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Skip Navigation HomeHelpResourcesContact Us Advanced Search Start of Main Content Significant New Use Rules: Certain Chemical Substances This Proposed Rule document was issued by the Environmental Protection Agency (EPA)For related information, Open Docket Folder Show agency attachment(s) ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2013-0399; FRL-9903-43]
SummaryEPA 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 (including 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.
DatesComments must be received on or before April 11, 2014.
AddressesSubmit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2013-0399, by one of the following methods:
Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. ATTN: Docket ID Number EPA-HQ-OPPT-2013-0399. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564-8930. Such deliveries are only accepted during the DCO's normal hours of operation, and special arrangements should be made for deliveries of boxed information. Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2013-0399. EPA's policy is that all comments received will be included in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential BusinessInformation (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or email. The regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.
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: moss.kenneth@epa.gov. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov. Supplementary InformationI. General InformationA. 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 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; see also 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to a final 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 a chemical substance that is the subject of a proposed or final SNUR, are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 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.
viii. Make sure to submit your comments by the comment period deadline identified.II. BackgroundA. 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-12-539, P-13-107, and P-13-109. 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 theFederal Registerof August 7, 2013 (78 FR 48051) (FRL-9393-4), EPA issued direct final SNURs on these three chemical substances in accordance with the procedures at § 721.160(c)(3)(i). EPA received notices of intent to submit adverse comments on these SNURs. Therefore, as required by § 721.160(c)(3)(ii), EPA removed the direct final SNURs in a separate final rule published in theFederal Registerof November 5, 2013 (78 FR 66279) (FRL-9902-16), and is now issuing thisproposed rule on the three chemical substances. The record for the direct final SNURs on these chemical substances was established as docket EPA-HQ-OPPT-2013-0399. That record includes information considered by the Agency in developing the direct final 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 § 721.5.C. Applicability of General ProvisionsGeneral 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 rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs must comply with the same notice requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in theFederal Registerits reasons for not taking action.III. Significant New Use DeterminationSection 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.
To determine what would constitute a significant new use for the three chemical substances that are the subject of this proposed rule, 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 RuleEPA 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.
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 and importation volume) and other uses designated in this proposed rule, may be claimed as CBI.
This proposed rule includes PMN substances P-12-539, P-13-107, and P-13-109 that are subject to a “risk-based” and “exposure-based” consent order under TSCA section 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II) where EPA determined that activities associated with the PMN substances may present unreasonable risk to human health or the environment, that the PMN substances are expected to be produced in substantial quantities, and that there may either be significant or substantial human exposure and/or the PMN substance may enter the environment in substantial quantities. This consent order requires protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “TSCA section 5(e) SNURs” on these PMN substances are proposed pursuant to § 721.160, and are based on and consistent with the provisions in the underlying consent order. The TSCA section 5(e) SNURs designate as a “significant new use” the absence of the protective measures required in the corresponding consent order.PMN Numbers P-12-539, P-13-107, and P-13-109 Chemical names: Alkanes, C21-34-branched and linear, chloro (P-12-539), alkanes, C22-30-branched and linear, chloro (P-13-107), and alkanes, C24-28, chloro (P-13-109).
Basis for TSCA section 5(e) consent order: The PMNs state that the uses of the PMN substances are as flame retardants/plasticizers in polymers and extreme pressure lubricants in metal working fluids (MWFs). There are also several CBI uses that are generically described as: Plasticizer and lubricant with flame retardant properties. By analogy to medium chain chlorinated paraffins (MCCPs—alkyl chain length of 14 to 17), EPA expects very long chain chlorinated paraffins (vLCCPs) and possible degradation products to be potentially highly persistent, potentially bioaccumulative, and potentially toxic. Transport and magnification across trophic levels may also result in toxicity to higher organisms, including fish, higher predators, and potentially humans. EPA has concerns about the potential for the vLCCPs to degrade to shorter chain chlorinated compounds, as well as concerns about potential impurities or small fractions of MCCPs and/or long-chain chlorinated paraffins (LCCPs—alkyl chain length of 18 to 20). The consent order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II) based on a finding that these PMN substances may present an unreasonable risk of injury to the environment and the PMN substances may be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities, and there may be significant (or substantial) human exposures to thePMN substances. To protect against these risks, the consent order requires:
CFR citations: 40 CFR 721.10673 (P-12-539), 40 CFR 721.10674 (P-13-107), and 40 CFR 721.10675 (P-13-109).V. Rationale and Objectives of the Proposed RuleA. RationaleDuring review of the PMNs submitted for the three chemical substances that are subject to these proposed SNURs, EPA concluded that regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health and environmental effects of the chemical substances. The basis for these findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent order.B. ObjectivesEPA is proposing these SNURs for specific chemical substances that 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 ensure that all manufacturers and processors of the same chemical substance that is subject to a TSCA section 5(e) consent order are subject to similar requirements.Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA 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 http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html. VI. Applicability of the Proposed Rule to Uses Occurring Before the Effective Date of the Final RuleTo 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. A TSCA section 5(e) consent order has been issued for these chemical substances and the PMN submitters are prohibited by the TSCA section 5(e) consent order from undertaking activities which EPA is designating as significant new uses. 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 other 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. However, TSCA section 5(e) consent orders have been issued for these chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) consent order from undertaking activities which would be designated as significant new uses. The identities of the chemical substances subject to this proposed rule have not been claimed as confidential and EPA has received no post-PMN bona fide submissions (per 40 CFR 720.25 and § 721.11). Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this proposed rule are ongoing.
Therefore, EPA designates February 10, 2014 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 § 721.45(h), the person would be considered exempt from the requirements of the SNUR. Consult theFederal Registerdocument of April 24, 1990 (55 FR 17376) for a more detailed discussion of the cutoff date for ongoing uses.VII. Test Data and Other InformationEPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN. The two exceptions are:
2. Development of test data may be necessary where the chemical substancehas 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 cases where EPA issued a TSCA section 5(e) consent order that requires or recommends certain testing, Unit IV. lists those tests. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.” The OECD test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org. In the TSCA section 5(e) consent order for three of the chemical substances in this proposed rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of toxicity tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. Under recent TSCA section 5(e) consent orders, each PMN submitter is required to submit each study before reaching the specified production limit. The SNURs contain the same production volume limits as the TSCA section 5(e) consent order. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture (including import) or processing.
Information on risks posed by the chemical substances compared to risks posed by potential substitutes.VIII. SNUN SubmissionsAccording to § 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 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 http://www.epa.gov/opptintr/newchems. IX. Economic AnalysisEPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances 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-2013-0399.X. Statutory and Executive Order ReviewsA. Executive Order 12866This proposed rule would establish SNURs for three chemical substances that were the subject of PMNs and a TSCA section 5(e) consent order. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993).B. Paperwork Reduction Act (PRA)According to 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 theFederal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable.
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 these SNURs 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 13132This 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 13175This 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 13045This 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 13211This 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 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 would not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), would not apply to this action.J. Executive Order 12898This 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).
Therefore, it is proposed that 40 CFR chapter I be amended as follows:Part 721 Amended
2. Add § 721.10673 to subpart E to read as follows:
§ 721.10673
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (manufacture of the PMN substance with less than 1 weight percent of chlorinated paraffins with an alkyl chain ≤20) and § 721.80(p) (1,200,000 kilograms (kg), 14,100,000 kg, 59,100,000 kg, 78,400,000 kg, and 86,100,000 kg of the aggregate of the PMN substances P-12-539 and P-13-109).
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of this substance.
3. Add § 721.10674 to subpart E to read as follows:
§ 721.10674
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (manufacture of the PMN substance with less than 1 weight percent of chlorinated paraffins with an alkyl chain ≤ 20) and § 721.80(p) (14,100,000 kilograms (kg), 59,100,000 kg, 78,400,000 kg, 86,100,000 kg of PMN substance P-13-107, from March 19, 2013).
4. Add § 721.10675 to subpart E to read as follows:
§ 721.10675
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (manufacture of the PMN substance with less than 1 weight percent of chlorinated paraffins with an alkyl chain ≤ 20) and § 721.80(p) (1,200,000 kilograms (kg), 14,100,000 kg, 78,400,000 kg, 86,100,000 kg of the aggregate of the PMN substances P-12-539 and P-13-109).
[FR Doc. 2014-02846 Filed 2-7-14; 8:45 am]BILLING CODE 6560-50-P
Attachments View All (0) View document: No documents available. Attachments View All (0) Comment Now! Comment Period Closed Apr 11 2014, at 11:59 PM ET ID: EPA-HQ-OPPT-2013-0399-0197 Tracking Number: View original printed format: Document Information Date Posted: Feb 10, 2014RIN: Not AssignedCFR: 40 CFR Part 721Federal Register Number: 2014-02846 Show More Details Submitter Information Comments1 Comments Received* Please see the attached comments from the Chlorinated Paraffins Industry Association. View Comment Docket Information This document is contained in EPA-HQ-OPPT-2013-0399 Related Dockets: NoneRelated RINs: NoneRelated Documents: Significant New Use Rule on Certain Chemical SubstancesSignificant New Uses; Removals: Certain Chemical SubstancesSignificant New Use Rules on Certain Chemical Substances Related Comments: View all * This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document. Document text and images courtesy of the Federal Register Home Search Advanced Search Browse By Category Learn About Us eRulemaking Program Media Toolkit Agencies Awards & Recognition Enhancements & Fixes Resources Site Data Regulatory Agenda Agency Reports Required by Statute API Overview Developers Help How to use Regulations.gov FAQs Glossary Connect With Contact Us Privacy and Security Notice User Notice Accessibility Statement Partner Sites We the People Federal Register Reginfo Congress.gov USA.gov E-Gov Opengov Participate Today!