Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Rules and Regulations 1067 

Protection of Children 

We have analyzed this rule under 

Executive Order 13045, Protection of 

Children from Environmental Health 

Risks and Safety Risks. This rule is not 

an economically significant rule and 

does not create an environmental risk to 

health or risk to safety that may 

disproportionately affect children. 

Indian Tribal Governments 

This rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have a substantial 

direct effect on one or more Indian 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

Energy Effects 

We have analyzed this rule under 

Executive Order 13211, Actions 

Concerning Regulations that 

Significantly Affect Energy Supply, 

Distribution, or Use. We have 

determined that it is not a ‘‘significant 

energy action’’ under that order because 

it is not a ‘‘significant regulatory action’’ 

under Executive Order 12866 and is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. The Administrator of the Office 

of Information and Regulatory Affairs 

has not designated it as a significant 

energy action. Therefore, it does not 

require a statement of Energy Effects 

under Executive Order 13211. 

Technical Standards 

The National Technology Transfer 

and Advancement Act (NTTAA) (15 

U.S.C. 272 note) directs agencies to use 

voluntary consensus standards in their 

regulatory activities unless the agency 

provides Congress, through the Office of 

Management and Budget, with an 

explanation of why using these 

standards would be inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedure; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This rule does not use technical 

standards. Therefore, we did not 

consider the use of voluntary consensus 

standards. 

Environment 

We have analyzed this rule under 

Department of Homeland Security 

Management Directive 023–01 and 

Commandant Instruction M16475.lD, 

which guide the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have concluded this action is one of a 

category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule is categorically 

excluded, under figure 2–1, paragraph 

(34)(g), of the Instruction. This rule 

involves the establishment of a security 

zone. An environmental analysis 

checklist and a categorical exclusion 

determination are available in the 

docket where indicated under 

ADDRESSES. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

■ For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1231; 46 U.S.C. 

Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 

33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; 

Pub. L. 107–295, 116 Stat. 2064; Department 

of Homeland Security Delegation No. 0170.1. 

■ 2. Add a new temporary section 

165.T09–1133 as follows: 

§ 165.T09–1133 Security Zone; 23rd 

Annual North American International Auto 

Show, Detroit River, Detroit, MI. 

(a) Location. The following area is a 

temporary security zone: An area of the 

Detroit River encompassed by a line 

beginning at a point of origin on land 

adjacent to the west end of Joe Lewis 

Arena at 42°19.44′ N, 083°03.11′ W; 

then extending offshore approximately 

150 yards to 42°19.39′ N, 083°03.07′ W; 

then proceeding upriver approximately 

2,000 yards to a point at 42°19.72′ N, 

083°01.88′ W; then proceeding onshore 

to a point on land adjacent to the 

Tricentennial State Park at 42°19.79′ N, 

083°01.90′ W; then proceeding 

downriver along the shoreline to 

connect back to the point of origin on 

land adjacent to the west end of the Joe 

Louis Arena. All geographic coordinates 

are North American Datum of 1983 

(NAD 83). 

(b) Effective and enforcement period. 

This section is effective from 9 a.m. on 

January 10, 2011, until 10 p.m. on 

January 23, 2011. The security zone will 

be enforced from 9 a.m. to 5 p.m. daily 

from January 10, 2011, through January 

23, 2011. 

(c) Regulations. (1) In accordance with 

the general regulations in section 165.23 

of this part, entry into, transiting, or 

anchoring within this security zone is 

prohibited unless authorized by the 

Captain of the Port Detroit, or his 

designated on-scene representative. 

(2) This security zone is closed to all 

vessel traffic, except as may be 

permitted by the Captain of the Port 

Detroit or his designated on-scene 

representative. 

(3) The ‘‘on-scene representative’’ of 

the Captain of the Port is any Coast 

Guard commissioned, warrant or petty 

officer who has been designated by the 

Captain of the Port to act on his behalf. 

The on-scene representative of the 

Captain of the Port will be aboard either 

a Coast Guard or Coast Guard Auxiliary 

vessel. The Captain of the Port or his 

designated on-scene representative may 

be contacted via VHF Channel 16. 

(4) Vessel operators desiring to enter 

or operate within the security zone shall 

contact the Captain of the Port Detroit 

or his on-scene representative to obtain 

permission to do so. 

(5) Vessel operators given permission 

to enter or operate in the security zone 

shall comply with all directions given to 

them by the Captain of the Port Detroit 

or his on-scene representative. 

Dated: December 23, 2010. 

J.E. Ogden, 

Captain, U.S. Coast Guard, Captain of the 

Port Detroit. 

[FR Doc. 2011–89 Filed 1–6–11; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 799 

[EPA–HQ–OPPT–2007–0531; FRL–8846–9] 

RIN 2070–AD16 

Testing of Certain High Production 

Volume Chemicals; Second Group of 

Chemicals 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is promulgating a final 

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

Toxic Substances Control Act (TSCA) to 

require manufacturers, importers, and 

processors of certain high production 

volume (HPV) chemical substances to 

conduct testing to obtain screening level 

data for health and environmental 

effects and chemical fate. 


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DATES: This final rule is effective 

February 7, 2011. The incorporation by 

reference of certain publications listed 

in the rule is approved by the Director 

of the Federal Register as of February 7, 

2011. For purposes of judicial review, 

this final rule shall be promulgated at 

1 p.m. eastern daylight/standard time on 

January 24, 2011. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPPT–2007–0531. All documents in the 

docket are listed on the regulations.gov 

Web site. Although listed in the index, 

some information is not publicly 

available, i.e., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

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

3334, EPA West Bldg., 1301 

Constitution Ave., NW., Washington, 

DC. The EPA/DC Public Reading Room 

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

p.m., Monday through Friday, excluding 

legal holidays. The telephone number of 

the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Paul 

Campanella or John Schaeffer, Chemical 

Control Division (7405M), Office of 

Pollution Prevention and Toxics, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone numbers: 

(202) 564–8091 or (202) 564–8173; 

e-mail addresses: 

campanella.paul@epa.gov or 

schaeffer.john@epa.gov. 

For general information contact: The 

TSCA–Hotline, ABVI–Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

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

SUPPLEMENTARY INFORMATION: 

I. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture (defined 

by statute to include import) or process 

any of the chemical substances that are 

listed in § 799.5087(j) of the regulatory 

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

in this document will encompass 

‘‘import,’’ unless otherwise stated. In 

addition, as described in Unit VI., once 

the Agency issues a final rule, any 

person who exports, or intends to 

export, any of the chemical substances 

included in the final rule will be subject 

to the export notification requirements 

in 40 CFR part 707, subpart D. 

Potentially affected entities may 

include, but are not limited to: 

• Manufacturers (defined by statute to 

include importers) of one or more of the 

19 subject chemical substances (NAICS 

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

manufacturing and petroleum refineries. 

• Processors of one or more of the 19 

subject chemical substances (NAICS 

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

manufacturing and petroleum refineries. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

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

the regulatory text. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

either of the technical persons listed 

under FOR FURTHER INFORMATION

CONTACT. 

II. Background 

A. What action is the agency taking? 

EPA is promulgating a final test rule 

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

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

manufacturers and processors of 19 

chemical substances to conduct testing 

for environmental fate (including 5 tests 

for physical/chemical properties and 

biodegradation); ecotoxicity (in fish, 

Daphnia, and algae); acute toxicity; 

genetic toxicity (gene mutations and 

chromosomal aberrations); repeat dose 

toxicity; and developmental and 

reproductive toxicity. The chemical 

substances are HPV chemicals (i.e., 

chemical substances with a production/ 

import volume equal to or greater than 

1 million pounds (lbs) per year). A 

detailed discussion regarding efforts to 

enhance the availability of screening 

level hazard and environmental fate 

information about HPV chemicals can 

be found in a Federal Register notice 

which published on December 26, 2000 

(Ref. 1). 

In the proposed rule for this final rule, 

published in the Federal Register of 

July 24, 2008, EPA proposed Screening 

Information Data Set (SIDS) testing for 

19 HPV chemicals (Ref. 2). Comments 

were received on the proposed rule. In 

consideration of those comments, EPA 

changed some testing requirements for 

certain HPV chemicals, as explained in 

Unit III. However, none of these changes 

resulted in dropping all testing 

proposed for any of the chemical 

substances, and EPA is still requiring 

testing for each of the 19 HPV chemicals 

originally proposed for testing in 2008. 

This action also follows an earlier 

testing action for certain HPV chemicals 

(see the proposed and final rules 

entitled ‘‘Testing of Certain High 

Production Volume Chemicals; 

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

Certain High Production Volume 

Chemicals; Final Rule’’ (Ref. 4)). 

EPA has also proposed testing for a 

third group of HPV chemicals (Ref. 5), 

and plans to propose testing for 

additional HPV chemicals as the Agency 

learns more about these chemical 

substances with respect to human 

exposure, release, and sufficiency of 

data and experience available on their 

potential hazards. 

B. What is the agency’s authority for 

taking this action? 

This final rule is being promulgated 

under TSCA section 4(a) (15 U.S.C. 

2603(a)), which directs EPA to require 

the development of data relevant to 

assessing whether activities associated 

with chemical substances and mixtures 

present an unreasonable risk of injury to 

health or the environment, when 

appropriate findings are made. Section 

2(b)(1) of TSCA (15 U.S.C. 2603(b)(1)) 

states that it is the policy of the United 

States that: 

* * * adequate data should be developed 

with respect to the effect of chemical 

substances and mixtures on health and the 

environment and that the development of 

such data should be the responsibility of 

those who manufacture [which is defined by 

statute to include import] and those who 

process such chemical substances and 

mixtures[.] 

To implement this policy, EPA is 

promulgating this test rule under TSCA 

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

2603(a)(1)(B)). Section 4(a) of TSCA 

mandates EPA require by rule that 

manufacturers and/or processors of 


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chemical substances and mixtures 

conduct testing if the EPA 

Administrator finds that: 

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

will be produced in substantial quantities, 

and (I) it enters or may reasonably be 

anticipated to enter the environment in 

substantial quantities or (II) there is or may 

be significant or substantial human exposure 

to such substance or mixture, 

(ii) there are insufficient data and 

experience upon which the effects of the 

manufacture, distribution in commerce, 

processing, use, or disposal of such substance 

or mixture or of any combination of such 

activities on health or the environment can 

reasonably be determined or predicted, and 

(iii) testing of such substance or mixture 

with respect to such effects is necessary to 

develop such data [.] 

If EPA makes these findings for a 

chemical substance or mixture, the EPA 

Administrator shall require by rule that 

testing be conducted on that chemical 

substance or mixture to develop data 

about health or environmental effects 

for which there is an insufficiency of 

data and experience, and which are 

relevant to a determination that the 

manufacture, distribution in commerce, 

processing, use, or disposal of the 

chemical substance or mixture, or any 

combination of such activities, does or 

does not present an unreasonable risk of 

injury to health or the environment 

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

Once the EPA Administrator has 

made a finding under TSCA section 

4(a)(1)(A) or TSCA section 4(a)(1)(B), 

EPA may require any type of health or 

environmental effects testing necessary 

to address unanswered questions about 

the effects of the chemical substance or 

mixture that are relevant to whether the 

manufacture, distribution in commerce, 

processing, use, or disposal of the 

chemical substance or mixture, or any 

combination of such activities, presents 

an unreasonable risk of injury to health 

or the environment. EPA need not limit 

the scope of testing required to the 

factual basis for the TSCA section 

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

4(a)(1)(B)(i) findings. This approach is 

explained in more detail in EPA’s TSCA 

section 4(a)(1)(B) Final Statement of 

Policy published in the Federal Register 

issue of May 14, 1993 (‘‘B’’ policy) (Ref. 

6, pp. 28738). 

In this final rule, EPA is using its 

broad TSCA section 4(a) authority to 

obtain data necessary to support the 

development of preliminary or 

‘‘screening level’’ hazard and risk 

characterizations for certain HPV 

chemicals specified in Table 2 in 

§ 799.5087(j) of the regulatory text. 

Following consideration of the public 

comments received by EPA on the 

proposed rule (Ref. 2) and production 

volume information (i.e., 2006 Inventory 

Update Rule (IUR) data), EPA is making 

the following findings for the 19 

chemical substances under TSCA 

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

substantial quantities; there is or may be 

substantial human exposure to them; 

existing data are insufficient to 

determine or predict their health and 

environmental effects; and testing is 

necessary to develop such data. 

C. Why is EPA taking this action? 

In April 1998, EPA initiated a 

national effort to make certain basic 

information about the environmental 

fate and potential health and 

environmental hazards associated with 

the most widespread chemical 

substances in commerce available to the 

public. Mechanisms to collect or, where 

necessary, develop needed data on U.S. 

HPV chemicals include the voluntary 

HPV Challenge Program, certain 

international efforts (the Organization 

for Economic Cooperation and 

Development (OECD) HPV SIDS 

Program, and the International Council 

of Chemical Associations (ICCA) HPV 

Initiative), and TSCA section 4 test 

rules. The voluntary HPV Challenge 

Program was created to ensure that a 

baseline set of data on approximately 

2,800 HPV chemicals would be made 

available to EPA and the public. HPV 

chemicals are manufactured or imported 

in amounts equal to or greater than 1 

million lbs per year and were first 

identified for this program through data 

reported under the 1990 IUR. The SIDS 

data set sought by the HPV Challenge 

Program was developed by OECD, of 

which the United States is a member. 

The SIDS provides an internationally 

agreed-upon set of test data for 

screening HPV chemicals for human 

and environmental hazards, and assists 

the Agency and others in making an 

informed, preliminary judgment about 

the hazards of HPV chemicals. 

The voluntary HPV Challenge 

Program was designed to make 

maximum use of scientifically adequate 

existing test data and to avoid 

unnecessary and duplicative testing of 

U.S. HPV chemicals. Therefore, EPA is 

continuing to participate in the 

voluntary international efforts, 

complementary to the voluntary HPV 

Challenge Program, that are being 

coordinated by OECD to secure basic 

hazard information on HPV chemicals 

in use worldwide, including some of 

those on the 1990 U.S. HPV chemicals 

list (Ref. 7). This includes agreements to 

sponsor a U.S. HPV chemical under 

either the OECD HPV SIDS Program 

(Ref. 8), including sponsorship by OECD 

member countries beyond the United 

States, or the international HPV 

Initiative that is being organized by the 

ICCA (Ref. 9). 

Additional details regarding the 

voluntary HPV Challenge Program and 

these international efforts were 

provided in the prior HPV TSCA section 

4 rules (Refs. 2–4). 

As EPA stated in the first HPV test 

rule, U.S. data needs that remained 

unmet in the voluntary HPV Challenge 

Program or through international efforts 

could be addressed through TSCA 

section 4 rulemakings, such as the final 

test rule promulgated by EPA on March 

16, 2006 (Ref. 4). This second final 

TSCA section 4 HPV SIDS rule 

addresses the unmet data needs for 19 

chemical substances. 

EPA intends to make the information 

collected under the final rule available 

to the public, other Federal agencies, 

and any other interested parties on its 

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

and in the docket for the final rule 

identified under ADDRESSES. As 

appropriate, this information will be 

used to ensure a scientifically sound 

basis for risk assessment/management 

actions. 

D. Why is EPA focusing on HPV 

chemicals and SIDS testing? 

This final rule pertains to HPV 

chemicals, which EPA determined 

account for 95% of total chemical 

production in the United States (Ref. 10, 

p. 32296). EPA found that, of those HPV 

non-polymeric organic substances based 

on 1990 IUR reporting, only 7% had a 

full set of publicly available and 

internationally recognized basic 

screening test data for health and 

environmental effects (Ref. 11). Of the 

over 2,800 U.S. HPV chemicals, 43% 

had no publicly available basic hazard 

data. For the remaining chemical 

substances, limited amounts of the data 

were available. This lack of available 

hazard data compromises EPA’s and 

others’ ability to determine whether 

these HPV chemicals pose potential 

risks to human health or the 

environment, as well as the public’s 

ability to know about the hazards of 

chemical substances that may be found 

in their environment, their homes, their 

workplaces, and the products they buy. 

SIDS testing evaluates the following 

six testing endpoints (Ref. 8): 

• Acute toxicity. 

• Repeat dose toxicity. 

• Developmental and reproductive 

toxicity. 

• Genetic toxicity (gene mutations 

and chromosomal aberrations). 

• Ecotoxicity (studies in fish, 

Daphnia, and algae). 


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• Environmental fate (including 

physical/chemical properties (melting 

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

water solubility), photolysis, hydrolysis, 

transport/distribution, and 

biodegradation). 

Data on the six SIDS endpoints 

provide a consistent minimum set of 

information that can be used to help 

assess the relative risks of chemical 

substances and whether additional 

testing or assessment is necessary. 

E. How would the data developed under 

this final rule be used? 

EPA will use the data obtained from 

this final rule to support development of 

preliminary hazard and risk assessments 

for the 19 HPV chemicals subject to the 

rule. The data will also be used by EPA 

to set priorities for further testing that 

may produce hazard information on 

these chemicals that may be needed by 

EPA, other Federal agencies, the public, 

industry, and others, to support 

adequate risk assessments. As 

appropriate, this information will be 

used to ensure a scientifically sound 

basis for risk characterizations and risk 

management actions. As such, this effort 

will serve to further the Agency’s goal 

of identifying and controlling human 

and environmental risks as well as 

providing greater knowledge and 

protection to the public. EPA uses data 

from test rules to support such actions 

as the risk management decisions and 

activities under TSCA, development of 

water quality criteria, Toxic Release 

Inventory (TRI) listings, and reduction 

of workplace exposures. 

In addition, a key goal of the HPV 

Challenge Program was making basic 

health and environmental effects data 

for HPV chemicals available to the 

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

Initiative. A basic premise of the HPV 

Challenge Program was that the public 

has a right to know about the hazards 

associated with chemical substances in 

their environment. Everyone—including 

industry, environmental protection 

groups, animal welfare organizations, 

government groups, and the general 

public, among others—can use the data 

provided through the HPV Challenge 

Program, and also data collected on 

HPV chemicals through other means, 

including TSCA section 4 testing, to 

make informed decisions related to the 

human and the environmental hazards 

of chemical substances that they 

encounter in their daily lives. 

III. Response to Public Comments 

EPA received a number of comments 

in response to the proposed rule (Ref. 2). 

A summary of those comments and 

EPA’s response to each comment are 

presented in the document entitled 

‘‘Response to Public Comments’’ (Ref. 

12). The comments and EPA’s 

‘‘Response to Public Comments’’ 

document are available in the docket. 

The comments on the proposed rule 

were submitted by the Acetaldehyde 

Working Group (AWG) of the Vinyl 

Acetate Council; Albemarle Corporation 

(Albemarle); American Chemistry 

Council (ACC); Chlorinated Paraffins 

Industry Association (CPIA); Dyno 

Nobel, Inc. (Dyno Nobel); and Vertellus 

Specialties, Inc. (Vertellus). Comments 

were also submitted by People for the 

Ethical Treatment of Animals (PETA), 

the Physicians Committee for 

Responsible Medicine (PCRM), the 

Alternatives Research Development 

Foundation (ARDF), and the American 

Anti-Vivisection Society (AAVS). 

Additional comments submitted by 

PCRM were also on behalf of the Doris 

Day Animal League (DDAL) and the 

Humane Society of the United States 

(HSUS). EPA also received comments 

from numerous private citizens. In 

response to these comments, EPA made 

the following changes to the regulatory 

text in the final rule: 

1. The screening test for reproduction/ 

developmental toxicity is not required 

for 2,4-hexadienoic acid, (E,E)- 

(Chemical Abstract Service Registry 

Number (CASRN) 110–44–1), also 

known as sorbic acid. This change is 

further discussed in Unit VII.A. and in 

the ‘‘Response to Public Comments’’ 

document (Ref. 12). 

2. Screening testing for reproductive/ 

developmental toxicity is not required 

for ethanedioic acid (CASRN 144–62–7). 

This change is further discussed in Unit 

VII.B. and in the ‘‘Response to Public 

Comments’’ document (Ref. 12). 

3. Vapor pressure, water solubility, nOctanol/Water Partition Coefficient (log 

10 basis) or ‘‘log Kow,’’ and aquatic 

toxicity testing are not required for 

castor oil, oxidized (CASRN 68187–84– 

8). EPA is also not requiring water 

solubility or log Kow testing for castor 

oil, sulfated, sodium salt (CASRN 

68187–76–8). These changes are further 

discussed in Unit VII.C. and in the 

‘‘Response to Public Comments’’ 

document (Ref. 12). In addition, for 

castor oil, oxidized (CASRN 68187–84– 

8), the acute mammalian toxicity test is 

not required. This change is further 

discussed in Unit VII.D. and in the 

‘‘Response to Public Comments’’ 

document (Ref. 12). 

4. Boiling point is not required for 

benzenediamine, ar,ar-diethyl-armethyl—(CASRN 68479–98–1). This 

change is further discussed in Unit 

VII.E. and in the ‘‘Response to Public 

Comments’’ document (Ref. 12). 

5. Acute mammalian toxicity, 

repeated-dose toxicity, and in vitro 

mutagenicity tests are not required for 

alkenes, C12–24, chloro. These changes 

are further discussed in Unit VII.F. and 

in the ‘‘Response to Public Comments’’ 

document (Ref. 12). 

IV. Findings 

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

to test these chemical substances? 

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

promulgate a rule under TSCA section 

4(a) requiring the testing of chemical 

substances or mixtures, EPA must, 

among other things, make certain 

findings regarding either risk (TSCA 

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

combined with either chemical release 

or human exposure (TSCA section 

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

chemical substances. EPA is requiring 

testing of the chemical substances 

included in this final test rule based on 

its findings under TSCA section 

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

production and ‘‘substantial human 

exposure,’’ as well as findings under 

TSCA section 4(a)(1)(B)(ii) and (iii) 

relating to sufficient data and the need 

for testing. The chemical substances 

included in this final rule are listed in 

Table 2 in § 799.5087(j) of the regulatory 

text along with their CASRN. 

‘‘Substantial production’’ of a 

chemical substance or mixture under 

TSCA section 4(a)(1)(B)(i) is generally 

considered to be aggregate production 

(including import) volume equaling or 

exceeding 1 million lbs per year of that 

chemical substance or mixture and 

exposure of 1,000 workers or more on a 

routine or episodic basis to a chemical 

substance or mixture is considered to be 

‘‘substantial exposure.’’ See EPA’s ‘‘B’’ 

policy (Ref. 6) for further discussion on 

how EPA generally evaluates chemical 

substances or mixtures under TSCA 

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

EPA finds that, under TSCA section 

4(a)(1)(B)(i), each of the 19 chemical 

substances included in this final rule is 

produced in ‘‘substantial’’ quantities and 

that there is or may be ‘‘substantial 

human exposure’’ to each chemical 

substance (Ref. 13). Also, for three 

substances, EPA finds that, under TSCA 

section 4(a)(1)(B)(i), the substance enters 

or may reasonably be anticipated to 

enter the environment in substantial 

quantities (Ref. 13). In addition, under 

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

that there are insufficient data and 

experience to reasonably determine or 

predict the effects of the manufacture, 

processing, or use of these chemical 


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substances, or of any combination of 

such activities, on human health or the 

environment. EPA also finds that testing 

the 19 chemical substances identified in 

this final rule is necessary to develop 

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

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

any ‘‘additional factors’’ as discussed in 

the ‘‘B’’ policy (Ref. 6) to cause the 

Agency to use decisionmaking criteria 

other than the general thresholds 

described in the ‘‘B’’ policy with respect 

to the chemical substances included in 

this final rule. 

The chemical substances included in 

this final rule are listed in § 799.5087(j) 

of the regulatory text along with their 

CASRN. For a chemical-by-chemical 

summary of each of the findings, see 

Table 1 of this unit. 

TABLE 1—EXPOSURE-BASED FINDINGS

CASRN 

2006 IUR 

production volume 

(lbs) 

Meet exposure 

based criteria 

for Mfg & 

industrial 

workers 

NOES 

(number of 

workers) 

Meet exposure-based 

criteria for 

commercial 

workers 

Meet 

exposurebased 

criteria for 

consumers 

Meet 

substantial or 

significant 

release 

criteria 

NLM 

household 

chemicals 

database 

75–07–0 ................. > 100 M–500 M ... X 216,533 ........................ X X X 

78–11–5 ................. > 1 M–10 M ......... X 2,650 ........................ X ........................ ........................

84–65–1 ................. > 10 M–50 M ....... X 6,187 X X ........................ ........................

89–32–7 ................. > 1 M–10 M ......... X 1,926 ........................ ........................ ........................ ........................

110–44–1 ............... > 1 M–10 M ......... X 69,243 X X ........................ X 

118–82–1 ............... > 1 M–10 M ......... X 120,009 X X ........................ ........................

119–61–9 ............... > 1 M–10 M ......... X 41,516 X X ........................ X 

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

149–44–0 ............... > 1 M–10 M ......... X 239,465 X X ........................ ........................

2524–04–1 ............. > 10 M–50 M ....... X 1,088 ........................ ........................ ........................ ........................

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

6381–77–7 ............. > 1 M–10 M ......... X 19,468 ........................ ........................ ........................ ........................

31138–65–5 ........... > 1 M–10 M ......... X 74,165 X X ........................ ........................

66241–11–0 ........... > 1 M–10 M ......... X 38,555 X X ........................ ........................

68187–76–8 ........... > 1 M–10 M ......... X 11,164 X X 

68187–84–8 ........... > 1 M–10 M ......... X 36,381 X X ........................ X 

68479–98–1 ........... > 10 M–50 M ....... X 4,121 ........................ ........................ ........................ ........................

68527–02–6 ........... > 1 M–10 M ......... X 84,192 ........................ ........................ ........................ ........................

68647–60–9 ........... > 1 Billion ............. X 1,257 

Notes: CASRN—Chemical Abstract Service Registry Number, IUR—Inventory Update Rule, M—Million, Mfg—Manufacturing, NOES—National 

Occupational Exposure Survey, NLM—National Library of Medicine. 

B. Are these chemical substances 

produced and/or imported in 

substantial quantities? 

EPA finds that each of the chemical 

substances included in this final rule is 

produced and/or imported in an amount 

equal to or greater than 1 million lbs per 

year (Ref. 13), based on information 

gathered pursuant to the 2006 IUR (40 

CFR part 710), which is the most 

recently available compilation of TSCA 

Chemical Substance Inventory data. 

EPA believes that these annual 

production and/or importation volumes 

are ‘‘substantial’’ as that term is used 

with reference to production in TSCA 

section 4(a)(1)(B)(i) (see Ref. 6, p. 

28746). A discussion of EPA’s 

‘‘substantial production’’ finding for 

each chemical substance included in 

this final rule is contained in a separate 

document (Ref. 13). 

C. Are a substantial number of workers 

exposed to these chemical substances? 

EPA finds that the manufacture, 

processing, and use of the 19 chemical 

substances included in this action result 

or may result in exposure of a 

substantial number of workers to the 

chemical substances. These chemical 

substances are used in a wide variety of 

industrial applications which result in 

potential exposures to workers, as 

described in the exposure support 

document for this final rule (Ref. 13). 

This finding is based, in large part, on 

information submitted in accordance 

with the 2006 IUR. For chemicals whose 

total production volume (manufactured 

and imported) exceeded 300,000 lbs at 

a site during calendar year 2005, 

manufacturers and importers were 

required to report the number of 

potentially exposed workers during 

industrial processing and use to the 

extent the information was readily 

obtainable. In addition, the submitters 

were required to provide information 

regarding the commercial and consumer 

uses of the chemical substance. 

In accordance with the Agency’s ‘‘B’’ 

policy (Ref. 6), EPA believes, as a 

general matter, that an exposure of over 

1,000 workers to a chemical substance 

is ‘‘substantial’’ as that term is used with 

reference to ‘‘human exposure’’ in TSCA 

section 4(a)(1)(B)(i). EPA further 

believes, based on experience gained 

through case-by-case analysis of existing 

chemicals, that an exposure of 1,000 

workers or more to a chemical substance 

is a reasonable interpretation of the 

phrase ‘‘substantial human exposure’’ in 

TSCA section 4(a)(1)(B)(i) (see Ref. 6). 

EPA is not aware of any facts in this 

case that warrant departure from this 

policy, and finds that there is or may be 

substantial human exposure (workers) 

to these 19 chemical substances. 

Besides the 2006 IUR data, EPA also 

reviewed National Occupational 

Exposure Survey (NOES) data 

developed by the National Institute for 

Occupational Safety and Health 

(NIOSH). The NOES data additionally 

support EPA’s finding that more than 

1,000 workers are exposed to each of the 

19 chemical substances that are the 

subject of this final rule. The NOES was 

a nationwide data gathering project 

conducted by NIOSH, which was 

designed to develop national estimates 

for the number of workers potentially 

exposed to various chemical, physical, 

and biological agents and describe the 

distribution of these potential 

exposures. Begun in 1980 and 

completed in 1983, the survey involved 

a walk-through investigation by trained 

surveyors of 4,490 facilities in 523 

different types of industries. Surveyors 

recorded potential exposures when a 

chemical agent was likely to enter or 

contact the worker’s body for a 

minimum duration. These potential 


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exposures could be observed or inferred. 

Information from these representative 

facilities was extrapolated to generate 

national estimates of potentially 

exposed workers for more than 10,000 

different chemical substances (Refs. 14– 

16). EPA also compared production 

volumes from the 1986 IUR data 

collection to the production volumes for 

the 2006 IUR data collection. Of the 19 

chemical substances in this final rule, 

only one chemical’s (acetaldehyde, 

CASRN 75–07–0) production volume 

decreased from 1986 to 2006 (Ref. 13). 

The 2006 IUR production volume data 

are consistent with NOES results, as the 

production volumes for the remaining 

chemical substances either stayed the 

same or increased since 1986, thereby 

indicating that the usage of these 

chemical substances is no less than 

when NOES data were gathered. 

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

substances and carefully considered the 

industrial process and use information 

along with the commercial and 

consumer use information from the 

2006 IUR submissions. Commercial uses 

are defined as ‘‘The use of a chemical 

substance or mixture in a commercial 

enterprise providing saleable goods or 

services (e.g., dry cleaning 

establishment, painting contractor)’’ (40 

CFR 710.43). Detailed information from 

the 2006 IUR submissions can be found 

in ‘‘Testing of Certain High Production 

Volume Chemicals; Second Group of 

Chemicals (Exposure Findings 

Supporting Information)’’ (Ref. 13). 

Based on the nature of the IUR uses, 

EPA considers that chemical substances 

with reported commercial uses may 

result in potential exposure to 1,000 

workers or more. The total number of 

workers reported under the 2006 IUR is 

the sum of information on both 

industrial workers plus commercial use 

workers. 

In 2003, EPA partially exempted 

certain petroleum process streams 

(including ‘‘Hydrocarbons, C>4’’ 

(CASRN 68647–60–9) and ‘‘Oils, 

reclaimed’’ (CASRN 69029–75–0)) from 

reporting certain processing and use 

data under the TSCA section 8(a) 2006 

IUR. The exemption was not based on 

an assessment of the toxicity of the 

process streams but on the fact that the 

chemical substances are frequently 

processed, transported, and stored in 

vessels that minimize the potential for 

releases and exposure to workers (Refs. 

17 and 18). Despite the fact that the 

degree of exposure is expected to be 

diminished to particular workers 

because of the chemical processing and 

handling practices used, available data 

indicate that more than 1,000 workers 

are potentially exposed to these 

chemical substances, supporting the 

finding of substantial human exposure 

(Ref. 13). 

D. Are a substantial number of 

consumers exposed to these chemical 

substances? 

Based on 2006 IUR data, EPA finds 

that the uses of 13 of the chemical 

substances included in this action result 

or may result in exposure to a 

substantial number of consumers (Ref. 

13). EPA reviewed the consumer use 

information reported for the 2006 IUR 

and carefully considered the nature of 

those uses. Upon completion of the 

review, EPA concluded that the 

reported consumer uses for these 13 

chemical substances may result in at 

least 10,000 potentially exposed 

consumers, thus meeting the exposure 

based finding for consumers. 

In addition to findings made based on 

the 2006 IUR data, EPA has also made 

consumer exposure based findings 

based on the National Library of 

Medicine (NLM) Household Products 

Database (see Ref. 13). The chemical 

substances reported in the NLM 

Household Products Database are 

present in multiple household products 

subject to TSCA including hobby/craft 

products, personal care products, home 

cleaning products, home maintenance 

products, and automotive products. The 

NLM Household Products Database 

provides information on the chemical 

ingredients and their percentage in 

specific brands of household products. 

Information in the NLM Household 

Products Database is from a variety of 

publicly available sources including 

brand-specific labels and Material 

Safety Data Sheets when available from 

manufacturers and manufacturers’ Web 

sites. 

EPA believes that use of the consumer 

products identified in the NLM 

Household Products Database may 

expose a substantial number of 

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

these chemical substances. EPA believes 

that an exposure of over 10,000 

consumers to a chemical substance is 

‘‘substantial’’ as that term is used with 

reference to ‘‘human exposure’’ in TSCA 

section 4(a)(1)(B)(i). EPA further 

believes, based on experience gained 

through case-by-case analysis of existing 

chemical substances, that an exposure 

of 10,000 consumers or more to a 

chemical substance is a reasonable 

interpretation of the phrase ‘‘substantial 

human exposure’’ in TSCA section 

4(a)(1)(B)(i) (see Ref. 6). Therefore, EPA 

finds that there is or may be substantial 

human exposure (consumers) to these 

chemical substances. 

A discussion of EPA’s ‘‘substantial 

exposure’’ finding for consumers is 

contained in a separate document (see 

Ref. 13). 

E. Are substantial quantities of these 

chemical substances released to the 

environment? 

EPA finds for three chemical 

substances in this final rule that there 

are substantial releases to the 

environment. One substance, 

acetaldehyde (CASRN 75–07–0) is 

included in TRI and has estimated 

environmental release in 2005 of 

13,567,452 lbs (see Ref. 13). TRI 

contains information about releases of 

certain chemical substances and 

management of wastes at a wide variety 

of sources, including manufacturing 

operations, certain service businesses, 

and Federal facilities. Two additional 

chemical substances (ethanedioic acid 

(CASRN 144–62–7) and 1,3,5-triazine1,3,5(2H,4H,6H)-triethanol (CASRN 

4719–04–4)) also meet the substantial 

release criteria based on the 

environmental releases from their 

reported 2006 IUR uses. 

EPA believes that in general an 

environmental release of a chemical 

substance in an amount equal to or 

greater than 1 million lbs per year or 

greater than 10% of the reported 

production volume is ‘‘substantial’’ as 

that term is used with reference to 

‘‘enter the environment in substantial 

quantities’’ in TSCA section 4(a)(1)(B)(i) 

(see Ref. 6). 

A discussion of EPA’s ‘‘substantial 

release to the environment’’ finding is 

contained in a separate document (see 

Ref. 13). 

F. Do sufficient data exist for these 

chemical substances? 

EPA has determined that for the 19 

chemical substances for which testing is 

required under this final rule, there are 

either no data available on SIDS testing 

endpoints or these data are insufficient 

to reasonably determine or predict the 

effects on human health or the 

environment that may result from 

exposures to the chemical substances 

included in this final rule during the 

manufacturing, processing, or use of the 

subject chemical substances. 

The finding for insufficient data is 

based on the results of searches for data 

on SIDS endpoints by EPA, including 

available data as summarized on its 

High Production Volume Information 

System (HPVIS) (Refs. 2, 19, and 20). 

This finding is also based on the results 

of EPA’s review of studies/data 

identified by commenters in response to 

the proposal or identified by EPA after 

the publication of the proposal to this 


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Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Rules and Regulations 1073 

final rule. The studies and data 

submitted or identified subsequent to 

the proposal were found to be sufficient 

for some proposed tests of certain 

chemical substances and those tests are 

not required for those chemical 

substances in this final rule (see Unit 

VII.). 

EPA encouraged the submission of 

existing data on SIDS testing endpoints 

which are relevant to characterizing the 

hazard of those chemical substances for 

which testing was proposed. All such 

submitted information was carefully 

evaluated by EPA in the development of 

the final testing requirements in this 

rule. However, if persons required to 

test under this final rule become aware 

of additional relevant scientifically 

adequate existing data (including 

structure-activity relationships (SAR) 

information or a scientifically defensible 

category approach) and submit this 

information to EPA at any time before 

testing is initiated, the Agency would 

consider such data to determine if they 

satisfy the testing requirement and 

would take appropriate necessary action 

to ensure that the testing in this rule is 

no longer required. In fact, they may 

submit such information as a requested 

modification to the testing requirements 

under 40 CFR 790.55 at anytime as long 

as the request is made at least 60 days 

before the reporting deadline for the test 

in question. 

Section 799.5087(j) of the regulatory 

text lists each chemical substance and 

the SIDS tests for which adequate data 

are not currently available to the 

Agency. The Agency finds that the 

existing data for one or more of the SIDS 

testing endpoints for each of the 

chemical substances listed in Table 2 in 

§ 799.5087(j) of the regulatory text 

(including environmental fate 

(comprising five tests for physical/ 

chemical properties [melting point, 

boiling point, vapor pressure, n-octanol/ 

water partition coefficient, and water 

solubility] and biodegradation); 

ecotoxicity (tests in fish, Daphnia, and 

algae); acute toxicity; genetic toxicity 

(gene mutations and chromosomal 

aberrations); repeat dose toxicity; and 

developmental and reproductive 

toxicity) are insufficient to enable EPA 

to reasonably determine or predict the 

human health and environmental effects 

resulting from manufacture, processing, 

and use of these chemical substances. 

G. Is testing necessary for these 

chemical substances? 

As discussed in Unit II.D., data on 

SIDS testing endpoints, including acute 

toxicity, repeat dose toxicity, 

developmental and reproductive 

toxicity, genetic toxicity (gene 

mutations and chromosomal 

aberrations), ecotoxicity (tests in fish, 

Daphnia, and algae), and environmental 

fate (five tests for physical/chemical 

properties [melting point, boiling point, 

vapor pressure, n-octanol/water 

partition coefficient, and water 

solubility] and biodegradation), are 

necessary in ascertaining the health and 

environmental effects of the 19 chemical 

substances in this final rule. EPA knows 

of no other means to generate the SIDS 

data other than the testing described in 

this rule, and therefore believes that 

conducting the needed SIDS testing 

identified for the 19 subject chemical 

substances is necessary to provide data 

relevant to a determination of whether 

the manufacture, processing, and use of 

the chemical substances does or does 

not present an unreasonable risk of 

injury to human health and the 

environment. EPA also believes it is 

important to make these data available 

to satisfy the ‘‘Right-to-Know’’ principles 

included in the HPV Challenge Program 

goals. 

V. Final Rule 

A. What testing is being required in this 

action? 

EPA is requiring specific testing and 

reporting requirements for the chemical 

substances specified in § 799.5087(j) of 

the regulatory text. The testing 

requirements for each chemical are 

denoted by alphanumeric symbols in 

Table 2 in § 799.5087(j) of the regulatory 

text. Table 3 in § 799.5087(j) of the 

regulatory text provides the key to 

identify the tests denoted by the 

alphanumeric symbols and lists special 

conditions which might apply when 

conducting some of those tests. The test 

methods listed in Table 3 in 

§ 799.5087(j) of the regulatory text are 

grouped according to the endpoint that 

they address. The following endpoints 

and test standards are required under 

this final rule; also discussed in this 

unit are the special conditions which 

EPA has identified and is requiring for 

several of the required test standards. 

1. Physical/Chemical Properties 

Melting Point: American Society for 

Testing and Materials (ASTM) E 324–99 

(capillary tube) (Ref. 21). (If a Freezing Point: 

OECD102 (melting point/melting range) (Ref. 

25)). 

Boiling Point: ASTM E 1719–05 

(ebulliometry) (Ref. 22). 

Vapor Pressure: ASTM E 1782–08 (thermal 

analysis) (Ref. 23). 

n-Octanol/Water Partition Coefficient: 

Method A (40 CFR 799.6755—shake flask). 

Method B (ASTM E 1147–92 (Reapproved 

2005)—liquid chromatography) (Ref. 24). 

Method C (40 CFR 799.6756—generator 

column). 

Water Solubility: Method A (ASTM E 

1148–02 (Reapproved 2008)—shake flask) 

(Ref. 26). 

Method B (40 CFR 799.6784—shake flask). 

Method C (40 CFR 799.6784—column 

elution). 

Method D (40 CFR 799.6786—generator 

column). 

EPA is requiring, for those chemical 

substances for which melting points 

determinations are needed, that melting 

points be determined according to the 

method ASTM E 324–99. ASTM has 

explained that ASTM E 324–99 was 

withdrawn because: 

The standard utilizes old, well-developed 

technology; it is highly unlikely that any 

additional [changes] and/or modifications 

will ever be pursued by the E15 [committee]. 

The time and effort needed to maintain these 

documents detract from the time available to 

develop new standards which use modern 

technology. (Ref. 27). 

However, ASTM still makes the 

method available for informational 

purposes and it can still be purchased 

from ASTM at the address listed in 

§ 799.5087(h) of the regulatory text. 

EPA concludes that ASTM’s 

withdrawal of ASTM E 324–99 does not 

have negative implications on the 

validity of the method; therefore, EPA is 

requiring, for those chemical substances 

for which melting points determinations 

are needed, that melting points be 

determined according to the method 

ASTM E 324–99. 

However, EPA received public 

comment about testing a substance that 

is a liquid at room temperature (Ref. 12). 

In its response, EPA notes that the 

melting point ideally is identical with 

the solidification or freezing point. 

Therefore, a measured freezing point 

would in this case meet the obligation 

to report the melting point. Since ASTM 

E 324–99 (capillary tube) does not 

specifically include instructions for 

determining freezing point, EPA is 

instead requiring, for substances which 

are liquid at room temperature, OECD 

102 (melting point/melting range), 

which includes guidance for 

determining freezing point. 

For the vapor pressure endpoint, 

ASTM has updated and revised its test 

method for vapor pressure (ASTM E 

1782–08—thermal analysis) since the 

time of the proposed rule. Some 

material related to alternative test 

methods and some unnecessary 

descriptive material was omitted in the 

revision, but the test method itself is 

unchanged. The updated and revised 

method (ASTM E 1782–08) is listed as 

the required test method for the vapor 

pressure endpoint in this final rule. 

Note: ASTM issues its test methods 

under a fixed designation (e.g., E1719); 


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‘‘the number immediately following the 

designation indicates the year of 

original adoption or, in the case of 

revision, the year of last revision. A 

number in parentheses indicates the 

year of last reapproval. A superscript 

epsilon (e) indicates an editorial change 

since the last revision or reapproval’’ 

(Ref. 22). 

In addition, ASTM has updated its 

test method for Measurement of 

Aqueous Solubility (ASTM E 1148–02). 

The test method was reapproved in 

2008. There was a minor change in 

‘‘Referenced Documents,’’ but the test 

method itself is unchanged. When 

required, the updated method (ASTM E 

1148–02 (Reapproved 2008)) is listed as 

the required test method for the ‘‘Water 

Solubility’’ endpoint in this final rule 

(Ref. 26). 

For the log Kow and water solubility 

endpoints, EPA is requiring that certain 

‘‘special conditions’’ be considered by 

test sponsors in determining the 

appropriate test method that would be 

used from among those included for 

these endpoints in Table 3 in 

§ 799.5087(j) of the regulatory text. 

For the log Kow endpoint, EPA is 

requiring that an appropriate selection 

be made from among three alternative 

methods for measuring the chemical 

substance’s log Kow. Prior to 

determining the appropriate standard to 

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

water partition coefficient, EPA is 

recommending that the log Kow be 

quantitatively estimated. EPA 

recommends that the method described 

in ‘‘Atom/Fragment Contribution 

Method for Estimating Octanol-Water 

Partition Coefficients’’ (Ref. 28) be used 

in making such estimation. EPA is 

requiring that test sponsors must submit 

with the final study report the 

underlying rationale for the test 

standard selected for this endpoint. EPA 

is requiring this approach in recognition 

of the fact that depending on the 

chemical substance’s log Kow, one or 

more test methods may provide 

adequate information for determining 

the log Kow, but that in some instances 

one particular test method may be more 

appropriate. In general, EPA believes 

that the more hydrophobic a subject 

chemical substance is, Method B (ASTM 

E 1147–92 (Reapproved 2005)) and 

especially Method C (40 CFR 

799.6756—generator column) become 

more suitable than Method A (40 CFR 

799.6755—shake flask). The required 

test methodologies have been developed 

to meet a wide variety of needs and, as 

such, are silent on experimental 

conditions related to pH. Therefore, 

EPA highly recommends that all 

required n-octanol/water partition 

coefficient tests be conducted at pH 7 to 

ensure environmental relevance. The 

required test standards and log Kow

ranges that would determine which tests 

must be conducted for this endpoint are 

shown in Table 2 of this unit. 

TABLE 2—TEST REQUIREMENTS FOR THE PHYSICAL/CHEMICAL PROPERTIES

Testing category Test requirements and references Special conditions 

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

or log Kow: 

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

or log Kow: 

The appropriate log Kow test, if any, would be 

selected from those listed in this column—see 

Special Conditions in the adjacent column 

Which method is required, if any, is determined 

by the test substance’s estimated log Kow as 

follows: 

Method A: 40 CFR 799.6755 (shake flask). 

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

(liquid chromatography) 

Method C: 40 CFR 799.6756 (generator column). 

log Kow <0: No testing required. 

log Kow range 0–1: Method A or B. 

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

log Kow range > 4–6: Method B or C. 

log Kow >6: Method C. 

Test sponsors must provide in the final study 

report the underlying rationale for the method 

and pH selected. In order to ensure environmental relevance, EPA highly recommends 

that the selected study be conducted at pH 7. 

Note: ASTM—American Society for Testing and Materials. 

For the ‘‘Water Solubility’’ endpoint, 

EPA is requiring that the appropriate 

selection be made from among four 

alternative methods for measuring that 

endpoint. The test method used, if any, 

would be determined by first 

quantitatively estimating the test 

substance’s water solubility. One 

recommended method for estimating 

water solubility is described in 

‘‘Improved Method for Estimating Water 

Solubility from Octanol/Water Partition 

Coefficient’’ (Ref. 29). EPA is also 

requiring that test sponsors submit in 

the final study report the underlying 

rationale for the test standard selected 

for this endpoint. The required test 

methodologies have been developed to 

meet a wide variety of needs and, as 

such, are silent on experimental 

conditions related to pH. Therefore, 

EPA highly recommends that all 

required water solubility tests be 

conducted starting at pH 7 to ensure 

environmental relevance. The estimated 

water solubility ranges that EPA is 

requiring for use in this final rule to 

select the appropriate test standard are 

shown in Table 3 of this unit. 

TABLE 3—TEST REQUIREMENTS FOR THE WATER SOLUBILITY ENDPOINT

Testing category Test requirements and references Special conditions 

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


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TABLE 3—TEST REQUIREMENTS FOR THE WATER SOLUBILITY ENDPOINT—Continued 

Testing category Test requirements and references Special conditions 

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

water solubility would be selected from those 

listed in this column—see Special Conditions in 

the adjacent column. 

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

(shake flask). 

Method B: 40 CFR 799.6784 (shake flask). 

Method C: 40 CFR 799.6784 (column elution). 

Method D: 40 CFR 799.6786 (generator column). 

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 mg/L: Method A or B. 

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

> 0.001 mg/L–10 mg/L: Method C or D. 

≤ 0.001 mg/L: No testing required. 

Note: ASTM—American Society for Testing and Materials, mg/L—milligrams/liters. 

2. Environmental Fate and Pathways 

Ready Biodegradation: Method A: ASTM E 

1720–01 (Reapproved 2008) (Sealed vessel 

CO2 production test) (Ref. 30). 

Method B: International Organization for 

Standardization (ISO) 14593:1999(E) (CO2

headspace test) (Ref. 31). 

Method C: ISO 7827:1994(E) (Method by 

analysis of dissolved organic carbon (DOC)) 

(Ref. 32). 

Method D: ISO 9408:1999(E) 

(Determination of oxygen demand in a closed 

respirometer) (Ref. 33). 

Method E: ISO 9439:1999(E) (Carbon 

dioxide evolution test) (Ref. 34). 

Method F: ISO 10707:1994(E) (Closed 

bottle test) (Ref. 35). 

Method G: ISO 10708:1997(E) (Two-phase 

closed bottle test) (Ref. 36). 

ASTM has updated its test method for 

Determining Ready, Ultimate, 

Biodegradability of Organic Chemicals 

in a Sealed Vessel CO2 Production Test 

(ASTM E 1720–01). The test method 

was reapproved in 2008. There were 

minor changes, including the deletion of 

mention of specific apparatus brands in 

the ‘‘Apparatus’’ section; however the 

test method itself is unchanged. When 

required, the reapproved method 

(ASTM E 1720–01 (Reapproved 2008)) 

is listed as the required test method for 

the ‘‘Ready Biodegradation’’ endpoint in 

this final rule (Ref. 30). 

For the ‘‘Ready Biodegradation’’ 

endpoint, EPA is requiring that the 

appropriate selection be made from 

among seven alternative methods for 

measuring the substance’s ready 

biodegradability. For most test 

substances, EPA considers Method A 

(ASTM E 1720–01 (Reapproved 2008)) 

and Method B (ISO 14593:1999(E)) to be 

generally applicable, cost effective, and 

widely accepted internationally. 

However, the test method used, if any, 

will depend on the physical and 

chemical properties of the test 

substance, including its water solubility. 

An additional document, ISO 

10634:1995(E) (Ref. 37), provides 

guidance for selection of the appropriate 

test method for a given test substance 

considering the substances physical and 

chemical properties. EPA is also 

requiring that test sponsors submit in 

the final study report the underlying 

rationale for the test standard selected 

for this endpoint. 

3. Aquatic Toxicity 

Test Group 1: Acute toxicity to fish (ASTM 

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

toxicity to Daphnia (ASTM E 729–96 

(Reapproved 2007)) (Ref. 38), and Toxicity to 

plants (algae) (ASTM E 1218–04e1) (Ref. 39). 

Test Group 2: Chronic toxicity to Daphnia 

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

40) and Toxicity to plants (algae) (ASTM E 

1218–04e1) (Ref. 39). 

ASTM has updated its test method for 

Conducting Acute Toxicity Tests on 

Test Materials with Fishes, 

Macroinvertebrates, and Amphibians 

(ASTM E 729–96 (Reapproved 2002)). 

The test method was reapproved in 

2007. There were minor changes, for 

example, reference to ASTM Web site in 

place of Annual Book of ASTM 

Standards minor changes in references 

and dates, titles of ASTM documents 

changed to correspond to new titles, 

etc., however the test method itself is 

unchanged. When required, the updated 

method (ASTM E 729–96 (Reapproved 

2007)) is listed as the required test 

method for the ‘‘Aquatic Toxicity’’ 

endpoints in this final rule (Ref. 38). 

For the ‘‘Aquatic Toxicity’’ endpoint, 

the OECD HPV SIDS Program recognizes 

that, for certain chemical substances, 

acute toxicity studies are of limited 

value in assessing the substances’ 

aquatic toxicity. This issue arises when 

considering chemical substances with 

high log Kow values. In such cases, 

toxicity is unlikely to be observed over 

the duration of acute toxicity studies 

because of reduced uptake and the 

extended amount of time required for 

such substances to reach steady state or 

toxic concentrations in the test 

organism. For such situations, the OECD 

HPV SIDS Program recommends use of 

chronic toxicity testing in Daphnia in 

place of acute toxicity testing in fish and 

Daphnia. EPA is requiring that the 

aquatic toxicity testing requirement be 

determined based on the test 

substance’s measured log Kow as 

determined by using the approach 

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

discussion of ‘‘n-Octanol/Water 

Coefficient,’’ and in Table 3 in 

§ 799.5087(j) of the regulatory text. For 

test substances determined to have a log 

Kow of less than 4.2, one or more of the 

following tests (described as ‘‘Test 

Group 1’’ in Table 3 in § 799.5087(j) of 

the regulatory text) are required: Acute 

toxicity to fish (ASTM E 729–96 

(Reapproved 2007)); Acute toxicity to 

Daphnia (ASTM E 729–96 (Reapproved 

2007)); and Toxicity to plants (algae) 

(ASTM E 1218–04e1). For test 

substances determined to have a log Kow

that is greater than or equal to 4.2, one 

or both of the following tests (described 

as ‘‘Test Group 2’’ in Table 3 in 

§ 799.5087(j) of the regulatory text) are 

required: Chronic toxicity to Daphnia 

(ASTM E 1193–97 (Reapproved 2004)) 

and Toxicity to plants (algae) (ASTM E 

1218–04e1). As outlined in Table 3 in 

§ 799.5087(j) of the regulatory text, 

depending on the testing required in 

Test Group 1, the Test Group 2 chronic 

Daphnia test may substitute for either or 

both the acute fish toxicity test and the 

acute Daphnia test. 

Using SAR, a log Kow of 4.2 

corresponds with a fish 

bioconcentration factor (BCF) of about 

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

substance with a fish BCF value of 1,000 

or more is characterized as having a 

tendency to accumulate in living 

organisms relative to the concentration 

of the chemical substance in the 

surrounding environment (Ref. 42). For 

the purposes of this final rule, EPA’s use 


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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 

(Ref. 43). EPA has also used a measured 

BCF that is equal to or greater than 

1,000 or, in the absence of 

bioconcentration data, a log P [same as 

log Kow ] value equal to or greater than 

4.3 to help define the potential of a new 

chemical substance to cause significant 

adverse environmental effects (Ref. 44). 

EPA considers the difference between 

the log Kow of 4.3 cited in the 1989 

Federal Register document (Ref. 44) and 

the log Kow value of 4.2 cited in this 

final TSCA section 4 test rule to be 

negligible. 

EPA recognizes that in some 

circumstances, acute aquatic toxicity 

testing (Test Group 1) may be relevant 

for certain chemical substances having a 

log Kow equal to or greater than 4.2. 

Chemical substances that are dispersible 

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

aliphatic amines, and cationic dyes) 

may have log Kow values greater than 4.2 

and may still be acutely toxic to aquatic 

organisms. For any chemical substance 

listed in Table 3 in § 799.5087(j) of the 

regulatory text for which a test sponsor 

believes that an alternative to the log 

Kow threshold of 4.2 is appropriate, the 

test sponsor may request a modification 

of the test standard in the final rule as 

described in 40 CFR 790.55. Based upon 

the supporting rationale provided by the 

test sponsor, EPA may allow an 

alternative threshold or method to be 

used for determining whether acute or 

chronic aquatic toxicity testing must be 

performed for a specific substance. 

4. Mammalian Toxicity—Acute 

Acute Inhalation Toxicity (rat): Method A 

(40 CFR 799.9130). 

Acute Oral Toxicity (rat): Method B (ASTM 

E 1163–98 (Reapproved 2002) (Ref. 45) or 40 

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

For the ‘‘Mammalian Toxicity— 

Acute’’ endpoint, EPA is requiring that 

certain ‘‘Special Conditions’’ in the form 

of the chemical substance’s physical/ 

chemical properties or physical state be 

considered in determining the 

appropriate test method that would be 

used from among those included for this 

endpoint in Table 3 in § 799.5087(j) of 

the regulatory text. The OECD HPV 

SIDS Program recognizes that, for most 

chemical substances, the oral route of 

administration will suffice for this 

endpoint. However, consistent with the 

approach taken under the voluntary 

HPV Challenge Program, EPA is 

requiring that, for test substances that 

are gases at room temperature (25 °C), 

the acute mammalian toxicity study be 

conducted using inhalation as the 

exposure route (described as Method A 

(40 CFR 799.9130) in Table 3 in 

§ 799.5087(j) of the regulatory text). In 

the case of a potentially explosive test 

substance, care must be taken to avoid 

the generation of explosive 

concentrations. For all other chemical 

substances (i.e., those that are either 

liquids or solids at room temperature), 

EPA is requiring that the acute toxicity 

testing be conducted via oral 

administration using an ‘‘Up/Down’’ test 

method (described as Method B (ASTM 

E 1163–98 (Reapproved 2002) or 40 CFR 

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

§ 799.5087(j) of the regulatory text). 

Consistent with the voluntary HPV 

Challenge Program, EPA is allowing the 

use of the Neutral Red Uptake (NRU) 

basal cytotoxicity assay to select the 

starting dose for the acute oral toxicity 

test. This test is included as a special 

condition in Table 3 in § 799.5087(j) of 

the regulatory text. A document 

developed by the National Institutes of 

Environmental Health Sciences (NIEHS) 

provides guidance on how to use the 

NRU assay to estimate a starting dose for 

an acute oral toxicity test (Ref. 46). 

Recent versions of the standardized 

protocols for the NTU assay are 

available at the NIEHS/Interagency 

Coordination Committee on the 

Validation of Alternative Methods 

(ICCVAM) website (Refs. 47–49). 

5. Mammalian Toxicity—Genotoxicity 

Gene Mutations: Bacterial Reverse 

Mutation Test (in vitro): 40 CFR 799.9510. 

Chromosomal Damage: In Vitro 

Mammalian Chromosome Aberration Test (40 

CFR 799.9537), or the In Vivo Mammalian 

Bone Marrow Chromosomal Aberration Test 

(rodents: Mouse (preferred species), rat, or 

Chinese hamster) (40 CFR 799.9538), or the 

In Vivo Mammalian Erythrocyte 

Micronucleus Test (sampled in bone marrow) 

(rodents: Mouse (preferred species), rat, or 

Chinese hamster) (40 CFR 799.9539). 

Persons required to conduct testing 

for chromosomal damage are 

encouraged to use in vitro genetic 

toxicity testing (i.e., the Mammalian 

Chromosome Aberration Test) to 

generate the needed genetic toxicity 

screening data, unless known chemical 

properties preclude its use. These could 

include, for example, physical chemical 

properties or chemical class 

characteristics. A subject person who 

uses one of the in vivo methods instead 

of the in vitro method to address this 

end-point would be required to submit 

to EPA a rationale for conducting that 

alternate test in the final study report. 

6. Mammalian Toxicity—Repeated 

Dose/Reproduction/Developmental 

Combined Repeated Dose Toxicity Study 

with the Reproduction/Developmental 

Toxicity Screening Test: 40 CFR 799.9365. 

Reproduction/Developmental Toxicity 

Screening Test: 40 CFR 799.9355. 

Repeated Dose 28-Day Oral Toxicity Study: 

40 CFR 799.9305. 

For the ‘‘Mammalian Toxicity— 

Repeated Dose/Reproduction/ 

Developmental’’ endpoint, EPA 

recommends the use of the Combined 

Repeated Dose Toxicity Study with the 

Reproduction/Developmental Toxicity 

Screening Test (40 CFR 799.9365) as the 

test of choice. EPA recognizes, however, 

that there may be reasons to test a 

particular chemical substance using 

both the Reproduction/Developmental 

Toxicity Screening Test (40 CFR 

799.9355) and the Repeated Dose 28- 

Day Oral Toxicity Study (40 CFR 

799.9305) instead of the Combined 

Repeated Dose Toxicity Study with the 

Reproduction/Developmental Toxicity 

Screening Test (40 CFR 799.9365). With 

regard to such cases, EPA is requiring 

that a subject person who uses the 

combination of the Reproduction/ 

Developmental Toxicity Screening Test 

and the Repeated Dose 28-Day Oral 

Toxicity Study in place of the Combined 

Repeated Dose Toxicity Study with 

Reproduction/Developmental Toxicity 

Screen submit to EPA a rationale for 

conducting these alternate tests in the 

final study reports. 

In the proposal (Ref. 2) to this final 

rule, EPA stated that certain of the 

chemical substances for which 

mammalian toxicity—repeated dose/ 

reproduction/developmental toxicity 

testing is required may be used solely as 

‘‘closed system intermediates,’’ and if 

that were the case, such chemical 

substances may be eligible for a reduced 

testing battery which substitutes a 

developmental toxicity study for the 

SIDS requirement to address repeated 

dose, reproduction, and developmental 

toxicity. EPA requested persons who 

believe that their chemical substance is 

used solely as a closed system 

intermediate to submit appropriate 

information along with their comments 

which substantiate this belief. If EPA 

agreed that the chemical substance is 

used solely as a closed system 

intermediate, EPA would defer repeated 

dose, reproduction, and developmental 

toxicity testing and address any needed 

developmental toxicity testing in 

subsequent rulemaking. In its comments 

on the proposal to this final rule, PETA 

(Ref. 50) claimed that the chemical 

substance phosphorochloridothioic 

acid, O,O-diethyl ester (CASRN 2524– 


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04–1) is a closed system intermediate; 

Albemarle further claimed that this 

chemical substance is no longer being 

manufactured (Ref. 51). EPA has not 

found, at this time, that these claims 

result in a change of the testing 

requirements for this substance. 

Albemarle is not the only producer of 

this chemical and existing production 

data indicate that this chemical is still 

an HPV chemical. Furthermore, EPA has 

not received any claims from a chemical 

manufacturer that this substance is used 

solely as a closed system intermediate. 

EPA’s response to these claims is 

discussed in Unit E.12. of the ‘‘Response 

to Public Comments’’ document (Ref. 

12). 

B. When will the testing imposed by this 

final rule begin? 

Once this final rule is effective, which 

is 30 days after its publication in the 

Federal Register, the required testing 

must be initiated at a time sufficient to 

allow the required final report to be 

submitted by the deadline indicated in 

§ 799.5087(i) of the regulatory text. 

C. How must the studies required under 

this test rule be conducted? 

Persons required to comply with this 

final rule must conduct the necessary 

testing in accordance with the testing 

requirements listed in Tables 2 and 3 in 

§ 799.5087(j) of the regulatory text, the 

reporting requirements described in 

§ 799.5087(i) of the regulatory text, and 

with 40 CFR Part 792—TSCA Good 

Laboratory Practice Standards. 

D. What form of test substances will be 

tested under this rule? 

EPA is specifying two distinct 

approaches for identifying the specific 

substances that would be tested under 

this rule, the application of which 

would depend on whether the substance 

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

‘‘Class 2’’ chemical substance. First 

introduced when EPA compiled the 

TSCA Chemical Substance Inventory, 

the term Class 1 chemical substance 

refers to a chemical substance having a 

chemical composition that consists of a 

single chemical species (not including 

impurities) that can be represented by a 

specific, complete structure diagram. By 

contrast, the term Class 2 chemical 

substance refers to a chemical substance 

having a composition that cannot be 

represented by a specific, complete 

chemical structure diagram, because 

such a substance generally contains two 

or more different chemical species (not 

including impurities). Table 2 in 

§ 799.5087(j) of the regulatory text 

identifies the listed substances as either 

Class 1 or Class 2 substances. 

The ‘‘Class 1’’ chemical substances 

listed in Table 2 in § 799.5087(j) of the 

regulatory text (i.e., 14 of the 19 

chemical substances included in this 

final rule) must be tested at a purity of 

at least 99%. In those instances in 

which the test sponsor(s) believes that a 

99% level of purity is unattainable for 

a given chemical substance, the sponsor 

may request a modification under the 

procedures described in 40 CFR 790.55. 

For the ‘‘Class 2’’ chemical substances 

listed in Table 2 in § 799.5087(j) of the 

regulatory text (i.e., 5 of the 19 chemical 

substances included in this final rule), 

EPA is requiring that the substance to be 

tested be any representative form of the 

chemical substance. 

In requiring a different approach for 

identifying the chemical substance to be 

tested with regard to Class 2 chemical 

substances, EPA recognizes two 

characteristics which further distinguish 

Class 1 from Class 2 chemical 

substances. First, unlike for Class 1 

chemical substances, knowledge of the 

composition of commercial Class 2 

chemical substances can vary in quality 

and specificity from substance to 

substance. 

The composition of the chemical 

species which comprise a Class 2 

chemical substance may be: 

• Well-characterized in terms of 

molecular formulae, structural 

diagrams, and compositional 

percentages of all species present (for 

example, methyl phenol); 

• Less well-characterized, for 

example, characterized only by 

molecular formulae, non-specific 

structural diagrams, and/or by 

incomplete or unknown compositional 

percentages of the species present (for 

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

• Poorly characterized because all 

that is known is the identity of only 

some of the chemical species present 

and their percentages of composition, or 

of only the feedstocks and method of 

manufacture used to manufacture the 

substance (for example, nut shell liquor 

of cashew). 

Secondly, the composition of some 

Class 2 chemical substances may vary 

from one manufacturer to another, or, 

for a single manufacturer, from 

production run to production run, 

because of small variations in 

feedstocks, manufacturing methods, or 

other production variables. A ‘‘Class 2’’ 

designation most frequently represents a 

group of substances that have similar 

combinations of different chemical 

species and/or that were prepared from 

similar feedstocks using similar 

production methods. By contrast, Class 

1 substances generally represent a much 

narrower group of substances for which 

the only variables are their impurities. 

EPA believes that, for purposes of this 

final rule, the testing of any 

representative form of a subject Class 2 

substance would provide the data 

necessary to support the development of 

preliminary or screening level hazard 

and risk characterizations for the subject 

Class 2 substance. However, EPA would 

encourage the selection of 

representative forms of test substances 

that meet industry or consensus 

standards, where they exist. In 

accordance with TSCA Good Laboratory 

Practice Standards (GLPS) at 40 CFR 

part 792, the final study report would be 

required to include test substance 

identification information, including 

name, CASRN, strength, purity, and 

composition, or other appropriate 

characteristics (see 40 CFR 792.185). In 

future TSCA section 4 test rules 

involving Class 2 substances, testing 

requirements relative to the number and 

specificity of the representative form of 

the substance may differ from the 

testing requirement in this final rule 

(i.e., testing of any representative form 

of the subject Class 2 substances). For 

example, EPA may require testing of 

more than one representative form of a 

Class 2 chemical substance or may 

specify the representative form to be 

tested and/or may specify equivalence 

data that must be submitted by 

exemption applicants (see 40 CFR 

790.82). 

E. Am I required to test under this rule? 

1. Am I subject to this rule? You are 

subject to this final rule and may be 

required to test if you manufacture 

(which is defined by statute to include 

import) or process, or intend to 

manufacture or process, one or more 

chemical substances listed in this final 

rule during the time period discussed in 

Unit V.E.2. However, if you do not 

know or cannot reasonably ascertain 

that you manufacture or process a 

chemical substance listed in this final 

rule (based on all information in your 

possession or control, as well as all 

information that a reasonable person 

similarly situated might be expected to 

possess, control, or know, or could 

obtain without unreasonable burden), 

you are not subject to this final rule for 

that listed substance. 

2. When will my manufacture or 

processing (or my intent to do so) cause 

me to be subject to this final rule? You 

are subject to this final rule if you 

manufacture or process, or intend to 

manufacture or process, a chemical 

substance listed in Table 2 in 

§ 799.5087(j) of the regulatory text at 

any time from the effective date of the 


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final test rule to the end of the test cost 

reimbursement period. 

3. Will I be required to test if I am 

subject to this final rule? It depends on 

the nature of your activities. All persons 

who are subject to this final TSCA 

section 4(a) test rule, which, unless 

otherwise noted in the regulatory text, 

incorporates EPA’s generic procedures 

applicable to TSCA section 4(a) test 

rules (contained within 40 CFR part 

790), fall into one of two groups, 

designated here as Tier 1 and Tier 2. 

Persons in Tier 1 (those who would 

have to initially comply with the final 

rule) must either: 

• Submit to EPA letters of intent to 

conduct testing, conduct this testing, 

and submit the test data to EPA, or 

• Apply to and obtain from EPA 

exemptions from testing. 

Persons in Tier 2 (those who do not 

have to initially comply with the final 

rule) need not take any action unless 

they are notified by EPA that they are 

required to do so (because, for example, 

no person in Tier 1 had submitted a 

letter of intent to conduct testing), as 

described in Unit V.E.3.f. Note that both 

persons in Tier 1 who obtain 

exemptions and persons in Tier 2 would 

nonetheless be subject to providing 

reimbursement to persons who actually 

conduct the testing, as described in Unit 

V.E.4. 

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

4 of this unit describes who is in Tier 

1 and Tier 2. 

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

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

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

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

Tier 2.

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

the following: 

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

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

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

710.4(b)); 

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

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

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

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

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

—In small quantities solely for R&D (as described at 40 CFR 

790.42(a)(5)). 

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

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

Note: kg—kilogram, R&D—research and development, TSCA—Toxic Substances Control Act. 

Under 40 CFR 790.2, EPA may 

establish procedures applying to 

specific test rules that differ from the 

generic procedures governing TSCA 

section 4(a) test rules in 40 CFR part 

790. For purposes of this final rule, EPA 

has established certain requirements 

that differ from those under 40 CFR part 

790. 

In this final test rule, EPA has 

reconfigured the tiers in 40 CFR 790.42. 

In addition to processors, manufacturers 

of less than 500 kilograms (kgs) (1,100 

lbs) per year (small-volume 

manufacturers), and manufacturers of 

small quantities for research and 

development (R&D manufacturers), EPA 

has added the following persons to Tier 

2: 

Byproduct manufacturers, impurity 

manufacturers, manufacturers of 

naturally occurring substances, 

manufacturers of non-isolated 

intermediates, and manufacturers of 

components of Class 2 substances. The 

Agency took administrative burden and 

complexity into account in determining 

who was to be in Tier 1 in this final 

rule. EPA believes that those persons in 

Tier 1 who are required to conduct 

testing under this final rule are 

generally large chemical manufacturers 

who, in the experience of the Agency, 

have traditionally conducted testing or 

participated in testing consortia under 

previous TSCA section 4(a) test rules. 

The Agency also believes that 

byproduct manufacturers, impurity 

manufacturers, manufacturers of 

naturally occurring substances, 

manufacturers of non-isolated 

intermediates, and manufacturers of 

components of Class 2 substances 

historically have not themselves 

participated in testing or contributed to 

reimbursement of those persons who 

have conducted testing. EPA 

understands that these manufacturers 

may include persons for whom the 

marginal transaction costs involved in 

negotiating and administering testing 

arrangements are deemed likely to raise 

the expense and burden of testing to a 

level that is disproportional to the 

additional benefits of including these 

persons in Tier 1. Therefore, EPA does 

not believe that the likelihood of the 

persons added to Tier 2 actually 

conducting the testing is sufficiently 

high to justify burdening these persons 

with Tier 1 requirements (e.g., 

submitting requests for exemptions). 

Nevertheless, these persons, along with 

all other persons in Tier 2, would be 

subject to reimbursement obligations to 

persons who actually conduct the 

testing, as described in Unit V.E.4. 

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

manufacturers and/or processors of a 

chemical substance to test that chemical 

substance if EPA has made findings 

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

TSCA section 4(a)(1)(B)(ii) for that 

chemical substance, and issued a TSCA 

section 4(a) test rule requiring testing. 

However, practicality must be a factor in 

determining who is subject to a 

particular test rule. Thus, persons who 

do not know or cannot reasonably 

ascertain that they are manufacturing or 

processing a substance subject to this 

final rule, (e.g., manufacturers or 

processors of a substance as a trace 

contaminant who are not aware of and 

cannot reasonably ascertain these 

activities) are not be subject to the rule. 

See Unit V.E.1. and § 799.5087(b)(2) of 

the regulatory text. 

b. Subdivision of Tier 2 entities. In 

this final rule the Agency has prioritized 

which persons in Tier 2 would be 

required to perform testing, if needed. 

Specifically, the Agency subdivided 

Tier 2 entities into: 

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

those who manufacture, or intend to 

manufacture, a test rule chemical 

substance solely as one or more of the 


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following: A byproduct, an impurity, a 

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

Class 2 chemical substance, in amounts 

less than 1,100 lbs annually, or in small 

quantities solely for research and 

development. 

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

who process, or intend to process, a test 

rule chemical substance (in any form). 

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

defined by TSCA section 3(10) and 

TSCA section 3(11), respectively. 

If the Agency needs testing from 

persons in Tier 2, EPA would seek 

testing from persons in Tier 2A before 

proceeding to Tier 2B. It is appropriate 

to require manufacturers in Tier 2A to 

submit letters of intent to test or 

exemption applications before 

processors are called upon because the 

Agency believes that testing costs are 

traditionally passed by manufacturers 

along to processors, enabling them to 

share in the costs of testing (Ref. 52). In 

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

processors [of a given test rule chemical 

substance] that it would be difficult to 

include them all in the technical 

decisions about the tests and in the 

financial decisions about how to 

allocate the costs’’ (Ref. 53). 

c. When is it appropriate for a person 

required to comply with the rule to 

apply for an exemption rather than to 

submit a letter of intent to conduct 

testing? You may apply for an 

exemption if you believe that the 

required testing will be performed by 

another person (or a consortium of 

persons formed under TSCA section 

4(b)(3)(A)). You can find procedures 

relating to exemptions in 40 CFR 790.80 

through 790.99, and § 799.5087(c)(2), 

(c)(5), (c)(7), and (c)(11) of the regulatory 

text. In this final rule, EPA will not 

require the submission of equivalence 

data (i.e., data demonstrating that your 

substance is equivalent to the substance 

actually being tested) as a condition for 

approval of your exemption. Therefore, 

40 CFR 790.82(e)(1) and 790.85 do not 

apply to this final rule. 

d. What will happen if I submit an 

exemption application? EPA believes 

that requiring the collection of 

duplicative data is unnecessarily 

burdensome. As a result, if EPA has 

received a letter of intent to test from 

another source or has received (or 

expects to receive) the test data that 

would be required under this rule, the 

Agency would conditionally approve 

your exemption application under 40 

CFR 790.87. 

The Agency would terminate 

conditional exemptions if a problem 

occurs with the initiation, conduct, or 

completion of the required testing, or 

with the submission of the required data 

to EPA. EPA may then require you to 

submit a notice of intent to test or an 

exemption application. See 40 CFR 

790.93 and § 799.5087(c)(8) of the 

regulatory text. In addition, the Agency 

would terminate a conditional 

exemption if no letter of intent to test 

has been received by persons required 

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

§ 799.5087(c)(6) of the regulatory text. 

Note that the provisions at 40 CFR 

790.48(b) have been incorporated into 

the regulatory text of this final rule; 

thus, persons subject to this final rule 

are not required to comply with 40 CFR 

790.48 itself (see § 799.5087(c)(4)–(c)(7) 

and § 799.5087(d)(3) of the regulatory 

text). Note that persons who obtain 

exemptions or receive them 

automatically would nonetheless be 

subject to providing reimbursement to 

persons who do actually conduct the 

testing, as described in Unit V.E.4. 

e. What are my obligations if I am in 

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

be subject to the rule and you would be 

responsible for providing 

reimbursement to persons in Tier 1, as 

described in Unit V.E.4. You are 

considered to have an automatic 

conditional exemption. You do not need 

to submit a letter of intent to test or an 

exemption application unless you are 

notified by EPA that you are required to 

do so. 

If a problem occurs with the 

initiation, conduct, or completion of the 

required testing, or with the submission 

of the required data to EPA, the Agency 

may require you to submit a notice of 

intent to test or an exemption 

application. See 40 CFR 790.93 and 

§ 799.5087(c)(10) of the regulatory text. 

In addition, you will need to submit 

a notice of intent to test or an exemption 

application if: 

• No manufacturer in Tier 1 has 

notified EPA of its intent to conduct 

testing; and 

• EPA has published a Federal 

Register document directing persons in 

Tier 2 to submit to EPA letters of intent 

to conduct testing or exemption 

applications. 

See § 799.5087(c)(4), (c)(5), (c)(6), and 

(c)(7) of the regulatory text. The Agency 

will conditionally approve an 

exemption application under 40 CFR 

790.87, if EPA has received a letter of 

intent to test or has received (or expects 

to receive) the test data required under 

this rule. EPA is not aware of any 

circumstances in which test rule Tier 1 

entities have sought reimbursement 

from Tier 2 entities either through 

private agreements or by soliciting the 

involvement of the Agency under the 

reimbursement regulations at 40 CFR 

part 791. 

f. What will happen if no one submits 

a letter of intent to conduct testing? EPA 

anticipates that it will receive letters of 

intent to conduct testing for all of the 

tests specified and chemical substances 

included in this final rule. However, in 

the event it does not receive a letter of 

intent for one or more of the tests 

required for any of the chemical 

substances in this rule within 30 days 

after the publication of a Federal 

Register document notifying Tier 2 

manufacturers and processors of the 

obligation to submit a letter of intent to 

conduct testing or to apply for an 

exemption from testing, EPA will notify 

all manufacturers and processors of the 

chemical substance of this fact by 

certified letter or by publishing a 

Federal Register document specifying 

the test(s) for which no letter of intent 

has been submitted. This letter or 

Federal Register document will 

additionally notify all manufacturers 

and processors that all exemption 

applications concerning the test(s) have 

been denied, and will give them an 

opportunity to take corrective action. If 

no one has notified EPA of its intent to 

conduct the required testing of the 

chemical substance within 30 days after 

receipt of the certified letter or 

publication of the Federal Register 

document, all manufacturers and 

processors subject to the rule with 

respect to that chemical substance who 

are not already in violation of the rule 

would be in violation of the rule. 

4. How do the reimbursement 

procedures work? In the past, persons 

subject to test rules have independently 

worked out among themselves their 

respective financial contributions to 

those persons who have actually 

conducted the testing. However, if 

persons are unable to agree privately on 

reimbursement, they may take 

advantage of EPA’s reimbursement 

procedures at 40 CFR part 791, 

promulgated under the authority of 

TSCA section 4(c). These procedures 

include: The opportunity for a hearing 

with the American Arbitration 

Association; publication by EPA of a 

document in the Federal Register 

concerning the request for a hearing; 

and the appointment of a hearing officer 

to propose an order for fair and 

equitable reimbursement. The hearing 

officer may base his or her proposed 

order on the production volume formula 

set out at 40 CFR 791.48, but is not 

obligated to do so. Under this final rule, 

amounts manufactured as impurities 

would be included in production 

volume (40 CFR 791.48(b)), subject to 

the discretion of the hearing officer (40 


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

proposed order may become the 

Agency’s final order, which is 

reviewable in Federal court (40 CFR 

791.60). 

F. What are the reporting requirements 

under this final rule? 

A final report must be submitted for 

each test for each chemical substance 13 

months after the effective date of the 

final rule, i.e., by the deadline indicated 

in § 799.5087(i) of the regulatory text. 

EPA also requests that a robust 

summary of the final report for each 

specific test be submitted in addition to 

and at the same time as the final report. 

The term ‘‘robust summary’’ is used to 

describe the technical information 

necessary to adequately describe an 

experiment or study and includes the 

objectives, methods, results, and 

conclusions of the full study report 

which can be either an experiment or in 

some cases an estimation or prediction 

method. Guidance for the compilation 

of robust summaries is described in a 

document entitled ‘‘Draft Guidance on 

Developing Robust Summaries’’ (Ref. 

19). Persons who submit robust 

summaries are also encouraged to 

submit the robust summary 

electronically via HPVIS to allow for its 

ready incorporation into HPVIS. 

Directions for electronic submission of 

robust summary information into HPVIS 

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

oppthpv/metadata.html. This link will 

direct you to the ‘‘HPVIS Quick Start 

and User’s Guide.’’ 

G. What would I need to do if I cannot 

complete the testing required by the 

final rule? 

A company that submits a letter of 

intent to test under the final rule and 

that subsequently anticipates difficulties 

in completing the testing by the 

deadline set forth in the final rule may 

submit a modification request to the 

Agency, pursuant to 40 CFR 790.55. 

EPA will determine whether 

modification of the test schedule is 

appropriate, and may first seek public 

comment on the modification. 

H. Will there be sufficient test facilities 

and personnel to undertake the testing 

required under this test rule? 

EPA’s most recent analysis of 

laboratory capacity (Ref. 54) indicates 

that available test facilities and 

personnel would adequately 

accommodate the testing specified in 

this rule. 

I. Might EPA seek further testing of the 

chemical substances in this final test 

rule? 

If EPA determines that it needs 

additional data regarding any of the 

chemical substances included in this 

final rule, the Agency would seek 

further health and/or environmental 

effects testing for these chemical 

substances. Should the Agency decide 

to seek such additional testing via a test 

rule, EPA would initiate a separate 

action for this purpose. 

VI. Export Notification 

Any person who exports, or intends to 

export, one of the chemical substances 

contained in this final rule in any form 

(e.g., as byproducts, impurities, 

components of Class 2 substances, etc.) 

is subject to the export notification 

requirements in TSCA section 12(b)(1) 

and 40 CFR part 707, subpart D. Export 

notification is generally not required for 

articles, as provided by 40 CFR 

707.60(b). Section 12(b) of TSCA states, 

in part, that any person who exports or 

intends to export to a foreign country a 

chemical substance or mixture for 

which the submission of data is 

required under TSCA section 4 must 

notify the EPA Administrator of such 

export or intent to export. The EPA 

Administrator in turn will notify the 

government of the importing country of 

EPA’s regulatory action with respect to 

the substance. 

VII. Decision Not To Require Testing 

for Certain Endpoints 

For certain testing endpoints for 

certain chemicals listed in the proposed 

rule, EPA is not making the TSCA 

section 4(a)(1)(B)(ii) finding that ‘‘* * * 

there are insufficient data and 

experience to reasonably determine or 

predict the effects of the manufacture, 

processing, or use of these chemical 

substances, or of any combination of 

such activities, on human health or the 

environment * * *’’ and is not 

finalizing the proposed testing. Table 2 

in § 799.5087(j) of the regulatory text, 

which lists the chemical substances and 

testing requirements, has been revised 

to reflect this. Further discussion 

follows in Units VII.A. through VII.F. 

A. Screening Reproduction/ 

Developmental Toxicity of 2,4- 

Hexadienoic Acid, (E,E)- 

As discussed in Unit E.3. of the 

‘‘Response to Public Comments’’ 

document (Ref. 12), EPA reviewed 

additional data, including studies 

submitted by the PETA (PETA 

submitted on behalf of themselves and 

other Animal Welfare Organizations 

(AWOs)) for 2,4-hexadienoic acid, (E,E)- 

(CASRN 110–44–1), also known as 

sorbic acid. After reviewing these data, 

EPA finds existing studies are adequate 

to evaluate reproduction/developmental 

toxicity and is not finalizing the 

proposed testing for reproduction/ 

developmental toxicity for sorbic acid. 

B. Screening Reproduction/ 

Developmental Toxicity of Ethanedioic 

Acid 

As discussed in Unit E.4. of the 

‘‘Response to Public Comments’’ 

document (Ref. 12), EPA reviewed 

additional data, including studies 

submitted by PETA (PETA submitted on 

behalf of themselves and other AWOs) 

for ethanedioic acid (CASRN 144–62–7). 

After reviewing these data, EPA finds 

existing studies are adequate to evaluate 

reproduction/developmental toxicity 

and is not finalizing the proposed 

testing for reproduction/developmental 

toxicity for ethanedioic acid. However, 

as further discussed in the ‘‘Response to 

Public Comments’’ document, EPA finds 

studies submitted for other endpoints 

inadequate and is still requiring the 

testing of ethanedioic acid for 

chromosomal damage, aquatic toxicity 

and chemical/physical endpoints as 

described in Table 2 in § 799.5087(j) of 

the regulatory text. 

C. Physical Chemical Properties and 

Aquatic Toxicity of Castor Oil, 

Oxidized, and Physical Chemical 

Properties of Castor Oil, Sulfated, 

Sodium Salt 

As discussed in Unit E.7. of the 

‘‘Response to Public Comments’’ 

document (Ref. 12), EPA reviewed data 

submitted by Vertellus on vapor 

pressure, water solubility, and Log Kow. 

Based on information provided by 

Vertellus, indicating the extremely low 

water solubility and vapor pressure, and 

extremely high Log Kow of this 

substance, EPA is not finalizing the 

proposed testing for these endpoints for 

castor oil, oxidized (CASRN 68187–84– 

8). In addition, EPA agrees with 

Vertellus that the extreme insolubility of 

this substance makes aquatic toxicity 

testing for this chemical substance not 

feasible. Therefore, EPA is not finalizing 

the proposed testing for aquatic toxicity 

testing for castor oil, oxidized. However, 

EPA is still requiring a ‘‘melting point’’ 

test be conducted for this substance. 

EPA acknowledges Vertellus’ comment 

that the substance is a liquid at room 

temperature. In these cases the melting 

point determination would actually 

involve determination of a freezing 

point. Since ASTM E 324–99 (capillary 

tube) does not specifically include 

instructions for determining a freezing 

point, for that particular endpoint EPA 


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Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Rules and Regulations 1081 

is requiring OECD Guideline 102 

(melting point/melting range) be used 

instead of ASTM E 324–99 for that test. 

Furthermore, as discussed in Unit E.7. 

of the ‘‘Response to Public Comments’’ 

document, because of its structural 

similarity with castor oil, oxidized, EPA 

is also not requiring water solubility and 

log Kow for castor oil, sulfated, sodium 

salt (CASRN 68187–76–8). However, 

because of its surfactant properties, EPA 

is still requiring aquatic toxicity testing 

for castor oil, sulfated, sodium salt. 

D. Mammalian Toxicity—Acute, of 

Castor Oil, Oxidized 

As discussed in Unit E.7. of the 

‘‘Response to Public Comments’’ 

document (Ref. 12), EPA reviewed data 

submitted by Vertellus on acute toxicity 

of oxidized castor oil (CASRN 68187– 

84–8) and has concluded that these data 

are adequate. However, while EPA 

believes that data for certain endpoints, 

as just discussed, are adequate for castor 

oil, sulfated; and castor oil, oxidized; 

data are still needed on the other endpoints listed for these chemical 

substances in Table 2 in § 799.5087(j) of 

the regulatory text, including, for castor 

oil, sulfated, mammalian acute toxicity 

testing, for which EPA received no data 

contraindicating this testing need. 

E. Boiling Point of Benzenediamine, 

Ar,Ar-Diethyl-Ar-MethylBoiling point is not required for 

benzenediamine, ar,ar-diethyl-armethyl- (CASRN 68479–98–1), as 

discussed in Unit E.8. of the ‘‘Response 

to Public Comments’’ document (Ref. 

12). Albemarle provided EPA with data 

which are adequate for this endpoint. 

F. Acute Mammalian Toxicity, 

Repeated-Dose Toxicity, and 

Mutagenicity Endpoints of Alkenes, 

C12–24, Chloro 

As discussed in Unit E.9. of the 

‘‘Response to Public Comments’’ 

document (Ref. 12), EPA reviewed 

additional data including studies 

submitted by AWOs and CPIA. In 

addition to data on this group of 

chemicals, comments focused on the 

potential acceptability of using analog 

data available for other similar classes of 

chlorinated paraffins. For certain 

proposed tests, EPA has accepted 

certain of these data, including analog 

data on similar substances. However, for 

other testing endpoints, EPA does not 

agree that the surrogate chemicals are 

acceptable analogs, or has found some 

of the submitted studies inadequate. 

Specifically, EPA finds that data are 

acceptable for the acute mammalian, 

repeated-dose, and mutagenicity 

endpoints. EPA continues to require 

testing on physical/chemical properties 

(all), biodegradation, aquatic toxicity 

testing (C1, Test Group 2), in vitro 

chromosomal aberrations, and 

reproductive and developmental 

toxicity. 

VIII. Economic Impacts 

EPA has prepared an economic 

assessment entitled ‘‘Economic Impact 

Analysis for the Final Section 4 Test 

Rule for High Production Volume 

Chemicals’’ (Ref. 55), a copy of which 

has been placed in the docket this final 

rule. This economic assessment 

evaluates the potential for significant 

economic impacts as a result of the 

testing required by this final rule. The 

analysis covers 19 chemical substances. 

The total social cost of providing test 

data on the 19 chemical substances that 

were evaluated in this economic 

analysis is estimated to be $4.19 

million. (Ref. 55). 

While legally subject to this test rule, 

processors of a subject chemical 

substance would be required to comply 

with the requirements of the rule only 

if they are directed to do so by EPA as 

described in § 799.5087(c)(5) and (c)(6) 

of the regulatory text. EPA would only 

require processors to test if no person in 

Tier 1 has submitted a notice of its 

intent to conduct testing, or if under 40 

CFR 790.93, a problem occurs with the 

initiation, conduct, or completion of the 

required testing or the submission of the 

required data to EPA. Because EPA has 

identified at least one manufacturer in 

Tier 1 for each subject chemical 

substance, the Agency assumes that, for 

each chemical substance in this final 

rule, at least one such person will 

submit a letter of intent to conduct the 

required testing and that person will 

conduct such testing and will submit 

the test data to EPA. Because EPA does 

not expect that processors will need to 

comply with the final rule, the 

economic assessment does not address 

processors. 

To evaluate the potential for an 

adverse economic impact of testing on 

manufacturers of the chemical 

substances in this final rule, EPA 

employed a screening approach that 

estimated the impact of testing 

requirements as a percentage of each 

chemical substance’s sale price. This 

measure compares annual revenues 

from the sale of a chemical substance to 

the annualized compliance cost for that 

chemical substance to assess the 

percentage of testing costs that can be 

accommodated by the revenue stream 

generated by that chemical substance 

over a number of years. Compliance 

costs include costs of testing and 

administering the testing, as well as 

reporting costs. Annualized compliance 

costs divide testing expenditures into an 

equivalent, constant yearly expenditure 

over a longer period of time. To 

calculate the percent price impact, 

testing costs (including laboratory and 

administrative expenditures) are 

annualized over 15 years using a 7% 

discount rate. Annualized testing costs 

are then divided by the estimated 

annual revenue of the chemical 

substance to derive the cost-to-sales 

ratio. EPA estimates the total annualized 

compliance cost of testing for the 19 

chemical substances evaluated in the 

economic analysis to be $1.48 million 

under the average cost scenario. In 

addition, the TSCA section 12(b) export 

notification requirements (included in 

the total and annualized cost estimates) 

that would be triggered by this final rule 

are expected to have a negligible impact 

on exporters. The estimated cost of the 

TSCA section 12(b) export notification 

requirements, which, under this final 

rule, would be required for the first 

export to a particular country of a 

chemical substance subject to the rule, 

is estimated to range from $25.56 per 

notice to $80.22 per notice (Ref. 55). The 

Agency’s estimated total costs of testing 

(including both laboratory and 

administrative costs) annualized testing 

cost, and public reporting burden hours 

for this final rule are presented in the 

economic assessment. 

Under a least cost scenario, 16 out of 

the 19 chemical substances (84%) 

would have a price impact at less than 

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

chemical substances (79%) would be 

impacted at less than the 1% level 

under an average cost scenario. Thus, 

the potential for adverse economic 

impact due to this final test rule is low 

for at least 79% of the chemical 

substances in this rule. Approximately 4 

chemical substances (21%) of the 19 

chemical substances for which price 

data are available would have a price 

impact at a level greater than or equal 

to 1% under the least (average) cost 

scenario. 

EPA believes, on the basis of these 

calculations, that the testing of the 

chemical substances in this final rule 

presents a low potential for adverse 

economic impact for the majority of 

chemical substances. Because the 

subject chemical substances have 

relatively large production volumes, the 

annualized costs of testing, expressed as 

a percentage of annual revenue, are very 

small for most chemical substances. 

There are, however, some chemical 

substances for which the price impact is 

expected to exceed 1% of the revenue 

from that chemical substance. The 

potential for adverse economic impact is 


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1082 Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Rules and Regulations 

expected to be higher for these chemical 

substances. In these cases, companies 

may choose to use revenue sources 

other than the profits from the 

individual chemical substances to pay 

for testing. Smaller businesses are less 

likely to have additional revenue 

sources to cover the compliance costs in 

this situation. Therefore, the Agency 

also compared the costs of compliance 

to company sales for small businesses. 

EPA does not provide quantitative 

estimates of the benefits from these 

tests. Ideally, a discussion of benefits 

would focus on the additional benefits 

to be gained from new information 

relative to information that already 

exists. Such an approach could examine 

the value of new information provided 

as a result of the test rule where such 

information has not been publicly 

available. Because of constraints on 

information on the value of information, 

our evaluation of benefits is qualitative 

and does not address incremental 

benefits. We believe, however, that the 

net benefits of the new information are 

positive. 

X. Materials in the Docket 

As indicated under ADDRESSES, a 

docket was established for this final rule 

under docket ID number EPA–HQ– 

OPPT–2007–0531. The following is a 

listing of the documents that have been 

placed in the docket for this final rule. 

The docket includes information 

considered by EPA in developing this 

final rule, including the documents 

listed in this unit, which are physically 

located in the docket. In addition, 

interested parties should consult 

documents that are referenced in the 

documents that EPA has placed in the 

docket, regardless of whether these 

referenced documents are physically 

located in the docket. For assistance in 

locating documents that are referenced 

in documents that EPA has placed in 

the docket, but that are not physically 

located in the docket, consult either of 

the technical persons listed under FOR

FURTHER INFORMATION CONTACT. The 

docket is available for review as 

specified under ADDRESSES. 

1. EPA. Data Collection and 

Development on High Production 

Volume (HPV) Chemicals. Notice. 

Federal Register (65 FR 81686, 

December 26, 2000) (FRL–6754–6). 

2. EPA. Testing of Certain High 

Production Volume Chemicals; Second 

Group of Chemicals. Proposed Rule. 

Federal Register (73 FR 43314, July 24, 

2008) (FRL–8373–9). 

3. EPA. Testing of Certain High 

Production Volume Chemicals. 

Proposed Rule. Federal Register (65 FR 

81658, December 26, 2000) (FRL–6758– 

4). 

4. EPA. Testing of Certain High 

Production Volume Chemicals. Final 

Rule. Federal Register (71 FR 13707, 

March 16, 2006) (FRL–7335–2). 

5. EPA. Testing of Certain High 

Production Volume Chemicals; Third 

Group of Chemicals. Proposed Rule. 

Federal Register (75 FR 8575, February 

25, 2010) (FRL–8805–8). 

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

Statement of Policy; Criteria for 

Evaluating Substantial Production, 

Substantial Release, Substantial or 

Significant Human Exposure. Notice. 

Federal Register (58 FR 28736, May 14, 

1993). 

7. EPA, Office of Pollution Prevention 

and Toxics (OPPT). HPV Challenge 

Program Chemical List. Available online at: http://www.epa.gov/oppt/ 

chemrtk/pubs/update/hpvchmlt.htm. 

8. OECD Secretariat. Manual for the 

Investigation of HPV Chemicals. OECD 

Programme on the Co-Operative 

Investigation of High Production 

Volume Chemicals. Paris, France. 

September 2004. Available on-line at: 

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

0,2340,en_2649_34379_1947463_1_1_1_

1,00.htm. 

9. ICCA. ICCA HPV Working List of 

Chemicals. October 2005. Available online at: http://www.cefic.org/activities/

hse/mgt/hpv/hpvinit.htm and http:// 

www.iccahpv.com/hpvchallenge/

about.cfm. 

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

Proposed Statement of Policy. Notice. 

Federal Register (56 FR 32294, July 15, 

1991). 

11. Chemical Manufacturing 

Association (CMA) now American 

Chemistry Council (ACC). Comments on 

EPA’s TSCA section 4(a)(1)(B) Proposed 

Statement of Policy submitted to the 

TSCA Public Docket Office, EPA. 

September 13, 1991. 

12. EPA, OPPT, Chemical Information 

and Testing Branch (CITB). Response to 

public comments regarding testing of 

certain high production volume 

chemicals. August 2010. 

13. EPA, OPPT, Economics, Exposure 

and Technology Division (EETD). 

Testing of Certain High Production 

Volume Chemicals-2 (Exposure 

Findings Supporting Information). July 

2010. 

14. Department of Health and Human 

Services (DHHS), Centers for Disease 

Control (CDC), NIOSH. National 

occupational exposure survey field 

guidelines. Vol. I. Seta, J.A.; Sundin, 

D.S.; and Pedersen, D.H., eds. 

Cincinnati, OH. DHHS (NIOSH) 

Publication No. 88–106. Available online at: http://www.cdc.gov/niosh/88-

106.html. 1988. 

15. DHHS, CDC, NIOSH. National 

occupational exposure survey analysis 

of management interview responses. 

Vol. III. Pedersen, D.H. and Sieber, 

W.K., eds. Cincinnati, OH. DHHS 

(NIOSH) Publication No. 89–103. 

Available on-line at: http:// 

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

16. DHHS, CDC, NIOSH. National 

occupational exposure survey sampling 

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

Cincinnati, OH. DHHS (NIOSH) 

Publication No. 89–102. Available online at: http://www.cdc.gov/niosh/89–

102.html. 1989. 

17. EPA. TSCA Inventory Update Rule 

Amendments. Final Rule. Federal 

Register (68 FR 848, January 7, 2003) 

(FRL–6767–4). 

18. EPA. TSCA Inventory Update 

Reporting Revisions. Final Rule. Federal 

Register (70 FR 75059, December 19, 

2005) (FRL–7743–9). 

19. EPA, OPPT. Draft Guidance on 

Developing Robust Summaries. October 

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

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

robsumgd.htm. 

20. EPA. OPPT. High Production 

Volume Chemical Data Information 

System (HPVIS). Data from HVPIS on 

eighteen HPV chemicals. May 2008. 

21. ASTM International. Standard 

Test Method for Relative Initial and 

Final Melting Points and the Melting 

Range of Organic Chemicals. ASTM E 

324–99. 1999. 

22. ASTM International. Standard 

Test Method for Vapor Pressure of 

Liquids by Ebulliometry. ASTM E 1719– 

05. 2005. 

23. ASTM International. Standard 

Test Method for Determining Vapor 

Pressure by Thermal Analysis. ASTM E 

1782–08. 2008. 

24. ASTM International. Standard 

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

Chromatography. ASTM E 1147–92 

(Reapproved 2005). 

25. OECD. Guideline for the Testing of 

Chemicals: Melting Point/Melting 

Range. OECD 102. July 27, 1995. 

26. ASTM International. Standard 

Test Method for Measurements of 

Aqueous Solubility. ASTM E 1148–02 

(Reapproved 2008). 

27. ASTM International. Question 

about ASTM E 324. E-mail from Diane 

Rehiel, ASTM, to Greg Schweer, CITB, 

Chemical Control Division, OPPT, EPA. 

September 15, 2004. 

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

Atom/Fragment Contribution Method 

for Estimating Octanol-Water Partition 

Coefficients. Journal of Pharmaceutical 

Sciences. 84(1):83–92. 1995. 


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29. Meylan, W.M.; Howard, P.H.; and 

Boethling, R.S. Improved Method for 

Estimating Water Solubility from 

Octanol/Water Partition Coefficient. 

Environmental Toxicology and 

Chemistry. 15(2):100–106. 1996. 

30. ASTM International. Standard 

Test Method for Determining Ready, 

Ultimate, Biodegradability of Organic 

Chemicals in a Sealed Vessel CO2

Production Test. ASTM E 1720–01 

(Reapproved 2008). 

31. International Organization for 

Standardization (ISO). Water Quality— 

Evaluation of Ultimate Aerobic 

Biodegradability of Organic Compounds 

in Aqueous Medium—Method by 

Analysis of Inorganic Carbon in Sealed 

Vessels (CO2 Headspace Test). ISO 

14593:1999(E). 

32. ISO. Water Quality—Evaluation in 

an Aqueous Medium of the ‘‘Ultimate’’ 

Aerobic Biodegradability of Organic 

Compounds—Method by Analysis of 

Dissolved Organic Carbon (DOC). ISO 

7827:1994(E). 

33. ISO. Water Quality—Evaluation of 

Ultimate Aerobic Biodegradability of 

Organic Compounds in Aqueous 

Medium By Determination Of Oxygen 

Demand in a Closed Respirometer. ISO 

9408:1999(E). 

34. ISO. Water Quality—Evaluation of 

Ultimate Aerobic Biodegradability of 

Organic Compounds in Aqueous 

Medium—Carbon Dioxide Evolution 

Test. ISO 9439:1999(E). 

35. ISO. Water Quality—Evaluation in 

an Aqueous Medium of the ‘‘Ultimate’’ 

Aerobic Biodegradability of Organic 

Compounds—Method by Analysis of 

Biochemical Oxygen Demand (Closed 

Bottle Test). ISO 10707:1994(E). 

36. ISO. Water Quality—Evaluation in 

an Aqueous Medium of the Ultimate 

Aerobic Biodegradability of Organic 

Compounds—Determination Of 

Biochemical Oxygen Demand in a TwoPhase Closed Bottle Test (available in 

English only). ISO 10708:1997(E). 

37. ISO. Water Quality—Guidance for 

the Preparation and Treatment of Poorly 

Water-Soluble Organic Compounds for 

the Subsequent Evaluation of Their 

Biodegradability in an Aqueous 

Medium. ISO 10634:1995(E). 

38. ASTM International. Standard 

Guide for Conducting Acute Toxicity 

Tests on Test Materials with Fishes, 

Macroinvertebrates, and Amphibians. 

ASTM E 729–96 (Reapproved 2007). 

39. ASTM International. Standard 

Guide for Conducting Static Toxicity 

Tests with Microalgae. ASTM E 1218– 

04e1. 2004. 

40. ASTM International. Standard 

Guide for Conducting Daphnia magna 

Life-Cycle Toxicity Tests. ASTM E 

1193–97 (Reapproved 2004). 

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

Estimating bioconcentration potential 

from octanol/water partition 

coefficients. Physical Behavior of PCB’s 

in the Great Lakes. (MacKay, Paterson, 

Eisenreich, and Simmons, eds.). Ann 

Arbor Science, Ann Arbor, MI. 1982. 

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

Karcher, W. Nonlinear Dependence of 

Fish Bioconcentration on n-Octanol/ 

Water Partition Coefficient. SAR and 

QSAR in Environmental Research, Vol. 

1, pp. 29–39. 1993. 

43. EPA. Document containing EPA’s 

Policy Statement under TSCA section 5. 

Category for Persistent, 

Bioaccumulative, and Toxic New 

Chemical Substances. Notice. Federal 

Register (64 FR 60194, November 4, 

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

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

pubs/pbtpolcy.htm. 

44. EPA. Significant New Use Rules; 

General Provisions for New Chemical 

Followup. Final Rule. Federal Register 

(54 FR 31298, July 27, 1989). 

45. ASTM International. Standard 

Test Method for estimating Acute Oral 

Toxicity in Rats. ASTM E 1163–98 

(Reapproved 2002). 

46. NIEHS 2001b. Guidance 

Document on Using In Vitro Data to 

Estimate In Vivo Starting Doses for 

Acute Toxicity. NIH Publication No. 01– 

4500. August 2001. Available on-line at: 

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

acutetox/inv_cyto_guide.htm. 

47. NIEHS 2003a. Test Method 

Protocol for Solubility Determination, In 

Vitro Cytotoxicity Validation Study— 

Phase III. National Toxicology Program 

(NTP) Interagency Center for the 

Evaluation of Alternative Toxicological 

Methods (NICEATM). September 24, 

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

iccvam.niehs.nih.gov/methods/ 

acutetox/invitrocyto/invcyt_proto.htm. 

48. NIEHS 2003b. Test Method 

Protocol for the BALB/c 3T3 Neutral 

Red Uptake Cytotoxicity Test, a Test for 

Basal Cytotoxicity for an In Vitro 

Validation Study—Phase III. NTP/ 

NICEATM. November 4, 2003. Available 

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

methods/acutetox/invitrocyto/ 

invcyt_proto.htm. 

49. NIEHS 2003c. Test Method 

Protocol for the NHK Neutral Red 

Uptake Cytotoxicity Test, a Test for 

Basal Cytotoxicity for an In Vitro 

Validation Study—Phase III. NTP/ 

NICEATM. November 4, 2003. Available 

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

methods/acutetox/invitrocyto/ 

invcyt_proto.htm. 

50. PETA. Comments on EPA’s 

Proposed Test Rule for Testing of 

Certain High Production Volume 

Chemicals; Second Group of Chemicals 

submitted to the TSCA Public Docket 

Office, EPA. October 22, 2008. 

51. Albemarle. Comments on EPA’s 

Proposed Test Rule for Testing of 

Certain High Production Volume 

Chemicals; Second Group of Chemicals 

submitted to the TSCA Public Docket 

Office, EPA. October 21, 2008. 

52. EPA. Toxic Substances; Test Rule 

Development and Exemption 

Procedures. Interim Final Rule. Federal 

Register (50 FR 20652, 20654, May 17, 

1985). 

53. EPA. Toxic Substances Control 

Act; Data Reimbursement. Final Rule. 

Federal Register (48 FR 31786, 31789, 

July 11, 1983). 

54. EPA, Economics and Policy 

Analysis Branch (EPAB). Analysis of 

Laboratory Capacity to Support U.S. 

EPA Chemical Testing Program 

Initiatives. Washington, DC. August 

2004. 

55. EPA, OPPT. Economic Impact 

Analysis for the Final Section 4 Test 

Rule for High Production Volume 

Chemicals–2. Prepared by the OPPT 

Economic and Policy Analysis Branch. 

July 2010. 

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

High Production Volume Chemicals 

Challenge Program. August 26, 1999. 

Available on-line at: http:// 

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

sarfinl1.htm. 

57. EPA, OPPT, EETD, EPAB. 

Economic Analysis in Support of the 

TSCA 12(b) Information Collection 

Request. Washington, DC. October 30, 

1998. 

X. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

Under Executive Order 12866, 

entitled Regulatory Planning and 

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

this rule is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget (OMB) 

under Executive Order 12866, because it 

does not raise novel legal or policy 

issues arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in section 3(f)(4) of the 

Executive Order. Accordingly, EPA did 

not submit this final rule to OMB for 

review under Executive Order 12866. 

EPA has prepared an economic 

analysis of this action, which is 

contained in a document entitled 

Economic Impact Analysis for the Final 

Section 4 Test Rule for High Production 

Volume Chemicals–2 (Ref. 55). A copy 

of the economic analysis is available in 

the docket for this final rule and is 

summarized in Unit VIII. 


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B. Paperwork Reduction Act 

This final rule does not impose any 

new or amended paperwork collection 

requirements that would require 

additional review and/or approval by 

OMB under the Paperwork Reduction 

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

information collection requirements 

contained in TSCA section 4 test rules 

have already been approved by OMB 

under PRA, and have been assigned 

OMB control number 2070–0033 (EPA 

ICR No. 1139). In the context of 

developing a new test rule, the Agency 

must determine whether the total 

annual burden covered by the approved 

ICR needs to be amended to 

accommodate the burden associated 

with the new test rule. If so the Agency 

must submit an Information Correction 

Worksheet (ICW) to OMB and obtain 

OMB approval of an increase in the total 

approved annual burden in the 

approved EPA ICR No. 0795. The 

Agency’s estimated burden for this test 

rule is provided in the economic 

analysis (Ref. 55). 

The information collection activities 

related to export notification under 

TSCA section 12(b)(1) are already 

approved under OMB control number 

2070–0030 (EPA ICR No. 0795). This 

final rule does not impose any new or 

changes to the export notification 

requirements, and is not expected to 

result in any substantive changes in the 

burden estimates for EPA ICR No. 0795 

that would require additional review 

and/or approval by OMB. Under PRA, 

an agency may not conduct or sponsor, 

and a person is not required to respond 

to, an information collection request 

unless it displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations are listed 

in 40 CFR part 9 and included on the 

related collection instrument. EPA is 

amending the table in 40 CFR part 9 to 

list the OMB approval number for the 

information collection requirements 

contained in this final rule. This listing 

of the OMB control numbers and their 

subsequent codification in the CFR 

satisfies the display requirements of 

PRA and OMB’s implementing 

regulations at 5 CFR part 1320. This ICR 

was previously subject to public notice 

and comment prior to OMB approval, 

and given the technical nature of the 

table, EPA finds that further notice and 

comment to amend it is unnecessary. In 

addition, EPA is correcting 

typographical errors in several listings 

which were introduced into the table by 

a final rule published in the Federal 

Register issue of June 30, 2010 (75 FR 

37722) (FRL–8833–7). 

As a result, EPA finds that there is 

‘‘good cause’’ under section 553(b)(3)(B) 

of the Administrative Procedure Act, 5 

U.S.C. 553(b)(3)(B), to amend this table 

without further notice and comment. 

The standard chemical testing 

program involves the submission of 

letters of intent to test (or exemption 

applications), study plans, semi-annual 

progress reports, test results, and some 

administrative costs. For this final rule, 

EPA estimates the public reporting 

burden for all 19 chemical substances is 

9,008 hours, with an estimated burden 

per chemical substance of 474 hours 

(Ref. 55). The estimated burden of the 

information collection activities related 

to export notification is estimated to 

average 1 burden hour for each chemical 

substance/country combination for an 

initial notification and 0.5 hours for 

each subsequent notification (Ref. 55). 

In estimating the total burden hours 

approved for the information collection 

activities related to export notification, 

the Agency has included sufficient 

burden hours to accommodate any 

export notifications that may be 

required by the Agency’s issuance of 

final test rules for chemical substances. 

As such, EPA does not expect to need 

to request an increase in the total 

burden hours approved by OMB for 

export notifications. 

As defined by PRA and 5 CFR 

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

time, effort, or financial resources 

expended by persons to generate, 

maintain, retain, or disclose or provide 

information to or for a Federal agency. 

This includes the time needed to: 

Review instructions; develop, acquire, 

install, and utilize technology and 

systems for the purposes of collecting, 

validating, and verifying information, 

processing and maintaining 

information, and disclosing and 

providing information; adjust the 

existing ways to comply with any 

previously applicable instructions and 

requirements; train personnel to be able 

to respond to a collection of 

information; search data sources; 

complete and review the collection of 

information; and transmit or otherwise 

disclose the information. 

C. Regulatory Flexibility Act 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA), 5 

U.S.C. 601 et seq., after considering the 

potential economic impacts on small 

entities, the Agency hereby certifies that 

this final rule would not have a 

significant adverse economic impact on 

a substantial number of small entities. 

The factual basis for the Agency’s 

determination is presented in the small 

entity impact analysis prepared as part 

of the economic analysis for this final 

rule (Ref. 55), which is summarized in 

Unit VIII., and a copy of which is 

available in the docket for this final 

rule. The following is a brief summary 

of the factual basis for this certification. 

Under RFA, small entities include 

small businesses, small organizations, 

and small governmental jurisdictions. 

For purposes of assessing the impacts of 

this final rule on small entities, small 

entity is defined in accordance with 

RFA as: 

1. A small business as defined by the 

Small Business Administration’s (SBA) 

regulations at 13 CFR 121.201. 

2. A small governmental jurisdiction 

that is a government of a city, county, 

town, school district, or special district 

with a population of less than 50,000. 

3. A small organization that is any 

not-for-profit enterprise which is 

independently owned and operated and 

is not dominant in its field. Based on 

the industry profile that EPA prepared 

as part of the economic analysis for this 

final rule (Ref. 55), EPA has determined 

that this final rule is not expected to 

impact any small not-for-profit 

organizations or small governmental 

jurisdictions. As such, the Agency’s 

analysis presents only the estimated 

potential impacts on small business. 

Two factors are examined in EPA’s 

small entity impact analysis (Ref. 55) in 

order to characterize the potential small 

entity impacts of this final rule on small 

business: 

• The size of the adverse economic 

impact (measured as the ratio of the cost 

to sales or revenue). 

• The total number of small entities 

that experience the adverse economic 

impact. Section 601(3) of RFA 

establishes as the default definition of 

‘‘small business’’ the definition used in 

section 3 of the Small Business Act, 15 

U.S.C. 632, under which SBA 

establishes small business size 

standards (13 CFR 121.201). For this 

final rule, EPA has analyzed the 

potential small business impacts using 

the size standards established under this 

default definition. The SBA size 

standards, which are primarily intended 

to determine whether a business entity 

is eligible for government programs and 

preferences reserved for small 

businesses (13 CFR 121.101), ‘‘seek to 

ensure that a concern that meets a 

specific size standard is not dominant in 

its field of operation.’’ (13 CFR 

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

Small Business Act. In analyzing 

potential impacts, RFA recognizes that 

it may be appropriate at times to use an 

alternate definition of small business. 

As such, section 601(3) of RFA provides 

that an agency may establish a different 


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Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Rules and Regulations 1085 

definition of small business after 

consultation with the SBA Office of 

Advocacy and after notice and an 

opportunity for public comment. Even 

though the Agency has used the default 

SBA definition of small business to 

conduct its analysis of potential small 

business impacts for this final rule, EPA 

does not believe that the SBA size 

standards are generally the best size 

standards to use in assessing potential 

small entity impacts with regard to 

TSCA section 4(a) test rules. 

The SBA size standard is generally 

based on the number of employees an 

entity in a particular industrial sector 

may have. For example, in the chemical 

manufacturing industrial sector (i.e., 

NAICS code 325 and NAICS code 

324110), approximately 98% of the 

firms would be classified as small 

businesses under the default SBA 

definition. The SBA size standard for 

75% of this industry sector is 500 

employees, and the size standard for 

23% of this industry sector is either 750; 

1,000; or 1,500 employees. When 

assessing the potential impacts of test 

rules on chemical manufacturers, EPA 

believes that a standard based on total 

annual sales may provide a more 

appropriate means to judge the ability of 

a chemical manufacturing firm to 

support chemical testing without 

significant costs or burdens. 

EPA is currently determining what 

level of annual sales would provide the 

most appropriate size cutoff with regard 

to various segments of the chemical 

industry usually impacted by TSCA 

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

reached a determination. As stated 

above, therefore, the factual basis for the 

RFA determination for this final rule is 

based on an analysis using the default 

SBA size standards. Although EPA is 

not currently proposing to establish an 

alternate definition for use in the 

analysis conducted for this final rule, 

the analysis for this final rule also 

presents the results of calculations using 

a standard based on total annual sales 

(40 CFR 704.3). 

The SBA has developed 6-digit 

NAICS code-specific size standards 

based on employment thresholds. These 

size standards range from 500 to 1,500 

employees for the various 6-digit NAICS 

codes that are potentially impacted (Ref. 

55). For a conservative estimate of the 

number of small businesses affected by 

the HPV rule, the Agency chose an 

employment threshold of less than 

1,500 employees for all businesses 

regardless of the NAIC-specific 

threshold to determine small business 

status. 

For each manufacturer of the 19 

chemical substances covered by this 

final rule, the parent company (ultimate 

corporate entity (UCE)) was identified 

and sales and employment data were 

obtained for companies where data was 

publicly available. The search 

determined that there were 48 affected 

UCEs. Sales and employment data could 

be found for 45 and 46 of these UCEs 

(88%), respectively. 

Parent company sales data were 

collected to identify companies that 

qualified as a ‘‘small business’’ for 

purposes of RFA analysis. Based on the 

SBA size standard applied (1,500 

employees or less), 20 companies were 

identified as small. 

The potential significance of this final 

rule’s impact on small businesses was 

analyzed by examining the number of 

small entities that experienced different 

levels of costs as a percentage of their 

sales. Small businesses were placed in 

the following categories on the basis of 

cost-to-sales ratios: Less than 1%, 

greater than 1%, and greater than 3%. 

This analysis was conducted under both 

a least- and average-cost scenario. 

Of the 20 small businesses analyzed 

for small business impacts, one 

company had no sales data available. 

Another two companies could not be 

classified as small or large because there 

were no employment data available, but 

were still included in the small business 

impact analysis. Of the 19 designated as 

small businesses, none had cost-to-sales 

ratios of greater than 1% under both the 

least- and average-cost scenarios. For 

the chemical substances where sales 

data were unavailable, EPA used the 

median sales value sales of all other 

small businesses equal to $15.4 million. 

The costs for the three companies were 

estimated to be well below 0.01% of this 

sales level. Given these results, the 

Agency has determined that there is not 

a significant economic impact on a 

substantial number of small entities as 

a result of this final rule. 

The estimated cost of the TSCA 

section 12(b)(1) export notification, 

which, as a result of the final rule, 

would be required for the first export to 

a particular country of a chemical 

substance subject to the rule, is 

estimated to be $80.22 for the first time 

that an exporter must comply with 

TSCA section 12(b)(1) export 

notification requirements, and $25.56 

for each subsequent export notification 

submitted by that exporter (Refs. 55–57). 

EPA has concluded that the costs of 

TSCA section 12(b)(1) export 

notification would have a negligible 

impact on exporters of the chemical 

substances in the final rule, regardless 

of the size of the exporter. 

D. Unfunded Mandates Reform Act 

Pursuant to Title II of the Unfunded 

Mandates Reform Act of 1995 (UMRA), 

Public Law 104–4, EPA has determined 

that this final rule does not contain a 

Federal mandate that may result in 

expenditures of $100 million or more 

for State, local, and tribal governments, 

in the aggregate, or the private sector in 

any 1 year. It is estimated that the total 

aggregate costs of this final rule, which 

are summarized in Unit VIII., would be 

$4.19 million. The total annualized 

costs of this final rule are estimated to 

be $1.48 million. In addition, since EPA 

does not have any information to 

indicate that any State, local, or tribal 

government manufactures or processes 

the chemical substances covered by this 

action such that this rule would apply 

directly to State, local, or tribal 

governments, EPA has determined that 

this final rule would not significantly or 

uniquely affect small governments. 

Accordingly, this final rule is not 

subject to the requirements of sections 

202, 203, 204, and 205 of UMRA. 

E. Executive Order 13132 

Under Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999), EPA has determined 

that this final rule does not have 

‘‘federalism implications’’ because it will 

not have substantial direct effects on the 

States, on the relationship between the 

national government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government, as specified in the 

Executive Order. This final rule would 

establish testing and recordkeeping 

requirements that apply to 

manufacturers (including importers) 

and processors of certain chemical 

substances. Because EPA has no 

information to indicate that any State or 

local government manufactures or 

processes the chemical substances 

covered by this action, this rule does not 

apply directly to States and localities 

and will not affect State and local 

governments. Thus, Executive Order 

13132 does not apply to this final rule. 

F. Executive Order 13175 

Under Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000), EPA has 

determined that this final rule does not 

have tribal implications because it will 

not have any affect on tribal 

governments, on the relationship 

between the Federal Government and 

the Indian tribes, or on the distribution 

of power and responsibilities between 

the Federal Government and Indian 


jdjones on DSK8KYBLC1PROD with RULES
1086 Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Rules and Regulations 

tribes, as specified in the Order. As 

indicated previously, EPA has no 

information to indicate that any tribal 

government manufactures or processes 

the chemical substances covered by this 

action. Thus, Executive Order 13175 

does not apply to this rule. 

G. Executive Order 13045 

This final rule is not subject to 

Executive Order 13045, entitled 

Protection of Children from 

Environmental Health Risks and Safety 

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

because it does not establish an 

environmental standard intended to 

mitigate health or safety risks, will not 

have an annual effect on the economy 

of $100 million or more, nor does it 

otherwise have a disproportionate effect 

on children. This final rule would 

establish testing and recordkeeping 

requirements that apply to 

manufacturers (including importers) 

and processors of certain chemical 

substances, and would result in the 

development of data about those 

chemical substances that can 

subsequently be used to assist the 

Agency and others in determining 

whether the chemical substances in this 

final rule present potential risks, 

allowing the Agency and others to take 

appropriate action to investigate and 

mitigate those risks. 

H. Executive Order 13211 

This final rule is not subject to 

Executive Order 13211, entitled Actions 

Concerning Regulations that 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001), because it is unlikely to have 

any significant adverse effect on the 

supply, distribution, or use of energy. 

I. National Technology Transfer and 

Advancement Act 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (NTTAA), Public Law 104– 

113, section 12(d) (15 U.S.C. 272 note), 

directs EPA to use voluntary consensus 

standards in its regulatory activities 

unless to do so would be inconsistent 

with applicable law or otherwise 

impractical. Voluntary consensus 

standards are technical standards (e.g., 

materials specifications, test methods, 

sampling procedures and business 

practices) that are developed or adopted 

by voluntary consensus standards 

bodies. The NTTAA directs EPA to 

provide Congress, through OMB, 

explanations when the Agency decides 

not to use available and applicable 

voluntary consensus standards. This 

final rule involves technical standards 

that require the use of particular test 

methods. When the Agency makes 

findings under TSCA section 4(a), EPA 

is required by TSCA section 4(b) to 

include specific standards or test 

methods that are to be used for the 

development of the data required in the 

test rules issued under TSCA section 4. 

For some of the testing that is required 

by this rule, EPA is requiring the use of 

voluntary consensus standards issued 

by ASTM and ISO which evaluate the 

same type of toxicity as the TSCA and 

OECD test methods, where applicable. 

Copies of the 18 ASTM, ISO, and OECD 

test methods referenced in § 799.5087(h) 

of the regulatory text have been placed 

in the docket for this final rule. You 

may obtain copies of the ASTM 

standards from the American Society for 

Testing and Materials, 100 Bar Harbor 

Dr., West Conshohocken, PA 19428– 

2959, and copies of the ISO standards 

from the International Organization for 

Standardization, Case Postale, 56 CH– 

1211 Gene`ve 20 Switzerland. EPA 

received the required approval from the 

Director of the Federal Register for the 

incorporation by reference of the ASTM 

and ISO standards used in this final rule 

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

1 CFR part 51. 

EPA is not aware of any potentially 

applicable voluntary consensus 

standards which evaluate partition 

coefficient (n-octanol/water) generator 

column, water solubility (column 

elution and generator column), acute 

inhalation toxicity, bacterial reverse 

mutations, in vivo mammalian bone 

marrow chromosomal aberrations, 

combined repeated dose with 

reproductive/developmental toxicity 

screen, repeated dose 28–day oral 

toxicity screen, or the reproductive 

developmental toxicity screen which 

could be considered in lieu of the TSCA 

test methods, 40 CFR 799.6756, 

799.6784, 799.6786, 799.9130, 799.9510, 

799.9538, 799.9365, 799.9305, and 

799.9355, respectively, upon which the 

test standards in this final rule are 

based. 

J. Executive Order 12898 

This final rule does not have an 

adverse impact on the environmental 

and health conditions in low-income 

and minority communities that require 

special consideration by the Agency 

under Executive Order 12898, entitled 

Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). The Agency believes that the 

information collected under this final 

rule will assist EPA and others in 

determining the potential hazards and 

risks associated with the chemical 

substances covered by the rule. 

Although not directly impacting 

environmental justice-related concerns, 

this information will better enable the 

Agency to better protect human health 

and the environment, including in lowincome and minority communities. 

XI. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This rule is not a ‘‘major rule’’ 

as defined by 5 U.S.C. 804(2). 

List of Subjects 

40 CFR Part 9 

Environmental protection, 

Administrative practice and procedure, 

Reporting and recordkeeping 

requirements. 

40 CFR Part 799 

Environmental protection, Chemicals, 

Hazardous substances, Incorporation by 

reference, Laboratories, Reporting and 

recordkeeping requirements. 

Dated: December 21, 2010. 

Stephen A. Owens, 

Assistant Administrator, Office of Chemical 

Safety and Pollution Prevention. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 9—[AMENDED] 

■ 1. The authority citation for part 9 

continues to read as follows: 

Authority: 7 U.S.C. 135 et seq., 136–136y; 

15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671, 

21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 

U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 

1321, 1326, 1330, 1342, 1344, 1345(d) and 

(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR 

1971–1975, Comp. p. 973; 42 U.S.C. 241, 

242b, 243, 246, 300f, 300g, 300g–1, 300g–2, 

300g–3, 300g–4, 300g–5, 300g–6, 300j–1, 

300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., 

6901–6992k, 7401–7671q, 7542, 9601–9657, 

11023, 11048. 

■ 2. In § 9.1, in the table, revise the 

entries ‘‘Part 725, Part 749, Part 761, Part 

790, and Part 799’’ under the 

appropriate undesignated center 

heading indicated below to read as 

follows: 


jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Rules and Regulations 1087 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR citation OMB control 

No. 

*****

Reporting Requirements and Review 

Processes for Microorganisms 

Part 725 ................................ 2070–0012 

*****

Water Treatment Chemicals 

Part 749 ................................ 2070–0193 

*****

Polychlorinated Biphenyls (PCBs) Manufacturing, Processing, Distribution in 

Commerce, and Use Prohibitions 

Part 761 ................................ 2070–0012 

*****

Procedures Governing Testing Consent 

Agreements and Test Rules 

Part 790 ................................ 2070–0033 

40 CFR citation OMB control 

No. 

*****

Identification of Specific Chemical Substance and Mixture Testing Requirements 

Part 799 ................................ 2070–0033 

* * * * * 

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 § 799.5087 to subpart D to read 

as follows: 

§ 799.5087 Chemical testing requirements 

for second group of high production 

volume chemicals (HPV2). 

(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 

February 7, 2011 to the end of the test 

data reimbursement period as defined in 

40 CFR 791.3(h), you are subject to this 

section with respect to that chemical 

substance. 

(2) If you do not know or cannot 

reasonably ascertain that you 

manufacture or process a chemical 

substance listed in Table 2 in paragraph 

(j) of this section during the time period 

described in paragraph (b)(1) of this 

section (based on all information in 

your possession or control, as well as all 

information that a reasonable person 

similarly situated might be expected to 

possess, control, or know, or could 

obtain without unreasonable burden), 

you are not subject to this section with 

respect to that chemical substance. 

(c) If I am subject to this section, when 

must I comply with it? (1)(i) Persons 

subject to this section are divided into 

two groups, as set forth in Table 1 of 

this paragraph: Tier 1 (persons initially 

required to comply), and Tier 2 (persons 

not initially required to comply). If you 

are subject to this section, you must 

determine if you fall within Tier 1 or 

Tier 2, based on Table 1 of this 

paragraph. 

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

Persons initially required to comply with this 

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 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)). 

B. Persons who process (as defined at TSCA section 3(10)) or intend to process a chemical substance included in this section (see 40 CFR 790.42(a)(2)). 

Note: kg—kilogram, TSCA—Toxic Substances Control Act. 

(ii) Table 1 of paragraph (c)(1)(i) of 

this section expands the list of persons 

in Tier 2, that is, those persons specified 

in 40 CFR 790.42(a)(2), (a)(4), and (a)(5), 

who, while legally subject to this 

section, must comply with the 

requirements of this section only if 

directed to do so by EPA under the 

circumstances set forth in paragraphs 

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

this section. 

(2) If you are in Tier 1 with respect 

to a chemical substance listed in Table 

2 in paragraph (j) of this section, you 

must, for each test required under this 

section for that chemical substance, 

either submit to EPA a letter of intent 

to test or apply to EPA for an exemption 

from testing. The letter of intent to test 

or the exemption application must be 

received by EPA no later than February 

7, 2011. 

(3) If you are in Tier 2 with respect 

to a chemical substance listed in Table 

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

considered to have an automatic 

conditional exemption and you will be 

required to comply with this section 

with regard to that chemical substance 

only if directed to do so by EPA under 

paragraphs (c)(5), (c)(7), or (c)(10) of this 

section. 


jdjones on DSK8KYBLC1PROD with RULES
1088 Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Rules and Regulations 

(4) If no person in Tier 1 has notified 

EPA of its intent to conduct one or more 

of the tests required by this section on 

any chemical substance listed in Table 

2 in paragraph (j) of this section on or 

before February 7, 2011, EPA will 

publish a Federal Register document 

that would specify the test(s) and the 

chemical substance(s) for which no 

letter of intent has been submitted and 

notify manufacturers in Tier 2A of their 

obligation to submit a letter of intent to 

test or to apply for an exemption from 

testing. 

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

in Table 1 in paragraph (c) of this 

section) with respect to a chemical 

substance listed in Table 2 in paragraph 

(j) of this section, and if you 

manufacture, or intend to manufacture, 

this chemical substance as of February 

7, 2011, or within 30 days after 

publication of the Federal Register 

document described in paragraph (c)(4) 

of this section, you must, for each test 

specified for that chemical substance in 

the document described in paragraph 

(c)(4) of this section, either submit to 

EPA a letter of intent to test or apply to 

EPA for an exemption from testing. The 

letter of intent to test or the exemption 

application must be received by EPA no 

later than 30 days after publication of 

the document described in paragraph 

(c)(4) of this section. 

(6) If no manufacturer in Tier 1 or Tier 

2A has notified EPA of its intent to 

conduct one or more of the tests 

required by this section on any chemical 

substance listed in Table 2 in paragraph 

(j) of this section within 30 days after 

the publication of the Federal Register 

document described in paragraph (c)(4) 

of this section, EPA will publish another 

Federal Register document that would 

specify the test(s) and the chemical 

substance(s) for which no letter of intent 

has been submitted, and notify 

processors in Tier 2B of their obligation 

to submit a letter of intent to test or to 

apply for an exemption from testing. 

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

in Table 1 in paragraph (c) of this 

section) with respect to a chemical 

substance listed in Table 2 in paragraph 

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

intend to process, this chemical 

substance as of February 7, 2011, or 

within 30 days after publication of the 

Federal Register document described in 

paragraph (c)(6) of this section, you 

must, for each test specified for that 

chemical substance in the document 

described in paragraph (c)(6) of this 

section, either submit to EPA a letter of 

intent to test or apply to EPA for an 

exemption from testing. The letter of 

intent to test or the exemption 

application must be received by EPA no 

later than 30 days after publication of 

the document described in paragraph 

(c)(6) of this section. 

(8) If no manufacturer or processor 

has notified EPA of its intent to conduct 

one or more of the tests required by this 

section for any of the chemical 

substances listed in Table 2 in 

paragraph (j) of this section within 30 

days after the publication of the Federal 

Register document described in 

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

notify all manufacturers and processors 

of those chemical substances of this fact 

by certified letter or by publishing a 

Federal Register document specifying 

the test(s) for which no letter of intent 

has been submitted. This letter or 

Federal Register document will 

additionally notify all manufacturers 

and processors that all exemption 

applications concerning the test(s) have 

been denied, and will give the 

manufacturers and processors of the 

chemical substance(s) an opportunity to 

take corrective action. 

(9) If no manufacturer or processor 

has notified EPA of its intent to conduct 

one or more of the tests required by this 

section for any of the chemical 

substances listed in Table 2 in 

paragraph (j) of this section within 30 

days after receipt of the certified letter 

or publication of the Federal Register 

document described in paragraph (c)(8) 

of this section, all manufacturers and 

processors subject to this section with 

respect to that chemical substance who 

are not already in violation of this 

section will be in violation of this 

section. 

(10) If a problem occurs with the 

initiation, conduct, or completion of the 

required testing or the submission of the 

required data with respect to a chemical 

substance listed in Table 2 in paragraph 

(j) of this section, under the procedures 

in 40 CFR 790.93 and 790.97, EPA may 

initiate termination proceedings for all 

testing exemptions with respect to that 

chemical substance and may notify 

persons in Tier 1 and Tier 2 that they 

are required to submit letters of intent 

to test or exemption applications within 

a specified period of time. 

(11) If you are required to comply 

with this section, but your manufacture 

or processing of, or intent to 

manufacture or process, a chemical 

substance listed in Table 2 in paragraph 

(j) of this section begins after the 

applicable compliance date referred to 

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

this section, you must either submit a 

letter of intent to test or apply to EPA 

for an exemption. The letter of intent to 

test or the exemption application must 

be received by EPA no later than the day 

you begin manufacture or processing. 

(d) What must I do to comply with 

this section? (1) To comply with this 

section you must either submit to EPA 

a letter of intent to test, or apply to and 

obtain from EPA an exemption from 

testing. 

(2) For each test with respect to which 

you submit to EPA a letter of intent to 

test, you must conduct the testing 

specified in paragraph (h) of this section 

and submit the test data to EPA. 

(3) You must also comply with the 

procedures governing test rule 

requirements in 40 CFR part 790 (except 

for those requirements listed in this 

paragraph as not applicable to this 

section), including the submission of 

letters of intent to test or exemption 

applications, the conduct of testing, and 

the submission of data; 40 CFR Part 

792—Good Laboratory Practice 

Standards; and this section. The 

following provisions of 40 CFR part 790 

do not apply to this section: Paragraphs 

(a), (d), (e), and (f) of § 790.45; paragraph 

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

§ 790.82(e)(1); § 790.85; and § 790.48. 

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

when will I be considered in violation of 

it? You will be considered in violation 

of this section as of 1 day after the date 

by which you are required to comply 

with this section. 

(f) How are EPA’s data reimbursement 

procedures affected for purposes of this 

section? If persons subject to this section 

are unable to agree on the amount or 

method of reimbursement for test data 

development for one or more chemical 

substances included in this section, any 

person may request a hearing as 

described in 40 CFR part 791. In the 

determination of fair reimbursement 

shares under this section, if the hearing 

officer chooses to use a formula based 

on production volume, the total 

production volume amount will include 

amounts of a chemical substance 

produced as an impurity. 

(g) Who must comply with the export 

notification requirements? Any person 

who exports, or intends to export, a 

chemical substance listed in Table 2 in 

paragraph (j) of this section is subject to 

40 CFR part 707, subpart D. 

(h) How must I conduct my testing? 

(1) The tests that are required for each 

chemical substance are indicated in 

Table 2 in paragraph (j) of this section. 

The test methods that must be followed 

are provided in Table 3 in paragraph (j) 

of this section. You must proceed in 

accordance with these test methods as 

required according to Table 3 in 

paragraph (j) of this section, or as 

appropriate if more than one alternative 

is allowed according to Table 3 in 

paragraph (j) of this section. Included in 

Table 3 in paragraph (j) of this section 


jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Rules and Regulations 1089 

are the following 18 test methods which 

are incorporated by reference: 

(i) Standard Test Method for Relative 

Initial and Final Melting Points and the 

Melting Range of Organic Chemicals, 

ASTM E 324–99, approved September 

10, 1999. 

(ii) Standard Test Method for Partition 

Coefficient (N-Octanol/Water) 

Estimation by Liquid Chromatography, 

ASTM E 1147–92 (Reapproved 2005), 

approved August 1, 2005. 

(iii) Standard Guide for Conducting 

Acute Toxicity Tests on Test Materials 

with Fishes, Macroinvertebrates, and 

Amphibians, ASTM E 729–96 

(Reapproved 2007), approved October 1, 

2007. 

(iv) Standard Test Method for 

Measurements of Aqueous Solubility, 

ASTM E 1148–02 (Reapproved 2008), 

approved February 1, 2008. 

(v) Standard Test Method for 

Estimating Acute Oral Toxicity in Rats, 

ASTM E 1163–98 (Reapproved 2002), 

approved October 10, 2002. 

(vi) Standard Guide for Conducting 

Daphnia Magna Life-Cycle Toxicity 

Tests, ASTM E 1193–97 (Reapproved 

2004), approved April 1, 2004. 

(vii) Standard Guide for Conducting 

Static Toxicity Tests with Microalgae, 

ASTM E 1218–04e1, approved April 1, 

2004. 

(viii) Standard Test Method for Vapor 

Pressure of Liquids by Ebulliometry, 

ASTM E 1719–05, approved March 1, 

2005. 

(ix) Standard Test Method for 

Determining Ready, Ultimate, 

Biodegradability of Organic Chemicals 

in a Sealed Vessel CO2 Production Test. 

ASTM E 1720–01 (Reapproved 2008), 

approved February 1, 2008. 

(x) Standard Test Method for 

Determining Vapor Pressure by Thermal 

Analysis, ASTM E 1782–08, approved 

March 1, 2008. 

(xi) Water Quality—Evaluation of 

Ultimate Aerobic Biodegradability of 

Organic Compounds in Aqueous 

Medium—Method by Analysis of 

Inorganic Carbon in Sealed Vessels (CO2

Headspace Test). First Edition, March 

15, 1999. ISO 14593:1999(E). 

(xii) Water Quality—Evaluation in an 

Aqueous Medium of the ‘‘Ultimate’’ 

Aerobic Biodegradability of Organic 

Compounds—Method by Analysis of 

Dissolved Organic Carbon (DOC). 

Second Edition, September 15, 1994. 

ISO 7827:1994(E). 

(xiii) Water Quality—Evaluation of 

Ultimate Aerobic Biodegradability of 

Organic Compounds in Aqueous 

Medium by Determination of Oxygen 

Demand in a Closed Respirometer. 

Second Edition, August 1, 1999. ISO 

9408:1999(E). 

(xiv) Water Quality—Evaluation of 

Ultimate Aerobic Biodegradability of 

Organic Compounds in Aqueous 

Medium—Carbon Dioxide Evolution 

Test. Second Edition, March 1, 1999. 

ISO 9439:1999(E). 

(xv) Water Quality—Evaluation in an 

Aqueous Medium of The ‘‘Ultimate’’ 

Aerobic Biodegradability of Organic 

Compounds—Method by Analysis of 

Biochemical Oxygen Demand (Closed 

Bottle Test). First Edition, October 15, 

1994. ISO 10707:1994(E). 

(xvi) Water Quality—Evaluation in an 

Aqueous Medium of the Ultimate 

Aerobic Biodegradability of Organic 

Compounds—Determination of 

Biochemical Oxygen Demand in a TwoPhase Closed Bottle Test. First Edition, 

February 1, 1997. ISO 10708:1997(E). 

(xvii) Water Quality—Guidance for 

the Preparation and Treatment of Poorly 

Water-Soluble Organic Compounds for 

the Subsequent Evaluation of Their 

Biodegradability in an Aqueous 

Medium. First Edition, August 15, 1995. 

ISO 10634:1995(E). 

(xviii) Guideline for the Testing of 

Chemicals: Melting Point/Melting 

Range. OECD 102. July 27, 1995. 

(2) The Director of the Federal 

Register approved this incorporation by 

reference in accordance with 5 U.S.C. 

552(a) and 1 CFR part 51. You may 

obtain copies of the ASTM test methods 

from the American Society for Testing 

and Materials, 100 Bar Harbor Dr., P.O. 

Box C700, West Conshohocken, PA 

19428–2959, telephone number: (610) 

832–9585, web address: http:// 

www.astm.org; copies of the ISO test 

methods from the International 

Organization for Standardization, 1, ch. 

de la Voie-Creuse, Case postale, 56 CH– 

1211 Geneve 20 Switzerland, telephone 

number: +41 22 749 01 11, web address: 

http://www.iso.org; and a copy of the 

OECD guideline from the Organization 

for Economic Cooperation and 

Development, 2, rue Andre ́ Pascal,75775 

Paris Cedex 16 France, telephone 

number: +33 1 45 24 82 00, web 

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

inspect each test method and guideline 

at the EPA Docket Center, EPA West, 

Rm. B102, 1301 Constitution Ave., NW., 

Washington, DC 20004, telephone 

number: (202) 566–1744, or at the 

National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call (202) 741–6030, 

or go to: http://www.archives.gov/ 

federal-register/cfr/ibr-locations.html. 

(i) Reporting requirements. A final 

report for each specific test for each 

subject chemical substance must be 

received by EPA by March 7, 2012, 

unless an extension is granted in writing 

pursuant to 40 CFR 790.55. A robust 

summary of the final report for each 

specific test should be submitted in 

addition to and at the same time as the 

final report. The term ‘‘robust summary’’ 

is used to describe the technical 

information necessary to adequately 

describe an experiment or study and 

includes the objectives, methods, 

results, and conclusions of the full 

study report which can be either an 

experiment or in some cases an 

estimation or prediction method. 

Guidance for the compilation of robust 

summaries is described in a document 

entitled ‘‘Draft Guidance on Developing 

Robust Summaries’’ which is available 

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

pubs/general/robsumgd.htm. 

(j) Designation of specific chemical 

substances and testing requirements. 

The chemical substances identified by 

chemical name, Chemical Abstract 

Service Registry Number (CASRN), and 

class in Table 2 of this paragraph must 

be tested in accordance with the 

requirements designated in Tables 2 and 

3 of this paragraph, and the 

requirements described in 40 CFR part 

792—Good Laboratory Practice 

Standards: 

TABLE 2—CHEMICAL SUBSTANCES AND TESTING REQUIREMENTS

CASRN Chemical name Class Required tests/(See table 3 of this section) 

75–07–0 ............ Acetaldehyde ................................................................ 1 C2, F2. 

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

(ester).

1 C4. 

84–65–1 ............ 9,10-Anthracenedione ................................................... 1 C6. 

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

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

118–82–1 .......... Phenol, 4,4′-methylenebis[2,6-bis(1,1-dimethylethyl)- .. 1 C1. 

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


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1090 Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Rules and Regulations 

TABLE 2—CHEMICAL SUBSTANCES AND TESTING REQUIREMENTS—Continued 

CASRN Chemical name Class Required tests/(See table 3 of this section) 

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

149–44–0 .......... Methanesulfinic acid, ....................................................

hydroxy-, monosodium salt ...........................................

1 E1. 

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

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

6381–77–7 ........ D-erythro-hex-2-enonic acid, gamma.-lactone, monosodium salt.1 A4, B, C1. 

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

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

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

68187–84–8 ...... Castor oil, oxidized ....................................................... 2 A1, A2, B, E1, E2, F1. 

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

68527–02–6 ...... Alkenes, C12–24, chloro ................................................. 2 A1, A2, A3, A4, A5, B, C1, E2, F2. 

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

Note: CASRN = Chemical Abstract Service Registry Number. 

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

[Note: The ASTM and ISO test methods and the OECD guideline required in this paragraph are incorporated by reference; see paragraph (h) of 

this section.] 

Testing 

category 

Test 

symbol Test requirements and references Special conditions 

Physical/chemical properties.A 1. Melting Point: American Society for Testing and 

Materials (ASTM) E 324–99 (capillary tube), if a 

Freezing Point: Organization for Economic Cooperation and Development (OECD) 102 (melting point/melting range).

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

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

analysis).

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

basis) or log KOW: (See Special Conditions for 

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

in this column.).

Method A: 40 CFR 799.6755 (shake flask) .........

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

(liquid chromatography).

Method C: 40 CFR 799.6756 (generator column) 

5. Water Solubility: (See Special Conditions for the 

water solubility test requirement and select the 

appropriate method to use, if any, from those 

listed in this column.).

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

(shake flask).

Method B: 40 CFR 799.6784 (shake flask) .........

Method C: 40 CFR 799.6784 (column elution) ....

Method D: 40 CFR 799.6786 (generator column) 

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

or log KOW: 

Which method is required, if any, is determined by 

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

log KOW < 0: No testing required. 

log KOW range 0–1: Method A or B. 

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

log KOW range > 4–6: Method B or C. 

log KOW > 6: Method C. 

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

pH selected. In order to ensure environmental 

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

Water Solubility: 

Which method is required, if any, is determined by 

the test substance’s estimated ii water solubility. 

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

pH selected. In order to ensure environmental 

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

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

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

> 0.001 mg/L–10 mg/L: Method C or D. 

≤ 0.001 mg/L: No testing required. 

Environmental fate and 

pathways—ready biodegradation.

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

and choose one of the methods listed in this column:.

1. ASTM E 1720–01 (Reapproved 2008) (sealed 

vessel CO2 production test) OR.

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

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

4. ISO 9408:1999(E) (determination of oxygen demand in a closed respirometer) OR.

Which method is required, if any, is determined by 

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

10634:1995(E) provides guidance for selection of 

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

study report the underlying rationale for the 

method selected. 

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

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

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

test).


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

Continued 

[Note: The ASTM and ISO test methods and the OECD guideline required in this paragraph are incorporated by reference; see paragraph (h) of 

this section.] 

Testing 

category 

Test 

symbol Test requirements and references Special conditions 

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

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

Test Group 1 for C1: ................................................

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

2. Acute Toxicity to Daphnia: ASTM E 729–96 (Reapproved 2007).

3. Toxicity to Plants (Algae): ASTM E 1218–04 e1 ..

Test Group 2 for C1: ................................................

1. Chronic Toxicity to Daphnia: ASTM E 1193–97 

(Reapproved 2004).

2. Toxicity to Plants (Algae): ASTM E 1218—04 e1

The following are the special conditions for C1, C2, 

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

conditions for C6. 

Which test group is required is determined by the 

test substance’s measured log KOW as obtained 

under Test Category A, or using an existing 

measured log KOW. iii

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

If log KOW ≥ 4.2: Test Group 2 is required 

C2 For C2, Test Group 1 or Test Group 2 listed in this 

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

Test Group 1 for C2:.

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

2. Toxicity to Plants (Algae): ASTM E 1218–04 e1.

Test Group 2 for C2:.

1. Chronic Toxicity to Daphnia: ASTM E 1193–97 

(Reapproved 2004).

2. Toxicity to Plants (Algae): ASTM E 1218–04 e1.

C3 For C3, Test Group 1 or Test Group 2 listed in this 

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

Test Group 1 for C3:.

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

2. Toxicity to Plants (Algae): ASTM E 1218–04 e1.

Test Group 2 for C3:.

1. Chronic Toxicity to Daphnia: ASTM E 1193–97 

(Reapproved 2004).

2. Toxicity to Plants (Algae): ASTM E 1218–04 e1.

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

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

Test Group 1 for C4:.

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

2. Acute Toxicity to Daphnia: ASTM E 729–96 (Reapproved 2007).

Test Group 2 for C4:.

1. Chronic Toxicity to Daphnia: ASTM E 1193–97 

(Reapproved 2004).

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

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

Test Group 1 for C5:.

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

Test Group 2 for C5:.

1. Chronic Toxicity to Daphnia: ASTM E 1193–97 

(Reapproved 2004).

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

...................................... C7 For C7, Test Group 1 or Test Group 2 listed in this 

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

Test Group 1 for C7:.

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

Test Group 2 for C7:.

1. Chronic Toxicity to Daphnia: ASTM E 1193–97 

(Reapproved 2004).


jdjones on DSK8KYBLC1PROD with RULES
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TABLE 3—KEY TO THE TEST REQUIREMENTS DENOTED BY ALPHANUMERIC SYMBOLS IN TABLE 2 OF THIS PARAGRAPH— 

Continued 

[Note: The ASTM and ISO test methods and the OECD guideline required in this paragraph are incorporated by reference; see paragraph (h) of 

this section.] 

Testing 

category 

Test 

symbol Test requirements and references Special conditions 

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

select the method that must be used from those 

listed in this column..

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

799.9130.

Method B: EITHER: .................................................

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

1163–98 (Reapproved 2002).

OR ........................................................................

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

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

Which testing method is required is determined by 

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

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

listed under Method B. 

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

the OECD 425 Up/Down Procedure.iv

Estimating starting dose for Method B: Data from 

the neutral red uptake basal cytotoxicity assay v

using normal human keratinocytes or mouse 

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

starting dose. 

Mammalian toxicity— 

genotoxicity.

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

799.9510.

None 

E2 Conduct any one of the following three tests for 

chromosomal damage: In vitro Mammalian Chromosome Aberration Test: 40 CFR 799.9537.

OR ........................................................................

Mammalian Bone Marrow Chromosomal Aberration 

Test (in vivo in rodents: mouse (preferred species), rat, or Chinese hamster): 40 CFR 

799.9538.

OR ........................................................................

Mammalian Erythrocyte Micronucleus Test [sampled in bone marrow] (in vivo in rodents: Mouse 

(preferred species), rat, or Chinese hamster): 40 

CFR 799.9539.

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

vitro Mammalian Chromosome Aberration Test 

(40 CFR 799.9537) to generate the needed data 

unless known chemical properties (e.g., physical/ 

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

one of the in vivo methods instead of the in vitro 

method to address a chromosomal damage test 

requirement must submit to EPA a rationale for 

conducting that alternate test in the final study 

report. 

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

Reproduction/Developmental Toxicity Screening 

Test: 40 CFR 799.9365.

OR ........................................................................

Reproduction/Developmental Toxicity Screening 

Test: 40 CFR 799.9355.

AND ......................................................................

Repeated Dose 28–Day Oral Toxicity Study in rodents: 40 CFR 799.9305.

Where F1 is required, EPA recommends use of the 

Combined Repeated Dose Toxicity Study with 

the Reproduction/Developmental Toxicity 

Screening Test (40 CFR 799.9365). However, 

there may be valid reasons to test a particular 

chemical using both 40 CFR 799.9355 and 40 

CFR 799.9305 to fill Mammalian Toxicity—Repeated Dose/Reproduction/Developmental data 

needs. A subject person who uses the combination of 40 CFR 799.9355 and 40 CFR 799.9305 

in place of 40 CFR 799.9365 must submit to 

EPA a rationale for conducting these alternate 

tests in the final study reports. Where F2 or F3 

is required, no rationale for conducting the required test need be provided in the final study 

report. 

F2 Reproduction/Developmental Toxicity Screening 

Test: 40 CFR 799.9355.

F3 Repeated Dose 28–Day Oral Toxicity Study in rodents: 40 CFR 799.9305.

iEPA recommends, but does not require, that log KOW be quantitatively estimated prior to initiating this study. One method, among many similar methods, for estimating log KOW is described in the article entitled ‘‘Atom/Fragment Contribution Method for Estimating Octanol-Water Partition Coefficients’’ by W.M. Meylan and P.H. Howard in the Journal of Pharmaceutical Sciences. 84(1):83–92. January 1992. This reference is 

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

Washington, DC 20004, telephone number: (202) 566–1744, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. iiEPA recommends, but does not require, that water solubility be quantitatively estimated prior to initiating this study. One method, among 

many similar methods, for estimating water solubility is described in the article entitled ‘‘Improved Method for Estimating Water Solubility From 

Octanol/Water Partition Coefficient’’ by W.M. Meylan, P.H. Howard, and R.S. Boethling in Environmental Toxicology and Chemistry. 15(2):100– 

106. 1996. This reference is available in docket ID number EPA–HQ–OPPT–2007–0531 at the EPA Docket Center, Rm. 3334, EPA West Bldg., 

1301 Constitution Ave., NW., Washington, DC 20004, telephone number: (202) 566–1744, from 8:30 a.m. to 4:30 p.m., Monday through Friday, 

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

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

for determining whether acute or chronic aquatic toxicity testing be performed for a specific substance. ivThe OECD 425 Up/Down Procedure, revised by OECD in December 2001, is available in docket ID number EPA–HQ–OPPT–2007–0531 at 

the EPA Docket Center, Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC 20004, telephone number: (202) 566–1744, 

from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. 


jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Rules and Regulations 1093 

vThe neutral red uptake basal cytotoxicity assay, which may be used to estimate the starting dose for the mammalian toxicity-acute endpoint, 

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

NW., Washington, DC 20004, telephone number: (202) 566–1744, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. 

[FR Doc. 2010–33313 Filed 1–6–11; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 67 

[Docket ID FEMA–2010–0003] 

Final Flood Elevation Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: Base (1% annual-chance) 

Flood Elevations (BFEs) and modified 

BFEs are made final for the 

communities listed below. The BFEs 

and modified BFEs are the basis for the 

floodplain management measures that 

each community is required either to 

adopt or to show evidence of being 

already in effect in order to qualify or 

remain qualified for participation in the 

National Flood Insurance Program 

(NFIP). 

DATES: The date of issuance of the Flood 

Insurance Rate Map (FIRM) showing 

BFEs and modified BFEs for each 

community. This date may be obtained 

by contacting the office where the maps 

are available for inspection as indicated 

in the table below. 

ADDRESSES: The final BFEs for each 

community are available for inspection 

at the office of the Chief Executive 

Officer of each community. The 

respective addresses are listed in the 

table below. 

FOR FURTHER INFORMATION CONTACT: Luis 

Rodriguez, Chief, Engineering 

Management Branch, Federal Insurance 

and Mitigation Administration, Federal 

Emergency Management Agency, 500 C 

Street, SW., Washington, DC 20472, 

(202) 646–4064, or (e-mail) 

luis.rodriguez1@dhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Federal Emergency Management Agency 

(FEMA) makes the final determinations 

listed below for the modified BFEs for 

each community listed. These modified 

elevations have been published in 

newspapers of local circulation and 

ninety (90) days have elapsed since that 

publication. The Deputy Federal 

Insurance and Mitigation Administrator 

has resolved any appeals resulting from 

this notification. 

This final rule is issued in accordance 

with section 110 of the Flood Disaster 

Protection Act of 1973, 42 U.S.C. 4104, 

and 44 CFR part 67. FEMA has 

developed criteria for floodplain 

management in floodprone areas in 

accordance with 44 CFR part 60. 

Interested lessees and owners of real 

property are encouraged to review the 

proof Flood Insurance Study and FIRM 

available at the address cited below for 

each community. The BFEs and 

modified BFEs are made final in the 

communities listed below. Elevations at 

selected locations in each community 

are shown. 

National Environmental Policy Act. 

This final rule is categorically excluded 

from the requirements of 44 CFR part 

10, Environmental Consideration. An 

environmental impact assessment has 

not been prepared. 

Regulatory Flexibility Act. As flood 

elevation determinations are not within 

the scope of the Regulatory Flexibility 

Act, 5 U.S.C. 601–612, a regulatory 

flexibility analysis is not required. 

Regulatory Classification. This final 

rule is not a significant regulatory action 

under the criteria of section 3(f) of 

Executive Order 12866 of September 30, 

1993, Regulatory Planning and Review, 

58 FR 51735. 

Executive Order 13132, Federalism. 

This final rule involves no policies that 

have federalism implications under 

Executive Order 13132. 

Executive Order 12988, Civil Justice 

Reform. This final rule meets the 

applicable standards of Executive Order 

12988. 

List of Subjects in 44 CFR Part 67 

Administrative practice and 

procedure, Flood insurance, Reporting 

and recordkeeping requirements. 

■ Accordingly, 44 CFR part 67 is 

amended as follows: 

PART 67—[AMENDED] 

■ 1. The authority citation for part 67 

continues to read as follows: 

Authority: 42 U.S.C. 4001 et seq.; 

Reorganization Plan No. 3 of 1978, 3 CFR, 

1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 

3 CFR, 1979 Comp., p. 376. 

§ 67.11 [Amended] 

■ 2. The tables published under the 

authority of § 67.11 are amended as 

follows: 

Flooding source(s) Location of referenced elevation 

* Elevation in feet 

(NGVD) 

+ Elevation in feet 

(NAVD) 

# Depth in feet 

above ground 

∧Elevation in 

meters (MSL) 

Modified 

Communities 

affected 

Stephenson County, Illinois, and Incorporated Areas 

Docket No.: FEMA–B–1087 

Indian Creek ............................. Approximately 0.61 mile upstream of State Route 73 ........ +782 Unincorporated Areas of Stephenson County. 

Approximately 0.78 mile upstream of State Route 73 ........ +782 

Pecatonica River ....................... Approximately 1.2 miles downstream of North Rock City 

Road.

+749 Village of Ridott. 

Approximately 1.93 miles upstream of North Rock City 

Road.

+754 

Pecatonica River ....................... Approximately 0.43 mile downstream of State Route 75 

(Stephenson Street).

+762 City of Freeport. 

Approximately 4.0 miles upstream of State Route 26 ........ +767 


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