[Federal Register: June 9, 2008 (Volume 73, Number 111)]
[Proposed Rules]
[Page 32508-32514]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jn08-17]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2006-0898; FRL-8351-4]
RIN 2070-AB27
Proposed Significant New Use Rules on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing 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 dodecandioic 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 would
require 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 proposed rule to notify EPA at least 90
days before commencing that activity. 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: Comments must be received on or before July 9, 2008.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2006-0898, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2006-0898. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is (202) 564-8930. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2006-0898. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available electronically at http://
www.regulations.gov, or, if only available in hard copy, at the OPPT
[[Page 32509]]
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: Tracey Pennington, Chemical
Control Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-2209; e-mail
address: pennington.tracey@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture,
import, process, or use the chemical substances contained in this
proposed rule. Potentially affected entities may include, but are not
limited to:
Manufacturers, importers, or processors of one or both subject
chemical substances (NAICS codes 325 and 324110), e.g., Chemical
manufacturing and petroleum refineries.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in 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 proposed rule on or after July 9,
2008 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.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM
that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and
then identify electronically within the disk or CD-ROM the specific
information that is claimed as CBI. In addition to one complete version
of the comment that includes information claimed as CBI, a copy of the
comment that does not contain the information claimed as CBI must be
submitted for inclusion in the public docket. Information so marked
will not be disclosed except in accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What Action is the Agency Taking?
EPA is proposing significant new use rules (SNURs) under section
5(a)(2) of TSCA for two chemical substances which were the subject of
premanufacture notices (PMNs). The two substances are dodecandioic
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). These SNURs would require persons who intend to manufacture,
import, or process either of these two substances for an activity
designated as a significant new use to notify EPA at least 90 days
before commencing that activity.
In the Federal Register of September 19, 2007 (72 FR 53470) (FRL-
8135-8), EPA issued direct final SNURs on these two substances in
accordance with the procedures at 40 CFR 721.170(d)(4)(i)(A). EPA
received notices of intent to submit adverse comments on these SNURs.
Therefore, as required by 40 CFR 721.170(d)(4)(i)(B), on November 19,
2007 (72 FR 64951) (FRL-8340-8), EPA withdrew the direct final SNURs on
these two substances and is now proposing these SNURs. The record for
the direct final 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 rules and the notices of
intent to submit adverse comments.
The rationale for this proposed rule as well as requests for public
comment on specific issues is included in Unit IV.
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
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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) 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 (15 U.S.C.
2604(a)(1)(B)). As described in unit II.C., the general SNUR provisions
are found at 40 CFR part 721, subpart A.
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 significant new
use activities described in 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. Substances Subject to this Rule
EPA is proposing to establish significant new use and recordkeeping
requirements for two chemical substances under 40 CFR part 721, subpart
E. In this unit, EPA provides the following information for each
chemical substance:
PMN number.
Chemical name (generic name if the specific name is
claimed as CBI).
CAS number (if assigned for non-confidential chemical
identities).
Basis for the SNUR.
Toxicity concerns.
Tests recommended by EPA to provide sufficient information
to evaluate the chemical substance (see Unit VI. for more information).
CFR citation assigned in the regulatory text section of
this proposed rule.
The specific activities designated as significant new uses are
listed in 40 CFR part 721, subpart E.
PMN Numbers P-01-759 and P-05-555
Chemical name: Dodecandioic acid, 1, 12-dihydrazide.
CAS number: 4080-98-2.
Basis for action: The PMNs (submitted by two different chemical
manufacturing companies) state that the generic (non-confidential) uses
of the substance will be as a raw material for coating and sealants and
as a curing agent, respectively. Based on the molecular structure of
the PMN substance and test data on analogous substances, EPA believes
the PMN substance may cause carcinogenicity, developmental toxicity,
and irritation to mucous membranes. Also, based on test data on the PMN
substance, it may cause dermal sensitization. As described in the
companies' PMNs and accompanying Material Safety Data Sheets, workers
will be warned that the substance may cause dermal sensitization and
will wear gloves and National Institute for Occupational Safety and
Health (NIOSH) approved respirators with an assigned protection factor
(APF) of 50 or greater. Based on this expectation that adequate hazard
communication and personal protective equipment will be used, EPA
believes significant worker exposure is unlikely. Further, consumer use
is not expected. EPA has determined, however, that potential use of the
substance without workers wearing gloves and a respirator, and without
an appropriate hazard communication program, may cause serious human
health effects. Respirators must provide a NIOSH 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. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170 (b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day
oral toxicity test in rats (OPPTS 870.3100 test guideline) and a
mammalian erythrocyte micronucleus test (OPPTS 870.5395 test guideline)
would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10057.
PMN Number P-07-283
Chemical name: Thiophene, 2,5-dibromo-3-hexyl-.
CAS number: 116971-11-0.
Basis for action: The PMN states that the substance will be used as a
reactive intermediate monomer for use in manufacturing a p-type organic
semiconductor polymer. The polymer will be used in printed organic
electronics applications. Based on structure activity relationship
analyses for thiophenes, EPA is concerned that toxicity to aquatic
organisms may occur at concentrations above 1 part per billion (ppb) of
the PMN substance in surface waters. At the production volume stated
for the company in the PMN, releases of the PMN substance are not
expected to result in surface water concentrations above 1 ppb.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance, as described in the PMN, may
present an unreasonable risk. EPA has determined, however, that
potential increased production or importation volumes or other uses of
the substance resulting in surface water concentrations above 1 ppb may
cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS 850.1400 test guideline (public
draft)); a daphnid chronic toxicity test (OPPTS 850.1300 test guideline
(public draft)); and an algal toxicity test, tiers I and II (OPPTS
850.5400 test guideline (public draft)) would help characterize the
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environmental effects of the PMN substance. The fish and daphnid tests
should use flow-through conditions and measured concentrations.
CFR citation: 40 CFR 721.10088.
IV. Objectives and Rationale of the Rule
A. Rationale
During review of the PMNs submitted for these two chemical
substances, EPA determined that one or more of the criteria of concern
established at 40 CFR 721.170 were met, as discussed in Unit III.
1. Rationale for the proposed SNUR for dodecandioic acid, 1, 12-
dihydrazide (CAS No. 4080-98-2). The hazard communication terms of the
SNUR being proposed today for dodecandioic acid, 1, 12-dihydrazide (CAS
No. 4080-98-2) differ from the terms in the direct final SNUR, based on
submitted comments that clarified existing uses of the substance. The
notice of intent to submit adverse comment states that hazard
communication materials currently in use for this substance in the
marketplace do not contain two of the health hazard statements included
in the direct final SNUR. The two statements are, ``this substance may
cause cancer'' and ``this substance may cause developmental toxicity.''
As EPA interprets its SNUR authority under section 5(a)(2) of TSCA, if
an activity is already ongoing before EPA first publishes a Federal
Register notice of intent to designate that activity as a significant
new use, then EPA may not issue a SNUR designating that activity as a
significant ``new'' use. Therefore, EPA is proposing a SNUR that would
not designate as a ``significant new use'' the failure to identify
cancer and developmental toxicity in workplace hazard communication
materials accompanying this chemical substance (under 40 CFR 721.72).
However, for the reasons described in this paragraph and in the direct
final rule preamble, the Agency's concerns for these toxic endpoints
remain. Therefore, the Agency encourages companies to voluntarily
include these potential health concerns in their hazard communication
materials for the substance. The workplace personal protective
equipment requirements (under 40 CFR 721.63) and other requirements
listed in the direct final rule would remain unchanged in today's
proposed SNUR. The Agency requests comments on the approach being taken
in the proposed SNUR for this substance.
2. Rationale for the proposed SNUR for thiophene, 2,5-dibromo-3-
hexyl- (CAS No. 116971-11-0). The Agency is requesting comments on the
proposed SNUR for this substance as well as two alternative approaches.
A discussion of the rationale behind each option and specific issues on
which the Agency is requesting comment follows. EPA requests that
commenters making specific recommendations include supporting
documentation where appropriate.
i. Proposed SNUR - maximum surface water concentration of 1 ppb
from manufacturing, processing, or use activities and annual company
production limit of 500 kg. The terms of the SNUR being proposed today
for thiophene, 2,5-dibromo-3-hexyl- (CAS No. 116971-11-0) remain the
same as in the direct final SNUR. See proposed Sec. 721.10088
(a)(2)(i) and (a)(2)(ii). EPA is proposing to designate the surface
water release and production volume limits as significant new uses for
the reasons stated in Unit V., including concerns associated with
potential changes in the extent to which these activities could
increase the magnitude and duration of exposure of human beings or the
environment to the chemical substance. Inclusion of a production volume
limit gives the Agency an opportunity to review the substance again at
a higher production volume.
ii. Alternative A -maximum surface water concentration of 1 ppb
from manufacture, processing, or use activities up to an annual
production volume of 500 kg, and no release to surface water at annual
company production volumes higher than 500 kg. This option was
suggested in the notice of intent to submit adverse comment on the
direct final SNUR for this substance. The commenter also stated that
they recognize the Agency's concern for water releases of the
substance. While this option would be protective of the aquatic
environment, the Agency requests comment on whether industry compliance
would be impractical or confusing.
iii. Alternative B - SNUR for no release to surface water. If the
substance is not currently being released to water during
manufacturing, processing, or use activities, the Agency could consider
finalizing a SNUR designating any release to water during those
activities as a significant new use. This option would be sufficiently
protective of the aquatic environment and is less complicated than
Alternative A. To implement this option, EPA would need to be satisfied
that there are no ongoing releases to water, taking into account 40 CFR
721.90 (a)(1), (b)(1), and (c)(1). EPA solicits comment on whether
there are ongoing releases to water during manufacturing, processing,
or use activities.
B. Objectives
EPA is proposing 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 proposed rule:
EPA would 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 would 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 would 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.
V. 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.
To determine what would constitute a significant new use of the two
chemical substances that are the subject of this proposed rule, EPA
considered relevant information about the toxicity of the substances,
likely human exposures and environmental releases associated with
possible uses, and the four factors listed in section 5(a)(2) of TSCA.
In these cases, EPA did not find that the use scenarios described in
the three PMNs triggered the determinations set forth
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under section 5(e) of TSCA. EPA did, however, believe that certain
changes from the use scenarios described in the PMNs could result in
increased exposures, and constitute ``significant new uses.'' These so-
called ``Non-5(e) SNURs'' (i.e., SNURs for chemicals that are not
regulated by a section 5(e) Consent Order under Sec. 721.160) are
promulgated pursuant to 40 CFR 721.170. EPA has determined that every
activity designated as a ``significant new use'' in all the non-5(e)
SNURs issued under 40 CFR 721.170 satisfies the two requirements
stipulated in Sec. 721.170(c)(2), i.e., these significant new use
activities, ``(i) are different from those described in the
premanufacture notice for the substance, including any amendments,
deletions, and additions of activities to the premanufacture notice,
and (ii) may be accompanied by changes in exposure or release levels
that are significant in relation to the health or environmental
concerns identified'' for the PMN substance.
VI. Applicability of Rule to Uses Occurring Before Effective Date of
the Final Rule
To establish a significant ``new'' use, EPA must determine that the
use is not ongoing. EPA solicits comments on whether any of the uses
proposed as significant new uses are ongoing. As discussed in the
Federal Register of April 24, 1990 (55 FR 17376), EPA has decided that
the intent of section 5(a)(1)(B) of TSCA is best served by designating
a use as a significant new use as of the date of publication of the
proposed rule, rather than as of the effective date of the final rule.
If uses begun after publication of the proposed rule were considered
ongoing rather than new, it would be difficult for EPA to establish
SNUR notice requirements, because a person could defeat the SNUR by
initiating the significant new use before the rule became final, and
then argue that the use was ongoing as of the effective date of the
final rule. Thus, persons who begin commercial manufacture, import, or
processing activities with the chemical substances that would be
regulated as a ``significant new use'' through this proposed rule, must
cease any such activity as of the effective date of the rule if and
when finalized. To resume their activities, these persons would have to
comply with all applicable SNUR notice requirements and wait until the
notice review period, including all extensions, expires.
EPA has promulgated provisions to allow persons to comply with this
SNUR before the effective date. If a person were to meet the conditions
of advance compliance under Sec. 721.45(h), the person would be
considered to have met the requirements of the final SNUR 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. 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 (15 U.S.C.
2604(d); 40 CFR 721.25 and 720.50). However, upon review of PMNs and
SNUNs, the Agency has the authority to require appropriate testing.
Unit III. lists recommended testing for the two chemical substances
that are the subject of these proposed SNURs. Descriptions of tests are
provided for informational purposes. EPA strongly encourages persons,
before performing any testing, to consult with the Agency pertaining to
protocol selection. 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 assessing the
potential toxicity, exposure, and risks of the chemical substances
regulated under this rule. However, submitting SNUNs 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
EPA recommends that submitters consult with the Agency prior to
submitting a SNUN to discuss what data may be useful in evaluating a
significant new use. Discussions with the Agency prior to notice
submission can afford ample time to conduct any tests that might be
helpful in evaluating risks posed by the substance. According to 40 CFR
721.1(c), persons submitting a SNUN must comply with the same notice
requirements and EPA regulatory procedures as persons submitting a PMN,
including submission of test data on health and environmental effects
as described in 40 CFR 720.50.
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 and information are also available electronically at http://
www.epa.gov/opptintr/newchems/pubs/pmnforms.htm.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers, importers, and processors of
the 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 (EPA-HQ-OPPT-2006-0898). The difference in
hazard communication requirements in the direct final SNUR and this
proposed rule (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. The difference in a production
volume trigger and type of release to water restriction in the direct
final SNUR and this proposed rule will not impact the estimated costs
to regulated entities.
X. Statutory and Executive Order Reviews
A. Executive Order 12866
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has determined that this proposed rule is not a
``significant regulatory action'' because it does not meet the criteria
in section 3(f) of the Executive order.
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
[[Page 32513]]
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. 574). This action does not impose any
burden requiring additional OMB approval. If an entity were to submit a
SNUN to the Agency, the annual burden is estimated to average between
30 and 170 hours per submission. 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 would not have a significant adverse economic impact on
a substantial number of small entities. The rationale supporting this
conclusion is as follows. A SNUR applies to any person (including small
or large entities) who intends to engage in any activity described in
the proposed rule as a ``significant new use.'' By definition of the
word ``new,'' and based on all information currently available to EPA,
it appears that no small or large entities presently engage in such
activity. Since a SNUR only requires that any person who intends to
engage in such activity in the future must first notify EPA by
submitting a SNUN, no economic impact would even occur until someone
decides to engage in those activities. Although some small entities may
decide to conduct such activities 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 10 notices per year. Of those SNUNs
submitted, none appear to be from small entities in response to any
SNUR. In addition, the estimated reporting cost for submission of a
SNUN (see Unit IX.) are 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 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 proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government would be impacted by this
rulemaking. As such, EPA has determined that this regulatory action
would 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
Reform Act of 1995 (UMRA) (Public Law 104-4).
E. Executive Order 13132
This action would 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 proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly or uniquely affect the
communities of Indian Tribal governments, nor would 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 6,
2000), do not apply to this proposed 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 proposed 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).
K. Executive Order 12988
In issuing this proposed rule, EPA has taken the necessary steps to
eliminate drafting errors and ambiguity, minimize potential litigation,
and provide a clear legal standard for affected conduct, as required by
section 3 of Executive Order 12988, entitled Civil Justice Reform (61
FR 4729, February 7, 1996).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: May 30, 2008.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR part 721 be amended as
follows:
PART 721--[AMENDED]
1. The authority citation for part 721 would continue to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
[[Page 32514]]
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.
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) (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. E8-12862 Filed 6-6-08; 8:45 am]
BILLING CODE 6560-50-S