Source: http://www.regulations.gov/?_escaped_fragment_=documentDetail;D=EPA-HQ-OPPT-2011-0942-0001
Timestamp: 2016-09-29 10:11:14
Document Index: 637326010

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[EPA-HQ-OPPT-2011-0942; FRL-9333-3]
SummaryEPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 17 chemical substances which were the subject of premanufacture notices (PMNs). Two of these chemical substances are subject to TSCA consent orders issued by EPA. This action requires persons who intend to manufacture, import, or process any of these 17 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 will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.
DatesThis rule is effective on June 4, 2012. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on April 18, 2012.
AddressesSubmit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2011-0942, by one of the following methods: Federal eRulemaking Portal: . Follow the online instructions for submitting comments.
Hand Delivery: OPPT Document Control Office (DCO), EPA East, Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. Attention: Docket ID Number EPA-HQ-OPPT-2011-0942. 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-2011-0942. EPA's policy is that all comments received will be included in the docket without change and may be made available online at , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (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: . For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: . Supplementary InformationI. General InformationA. Does this action apply to me?You may be potentially affected by this action if you manufacture, import, process, or use the chemical substances contained in this rule. Potentially affected entities may include, but are not limited to: Manufacturers, importers, or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in § 721.5. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.
To determine what would constitute a significant new use for the 17 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 RuleEPA is establishing significant new use and recordkeeping requirements for 17 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance: PMN number.
This rule also includes SNURs on 15 PMN substances (P-09-248, P-11-33, P-11-34, P-11-188, P-11-316, P-11-333, P-11-424, P-11-511, P-11-546, P-11-578, P-11-580, P-11-591, P-11-608, P-11-637, and P-11-662) that are not subject to consent orders under TSCA section 5(e). In these cases, for a variety of reasons, EPA did not find that the use scenario described in the PMN triggered the determinations set forth under TSCA section 5(e). However, EPA does believe that certain changes from the use scenario described in the PMN could result in increased exposures, thereby constituting a “significant new use.” These so-called “non-5(e) SNURs” are promulgated pursuant to § 721.170. EPA has determined that every activity designated as a “significant new use” in all non-5(e) SNURs issued under § 721.170 satisfies the two requirements stipulated in § 721.170(c)(2), i.e., these significant new use activities, “(i) are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to the premanufacture notice, and (ii) may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified” for the PMN substance.PMN Number P-09-248 Chemical name: Ethyleneamine polyphosphates (generic).
CFR citation: 40 CFR 721.10282.PMN Numbers P-10-486 and P-10-487 Chemical names: (P-10-486) Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-, C12-13-branched and linear alkyl ethers, sodium salts and (P-10-487) Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-, C14-15-branched and linear alkyl ethers, sodium salts.
CFR citations: 40 CFR 721.10283 (P-10-486) and 40 CFR 721.10284 (P-10-487).PMN Number P-11-33 Chemical name: Formaldehyde, polymer with 4-(1,1-dimethylethyl)phenol, reaction products with 1-piperazineethanamine.
CFR citation: 40 CFR 721.10285.PMN Number P-11-34 Chemical name: Formaldehyde, polymer with .alpha.-(2-aminomethylethyl)-.omega.-(2-aminomethylethoxy)poly[oxy(methyl-1,2-ethanediyl)] and 4-(1,1-dimethylethyl)phenol.
CFR citation: 40 CFR 721.10286.PMN Number P-11-188 Chemical name: Infused carbon nanostructures (generic).
CFR citation: 40 CFR 721.10287.PMN Number P-11-316 Chemical name: Cyclohexane, oxidized, by-products from, distn. residues.
CFR citation: 40 CFR 721.10288.PMN Number P-11-333 Chemical name: Hexanedioic acid polymer with aliphatic polyol dihydrogen phosphate aromatic ester (generic).
CFR citation: 40 CFR 721.10289.PMN Number P-11-424 Chemical name: Alkenoyloxy arylphenone (generic).
CFR citation: 40 CFR 721.10290.PMN Number P-11-511 Chemical name: C15 olefins (generic).
CFR citation: 40 CFR 721.10291.PMN Number P-11-546 Chemical name: Silicate (2-), hexafluoro-, cesium (1:2).
CFR citation: 40 CFR 721.10292.PMN Number P-11-578 Chemical name: Benzoic acid, 4-(1,1-dimethylethyl)-, hydrazide.
CFR citation: 40 CFR 721.10293.PMN Number P-11-580 Chemical name: Cyclohexanol, 2,6-bis(1,1-dimethylethyl)-4-methyl-.
CFR citation: 40 CFR 721.10294.PMN Number P-11-591 Chemical name: IPDI modified isophthalic acid, neopentyl glycol and adipic acid (generic).
CFR citation: 40 CFR 721.10295.PMN Number P-11-608 Chemical name: 1,3-Benzenediol, 4-[1-[[3-(1H-imidazol-1-yl)propyl]imino]ethyl]-.
CFR citation: 40 CFR 721.10296.PMN Number P-11-637 Chemical name: Tin, C16-18 and C18-unsatd. fatty acids castor-oil fatty acids complexes.
CFR citation: 40 CFR 721.10297.PMN Number P-11-662 Chemical name: MDI terminated polyester polyurethane polymer (generic).
CFR citation: 40 CFR 721.10298.V. Rationale and Objectives of the RuleA. RationaleDuring review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for two of the 17 chemical substances, regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such 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 orders. These SNURs are promulgated pursuant to § 721.160 (see Unit II.).
In the other 15 cases, where the uses are not regulated under a TSCA section 5(e) consent order, EPA determined that one or more of the criteria of concern established at § 721.170 were met, as discussed in Unit IV.B. ObjectivesEPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule: EPA will receive notice of any person's intent to manufacture, import, or process a listed chemical substance for the described significant new use before that activity begins.
EPA will ensure that all manufacturers, importers, and processors of the same chemical substance that is subject to a TSCA section 5(e) consent order are subject to similar requirements.Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Inventory. Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at . VI. Direct Final ProceduresEPA is issuing these SNURs as a direct final rule, as described in § 721.160(c)(3) and § 721.170(d)(4). In accordance with § 721.160(c)(3)(ii) and § 721.170(d)(4)(i)(B), the effective date of this rule is June 4, 2012 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before May 4, 2012.
This rule establishes SNURs for a number of chemical substances. Any person who submits adverse or critical comments, or notice of intent to submit adverse or critical comments, must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in the comment.VII. Applicability of Rule to Uses Occurring Before Effective Date of the Rule Significant new use designations for a chemical substance are legally established as of the date of publication of this direct final rule, April 4, 2012.
To establish a significant “new” use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. TSCA section 5(e) consent orders have been issued for two chemical substances and the PMN submitters are prohibited by the TSCA section 5(e) consent orders 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. For chemical substances for which an NOC has not been submitted at this time, EPA concludes that the uses are not ongoing. However, EPA recognizes that prior to the effective date of the rule, when chemical substances identified in this SNUR are added to the TSCA Inventory, other persons may engage in a significant new use as defined in this rule before the effective date of the rule. However, 7 of the 17 chemical substances contained in this rule have CBI chemical identities, and since EPA has received a limited number of post-PMN bona fide submissions (per §§ 720.25 and 721.11), the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.
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 § 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. Unit IV. also lists recommended testing for non-5(e) SNURs. 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 harmonized test guidelines referenced in this document electronically, please go to and select “Test Methods and Guidelines.”
If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture, import, or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.X. 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 § 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 §§ 721.25 and 720.40. E-PMN software is available electronically at . XI. Economic AnalysisEPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers, importers, and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2011-0942.XII. Statutory and Executive Order ReviewsA. Executive Order 12866This rule establishes SNURs for several new chemical substances that were the subject of PMNs, or TSCA section 5(e) consent orders. 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 ActAccording to the Paperwork Reduction Act (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.
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 ActOn February 18, 2012, EPA certified pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (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, and (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 XI and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true: (1) A significant number of SNUNs would not be submitted by small entities in response to the SNUR and (2) 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 ActBased 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 rule. As such, EPA has determined that this rule does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any affect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).E. This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999).F. This rule does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This rule does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000), do not apply to this rule.G. 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. 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 ActIn addition, since this action does not involve any technical standards, section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note), does not apply to this action.J. 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).XIII. Congressional Review ActThe Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This rule is not a “major rule” as defined by 5 U.S.C. 804(2).
* * * * * Significant New Uses of Chemical Substances * * * * * 721.102822070-0012
721.102832070-0012
721.102842070-0012
721.102852070-0012
721.102862070-0012
721.102872070-0012
721.102882070-0012
721.102892070-0012
721.102902070-0012
721.102912070-0012
721.102922070-0012
721.102932070-0012
721.102942070-0012
721.102952070-0012
721.102962070-0012
721.102972070-0012
721.102982070-0012
4. Add § 721.10282 to subpart E to read as follows:
§ 721.10282 Ethyleneamine polyphosphates (generic).
5. Add § 721.10283 to subpart E to read as follows:
§ 721.10283 Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-, C12-13-branched and linear alkyl ethers, sodium salts.
6. Add § 721.10284 to subpart E to read as follows:
§ 721.10284 Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-, C14-15-branched and linear alkyl ethers, sodium salts.
7. Add § 721.10285 to subpart E to read as follows:
§ 721.10285 Formaldehyde, polymer with 4-(1,1-dimethylethyl)phenol, reaction products with 1-piperazineethanamine.
8. Add § 721.10286 to subpart E to read as follows:
§ 721.10286 Formaldehyde, polymer with .alpha.-(2-aminomethylethyl)-.omega.-(2-aminomethylethoxy)poly[oxy(methyl-1,2-ethanediyl)] and 4-(1,1-dimethylethyl)phenol.
9. Add § 721.10287 to subpart E to read as follows:
§ 721.10287 Infused carbon nanostructures (generic).
10. Add § 721.10288 to subpart E to read as follows:
§ 721.10288 Cyclohexane, oxidized, by-products from, distn. residues.
(i) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N = 4 ppb).
11. Add § 721.10289 to subpart E to read as follows:
§ 721.10289 Hexanedioic acid polymer with aliphatic polyol dihydrogen phosphate aromatic ester (generic).
12. Add § 721.10290 to subpart E to read as follows:
§ 721.10290 Alkenoyloxy arylphenone (generic).
13. Add § 721.10291 to subpart E to read as follows:
§ 721.10291 C15 olefins (generic).
14. Add § 721.10292 to subpart E to read as follows:
§ 721.10292 Silicate (2-), hexafluoro-, cesium (1:2).
15. Add § 721.10293 to subpart E to read as follows:
§ 721.10293 Benzoic acid, 4-(1,1-dimethylethyl)-, hydrazide.
16. Add § 721.10294 to subpart E to read as follows:
§ 721.10294 Cyclohexanol, 2,6-bis(1,1-dimethylethyl)-4-methyl-.
17. Add new § 721.10295 to subpart E to read as follows:
§ 721.10295 IPDI modified isophthalic acid, neopentyl glycol and adipic acid (generic).
18. Add new § 721.10296 to subpart E to read as follows:
§ 721.10296 1,3-Benzenediol, 4-[1-[[3-(lH-imidazol-1-yl)propyl]imino] ethyl]-.
19. Add new § 721.10297 to subpart E to read as follows:
§ 721.10297 Tin, C16-18 and C18-unsatd. fatty acids castor-oil fatty acids complexes.
20. Add new § 721.10298 to subpart E to read as follows:
§ 721.10298 MDI terminated polyester polyurethane polymer (generic).
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.[FR Doc. 2012-8092 Filed 4-3-12; 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 May 4 2012, at 11:59 PM ET ID: EPA-HQ-OPPT-2011-0942-0001 Tracking Number: View original printed format: Document Information Date Posted: Apr 4, 2012RIN: Not AssignedCFR: 40 CFR Parts 9 and 721Federal Register Number: 2012-08092 Show More Details Submitter Information Comments1 Comments Received* Comment View Comment Docket Information This document is contained in EPA-HQ-OPPT-2011-0942 Related Dockets: NoneRelated RINs: NoneRelated Documents: Significant New Use Rule on Certain Chemical Substance... 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!