Document ID: EPA-HQ-OPPT-2005-0033-0468
Agency: epa
Document Type: Rule
Title: Revocation of Toxic Substance Control Act Testing Requirements: One High Production Volume Chemical Substance
Posted Date: 2013-05-13T04:00Z

[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.

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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 
http://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 
http://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).

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    (j) * * *

                              Table 2--Chemical Substances and Testing Requirements
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                                                                                 Required tests (see table 3 of
             CAS No.                      Chemical name              Class                this section)
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                                                  * * * * * * *
1324-76-1........................  Benzenesulfonic acid, [[4-                2  A4, C2, F1.
                                    [[4-(phenylamino)phenyl][4-
                                    (phenylimino)-2,5-
                                    cyclohexadien-1-
                                    ylidene]methyl]phenyl]amin
                                    o]-
 
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[FR Doc. 2013-11313 Filed 5-10-13; 8:45 am]
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