Proposed Revocation of Significant New Uses of Certain Chemical Substances

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

EPA is proposing to revoke significant new use rules (SNURs) for four substances promulgated under section 5(a)(2) of the Toxic Substances Control Act (TSCA) based on new data. Based on the new data the Agency no longer finds that activities not described in the corresponding TSCA section 5(e) consent orders or premanufacture notices (PMN) for these chemical substances may result in significant changes in human or environmental exposure.

DATES:

Comments, identified by docket ID number OPPT-2002-0031, must be received on or before October 21, 2002.

ADDRESSES:

Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPPT-2002-0031 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

For general information contact: Barbara Cunningham, Acting Director, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov.

For technical information contact: James Alwood, Chemical Control Division, Office of Pollution Prevention and Toxics (7405M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 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 categories and entities may include, but are not limited to:

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 the table 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 or not this action applies to certain entities. To determine whether you or your business is affected by this action, you should carefully examine the applicability provisions in title 40 of the Code of Federal Regulations (CFR) at 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. How Can I Get Additional Information, Including Copies of this Document or Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/ . To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 721 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr721_00.html , a beta site currently under development.

2. In person. The Agency has established an official record for this action under docket ID number OPPT-2002-0031. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the EPA Docket Center, Rm. B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is (202) 566-1744 and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is (202) 566-0280.

C. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPPT-2002-0031 in the subject line on the first page of your response.

1. By mail. Submit your comments to: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier. Deliver your comments to: OPPT Document Control Office (DCO) in EPA East Building Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 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.

3. Electronically. You may submit your comments electronically by e-mail to: oppt.ncic@epa.gov, or mail your computer disk to the address identified above. Do not submit any information electronically that you consider to be CBI. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on standard disks in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket ID number OPPT-2002-0031. Electronic comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI Information That I Want to Submit to the Agency?

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any 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 version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

We invite you to provide your views on the various options we propose, new approaches we have not considered, the potential impacts of the various options (including possible unintended consequences), and any data or information that you would like the Agency to consider during the development of the final action. You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Offer alternative ways to improve the proposed rule.

7. Make sure to submit your comments by the deadline in this document.

8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. Background

A. What Action is the Agency Taking?

In the Federal Register referenced for each substance, OPPTS-50577, June 26, 1990 (55 FR 26111), OPPTS-50588, November 6, 1990 (55 FR 46773), OPPTS-50622, August 30, 1995 (60 FR 45082) (FRL-4629-2), OPPTS-50632, August 20, 1998 (63 FR 44575) (FRL-5788-7), establishing significant new uses for the substances, EPA issued a SNUR. Because of additional data EPA has received for these substances, EPA is proposing to revoke the significant new use and recordkeeping requirements for the following chemical substances under 40 CFR part 721, subpart E. In this unit, EPA provides a brief description for each substance, including its PMN number, chemical name (generic name if the specific name is claimed as CBI), CAS number (if assigned), basis for the revocation of the TSCA section 5(e) consent order for the substance, and the CFR citation. Further background information for the substances is contained in Unit I.B.2 of this document.

PMN Number P-86-1491

Chemical name: 3-Hydroxy-1,1-dimethylbutyl derivative (generic).

CAS number: Not applicable.

Federal Register publication date and reference: August 30, 1995 (60 FR 45082).

Docket number: OPPTS-50622.

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 cancer by analogy to structurally similar peroxides. Based on the results of test data developed by an industry consortium to address potential toxicity of peroxides, EPA has concluded that available information does not support identification of peroxides as potential carcinogens. Therefore, EPA determined that it could no longer conclude that the manufacturing, processing, and use of P-86-1491 may present an unreasonable risk under section 5(e) of TSCA and has, therefore, revoked the consent order for P-86-1491. EPA can no longer make the finding that activities not described in the TSCA section 5(e) consent order may result in significant changes in human exposure.

CFR citation: 40 CFR 721.4466.

PMN Number P-86-1492

Chemical name: Alkyl peroxy-2-ethyl hexanoate (generic).

CAS number: Not applicable.

Federal Register publication date and reference: November 6, 1990 (55 FR 46773).

Docket number: OPPTS-50588.

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 cancer by analogy to structurally similar peroxides. Based on the results of test data developed by an industry consortium to address potential toxicity of peroxides, EPA has concluded that available information does not support identification of peroxides as potential carcinogens. Therefore, EPA determined that it could no longer conclude that the manufacturing, processing, and use of P-86-1492 may present an unreasonable risk under section 5(e) of TSCA and has, therefore, revoked the consent order for P-86-1492. EPA can no longer make the finding that activities not described in the TSCA section 5(e) consent order may result in significant changes in human exposure.

CFR citation: 40 CFR 721.4240 (Formerly 40 CFR 721.1208).

PMN Number P-86-1493

Chemical name: Substituted alkyl peroxyhexane carboxylate (mixed isomers) (generic).

CAS number: Not applicable.

Federal Register publication date and reference: June 26, 1990 (55 FR 26111).

Docket number: OPPTS-50577.

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 cancer by analogy to structurally similar peroxides. Based on the results of test data developed by an industry consortium to address potential toxicity of peroxides, EPA has concluded that available information does not support identification of peroxides as potential carcinogens. Therefore, EPA determined that it could no longer conclude that the manufacturing, processing, and use of P-86-1493 may present an unreasonable risk under section 5(e) of TSCA and has, therefore, revoked the consent order for P-86-1493. EPA can no longer make the finding that activities not described in the TSCA section 5(e) consent order may result in significant changes in human exposure.

CFR citation: 40 CFR 721.4200 (Formerly 40 CFR 721.1565).

PMN Number P-98-24

Chemical name: Methoxy benzoic acid derivative (generic).

CAS number: Not applicable.

Federal Register publication date and reference: August 20, 1998 (63 FR 44575).

Docket number: OPPTS-50632.

Basis for revocation of SNUR: EPA issued a SNUR for this substance based on the concern criteria at § 721.170(b)(4)(1). The PMN submitter petitioned EPA to revoke the SNUR based on existing toxicity, fate, and economic data. The results of acute fish, daphnia, and algae studies for the substance demonstrated acute LC₅₀ values ranging from 60-90 parts per million (ppm). EPA's concern concentration of 40 parts per billion (ppb) for the substance is based on potential chronic toxicity. A biodegradation study for the PMN substance measured 90% degradation in 28 days. Commercial use of the PMN substance is limited to use as a mediator in enzyme catalyzed reactions. In addition, EPA expects that most of the PMN substance is destroyed when used in this manner resulting in little or no release of the substance. EPA could not identify additional uses of the PMN substance. Based on this data EPA can no longer make the finding that reasonably anticipated conditions of release may result in significant releases above 40 ppb. Therefore, EPA has concluded that based on available information, the substance does not meet the concern criteria at § 721.170(b)(4)(1).

CFR citation: 40 CFR 721.1710.

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 721.5.

During review of the PMNs submitted for the chemical substances that are the subject of this proposed revocation, EPA concluded that regulation was warranted based on available information that indicated activities not described in the TSCA section 5(e) consent order or PMN might result in significant changes in human or environmental exposure as described in section 5(a)(2) of TSCA. Based on these findings, SNURs were promulgated.

EPA has revoked the TSCA section 5(e) consent orders that are the basis for these SNURs and no longer finds that activities other than those described in the TSCA section 5(e) consent orders or PMN may result in significant changes in human or environmental exposure. The revocation of SNUR provisions for these substances is consistent with the findings set forth in the preamble to the proposed revocation of each individual SNUR.

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. In addition, export notification under section 12(b) of TSCA 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 Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).

Since this proposed rule does not impose any requirements, it does not contain any information collections subject to approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq.

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency has determined that SNUR revocations, which eliminate requirements without imposing any new ones have no adverse economic impacts.

Since this proposed rule does not impose any requirements it does not require any other action under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

This action will not have a substantial direct effect 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).

This proposed rule does not have tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This does not significantly or uniquely affect the communities of Indian tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000), do not apply to this proposed rule.

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 by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

This proposed rule 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.

In addition, since 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).

EPA has complied with Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights (53 FR 8859, March 15, 1988), by examining the takings implications of this proposed rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive Order.

In issuing this proposed rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR 4729, February 7, 1996).

List of Subjects in 40 CFR Part 721

• Environmental protection
• Chemicals
• Hazardous substances
• Reporting and recordkeeping requirements

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).

2. By removing §§ 721.1710, 721.4200, 721.4240, and 721.4466.