[Federal Register: October 6, 2006 (Volume 71, Number 194)]
[Proposed Rules]
[Page 59066-59069]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06oc06-16]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2006-0213; FRL-7770-9]
RIN 2070-AB27
Proposed Revocation of Significant New Use Rules on Certain
Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to revoke significant new use rules (SNURs)
promulgated under section 5(a)(2) of the Toxic Substances Control Act
(TSCA) for four chemical substances. The SNUR for the chemical
substance covered by premanufacture notice (PMN) P-98-475 designated
certain activities as significant new uses based on concerns identified
in a corresponding TSCA section 5(e) consent order for that chemical
substance and pursuant to 40 CFR 721.160. For the chemical substances
covered by PMNs P-98-1043, P-99-0467, and P-01-71, EPA issued non-5(e)
SNURs (i.e., SNURS on substances that are not subject to TSCA section
5(e) consent orders) designating certain activities as significant new
uses based on the concern criteria in 40 CFR 721.170(b). EPA has
received and reviewed new information and test data for each of the
chemical substances, and proposes to revoke the SNURs pursuant to 40
CFR 721.185.
DATES: Comments must be received on or before November 6, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2006-0213, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID number EPA-HQ-OPPT-2006-0213. 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.
[[Page 59067]]
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2006-0213. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the public 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
regulations.gov index. Although listed in the index, some information
is not publicly available, e.g., CBI or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available electronically at
http://www.regulations.gov, or, if only available in hard copy, at the
OPPT Docket, EPA Docket Center (EPA/DC). The EPA/DC suffered structural
damage due to flooding in June 2006. Although the EPA/DC is continuing
operations, there will be temporary changes to the EPA/DC during the
clean-up. The EPA/DC Public Reading Room, which was temporarily closed
due to flooding, has been relocated in the EPA Headquarters Library,
Infoterra Room (Room Number 3334) in the EPA West Bldg., located at
1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading
Room is open from 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. EPA visitors are required to show
photographic identification and sign the EPA visitor log. Visitors to
the EPA/DC Public Reading Room will be provided with an EPA/DC badge
that must be visible at all times while in the EPA Building and
returned to the guard upon departure. In addition, security personnel
will escort visitors to and from the new EPA/DC Public Reading Room
location. Up-to-date information about the EPA/DC is on the EPA web
site at http://www.epa.gov/epahome/dockets.htm.
FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address:
TSCA-Hotline@epa.gov.
For technical information contact: James Alwood, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-8974; e-mail
address: alwood.jim@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture,
import, process, or use the chemical substances contained in this
proposed revocation. Potentially affected entities may include, but are
not limited to:
Chemical manufacturers (NAICS code 325), e.g., persons
manufacturing, importing, processing, or using chemicals for commercial
purposes.
Petroleum and coal product industries (NAICS code 324),
e.g., persons manufacturing, importing, processing, or using chemicals
for commercial purposes.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in 40 CFR 721.5. If you
have any questions regarding the applicability of this action to a
particular entity, consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed 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 the estimate.
vi. Provide specific examples to illustrate your concerns and
suggested 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?
In the documents that published in the Federal Register of January
5, 2000 (65 FR 373, 374) (FRL-6055-2), December 26, 2000 (65 FR 81400)
(FRL-6592-8), and December 17, 2003 (68 FR
[[Page 59068]]
70179) (FRL-7307-3), EPA issued separate SNURs for four separate
chemical substances. The SNUR for the chemical substance covered by PMN
P-98-475 designated certain activities as significant new uses based on
concerns identified in a corresponding TSCA section 5(e) consent order
for that chemical substance and pursuant to 40 CFR 721.160. For the
other three chemical substances covered by PMNs P-98-1043, P-99-0467,
and P-01-71, EPA issued non-5(e) SNURs designating certain activities
as significant new uses based on the concern criteria identified in 40
CFR 721.170(b). EPA has received and reviewed new information and test
data for each of these four chemical substances, and, based on that
information and test data, EPA now proposes to revoke the SNURs
pursuant to 40 CFR 721.185. In this unit, EPA provides a brief
description for each chemical substance, including its PMN number,
chemical name (generic name if the specific name is claimed as CBI),
CAS number (if assigned and not claimed as CBI), basis for the
revocation of the TSCA section 5(e) consent order, if any, for the
substance, the basis for revoking the SNUR under 40 CFR 721.185, and
the CFR citation of the SNUR.
PMN Number P-98-475
Chemical name: Benzenesulfonic acid, 2,2'-[(1E)-1,2-ethenediyl] bis[5-
[[4-(methylamino)-6-[[4-[(methylamino)carbonyl-phenyl]amino]-1,3,5-
triazin-2-yl]amino]-,disodium salt.
CAS number: 180850-95-7.
Federal Register publication date and reference: January 5, 2000 (65 FR
373).
Docket number: OPPTS-50635.
Basis for revocation of SNUR: EPA issued a TSCA section 5(e) consent
order between EPA and the PMN submitter for this substance based on a
potential unreasonable risk of developmental and reproductive toxicity
of the PMN substance, based on test data for the chemical category for
stilbene, derivatives of 4,4-bis(triazin-2-ylamino)-. EPA also
promulgated a SNUR for this chemical substance pursuant to 40 CFR
721.160. Subsequently, an industry consortium conducted a range-finding
and definitive 2-generation study in rats (gavage) and range-finding
and definitive developmental toxicity studies in rats and rabbits
(gavage) for C.I. Fluorescent Brightener 220 (CAS No. 16470-24-9).
Based on the results of that testing, EPA has concluded that available
information does not support continued identification of stilbenes as a
new chemical category presenting concerns for possible developmental
and reproductive toxicity. Thus, EPA concludes that a rational basis no
longer exists for finding that activities involving the chemical
substance may present an unreasonable risk of injury to human health as
required by section 5(e)(1)(A) of TSCA. Therefore, EPA has revoked the
consent order for P-98-475 and, pursuant to 40 CFR 721.185(a)(5),
proposes that the SNUR for this chemical substance be revoked.
CFR citation: 40 CFR 721.9785.
PMN Number P-98-1043
Chemical name: Substituted amino alkyl triazinyl benzenesulfonic acid
derivative (generic).
CAS number: CBI.
Federal Register publication date and reference: January 5, 2000 (65 FR
374).
Docket number: OPPTS-50635.
Basis for revocation of SNUR: EPA issued a SNUR for this substance
based on the concern criteria at Sec. 721.170(b)(3)(ii). The PMN
submitter petitioned EPA to revoke the SNUR based on the results of
test data developed by an industry consortium which consisted of a
range-finding and definitive 2-generation study in rats (gavage) and
range-finding and definitive developmental toxicity studies in rats and
rabbits (gavage) for C.I. Fluorescent Brightener 220 (CAS No. 16470-24-
9). EPA has concluded that available information does not support
continued identification of stilbenes as a new chemical category
presenting concerns for possible developmental and reproductive
toxicity and that, based on available information, the substance no
longer meets the concern criteria at Sec. 721.170(b)(3)(ii).
Therefore, EPA proposes that the SNUR for this chemical substance be
revoked pursuant to 40 CFR 721.185(a)(4).
CFR citation: 40 CFR 721.9810.
PMN Number P-99-0467
Chemical name: Acrylated (long-chainalkyl) glycidal ether (generic).
CAS number: CBI.
Federal Register publication date and reference: December 26, 2000 (65
FR 81400).
Docket number: OPPTS-50638.
Basis for revocation of SNUR: EPA issued a SNUR for this substance
based on the concern criteria at Sec. 721.170(b)(4)(ii). Subsequently,
the PMN submitter petitioned EPA to revoke the SNUR based on the
results of acute aquatic toxicity test data for fish, daphnia, and
algae, as well as the results of biodegradation testing. The toxicity
testing demonstrated concerns for potential chronic environmental
toxicity at concentrations as low as 2 parts per billion (ppb).
However, biodegradation testing demonstrated that the substance is
readily biodegradable, mitigating concerns for chronic toxicity.
Therefore, EPA no longer finds that releases to water resulting in
stream concentrations greater than 2 ppb may cause significant adverse
environmental effects. Therefore, based on available information, the
substance no longer meets the concern criteria at Sec.
721.170(b)(4)(ii) and EPA proposes that the SNUR for this chemical
substance be revoked pursuant to 40 CFR 721.185(a)(4).
CFR citation: 40 CFR 721.3850.
PMN Number P-01-71
Chemical name: Phenol, 2,2'-[6-(2,4-dibutoxyphenyl)-1,3,5-triazine-2,4-
diyl]bis[5-butoxy-.
CAS number: 208343-47-9.
Federal Register publication date and reference: December 17, 2003 (68
FR 70179).
Docket number: OPPT-2002-0078.
Basis for revocation of SNUR: EPA issued a SNUR for this substance
based on the concern criteria at Sec. 721.170(b)(4)(ii). Subsequently,
the PMN submitter petitioned EPA to revoke the SNUR based on the
results of chronic fish and daphnia testing. The toxicity testing
demonstrated that there were no effects at saturation (i.e., the
maximum concentration at which the PMN substance can be dissolved in
water). A concentration of concern was not established. The substance
was determined to pose low concern for environmental toxicity, and has
a low ``persistence, bioaccumulation, and toxicity'' (PBT) rating of
P2B1T1 (on a scale of 1 to 3, with 3 being the highest). Therefore, EPA
no longer finds that releases to water may result in exposures which
may cause significant adverse environmental effects. Therefore, based
on available information, the substance no longer meets the concern
criteria at Sec. 721.170(b)(4)(ii) and EPA proposes that the SNUR for
this chemical substance be revoked pursuant to 40 CFR 721.185(a)(4).
CFR citation: 40 CFR 721.5718.
B. What is the Agency's Authority for Taking this Action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in section 5(a)(2) of TSCA.
Once EPA determines that a use of a chemical substance is a
[[Page 59069]]
significant new use, section 5(a)(1)(B) of TSCA requires persons to
submit a notice to EPA at least 90 days before they manufacture,
import, or process the substance for that use. The mechanism for
reporting under this requirement is established under 40 CFR part 721.
During a review of PMN P-98-475, EPA concluded that regulation was
warranted and issued a TSCA section 5(e) consent order for the chemical
substance and promulgated a corresponding SNUR under 40 CFR 721.160.
Upon conclusion of the reviews of PMNs P-98-1043, P-99-0467, and P-01-
71, based on the concern criteria in 40 CFR 721.170(b)(3)(ii) or
(b)(4)(ii) as discussed in Unit II.A., EPA determined that there was a
concern about the substances' health or environmental effects and
promulgated non-5(e) SNURs for these chemical substances.
Under 40 CFR 721.185, EPA may at any time revoke a SNUR for a
chemical substance which has been added to subpart E of 40 CFR part 721
if EPA makes one of the determinations set forth in Sec. 721.185(a)(1)
through (a)(6). Revocation may occur at EPA's initiative or in response
to a written request. Under Sec. 721.185(b)(3), if EPA concludes that
a SNUR should be revoked, the Agency will propose the changes in the
Federal Register, briefly describe the grounds for the action and
provide interested parties an opportunity to comment.
EPA has determined that the criteria set forth in Sec. 721.185(a)
have been satisfied for each of the four chemical substances, and
therefore EPA is proposing to revoke the SNUR provisions for these
chemical substances. When this revocation becomes final, EPA will no
longer require notice of intent to manufacture, import, or process
these substances for any significant new uses. In addition, export
notification requirements under section 12(b) of TSCA triggered by
these SNURs will no longer be required.
III. Statutory and Executive Order Reviews
This proposed rule revokes or eliminates an existing regulatory
requirement and does not contain any new or amended requirements. As
such, the Agency has determined that this SNUR revocation will not have
any adverse impacts, economic or otherwise.
The Office of Management and Budget (OMB) has exempted these types
of regulatory actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This
proposed rule does not contain any information collections subject to
approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et
seq.). Since this proposed rule eliminates a reporting requirement, the
Agency certifies pursuant to section 605(b) of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), that this SNUR revocation
will not have a significant economic impact on a substantial number of
small entities.
For the same reasons, this action does not require any action under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). This proposed rule has neither Federalism implications, because
it will not have substantial direct effects on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999), nor tribal implications, because it
will not have substantial direct effects on one or more Indian tribes,
on the relationship between the Federal Government and Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes, as specified in Executive Order
13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000).
This action is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because this is not an economically
significant regulatory action as defined under Executive Order 12866,
and it does not address environmental health or safety risks
disproportionately affecting children. It is not subject to Executive
Order 13211, entitled Actions Concerning Regulations That Significantly
Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001),
because this action is not expected to affect energy supply,
distribution, or use. Because this action does not involve any
technical standards, section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note), does not apply to this action. This action does
not involve special considerations of environmental justice related
issues as required by 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 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: September 26, 2006.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR part 721 be amended as
follows:
PART 721--[AMENDED]
1. The authority citation for part 721 would continue to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
Sec. Sec. 721.3850, 721.5718, 721.9785, and 721.9810 [Removed]
2. Remove Sec. Sec. 721.3850, 721.5718, 721.9785, and 721.9810.
[FR Doc. E6-16574 Filed 10-5-06; 8:45 am]
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