Document ID: EPA-HQ-OPPT-2005-0033-0415
Agency: epa
Document Type: Proposed Rule
Title: Revocation of Toxic Substances Control Act  Section 4 Testing Requirements: One High Production Volume Chemical Substance
Posted Date: 2012-05-14T04:00Z

[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: http://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 http://www.regulations.gov, including any personal information provided, 
unless the comment includes information claimed to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Do not submit information that you consider to 
be CBI or otherwise protected through regulations.gov or 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 http://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 
http://www.regulations.gov, or, if only available in hard copy, at the 
OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/
DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave. NW., 
Washington, DC. The EPA/DC Public Reading Room hours of operation are 
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 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 
http://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
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                                                                                   Required tests/ (See Table 3
                CAS No.                           Chemical name           Class          of this section)
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                                                  * * * * * * *
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