82 FR 26644 - Significant New Use Rule on Certain Chemical Substances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 109 (June 8, 2017)
Federal Register Volume 82, Issue 109 (June 8, 2017)
| Page Range | 26644-26649 | |
| FR Document | 2017-11695 |
[Federal Register Volume 82, Number 109 (Thursday, June 8, 2017)] [Proposed Rules] [Pages 26644-26649] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-11695] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 [EPA-HQ-OPPT-2016-0207; FRL-9959-37] RIN 2070-AB27 Significant New Use Rule on Certain Chemical Substances AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: EPA is proposing a significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA) for one chemical substance that was the subject of a premanufacture notice (PMN). The applicable review period for the PMN submitted for this chemical substance ended prior to June 22, 2016, the date on which President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (which amends TSCA). This action would require persons who intend to manufacture (defined by statute to include import) or process the chemical substance for an activity that is designated as a significant new use by this proposed 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 review of the notice, made an appropriate determination on the notice, and take such actions as are required with that determination. DATES: Comments must be received on or before July 10, 2017. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2016-0207, by one of the following methods:Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. 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 contained in this proposed rule. 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 [[Page 26645]] determine whether this document applies to them. Potentially affected entities may include: 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 these SNURs 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 a chemical substance to a proposed or 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. B. What should I consider as I prepare my comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html. II. Background A. What action is the Agency taking? EPA is proposing this SNUR under TSCA section 5(a)(2) for the chemical substance that was the subject of PMN P-11-482. This SNUR would require persons who intend to manufacture or process this chemical substance for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. In accordance with the procedures at Sec. 721.160(c)(3)(i), in the Federal Register publication of November 17, 2016 (81 FR 81250) (FRL- 9953-41) EPA issued a direct final SNUR on this chemical substance, which is the subject of a PMN. EPA received a notice of intent to submit adverse comments on this SNUR. Therefore, as required by Sec. 721.160(c)(3)(ii), EPA withdrew the direct final SNURs in the Federal Register of January 19, 2017 (82 FR 6277) (FRL-9958-20), and is now issuing this proposed rule on the chemical substance. The records for the direct final SNUR on the chemical substance were established as docket EPA-HQ-OPPT-2016-0207. Those records include information considered by the Agency in developing the direct final rule. While notices of intent to submit adverse comments were received during the direct final rule phase, only one substantive comment was submitted. The commenter noted a discrepancy between requirements in the consent order and SNUR. While the consent order allows limited surface water releases from the manufacturing process, the direct final SNUR designated as a significant new use any purposeful or predictable releases to surface waters. To make the SNUR consistent with consent order requirements, in this proposed SNUR EPA has designated as a significant new use any predictable or purposeful releases to water from manufacturing, processing, or use other than the water releases described in the PMN for the manufacturing process of P-11-482. EPA awaits further comment during the open comment period for this proposed rule. 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. 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 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. 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 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, [[Page 26646]] processing, distribution in commerce, and disposal of a chemical substance. In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorized EPA to consider any other relevant factors. To determine what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, 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. Substances Subject to This Proposed Rule EPA is proposing significant new use and recordkeeping requirements for one chemical substance in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for the chemical substance: PMN number. Chemical name (generic name, if the specific name is claimed as CBI). Chemical Abstracts Service (CAS) Registry number (assigned for non-confidential chemical identities). Public comments and EPA's response to comments on the direct final SNURs. Basis for the TSCA non-section 5(e) SNURs (i.e., SNURs without TSCA section 5(e) consent orders). Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VII. for more information). CFR citation assigned in the regulatory text section of this proposed rule. The regulatory text section of this proposed rule specifies the activities designated as significant new uses. Certain new uses, including production volume limits (i.e., limits on manufacture volume) and other uses designated in this proposed rule, may be claimed as CBI. PMN Number P-11-482 Chemical name: Bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic use of the PMN substance will be as a specialty additive. Based on test data on analogous respirable, poorly soluble particulates and nanocarbon materials, EPA identified concerns for pulmonary toxicity and oncogenicity. Based on test data for other nanocarbon materials EPA identified concerns for environmental toxicity. The Order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the consent order requires: 1. Use of personal protective equipment involving impervious gloves and protective clothing (where there is a potential for dermal exposures) and 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 (where there is a potential for inhalation exposures). 2. Submission of a dustiness test within six months of notice of commencement of manufacture (NOC). 3. Submission of certain physical chemical properties data within the time limits specified in the consent order. 4. Processing and use of the PMN substance only for the use specified in the consent order, including no application method that generates a vapor, mist or aerosol unless the application method occurs in an enclosed process. 5. No predictable or purposeful releases to water from manufacturing, processing, or use other than the water releases described in the PMN for the manufacturing process of P-11-482 and disposal of the PMN substance only by landfill or incineration. The SNUR would designate as a ``significant new use'' the absence of these protective measures. Recommended testing: EPA has determined that the development of data on certain physical-chemical properties, as well as certain human health and environmental toxicity testing would help characterize possible effects of the substance. The submitter has agreed to provide a dustiness test (European Standard EU 15051) by six months from commencement of manufacture. In addition, the submitter has agreed to provide certain physical chemical property testing as required in the consent order after the commencement of manufacture. Although the order does not require a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465 or Organisation for Economic Co- operation and Development (OECD) Test Guideline 413) in rats with a post-exposure observation period of up to 9 months (including BALF analysis, a determination of cardiovascular toxicity (clinically-based blood/plasma protein analyses), and histopathology of the heart), a two-year inhalation bioassay (OPPTS Test Guideline 870.4200), a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), a fish early life stage toxicity test (OPPTS Test Guideline 850.1400), or an algal toxicity test (OCSPP Test Guideline 850.4500), the Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.10927. V. Rationale and Objectives of the Proposed Rule A. Rationale During review of the PMN submitted for the chemical substance that is subject to this SNUR, EPA determined that one or more of the criteria of concern established at Sec. 721.170 were met. For additional discussion on this chemical substance, see Units II. and IV. of this proposed rule. B. Objectives EPA is proposing this SNUR for specific chemical substance which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this proposed rule: EPA would receive notice of any person's intent to manufacture or process the listed chemical substance for the described significant new use before that activity begins. EPA would have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing the listed chemical substance for the described significant new use. EPA would 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. Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at https://www.epa.gov/tsca-inventory. [[Page 26647]] VI. Applicability of the Proposed Rule to Uses Occurring Before the Effective Date of the Final Rule To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substance subject to this proposed rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing. When the chemical substance identified in this proposed rule is added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. The identity of the chemical substance subject to this proposed rule has been claimed as confidential and EPA has received no post-PMN bona fide submissions (per Sec. Sec. 720.25 and 721.11). Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this proposed rule are ongoing. Therefore, EPA designates February 28, 2017 (the date of public release/web posting of this proposed rule), as the cutoff date for determining whether the new use is ongoing. This designation varies slightly from EPA's past practice of designating the date of Federal Register publication as the date for making this determination. The objective of EPA's approach has been to ensure that a person could not defeat a SNUR by initiating a significant new use before the effective date of the proposed rule. In developing this proposed rule, EPA has recognized that, given EPA's practice of now posting rules on its Web site a week or more in advance of Federal Register publication, this objective could be thwarted even before that publication. Thus, EPA has slightly modified its approach in this rulemaking and plans to follow this modified approach in future significant new use rulemakings. Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of that date would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until the notice review period, including any extensions, expires. If such a person met the conditions of advance compliance under Sec. 721.45(h), the person would be considered exempt from the requirements of the SNUR. Consult the Federal Register document of April 24, 1990 (55 FR 17376) for a more detailed discussion of the cutoff date for ongoing uses. VII. 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 Guidelines for Pesticides and Toxic Substances.'' The recommended tests specified in Unit IV. 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 and define the terms of any potentially necessary controls if the submitter provides detailed information on the following: Human exposure and environmental release that may result from the significant new use of the chemical substances. VIII. 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-chemicals-under-toxic-substances-control-act-tsca/how-submit-e-pmn. 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. Economic Analysis EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this proposed rule, during the development of the direct final rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2016-0207. [[Page 26648]] XI. Statutory and Executive Order Reviews A. Executive Order 12866 This proposed rule would establish SNUR for the chemical substance that was the subject of PMN. 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 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. The information collection requirements related to this proposed rule have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This proposed rule would not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average 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 proposed rule. This proposed rule 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 would be impacted by this proposed rule. As such, EPA has determined that this proposed rule would 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 proposed rule would 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 proposed rule would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly nor uniquely affect the communities of Indian Tribal governments, nor would 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 proposed rule. G. Executive Order 13045 This proposed rule 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 proposed rule does not address environmental health or safety risks disproportionately affecting children. H. Executive Order 13211 This proposed rule is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because this proposed rule is not expected to affect energy supply, distribution, or use and because this proposed rule is not a significant regulatory action under Executive Order 12866. I. National Technology Transfer and Advancement Act (NTTAA) In addition, since this proposed rule would not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), would not apply to this proposed rule. J. Executive Order 12898 This proposed rule 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). List of Subjects in 40 CFR Part 721 Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. Dated: February 21, 2017. Maria J. Doa, Director, Chemical Control Division, Office of Pollution Prevention and Toxics. Therefore, it is proposed that 40 CFR chapter I be amended as follows: PART 721--[AMENDED] 0 1. The authority citation for part 721 continues to read as follows: Authority: 15 U.S.C. 2604, 2607, and 2625(c). 0 2. Add Sec. 721.10927 to subpart E to read as follows: [[Page 26649]] 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 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. 2017-11695 Filed 6-7-17; 8:45 am] BILLING CODE 6560-50-P
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however, based on the structural protectant (PIP) Bacillus thuringiensis 90 days before commencing that
similarity between tolfenpyrad and PT– Cry14Ab-1 protein in or on soybean. activity. The required notification
CA, it is anticipated that the The petitioner believes no analytical initiates EPA’s evaluation of the
multiresidue method protocols would method is needed because this petition intended use within the applicable
not be suitable for analysis of PT–CA. is for a temporary exemption from the review period. Manufacture and
Contact: RD. requirement of a tolerance without processing for the significant new use is
9. PP 6E8450. (EPA–HQ–OPP–2016– numerical limitation; thus, an analytical unable to commence until EPA has
0519). Interregional Research Project method should not be required. Contact: conducted a review of the notice, made
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Rutgers, The State University of New 2. PP IN–11022 (EPA–HQ–OPP–2017– notice, and take such actions as are
Jersey, 500 College Road East, Suite 0115). Bayer CropScience LP, 2 T.W. required with that determination.
201W, Princeton, NJ 08540, requests to Alexander Dr., Research Triangle Park, DATES: Comments must be received on
establish tolerances in 40 CFR part NC 27709, requests to establish an or before July 10, 2017.
180.614 for residues of the bactericide, exemption from the requirement of a ADDRESSES: Submit your comments,
Kasugamycin, (3–O-[2-amino-4- tolerance in 40 CFR part 174 for
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subgroup 12–12A at 0.6 parts per (HPPD–4) in or on all food commodities.
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The petitioner believes no analytical instructions for submitting comments.
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evaluate the chemical kasugamycin. requirement of a tolerance without
Contact: RD. Confidential Business Information (CBI)
numerical limitation; thus, an analytical or other information whose disclosure is
New Tolerance Exemptions for Non- method should not be required. Contact: restricted by statute.
Inerts (Except PIPS) BPPD. • Mail: Document Control Office
PP 6F8520. (EPA–HQ–OPP–2017– Authority: 21 U.S.C. 346a. (7407M), Office of Pollution Prevention
0080). Monsanto Company, 1300 I (Eye) Dated: April 27, 2017. and Toxics (OPPT), Environmental
St. NW., Suite 450 East, Washington, DC Delores Barber, Protection Agency, 1200 Pennsylvania
20005, requests to establish an Director, Information Technology and Ave. NW., Washington, DC 20460–0001.
exemption from the requirement of a Resources Management Division, Office of • Hand Delivery: To make special
tolerance in 40 CFR part 180 for Pesticide Programs. arrangements for hand delivery or
residues of the plant growth regulator [FR Doc. 2017–11927 Filed 6–7–17; 8:45 am] delivery of boxed information, please
LCO SP104: D-Glucose,O–2-deoxy-2- BILLING CODE 6560–50–P
follow the instructions at http://
[[(11Z)-1-oxo-11-octadecen-1-yl]amino]- www.epa.gov/dockets/contacts.html.
b-D-glucopyranosyl-(1→4)-O–2- Additional instructions on
(acetylamino)-2-deoxy-b-D- ENVIRONMENTAL PROTECTION commenting or visiting the docket,
glucopyranosyl-(1→4)-O–2- AGENCY along with more information about
(acetylamino)-2-deoxy-b-D- dockets generally, is available at http://
glucopyranosyl-(1→4)-O–2- 40 CFR Part 721 www.epa.gov/dockets.
(acetylamino)- 2-deoxy-b-D- [EPA–HQ–OPPT–2016–0207; FRL–9959–37] FOR FURTHER INFORMATION CONTACT:
glucopyranosyl-(1→4)-2-(acetylamino)- For technical information contact:
2-deoxy- in or on raw agricultural RIN 2070–AB27 Kenneth Moss, Chemical Control
commodities and processed foods. The Division (7405M), Office of Pollution
Significant New Use Rule on Certain
petitioner believes no analytical method Prevention and Toxics, Environmental
Chemical Substances
is needed because analytical methods Protection Agency, 1200 Pennsylvania
normally utilized for detection of AGENCY: Environmental Protection Ave. NW., Washington, DC 20460–0001;
compounds in crop plants are incapable Agency (EPA). telephone number: (202) 564–9232;
of quantifying the negligible levels of ACTION: Proposed rule. email address: moss.kenneth@epa.gov.
LCO SP104 that are predicted to be For general information contact: The
presented in raw or processed SUMMARY: EPA is proposing a significant TSCA-Hotline, ABVI-Goodwill, 422
agricultural commodities. Even in the new use rule (SNUR) under the Toxic South Clinton Ave., Rochester, NY
unlikely event that dietary exposure Substances Control Act (TSCA) for one 14620; telephone number: (202) 554–
does occur associated with the chemical substance that was the subject 1404; email address: TSCA-Hotline@
requested uses, the demonstrated of a premanufacture notice (PMN). The epa.gov.
favorable toxicological profile for LCO applicable review period for the PMN
SUPPLEMENTARY INFORMATION:
SP104 does not present a potential submitted for this chemical substance
hazard for humans or the environment. ended prior to June 22, 2016, the date I. General Information
on which President Obama signed into
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS
Contact: BPPD. A. Does this action apply to me?
law the Frank R. Lautenberg Chemical
New Tolerance Exemptions for PIPS Safety for the 21st Century Act (which You may be potentially affected by
1. PP 6F8541. (EPA–HQ–OPP–2017– amends TSCA). This action would this action if you manufacture, process,
0113). Bayer CropScience LP, 2 T.W. require persons who intend to or use the chemical substance contained
Alexander Dr., Research Triangle Park, manufacture (defined by statute to in this proposed rule. The following list
NC 27709, requests to establish an include import) or process the chemical of North American Industrial
exemption from the requirement of a substance for an activity that is Classification System (NAICS) codes is
tolerance in 40 CFR part 174 for designated as a significant new use by not intended to be exhaustive, but rather
residues of the plant-incorporated this proposed rule to notify EPA at least provides a guide to help readers
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![26648 Federal Register / Vol. 82, No. 109 / Thursday, June 8, 2017 / Proposed Rules
XI. Statutory and Executive Order 1. A significant number of SNUNs with Indian Tribal Governments’’ (65 FR
Reviews would not be submitted by small 67249, November 9, 2000), do not apply
entities in response to the SNUR. to this proposed rule.
A. Executive Order 12866 2. The SNUR submitted by any small
entity would not cost significantly more G. Executive Order 13045
This proposed rule would establish
SNUR for the chemical substance that than $8,300. This proposed rule is not subject to
was the subject of PMN. The Office of A copy of that certification is Executive Order 13045, entitled
Management and Budget (OMB) has available in the docket for this proposed ‘‘Protection of Children from
exempted these types of actions from rule. Environmental Health Risks and Safety
review under Executive Order 12866, This proposed rule is within the Risks’’ (62 FR 19885, April 23, 1997),
entitled ‘‘Regulatory Planning and scope of the February 18, 2012 because this is not an economically
Review’’ (58 FR 51735, October 4, 1993). certification. Based on the Economic significant regulatory action as defined
Analysis discussed in Unit IX. And by Executive Order 12866, and this
B. Paperwork Reduction Act (PRA) EPA’s experience promulgating SNURs proposed rule does not address
According to PRA (44 U.S.C. 3501 et (discussed in the certification), EPA environmental health or safety risks
seq.), an agency may not conduct or believes that the following are true: disproportionately affecting children.
sponsor, and a person is not required to • A significant number of SNUNs
would not be submitted by small H. Executive Order 13211
respond to a collection of information
that requires OMB approval under PRA, entities in response to the SNUR. This proposed rule is not subject to
unless it has been approved by OMB • Submission of the SNUN would not Executive Order 13211, entitled
and displays a currently valid OMB cost any small entity significantly more ‘‘Actions Concerning Regulations That
control number. The OMB control than $8,300. Significantly Affect Energy Supply,
numbers for EPA’s regulations in title 40 Therefore, the promulgation of the Distribution, or Use’’ (66 FR 28355, May
of the CFR, after appearing in the SNUR would not have a significant 22, 2001), because this proposed rule is
Federal Register, are listed in 40 CFR economic impact on a substantial not expected to affect energy supply,
part 9, and included on the related number of small entities. distribution, or use and because this
collection instrument or form, if D. Unfunded Mandates Reform Act proposed rule is not a significant
applicable. (UMRA) regulatory action under Executive Order
The information collection 12866.
Based on EPA’s experience with
requirements related to this proposed proposing and finalizing SNURs, State, I. National Technology Transfer and
rule have already been approved by local, and Tribal governments have not Advancement Act (NTTAA)
OMB pursuant to PRA under OMB been impacted by these rulemakings, In addition, since this proposed rule
control number 2070–0012 (EPA ICR and EPA does not have any reasons to would not involve any technical
No. 574). This proposed rule would not believe that any State, local, or Tribal standards, NTTAA section 12(d) (15
impose any burden requiring additional government would be impacted by this U.S.C. 272 note), would not apply to
OMB approval. If an entity were to proposed rule. As such, EPA has this proposed rule.
submit a SNUN to the Agency, the determined that this proposed rule
annual burden is estimated to average would not impose any enforceable duty, J. Executive Order 12898
between 30 and 170 hours per response. contain any unfunded mandate, or This proposed rule does not entail
This burden estimate includes the time otherwise have any effect on small special considerations of environmental
needed to review instructions, search governments subject to the requirements justice related issues as delineated by
existing data sources, gather and of UMRA sections 202, 203, 204, or 205 Executive Order 12898, entitled
maintain the data needed, and (2 U.S.C. 1501 et seq.). ‘‘Federal Actions to Address
complete, review, and submit the Environmental Justice in Minority
required SNUN. E. Executive Order 13132
Populations and Low-Income
Send any comments about the This proposed rule would not have a Populations’’ (59 FR 7629, February 16,
accuracy of the burden estimate, and substantial direct effect on States, on the 1994).
any suggested methods for minimizing relationship between the national
respondent burden, including through government and the States, or on the List of Subjects in 40 CFR Part 721
the use of automated collection distribution of power and Environmental protection, Chemicals,
techniques, to the Director, Collection responsibilities among the various Hazardous substances, Reporting and
Strategies Division, Office of levels of government, as specified in recordkeeping requirements.
Environmental Information (2822T), Executive Order 13132, entitled Dated: February 21, 2017.
Environmental Protection Agency, 1200 ‘‘Federalism’’ (64 FR 43255, August 10, Maria J. Doa,
Pennsylvania Ave. NW., Washington, 1999).
DC 20460–0001. Please remember to Director, Chemical Control Division, Office
F. Executive Order 13175 of Pollution Prevention and Toxics.
include the OMB control number in any
correspondence, but do not submit any This proposed rule would not have Therefore, it is proposed that 40 CFR
completed forms to this address. Tribal implications because it is not chapter I be amended as follows:
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS
expected to have substantial direct
C. Regulatory Flexibility Act (RFA) PART 721—[AMENDED]
effects on Indian Tribes. This proposed
On February 18, 2012, EPA certified rule would not significantly nor ■ 1. The authority citation for part 721
pursuant to RFA section 605(b) (5 U.S.C. uniquely affect the communities of continues to read as follows:
601 et seq.), that promulgation of a Indian Tribal governments, nor would it
SNUR does not have a significant involve or impose any requirements that Authority: 15 U.S.C. 2604, 2607, and
economic impact on a substantial affect Indian Tribes. Accordingly, the 2625(c).
number of small entities where the requirements of Executive Order 13175, ■ 2. Add § 721.10927 to subpart E to
following are true: entitled ‘‘Consultation and Coordination read as follows:
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![Federal Register / Vol. 82, No. 109 / Thursday, June 8, 2017 / Proposed Rules 26649
§ 721.10927 Bimodal mixture consisting of (3) Determining whether a specific use Please allow sufficient time for mailed
multi-walled carbon nanotubes and other is subject to this section. The provisions comments to be received before the
classes of carbon nanotubes (generic). of § 721.1725 (b)(1) apply to paragraph close of the comment period.
(a) Chemical substance and (a)(2)(ii) of this section. 3. By express or overnight mail. You
significant new uses subject to reporting. [FR Doc. 2017–11695 Filed 6–7–17; 8:45 am] may send written comments to the
(1) The chemical substance identified BILLING CODE 6560–50–P
following address ONLY: Centers for
generically as a bimodal mixture Medicare & Medicaid Services,
consisting of multi-walled carbon Department of Health and Human
nanotubes and other classes of carbon Services, Attention: CMS–3342–P, Mail
nanotubes (PMN P–11–482) is subject to DEPARTMENT OF HEALTH AND Stop C4–26–05, 7500 Security
reporting under this section for the HUMAN SERVICES Boulevard, Baltimore, MD 21244–1850.
significant new uses described in 4. By hand or courier. Alternatively,
paragraph (a)(2) of this section. Centers for Medicare & Medicaid you may deliver (by hand or courier)
(2) The significant new uses are: Services your written comments ONLY to the
(i) Protection in the workplace. following addresses prior to the close of
Requirements as specified in § 721.63 42 CFR Part 483 the comment period:
(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), a. For delivery in Washington, DC—
[CMS–3342–P] Centers for Medicare & Medicaid
(a)(6) (particulate), and (c). When
determining which persons are Services, Department of Health and
RIN 0938–AT18
reasonably likely to be exposed as Human Services, Room 445–G, Hubert
required for § 721.63 (a)(1) and (a)(4), Medicare and Medicaid Programs; H. Humphrey Building, 200
engineering control measures (e.g., Revision of Requirements for Long- Independence Avenue SW.,
enclosure or confinement of the Term Care Facilities: Arbitration Washington, DC 20201.
operation, general and local ventilation) Agreements (Because access to the interior of the
or administrative control measures (e.g., Hubert H. Humphrey Building is not
workplace policies and procedures) AGENCY: Centers for Medicare & readily available to persons without
shall be considered and implemented to Medicaid Services (CMS), HHS. Federal government identification,
prevent exposure, where feasible. A ACTION: Proposed rule. commenters are encouraged to leave
National Institute for Occupational their comments in the CMS drop slots
Safety and Health (NIOSH)-certified air SUMMARY: This proposed rule would located in the main lobby of the
purifying, tight-fitting full-face revise the requirements that Long-Term building. A stamp-in clock is available
respirator equipped with N–100, P–100, Care (LTC) facilities must meet to for persons wishing to retain a proof of
or R–100 cartridges, or power air participate in the Medicare and filing by stamping in and retaining an
purifying particulate respirator with an Medicaid programs. Specifically, it extra copy of the comments being filed.)
Assigned Protection Factor (APF) of at would remove provisions prohibiting b. For delivery in Baltimore, MD—
least 50 meets the requirements of binding pre-dispute arbitration and Centers for Medicare & Medicaid
§ 721.63 (a)(4). strengthen requirements regarding the Services, Department of Health and
(ii) Industrial, commercial, and transparency of arbitration agreements Human Services, 7500 Security
consumer activities. Requirements as in LTC facilities. This proposal would Boulevard, Baltimore, MD 21244–1850.
specified in § 721.80 (k) and (q). A support the resident’s right to make If you intend to deliver your
significant new use is any use involving informed choices about important comments to the Baltimore address, call
an application method that generates a aspects of his or her health care. In telephone number (410) 786–9994 in
vapor, mist or aerosol. addition, this proposal is consistent advance to schedule your arrival with
(iii) Disposal. Requirements as with our approach to eliminating one of our staff members.
specified in § 721.85 (a)(1), (a)(2), (b)(1), unnecessary burden on providers. Comments erroneously mailed to the
(b)(2), (c)(1), and (c)(2). DATES: To be assured consideration, addresses indicated as appropriate for
(iv) Release to water. Requirements as comments must be received at one of hand or courier delivery may be delayed
specified in § 721.90 (b)(1) and (c)(1). the addresses provided below, no later and received after the comment period.
Any predictable or purposeful release of than 5 p.m. on August 7, 2017. For information on viewing public
a manufacturing stream associated with ADDRESSES: In commenting, please refer comments, see the beginning of the
any use of the substance from any site to file code CMS–3342–P. Because of SUPPLEMENTARY INFORMATION section.
is a significant new use other than the staff and resource limitations, we cannot FOR FURTHER INFORMATION CONTACT: LTC
water releases described in the accept comments by facsimile (FAX) Regulations Team: Diane Corning,
manufacturing process of PMN P–11– transmission. Sheila Blackstock or Lisa Parker at (410)
482. You may submit comments in one of 786–6633.
(b) Specific requirements. The four ways (please choose only one of the SUPPLEMENTARY INFORMATION:
provisions of subpart A of this part ways listed): Inspection of Public Comments: All
apply to this section except as modified 1. Electronically. You may submit comments received before the close of
by this paragraph. electronic comments on this regulation the comment period are available for
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS
(1) Recordkeeping. Recordkeeping to http://www.regulations.gov. Follow viewing by the public, including any
requirements as specified in § 721.125 the ‘‘Submit a comment’’ instructions. personally identifiable or confidential
(a) through (e), (i), (j), and (k) are 2. By regular mail. You may mail business information that is included in
applicable to manufacturers and written comments to the following a comment. We post all comments
processors of this substance. address ONLY: Centers for Medicare & received before the close of the
(2) Limitations or revocation of Medicaid Services, Department of comment period on the following Web
certain notification requirements. The Health and Human Services, Attention: site as soon as possible after they have
provisions of § 721.185 apply to this CMS–3342–P, P.O. Box 8010, Baltimore, been received: http://
section. MD 21244–1850. www.regulations.gov. Follow the search
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Document Created: 2018-11-14 10:07:17
Document Modified: 2018-11-14 10:07:17
| 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 | Proposed Rules | |
| Action | Proposed rule. | |
| Dates | Comments must be received on or before July 10, 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 26644 | |
| RIN Number | 2070-AB27 | |
| CFR Associated | Environmental Protection; Chemicals; Hazardous Substances and Reporting and Recordkeeping Requirements |
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