82 FR 45990 - Significant New Use Rule on Certain Chemical Substances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 190 (October 3, 2017)
Federal Register Volume 82, Issue 190 (October 3, 2017)
| Page Range | 45990-45995 | |
| FR Document | 2017-21237 |
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)] [Rules and Regulations] [Pages 45990-45995] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21237] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 9 and 721 [EPA-HQ-OPPT-2016-0207; FRL-9966-84] RIN 2070-AB27 Significant New Use Rule on Certain Chemical Substances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: EPA is finalizing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes, which was the subject of premanufacture notice (PMN) P-11-482. This action requires persons who intend to manufacture (defined by statute to include 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. The required notification initiates EPA's evaluation of the intended use within the applicable review period. Manufacture and processing for the significant new use is unable to commence until EPA has conducted a [[Page 45991]] review of the notice, made an appropriate determination on the notice, and take such actions as are required with that determination. 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 November 2, 2017. ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPPT-2016-0207. 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; email address: [email protected]. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you manufacture, process, or use the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes (PMN P-11-482). The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include, but are not limited to: Manufacturers (including importers) or processors of the subject chemical substance (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries. 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, and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to a SNUR must certify their 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 the chemical substance that is the subject of a proposed or 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. II. Background A. What action is the Agency taking? EPA is finalizing a SNUR for the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes (PMN P-11-482). This final action requires persons who intend to manufacture or process the 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 of June 8, 2017 (79 FR 26644) (FRL-9959-37), EPA proposed a SNUR for this chemical substance that was the subject of P-11-482. EPA received no comments to the proposed SNUR and is finalizing the SNUR as proposed. See the proposed SNUR for details and the basis of the proposed SNUR. 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 the four bulleted TSCA section 5(a)(2) factors listed in Unit III of this document. 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 (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore prohibits such manufacturing or processing from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A. Persons who must report are described in Sec. 721.5. C. 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 SNUN 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 must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. If EPA determines that the significant new use is not likely to [[Page 45992]] present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register, a statement of EPA's findings. III. 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 identified generically as bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes (PMN P-11-482), EPA considered relevant information about the toxicity of the chemical substance, likely human exposures and environmental releases associated with possible uses, and the four bulleted TSCA section 5(a)(2) factors listed in this unit. IV. Rationale and Objectives for the Rule A. Rationale During review of the PMN P-11-482, the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes, EPA concluded that one or more of the criteria of concern established at Sec. 721.170 were met. For additional discussion on this chemical substance, see Unit II. of this rule. B. Objectives EPA is issuing this SNUR for a specific chemical substance which has undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule: EPA will receive notice of any person's intent to manufacture or process a TSCA Chemical Substance Inventory (TSCA Inventory) 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 or processing a listed chemical substance for the described significant new use. EPA will be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs. EPA will ensure that all manufacturers 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 the Internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html. V. Applicability of the Significant New Use Designation If uses begun after the proposed rule was published were considered ongoing rather than new, any person could defeat the SNUR by initiating the significant new use before the final rule was issued. Therefore, EPA designated the date of public release/web posting of the proposed rule, as the cutoff date for determining whether the new use is ongoing. Consult the Federal Register Notice of April 24, 1990 (55 FR 17376), (FRL-3658-5) for a more detailed discussion of the cutoff date for ongoing uses. Any person who began commercial manufacture or processing of the chemical substances identified in this rule 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 the final rule. Persons who ceased those activities will have to first comply with all applicable SNUR notification requirements and wait until the notice review period, including any extensions, expires, before engaging in any activities designated as significant new uses. If a person were to meet the conditions of advance compliance under 40 CFR 721.45(h), the person would be considered to have met the requirements of the final SNUR for those activities. VI. Development and Submission of Information EPA recognizes that TSCA section 5 does not require developing any particular new information (e.g., generating test data) before submission of a SNUN. There is an exception: Development of test data is required where the chemical substance subject to the SNUR is also subject to a rule, order or consent agreement under TSCA section 4 (see TSCA section 5(b)(1)). In the absence of a TSCA section 4 test rule covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.'' The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org. In the TSCA section 5(e) consent orders for the chemical substances regulated under this rule, EPA has established production volume limits 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 substances. These limits cannot be exceeded unless the PMN submitter first submits the results of toxicity tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. Under recent TSCA section 5(e) consent orders, each PMN submitter is required to submit each study at least 14 weeks (earlier TSCA section 5(e) consent orders required submissions at least 12 weeks) before reaching the specified production limit. Listings of the tests specified in the TSCA section 5(e) consent orders are included in Unit IV. The SNURs contain the same production volume limits as the TSCA section 5(e) consent orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the [[Page 45993]] production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture or processing. Any request by EPA for the triggered and pended testing described in the Consent Order was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the PMN substance. Further, any such testing request on the part of EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models. The recommended tests specified in Unit IV. of the proposed rule may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data may increase the likelihood that EPA will take 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. 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 substances. VII. SNUN Submissions According to Sec. 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca/how-submit-e-pmn. VIII. Economic Analysis EPA evaluated the potential costs of establishing SNUN requirements for potential manufacturers 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-2016-0207. IX. Scientific Standards, Evidence, and Available Information EPA has used scientific information, technical procedures, measures, methods, protocols, methodologies, and models consistent with the risk assessment documents included in the public docket. These information sources supply information relevant to whether a particular use would be a significant new use, based on relevant factors including those listed under TSCA section 5(a)(2). The clarity and completeness of the data, assumptions, methods, quality assurance, and analyses employed in EPA's decision are documented, as applicable and to the extent necessary for purposes of this proposed significant new use rule, in Unit II and in the documents noted above. EPA recognizes, based on the available information, that there is variability and uncertainty in whether any particular significant new use would actually present an unreasonable risk. For precisely this reason, it is appropriate to secure a future notice and review process for these uses, at such time as they are known more definitely. The extent to which the various information, procedures, measures, methods, protocols, methodologies or models used in EPA's decision have been subject to independent verification or peer review is adequate to justify their use, collectively, in the record for a significant new use rule. X. Statutory and Executive Order Reviews A. Executive Order 12866 This action establishes a SNUR for the chemical substance that is 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). B. Paperwork Reduction Act (PRA) According to the 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 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. C. Regulatory Flexibility Act (RFA) On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities where the following are true: 1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR. 2. The SNUR submitted by any small entity would not cost significantly more than $8,300. A copy of that certification is available in the docket for this action. [[Page 45994]] This action is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit IX. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true: A significant number of SNUNs would not be submitted by small entities in response to the SNUR. Submission of the SNUN would not cost any small entity significantly more than $8,300. Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities. D. Unfunded Mandates Reform Act (UMRA) 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 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 UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.). E. 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). F. 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. G. 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. H. 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. I. National Technology Transfer and Advancement Act (NTTAA) In addition, since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action. J. 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). XI. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 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: September 15, 2017. Maria J. Doa, Director, Chemical Control Division, 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. In Sec. [emsp14]9.1, add 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. * * * * * ------------------------------------------------------------------------ OMB control 40 CFR citation No. ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ Significant New Uses of Chemical Substances ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ 721.10927............................................... 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. 721.10927 to subpart E to read as follows: Sec. 721.10927 Bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes (PMN P-11-482) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(6) (particulate), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the [[Page 45995]] operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. A National Institute for Occupational Safety and Health (NIOSH)-certified air purifying, tight-fitting full-face respirator equipped with N-100, P- 100, or R-100 cartridges, or power air purifying particulate respirator with an Assigned Protection Factor (APF) of at least 50 meets the requirements of Sec. 721.63(a)(4). (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k) and (q). A significant new use is any use involving an application method that generates a vapor, mist or aerosol. (iii) Disposal. Requirements as specified in Sec. 721.85(a)(1), (a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). (iv) Release to water. Requirements as specified in Sec. 721.90(b)(1) and (c)(1). Any predictable or purposeful release of a manufacturing stream associated with any use of the substance from any site is a significant new use other than the water releases described in the manufacturing process of PMN P-11-482. (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) through (e), (i), (j), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section. [FR Doc. 2017-21237 Filed 10-2-17; 8:45 am] BILLING CODE 6560-50-P
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D. Federalism and Indian Tribal Consideration supporting this Port Jacksonville or a designated
Governments determination is available in the docket representative.
where indicated under ADDRESSES. (2) Persons and vessels desiring to
A rule has implications for federalism
enter, transit through, anchor in, or
under Executive Order 13132, G. Protest Activities remain within the regulated area may
Federalism, if it has a substantial direct
The Coast Guard respects the First contact the Captain of the Port
effect on the States, on the relationship
Amendment rights of protesters. Jacksonville by telephone at (904) 714–
between the national government and
Protesters are asked to contact the 7557, or a designated representative via
the States, or on the distribution of
person listed in the FOR FURTHER VHF–FM radio on channel 16, to
power and responsibilities among the
INFORMATION CONTACT section to request authorization. If authorization is
various levels of government. We have
coordinate protest activities so that your granted, all persons and vessels
analyzed this rule under that Order and
message can be received without receiving such authorization must
have determined that it is consistent
jeopardizing the safety or security of comply with the instructions of the
with the fundamental federalism
people, places or vessels. COTP Jacksonville or a designated
principles and preemption requirements
representative.
described in Executive Order 13132. List of Subjects in 33 CFR Part 165 (3) The Coast Guard will provide
Also, this rule does not have tribal notice of the regulated area through
implications under Executive Order Harbors, Marine safety, Navigation
(water), Reporting and recordkeeping Broadcast Notice to Mariners via VHF–
13175, Consultation and Coordination FM channel 16 or by on-scene
with Indian Tribal Governments, requirements, Security measures,
Waterways. designated representatives.
because it does not have a substantial (d) Enforcement period. This rule will
direct effect on one or more Indian For the reasons discussed in the
be enforced daily from 8 a.m. until 5
tribes, on the relationship between the preamble, the Coast Guard amends 33
p.m. from November 3, 2017 through
Federal Government and Indian tribes, CFR part 165 as follows:
November 5, 2017.
or on the distribution of power and
responsibilities between the Federal PART 165—REGULATED NAVIGATION Dated: September 28, 2017.
Government and Indian tribes. If you AREAS AND LIMITED ACCESS AREAS Todd C. Wiemers,
believe this rule has implications for Captain, U.S. Coast Guard, Captain of the
federalism or Indian tribes, please ■ 1. The authority citation for part 165 Port Jacksonville.
contact the person listed in the FOR continues to read as follows: [FR Doc. 2017–21196 Filed 10–2–17; 8:45 am]
FURTHER INFORMATION CONTACT section. Authority: 33 U.S.C. 1231; 50 U.S.C. 191; BILLING CODE 9110–04–P
33 CFR 1.05–1, 6.04–1, 6.04–6 and 160.5;
E. Unfunded Mandates Reform Act Department of Homeland Security Delegation
The Unfunded Mandates Reform Act No. 0170.1.
ENVIRONMENTAL PROTECTION
of 1995 (2 U.S.C. 1531–1538) requires ■ 2. Add § 165.T07–0577 to read as AGENCY
Federal agencies to assess the effects of follows:
their discretionary regulatory actions. In 40 CFR Parts 9 and 721
§ 165.T07–0577 Safety Zone, Blue Angels
particular, the Act addresses actions Air Show; St. Johns River, Jacksonville, FL. [EPA–HQ–OPPT–2016–0207; FRL–9966–84]
that may result in the expenditure by a
State, local, or tribal government, in the (a) Regulated area. The following area RIN 2070–AB27
aggregate, or by the private sector of is a safety zone located on the St. Johns
$100,000,000 (adjusted for inflation) or River in Jacksonville, FL. All waters of Significant New Use Rule on Certain
more in any one year. Though this rule the St. Johns River encompassed within Chemical Substances
will not result in such an expenditure, an imaginary line connecting the AGENCY: Environmental Protection
we do discuss the effects of this rule following points: Starting at Point 1 in Agency (EPA).
elsewhere in this preamble. position 30°13′41″ N.; 081°39′45″ W.
ACTION: Final rule.
thence due east to Point 2 in position
F. Environment 30°13″41″ N.; 081°38′35″ W. thence SUMMARY: EPA is finalizing a significant
We have analyzed this rule under south to Point 3 in position 30°14′27″ new use rule (SNUR) under section
Department of Homeland Security N.; 081°38′35″ W. thence west to Point 5(a)(2) of the Toxic Substances Control
Management Directive 023–01 and 4 in position 30°14′27″ N.; 081°39′45″ Act (TSCA) for the chemical substance
Commandant Instruction M16475.lD, W. thence following the shoreline north identified generically as bimodal
which guide the Coast Guard in back to the point of origin. These mixture consisting of multi-walled
complying with the National coordinates are based on North carbon nanotubes and other classes of
Environmental Policy Act of 1969 (42 American Datum 1983. carbon nanotubes, which was the
U.S.C. 4321–4370f), and have (b) Definition. The term ‘‘designated subject of premanufacture notice (PMN)
determined that this action is one of a representative’’ means Coast Guard P–11–482. This action requires persons
category of actions that do not Patrol Commanders, including Coast who intend to manufacture (defined by
individually or cumulatively have a Guard coxswains, petty officers, and statute to include import) or process the
significant effect on the human other officers operating Coast Guard chemical substance for a use that is
environment. This rule involves a safety vessels, and Federal, state, and local designated as a significant new use by
zone that would prohibit persons and officers designated by or assisting the this final rule to notify EPA at least 90
jstallworth on DSKBBY8HB2PROD with RULES
vessels from transiting through a one Captain of the Port Jacksonville in the days before commencing that activity.
square mile regulated area during a enforcement of the regulated area. The required notification initiates EPA’s
three day air show lasting nine hours (c) Regulations. (1) All persons and evaluation of the intended use within
daily. It is categorically excluded from vessels are prohibited from entering, the applicable review period.
further review under paragraph 34(g) of transiting through, anchoring in, or Manufacture and processing for the
Figure 2–1 of the Commandant remaining within the regulated area significant new use is unable to
Instruction. A Record of Environmental unless authorized by the Captain of the commence until EPA has conducted a
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![45994 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Rules and Regulations
This action is within the scope of the economically significant regulatory Authority: 7 U.S.C. 135 et seq., 136–136y;
February 18, 2012 certification. Based action as defined by Executive Order 15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671;
on the Economic Analysis discussed in 12866, and this action does not address 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,
Unit IX. and EPA’s experience environmental health or safety risks 1321, 1326, 1330, 1342, 1344, 1345 (d) and
promulgating SNURs (discussed in the disproportionately affecting children. (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
certification), EPA believes that the 1971–1975 Comp. p. 973; 42 U.S.C. 241,
H. Executive Order 13211
following are true: 242b, 243, 246, 300f, 300g, 300g–1, 300g–2,
• A significant number of SNUNs This action is not subject to Executive 300g–3, 300g–4, 300g–5, 300g–6, 300j–1,
would not be submitted by small Order 13211, entitled ‘‘Actions 300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq.,
entities in response to the SNUR. Concerning Regulations That 6901–6992k, 7401–7671q, 7542, 9601–9657,
• Submission of the SNUN would not Significantly Affect Energy Supply, 11023, 11048.
cost any small entity significantly more Distribution, or Use’’ (66 FR 28355, May ■ 2. In § 9.1, add the following section
than $8,300. 22, 2001), because this action is not in numerical order under the
Therefore, the promulgation of the expected to affect energy supply, undesignated center heading
SNUR would not have a significant distribution, or use and because this ‘‘Significant New Uses of Chemical
economic impact on a substantial action is not a significant regulatory Substances’’ to read as follows:
number of small entities. action under Executive Order 12866.
§ 9.1 OMB approvals under the Paperwork
D. Unfunded Mandates Reform Act I. National Technology Transfer and Reduction Act.
(UMRA) Advancement Act (NTTAA) * * * * *
Based on EPA’s experience with In addition, since this action does not
proposing and finalizing SNURs, State, involve any technical standards, OMB control
40 CFR citation
local, and Tribal governments have not No.
NTTAA section 12(d) (15 U.S.C. 272
been impacted by these rulemakings, note), does not apply to this action.
and EPA does not have any reasons to * * * * *
believe that any State, local, or Tribal J. Executive Order 12898
government will be impacted by this This action does not entail special Significant New Uses of Chemical
final rule. As such, EPA has determined considerations of environmental justice Substances
that this final rule does not impose any related issues as delineated by
enforceable duty, contain any unfunded Executive Order 12898, entitled
* * * * *
mandate, or otherwise have any effect ‘‘Federal Actions to Address
on small governments subject to the Environmental Justice in Minority 721.10927 ............................. 2070–0012
requirements of UMRA sections 202, Populations and Low-Income
203, 204, or 205 (2 U.S.C. 1501 et seq.). Populations’’ (59 FR 7629, February 16, * * * * *
1994).
E. Executive Order 13132 * * * * *
This action will not have a substantial XI. Congressional Review Act
direct effect on States, on the Pursuant to the Congressional Review PART 721—[AMENDED]
relationship between the national Act (5 U.S.C. 801 et seq.), EPA will
government and the States, or on the submit a report containing this rule and ■ 3. The authority citation for part 721
distribution of power and other required information to the U.S. continues to read as follows:
responsibilities among the various Senate, the U.S. House of Authority: 15 U.S.C. 2604, 2607, and
levels of government, as specified in Representatives, and the Comptroller 2625(c).
Executive Order 13132, entitled General of the United States prior to ■ 4. Add § 721.10927 to subpart E to
‘‘Federalism’’ (64 FR 43255, August 10, publication of the rule in the Federal read as follows:
1999). Register. This rule is not a ‘‘major rule’’
as defined by 5 U.S.C. 804(2). § 721.10927 Bimodal mixture consisting of
F. Executive Order 13175 multi-walled carbon nanotubes and other
This final rule does not have Tribal List of Subjects classes of carbon nanotubes (generic).
implications because it is not expected 40 CFR Part 9 (a) Chemical substance and
to have substantial direct effects on significant new uses subject to reporting.
Indian Tribes. This final rule does not Environmental protection, Reporting (1) The chemical substance identified
significantly nor uniquely affect the and recordkeeping requirements. generically as a bimodal mixture
communities of Indian Tribal 40 CFR Part 721 consisting of multi-walled carbon
governments, nor does it involve or nanotubes and other classes of carbon
Environmental protection, Chemicals,
impose any requirements that affect nanotubes (PMN P–11–482) is subject to
Hazardous substances, Reporting and
Indian Tribes. Accordingly, the reporting under this section for the
recordkeeping requirements.
requirements of Executive Order 13175, significant new uses described in
entitled ‘‘Consultation and Coordination Dated: September 15, 2017. paragraph (a)(2) of this section.
with Indian Tribal Governments’’ (65 FR Maria J. Doa, (2) The significant new uses are:
67249, November 9, 2000), do not apply Director, Chemical Control Division, Office (i) Protection in the workplace.
to this final rule. of Pollution Prevention and Toxics. Requirements as specified in
jstallworth on DSKBBY8HB2PROD with RULES
§ 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3),
G. Executive Order 13045 Therefore, 40 CFR parts 9 and 721 are
(a)(4), (a)(6) (particulate), and (c). When
amended as follows:
This action is not subject to Executive determining which persons are
Order 13045, entitled ‘‘Protection of PART 9—[AMENDED] reasonably likely to be exposed as
Children from Environmental Health required for § 721.63(a)(1) and (a)(4),
Risks and Safety Risks’’ (62 FR 19885, ■ 1. The authority citation for part 9 engineering control measures (e.g.,
April 23, 1997), because this is not an continues to read as follows: enclosure or confinement of the
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![Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Rules and Regulations 45995
operation, general and local ventilation) SUMMARY: The Environmental Protection Atlanta, Georgia 30303–8960. Mr.
or administrative control measures (e.g., Agency (EPA) is taking final action to Febres can be reached by telephone at
workplace policies and procedures) approve a revision to the South Carolina (404) 562–8966 or via electronic mail at
shall be considered and implemented to State Implementation Plan (SIP), febres-martinez.andres@epa.gov.
prevent exposure, where feasible. A submitted by the South Carolina SUPPLEMENTARY INFORMATION:
National Institute for Occupational Department of Health and
Safety and Health (NIOSH)-certified air Environmental Control (DHEC), on I. Background
purifying, tight-fitting full-face December 7, 2016, addressing the Clean By statute, SIPs meeting the
respirator equipped with N–100, P–100, Air Act (CAA) interstate transport requirements of sections 110(a)(1) and
or R–100 cartridges, or power air (prongs 1 and 2) infrastructure SIP (2) of the CAA are to be submitted by
purifying particulate respirator with an requirements for the 2010 1-hour states within three years after
Assigned Protection Factor (APF) of at Nitrogen Dioxide (NO2) National promulgation of a new or revised
least 50 meets the requirements of Ambient Air Quality Standard NAAQS to provide for the
§ 721.63(a)(4). (NAAQS). The CAA requires that each implementation, maintenance, and
(ii) Industrial, commercial, and state adopt and submit a SIP for the enforcement of the new or revised
consumer activities. Requirements as implementation, maintenance, and NAAQS. EPA has historically referred to
specified in § 721.80(k) and (q). A enforcement of each NAAQS these SIP submissions made for the
significant new use is any use involving promulgated by EPA, commonly purpose of satisfying the requirements
an application method that generates a referred to as an ‘‘infrastructure SIP.’’ of sections 110(a)(1) and 110(a)(2) as
vapor, mist or aerosol. Specifically, EPA is taking final action ‘‘infrastructure SIP’’ submissions.
(iii) Disposal. Requirements as to approve South Carolina’s December Sections 110(a)(1) and (2) require states
specified in § 721.85(a)(1), (a)(2), (b)(1), 7, 2016, SIP submission addressing to address basic SIP elements such as
(b)(2), (c)(1), and (c)(2). prongs 1 and 2 to ensure that air requirements for monitoring, basic
(iv) Release to water. Requirements as emissions in the State do not program requirements, and legal
specified in § 721.90(b)(1) and (c)(1). significantly contribute to authority that are designed to assure
Any predictable or purposeful release of nonattainment or interfere with attainment and maintenance of the
a manufacturing stream associated with maintenance of the 2010 1-hour NO2 newly established or revised NAAQS.
any use of the substance from any site NAAQS in any other state. More specifically, section 110(a)(1)
is a significant new use other than the DATES: This rule will be effective provides the procedural and timing
water releases described in the November 2, 2017. requirements for infrastructure SIPs.
manufacturing process of PMN P–11– ADDRESSES: EPA has established a Section 110(a)(2) lists specific elements
482. docket for this action under Docket that states must meet for the
(b) Specific requirements. The Identification No. EPA–R04–OAR– infrastructure SIP requirements related
provisions of subpart A of this part 2017–0045. All documents in the docket to a newly established or revised
apply to this section except as modified are listed on the www.regulations.gov NAAQS. The contents of an
by this paragraph. Web site. Although listed in the index, infrastructure SIP submission may vary
(1) Recordkeeping. Recordkeeping some information may not be publicly depending upon the data and analytical
requirements as specified in available, i.e., Confidential Business tools available to the state, as well as the
§ 721.125(a) through (e), (i), (j), and (k) Information or other information whose provisions already contained in the
are applicable to manufacturers and disclosure is restricted by statute. state’s implementation plan at the time
processors of this substance. Certain other material, such as in which the state develops and submits
(2) Limitations or revocation of copyrighted material, is not placed on the submission for a new or revised
certain notification requirements. The the Internet and will be publicly NAAQS.
provisions of § 721.185 apply to this available only in hard copy form. Section 110(a)(2)(D) has two
section. Publicly available docket materials are components: 110(a)(2)(D)(i) and
(3) Determining whether a specific use available either electronically through 110(a)(2)(D)(ii). Section 110(a)(2)(D)(i)
is subject to this section. The provisions www.regulations.gov or in hard copy at includes four distinct components,
of § 721.1725(b)(1) apply to paragraph the Air Regulatory Management Section, commonly referred to as ‘‘prongs,’’ that
(a)(2)(ii) of this section. Air Planning and Implementation must be addressed in infrastructure SIP
[FR Doc. 2017–21237 Filed 10–2–17; 8:45 am] Branch, Air, Pesticides and Toxics submissions. The first two prongs,
BILLING CODE 6560–50–P Management Division, U.S. which are codified in section
Environmental Protection Agency, 110(a)(2)(D)(i)(I), are provisions that
Region 4, 61 Forsyth Street SW., prohibit any source or other type of
ENVIRONMENTAL PROTECTION Atlanta, Georgia 30303–8960. EPA emissions activity in one state from
AGENCY requests that if at all possible, you contributing significantly to
contact the person listed in the FOR nonattainment of the NAAQS in another
40 CFR Part 52 FURTHER INFORMATION CONTACT section to state (prong 1) and from interfering with
schedule your inspection. The Regional maintenance of the NAAQS in another
[EPA–R04–OAR–2017–0045; FRL–9968–73– Office’s official hours of business are state (prong 2). The third and fourth
Region 4] Monday through Friday 8:30 a.m. to prongs, which are codified in section
4:30 p.m., excluding Federal holidays. 110(a)(2)(D)(i)(II), are provisions that
jstallworth on DSKBBY8HB2PROD with RULES
Air Plan Approval; South Carolina; FOR FURTHER INFORMATION CONTACT: prohibit emissions activity in one state
Interstate Transport (Prongs 1 and 2) Andres Febres of the Air Regulatory from interfering with measures required
for the 2010 1-Hour NO2 Standard Management Section, Air Planning and to prevent significant deterioration of air
AGENCY: Environmental Protection Implementation Branch, Air, Pesticides quality in another state (prong 3) and
Agency. and Toxics Management Division, U.S. from interfering with measures to
Environmental Protection Agency, protect visibility in another state (prong
ACTION: Final rule.
Region 4, 61 Forsyth Street SW., 4). Section 110(a)(2)(D)(ii) requires SIPs
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Document Created: 2017-10-03 01:01:36
Document Modified: 2017-10-03 01:01:36
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This final rule is effective November 2, 2017. | |
| 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; email | |
| FR Citation | 82 FR 45990 | |
| RIN Number | 2070-AB27 | |
| CFR Citation | 40
CFR
721 40 CFR 9 | |
| CFR Associated | Chemicals; Hazardous Substances; Environmental Protection and Reporting and Recordkeeping Requirements |
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