Document ID: EPA-HQ-OPPT-2006-0213-0001
Agency: epa
Document Type: Proposed Rule
Title: Proposed Revocation of Significant New Use Rules on Certain Chemical Substances
Posted Date: 2006-10-06T12:22:26Z

[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]

BILLING CODE 6560-50-S