Source: http://www.regulations.gov/?_escaped_fragment_=documentDetail;D=EPA-HQ-OPPT-2012-0182-0002
Timestamp: 2016-09-29 13:41:30
Document Index: 334149144

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[EPA-HQ-OPPT-2012-0182; FRL-9345-4]
SummaryEPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 23 chemical substances which were the subject of premanufacture notices (PMNs). Nine 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 23 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 25, 2012. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on May 9, 2012.
AddressesSubmit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2012-0182, 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-2012-0182. 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-2012-0182. 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 ContactFor 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.
This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule 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 promulgating these SNURs using direct final procedures. These SNURs will require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of a chemical substance for any activity designated by these SNURs as a significant new use. 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. Additional rationale and background to these rules are more fully set out in the preamble to EPA's first direct final SNUR published in the Federal Register issue of April 24, 1990 (55 FR 17376) (April 24, 1990 SNUR). Consult that preamble for further information on the objectives, rationale, and procedures for SNURs and on the basis for significant new use designations, including provisions for developing test data.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, import, 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 sections 5(h)(1), 5(h)(2), 5(h)(3), and 5(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.III. Significant New Use 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 23 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 23 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 rule.The regulatory text section of this 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 rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use.
This rule also includes SNURs on 14 PMN substances (P-05-714, P-11-128, P-11-338, P-11-481, P-11-594, P-11-654, P-12-22, P-12-23, P-12-24, P-12-25, P-12-26, P-12-33, P-12-51, and P-12-52) 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 or releases, 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-05-714 Chemical name: Polyether ester acid compound with a polyamine amide (generic).
CFR citation: 40 CFR 721.10410.PMN Number P-07-537 Chemical name: Alkanenitrile, bis(cyanoalkyl)amino (generic).
Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the PMN substance will be as a chemical intermediate. Based on test data on the PMN substance, EPA identified concerns for neurotoxicity to workers from dermal and inhalation exposures. The NCEL is 70 microgram/cubic meter (μg/m 3) as an 8-hour time-weighted average. In addition, based on ecological structure-activity relationship (EcoSAR) analysis of test data on structurally similar aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 700 parts per billion (ppb). The consent order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that this substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the consent order requires:
1. Use of personal protective equipment including impervious gloves (when there is potential dermal exposure) and either a National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 5, or compliance with a NCEL of 70 μg/m 3 as an 8-hour time-weighted average (when there is potential inhalation exposure).
CFR citation: 40 CFR 721.10411.PMN Number P-07-706 Chemical name: Phosphonic acid ester (generic).
Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a chemical intermediate. Based on test data on the PMN substance and an analogous chemical, EPA identified concerns for oncogenicity, mutagenicity, reproductive/developmental toxicity, skin irritation, and sensitization to workers from dermal and inhalation exposures. The NCEL is 1.0 milligram (mg)/m 3 as an 8-hour time-weighted average. The consent order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that this substance may present an unreasonable risk of injury to human health. To protect against this risk, the consent order requires:
1. Use of personal protective equipment including dermal protection (when there is potential dermal exposure) and a NIOSH-certified respirator with an assigned protection factor (APF) of at least 15, or compliance with a NCEL of 1.0 mg/m 3 as an 8-hour time-weighted average (when there is potential inhalation exposure).
CFR citation: 40 CFR 721.10412.PMN Number P-10-135 Chemical name: Fluorinated dialkyl ketone (generic).
CFR citation: 40 CFR 721.10413.PMN Number P-10-358 Chemical name: Iron(1+), chloro[rel-1,5-dimethyl (1R,2S,4R,5S)- 9,9-dihydroxy-3-methyl-2,4-di(2-pyridinyl-.kappa.N)-7-[(2-pyridinyl-.kappa.N)methyl]-3,7-diazabicyclo[3.3.1]nonane-1,5-dicarboxylate-.kappa.N3,.kappa.N7]-, chloride (1:1), (OC-6-63)-.
CFR citation: 40 CFR 721.10414.PMN Number P-11-128 Chemical name: 3H-indolium, 2-[2-[3-[2-(1,3-dihydro-1,3,3-trimethyl-2H-indol-2-ylidene)ethylidene]-2-[(1-phenyl-1H-tetrazol-5-yl)thio]-1-cyclohexen-1-yl]ethenyl]-1,3, 3-trimethyl-, chloride (1:1).
CFR citation: 40 CFR 721.10415.PMN Number P-11-264 Chemical name: Brominated polyphenyl ether (generic).
CFR citation: 40 CFR 721.10416.PMN Number P-11-338 Chemical name: Biphenyl alkyl morpholino ketone (generic).
CFR citation: 40 CFR 721.10417.PMN Number P-11-481 Chemical name: 1,2-Cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester.
CFR citation: 40 CFR 721.10418.PMN Number P-11-561 Chemical name: Tetrafluoroethylene chlorotrifluoroethylene copolymer (generic).
CFR citation: 40 CFR 721.10419.PMN Numbers P-11-567, P-11-568, and P-11-569 Chemical name: Fluoropolymers (generic).
CFR citation: 40 CFR 721.10420.PMN Number P-11-594 Chemical name: Mercaptoalkoxysilane (generic).
CFR citation: 40 CFR 721.10421.PMN Number P-11-654 Chemical name: Phenol, 2-[[[3-(1H-imidazol-1-yl)propyl]imino]phenylmethyl]-5-(octyloxy)-.
CFR citation: 40 CFR 721.10422.PMN Numbers: P-12-22, P-12-23, P-12-24, P-12-25, and P-12-26 Chemical names: Complex strontium aluminum, rare earth doped (generic).
CFR citation: 40 CFR 721.10423.PMN Number P-12-33 Chemical name: Benzoic acid, 4-(1,1-dimethylethyl)-, methyl.
CFR citation: 40 CFR 721.10424.PMN Numbers: P-12-51 and P-12-52 Chemical names: Substituted alkylamides (generic).
CFR citation: 40 CFR 721.10425.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 9 of the 23 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 14 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 25, 2012 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before May 25, 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 RuleSignificant new use designations for a chemical substance are legally established as of the date of publication of this direct final rule April 25, 2012.
EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. If a person meets the conditions of advance compliance under § 721.45(h), the person is considered exempt from the requirements of the SNUR.VIII. 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:
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. describes 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 and test reporting. To access the harmonized test guidelines referenced in this document electronically, please go to and select “Test Methods and Guidelines.” The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at or SourceOECD at . To access EPA Method 8290A, please go to . In the TSCA section 5(e) consent orders for several of the chemical substances regulated under this 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. Listings of the tests specified in the TSCA section 5(e) consent orders are included in Unit IV. The SNURs contain the same production limits as the TSCA section 5(e) consent orders. 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, import, or processing.
Information on risks posed by the chemical substances compared to risks posed by potential substitutes.IX. Procedural DeterminationsBy this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at § 721.1725(b)(1).
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 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 § 721.25 and 40 CFR 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-2012-0182.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.
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 effect 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 ActPursuant 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).
* * * * * Significant New Uses of Chemical Substances * * * * * 721.104102070-0012
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* * * * * * * * * *Part 721 Amended
4. Add § 721.10410 to subpart E to read as follows:
§ 721.10410 Polyether ester acid compound with a polyamine amide (generic) (P-05-714).
5. Add § 721.10411 to subpart E to read as follows:
§ 721.10411 Alkanenitrile, bis(cyanoalkyl)amino (generic) (P-07-537).
(A) As an alternative to the respiratory requirements listed in paragraph (a)(2)(i), a manufacturer, importer, or processor may choose to follow the new chemical exposure limit (NCEL) provisions listed in the TSCA section 5(e) consent order for this substance. The NCEL is 70 microgram/cubic meter (μg/m 3) as an 8-hour time-weighted average. Persons who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will receive NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order.
(ii) Hazard communication program. Requirements as specified in § 721.72(a), (b), (c), (d), (e)(concentration set at 1.0 percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(iv), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv) (use respiratory protection, or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 70 μg/m 3), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), (g)(4)(iii), and (g)(5).
6. Add § 721.10412 to subpart E to read as follows:
§ 721.10412 Phosphonic acid ester (generic) (P-07-706).
(A) As an alternative to the respiratory requirements listed in paragraph (a)(2)(i), a manufacturer, importer, or processor may choose to follow the new chemical exposure limit (NCEL) provisions listed in the TSCA section 5(e) consent order for this substance. The NCEL is 1.0 millgram/cubic meter (mg/m 3) as an 8-hour time-weighted-average. Persons who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will receive NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order.
(ii) Hazard communication program. Requirements as specified in § 721.72(a), (b), (c), (d), (e) (concentration set at 0.1 percent), (f), (g)(1)(i), (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv) (use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 1.0 mg/m 3), and (g)(5).
(iii) Industrial, commercial, and consumer activities . Requirements as specified in § 721.80(q).
(b) Specific requirements . The provisions of subpart A of this part apply to this section except as modified by this paragraph.
7. Add § 721.10413 to subpart E to read as follows:
§ 721.10413 Fluorinated dialkyl ketone (generic) (P-10-135).
8. Add § 721.10414 to subpart E to read as follows:
§ 721.10414 Polycyclic polyamine diester organometallic compound (generic) (P-10-358).
9. Add § 721.10415 to subpart E to read as follows:
§ 721.10415 3H-indolium, 2-[2-[3-[2-(1,3-dihydro-1,3,3-trimethyl-2H-indol-2-ylidene)ethylidene]-2-[(1-phenyl-1H-tetrazol-5-yl)thio]-1-cyclohexen-1-yl]ethenyl]-1, 3, 3-trimethyl-, chloride (1:1).
(i) Industrial, commercial, and consumer activities . Requirements as specified in § 721.80(s) (10,000 kilogram (kg)).
(1) Recordkeeping . Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance,
10. Add § 721.10416 to subpart E to read as follows:
§ 721.10416 Brominated polyphenyl ether (generic) (P-11-264).
11. Add § 721.10417 to subpart E to read as follows:
§ 721.10417 Biphenyl alkyl morpholino ketone (generic) (P-11-338).
(2) Limitations or revocation of certain notification requirements . The provisions of § 721.185 apply to this section.
12. Add § 721.10418 to subpart E to read as follows:
§ 721.10418 1,2-Cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester.
13. Add § 721.10419 to subpart E to read as follows:
§ 721.10419 Tetrafluoroethylene chlorotrifluoroethylene copolymer (generic) (P-11-561).
14. Add § 721.10420 to subpart E to read as follows:
§ 721.10420 Fluoropolymers (generic) (P-11-567, P-11-568, and P-11-569).
15. Add § 721.10421 to subpart E to read as follows:
§ 721.10421 Mercaptoalkoxysilane (generic) (P-11-594).
16. Add § 721.10422 to subpart E to read as follows:
§ 721.10422 Phenol, 2-[[[3-(1H-imidazol-1-yl)propyl]imino]phenylmethyl]-5-(octyloxy)-.
17. Add § 721.10423 to subpart E to read as follows:
§ 721.10423 Complex strontium aluminum, rare earth doped (generic) (P-12-22, P-12-23, P-12-24, P-12-25, and P-12-26).
18. Add § 721.10424 to subpart E to read as follows:
§ 721.10424 Benzoic acid, 4-(1,1-dimethylethyl)-, methyl.
19. Add § 721.10425 to subpart E to read as follows:
§ 721.10425 Substituted alkylamides (generic) (P-12-51 and P-12-52).
(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section.[FR Doc. 2012-9965 Filed 4-24-12; 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 25 2012, at 11:59 PM ET ID: EPA-HQ-OPPT-2012-0182-0002 Tracking Number: View original printed format: Document Information Date Posted: Apr 25, 2012RIN: Not AssignedCFR: 40 CFR Parts 9 and 721Federal Register Number: 2012-09965 Show More Details Submitter Information Comments4 Comments Received* Comment View Comment Comment View Comment May 24, 2012
To: Docket ID Number EPA-HQ-OPPT-2012-0182
Re: Notice of Adverse or Critical Comment on Direct Final Significant New Use Rule 40 C.F.R. § 721... View Comment Docket Information This document is contained in EPA-HQ-OPPT-2012-0182 Related Dockets: NoneRelated RINs: NoneRelated Documents: Significant New Use Rule on Certain Chemical SubstancesProposed Significant New Use Rule on Certain Chemical...Significant 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!