[Federal Register Volume 74, Number 129 (Wednesday, July 8, 2009)]
[Rules and Regulations]
[Pages 32460-32465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-15931]
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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: [email protected].
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: [email protected].
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