80 FR 70171 - Modification of Significant New Uses of Certain Chemical Substances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 80, Issue 219 (November 13, 2015)
Federal Register Volume 80, Issue 219 (November 13, 2015)
| Page Range | 70171-70175 | |
| FR Document | 2015-28844 |
[Federal Register Volume 80, Number 219 (Friday, November 13, 2015)] [Rules and Regulations] [Pages 70171-70175] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-28844] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 [EPA-HQ-OPPT-2014-0649; FRL-9935-43] RIN 2070-AB27 Modification of Significant New Uses of Certain Chemical Substances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: EPA is amending the significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for five chemical substances which were the subject of premanufacture notices (PMNs). This action amends the SNURs to allow certain uses without requiring a significant new use notice (SNUN), and extends SNUN requirements to certain additional uses. EPA is amending these SNURs based on review of new data for each chemical substance. This action requires persons who intend to manufacture (including import) or process any of these chemical substances for an activity that is designated as a significant new use by this 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 [[Page 70172]] prohibit or limit that activity before it occurs. DATES: This final rule is effective January 12, 2016. ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2014-0649, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566- 0280. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim Alwood, Chemical Control Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-8974; 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. 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 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 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 a modified SNUR must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export the chemical substance that is the subject of a final rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D. II. Background A. What action is the agency taking? In the Federal Register of April 9, 2015 (80 FR 19307) (FRL-9924- 10), EPA proposed amendments to the SNURs for 24 chemical substances in 40 CFR part 721 subpart E. This action would require persons who intend to manufacture or process these chemical substances for an activity that is designated as a significant new use by these amended rules to notify EPA at least 90 days before commencing that activity. Receipt of such notices allows EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs. The proposed rule included 23 chemical substances where EPA determined, based on new information, there is no need to require additional notice from persons who propose to engage in identical or similar activities, or a rational basis no longer exists for the findings that activities involving the substance may present an unreasonable risk of injury to human health or the environment required under section 5(e)(1)(A) of the Act. The proposed rule also included a chemical substance, P-01-781, where EPA is modifying the chemical identity information. In the Federal Register of June 30, 2015 (80 FR 37161) (FRL-9928-93), EPA issued amendments to the SNURs for 19 of those chemical substances in 40 CFR part 721 subpart E. EPA is now issuing a final SNUR amendment for the other five chemical substances. EPA received public comments for the proposed SNUR amendments for the remaining five chemical substances of the 24 included in the proposed rule subject to SNURs at 40 CFR 721.5575, 721.9675, and 721.10515. As described in Unit III., EPA is finalizing the SNURs as proposed for the SNURs at 40 CFR 721.9675, and 721.10515 and is finalizing the SNUR at 40 CFR 721.5575 with one change. EPA is now amending the SNURs of these five chemical substances pursuant to 40 CFR 721.185. B. What is the agency's authority for taking this action? Upon conclusion of the review of the five chemical substances in this SNUR amendment, EPA designated certain activities as significant new uses. Under Sec. 721.185, EPA may at any time amend a SNUR for a chemical substance which has been added to subpart E of 40 CFR part 721 if EPA makes one of the determinations set forth in Sec. 721.185. Amendments may occur on EPA's initiative or in response to a written request. Under Sec. 721.185(b)(3), if EPA concludes that a SNUR should be amended, the Agency will propose the changes in the Federal Register, briefly describe the grounds for the action, and provide interested parties an opportunity to comment. Pursuant to Sec. 721.185 and as described in Unit IV. of the proposed rule for the five chemical substances, EPA determined, based on new information, that there is no need to require additional notice from persons who propose to engage in identical or similar activities, or a rational basis no longer exists for the findings that activities involving the substance may present an unreasonable risk of injury to human health or the environment required under section 5(e)(1)(A) of the Act. III. Response to Comments on Proposed SNURs Comment 1: One commenter stated that for the chemical substance subject to 40 CFR 721.5575 SNUR requirements should be excluded when the substance is incorporated or encapsulated in plastic as there would no longer be exposure. Response: EPA reviewed uses of the chemical substance during PMN/ SNUN reviews where it was incorporated or encapsulated into plastic. EPA estimated limited human and environmental exposures that were not expected to cause an unreasonable risk. Therefore, the final SNUR will remove from the scope of the SNUR any use where the chemical substance is incorporated or encapsulated into plastic. Comment 2: One commenter stated that, for the chemical substance subject to 40 CFR 721.9675, one of the SNUN submitters cited in the proposed rule was actually manufacturing a different chemical substance, which was instead the subject of P-06-0149 and a SNUR at 40 CFR 721.10553. Response: Each of the SNUNs cited in the proposed SNUR modification were [[Page 70173]] submitted to EPA pertained to the chemical substance titanate [Ti 6 O13 (2-)], dipotassium, which is the chemical substance subject to 40 CFR 721.9675. But regardless of whether any of the SNUN submitters are manufacturing or processing a different chemical substance, any manufacturer and processor who is manufacturing potassium titanium oxide (which was the chemical substance submitted for P-06-149 and subject to the SNUR at 40 CFR 721.10553) is subject to the requirements of the SNUR at 40 CFR 721.10553. Comment 3: EPA proposed to modify the SNUR at 40 CFR 721.10515 to include P-10-184, because P-10-184 pertains to the same chemical substance as P-10-60, which is already the subject of 40 CFR 721.10515. A commenter asked EPA to clarify if the SNUR would require the PMN submitter of P-10-184 to conduct the same triggered testing required in the consent order for P-10-60. Response: The consent order for P-10-60 requires certain fate and physical property testing to be conducted at five different aggregate production volume limits. The consent order for P-10-184 does not require any testing to be conducted by production volume limits. The SNUR, however, requires notification before exceeding the manufacture of the five aggregate production volume limits. While the SNUR does not require the submitter of P-10-184, or any other manufacturer, to conduct testing, the SNUR does require that a SNUN be submitted before exceeding the aggregate production volume limit. If EPA receives a SNUN from the submitter of P-10-184, or any other manufacturer, EPA will then determine what testing, if any, would be required. This could be the testing required in the consent order for P-10-60 or other appropriate testing. This is the same procedure EPA uses for SNURs of consent orders with testing requirements at certain production volume or time limits. IV. Applicability of the Rule to Uses Occurring Before Effective Date of the Final Rule To establish a significant ``new'' use, EPA must determine that the use is not ongoing. As discussed in the Federal Register issue of April 24, 1990 (55 FR 17376) (FRL-3658-5), EPA has decided that the intent of TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the date of publication of the proposed SNUR rather than as of the effective date of the final rule. If uses begun after publication were considered ongoing rather than new, it would be difficult for EPA to establish SNUR notice requirements, because a person could defeat the SNUR by initiating the proposed significant new use before the rule became effective, and then argue that the use was ongoing as of the effective date of the final rule. Thus, any persons who begin commercial manufacture or processing activities with the chemical substances that are not currently a significant new use under the current rule but which would be regulated as a ``significant new use'' when this rule is finalized, must cease any such activity as of the effective date of the rule if and when finalized. To resume their activities, these persons would have to comply with all applicable SNUR notice requirements and wait until the notice review period, including all extensions, expires. EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. If a person were to meet the conditions of advance compliance under Sec. 721.45(h), the person would be considered to have met the requirements of the final SNUR for those activities. V. Test Data and Other Information EPA recognizes that TSCA section 5 does not require the development of any particular test data before submission of a SNUN. 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. In this case, EPA recommends persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.'' The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org. ASTM International standards are available at http://www.astm.org/Standard/index.shtml. The recommended testing specified in Unit IV. of the proposed rule may not be the only means of addressing the potential risks of the chemical substance. However, SNUNs submitted without any test data may increase the likelihood that EPA will 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. VI. SNUN Submissions According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in Sec. Sec. 721.25 and 720.40. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems. VII. Economic Analysis EPA evaluated the potential costs of SNUN requirements for potential manufacturers and processors of the chemical substances in the rule. The Agency's complete Economic Analysis is available in the docket under docket ID number EPA-HQ-OPPT-2014-0649. VIII. Statutory and Executive Order Reviews A. Executive Order 12866 This action will modify SNURs for five 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). [[Page 70174]] 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. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this rule. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is ``good cause'' under section 553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this table without further notice and comment. The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN. Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address. C. Regulatory Flexibility Act (RFA) On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities where the following are true: 1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR. 2. The SNUN 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 rule. This rule is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit VI and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true: A significant number of SNUNs would not be submitted by small entities in response to the SNUR. Submission of the SNUN would not cost any small entity significantly more than $8,300. Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities. D. Unfunded Mandates Reform Act (UMRA) Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this final rule. As such, EPA has determined that this rule would not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.). E. Executive Order 13132 This action 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 rule would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This rule would not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000), do not apply to this rule. G. Executive Order 13045 This action is not subject to Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children. H. Executive Order 13211 This action is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866. I. National Technology Transfer and Advancement Act (NTTAA) In addition, since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action. J. Executive Order 12898 This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994). IX. Congressional Review Act (CRA) Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 721 Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. [[Page 70175]] Dated: November 2, 2015. Maria J. Doa, Director, Chemical Control Division, Office of Pollution Prevention and Toxics. Therefore, 40 CFR chapter I is amended as follows: PART 721--[AMENDED] 0 1. The authority citation for part 721 continues to read as follows: Authority: 15 U.S.C. 2604, 2607, and 2625(c). 0 2. Amend Sec. 721.5575 by revising paragraphs (a)(1) and (a)(2)(iii) to read as follows: Sec. 721.5575 Oxirane, 2,2'-(1,6-hexanediylbis (oxymethylene)) bis-. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxirane, 2,2'-(1,6- hexanediylbis(oxymethylene))bis- (PMN P-88-2179; PMN P-89-539; and SNUN S-08-3; CAS No. 16096-31-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The reporting requirements of this rule do not apply once the chemical substance has been incorporated or encapsulated into plastic. (2) * * * (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(q). A significant new use of the chemical substance is any commercial use other than the commercial use described in S-08-3. * * * * * 0 3. Amend Sec. 721.9675 by revising paragraphs (a)(1) and (a)(2)(i), remove and reserve paragraph (a)(2)(ii), and revise paragraph (b)(1). The revisionso read as follows: Sec. 721.9675 Titanate [Ti 6 O13 (2-)], dipotassium. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as titanate [Ti6 O13 (2-)], dipotassium (PMN P-90-226; SNUNs P-96-1408, S-08-6, S-09-4, and S-13-49; CAS No. 12056-51-8)) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) * * * (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80 (f) and (l). In addition, a significant new use of the substance is importation of the chemical substance if: (A) Manufactured by other than the method described in premanufacture notice P-90-226 and significant new use notices P-96- 1408, S-08-6, S-09-4, and S-13-49. (B) Manufactured producing respirable, acicular fibers with an average aspect ratio of greater than 5. The average aspect ratio is defined as the ratio of average length to average diameter. * * * * * (b) * * * (1) Recordkeeping. The following recordkeeping requirements are applicable to manufacturers and processors of this substance as specified in Sec. 721.125 (a), (b), (c) and (i). * * * * * 0 4. Amend Sec. 721.10515 by revising paragraphs (a)(1) and (a)(2)(i) to read as follows: Sec. 721.10515 Partially fluorinated alcohol substituted glycols (generic). (a) * * * (1) The chemical substances identified generically as partially fluorinated alcohol substituted glycols (PMNs P-10-58, P-10-59, P-10- 60, and P-10-184) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) * * * (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k) (manufacture of the PMN substances according to the chemical synthesis and composition section of the TSCA section 5(e) consent order, including analysis, reporting, and limitations of maximum impurity levels of certain fluorinated impurities; manufacture and import of P-10-60 and P-10-184 other than when the mean number of moles of the ethoxy group is between 3 and 11 or the average number molecular weight is between 496 and 848 daltons based on the amounts of raw materials charged to the reactor; manufacture and import of P-10-58 and P-10-59 only as intermediates for the manufacture of P-10-60), and (q). * * * * * [FR Doc. 2015-28844 Filed 11-12-15; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Rules and Regulations 70171
benefit payments interest assumptions Because of the need to provide In consideration of the foregoing, 29
for December 2015.1 immediate guidance for the payment of CFR part 4022 is amended as follows:
The December 2015 interest benefits under plans with valuation
assumptions under the benefit payments dates during December 2015, PBGC PART 4022—BENEFITS PAYABLE IN
regulation will be 1.25 percent for the finds that good cause exists for making TERMINATED SINGLE-EMPLOYER
period during which a benefit is in pay the assumptions set forth in this PLANS
status and 4.00 percent during any years amendment effective less than 30 days
preceding the benefit’s placement in pay after publication. ■ 1. The authority citation for part 4022
status. In comparison with the interest PBGC has determined that this action continues to read as follows:
assumptions in effect for November is not a ‘‘significant regulatory action’’
under the criteria set forth in Executive Authority: 29 U.S.C. 1302, 1322, 1322b,
2015, these interest assumptions are 1341(c)(3)(D), and 1344.
unchanged. Order 12866.
Because no general notice of proposed
PBGC has determined that notice and ■ 2. In appendix B to part 4022, Rate Set
rulemaking is required for this
public comment on this amendment are 266, as set forth below, is added to the
amendment, the Regulatory Flexibility
impracticable and contrary to the public Act of 1980 does not apply. See 5 U.S.C. table.
interest. This finding is based on the 601(2). Appendix B to Part 4022—Lump Sum
need to determine and issue new Interest Rates for PBGC Payments
interest assumptions promptly so that List of Subjects in 29 CFR Part 4022
the assumptions can reflect current Employee benefit plans, Pension * * * * *
market conditions as accurately as insurance, Pensions, Reporting and
possible. recordkeeping requirements.
For plans with a valuation Deferred annuities
Immediate
date (percent)
Rate set annuity rate
(percent)
On or after Before i1 i2 i3 n1 n2
* * * * * * *
266 .................................... 12–1–15 1–1–16 1.25 4.00 4.00 4.00 7 8
■ 3. In appendix C to part 4022, Rate Set Appendix C to Part 4022—Lump Sum
266, as set forth below, is added to the Interest Rates for Private-Sector
table. Payments
* * * * *
For plans with a valuation Deferred annuities
Immediate
date (percent)
Rate set annuity rate
(percent)
On or after Before i1 i2 i3 n1 n2
* * * * * * *
266 ................................... 12–1–15 1–1–16 1.25 4.00 4.00 4.00 7 8
Issued in Washington, DC, on this 6th day ENVIRONMENTAL PROTECTION premanufacture notices (PMNs). This
of November 2015. AGENCY action amends the SNURs to allow
Judith Starr, certain uses without requiring a
General Counsel, Pension Benefit Guaranty 40 CFR Part 721 significant new use notice (SNUN), and
Corporation. [EPA–HQ–OPPT–2014–0649; FRL–9935–43] extends SNUN requirements to certain
[FR Doc. 2015–28763 Filed 11–12–15; 8:45 am] additional uses. EPA is amending these
RIN 2070–AB27
BILLING CODE 7709–02–P SNURs based on review of new data for
Modification of Significant New Uses each chemical substance. This action
of Certain Chemical Substances requires persons who intend to
manufacture (including import) or
AGENCY: Environmental Protection process any of these chemical
Agency (EPA). substances for an activity that is
ACTION: Final rule. designated as a significant new use by
SUMMARY: EPA is amending the this rule to notify EPA at least 90 days
significant new use rules (SNURs) under before commencing that activity. The
jstallworth on DSK7TPTVN1PROD with RULES
section 5(a)(2) of the Toxic Substances required notification would provide
Control Act (TSCA) for five chemical EPA with the opportunity to evaluate
substances which were the subject of the intended use and, if necessary, to
1 Appendix B to PBGC’s regulation on Allocation
benefits under terminating covered single-employer ERISA section 4044. Those assumptions are
of Assets in Single-Employer Plans (29 CFR part plans for purposes of allocation of assets under updated quarterly.
4044) prescribes interest assumptions for valuing
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submitted to EPA pertained to the rather than new, it would be difficult for at http://www.sourceoecd.org. ASTM
chemical substance titanate [Ti6O13 (2-)], EPA to establish SNUR notice International standards are available at
dipotassium, which is the chemical requirements, because a person could http://www.astm.org/Standard/
substance subject to 40 CFR 721.9675. defeat the SNUR by initiating the index.shtml.
But regardless of whether any of the proposed significant new use before the The recommended testing specified in
SNUN submitters are manufacturing or rule became effective, and then argue Unit IV. of the proposed rule may not
processing a different chemical that the use was ongoing as of the be the only means of addressing the
substance, any manufacturer and effective date of the final rule. potential risks of the chemical
processor who is manufacturing Thus, any persons who begin substance. However, SNUNs submitted
potassium titanium oxide (which was commercial manufacture or processing without any test data may increase the
the chemical substance submitted for P– activities with the chemical substances likelihood that EPA will take action
06–149 and subject to the SNUR at 40 that are not currently a significant new under TSCA section 5(e), particularly if
CFR 721.10553) is subject to the use under the current rule but which satisfactory test results have not been
requirements of the SNUR at 40 CFR would be regulated as a ‘‘significant obtained from a prior PMN or SNUN
721.10553. new use’’ when this rule is finalized, submitter. EPA recommends that
Comment 3: EPA proposed to modify must cease any such activity as of the potential SNUN submitters contact EPA
the SNUR at 40 CFR 721.10515 to effective date of the rule if and when early enough so that they will be able
include P–10–184, because P–10–184 finalized. To resume their activities, to conduct the appropriate tests.
pertains to the same chemical substance these persons would have to comply SNUN submitters should be aware
as P–10–60, which is already the subject with all applicable SNUR notice that EPA will be better able to evaluate
of 40 CFR 721.10515. A commenter requirements and wait until the notice SNUNs which provide detailed
asked EPA to clarify if the SNUR would review period, including all extensions, information on the following:
require the PMN submitter of P–10–184 expires. • Human exposure and
to conduct the same triggered testing EPA has promulgated provisions to environmental release that may result
required in the consent order for P–10– allow persons to comply with this from the significant new use of the
60. SNUR before the effective date. If a chemical substances.
Response: The consent order for P– person were to meet the conditions of • Potential benefits of the chemical
10–60 requires certain fate and physical advance compliance under § 721.45(h), substances.
property testing to be conducted at five the person would be considered to have • Information on risks posed by the
different aggregate production volume met the requirements of the final SNUR chemical substances compared to risks
limits. The consent order for P–10–184 for those activities. posed by potential substitutes.
does not require any testing to be VI. SNUN Submissions
conducted by production volume limits. V. Test Data and Other Information
The SNUR, however, requires EPA recognizes that TSCA section 5 According to 40 CFR 721.1(c), persons
notification before exceeding the does not require the development of any submitting a SNUN must comply with
manufacture of the five aggregate particular test data before submission of the same notice requirements and EPA
production volume limits. While the a SNUN. The two exceptions are: regulatory procedures as persons
SNUR does not require the submitter of 1. Development of test data is submitting a PMN, including
P–10–184, or any other manufacturer, to required where the chemical substance submission of test data on health and
conduct testing, the SNUR does require subject to the SNUR is also subject to a environmental effects as described in 40
that a SNUN be submitted before test rule under TSCA section 4 (see CFR 720.50. SNUNs must be on EPA
exceeding the aggregate production TSCA section 5(b)(1)). Form No. 7710–25, generated using e-
volume limit. If EPA receives a SNUN 2. Development of test data may be PMN software, and submitted to the
from the submitter of P–10–184, or any necessary where the chemical substance Agency in accordance with the
other manufacturer, EPA will then has been listed under TSCA section procedures set forth in §§ 721.25 and
determine what testing, if any, would be 5(b)(4) (see TSCA section 5(b)(2)). 720.40. E–PMN software is available
required. This could be the testing In the absence of a TSCA section 4 electronically at http://www.epa.gov/
required in the consent order for P–10– test rule or a TSCA section 5(b)(4) opptintr/newchems.
60 or other appropriate testing. This is listing covering the chemical substance, VII. Economic Analysis
the same procedure EPA uses for SNURs persons are required only to submit test
data in their possession or control and EPA evaluated the potential costs of
of consent orders with testing
to describe any other data known to or SNUN requirements for potential
requirements at certain production
reasonably ascertainable by them (see 40 manufacturers and processors of the
volume or time limits.
CFR 720.50). However, upon review of chemical substances in the rule. The
IV. Applicability of the Rule to Uses PMNs and SNUNs, the Agency has the Agency’s complete Economic Analysis
Occurring Before Effective Date of the authority to require appropriate testing. is available in the docket under docket
Final Rule In this case, EPA recommends persons, ID number EPA–HQ–OPPT–2014–0649.
To establish a significant ‘‘new’’ use, before performing any testing, to consult VIII. Statutory and Executive Order
EPA must determine that the use is not with the Agency pertaining to protocol Reviews
ongoing. As discussed in the Federal selection. To access the OCSPP test
Register issue of April 24, 1990 (55 FR guidelines referenced in this document A. Executive Order 12866
17376) (FRL–3658–5), EPA has decided electronically, please go to http:// This action will modify SNURs for
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that the intent of TSCA section www.epa.gov/ocspp and select ‘‘Test five chemical substances that were the
5(a)(1)(B) is best served by designating Methods and Guidelines.’’ The subject of PMNs. The Office of
a use as a significant new use as of the Organisation for Economic Co-operation Management and Budget (OMB) has
date of publication of the proposed and Development (OECD) test exempted these types of actions from
SNUR rather than as of the effective date guidelines are available from the OECD review under Executive Order 12866,
of the final rule. If uses begun after Bookshop at http:// entitled Regulatory Planning and
publication were considered ongoing www.oecdbookshop.org or SourceOECD Review (58 FR 51735, October 4, 1993).
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![Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Rules and Regulations 70175
Dated: November 2, 2015. ■ 3. Amend § 721.9675 by revising processors of this substance as specified
Maria J. Doa, paragraphs (a)(1) and (a)(2)(i), remove in § 721.125 (a), (b), (c) and (i).
Director, Chemical Control Division, Office and reserve paragraph (a)(2)(ii), and * * * * *
of Pollution Prevention and Toxics. revise paragraph (b)(1). ■ 4. Amend § 721.10515 by revising
Therefore, 40 CFR chapter I is The revisionso read as follows: paragraphs (a)(1) and (a)(2)(i) to read as
amended as follows: § 721.9675 Titanate [Ti6O13 (2-)], follows:
dipotassium.
PART 721—[AMENDED] § 721.10515 Partially fluorinated alcohol
(a) Chemical substance and substituted glycols (generic).
■ 1. The authority citation for part 721 significant new uses subject to reporting. (a) * * *
continues to read as follows: (1) The chemical substance identified as (1) The chemical substances
titanate [Ti6O13 (2-)], dipotassium (PMN identified generically as partially
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
P–90–226; SNUNs P–96–1408, S–08–6, fluorinated alcohol substituted glycols
S–09–4, and S–13–49; CAS No. 12056– (PMNs P–10–58, P–10–59, P–10–60, and
■ 2. Amend § 721.5575 by revising 51–8)) is subject to reporting under this
paragraphs (a)(1) and (a)(2)(iii) to read P–10–184) are subject to reporting under
section for the significant new uses this section for the significant new uses
as follows: described in paragraph (a)(2) of this described in paragraph (a)(2) of this
§ 721.5575 Oxirane, 2,2′-(1,6-hexanediylbis section. section.
(oxymethylene)) bis-. (2) * * * (2) * * *
(a) Chemical substance and (i) Industrial, commercial, and (i) Industrial, commercial, and
significant new uses subject to reporting. consumer activities. Requirements as consumer activities. Requirements as
(1) The chemical substance identified as specified in § 721.80 (f) and (l). In specified in § 721.80(k) (manufacture of
oxirane, 2,2′-(1,6- addition, a significant new use of the the PMN substances according to the
hexanediylbis(oxymethylene))bis- (PMN substance is importation of the chemical chemical synthesis and composition
P–88–2179; PMN P–89–539; and SNUN substance if: section of the TSCA section 5(e) consent
S–08–3; CAS No. 16096–31–4) is subject (A) Manufactured by other than the order, including analysis, reporting, and
to reporting under this section for the method described in premanufacture limitations of maximum impurity levels
significant new uses described in notice P–90–226 and significant new of certain fluorinated impurities;
paragraph (a)(2) of this section. The use notices P–96–1408, S–08–6, S–09–4, manufacture and import of P–10–60 and
reporting requirements of this rule do and S–13–49. P–10–184 other than when the mean
not apply once the chemical substance (B) Manufactured producing number of moles of the ethoxy group is
has been incorporated or encapsulated respirable, acicular fibers with an between 3 and 11 or the average number
into plastic. average aspect ratio of greater than 5. molecular weight is between 496 and
(2) * * * The average aspect ratio is defined as 848 daltons based on the amounts of
(iii) Industrial, commercial, and the ratio of average length to average raw materials charged to the reactor;
consumer activities. Requirements as diameter. manufacture and import of P–10–58 and
specified in § 721.80(q). A significant * * * * * P–10–59 only as intermediates for the
new use of the chemical substance is (b) * * * manufacture of P–10–60), and (q).
any commercial use other than the (1) Recordkeeping. The following * * * * *
commercial use described in S–08–3. recordkeeping requirements are [FR Doc. 2015–28844 Filed 11–12–15; 8:45 am]
* * * * * applicable to manufacturers and BILLING CODE 6560–50–P
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Document Created: 2018-03-01 11:23:23
Document Modified: 2018-03-01 11:23:23
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This final rule is effective January 12, 2016. | |
| Contact | For technical information contact: Jim Alwood, Chemical Control Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-8974; email | |
| FR Citation | 80 FR 70171 | |
| RIN Number | 2070-AB27 |
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