Document ID: EPA-HQ-OPPT-2006-0898-0070
Agency: epa
Document Type: Rule
Title: Dodecanedioic acid, 1, 12-dihydrazide and Thiophene, 2,5-dibromo-3-hexyl-; Significant New Use Rules
Posted Date: 2009-07-08T04:00Z

[Federal Register: July 8, 2009 (Volume 74, Number 129)]
[Rules and Regulations]               
[Page 32460-32465]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jy09-21]                         

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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.

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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

[[Page 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

[[Page 32462]]

(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-
hexyl-

    EPA 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 Sec.  721.170(b)(4)(iii) as well as the concern 
criteria at Sec.  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

[[Page 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 Sec.  
721.170(b)(4)(ii) and Sec.  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

[[Page 32464]]

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

[[Page 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.

0
Therefore, 40 CFR part 721 is amended as follows:

PART 721--[AMENDED]

0
1. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

0
2. By adding new Sec.  721.10057 to subpart E to read as follows:

Sec.  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 Sec.  
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 Sec.  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 
Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.

0
3. By adding new Sec.  721.10088 to subpart E to read as follows:

Sec.  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 Sec.  721.80(s) (4,500 kilograms).
    (ii) Release to water. Requirements as specified in Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.

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

BILLING CODE 6560-50-S