Toxic substances: Significant new uses— 2-ethoxyethanol, etc.,

[Federal Register: November 29, 2005 (Volume 70, Number 228)]

[Rules and Regulations]

[Page 71401-71406]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr29no05-6]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPT-2004-0111; FRL-7740-7]

RIN 2070-AJ12

2-ethoxyethanol, 2-ethoxyethanol acetate, 2-methoxyethanol, and 2-methoxyethanol acetate; Significant New Use Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is issuing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) which requires persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of 2-ethoxyethanol (CAS No. 110-80- 5) (2-EE), 2-ethoxyethanol acetate (CAS No. 111-15-9) (2-EEA), 2- methoxyethanol (CAS No. 109-86-4) (2-ME), or 2-methoxyethanol acetate (CAS No. 110-49-6) (2-MEA) for domestic use in a consumer product or the manufacture or import of 2-MEA at levels greater than 10,000 pounds per year. This action finalizes the SNUR proposed in the Federal Register of March 1, 2005 (70 FR 9902) (FRL-7692-8). EPA believes this action is necessary because these chemicals may be hazardous to human health and their use in a consumer product may result in human exposure. The required notice will provide EPA with the opportunity to evaluate intended new uses and associated activities, and if necessary, prohibit or limit those uses and activities before they occur.

DATES: This final rule is effective on December 29, 2005.

ADDRESSES: EPA has established a docket for this action under docket identification (ID) number OPPT-2004-0111. All documents in the docket are listed in the EDOCKET index at http://www.epa.gov/edocket. Although

listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will not be placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in EDOCKET or in hard copy at the OPPT Docket, EPA Docket Center, EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal

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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 the EPA Docket Center, is (202) 566-0280.

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: Amy Breedlove, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-9823; e-mail address: breedlove.amy@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   1. Does This Action Apply to Me?

      You may be potentially affected by this action if you manufacture, import, or process 2-EE (CAS No. 110-80-5), 2-EEA (CAS No. 111-15-9), 2-ME (CAS No. 109-86-4), or 2-MEA (CAS No. 110-49-6) for use in consumer products or manufacture or import 2-MEA (CAS No. 110-49-6) at levels greater than 10,000 pounds per year.

      Persons who intend to import any chemical substance governed by a final SNUR are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements, and to the regulations codified at 19 CFR 12.118 through 12.127 and 127.28. Those persons must certify that they are in compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D. Potentially affected entities may include, but are not limited to:

      Manufacturers (defined by statute to include importers) and processors of 2-EE, 2-EEA, 2-ME, and 2-MEA (NAICS 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

      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 for SNUR related obligations. 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.

   2. How Can I Access Electronic Copies of This Document and Other Related Information?

      In addition to using EDOCKET (http://www.epa.gov/edocket), you may

      access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 721

      is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

2. Background

   1. What Action Is the Agency Taking?

      EPA is designating the manufacture, import, or processing of 2-EE (CAS No. 110-80-5), 2-EEA (CAS No. 111-15-9), 2-ME (CAS No. 109-86-4), and 2-MEA (CAS No. 110-49-6) for domestic use in consumer products as a significant new use, as well as the manufacture or import of 2-MEA (CAS No. 110-49-6) at levels greater than 10,000 pounds per year. ``Consumer product'' is defined at 40 CFR 721.3 as ``a chemical substance that is directly, or as part of a mixture, sold or made available to consumers for their use in or around a permanent or temporary household or residence, in or around a school, or in recreation.'' This rule requires persons intending to manufacture or import 2-MEA at levels greater than 10,000 pounds per year as well as those intending to manufacture, import, or process 2-EE, 2-EEA, 2-ME, or 2-MEA for domestic use in a consumer product to submit a Significant New Use Notice (SNUN) to EPA at least 90 days before such activity.

   2. 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 TSCA section 5(a)(2). Once EPA determines that a use of a chemical substance is a significant new use, and promulgates a SNUR, section 5(a)(1)(B) of TSCA requires persons to submit a SNUN to EPA at least 90 days before commencement of manufacture, import, or processing of the chemical substance for that use.

   3. Applicability of General Provisions

      General regulatory provisions for SNURs appear under subpart A of 40 CFR part 721. These provisions describe persons subject to the rule, recordkeeping requirements, and exemptions to reporting requirements. Provisions relating to user fees appear at 40 CFR part 700. Persons subject to the rule are required to comply with the same notice requirements and EPA regulatory procedures as submitters of premanufacture notices (PMNs) under section 5(a)(1)(A) of TSCA. In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (2), (3), and (5), and the regulations at 40 CFR part 720. Receipt of a SNUN by EPA may trigger regulatory action under TSCA sections 5(e), 5(f), 6, or 7, if appropriate, to control the activities on which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.

      Persons who intend to export a substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. Persons who intend to import a chemical substance identified in a final SNUR are subject to the TSCA section 13 import certification requirements, which are codified at 19 CFR 12.118 through 12.127 and 127.28. Such persons must certify that they are in compliance with TSCA requirements. The EPA policy relating to import certification appears at 40 CFR part 707, subpart B.

3. Summary of and Response to Comments

   1. Final Rule

      In the Federal Register of March 1, 2005 (70 FR 9902), EPA proposed a SNUR for 2-ethoxyethanol, 2-ethoxyethanol acetate, 2-methoxyethanol, or 2-methoxyethanol acetate where the significant new uses were for domestic use in a consumer product or the manufacture or import of 2- methoxyethanol at levels greater than

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      10,000 pounds per year. The Agency reviewed and considered the six comments received by the end of the comment period (May 2, 2005) for the March 1, 2005 proposed rule. A discussion of the comments and the Agency's response follow in Unit III.B. None of the comments received identified any ongoing uses of these four chemicals in domestic consumer products nor any production of 2-methoxyethanol acetate. In addition, no new data were submitted or identified that would change EPA's findings regarding the SNUR for these four chemicals. Therefore, EPA is issuing the SNUR as proposed. This final rule requires persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of 2-EE (CAS No. 110-80-5), 2-EEA (CAS No. 111- 15-9), 2-ME (CAS No. 109-86-4), or 2-MEA (CAS No. 110-49-6) for domestic use in a consumer product or the manufacture or import of 2- MEA at levels greater than 10,000 pounds per year. A complete copy of all comments received is available in the public docket for this action.

   2. Response to Comments

      EPA received six comments, two from an individual and one each from the American Chemistry Council (ACC), on behalf of the Ethylene and Propylene Glycol Ethers Panel; the Lyondell Chemical Company (Lyondell); the National Paint and Coatings Association (NPCA); and The Dow Chemical Company (Dow). The one individual submitted two separate sets of comments. The first set was a general statement that the author did not think any new uses should be allowed or that the product should be for sale or use in the United States. The second set of comments pointed out the several statements in the SNUR that led the author to be concerned that these chemicals are sold or used at all. Neither set of comments recommended any specific changes to the SNUR.

      Comment: ACC and Lyondell expressed support for the SNUR. Both also requested that the Agency clarify whether or not products containing 1% or less of the substances listed in the rule are subject to the TSCA section 12(b) export notification requirements of 40 CFR part 707, subpart D. The NPCA pointed out that solvent substitutes may still contain trace amounts of the four chemicals listed in the SNUR which would trigger TSCA section 12(b) requirements. They also referred to EPA amending the final TSCA section 6 rulemaking for 40 CFR 749.68 (hexavalent chromium-based water treatment chemicals in cooling systems) to exclude those hexavalent chromium compounds that could not be used in the prohibited application from section 12(b) export notification requirements (59 FR 42769, August 19, 1994).

      EPA response: If an exporter is aware of the presence of a chemical subject to this SNUR, at any level in the products to be exported, then pursuant to TSCA section 12(b), the exporter must notify EPA of the export regardless of whether the substance is being exported for the use regulated by the SNUR. See Chemical Imports and Exports; Notification of Export, final rule (45 FR 82844, at 82845; December 16, 1980). Thirty days after publication in the Federal Register of a proposed SNUR, the export or intended export of a chemical subject to a SNUR requires export notification under TSCA section 12(b), regardless of the amount of the substance in a product, or its use or intended use. In the August 1994 hexavalent chromium rule-related action noted by NPCA, EPA amended 40 CFR 749.68 to clarify that only hexavalent chromium chemicals that can be used for water treatment were the subjects of the underlying TSCA section 6 regulation, not other hexavalent chromium chemicals. That amendment had the parallel effect of limiting the scope of TSCA section 12(b) export notifications that were required for those hexavalent chromium chemicals that could be used to treat water.

      Comment: ACC and Lyondell also noted that two of the SNUR references referred generally to glycol ethers and that all glycol ethers were not subject to the SNUR.

      EPA response: EPA agrees and notes that the SNUR refers only to the chemicals by their names, not the general term glycol ethers.

      Comment: The Dow Chemical Company requested the Agency clarify that the proposed rule does not apply when the subject substances appear as impurities in consumer products consisting primarily of other chemical substances. NPCA stated that EPA should limit the scope of the recordkeeping and reporting requirements to exempt products with only trace or de minimus amounts of these chemicals.

      EPA response: EPA does not intend for the SNUR reporting and recordkeeping requirements to apply to persons that manufacture, import, or process the subject substances only as an impurity.

4. Significant New Use Determination

   Section 5(a)(2) of TSCA provides that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors including:

   The projected volume of manufacturing and processing of a chemical substance.

   The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.

   The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.

   The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

   EPA construes the statute to allow consideration of any other relevant factors, in addition to those enumerated in section 5(a)(2)(A) through (D) of TSCA.

   To determine what would constitute a significant new use of 2-EE, 2-EEA, 2-ME, and 2-MEA, EPA considered relevant information about the toxicity of the substances, likely exposures/releases associated with possible uses, and the four factors listed in section 5(a)(2) of TSCA.

   The latest information available to EPA indicates that there is no ongoing domestic use of 2-EE, 2-EEA, 2-ME, or 2-MEA in consumer products. EPA believes that the renewed use of 2-EE, 2-EEA, 2-ME, or 2- MEA in a consumer product would increase the magnitude and duration of exposure. Considering the health concerns for 2-EE, 2-EEA, 2-ME, and 2- MEA, EPA believes that individuals could suffer adverse effects from their use in consumer products. Thus, EPA is designating ``domestic use in a consumer product,'' as well as the manufacture or import of 2-MEA at levels greater than 10,000 pounds per year, as a significant new use of 2-EE, 2-EEA, 2-ME, and 2-MEA.

   Based on these considerations, EPA is pursuing the following objectives with regard to the use of 2-EE, 2-EEA, 2-ME, and 2-MEA in consumer products:

   EPA wants to ensure that it would receive notice of any person's intent to manufacture or import 2-MEA at levels greater than 10,000 pounds per year or intending to manufacture, import, or process 2-EE, 2-EEA, 2-ME, and 2-MEA for domestic use in a consumer product before that activity begins.

   EPA wants to ensure that it would have the opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing, importing, or processing 2-EE, 2-EEA, 2-ME, and 2-MEA for domestic use in a consumer product or manufacturing or importing 2-MEA at

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   levels greater than 10,000 pounds per year.

   EPA wants to ensure that it would be able to regulate prospective manufacturers, importers, or processors of 2-EE, 2-EEA, 2- ME, and 2-MEA before use of any of these chemicals in a consumer product occurs as well as prospective manufacturers or imports of 2-MEA before manufacture or import of the substance at levels greater than 10,000 pounds per year occurs, provided that the degree of potential risk is sufficient to warrant such regulation.

   As noted in Unit III.B. of the proposed SNUR (70 FR 9902, March 1, 2005), the production of the chemicals included in this SNUR have declined significantly over time. EPA is not aware of current domestic consumer uses for the chemicals, and substitutes are available. The Agency will use information submitted pursuant to the Inventory Update Rule (40 CFR part 710) to track the production volumes and uses of these chemicals. If needed, EPA may pursue additional regulatory actions as appropriate under TSCA sections 4, 5, 6, or 8.

5. Test Data and Other Information

   EPA recognizes that section 5 of TSCA does not require the development of any particular test data before submission of a SNUN. Persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR 721.25).

   However, SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on:

   Human exposure and environmental releases that may result from the significant new use of the chemical substances.

   Potential benefits of the chemical substances.

   Information on risks posed by the chemical substances relative to risks posed by potential substitutes.

   Submitters should consider including with a SNUN any other available studies on the chemical substances or studies on analogous substances which may demonstrate that the significant new uses being reported are unlikely to present an unreasonable risk.

   In view of the potential risks posed by these chemicals, EPA would recommend that potential SNUN submitters include data that would permit a reasoned evaluation of risks posed by these chemicals. EPA encourages persons to consult with the Agency before submitting a SNUN for these substances. As part of this optional pre-notice consultation, EPA would discuss specific data it believes are necessary to evaluate a significant new use. A SNUN submitted without sufficient data to reasonably evaluate risks posed by a significant new use of 2-EE, 2- EEA, 2-ME, and/or 2-MEA may increase the likelihood that EPA will take action under TSCA section 5(e) to prohibit or limit activities associated with these chemicals. EPA recommends that potential SNUN submitters contact the Agency early enough that they will be able to conduct any appropriate tests.

6. SNUN Submissions

   SNUNs should be mailed to the Environmental Protection Agency, OPPT Document Control Office (7407M), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Information must be submitted in the form and manner set forth in EPA Form No. 7710-25. This form is available from the Environmental Assistance Division (7408M), OPPT, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001 (see 40 CFR 721.25(a) and 720.40(a)(2)(i)).

7. Applicability of Rule to Uses Occurring Before Effective Date of the Final Rule

   As discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA believes that the intent of TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the date of publication of the proposal rather than as of the effective date of the final rule. If uses begun after publication of the proposed SNUR were considered ongoing rather than new, it would be difficult for EPA to establish SNUR notice requirements, because a person could defeat the SNUR by initiating the proposed significant new use before the rule became effective.

   Any person who began manufacture, import, or processing of 2-EE, 2- EEA, 2-ME, or 2-MEA for the significant new use listed in the proposed SNUR after the date of publication of the proposed SNUR must stop that activity before the effective date of this final rule. Persons who ceased those activities will have to meet all SNUR notice requirements and wait until the end of the notification review period, including all extensions, before engaging in any activities designated as significant new uses. If, however, persons who began manufacture, import, or processing of any of these chemical substances between the date of publication of the proposed SNUR and the effective date of this final SNUR meet the conditions of advance compliance as codified at 40 CFR 721.45(h), those persons would be considered to have met the final SNUR requirements for those activities.

8. Economic Analysis

   EPA evaluated the potential costs of establishing SNUR reporting requirements for potential manufacturers, importers, and processors of the chemical substances included in this rule. While there is no precise way to calculate the total annual cost of compliance with the final rule, given the uncertainties related to predicting the number of SNUN's that would be submitted as a result of this SNUR, EPA estimates that the cost for preparing and submitting a SNUN is $7,174, including a $2,500 user fee required by 40 CFR part 700.45(b)(2)(iii). Small businesses with annual sales of less than $40 million when combined with those of the parent company (if any) are subject to a reduced user fee of $100 (40 CFR part 700.45(b)(1)). Based on past experience with SNURs and the low number of SNUNs which are submitted on an annual basis, EPA believes that there will be few, if any, SNUNs submitted as a result of this SNUR. The costs of submission of SNUNs will not be incurred by any company unless a company decides to pursue a significant new use as defined in this SNUR. Furthermore, while the expense of a notice and the uncertainty of possible EPA regulation may discourage certain innovations, that impact would be limited because such factors are unlikely to discourage an innovation that has high potential value. EPA's complete economic analysis is available in the public docket for this rule.

   Under section 12(b) of TSCA, among other requirements, exporters must notify EPA if they export or intend to export a chemical substance or mixture for which a rule has been proposed or promulgated under TSCA section 5, such as this SNUR. Notice must be provided for the first export or intended export to a particular country in a calendar year. In an economic analysis of an amendment to the rules implementing TSCA section 12(b), EPA estimated that the one-time cost of preparing and submitting an export notification was $62.60 in 1992, or $93.02 when inflated to 2003 dollars by a factor of approximately 1.5, from the Employment Cost Index for White Collar Occupations. The total costs of export notification will vary per chemical, depending on the number of required notifications (i.e., number of countries to which the chemical is exported). EPA is unable to make any

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   estimate of the likely number of export notifications for chemicals covered in this SNUR.

9. Statutory and Executive Order Reviews

   1. Executive Order 12866: Regulatory Planning and Review

      Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has determined that proposed or final SNURs are not a ``significant regulatory action'' subject to review by OMB, because they do not meet the criteria in section 3(f) of the Executive Order.

   2. Paperwork Reduction Act

      According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable.

      The information collection requirements related to this action have already been approved by OMB pursuant to the PRA under OMB control number 2070-0038 (EPA ICR No. 1188). This action would not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average 105 hours per submission. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

      Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

   3. Regulatory Flexibility Act

      Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation of this SNUR would not have a significant adverse economic impact on a substantial number of small entities. The rationale supporting this conclusion is as follows. A SNUR applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a ``significant new use.'' By definition of the word ``new,'' and based on all information currently available to EPA, it appears that no small or large entities presently engage in such activity. Since a SNUR only requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN, no economic impact would even occur until someone decides to engage in those activities. Although some small entities may decide to conduct such activities in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of over 1,000 SNURs, the Agency receives on average only 10 notices per year. Of those SNUNs submitted, none appear to be from small entities in response to any SNUR. In addition, the estimated reporting cost for submission of a SNUN (see Unit X. of the proposed SNUR (70 FR 9902, March 1, 2005), is minimal regardless of the size of the firm. Therefore, EPA believes that the potential economic impact of complying with this SNUR is not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published on June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that proposed and final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

   4. Unfunded Mandates Reform Act

      Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government would be impacted by this rulemaking. As such, EPA has determined that this regulatory action would not impose any enforceable duty, contain any unfunded mandate, or otherwise have any affect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

   5. Executive Order 13132: Federalism

      This action does 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).

   6. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments

      This rule does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This rule 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 rule.

   7. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks

      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.

   8. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use

      This 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.

1. National Technology Transfer Advancement Act

   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.

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   10. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

       This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

   11. Executive Order 12988: Civil Justice Reform

       In issuing this 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).

10. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the Agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

    List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.

    Dated: November 17, 2005. Charles M. Auer, Director, Office of Pollution Prevention and Toxics.

    0 Therefore, 40 CFR part 721 is amended as follows:

    PART 721--[AMENDED]

    0 1. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

    0 2. By adding new Sec. 721.10001 to subpart E to read as follows:

    Sec. 721.10001 2-Ethoxyethanol, 2-ethoxyethanol acetate, 2- methoxyethanol, and 2-methoxyethanol acetate.

    (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances identified as 2-ethoxyethanol (CAS No. 110-80-5), 2-ethoxyethanol acetate (CAS No. 111-15-9), 2- methoxyethanol (CAS No. 109-86-4), and 2-methoxyethanol acetate (CAS No. 110-49-6) are subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

    (2) The significant new use is domestic use in a consumer product or the manufacture or import of 2-methoxyethanol acetate at levels greater than 10,000 pounds per year.

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

    (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125 (a), (b), and (c) apply to the significant new use specified in Sec. 721.10001. In addition, records documenting compliance with the significant new use of domestic use in a consumer product or the manufacture or import of 2-methoxyethanol acetate at levels greater than 10,000 pounds per year must be maintained.

    (2) [Reserved]

    [FR Doc. 05-23421 Filed 11-28-05; 8:45 am]

    BILLING CODE 6560-50-S