ACTION:
Direct final rule.
SUMMARY:
EPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 43 chemical substances which were the subject of premanufacture notices (PMNs). Six 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 43 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 September 8, 2014. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on July 23, 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 August 8, 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 August 8, 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-2014-0166, by one of the following methods:
• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
• Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Kenneth Moss, Chemical Control Division (7405 M), 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 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 a proposed or final SNUR, are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
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 43 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 43 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 the basis for the TSCA non-section 5(e) SNURs (i.e., SNURs without TSCA section 5(e) consent orders).
• Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit 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 and importation volume) and other uses designated in this rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use.
This rule includes 6 PMN substances (P-11-526, P-12-241, P-12-242, P-12-557, P-12-558, and P-13-237) 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 “TSCA 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 TSCA 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 36 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 “TSCA 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 TSCA 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 Numbers P-08-512 and P-08-513
Chemical names: (P-08-512) Alcohol propoxylate (generic) and (P-05-513) Alcohol propoxylate sulfate salt (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that the generic (non-confidential) use of the substances are as a chemical intermediate (P-08-512), and for enhanced oil recovery applications (P- 08-513). Based on structural activity relationship (SAR) analysis of the test data on analogous neutral organics (P-08-512) and anionic surfactants (P-08-513), EPA predicts toxicity to aquatic organisms at concentrations that exceed 1 part per billion (ppb) of P-08-512 and 15 ppb of P-08-513 in surface waters. However, based on test data submitted on analogous chemical substances, EPA expects the actual risk to aquatic organisms in surface waters to be significantly mitigated following biological treatment at publicly owned treatment works or at on-site waste water treatment plants, injection to Class I or II wells, or incineration. As described in the PMN notices, releases are either injected into Class I or II wells, incinerated, or released to surface waters after biological treatment. 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 non-industrial use, or any release during manufacturing, processing, or use other than injection to Class I or II wells, incineration, or release to water following biological treatment and clarification may cause significant adverse environmental effects. Based on this information, the PMN substances meets the concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a Modified Shake-Flask Biodegradation Test (Cripe, C.R., Walker, W.W., Pritchard, P.H., Borquin, A.W. (1987). Shake-Flask Test for Estimation of Biodegradability of Toxic Organic Substances in the Aquatic Environment. Ecotoxicology and Environmental Safety 14:239-251) utilizing an algal toxicity test (Office of Chemical Safety and Pollution Prevention (OCSPP) Test Guideline 850.4500); an aquatic invertebrate toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075) with supplemental analytics to identify degradation products, would help to characterize the environmental effects of the PMN substances. Testing is recommended to be conducted on P-08-513. EPA suggests conducting the modified shake-flask biodegradation test first as the results may impact the ecotoxicity testing recommendations.
CFR citation: 40 CFR 721.10725 (P-08-512) and 40 CFR 721.10726 (P-08-513).
PMN Number P-11-526
Chemical name: Amphoteric fluorinated surfactant (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e) consent order: August 20, 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 surface active agent. Based on test data on the PMN substance and data currently available to the Agency on analogous perfluorooctanoic acid (PFOA), EPA identified concerns for potential incineration or other decomposition products or degradants of the PMN substance. EPA also has concerns that exposures to the PMN substance under certain conditions of use—particularly non-industrial, commercial, or consumer uses—could cause lung effects, based on data on analogous perfluorinated compounds. PFOA is expected to persist for years in the environment. Biodegradation and photolysis tests of analogous substances indicate little or no biodegradation or photolysis of perfluoroalkyl compounds. Bioaccumulation concerns are based on the measured presence of certain perfluoroalkyl compounds, including PFOA, in wildlife and in human blood samples. Toxicity studies on PFOA indicate developmental, reproductive and systemic toxicity in various species, as well as cancer. These factors taken together raise concerns for potential adverse chronic effects in humans and wildlife. The consent order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II) based on a finding that these 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 substance: (a) According to the chemical composition section of the consent order, including analyzing and reporting certain starting material impurities to EPA; and (b) within the maximum established limits of certain fluorinated impurities of the PMN substance as stated in the consent order.
3. Use of the substance only as described in the consent order.
4. Submission of certain testing prior to exceeding the confidential production volume limit of the PMN substance specified in the consent order.
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 Zahn-Wellens biodegradation test (OPPTS Test Guideline 835.5200) with analysis for degradation products as specified, and a hydrolysis test as a function of pH and temperature (OPPTS Test Guideline 835.2130). The PMN submitter has also agreed not to exceed the second production limit without performing a 90-day repeated dose oral toxicity study in rats with 1-generation reproduction parallel study (must include modifications) (OECD Test Guideline 421 modified) and a soil biodegradation study (OECD Test Guideline 307). The company has agreed not to exceed the third production limit without performing an ultraviolet (UV) visible light absorption study (OPPTS Test Guideline 830.7050), a direct photolysis test, if wavelengths greater than 290 nautical miles (nm) are absorbed in the previous test (OPPTS Test Guideline 830.7050) (OPPTS Test Guideline 835.2210), an indirect photolysis screening test (OPPTS Test Guideline 835.5270), an anaerobic biodegradability of organic compounds in digested sludge test (OECD Test Guideline 311), and an avian reproduction test (OPPTS Test Guideline 850.2300) in bobwhite quail. Further testing details are available in the consent order located in the docket under docket EPA-HQ-OPPT-2014-0166. The consent order does not require submission of the additional 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 citation: 40 CFR 721.10727.
PMN Numbers P-12-241 and P-12-242
Chemical names: (P-12-241) 2-Propenoic acid, 2-methyl-, 2-hydroxyethyl esters, telomers with C18-26-alkyl acrylate, 1-dodecanethiol, N-(hydroxymethyl)-2-methyl-2-propenamide, polyfluorooctyl methacrylate, 2,2′-[1,2-diazenediylbis(1-methylethylidene)]bis[4,5-dihydro-1H-imidazole]hydrochloride (1:2)-initiated (generic) and (P-12-242) 2-Propenoic acid, 2-methyl-, C16-18 esters, telomers with 3-chloro-2-hydroxypropyl methacrylate, 1-dodecanethiol, N-(hydroxymethyl)-2-methyl-2-propenamide, polyfluorooctyl methacrylate, and rel- (1R,2R,4R)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate, 2,2′-[1,2-diazenediylbis(1-methylethylidene)]bis[4,5-dihydro-1H-imidazole]hydrochloride (1:2)-initiated (generic).
CAS numbers: Claimed confidential.
Effective date of TSCA section 5(e) consent order: June 5, 2013.
Basis for TSCA section 5(e) consent order: The PMNs state that the generic (non-confidential) use of these substances is as a water and oil repellant. Based on analogy to other perfluorinated chemicals, including PFOA, EPA has concerns for potential fluorinated incineration or other decomposition products of the PMN substances. EPA has concerns that these perfluorinated products may be released to the environment from incomplete incineration of the PMN substances at low temperatures. EPA has preliminary evidence that suggests that, under some conditions, the PMN substances could degrade in the environment. Based on data on analogous chemicals, including PFOA, EPA has concerns that these degradation products will persist in the environment, could bioaccumulate or biomagnify, and could be toxic to people, wild mammals, and birds. PFOA is expected to persist for years in the environment. Biodegradation and photolysis tests of analogous substances indicate little or no biodegradation or photolysis of perfluoroalkyl compounds. Bioaccumulation concerns are based on the measured presence of certain perfluoroalkyl compounds, including PFOA, in wildlife and in human blood samples. Toxicity studies on PFOA indicate developmental, reproductive and systemic toxicity in various species, as well as possible cancer concerns. These factors, taken together, raise concerns for potential adverse chronic effects in humans and wildlife. 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 substances 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. Submission of certain environmental fate and toxicity testing prior to exceeding the confidential production volume limit of the aggregate amount of the PMN substances described in P-12-241 and P-12-242 specified in the consent order.
5. The individual annual manufacture volume for P-12-241 and P-12-242 must not reach the confidential annual production volume specified in the consent order.
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 hydrolysis as a function of pH and temperature test (OPPTS Test Guideline 835.2130), a ready biodegradation test (OPPTS Test Guideline 835.3110), a UV/Visible light spectrum test (OPPTS Test Guideline 830.7050), a direct photolysis test (OPPTS Test Guideline 835.2210) and an indirect photolysis screening test (OPPTS Test Guideline 835.5270). The company has also agreed not to exceed the second production limit without performing a modified semi-continuous activated sludge (SCAS) with analysis of degradation products test (OPPTS Test Guideline 835.5045/), an aerobic/anaerobic transformation in soil test (OECD Test Guideline 307), an anaerobic biodegradability of organic compounds in digested sludge test (OECD Test Guideline 311), a phototransformation of chemicals in soil test, 2002, surfaces—2 soils (draft OECD, a simulation test—aerobic sewage treatment (activated sludge units) (OECD Test Guideline 303A), an aerobic and anaerobic transformation in aquatic sediment systems test (OECD Test Guideline 308), and an acute inhalation toxicity test (OPPTS Test Guideline 870.1300). Further testing details are available in the consent order located in the docket under docket EPA-HQ-OPPT-2014-0166. 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 citation: 40 CFR 721.10728 (P-12-241) and 40 CFR 721.10729 (P-12-242).
PMN Numbers P-12-557 and P-12-558
Chemical names: (P-12-557) Tires, wastes, pyrolyzed, C6-39 oil fraction and (P-12-58) Tires, wastes, pyrolyzed, C7-56 oil fraction.
CAS numbers: (P-12-557) 1410795-89-9 and (P-12-558) 1410795-87-7.
Effective date of TSCA section 5(e) consent order: July 22, 2013.
Basis for TSCA section 5(e) consent order: The PMNs state that the substances will be used as naphtha used for high octane gas and cleaning fluids, kerosene used for jet fuels, distillate fuel oil used for off-highway diesel engines and power generation, and vacuum gas oil used for gasoline. Based on structure-activity relationship analysis of test data on analogous neutral organic chemicals, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 360 ppb (for P-12-557) and 170 ppb (for P-12-558) 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 these substances may present an unreasonable risk of injury to the environment. To protect against these risks, the consent order requires:
1. Establishment and use of a hazard communication program, including human health, environmental hazard precautionary statements on each label and the MSDS.
2. Use of the substances only as described in the consent order.
3. No use of the substances resulting in surface water concentrations exceeding the concentrations of concern identified in the releases to water section of the consent order.
Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity text, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substances. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substances and mixtures (OECD Test Guideline 23) be followed. The order does not require the submission of these tests at any specified time or production volume. However, the order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the order is modified or revoked by EPA based on submission of that or other relevant information.
CFR citation: 40 CFR 721.10730 (P-12-557) and 40 CFR 721.10731 (P-12-558).
PMN Number P-13-60
Chemical name: Neodymium, butadiene iso-Bu neodecanoate complexes.
CAS number: 1386395-00-1.
Basis for action: The PMN states that the use of the substance is as a precursor to polymerization catalyst. Based on SAR analysis of test data on analogous neodymium complexes, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 8 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 exceeding 8 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 8 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 (OPPT Test Guideline 850.1400); a daphnid chronic toxicity test (OPPT Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10732.
PMN Number P-13-237
Chemical name: Tires, wastes, pyrolyzed, C5-15 condensate oil fraction.
CAS number: Claimed confidential.
Chemical substance definition: A complex combination of hydrocarbons obtained from the substance produced by the pyrolysis of rubber-based tires after removal of the carbon black fraction. It consists predominantly of hydrocarbons having carbon numbers in the range of C5 through C15. It boils in the range of approximately 36 °C to 265 °C (97 °F to 509 °F).
Effective date of TSCA section 5(e) consent order: August 8, 2013.
Basis for TSCA section 5(e) consent order: The PMN states that the use of the substance will be as a raw feed stock for refineries. Based on data for benzene which comprises 6% of the PMN substance, EPA identified concerns for oncogenicity, immunotoxicity, and liver and blood toxicity. Based on data for limonene, which constitutes 13% of the PMN substance, EPA identified concerns for dermal sensitization. Based on SAR analysis for neutral organic chemicals the PMN substance may be toxic to aquatic organisms at concentrations as low as 4 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 this substance may present an unreasonable risk of injury to human health or the environment. To protect against this risk, the consent order requires:
1. An 8-hour time-weighted-average (TWA) inhalation exposure limit of 1 part per million (ppm) to the PMN substance.
2. Use of the PMN substance only as a raw feed stock for refineries.
3. No use of the substance resulting in surface water concentrations that exceed 4 ppb.
The SNUR designates as a “significant new use” the absence of these protective measures.
Recommended testing: EPA has determined that the results of inhalation monitoring data, collected according to the EPA draft Inhalation Monitoring Data Collection Guidelines (located in the docket to this rule); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.l010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance. The order does not require submission of these tests at any specified time or production volume. However, the order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substance will remain in effect until the order is modified or revoked by EPA based on submission of that or other relevant information.
CFR citation: 40 CFR 721.10733.
PMN Number P-13-248
Chemical name: Lithium salt of substituted imide (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an electrolyte. Based on test data on the PMN substance, and SAR analysis of test data on analogous lithium salts, the EPA identified concerns for irritation, possible corrosion, acute toxicity, blood and thyroid effects, neurotoxicity, and immunotoxicity from exposure to the PMN substance via inhalation and dermal exposures. As described in the PMN, occupational exposures are expected to be minimal due to the use of a National Institute of Occupational Safety and Health (NIOSH)-certified particulate respirator with an assigned protection factor (APF) of at least 10. Further, general population exposures are not expected as the PMN is not used in consumer products. 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 without a NIOSH-certified particulate respirator with an APF of at least 10, where there is a potential for inhalation exposures; or any use 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)(i) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of inhalation monitoring data, collected according to the EPA draft Inhalation Monitoring Data Collection Guidelines (located in the docket to this rule) would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10734.
PMN Number P-13-270
Chemical name: Aromatic dibenzoate (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-confidential) use of the substance is as a catalyst component. Based on SAR analysis of test data on analogous esters, EPA predicts chronic toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. Based on uses 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 should there be any new use of the substance resulting in releases to surface waters exceeding 1 ppb significant adverse environmental effects could occur. 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 sediment-water chironomid life-cycle toxicity test using spiked water or spiked sediment (OECD TestGuideline 233); a hydrolysis test (OECD Test Guideline 111); and a Zahn-Wellens inherent biodegradation test (OECD Test Guideline 302B) would help characterize the potential for chronic aquatic toxicity 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 to facilitate solubility in the test media, because of the PMN substance's low water solubility.
CFR citation: 40 CFR 721.10735.
PMN Number P-13-309
Chemical name: Alcohols, C9-11-branched, ethoxylated propoxylated.
CAS number: 1400790-00-2.
Basis for action: The PMN states that the use of the substance will be as a component of a pigment dispersant blend for inks and coatings. Based on SAR analysis of test data on analogous nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 170 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 substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 170 ppb for more than 20 days per year. 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 component of a pigment dispersant blend for inks and coatings 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 (OPPT Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); 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 to facilitate solubility in the test media, because of the PMN substance's low water solubility.
CFR citation: 40 CFR 721.10736.
PMN Number P-13-378
Chemical name: Carboxylic anhydride, polymer with -hydro-hydroxypoly(oxy-1,2-diethanediyl), compd. with 2,3,4,6,7,8,9,10-octahydropyrimido-[1,2-a]azepine (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the use of the substance is as a polyurethane catalyst. Based on SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 24 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 24 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 24 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 acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); a fish acute toxicity test mitigated by humic acid (OPPTS Test Guideline 850.1085); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10737.
PMN Number P-13-453
Chemical name: Formaldehyde, polymer with 2,3-dimethylphenol, 2,4-dimethylphenol, 2,5-dimethylphenol, 3,5-dimethylphenol, 3-ethylphenol, 4-ethylphenol, 3-methylphenol, 4-methylphenol and phenol.
CAS number: 1415313-86-8.
Basis for action: The PMN states that the substance will be used as a coating for electronic components. Based on SAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 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 5 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 5 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 fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substances and mixtures (OECD Test Guideline 23) be followed to facilitate solubility in the test media, because of the PMN substance's low water solubility.
CFR citation: 40 CFR 721.10738.
PMN Number P-13-465
Chemical name: Caprolactone homopolymer of substituted benzotriazole (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a UV stabilizer. Based on SAR analysis of test data on analogous benzotriazoles, esters, phenols, and amides, 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 water solubility test (OECD Test Guideline 105); a fish early life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) 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 to facilitate solubility in the test media, due to the low water solubility of the PMN material. EPA suggests conducting the water solubility test first as the results may impact the ecotoxicity testing recommendations.
CFR citation: 40 CFR 721.10739.
PMN Number P-13-473
Chemical name: Tin(2+) salt of alkylcarboxylic acid (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a catalyst. Based on test data on the PMN, as well as SAR analysis of test data on analogous tin compounds, the EPA identified potential human health concerns regarding eye corrosion, dermal sensitization, and asthma, from the PMN substance via dermal exposure. Further, based on SAR analysis of test data on analogous tin salts and anionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 27 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 substance to surface water, exceed releases from the use and production volume described in the PMN. For the use and production volume described in the PMN, environmental releases did not exceed 27 ppb for more than 20 days per year. 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 use of the substance without the use of impervious gloves and goggles, when there is a potential dermal exposure; use of the substance other than as described in the PMN; or any increase in the annual confidential production volume could result in exposures which may cause serious human health and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i), (b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has determined that a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. EPA also recommends filtration should be avoided and that the guidance document on aquatic toxicity testing of difficult substances and mixtures (OECD Test Guideline 23) followed to facilitate solubility in the test media, because of the PMN substance's low water solubility. Repeated dose health tests are not recommended because of the PMN substance's corrosive nature.
CFR citation: 40 CFR 721.10740.
PMN Number P-13-563
Chemical name: Propylene glycol, alpha isocyanate, omega silane (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a chemical intermediate for polyurethane polymers. Based on SAR analysis of analogous diisocyanates, EPA identified concerns for oncogenicity, mutagenicity, respiratory and dermal sensitization and lung and mucous membrane irritation from exposure to the PMN substance via inhalation and dermal exposures. For the use described in the PMN, EPA does not expect significant occupational or consumer exposure. 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 other than as an intermediate; or any use of the substance in consumer products, 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); a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465); and a carcinogenicity test (OPPTS Test Guideline 870.4200) would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10741.
PMN Numbers P-13-617, P-13-618, and P-13-619
Chemical names: (P-13-617) Aromatic dicarboxylic acid polymer with alkanediol, alkyl alkyl-2-alkenoate,1,4-dialkyl aromatic dicarboxylate, alkanedioic acid, alkanediol, .alpha.-hydro-.omega.-hydroxypoly[oxy(alkyl-alkanediyl)], hydroxyalkyl 2-alkyl-2-alkenoate, aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-alkyl-2-alkenoic acid (generic), (P-13-618) Alkanedioic acid, polymer with alkyl 2-alkyl-2-alkenoate, alkanedioic acid, alkanediol, .alpha.-hydro-.omega.-hydroxypoly[oxy(alkyl-1 2-alkanediyl)], hydroxyalkyl 2-alkyl-2-alkenoate, aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-alkyl-2-alkenoic acid (generic); and (P-13-619) Alkanedioic acid, polymer with alkyl alkyl-alkenoate, alkanedioic acid, alkanediol, .alpha.-hydro-.omega.-hydroxypoly[oxy(alkyl-1,2-alkanediyl)], aromatic diisocyanate, alkyl alkyl-alkeneoate and alkyl-alkenoic acid (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMN states that the generic (non-confidential) use of the substances will be as an adhesive. Based on SAR analysis of test data on analogous diisocyanates, EPA identified concerns for respiratory sensitization. For the use described in the PMN, EPA does not expect significant occupational or consumer inhalation exposure as the substances are not applied using a method that generates a vapor, mist, or aerosol, nor are they used in a consumer product. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances without a NIOSH-certified particulate respirator with an APF of at least 10, where there is a potential for inhalation exposures; any use in consumer products; or any use of the substances involving an application method that generates a vapor, mist, or aerosol may cause serious health effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substances.
CFR citation: 40 CFR 721.10742 (P-13-617); 40 CFR 721.10743 (P-03-618) and 40 CFR 721.10744 (P-13-619).
PMN Number P-13-722
Chemical name: Alkoxylated quaternary alkyl ammonium fluoroalkylsulfonimide (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a polymer additive. Based on SAR analysis of test data on analogous cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 9 ppb of the PMN substance in surface waters. For the use described in the PMN, environmental releases are not expected to result in surface water concentrations that exceed 9 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 9 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 acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OPPTS 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 to facilitate solubility in the test media, due to the low water solubility of the PMN material.
CFR citation: 40 CFR 721.10745.
PMN Number P-13-753
Chemical name: Isocyanate terminated urethane polymer (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an adhesive and sealant. Based on SAR analysis of test data on analogous isocyanates, EPA identified concerns for respiratory and dermal sensitization to workers from exposure to the PMN substance. In addition, based on test data submitted under the TSCA section 8(e) program, the Agency identified concern for mutagenicity. For the uses described in the PMN, significant occupational dermal and inhalation exposures are not expected. Further, general population exposures are not expected as the PMN is not used in consumer products. 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 exposure, or any use in consumer products 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 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 721.10746.
PMN Number P-13-773
Chemical name: 4-Pyrimidianamine, 2,5 dimethoxy-.
CAS number: 6960-17-4.
Basis for action: The PMN states that the substance will be used as an herbicide intermediate. Based on test data of the PMN substance, as well as SAR analysis of test data on analogous aromatic amines, EPA identified concerns for mutagenicity, oncogenicity, and developmental toxicity to workers exposed to the PMN substance. Further, based on SAR analysis of test data on analogous anilines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 7 ppb of the PMN substance in surface water. As 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 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 without a NIOSH-certified respirator with an APF of at least 10, where there is potential inhalation exposure; any use without impervious gloves, where there is potential for dermal exposure; or any use other than as an herbicide intermediate may cause serious health and environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(B), (b)(1)(i)(C), (b)(3)(ii), (b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a combined repeated dose toxicity test (OECD Test Guideline 422), with the reproduction/development toxicity screening test; a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465); and an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010) would help characterize the human health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10747.
PMN Numbers P-13-796, P-13-797, P-13-798, P-13-799, and P-13-800
Chemical names: (P-13-796, P-13-797, and P-13-798) Dicarbomonocycle-substituted carbomonocycledicarboxamide (generic); (P-13-799) Dicarboheterocycle-substituted carbomonocycledicarboxamide (generic); and (P-13-800) Tricarbomonocycle-substituted carbomonocycletricarboxamide (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMN states that the generic (non-confidential) use of the substances are as additives for polymer manufacturing. Based on SAR analysis of test data on analogous amides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 4 ppb (for P-13-796 and P-13-797); 14 ppb (for P-13-798);1 ppb (for P-13-799); and 2 ppb (for P-13-800) of the PMN substance in surface waters. For the use described in the PMNs, releases of the substances are not expected to result in surface water concentrations that exceed the respective concentrations for concern. 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 use of the substance resulting in releases to surface waters exceeding the respective concentrations of concern may result in significant adverse environmental effects. Based on this information, the PMN substances 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 fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) 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 to facilitate solubility in the test media, because of the PMN substance's low water solubility. EPA suggests conducting the biodegradation test first as the results may impact the ecotoxicity testing recommendations.
CFR citation: 40 CFR 721.10748 (P-13-796, P-13-797, and P-13-798);40 CFR 721.10749 (P-13-799); and 40 CFR 721.10750 (P-13-800).
PMN Number P-13-810, P-13-811, P-13-812, P-13-813, P-13-814, and P-13-815
Chemical names: Cycloalkylamino oleyl alkylamide acid salts (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that the generic (non-confidential) use of these substances are as inhibitors for oil field applications. Based on SAR analysis of test data on analogous aliphatic amines, EPA predicts chronic toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substances in surface waters. As described in the PMNs, releases of the substances are not expected to result in surface water concentrations exceeding 1 ppb of the aggregate of these PMN substances. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that use of the substances resulting in releases to surface waters exceeding 1 ppb may result in significant adverse environmental effects. Based on this information, the PMN substances meets the concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a water solubility: Column elution method; shake flask method test (OPPTS Test Guideline 830.7840) or a water solubility: Generator column method test (OPPTS Test Guideline 830.7860); a determination of the partition coefficient (n-octanol/water) by shake flask method (OPPTS Test Guideline 830.7550), generator column method (OPPTS Test Guideline 830.7560), or estimation by liquid chromatography (OPPTS Test Guideline 830.7570); and log Koc determination by adsorption-desorption using a batch equilibrium method (OECD Test Guideline 106) in representative salt water conditions would help characterize the environmental effects of the PMN substances. Based on the results of these studies, EPA would recommend either of the following as additional testing:
(A) Fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); a mysid acute toxicity test (OPPTS Test Guideline 850.1350); and an algal toxicity test (OCSPP Test Guideline 850.4500) or;
(B) the whole sediment acute toxicity test, invertebrates, marine (OPPTS Test Guideline 850.1740).
CFR citation: 40 CFR 721.10751.
PMN Numbers P-13-816, P-13-817, P-13-818, P-13-819, P-13-820, and P-13-821
Chemical names: Cycloalkylamino cocoalkyl alkylamide acid salts (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that the generic (non-confidential) use of these substances is as inhibitors for oil field applications. Based on SAR analysis of test data on analogous aliphatic amines, EPA predicts chronic toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substances in surface waters. As described in the PMNs, releases of the substances are not expected to result in surface water concentrations exceeding 1 ppb of the aggregate of these PMN substances. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that use of the substances resulting in releases to surface waters exceeding 1 ppb may result in significant adverse environmental effects. Based on this information, the PMN substances meets the concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a water solubility: Column elution method; shake flask method test (OPPTS Test Guideline 830.7840) or a water solubility: Generator column method test (OPPTS Test Guideline 830.7860); a determination of the partition coefficient (n-octanol/water) by shake flask method (OPPTS Test Guideline 830.7550), generator column method (OPPTS Test Guideline 830.7560), or estimation by liquid chromatography (OPPTS Test Guideline 830.7570); and log Koc determination by adsorption-desorption using a batch equilibrium method (OECD Test Guideline 106) in representative salt water conditions would help characterize the environmental effects of the PMN substances. Based on the results of these studies, EPA would recommend either of the following as additional testing:
(A) Fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); a mysid acute toxicity test (OPPTS Test Guideline 850.1350); and an algal toxicity test (OCSPP Test Guideline 850.4500) or;
(B) the whole sediment acute toxicity test, invertebrates, marine (OPPTS Test Guideline 850.1740).
CFR citation: 40 CFR 721.10752.
PMN Number P-13-839
Chemical name: Methanamine, N,N-dimethyl-, reaction products with alkylamine-epichlorohydrin polymer, chlorides (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an ingredient of pre-coat solution. Based on the test data submitted with this PMN as well as the structural activity relationships analysis for analogous polycationic polymers, 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 to surface waters are not expected. 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)(i) and (ii).
Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a fish acute toxicity mitigated by humic acid (OPPTS Test Guideline 850.1085); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); 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 to facilitate solubility in the test media, because of the PMN substance's low water solubility.
CFR citation: 40 CFR 721.10753.
PMN Number P-13-882
Chemical name: Mixture of alkylated benzene, brominated (generic) and alkylated benzene, dibrominated (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMN states that the use of the substance will be as a feed for a bromine recovery unit. Based on analogous chemical substances that contain bromine and alkylation potential of the PMN substance, EPA identified concerns for neurotoxicity, liver and kidney toxicities, mutagenicity, and oncogenicity, as well as concerns for developmental toxicity and dermal sensitization to workers exposed to the PMN substance. The Agency also identified the potential for human health risk due to the possible formation of dioxins. Further, based on test data on analogous benzyl halides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 ppb of the PMN substance in surface water. For the use described in the PMN, EPA does not expect significant occupational inhalation or dermal exposures; significant general population inhalation or drinking water exposures; or releases of the PMN substance that result in surface water concentrations that exceed 5 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 use other than for use other than as feed for a bromine recovery unit may cause serious health and significant environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(D), (b)(3)(ii) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10754.
PMN Number: P-14-42
Chemical name: Substituted perfluoroether (generic).
CAS Number: Claimed confidential.
Basis for Action: The PMN states that the generic (non-confidential) use of the substance is as a surfactant for laboratory use fluid. Based on SAR analysis of test data on analogous high molecular weight polymers, EPA identified concerns for lung toxicity if respirable droplets of the PMN substance are inhaled. Further, based on analogy to perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), EPA identified concerns for liver toxicity, acute toxicity, developmental and reproductive toxicity, and cancer, for the PMN substance, when the mean moles of each perfluoro propylene (PPO) unit is less than 5. The low molecular weight species have been identified as having the potential to be persistent, bioaccumulative, and toxic (PBT) chemicals. EPA does not have comparable toxicity information on the low molecular weight fraction of the PMN substance and unreacted starting material. EPA has concerns that this PMN substance will persist in the environment. In addition, the perfluoro degradation products could persist, bioaccumulate, and be toxic to people, wild mammals, and birds. EPA's concerns are based on analogy to other perfluoro chemicals, including PFOA and PFOS, which are both currently under review by EPA for PBT concerns. PFOA and PFOS are expected to persist for years in the environment. Biodegradation and photolysis tests of analogous substances indicate little or no biodegradation or photolysis of perfluoroalkyl compounds. Bioaccumulation concerns are based on the measured presence of certain perfluoroalkyl compounds, including PFOA, in wildlife and in human blood samples. In addition, EPA expects the PMN substance and the perfluoro degradation products to be highly persistent, and the low molecular weight fraction is expected to be mobile and bioaccumulate in the environment. No ecotoxicological concerns were raised for the PMN substance itself. However, there is high concern for possible environmental effects to mammals and wild birds from the perfluoro degradation products of the PMN substance. As stated previously, the analog PFOA is persistent in the environment; has a long bioretention time in various species; has been detected in a number of species of wildlife, including marine mammals; and is considered toxic to mammalian and other species. The toxicological properties and presence of PFOA in the environment continue to be investigated. For the use described in the PMN, EPA does not expect occupational, general population, or environmental exposures to the PMN substance. Therefore, EPA has not determined that the proposed manufacture, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as described in the PMN, or any manufacture of the PMN substance where the mean number of moles of each perfluoro propylene oxide unit is less than 5, may result in serious health effects or significant adverse environmental effects. Based on this information, the PMN meets the concern criteria at 721.170(b)(3)(i), (b)(3)(ii), (b)(4)(ii), and (b)(4)(iii).
Recommended Testing: EPA has determined that the results of the following testing on the presumed perfluoro degradation products of the PMN substance would be necessary to evaluate the potential human health effects of the PMN substance: a repeated dose metabolism and pharmacokinetics test (OPPTS Test Guideline 870.7485) in rats and mice; a 1-generation reproduction study (OECD Test Guideline 421), modified; a 90-day oral toxicity test (OPPTS Test Guideline 870.3100) in rats; a combined chronic toxicity/carcinogenicity test (OPPTS Test Guideline 870.4300 or OECD Test Guideline 453) in rats; and an avian reproduction test (OPPTS Test Guideline 850.2300 or OECD Test Guideline 206). EPA recommends that the Company conduct the pharmacokinetics testing first to confirm species acceptability and to provide a reliable half-life for this substance. Further, EPA has determined that the results of the following physical/chemical properties and fate and transport tests on the PMN substance would be necessary to evaluate the environmental fate and transport: A UV visible light absorption test (OPPTS Test Guideline 830.7050); a hydrolysis as a function of pH test (OPPTS Test Guideline 835.2130); a semi-continuous activated sludge (“SCAS”) test (OPPTS Test Guideline 835.5045, OPPTS Test Guideline 835.3210, or OECD Test Guideline 302A) modified for analysis for perfluoro degradation products; an aerobic transformation in soil test (OECD Test Guideline 307); an aerobic and anaerobic transformations test (OECD Test Guideline 308) in aquatic sediment systems; a direct photolysis test (OPPTS Test Guideline 835.2210); an indirect photolysis screening test (OPPTS Test Guideline 835.5270); phototransformation of chemicals on soil surfaces (Draft OECD Test Guideline January 2002) using 2 soils, a simulation test-aerobic sewage treatment (OECD Test Guideline 303A) activated sludge units; and an anaerobic biodegradability test (OECD Test Guideline 311) on organic compounds in digested sludge.
CFR Citation: 40 CFR 721.10764.
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 6 of the 43 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 36 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 September 8, 2014 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before August 8, 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 August 8, 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 6 of the 43 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 39 of the 43 chemical substances subject to this rule have been claimed as confidential and EPA has received no post-PMN bona fide submissions (per 40 CFR 720.25 and § 721.11). Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.
Therefore, EPA designates July 9, 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 TSCA 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. Under recent TSCA section 5(e) consent orders, each PMN submitter is required to submit each study before reaching the specified production limit. 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 § 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-2014-0166.
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).
XIV. 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: June 27, 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 § 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
*****
721.10725
2070-0012
721.10726
2070-0012
721.10727
2070-0012
721.10728
2070-0012
721.10729
2070-0012
721.10730
2070-0012
721.10731
2070-0012
721.10732
2070-0012
721.10733
2070-0012
721.10734
2070-0012
721.10735
2070-0012
721.10736
2070-0012
721.10737
2070-0012
721.10738
2070-0012
721.10739
2070-0012
721.10740
2070-0012
721.10741
2070-0012
721.10742
2070-0012
721.10743
2070-0012
721.10744
2070-0012
721.10745
2070-0012
721.10746
2070-0012
721.10747
2070-0012
721.10748
2070-0012
721.10749
2070-0012
721.10750
2070-0012
721.10751
2070-0012
721.10752
2070-0012
721.10753
2070-0012
721.10754
2070-0012
721.10764
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 § 721.10725 to subpart E to read as follows:
§ 721.10725
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alcohol propoxylate (PMN P-08-512) 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(l)
(ii) Disposal. Requirements as specified in § 721.85(a)(1), (a)(3) (Class I or II wells), (b)(1), (b)(3) (Class I or II wells), (c)(1), and (c)(3) (Class I or II wells).
(iii) Release to water. Requirements as specified in § 721.90(a)(2)(ii), (b)(2)(ii), and (c)(2)(ii).
(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 in § 721.125(a), (b), (c), (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.
5. Add § 721.10726 to subpart E to read as follows:
§ 721.10726
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alcohol propoxylate sulfate salt (PMN P-08-513) 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(l)
(ii) Disposal. Requirements as specified in § 721.85(a)(1), (a)(3) (Class I or II wells), (b)(1), (b)(3) (Class I or II wells), (c)(1), and (c)(3) (Class I or II wells).
(iii) Release to water. Requirements as specified in § 721.90(a)(2)(ii), (b)(2)(ii), and (c)(2)(ii).
(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 in § 721.125(a), (b), (c), (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.
6. Add § 721.10727 to subpart E to read as follows:
§ 721.10727
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as amphoteric fluorinated surfactant (PMN P-11-526) 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 (q).
(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), 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)(ii) of this section.
7. Add § 721.10728 to subpart E to read as follows:
§ 721.10728
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2-propenoic acid, 2-methyl-, 2-hydroxyethyl esters, telomers with C18-26-alkyl acrylate, 1-dodecanethiol, N-(hydroxymethyl)-2-methyl-2-propenamide, polyfluorooctyl methacrylate, 2,2′-[1,2-diazenediylbis(1-methylethylidene)]bis[4,5-dihydro-1H-imidazole]hydrochloride (1:2)-initiated (PMN P-12-241) 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), (q), and (t).
(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), 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)(ii) of this section.
8. Add § 721.10729 to subpart E to read as follows:
§ 721.10729
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2-propenoic acid, 2-methyl-, C16-18 esters, telomers with 3-chloro-2-hydroxypropyl methacrylate, 1-dodecanethiol, N-(hydroxymethyl)-2-methyl-2-propenamide, polyfluorooctyl methacrylate, and rel-(1R,2R,4R)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate, 2,2′-[1,2-diazenediylbis(1-methylethylidene)]bis[4,5-dihydro-1H-imidazole]hydrochloride (1:2)-initiated (PMN P-12-242) 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), (q), and (t).
(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), 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)(ii) of this section.
9. Add § 721.10730 to subpart E to read as follows:
§ 721.10730
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as tires, wastes, pyrolyzed, C6-39 oil fraction (P-12-557; CAS No. 1410795-89-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the chemical substance that has been blended into finished petroleum products or sent to a petroleum refinery for use as a chemical intermediate.
(2) The significant new uses are:
(i) Hazard communication program. Requirements as specified in § 721.72(a), (b), (c), (d), (e) (concentration set at 1.0 percent), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5).
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k).
(iii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=360).
(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), (g), (h), (i), 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)(1) of this section.
10. Add § 721.10731 to subpart E to read as follows:
§ 721.10731
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as tires, wastes, pyrolyzed, C7-56 oil fraction (P-12-558; CAS No. 1410795-87-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the chemical substance that has been blended into finished petroleum products or sent to a petroleum refinery for use as a chemical intermediate.
(2) The significant new uses are:
(i) Hazard communication program. Requirements as specified in § 721.72(a), (b), (c), (d), (e) (concentration set at 1.0 percent), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5).
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k).
(iii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=170).
(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), (g), (h), (i), 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)(1) of this section.
11. Add § 721.10732 to subpart E to read as follows:
§ 721.10732
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as neodymium, butadiene iso-Bu neodecanoate complexes (PMN P-13-60; CAS No. 1386395-00-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Releases to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=8).
(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), (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.
12. Add § 721.10733 to subpart E to read as follows:
§ 721.10733
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as tires, wastes, pyrolyzed, C5-15 condensate oil fraction (PMN P-13-237; chemical substance definition: A complex combination of hydrocarbons obtained from the substance produced by the pyrolysis of rubber-based tires after removal of the carbon black fraction. It consists predominantly of hydrocarbons having carbon numbers in the range of C5 through C15. It boils in the range of approximately 36 °C to 265 °C (97 °F to 509 °F).) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the PMN substances that have been blended into finished petroleum products or sent to a petroleum refinery for use as a chemical intermediate, or stored as described in the Distribution section of the order.
(2) The significant new uses are:
(i) Protection in the workplace. The significant new use is any exposure exceeding an 8 hour time weighted average (TWA) exposure limit of 1 part per million (ppm).
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80. A significant new use is any use other than as a raw feedstock for refineries.
(iii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=4).
(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), (i), (k), and records documenting that exposures do not exceed an 8 hour time weighted average (TWA) exposure limit of 1 part per million 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 significant new use rule.
13. Add § 721.10734 to subpart E to read as follows:
§ 721.10734
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as lithium salt of substituted imide (PMN P-13-248) 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), (b) (concentration set at 1.0 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 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).
(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), 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.
14. Add § 721.10735 to subpart E to read as follows:
§ 721.10735
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic dibenzoate (PMN P-13-270) 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) Releases 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.
15. Add § 721.10736 to subpart E to read as follows:
§ 721.10736
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as alcohols, C9-11-branched, ethoxylated propoxylated (PMN P-13-309; CAS No. 1400790-00-2) 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 component of a pigment dispersant blend for inks and coatings.
(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.
16. Add § 721.10737 to subpart E to read as follows:
§ 721.10737
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carboxylic anhydride, polymer with -hydro—hydroxypoly(oxy-1,2-diethanediyl), compd. with 2,3,4,6,7,8,9,10-octahydropyrimido-[1,2-a]azepine (PMN P-13-378) 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) Releases to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=24).
(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 § 721.10738 to subpart E to read as follows:
§ 721.10738
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as formaldehyde, polymer with 2,3-dimethylphenol, 2,4-dimethylphenol, 2,5-dimethylphenol, 3,5-dimethylphenol, 3-ethylphenol, 4-ethylphenol, 3-methylphenol, 4-methylphenol and phenol (PMN P-13-453; CAS No. 1415313-86-8) 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=5).
(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 § 721.10739 to subpart E to read as follows:
§ 721.10739
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as caprolactone homopolymer of substituted benzotriazole (PMN P-13-465) 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 § 721.10740 to subpart E to read as follows:
§ 721.10740
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as tin(2+) salt of alkylcarboxylic acid (PMN P-13-473) 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(j) and (s).
(ii) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(2)(iii), and (a)(3).
(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) 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)(1) of this section.
20. Add § 721.10741 to subpart E to read as follows:
§ 721.10741
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyalkylene glycol, alpha isocyanate, omega silane (PMN P-13-563) 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 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(g) and (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.
21. Add § 721.10742 to subpart E to read as follows:
§ 721.10742
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic dicarboxylic acid polymer with alkanediol, alkyl alkyl-2-alkenoate,1,4-dialkyl aromatic dicarboxylate, alkanedioic acid, alkanedioic acid. alkanediol, .alpha.-hydro-.omega.-hydroxypoly[oxy(alkyl-alkanediyl)], hydroxyalkyl 2-alkyl-2-alkenoate, aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-alkyl-2-alkenoic acid (PMN P-13-617) 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 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.
22. Add § 721.10743 to subpart E to read as follows:
§ 721.10743
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkanedioic acid, polymer with alkyl 2-alkyl-2-alkenoate, alkanedioic acid, alkanediol, .alpha.-hydro-.omega.-hydroxypoly[oxy(alkyl-1 2-alkanediyl)], hydroxyalkyl 2-alkyl-2-alkenoate, aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-alkyl-2-alkenoic acid (PMN P-13-618) 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 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.
23. Add § 721.10744 to subpart E to read as follows:
§ 721.10744
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkanedioic acid, polymer with alkyl alkyl-alkenoate, alkanedioic acid, alkanediol, .alpha.-hydro-.omega.-hydroxypoly[oxy(alkyl-1,2-alkanediyl)], aromatic diisocyanate, alkyl alkyl-alkeneoate and alkyl-alkenoic acid (PMN P-13-619) 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 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.
24. Add § 721.10745 to subpart E to read as follows:
§ 721.10745
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkoxylated quaternary alkyl ammonium fluoroalkylsulfonimide (PMN P-13-722) 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=9).
(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.
25. Add § 721.10746 to subpart E to read as follows:
§ 721.10746
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as isocyanate terminated urethane polymer (PMN P-13-753) 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 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).
(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.
26. Add § 721.10747 to subpart E to read as follows:
§ 721.10747
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 4-pyrimidianamine, 2,5 dimethoxy- (PMN P-13-773; CAS No. 6960-17-4) 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) (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 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. A significant new use is any use other than as an herbicide intermediate.
(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) 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 § 721.10748 to subpart E to read as follows:
§ 721.10748
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as dicarbomonocycle-substituted carbomonocycledicarboxamide (PMNs P-13-796, P-13-797, and P-13-798) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=4 for P-13-796 and P-13-797; and N=14 for P-13-798).
(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 significant new use rule.
28. Add § 721.10749 to subpart E to read as follows:
§ 721.10749
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as dicarboheterocycle-substituted carbomonocycledicarboxamide (PMN P-13-799) 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 significant new use rule.
29. Add § 721.10750 to subpart E to read as follows:
§ 721.10750
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as tricarbomonocycle-substituted carbomonocycletricarboxamide (PMN P-13-800) 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 significant new use rule.
30. Add § 721.10751 to subpart E to read as follows:
§ 721.10751
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as cycloalkylamino oleyl alkylamide acid salts (PMNs P-13-810, P-13-811, P-13-812, P-13-813, P-13-814, and P-13-815) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=1, for the aggregate of the PMN substances P-13-810, P-13-811, P-13-812, P-13-813, P-13-814, and P-13-815).
(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 § 721.10752 to subpart E to read as follows:
§ 721.10752
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as cycloalkylamino cocoalkyl alkylamide acid salts (PMNs P-13-816, P-13-817, P-13-818, P-13-819, P-13-820, and P-13-821) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=1, for the aggregate of the PMN substances P-13-816, P-13-817, P-13-818, P-13-819, P-13-820, and P-13-821).
(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.
32. Add § 721.10753 to subpart E to read as follows:
§ 721.10753
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as methanamine, N,N-dimethyl-, reaction products with alkylamine-epichlorohydrin polymer, chlorides (PMN P-13-839) 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.
33. Add § 721.10754 to subpart E to read as follows:
§ 721.10754
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixture of alkylated benzene, brominated and alkylated benzene, dibrominated (PMN P-13-882) 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 feed for a bromine recovery unit.
(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.
34. Add § 721.10764 to subpart E to read as follows:
§ 721.10764
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted perfluoroether (PMN P-14-42) 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 of this substance is: (1) Use of the substance for any application other than the confidential use identified in the Premanufacture Notice (PMN) or (2) Manufacture of the PMN substance where the mean number of moles of each perfluoro propylene oxide (“PPO”) unit is less than 5.
(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 § 721.180 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.
[FR Doc. 2014-15774 Filed 7-8-14; 8:45 am]
BILLING CODE 6560-50-P