ACTION:
Direct final rule.
SUMMARY:
EPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 35 chemical substances which were the subject of premanufacture notices (PMNs). Fourteen of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action requires persons who intend to manufacture (including import) or process any of these 35 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.
DATES:
This rule is effective on April 14, 2014. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on February 26, 2014.
Written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs must be received on or before March 14, 2014 (see Unit VI. of the SUPPLEMENTARY INFORMATION ). If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before March 14, 2014, EPA will withdraw the relevant sections of this direct final rule before its effective date.
For additional information on related reporting requirement dates, see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION .
ADDRESSES:
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2013-0739, by one of the following methods:
• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments.
• 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: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. ATTN: Docket ID Number EPA-HQ-OPPT-2013-0739. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564-8930. Such deliveries are only accepted during the DCO's normal hours of operation, and special arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2013-0739. EPA's policy is that all comments received will be included in the docket without change and may be made available at http://www.regulations.gov, 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.
Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.
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:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Manufacturers (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 that is the subject of this rule on or after March 14, 2014 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.
2. Tips for preparing your comments. When submitting comments, remember to:
i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
II. Background
A. 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, 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). 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 or process the chemical substance for that use. Persons who must report are described in § 721.5.
C. 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 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 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.
III. 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 35 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 Rule
EPA is establishing significant new use and recordkeeping requirements for 35 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 (if assigned for non-confidential chemical identities).
• Basis for the TSCA section 5(e) consent order or, for non-section 5(e) SNURs, the basis for the SNUR (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 VIII. for more information).
• 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 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 includes 14 PMN substances that are subject to “risk-based” consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the PMN substances may present unreasonable risk to human health or the environment. Those consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “section 5(e) SNURs” on these PMN substances are promulgated pursuant to § 721.160, and are based on and consistent with the provisions in the underlying consent orders. The section 5(e) SNURs designate as a “significant new use” the absence of the protective measures required in the corresponding consent orders.
This rule also includes SNURs on 21 PMN substances 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-section 5(e) SNURs” are promulgated pursuant to § 721.170. EPA has determined that every activity designated as a “significant new use” in all non-section 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-08-179
Chemical name: 1,2,3-Propanetricarboxamide, N1,N2,N3-tris(2-methylcyclohexyl)-.
CAS number: 160535-46-6.
Basis for action: The PMN states that the generic (non-confidential) use of the substance is as a nucleator for polymers. Based on ecological structure activity relationship (EcoSAR) analysis of test data on analogous amides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 12 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 12 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 water concentrations exceeding 12 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) 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 (Organisation for Economic Co-Operation (OECD) Test Guideline 23) be followed.
CFR citation: 40 CFR 721.10695.
PMN Numbers P-11-483, P-11-487, P-11-527, P-11-528, P-11-529, P-11-530, P-11-532, P-11-533, and P-11-534
Chemical names: Polyfluorinated alkyl thiol (generic) (P-11-483 and P-11-528); Polyfluorinated alkyl polyamide (generic) (P-11-487); Polyfluorinated alkyl halide (generic) (P-11-527); Polyfluorinated alkyl thio acrylamide (generic) (P-11-529); Polyfluorinated alkyl thio polyacrylamide (generic) (P-11-530 and P-11-533); Polyfluorinated alkyl amine (generic) (P-11-532); and Polyfluorinated alkyl thio polyacrylic acid-acrylamide (generic) (P-11-534).
CAS numbers: Not available.
Effective date of TSCA section 5(e) consent order: April 12, 2013.
Basis for TSCA section 5(e) consent order: The PMNs P-11-487, P-11-530, P-11-533, and P-11-534 state that the generic (non-confidential) use of these substances is as surfactants. The PMNs P-11-483, P-11-527, P-11-528, P-11-529, and P-11-532 state that the generic (non-confidential) use of these substances is as chemical intermediates. Based on analogy to other perfluorinated chemicals including perfluorooctanoic acid (PFOA), perfluorooctanesufonate (PFOS), and perfluorohexane sulfonate (PFHS), EPA has concerns that the PMN substances and/or degradation products will persist in the environment, could bioaccumulate or biomagnify, and be toxic (PBT) to people, wild mammals and birds. Some perfluorinated chemicals, PFOA and PFOS, are expected to persist for years in the environment. Biodegradation and photolysis tests of analogous substances to PFOA and PFOS indicate little or no biodegradation or photolysis of perfluoroalkyl compounds. Bioaccumulation concerns are based on concerns raised by the measured presence of certain perfluoroalkyl compounds with longer carbon chain length, including PFOA, PFOS, and PFHS in wildlife and in human blood samples. EPA has human health concerns for irritation to skin, eyes, lungs, mucous membranes, and lung toxicity if inhaled based on surfactant properties of the PMN substances. Toxicity studies on PFOA and PFOS indicate liver toxicity, blood toxicity, male reproductive toxicity, immunosuppression, and oncogenicity. These factors, taken together, raise concerns for potential adverse chronic effects of P-11-483, P-11-487, P-11-527, P-11-528, P-11-529, P-11-530, P-11-532, P-11-533, P-11-534 and/or degradation products. The consent order was issued under TSCA section 5(e)(1)(A) based on a finding that these substances may present an unreasonable risk of injury to human health and the environment, these substances may be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities, and there may be significant (or substantial) human exposure to the substances and their potential degradation products. To protect against these risks, the consent order requires:
1. Risk notification. If as a result of the test data required, the company becomes aware that the PMN substance may present a risk of injury to human health or the environment, the company must incorporate this new information, and any information on methods for protecting against such risk into a Material Safety Data Sheet (MSDS), within 90 days.
2. Manufacture of the PMN substances: (a) According to the chemical composition section of the consent order, including analyzing and reporting certain starting raw material impurities to EPA; and (b) within the maximum established limits of certain fluorinated impurities of the PMN substances as stated in the consent order.
3. Use of the substances only as described in the consent order.
4. No use of the PMN substances in consumer products with spray applications.
5. Submission of certain environmental fate testing prior to exceeding the confidential production volume limit of the aggregate amount of the PMN substances, P-11-487, P-11-530, P-11-533, and P-11-534 specified in the consent order.
6. The individual annual manufacture volume for P-11-487, P-11-530, P-11-533, and P-11-534 must not reach the confidential annual production volume specified in the consent order.
7. Incinerate all waste containing any of the PMN substances from manufacturing and processing in an incinerator with a combustion temperature of a minimum of 1,000 degrees Celsius (C) and a residence time of a minimum of 2 seconds.
8. No use of the substances resulting in releases to surface water.
The SNUR designates as a “significant new use” the absence of these protective measures.
Recommended testing: EPA has determined that the test data from certain human health, environmental fate, and ecotoxicity testing identified in the consent order would help characterize possible effects of the substances and their degradation products. The company has agreed not to exceed the first production limit without performing a metabolism and pharmacokinetics test (OPPTS Test Guideline 870.7485), and a combined repeated dose toxicity with the reproduction/development toxicity screening test (OPPTS Test Guideline 870.3650 modified or OECD Test Guideline 422 modified) on a species to be determined by the results of the pharmacokinetics studies with modifications, for the P-11-483 chemical substance. The PMN submitter has also agreed not to exceed the second production limit without performing the aerobic and anaerobic transformation in soil test (OECD Test Guideline 307) for the P-11-530 chemical substance. The company has agreed not to exceed the third production limit without performing the fish acute toxicity test, freshwater and marine test (OPPTS Test Guideline 850.1075), an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010), and an algal toxicity test (Office of Chemical Safety and Pollution Prevention (OCSPP) Test Guideline 850.4500) for the P-11-483 chemical substance. The company also has agreed to not to exceed the fourth production limit without performing the avian reproduction test (OPPTS Test Guideline 850.2300) for the P-11-483 chemical substance, and hydrolysis as a function of pH and temperature (OPPTS Test Guideline 835.2130), ultraviolet (UV)/visible absorption (OPPTS Test Guideline 830.7050), direct photolysis rate in water by sunlight test (OPPTS Test Guideline 835.2210), if wavelengths greater than 290 nanometers (nm) are absorbed in the previous test, indirect photolysis screening test: Sunlight photolysis in waters containing dissolved humic substances (OPPTS Test Guideline 835.5270), anaerobic biodegradability of organic compounds in digested sludge: By measurement of gas production (OPPTS Test Guideline 835.3420), and modified semi continuous activated sludge (SCAS) test for insoluble and volatile chemicals (OPPTS Guideline 835.5045), or inherent biodegradability: Zahn-Wellens/EVPA Test (OECD Test Guideline 302B), modified with analysis for degradation products for P-11-530 chemical substance. Further testing details are available in the consent order located in the docket under docket EPA-HQ-OPPT-2013-0739. EPA has also determined that the results of certain other human health, ecotoxicity, and environmental fate testing would help characterize the PMN substance. The consent order does not require submission of the pended testing detailed in the consent order at any specified time or production volume. However, the consent order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMNs will remain in effect until the consent order is modified or revoked by EPA based on submission of that or other relevant information.
CFR citations: 40 CFR 721.10696 (P-11-483 and P-11-528); 40 CFR 721.10697 (P-11-487); 40 CFR 721.10698 (P-11-527); 40 CFR 721.10699 (P-11-529); 40 CFR 721.10700 (P-11-530 and P-11-533); 40 CFR 721.10701 (P-11-532); and 40 CFR 721.10702 (P-11-534).
PMN Numbers P-12-416, P-12-417, P-12-418, and P-12-419
Chemical names: Multi-walled carbon nanotubes (generic).
CAS numbers: Not available.
Effective date of TSCA section 5(e) consent order: December 3, 2012.
Basis for TSCA section 5(e) consent order: The PMNs state that the use of the substances will be as: An additive for electro-static discharge (ESD) in semiconductor packaging and electronic devices; additive for weight-reduction in vehicles and windmill blades; additive to reinforce building frames and machine components; additive to improve conductivity in batteries and solar cells; additive in seat-heaters (heat generating element in heating devices and materials); electron emitter for lighting and x-ray sources; additive for heat transfer and thermal emission in electronic devices; additive for electromagnetic interface (EMI) shielding; catalyst support in chemical manufacturing; and filter additive to remove nanoscale materials. Based on test data on analogous respirable, poorly soluble particulates and other carbon nanotubes (CNTs), EPA identified concerns for pulmonary toxicity, fibrosis, carcinogenicity, mutagenicity, and immunotoxicity. Further, available data suggest that pulmonary deposition of some nanoparticles, including CNTs, may induce cardiovascular toxicity if inhaled. Although there are no environmental toxicity studies on CNTs available, EPA expects that some fraction of the CNTs, if released into the environment, will eventually be suspended in water. There have been sublethal effects observed for analogue single wall CNTs in rainbow trout at levels as low as 100 ppb. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that these substances 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 gloves and protective clothing impervious to the substances when there is a potential dermal exposure and a National Institute of Occupational Safety and Health (NIOSH)-certified air-purifying, tight-fitting full-face respirator equipped with N-100, or P-100, or R-100 filters or power air-purifying particulate respirator with an assigned protection factor (APF) of at least 50 when there is potential inhalation exposure.
2. No domestic manufacture.
3. Use of the substances only as described in the consent order.
4. Import of the substances at a cumulative, aggregate volume not to exceed a confidential volume specified in the consent order unless the company has submitted the results of certain health studies.
5. No use of the substances resulting in surface water releases.
The SNUR designates as a “significant new use” the absence of these protective measures.
Recommended testing: EPA has determined that the following tests would help characterize the human health effects of the PMN substances. The PMN submitter has agreed not to exceed the confidential production volume stated in the consent order without performing the 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) on P-12-416 with a post-exposure observation period of up to 3 months; bronchoalveolar lavage fluid (BALF) analysis; aggregation/agglomeration state, shape, particle size distribution and surface properties of material as-manufactured (dry) and as-administered; aggregation/agglomeration state, shape, particle size distribution and surface properties of materials of the delivered materials after administration; determination of cardiovascular toxicity, heart histopathology, and data on pulmonary deposition. In addition, in the consent order, the PMN submitter agreed to provide physical/chemical properties data within a specified time limit.
CFR citation: 40 CFR 721.10703.
PMN Number P-12-548
Chemical name: Aryl-substituted alkane (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: April 30, 2013.
Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a dielectric fluid. EPA has identified health and environmental concerns because the substance may be a persistent, bio-accumulative, and toxic (PBT) chemical, based on physical/chemical properties of the PMN substance, as described in the New Chemical Program's PBT category (64 FR 60194; November 4, 1999) (FRL-6097-7). EPA estimates that the PMN substance will persist in the environment more than two months and estimates a bioaccumulation factor of greater than or equal to 1,000. Also, based on submitted test data on the PMN substance, EPA identified concerns for developmental and liver toxicity to dermally exposed workers. Based on EcoSAR analysis of test data on neutral organic chemicals, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 8 ppb of the PMN substance in surface waters. 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 uncontrolled manufacture, processing, distribution in commerce, use, and disposal of this substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the consent order requires:
1. Use of personal protective equipment including gloves impervious to the substance when there is a potential dermal exposure.
2. Establishment and use of a hazard communication program.
3. Use of the substance only as described in the consent order.
4. Manufacture of the substance at a cumulative volume not to exceed a confidential volume specified in the consent order unless the company has submitted the results of certain health studies.
The SNUR designates as a “significant new use” the absence of these protective measures.
Recommended testing: EPA has determined that the following tests would help characterize the environmental and human health effects of the PMN substance. The consent order contains three confidential production volume limits. The PMN submitter has agreed not to exceed the first production volume limit without performing a 14-day dermal toxicity test (OPPTS Test Guideline 870.3200 or OECD Test Guideline 410). The PMN submitter has also agreed not to exceed the second (higher) production volume limit without performing a bioaccumulation in sediment-dwelling benthic oligochaetes test (OECD Test Guideline 315). The PMN submitter has also agreed not to exceed the third (higher) production volume limit without performing a sediment and soil adsorption/desorption isotherm test (OPPTS Test Guideline 835.1220). The PMN submitter has also agreed to submit to EPA the results of any other testing conducted to comply with REACH (Regulation, Evaluation, Authorization, and Restriction of Chemicals in the European Union) no later than 90 days after submission of the testing to the European Union.
CFR citation: 40 CFR 721.10704.
PMN Number P-12-572
Chemical name: Aromatic amine with cyclo amino carbonyls (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a reactive amine for enhancing pigment dispersions. Based on test data on the PMN substance as well as on analogous aromatic amines, EPA identified human health concerns regarding oncogenicity and mutagenicity from exposure to the PMN substance via inhalation, dermal, and drinking water exposures. Further, based on EcoSAR analysis of test data on analogous anilines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 11 ppb of the PMN substance in surface waters. This concentration is also expected by the Agency to be protective of human health concerns via drinking water exposure. As described in the PMN, occupational exposures are expected to be minimal due to the use of impervious gloves and a NIOSH-certified particulate respirator. Releases of the substance are not expected to result in surface water concentrations that exceed 11 ppb which then effectively limits drinking water exposures. 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 without the use of impervious gloves, where there is a potential for dermal exposure; use of the substance without a NIOSH-certified particulate respirator with an APF of at least 10, where there is a potential for inhalation exposures; use of the substance other than as an intermediate; or use of the substance resulting in surface water concentrations exceeding 11 ppb may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has determined that the results of an algal toxicity test (OCSPP Test Guideline 850.4500), an aquatic invertebrate acute toxicity test (OPPTS Test Guideline 850.1010), a fish acute toxicity test (OPPTS Test Guideline 850.1075), and a combined repeated dose toxicity with the reproduction/developmental toxicity test (OPPTS Test Guideline 870.3650) would help characterize the human health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10705.
PMN Number P-12-576
Chemical name: Infused carbon nanostructures (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) use of the substance is as an additive to provide conductive properties to reinforcements used in composites. Based on available information on analogous carbon structures, EPA identified concerns for lung effects. No significant inhalation exposures are expected when the PMN substance is manufactured according to the process identified in the PMN, to incorporate the PMN substance into pellets. 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 a manufacturing process other than as described in the PMN (the manufacturing process described in the PMN includes incorporation of the PMN substance into pellets), may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the following analysis of the PMN substance would help characterize the effects of the PMN substance: The dimensions, the structure, branching characteristics, presence of the catalyst in the PMN substance, and physical-chemical properties of the carbon nanostructures. These properties should be determined and reported to EPA once a year for three consecutive years.
CFR citation: 40 CFR 721.10706.
PMN Number P-13-127
Chemical name: Substituted benzyl acrylate (generic).
CAS number: Not available.
Basis for action: The PMN states that the use of the substance is as a resin for industrial coatings. Based on test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 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 1 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 releases to surface waters exceeding 1 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i).
Recommended testing: EPA has determined that the results of a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) and a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10707.
PMN Number P-13-152
Chemical name: Zirconium substituted heteropolycyclic (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) use of the substance is a contained use in electronic equipment. Based on EcoSAR analysis of test data on analogous zirconium compounds, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 10 ppb of the PMN substance in surface waters. As described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 10 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 releases to surface water concentrations exceeding 10 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of an algal toxicity test (OCSPP Test Guideline 850.4500), a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), and a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) would help characterize the environmental effects of the PMN substance. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substance and mixtures (OECD Test Guideline 23) be followed.
CFR citation: 40 CFR 721.10708.
PMN Number P-13-168
Chemical name: Alkylphenol (generic).
CAS number: Not available.
Basis for action: The PMN states that the use of the substance is as a reactant for a lubricant additive. Based on EcoSAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 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 1 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 water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400), and an algal toxicity test (OCSPP Test Guideline 850.4500) 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 721.10709.
PMN Number P-13-192
Chemical name: 4,7-Methano-1H-indene, 3a,4,7,7a-tetrahydro-, polymer with 2-methyl-1,3-butadiene and 5-(1-methylethenyl)bicyclo[2.2.1]hept-2-ene.
CAS number: 1412159-51-3.
Basis for action: The PMN states that the substance is used as a rubber additive. Based on EcoSAR analysis of test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 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 1 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 water concentrations exceeding 1 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400), and an algal toxicity test (OCSPP Test Guideline 850.4500) 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 721.10710.
PMN Number P-13-197
Chemical name: Alkyl substituted catechol (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a raw material for organic synthesis. Based on test data on an analog, EPA identified potential human health concerns regarding oncogenicity, skin and eye irritation and corrosion, dermal sensitization, mutagenicity, and developmental toxicity from exposure to the PMN substance via inhalation, dermal, and drinking water exposures. Further, based on EcoSAR analysis of test data on analogous polyphenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 20 ppb of the PMN substance in surface waters. This concentration is also expected by the Agency to be protective of human health concerns via drinking water exposures. As described in the PMN, occupational exposure is expected to be minimal due to the use of impervious gloves and a NIOSH-certified particulate respirator with an APF of 1,000; and releases to surface waters are not expected which then effectively limits drinking water exposures. 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 without the use of impervious gloves, where there is a potential for dermal exposure; use of the substance without a NIOSH-certified particulate respirator with an APF of 1,000, where there is a potential for inhalation exposures; use of the substance other than as an intermediate; or use of the substance resulting in surface water concentrations exceeding 20 ppb may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has determined that the results of an algal toxicity test (OCSPP Test Guideline 850.4500); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075), as well as either the in vitro skin corrosion: transcutaneous electrical resistance test (TER) (OECD Test Guideline 430) or the in vitro skin corrosion: human skin model test (OECD Test Guideline 431) or the in vitro membrane barrier test method for skin corrosion (OECD Test Guideline 435) would help characterize the human health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10711.
PMN Number P-13-217
Chemical name: Antimony tris(dialkyldithiocarbamate) (generic).
CAS number: Not available.
Basis for action: The PMN states that the use of the substance is as an extreme pressure, anti-wear additive for greases and oils. Based on EcoSAR analysis of test data on analogous dithiocarbamates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 4 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 4 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 water concentrations exceeding 4 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) and a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10712.
PMN Number P-13-259
Chemical name: Antimony tris(dialkyldithiocarbamate) (generic).
CAS number: Not available.
Basis for action: The PMN states that the use of the substance is as an extreme pressure, anti-wear additive for greases and oils containing the PMN substance and sulfurized isobutylene. Based on EcoSAR analysis of test data on analogous organic antimony dithiocarbamate, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 4 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 4 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 water concentrations exceeding 4 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a ready biodegradability test (OECD Test Guideline 301), a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), and a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) 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 721.10713.
PMN Number P-13-260
Chemical name: Zinc bis(dialkyldithiocarbamate) (generic).
CAS number: Not available.
Basis for action: The PMN states that the use of the substance is as an extreme pressure, anti-wear additive for greases and oils containing the PMN substance and process oil as well as an extreme pressure, anti-wear additive for greases and oils containing the PMN substance and sulfurized isobutylene. Based on EcoSAR analysis of test data on analogous zinc salts, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 7 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 7 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 water concentrations exceeding 7 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a ready biodegradability test (OECD Test Guideline 301), a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), and a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) 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 721.10714.
PMN Number P-13-346
Chemical name: Carbonic acid, dialkyl ester (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as an encapsulated part in a polymer matrix used as part of a fragrance slurry in consumer fabric care and cleaning products. Based on test data on the PMN substance and EcoSAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early-life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water exceed releases from importing 100,000 kilograms of the PMN substance per year. For the use described in the PMN and at the importation volume described in the PMN, environmental releases did not exceed 1 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed importing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any domestic manufacture of the PMN substance, use of the substance other than as described in the PMN, or importing the PMN substance at volumes greater than 100,000 kilograms per year, could result in exposures which may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10715.
PMN Number P-13-355
Chemical name: Phenol, 2,6-dimethyl-, homopolymer, ether with 2,2′,3,3′,5,5′-hexamethyl[1,1′-biphenyl]-4,4′-diol (2:1),bis[(ethenylphenyl)methyl] ether.
CAS number: 558452-77-0.
Basis for action: The PMN states that the use of the substance is as a polymeric coating. Based on test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 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 2 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 water concentrations exceeding 2 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i).
Recommended testing: EPA has determined that the results of a chironomid sediment toxicity test (OPPTS Test Guideline 850.1790); a whole sediment acute toxicity invertebrates, freshwater or marine (OPPTS Test Guideline 850.1735 or 850.1740); a sediment-water chironomid toxicity using spiked water test (OECD Test Guideline 219); a sediment-water chironomid toxicity test using spiked sediment (OECD Test Guideline 218); a sediment-water lumbriculus toxicity test using spiked sediment (OECD Test Guideline 225); a sediment-water chironomid life-cycle toxicity test using spiked water or spiked sediment (OECD Test Guideline 233); methods for measuring the toxicity and bioaccumulation of sediment-associated contaminants with freshwater invertebrates (EPA 600/R-99/064 March 2000; see http://nepis.epa.gov/Exe/ZyPDF.cgi/Docket=30003SBA.PDF ), and environmental monitoring of the PMN substance 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 721.10716.
PMN Number P-13-365
Chemical name: MDI modified polyalkene glycols (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an adhesive component. Based on test data on analogous diisocyanates, EPA identified concerns for dermal and respiratory sensitization, and lung and mucous membrane irritation effects. For the use described in the PMN, EPA does not expect significant occupational or consumer inhalation exposure due to the use of adequate personal protective equipment and because the substance is not applied using a method that generates a vapor, mist, or aerosol nor is it used in a consumer product. 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 without a NIOSH-certified particulate respirator with an APF of at least 10, where there is a potential for inhalation exposures; any use of the substance in consumer products; or any use of the substance involving an application method that generates a vapor, mist, or aerosol, may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin sensitization test (OPPTS Test Guideline 870.2600) and a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10717.
PMN Number P-13-374
Chemical name: Substituted picolinic acid (generic).
CAS number: Not available.
Basis for action: The PMN states that the specific use of the substance will be as a pesticide intermediate. Based on test data of the PMN substance and close analogs, the Agency identified human health concerns for systemic and developmental toxicities, neurotoxicity, and oncogenicity from dermal, drinking water, and inhalation exposures. Further, based on test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 180 ppb of the PMN substance in surface water. This concentration is also expected by the Agency to be protective of human health concerns via drinking water exposure. For the use described in the PMN, EPA does not expect significant occupational exposures and releases of the PMN substance are not expected to result in surface water concentrations that exceed 180 ppb which then effectively limits drinking water exposures. 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 other than as a pesticide intermediate could result in exposures which may cause serious health or ecological effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(i), and (b)(4)(i).
Recommended testing: EPA has determined that the results of industrial workplace monitoring and environmental release information would help characterize the health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10718.
PMN Number P-13-392
Chemical name: Acrylic acid esters polymers, reaction products with polyisocyanate (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be for wood, plastic, and automotive paint material. Based on test data on analogous diisocyanates, EPA identified concerns for dermal and respiratory sensitization, irritation to all moist tissues, and lung effects if inhaled based on the low molecular weight isocyanates, to workers exposed to the PMN substance. As described in the PMN, worker inhalation exposure is not expected and dermal exposure will be minimal due to the use of adequate personal protective equipment. 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 without a NIOSH-certified respirator with an APF of at least 10, where there is potential inhalation exposure; or any use of the PMN substance in a consumer product, may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin sensitization test (OPPTS Test Guideline 870.2600) and a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10719.
PMN Number P-13-393
Chemical name: 1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,4-dimethyl 1,4-benzenedicarboxylate, 2,2-dimethyl-1,3-propanediol,dodecanedioic acid, 1,2-ethanediol, hexanedioic acid, 1,6-hexanediol, alkyldiol ester and aromatic isocyanate (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an industrial adhesive. Based on test data on analogous diisocyanates, the Agency identified concerns for dermal and respiratory sensitization, irritation to all moist tissues, and lung effects if inhaled based on the low molecular weight isocyanates. For the use described in the PMN, EPA does not expect significant occupational or consumer inhalation exposure due to the use of adequate personal protective equipment and because the substance is not applied using a method that generates a vapor, mist, or aerosol nor is the substance used in a consumer product. 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 without a NIOSH-certified particulate respirator with an APF of at least 10, where there is a potential for inhalation exposures; any use of the substance in consumer products; or any use of the substance involving an application method that generates a vapor, mist, or aerosol, may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin sensitization test (OPPTS Test Guideline 870.2600) and a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10720.
PMN Number P-13-455
Chemical name: Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.′-[(1-methylethylidene)di-4,1-phenylene]bis[.omega.-[[6-(2,5-dihydro-2,5-dioxo-1H-pyrrol-1-yl)-1-oxohexyl]oxy]-.
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a conductive adhesive in the electronics industry. Based on EcoSAR analysis of test data on analogous imides and esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. For the specific use described in the PMN, environmental releases are not expected to result in surface water concentrations that exceed 1 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 PMN substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10721.
PMN Number P-13-468
Chemical name: Oxirane,2-[(1-propen-1-yloxy)methyl]-.
CAS number: 1607-23-4.
Basis for action: The PMN states that the substance will be used as a site-limited chemical intermediate to make a curable monomer. Based on test data on analogous epoxides, EPA identified concerns for skin and lung sensitization, mutagenicity, oncogenicity, developmental toxicity, male reproductive, liver, and kidney toxicity to workers exposed to the PMN substance. As described in the PMN, worker inhalation exposure is not expected and dermal exposure will be minimal due to the use as an intermediate and use of adequate personal protective equipment. 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 without a NIOSH-certified respirator with an APF of at least 10, where there is potential inhalation exposure; the use of the substance without impervious gloves, where there is potential for dermal exposure; or use other than as an intermediate may cause serious health effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a carcinogenicity test (OPPTS Test Guideline 870.4200) and a 90-day oral toxicity in rodents test (OPPTS Test Guideline 870.3100) would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10722.
PMN Number P-13-471
Chemical name: Methylene diisocyanate polymer with polypropylene glycol and diols (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an industrial adhesive. Based on test data on analogous diisocyanates, EPA identified concerns for oncogenicity, mutagenicity, respiratory and dermal sensitization, and lung and mucous membrane irritation to workers exposed to the PMN substance. As described in the PMN, worker inhalation exposure is not expected and dermal exposure will be minimal due to the use as an intermediate and use of adequate personal protective equipment. 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 without a NIOSH-certified particulate respirator with an APF of at least 10, where there is potential inhalation exposure, or the use of the substance in a consumer product, may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin sensitization test (OPPTS Test Guideline 870.2600) and a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10723.
PMN Number P-13-472
Chemical name: Oxirane,[[2-(2-ethenyloxy)ethoxy]methyl]-.
CAS number: 16801-19-7.
Basis for action: The PMN states that the substance will be used as a site-limited intermediate to manufacture a curable monomer. Based on test data on analogous epoxides, EPA identified concerns for skin and lung sensitization, mutagenicity, oncogenicity, developmental toxicity, male reproductive, liver, and kidney toxicity to workers exposed to the PMN substance. In addition, based on analogous vinyl ethers, there were concerns for oncogenicity, reproductive toxicity, and blood toxicity. As described in the PMN, worker inhalation exposure is not expected and dermal exposure will be minimal due to the use as an intermediate and use of adequate personal protective equipment. 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 without a NIOSH-certified respirator with an APF of at least 10, where there is potential inhalation exposure; the use of the substance without impervious gloves, where there is potential for dermal exposure; or use other than as an intermediate may cause serious health effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a carcinogenicity test (OPPTS Test Guideline 870.4200) and a 90-day oral toxicity in rodents test (OPPTS Test Guideline 870.3100) would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10724.
V. Rationale and Objectives of the Rule
A. Rationale
During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for 14 of the 35 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 VI.).
In the other 21 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. Objectives
EPA 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 or process a listed chemical substance for the described significant new use before that activity begins.
• EPA will 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 will be able to regulate prospective manufacturers or processors of a listed chemical substance before the 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.
• EPA will ensure that all manufacturers and processors of the same chemical substance that is subject to a TSCA section 5(e) consent order are subject to similar requirements.
Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.
VI. Direct Final Procedures
EPA 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 April 14, 2014 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before March 14, 2014.
If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before March 14, 2014, EPA will withdraw the relevant sections of this direct final rule before its effective date. EPA will then issue a proposed SNUR for the chemical substance(s) on which adverse or critical comments were received, providing a 30-day period for public comment.
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 the Significant New Use Designation
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. 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 rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) consent orders have been issued for 14 of the 35 chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) consent orders from undertaking activities which would be designated as significant new uses. The identities of 29 of the 35 chemical substances subject to this rule have been claimed as confidential and EPA has received no post-PMN bona fide submissions (per §§ 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 rule are ongoing.
Therefore, EPA designates February 12, 2014 as the cutoff date for determining whether the new use is ongoing. Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of that date would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until the notice review period, including any extensions, expires. If such a person met the conditions of advance compliance under § 721.45(h), the person would be considered exempt from the requirements of the SNUR. Consult the Federal Register document of April 24, 1990 for a more detailed discussion of the cutoff date for ongoing uses.
VIII. 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:
1. Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing covering the chemical substance, persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. In 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-section 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 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.
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 volume 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 or processing.
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.
IX. Procedural Determinations
By 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 40 CFR 721.1725(b)(1).
Under these procedures a manufacturer or processor may request EPA to determine whether a proposed use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in § 721.1725(b)(1) with that under § 721.11 into a single step.
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 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 Submissions
According to § 721.1(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.
XI. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers 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-2013-0739.
XII. Statutory and Executive Order Reviews
A. Executive Order 12866
This 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 Act (PRA)
According to PRA (44 U.S.C. 3501 et seq. ), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register , are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this rule. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and comment.
The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.
Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.
C. Regulatory Flexibility Act (RFA)
On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601 et seq. ), that promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities where the following are true:
1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR.
2. The 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 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:
• A significant number of SNUNs would not be submitted by small entities in response to the SNUR.
• Submission of the SNUN would not cost any small entity significantly more than $8,300.
Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this 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 UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq. ).
E. Executive Order 13132
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. Executive Order 13175
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. Executive Order 13045
This action is not subject to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.
H. Executive Order 13211
This action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action.
J. Executive Order 12898
This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).
XIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).
List of Subjects
Environmental protection, Reporting and recordkeeping requirements.
Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.
Dated: February 3, 2014.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and Toxics.
Therefore, 40 CFR parts 9 and 721 are amended as follows:
PART 9—[AMENDED]
1. The authority citation for part 9 continues to read as follows:
Authority:
7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.
2. In § 14;9.1, add the following sections in numerical order under the undesignated center heading “Significant New Uses of Chemical Substances” to read as follows:
§ 9.1
40 CFR citation
OMB control No.
*****
Significant New Uses of Chemical Substances
*****
721.10695
2070-0012
721.10696
2070-0012
721.10697
2070-0012
721.10698
2070-0012
721.10699
2070-0012
721.10700
2070-0012
721.10701
2070-0012
721.10702
2070-0012
721.10703
2070-0012
721.10704
2070-0012
721.10705
2070-0012
721.10706
2070-0012
721.10707
2070-0012
721.10708
2070-0012
721.10709
2070-0012
721.10710
2070-0012
721.10711
2070-0012
721.10712
2070-0012
721.10713
2070-0012
721.10714
2070-0012
721.10715
2070-0012
721.10716
2070-0012
721.10717
2070-0012
721.10718
2070-0012
721.10719
2070-0012
721.10720
2070-0012
721.10721
2070-0012
721.10722
2070-0012
721.10723
2070-0012
721.10724
2070-0012
*****
PART 721—[AMENDED]
3. The authority citation for part 721 continues to read as follows:
Authority:
15 U.S.C. 2604, 2607, and 2625(c).
4. Add § 721.10695 to subpart E to read as follows:
§ 721.10695
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,2,3-Propanetricarboxamide, N1,N2,N3-tris(2-methylcyclohexyl)- (PMN P-08-179; CAS No. 160535-46-6) 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 § 721.90(a)(4), (b)(4), and (c)(4) (N = 12).
(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 § 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 § 721.185 apply to this section.
5. Add § 721.10696 to subpart E to read as follows:
§ 721.10696
(a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances identified generically as polyfluorinated alkyl thiol (PMNs P-11-483 and P-11-528) 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) Hazard communication program. A significant new use of the substances is any manner or method of manufacture or processing associated with any use of the substances without providing risk notification as follows:
(A) If as a result of the test data required under the TSCA section 5(e) consent order for the substances, the employer becomes aware that the substances may present a risk of injury to human health or the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into a MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If the substance(s) are not being manufactured, processed, or used in the employer's workplace, the employer must add the new information to a MSDS before the substance(s) are reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN substance(s) from the employer, or who have received the PMN substance(s) from the employer within 5 years from the date the employer becomes aware of the new information described in paragraph (a)(2)(i)(A) of this section, are provided an MSDS containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (a significant new use is any use other than as allowed by the section 5(e) consent order which includes analysis and reporting and limitations of maximum impurity levels of certain fluorinated impurities), and (o) (use in a consumer product that could be spray applied).
(iii) Disposal. Requirements as specified in § 721.85(a)(1) and (b)(1) (at a temperature of at least 1,000 degrees C with a minimum residence time of 2 seconds).
(iv) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1), except for releases allowed by the section 5(e) the consent order .
(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 § 721.125(a), (b), (c), (d), (f), (h), (j) and (k) are applicable to manufacturers and processors of these substances.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.
6. Add § 721.10697 to subpart E to read as follows:
§ 721.10697
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyfluorinated alkyl polyamide (PMN P-11-487) 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) Hazard communication program. A significant new use of this substance is any manner or method of manufacture or processing associated with any use of this substance without providing risk notification as follows:
(A) If as a result of the test data required under the TSCA section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health or the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into a MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, processed, or used in the employer's workplace, the employer must add the new information to a MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN substance from the employer, or who have received the PMN substance from the employer within 5 years from the date the employer becomes aware of the new information described in paragraph (a)(2)(i)(A) of this section, are provided an MSDS containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (a significant new use is any use other than as allowed by the section 5(e) consent order which includes analysis and reporting and limitations of maximum impurity levels of certain fluorinated impurities), (o) (use in a consumer product that could be spray applied), (q), and (t).
(iii) Disposal. Requirements as specified in § 721.85(a)(1) and (b)(1) (at a temperature of at least 1,000 degrees C with a minimum residence time of 2 seconds).
(iv) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1), except for releases allowed by the section 5(e) the consent order.
(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 § 721.125(a), (b), (c), (f), (h), (i), (j), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.
7. Add § 721.10698 to subpart E to read as follows:
§ 721.10698
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyfluorinated alkyl halide (PMN P-11-527) 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) Hazard communication program. A significant new use of this substance is any manner or method of manufacture or processing associated with any use of this substance without providing risk notification as follows:
(A) If as a result of the test data required under the TSCA section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health or the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into a MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, processed, or used in the employer's workplace, the employer must add the new information to a MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN substance from the employer, or who have received the PMN substance from the employer within 5 years from the date the employer becomes aware of the new information described in paragraph (a)(2)(i)(A) of this section, are provided an MSDS containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (a significant new use is any use other than as allowed by the section 5(e) consent order which includes analysis and reporting and limitations of maximum impurity levels of certain fluorinated impurities), and (o) (use in a consumer product that could be spray applied).
(iii) Disposal. Requirements as specified in § 721.85(a)(1) and (b)(1) (at a temperature of at least 1,000 degrees C with a minimum residence time of 2 seconds).
(iv) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1), except for releases allowed by the section 5(e) the consent order.
(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 § 721.125(a), (b), (c), (d), (f), (h), (j), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.
8. Add § 721.10699 to subpart E to read as follows:
§ 721.10699
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyfluorinated alkyl thio acrylamide (PMN P-11-529) 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) Hazard communication program. A significant new use of this substance is any manner or method of manufacture or processing associated with any use of this substance without providing risk notification as follows:
(A) If as a result of the test data required under the TSCA section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health or the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into a MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, processed, or used in the employer's workplace, the employer must add the new information to a MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN substance from the employer, or who have received the PMN substance from the employer within 5 years from the date the employer becomes aware of the new information described in paragraph (a)(2)(i)(A) of this section, are provided an MSDS containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (a significant new use is any use other than as allowed by the section 5(e) consent order which includes analysis and reporting and limitations of maximum impurity levels of certain fluorinated impurities), and (o) (use in a consumer product that could be spray applied).
(iii) Disposal. Requirements as specified in § 721.85(a)(1) and (b)(1) (at a temperature of at least 1,000 degrees C with a minimum residence time of 2 seconds).
(iv) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1), except for releases allowed by the section 5(e) the consent order.
(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 § 721.125(a), (b), (c), (d), (f), (h), (j), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.
9. Add § 721.10700 to subpart E to read as follows:
§ 721.10700
(a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances identified generically as polyfluorinated alkyl thio polyacrylamide (PMNs P-11-530 and P-11-533) 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) Hazard communication program. A significant new use of the substances is any manner or method of manufacture, or processing associated with any use of the substances without providing risk notification as follows:
(A) If as a result of the test data required under the TSCA section 5(e) consent order for the substances, the employer becomes aware that the substances may present a risk of injury to human health or the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into a MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If the substance(s) is not being manufactured, processed, or used in the employer's workplace, the employer must add the new information to a MSDS before the substance(s) is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN substance(s) from the employer, or who have received the PMN substance(s) from the employer within 5 years from the date the employer becomes aware of the new information described in paragraph (a)(2)(i)(A) of this section, are provided an MSDS containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (a significant new use is any use other than as allowed by the section 5(e) consent order which includes analysis and reporting and limitations of maximum impurity levels of certain fluorinated impurities), (o) (use in a consumer product that could be spray applied), (q), and (t).
(iii) Disposal. Requirements as specified in § 721.85(a)(1) and (b)(1) (at a temperature of at least 1,000 degrees C with a minimum residence time of 2 seconds).
(iv) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1), except for releases allowed by the section 5(e) the consent order.
(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 § 721.125(a), (b), (c), (d), (f), (h), (j), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to paragraph (a)(2)(ii) of this section.
(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to this section.
10. Add § 721.10701 to subpart E to read as follows:
§ 721.10701
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyfluorinated alkyl amine (PMN P-11-532) 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) Hazard communication program. A significant new use of this substance is any manner or method of manufacture or processing associated with any use of this substance without providing risk notification as follows:
(A) If as a result of the test data required under the TSCA section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health or the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into a MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, processed, or used in the employer's workplace, the employer must add the new information to a MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN substance from the employer, or who have received the PMN substance from the employer within 5 years from the date the employer becomes aware of the new information described in paragraph (a)(2)(i)(A) of this section, are provided an MSDS containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (a significant new use is any use other than as allowed by the section 5(e) consent order which includes analysis and reporting and limitations of maximum impurity levels of certain fluorinated impurities), and (o) (use in a consumer product that could be spray applied).
(iii) Disposal. Requirements as specified in § 721.85(a)(1) and (b)(1) (at a temperature of at least 1,000 degrees C with a minimum residence time of 2 seconds).
(iv) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1), except for releases allowed by the section 5(e) the consent order.
(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 § 721.125(a), (b), (c), (f), (h), (i), (j), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.
11. Add § 721.10702 to subpart E to read as follows:
§ 721.10702
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyfluorinated alkyl thio polyacrylic acid-acrylamide (PMN P-11-534) 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) Hazard communication program. A significant new use of this substance is any manner or method of manufacture, or processing associated with any use of this substance without providing risk notification as follows:
(A) If as a result of the test data required under the TSCA section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health or the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into a MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, processed, or used in the employer's workplace, the employer must add the new information to a MSDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN substance from the employer, or who have received the PMN substance from the employer within 5 years from the date the employer becomes aware of the new information described in paragraph (a)(2)(i)(A) of this section, are provided an MSDS containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (a significant new use is any use other than as allowed by the section 5(e) consent order which includes analysis and reporting and limitations of maximum impurity levels of certain fluorinated impurities), (o) (use in a consumer product that could be spray applied), (q), and (t).
(iii) Disposal. Requirements as specified in § 721.85(a)(1) and (b)(1) (at a temperature of at least 1,000 degrees C with a minimum residence time of 2 seconds).
(iv) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1), except for releases allowed by the section 5(e) the consent order .
(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 § 721.125(a), (b), (c), (f), (h), (i), (j), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.
12. Add § 721.10703 to subpart E to read as follows:
§ 721.10703
(a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances identified generically as multi-walled carbon nanotubes (PMNs P-12-416, P-12-417, P-12-418, and P-12-419) are 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 substances that have been completely reacted (cured); incorporated or embedded into a polymer matrix that itself has been completely reacted (cured); imbedded into a permanent polymer form that is not intended to undergo further processing; or incorporated into an article as defined at 40 CFR 721.3(c).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (National Institute of Occupational Safety and Health (NIOSH)-certified air-purifying, tight-fitting full-face respirator equipped with N-100, or P-100, or R-100 filters or power air-purifying particulate respirator), (a)(6)(i), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (a)(4), 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 § 721.80(f), (k) and (q).
(iii) Release to water. Requirements as specified in § 721.90(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 § 721.125(a), (b), (c), (d), (e), (i), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.
13. Add § 721.10704 to subpart E to read as follows:
§ 721.10704
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as an aryl-substituted alkane (PMN P-12-548) 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) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1.0 percent), and (c).
(ii) Hazard communication program. Requirements as specified in § 721.72(a), (b), (c), (d), (e) (concentration set at 1.0 percent), (f), (g)(1)(iv), (g)(1)(ix), (g)(2)(i), (g)(2)(v), and (g)(3)(ii) and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) and (q). It is a significant new use to conduct testing on the chemical substance to comply with REACH (Regulation, Evaluation, Authorization, and Restriction of Chemicals in the European Union) without submitting all final reports and the underlying data of the testing to EPA no later than 90 days after submission of the testing to the European Union.
(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 § 721.125(a), (b), (c), (d), (e), (f), (g), (h), and (i) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.
14. Add § 721.10705 to subpart E to read as follows:
§ 721.10705
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic amine with cyclo amino carbonyls (PMN P-12-572) 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) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (NIOSH-certified particulate respirator with an APF of at least 10), (a)(6)(i), (a)(6)(ii), (b) (concentration set 0.1 percent), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(4), 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. The following NIOSH-certified respirators with an APF of at least 10 meet the requirements of § 721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or helmet and with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges in combination with high efficiency particulate absorption (HEPA) filters.
(B) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting face piece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air respirator with a full face piece.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(g).
(iii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N = 11).
(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 § 721.125(a), (b), (c), (d), (e), (i), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
15. Add § 721.10706 to subpart E to read as follows:
§ 721.10706
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as infused carbon nanostructures (PMN P-12-576) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80. A significant new use is any manufacturing process other than that described in the premanufacture notice (PMN) which includes the incorporation of the PMN substance into pellets.
(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 § 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
(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.
16. Add § 721.10707 to subpart E to read as follows:
§ 721.10707
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as substituted benzyl acrylate (PMN P-13-127) 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 § 721.90(a)(4), (b)(4), and (c)(4) (N=1).
(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 § 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 § 721.185 apply to this section.
17. Add § 721.10708 to subpart E to read as follows:
§ 721.10708
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as zirconium substituted heteropolycyclic (PMN P-13-152) 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 § 721.90(a)(4), (b)(4), and (c)(4) (N=10).
(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 § 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 § 721.185 apply to this section.
18. Add § 721.10709 to subpart E to read as follows:
§ 721.10709
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylphenol (PMN P-13-168) 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 § 721.90(a)(4), (b)(4), and (c)(4) (N=1).
(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 § 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 § 721.185 apply to this section.
19. Add § 721.10710 to subpart E to read as follows:
§ 721.10710
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 4, 7-methano-1H-indene, 3a, 4, 7, 7a-tetrahydro-, polymer with 2-methyl-1, 3-butadiene and 5-(1-methylethenyl)bicyclo[2.2.1]hept-2-ene (PMN P-13-192; CAS No. 1412159-51-3) 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 § 721.90(a)(4), (b)(4), and (c)(4) (N=1).
(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 § 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 § 721.185 apply to this section.
20. Add § 721.10711 to subpart E to read as follows:
§ 721.10711
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl substituted catechol (PMN P-13-197) 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) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4) (NIOSH-certified particulate respirator with an APF of at least 1,000), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., place policies and procedures) shall be considered and implemented to prevent exposure, where feasible. The following NIOSH-certified respirators with an APF of at least 1,000 meet the requirements of § 721.63(a)(4);
(A) NIOSH-certified continuous flow supplied-air respirator equipped with a full face piece.
(B) NIOSH-certified pressure-demand supplied-air respirator equipped with a full face piece.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(g).
(iii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=20).
(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 § 721.125(a), (b), (c), (d), (e), (i), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
21. Add § 721.10712 to subpart E to read as follows:
§ 721.10712
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as antimony tris(dialkyldithiocarbamate) (PMN P-13-217) 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 § 721.90(a)(4), (b)(4), and (c)(4) (N=4).
(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 § 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 § 721.185 apply to this section.
22. Add § 721.10713 to subpart E to read as follows:
§ 721.10713
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as antimony tris(dialkyldithiocarbamate) (PMN P- 13-259) 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 § 721.90(a)(4), (b)(4), and (c)(4) (N=4).
(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 § 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 § 721.185 apply to this section.
23. Add § 721.10714 to subpart E to read as follows:
§ 721.10714
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as zinc bis(dialkyldithiocarbamate) (PMN P-13-260) 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 § 721.90(a)(4), (b)(4), and (c)(4) (N=7).
(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 § 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 § 721.185 apply to this section.
24. Add § 721.10715 to subpart E to read as follows:
§ 721.10715
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carbonic acid, dialkyl ester (PMN P-13-346) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (j), and (s) (100,000 kilograms).
(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 § 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
25. Add § 721.10716 to subpart E to read as follows:
§ 721.10716
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phenol, 2,6-dimethyl-, homopolymer, ether with 2,2',3,3',5,5'-hexamethyl[1,1'-biphenyl]-4,4'-diol (2:1),bis[(ethenylphenyl)methyl] ether (PMN P-13-355, CAS No. 558452-77-0) 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 § 721.90(a)(4), (b)(4), and (c)(4) (N=2).
(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 § 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 § 721.185 apply to this section.
26. Add § 721.10717 to subpart E to read as follows:
§ 721.10717
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as MDI modified polyalkene glycols (PMN P-13-365) 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) Protection in the workplace. Requirements as specified in § 721.63(a)(4), (a)(6)(ii) and (a)(6)(v), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(4), 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. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or helmet and with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air respirator with a full facepiece.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o) and (y)(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 § 721.125(a), (b), (c), (d), and (i) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
27. Add § 721.10718 to subpart E to read as follows:
§ 721.10718
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted picolinic acid (PMN P-13-374) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80. A significant new use is any use other than as a pesticide intermediate.
(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 § 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
28. Add § 721.10719 to subpart E to read as follows:
§ 721.10719
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as acrylic acid esters polymers, reaction products with polyisocyanate (PMN P-13-392) 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) Protection in the workplace. Requirements as specified in § 721.63(a)(4), (a)(6)(ii), (a)(6)(v), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(4), 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. The following NIOSH-certified respirators with an APF of at least 10 meet the requirements of § 721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or helmet and with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting face piece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air respirator with a full face piece.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o).
(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 § 721.125(a), (b), (c), (d) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
29. Add § 721.10720 to subpart E to read as follows:
§ 721.10720
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,4-dimethyl 1,4-benzenedicarboxylate, 2,2-dimethyl-1,3-propanediol,dodecanedioic acid, 1,2-ethanediol, hexanedioic acid, 1,6-hexanediol, alkyldiol ester and aromatic isocyanate (PMN P-13-393) 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) Protection in the workplace. Requirements as specified in § 721.63(a)(4), (a)(6)(ii) and (a)(6)(v), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(4), 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. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or helmet and with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air respirator with a full facepiece.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o) and (y)(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 § 721.125(a), (b), (c), (d), and (i) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
30. Add § 721.10721 to subpart E to read as follows:
§ 721.10721
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly(oxy-1,2-ethanediyl), .alpha.,.alpha.′-[(1-methylethylidene)di-4,1-phenylene]bis[.omega.-[[6-(2,5-dihydro-2,5-dioxo-1H-pyrrol-1-yl)-1-oxohexyl]oxy]- (PMN P-13-455) 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 § 721.90(a)(4), (b)(4), and (c)(4) (N=1).
(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 § 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 § 721.185 apply to this section.
31. Add § 721.10722 to subpart E to read as follows:
§ 721.10722
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxirane,2-[(1-propen-1-yloxy)methyl]- (PMN P-13-468; CAS No. 1607-23-4) 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) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(ii), (a)(6)(v), (b)(1) (concentration set at 0.1 percent), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (a)(4), 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. The following NIOSH-certified respirators with an APF of at least 10 meet the requirements of § 721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or helmet and with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting face piece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air respirator with a full face piece.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(g).
(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 § 721.125(a) through (e) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
32. Add § 721.10723 to subpart E to read as follows:
§ 721.10723
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as methylene diisocyanate polymer with polypropylene glycol and diols (PMN P-13-471) 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) Protection in the workplace. Requirements as specified in § 721.63(a)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(4), 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. The following NIOSH-certified respirators with an APF of at least 10 meet the requirements of § 721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or helmet and with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting face piece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air respirator with a full face piece.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o).
(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 § 721.125(a), (b), (c), (d), and (i) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
33. Add § 721.10724 to subpart E to read as follows:
§ 721.10724
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxirane, [[2-(2-ethenyloxy)ethoxy]methyl]- (PMN P-13-472; CAS No. 16801-19-7) 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) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(ii), (a)(6)(v), (b)(concentration set at 0.1 percent), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (a)(4), 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. The following NIOSH-certified respirators with an APF of at least 10 meet the requirements of § 721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or helmet and with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting face piece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air respirator with a full face piece.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(g).
(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 § 721.125(a) through (e) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
[FR Doc. 2014-03079 Filed 2-11-14; 8:45 am]
BILLING CODE 6560-50-P