Revocation of TSCA Section 4 Testing Requirements for One High Production Volume Chemical Substance, 28340-28343 [2012-11491]
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emcdonald on DSK29S0YB1PROD with PROPOSALS
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Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Proposed Rules
EPA’s role is to approve state choices,
provided that they meet the criteria of
the CAA. Accordingly, this action
merely proposes to approve state law as
meeting Federal requirements and does
not impose additional requirements
beyond those imposed by state law. For
that reason, this proposed action:
• Is not a ‘‘significant regulatory
action’’ subject to review by the Office
of Management and Budget under
Executive Order 12866 (58 FR 51735,
October 4, 1993);
• Does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.);
• Is certified as not having a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act
(5 U.S.C. 601 et seq.);
• Does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• Does not have Federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the CAA; and
• Does not provide EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
In addition, this proposed rule
pertaining to Maryland RACT for the
1997 8-hour ozone NAAQS, does not
have tribal implications as specified by
Executive Order 13175 (65 FR 67249,
November 9, 2000), because the SIP is
not approved to apply in Indian country
located in the state, and EPA notes that
it will not impose substantial direct
costs on tribal governments or preempt
tribal law.
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Nitrogen dioxide,
Ozone, Reporting and recordkeeping
requirements, Volatile organic
compounds.
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Authority: 42 U.S.C. 7401 et seq.
Dated: May 2, 2012.
W.C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2012–11639 Filed 5–11–12; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 799
[EPA–HQ–OPPT–2005–0033; FRL–9350–1]
RIN 2070–AD16
Revocation of TSCA Section 4 Testing
Requirements for One High Production
Volume Chemical Substance
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing the
revocation of certain testing
requirements promulgated under the
Toxic Substances Control Act (TSCA)
for benzenesulfonic acid, [[4-[[4(phenylamino)phenyl][4-(phenylimino)2,5-cyclohexadien-1ylidene]methyl]phenyl]amino]- (CAS
No. 1324–76–1), also known as C.I.
Pigment Blue 61. EPA is basing its
decision to take this action on
information received since publication
of the final rule that established testing
requirements for this chemical
substance.
SUMMARY:
Comments must be received on
or before June 13, 2012.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2005–0033, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460–0001.
• Hand Delivery: OPPT Document
Control Office (DCO), EPA East Bldg.,
Rm. 6428, 1201 Constitution Ave. NW.,
Washington, DC. Attention: Docket ID
number EPA–HQ–OPPT–2005–0033.
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–
DATES:
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2005–0033. EPA’s policy is that all
comments received will be included in
the docket without change and may be
made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or
email. The regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an email comment directly
to EPA without going through
regulations.gov, your email address will
be automatically captured and included
as part of the comment that is placed in
the docket and made available on the
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
information in the body of your
comment and with any disk or CD–ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket
are listed in the docket index available
at https://www.regulations.gov. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
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 https://www.regulations.gov,
or, if only available in hard copy, at the
OPPT Docket. The OPPT Docket is
located in the EPA Docket Center (EPA/
DC) at Rm. 3334, EPA West Bldg., 1301
Constitution Ave. NW., Washington,
DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
legal holidays. The telephone number of
the EPA/DC Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket is (202)
566–0280. Docket visitors are required
to show photographic identification,
pass through a metal detector, and sign
the EPA visitor log. All visitor bags are
processed through an X-ray machine
and subject to search. Visitors will be
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Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Proposed Rules
provided an EPA/DC badge that must be
visible at all times in the building and
returned upon departure.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: Catherine
Roman, Chemical Control Division
(7405M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460–0001; telephone
number: (202) 564–8157; email address:
roman.catherine@epa.gov.
For general information contact: The
TSCA–Hotline, ABVI–Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA–
Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action is directed to the public
in general and may be of particular
interest to those persons who
manufacture (defined by statute to
include import), process, or export the
chemical substance identified in this
document. Because other persons may
also be interested, the Agency has not
attempted to describe all the specific
persons that may be affected by this
action. 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.
emcdonald on DSK29S0YB1PROD with PROPOSALS
B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI.
Do not submit this information to EPA
through regulations.gov or email.
Clearly mark the part or all of the
information that you claim to be CBI.
For CBI information in a disk or CD–
ROM that you mail to EPA, mark the
outside of the disk or CD–ROM 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
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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 to amend the TSCA
section 4(a) chemical testing
requirements for one high production
volume (HPV) chemical included in 40
CFR 799.5085. Specifically, this
amendment revokes some of the testing
requirements for C.I. Pigment Blue 61.
EPA is basing its decision to take this
action on information (discussed in Unit
III.) received since publication of the
final rule (Ref. 1) that established testing
requirements for this chemical
substance.
In the Federal Register of March 16,
2012 (77 FR 15609) (FRL–9335–6), EPA
issued a revocation of some or all of the
testing requirements for 10 chemical
substances by direct final rule. EPA
received an adverse comment
concerning the chemical substance C.I.
Pigment Blue 61. Consequently, in
accordance with the procedures
described in the March 16, 2012 Federal
Register document, EPA is withdrawing
the revocation of certain testing
requirements for C.I. Pigment Blue 61 in
a separate document published
elsewhere in today’s Federal Register,
and is now issuing this proposed rule.
B. What is the Agency’s authority for
taking this action?
Section 4(a) of TSCA authorizes EPA
to require testing if certain findings are
made. The TSCA section 4(a) findings
include:
1. The chemical substance was
produced in substantial quantities.
2. There are insufficient data upon
which the effects of manufacture,
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distribution, processing, use, or disposal
of a chemical substance on health or the
environment can reasonably be
determined or predicted.
3. Testing of the chemical substance
with respect to such effects is necessary
to develop such data. (See TSCA section
4(a)(1)(B)(i), (ii), and (iii); see also
Ref. 1).
EPA is amending the testing
requirements for C.I. Pigment Blue 61
because some of the findings that EPA
made for this chemical substance are no
longer supported.
III. Amendment to Chemical Testing
Requirements
On July 17, 2006, the Color Pigments
Manufacturers Association (CPMA)
submitted a test plan for C.I. Pigment
Blue 61. CPMA also submitted robust
summaries of existing data which
CPMA asked EPA to accept as satisfying
some of the Agency’s data needs for C.I.
Pigment Blue 61. Some of the existing
data described in the summaries
addressed C.I. Pigment Blue 56, a close
analog of C.I. Pigment Blue 61, which
CPMA requested EPA to accept as
satisfying the Agency’s data needs for
C.I. Pigment Blue 61, providing a
structure-activity relationship (SAR)
argument in the test plan to justify that
request (Refs. 2 and 3). CPMA also
asked EPA to accept results for water
solubility and octanol/water partition
coefficient that were obtained by using
an alternative method, due to the
extremely low predicted solubility of
C.I. Pigment Blue 61, instead of the
methods specified by the test rule (Ref.
2). Finally, CPMA asked EPA to accept
that determining a melting point for C.I.
Pigment Blue 61 was not relevant
because the pigment thermally
decomposes before it melts (Ref. 2).
EPA reviewed the submitted
information on physical/chemical
properties and decided that melting
point, boiling point, and vapor pressure
determinations were not relevant
because C.I. Pigment Blue 61
decomposes before it melts and the
decomposition temperature had been
reported (Ref. 4). EPA accepted the
submitted data on water solubility as
satisfying the Agency’s data needs for
that endpoint, but did not accept the
calculated value submitted to satisfy the
testing requirement for octanol/water
partition coefficient (Ref. 4). EPA
believes the calculated value would,
most likely, underestimate the measured
value (Ref. 4) required to be determined
by the test rule.
EPA reviewed CPMA’s SAR argument
concerning C.I. Pigment Blue 61 and C.I.
Pigment Blue 56 and agreed that C.I.
Pigment Blue 56 is an acceptable
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emcdonald on DSK29S0YB1PROD with PROPOSALS
surrogate for C.I. Pigment Blue 61,
thereby allowing adequate data on C.I.
Pigment Blue 56 to satisfy data needs for
C.I. Pigment Blue 61 (Ref. 5). As a result,
a biodegradation study of C.I. Pigment
Blue 56, found adequate by an EPA
review, satisfies the need for
biodegradation data on C.I. Pigment
Blue 61 (Ref. 5). Likewise, a fish acute
toxicity study and a chromosomal
damage test of C.I. Pigment Blue 56,
which EPA reviewed and found
adequate, will satisfy the data need for
those endpoints (Ref. 6) for C.I. Pigment
Blue 61. EPA’s review of the existing
data on C.I. Pigment Blue 61 found the
study on mammalian acute toxicity and
the bacterial mutation assay to be
adequate to satisfy the data needs for
those endpoints (Ref. 6). The existing
study on repeated-dose toxicity,
however, did not satisfy the test
requirement for that endpoint (Ref. 6).
Therefore, EPA is proposing to revoke
the testing requirements for melting
point, boiling point, vapor pressure,
water solubility, biodegradation, fish
acute toxicity, mammalian acute
toxicity, bacterial reverse mutation, and
chromosomal damage for C.I. Pigment
Blue 61 by removing those requirements
from those listed for that chemical
substance in Table 2 in 40 CFR
799.5085(j). In order to clarify that test
requirements for acute toxicity to
Daphnia (an aquatic invertebrate) and
toxicity to algae had not been satisfied
by existing studies, and that the fish
acute toxicity test requirement had been
satisfied, the test symbol C2 replaces C1
for C.I. Pigment Blue 61 in Table 2 in
40 CFR 799.5085(j). The testing
requirements for C.I. Pigment Blue 61
that are not proposed to be revoked
include tests for octanol/water partition
coefficient, acute toxicity to Daphnia,
toxicity to algae, and combined 28-day
repeated-dose toxicity with a
reproduction/developmental toxicity
screen. Studies responding to those test
requirements were submitted to the
Agency. The full studies and robust
summaries (Ref. 7) are in the docket for
this proposed rule, docket ID number
EPA–HQ–OPPT–2005–0033.
IV. Public Comment
EPA received one adverse comment
concerning the March 16, 2012 direct
final rule that revoked some of the
testing requirements for C.I. Pigment
Blue 61 and nine other chemical
substances. The comment concerned the
statement in the preamble of the direct
final rule that certain full studies for C.I.
Pigment Blue 61 had been claimed as
CBI and were therefore not available to
the public, although robust summaries
were available in the docket. The
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commenter objected to EPA’s placing
the robust summaries in the docket
rather than applying the disclosure
requirements of TSCA section 14(b) to
the full health and safety studies. The
submitter of these studies has
subsequently withdrawn the CBI claim
on these studies. The full studies and
the adverse comment are included in
the docket for this proposed rule, docket
ID number EPA–HQ–OPPT–2005–0033.
V. Economic Analysis
In the economic impact analysis for
the final rule (Ref. 1) establishing testing
requirements for C.I. Pigment Blue 61
and 16 other chemical substances, the
Agency estimated the total testing cost
to industry to be $4.03 million for all 17
chemical substances included in that
final rule, with an average of
approximately $237,000 per chemical
substance (Ref. 8). This total included
an additional 25% in administrative
costs. An amendment to the final rule
revoking testing requirements for cokeoven light oil (coal) reduced the total
cost to industry to an estimated $3.7
million for the remaining 16 chemical
substances, with an average compliance
cost of approximately $232,000 per
chemical substance. This proposed rule,
combined with the direct final rule
revoking all or some of the test rule
requirements for 9 other chemical
substances (see Ref. 1), would have the
effect of further reducing the total
testing cost by an estimated $1.5 million
(approximately 41%) (Ref. 9). In
addition, the 25% administrative costs
would be eliminated for these tests. The
reduced total cost for the remaining 12
chemical substances is estimated to be
$2.2 million (i.e., $3.7 million—$1.5
million), with an average compliance
cost per chemical substance of
approximately $184,000 (Ref. 9).
VI. Export Notification
Persons who export or intend to
export C.I. Pigment Blue 61 are and will
remain subject to TSCA section 12(b)
export notification requirements (See 40
CFR part 707, subpart D).
VII. References
The following documents are
specifically referenced in the preamble
for this proposed rule. In addition to
these documents, other materials may
be available in the docket established
for this proposed rule under Docket ID
number EPA–HQ–OPPT–2005–0033,
which you can access through https://
www.regulations.gov. Those interested
in the information considered by EPA in
developing this proposed rule should
also consult documents that are
referenced in the documents that EPA
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has placed in the docket, regardless of
whether the other documents are
physically located in the docket.
1. EPA. Testing of Certain High Production
Volume Chemicals; Final Rule. Federal
Register (71 FR 13708, March 16, 2006)
(FRL–7335–2). Document ID number
EPA–HQ–OPPT–2005–0033–0001.
2. CPMA. Letter to EPA from J. Lawrence
Robinson concerning existing data and
test plan. July 17, 2006. Document ID
number EPA–HQ–OPPT–2005–0033–
0185.
3. CPMA. Letter to EPA from J. Lawrence
Robinson concerning existing data and
test plan. May 9, 2007. Document ID
EPA–HQ–OPPT–2005–0033–0246.
4. EPA. Memorandum from Diana Darling,
Industrial Chemistry Branch (ICB),
Economics, Exposure, and Technology
Division (EETD), OPPT to Greg Schweer,
Chemical Information and Testing
Branch (CITB), Chemical Control
Division (CCD), OPPT. Testing
requirements and existing data for
physical/chemical properties of the HPV
test rule chemical, C.I. Pigment Blue 61
(CAS No. 1324–76–1). May 17, 2007.
Document ID number EPA–HQ–OPPT–
2005–0033–0280.
5. EPA. Memorandum from Bob Boethling,
Exposure Assessment Branch (EAB),
OPPT to Greg Schweer, CITB, CCD,
OPPT. Review of SAR argument and a
biodegradation test concerning an HPV
test rule chemical, C.I. Pigment Blue 61
(CAS No. 1324–76–1). May 15, 2007.
Document ID number EPA–HQ–OPPT–
2005–0033–0279.
6. EPA. Email and attached review from
David Brooks, Risk Assessment Division
(RAD), OPPT to Greg Schweer and
Catherine Roman, CITB, CCD, OPPT.
Review of C.I. Pigment Blue (CAS No.
1324–76–1). August 22, 2007. Document
ID number EPA–HQ–OPPT–2005–0033–
0286.
7. CPMA. Robust summaries submitted for
C.I. Pigment Blue 61 on octanol/water
partition coefficient, acute toxicity to
Daphnia, toxicity to algae, and combined
28-day repeated-dose toxicity with a
reproduction/developmental toxicity
screen. Submitted on November 14,
2008. Document ID number EPA–HQ–
OPPT–2005–0033–0318.
8. EPA. Economic Analysis for the Final
Section 4 Test Rule for High Production
Volume Chemicals. Prepared by
Economic Policy and Analysis Branch
(EPAB), EETD, OPPT. October 28, 2005.
Document ID number EPA–HQ–OPPT–
2005–0033–0131.
9. EPA. Email from Stephanie Suazo to
Catherine Roman RE: ‘‘Revised
Economic Analysis for Revocation of
Testing Requirements’’ with attached
economic analysis. December 14, 2009.
(Document ID number EPA–HQ–OPPT–
2005–0033–0350).
VIII. Statutory and Executive Order
Reviews
This proposed rule only eliminates
existing requirements; it does not
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Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Proposed Rules
otherwise impose any new or revised
requirements. As such, this action is not
subject to review by the Office of
Management and Budget (OMB) as a
significant regulatory action under
Executive Order 12866, entitled
‘‘Regulatory Planning and Review’’ (58
FR 51735, October 4, 1993). Nor does it
impose or change any information
collection burden that requires
additional review by OMB under the
provisions of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).
Because this proposed rule eliminates
existing requirements without imposing
any new or revised requirements, the
Agency certifies pursuant to section
605(b) of the Regulatory Flexibility Act
(RFA) (5 U.S.C. 601 et seq.), that this
action will not have a significant
economic impact on a substantial
number of small entities.
For the same reasons, it is not subject
to the requirements of sections 202 and
205 of the Unfunded Mandates Reform
Act (UMRA) (2 U.S.C. 1531–1538), and
does not significantly or uniquely affect
small governments or impose a
significant intergovernmental mandate,
as described in UMRA sections 203 and
204. This proposed rule does not have
tribal implications, as specified in
Executive Order 13175, entitled
‘‘Consultation and Coordination with
Indian Tribal Governments’’ (65 FR
67249, November 9, 2000), or federalism
implications as specified in Executive
Order 13132, entitled ‘‘Federalism’’ (64
FR 43255, August 10, 1999).
Since this action is not economically
significant under Executive Order
12866, it is not subject to Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997), and Executive Order
13211, entitled ‘‘Actions concerning
Regulations that Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001).
This action does not involve technical
standards; thus, the requirements of
section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not
apply.
This proposed rule does not involve
special consideration of environmental
justice related issues as specified in
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
List of Subjects in 40 CFR Part 799
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: May 8, 2012.
James J. Jones,
Acting Assistant Administrator, Office of
Chemical Safety and Pollution Prevention.
Therefore, 40 CFR chapter I is
proposed to be amended as follows:
PART 799—[AMENDED]
1. The authority citation for part 799
continues to read as follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
2. In § 799.5085, revise the entry
‘‘CAS No. 1324–76–1’’ in Table 2 of
paragraph (j) to read as follows:
§ 799.5085 Chemical testing requirements
for certain high production volume
chemicals.
*
*
*
(j) * * *
*
*
TABLE 2—CHEMICAL SUBSTANCES AND TESTING REQUIREMENTS
CAS No.
*
Chemical name
*
*
1324–76–1 ..........................................
*
*
*
*
*
*
*
*
BILLING CODE 6560–50–P
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety
Administration
49 CFR Part 544
emcdonald on DSK29S0YB1PROD with PROPOSALS
[Docket No.: NHTSA–2012–0020]
RIN 2127–AL22
Insurer Reporting Requirements; List
of Insurers Required To File Reports
National Highway Traffic
Safety Administration (NHTSA),
Department of Transportation (DOT).
ACTION: Notice of proposed rulemaking.
AGENCY:
14:46 May 11, 2012
*
*
*
*
This document proposes to
amend appendices to NHTSA
regulations on Insurer Reporting
Requirements. The appendices list those
passenger motor vehicle insurers that
are required to file reports on their
motor vehicle theft loss experiences. An
insurer included in any of these
appendices would be required to file
three copies of its report for the 2009
calendar year before October 25, 2012.
If the passenger motor vehicle insurers
remain listed, they must submit reports
by each subsequent October 25. We are
proposing to add and remove several
insurers from relevant appendices.
SUMMARY:
[FR Doc. 2012–11491 Filed 5–11–12; 8:45 am]
VerDate Mar<15>2010
*
Benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5cyclohexadien-1-ylidene]methyl]phenyl]amino]-.
*
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Comments must be submitted
not later than July 13, 2012. Insurers
listed in the appendices are required to
submit reports on or before October 25,
2012.
DATES:
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Required tests/
(See Table 3 of
this section)
Class
*
2
A4, C2, F1.
*
You may submit comments,
identified by DOT Docket No. NHTSA–
2012–0020 by any of the following
methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov. Follow the
online instructions for submitting
comments.
• Mail: Docket Management Facility:
U.S. Department of Transportation, 1200
New Jersey Avenue SE., West Building,
Ground Floor, Room W12–140,
Washington, DC 20590–0001.
• Hand Delivery or Courier: West
Building Ground Floor, Room W12–140,
1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and
5 p.m. ET, Monday through Friday,
except Federal holidays.
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ADDRESSES:
E:\FR\FM\14MYP1.SGM
14MYP1
Agencies
[Federal Register Volume 77, Number 93 (Monday, May 14, 2012)]
[Proposed Rules]
[Pages 28340-28343]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11491]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[EPA-HQ-OPPT-2005-0033; FRL-9350-1]
RIN 2070-AD16
Revocation of TSCA Section 4 Testing Requirements for One High
Production Volume Chemical Substance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing the revocation of certain testing
requirements promulgated under the Toxic Substances Control Act (TSCA)
for benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylimino)-
2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]- (CAS No. 1324-76-1),
also known as C.I. Pigment Blue 61. EPA is basing its decision to take
this action on information received since publication of the final rule
that established testing requirements for this chemical substance.
DATES: Comments must be received on or before June 13, 2012.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2005-0033, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC.
Attention: Docket ID number EPA-HQ-OPPT-2005-0033. 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-
2005-0033. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at https://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at https://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, 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
https://www.regulations.gov, or, if only available in hard copy, at the
OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/
DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave. NW.,
Washington, DC. The EPA/DC Public Reading Room hours of operation are
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number of the EPA/DC Public Reading Room is
(202) 566-1744, and the telephone number for the OPPT Docket is (202)
566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be
[[Page 28341]]
provided an EPA/DC badge that must be visible at all times in the
building and returned upon departure.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Catherine Roman, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-8157; email address: roman.catherine@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action is directed to the public in general and may be of
particular interest to those persons who manufacture (defined by
statute to include import), process, or export the chemical substance
identified in this document. Because other persons may also be
interested, the Agency has not attempted to describe all the specific
persons that may be affected by this action. 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.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI.
Do not submit this information to EPA through regulations.gov or
email. Clearly mark the part or all of the information that you claim
to be CBI. For CBI information in a disk or CD-ROM that you mail to
EPA, mark the outside of the disk or CD-ROM 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 to amend the TSCA section 4(a) chemical testing
requirements for one high production volume (HPV) chemical included in
40 CFR 799.5085. Specifically, this amendment revokes some of the
testing requirements for C.I. Pigment Blue 61. EPA is basing its
decision to take this action on information (discussed in Unit III.)
received since publication of the final rule (Ref. 1) that established
testing requirements for this chemical substance.
In the Federal Register of March 16, 2012 (77 FR 15609) (FRL-9335-
6), EPA issued a revocation of some or all of the testing requirements
for 10 chemical substances by direct final rule. EPA received an
adverse comment concerning the chemical substance C.I. Pigment Blue 61.
Consequently, in accordance with the procedures described in the March
16, 2012 Federal Register document, EPA is withdrawing the revocation
of certain testing requirements for C.I. Pigment Blue 61 in a separate
document published elsewhere in today's Federal Register, and is now
issuing this proposed rule.
B. What is the Agency's authority for taking this action?
Section 4(a) of TSCA authorizes EPA to require testing if certain
findings are made. The TSCA section 4(a) findings include:
1. The chemical substance was produced in substantial quantities.
2. There are insufficient data upon which the effects of
manufacture, distribution, processing, use, or disposal of a chemical
substance on health or the environment can reasonably be determined or
predicted.
3. Testing of the chemical substance with respect to such effects
is necessary to develop such data. (See TSCA section 4(a)(1)(B)(i),
(ii), and (iii); see also Ref. 1).
EPA is amending the testing requirements for C.I. Pigment Blue 61
because some of the findings that EPA made for this chemical substance
are no longer supported.
III. Amendment to Chemical Testing Requirements
On July 17, 2006, the Color Pigments Manufacturers Association
(CPMA) submitted a test plan for C.I. Pigment Blue 61. CPMA also
submitted robust summaries of existing data which CPMA asked EPA to
accept as satisfying some of the Agency's data needs for C.I. Pigment
Blue 61. Some of the existing data described in the summaries addressed
C.I. Pigment Blue 56, a close analog of C.I. Pigment Blue 61, which
CPMA requested EPA to accept as satisfying the Agency's data needs for
C.I. Pigment Blue 61, providing a structure-activity relationship (SAR)
argument in the test plan to justify that request (Refs. 2 and 3). CPMA
also asked EPA to accept results for water solubility and octanol/water
partition coefficient that were obtained by using an alternative
method, due to the extremely low predicted solubility of C.I. Pigment
Blue 61, instead of the methods specified by the test rule (Ref. 2).
Finally, CPMA asked EPA to accept that determining a melting point for
C.I. Pigment Blue 61 was not relevant because the pigment thermally
decomposes before it melts (Ref. 2).
EPA reviewed the submitted information on physical/chemical
properties and decided that melting point, boiling point, and vapor
pressure determinations were not relevant because C.I. Pigment Blue 61
decomposes before it melts and the decomposition temperature had been
reported (Ref. 4). EPA accepted the submitted data on water solubility
as satisfying the Agency's data needs for that endpoint, but did not
accept the calculated value submitted to satisfy the testing
requirement for octanol/water partition coefficient (Ref. 4). EPA
believes the calculated value would, most likely, underestimate the
measured value (Ref. 4) required to be determined by the test rule.
EPA reviewed CPMA's SAR argument concerning C.I. Pigment Blue 61
and C.I. Pigment Blue 56 and agreed that C.I. Pigment Blue 56 is an
acceptable
[[Page 28342]]
surrogate for C.I. Pigment Blue 61, thereby allowing adequate data on
C.I. Pigment Blue 56 to satisfy data needs for C.I. Pigment Blue 61
(Ref. 5). As a result, a biodegradation study of C.I. Pigment Blue 56,
found adequate by an EPA review, satisfies the need for biodegradation
data on C.I. Pigment Blue 61 (Ref. 5). Likewise, a fish acute toxicity
study and a chromosomal damage test of C.I. Pigment Blue 56, which EPA
reviewed and found adequate, will satisfy the data need for those
endpoints (Ref. 6) for C.I. Pigment Blue 61. EPA's review of the
existing data on C.I. Pigment Blue 61 found the study on mammalian
acute toxicity and the bacterial mutation assay to be adequate to
satisfy the data needs for those endpoints (Ref. 6). The existing study
on repeated-dose toxicity, however, did not satisfy the test
requirement for that endpoint (Ref. 6).
Therefore, EPA is proposing to revoke the testing requirements for
melting point, boiling point, vapor pressure, water solubility,
biodegradation, fish acute toxicity, mammalian acute toxicity,
bacterial reverse mutation, and chromosomal damage for C.I. Pigment
Blue 61 by removing those requirements from those listed for that
chemical substance in Table 2 in 40 CFR 799.5085(j). In order to
clarify that test requirements for acute toxicity to Daphnia (an
aquatic invertebrate) and toxicity to algae had not been satisfied by
existing studies, and that the fish acute toxicity test requirement had
been satisfied, the test symbol C2 replaces C1 for C.I. Pigment Blue 61
in Table 2 in 40 CFR 799.5085(j). The testing requirements for C.I.
Pigment Blue 61 that are not proposed to be revoked include tests for
octanol/water partition coefficient, acute toxicity to Daphnia,
toxicity to algae, and combined 28-day repeated-dose toxicity with a
reproduction/developmental toxicity screen. Studies responding to those
test requirements were submitted to the Agency. The full studies and
robust summaries (Ref. 7) are in the docket for this proposed rule,
docket ID number EPA-HQ-OPPT-2005-0033.
IV. Public Comment
EPA received one adverse comment concerning the March 16, 2012
direct final rule that revoked some of the testing requirements for
C.I. Pigment Blue 61 and nine other chemical substances. The comment
concerned the statement in the preamble of the direct final rule that
certain full studies for C.I. Pigment Blue 61 had been claimed as CBI
and were therefore not available to the public, although robust
summaries were available in the docket. The commenter objected to EPA's
placing the robust summaries in the docket rather than applying the
disclosure requirements of TSCA section 14(b) to the full health and
safety studies. The submitter of these studies has subsequently
withdrawn the CBI claim on these studies. The full studies and the
adverse comment are included in the docket for this proposed rule,
docket ID number EPA-HQ-OPPT-2005-0033.
V. Economic Analysis
In the economic impact analysis for the final rule (Ref. 1)
establishing testing requirements for C.I. Pigment Blue 61 and 16 other
chemical substances, the Agency estimated the total testing cost to
industry to be $4.03 million for all 17 chemical substances included in
that final rule, with an average of approximately $237,000 per chemical
substance (Ref. 8). This total included an additional 25% in
administrative costs. An amendment to the final rule revoking testing
requirements for coke-oven light oil (coal) reduced the total cost to
industry to an estimated $3.7 million for the remaining 16 chemical
substances, with an average compliance cost of approximately $232,000
per chemical substance. This proposed rule, combined with the direct
final rule revoking all or some of the test rule requirements for 9
other chemical substances (see Ref. 1), would have the effect of
further reducing the total testing cost by an estimated $1.5 million
(approximately 41%) (Ref. 9). In addition, the 25% administrative costs
would be eliminated for these tests. The reduced total cost for the
remaining 12 chemical substances is estimated to be $2.2 million (i.e.,
$3.7 million--$1.5 million), with an average compliance cost per
chemical substance of approximately $184,000 (Ref. 9).
VI. Export Notification
Persons who export or intend to export C.I. Pigment Blue 61 are and
will remain subject to TSCA section 12(b) export notification
requirements (See 40 CFR part 707, subpart D).
VII. References
The following documents are specifically referenced in the preamble
for this proposed rule. In addition to these documents, other materials
may be available in the docket established for this proposed rule under
Docket ID number EPA-HQ-OPPT-2005-0033, which you can access through
https://www.regulations.gov. Those interested in the information
considered by EPA in developing this proposed rule should also consult
documents that are referenced in the documents that EPA has placed in
the docket, regardless of whether the other documents are physically
located in the docket.
1. EPA. Testing of Certain High Production Volume Chemicals; Final
Rule. Federal Register (71 FR 13708, March 16, 2006) (FRL-7335-2).
Document ID number EPA-HQ-OPPT-2005-0033-0001.
2. CPMA. Letter to EPA from J. Lawrence Robinson concerning existing
data and test plan. July 17, 2006. Document ID number EPA-HQ-OPPT-
2005-0033-0185.
3. CPMA. Letter to EPA from J. Lawrence Robinson concerning existing
data and test plan. May 9, 2007. Document ID EPA-HQ-OPPT-2005-0033-
0246.
4. EPA. Memorandum from Diana Darling, Industrial Chemistry Branch
(ICB), Economics, Exposure, and Technology Division (EETD), OPPT to
Greg Schweer, Chemical Information and Testing Branch (CITB),
Chemical Control Division (CCD), OPPT. Testing requirements and
existing data for physical/chemical properties of the HPV test rule
chemical, C.I. Pigment Blue 61 (CAS No. 1324-76-1). May 17, 2007.
Document ID number EPA-HQ-OPPT-2005-0033-0280.
5. EPA. Memorandum from Bob Boethling, Exposure Assessment Branch
(EAB), OPPT to Greg Schweer, CITB, CCD, OPPT. Review of SAR argument
and a biodegradation test concerning an HPV test rule chemical, C.I.
Pigment Blue 61 (CAS No. 1324-76-1). May 15, 2007. Document ID
number EPA-HQ-OPPT-2005-0033-0279.
6. EPA. Email and attached review from David Brooks, Risk Assessment
Division (RAD), OPPT to Greg Schweer and Catherine Roman, CITB, CCD,
OPPT. Review of C.I. Pigment Blue (CAS No. 1324-76-1). August 22,
2007. Document ID number EPA-HQ-OPPT-2005-0033-0286.
7. CPMA. Robust summaries submitted for C.I. Pigment Blue 61 on
octanol/water partition coefficient, acute toxicity to Daphnia,
toxicity to algae, and combined 28-day repeated-dose toxicity with a
reproduction/developmental toxicity screen. Submitted on November
14, 2008. Document ID number EPA-HQ-OPPT-2005-0033-0318.
8. EPA. Economic Analysis for the Final Section 4 Test Rule for High
Production Volume Chemicals. Prepared by Economic Policy and
Analysis Branch (EPAB), EETD, OPPT. October 28, 2005. Document ID
number EPA-HQ-OPPT-2005-0033-0131.
9. EPA. Email from Stephanie Suazo to Catherine Roman RE: ``Revised
Economic Analysis for Revocation of Testing Requirements'' with
attached economic analysis. December 14, 2009. (Document ID number
EPA-HQ-OPPT-2005-0033-0350).
VIII. Statutory and Executive Order Reviews
This proposed rule only eliminates existing requirements; it does
not
[[Page 28343]]
otherwise impose any new or revised requirements. As such, this action
is not subject to review by the Office of Management and Budget (OMB)
as a significant regulatory action under Executive Order 12866,
entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4,
1993). Nor does it impose or change any information collection burden
that requires additional review by OMB under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
Because this proposed rule eliminates existing requirements without
imposing any new or revised requirements, the Agency certifies pursuant
to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
et seq.), that this action will not have a significant economic impact
on a substantial number of small entities.
For the same reasons, it is not subject to the requirements of
sections 202 and 205 of the Unfunded Mandates Reform Act (UMRA) (2
U.S.C. 1531-1538), and does not significantly or uniquely affect small
governments or impose a significant intergovernmental mandate, as
described in UMRA sections 203 and 204. This proposed rule does not
have tribal implications, as specified in Executive Order 13175,
entitled ``Consultation and Coordination with Indian Tribal
Governments'' (65 FR 67249, November 9, 2000), or federalism
implications as specified in Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999).
Since this action is not economically significant under Executive
Order 12866, it is not subject to Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), and Executive Order 13211,
entitled ``Actions concerning Regulations that Significantly Affect
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001).
This action does not involve technical standards; thus, the
requirements of section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.
This proposed rule does not involve special consideration of
environmental justice related issues as specified in Executive Order
12898, entitled ``Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations'' (59 FR 7629, February
16, 1994).
List of Subjects in 40 CFR Part 799
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: May 8, 2012.
James J. Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
Therefore, 40 CFR chapter I is proposed to be amended as follows:
PART 799--[AMENDED]
1. The authority citation for part 799 continues to read as
follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
2. In Sec. 799.5085, revise the entry ``CAS No. 1324-76-1'' in
Table 2 of paragraph (j) to read as follows:
Sec. 799.5085 Chemical testing requirements for certain high
production volume chemicals.
* * * * *
(j) * * *
Table 2--Chemical Substances and Testing Requirements
----------------------------------------------------------------------------------------------------------------
Required tests/ (See Table 3
CAS No. Chemical name Class of this section)
----------------------------------------------------------------------------------------------------------------
* * * * * * *
1324-76-1.............................. Benzenesulfonic acid, [[4-[[4- 2 A4, C2, F1.
(phenylamino)phenyl][4-
(phenylimino)-2,5-
cyclohexadien-1-
ylidene]methyl]phenyl]amino]-.
* * * * * * *
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* * * * *
[FR Doc. 2012-11491 Filed 5-11-12; 8:45 am]
BILLING CODE 6560-50-P