Significant New Use Rule on Certain Chemical Substances
Federal Register, Volume 80 Issue 111 (Wednesday, June 10, 2015)
Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)
Proposed Rules
Pages 32879-32885
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2015-13941
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
EPA-HQ-OPPT-2014-0390; FRL-9927-60
RIN 2070-AB27
Significant New Use Rule on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 30 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.
DATES: Comments must be received on or before July 10, 2015.
ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2014-0390, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-9232; email address: 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 INFORMATION:
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General Information
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Does this action apply to me?
You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this proposed rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
Manufacturers (including importers) or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance to a proposed or final rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see Sec. 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
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What should I consider as I prepare my comments for EPA?
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Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark
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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.
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Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
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Background
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What action is the Agency taking?
EPA is proposing these SNURs under TSCA section 5(a)(2) for 30 chemical substances which were the subject of PMNs P-13-793, P-14-72, P-14-89, P-14-90, P-14-91, P-14-92, P-14-158, P-14-159, P-14-161, P-14-
162, P-14-163, P-14-173, P-14-175, P-14-176, P-14-177, P-14-178, P-14-
179, P-14-180, P-14-181, P-14-182, P-14-183, P-14-184, P-14-185, P-14-
186, P-14-187, P-14-188, P-14-190, P-14-191, P-14-192, and P-14-193. These SNURs would require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. In accordance with the procedures at Sec. 721.160(c)(3)(i), in the Federal Register publication of October 27, 2014 (79 FR 63821) (FRL-9914-56) EPA issued direct final SNURs on these chemical substances, which are the subject of PMNs. EPA received notices of intent to submit adverse comments on these SNURs. Therefore, as required by Sec. 721.160(c)(3)(ii), EPA withdrew the direct final SNURs in the Federal Register of December 23, 2014 (79 FR 76900) (FRL-
9920-6325), and is now issuing this proposed rule on these 30 chemical substances. The records for the direct final SNURs on these 30 chemical substances were established as docket EPA-HQ-OPPT-2014-0390. Those records include information considered by the Agency in developing the direct final rule. Adverse comments received regarding these substances and the direct final rule are discussed in Unit IV.
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What is the Agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a ``significant new use.'' EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use. Persons who must report are described in Sec. 721.5.
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Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the final rule. Provisions relating to user fees appear at 40 CFR part 700. According to Sec. 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.
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Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a chemical substance.
The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorized EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four bulleted TSCA section 5(a)(2) factors listed in this unit.
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Substances Subject to This Proposed Rule
EPA is proposing significant new use and recordkeeping requirements for 30 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:
PMN number.
Chemical name (generic name, if the specific name is claimed as CBI).
Chemical Abstracts Service (CAS) Registry number (assigned for non-confidential chemical identities).
Public comments and EPA's response to comments on the 30 direct final SNURs subject to PMNs P-13-793, P-14-72, P-14-89, P-14-90, P-14-91, P-14-92, P-14-158, P-14-159, P-14-161, P-14-162, P-14-163, P-
14-173, P-14-175, P-14-176, P-14-177, P-14-178, P-14-179, P-14-180, P-
14-181, P-14-182, P-14-183, P-14-184, P-14-185, P-14-186, P-14-187, P-
14-188, P-14-190, P-14-191, P-14-192, and P-14-193
Basis for the TSCA non-section 5(e) SNURs (i.e., SNURs without TSCA section 5(e) consent orders).
Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VII. for more information).
CFR citation assigned in the regulatory text section of this proposed rule.
The regulatory text section of this proposed rule specifies the activities designated as significant new uses. Certain new uses, including production volume limits (i.e., limits on manufacture and importation volume) and other uses designated in this proposed rule, may be claimed as CBI.
PMN Number P-13-793
Chemical name: Functionalized carbon nanotubes (generic).
CAS number: Claimed confidential.
Public comment: A notice of intent to adversely comment has been submitted.
EPA response: EPA awaits the adverse comment during the open comment
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period for this notice of proposed rulemaking.
Basis for action: The PMN states that the substance will be used as a thin film for electronic device applications. Based on structure activity relationship (SAR) analysis of test data on analogous carbon nanotubes and other respirable poorly soluble particulates, EPA identified potential lung effects, developmental toxicity, and dermal toxicity from exposure to the PMN substance via inhalation, dermal, and oral routes. Further, EPA predicts toxicity to aquatic organisms via releases of the PMN substance to surface water. Although there is potential for dermal exposure, EPA does not expect significant occupational exposures due to the use of impervious gloves, and because the PMN is used in liquid form and is not spray applied. Further, EPA does not expect environmental releases during the use identified in the PMN submission. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk human health or the environment. EPA has determined, however, that any use of the substance without the use of impervious gloves, where there is a potential for dermal exposure; manufacturing the PMN substance for use other than as a thin film for electronic device applications; manufacturing, processing, or using the PMN substance in a form other than a liquid; use of the PMN substance involving an application method that generates a mist, vapor, or aerosol; or any release of the PMN substance into surface waters may cause serious health effects or significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria in Sec. 721.170 (b)(3)(ii) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of an oral and inhalation pharmacokinetic test (OPPTS Test Guideline 870.7485); a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); an algal toxicity test (OCSPP Test Guideline 850.4500); and a surface charge by electrophoresis by either the (ASTM Test Guideline E2865-12) or measuring the zeta potential of nanoparticles (Nanotechnology Characterization Library (NCL) Method PCC-2) (located in the Docket under Docket ID number EPA-HQ-OPPT-2014-0390); would help characterize the human health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10776.
PMN Number P-14-72
Chemical name: Propaneperoxoic acid, 2,2-dimethyl-, 1,1,3,3-
tetramethylbutyl ester.
CAS number: 22288-41-1.
Public comment: A notice of intent to adversely comment has been submitted.
EPA response: EPA awaits the adverse comment during the open comment period for this notice of proposed rulemaking.
Basis for action: The PMN states that the use of the substance will be as a polymerization initiator for the production of polyvinyl chloride (PVC) and polyethylene resin. Based on test data on the PMN substance, as well as ecological SAR analysis of test data on analogous peroxy esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 3 parts per billion (ppb) of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 3 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface waters concentrations exceeding 3 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170 (b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a ready biodegradability test (Organisation for Economic Co-operation and Development (OECD) Test Guideline 301C) with product-specific chemical analytics to validate the degradation products (including intermediate products) and the rates of degradation (including intermediate degradation rates); and a hydrolysis as a function of pH and temperature test (OPPTS Test Guideline 835.2130) would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10780.
PMN Numbers P-14-89, P-14-90, P-14-91, and P-14-92
Chemical names: Fatty acid amide hydrochlorides (generic).
CAS numbers: Claimed confidential.
Public comment: A notice of intent to adversely comment has been submitted, by the PMN submitter. The comment expressed concern that EPA's approach for these SNURs changed from that transmitted in writing by EPA during the PMN review period. As a result, the PMN submitter was not given the opportunity to discuss, provide pertinent information on, respond to, or comment on this change.
EPA response: EPA met with the PMN submitter on December 17, 2014 to discuss procedural and policy issues raised in connection with the withdrawn SNURs. EPA awaits formal comment during the open comment period for this proposed rule.
Basis for action: The consolidated PMN states that the substances will be used as surfactants for use in asphalt emulsions. Based on ecological SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed the following values of the PMN substances in surface waters:
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PMN No. Concentration of concern
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P-14-89, P-14-92......................... 110 ppb.
P-14-90.................................. 240 ppb.
P-14-91.................................. 53 ppb.
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For the use described in the PMNs, releases of the substances are not expected to result in surface water concentrations that exceed these values. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substances resulting in surface water concentrations exceeding the aforementioned concentrations of concern may result in significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substances. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substances and mixtures (OECD Test Guideline 23) be followed.
CFR citation: 40 CFR 721.10781.
PMN Numbers P-14-158, P-14-159, P-14-161, P-14-162, and P-14-163
Chemical names: Fatty acid amides (generic).
CAS numbers: Claimed confidential.
Public comment: A notice of intent to adversely comment has been submitted,
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by the PMN submitter. The comment expressed concern that EPA's approach for these SNURs changed from that transmitted in writing by EPA during the PMN review period. As a result, the PMN submitter was not given the opportunity to discuss, provide pertinent information on, respond to, or comment on this change.
EPA response: EPA met with the PMN submitter on December 17, 2014 to discuss procedural and policy issues raised in connection with the withdrawn SNURs. EPA awaits formal comment during the open comment period for this proposed rule.
Basis for action: The consolidated PMN states that the substances will be used as chemical intermediates and additives for flotation products. Based on ecological SAR analysis of test data on analogous amides and aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed the following values of the PMN substances in surface waters:
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PMN No. Concentration of concern
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P-14-158, P-14-159, P-14-161, P-14-163... 1 ppb.
P-14-162................................. 140 ppb.
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For the use described in the PMNs, releases of the substances are not expected to result in surface water concentrations that exceed these values. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substances resulting in surface water concentrations exceeding the aforementioned concentrations of concern may result in significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of (1) a water solubility: Column elution method; shake flask method test (OPPTS Test Guideline 830.7840) or a water solubility generator column method test (OPPTS Test Guideline 830.7860); and (2) a determination of the partition coefficient (n-octanol/water) by shake flask method (OPPTS Test Guideline 830.7550), or generator column method (OPPTS Test Guideline 830.7560), or estimation by liquid chromatography (OPPTS Test Guideline 830.7570) would help characterize the physical/chemical properties of the PMN substances. Depending upon the results of these data, the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) may be recommended to help characterize the environmental effects of the PMN substances.
CFR citation: 40 CFR 721.10782.
PMN Numbers P-14-173, P-14-175, P-14-176, P-14-177, P-14-178, P-14-179, P-14-180, P-14-181, P-14-182, P-14-183, P-14-184, P-14-185, P-14-186, P-14-187, P-14-188, P-14-190, P-14-191, P-14-192, and P-14-193
Chemical names: Fatty acid amide acetates (generic).
CAS numbers: Claimed confidential.
Public comment: A notice of intent to adversely comment has been submitted, by the PMN submitter. The comment expressed concern that EPA's approach for these SNURs changed from that transmitted in writing by EPA during the PMN review period. As a result, the PMN submitter was not given the opportunity to discuss, provide pertinent information on, respond to, or comment on this change.
EPA response: EPA met with the PMN submitter on December 17, 2014 to discuss procedural and policy issues raised in connection with the withdrawn SNURs. EPA awaits formal comment during the open comment period for this proposed rule.
Basis for action: The PMNs state that the substances will be used as flotation additives for use in mineral processing. Based on ecological SAR analysis of test data on analogous amides and aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed the following values of the PMN substances in surface waters:
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PMN No. Concentration of concern
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P-14-173, P-14-175, P-14-178, P-14-179, P- 1 ppb.
14-181, P-14-183, P-14-184, P-14-192, P-
14-193.
P-14-176, P-14-180, P-14-185, P-14-186, P- 2 ppb.
14-187, P-14-190.
P-14-177, P-14-188....................... 3 ppb.
P-14-191................................. 4 ppb.
P-14-182................................. 140 ppb.
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For the use described in the PMNs, releases of the substances are not expected to result in surface water concentrations that exceed these values. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substances resulting in surface water concentrations exceeding the aforementioned concentrations of concern may result in significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) on P-14-184, and any one of the remaining PMN substances, would help characterize the environmental effects of the PMN substances. Further, EPA determined that the results of a fish acute toxicity mitigated by humic acid test (OPPTS Test Guideline 850.1085) on PMN P-14-184 would help characterize the environmental effects of the PMN substance. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substances and mixtures (OECD Test Guideline 23) be followed.
CFR citation: 40 CFR 721.10783.
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Rationale and Objectives of the Proposed Rule
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Rationale
During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA determined that one or more of the criteria of concern established at Sec. emsp14721.170 were met. For additional discussion on these chemical substances, see Units II. and IV. of this proposed rule.
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Objectives
EPA is proposing 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 proposed rule:
EPA would receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins.
EPA would have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.
EPA would be able to regulate prospective manufacturers or processors of a listed chemical substance before the
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described significant new use of that chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.
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Applicability of the Proposed Rule to Uses Occurring Before the Effective Date of the Final Rule
To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this proposed rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing.
When chemical substances identified in this proposed rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. The identities of 29 of the 30 chemical substances subject to this proposed rule have been claimed as confidential and EPA has received no post-PMN bona fide submissions (per Sec. Sec. 720.25 and 721.11). Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this proposed rule are ongoing.
Therefore, EPA designates June 10, 2015 as the cutoff date for determining whether the new use is ongoing. Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of that date would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until the notice review period, including any extensions, expires. If such a person met the conditions of advance compliance under Sec. 721.45(h), the person would be considered exempt from the requirements of the SNUR. Consult the Federal Register document of April 24, 1990 (55 FR 17376) for a more detailed discussion of the cutoff date for ongoing uses.
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Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN. The two exceptions are:
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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)).
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Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing covering the chemical substance, persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ``Test 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 tests specified in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior PMN or SNUN submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result from the significant new use of the chemical substances.
Potential benefits of the chemical substances.
Information on risks posed by the chemical substances compared to risks posed by potential substitutes.
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SNUN Submissions
According to Sec. emsp14721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.
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Economic Analysis
EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this proposed rule, during the development of the direct final rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2014-0390.
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Statutory and Executive Order Reviews
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Executive Order 12866
This proposed rule would establish SNURs for 30 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).
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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.
The information collection requirements related to this proposed rule have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This proposed rule would not impose any burden requiring additional OMB approval. If an entity were to
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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.
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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:
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A significant number of SNUNs would not be submitted by small entities in response to the SNUR.
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The SNUR submitted by any small entity would not cost significantly more than $8,300.
A copy of that certification is available in the docket for this proposed rule.
This proposed rule is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit IX. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true:
A significant number of SNUNs would not be submitted by small entities in response to the SNUR.
Submission of the SNUN would not cost any small entity significantly more than $8,300.
Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities.
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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.).
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Executive Order 13132
This proposed rule would not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999).
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Executive Order 13175
This proposed rule would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly nor uniquely affect the communities of Indian Tribal governments, nor would it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000), do not apply to this proposed rule.
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Executive Order 13045
This proposed rule is not subject to Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this proposed rule does not address environmental health or safety risks disproportionately affecting children.
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Executive Order 13211
This proposed rule is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because this proposed rule is not expected to affect energy supply, distribution, or use and because this proposed rule is not a significant regulatory action under Executive Order 12866.
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National Technology Transfer and Advancement Act (NTTAA)
In addition, since this proposed rule would not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), would not apply to this proposed rule.
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Executive Order 12898
This proposed rule does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.
Dated: June 1, 2015.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR chapter I be amended as follows:
PART 721--AMENDED
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The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
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Add Sec. 721.10776 to subpart E to read as follows:
Sec. 721.10776 Functionalized carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as functionalized carbon nanotubes (PMN P-13-793) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec. 721.63 (a)(1), (a)(2)(i), and (a)(3). When determining which persons are reasonably likely to be exposed as required for Sec. 721.63 (a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(j) (a significant new use is use other than as a thin film for electronic device applications), (v)(1), (v)(2), (w)(1), (w)(2), (x)(1), (x)(2), and (y)(1).
Page 32885
(iii) Release to water. Requirements as specified in Sec. 721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (e), (i), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section.
0
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Add Sec. 721.10780 to subpart E to read as follows:
Sec. 721.10780 Propaneperoxoic acid, 2,2-dimethyl-, 1,1,3,3-
tetramethylbutyl ester.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as propaneperoxoic acid, 2,2-dimethyl-, 1,1,3,3-tetramethylbutyl ester (PMN P-14-72; CAS No. 22288-41-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=3).
(ii) Reserved
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section.
0
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Add Sec. 721.10781 to subpart E to read as follows:
Sec. 721.10781 Fatty acid amide hydrochlorides (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acid amide hydrochlorides (PMNs P-14-89, P-14-90, P-14-91 and P-14-92) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (where N = 110 for PMNs P-14-89 and P-
14-92; N = 240 for PMN P-14-90; N = 53 for PMN P-14-91).
(ii) Reserved
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (k) are applicable to manufacturers and processors of these substances.
(2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section.
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Add Sec. 721.10782 to subpart E to read as follows:
Sec. 721.10782 Fatty acid amides (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acid amides (PMN P-14-158, P-14-159, P-14-161, P-14-162, and P-14-163) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (where N = 1 for PMNs P-14-158, P-14-
159, P-14-161, and P-14-163; N = 140 for PMN P-14-162).
(ii) Reserved
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (k) are applicable to manufacturers and processors of these substances.
(2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section.
0
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Add Sec. 721.10783 to subpart E to read as follows:
Sec. 721.10783 Fatty acid amide acetates (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acid amide acetates (PMNs P-14-173, P-14-175, P-14-176, P-14-177, P-14-
178, P-14-179, P-14-180, P-14-181, P-14-182, P-14-183, P-14-184, P-14-
185, P-14-186, P-14-187, P-14-188, P-14-190, P-14-191, P-14-192 and P-
14-193) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (where N = concentration of concern as follows):
------------------------------------------------------------------------
PMN No. Concentration of concern
------------------------------------------------------------------------
P-14-173, P-14-175, P-14-178, P-14-179, P- 1 ppb.
14-181, P-14-183, P-14-184, P-14-192, P-
14-193.
P-14-176, P-14-180, P-14-185, P-14-186, P- 2 ppb.
14-187, P-14-190.
P-14-177, P-14-188....................... 3 ppb.
P-14-191................................. 4 ppb.
P-14-182................................. 140 ppb.
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(ii) Reserved
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (k) are applicable to manufacturers and processors of these substances.
(2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section.
FR Doc. 2015-13941 Filed 6-9-15; 8:45 am
BILLING CODE 6560-50-P
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