48858 Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Though this rule 

will not result in such an expenditure, 

we do discuss the effects of this rule 

elsewhere in this preamble. 

7. Taking of Private Property 

This rule will not cause a taking of 

private property or otherwise have 

taking implications under Executive 

Order 12630, Governmental Actions and 

Interference with Constitutionally 

Protected Property Rights. 

8. Civil Justice Reform 

This rule meets applicable standards 

in sections 3(a) and 3(b)(2) of Executive 

Order 12988, Civil Justice Reform, to 

minimize litigation, eliminate 

ambiguity, and reduce burden. 

9. 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. 

10. 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. 

11. Energy Effects 

This action is not a ‘‘significant 

energy action’’ under Executive Order 

13211, Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use. 

12. Technical Standards 

This rule does not use technical 

standards. Therefore, we did not 

consider the use of voluntary consensus 

standards. 

13. 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 determined that 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 involves 

establishment of a safety zone, and, 

therefore, it is categorically excluded 

from further review under paragraph 

34(g) of Figure 2–1 of the Commandant 

Instruction. An environmental analysis 

checklist supporting this determination 

and a Categorical Exclusion 

Determination are available in the 

docket where indicated under 

ADDRESSES. We seek any comments or 

information that may lead to the 

discovery of a significant environmental 

impact from this rule. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping, 

Security measure, 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 § 165.T09–0729 to read as 

follows: 

§ 165.T09–0729 Safety Zone; Superior Bay, 

Duluth, MN. 

(a) Location. The following area is a 

temporary safety zone: All waters of the 

Duluth Harbor Basin, Northern Section, 

including the Duluth Entry 

encompassed in an imaginary line 

beginning at point 46 46′36.1236′′ N 092 

06′06.987′′ W, running southeast to 46 

46′32.7534′′ N 092 06′01.7382′′ W, 

running northeast to 46 46′45.9228′′ N 

092 05′45.1818′′ W, running northwest 

to 46 46′49.4718′′ N 092 05′49.349′′ W 

and finally running southwest to the 

original point. 

(b) Effective and Enforcement Period. 

This rule will be effective and enforced 

from 6 a.m. to 8:30 a.m. on August 26, 

2012. 

(c) Regulations. (1) In accordance with 

the general regulations in § 165.23, entry 

into, transiting or anchoring within this 

safety zone is prohibited unless 

authorized by the Captain of the Port, 

Marine Safety Unit Duluth, or his 

designated representative. 

(2) This safety zone is closed to all 

vessel traffic, except as may be 

permitted by the Captain of the Port, 

Marine Safety Unit Duluth or his 

designated 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 will be 

aboard either a Coast Guard or Coast 

Guard auxiliary vessel. The Captain of 

the Port representative may be contacted 

via VHF channel 16. 

(4) Vessel operators desiring to enter 

or operate within the safety zone shall 

contact the Captain of the Port, Marine 

Safety Unit Duluth or his on-scene 

representative to request permission to 

do so. Vessel operators must comply 

with all directions given to them by the 

Captain of the Port, Marine Safety Unit 

Duluth or his on-scene representative. 

Dated: July 27, 2012. 

K.R. Bryan, 

Commander, U.S. Coast Guard, Captain of 

the Port Marine Safety Unit Duluth. 

[FR Doc. 2012–20004 Filed 8–14–12; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2012–0450; FRL–9358–1] 

RIN 2070–AB27 

Significant New Use Rules on Certain 

Chemical Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: EPA is promulgating 

significant new use rules (SNURs) under 

the Toxic Substances Control Act 

(TSCA) for 25 chemical substances 

which were the subject of 

premanufacture notices (PMNs). 

Fourteen of these chemical substances 

are subject to TSCA section 5(e) consent 

orders issued by EPA. This action 

requires persons who intend to 

manufacture, import, or process any of 

these 25 chemical substances for an 

activity that is designated as a 

significant new use by this rule to notify 

EPA at least 90 days before commencing 

that activity. The required notification 

will provide EPA with the opportunity 

to evaluate the intended use and, if 

necessary, to prohibit or limit that 

activity before it occurs. 

DATES: This rule is effective on October 

15, 2012. For purposes of judicial 


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Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 48859 

review, this rule shall be promulgated at 

1 p.m. (e.s.t.) on August 29, 2012. 

Written adverse or critical comments, 

or notice of intent to submit adverse or 

critical comments, on one or more of 

these SNURs must be received on or 

before September 14, 2012 (see Unit VI. 

of the SUPPLEMENTARY INFORMATION). 

For additional information on related 

reporting requirement dates, see Units 

I.A., VI., and VII. of the SUPPLEMENTARY

INFORMATION. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2012–0450, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

• Mail: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001. 

• Hand Delivery: OPPT Document 

Control Office (DCO), EPA East, Rm. 

6428, 1201 Constitution Ave. NW., 

Washington, DC. Attention: Docket ID 

Number EPA–HQ–OPPT–2012–0450. 

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

Monday through Friday, excluding legal 

holidays. The telephone number for the 

DCO is (202) 564–8930. Such deliveries 

are only accepted during the DCO’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPPT– 

2012–0450. EPA’s policy is that all 

comments received will be included in 

the docket without change and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or 

email. The regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an email comment directly 

to EPA without going through 

regulations.gov, your email address will 

be automatically captured and included 

as part of the comment that is placed in 

the docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: All documents in the docket 

are listed in the docket index available 

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

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in hard 

copy. Publicly available docket 

materials are available electronically at 

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

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

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

3334, EPA West Bldg., 1301 

Constitution Ave. NW., Washington, 

DC. The EPA/DC Public Reading Room 

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

p.m., Monday through Friday, excluding 

legal holidays. The telephone number of 

the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Kenneth 

Moss, Chemical Control Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–9232; email address: 

moss.kenneth@epa.gov. 

For general information contact: The 

TSCA–Hotline, ABVI–Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture, import, 

process, or use the chemical substances 

contained in this rule. Potentially 

affected entities may include, but are 

not limited to: 

• Manufacturers, importers, or 

processors of one or more 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 

§ 721.5. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the 

technical person listed under FOR

FURTHER INFORMATION CONTACT. 

This action may also affect certain 

entities through pre-existing import 

certification and export notification 

rules under TSCA. Chemical importers 

are subject to the TSCA section 13 (15 

U.S.C. 2612) import certification 

requirements promulgated at 19 CFR 

12.118 through 12.127 and 19 CFR 

127.28. Chemical importers must certify 

that the shipment of the chemical 

substance complies with all applicable 

rules and orders under TSCA. Importers 

of chemicals subject to these SNURs 

must certify their compliance with the 

SNUR requirements. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B. In 

addition, any persons who export or 

intend to export a chemical substance 

that is the subject of this rule are subject 

to the export notification provisions of 

TSCA section 12(b) (15 U.S.C. 2611(b)) 

(see § 721.20), and must comply with 

the export notification requirements in 

40 CFR part 707, subpart D. 

B. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 


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48860 Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

II. Background 

A. What action is the agency taking? 

EPA is promulgating these SNURs 

using direct final procedures. These 

SNURs will require persons to notify 

EPA at least 90 days before commencing 

the manufacture, import, or processing 

of a chemical substance for any activity 

designated by these SNURs as a 

significant new use. Receipt of such 

notices allows EPA to assess risks that 

may be presented by the intended uses 

and, if appropriate, to regulate the 

proposed use before it occurs. 

Additional rationale and background to 

these rules are more fully set out in the 

preamble to EPA’s first direct final 

SNUR published in the Federal Register 

issue of April 24, 1990 (55 FR 17376) 

(April 24, 1990 SNUR). Consult that 

preamble for further information on the 

objectives, rationale, and procedures for 

SNURs and on the basis for significant 

new use designations, including 

provisions for developing test data. 

B. What is the agency’s authority for 

taking this action? 

Section 5(a)(2) of TSCA (15 U.S.C. 

2604(a)(2)) authorizes EPA to determine 

that a use of a chemical substance is a 

‘‘significant new use.’’ EPA must make 

this determination by rule after 

considering all relevant factors, 

including the four bulleted TSCA 

section 5(a)(2) factors listed in Unit III. 

Once EPA determines that a use of a 

chemical substance is a significant new 

use, TSCA section 5(a)(1)(B) requires 

persons to submit a significant new use 

notice (SNUN) to EPA at least 90 days 

before they manufacture, import, or 

process the chemical substance for that 

use. Persons who must report are 

described in § 721.5. 

C. Applicability of General Provisions 

General provisions for SNURs appear 

in 40 CFR part 721, subpart A. These 

provisions describe persons subject to 

the rule, recordkeeping requirements, 

exemptions to reporting requirements, 

and applicability of the rule to uses 

occurring before the effective date of the 

rule. Provisions relating to user fees 

appear at 40 CFR part 700. According to 

§ 721.1(c), persons subject to these 

SNURs must comply with the same 

notice requirements and EPA regulatory 

procedures as submitters of PMNs under 

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

these requirements include the 

information submission requirements of 

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

exemptions authorized by TSCA 

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

5(h)(5), and the regulations at 40 CFR 

part 720. Once EPA receives a SNUN, 

EPA may take regulatory action under 

TSCA section 5(e), 5(f), 6, or 7 to control 

the activities for which it has received 

the SNUN. If EPA does not take action, 

EPA is required under TSCA section 

5(g) to explain in the Federal Register 

its reasons for not taking action. 

III. Significant New Use Determination 

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

EPA’s determination that a use of a 

chemical substance is a significant new 

use must be made after consideration of 

all relevant factors, including: 

• The projected volume of 

manufacturing and processing of a 

chemical substance. 

• The extent to which a use changes 

the type or form of exposure of human 

beings or the environment to a chemical 

substance. 

• The extent to which a use increases 

the magnitude and duration of exposure 

of human beings or the environment to 

a chemical substance. 

• The reasonably anticipated manner 

and methods of manufacturing, 

processing, distribution in commerce, 

and disposal of a chemical substance. 

In addition to these factors 

enumerated in TSCA section 5(a)(2), the 

statute authorized EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the 25 chemical 

substances that are the subject of these 

SNURs, EPA considered relevant 

information about the toxicity of the 

chemical substances, likely human 

exposures and environmental releases 

associated with possible uses, and the 

four bulleted TSCA section 5(a)(2) 

factors listed in this unit. 

IV. Substances Subject to This Rule 

EPA is establishing significant new 

use and recordkeeping requirements for 

25 chemical substances in 40 CFR part 

721, subpart E. In this unit, EPA 

provides the following information for 

each chemical substance: 

• PMN number. 

• Chemical name (generic name, if 

the specific name is claimed as CBI). 

• Chemical Abstracts Service (CAS) 

number (if assigned for non-confidential 

chemical identities). 

• Basis for the TSCA section 5(e) 

consent order or, for non-section 5(e) 

SNURs, the basis for the SNUR (i.e., 

SNURs without TSCA section 5(e) 

consent orders). 

• Tests recommended by EPA to 

provide sufficient information to 

evaluate the chemical substance (see 

Unit VIII. for more information). 

• CFR citation assigned in the 

regulatory text section of this rule. 

The regulatory text section of this rule 

specifies the activities designated as 

significant new uses. Certain new uses, 

including production volume limits 

(i.e., limits on manufacture and 

importation volume) and other uses 

designated in this rule may be claimed 

as CBI. Unit IX. discusses a procedure 

companies may use to ascertain whether 

a proposed use constitutes a significant 

new use. 

This rule includes 14 PMN substances 

(P–10–405, P–10–485, P–11–48, P–11– 

63, P–11–160, P–11–181, P–11–203, P– 

11–247, P–11–384, P–11–557, P–11– 

646, P–12–30, P–12–31, and P–12–32) 

that are subject to ‘‘risk-based’’ consent 

orders under TSCA section 

5(e)(1)(A)(ii)(I) where EPA determined 

that activities associated with the PMN 

substances may present unreasonable 

risk to human health or the 

environment. Those consent orders 

require protective measures to limit 

exposures or otherwise mitigate the 

potential unreasonable risk. The socalled ‘‘5(e) SNURs’’ on these PMN 

substances are promulgated pursuant to 

§ 721.160, and are based on and 

consistent with the provisions in the 

underlying consent orders. The 5(e) 

SNURs designate as a ‘‘significant new 

use’’ the absence of the protective 

measures required in the corresponding 

consent orders. 


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Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 48861 

This rule also includes SNURs on 11 

PMN substances (P–11–411, P–11–412, 

P–11–413, P–11–414, P–12–35, P–12– 

87, P–12–149, P–12–167, P–12–182, P– 

12–260, and P–12–275) that are not 

subject to consent orders under TSCA 

section 5(e). In these cases, for a variety 

of reasons, EPA did not find that the use 

scenario described in the PMN triggered 

the determinations set forth under 

TSCA section 5(e). However, EPA does 

believe that certain changes from the 

use scenario described in the PMN 

could result in increased exposures, 

thereby constituting a ‘‘significant new 

use.’’ These so-called ‘‘non-5(e) SNURs’’ 

are promulgated pursuant to § 721.170. 

EPA has determined that every activity 

designated as a ‘‘significant new use’’ in 

all non-5(e) SNURs issued under 

§ 721.170 satisfies the two requirements 

stipulated in § 721.170(c)(2), i.e., these 

significant new use activities, ‘‘(i) are 

different from those described in the 

premanufacture notice for the 

substance, including any amendments, 

deletions, and additions of activities to 

the premanufacture notice, and (ii) may 

be accompanied by changes in exposure 

or release levels that are significant in 

relation to the health or environmental 

concerns identified’’ for the PMN 

substance. 

PMN Number P–10–405 

Chemical name: Perfluorinated 

alkylthio betaine (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: May 3, 2012. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as a surfactant additive for 

dispersive use in fire fighting foams and 

vapor suppressing foams. In addition, 

EPA has concerns for the formation of 

potential incineration or other 

decomposition products from the PMN 

substance. These perfluorinated 

products may be released to the 

environment from incomplete 

incineration of the PMN substance at 

low temperatures. EPA has preliminary 

evidence suggesting that, under some 

conditions, the PMN substance could 

degrade in the environment. EPA has 

concerns that the degradation products 

of the PMN substance will persist in the 

environment, could bioaccumulate or 

biomagnify, and could be toxic to 

people, wild mammals, and birds. These 

concerns are based on data on analog 

chemicals, including perfluorooctanoic 

acid (PFOA) and other perfluorinated 

carboxylates, such as the presumed 

environmental degradant of the PMN 

substance. Toxicity studies on PFOA 

indicate developmental, reproductive, 

and systemic toxicity in various species, 

as well as cancer. These factors, taken 

together, raise concerns for potential 

adverse chronic effects from the 

presumed degradation product of this 

PMN substance on humans and wildlife. 

The consent order was issued under 

TSCA sections 5(e)(1)(A)(i), 

5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), 

based on a finding that this substance 

may present an unreasonable risk of 

injury to human health and the 

environment, the substance may be 

produced in substantial quantities and 

may reasonably be anticipated to enter 

the environment in substantial 

quantities, and there may be significant 

(or substantial) human exposure to the 

substance and its potential degradation 

products. To protect against these risks, 

the consent order requires: 

1. Manufacture of the PMN substance 

(a) according to the chemical 

composition section of the consent 

order, including analyzing and reporting 

certain starting raw material impurities 

to EPA and (b) within the maximum 

established limits of certain fluorinated 

impurities of the PMN substances as 

stated in the consent order. 

2. Manufacture of the PMN substance 

at an annual manufacturing and import 

volume not to exceed the confidential 

production volume stated in the consent 

order. 

3. Submission of certain testing prior 

to exceeding the two confidential 

production volume limits specified in 

the consent order. 

4. Disposal of manufacturing wastes 

by incineration. 

5. Releases to surface waters not to 

exceed 50 ppb for the specific 

processing and use streams identified in 

the consent order. 

6. Risk notification. If as a result of 

the test data required, the Company 

becomes aware that the PMN substance 

may present a risk of injury to human 

health or the environment, the Company 

must incorporate this new information, 

and any information on methods for 

protecting against such risk into a 

Material Safety Data Sheet (‘‘MSDS’’), 

within 90 days. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of certain 

fate and physical/chemical property 

testing identified in the consent order 

would help characterize possible effects 

of the substances and their degradation 

products. The company has agreed not 

to exceed the first production limit 

without performing a modified semicontinuous activated sludge (SCAS) test 

(OPPTS Test Guideline 835.5045 or 

Organisation for Economic Co-operation 

and Development (OECD) Test 

Guideline 302A). The PMN submitter 

has also agreed not to exceed the second 

production limit without performing a 

hydrolysis as a function of pH and 

temperature test (OPPTS Test Guideline 

835.3120 or OECD Test Guideline 111); 

a metabolism and pharmacokinetic test 

(OPPTS Test Guideline 870.7485 or 

OECD Test Guideline 417); a modified 

1-generation reproduction test (OECD 

Test Guidelines 421 or 422) in rats or 

mice); and an avian reproduction test 

(OECD Test Guideline 206) in mallard 

ducks. EPA has also determined that the 

results of certain additional human 

health, ecotoxicity, and fate testing 

would help characterize the PMN 

substance. The consent order does not 

require submission of the pended 

testing specified in the consent order at 

any specified time or production 

volume. However, the consent order’s 

restrictions on manufacture, import, 

processing, distribution in commerce, 

use, and disposal of the PMNs will 

remain in effect until the consent order 

is modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10516. 

PMN Numbers P–10–485 and P–11–48 

Chemical names: P–10–485: Alkyl 

methacrylates, polymer with substituted 

carbomonocycle, hydroxymethyl 

acrylamide and fluorinatedalkyl acrylate 

(generic); P–11–48: and Diethylene 

glycol, polymer with 

diisocyanatoalkane, polyethylene glycol 

monomethyl ether- and 

fluorinatedalkanol -blocked (generic). 

CAS numbers: Not available. 

Effective date of section 5(e) consent 

order: January 27, 2012. 

Basis for section 5(e) consent order: 

The PMNs states that the substances 

will be used as open, non-dispersive 

textile finishes. EPA has concerns for 

the formation of potential incineration 

or other decomposition products from 

the PMN substances. These 

perfluorinated products may be released 

to the environment from incomplete 

incineration of the PMN substances at 

low temperatures. EPA has preliminary 

evidence, including data on some 

fluorinated polymers, suggesting that, 

under some conditions, the PMN 

substances could degrade in the 

environment. EPA has concerns that the 

degradation products of the PMN 

substances will persist in the 

environment, could bioaccumulate or 

biomagnify, and could be toxic to 

people, wild mammals, and birds. These 

concerns are based on data on analog 

chemicals, including PFOA and other 


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perfluorinated carboxylates, which 

include the presumed environmental 

degradant of the PMN substances. There 

is pharmacokinetic and toxicological 

data in animals on PFOA, as well as 

epidemiological and blood monitoring 

data in humans. Toxicity studies on 

PFOA indicate developmental, 

reproductive, and systemic toxicity in 

various species, as well as cancer. These 

factors, taken together, raise concerns 

for potential adverse chronic effects 

from the presumed degradation 

products of the PMN substances in 

humans and wildlife. The consent order 

was issued under TSCA sections 

5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 

5(e)(1)(A)(ii)(II), based on a finding that 

these substances may present an 

unreasonable risk of injury to human 

health and the environment; may be 

produced in substantial quantities and 

may reasonably be anticipated to enter 

the environment in substantial 

quantities; and there may be significant 

(or substantial) human exposure to the 

substances and their potential 

degradation products. To protect against 

these risks, the consent order requires: 

1. Monitoring of the effluent waste 

water stream during manufacture in 

addition to the requirements of any 

existing NPDES permit. Data will be 

collected on the confidential analytes 

specified in the consent order and 

submitted to the Agency quarterly. 

2. Manufacture of the PMN substances 

(a) according to the chemical 

composition section of the consent 

order, including analyzing and reporting 

certain starting raw material impurities 

to EPA and (b) within the maximum 

established limits of certain fluorinated 

impurities of the PMN substances as 

stated in the consent order. 

3. Risk notification. If as a result of 

the test data required, the Company 

becomes aware that the PMN substance 

may present a risk of injury to human 

health or the environment, the Company 

must incorporate this new information, 

and any information on methods for 

protecting against such risk into a 

MSDS, within 90 days. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of a 

modified reproduction/developmental 

toxicity screening test (OECD Test 

Guideline 421), an avian reproduction 

test (OPPTS Test Guideline 850.2300), 

ready biodegradability test (OPPTS Test 

Guideline 835.3110), hydrolysis as a 

function of pH test (OPPTS Test 

Guideline 835.2110), and indirect 

photolysis screening test: Sunlight 

photolysis in waters containing 

dissolved humic substances (OPPTS 

Test Guideline 835.5270) would help 

characterize possible effects of the 

substances and their degradation 

products. The consent order does not 

require the submission of this testing at 

any specified time or production 

volume. However, the consent order’s 

restrictions on manufacture, import, 

processing, distribution in commerce, 

use, and disposal of the PMN substances 

will remain in effect until the consent 

order is modified or revoked by EPA 

based on submission of that or other 

relevant information. 

CFR citations: 40 CFR 721.10517 (P– 

10–485) and 40 CFR 721.10518 (P–11– 

98). 

PMN Number P–11–63 

Chemical name: Perfluoroalkyl 

acrylate copolymer (generic). 

CAS number: Not available. 

Effective date of section 5(e) consent 

order: February 23, 2012. 

Basis for section 5(e) consent order: 

The PMN states that the substance will 

be used as a coating material for uses in 

textiles and/or paper. EPA has concerns 

that the PMN substance under some 

conditions of use could cause lung 

effects, based on limited data on some 

perfluorinated compounds. In addition, 

EPA has concerns for the formation of 

potential incineration or other 

decomposition products from the PMN 

substance. These perfluorinated 

products may be released to the 

environment from incomplete 

incineration of the PMN substance at 

low temperatures. EPA has preliminary 

evidence, including data on some 

fluorinated polymers, suggesting that, 

under some conditions, the PMN 

substance could degrade in the 

environment. EPA has concerns that the 

degradation products of the PMN 

substance will persist in the 

environment, could bioaccumulate or 

biomagnify, and could be toxic to 

people, wild mammals, and birds. These 

concerns are based on data on analog 

chemicals, including PFOA and other 

perfluorinated carboxylates, which 

include the presumed environmental 

degradant of the PMN substance. There 

is pharmacokinetic and toxicological 

data in animals on PFOA, as well as 

epidemiological and blood monitoring 

data in humans. Toxicity studies on 

PFOA indicate developmental, 

reproductive, and systemic toxicity in 

various species, as well as cancer. These 

factors, taken together, raise concerns 

for potential adverse chronic effects 

from the presumed degradation product 

of the PMN substance on humans and 

wildlife. The consent order was issued 

under TSCA sections 5(e)(1)(A)(i), 

5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), 

based on a finding that this substance 

may present an unreasonable risk of 

injury to human health and the 

environment, the substance may be 

produced in substantial quantities and 

may reasonably be anticipated to enter 

the environment in substantial 

quantities, and there may be significant 

(or substantial) human exposure to the 

substance and its potential degradation 

products. To protect against these risks, 

the consent order requires: 

1. Manufacture of the PMN substances 

(a) according to the chemical 

composition section of the consent 

order, including analyzing and reporting 

certain starting raw material impurities 

to EPA and (b) within the maximum 

established limits of certain fluorinated 

impurities of the PMN substances as 

stated in the consent order. 

2. No use of the PMN substance in 

consumer products with spray 

applications. 

3. Submission of certain fate testing 

prior to exceeding the confidential 

production volume limit specified in 

the consent order. 

4. Risk notification. If as a result of 

the test data required, the Company 

becomes aware that the PMN substance 

may present a risk of injury to human 

health or the environment, the Company 

must incorporate this new information, 

and any information on methods for 

protecting against such risk into a 

MSDS, within 90 days. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of certain 

fate testing specified in the consent 

order would help characterize possible 

effects of the substance and its 

degradation products. The PMN 

submitter has agreed not to exceed the 

confidential production volume limit 

without performing the following tests 

which are further specified in the 

consent order: a combined direct and 

indirect photolysis with hydrolysis 

study, a highly modified inherent 

biodegradability: Zahn-Wellens/EMPA 

test (OECD Test Guideline 302B), 

accelerated weathering for textiles with 

a water component test, and an aerobic 

and anaerobic transformation in soil test 

(OECD Test Guideline 307). The consent 

order does not require submission of the 

pended testing described in the consent 

order at any specified time or 

production volume. However, the 

consent order’s restrictions on 

manufacture, import, processing, 

distribution in commerce, use, and 

disposal of the PMNs will remain in 

effect until the consent order is 


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Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 48863 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10519. 

PMN Number P–11–160 

Chemical name: Acetylated fatty acid 

glycerides (generic). 

CAS number: Not available. 

Effective date of section 5(e) consent 

order: February 27, 2012. 

Basis for section 5(e) consent order: 

The PMN states that the generic (nonconfidential) use of the substance will 

be as a resin. Based on ecological 

structure activity relationship (EcoSAR) 

analysis of test data on analogous esters, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 3 ppb for the PMN in 

surface waters. The consent order was 

issued under TSCA sections 5(e)(1)(A)(i) 

and 5(e)(1)(A)(ii)(I) based on a finding 

that this substance may present an 

unreasonable risk of injury to the 

environment. To protect against this 

risk, the order requires use of the 

substance only as described in the 

order, and submission of certain 

ecotoxicity testing prior to exceeding 

the confidential production volume 

limit specified in the order. The SNUR 

designates as a ‘‘significant new use’’ 

the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPTS Test 

Guideline 850.1400) and a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300) would help 

characterize the environmental effects of 

the PMN substance. The PMN submitter 

has agreed not to exceed the 

confidential production volume limit 

specified in the order without 

performing these tests. 

CFR citation: 40 CFR 721.10520. 

PMN Number P–11–181 

Chemical name: Fluorosurfactant 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: February 17, 2012. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as a surfactant for laboratory use 

fluid. Based on structure activity 

relationship (SAR) analysis of test data 

on analogous high molecular weight 

polymers, EPA identified concerns for 

lung toxicity for the PMN substance if 

respirable droplets are inhaled. In 

addition, based on SAR analysis of 

analogous substances, including PFOA 

and perfluorooctane sulfonate (PFOS), 

EPA identified concerns for liver 

toxicity, acute toxicity, developmental 

and reproductive toxicity, and cancer, 

when the mean moles of each perfluoro 

propylene oxide (PPO) unit is less than 

5. Further, EPA expected the PMN 

substance and the perfluoro degradation 

products to be highly persistent, and the 

low molecular weight fraction is 

expected to be mobile and 

bioaccumulate in the environment. 

Although there are no ecological 

concerns for the PMN substance itself, 

there is high concern for possible 

environmental effects to mammals and 

wild birds from the perfluoro 

degradation products of the PMN 

substance. These concerns are based on 

data on analog chemicals, including 

PFOA and other perfluorinated 

carboxylates, which include the 

presumed environmental degradant of 

the PMN substance. There is 

pharmacokinetic and toxicological data 

in animals on PFOA, as well as 

epidemiological and blood monitoring 

data in humans. Toxicity studies on 

PFOA indicate developmental, 

reproductive, and systemic toxicity in 

various species, as well as cancer. These 

factors, taken together, raise concerns 

for potential adverse chronic effects 

from the presumed degradation product 

of the PMN substance in humans and 

wildlife. The consent order was issued 

under TSCA sections 5(e)(1)(A)(i), 

5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), 

based on a finding that this substance 

may present an unreasonable risk of 

injury to human health and the 

environment, the substance may be 

produced in substantial quantities and 

may reasonably be anticipated to enter 

the environment in substantial 

quantities, and there may be significant 

(or substantial) human exposure to the 

substance and its potential degradation 

products. To protect against this 

exposure and risk, the consent order 

requires: 

1. Manufacture of the PMN substance 

(a) according to the chemical 

composition section of the consent 

order, including analyzing and reporting 

to EPA the average number molecular 

weight at each manufacturing facility at 

the time of initial commencement and 

annually thereafter, and (b) where the 

mean number of moles of each PPO unit 

must be greater than or equal to 5. 

2. Manufacture of the PMN substance 

at an annual manufacturing and import 

volume not to exceed the confidential 

production volume limit stated in the 

consent order. 

3. Risk notification. If as a result of 

the test data required, the Company 

becomes aware that the PMN substance 

may present a risk of injury to human 

health or the environment, the Company 

must incorporate this new information, 

and any information on methods for 

protecting against such risk into a 

MSDS, within 90 days. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of certain 

health, fate, and physical/chemical 

property testing identified in the 

consent order would help characterize 

possible effects of the substances and 

their degradation products. The consent 

order does not require submission of the 

testing at any specified time or 

production volume. However, the 

consent order’s restrictions on 

manufacture, import, processing, 

distribution in commerce, use, and 

disposal of the PMN will remain in 

effect until the consent order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10521. 

PMN Number P–11–203 

Chemical name: Perfluoroalkylethyl 

methacrylate copolymer with 

dialkylaminoethylmethacrylate 

(generic). 

CAS number: Not available. 

Effective date of section 5(e) consent 

order: March 13, 2012. 

Basis for section 5(e) consent order: 

The PMN states that the substance will 

be used as a paper treatment. EPA has 

concerns for the formation of potential 

incineration or other decomposition 

products from the PMN substance. 

These perfluorinated products may be 

released to the environment from 

incomplete incineration of the PMN 

substance at low temperatures. EPA has 

preliminary evidence, including data on 

some fluorinated polymers, suggesting 

that, under some conditions, the PMN 

substance could degrade in the 

environment. EPA has concerns that 

these degradation products will persist 

in the environment, could 

bioaccumulate or biomagnify, and could 

be toxic to people, wild mammals, and 

birds. These concerns are based on data 

on analog chemicals, including PFOA 

and other perfluorinated carboxylates, 

which include the presumed 

environmental degradant of the PMN 

substance. There is pharmacokinetic 

and toxicological data in animals on 

PFOA, as well as epidemiological and 

blood monitoring data in humans. 

Toxicity studies on PFOA indicate 

developmental, reproductive, and 

systemic toxicity in various species, as 

well as cancer. These factors, taken 

together, raise concerns for potential 

adverse chronic effects from the 


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presumed degradation product of the 

PMN substance in humans and wildlife. 

The consent order was issued under 

TSCA sections 5(e)(1)(A)(i), 

5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), 

based on a finding that this substance 

may present an unreasonable risk of 

injury to human health and the 

environment, the substance may be 

produced in substantial quantities and 

may reasonably be anticipated to enter 

the environment in substantial 

quantities, and there may be significant 

(or substantial) human exposure to the 

substance and its potential degradation 

products. To protect against these risks, 

the consent order requires submission of 

certain fate testing prior to September 

30, 2014, and risk notification. If as a 

result of the test data required, the 

Company becomes aware that the PMN 

substance may present a risk of injury 

to human health or the environment, the 

Company must incorporate this new 

information, and any information on 

methods for protecting against such risk 

into a MSDS, within 90 days. The SNUR 

designates as a ‘‘significant new use’’ 

the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of certain 

fate testing identified in the consent 

order would help characterize possible 

effects of the substance and its 

degradation products. The PMN 

submitter has agreed not to manufacture 

or import the PMN substance after 

September 30, 2014 without performing 

a modified SCAS test (OPPTS Test 

Guideline 835.5045 or OECD Test 

Guideline 302A), a UV/visible 

absorption test (OPPTS Test Guideline 

830.7050), direct photolysis rate in 

water by sunlight test (OPPTS Test 

Guideline 835.2210), a hydrolysis as a 

function of pH and temperature test 

(OPPTS Test Guideline 835.3120 or 

OECD Test Guideline 111); an indirect 

photolysis screening test: sunlight 

photolysis in waters containing 

dissolved humic substances (OPPTS 

Test Guideline 835.5270), a photolysis 

on soils study using the 

Phototransformation of Chemicals on 

Soil Surfaces OECD Test Guideline 2005 

Draft (located in the docket under 

docket ID number EPA–HQ–OPPT– 

2012–0450), aerobic and anaerobic 

transformation in aquatic sediment 

systems (OECD Test Guideline 308), and 

an anaerobic biodegradability of organic 

compounds in digested sludge by 

measurement of gas production test 

(OECD Test Guideline 311). These tests 

are further detailed in the consent order. 

EPA has determined that the results of 

certain health testing identified in the 

consent order would help characterize 

possible effects of the substances and 

their degradation products. The consent 

order does not require submission of the 

testing at any specified time or 

production volume. However, the 

consent order’s restrictions on 

manufacture, import, processing, 

distribution in commerce, use, and 

disposal of the PMN will remain in 

effect until the consent order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10522. 

PMN Number P–11–247 

Chemical name: Perfluoroalkylethyl 

methacrylate copolymer with 

hydroxymethyl acrylamide, vinyl 

chloride and long chain fatty alkyl 

acrylate (generic). 

CAS number: Not available. 

Effective date of section 5(e) consent 

order: March 13, 2012. 

Basis for section 5(e) consent order: 

The PMN states that the PMN substance 

will be used as a treatment for textiles. 

EPA has concerns for the formation of 

potential incineration or other 

decomposition products from the PMN 

substance. These perfluorinated 

products may be released to the 

environment from incomplete 

incineration of the PMN substance at 

low temperatures. EPA has preliminary 

evidence, including data on some 

fluorinated polymers, suggesting that, 

under some conditions, the PMN 

substance could degrade in the 

environment. EPA has concerns that 

these degradation products will persist 

in the environment, could 

bioaccumulate or biomagnify, and could 

be toxic to people, wild mammals, and 

birds. These concerns are based on data 

on analog chemicals, including PFOA 

and other perfluorinated carboxylates, 

which include the presumed 

environmental degradant of the PMN 

substance. There is pharmacokinetic 

and toxicological data in animals on 

PFOA, as well as epidemiological and 

blood monitoring data in humans. 

Toxicity studies on PFOA indicate 

developmental, reproductive, and 

systemic toxicity in various species, as 

well as, cancer. These factors, taken 

together, raise concerns for potential 

adverse chronic effects from the 

presumed degradation product of the 

PMN substance on humans and wildlife. 

The consent order was issued under 

TSCA sections 5(e)(1)(A)(i), 

5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), 

based on a finding that this substance 

may present an unreasonable risk of 

injury to human health and the 

environment, the substance may be 

produced in substantial quantities and 

may reasonably be anticipated to enter 

the environment in substantial 

quantities, and there may be significant 

(or substantial) human exposure to the 

substance and its potential degradation 

products. To protect against these risks, 

the consent order requires submission of 

certain fate testing prior to March 31, 

2015, and risk notification. If as a result 

of the test data required, the Company 

becomes aware that the PMN substance 

may present a risk of injury to human 

health or the environment, the Company 

must incorporate this new information, 

and any information on methods for 

protecting against such risk into a 

MSDS, within 90 days. The SNUR 

designates as a ‘‘significant new use’’ 

the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of certain 

fate testing identified in the consent 

order would help characterize possible 

effects of the substance and its 

degradation products. The PMN 

submitter has agreed not to manufacture 

or import the PMN substance after 

March 31, 2015 without performing a 

modified SCAS test (OPPTS Test 

Guideline 835.5045 or OECD Test 

Guideline 302A), a UV/visible 

absorption test (OPPTS Test Guideline 

830.7050), direct photolysis rate in 

water by sunlight test (OPPTS Test 

Guideline 835.2210), a hydrolysis as a 

function of pH and temperature test 

(OPPTS Test Guideline 835.3120 or 

OECD Test Guideline 111); an indirect 

photolysis screening test: sunlight 

photolysis in waters containing 

dissolved humic substances (OPPTS 

Test Guideline 835.5270), a photolysis 

on soils study using the 

Phototransformation of Chemicals on 

Soil Surfaces OECD Test Guideline 2005 

Draft (located in the docket under 

docket ID number EPA–HQ–OPPT– 

2012–0450), aerobic and anaerobic 

transformation in aquatic sediment 

systems (OECD Test Guideline 308), and 

an anaerobic biodegradability of organic 

compounds in digested sludge by 

measurement of gas production test 

(OECD Test Guideline 311). These tests 

are further detailed in the consent order. 

EPA has determined that the results of 

certain health testing identified in the 

consent order would help characterize 

possible effects of the substances and 

their degradation products. The consent 

order does not require submission of the 

testing at any specified time or 

production volume. However, the 

consent order’s restrictions on 

manufacture, import, processing, 

distribution in commerce, use, and 


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Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 48865 

disposal of the PMN will remain in 

effect until the consent order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10523. 

PMN Number P–11–384 

Chemical name: Fluorinated 

alkylsulfonamidol urethane polymer 

(generic). 

CAS number: Not available. 

Effective date of section 5(e) consent 

order: January 18, 2012. 

Basis for section 5(e) consent order: 

The PMN states that the generic (nonconfidential) use of the substance will 

be as a protective treatment. Based on 

EPA analysis of the potential content of 

the polymer, EPA is concerned that 

some perfluorinated substances could 

be present and if degraded, could be 

released into the environment. EPA has 

concerns that the PMN substance and its 

degradation products will persist in the 

environment, could bioaccumulate or 

biomagnify, and could be toxic to 

various species. These concerns are 

based on data on analog chemicals, 

including PFOS and other 

perfluorinated carboxylates, such as the 

presumed ultimate perfluorinated 

degradant of the PMN substance, 

perfluorobutanesulfonic acid (PFBS). 

Although some data indicate a different 

and less toxic toxicological and 

ecological profile for PFBS than for 

PFOS and PFOA, EPA believes that, 

based on the persistence of PFBS, 

potential intermediate fate products, 

and the fact that these products may be 

major substitutes for some uses of PFOS, 

more information is warranted on the 

fate and physical/chemical properties of 

PFBS-derived polymers in the 

environment. The consent order was 

issued under TSCA sections 5(e)(1)(A)(i) 

5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II) 

based on a finding that this substance 

may present an unreasonable risk of 

injury to the environment, the substance 

may be produced in substantial 

quantities, and there may be significant 

(or substantial) human exposure to the 

substance and its potential degradation 

products. To protect against this risk, 

the order requires submission of certain 

abiotic fate testing prior to exceeding an 

aggregate manufacturing and import 

volume of 150,000 kilograms and 

submission of certain biotic fate testing 

prior to exceeding an aggregate 

manufacturing and import volume of 

550,000 kilograms. The SNUR 

designates as a ‘‘significant new use’’ 

the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of certain 

fate testing identified in the consent 

order would help characterize possible 

effects of the substances and their 

degradation products. The PMN 

submitter has agreed not to exceed the 

first production volume limit without 

performing a highly modified indirect 

photolysis screening test, and not to 

exceed the second production volume 

limit without performing a highly 

modified aerobic activated sludge 

biodegradation test and a modified 

aerobic and anaerobic transformation in 

sludge-amended to soil test. These tests 

are further detailed in the consent order. 

EPA has determined that the results of 

certain health and environmental effects 

testing identified in the consent order 

would help characterize possible effects 

of the substances and their degradation 

products. The consent order does not 

require submission of the testing at any 

specified time or production volume. 

However, the consent order’s 

restrictions on manufacture, import, 

processing, distribution in commerce, 

use, and disposal of the PMN will 

remain in effect until the consent order 

is modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10524. 

PMN Numbers P–11–411, P–11–412, P– 

11–413 and P–11–414 

Chemical names: Alkoxy dialkyl 

aminoalkanol carboxylate (generic). 

CAS numbers: Not available. 

Basis for action: The PMN states that 

the generic (non confidential) use of the 

substances is for contained use in 

energy production. Based on EcoSAR 

analysis of test data on analogous 

cationic surfactants, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 17 ppb of 

the PMN substances in surface waters. 

As described in the consolidated PMN, 

releases to surface waters are not 

expected to exceed 17 ppb. Therefore, 

EPA has not determined that the 

proposed manufacturing, processing, or 

use of the substances may present an 

unreasonable risk. EPA has determined, 

however, that any use of the substances 

resulting in surface water 

concentrations exceeding 17 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substances meet the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); an aquatic invertebrate acute 

toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010); and 

an algal toxicity test (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substances. 

CFR citation: 40 CFR 721.10525. 

PMN Number P–11–557 

Chemical name: 2–Propenoic acid, 2- 

methyl-, 2-hydroxyethyl ester, telomers 

with C18–26-alkyl acrylate, 1- 

dodecanethiol, N-(hydroxymethyl)-2- 

methyl-2-propenamide, polyfluorooctyl 

methacrylate and vinylidene chloride, 

2,2’-[1,2-diazenediylbis(1- 

methylethylidene)bis[4,5-dihydro-1Himidazole] hydrochloride (1:2)-initiated 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: March 22, 2012. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as a water and oil repellant. 

Based on SAR analysis of test data on 

analogous high molecular weight 

polymers, EPA identified concerns for 

lung effects through lung overload if 

respirable particles of the intact PMN 

substances are inhaled. In addition, EPA 

has concerns for the formation of 

potential incineration or other 

decomposition products from the PMN 

substance. These perfluorinated 

products may be released to the 

environment from incomplete 

incineration of the PMN substance at 

low temperatures. EPA has preliminary 

evidence, including data on some 

fluorinated polymers, suggesting that, 

under some conditions, the PMN 

substance could degrade in the 

environment. EPA has concerns that 

these degradation products will persist 

in the environment, could 

bioaccumulate or biomagnify, and could 

be toxic to people, wild mammals, and 

birds. These concerns are based on data 

on analog chemicals, including PFOA 

and other perfluorinated carboxylates, 

which include the presumed 

environmental degradant of the PMN 

substance. There is pharmacokinetic 

and toxicological data in animals on 

PFOA, as well as epidemiological and 

blood monitoring data in humans. 

Toxicity studies on PFOA indicate 

developmental, reproductive, and 

systemic toxicity in various species, as 

well as cancer. These factors, taken 

together, raise concerns for potential 

adverse chronic effects from the 

presumed degradation product in 

humans and wildlife. The consent order 

was issued under TSCA sections 

5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 

5(e)(1)(A)(ii)(II), based on a finding that 

this substance may present an 

unreasonable risk of injury to human 

health and the environment, the 


srobinson on DSK4SPTVN1PROD with RULES
48866 Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 

substance may be produced in 

substantial quantities and may 

reasonably be anticipated to enter the 

environment in substantial quantities, 

and there may be significant (or 

substantial) human exposure to the 

substance and its potential degradation 

products. To protect against these risks, 

the consent order requires: 

1. Manufacture of the PMN substance 

(a) according to the chemical 

composition section of the consent 

order, including analyzing and reporting 

certain starting raw material impurities 

to EPA and (b) within the maximum 

established limits of certain fluorinated 

impurities of the PMN substances as 

stated in the consent order. 

2. Manufacture of the PMN substance 

at an annual manufacturing and import 

volume not to exceed the confidential 

production volume stated in the consent 

order. 

3. No use of the PMN substance in 

consumer products with spray 

applications. 

4. Risk notification. If as a result of 

the test data required, the Company 

becomes aware that the PMN substance 

may present a risk of injury to human 

health or the environment, the Company 

must incorporate this new information, 

and any information on methods for 

protecting against such risk into a 

MSDS, within 90 days. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of certain 

health and environmental effects, fate, 

and physical/chemical property testing 

identified in the consent order would 

help characterize possible effects of the 

substances and their degradation 

products. The consent order does not 

require submission of the testing at any 

specified time or production volume. 

However, the consent order’s 

restrictions on manufacture, import, 

processing, distribution in commerce, 

use, and disposal of the PMNs will 

remain in effect until the consent order 

is modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10526. 

PMN Number P–11–646 

Chemical name: Perfluoroalkylethyl 

methacrylate copolymer (generic). 

CAS number: Not available. 

Effective date of section 5(e) consent 

order: March 23, 2012. 

Basis for section 5(e) consent order: 

The PMN states that the substance will 

be used as a fabric treatment. EPA 

identified concerns for the formation of 

potential incineration or other 

decomposition products from the PMN 

substance. These perfluorinated 

products may be released to the 

environment from incomplete 

incineration of the PMN substance at 

low temperatures. EPA has preliminary 

evidence, including data on some 

fluorinated polymers, suggesting that, 

under some conditions, the PMN 

substance could degrade in the 

environment. EPA has concerns that 

these degradation products will persist 

in the environment, could 

bioaccumulate or biomagnify, and could 

be toxic to people, wild mammals, and 

birds. These concerns are based on data 

on analog chemicals, including PFOA 

and other perfluorinated carboxylates, 

which include the presumed 

environmental degradant of the PMN 

substance. There is pharmacokinetic 

and toxicological data in animals on 

PFOA, as well as epidemiological and 

blood monitoring data in humans. 

Toxicity studies on PFOA indicate 

developmental, reproductive, and 

systemic toxicity in various species, as 

well as, cancer. These factors, taken 

together, raise concerns for potential 

adverse chronic effects from the 

presumed degradation product of the 

PMN substance in humans and wildlife. 

The consent order was issued under 

TSCA sections 5(e)(1)(A)(i), 

5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), 

based on a finding that this substance 

may present an unreasonable risk of 

injury to human health and the 

environment, the substance may be 

produced in substantial quantities and 

may reasonably be anticipated to enter 

the environment in substantial 

quantities, and there may be significant 

(or substantial) human exposure to the 

substance and its potential degradation 

products. To protect against these risks, 

the consent order requires submission of 

certain fate testing prior to March 31, 

2015, and risk notification. If as a result 

of the test data required, the Company 

becomes aware that the PMN substance 

may present a risk of injury to human 

health or the environment, the Company 

must incorporate this new information, 

and any information on methods for 

protecting against such risk into a 

MSDS, within 90 days. The SNUR 

designates as a ‘‘significant new use’’ 

the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of certain 

fate testing identified in the consent 

order would help characterize possible 

effects of the substance and its 

degradation products. The PMN 

submitter has agreed not to manufacture 

or import the PMN substance after 

March 31, 2015 without performing a 

modified SCAS test (OPPTS Test 

Guideline 835.5045 or OECD Test 

Guideline 302A), a UV/visible 

absorption test (OPPTS Test Guideline 

830.7050), direct photolysis rate in 

water by sunlight test (OPPTS Test 

Guideline 835.2210), a hydrolysis as a 

function of pH and temperature test 

(OPPTS Test Guideline 835.3120 or 

OECD Test Guideline 111); an indirect 

photolysis screening test: sunlight 

photolysis in waters containing 

dissolved humic substances (OPPTS 

Test Guideline 835.5270), a photolysis 

on soils study using the 

Phototransformation of Chemicals on 

Soil Surfaces OECD Test Guideline 2005 

Draft (located in the docket under 

docket ID number EPA–HQ–OPPT– 

2012–0450), aerobic and anaerobic 

transformation in aquatic sediment 

systems (OECD Test Guideline 308), and 

an anaerobic biodegradability of organic 

compounds in digested sludge by 

measurement of gas production test 

(OECD Test Guideline 311). EPA has 

also determined that the results of 

certain additional human health and 

environmental effects testing would 

help characterize the PMN substance. 

The consent order does not require 

submission of the pended testing 

specified in the consent order at any 

specified time or production volume. 

However, the consent order’s 

restrictions on manufacture, import, 

processing, distribution in commerce, 

use, and disposal of the PMNs will 

remain in effect until the consent order 

is modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10527. 

PMN Numbers P–12–30, P–12–31, and 

P–12–32 

Chemical names: Modified 

fluorinated acrylates (generic). 

CAS numbers: Not available. 

Effective date of section 5(e) consent 

order: April 18, 2012. 

Basis for section 5(e) consent order: 

The PMN states that the substances will 

be used as an open, non-dispersive 

textile finish. EPA has concerns for the 

formation of potential incineration or 

other decomposition products from the 

PMN substances. These perfluorinated 

products may be released to the 

environment from incomplete 

incineration of the PMN substances at 

low temperatures. EPA has preliminary 

evidence, including data on some 

fluorinated polymers, suggesting that, 

under some conditions, the PMN 

substances could degrade in the 

environment. EPA has concerns that 

these degradation products will persist 


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in the environment, could 

bioaccumulate or biomagnify, and could 

be toxic to people, wild mammals, and 

birds. These concerns are based on data 

on analog chemicals, including PFOA 

and other perfluorinated carboxylates, 

which include the presumed 

environmental degradant of the PMN 

substances. There is pharmacokinetic 

and toxicological data in animals on 

PFOA, as well as epidemiological and 

blood monitoring data in humans. 

Toxicity studies on PFOA indicate 

developmental, reproductive, and 

systemic toxicity in various species, as 

well as cancer. These factors, taken 

together, raise concerns for potential 

adverse chronic effects from the 

presumed degradation product in 

humans and wildlife. The consent order 

was issued under TSCA sections 

5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 

5(e)(1)(A)(ii)(II), based on a finding that 

these substances may present an 

unreasonable risk of injury to human 

health and the environment, the 

substances may be produced in 

substantial quantities and may 

reasonably be anticipated to enter the 

environment in substantial quantities, 

and there may be significant (or 

substantial) human exposure to the 

substances and their potential 

degradation products. To protect against 

these risks, the consent order requires: 

1. Monitoring of the effluent waste 

water stream during manufacture in 

addition to the requirements of any 

existing NPDES permit. Data will be 

collected on the confidential analytes 

specified in the consent order and 

submitted to the Agency quarterly. 

2. Manufacture of the PMN substances 

(a) according to the chemical 

composition section of the consent 

order, including analyzing and reporting 

certain starting raw material impurities 

to EPA, and (b) within the maximum 

established levels of certain fluorinated 

impurities of the PMN substances as 

stated in the consent order. 

2. Risk notification. If as a result of 

the test data required, the Company 

becomes aware that the PMN substance 

may present a risk of injury to human 

health or the environment, the Company 

must incorporate this new information, 

and any information on methods for 

protecting against such risk into a 

MSDS, within 90 days. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of an aerobic 

and anaerobic transformation in soil test 

(OECD Test Guideline 307), fish shortterm reproduction test (OPPTS Test 

Guideline 890.1350), ready 

biodegradability test (OPPTS Test 

Guideline 835.3110), hydrolysis as a 

function of pH test (OPPTS Test 

Guideline 835.2110), and indirect 

photolysis screening test: sunlight 

photolysis in waters containing 

dissolved humic substances (OPPTS 

Test Guideline 835.5270) would help 

characterize possible effects of the 

substance and its degradation products. 

The consent order does not require the 

submission of this testing at any 

specified time or production volume. 

However, the consent order’s 

restrictions on manufacture, import, 

processing, distribution in commerce, 

use, and disposal of the PMNs will 

remain in effect until the consent order 

is modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10528. 

PMN Number P–12–35 

Chemical name: Cobalt iron 

manganese oxide, carboxylic acidmodified (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as a ferrite 

dispersion ink additive to ensure 

magnetic performance characteristics. 

Based on test data on analogous 

respirable, poorly soluble particulates 

(subcategory: lithium manganese oxide), 

EPA identified concerns for lung effects 

to workers exposed to the PMN 

substance. EPA also identified concerns 

for mutagenicity based on the amount of 

cobalt and manganese in the PMN 

substance and neurotoxicity for 

manganese. For the uses described in 

the PMN, significant exposures to 

workers or the general population is 

unlikely. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

the following may cause serious health 

effects: 

1. Domestic manufacture. 

2. Use of the substance other than as 

described in the PMN. 

3. Use in a consumer product. 

4. Processing or use of the substance 

in a solid form. 

5. Manufacturing, processing, or use 

of the PMN substance without an 

appropriate material safety data sheet 

that warns to not release to water. 

6. Any use of the substance resulting 

in surface water release. 

Based on this information, the PMN 

substance meets the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) with 60-day 

holding period; workplace exposure 

monitoring; characterization of the 

mobility of the particles in soil using a 

modified version of the leaching test 

(OPPTS Test Guideline 835.1240) and/ 

or an adsorption/desorption (batch 

equilibrium) test (OPPTS Test Guideline 

835.1230); a ready biodegradability 

(OECD Test Guideline 301) to 

characterize the persistence of the 

functional groups; and physicalchemical characterization data 

including particle size distribution by 

count, surface area, morphology, shape, 

and size; aggregation and agglomeration 

states using transmission electron 

microscopy, scanning-transmission and 

electron microscopy atomic force 

microscopy, porosity using mercury 

intrusion, surface chemistry including 

elemental composition using electronenergy loss spectroscopy, X-ray 

photoelectron spectroscopy, auger 

electron spectroscopy, or atomic force 

microscopy; surface charge using 

zetasizer, water solubility (OECD Test 

Guideline 105), and density of liquids 

and solids (OECD Test Guideline 109) 

would help characterize the health 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10529. 

PMN Number P–12–87 

Chemical name: Acrylate 

manufacture byproduct distillation 

residue (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the uses of the substance are as a 

viscosity modifier/flow enhancer for 

crude oil and in boiler fuels as a burn 

promoter for fuel value. Based on test 

data on the PMN substance, and 

EcoSAR analysis of test data on 

analogous acrylates, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 ppb of 

the PMN substance in surface waters. As 

described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

1 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

surface water concentrations exceeding 

1 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); an aquatic invertebrate acute 


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toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010); and 

an algal toxicity test (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10530. 

PMN Number P–12–149 

Chemical name: Distillation bottoms 

from manufacture of brominated 

cycloalkanes (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be for destructive use in 

bromine recovery. Based on EcoSAR 

analysis of test data on analogous 

neutral organic chemicals, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 2 ppb of 

the PMN substance in surface waters. As 

described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

2 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

surface water concentrations exceeding 

2 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPTS Test 

Guidelines 850.1400); a daphnid 

chronic toxicity study (OPPTS Test 

Guidelines 850.1300); and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help characterize the 

environmental effects of the PMN 

substance. When testing the PMN 

substance, if difficulty is encountered in 

dissolving the chemical in the test 

media, consult the special consideration 

for conducting aquatic laboratory 

studies (OPPTS Test Guideline 

850.1000). 

CFR citation: 40 CFR 721.10531. 

PMN Number P–12–167 

Chemical name: Tar, brown coal. 

CAS number: 101316–83–0. 

Basis for action: The PMN states that 

the substance will be used for blending 

existing tar oil with petroleum oil for 

feed to refineries. EPA has identified 

health and environmental concerns 

because the substance may be a 

persistent, bio-accumulative, and toxic 

(PBT) chemical, based on physical/ 

chemical properties of the PMN 

substance, as described in the New 

Chemical Program’s PBT category (64 

FR 60194; November 4, 1999) (FRL– 

6097–7). EPA estimates that the PMN 

substance will persist in the 

environment more than two months and 

estimates a bioaccumulation factor of 

greater than or equal to 1,000. Also, 

based on SAR analysis of test data on 

analogous polycyclic aromatic 

hydrocarbons, EPA identified concerns 

for irritation and possible corrosion to 

all exposed tissues, solvent 

neurotoxicity, liver and kidney toxicity, 

effects to the pancreas and spleen, 

photosensitization, and oncogenicity. 

These concerns are for workers exposed 

via inhalation or dermal contact with 

the PMN substance. Additionally, based 

on EcoSAR analysis of test data on 

analogous neutral organic chemicals, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 1 ppb of the PMN substance 

in surface waters. For the uses described 

in the PMN, significant exposures to 

workers or the general population is 

unlikely and the substance is not 

released to surface waters. Therefore, 

EPA has not determined that the 

proposed manufacturing, processing, or 

use of the substance may present an 

unreasonable risk to the human health 

or the environment. EPA has 

determined, however, that any 

predictable or purposeful release 

containing the PMN substance into the 

waters of the United States may cause 

serious health effects and significant 

adverse environmental effects. Based on 

this information, the PMN substance 

meets the concern criteria at § 721.170 

(b)(1)(i)(C), (b)(3)(ii), (b)(4)(ii), and 

(b)(4)(iii). 

Recommended testing: EPA has 

determined that the results of the 

aerobic and anaerobic transformation in 

aquatic sediment systems test (OECD 

Test Guideline 308) and the 

bioconcentration: flow-through fish test 

(OECD Test Guideline 305) would help 

characterize the persistent and 

bioaccumulative attributes of the PMN 

substance. In addition, the results of a 

fish early-life stage toxicity test (OPPTS 

Test Guideline 850.1400); a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300); and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help characterize the 

environmental effects of the PMN 

substance. When testing the PMN 

substance, if difficulty is encountered in 

dissolving the chemical in the test 

media, consult the special 

considerations for conducting aquatic 

laboratory studies (OPPTS Test 

Guideline 850.1000). 

CFR citation: 40 CFR 721.10532. 

PMN Number P–12–182 

Chemical name: Amine-modified 

urea-formaldehyde polymer (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a mining chemical. 

Based on EcoSAR analysis of test data 

on analogous polycationic polymers, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 56 ppb of the PMN 

substance in surface waters. As 

described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

56 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

surface water concentrations exceeding 

56 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity mitigated by humic acid 

test (OPPTS Test Guidelines 850.1085); 

a fish acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); an aquatic invertebrate acute 

toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010); and 

an algal toxicity test (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10533. 

PMN Number P–12–260 

Chemical name: Brominated aliphatic 

alcohol (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be for destructive use. 

Based on EcoSAR analysis of test data 

on analogous halo-alcohols, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

3 ppb of the PMN substance in surface 

waters. As described in the PMN, 

releases of the substance are not 

expected to result in surface water 

concentrations that exceed 3 ppb. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance resulting in surface water 

concentrations exceeding 3 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 


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PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); an aquatic invertebrate acute 

toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010); and 

algal toxicity test (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. EPA also 

recommends that the special 

considerations for conducting aquatic 

laboratory studies (OPPTS Test 

Guideline 850.1000) be followed. 

CFR citation: 40 CFR 721.10534. 

PMN Number P–12–275 

Chemical name: Phosphonium, 

tributyltetradecyl-, chloride (1:1). 

CAS number: 81741–28–8. 

Basis for action: The PMN states that 

the substance will be used as reactant 

for the production of proprietary 

chemicals in the electronics industry. 

EPA has identified environmental 

concerns because the substance may be 

a PBT chemical, based on physical/ 

chemical properties of the PMN 

substance, as described in the New 

Chemical Program’s PBT category. EPA 

estimates that the PMN substance will 

persist in the environment more than 

two months and estimates a 

bioaccumulation factor of greater than 

or equal to 1,000. Additionally, based 

on EcoSAR analysis of test data on 

analogous cationic surfactants, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

11 ppb of the PMN substance in surface 

waters. As described in the PMN, the 

substance is not released to surface 

waters. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any predictable or purposeful release 

containing the PMN substance into the 

waters of the United States may cause 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii) and 

(b)(4)(iii). 

Recommended testing: EPA has 

determined that the results of the 

aerobic and anaerobic transformation in 

aquatic sediment systems test (OECD 

Test Guideline 308) and the 

bioconcentration: Flow-through fish test 

(OECD Test Guideline 305) would help 

characterize the persistent and 

bioaccumulative attributes of the PMN 

substance. In addition, EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPTS Test 

Guideline 850.1400); a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300); and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help characterize environmental effects 

of the PMN substance. When testing the 

PMN substance, if difficulty is 

encountered in dissolving the chemical 

in the test media, consult the special 

considerations for conducting aquatic 

laboratory studies (OPPTS Test 

Guideline 850.1000). 

CFR citation: 40 CFR 721.10535. 

V. Rationale and Objectives of the Rule 

A. Rationale 

During review of the PMNs submitted 

for the chemical substances that are 

subject to these SNURs, EPA concluded 

that for 14 of the 25 chemical 

substances, regulation was warranted 

under TSCA section 5(e), pending the 

development of information sufficient to 

make reasoned evaluations of the health 

or environmental effects of the chemical 

substances. The basis for such findings 

is outlined in Unit IV. Based on these 

findings, TSCA section 5(e) consent 

orders requiring the use of appropriate 

exposure controls were negotiated with 

the PMN submitters. The SNUR 

provisions for these chemical 

substances are consistent with the 

provisions of the TSCA section 5(e) 

consent orders. These SNURs are 

promulgated pursuant to § 721.160 (see 

Unit II.). 

In the other 11 cases, where the uses 

are not regulated under a TSCA section 

5(e) consent order, EPA determined that 

one or more of the criteria of concern 

established at § 721.170 were met, as 

discussed in Unit IV. 

B. Objectives 

EPA is issuing these SNURs for 

specific chemical substances which 

have undergone premanufacture review 

because the Agency wants to achieve 

the following objectives with regard to 

the significant new uses designated in 

this rule: 

• EPA will receive notice of any 

person’s intent to manufacture, import, 

or process a listed chemical substance 

for the described significant new use 

before that activity begins. 

• EPA will have an opportunity to 

review and evaluate data submitted in a 

SNUN before the notice submitter 

begins manufacturing, importing, or 

processing a listed chemical substance 

for the described significant new use. 

• EPA will be able to regulate 

prospective manufacturers, importers, 

or processors of a listed chemical 

substance before the described 

significant new use of that chemical 

substance occurs, provided that 

regulation is warranted pursuant to 

TSCA sections 5(e), 5(f), 6, or 7. 

• EPA will ensure that all 

manufacturers, importers, and 

processors of the same chemical 

substance that is subject to a TSCA 

section 5(e) consent order are subject to 

similar requirements. 

Issuance of a SNUR for a chemical 

substance does not signify that the 

chemical substance is listed on the 

TSCA Inventory. Guidance on how to 

determine if a chemical substance is on 

the TSCA Inventory is available on the 

Internet at http://www.epa.gov/opptintr/ 

existingchemicals/pubs/tscainventory/ 

index.html. 

VI. Direct Final Procedures 

EPA is issuing these SNURs as a 

direct final rule, as described in 

§ 721.160(c)(3) and § 721.170(d)(4). In 

accordance with § 721.160(c)(3)(ii) and 

§ 721.170(d)(4)(i)(B), the effective date 

of this rule is October 15, 2012 without 

further notice, unless EPA receives 

written adverse or critical comments, or 

notice of intent to submit adverse or 

critical comments before September 14, 

2012. 

If EPA receives written adverse or 

critical comments, or notice of intent to 

submit adverse or critical comments, on 

one or more of these SNURs before 

September 14, 2012, EPA will withdraw 

the relevant sections of this direct final 

rule before its effective date. EPA will 

then issue a proposed SNUR for the 

chemical substance(s) on which adverse 

or critical comments were received, 

providing a 30-day period for public 

comment. 

This rule establishes SNURs for a 

number of chemical substances. Any 

person who submits adverse or critical 

comments, or notice of intent to submit 

adverse or critical comments, must 

identify the chemical substance and the 

new use to which it applies. EPA will 

not withdraw a SNUR for a chemical 

substance not identified in the 

comment. 

VII. Applicability of Rule to Uses 

Occurring Before Effective Date of the 

Rule 

Significant new use designations for a 

chemical substance are legally 

established as of the date of publication 

of this direct final rule August 15, 2012. 

To establish a significant ‘‘new’’ use, 

EPA must determine that the use is not 

ongoing. The chemical substances 

subject to this rule have undergone 

premanufacture review. TSCA section 

5(e) consent orders have been issued for 

14 chemical substances and the PMN 


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48870 Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 

submitters are prohibited by the TSCA 

section 5(e) consent orders from 

undertaking activities which EPA is 

designating as significant new uses. In 

cases where EPA has not received a 

notice of commencement (NOC) and the 

chemical substance has not been added 

to the TSCA Inventory, no other person 

may commence such activities without 

first submitting a PMN. For chemical 

substances for which an NOC has not 

been submitted at this time, EPA 

concludes that the uses are not ongoing. 

However, EPA recognizes that prior to 

the effective date of the rule, when 

chemical substances identified in this 

SNUR are added to the TSCA Inventory, 

other persons may engage in a 

significant new use as defined in this 

rule before the effective date of the rule. 

However, 23 of the 25 chemical 

substances contained in this rule have 

CBI chemical identities, and since EPA 

has received a limited number of postPMN bona fide submissions (per 

§§ 720.25 and 721.11), the Agency 

believes that it is highly unlikely that 

any of the significant new uses 

described in the regulatory text of this 

rule are ongoing. 

As discussed in the April 24, 1990 

SNUR, EPA has decided that the intent 

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

by designating a use as a significant new 

use as of the date of publication of this 

direct final rule rather than as of the 

effective date of the rule. If uses begun 

after publication were considered 

ongoing rather than new, it would be 

difficult for EPA to establish SNUR 

notice requirements because a person 

could defeat the SNUR by initiating the 

significant new use before the rule 

became effective, and then argue that 

the use was ongoing before the effective 

date of the rule. Thus, persons who 

begin commercial manufacture, import, 

or processing of the chemical substances 

regulated through this SNUR will have 

to cease any such activity before the 

effective date of this rule. To resume 

their activities, these persons would 

have to comply with all applicable 

SNUR notice requirements and wait 

until the notice review period, 

including any extensions expires. 

EPA has promulgated provisions to 

allow persons to comply with this 

SNUR before the effective date. If a 

person meets the conditions of advance 

compliance under § 721.45(h), the 

person is considered exempt from the 

requirements of the SNUR. 

VIII. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not require developing any 

particular test data before submission of 

a SNUN. The two exceptions are: 

1. Development of test data is 

required where the chemical substance 

subject to the SNUR is also subject to a 

test rule under TSCA section 4 (see 

TSCA section 5(b)(1)). 

2. Development of test data may be 

necessary where the chemical substance 

has been listed under TSCA section 

5(b)(4) (see TSCA section 5(b)(2)). 

In the absence of a TSCA section 4 

test rule or a TSCA section 5(b)(4) 

listing covering the chemical substance, 

persons are required only to submit test 

data in their possession or control and 

to describe any other data known to or 

reasonably ascertainable by them (see 

§ 720.50). However, upon review of 

PMNs and SNUNs, the Agency has the 

authority to require appropriate testing. 

In cases where EPA issued a TSCA 

section 5(e) consent order that requires 

or recommends certain testing, Unit IV. 

lists those tests. Unit IV. also lists 

recommended testing for non-5(e) 

SNURs. Descriptions of tests are 

provided for informational purposes. 

EPA strongly encourages persons, before 

performing any testing, to consult with 

the Agency pertaining to protocol 

selection. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines’’ or for 

guidelines that are not currently 

available on the Web site, EPA has 

placed a copy of that guideline in the 

public docket. The Organization for 

Economic Co-operation and 

Development (OECD) test guidelines are 

available from the OECD Bookshop at 

http://www.oecdbookshop.org or 

SourceOECD at http:// 

www.sourceoecd.org. 

In the TSCA section 5(e) consent 

orders for several of the chemical 

substances regulated under this rule, 

EPA has established production volume 

limits in view of the lack of data on the 

potential health and environmental 

risks that may be posed by the 

significant new uses or increased 

exposure to the chemical substances. 

These limits cannot be exceeded unless 

the PMN submitter first submits the 

results of toxicity tests that would 

permit a reasoned evaluation of the 

potential risks posed by these chemical 

substances. Under recent TSCA section 

5(e) consent orders, each PMN submitter 

is required to submit each study before 

reaching the specified production limit. 

Listings of the tests specified in the 

TSCA section 5(e) consent orders are 

included in Unit IV. The SNURs contain 

the same production volume limits as 

the TSCA section 5(e) consent orders. 

Exceeding these production limits is 

defined as a significant new use. 

Persons who intend to exceed the 

production limit must notify the Agency 

by submitting a SNUN at least 90 days 

in advance of commencement of nonexempt commercial manufacture, 

import, or processing. 

The recommended tests specified in 

Unit IV. may not be the only means of 

addressing the potential risks of the 

chemical substance. However, 

submitting a SNUN without any test 

data may increase the likelihood that 

EPA will take action under TSCA 

section 5(e), particularly if satisfactory 

test results have not been obtained from 

a prior PMN or SNUN submitter. EPA 

recommends that potential SNUN 

submitters contact EPA early enough so 

that they will be able to conduct the 

appropriate tests. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs which provide detailed 

information on the following: 

• Human exposure and 

environmental release that may result 

from the significant new use of the 

chemical substances. 

• Potential benefits of the chemical 

substances. 

• Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

IX. Procedural Determinations 

By this rule, EPA is establishing 

certain significant new uses which have 

been claimed as CBI subject to Agency 

confidentiality regulations at 40 CFR 

part 2 and 40 CFR part 720, subpart E. 

Absent a final determination or other 

disposition of the confidentiality claim 

under 40 CFR part 2 procedures, EPA is 

required to keep this information 

confidential. EPA promulgated a 

procedure to deal with the situation 

where a specific significant new use is 

CBI, at 40 CFR 721.1725(b)(1). 

Under these procedures a 

manufacturer, importer, or processor 

may request EPA to determine whether 

a proposed use would be a significant 

new use under the rule. The 

manufacturer, importer, or processor 

must show that it has a bona fide intent 

to manufacture, import, or process the 

chemical substance and must identify 

the specific use for which it intends to 

manufacture, import, or process the 

chemical substance. If EPA concludes 

that the person has shown a bona fide 

intent to manufacture, import, or 

process the chemical substance, EPA 

will tell the person whether the use 

identified in the bona fide submission 

would be a significant new use under 

the rule. Since most of the chemical 

identities of the chemical substances 

subject to these SNURs are also CBI, 


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manufacturers, importers, and 

processors can combine the bona fide 

submission under the procedure in 

§ 721.1725(b)(1) with that under 

§ 721.11 into a single step. 

If EPA determines that the use 

identified in the bona fide submission 

would not be a significant new use, i.e., 

the use does not meet the criteria 

specified in the rule for a significant 

new use, that person can manufacture, 

import, or process the chemical 

substance so long as the significant new 

use trigger is not met. In the case of a 

production volume trigger, this means 

that the aggregate annual production 

volume does not exceed that identified 

in the bona fide submission to EPA. 

Because of confidentiality concerns, 

EPA does not typically disclose the 

actual production volume that 

constitutes the use trigger. Thus, if the 

person later intends to exceed that 

volume, a new bona fide submission 

would be necessary to determine 

whether that higher volume would be a 

significant new use. 

X. SNUN Submissions 

According to § 721.1(c), persons 

submitting a SNUN must comply with 

the same notice requirements and EPA 

regulatory procedures as persons 

submitting a PMN, including 

submission of test data on health and 

environmental effects as described in 

§ 720.50. SNUNs must be submitted on 

EPA Form No. 7710–25, generated using 

e-PMN software, and submitted to the 

Agency in accordance with the 

procedures set forth in §§ 721.25 and 

720.40. E–PMN software is available 

electronically at http://www.epa.gov/ 

opptintr/newchems. 

XI. Economic Analysis 

EPA has evaluated the potential costs 

of establishing SNUN requirements for 

potential manufacturers, importers, and 

processors of the chemical substances 

subject to this rule. EPA’s complete 

economic analysis is available in the 

docket under docket ID number EPA– 

HQ–OPPT–2012–0450. 

XII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This rule establishes SNURs for 

several new chemical substances that 

were the subject of PMNs and, in some 

cases, TSCA section 5(e) consent orders. 

The Office of Management and Budget 

(OMB) has exempted these types of 

actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). 

B. Paperwork Reduction Act 

According to the Paperwork 

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

seq., an Agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information 

that requires OMB approval under PRA, 

unless it has been approved by OMB 

and displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations in title 40 

of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9, and included on the related 

collection instrument or form, if 

applicable. EPA is amending the table in 

40 CFR part 9 to list the OMB approval 

number for the information collection 

requirements contained in this 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 

Information Collection Request (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. 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 information collection 

requirements related to this action have 

already been approved by OMB 

pursuant to PRA under OMB control 

number 2070–0012 (EPA ICR No. 574). 

This action does not impose any burden 

requiring additional OMB approval. If 

an entity were to submit a SNUN to the 

Agency, the annual burden is estimated 

to average between 30 and 170 hours 

per response. This burden estimate 

includes the time needed to review 

instructions, search existing data 

sources, gather and maintain the data 

needed, and complete, review, and 

submit the required SNUN. 

Send any comments about the 

accuracy of the burden estimate, and 

any suggested methods for minimizing 

respondent burden, including through 

the use of automated collection 

techniques, to the Director, Collection 

Strategies Division, Office of 

Environmental Information (2822T), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. Please remember to 

include the OMB control number in any 

correspondence, but do not submit any 

completed forms to this address. 

C. Regulatory Flexibility Act 

On February 18, 2012, EPA certified 

pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), that promulgation of 

a SNUR does not have a significant 

economic impact on a substantial 

number of small entities where the 

following are true: 

1. A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

2. The SNUN submitted by any small 

entity would not cost significantly more 

than $8300. A copy of that certification 

is available in the docket for this rule. 

This rule is within the scope of the 

February 18, 2012, certification. Based 

on the Economic Analysis discussed in 

Unit XI. and EPA’s experience 

promulgating SNURs (discussed in the 

certification), EPA believes that the 

following are true: 

• A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

• Submission of the SNUN would not 

cost any small entity significantly more 

than $8300. 

Therefore, the promulgation of the 

SNUR would not have a significant 

economic impact on a substantial 

number of small entities. 

D. Unfunded Mandates Reform Act 

Based on EPA’s experience with 

proposing and finalizing SNURs, State, 

local, and Tribal governments have not 

been impacted by these rulemakings, 

and EPA does not have any reasons to 

believe that any State, local, or Tribal 

government will be impacted by this 

rule. As such, EPA has determined that 

this rule does not impose any 

enforceable duty, contain any unfunded 

mandate, or otherwise have any effect 

on small governments subject to the 

requirements of sections 202, 203, 204, 

or 205 of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

104–4). 

E. Executive Order 13132 

This action will not have a substantial 

direct effect on 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 

Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999). 

F. Executive Order 13175 

This rule does not have Tribal 

implications because it is not expected 

to have substantial direct effects on 


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Indian Tribes. This rule does not 

significantly nor uniquely affect the 

communities of Indian Tribal 

governments, nor does it involve or 

impose any requirements that affect 

Indian Tribes. Accordingly, the 

requirements of Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000), do not apply 

to this rule. 

G. Executive Order 13045 

This action 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 this is not an 

economically significant regulatory 

action as defined by Executive Order 

12866, and this action does not address 

environmental health or safety risks 

disproportionately affecting children. 

H. Executive Order 13211 

This action 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 this action is not 

expected to affect energy supply, 

distribution, or use and because this 

action is not a significant regulatory 

action under Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act 

In addition, since this action does not 

involve any technical standards, 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), does not 

apply to this action. 

J. Executive Order 12898 

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

XIII. 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, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. 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, Reporting 

and recordkeeping requirements. 

40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: August 9, 2012. 

Maria J. Doa, 

Director, Chemical Control Division, Office 

of Pollution Prevention and Toxics. 

Therefore, 40 CFR parts 9 and 721 are 

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. The table in § 9.1 is amended by 

adding the following sections in 

numerical order under the undesignated 

center heading ‘‘Significant New Uses of 

Chemical Substances’’ to read as 

follows: 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR citation OMB control 

No. 

* * * * * 

Significant New Uses of Chemical 

Substances 

* * * * * 

721.10516 ............................. 2070–0012 

721.10517 ............................. 2070–0012 

721.10518 ............................. 2070–0012 

721.10519 ............................. 2070–0012 

721.10520 ............................. 2070–0012 

721.10521 ............................. 2070–0012 

721.10522 ............................. 2070–0012 

721.10523 ............................. 2070–0012 

721.10524 ............................. 2070–0012 

721.10525 ............................. 2070–0012 

721.10526 ............................. 2070–0012 

721.10527 ............................. 2070–0012 

721.10528 ............................. 2070–0012 

40 CFR citation OMB control 

No. 

721.10529 ............................. 2070–0012 

721.10530 ............................. 2070–0012 

721.10531 ............................. 2070–0012 

721.10532 ............................. 2070–0012 

721.10533 ............................. 2070–0012 

721.10534 ............................. 2070–0012 

721.10535 ............................. 2070–0012 

* * * * * 

* * * * * 

PART 721—[AMENDED] 

■ 3. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

■ 4. Add § 721.10516 to subpart E to 

read as follows: 

§ 721.10516 Perfluorinated alkylthio 

betaine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as perfluorinated alkylthio 

betaine (PMN P–10–405) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Hazard communication program. A 

significant new use of this substance is 

any manner or method of manufacture, 

import, or processing associated with 

any use of this substance without 

providing risk notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

company becomes aware that this 

substance may present a risk of injury 

to human health, the employer must 

incorporate this new information, and 

any information on methods for 

protecting against such risk, into a 

Material Safety Data Sheet (MSDS) as 

described in § 721.72(c) within 90 days 

from the time the employer becomes 

aware of the new information. If this 

substance is not being manufactured, 

imported, processed, or used in the 

employer’s workplace, the employer 

must add the new information to a 

MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive this substance 

from the employer are provided a MSDS 

as described in § 721.72(c) containing 

the information required under 

paragraph (a)(2)(i)(A) of this section 

within 90 days from the time the 

employer becomes aware of the new 

information. 


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Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 48873 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (analysis, 

reporting, and limitation of maximum 

impurity levels of certain fluorinated 

impurities as described in the chemical 

composition section of the consent 

order), (q), and (t). 

(iii) Disposal. Requirements as 

specified in § 721.85(a)(1). 

(iv) Release to water. Requirements as 

specified in § 721.90(b)(4) and (c)(4) 

(N=50 for the specific release waste 

streams specified in the consent order). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (f), (i), (j), and (k) 

are applicable to manufacturers, 

importers, and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraphs 

(a)(2)(ii) and (iv) of this section. 

■ 5. Add § 721.10517 to subpart E to 

read as follows: 

§ 721.10517 Alkyl methacrylates, polymer 

with substituted carbomonocycle, 

hydroxymethyl acrylamide and 

fluorinatedalkyl acrylate (generic). 

(a) Chemical substances and 

significant new uses subject to 

reporting. (1) The chemical substance 

identified generically as alkyl 

methacrylates, polymer with substituted 

carbomonocycle, hydroxymethyl 

acrylamide and fluorinatedalkyl acrylate 

(PMN P–10–485) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Hazard communication program. A 

significant new use of this substance is 

any manner or method of manufacture, 

import, or processing associated with 

any use of this substance without 

providing risk notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health, the employer must 

incorporate this new information, and 

any information on methods for 

protecting against such risk, into a 

Material Safety Data Sheet (MSDS) as 

described in § 721.72(c) within 90 days 

from the time the employer becomes 

aware of the new information. If this 

substance is not being manufactured, 

imported, processed, or used in the 

employer’s workplace, the employer 

must add the new information to a 

MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive this substance 

from the employer are provided a MSDS 

as described in § 721.72(c) containing 

the information required under 

paragraph (a)(2)(i)(A) of this section 

within 90 days from the time the 

employer becomes aware of the new 

information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (Monitoring of 

the effluent waste water stream during 

manufacture in addition to any existing 

NPDES permit. Monitoring data will be 

collected on the confidential analytes 

and submitted to the Agency quarterly. 

Analysis, reporting, and limitation of 

maximum impurity levels of certain 

fluorinated impurities.). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (f), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 6. Add § 721.10518 to subpart E to 

read as follows: 

§ 721.10518 Diethylene glycol, polymer 

with diisocyanatoalkane, polyethylene 

glycol monomethyl ether- and 

fluorinatedalkanol-blocked (generic). 

(a) Chemical substances and 

significant new uses subject to 

reporting. (1) The chemical substance 

identified generically as diethylene 

glycol, polymer with 

diisocyanatoalkane, polyethylene glycol 

monomethyl ether- and 

fluorinatedalkanol-blocked (PMN P–11– 

48) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Hazard communication program. A 

significant new use of this substance is 

any manner or method of manufacture, 

import, or processing associated with 

any use of this substance without 

providing risk notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health, the employer must 

incorporate this new information, and 

any information on methods for 

protecting against such risk, into a 

Material Safety Data Sheet (MSDS) as 

described in § 721.72(c) within 90 days 

from the time the employer becomes 

aware of the new information. If this 

substance is not being manufactured, 

imported, processed, or used in the 

employer’s workplace, the employer 

must add the new information to a 

MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive this substance 

from the employer are provided a MSDS 

as described in § 721.72(c) containing 

the information required under 

paragraph (a)(2)(i)(A) of this section 

within 90 days from the time the 

employer becomes aware of the new 

information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (Monitoring of 

the effluent waste water stream during 

manufacture in addition to any existing 

NPDES permit. Monitoring data will be 

collected on the confidential analytes 

and submitted to the Agency quarterly. 

Analysis, reporting, and limitation of 

maximum impurity levels of certain 

fluorinated impurities.). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (f), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 7. Add § 721.10519 to subpart E to 

read as follows: 

§ 721.10519 Perfluoroalkyl acrylate 

copolymer (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as perfluoroalkyl acrylate 

copolymer (PMN P–11–63) is subject to 

reporting under this section for the 


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48874 Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Hazard communication program. A 

significant new use of this substance is 

any manner or method of manufacture, 

import, or processing associated with 

any use of this substance without 

providing risk notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health, the employer must 

incorporate this new information, and 

any information on methods for 

protecting against such risk, into a 

Material Safety Data Sheet (MSDS) as 

described in § 721.72(c) within 90 days 

from the time the employer becomes 

aware of the new information. If this 

substance is not being manufactured, 

imported, processed, or used in the 

employer’s workplace, the employer 

must add the new information to a 

MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive this substance 

from the employer are provided a MSDS 

as described in § 721.72(c) containing 

the information required under 

paragraph (a)(2)(i)(A) of this section 

within 90 days from the time the 

employer becomes aware of the new 

information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (analysis and 

reporting and limitations of maximum 

impurity levels of certain fluorinated 

impurities), (o)(use in a consumer 

product that could be spray applied), 

and (q). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (f), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 8. Add § 721.10520 to subpart E to 

read as follows: 

§ 721.10520 Acetylated fatty acid 

glycerides (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as acetylated fatty acid 

glycerides (PMN P–11–160) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. The 

requirements of this rule do not apply 

to quantities of the PMN substance after 

it has been completely reacted (cured) 

or entrained in a film. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) and (q). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(i) of this section. 

■ 9. Add § 721.10521 to subpart E to 

read as follows: 

§ 721.10521 Fluorosurfactant (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fluorosurfactant (PMN P– 

11–181) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Hazard communication program. A 

significant new use of this substance is 

any manner or method of manufacture, 

import, or processing associated with 

any use of this substance without 

providing risk notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health, the employer must 

incorporate this new information, and 

any information on methods for 

protecting against such risk, into a 

Material Safety Data Sheet (MSDS) as 

described in § 721.72(c) within 90 days 

from the time the employer becomes 

aware of the new information. If this 

substance is not being manufactured, 

imported, processed, or used in the 

employer’s workplace, the employer 

must add the new information to a 

MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive this substance 

from the employer are provided a MSDS 

as described in § 721.72(c) containing 

the information required under 

paragraph (a)(2)(i)(A) of this section 

within 90 days from the time the 

employer becomes aware of the new 

information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (manufacture of 

the PMN substance according to the 

chemical composition section of the 

consent order, including analyzing and 

reporting to EPA the average number 

molecular weight at each manufacturing 

facility at the time of initial 

commencement and annually thereafter, 

and where the mean number of moles of 

each PPO unit must be greater than or 

equal to 5) and (t). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (f), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 10. Add § 721.10522 to subpart E to 

read as follows: 

§ 721.10522 Perfluoroalkylethyl 

methacrylate copolymer with 

dialkylaminoethylmethacrylate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as perfluoroalkylethyl 

methacrylate copolymer with 

dialkylaminoethylmethacrylate (PMN 

P–11–203) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Hazard communication program. A 

significant new use of this substance is 

any manner or method of manufacture, 

import, or processing associated with 

any use of this substance without 

providing risk notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health, the employer must 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 48875 

incorporate this new information, and 

any information on methods for 

protecting against such risk, into a 

Material Safety Data Sheet (MSDS) as 

described in § 721.72(c) within 90 days 

from the time the employer becomes 

aware of the new information. If this 

substance is not being manufactured, 

imported, processed, or used in the 

employer’s workplace, the employer 

must add the new information to a 

MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive this substance 

from the employer are provided a MSDS 

as described in § 721.72(c) containing 

the information required under 

paragraph (a)(2)(i)(A) of this section 

within 90 days from the time the 

employer becomes aware of the new 

information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(p) (any amount 

after September 30, 2014). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (f), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 11. Add § 721.10523 to subpart E to 

read as follows: 

§ 721.10523 Perfluoroalkylethyl 

methacrylate copolymer with 

hydroxymethyl acrylamide, vinyl chloride 

and long chain fatty alkyl acrylate (generic). 

(a) Chemical substance and significant 

new uses subject to reporting. (1) The 

chemical substance identified 

generically as perfluoroalkylethyl 

methacrylate copolymer with 

hydroxymethyl acrylamide, vinyl 

chloride and long chain fatty alkyl 

acrylate (PMN P–11–247) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Hazard communication program. A 

significant new use of this substance is 

any manner or method of manufacture, 

import, or processing associated with 

any use of this substance without 

providing risk notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health, the employer must 

incorporate this new information, and 

any information on methods for 

protecting against such risk, into a 

Material Safety Data Sheet (MSDS) as 

described in § 721.72(c) within 90 days 

from the time the employer becomes 

aware of the new information. If this 

substance is not being manufactured, 

imported, processed, or used in the 

employer’s workplace, the employer 

must add the new information to a 

MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive this substance 

from the employer are provided a MSDS 

as described in § 721.72(c) containing 

the information required under 

paragraph (a)(2)(i)(A) of this section 

within 90 days from the time the 

employer becomes aware of the new 

information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(p) (any amount 

after March 31, 2015). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 12. Add § 721.10524 to subpart E to 

read as follows: 

§ 721.10524 Fluorinated alkylsulfonamidol 

urethane polymer (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fluorinated 

alkylsulfonamidol urethane polymer 

(PMN P–11–384) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(p) (production 

limits set at 150,000 kilograms and at 

550,000 kilograms). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 13. Add § 721.10525 to subpart E to 

read as follows: 

§ 721.10525 Alkoxy dialkyl aminoalkanol 

carboxylate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as alkoxy dialkyl 

aminoalkanol carboxylate (PMNs P–11– 

411, P–11–412, P–11–413 and P–11– 

414) are subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4)(N = 17). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c) and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 14. Add § 721.10526 to subpart E to 

read as follows: 

§ 721.10526 2-Propenoic acid, 2-methyl-, 2- 

hydroxyethyl ester, telomers with C18-26- 

alkyl acrylate, 1-dodecanethiol, N- 

(hydroxymethyl)-2-methyl-2-propenamide, 

polyfluorooctyl methacrylate and vinylidene 

chloride, 2,2’-[1,2-diazenediylbis(1- 

methylethylidene)bis[4,5-dihydro-1Himidazole] hydrochloride (1:2)-initiated 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 2-propenoic acid, 2- 

methyl-, 2-hydroxyethyl ester, telomers 

with C18-26-alkyl acrylate, 1- 

dodecanethiol, N-(hydroxymethyl)-2- 

methyl-2-propenamide, polyfluorooctyl 

methacrylate and vinylidene chloride, 

2,2′-[1,2-diazenediylbis(1- 

methylethylidene)bis[4,5-dihydro-1Himidazole] hydrochloride (1:2)-initiated 


srobinson on DSK4SPTVN1PROD with RULES
48876 Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 

(PMN P–11–557) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Hazard communication program. A 

significant new use of this substance is 

any manner or method of manufacture, 

import, or processing associated with 

any use of this substance without 

providing risk notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health, the employer must 

incorporate this new information, and 

any information on methods for 

protecting against such risk, into a 

Material Safety Data Sheet (MSDS) as 

described in § 721.72(c) within 90 days 

from the time the employer becomes 

aware of the new information. If this 

substance is not being manufactured, 

imported, processed, or used in the 

employer’s workplace, the employer 

must add the new information to a 

MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive this substance 

from the employer are provided a MSDS 

as described in § 721.72(c) containing 

the information required under 

paragraph (a)(2)(i)(A) of this section 

within 90 days from the time the 

employer becomes aware of the new 

information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (Manufacture of 

the PMN substance according to the 

chemical composition section of the 

consent order, where the company must 

analyze and report certain starting raw 

material impurities, and within the 

maximum established levels of certain 

fluorinated impurities of the PMN 

substances), (j) (use in a consumer 

product that could be spray applied), 

and (t). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (f), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 15. Add § 721.10527 to subpart E to 

read as follows: 

§ 721.10527 Perfluoroalkylethyl 

methacrylate copolymer (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as perfluoroalkylethyl 

methacrylate copolymer (PMN P–11– 

646) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Hazard communication program. A 

significant new use of this substance is 

any manner or method of manufacture, 

import, or processing associated with 

any use of this substance without 

providing risk notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health, the employer must 

incorporate this new information, and 

any information on methods for 

protecting against such risk, into a 

Material Safety Data Sheet (MSDS) as 

described in § 721.72(c) within 90 days 

from the time the employer becomes 

aware of the new information. If this 

substance is not being manufactured, 

imported, processed, or used in the 

employer’s workplace, the employer 

must add the new information to a 

MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive this substance 

from the employer are provided a MSDS 

as described in § 721.72(c) containing 

the information required under 

paragraph (a)(2)(i)(A) of this section 

within 90 days from the time the 

employer becomes aware of the new 

information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(p) (any amount 

after March 31, 2015). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (f), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 16. Add § 721.10528 to subpart E to 

read as follows: 

§ 721.10528 Modified fluorinated acrylates 

(generic). 

(a) Chemical substances and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as modified fluorinated 

acrylates (PMNs P–12–30, P–12–31, and 

P–12–32) are subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Hazard communication program. A 

significant new use of this substance is 

any manner or method of manufacture, 

import, or processing associated with 

any use of this substance without 

providing risk notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health, the employer must 

incorporate this new information, and 

any information on methods for 

protecting against such risk, into a 

Material Safety Data Sheet (MSDS) as 

described in § 721.72(c) within 90 days 

from the time the employer becomes 

aware of the new information. If this 

substance is not being manufactured, 

imported, processed, or used in the 

employer’s workplace, the employer 

must add the new information to a 

MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive this substance 

from the employer are provided a MSDS 

as described in § 721.72(c) containing 

the information required under 

paragraph (a)(2)(i)(A) of this section 

within 90 days from the time the 

employer becomes aware of the new 

information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (Monitoring of 

the effluent waste water stream during 

manufacture in addition to the existing 

NPDES permit. Monitoring data will be 

collected on the confidential analytes 

and submitted to the Agency quarterly. 

Analysis, reporting, and limitation of 

maximum impurity levels of certain 

fluorinated impurities.). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (f), and (i) are 


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Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 48877 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 17. Add § 721.10529 to subpart E to 

read as follows: 

§ 721.10529 Cobalt iron manganese oxide, 

carboxylic acid-modified (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as cobalt iron manganese 

oxide, carboxylic acid-modified (PMN 

P–12–35) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Hazard communication program. 

Requirements as specified in § 721.72(c) 

and (g) (do not release to water). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (j) (ferrite 

dispersion ink additive to ensure 

magnetic performance characteristics), 

(o), (v)(2), and (x)(2). 

(iii) Release to water. Requirements as 

specified in § 721.90(a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (f), (i), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 18. Add § 721.10530 to subpart E to 

read as follows: 

§ 721.10530 Acrylate manufacture 

byproduct distillation residue (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance is identified 

generically as acrylate manufacture 

byproduct distillation residue (PMN P– 

12–87) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4) (N = 1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance, 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 19. Add § 721.10531 to subpart E to 

read as follows: 

§ 721.10531 Distillation bottoms from 

manufacture of brominated cycloalkanes 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as distillation bottoms from 

manufacture of brominated cycloalkanes 

(PMN P–12–149) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4) (N =2). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 20. Add § 721.10532 to subpart E to 

read as follows: 

§ 721.10532 Tar, brown coal. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

tar, brown coal (PMN P–12–167, CAS 

No. 101316–83–0) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

specified in § 721.90(a)(1), (b)(1), and 

(c)(1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Record keeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 21. Add § 721.10533 to subpart E to 

read as follows: 

§ 721.10533 Amine-modified ureaformaldehyde polymer (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as amine-modified ureaformaldehyde polymer (PMN P–12–182) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4) (N = 56). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 22. Add § 721.10534 to subpart E to 

read as follows: 

§ 721.10534 Brominated aliphatic alcohol 

(generic). 

(a) Chemical substance and significant 

new uses subject to reporting. (1) The 

chemical substance identified 

generically as brominated aliphatic 

alcohol (PMN P–12–260) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4) (N = 3). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 


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48878 Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 

■ 23. Add § 721.10535 to subpart E to 

read as follows: 

§ 721.10535 Phosphonium, 

tributyltetradecyl-, chloride (1:1). 

(a) Chemical substance and significant 

new uses subject to reporting. (1) The 

chemical substance identified as 

phosphonium, tributyltetradecyl-, 

chloride (1:1) (PMN P–12–275; CAS No. 

81741–28–8) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

specified in § 721.90(a)(1), (b)(1), and 

(c)(1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Record keeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

[FR Doc. 2012–20039 Filed 8–14–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 49 

[EPA–R08–OAR–2012–0479; FRL–9710–4] 

Approval and Promulgation of Federal 

Implementation Plan for Oil and 

Natural Gas Well Production Facilities; 

Fort Berthold Indian Reservation 

(Mandan, Hidatsa, and Arikara 

Nations), ND 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is taking final action to 

promulgate a Reservation-specific 

Federal Implementation Plan in order to 

regulate emissions from oil and natural 

gas production facilities located on the 

Fort Berthold Indian Reservation 

located in North Dakota. The Federal 

Implementation Plan includes basic air 

quality regulations for the protection of 

communities in and adjacent to the Fort 

Berthold Indian Reservation. The 

Federal Implementation Plan requires 

owners and operators of oil and natural 

gas production facilities to reduce 

emissions of volatile organic 

compounds emanating from well 

completions, recompletions, and 

production and storage operations. This 

Federal Implementation Plan will be 

implemented by EPA, or a delegated 

Tribal Authority, until replaced by a 

Tribal Implementation Plan. EPA is 

proposing a Reservation-specific Federal 

Implementation Plan concurrently with 

this final rule. 

DATES: This rule is effective in the CFR 

on August 15, 2012. This rule is 

effective with actual notice by EPA to 

the owners and operators for purposes 

of enforcement beginning at 5 p.m. 

(eastern daylight time) on August 3, 

2012. 

Public Hearing: EPA will hold a 

public hearing on the following date: 

September 12, 2012. The hearing will 

start at 1 p.m. local time and continue 

until 4 p.m. or until everyone has had 

a chance to speak. Additionally, an 

evening session will be held from 6 p.m. 

until 8 p.m. The hearing will be held at 

the 4 Bears Casino & Lodge, 202 

Frontage Rd, New Town, ND 58763, 

(701) 627–4018. 

ADDRESSES: 

Docket: All documents in the docket 

are listed in the http:// 

www.regulations.gov index. Although 

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in hard 

copy. Publicly-available docket 

materials are available either 

electronically in http:// 

www.regulations.gov or in hard copy at 

the following locations: Air Program, 

U.S. Environmental Protection Agency 

(EPA), Region 8, Mailcode 8P–AR, 1595 

Wynkoop, Denver, Colorado 80202– 

1129; and Environmental Division, 

Three Affiliated Tribes, 204 West Main, 

New Town, North Dakota 58763–9404. 

EPA requests that if at all possible, you 

contact the individuals listed in the FOR

FURTHER INFORMATION CONTACT section to 

view the hard copy of the docket. You 

may view the hard copy of the docket 

Monday through Friday, 8 a.m. to 4 

p.m., excluding Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Deirdre Rothery, U. S. Environmental 

Protection Agency, Region 8, Air 

Program, Mail Code 8P–AR, 1595 

Wynkoop Street, Denver, Colorado 

80202–1129, (303) 312–6431, 

rothery.deirdre@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document, ‘‘we,’’ ‘‘us’’ 

and ‘‘our’’ refer to the EPA. 

Definitions 

For the purpose of this document, we are 

giving meaning to certain words or initials as 

follows: 

(i) The initials APA mean or refer to the 

Administrative Procedure Act. 

(ii) The words or initials Act or CAA mean 

or refer to the Clean Air Act, unless the 

context indicates otherwise. 

(iii) The initials BTU mean or refer to British 

Thermal Unit. 

(iv) The initials CAFOs mean or refer to 

Consent Agreement Final Orders. 

(v) The initials CDPHE mean or refer to 

Colorado Department of Public Health and 

Environment Air Pollution Control 

Division. 

(vi) The initials CO mean or refer to carbon 

monoxide. 

(vii) The words EPA, we, us or our mean or 

refer to the United States Environmental 

Protection Agency. 

(viii) The words Reservation or the initials 

FBIR mean or refer to the Fort Berthold 

Indian Reservation. 

(ix) The initials FIP mean or refer to Federal 

Implementation Plan. 

(x) The initials GOR mean or refer to gas-tooil ratio. 

(xi) The initials LACT mean or refer to lease 

automatic custody transfer. 

(xii) The initials MDEQ mean or refer to 

Montana Department of Environmental 

Quality. 

(xiii) The initials NAAQS mean or refer to 

the National Ambient Air Quality 

Standards. 

(xiv) The initials NAICS mean or refer to the 

North American Industry Classification 

System. 

(xv) The initials NDDoH mean or refer to the 

North Dakota Department of Health. 

(xvi) The initials NDIC mean or refer to the 

North Dakota Industrial Commission. 

(xvii) The initials NESHAP mean or refer to 

National Emission Standards for 

Hazardous Air Pollutants. 

(xviii) The initials NMED mean or refer to 

New Mexico Environment Department Air 

Quality Bureau. 

(xix) The initials NOX mean or refer to 

nitrogen oxides. 

(xx) The initials NO2 mean or refer to 

nitrogen dioxide. 

(xxi) The initials NSPS mean or refer to New 

Source Performance Standards. 

(xxii) The initials NSR mean or refer to new 

source review. 

(xxiii) The initials ODEQ mean or refer to 

Oklahoma Department of Environmental 

Quality Air Quality Division. 

(xxiv) The initials PM mean or refer to 

particulate matter. 

(xxv) The initials PSD mean or refer to 

prevention of significant deterioration. 

(xxvi) The initials PTE mean or refer to 

potential to emit. 

(xxvii) The initials RCT mean or refer to 

Railroad Commission of Texas, Oil and Gas 

Division. 

(xxviii) The initials SCADA mean or refer to 

Supervisory Control and Data Acquisition. 

(xxix) The initials SIP mean or refer to State 

Implementation Plan. 

(xxx) The initials SO2 mean or refer to sulfur 

dioxide. 


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