32460 Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to 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). 

VIII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and 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 this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 25, 2009. 

Lois Rossi, 

Director, Registration Division, Office of 

Pestiicide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In §180.910, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

* * * * * * * 

Polyglyceryl phthalate 

ester of coconut oil fatty 

acids (CAS Reg. Nos. 

67746–6070–9 

Surfactants, related 

adjuvants of 

surfactants 

* * * * * * * 

[FR Doc. E9–15927 Filed 7–7–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2006–0898; FRL–8398–5] 

RIN 2070–AB27 

Dodecanedioic acid, 1, 12-dihydrazide 

and Thiophene, 2,5-dibromo-3-hexyl-; 

Significant New Use Rules 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is issuing significant new 

use rules (SNURs) under section 5(a)(2) 

of the Toxic Substances Control Act 

(TSCA) for two chemical substances 

which were the subject of 

premanufacture notices (PMNs). The 

two substances are dodecanedioic acid, 

1, 12-dihydrazide (CAS No. 4080–98–2; 

PMNs P–01–759 and P–05–555) and 

thiophene, 2,5-dibromo-3-hexyl- (CAS 

No. 116971–11–0; PMN P–07–283). 

Today’s action requires persons who 

intend to manufacture, import, or 

process either of these two substances 

for a use that is designated as a 

significant new use by this final rule to 

notify EPA at least 90 days before 

commencing that activity. EPA believes 

that this action is necessary because 

these chemical substances may be 

hazardous to human health and the 

environment. The required notification 

would provide EPA with the 

opportunity to evaluate the intended 

use and, if necessary, to prohibit or limit 

that activity before it occurs. 

DATES: This final rule is effective August 

7, 2009 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPPT–2006–0898. 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., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

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

3334, EPA West Bldg., 1301 

Constitution Ave., NW., Washington, 

DC. The EPA/DC Public Reading Room 

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

p.m., Monday through Friday, excluding 

Federal holidays. The telephone number 

of the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

FOR FURTHER INFORMATION CONTACT: For 

general information contact: Colby 

Lintner, Regulatory Coordinator, 

Environmental Assistance Division 

(7408M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

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

TSCA-Hotline@epa.gov. 

For technical information contact: 

Karen Chu, Chemical Control Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–8773; e-mail address: 

chu.karen@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you manufacture, import, 

process, or use either of the chemical 

substances contained in this rule: 

Dodecanedioic acid, 1, 12-dihydrazide 

(CAS No. 4080–98–2; PMNs P–01–759 

and P–05–555) and thiophene, 2,5- 

dibromo-3-hexyl- (CAS No. 116971–11– 

0; PMN P–07–283). Potentially affected 

entities may include, but are not limited 

to: 

• Manufacturers, importers, or 

processors of one or more subject 

chemical substances (NAICS codes 325 


sroberts on DSKD5P82C1PROD with RULES
Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations 32461 

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 

40 CFR 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. Persons who import 

any chemical substance governed by a 

final SNUR are subject to the TSCA 

section 13 (15 U.S.C. 2612) import 

certification requirements and the 

corresponding regulations at 19 CFR 

12.118 through 12.127 and 19 CFR 

127.28. Those persons must certify that 

the shipment of the chemical substance 

complies with all applicable rules and 

orders under TSCA, including any 

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 40 CFR 721.20), and must comply 

with the export notification 

requirements in 40 CFR part 707, 

subpart D. 

II. Background 

A. What Action is the Agency Taking? 

EPA is finalizing SNURs under 

section 5(a)(2) of TSCA for two chemical 

substances which were the subject of 

premanufacture notices (PMNs). The 

two substances are dodecanedioic acid, 

1, 12-dihydrazide (CAS No. 4080–98–2; 

PMNs P–01–759 and P–05–555) and 

thiophene, 2,5-dibromo-3-hexyl- (CAS 

No. 116971–11–0; PMN P–07–283). This 

action requires persons who intend to 

manufacture, import, or process either 

of these two substances for an activity 

that is designated as a significant new 

use by this final rule to notify EPA at 

least 90 days before commencing that 

activity. 

Previously, in the Federal Register of 

September 19, 2007 (72 FR 53470) 

(FRL–8135–8), EPA issued direct final 

SNURs on these two substances (see 40 

CFR 721.10057 and 721.10088). 

However, EPA received notices of intent 

to submit adverse comments on these 

SNURs. Therefore, as required by 40 

CFR 721.170(d)(4)(i)(B), EPA withdrew 

the direct final SNURs on these two 

substances and subsequently proposed 

SNURs under notice and comment 

procedures (June 9, 2008 (73 FR 32508) 

(FRL–8351–4)). The record for the direct 

final and proposed SNURs for these 

substances was established as docket 

EPA–HQ–OPPT–2006–0898. That 

record includes information considered 

by the Agency in developing the direct 

final rule and this final rule including 

comments on the direct final and 

proposed rules. 

EPA received no comments regarding 

the proposed SNUR on dodecanedioic 

acid, 1, 12-dihydrazide (CAS No. 4080– 

98–2; PMNs P–01–759 and P–05–555) 

and is finalizing the rule as proposed. 

Significant new use designations for this 

substance are summarized as follows: 

Use of the substance without 1) workers 

wearing gloves, 2) workers wearing a 

National Institute for Occupational 

Safety and Health (NIOSH) approved 

full-face respirator with an assigned 

protection factor (APF) of at least 50, 

and 3) appropriate hazard 

communication. See the proposed rule 

for a complete discussion of the basis 

for EPA’s action, including hazard 

concerns for the substance and 

recommended testing. 

EPA received comments from 

Plextronics, the submitter of the PMN 

on thiophene, 2,5-dibromo-3-hexyl- 

(CAS No. 116971–11–0; PMN P–07–283) 

(Ref. 1). A discussion of EPA’s response 

to these comments is included in Unit 

V. Based on these comments, EPA is 

issuing a modified final rule on this 

substance that (1) retains the proposed 

maximum surface water concentration 

limit trigger of 1 part per billion (ppb) 

from manufacturing, processing, and 

use, and (2) raises the annual company 

manufacture and import volume limit 

trigger from 500 kilograms to 4,500 

kilograms. 

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 those listed in TSCA section 

5(a)(2). Once EPA determines that a use 

of a chemical substance is a significant 

new use, TSCA section 5(a)(1)(B) (15 

U.S.C. 2604(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 submit a SNUN are described 

in 40 CFR 721.5. 

C. Applicability of General Provisions 

General provisions for SNURs appear 

under 40 CFR part 721, subpart A. 

These provisions describe persons 

subject to the rule, recordkeeping 

requirements, exemptions to reporting 

requirements, and applicability of the 

rule to uses occurring before the 

effective date of the final rule. 

Provisions relating to user fees appear at 

40 CFR part 700. According to 40 CFR 

721.1(c), persons subject to 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 section 

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

regulations at 40 CFR part 720. Once 

EPA receives a SNUN, EPA may take 

regulatory action under TSCA section 

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

on which it has received the SNUN. If 

EPA does not take action, EPA is 

required under TSCA section 5(g) to 

explain in the Federal Register its 

reasons for not taking action. 

Persons who export or intend to 

export a chemical substance identified 

in a proposed or final SNUR are subject 

to the export notification provisions of 

TSCA section 12(b). The regulations that 

interpret TSCA section 12(b) appear at 

40 CFR part 707, subpart D. Persons 

who import a chemical substance 

identified in a final SNUR are subject to 

the TSCA section 13 import certification 

requirements, codified at 19 CFR 12.118 

through 12.127 and 19 CFR 127.28. 

Such persons must certify that the 

shipment of the chemical substance 

complies with all applicable rules and 

orders under TSCA, including any 

SNUR requirements. The EPA policy 

statement in support of the import 

certification appears at 40 CFR part 707, 

subpart B. 

III. 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 

determined that one or more of the 

criteria of concern established at 40 CFR 

721.170 were met. For a discussion of 

the rationale for the SNUR on 

dodecanedioic acid, 1, 12-dihydrazide 


sroberts on DSKD5P82C1PROD with RULES
32462 Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations 

(CAS No. 4080–98–2; PMNs P–01–759 

and P–05–555), see Unit III. of the direct 

final SNUR (September 19, 2007 (72 FR 

53470)) and Unit IV. of the proposed 

SNUR (June 9, 2008 (73 FR 32508)). For 

a discussion of the rationale for the 

SNUR on thiophene, 2,5-dibromo-3- 

hexyl- (CAS No. 116971–11–0; PMN P– 

07–283), see Units IV. and V. of this 

document, as well as Unit III. of the 

direct final SNUR (September 19, 2007 

(72 FR 53470)) and Unit IV. of the 

proposed SNUR (June 9, 2008 (73 FR 

32508)). 

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. 

IV. 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 authorizes EPA to consider any 

other relevant factors. 

EPA’s decision to designate a 

maximum surface water concentration 

of 1 ppb as a significant new use for 

thiophene, 2,5-dibromo-3-hexyl- (CAS 

No. 116971–11–0; PMN P–07–283) 

primarily reflects consideration of the 

third and fourth factors listed in the 

bulleted items in Unit IV. Based on 

structure activity relationship analyses 

for thiophenes, EPA is concerned that 

toxicity to aquatic organisms may occur 

at concentrations above 1 ppb of the 

PMN substance in surface waters. Initial 

review of the PMN showed that releases 

of the PMN substance to surface waters 

from manufacturing, processing, and 

use of the PMN substance at sites other 

than those identified in the PMN that 

have less protective management 

practices could result in surface water 

concentrations above 1 ppb for more 

than 20 days per year, thereby 

presenting a chronic risk to aquatic 

organisms (Ref. 2). Additionally, the 

substance is expected to significantly 

bioaccumulate (Ref. 5). 

EPA’s decision to also designate an 

annual manufacture and import volume 

of 4,500 kilograms as a significant new 

use for thiophene, 2,5-dibromo-3-hexyl- 

(CAS No. 116971–11–0; PMN P–07–283) 

reflects consideration of the first factor, 

the projected volume of manufacturing 

and processing of a chemical substance. 

The use of thiophene and its derivatives 

in electronic applications is escalating. 

Plextronics’ website indicates the 

technology involving this substance 1) 

is capable of ‘‘commercial-scale 

manufacturability,’’ and 2) that the 

market for such ‘‘printed electronics 

was approximately $1 billion in 2006 

and is expected to exceed $300 billion 

within 20 years’’ (Ref. 3). Thus, it is 

reasonable to expect that use of the 

substance may grow significantly 

beyond the 3rd–year estimate in the 

PMN and that those higher manufacture 

and import volumes would result in 

increased environmental exposure to 

the PMN substance. 

V. Response to Comments on Proposed 

SNUR on Thiophene, 2,5-dibromo-3- 

hexylEPA received comments from the 

submitter, Plextronics, on the proposed 

SNUR for thiophene, 2,5-dibromo-3- 

hexyl- (CAS No. 116971–11–0; PMN P– 

07–283) (Ref. 1). A discussion of the 

comments and the Agency’s responses 

follows. 

Comment 1: EPA’s structure activity 

relationship analysis is not supported 

by valid test data on analogous 

substances. 

Response: EPA’s Structure Activity 

Relationships (SARs) predictions for 

thiophenes are supported by 

scientifically valid ecotoxicity test 

results on algae, daphnia, and fish on 

multiple thiophene substances (Ref. 4). 

For example, the measured daphnid 

chronic value was 1.8 parts per million 

(ppm) for one thiophene substance, 

whose chemical identity was claimed as 

TSCA confidential business 

information. The measured log octanol/ 

water partition coefficient (log Kow) 

value for this CBI substance was 1.7. 

The difference between the measured 

toxicity values supporting the thiophene 

SARs and the predicted chronic aquatic 

concentration of concern of 1 ppb for 

thiophene, 2,5-dibromo-3-hexyl is 

almost completely due to differences in 

their measured or estimated log Kow

values. This is especially the case at 

relatively high log Kow values. The 

estimated log Kow for thiophene, 2,5- 

dibromo-3-hexyl is 6.6. 

Importantly, because the toxicity of 

chemical classes converge at log Kow

values of 5–8, the 1 ppb level is also 

supported by use of neutral organic 

SARs, which are supported by many 

valid test data points (Ref. 4). The 

predicted chronic concentration of 

concern for thiophene, 2,5-dibromo-3- 

hexyl (CAS No. 116971–11–0; PMN P– 

07–283) using neutral organic SARs is 

also 1 ppb. Thus, based on this further 

examination of the data and calculations 

regarding the aquatic toxicity of the 

substance, the Agency finds that the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(iii) as well as 

the concern criteria at 

§ 721.170(b)(4)(ii), which was indicated 

in the previous direct final rule and 

proposed rule on the substance. 

Comment 2: The rulemaking record 

does not contain information indicating 

that release of the substance may 

present an unreasonable risk, i.e., result 

in surface water concentrations above 

the 1 ppb concentration of concern, at 

an annual production volume of 500 

kilograms or greater. Therefore, the 

Agency has not justified the need for a 

production volume limit. 

Response: Congress did not require in 

TSCA that EPA must find that a 

significant new use may present 

unreasonable risk. Rather, TSCA section 

5(a)(2) requires only that EPA ‘‘consider 

all relevant factors’’ when promulgating 

a SNUR. According to 40 CFR 

721.170(a), EPA may issue significant 

new use notification and recordkeeping 

requirements if EPA determines that 

‘‘activities other than those in the 

premanufacture notice may result in 

significant changes in human exposure 

or environment release levels and/or 

concern exists about the substance’s 

health or environmental effects’’ (also 

see 40 CFR 721.170(c)(2)). As discussed 


sroberts on DSKD5P82C1PROD with RULES
Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations 32463 

in Unit IV., it is reasonable to expect 

that use of the substance may grow 

significantly beyond the 3rd–year 

estimate stated in the PMN and that 

higher production volumes will result 

in increased environmental exposure to 

the PMN substance. Also, EPA has 

hazard concerns for the substance; the 

Agency has determined that the 

substance may be highly toxic to aquatic 

organisms and meets the concern 

criterion at § 721.170(b)(4)(ii) and 

§ 721.170(b)(4)(iii). Receipt of a SNUN 

allows EPA to review and assess 

potential risks that might be presented 

by significant new use activities. 

Additionally, the EPA exposure report 

in the docket that predicts low concern 

for aquatic toxicity effects at the stated 

PMN production volume reflects surface 

water concentration estimates based on 

the site, operations, and management 

practices identified in the PMN and 

subsequent submitter correspondence. 

Initial review of the PMN showed that 

manufacturing, processing, and use of 

the PMN at sites other than those 

identified in the PMN that have less 

protective management practices could 

result in releases of the substance that 

would result in surface water 

concentrations above 1 ppb for more 

than 20 days per year (Ref. 2). This 

difference in risk estimates based on site 

and management practices further 

supports the Agency’s concerns 

regarding the chemical substance and 

the basis for this SNUR. 

Comment 3: Designation of both 

annual production (i.e., manufacture 

and import) volume and water release 

triggers as a significant new use is 

unjustified. 

Response: EPA respectfully disagrees. 

Unit IV. contains the justifications for 

the water release and production 

volume significant new use triggers. 

Surface water concentration and 

production volume each may make an 

independent contribution to risk. This is 

because production volume can be 

highly related to exposure even where 

surface water concentration remains the 

same. The Agency currently uses the 

industry-provided, 3rd-year production 

volume estimate in the PMN to assess 

the potential environmental and health 

effects of a new chemical. Thus, if EPA 

has reason to believe that the 

production volume for a substance of 

concern could significantly surpass that 

designated in the PMN for the first three 

years of manufacture, EPA will consider 

taking regulatory action and designating 

some production volume as a significant 

new use. 

Comment 4: If a production (i.e., 

manufacture and import) volume limit 

is justified, it should be set at a 

significant level above the 3rd-year 

volume in the PMN and also be set at 

a level where the recommended testing 

is economically feasible. 

Response: In consideration of the 

comments received on the proposed 

SNUR, expected market growth, and 

review of analogous substances, EPA is 

raising the annual company production 

volume limit in the final SNUR to 4,500 

kilograms. EPA views this volume as 

significantly different from the 3rd-year 

production volume estimate in the 

PMN. Notably, in designating this 

volume as a significant new use, EPA is 

not trying to predict or imply at what 

volume a risk could occur or to estimate 

at what aggregate volume would any 

recommended testing on the substance 

be economically feasible. 

VI. Applicability of Rule to Uses 

Occurring Before Effective Date of the 

Final Rule 

As discussed in the Federal Register 

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

has decided that the intent of 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 the 

proposed SNUR rather than as of the 

effective date of the final rule. If uses 

begun after publication of the proposed 

SNUR were considered ongoing, rather 

than new, it would be difficult for EPA 

to establish SNUR notice requirements 

because a person could defeat the SNUR 

by initiating the proposed significant 

new use before the rule became 

effective, and then argue that the use 

was ongoing as of the effective date of 

the final rule. 

Any person who began commercial 

manufacture, import, or processing of 

dodecanedioic acid, 1, 12-dihydrazide 

(CAS No. 4080–98–2; PMNs P–01–759 

and P–05–555) or thiophene, 2,5- 

dibromo-3-hexyl- (CAS No. 116971–11– 

0; PMN P–07–283) for any of the 

significant new uses designated in the 

proposed SNUR after the date of 

publication of the proposed SNUR must 

stop that activity before the effective 

date of this rule. Persons who ceased 

those activities will have to meet all 

SNUR notice requirements and wait 

until the end of the notification review 

period, including all extensions, before 

engaging in any activities designated as 

significant new uses. If, however, 

persons who began manufacture, 

import, or processing of either of these 

chemical substances between the date of 

publication of the proposed SNUR and 

the effective date of this final SNUR 

meet the conditions of advance 

compliance as codified at 40 CFR 

721.45(h), those persons would be 

considered to have met the final SNUR 

requirements for those activities. 

VII. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not require developing any 

particular test data before submission of 

a SNUN (except where the chemical 

substance subject to the SNUN is also 

subject to a section 4 test rule). Persons 

are required only to submit test data in 

their possession or control and to 

describe any other data known to or 

reasonably ascertainable by them (40 

CFR 721.25(a) and 720.50.) However, 

upon review of PMNs and SNUNs, the 

Agency has the authority to require 

appropriate testing. Unit III. of the 

proposed rule (June 9, 2008 (73 FR 

32508)) lists recommended testing for 

these two substances. 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. Many test guidelines 

are now available on the Internet at 

http://www.epa.gov/opptsfrs/home/ 

guidelin.htm. 

The recommended tests may not be 

the only means of addressing the 

potential risks of the chemical 

substance. However, SNUNs submitted 

for significant new uses 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 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. 

VIII. SNUN Submissions 

SNUNs must be mailed to the 

Environmental Protection Agency, 

OPPT Document Control Office 

(7407M), 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. 

Information must be submitted in the 

form and manner set forth in EPA Form 

No. 7710–25. This form is available 

from the Environmental Assistance 

Division (7408M), 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–0001 

(see 40 CFR 721.25 and 720.40). Forms 


sroberts on DSKD5P82C1PROD with RULES
32464 Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations 

and information are also available 

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

opptintr/newchems/pubs/ 

pmnforms.htm. 

IX. Economic Analysis 

EPA evaluated the potential costs of 

establishing SNUN requirements for 

potential manufacturers, importers, and 

processors of these two chemical 

substances at the time of the direct final 

rule. The Agency’s complete Economic 

Analysis is available in the public 

docket for the direct final rule (Ref. 6). 

For dodecanedioic acid, 1, 12- 

dihydrazide (CAS No. 4080–98–2; 

PMNs P–01–759 and P–05–555), the 

difference in hazard communication 

requirements between this final SNUR 

and the direct final SNUR (i.e., removal 

of the requirement for specific 

identification of cancer and 

developmental toxicity endpoints in 

workplace hazard communication 

materials) could slightly reduce 

estimated costs to regulated entities. For 

thiophene, 2,5-dibromo-3-hexyl- (CAS 

No. 116971–11–0; PMN P–07–283), the 

manufacture and import volume limit is 

higher in the final SNUR than in the 

direct final SNUR (4,500 kg/yr vs. 500 

kg/yr). While the higher manufacture 

and import volume limit does not 

directly change SNUN costs, it should 

make it more feasible for regulated 

entities to elect to submit the 

recommended testing for the substance 

with the SNUN. 

X. References 

The official record for this final rule 

has been established. The following is a 

listing of the documents referenced in 

this preamble that have been placed in 

the docket for this final rule under 

docket ID number EPA–HQ–OPPT– 

2006–0898, which is available for 

inspection as specified under 

ADDRESSES. 

1. Plextronics. Comments on the 

Proposed Significant New Use Rule for 

the Chemical Substance under 

Premanufacture Notice Case Number P– 

07–0283. July 8, 2008. EPA–HQ–OPPT– 

2006–0898–0069.2. 

2. EPA. Sanitized Initial Review 

Exposure Report for P–07–283 at SIC 

Code. March 16, 2007. EPA–HQ–OPPT– 

2006–0898–0083. 

3. Plextronics. Plextronics Webpage 

(www.plextronics.com/aboutus.aspx). 

November 5, 2008. EPA–HQ–OPPT– 

2006–0898–0084. 

4. EPA. Ecological Structure Activity 

Relationships for Neutral Organics and 

Thiophenes. 2007. EPA–HQ–OPPT– 

2006–0898–0086. 

5. EPA. Sanitized Engineering and 

Structure Activity Team Reports for P– 

07–283. March, 2007. EPA–HQ–OPPT– 

2006–0898–0057. 

6. EPA. Economic Analysis of 

Expedited Significant New Use Rule for 

38 Chemical Substances. August 13, 

2007. EPA–OPPT–2006–0898–0058. 

XI. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This final rule establishes SNURs for 

several new chemical substances that 

were the subject of PMNs, or 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 the 

PRA, unless it has been approved by 

OMB and displays a currently valid 

OMB control number. The OMB control 

numbers for EPA’s regulations in title 40 

of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9, and included on the related 

collection instrument or form, if 

applicable. 

The information collection 

requirements related to this action have 

already been approved by OMB 

pursuant to the PRA under OMB control 

number 2070–0012 (EPA ICR No. 0574). 

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 110 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 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), the Agency hereby 

certifies that promulgation of these 

SNURs will not have a significant 

adverse economic impact on a 

substantial number of small entities. 

The rationale supporting this 

conclusion is as follows. The 

requirement to submit a SNUN applies 

to any person (including small or large 

entities) who intends to engage in any 

activity described in the rule as a 

‘‘significant new use.’’ Because these 

uses are ‘‘new,’’ based on all 

information currently available to EPA, 

it appears that no small or large entities 

presently engage in such activities. A 

SNUR requires that any person who 

intends to engage in such activity in the 

future must first notify EPA by 

submitting a SNUN. Although some 

small entities may decide to pursue a 

significant new use in the future, EPA 

cannot presently determine how many, 

if any, there may be. However, EPA’s 

experience to date is that, in response to 

the promulgation of over 1,000 SNURs, 

the Agency receives on average only 5 

notices per year. Of those SNUNs 

submitted from 2006–2008, only one 

appears to be from a small entity. In 

addition, the estimated reporting cost 

for submission of a SNUN (see Unit IX.) 

is minimal regardless of the size of the 

firm. Therefore, EPA believes that the 

potential economic impacts of 

complying with these SNURs are not 

expected to be significant or adversely 

impact a substantial number of small 

entities. In a SNUR that published on 

June 2, 1997 (62 FR 29684) (FRL–5597– 

1), the Agency presented its general 

determination that proposed and final 

SNURs are not expected to have a 

significant economic impact on a 

substantial number of small entities, 

which was provided to the Chief 

Counsel for Advocacy of the Small 

Business Administration. 

D. Unfunded Mandates Reform Act 

Based on EPA’s experience with 

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 rulemaking. As 

such, EPA has determined that this 

regulatory action does not impose any 

enforceable duty, contain any unfunded 

mandate, or otherwise have any affect 

on small governments subject to the 

requirements of sections 202, 203, 204, 

or 205 of the Unfunded Mandates 


sroberts on DSKD5P82C1PROD with RULES
Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations 32465 

Reform Act of 1995 (UMRA) (Public 

Law 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 

Indian Tribes. This rule does not 

significantly or 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 rule is not subject to Executive 

Order 13211, entitled Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001), because this action is not 

expected to affect energy supply, 

distribution, or use. 

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). 

XII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, 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 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 in 40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: June 30, 2009. 

Wendy C. Hamnett, 

Acting Director, Office of Pollution Prevention 

and Toxics. 

■ Therefore, 40 CFR part 721 is 

amended as follows: 

PART 721—[AMENDED] 

■ 1. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

■ 2. By adding new § 721.10057 to 

subpart E to read as follows: 

§ 721.10057 Dodecanedioic acid, 1, 12- 

dihydrazide. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

dodecanedioic acid, 1, 12-dihydrazide 

(PMNs P–01–759 and P–05–555; CAS 

No. 4080–98–2) 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) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(5), 

(a)(6)(i), (a)(6)(ii), (b), and (c). 

Respirators must provide a National 

Institute for Occupational Safety and 

Health (NIOSH) assigned protection 

factor (APF) of at least 50. The following 

NIOSH-approved respirators meet the 

minimum requirement for 

§ 721.63(a)(4): Air-purifying, tight-fitting 

full-face respirator equipped with N100 

(if oil aerosols absent), R100, or P100 

filters; powered air-purifying respirator 

equipped with a tight-fitting full 

facepiece and High Efficiency 

Particulate Air (HEPA) filters; supplied 

air respirator operated in pressure 

demand or continuous flow mode and 

equipped with a tight-fitting full 

facepiece. Because the substance is a 

dermal sensitizer and irritates mucous 

membranes, half-face respirators do not 

provide adequate protection. 

(ii) Hazard communication program. 

Requirements as specified in § 721.72 

(a), (b), (c), (d), (e) (concentration set at 

0.1 percent), (f), (g)(1)(i), and (g)(2)(i). 

(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), (d), (e), (f), (g), and (h) 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. By adding new § 721.10088 to 

subpart E to read as follows: 

§ 721.10088 Thiophene, 2,5-dibromo-3- 

hexyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

thiophene, 2,5-dibromo-3-hexyl- (PMN 

P–07–283; CAS No. 116971–11–0) 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) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(s) (4,500 

kilograms). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=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), (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. 

[FR Doc. E9–15931 Filed 7–7–09; 8:45 am] 

BILLING CODE 6560–50–S 


sroberts on DSKD5P82C1PROD with RULES