Significant New Use Rules:
Federal Register Volume 76, Number 152 (Monday, August 8, 2011)
Rules and Regulations
Pages 47996-48002
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
FR Doc No: 2011-20021
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 9 and 721
EPA-HQ-OPPT-2009-0922; FRL-8878-2
RIN 2070-AB27
Cobalt Lithium Manganese Nickel Oxide; 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) for the chemical substance identified as cobalt lithium manganese nickel oxide (CAS No. 182442-95-1), which was the subject of premanufacture notice (PMN) P- 04-269. This action requires persons who intend to manufacture, import, or process the chemical substance for a use that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity. EPA believes that this action is necessary because the chemical substance may be hazardous to human health and the environment. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.
DATES: This final rule is effective September 7, 2011.
ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPPT-2009-0922. All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket
Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave.,
NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 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. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-9232; e-mail address: moss.kenneth@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
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Does this action apply to me?
You may be potentially affected by this action if you manufacture, import, process, or use the chemical substance
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which is the subject of this final rule. Potentially affected entities may include, but are not limited to:
Manufacturers, importers, or processors of the subject chemical substance (NAICS codes 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 Sec. 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.
This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. For importers of the chemical substance subject to this SNUR, those requirements include the SNUR. 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 the chemical substance that is the subject of this final rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see Sec. 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
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Background
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What action is the agency taking?
EPA is finalizing a SNUR under TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) for the chemical substance identified as cobalt lithium manganese nickel oxide (PMN P-04-269; CAS No. 182442-95-1). This action requires persons who intend to manufacture, import, or process the subject chemical substance for an activity that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity.
In the Federal Register issue of September 20, 2010 (75 FR 57169)
(FRL-8839-7), EPA issued a direct final SNUR on the chemical substance.
However, EPA received notices of intent to submit adverse comments on this SNUR. Therefore, as required by Sec. 721.160(c)(3)(ii), in the
Federal Register issue of November 18, 2010 (75 FR 70583) (FRL-8853-2),
EPA withdrew the direct final SNUR on the chemical substance and simultaneously proposed a SNUR using notice and comment procedures (75
FR 70665) (FRL-8853-3). More information on the specific chemical substance subject to this final rule can be found in the direct final and proposed SNUR. The docket for this action, as well as the preceding direct final and proposed SNUR on this chemical substance, is found under docket ID number EPA-HQ-OPPT-2009-0922. That docket includes information considered by the Agency in developing this final rule, including public comments on the proposed and direct final rules.
EPA received several comments on the proposed rule. A full discussion of EPA's response to these comments is included in Unit V. of this document. Taking into consideration these comments, EPA is issuing a final rule on this chemical substance that: 1. Retains the proposed workplace protection, hazard communication, and release to water provisions as significant new uses. 2. Retains the proposed recommended human health and environmental effects testing. 3. Provides clarification on the exemptions from applicability of the SNUR. This exemption applies to quantities of the PMN substance after it has been completely reacted (cured).
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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, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the chemical substance for that use. Persons who must report are described in Sec. 721.5.
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Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the final rule. Provisions relating to user fees appear at 40 CFR part 700.
According to Sec. 721.1(c), persons subject to these SNURs must comply with the same notice requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). 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), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under
TSCA section 5(e), 5(f), 6, or 7 to control the activities for 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.
Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. For importers of a chemical substance subject to a final SNUR those requirements include the SNUR.
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 identified in a final SNUR are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611 (b)) (see Sec. 721.20) and must comply with the export notification requirements in 40 CFR part 707, subpart D.
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Rationale and Objectives of the Rule
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Rationale
During review of the chemical substance the subject of PMN P-04- 269, EPA concluded that regulation was warranted under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), pending the development of information sufficient to make reasoned evaluations of the human health and environmental effects of the chemical substance. Based on these findings, a TSCA section 5(e) consent order requiring the use of appropriate exposure controls was negotiated with the PMN submitter.
The SNUR provisions for this chemical substance are consistent with the provisions of the TSCA section 5(e) consent order. This final SNUR is issued
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pursuant to Sec. 721.160. For additional discussion on the rationale for this action, see Units II. and V. of this document.
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Objectives
EPA is issuing this final SNUR for a specific chemical substance that has undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this final rule:
EPA will receive notice of any person's intent to manufacture, import, or process a listed chemical substance for the described significant new use before that activity begins.
EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing, importing, or processing a listed chemical substance for the described significant new use.
EPA will be able to regulate prospective manufacture, import, or processing of the chemical substance before the described significant new use of that chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
EPA will ensure that all manufacturers, importers, and processors of the same chemical substance that is subject to a TSCA section 5(e) consent order are subject to similar requirements.
Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Inventory. Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on-line at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.
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Significant New Use Determination
Section 5(a)(2) of TSCA states 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.
In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the chemical substance subject to this final SNUR, EPA considered relevant information about the toxicity of the chemical substance, likely human exposures and environmental releases associated with possible uses, taking into consideration the four bulleted TSCA section 5(a)(2) factors listed in this unit.
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Response to Comments on Proposed SNUR on Cobalt Lithium Manganese
Nickel Oxide
EPA received several public comments on the proposed rule. Of these comments, two commenters were supportive of EPA's findings and agreed with the issuance of this regulation. A discussion of the remaining substantive comments received and the Agency's responses follows.
Comment 1: One commenter examined the solubility and release of cobalt and nickel ions in water to confirm the commenter's assumption that the PMN substance can be best described as an alloy, without the potential to release the individual ions. The commenter believes that the substance should therefore behave in the respiratory tract as an
``inert'' dust, and recommended a time weighted average (TWA) of 1 mg/ m\3\ in accordance with ``similar compounds,'' rather than the
Occupational Safety and Health Administration (OSHA) Permissible
Exposure Level (PEL) of 0.1 mg/m\3\ for nickel. The commenter included solubility data with the submission for Agency review.
Response: An alloy is a mixture of elemental metals. In contrast, based on submitted weight-fraction data, the PMN substance is characterized as a mixed-metal oxide, in which all of the metal species are oxidized (none exist in an elemental state) and accordingly would have the potential to dissociate into free metal ions upon release.
Therefore, the Agency does not believe a change to the proposed New
Chemicals Exposure Limit (NCEL) of 0.1 mg/m\3\ is supportable at this time. In addition, solubility data submitted by the commenter supports the Agency's predictions that the metals would be soluble well above the 1 part per billion (ppb) aquatic toxicity concentration of concern
(COC) for the PMN substance in surface waters. As a result, EPA will retain the recommended human health and aquatic toxicity studies listed in the proposed rule.
Comment 2: One commenter submitted a number of studies that were completed for a new chemical notification for cobalt lithium manganese nickel oxide for Belgium. Those studies included: An acute oral toxicity (Organisation for Economic Co-operation and Development (OECD)
Test Guideline 420) in rats; an acute dermal toxicity (OECD Test
Guideline 402) in rats; an acute dermal irritation (OECD Test Guideline 404) in rabbits; an acute eye irritation (OECD Test Guideline 405) in rabbits; a local lymph node assay (OECD Test Guideline 429) in mice; a 28-day repeated does oral (gavage) toxicity (OECD Test Guideline 407) in rats; a reverse mutation assay Ames Test (OECD Test Guideline 471) using Salmonella typhimurium and Escherichia coli; an in vitro chromosome aberration test (OECD Test Guideline 473) on human lymphocytes; and physical/chemical properties data for: melting/ freezing temperature (American Society for Testing and Materials (ASTM)
E537-86, Method A1 of European Commission (EC) Directive 92/69/EEC); relative density (gas comparison pycnometer); water solubility (flask method); particle size distribution (OECD Test Guideline 110); flammability (EC Method A10); explosive properties (EC Method A14); oxidizing properties (EC Method A16); and relative self-ignition temperature for solids (EC Method A10)). The submitter stated that it believed information contained in the studies may be of use to the EPA in preparation of a final rule.
Response: Summaries of the results of the aforementioned submitted data are included in the public docket at EPA-HQ-OPPT-2009-0922-0150.
While the submitted information was informative, it did not change
EPA's human health and environmental concerns for the chemical, for the reasons described as follows: a. Human health effects. EPA's primary human health concern for the
PMN substance is lung carcinogenesis from respirable crystalline material. EPA determined that the acute oral and 28-day oral gavage studies had little bearing on those concerns. The physical-chemical data confirmed that the PMN substance is in the respirable range. The dermal and eye irritation studies indicate that the PMN substance is of low dermal toxicity, is not a skin irritant, does not pose a skin sensitization hazard, and is a minimal eye irritant (class 3 on a scale of 1 to 8). The substance is not a gene mutagen or a chromosome mutagen in human cells. b. Environmental effects. The submitted acute and chronic aquatic toxicity assessment was consistent with
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the EPA toxicity profiles for the metals, from which the Agency derived the aquatic toxicity concern concentration of 1 ppb.
Comment 3: One commenter believed that the release-to-water provision in the proposed SNUR, for requirements at Sec. 721.90
(a)(1), (b)(1), and (c)(1), is an unreasonable and overbroad restriction that would lead to domestic manufacturers being subject to manufacturing limitations not applicable to their off-shore competitors. The comment stated that discharges of cobalt, lithium, manganese, and nickel oxide can be expected to be adequately regulated under a facility's pre-treatment or direct discharge permit issued under the Clean Water Act (CWA), which is specifically intended to regulate such discharges and ensure that effluent does not compromise aquatic organisms. Additionally, the comment stated that the PMN substance represents a battery technology that offers significant environmental benefits, based on the capability of storing much larger amounts of electricity, which will diminish the use of fossil fuels and power more sustainable and energy-efficient automobiles and other electronics. The comment requested that the release-to-water provision should either be eliminated altogether or revised to provide for no- release-to-water without valid authorization under the CWA, or similar language that would allow dischargers operating under valid pre- treatment or direct discharge permits to continue to operate as allowed under the terms of those CWA-issued permits.
Response: Through the National Pollutant Discharge Elimination
System (NPDES) Permit Program and the National Pretreatment Program, a component of the NPDES Permit Program, Federal, State, and local governments control water pollution by regulating point sources that discharge pollutants into waters of the United States. However, for the regulation of toxic pollutants, the NPDES Permit Program focuses on the
CWA section 307(a)(1) list of priority pollutants (which do not include cobalt, lithium, or manganese). When a pollutant discharged by a direct or indirect discharging industry is not specifically limited in an effluent guideline or by pretreatment standards, respectively, it is up to the permit writer or state/local agency to utilize best professional judgment to establish technology-based limits or determine other appropriate means to control its discharge. Permit writers may not be aware of the discharge of certain toxic chemical substances by a specific facility, such as chemical substances that have been assessed under the TSCA New Chemicals Program and which may be discharged by manufacturers, processors, and users of the chemical substance.
Therefore, EPA generally includes disposal provisions in new chemical
SNURs when it determines that disposal of the substance may not be adequately addressed by existing rules under other statutes. However, the SNUR regulations in Sec. 721.30 provide the opportunity for persons who intend to manufacture, import, or process a chemical substance subject to a SNUR to request a ``determination of equivalency'' from EPA. In such a request, the person must demonstrate that their intended activities will provide substantially the same degree of protection to health and the environment as the measures identified in the SNUR to control environmental release. Similarly, a person who intends to manufacture, import, or process a chemical substance subject to a SNUR can submit a SNUN that provides such
``equivalency'' information (e.g., specific NPDES or pretreatment limits for a specific facility or industry that will control the pollutants of concern).
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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 has decided 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 proposed SNUR rather than as of the effective date of the final rule. If uses begun after publication 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, and then argue that the use was ongoing before the effective date of the final rule.
Any person who began commercial manufacture, import, or processing of the chemical substance PMN P-04-269 for any of the significant new uses designated 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 the chemical substance 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 Sec. 721.45(h), those persons would be considered to have met the final SNUR requirements for those activities.
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Test Data and Other Information
EPA recognizes that TSCA section 5 does not require the development of any particular test data before submission of a SNUN. There are two exceptions: 1. Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)). 2. Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing covering the chemical substance, 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 (see Sec. 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. In this case, EPA recommends persons, before performing any testing, to consult with the Agency pertaining to protocol selection.
In the TSCA section 5(e) consent order for the chemical substance regulated under this final rule, EPA has established requirements for the use of dermal personal protective equipment, including gloves demonstrated to be impervious; use of respiratory personal protective equipment, including a National Institute of Occupational Safety and
Health (NIOSH)-approved respirator with an assigned protection factor
(APF) of at least 150, or compliance with an alternative NCEL of 0.1 mg/m\3\ as an 8-hour time weighted average; establishment of a hazard communication program, and prohibits releases-to-water in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substance. These requirements will remain until such time as the PMN submitter provides the results of toxicity tests that would permit a reasoned evaluation of the potential risks posed by the chemical substance. A listing of the specific human health and environmental toxicity tests specified in the TSCA section 5(e) consent order is included in Unit IV. of the proposed rule. The SNUR contains notification
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requirements that mirror the restrictions in the TSCA section 5(e) consent order. Significant new uses under this SNUR are activities restricted in the TSCA section 5(e) consent order. Persons who intend to commence any of these activities identified as a significant new use must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture, import, or processing.
The recommended testing specified in Unit IV. of the proposed rule may not be the only means of addressing the potential risks of the chemical substance. However, SNUNs submitted without any test data may increase the likelihood that EPA will respond by taking action under
TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior PMN or SNUN submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests prior to submitting a SNUN.
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result from the significant new use of the chemical substance.
Potential benefits of the chemical substance.
Information on risks posed by the chemical substance compared to risks posed by potential substitutes.
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SNUN Submissions
According to Sec. 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in Sec. 720.50. SNUNs must be on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in Sec. Sec. 721.25 and 720.40. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.
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Economic Analysis
EPA evaluated the potential costs of establishing SNUN requirements for potential manufacturers, importers, and processors of the chemical substance during the development of the direct final rule. The Agency's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2009-0922.
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Statutory and Executive Order Reviews
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Executive Order 12866
This final rule establishes a SNUR for a chemical substance that was the subject of a PMN and a TSCA section 5(e) consent order. 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).
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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 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. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this final rule. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request
(ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is ``good cause'' under section 553(b)(3)(B) of the
Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this table without further notice and comment.
The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does 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 between 30 and 170 hours per response. 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.
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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 will not have a significant adverse economic impact on a substantial number of small entities. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a
``significant new use.'' Because these uses are ``new,'' based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use 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
SNURs covering over 1,000 chemicals, the Agency receives only a handful of notices per year. For example, the number of SNUNs was four in
Federal fiscal year (FY) 2005, eight in FY 2006, six in FY 2007, eight in FY 2008, and seven in FY 2009. During this five-year period, three small entities submitted a SNUN. In addition, the estimated reporting cost for submission of a SNUN (see Unit IX.) is minimal regardless of the size of the firm. Therefore, the potential economic impacts of complying with this SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL- 5597-1), the Agency presented its general determination that 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.
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Unfunded Mandates Reform Act
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not
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been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this final rule. As such, EPA has determined that this final rule does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
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Executive Order 13132
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).
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Executive Order 13175
This final rule does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This final rule does not significantly nor 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 9, 2000), do not apply to this final rule.
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Executive Order 13045
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.
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Executive Order 13211
This action 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 and because this action is not a significant regulatory action under
Executive Order 12866.
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National Technology Transfer and 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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Executive Order 12898
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).
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Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report 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 40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements. 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: August 1, 2011.
Barbara A. Cunningham,
Acting Director, Office of Pollution Prevention and Toxics.
Therefore, 40 CFR parts 9 and 721 are amended as follows:
PART 9--[AMENDED] 0 1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048. 0 2. The table in Sec. [emsp14]9.1 is amended by adding the following section in numerical order under the undesignated center heading
``Significant New Uses of Chemical Substances'' to read as follows:
Sec. [emsp14]9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
40 CFR citation
OMB control No.
* * * * *
Significant New Uses of Chemical Substances
* * * * * 721.10201...........................................
2070-0012
* * * * *
* * * * *
PART 721--[AMENDED] 0 3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c). 0 4. Add Sec. [emsp14]721.10201 to subpart E to read as follows:
Sec. 721.10201 Cobalt lithium manganese nickel oxide.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as cobalt lithium manganese nickel oxide (PMN P-04-269; CAS No. 182442-95-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after it has been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec. 721.63 (a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(5), (a)(6), (b)
(concentration set at 0.1 percent), and (c). Respirators must provide a
National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 150. The following NIOSH-certified respirators meet the requirements of Sec. 721.63(a)(4): Supplied-air respirator operated in positive pressure demand or other positive pressure mode and equipped with a tight-fitting full facepiece. As an alternative to the respirator requirements listed here, a manufacturer, importer, or processor may choose to follow the New Chemical Exposure
Limit (NCEL) provisions listed in the Toxic Substances Control Act
Page 48002
(TSCA) section 5(e) consent order for this substance. The NCEL is 0.1 mg/m\3\ as an 8-hour time-weighted average. Persons who wish to pursue
NCELs as an alternative to the Sec. 721.63 respirator may request to do as under Sec. 721.30. Persons whose Sec. 721.30 requests to use the NCELs approach are approved by EPA will receive NCELs provisions comparable to those listed in the corresponding section 5(e) consent order.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(vii), (g)(1)(ix), (g)(2),
(g)(3), (g)(4)(iii), and (g)(5).
(iii) Release to water. Requirements as specified in Sec. 721.90(a)(1), (b)(1), and (c)(1).
(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), (c), (d), (e), (f), (g), (h), and (k) are applicable to manufacturers, importers, and processors of this chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
FR Doc. 2011-20021 Filed 8-5-11; 8:45 am
BILLING CODE 6560-50-P
