81 FR 21830 - Significant New Use Rule on Certain Chemical Substances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 71 (April 13, 2016)
Federal Register Volume 81, Issue 71 (April 13, 2016)
| Page Range | 21830-21835 | |
| FR Document | 2016-08511 |
[Federal Register Volume 81, Number 71 (Wednesday, April 13, 2016)] [Proposed Rules] [Pages 21830-21835] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-08511] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 [EPA-HQ-OPPT-2015-0388; FRL-9944-43] RIN 2070-AB27 Significant New Use Rule on Certain Chemical Substances AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for three chemical substances which were the subject of premanufacture notices (PMNs). This action would require persons who intend to manufacture (defined by statute to include import) or process any of the chemical substances 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 would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit the activity before it occurs. DATES: Comments must be received on or before May 13, 2016. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2015-0388, 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 [[Page 21831]] 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 substances 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 determine whether this document applies to them. Potentially affected entities may include: Manufacturers (including importers) or processors of one or more subject chemical substances (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 these SNURs under TSCA section 5(a)(2) for three chemical substances which were the subject of PMNs P-15-221, P-15-247, and P-15-278. These SNURs would require persons who intend to manufacture or process any of these chemical substances 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 October 2, 2015 (80 FR 59583) (FRL-9933-30) EPA issued direct final SNURs on these chemical substances, which are the subject of PMNs. EPA received notices of intent to submit adverse comments on these SNURs. Therefore, as required by Sec. 721.160(c)(3)(ii), EPA withdrew the direct final SNURs in the Federal Register of November 20, 2015 (80 FR 72592) (FRL-9936-98), and is now issuing this proposed rule on these three chemical substances. The records for the direct final SNURs on these three chemical substances were established as docket EPA-HQ-OPPT- 2015-0388. 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, no substantive comments were submitted. EPA awaits the adverse comments 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. 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 may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action. 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. [[Page 21832]] 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 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 three chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each 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 three 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-15-221 Chemical name: Isocyanate prepolymer (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as ingredient in an industrial adhesive. Based on Structure Activity Relationship (SAR) analysis of test data on analogous diisocyanates, EPA identified concerns for irritation and sensitization to the skin and lungs. As described in the PMN, EPA does not expect significant occupational dermal or inhalation exposure due to use of adequate personal protective equipment and consumer exposures are not expected as the PMN substance is not used in consumer products. Therefore, EPA has not determined that the proposed manufacture, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without a National Institute for Occupational Safety and Health (NIOSH)-certified particulate respirator with an Assigned Protection Factor (APF) of at least 10 where there is a potential for inhalation exposure, or any use in consumer products may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(ii). Recommended testing: EPA has determined that the results of a skin sensitization test (OPPTS Test Guideline 870.2600) and a 90-day subchronic inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance. CFR Citation: 40 CFR 721.10871. PMN Number P-15-247 Chemical name: Methylene diisocyanate polymer with diols and triols (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as an industrial adhesive. Based on SAR analysis of test data on analogous diisocyanates, EPA identified concerns for respiratory and dermal sensitization and lung and mucous membrane irritation based on the isocyanate moiety. As described in the PMN, EPA does not expect significant occupational dermal or inhalation exposure due to use of adequate personal protective equipment and consumer exposures are not expected as the PMN substance is not used in consumer products. Therefore, EPA has not determined that the proposed manufacture, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without a NIOSH-certified particulate respirator with an APF of at least 10 where there is a potential for inhalation exposure, or any use in consumer products, may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(ii). Recommended testing: EPA has determined that the results of a skin sensitization test (OPPTS Test Guideline 870.2600) and a 90-day subchronic inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance. CFR Citation: 40 CFR 721.10873. PMN Number P-15-278 Chemical name: Polymer of isophorone diisocyanate and amine- terminated propoxylatedpolyol (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as a crosslinker. Based on analogous diisocyanates, EPA identified concerns for potential dermal and respiratory sensitization from dermal and inhalation exposures and for pulmonary toxicity from inhalation exposure to the PMN substance when the average molecular weight is below 2,500 daltons and any molecular weight species below 1,000 daltons is present. EPA does not expect significant exposures from the form of the PMN substance as described in the PMN. Therefore, EPA has not determined that the proposed manufacture of the substance may present an unreasonable risk. EPA has determined, however, that any manufacture of the PMN substance with an average molecular weight of below 2,500 daltons and with any molecular weight species below 1,000 daltons may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(ii). Recommended testing: EPA has determined that the results of a skin sensitization test (OPPTS Test Guideline 870.2600) and a 90-day subchronic inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance. CFR Citation: 40 CFR 721.10874. V. Rationale and Objectives of the Proposed Rule A. Rationale During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA determined that one or more of the criteria of concern established at Sec. 721.170 were met. For additional discussion on these chemical substances, see Units II. and IV. of this proposed rule. B. Objectives EPA is proposing these SNURs for specific chemical substances which [[Page 21833]] 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 a 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 a listed chemical substance for the described significant new use. EPA would be able to regulate prospective manufacturers or processors of a listed chemical substance before the described significant new use of that chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7. 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. 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 substances 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 chemical substances identified in this proposed rule are 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 identities of the three chemical substances subject to this proposed rule have 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 April 13, 2016 as the cutoff date for determining whether the new use is ongoing. 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. Test Data and Other Information EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN. The two exceptions are: 1. Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)). 2. Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)). In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing covering the chemical substance, persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (see 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 which provide detailed information on the following: Human exposure and environmental release that may result from the significant new use of the chemical substances. Potential benefits of the chemical substances. Information on risks posed by the chemical substances compared to risks posed by potential substitutes. 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. 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-2015-0388. X. Statutory and Executive Order Reviews A. Executive Order 12866 This proposed rule would establish SNURs for three chemical substances that were the subject of PMNs. 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 [[Page 21834]] 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: April 6, 2016. 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. 721.10871 to subpart E to read as follows: Sec. 721.10871 Isocyanate prepolymer (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as isocyanate prepolymer (PMN P-15-221) 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)(4), (a)(6)(ii), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 721.63(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 [[Page 21835]] exposure, where feasible. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of Sec. 721.63(a)(4): (A) NIOSH-certified power air purifying respirator with a hood or helmet and with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges in combination with HEPA filters. (B) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece, hood, or helmet. (C) NIOSH-certified negative pressure (demand) supplied-air respirator with a full facepiece. (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(o). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125 (a), (b), (c), (d), and (i) 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. 0 3. Add Sec. 721.10873 to subpart E to read as follows: Sec. 721.10873 Methylene diisocyanate polymer with diols and triols (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as methylene diisocyanate polymer with diols and triols (PMN P-15-247) 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)(4), (a)(6)(ii), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 721.63(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. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of Sec. 721.63(a)(4): (A) NIOSH-certified power air purifying respirator with a hood or helmet and with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges in combination with HEPA filters. (B) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece, hood, or helmet. (C) NIOSH-certified negative pressure (demand) supplied-air respirator with a full facepiece. (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(o). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125 (a), (b), (c), (d), and (i) 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. 0 4. Add Sec. 721.10874 to subpart E to read as follows: Sec. 721.10874 Polymer of isophorone diisocyanate and amine- terminated propoxylatedpolyol (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polymer of isophorone diisocyanate and amine-terminated propoxylatedpolyol (PMN P-15-278) 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) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80. The significant new use is manufacture of the substance where the average molecular weight is below 2,500 daltons and where any molecular weight species is below 1,000 daltons. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125 (a), (b), (c), and (i) 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. [FR Doc. 2016-08511 Filed 4-12-16; 8:45 am] BILLING CODE 6560-50-P
![21830 Federal Register / Vol. 81, No. 71 / Wednesday, April 13, 2016 / Proposed Rules
TABLE 5—PROPOSED RULES FOR INCORPORATION BY REFERENCE
[EPA approved Oregon Administrative Rules (OAR)]
State EPA
State citation Title/Subject Explanations
effective date approval date
Division 240—Rules for Areas with Unique Air Quality Needs
Klamath Falls Nonattainment Area Contingency Measures
240–0570 ................................ Applicability ............................................................................. 12/11/2012
240–0580 ................................ Existing Industrial Sources Control Efficiency ....................... 12/11/2012
240–0610 ................................ Continuous Monitoring for Industrial Sources ........................ 12/11/2012
240–0620 ................................ Contingency Measures: New Industrial Sources ................... 12/11/2012
240–0630 ................................ Contingency Enhanced Curtailment of Use of Solid Fuel 12/11/2012
Burning Devices and Fireplaces.
Division 262—Heat Smart Program for Residential Woodstoves and Other Solid Fuel Heating Devices
262–1000 ................................ Wood Burning Contingency Measures for PM2.5 Nonattain- 12/11/2012
ment Areas.
VI. Statutory and Executive Order • is not subject to requirements of ENVIRONMENTAL PROTECTION
Reviews Section 12(d) of the National AGENCY
Under the CAA, the Administrator is Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because 40 CFR Part 721
required to approve a SIP submission
that complies with the provisions of the application of those requirements would [EPA–HQ–OPPT–2015–0388; FRL–9944–43]
Act and applicable Federal regulations. be inconsistent with the Clean Air Act;
RIN 2070–AB27
42 U.S.C. 7410(k); 40 CFR 52.02(a). and
Thus, in reviewing SIP submissions, the • does not provide the EPA with the Significant New Use Rule on Certain
EPA’s role is to approve state choices, discretionary authority to address, as Chemical Substances
provided that they meet the criteria of appropriate, disproportionate human
the CAA. Accordingly, this action AGENCY: Environmental Protection
health or environmental effects, using Agency (EPA).
merely approves state law as meeting practicable and legally permissible
Federal requirements and does not ACTION: Proposed rule.
methods, under Executive Order 12898
impose additional requirements beyond (59 FR 7629, February 16, 1994). SUMMARY: EPA is proposing significant
those imposed by state law. For that new use rules (SNURs) under the Toxic
reason, this action: In addition, this proposed rule does
not have tribal implications as specified Substances Control Act (TSCA) for three
• Is not a ‘‘significant regulatory chemical substances which were the
action’’ subject to review by the Office by Executive Order 13175 (65 FR 67249,
subject of premanufacture notices
of Management and Budget under November 9, 2000), because the SIP is
(PMNs). This action would require
Executive Order 12866 (58 FR 51735, not approved to apply on any Indian persons who intend to manufacture
October 4, 1993); reservation land in Oregon or any other (defined by statute to include import) or
• does not impose an information area where the EPA or an Indian tribe process any of the chemical substances
collection burden under the provisions has demonstrated that a tribe has for an activity that is designated as a
of the Paperwork Reduction Act (44 jurisdiction. significant new use by this proposed
U.S.C. 3501 et seq.); rule to notify EPA at least 90 days before
List of Subjects in 40 CFR Part 52
• is certified as not having a commencing that activity. The required
significant economic impact on a Environmental protection, Air notification would provide EPA with
substantial number of small entities pollution control, Incorporation by the opportunity to evaluate the intended
under the Regulatory Flexibility Act (5 reference, Nitrogen dioxide, Ozone, use and, if necessary, to prohibit or limit
U.S.C. 601 et seq.); Particulate matter, Reporting and the activity before it occurs.
• does not contain any unfunded recordkeeping requirements, Sulfur DATES: Comments must be received on
mandate or significantly or uniquely oxides, Volatile organic compounds. or before May 13, 2016.
affect small governments, as described ADDRESSES: Submit your comments,
in the Unfunded Mandates Reform Act Dated: April 1, 2016.
identified by docket identification (ID)
of 1995 (Pub. L. 104–4); Dennis J. McLerran,
number EPA–HQ–OPPT–2015–0388, by
• does not have Federalism Regional Administrator, Region 10. one of the following methods:
implications as specified in Executive [FR Doc. 2016–08384 Filed 4–12–16; 8:45 am] • Federal eRulemaking Portal: http://
Order 13132 (64 FR 43255, August 10, www.regulations.gov. Follow the online
jstallworth on DSK7TPTVN1PROD with PROPOSALS
BILLING CODE 6560–50–P
1999); instructions for submitting comments.
• is not an economically significant Do not submit electronically any
regulatory action based on health or information you consider to be
safety risks subject to Executive Order Confidential Business Information (CBI)
13045 (62 FR 19885, April 23, 1997); or other information whose disclosure is
• is not a significant regulatory action restricted by statute.
subject to Executive Order 13211 (66 FR • Mail: Document Control Office
28355, May 22, 2001); (7407M), Office of Pollution Prevention
VerDate Sep<11>2014 14:59 Apr 12, 2016 Jkt 238001 PO 00000 Frm 00073 Fmt 4702 Sfmt 4702 E:\FR\FM\13APP1.SGM 13APP1](https://thefederalregister.org/doc/81_FR_21901/page/1.svg)
![21834 Federal Register / Vol. 81, No. 71 / Wednesday, April 13, 2016 / Proposed Rules
of the CFR, after appearing in the economic impact on a substantial not expected to affect energy supply,
Federal Register, are listed in 40 CFR number of small entities. distribution, or use and because this
part 9, and included on the related proposed rule is not a significant
D. Unfunded Mandates Reform Act
collection instrument or form, if regulatory action under Executive Order
(UMRA)
applicable. 12866.
The information collection 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
would not impose any enforceable duty, J. Executive Order 12898
annual burden is estimated to average
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
E. Executive Order 13132
required SNUN. 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
government and the States, or on the List of Subjects in 40 CFR Part 721
respondent burden, including through
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: April 6, 2016.
Environmental Protection Agency, 1200 ‘‘Federalism’’ (64 FR 43255, August 10, Maria J. Doa,
Pennsylvania Ave. NW., Washington, 1999).
Director, Chemical Control Division, Office
DC 20460–0001. Please remember to 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:
expected to have substantial direct
C. Regulatory Flexibility Act (RFA) effects on Indian Tribes. This proposed PART 721—[AMENDED]
On February 18, 2012, EPA certified rule would not significantly nor
uniquely affect the communities of ■ 1. The authority citation for part 721
pursuant to RFA section 605(b) (5 U.S.C. 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 § 721.10871 to subpart E to
following are true: entitled ‘‘Consultation and Coordination read as follows:
1. A significant number of SNUNs with Indian Tribal Governments’’ (65 FR
§ 721.10871 Isocyanate prepolymer
would not be submitted by small 67249, November 9, 2000), do not apply
(generic).
entities in response to the SNUR. to this proposed rule.
2. The SNUR submitted by any small (a) Chemical substance and
G. Executive Order 13045 significant new uses subject to reporting.
entity would not cost significantly more
than $8,300. This proposed rule is not subject to (1) The chemical substance identified
A copy of that certification is Executive Order 13045, entitled generically as isocyanate prepolymer
available in the docket for this proposed ‘‘Protection of Children from (PMN P–15–221) is subject to reporting
rule. Environmental Health Risks and Safety under this section for the significant
This proposed rule is within the Risks’’ (62 FR 19885, April 23, 1997), new uses described in paragraph (a)(2)
scope of the February 18, 2012 because this is not an economically of this section.
certification. Based on the Economic significant regulatory action as defined (2) The significant new uses are:
Analysis discussed in Unit IX. And by Executive Order 12866, and this (i) Protection in the workplace.
EPA’s experience promulgating SNURs proposed rule does not address Requirements as specified in
(discussed in the certification), EPA environmental health or safety risks § 721.63(a)(4), (a)(6)(ii), and (c). When
disproportionately affecting children. determining which persons are
jstallworth on DSK7TPTVN1PROD with PROPOSALS
believes that the following are true:
• A significant number of SNUNs reasonably likely to be exposed as
H. Executive Order 13211 required for § 721.63(a)(4), engineering
would not be submitted by small
entities in response to the SNUR. This proposed rule is not subject to control measures (e.g., enclosure or
• Submission of the SNUN would not Executive Order 13211, entitled confinement of the operation, general
cost any small entity significantly more ‘‘Actions Concerning Regulations That and local ventilation) or administrative
than $8,300. Significantly Affect Energy Supply, control measures (e.g., workplace
Therefore, the promulgation of the Distribution, or Use’’ (66 FR 28355, May policies and procedures) shall be
SNUR would not have a significant 22, 2001), because this proposed rule is considered and implemented to prevent
VerDate Sep<11>2014 14:59 Apr 12, 2016 Jkt 238001 PO 00000 Frm 00077 Fmt 4702 Sfmt 4702 E:\FR\FM\13APP1.SGM 13APP1](https://thefederalregister.org/doc/81_FR_21901/page/5.svg)
![Federal Register / Vol. 81, No. 71 / Wednesday, April 13, 2016 / Proposed Rules 21835
exposure, where feasible. The following described in paragraph (a)(2) of this (2) Limitations or revocation of
National Institute for Occupational section. certain notification requirements. The
Safety and Health (NIOSH)-certified (2) The significant new uses are: provisions of § 721.185 apply to this
respirators with an assigned protection (i) Protection in the workplace. section.
factor (APF) of at least 10 meet the Requirements as specified in ■ 4. Add § 721.10874 to subpart E to
requirements of § 721.63(a)(4): § 721.63(a)(4), (a)(6)(ii), and (c). When read as follows:
(A) NIOSH-certified power air determining which persons are
purifying respirator with a hood or reasonably likely to be exposed as § 721.10874 Polymer of isophorone
helmet and with appropriate gas/vapor required for § 721.63(a)(4), engineering diisocyanate and amine-terminated
(acid gas, organic vapor, or substance propoxylatedpolyol (generic).
control measures (e.g., enclosure or
specific) cartridges in combination with confinement of the operation, general (a) Chemical substance and
HEPA filters. and local ventilation) or administrative significant new uses subject to reporting.
(B) NIOSH-certified continuous flow control measures (e.g., workplace (1) The chemical substance identified
supplied-air respirator equipped with a policies and procedures) shall be generically as polymer of isophorone
loose fitting facepiece, hood, or helmet. considered and implemented to prevent diisocyanate and amine-terminated
(C) NIOSH-certified negative pressure exposure, where feasible. The following propoxylatedpolyol (PMN P–15–278) is
(demand) supplied-air respirator with a National Institute for Occupational subject to reporting under this section
full facepiece. Safety and Health (NIOSH)-certified for the significant new uses described in
(ii) Industrial, commercial, and respirators with an assigned protection paragraph (a)(2) of this section.
consumer activities. Requirements as factor (APF) of at least 10 meet the (2) The significant new uses are:
specified in § 721.80(o). requirements of § 721.63(a)(4):
(b) Specific requirements. The (i) Industrial, commercial, and
(A) NIOSH-certified power air consumer activities. Requirements as
provisions of subpart A of this part purifying respirator with a hood or
apply to this section except as modified specified in § 721.80. The significant
helmet and with appropriate gas/vapor new use is manufacture of the substance
by this paragraph. (acid gas, organic vapor, or substance
(1) Recordkeeping. Recordkeeping where the average molecular weight is
specific) cartridges in combination with below 2,500 daltons and where any
requirements as specified in § 721.125
HEPA filters. molecular weight species is below 1,000
(a), (b), (c), (d), and (i) are applicable to
(B) NIOSH-certified continuous flow daltons.
manufacturers and processors of this
supplied-air respirator equipped with a (ii) [Reserved]
substance.
(2) Limitations or revocation of loose fitting facepiece, hood, or helmet. (b) Specific requirements. The
certain notification requirements. The (C) NIOSH-certified negative pressure provisions of subpart A of this part
provisions of § 721.185 apply to this (demand) supplied-air respirator with a apply to this section except as modified
section. full facepiece. by this paragraph.
■ 3. Add § 721.10873 to subpart E to
(ii) Industrial, commercial, and
consumer activities. Requirements as (1) Recordkeeping. Recordkeeping
read as follows: requirements as specified in § 721.125
specified in § 721.80(o).
§ 721.10873 Methylene diisocyanate (b) Specific requirements. The (a), (b), (c), and (i) are applicable to
polymer with diols and triols (generic). provisions of subpart A of this part manufacturers and processors of this
(a) Chemical substance and apply to this section except as modified substance.
significant new uses subject to reporting. by this paragraph. (2) Limitations or revocation of
(1) The chemical substance identified (1) Recordkeeping. Recordkeeping certain notification requirements. The
generically as methylene diisocyanate requirements as specified in § 721.125 provisions of § 721.185 apply to this
polymer with diols and triols (PMN P– (a), (b), (c), (d), and (i) are applicable to section.
15–247) is subject to reporting under manufacturers and processors of this [FR Doc. 2016–08511 Filed 4–12–16; 8:45 am]
this section for the significant new uses substance. BILLING CODE 6560–50–P
jstallworth on DSK7TPTVN1PROD with PROPOSALS
VerDate Sep<11>2014 14:59 Apr 12, 2016 Jkt 238001 PO 00000 Frm 00078 Fmt 4702 Sfmt 9990 E:\FR\FM\13APP1.SGM 13APP1](https://thefederalregister.org/doc/81_FR_21901/page/6.svg)
Document Created: 2016-04-13 03:10:31
Document Modified: 2016-04-13 03:10:31
| 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 May 13, 2016. | |
| 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 | 81 FR 21830 | |
| RIN Number | 2070-AB27 | |
| CFR Associated | Environmental Protection; Chemicals; Hazardous Substances and Reporting and Recordkeeping Requirements |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR