguishing positive and negative 

results, the effects of non-compliance, 

chemicals for which the testing 

reimbursement period has passed, and 

imports and exports. 

Persons who export or intend to 

export a chemical substance identified 

in a final test rule are subject to the 

export notification provisions of TSCA 

section 12(b). Regulations that interpret 

TSCA section 12(b) appear at 40 CFR 

part 707, subpart D, notices of export 

under section 12(b). 

2. SNUR. General provisions for 

SNURs appear under 40 CFR part 721, 

subpart A. These provisions describe 

persons subject to the rule, 

recordkeeping requirements, 

exemptions to reporting requirements, 

and applicability of the rule to uses 

occurring before the effective date of the 

final rule. Provisions relating to user 

fees appear at 40 CFR part 700. 

According to 40 CFR 721.1(c), persons 

subject to SNURs must comply with the 

same notice requirements and EPA 

regulatory procedures as submitters of 

Premanufacture Notices (PMNs) under 

TSCA section 5(a)(1)(A). In particular, 

these requirements include the 

information submission requirements of 

TSCA section 5(b) and 5(d)(1), the 

exemptions authorized by TSCA section 

5(h)(1), (h)(2), (h)(3), and (h)(5), and the 

regulations at 40 CFR part 720. Once 

EPA receives a SNUN, EPA may take 

regulatory action under TSCA section 

5(e), 5(f), 6 or 7 to control the activities 

on which it has received the SNUN. If 

EPA does not take action, EPA is 

required under TSCA section 5(g) to 

explain in the Federal Register its 

reasons for not taking action. 

D. What is the agency’s ‘‘B Policy’’? 

TSCA section 2(b) states that it is the 

policy of the United States that: (1) 

Adequate data should be developed 

with respect to the effect of chemical 

substances and mixtures on health and 

the environment and that the 

development of such data should be the 

responsibility of those who manufacture 

and those who process such chemical 

substances and mixtures; (2) adequate 

authority should exist to regulate 

chemical substances and mixtures 

which present an unreasonable risk of 

injury to health or the environment and 

to take action with respect to chemical 

substances and mixtures which are 

imminent hazards; and (3) authority 

over chemical substances and mixtures 

should be exercised in such a manner as 

not to impede unduly or create 

unnecessary economic barriers to 

technological innovation while fulfilling 

the primary purpose of this Act to 

assure that such innovation and 

commerce in such chemical substances 

and mixtures do not present an 

unreasonable risk of injury to health or 

the environment (15 U.S.C. 2601(b)(1)). 

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

and requires EPA to issue a test rule for 

a chemical substance if EPA finds, 

among other things, that the chemical 

substance ‘‘is or will be produced in 

substantial quantities’’ and either 

‘‘enters or may reasonably be 

anticipated to enter the environment in 

substantial quantities’’ or ‘‘there is or 

may be significant or substantial human 

exposure.’’ 

TSCA, however, does not say what is 

‘‘significant’’ or ‘‘substantial’’ under 

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

therefore, published a policy, known as 

the ‘‘B Policy,’’ in 1993 (Ref. 2) for 

aiding in the determination of when 

production or environmental release is 

substantial or when human exposure is 

either significant or substantial for the 

purpose of issuing a test rule under 

TSCA section (4)(a)(1)(B). Under the ‘‘B 

Policy,’’ ‘‘produced in substantial 

quantities’’ generally means 

manufactured or imported in one 

million pounds or more per year; a 

‘‘substantial environmental release’’ is 

generally either one million pounds per 

year or ten percent of total 

manufactured and imported volume, 

whichever is less; and ‘‘substantial 

human exposure’’ is generally 100,000 

or more people in the general 

population, or 10,000 or more 

consumers, or 1,000 or more workers. 

E. Why is the agency proposing both a 

test rule and a SNUR? 

EPA is proposing these two actions 

together because the Agency believes 

the actions are complementary and will 

best ensure these HPV chemicals are 

adequately evaluated by the Agency. For 

example, if EPA receives comments on 

this proposal sufficient to establish that 

one of the 23 chemical substances 

proposed to be regulated under the test 

rule is not used in a way that meets the 

substantial exposure criteria, but 

information received indicates that the 

chemical substance meets the criteria 

for the SNUR, EPA intends to include 

the chemical substance in the final 

SNUR rather than the test rule, without 

further public notice and comment. 

Simply removing such a chemical 

substance from the test rule in such 

circumstances, without including it in 

the SNUR, would not provide a 

regulatory mechanism for timely 

notification to EPA in the event of 

changed circumstances that would 

likely justify the issuance of a test rule 

for the chemical substance. Further, if 

public comment on these proposed 

actions is sufficient to establish that any 

of the uses to be covered for the 22 

chemical substances proposed in the 

SNUR are, in fact, on-going, yet such 

comments also establish that there is 

already substantial exposure to the 

chemical substance, EPA intends to 

review the status of the chemical 

substance and, as warranted, take 

appropriate steps to promulgate a test 

rule rather than a SNUR for the 


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Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Proposed Rules 65583 

chemical substance. Unit IV. of this 

document details the proposed findings 

to issue a test rule for the 23 chemical 

substances listed in Table A. and 

provides additional discussion 

pertaining to whether the promulgation 

of a test rule for 22 chemical substances 

listed in Table B. may be warranted. 

Unit V. of this document details the 

proposed findings to issue a SNUR for 

the 22 chemical substances listed in 

Table B. and the basis to issue a SNUR 

for the 23 chemical substances listed in 

Table A. in the event that public 

comments provide additional data 

establishing that, for one or more of 

such chemical substances, there is no 

ongoing use in a consumer product and 

no ongoing use reasonably likely to 

expose 1,000 or more workers. 

F. What are some future considerations? 

One of EPA’s top priorities is to 

assure the safety of chemical substances 

in commerce. Under TSCA, EPA has a 

primary mission to identify and, where 

appropriate, control unreasonable risks 

of manufacturing, processing, 

distribution in commerce, use, and 

disposal of chemical substances. It is 

essential that chemical substance review 

be supported by information sufficient 

to allow informed decision making and 

that information and decisions are of 

high quality and are widely 

understandable. As such, EPA continues 

to collect information from existing 

sources, to request new and better 

information where it is determined to be 

needed, and to make all supporting 

information publicly available, to the 

extent permitted under TSCA section 14 

and 40 CFR part 2. Open access to 

information allows individuals, 

communities, businesses, and 

governments to make informed 

decisions and policies that incorporate 

environmental and health 

considerations and minimize external 

and/or unintended harmful impacts. 

Therefore, EPA intends to continue to 

focus on filling data needs on priority 

chemical substances, including high 

production volume chemical 

substances. EPA is interested in 

stakeholder input on a number of issues 

described in this section. Some specific 

issues EPA has identified to date follow. 

1. Coordination of simultaneous test 

rule and SNUR proposals. In this action, 

EPA is simultaneously proposing a test 

rule and SNUR to regulate two sets of 

chemical substances. EPA believes that 

this is an efficient way to require 

submission of test data on chemical 

substances that meet all of the necessary 

test rule criteria and (for the latter group 

of chemical substances) to require 

submission of advance notification to 

EPA of use in a consumer product or of 

any use, or combination of uses, that is 

reasonably likely to expose 1,000 or 

more workers. With respect to chemical 

substances that meet some, but 

potentially not all test rule criteria, the 

SNUR also facilitates efficiency by 

mitigating the need for EPA to 

continually reevaluate each HPV 

chemical substance to determine 

whether exposure potential has 

changed. EPA is considering issuing 

further coordinated proposals of test 

rules and SNURs. This would occur in 

conjunction with future Inventory 

Update Reporting (IUR) rule data 

releases, covering all newly-HPV 

chemical substances. EPA requests 

comment on this approach. In 

September 2011, the IUR was renamed 

Chemical Data Reporting (CDR) and 

moved from 40 CFR part 710 subpart C 

to 40 CFR part 711 (76 FR 50816, 

August 16, 2011) (FRL–8872–9). For 

more information on this change go to 

http://www.epa.gov/cdr. 

2. Minimum data set. For more than 

15 years, EPA has used OECD’s SIDS to 

facilitate and standardize the screening 

of the relatively large number of HPV 

chemical substances on the TSCA 

Inventory. EPA requests comment on 

whether SIDS continues to be the most 

appropriate data set to screen chemical 

substances for potential environmental 

and health hazards. Are additional or 

different tests also appropriate? Should 

EPA consider having more than one 

screening data set depending on the 

nature of exposures (e.g., a different set 

of tests for children’s exposures or 

environmental releases)? 

3. Computational toxicology. The U.S. 

National Academy of Sciences National 

Research Council in their 2007 report 

‘‘Toxicity Testing in the 21st Century: A 

Vision and a Strategy’’ (Ref. 3) 

encouraged ‘‘work[ing] towards a 

transition to new integrative and 

predictive molecular and computational 

techniques to enhance efficiency and 

accuracy and to reduce reliance on 

animal testing.’’ EPA requests 

suggestions on practical, implementable 

ways to work toward this goal in its 

actions under TSCA. Should tools such 

as ToxCast (at http://www.epa.gov/ 

comptox/toxcast) (Ref. 4) be used to 

prioritize chemical substances and 

support hazard findings for testing? 

III. Chemical Substances Subject to 

This Action 

The 45 chemical substances included 

in this action are the remaining 

unsponsored/orphan chemical 

substances, which have not previously 

been subject to test rules or other HPV 

Challenge-related follow-up actions. 

EPA is proposing to issue a test rule 

under TSCA section 4(a)(1)(B) for the 23 

chemical substances listed in Table A. 

in this unit and proposing to establish 

a SNUR under TSCA section 5(a)(2) for 

the other 22 chemical substances (see 

Table B. in this unit). Respecting the 23 

chemical substances proposed for a 

section 4(a)(1)(B) test rule (i.e., those in 

Table A.), in the event that public 

comments provide additional data 

respecting any of these chemical 

substances, establishing that there is no 

ongoing use in a consumer product and 

no ongoing use reasonably likely to 

expose 1,000 or more workers for any 

such substance, EPA intends to finalize 

a SNUR for each such chemical 

substance. Finally, with respect to the 

22 chemical substances proposed for a 

SNUR (i.e., those in Table B.), in the 

event that public comments provide 

additional data establishing that there is 

already substantial exposure to the 

chemical substance, EPA intends to 

review the status of the chemical 

substance and, as warranted, take 

appropriate steps to promulgate a 

section 4(a)(1)(B) test rule for the 

chemical substance. For each of these 

chemical substances, Tables A. and B. 

provide the Chemical Abstract (CA) 

Index Name, Chemical Abstract Service 

(CAS) Registry Number (CASRN), and 

2006 IUR information on production 

volume, number of workers exposed, 

and commercial/consumer uses. 

Substantial worker exposure is deduced 

from the number of workers reported. 

Substantial consumer exposure is 

deduced from production volume and 

consumer uses if production volume 

exceeds one million pounds per year 

and consumer uses are indicated, it is 

likely that consumer exposure exceeds 

ten thousand people. 

For each of the test rule candidate 

chemical substances, EPA has used the 

2006 IUR information to preliminarily 

determine that the chemical substance 

is produced in substantial quantities 

and that there is substantial human 

exposure. For each of the significant 

new use (SNU) candidates, EPA has 

considered the 2006 IUR information in 

determining the proposed SNU 

designations. These findings are 

discussed further in Unit IV.A.1., Unit 

V.A., and Ref. 5. 


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TABLE A—CHEMICAL SUBSTANCES FOR WHICH A TEST RULE IS PROPOSED AND FOR WHICH A SNUR IS BEING

CONSIDERED AS AN ALTERNATIVE OPTION

CASRN CA Index name 

2006 IUR 

production 

volume 

(million lbs.) 

2006 IUR 

number of 

workers 

exposed 

Chemical 

substance 

meets the 

‘‘B 

finding’’ 

criteria of 

≥1,000 workers exposed 

Commercial/Consumer uses 

indicated in 2006 IUR 

Chemical 

substance 

meets the 

‘‘B finding’’ 

criteria of 

≥10,000 

consumers 

exposed 

56–40–6 ....... Glycine ..................................... 1 ≤ 10 .......... 1,000+ ......... Yes .............. Other; CBI ................................ Yes. 

67–72–1 ....... Ethane, 1,1,1,2,2,2-hexachloro- 1 ≤ 10 .......... 1,000+ ......... Yes .............. None ......................................... No. 

78–00–2 ....... Plumbane, tetraethyl- ............... 1 ≤ 10 .......... 100–999 ...... No ................ Lubricants, greases and fuel 

additives.

Yes. 

95–14–7 ....... 1H-Benzotriazole ...................... 1 ≤ 10 .......... 100–999 ...... No ................ Lubricants, greases and fuel 

additives; metal products; 

other.

Yes. 

118–48–9 ..... 2H-3,1-Benzoxazine-2,4(1H)- 

dione.

10 ≤ 50 ........ 100–999 ...... No ................ Agricultural products (non-pesticidal); other.Yes. 

128–44–9 ..... 1,2-Benzisothiazol-3(2H)-one, 

1,1-dioxide, sodium salt (1:1).

1 ≤ 10 .......... 100–999 ...... No ................ Other ........................................ Yes. 

928–72–3 ..... Glycine, N-(carboxymethyl)-, 

sodium salt (1:2).

500 ≤ 1,000 1,000+ ......... Yes .............. None ......................................... No. 

1809–19–4 ... Phosphonic acid, dibutyl ester 1 ≤ 10 .......... 1,000+ ......... Yes .............. CBI ........................................... Yes. 

25377–73–5 2,5-Furandione, 3-(dodecen-1- 

yl)dihydro-.

1 ≤ 10 .......... 1–99 ............ No ................ Other ........................................ Yes. 

26544–38–7 2,5-Furandione, dihydro-3- 

(tetrapropenyl)-.

1 ≤ 10 .......... 100–999 ...... No ................ Lubricants, greases and fuel 

additives; paints and coatings; not readily obtainable 

(NRO).

Yes. 

27859–58–1 Butanedioic acid,2- 

(tetrapropenyl)-.

1 ≤ 10 .......... 1,000+ ......... Yes .............. Lubricants, greases and fuel 

additives; CBI.

Yes. 

28777–98–2 2,5-Furandione, dihydro-3- 

(octadecen-1-yl)-.

10 ≤ 50 ........ 100–999 ...... No ................ Paper products ......................... Yes. 

29385–43–1 1H-Benzotriazole, 6(or75)- 

methyl-.

1 ≤ 10 .......... 100–999 ...... No ................ Lubricants, greases and fuel 

additives.

Yes. 

32072–96–1 2,5-Furandione, 3-(hexadecen1-yl)dihydro-.50 ≤ 100 ...... 1,000+ ......... Yes .............. Paper products ......................... Yes. 

61789–73–9 Quaternary ammonium compounds, 

benzylbis(hydrogenated tallow alkyl)methyl, chlorides.

1 ≤ 10 .......... 100–999 ...... No ................ CBI ........................................... Yes. 

64665–57–2 1H-Benzotriazole, 6(or7)-methyl-, sodium salt.1 ≤ 10 .......... 100–999 ...... No ................ Other ........................................ Yes. 

68131–13–5 Naphthenic acids, reaction 

products with 

diethylenetriamine.

1 ≤ 10 .......... 1,000+ ......... Yes .............. None ......................................... No. 

68153–60–6 Fatty acids, tall-oil, reaction 

products with 

diethylenetriamine, acetates.

1 ≤ 10 .......... 1,000+ ......... Yes .............. None ......................................... No. 

68424–85–1 Quaternary ammonium compounds, benzyl-C12-16- 

alkyldimethyl, chlorides.

1 ≤ 10 .......... 1,000+ ......... Yes .............. Other; CBI ................................ Yes. 

68442–77–3 2-Butenediamide, (2E)-, N1,N4- 

bis[2-(4,5-dihydro-2-nortall-oil 

alkyl-1H-imidazol-1-yl)ethyl] 

derivs.

1 ≤ 10 .......... 1,000+ ......... Yes .............. None ......................................... No. 

68607–28–3 Quaternary ammonium compounds, (oxydi-2,1- 

ethanediyl)bis[coco 

alkyldimethyl, dichlorides.

1 ≤ 10 .......... 1,000+ ......... Yes .............. Other ........................................ Yes. 

68909–18–2 Pyridinium, 1-(phenylmethyl)-, 

Et Me derivs., chlorides.

1 ≤ 10 .......... 1,000+ ......... Yes .............. Other ........................................ Yes. 

69834–17–9 Benzene, decylphenoxy- .......... 1 ≤ 10 .......... 100–999 ...... No ................ Soaps and detergents .............. Yes. 


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TABLE B—LIST OF CHEMICAL SUBSTANCES FOR WHICH A SNUR IS PROPOSED AND FOR WHICH A TEST RULE IS BEING

CONSIDERED AS AN ALTERNATIVE OPTION

CASRN CA Index name 

2006 IUR 

production 

volume 

(million 

lbs.) 

2006 IUR 

number of 

workers 

exposed 

Chemical 

substance 

meets the 

‘‘B finding’’ 

criteria of 

≥ 1,000 

workers 

exposed 

Commercial/consumer uses indicated in 2006 IUR 

Chemical 

substance 

meets the 

‘‘B finding’’ 

criteria of 

≥ 10,000 

consumers 

exposed 

98–16–8 ........ Benzenamine, 3-(trifluoromethyl)- ......................... 1 ≤ 10 ...... 1–99 ........ No ............ None ...................... No. 

100–53–8 ...... Benzenemethanethiol ............................................ 1 ≤ 10 ...... 1–99 ......... No ............ None ...................... No. 

104–91–6 ...... Phenol, 4-nitroso- .................................................. 1 ≤ 10 ...... 1–99 ......... No ............ None ...................... No. 

110–03–2 ...... 2,5-Hexanediol, 2,5-dimethyl- ............................... 1 ≤ 10 ...... 100–999 .. No ............ None ...................... No. 

124–63–0 ...... Methanesulfonyl chloride ....................................... 1 ≤ 10 ...... 100–999 .. No ............ None ...................... No. 

142–30–3 ...... 3-Hexyne-2,5-diol, 2,5-dimethyl- ........................... 1 ≤ 10 ...... 100–999 .. No ............ None ...................... No. 

460–00–4 ...... Benzene, 1-bromo-4-fluoro- .................................. 1 ≤ 10 ...... 100–999 .. No ............ Not readily obtainable (NRO).No. 

542–92–7 ...... 1,3-Cyclopentadiene .............................................. 1 ≤ 10 ...... 1–99 ........ No ............ None ...................... No. 

553–26–4 ...... 4,4′-Bipyridine ........................................................ 10 ≤ 50 .... 100–999 .. No ............ None ...................... No 

8007–45–2 .... Tar, coal ................................................................ 1 ≤ 10 ...... 1–99 ........ No ............ None ...................... No. 

28106–30–1 .. Benzene, ethenylethyl- .......................................... 1 ≤ 10 ...... 100–999 ... No ............ None ...................... No. 

35203–06–6 .. Benzenamine, 2-ethyl-6-methyl-N-methylene- ...... 10 ≤ 50 .... 1–99 ........ No ............ None ...................... No. 

35203–08–8 .. Benzenamine, 2,6-diethyl-N-methylene- ............... 10 ≤ 50 .... 1–99 ........ No ............ None ...................... No. 

37734–45–5 .. Carbonochloridothioic acid, S-(phenylmethyl) 

ester.

1 ≤ 10 ...... 100–999 .. No ............ None ...................... No. 

37764–25–3 .. Acetamide, 2,2-dichloro-N,N-di-2-propen-1-yl- ..... 1 ≤ 10 ...... 1–99 ......... No ............ None ...................... No. 

61789–72–8 .. Quaternary ammonium compounds, benzyl(hydrogenated tallow alkyl)dimethyl, 

chlorides.

1 ≤ 10 ...... 100–999 ... No ............ None ...................... No. 

61790–13–4 .. Naphthenic acids, sodium salts ............................ 1 ≤ 10 ...... 100–999 .. No ............ None ...................... No. 

65996–91–0 .. Distillates (coal tar), upper .................................... 1 ≤ 10 ...... 100–999 .. No ............ None ...................... No. 

68308–01–0 .. Tail gas (petroleum), cracked distillate 

hydrotreater stripper.

10 ≤ 50 .... 100–999 ... No ............ None ...................... No. 

68478–20–6 .. Residues (petroleum), steam-cracked petroleum 

distillates cyclopentadiene conc., C4- 

cyclopentadiene-free.

10 ≤ 50 .... 1–99 ......... No ............ None ...................... No. 

68526–82–9 .. Alkenes, C6-10, hydroformylation products, highboiling.1 ≤ 10 ...... 100–999 .. No ............ NRO ....................... No. 

68909–77–3 .. Ethanol, 2,2′-oxybis-, reaction products with ammonia, morpholine derivs. residues.1 ≤ 10 ...... 100–999 ... No ............ None ...................... No. 

IV. Proposed Section 4(a)(1)(B) Test 

Rule and Basis to Also Consider Table 

B. Chemical Substances for a Section 

4(a)(1)(B) Test Rule 

A. What are the proposed findings? 

1. Exposure findings. EPA is 

proposing to require testing of the 

chemical substances listed in Table A. 

based on its preliminary findings under 

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

‘‘substantial’’ production and 

‘‘substantial human exposure,’’ as well 

as findings under TSCA sections 

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

insufficient data and the need for 

testing. The chemical substances in 

Table A. are also listed in Table 2. of 

§ 799.5090(j) of the proposed regulatory 

text along with their CASRNs. 

i. Are these chemical substances 

produced in substantial quantities? EPA 

has made preliminary findings that each 

of the chemical substances included in 

this proposed test rule are produced in 

substantial quantities. In accordance 

with the ‘‘B policy’’ (discussed in Unit 

II.D.), each of these substances is 

manufactured (which, as noted in Unit 

I.A., includes imported) in an amount 

equal to or greater than 1 million lbs. 

per year (Ref. 5). These findings are 

based on information gathered in the 

2006 IUR the most recently available 

compilation of IUR (now CDR) data. 

ii. Are a substantial number of 

workers exposed to these chemical 

substances? EPA has made preliminary 

findings that the manufacture, 

processing, and use of 12 of the 23 

chemical substances listed in Table A. 

result or may result in exposure of a 

substantial number of workers to the 

chemical substances (Ref. 5). 

For chemical substances whose total 

production volume (manufactured and 

imported) exceeded 300,000 lbs. at a site 

during calendar year 2005, 

manufacturers (which as noted in Unit 

I.A., includes importers) were required 

through the 2006 IUR to report the 

number of potentially exposed workers 

during industrial processing and use to 

the extent the information was readily 

obtainable. Manufacturers of 12 of the 

23 chemical substances listed in Table 

A. reported that more than 1,000 

workers or more were potentially 

exposed to these chemical substances. 

Based on the threshold values stated in 

EPA’s ‘‘B Policy,’’ EPA believes that an 

exposure of 1,000 workers or more on a 

routine or episodic basis to a chemical 

substance or mixture is ‘‘substantial’’ as 

that term is used with reference to 

‘‘human exposure’’ in TSCA section 

4(a)(1)(B)(i). Therefore, EPA’s 

preliminary finding is that there is or 

may be substantial human exposure 

(workers) to 12 of these 23 chemical 

substances. 

iii. Are a substantial number of 

consumers exposed to these chemical 

substances? EPA has made preliminary 

findings that the manufacture, 

processing, and use of 18 of the 23 

chemical substances listed in Table A. 

result or may result in exposure of a 

substantial number of consumers to the 

chemical substances (Ref. 5). 


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In addition to worker exposure 

information, manufacturers of more 

than 300,000 lbs. of a given chemical 

substance at a site during calendar year 

2005 were required to provide 

information regarding the commercial 

and consumer uses of the chemical 

substance. EPA reviewed the consumer 

use information reported for the 2006 

IUR and carefully considered the nature 

of those uses. These 18 chemical 

substances were found to be used in 

such products as tires, footwear, 

flooring, bottles, sporting equipment, 

games, soaps and detergents, and paper 

products. Based on this review, EPA has 

preliminarily concluded that the 

reported consumer uses may result in 

exposures to at least 10,000 consumers. 

Based on the threshold values stated in 

EPA’s ‘‘B Policy,’’ EPA believes that an 

exposure of 10,000 consumers or more 

to a chemical substance is ‘‘substantial’’ 

as that term is used with reference to 

‘‘human exposure’’ in TSCA section 

4(a)(1)(B)(i). Therefore, EPA’s 

preliminary finding is that there is or 

may be substantial human exposure 

(consumers) to 18 of these 23 chemical 

substances. 

2. Are sufficient data available to 

evaluate these chemical substances? 

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

has preliminarily determined for the 

chemical substances in Table A. that 

there are insufficient data and 

experience to reasonably determine or 

predict the effects of the manufacture, 

distribution in commerce, processing, 

use, or disposal of these chemical 

substances, or of any combination of 

such activities, on human health or the 

environment. 

In developing the testing 

requirements for chemical substances 

contained in Table A., EPA searched for 

available information on chemical/ 

physical properties, environmental fate, 

ecotoxicity and human health effects, 

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. 1) such as: The 

Beilstein Database, Chemical Rubber 

Company’s Handbook of Chemistry and 

Physics, Hawley’s Condensed Chemical 

Dictionary, Illustrated Handbooks of 

Physical-Chemical Properties and 

Environmental Fate for Organic 

Chemicals, Merck Index, Hazardous 

Substances Data Bank (HSDB), 

Toxicology Literature Online 

(TOXLINE), and the National Technical 

Information Service (NTIS). EPA also 

searched for available data as 

summarized in its HPV Information 

System (HPVIS) (Ref. 6). 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 Web site (http:// 

www.epa.gov/hpv): ‘‘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. 

1). The results of EPA’s data adequacy 

analysis can be found in the HPV4 Data 

Adequacy Evaluations document 

(Ref. 7). 

Section 799.5090(j) of the proposed 

regulatory text lists each chemical 

substance and the SIDS tests for which 

adequate data are not currently available 

to the Agency. The Agency 

preliminarily finds that the existing data 

for one or more of the SIDS testing 

endpoints for each of the chemical 

substances listed in Table 2. in 

§ 799.5090(j) of the proposed regulatory 

text (i.e., chemical substances in Table 

A.) are insufficient to enable EPA to 

reasonably determine or predict the 

human health and environmental effects 

resulting from manufacture, distribution 

in commerce, processing, use, and 

disposal of 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 may prepare a robust 

summary (Ref. 8) for each such study to 

facilitate EPA’s review of the full study 

report or publication. 

Persons who believe that adequate 

information regarding a chemical 

substance 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 substantiating 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. 

3. Is testing necessary for these 

chemical substances? EPA has also 

found preliminarily that testing the 23 

chemical substances identified in Table 

A. is necessary to develop the needed 

data (TSCA section 4(a)(1)(B)(iii)). EPA 

has not identified any ‘‘additional 

factors’’ as discussed in the ‘‘B Policy’’ 

(Ref. 2, p. 28743) to cause the Agency 

to use decision making criteria other 

than those described in the ‘‘B Policy.’’ 

EPA knows of no other means to 

generate the SIDS data other than the 

testing proposed in this document, and 

therefore has preliminarily found that 

conducting the needed SIDS testing 

identified for the 23 chemical 

substances in Table A. 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. 

B. What is the basis to also consider 

chemical substances from Table B. for 

testing under section 4(a)(1)(B)? 

As an alternative to issuing a SNUR, 

EPA is considering requiring testing of 

one or more of the chemical substances 

listed in Table B. EPA will consider this 

approach based on its preliminary 

findings under TSCA section 

4(a)(1)(B)(i) relating to ‘‘substantial’’ 

production, its further analysis of the 

factors listed under TSCA sections 4 

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

insufficient data and the need for testing 

and additional data received in public 

comments. If information received in 

public comments establishes that 

consumer uses, or uses that could affect 

1,000 workers or more, are already 

ongoing, then that information may 

indicate that a SNUR is inappropriate 

for the particular chemical substance 

listed in Table B. The same information, 

however, may prompt EPA to conclude 

that a test rule is appropriate for such 

a substance, since evidence of ongoing 

use may also be evidence of substantial 

human exposure. If public comments 

provide the basis to conclude that there 

is already or may be substantial human 

exposure to one of the chemical 

substances in Table B., and there is a 

basis to make the other findings 

required under TSCA sections 4 

(a)(1)(B)(ii) and (a)(1)(B)(iii), then EPA 

intends to review the status of the 

chemical substance and, as warranted, 

take appropriate steps to promulgate a 

test rule rather than a SNUR for the 

chemical substance. 

EPA has made preliminary findings 

that each of the chemical substances 

listed in Table B. are produced in 

substantial quantities (manufactured, 

including imported, in an amount equal 

to or greater than 1 million lbs. per year 

(Ref. 5)). These findings are based on 

information gathered in the 2006 IUR 


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rule. The 2006 data are the most 

recently available compilation of IUR 

(now CDR) data. 

C. What testing is being proposed in this 

action and is also being considered for 

chemical substances in Table B.? 

EPA is proposing specific testing and 

reporting requirements for the chemical 

substances from Table A. (specified in 

§ 799.5090(j) of the proposed regulatory 

text) and is also considering the same 

requirements with respect to the 

chemical substances listed in Table B. 

All of the proposed testing requirements 

are listed in Table 2. in § 799.5090(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, to comply with the testing 

being proposed, EPA is proposing that 

testing must be conducted in 

accordance with ASTM International or 

TSCA 799 test guidelines. Note: ASTM 

issues its test methods under a fixed 

designation (e.g., E1719); the number 

immediately following the designation 

indicates the year of original adoption 

or, in the case of revision, the year of 

last revision. A number in parentheses 

indicates the year of last re-approval. A 

superscript epsilon (e) indicates an 

editorial change since the last revision 

or re-approval. 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 test standards are 

included in this proposed test rule. 

1. Physical/chemical properties. 

Melting Point: ASTM E 324–99 

(capillary tube) (Refs. 9 and 10). 

Boiling Point: ASTM E 1719–05 

(ebulliometry) (Ref. 11). Vapor Pressure: 

ASTM E 1782–08 (thermal analysis) 

(Ref. 12). n-Octanol/Water Partition 

Coefficient: Method A (40 CFR 

799.6755—shake flask); Method B 

(ASTM E 1147–92(2005)—liquid 

chromatography) (Ref. 13); Method C 

(40 CFR 799.6756—generator column). 

Water Solubility: Method A (ASTM E 

1148–02—shake flask) (Ref. 14); 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 Web site, http://www.

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. 15). 

ASTM International still makes the 

method available for informational 

purposes and it can still be purchased 

from ASTM International at the address 

listed in § 799.5090(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 those chemical substances that are 

liquid at room temperature, EPA is 

proposing a measured freezing point to 

meet the obligation to report the melting 

point. Since ASTM E 324–99 (capillary 

tube) does not specifically include 

instructions for determining freezing 

point, EPA is instead proposing to 

require, for substances which are liquid 

at room temperature, OECD 102 

(melting point/melting range), which 

includes guidance for determining 

freezing point (Ref. 10). 

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 C. 

of this unit and in Table 3. in 

§ 799.5090(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. 16) 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 substance 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 needs and, as 

such, are silent on experimental 

conditions related to pH. Therefore, 

EPA highly recommends that all 

required n-Octanol/Water Partition 

Coefficient tests be conducted at pH 7 

to ensure environmental relevance.’’ 

Table C. of this unit shows the proposed 

test standards and log Kow ranges that 

would determine which tests must be 

conducted for this endpoint. 


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65588 Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Proposed Rules 

TABLE C—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: 

n-Octanol/water partition coefficient 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) 

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. 17). 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 D. of this 

unit. 

TABLE D—TEST REQUIREMENTS FOR THE WATER SOLUBILITY ENDPOINT

Testing category Test requirements and references Special conditions 

Physical/chemical properties .............................. Water solubility: 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 (Re-approved 2008) (shake flask) 

Method B: 40 CFR 799.6784 (shake 

flask) 

Method C: 40 CFR 799.6784 (column 

elution) 

Method D: 40 CFR 799.6786 (generator 

column) 

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 milligrams/liters (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(Reapproved 2008) 

(Sealed vessel CO2 production test) (Ref. 

18); Method B—International 

Organization for Standardization (ISO) 

14593 (CO2 headspace test) (Ref. 19); 

Method C— ISO 7827 (Method by 

analysis of dissolved organic carbon 

(DOC)) (Ref. 20); Method D—ISO 9408 

(Determination of oxygen demand in a 

closed respirometer) (Ref. 21); Method 

E—ISO 9439 (Carbon dioxide evolution 

test) (Ref. 22); Method F—ISO 10707 

(Closed bottle test) (Ref. 23); Method 

G—ISO 10708 (Two-phase closed bottle 

test) (Ref. 24). 

For the ‘‘Ready Biodegradation’’ 

endpoint, EPA proposes an appropriate 

selection be made from among seven 

alternative methods for measuring the 

chemical 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, any test 

method used will depend on the 

physical and chemical properties of the 

test substance, including its water 

solubility. An additional document, ISO 

10631 (Ref. 25), provides guidance for 

selection of an appropriate test method 

for a given test substance considering 

the substance’s 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 

(2007)) (Ref. 26); Acute toxicity to 

Daphnia (ASTM E 729–96(2007)) (Ref. 

26); and Toxicity to plants (algae) 

(ASTM E 1218–04e1) (Ref. 27). Test 


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Group 2: Chronic toxicity to Daphnia 

(ASTM E 1193–97 (2004)) (Ref. 28); and 

Toxicity to plants (algae) (ASTM E 

1218–04e1) (Ref. 27). 

For the ‘‘Aquatic Toxicity’’ endpoint, 

the OECD HPV SIDS Program recognizes 

that, for certain chemical substances, 

acute toxicity studies are of limited 

value in assessing the chemical 

substance’s aquatic toxicity. This issue 

arises when considering chemical 

substances with high log Kow values. In 

such cases, toxicity is unlikely to be 

observed over the duration of acute 

toxicity studies because of reduced 

uptake and the extended amount of time 

required for such chemical substances 

to reach steady state or toxic 

concentrations in the test organism. For 

such situations, the OECD HPV SIDS 

Program recommends use of chronic 

toxicity testing in Daphnia in place of 

acute toxicity testing in fish and 

Daphnia. EPA is proposing that the 

aquatic toxicity testing requirement be 

determined based on the test chemical 

substance’s measured log Kow as 

determined by using the approach 

outlined in this unit in the discussion 

of ‘‘n-Octanol/Water Coefficient,’’ and 

in Table 3. in § 799.5090(j) of the 

proposed regulatory text. For test 

chemical 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 § 799.5090(j) of 

the proposed regulatory text) are 

proposed: Acute toxicity to fish (ASTM 

E 729–96 (2007)); Acute toxicity to 

Daphnia (ASTM E 729–96 (2007)); and 

Toxicity to plants (algae) (ASTM E 

1218–04e1). For test chemical 

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 

§ 799.5090(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 Unit IV.C.3. 

and in § 799.5090(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. 17, 29, and 30). A chemical 

substance with a fish BCF value of 1,000 

or more is characterized as having a 

tendency to accumulate in living 

organisms relative to the concentration 

of the chemical substance in the 

surrounding environment (Ref. 30). 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. 31). 

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. 32; 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. 32) 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 § 799.5090(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. 33) or 40 CFR 799.9110(d)(1)(i)(A)). 

For the ‘‘Mammalian Toxicity— 

Acute’’ endpoint, EPA is proposing that 

certain special conditions such as the 

chemical substance’s physical/chemical 

properties or physical state be 

considered in determining the 

appropriate test method from among 

those included for this endpoint in 

Table 3. in § 799.5090(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, EPA is proposing that, 

for test chemical 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 

§ 799.5090(j) of the proposed regulatory 

text). In the case of a potentially 

explosive test chemical substance, care 

must be taken to avoid the generation of 

explosive concentrations. For all other 

chemical substances (i.e., those that are 

either liquids or solids at room 

temperature), EPA is proposing that 

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 § 799.5090(j) of the proposed 

regulatory text). Consistent with the 

voluntary HPV Challenge, 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 (Refs. 

34 and 35). This test is included as a 

Special Condition in Table 3. in 

§ 799.5090(j) of the proposed regulatory 

text. A document developed by National 

Institutes of Health/National Institute 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. 

36). 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) Web site, http:// 

iccvam.niehs.nih.gov/methods/ 

acutetox/invitrocyto/invcyt_proto.htm 

(Refs. 34, 35, and 37). 

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). 


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Persons who would be required to 

conduct testing for chromosomal 

damage are encouraged to use in vitro 

genetic toxicity testing (i.e., the 

Mammalian Chromosome Aberration 

Test) to generate the needed genetic 

toxicity screening data, unless known 

chemical properties preclude its use. 

These could include, for example, 

physical chemical properties or 

chemical class characteristics. A 

primary focus of both the voluntary 

HPV Challenge 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. 

1). A person subject to this rule 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 in the final report a rationale for 

conducting that alternate test. 

6. Mammalian toxicity—repeated 

dose/reproduction/developmental. 

Combined Repeated Dose Toxicity 

Study with the Reproduction/ 

Developmental Toxicity Screening Test: 

40 CFR 799.9365. Reproduction/ 

Developmental Toxicity Screening Test: 

40 CFR 799.9355. Repeated Dose 28-Day 

Oral Toxicity Study: 40 CFR 799.9305. 

For the ‘‘Mammalian Toxicity— 

Repeated Dose/Reproduction/ 

Developmental’’ endpoint, EPA 

recommends the use of the Combined 

Repeated Dose Toxicity Study with the 

Reproduction/Developmental Toxicity 

Screening Test (40 CFR 799.9365) as the 

test of choice. EPA recognizes, however, 

that there may be reasons to test a 

particular chemical substance using 

both the Reproduction/Developmental 

Toxicity Screening Test (40 CFR 

799.9355) and the Repeated Dose 28- 

Day Oral Toxicity Study (40 CFR 

799.9305) instead of the Combined 

Repeated Dose Toxicity Study with the 

Reproduction/Developmental Toxicity 

Screening Test (40 CFR 799.9365). With 

regard to such cases, EPA is proposing 

that a person subject to this rule, 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 in the final 

study reports a rationale for conducting 

these alternate tests. 

Certain of the chemical substances for 

which Mammalian Toxicity—Repeated 

Dose/Reproduction/Developmental 

testing is proposed may be used solely 

as ‘‘closed system intermediates,’’ as 

described in the EPA guidance 

document developed for the voluntary 

HPV Challenge (Ref. 38). As described 

in that guidance, such chemical 

substances may be eligible for a reduced 

testing battery which substitutes a 

developmental toxicity study for the 

SIDS requirement to address repeated 

dose (e.g., subchronic), reproductive, 

and developmental toxicity. In other 

words, since only the developmental 

toxicity study would be conducted for 

those chemical substances that qualify 

for a reduced testing battery, repeated 

dose (e.g., subchronic) and reproductive 

studies would not be conducted. At the 

present time, EPA does not have 

sufficient information to know with any 

degree of certainty which if any of the 

chemical substances that are listed in 

the proposed regulatory text are solely 

closed system intermediates as defined 

in the voluntary HPV Challenge 

guidance document (Ref. 38). Persons 

who believe that a chemical substance 

fully satisfies the terms outlined in the 

guidance document are encouraged to 

submit appropriate information along 

with their comments on this proposed 

rule which substantiate this belief. If, 

based on submitted information and 

other information available to EPA, the 

Agency believes that a chemical 

substance is considered likely to meet 

the requirements for use solely as a 

closed system intermediate, EPA would 

not address any developmental toxicity 

testing needs in this proposed rule. 

D. 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 test 

rule. Based on the effective date of the 

final test 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 in § 799.5090(i) of the 

proposed regulatory text. 

E. 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. 

F. What forms of chemical substances 

would be tested under this rule? 

EPA is proposing two distinct 

approaches for identifying the specific 

chemical substances that would be 

tested under a final rule originating 

from this proposed rule, the application 

of which would depend on whether the 

chemical substance is considered to be 

a ‘‘Class 1’’ or a ‘‘Class 2’’ chemical 

substance. First introduced when EPA 

compiled the TSCA Chemical Substance 

Inventory, the term Class 1 chemical 

substance refers to a chemical substance 

having a chemical composition that 

consists of a single chemical species 

(not including impurities) that can be 

represented by a specific, complete 

structure diagram. By contrast, a Class 2 

chemical substance has a composition 

that cannot be represented by a specific, 

complete chemical structure diagram, 

because such a substance generally 

contains two or more different chemical 

species (not including impurities). Table 

2. in § 799.5090(j) of the proposed 

regulatory text identifies the listed 

chemical substances as either Class 1 or 

Class 2 chemical substances. 

EPA is proposing that, for the Class 1 

chemical substances that are listed in 

this proposed rule, the test chemical 

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 

this proposed rule, EPA is proposing 

that the test chemical substance be any 

representative form of the chemical 

substance, to be defined by the test 

sponsor(s). 

EPA solicits comment on the 

proposed alternative approach to the 

testing of Class 2 chemical substances 

included in this proposed rule. 

G. Who would be required to test under 

this rule? 

1. Would I be subject to this rule? If 

this proposed rule becomes final, you 

would be subject to the final rule and 

may be required to test if you 

manufacture (which is defined by 

statute to include import) or process, or 

intend to manufacture or process, one or 

more chemical substances listed in this 


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proposed rule during the time period 

described in this unit. 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. 

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. Addresses of 

the EPA Document Control Office where 

this information should be sent are 

found in this document under 

ADDRESSES. 

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). 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. 

4. 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 E. of this unit describes who is in 

Tier 1 and Tier 2. 

TABLE E—PERSONS SUBJECT TO THE RULE: TIER 1 AND TIER 2 

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

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

to manufacture, a test rule chemical 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 chemical 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 & 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 for specific test 

rules that differ from the generic 

procedures governing TSCA section 4(a) 

test rules in 40 CFR part 790. For 

purposes of this 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. 39, 40, 

and 41). 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 manufacturers of 

chemical substances 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 

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. 

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

manufacturers and/or processors of a 


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chemical substance to test that chemical 

substance if EPA has made findings 

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

(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 § 799.5090(b)(2) of the 

proposed regulatory text. 

5. Who is in the Tier 2 subdivisions? 

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. 42). In 

addition, as stated by EPA in the Data 

Reimbursement rule, ‘‘[t]here are 

[typically] so many processors [of a 

given test rule chemical substance] that 

it would be difficult to include them all 

in the technical decisions about the tests 

and in the financial decisions about 

how to allocate the costs’’ (Ref. 43). 

6. 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)). Procedures 

relating to exemptions are in 40 CFR 

790.80 through 790.99, and 

§ 799.5090(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. 

7. What would happen if I submitted 

an exemption application? 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 may 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 § 799.5090(c)(8) of the 

proposed regulatory text for details on 

submitting this notice. In addition, the 

Agency would terminate a conditional 

exemption if no letter of intent to test 

has been received from persons required 

to comply with the rule. See, e.g., 

§ 799.5090(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 the final rule are not required to 

comply with 40 CFR 790.48 itself (see 

§ 799.5090(c)(4)–(c)(7) and 

§ 799.5090(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.G.4. 

8. 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. The 

obligation to provide reimbursement is 

not affected by placement in Tier 2A or 

Tier 2B. 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. 

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 

§ 799.5090(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: i. no 

manufacturer in Tier 1 has notified EPA 

of its intent to conduct testing; and ii. 

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 § 799.5090(c)(4), (c)(5), 

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

regulatory text. 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. 

9. What would happen if no one 

submitted a letter of intent to conduct 

testing? EPA anticipates that it will 

receive letters of intent to conduct 

testing for all of the tests specified and 

chemical substances included in the 

final rule. However, in the event it does 

not receive a letter of intent for one or 

more of the tests required by the final 

rule for any of the chemical substances 

in the 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 


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rule would be in violation of the final 

rule. 

10. What are the reimbursement 

procedures? In the past, persons subject 

to test rules have independently worked 

out among themselves their respective 

financial contributions to those persons 

who have actually conducted the 

testing. However, if persons are unable 

to agree privately on reimbursement, 

they may take advantage of EPA’s 

reimbursement procedures at 40 CFR 

part 791, promulgated under the 

authority of TSCA section 4(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). 

H. What reporting requirements would 

be required under this test rule? 

For each test for each chemical 

substance, you would be required to 

submit a study plan 90 days after the 

effective date of the final rule and 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 § 799.5090(i) of the 

regulatory text. Addresses of the EPA 

Document Control Office where this 

information should be sent are found in 

this document under ADDRESSES. 

I. 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. 

J. 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. 44) indicates 

that available test facilities and 

personnel would adequately 

accommodate the testing proposed in 

this rule. 

K. Might EPA seek further testing of the 

chemical substances 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. Proposed TSCA Section 5(a)(2) 

SNUR and Basis To Potentially Add 

One or More Chemical Substances 

From Table A. to the SNUR 

EPA has preliminarily determined 

that each of the 45 substances listed in 

Tables A. and B. in Unit III. is produced 

in substantial quantities (≥1 million 

lbs./yr) and made preliminary findings 

that there may be substantial human 

exposure to 23 of these substances. 

However, for 22 of the 45 chemical 

substances, the Agency does not 

currently have exposure information 

that would adequately support such 

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

For those remaining 22 chemical 

substances (i.e., Table B.), EPA is 

proposing to establish significant new 

use reporting and recordkeeping 

requirements under TSCA section 

5(a)(2) that would require EPA 

notification prior to worker or consumer 

exposures rising to substantial levels. 

A. What are the rationale and objectives 

for taking this action? 

1. Rationale. Each of the chemical 

substances included in Table B. is 

produced in substantial quantities. EPA 

considered the factors set out in TSCA 

section 5(a)(2) and the longstanding use 

of the exposure thresholds in the ‘‘B 

Policy’’ (see Unit V.B.) to determine that 

manufacturers and processors of any of 

these chemical substances should be 

required to notify EPA if exposure to 

any of these chemical substances is 

expected to increase significantly. 

Accordingly, the significant new uses 

are: Any use in a consumer product, and 

any use or combination of uses that is 

reasonably likely to expose 1,000 or 

more workers at a single corporate 

entity (defined as the aggregate of all of 

the domestic facilities owned or 

operated by an individual corporation). 

The SNUR facilitates efficiency by 

mitigating the need for EPA to 

continually reevaluate each HPV 

chemical substance to determine 

whether exposure potential has 

increased so that there is or may be 

substantial human exposure. EPA 

recognizes, however, that the proposed 

SNU designation would not encompass 

every new use that could potentially 

give rise to significant or substantial 

human exposure. 

Consistent with EPA’s past practice 

for issuing SNURs under TSCA Section 

5(a)(2), EPA’s decision to propose a 

SNUR for a particular chemical use 

need not be based on an extensive 

evaluation of the hazard, exposure, or 

potential risk associated with that use. 

Rather, the Agency’s action is based on 

EPA’s determination that if the use 

begins or resumes, it may present a risk 

that EPA should evaluate before the 

manufacturing or processing for that use 

begins. Since the new use does not 

currently exist, deferring a detailed 

consideration of potential risks or 

hazards related to that use is an effective 

use of resources. If a person decides to 

begin manufacturing or processing the 

chemical for the use, the notice to EPA 

allows EPA to evaluate the use 

according to the specific parameters and 

circumstances surrounding that 

intended use. 

2. Objectives. Under TSCA section 

5(a)(1)(B), any person intending to 

manufacture, import, or process any of 

these chemical substances for one or 

more of the designated SNUs would be 

required to notify EPA with a SNUN 

before that activity begins. EPA would 

then have an opportunity to review and 

evaluate data submitted in a SNUN and, 

if warranted pursuant to TSCA sections 

5(e), 5(f), 6 or 7, EPA would be able to 

regulate prospective manufacturers 

(which, as noted in Unit I.A., includes 

importers) or processors of the chemical 

substances before the designated SNUs 

of the chemical substance occurs. 

B. How were the significant new uses 

determined? 

Section 5(a)(2) of TSCA states that 

EPA’s determination that a use of a 

chemical substance is a SNU must be 

made after consideration of all relevant 

factors including: 

1. The projected volume of 

manufacturing and processing of a 

chemical substance. 

2. The extent to which a use changes 

the type or form of exposure of human 

beings or the environment to a chemical 

substance. 


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3. The extent to which a use increases 

the magnitude and duration of exposure 

of human beings or the environment to 

a chemical substance. 

4. The reasonably anticipated manner 

and methods of manufacturing, 

processing, distribution in commerce, 

and disposal of a chemical substance. 

In addition to these factors, the statute 

authorizes EPA to consider any other 

relevant factors. To determine what 

would constitute a SNU of the chemical 

substances listed in Table B. and of the 

chemical substances listed in Table A., 

EPA considered the section 5(a)(2) 

factors, as well as EPA’s 1993 ‘‘B 

Policy’’ (Ref. 2), discussed in Unit II.D. 

For the first section 5(a)(2) factor, 

production volume, EPA considered the 

fact that all 22 of the chemical 

substances in Table B., and all 23 of the 

chemical substances in Table A., have 

been produced in substantial amounts, 

i.e., volumes above one million lbs./ 

year. EPA would expect that increased 

or expanded use of these chemical 

substances could correspond to a further 

increase in annual production volume 

and thereby increase exposures. 

Next, EPA considered the extent to 

which a use changes the type or form of 

exposure of human beings or the 

environment to a chemical substance. 

Current IUR information available to 

EPA indicates that all but 2 of the 22 

chemical substances in Table B. are 

used solely for industrial purposes. For 

the remaining two chemical substances 

in Table B., EPA could find no evidence 

of any ongoing consumer uses. With 

respect to these 22 chemical substances 

(i.e., Table B.), any use in consumer 

products would likely result in new 

consumer exposures to these chemical 

substances. These potential new users 

could be exposed via pathways different 

from industrial users, and consumers 

may be less likely to use, or have access 

to, appropriate protective equipment 

(e.g. gloves or respirators) than 

industrial users. An expansion into use 

in consumer products may also include 

new environmental releases, deliberate 

or accidental (e.g., consumers may 

dispose of a chemical substance by 

pouring it down a storm drain or 

household sink). 

With respect to the chemical 

substances listed in Table A., EPA has 

information indicating that ongoing use 

of certain of these chemical substances 

already involves the exposure of 10,000 

or more consumers. If public comment 

on this proposal is accompanied by 

additional information that contradicts 

the information upon which EPA has 

based its preliminary conclusions (i.e., 

less than 10,000 consumers are 

exposed), that information could 

potentially also establish that there are 

no ongoing uses of the chemical 

substance in consumer products. If EPA 

concludes, on the basis of public 

comments, that there is an inadequate 

basis to issue a test rule for the chemical 

substance, it would also conclude, as a 

general matter, that there is an adequate 

basis to issue a SNUR for the chemical 

substance. In such a case, EPA intends 

to incorporate the chemical substance 

into the final SNUR without further 

opportunity for public notice and 

comment. EPA believes that the 

commencement of consumer uses of the 

chemical substances in Table A. (if such 

uses are not currently ongoing) would 

be a SNU of the chemical substances. 

This is because potential new users 

could be exposed via pathways different 

from industrial users, and may be less 

likely to use appropriate protective 

equipment (e.g. gloves or respirators) 

than industrial users. An expansion into 

use in consumer products may also 

include new environmental releases 

(e.g., consumers may dispose of a 

chemical substance by pouring it down 

a storm drain or household sink). 

EPA also considered the extent to 

which a use increases the magnitude 

and duration of human or 

environmental exposure to a chemical 

substance. Commencement of a 

chemical substance’s use in a consumer 

product would increase the amount and 

time that consumers were exposed to 

the chemical substance. In determining 

substantial consumer exposure, EPA 

considered the production volume and 

consumer uses. If production volume 

exceeds one million pounds per year 

and consumer uses are indicated, it is 

likely that consumer exposure exceeds 

the substantial threshold of ten 

thousand people as defined by the ‘‘B 

Policy.’’ EPA has reached this 

conclusion with respect to the chemical 

substances in Table B. and the chemical 

substances in Table A. (to the extent 

that use of the chemical substances in 

Table A. in consumer products is not 

already ongoing). 

EPA also considered how the number 

of workers exposed (as reported under 

the IUR rule) might change if use of a 

chemical substance changed or 

expanded. For example, the 

commencement of additional new uses 

may increase the total production 

volume of a chemical substance, thereby 

increasing the magnitude and duration 

of exposure for industrial workers. None 

of the 22 chemical substances listed in 

Table B. are known to meet the ‘‘B 

Policy’’ threshold for substantial worker 

exposure (≥ 1,000 workers) at this time. 

However, if exposure were to increase 

such that 1,000 or more workers at a 

single corporate entity were reasonably 

likely to be exposed, EPA believes that 

the increased exposure would be a 

significant change. In this context, 

‘‘single corporate entity’’ refers to the 

aggregate of all of the domestic facilities 

owned or operated by an individual 

corporation. Therefore, the SNUR 

notification requirements would be 

triggered 90 days before the sum of all 

potentially exposed workers at domestic 

facilities comprising the single 

corporate entity was expected to reach 

1,000 workers or more. 

With respect to the chemical 

substances listed in Table A., EPA has 

information that ongoing use of certain 

of these chemical substances already 

involves the exposure of 1,000 or more 

workers. If EPA concludes, on the basis 

of public comments, that there is no 

basis to issue a test rule for such 

chemical substance then it would also 

conclude, as a general matter, that there 

is an adequate basis to issue a SNUR for 

the chemical substance. In such a case, 

EPA intends to incorporate the chemical 

substance into the final SNUR without 

further opportunity for public notice 

and comment. Chemical substances 

from Table A., like the chemical 

substances from Table B., are high 

production volume chemical 

substances. If exposure to a Table A. 

chemical substance were to increase 

such that 1,000 or more workers at a 

single corporate entity were to become 

reasonably likely to be exposed, EPA 

believes that the increased exposure 

would be a significant change. 

With respect to the chemical 

substances in Tables A. and B., EPA also 

considered the reasonably anticipated 

manner and methods of manufacturing, 

processing, distribution in commerce, 

and disposal of these chemical 

substances in determining what would 

be a SNU. Given the production volume 

of these chemical substances, any 

change in these methods or practices 

could affect human or environmental 

exposures, but the lack of available 

toxicity data, and of more detailed 

information about existing methods and 

practices, hampers EPA’s ability to more 

fully consider this fourth factor. 

Finally, EPA considered the ‘‘B 

Policy.’’ Since 1993, EPA has used the 

production, exposure, and release 

benchmarks in the ‘‘B Policy’’ for 

making TSCA section 4 test rule 

findings. EPA has also considered and 

incorporated the production, worker, 

and consumer exposure benchmarks in 

the selection of chemical substances to 

be included and development of the 

SNUs included in today’s proposed 

action. These chemical substances have 

already been in production at high 


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volumes, and at least some workers are 

exposed. EPA is proposing to 

incorporate certain ‘‘B Policy’’ exposure 

thresholds into its rationale for the 

proposed SNUs because they are clear 

numeric criteria that have been used to 

determine substantial human exposure 

since 1993. They have provided a clear 

threshold—well understood by EPA, 

industry, and other stakeholders—of 

levels of worker or consumer exposure 

that are important under TSCA. EPA is 

interested in receiving comment 

concerning use of the ‘‘B Policy’’ in this 

context. 

C. What were the alternatives to 

proposing this SNUR? 

Before proposing this SNUR, EPA 

considered promulgating a TSCA 

section 8(a) reporting rule. Under a 

TSCA section 8(a) rule, EPA could, 

among other things, generally require 

persons to report information to the 

Agency when they intend to 

manufacture, import, or process a listed 

chemical substance for a specific use or 

any use. However, if EPA were to 

require reporting under TSCA section 

8(a) instead of TSCA section 5(a), EPA 

would not have the opportunity to 

assess the risk of the new use prior to 

commencement of that activity, or, if 

warranted, to take immediate follow-up 

regulatory action under TSCA sections 

5(e) or 5(f) to prohibit or limit the 

activity before it begins. 

D. What would be the applicability of 

the final rule to uses occurring before 

the effective date of the final rule? 

As discussed in the Federal Register 

of April 24, 1990 (55 FR 17376), EPA 

has decided that the intent of section 

5(a)(1)(B) of TSCA is best served by 

designating a use as a SNU as of the date 

of publication of the proposed rule 

rather than as of the effective date of the 

final rule. If uses begun after publication 

of the proposed rule were considered 

ongoing rather than new, it would be 

difficult for EPA to establish SNUR 

notice requirements, because a person 

could defeat the SNUR by initiating the 

proposed SNU before the rule became 

final, and then argue that the use was 

ongoing as of the effective date of the 

final rule. Thus, persons who, after 

publication of the proposed SNUR, 

begin commercial manufacture, import, 

or processing of the chemical 

substance(s) listed in Table B. for a use 

proposed in this action for a SNU would 

have to cease any such activity before 

the effective date of the rule if and when 

finalized. To resume their activities, 

these persons would have to comply 

with all applicable SNUR notice 

requirements and wait until the notice 

review period, including all extensions, 

expires. EPA has promulgated 

provisions to allow persons to comply 

with SNURs before the effective date. If 

a person were to meet the conditions of 

advance compliance under § 721.45(h), 

that person would be considered to have 

met the requirements of the final SNUR 

for those activities. 

E. Do test data and other information 

have to be submitted? 

TSCA section 5 does not require 

developing any particular test data 

before submission of a SNUN, except 

where the chemical substance is also 

subject to a test rule under TSCA 

section 4 (see TSCA section 5(b)), or 

when a chemical substance is included 

on the list described under section 

5(b)(4). Unless submission of data is 

required under section 4 or 5(b)(4), 

persons are required only to submit test 

data in their possession or control and 

to describe any other data known to or 

reasonably ascertainable by them (40 

CFR 721.25). However, as a general 

matter, EPA recommends that SNUN 

submitters include data that would 

permit a reasoned evaluation of risks 

posed by the chemical substance during 

its manufacture, import, processing, use, 

distribution in commerce, or disposal. 

EPA encourages persons to consult with 

the Agency before submitting a SNUN. 

As part of this optional pre-notice 

consultation, EPA would discuss 

specific data it believes may be useful 

in evaluating a significant new use. 

SNUNs submitted for significant new 

uses without any test data may increase 

the likelihood that EPA will take action 

under TSCA section 5(e) to prohibit or 

limit activities associated with this 

chemical substance. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs that provide detailed 

information on: 

1. Human exposure and 

environmental releases that may result 

from the significant new uses of the 

chemical substances. 

2. Potential benefits of the chemical 

substances. 

3. Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

F. How do I submit a SNUN? 

EPA recommends that submitters 

consult with the Agency prior to 

submitting a SNUN to discuss what data 

may be useful in evaluating a SNU. 

Discussions with the Agency prior to 

submission can afford ample time to 

conduct any tests that might be helpful 

in evaluating risks posed by the 

substance. According to 40 CFR 

721.1(c), persons submitting a SNUN 

must comply with the same notice 

requirements and EPA regulatory 

procedures as persons submitting a 

PMN, including submission of test data 

on health and environmental effects as 

described in 40 CFR 720.50. SNUNs 

must be submitted to EPA, on EPA Form 

No. 7710–25 in accordance with the 

procedures set forth in 40 CFR 721.25 

and 40 CFR 720.40. 

EPA published a final rule on January 

6, 2010 (75 FR 773) (FRL–8794–5), that 

established standards and requirements 

for the use of the electronic-PMN (ePMN) software and EPA’s Central Data 

Exchange (CDX) to electronically submit 

these notices. The Agency is 

introducing electronic reporting via 

CDX using the e-PMN in three phases 

over a two-year period. The effective 

date of the rule was April 6, 2010. Until 

April 6, 2011, submissions were 

permitted via CDX, optical disc, or 

paper. After April 6, 2011, paper 

submissions are no longer being 

accepted. After April 6, 2012, all 

submissions will be required to be 

submitted electronically via CDX. 

Regardless of the delivery method, EPA 

requires that all submissions be 

generated using the new e-PMN 

software. For additional information 

and instructions go to: http:// 

www.epa.gov/opptintr/newchems/ 

epmn/epmn-index.htm. Until April 6, 

2012, SNUNs may still be mailed to the 

Environmental Protection Agency, 

OPPT Document Control Office 

(7407M), 1200 Pennsylvania Avenue, 

NW., Washington, DC 20460–0001. 

G. What are the recordkeeping 

requirements? 

EPA is proposing that persons subject 

to this proposed SNUR be required to 

maintain several records in addition to 

those required by 40 CFR 721.40 

(persons required to submit a SNUN 

must retain documentation of 

information contained in that SNUN). 

EPA is proposing to require 

manufacturers and processors to 

maintain the records described in 40 

CFR 721.125 (a), (b), and (c) in this 

SNUR. Section 721.125(a) requires 

records documenting manufacture and 

importation volume and dates; 

§ 721.125(b) documents volumes 

purchased in the U.S. by processors, the 

names and addresses of suppliers, and 

the dates of purchase; and § 721.125(c) 

requires records documenting the names 

and addresses (including shipment 

destination address, if different) of all 

persons outside the site of manufacture, 

importation, or processing to whom the 

manufacturer, importer, or processor 

directly sells or transfers the chemical 


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substance, the date, and the quantity of 

each sale or transfer. These records 

would help EPA to determine 

compliance with the SNUR. 

VI. Export Notification Requirements 

Test rule: Any person who exports, or 

intends to export, one of the chemical 

substances contained in this proposed 

test 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 

the availability of data. 

VII. Economic Impacts 

A. What would be the economic impacts 

of the proposed test rule? 

EPA has prepared an economic 

assessment entitled ‘‘Economic Analysis 

for the Proposed High Production 

Volume Challenge Chemicals Test 

Rule—Fourth Group of Chemicals’’ (Ref. 

45), 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 23 chemical 

substances. The total social cost of 

providing test data on the 23 chemical 

substances that were evaluated in this 

economic analysis is estimated to be 

$7.72 million assuming an average cost 

scenario. Total costs of compliance to 

industry are estimated at $7.65 million 

(Ref. 45). 

While legally subject to this test rule, 

processors of a subject chemical 

substance 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 § 799.5090(c)(5) and 

(c)(6) of the proposed regulatory text. 

EPA would only require processors to 

test if no person in Tier 1 has submitted 

a notice of its intent to conduct testing, 

or if under 40 CFR 790.93, a problem 

occurs with the initiation, conduct, or 

completion of the required testing or the 

submission of the required data to EPA. 

Because EPA has identified at least one 

manufacturer in Tier 1 for each subject 

chemical 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. 

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 $27.50 per 

notice to $86.99 per notice (Ref. 45). 

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. 

The potential for adverse economic 

impact as a result of the rule is expected 

to be higher for smaller businesses. 

Smaller businesses are less likely to 

have additional revenue sources to 

cover the compliance costs. Therefore, 

the Agency compared the costs of 

compliance to company sales for small 

businesses. EPA estimates that there are 

25 small entities that would be affected 

by this proposed rule. Of these, EPA 

estimates that there is no small business 

for which the cost impact of the testing 

exceeds 1 percent of the company’s 

revenue. 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. 

The benefits resulting from this 

proposed test rule are discussed 

qualitatively in the ‘‘Economic Analysis 

for the Proposed High Production 

Volume Challenge Chemicals Test RuleFourth Group of Chemicals’’ (Ref. 45). 

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. 

B. What would be the economic impacts 

of the proposed SNUR? 

1. SNUNs. EPA has evaluated the 

potential costs of establishing SNUR 

reporting and recordkeeping 

requirements for potential 

manufacturers, importers, and 

processors of the chemical substance 

included in this proposed rule. While 

most businesses are subject to a $2,500 

user fee required by 40 CFR 

700.45(b)(2)(iii), small businesses with 

an annual sales of less than $40 million 

when combined with those of the parent 

company (if any) are subject to a 

reduced user fee of $100 (40 CFR 

700.45(b)(1)). The costs of submission of 

SNUNs will not be incurred by any 

company unless a company decides to 

pursue a SNU as defined in this 

proposed SNUR. However there are 

limited costs associated with the 

recordkeeping requirements required by 

this SNUR, whether or not a SNUN is 

submitted. Furthermore, while the 

expense of a notice and the 

uncertainties of possible EPA regulation 

may discourage certain innovations, that 

impact would be limited because such 

factors are unlikely to discourage an 

innovation that has high potential value. 

EPA’s complete economic analysis is 

available in the public docket for this 

proposed rule (Ref. 46). 

2. Export notification. Under section 

12(b) of TSCA and the implementing 

regulations at 40 CFR part 707, subpart 

D, exporters must notify EPA if they 

export or intend to export a chemical 

substance or mixture for which, among 

other things, a rule has been proposed 

or promulgated under TSCA section 5. 

For persons exporting a chemical 

substance the subject of a proposed or 

final SNUR, a one-time notice must be 

provided for the first export or intended 

export to a particular country. The total 

costs of export notification will vary by 

chemical substance, depending on the 

number of required notifications (i.e., 

the number of countries to which the 

chemical substance is exported). 

Although EPA estimates that an 

exporting company making notifications 

may need to prepare 12 notifications per 

year at a cost of $78.56 each, EPA is 

unable to make any estimate of the 

likely number of export notifications for 

the chemical substances covered in this 

proposed SNUR (Ref. 46). 

VIII. Request for Public Comment 

EPA is interested in stakeholder input 

on a number of issues in this action as 

well as future actions on high 

production volume chemical 

substances. 

1. In this document, EPA is proposing 

either a test rule or SNUR to regulate a 

given set of chemical substances. EPA 

believes that this is an efficient way to 

require submission of test data on 

chemical substances that meet all of the 

necessary exposure criteria and require 

submission of a notification to EPA if 


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and when additional exposure criteria 

are met. The SNUR also facilitates 

efficiency by mitigating the need for 

EPA to continually reevaluate each HPV 

chemical substance to determine 

whether conditions have changed so as 

to increase potential exposure. EPA is 

considering proposing further combined 

test rules/SNURs in conjunction with 

future CDR data releases, covering all 

newly-HPV chemical substances. EPA 

requests comment on this approach. 

2. EPA is proposing to incorporate the 

‘‘B Policy’’ worker exposure threshold 

into the proposed SNU designations 

because it is a clear, numeric criterion 

that has been used to determine 

substantial human exposure since 1993. 

EPA is interested in receiving comment 

concerning use of the ‘‘B Policy’’ in this 

context. 

3. EPA solicits comment on whether 

any of the chemical substances 

proposed for the SNUR are already 

being manufactured or processed for 

one of the significant new uses listed in 

Unit V., and should consequently be 

included in the test rule. Analogously, 

EPA solicits comment on whether any 

of the chemical substances proposed for 

the test rule are no longer used in 

applications that meet the substantial 

human exposure finding described in 

the ‘‘B Policy’’ and should consequently 

be included in the SNUR. 

4. EPA solicits comment on whether 

any of the chemical substances 

proposed for the test rule or the SNUR 

should be subject to neither a test rule 

nor a SNUR. EPA requests comment on 

this topic so as to confirm or refute the 

Agency’s general expectation that either 

a SNUR or a test rule is warranted for 

each chemical substance listed in Tables 

A. and B. of Unit III. EPA’s general 

expectation is as follows: If additional 

information indicates that a test rule is 

not warranted for a particular chemical 

substance listed in Table A. because 

particular uses are not ongoing, EPA 

generally anticipates that such 

information would indicate that a SNUR 

is warranted instead. Conversely, if 

additional information indicates that a 

SNUR is not warranted for a particular 

chemical substance listed in Table B. 

because particular uses are already 

ongoing, EPA generally anticipates that 

such information would indicate that a 

test rule is warranted instead. 

5. EPA solicits comment on whether 

there is a better alternative to proposing 

the SNUR trigger of ≥1000 workers 

exposed at a single corporate entity. The 

test rule findings are based on ≥1000 

workers exposed at the national level. 

EPA asks for comment on whether there 

is an approach that would reduce the 

discrepancy between the corporate level 

for the SNUR and national level for the 

test rule. 

6. EPA solicits comment respecting 

relevant trends in production volume 

for the chemical substances proposed to 

be subject to either a test rule or a 

SNUR. EPA is especially interested in 

such trend information in the case that 

a commenter believes that neither a test 

rule nor a SNUR is warranted for a 

chemical substance because the 

chemical substance currently has an 

overall production volume of less than 

1 million lbs. per year. Because 

production volume may vary from year 

to year, EPA does not believe that the 

mere fact that the most recent annual 

production volume is less than 1 

million pounds would necessarily 

establish that a test rule is not warranted 

(and such information would not by 

itself suggest that a SNUR is 

unwarranted, since substantial 

production is not a required finding for 

SNURs). More detailed comments, 

distinguishing a long-term decline in 

production volume from a short-term 

dip, would be especially helpful to the 

Agency in evaluating any comments 

that current production volumes are too 

low to warrant the regulatory action 

proposed. 

7. As described in Unit IV.B., to the 

extent that EPA learns that consumer 

uses, or uses that could affect 1,000 

workers or more, are already ongoing for 

a chemical substance listed in Table B., 

it intends to evaluate whether taking 

steps to promulgate a test rule for the 

chemical substance is warranted. To 

assist the Agency in such 

circumstances, EPA solicits comment 

respecting the sufficiency of the 

available data and the need for 

additional testing on the chemical 

substances in Table B., consistent with 

the standards set forth in TSCA sections 

4 (a)(1)(B)(ii) and (a)(1)(B)(iii). 

8. The U.S. National Academy of 

Sciences National Research Council in 

their 2007 report ‘‘Toxicity Testing in 

21st Century: A Vision and a Strategy’’ 

encouraged ‘‘work[ing] towards a 

transition to new integrative and 

predictive molecular and computational 

techniques to enhance efficiency and 

accuracy and to reduce reliance on 

animal testing.’’ EPA requests 

suggestions on practical, implementable 

ways to work toward this goal in its 

actions under TSCA. Should tools such 

as ToxCast (http://www.epa.gov/ncct/ 

toxcast/) be used to prioritize chemical 

substances and support hazard findings 

for testing in the future? 

9. EPA solicits comments which 

identify existing data that may meet the 

requirements of studies under the 

proposed test rule. To the extent that 

data relevant to the testing specified in 

the 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 

the 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. 8). To the extent that 

studies required under the proposed 

rule are currently available, and the data 

are judged sufficient by EPA, testing for 

the endpoint/chemical substance 

combination will not be required in the 

final test rule based on this proposed 

rule. 

10. Persons who believe that adequate 

information regarding a chemical 

substance subject to the proposed test 

rule can be developed using a category 

or the SAR approach are encouraged to 

submit appropriate information, along 

with their rationale substantiating this 

belief, during the comment period on 

the proposed rule. 

11. EPA solicits comment on the 

proposed test rule approaches for Class 

1 and Class 2 chemical substances. 

Should each Class 1 chemical substance 

be tested at a purity of 99% or more? 

Should the proposed test substance 

purity for Class 1 chemical substances 

be applied to any Class 2 chemical 

substances? Should the proposed 

approach for testing Class 2 chemical 

substances (i.e., that a representative 

sample of each Class 2 chemical 

substance be tested) be applied to any 

Class 1 chemical substances? 

12. For more than 15 years, EPA has 

used OECD’s SIDS to facilitate and 

standardize the screening of the 

relatively large number of chemical 

substances on the TSCA Inventory. EPA 

requests comment on whether SIDS 

continues to be the most appropriate 

data set to screen chemical substances 

for potential environmental and health 

hazards and whether EPA should 

consider other data sets in the event of 

any future test rule on new HPV 

chemical substances. Are additional or 

different tests also appropriate? Should 

EPA consider having more than one 

screening data set depending on the 

nature of exposures, e.g., a different set 

of tests for children’s exposures or 

environmental releases? 

13. At the present time, EPA does not 

have sufficient information to know 

with any degree of certainty which if 

any of the chemical substances that are 

listed in the proposed regulatory text are 

solely closed system intermediates as 

defined in the voluntary HPV Challenge 

guidance document (Ref. 38). Persons 

who believe that a chemical substance 


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65598 Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Proposed Rules 

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. 

IX. Materials in the Docket 

As indicated under ADDRESSES, a 

docket has been established for this 

proposed rule under docket ID number 

EPA–HQ–OPPT–2010–0520. 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. OECD Secretariat. Manual for the 

Investigation of HPV Chemicals. OECD 

Programme on the Co-Operative 

Investigation of High Production Volume 

Chemicals. Paris, France. December, 

2009. Available on-line at: http://www.

oecd.org/document/7/0,3746,en_2649

_34379_1947463_1_1_1_1,00.html. 

2. 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). 

3. U.S. National Academy of Sciences, 

National Research Council. ‘‘Toxicity 

Testing in the 21st Century: A Vision 

and a Strategy.’’ 2007. Available on-line 

at: http://dels.nas.edu/resources/staticassets/materials-based-on-reports/

reports-in-brief/Toxicity_Testing_final.

pdf. 

4. EPA. National Center for Computational 

Toxicology. ToxCastTM. 2007. http://

www.epa.gov/ncct/toxcast/. 

5. EPA. OPPT. Testing of Certain High 

Production Volume Chemicals-4 

(Exposure Findings Supporting 

Information). Prepared by OPPT, 

Economics, Exposure and Technology 

Division. March, 2011. 

6. EPA. OPPT. High Production Volume 

Chemical Data Information System 

(HPVIS). Data from HPVIS on 23 HPV 

chemicals. June 2011. 

7. EPA. OPPT. Risk Assessment Division. 

HPV4 Data Adequacy Evaluations. 2010. 

8. EPA. OPPT. Draft Guidance on Developing 

Robust Summaries. October 22, 1999. 

Available on-line at: http://www.epa.

gov/chemrtk/pubs/general/robsumgd.

htm. 

9. ASTM International. Standard Test 

Method for Relative Initial and Final 

Melting Points and the Melting Range of 

Organic Chemicals. ASTM E 324–99. 

1999. 

10. OECD. Guideline for the Testing of 

Chemicals: Melting Point/Melting Range. 

OECD 102. July 27, 1995. 

11. ASTM International. Standard Test 

Method for Vapor Pressure of Liquids by 

Ebulliometry. ASTM E 1719–05. 2005. 

12. ASTM International. Standard Test 

Method for Determining Vapor Pressure 

by Thermal Analysis. ASTM E 1782–03 

(2008). 

13. ASTM International. Standard Test 

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

Chromatography. ASTM E 1147–92 

(2005). 

14. ASTM International. Standard Test 

Method for Measurements of Aqueous 

Solubility. ASTM E 1148–02 (2008). 

15. ASTM International. Question about 

ASTM E 324. E-mail from Diane Rehiel, 

ASTM, to Greg Schweer, CITB, CCD, 

OPPT, EPA. September 15, 2004. 

16. 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. 

17. 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. 

18. ASTM International. Standard Test 

Method for Determining Ready, 

Ultimate, Biodegradability of Organic 

Chemicals in a Sealed Vessel CO2

Production Test. ASTM E 1720–01. 

(Reapproved 2008). 

19. 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. 

20. 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. 

21. 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. 

22. ISO. Water quality—Evaluation of 

ultimate aerobic biodegradability of 

organic compounds in aqueous 

medium—Carbon dioxide evolution test. 

ISO 9439. 1999. 

23. 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. 

24. ISO. Water quality—Evaluation in an 

aqueous medium of the ultimate aerobic 

biodegradability of organic compounds— 

Determination of biochemical oxygen 

demand in a two-phase closed bottle test 

(available in English only). ISO 10708. 

1997. 

25. 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 10631. 1995. 

26. ASTM International. Standard Guide for 

Conducting Acute Toxicity Tests on Test 

Materials with Fishes, 

Macroinvertebrates, and Amphibians. 

ASTM E 729–96 (2007). 

27. ASTM International. Standard Guide for 

Conducting Static Toxicity Tests with 

Microalgae. ASTM E 1218–04e1. 2004. 

28. ASTM International. Standard Guide for 

Conducting Daphnia magna Life-Cycle 

Toxicity Tests. ASTM E 1193–97 (2004). 

29. Veith, G.D. and Kosian, P. Estimating 

bioconcentration potential from Octanol/ 

Water Partition Coefficients, in Physical 

Behavior of PCBs in the Great Lakes 

(MacKay, Paterson, Eisenreich, and 

Simmons, eds.), Ann Arbor Science, Ann 

Arbor, MI. 1982. 

30. 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. 

31. EPA. Category for Persistent, 

Bioaccumulative, and Toxic New 

Chemical Substances; Notice. Federal 

Register (64 FR 60194, November 4, 

1999) (FRL–6097–7). Available online at: 

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

pubs/pbtpolcy.htm. 

32. EPA. Significant New Use Rules; General 

Provisions for New Chemical Follow-Up; 

Final Rule. Federal Register (54 FR 

31298, July 27, 1989). 

33. ASTM International. Standard Test 

Method for Estimating Acute Oral 

Toxicity in Rats. ASTM E 1163–98 

(2002). 

34. NIEHS 2003b. Test Method Protocol for 

the BALB/c 3T3 Neutral Red Uptake 

Cytotoxicity Test, a Test for Basal 

Cytotoxicity for an in vitro Validation 

Study—Phase III. NTP/NICEATM. 

November 4, 2003. Available online at: 

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

acutetox/invidocs/phIIIprot/3t3phIII.pdf. 

35. NIEHS 2003c. Test Method Protocol for 

the NHK Neutral Red Uptake 

Cytotoxicity Test, a Test for Basal 

Cytotoxicity for an in vitro Validation 

Study—Phase III. NTP/NICEATM. 

November 4, 2003. Available online at: 

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

acutetox/invidocs/phIIIprot/nhkphIII.

pdf. 

36. NIEHS 2001b. Guidance Document on 

Using In Vitro Data to Estimate In Vivo 

Starting Doses for Acute Toxicity. NIH 

Publication No. 01–4500. August 2001. 

Available online at: http://iccvam.niehs.

nih.gov/methods/acutetox/inv_cyto_

guide.htm. 

37. NIEHS 2003a. Test Method Protocol for 

Solubility Determination, in vitro 


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Cytotoxicity Validation Study—Phase III. 

National Toxicology Program (NTP) 

Interagency Center for the Evaluation of 

Alternative Toxicological Methods 

(NICEATM). September 24, 2003. 

Available online at: http://iccvam.niehs.

nih.gov/methods/acutetox/invidocs/

phIIIprot/solphIII.pdf. 

38. EPA. OPPT. Guidance for Testing Closed 

System Intermediates for the HPV 

Challenge Program (Draft) (March 17, 

1999). Available online at: http://www.

epa.gov/oppt/chemrtk/pubs/general/

closed9.htm. 

39. EPA. Testing of Certain High Production 

Volume Chemicals; Final Rule. Federal 

Register (71 FR 13708, March 16, 2006) 

(FRL–7335–2). 

40. 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). 

41. EPA. Proposed Test Rule for the Testing 

of Certain High Production Volume 

Chemicals; Third Group of Chemicals. 

Federal Register (75 FR, February 25, 

2010) (FRL–9116–2). 

42. EPA. Toxic Substances; Test Rule 

Development and Exemption 

Procedures; Interim Final Rule. Federal 

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

43. EPA. Toxic Substances Control Act; Data 

Reimbursement; Final Rule. Federal 

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

44. EPA. Analysis of Laboratory Capacity to 

Support U.S. EPA Chemical Testing 

Program Initiatives. Economic and Policy 

Analysis Branch. Washington, DC. 

October 28, 2010. 

45. EPA. OPPT. Economic Analysis for the 

Proposed High Production Volume 

Challenge Chemicals Test Rule—Fourth 

Group of Chemicals. Prepared by the 

Economic and Policy Analysis Branch, 

Economics, Exposure and Technology 

Division. August 15, 2011. 

46. EPA. OPPT. Economic Analysis of the 

Significant New Use Rule for High 

Production Volume Chemical 

Substances. Prepared by the Economic 

and Policy Analysis Branch, Economics, 

Exposure and Technology Division. 

May 26, 2011. 

X. Statutory and Executive Order 

Reviews 

A. Regulatory Planning and Review 

This proposed rule is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866, entitled 

Regulatory Planning and Review (58 FR 

51735, October 4, 1993) and 13563, 

entitled (76 FR 3821, January 21, 2011). 

B. Paperwork Activities 

According to the Paperwork 

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

seq., an Agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information 

that requires approval by the Office of 

Management and Budget (OMB) under 

the PRA, unless it has been approved by 

OMB and displays a currently valid 

OMB control number. The OMB control 

numbers for EPA’s regulations in title 40 

of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9, and included on the related 

collection instrument, or form, if 

applicable. 

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. 

For this rulemaking, the paperwork 

activities are addressed in 3 parts, based 

on the separate activities. 

1. Paperwork activities related to 

testing. The proposed testing in this 

rulemaking does not impose any new or 

amended paperwork collection 

requirements that would require 

additional review and/or approval by 

OMB under the PRA. 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. 

45). 

The standard chemical substance 

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 23 chemical substances is 

38,000 hours (average cost scenario). 

EPA assumes that industry will form a 

‘‘task force’’ or panel to coordinate 

testing where appropriate. A consortium 

represents all the manufacturers of a 

chemical substance. EPA estimates 23 

consortia for the proposed rule; with an 

estimated burden per consortium of 

2,000 hours (rounded) (Ref. 45). 

2. Paperwork activities related to 

SNUNs. The information collection 

requirements related to the proposed 

SNUR have already been approved by 

OMB pursuant to the PRA under OMB 

control number 2070–0038 (EPA ICR 

No. 1188). This action does not impose 

any burden requiring additional OMB 

approval. 

If an entity were to submit a SNUN to 

the Agency, the annual burden is 

estimated to average 91.68 hours per 

response. This burden estimate includes 

the time needed to review instructions, 

search existing data sources, gather and 

maintain the data needed, and 

complete, review, and submit the 

required SNUN. In addition, depending 

on whether or not an entity submits a 

SNUN, EPA has estimated the burden of 

the associated recordkeeping 

requirements (Ref. 46). 

3. Paperwork activities related to 

export notifications. 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. 

The estimated burden of the 

information collection activities related 

to export notification is estimated to 

average 1 burden hour for each chemical 

substance/country combination for an 

initial notification and 0.5 hours for 

each subsequent notification (Ref. 46). 

In estimating the total burden hours 

approved for the information collection 

activities related to export notification, 

the Agency has included sufficient 

burden hours to accommodate any 

export notifications that may be 

required by the Agency’s issuance of 

final chemical substance test rules. As 

such, EPA does not expect to need to 

request an increase in the total burden 

hours approved by OMB for export 

notifications. 

Comments are requested on the 

Agency’s need for this information, the 


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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. Small Entity Impacts 

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 each of the economic analyses for this 

proposed rule (Refs. 45 and 46), which 

are summarized in Unit VII., and copies 

of which are 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: 

• A small business as defined by the 

Small Business Administration’s (SBA) 

regulations at 13 CFR 121.201. 

• 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. 

• 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. 45), 

EPA has determined that this proposed 

rule is not expected to impact any small 

not-for-profit organizations or small 

governmental jurisdictions. As such, the 

Agency’s analysis presents only the 

estimated potential impacts on small 

business. 

For this rulemaking, EPA considered 

the potential impact on small entities 

associated with the proposed testing, 

SNU notifications, and export 

notifications. 

1. Potential small entity impacts 

related to the proposed testing. Two 

factors are examined in EPA’s small 

entity impact analysis (Ref. 45) in order 

to characterize the potential small entity 

impacts of the proposed testing 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 

substance 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 substance 

manufacturers, EPA believes that a 

standard based on total annual sales 

may provide a more appropriate means 

to judge the ability of a chemical 

substance manufacturing firm to 

support chemical substance 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 

substance 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. 

45). 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 (Ref. 45). 

For each manufacturer of the 23 

chemical substances covered by the 

proposed testing, 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 59 affected 

UCEs. Sales data could be found for 52 

of these UCE’s and employment data 

could be found for 57 of these UCEs. 

Two companies could not be classified 

as small or large because there were no 

employment data available (Ref. 45). 

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), 25 companies 

(42.4%) were identified as small (Ref. 

45). 

The potential significance of the 

proposed testing’s impact on small 

businesses was analyzed by examining 


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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 (Ref. 45). 

Of the 25 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 revenue of all other 

small businesses equal to $2.56 million. 

The costs for these 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 the proposed testing, if 

finalized (Ref. 45). 

2. Potential small entity impacts 

related to the SNUR. A SNUR applies to 

any person (including small or large 

entities) who intends to engage in any 

activity described in the rule as a 

‘‘significant new use.’’ By definition of 

the word ‘‘new’’ and based on all 

information currently available to EPA, 

it appears that no small or large entities 

presently engage in such activity. Since 

a SNUR only requires that any person 

who intends to engage in such activity 

in the future must first notify EPA by 

submitting a SNUN, there are no costs 

associated with the SNUN until it is 

submitted. However there are limited 

costs associated with the recordkeeping 

requirements required by this SNUR, 

whether or not a SNUN is submitted. 

Although some small entities may 

decide to conduct such activities in the 

future, EPA cannot presently determine 

how many, if any, there may be. 

EPA’s experience to date is that, in 

response to the promulgation of over 

1,000 SNURs, the Agency receives on 

average less than 10 notices per year. Of 

those SNUNs submitted, none appear to 

be from small entities in response to any 

SNUR. In addition, the estimated 

reporting cost for submission of a SNUN 

(see Unit VII.), are minimal regardless of 

the size of the firm. Therefore, EPA 

believes that the potential economic 

impact of complying with this SNUR is 

not expected to be significant or 

adversely impact a substantial number 

of small entities. In a SNUR that 

published on June 2, 1997 (62 FR 29684) 

(FRL–5597–1), the Agency presented its 

general determination that proposed 

and final SNURs are not expected to 

have a significant economic impact on 

a substantial number of small entities, 

which was also provided to the Chief 

Counsel for Advocacy of the Small 

Business Administration (Ref. 46). 

3. Potential small entity impacts 

related to export notifications. 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. 45 and 

46). 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 potential 

adverse economic 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 

Pursuant to Title II of the Unfunded 

Mandates Reform Act of 1995 (UMRA), 

2 U.S.C. 1531–1538, 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 one year. It is 

estimated that the total aggregate costs 

of this proposed rule to the private 

sector, which are summarized in Unit 

VII., would be $7.65 million. The total 

annualized costs of this proposed rule to 

the private sector are estimated to be 

$2.71 and $2.92 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 

test rule and SNUR 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. Federalism 

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 they 

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 these actions, this proposed 

test rule and SNUR is not expected to 

affect any State or local governments. 

Thus, Executive Order 13132 does not 

apply to this proposed rule. 

F. Indian Tribal Government 

Implications 

Under Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (59 FR 

22951, November 9, 2000), EPA has 

determined that this proposed rule does 

not have Tribal implications because it 

will not have substantial direct effects 

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. Thus, 

Executive Order 13175 does not apply 

to this proposed rule. 

G. Protection of Children 

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 the rulemaking 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, 

notification and recordkeeping 

requirements that apply to 

manufacturers (including importers) 

and processors of certain chemical 

substances. The development of data 

about those chemical substances can 

subsequently be used to assist the 

Agency and others in determining 


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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. Effect on Energy Supply, Distribution, 

or Use 

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 not a significant 

regulatory action under Executive Order 

12866. 

I. Technical Standards 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act (NTTAA), 15 U.S.C. 272 note, 

directs EPA to use voluntary consensus 

standards in its regulatory activities 

unless to do so would be inconsistent 

with applicable law or otherwise 

impractical. Voluntary consensus 

standards are technical standards (e.g., 

materials specifications, test methods, 

sampling procedures, and business 

practices) that are developed or adopted 

by voluntary consensus standards 

bodies. The NTTAA directs EPA to 

provide Congress, through OMB, 

explanations when the Agency decides 

not to use available and applicable 

voluntary consensus standards. 

The proposed test 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 § 799.5090(h) have 

been placed in the docket for this 

proposed rule. You may obtain copies of 

the ASTM International standards from 

the American Society for Testing and 

Materials International, 100 Bar Harbor 

Dr., West Conshohocken, PA 19428– 

2959, and copies of the ISO standards 

from the International Organization for 

Standardization, Case Postale, 56 CH– 

1211 Geneve 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. Environmental Justice 

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 test rule, if finalized, will 

assist EPA and others in determining 

the potential hazards and risks 

associated with the chemical substances 

covered by this proposed test 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 

40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

40 CFR Part 799 

Environmental protection, Chemicals, 

Hazardous substances, Laboratories, 

Reporting and recordkeeping 

requirements. 

Dated: September 28, 2011. 

Stephen A. Owens, 

Assistant Administrator, Office of Chemical 

Safety and Pollution Prevention. 

Therefore, it is proposed that 40 CFR 

chapter I be amended as follows: 

PART 721—[AMENDED] 

1. The authority citation for part 721 

continues to read as follows: 

Authority: 15 U.S.C. 2604, 2607, and 

2625(c). 

2. Add § 721.10228 to subpart E to 

read as follows: 

§ 721.10228 High production volume 

challenge program chemical substances. 

(a) Chemical substances and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

in Table 1. are subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

TABLE 1—LIST OF CHEMICAL SUBSTANCES INCLUDED IN THE SNUR 

Chemical abstract service 

registry number 

(CASRN) 

Chemical abstract (CA) index name 

98–16–8 .............................. Benzenamine, 3-(trifluoromethyl)-. 

100–53–8 ............................ Benzenemethanethiol. 

104–91–6 ............................ Phenol, 4-nitroso-. 

110–03–2 ............................ 2,5-Hexanediol, 2,5-dimethyl-. 

124–63–0 ............................ Methanesulfonyl chloride. 

142–30–3 ............................ 3-Hexyne-2,5-diol, 2,5-dimethyl-. 

460–00–4 ............................ Benzene, 1-bromo-4-fluoro-. 

542–92–7 ............................ 1,3-Cyclopentadiene. 


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TABLE 1—LIST OF CHEMICAL SUBSTANCES INCLUDED IN THE SNUR—Continued 

Chemical abstract service 

registry number 

(CASRN) 

Chemical abstract (CA) index name 

553–26–4 ............................ 4,4′-Bipyridine. 

8007–45–2 .......................... Tar, coal. 

28106–30–1 ........................ Benzene, ethenylethyl-. 

35203–06–6 ........................ Benzenamine, 2-ethyl-6-methyl-N-methylene-. 

35203–08–8 ........................ Benzenamine, 2,6-diethyl-N-methylene-. 

37734–45–5 ........................ Carbonochloridothioic acid, S-(phenylmethyl) ester. 

37764–25–3 ........................ Acetamide, 2,2-dichloro-N,N-di-2-propen-1-yl-. 

61789–72–8 ........................ Quaternary ammonium compounds, benzyl(hydrogenated tallow alkyl)dimethyl, chlorides. 

61790–13–4 ........................ Naphthenic acids, sodium salts. 

65996–91–0 ........................ Distillates (coal tar), upper. 

68308–01–0 ........................ Tail gas (petroleum), cracked distillate hydrotreater stripper. 

68478–20–6 ........................ Residues (petroleum), steam-cracked petroleum distillates cyclopentadiene conc., C4-cyclopentadiene-free. 

68526–82–9 ........................ Alkenes, C6–10, hydroformylation products, high-boiling. 

68909–77–3 ........................ Ethanol, 2,2′-oxybis-, reaction products with ammonia, morpholine derivs. residues. 

(2) The significant new uses are: 

(i) Use in a consumer product. 

(ii) Any use, or combination of uses, 

that is reasonably likely to expose 1,000 

or more workers at a single corporate 

entity (defined as the aggregate of all of 

the domestic facilities owned or 

operated by an individual corporation). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), and (c) are applicable to 

manufacturers, importers, and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

PART 799—[AMENDED] 

3. The authority citation for part 799 

continues to read as follows: 

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

4. Add § 799.5090 to subpart D to read 

as follows: 

§ 799.5090 Chemical testing requirements 

for certain high production volume 

chemicals; fourth 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. 

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

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

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

chemical substance included in this section.

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 chemical substance (as described 

at 40 CFR 720.45(a)(1)(i)); 

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

—For research and development (as described at 40 CFR 

790.42(a)(5)). 


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

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

Tier 2B. 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 40 CFR 790.42(a)(2), (a)(4) and (a)(5), 

who, while legally subject to this 

section, must comply with the 

requirements of this section only if 

directed to do so by EPA under the 

circumstances set forth in paragraphs 

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

this section. 

(2) If you are in Tier 1 with respect 

to a chemical substance listed in Table 

2. in paragraph (j) of this section, you 

must, for each test required under this 

section for that chemical substance, 

either submit to EPA a letter of intent 

to test or apply to EPA for an exemption 

from testing. The letter of intent to test 

or the exemption application must be 

received by EPA no later than 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 [date 30 

days after date of publication of the 

final rule in the Federal Register], or 

within 30 days after publication of the 

Federal Register document described in 

paragraph (c)(4) of this section, you 

must, for each test specified for that 

chemical substance in the document 

described in paragraph (c)(4) of this 

section, either submit to EPA a letter of 

intent to test or apply to EPA for an 

exemption from testing. The letter of 

intent to test or the exemption 

application must be received by EPA no 

later than 30 days after publication of 

the 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 [date 30 days after date 

of publication of the final rule in the 

Federal Register], or within 30 days 

after publication of the Federal Register 

document described in paragraph (c)(6) 

of this section, you must, for each test 

specified for that chemical substance in 

the 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 

section will be in violation of this 

section. 

(10) If a problem occurs with the 

initiation, conduct, or completion of the 

required testing or the submission of the 

required data with respect to a chemical 

substance listed in Table 2. in paragraph 

(j) of this section, under the procedures 

in 40 CFR 790.93 and 790.97, EPA may 

initiate termination proceedings for all 

testing exemptions with respect to that 

chemical substance and may notify 

persons in Tier 1 and Tier 2 that they 

are required to submit letters of intent 

to test or exemption applications within 

a specified period of time. 

(11) If you are required to comply 

with this section, but your manufacture 

or processing of, or intent to 

manufacture or process, a chemical 

substance listed in Table 2. in paragraph 

(j) of this section begins after the 

applicable compliance date referred to 

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

this section, you must either submit a 

letter of intent to test or apply to EPA 

for an exemption. The letter of intent to 

test or the exemption application must 

be received by EPA no later than the day 

you begin manufacture or processing. 

(d) What must I do to comply with 

this section? (1) To comply with this 

section you must either submit to EPA 

a letter of intent to test, or apply to and 


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Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Proposed Rules 65605 

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; 40 CFR part 792— 

Good Laboratory Practice Standards; 

and this section. The following 

provisions of 40 CFR part 790 do not 

apply to this section: Paragraphs (a), (d), 

(e), and (f) of § 790.45; § 790.48; 

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 one day after the 

date by which you are required to 

comply with this section. 

(f) How are EPA’s data reimbursement 

procedures affected for purposes of this 

section? If persons subject to this section 

are unable to agree on the amount or 

method of reimbursement for test data 

development for one or more chemical 

substances included in this section, any 

person may request a hearing as 

described in 40 CFR part 791. In the 

determination of fair reimbursement 

shares under this section, if the hearing 

officer chooses to use a formula based 

on production volume, the total 

production volume amount will include 

amounts of a chemical substance 

produced as an impurity. 

(g) Who must comply with the export 

notification requirements? Any person 

who exports, or intends to export, a 

chemical substance listed in Table 2. in 

paragraph (j) of this section is subject to 

40 CFR part 707, subpart D. 

(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 [date 13 months 

after the effective date of publication of 

the final rule in the Federal Register] 

unless an extension is granted in writing 

pursuant to 40 CFR 790.55. A robust 

summary of the final report for each 

specific test may 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 substance name, Chemical 

Abstract Service Registry Number 

(CASRN), and class in Table 2. of this 

paragraph must be tested in accordance 

with the requirements designated in 

Tables 2. and 3. of this paragraph, and 

the requirements described in 40 CFR 

part 792—Good Laboratory Practice 

Standards. 

TABLE 2—CHEMICAL SUBSTANCES AND TESTING REQUIREMENTS

Chemical abstract 

service registry 

number 

(CASRN) 

Chemical abstract (CA) index name Class Required tests 

(see Table 3. of this section) 

56–40–6 ..................... Glycine .................................................................................................... 1 A3 

67–72–1 ..................... Ethane, 1,1,1,2,2,2-hexachloro- ............................................................. 1 C6 

78–00–2 ..................... Plumbane, tetraethyl- ............................................................................. 1 A4, A5, C6, E2 

95–14–7 ..................... 1H-Benzotriazole .................................................................................... 1 A3, C6, F1 

118–48–9 ................... 2H-3,1-Benzoxazine-2,4(1H)-dione ........................................................ 1 A3, A4, A5, C3, E1, E2, F1 

128–44–9 ................... 1,2–Benzisothiazol-3(2H)-one, 1,1-dioxide, sodium salt (1:1) ............... 1 A2, A3, A4, A5, C1, F1 

928–72–3 ................... Glycine, N-(carboxymethyl)-, sodium salt (1:2) ...................................... 1 A1, A3, A4, A5, B 

1809–19–4 ................. Phosphonic acid, dibutyl ester ............................................................... 1 A1, A4, C1, E1, E2, F1 

25377–73–5 ............... 2,5-Furandione, 3-(dodecen-1-yl)dihydro- .............................................. 1 A1, A2, A3, A4, A5, B, C1, D, E2, 

F1 

26544–38–7 ............... 2,5-Furandione, dihydro-3-(tetrapropenyl)- ............................................ 1 A1, A2, A3, A4, A5, B, C1, D, E1, 

E2, F1 

27859–58–1 ............... Butanedioic acid, 2-(tetrapropenyl)- ....................................................... 1 A1, A2, A3, A4, A5, C1, D, E1, E2, 

F1 

28777–98–2 ............... 2,5-Furandione, dihydro-3-(octadecen-1-yl)- .......................................... 1 A2, A3, A4, A5, C1, D, E1, E2, F1 

29385–43–1 ............... 1H-Benzotriazole, 6(or 7)-methyl- .......................................................... 1 A3, A4, A5, E2, F1 

32072–96–1 ............... 2,5-Furandione, 3-(hexadecen-1-yl)dihydro- .......................................... 1 A1, A2, A3, A4, A5, B, C1, D, E1, 

E2, F1 

61789–73–9 ............... Quaternary ammonium compounds, benzylbis(hydrogenated tallow 

alkyl)methyl, chlorides.

2 A3 

64665–57–2 ............... 1H-Benzotriazole, 6(or 7)-methyl-, sodium salt ...................................... 1 A1, A3, A4, A5, E1, E2, F1, 

68131–13–5 ............... Naphthenic acids, reaction products with diethylenetriamine ................ 2 C1, D, E1, E2, F1 

68153–60–6 ............... Fatty acids, tall-oil, reaction products with diethylenetriamine, acetates 2 A1, A2, A3, A4, A5, B, C1, D, E1, 

E2, F1 

68424–85–1 ............... Quaternary ammonium compounds, benzyl-C12–16- 

alkyldimethyl,chlorides.

1 A1, A2, A3 

68442–77–3 ............... 2-Butenediamide, (2E)-, N1,N4-bis[2-(4,5-dihydro-2-nortall-oil alkyl-1Himidazol-1-yl)ethyl] derivs.2 A1, A2, A3, A4, A5, B, 

C1, D, E1, E2, F1 

68607–28–3 ............... Quaternary ammonium compounds, (oxydi-2,1-ethanediyl)bis[coco 

alkyldimethyl, dichlorides.

2 A1, A2, A3, A4, A5, 


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TABLE 2—CHEMICAL SUBSTANCES AND TESTING REQUIREMENTS—Continued 

Chemical abstract 

service registry 

number 

(CASRN) 

Chemical abstract (CA) index name Class Required tests 

(see Table 3. of this section) 

68909–18–2 ............... Pyridinium, 1-(phenylmethyl)-, Et Me derivs., chlorides ......................... 2 A1, A2, A3, A4, A5, C1, D, E1, E2, 

F1 

69834–17–9 ............... Benzene, decylphenoxy- ........................................................................ 1 A1, A2, A3, A4, A5, B, C1, D, E1, 

E2, F1 

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

Testing category Test 

symbol Test requirements and references Special conditions 

Physical/chemical properties.A 1. Melting Point: ASTM E 324–99 (capillary tube), if 

a Freezing Point: Organisation for Economic Cooperation and Development (OECD) 102 (melting 

point/melting range). 

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

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

analysis). 

Physical/chemical properties (continued).A 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) 

n-Octanol/Water Partition Coefficient or log Kow: 

Which method is required, if any, is determined 

by the test substance’s estimated 1 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. 

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) 

Water Solubility: 

Which method is required, if any, is determined by 

the test substance’s estimated 2 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 10631 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 

Which method is required, if any, is determined by 

the test substance’s physical and chemical properties, including its water solubility. ISO 10631 

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. 

5. ISO 9439 (CO2 evolution test) or 

6. ISO 10707 (closed bottle test) or 

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

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

(2007). 

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

(2007). 

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.3

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—Continued 

Testing category Test 

symbol 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 

(2007). 

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 

(2007).

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 

(2007).

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

(2007).

Test Group 2 for C4: 

1. Chronic Toxicity To Daphnia: ASTM E 

1193–97 (2004).

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

column must be used to fulfill the testing requirements—see special conditions.

Test Group 1 for C5: 

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

(2007).

Test Group 2 for C5: 

1. Chronic Toxicity To Daphnia: ASTM E 

1193–97 (2004).

C6 Toxicity To Plants (Algae): ASTM E 1218–04e1.

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 

(2007).

Test Group 2 for C7: 

1. Chronic Toxicity To Daphnia: ASTM E 

1193–97 (2004). 

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

select the method that must be used from those 

listed in this column.

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

799.9130. 

Method B: either: 

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

E 1163–98 (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.4

Estimating starting dose for Method B: Data from 

the neutral red uptake basal cytotoxicity assay 5

using normal human keratinocytes or mouse 

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

starting dose. 

Mammalian toxicity— 

genotox-icity.

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

799.9510.

None. 


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TABLE 3—KEY TO THE TEST REQUIREMENTS DENOTED BY ALPHANUMERIC SYMBOLS IN TABLE 2—Continued 

Testing category Test 

symbol Test requirements and references Special conditions 

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 

substance 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.

1EPA 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–2010–0520 at the EPA Docket Center, Rm. 3331 in the EPA West Building located at 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. 2EPA 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–2010–0520 at the EPA Docket Center, Rm. 3331 in the EPA West 

Building located at 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. 3 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. 4The OECD 425 Up/Down Procedure, revised by OECD in December 2001, is available under docket ID number EPA–HQ–OPPT–2010–0520 

at the EPA Docket Center, Rm. 3331 in the EPA West Building located at 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding legal holidays. 5The 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–2010–0520 at the EPA Docket Center, Rm. 3331 in the EPA West Building 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 [date 30 days after date of 

publication of the final rule in the 

Federal Register]. 

[FR Doc. 2011–26894 Filed 10–20–11; 8:45 am] 

BILLING CODE 6560–50–P 


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