E6-16574. Proposed Revocation of Significant New Use Rules on Certain Chemical Substances

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

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 [phone]. 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-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 [phone], and the telephone number for the OPPT Docket is [phone]. 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: [phone]; e-mail address: [e-mail].

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: [phone]; e-mail address: [e-mail].

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 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 § 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 § 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 § 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 § 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 § 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 § 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 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 § 721.185(a)(1) through (a)(6). Revocation may occur at EPA's initiative or in response to a written request. Under § 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 § 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).

§§ 721.3850, 721.5718, 721.9785, and 721.9810

[Removed]

2. Remove §§ 721.3850, 721.5718, 721.9785, and 721.9810.