Revocation of TSCA Section 4 Testing Requirements for One High Production Volume Chemical Substance, 27860-27863 [2013-11313]
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Federal Register / Vol. 78, No. 92 / Monday, May 13, 2013 / Rules and Regulations
1. The authority citation continues to
read as follows:
■
Authority: 5 U.S.C. 301, R.S. 463 and 465;
25 U.S.C. 2 and 9. Interpret or apply sec. 3,
26 Stat. 795, sec. 1, 28 Stat. 305, secs. 1, 2,
31 Stat. 229, 246, secs. 7, 12, 34 Stat. 545,
34 Stat. 1015, 1034, 35 Stat. 70, 95, 97, sec.
4, 36 Stat. 856, sec. 1, 39 Stat. 128, 41 Stat.
415, as amended, 751, 1232, sec. 17, 43 Stat.
636, 641, 44 Stat. 658, as amended, 894,
1365, as amended, 47 Stat. 1417, sec. 17, 48
Stat. 984, 988, 49 Stat. 115, 1135, sec. 55, 49
Stat. 781, sec. 3, 49 Stat. 1967, 54 Stat. 745,
1057, 60 Stat. 308, secs. 1, 2, 60 Stat. 962,
sec. 5, 64 Stat. 46, secs. 1, 2, 4, 5, 6, 64 Stat.
470, 69 Stat. 539, 540, 72 Stat. 968, 107 Stat.
2011, 108 Stat. 4572, March 20, 1996, 110
Stat. 4016; 25 U.S.C. 380, 393, 393a, 394, 395,
397, 402, 402a, 403, 403a, 403b, 403c, 409a,
413, 415, 415a, 415b, 415c, 415d, 416, 477,
635, 2201 et seq., 3701, 3702, 3703, 3712,
3713, 3714, 3715, 3731, 3733, 4211; 44 U.S.C.
3101 et seq.
2. Under the heading Subpart F—
Special Requirements for Certain
Reservations, redesignate §§ 162.500
through 162.503, as §§ 162.600 through
162.603.
■
Dated: May 3, 2013.
Kevin K. Washburn,
Assistant Secretary—Indian Affairs.
[FR Doc. 2013–11241 Filed 5–10–13; 8:45 am]
BILLING CODE 4310–6W–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 799
[EPA–HQ–OPPT–2005–0033; FRL–9369–1]
RIN 2070–AD16
Revocation of TSCA Section 4 Testing
Requirements for One High Production
Volume Chemical Substance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: This final rule implements
EPA’s decision to revoke certain testing
requirements promulgated under the
Toxic Substance Control Act (TSCA) for
the High Production Volume (HPV)
chemical substance, 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. After publication in
the Federal Register of a final rule
requiring testing for C.I. Pigment Blue
61, EPA received adequate, existing
studies which eliminated the need for
testing.
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This final rule is effective June
12, 2013.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPPT–2005–0033, is
available at https://www.regulations.gov
or at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket),
Environmental Protection Agency
Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket is (202)
566–0280. Please review the visitor
instructions and additional information
about the docket available at https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact:
Yvonne Gonzalez, Chemical Control
Division, Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460–0001; telephone
number: (202) 564–2912; email address:
gonzalez.yvonne@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: TSCAHotline@epa.gov.
SUPPLEMENTARY INFORMATION:
DATES:
PART 162—LEASES and PERMITS
I. 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.
II. Background
A. What action is the Agency taking?
In this document, EPA is amending
the TSCA section 4(a) chemical testing
requirements for one HPV chemical
substance included in 40 CFR 799.5085.
Specifically, the amendment revokes
some of the testing requirements for C.I.
Pigment Blue 61. EPA bases its decision
on information (discussed in Unit III.)
received since publication of the final
rule (Ref. 1) that established testing
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requirements for this chemical
substance.
In the Federal Register issue of March
16, 2012 (Ref. 2), EPA issued a direct
final rule revoking some or all of the
testing requirements for 10 chemical
substances, including C.I. Pigment Blue
61. EPA received an adverse comment
pertaining to a statement in the
preamble of the direct final rule that
certain full studies for C.I. Pigment Blue
61 had been claimed as Confidential
Business Information (CBI) and were,
therefore, not available to the public,
although robust summaries were
available in the docket. The
Environmental Defense Fund (EDF)
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. Consequently, in
accordance with the procedures
described in the March 16, 2012 Federal
Register document (Ref. 2), EPA
withdrew the revocation of certain
testing requirements for C.I. Pigment
Blue 61 in a separate final rule
document published in the Federal
Register issue of May 14, 2012 (Ref. 3),
and also published a proposed rule
document in the same Federal Register
issue (Ref. 4) asking for comment. EPA
is now issuing the final rule based on
the May 14, 2012 Federal Register
proposed rule document (Ref. 4).
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 amends the testing requirements
for C.I. Pigment Blue 61 because some
of the findings that EPA made under the
criteria listed in this unit 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
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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, arguing that there
was a sufficiently close structureactivity relationship (SAR) between the
two chemical substances to justify that
request (Refs. 5 and 6). 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.
5). 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. 5).
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. 7). 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. 7). EPA
believes the calculated value would,
most likely, underestimate the measured
value (Ref. 7) 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
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. 8). 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. 8). 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. 9) 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 reverse mutation assay to
be adequate to satisfy the data needs for
those endpoints (Ref. 9). The existing
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study on repeated-dose toxicity,
however, did not satisfy the test
requirement for that endpoint (Ref. 9).
Therefore, EPA is revoking 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 has
not been satisfied by existing studies,
and that the fish acute toxicity test
requirement has 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
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 conducted
and submitted pursuant to the test rule
and found by EPA to be adequate (Refs.
10–18)).
IV. Public Comment
Only one comment was received,
from EDF, on the May 14, 2012 Federal
Register proposed rule document (Ref.
4). The EDF comment indicated support
for the May 14, 2012 Federal Register
proposed rule document (Ref. 4) that
revoked some of the testing
requirements for C.I. Pigment Blue 61.
The EDF acknowledged steps were
taken to address the concerns that
motivated the previous filing of an
adverse comment. Namely, the
submitter of the C.I. Pigment Blue 61
studies had withdrawn the CBI claim on
the studies and the studies were made
available to the public. The full studies
and EDF’s comment are included in the
docket for the May 14, 2012 Federal
Register proposed rule document
(Ref. 4).
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. 19). This total included
an additional 25% in administrative
costs. An amendment to the final rule
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27861
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 final 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. 20). In
addition, the 25% administrative costs
would be eliminated for these tests. The
reduced total cost for the remaining 12
chemicals is estimated to be $2.2
million (i.e., $3.7 million minus $1.5
million), with an average compliance
cost per chemical substance of
approximately $184,000 (Ref. 20).
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
As indicated under ADDRESSES, a
docket has been established for this
final rule under docket ID number EPA–
HQ–OPPT–2005–0033. The following is
a listing of the documents that are
specifically referenced in this action.
The docket includes these documents
and other information considered by
EPA, including documents that are
referenced within the documents that
are included in the docket, even if the
referenced document is not physically
located in the docket. For assistance in
locating these other documents, please
consult the technical person listed
under FOR FURTHER INFORMATION
CONTACT.
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. EPA. Revocation of TSCA Section 4
Testing Requirements Certain High
Production Volume Chemical
Substances; Direct Final Rule. Federal
Register (77 FR 15609, March 16, 2012)
(FRL–9335–6). Document ID number
EPA–HQ–OPPT–2005–0033–0402.
3. EPA. Withdrawal of Revocation of TSCA
Section 4 Testing Requirements for One
High Production Volume Chemical
Substance; Final Rule. Federal Register
(77 FR 28281, May 14, 2012) (FRL–9350–
2). Document ID number EPA–HQ–
OPPT–2005–0033–0414.
4. EPA. Revocation of TSCA Section 4
Testing Requirements for One High
Production Volume Chemical Substance;
Proposed Rule. Federal Register (77 FR
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28340, May 14, 2012) (FRL–9350–1).
Document EPA–HQ–OPPT–2005–0033–
0415.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. CPMA. Octanol/Water Partition
Coefficient Test study with C.I. Pigment
Blue 61. Submitted on April 13, 2012.
Document ID number EPA–HQ–OPPT–
2005–0033–0440.
12. CPMA. Acute Toxicity Study in the
Daphnia Magna with C.I. Pigment Blue
61. Submitted on April 13, 2012.
Document ID number EPA–HQ–OPPT–
2005–0033–0443.
13. CPMA. Fresh Water Algal Growth
Inhibition Test with C.I. Pigment Blue 61
study. Submitted on April 13, 2012.
Document ID number EPA–HQ–OPPT–
2005–0033–0442.
14. CPMA. A Combined 28-Day Repeated
Dose Toxicity Study with the
Reproduction/Developmental Toxicity
Screening Test Study of C.I. Pigment
Blue 61 of Rats by Oral Gavage.
Submitted on April 13, 2012. Document
ID number EPA–HQ–OPPT–2005–0033–
0445.
15. EPA. Memorandum and attached review
from Tracy Williamson, ICB, EETD,
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OPPT, to Jim Willis, CITB, CCD, OPPT.
Review of Determination of Log Kow for
C.I. Pigment Blue 61. Submitted January
20, 2010. Document ID number EPA–
HQ–OPPT–0033–0404.
16. EPA. Email and attached review from
Ryan Wallace, EAD, OPPT, to Jeff
Santacroce, RDMB, IMD, OPPT; Scott
Sherlock, EAD, OPPT; and Catherine
Roman, CITB, CCD, OPPT. Review of
acute toxicity to Daphnia of C.I. Pigment
Blue 61(CAS No. 1324–76–1). Submitted
June 14, 2012. Document ID number
EPA–HQ–OPPT–2005–0033–0450.
17. EPA. Email and attached review from
Ryan Wallace, EAD, OPPT, to Jeff
Santacroce, RDMB, IMD, OPPT; Scott
Sherlock, EAD, OPPT; and Catherine
Roman, CITB, CCD, OPPT. Review of
toxicity to algae of C.I. Pigment Blue 61
(CAS No. 1324–76–1). Submitted July 11,
2012. Document ID number EPA–HQ–
OPPT–2005–0033–0453.
18. EPA. Email and attached review from
Ryan Wallace, EAD, OPPT, to Jeff
Santacroce, RDMB, IMD, OPPT; Scott
Sherlock, EAD, OPPT; and Catherine
Roman, CITB, CCD, OPPT. Review of
repeat-dose toxicity of C.I. Pigment Blue
61 (CAS No. 1324–76–1). Submitted June
14, 2012. Document ID number EPA–
HQ–OPPT–2005–0033–0448.
19. 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.
20. 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 final rule only eliminates
existing requirements; it does not
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 (PRA) (44 U.S.C. 3501 et
seq.).
Because this final 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.
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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 final 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.
The final 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).
IX. Congressional Review Act (CRA)
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 799
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: May 6, 2013.
James Jones,
Acting Assistant Administrator, Office of
Chemical Safety and Pollution Prevention.
Therefore, 40 CFR chapter I is
amended as follows:
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Authority: 15 U.S.C. 2603, 2611, 2625.
PART 799—[AMENDED]
2. In § 799.5085, revise CAS No.
‘‘1324–76–1’’ in Table 2 of paragraph (j)
to read as follows:
■
1. The authority citation for part 799
continues to read as follows:
■
§ 799.5085 Chemical testing requirements
for first group of high production volume
chemicals (HPV1).
*
*
*
(j) * * *
*
*
TABLE 2—CHEMICAL SUBSTANCES AND TESTING REQUIREMENTS
CAS No.
Chemical name
*
1324–76–1 ........
*
*
*
*
Benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1ylidene]methyl]phenyl]amino]-
*
*
*
*
*
*
*
*
BILLING CODE 6560–50–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 679
[Docket No. 120918468–3111–02]
RIN 0648–XC673
Fisheries of the Exclusive Economic
Zone Off Alaska; Big Skate in the
Central Regulatory Area of the Gulf of
Alaska
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; closure.
AGENCY:
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SUMMARY: NMFS is prohibiting retention
of big skate in the Central Regulatory
Area of the Gulf of Alaska (GOA). This
action is necessary because the 2013
total allowable catch of big skate in the
Central Regulatory Area of the GOA has
been reached.
DATES: Effective 1200 hrs, Alaska local
time (A.l.t.), May 8, 2013, through 2400
hrs, A.l.t., December 31, 2013.
FOR FURTHER INFORMATION CONTACT:
Obren Davis, 907–586–7228.
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2
*
A4, C2, F1.
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NMFS
manages the groundfish fishery in the
GOA exclusive economic zone
according to the Fishery Management
Plan for Groundfish of the Gulf of
Alaska (FMP) prepared by the North
Pacific Fishery Management Council
under authority of the MagnusonStevens Fishery Conservation and
Management Act. Regulations governing
fishing by U.S. vessels in accordance
with the FMP appear at subpart H of 50
CFR part 600 and 50 CFR part 679.
The 2013 total allowable catch (TAC)
of big skate in the Central Regulatory
Area of the GOA is 1,793 metric tons
(mt) as established by the final 2013 and
2014 harvest specifications for
groundfish of the GOA (78 FR 13162,
February 26, 2013).
In accordance with § 679.20(d)(2), the
Administrator, Alaska Region, NMFS
(Regional Administrator), has
determined that the 2013 TAC of big
skate in the Central Regulatory Area of
the GOA has been reached. Therefore,
NMFS is requiring that big skate caught
in the Central Regulatory Area of the
GOA be treated as prohibited species in
accordance with § 679.21(b).
requirement to provide prior notice and
opportunity for public comment
pursuant to the authority set forth at 5
U.S.C. 553(b)(B) as such requirement is
impracticable and contrary to the public
interest. This requirement is
impracticable and contrary to the public
interest as it would prevent NMFS from
responding to the most recent fisheries
data in a timely fashion and would
delay prohibiting the retention of big
skate in the Central Regulatory Area of
the GOA. NMFS was unable to publish
a notice providing time for public
comment because the most recent,
relevant data only became available as
of May 7, 2013.
The AA also finds good cause to
waive the 30-day delay in the effective
date of this action under 5 U.S.C.
553(d)(3). This finding is based upon
the reasons provided above for waiver of
prior notice and opportunity for public
comment.
This action is required by § 679.20
and § 679.21 and is exempt from review
under Executive Order 12866.
Classification
Dated: May 8, 2013.
James P. Burgess,
Acting Deputy Director, Office of Sustainable
Fisheries, National Marine Fisheries Service.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2013–11313 Filed 5–10–13; 8:45 am]
Required tests
(see table 3 of
this section)
Class
This action responds to the best
available information recently obtained
from the fishery. The Acting Assistant
Administrator for Fisheries, NOAA
(AA), finds good cause to waive the
PO 00000
Frm 00011
Fmt 4700
Sfmt 9990
Authority: 16 U.S.C. 1801 et seq.
[FR Doc. 2013–11311 Filed 5–8–13; 4:15 pm]
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E:\FR\FM\13MYR1.SGM
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Agencies
[Federal Register Volume 78, Number 92 (Monday, May 13, 2013)]
[Rules and Regulations]
[Pages 27860-27863]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11313]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[EPA-HQ-OPPT-2005-0033; FRL-9369-1]
RIN 2070-AD16
Revocation of TSCA Section 4 Testing Requirements for One High
Production Volume Chemical Substance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule implements EPA's decision to revoke certain
testing requirements promulgated under the Toxic Substance Control Act
(TSCA) for the High Production Volume (HPV) chemical substance,
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. After publication in the Federal
Register of a final rule requiring testing for C.I. Pigment Blue 61,
EPA received adequate, existing studies which eliminated the need for
testing.
DATES: This final rule is effective June 12, 2013.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2005-0033, is available at
https://www.regulations.gov or at the Office of Pollution Prevention and
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is (202) 566-1744, and the telephone
number for the OPPT Docket is (202) 566-0280. Please review the visitor
instructions and additional information about the docket available at
https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Yvonne Gonzalez, Chemical
Control Division, Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number: (202) 564-2912; email
address: gonzalez.yvonne@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. 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.
II. Background
A. What action is the Agency taking?
In this document, EPA is amending the TSCA section 4(a) chemical
testing requirements for one HPV chemical substance included in 40 CFR
799.5085. Specifically, the amendment revokes some of the testing
requirements for C.I. Pigment Blue 61. EPA bases its decision 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 issue of March 16, 2012 (Ref. 2), EPA
issued a direct final rule revoking some or all of the testing
requirements for 10 chemical substances, including C.I. Pigment Blue
61. EPA received an adverse comment pertaining to a statement in the
preamble of the direct final rule that certain full studies for C.I.
Pigment Blue 61 had been claimed as Confidential Business Information
(CBI) and were, therefore, not available to the public, although robust
summaries were available in the docket. The Environmental Defense Fund
(EDF) 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. Consequently, in accordance with
the procedures described in the March 16, 2012 Federal Register
document (Ref. 2), EPA withdrew the revocation of certain testing
requirements for C.I. Pigment Blue 61 in a separate final rule document
published in the Federal Register issue of May 14, 2012 (Ref. 3), and
also published a proposed rule document in the same Federal Register
issue (Ref. 4) asking for comment. EPA is now issuing the final rule
based on the May 14, 2012 Federal Register proposed rule document (Ref.
4).
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 amends the testing requirements for C.I. Pigment Blue 61
because some of the findings that EPA made under the criteria listed in
this unit 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
[[Page 27861]]
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,
arguing that there was a sufficiently close structure-activity
relationship (SAR) between the two chemical substances to justify that
request (Refs. 5 and 6). 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. 5). 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.
5).
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. 7). 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. 7). EPA
believes the calculated value would, most likely, underestimate the
measured value (Ref. 7) 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 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. 8). 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. 8). 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. 9) 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 reverse mutation assay to be
adequate to satisfy the data needs for those endpoints (Ref. 9). The
existing study on repeated-dose toxicity, however, did not satisfy the
test requirement for that endpoint (Ref. 9).
Therefore, EPA is revoking 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 has not been satisfied by existing studies, and
that the fish acute toxicity test requirement has 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 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 conducted
and submitted pursuant to the test rule and found by EPA to be adequate
(Refs. 10-18)).
IV. Public Comment
Only one comment was received, from EDF, on the May 14, 2012
Federal Register proposed rule document (Ref. 4). The EDF comment
indicated support for the May 14, 2012 Federal Register proposed rule
document (Ref. 4) that revoked some of the testing requirements for
C.I. Pigment Blue 61. The EDF acknowledged steps were taken to address
the concerns that motivated the previous filing of an adverse comment.
Namely, the submitter of the C.I. Pigment Blue 61 studies had withdrawn
the CBI claim on the studies and the studies were made available to the
public. The full studies and EDF's comment are included in the docket
for the May 14, 2012 Federal Register proposed rule document (Ref. 4).
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. 19). 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 final 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. 20). In addition, the 25% administrative
costs would be eliminated for these tests. The reduced total cost for
the remaining 12 chemicals is estimated to be $2.2 million (i.e., $3.7
million minus $1.5 million), with an average compliance cost per
chemical substance of approximately $184,000 (Ref. 20).
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
As indicated under ADDRESSES, a docket has been established for
this final rule under docket ID number EPA-HQ-OPPT-2005-0033. The
following is a listing of the documents that are specifically
referenced in this action. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
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. EPA. Revocation of TSCA Section 4 Testing Requirements Certain
High Production Volume Chemical Substances; Direct Final Rule.
Federal Register (77 FR 15609, March 16, 2012) (FRL-9335-6).
Document ID number EPA-HQ-OPPT-2005-0033-0402.
3. EPA. Withdrawal of Revocation of TSCA Section 4 Testing
Requirements for One High Production Volume Chemical Substance;
Final Rule. Federal Register (77 FR 28281, May 14, 2012) (FRL-9350-
2). Document ID number EPA-HQ-OPPT-2005-0033-0414.
4. EPA. Revocation of TSCA Section 4 Testing Requirements for One
High Production Volume Chemical Substance; Proposed Rule. Federal
Register (77 FR
[[Page 27862]]
28340, May 14, 2012) (FRL-9350-1). Document EPA-HQ-OPPT-2005-0033-
0415.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. CPMA. Octanol/Water Partition Coefficient Test study with C.I.
Pigment Blue 61. Submitted on April 13, 2012. Document ID number
EPA-HQ-OPPT-2005-0033-0440.
12. CPMA. Acute Toxicity Study in the Daphnia Magna with C.I.
Pigment Blue 61. Submitted on April 13, 2012. Document ID number
EPA-HQ-OPPT-2005-0033-0443.
13. CPMA. Fresh Water Algal Growth Inhibition Test with C.I. Pigment
Blue 61 study. Submitted on April 13, 2012. Document ID number EPA-
HQ-OPPT-2005-0033-0442.
14. CPMA. A Combined 28-Day Repeated Dose Toxicity Study with the
Reproduction/Developmental Toxicity Screening Test Study of C.I.
Pigment Blue 61 of Rats by Oral Gavage. Submitted on April 13, 2012.
Document ID number EPA-HQ-OPPT-2005-0033-0445.
15. EPA. Memorandum and attached review from Tracy Williamson, ICB,
EETD, OPPT, to Jim Willis, CITB, CCD, OPPT. Review of Determination
of Log Kow for C.I. Pigment Blue 61. Submitted January 20, 2010.
Document ID number EPA-HQ-OPPT-0033-0404.
16. EPA. Email and attached review from Ryan Wallace, EAD, OPPT, to
Jeff Santacroce, RDMB, IMD, OPPT; Scott Sherlock, EAD, OPPT; and
Catherine Roman, CITB, CCD, OPPT. Review of acute toxicity to
Daphnia of C.I. Pigment Blue 61(CAS No. 1324-76-1). Submitted June
14, 2012. Document ID number EPA-HQ-OPPT-2005-0033-0450.
17. EPA. Email and attached review from Ryan Wallace, EAD, OPPT, to
Jeff Santacroce, RDMB, IMD, OPPT; Scott Sherlock, EAD, OPPT; and
Catherine Roman, CITB, CCD, OPPT. Review of toxicity to algae of
C.I. Pigment Blue 61 (CAS No. 1324-76-1). Submitted July 11, 2012.
Document ID number EPA-HQ-OPPT-2005-0033-0453.
18. EPA. Email and attached review from Ryan Wallace, EAD, OPPT, to
Jeff Santacroce, RDMB, IMD, OPPT; Scott Sherlock, EAD, OPPT; and
Catherine Roman, CITB, CCD, OPPT. Review of repeat-dose toxicity of
C.I. Pigment Blue 61 (CAS No. 1324-76-1). Submitted June 14, 2012.
Document ID number EPA-HQ-OPPT-2005-0033-0448.
19. 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.
20. 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 final rule only eliminates existing requirements; it does not
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 (PRA) (44 U.S.C. 3501 et seq.).
Because this final 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 final 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.
The final 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).
IX. Congressional Review Act (CRA)
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 799
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: May 6, 2013.
James Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
Therefore, 40 CFR chapter I is amended as follows:
[[Page 27863]]
PART 799--[AMENDED]
0
1. The authority citation for part 799 continues to read as follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
0
2. In Sec. 799.5085, revise CAS No. ``1324-76-1'' in Table 2 of
paragraph (j) to read as follows:
Sec. 799.5085 Chemical testing requirements for first group of high
production volume chemicals (HPV1).
* * * * *
(j) * * *
Table 2--Chemical Substances and Testing Requirements
----------------------------------------------------------------------------------------------------------------
Required tests (see table 3 of
CAS No. Chemical name Class this section)
----------------------------------------------------------------------------------------------------------------
* * * * * * *
1324-76-1........................ Benzenesulfonic acid, [[4- 2 A4, C2, F1.
[[4-(phenylamino)phenyl][4-
(phenylimino)-2,5-
cyclohexadien-1-
ylidene]methyl]phenyl]amin
o]-
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
[FR Doc. 2013-11313 Filed 5-10-13; 8:45 am]
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