81 FR 31172 - Quaternary Ammonium Compounds, Benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium Salts With Sepiolite; and Quaternary Ammonium Compounds, Benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium Salts With Saponite; Exemptions From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 96 (May 18, 2016)
Federal Register Volume 81, Issue 96 (May 18, 2016)
| Page Range | 31172-31177 | |
| FR Document | 2016-11743 |
[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)] [Rules and Regulations] [Pages 31172-31177] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-11743] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0018, EPA-HQ-OPP-2015-0020; FRL-9945-76] Quaternary Ammonium Compounds, Benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium Salts With Sepiolite; and Quaternary Ammonium Compounds, Benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium Salts With Saponite; Exemptions From the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite (CAS Reg. No. 1574487-61-8) when used as an inert ingredient (suspending or structuring agent) in pesticide formulations applied to growing crops at a concentration not to exceed 2.0% by weight in the formulation, asbestos free and containing less than 1% crystalline silica. This regulation also establishes an exemption from the requirement of a tolerance for residues of quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite (CAS Reg. No. 1588523-05-0) when used as an inert ingredient (suspending or structuring agent) in pesticide formulations applied to growing crops at a concentration not to exceed 1.0% by weight in the formulation. Technology Sciences Group on behalf of BYK Additives Inc. submitted petitions to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite. DATES: This regulation is effective May 18, 2016. Objections and requests for hearings must be received on or before July 18, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The dockets for these actions, identified by docket identification (ID) number EPA-HQ-OPP-2015-0018, EPA-HQ-OPP-2015-0020 are available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. 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:Crop production (NAICS code 111). Animal production (NAICS code 112). Food manufacturing (NAICS code 311). Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. 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.'' C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0018 (CAS Reg. No. 1574487-61-8), EPA- HQ-OPP-2015-0020 (CAS Reg. No. 1588523-05-0) in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before July 18, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0018, EPA-HQ- OPP-2015-0020 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 CBI or other information whose disclosure is restricted by statute. [[Page 31173]] Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 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. II. Petition for Exemption In the Federal Register of April 6, 2015 (80 FR 18327) (FRL-9924- 00), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of pesticide petitions (PP IN-10780) and (PP IN-10781) by Technology Sciences Group on behalf of BYK Additives Inc., 1600 West Hill Street, Louisville, KY 40210. The petitions requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite (CAS Reg. No. 1574487-61-8) when used as an inert ingredient suspending or structuring agent in pesticide formulations applied to growing crops with a limitation of 2.0% in formulation, asbestos free and containing less than 1% crystalline silica; and quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite (CAS Reg. No. 1588523-05-0) when used as an inert ingredient suspending or structuring agent in pesticide formulations applied to growing crops with a limitation of 1.0% in formulation. That document referenced a summary of the petitions prepared by Technology Science Group, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notices of filing. III. Inert Ingredient Definition Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term ``inert'' is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients. IV. Aggregate Risk Assessment and Determination of Safety Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .'' EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite, and quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by both quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite as well as the no-observed-adverse-effect-level (NOAEL) and the lowest- observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit. Based on data in structurally similar quaternary ammonium clay substances, quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite have low acute toxicity via the oral, dermal and inhalation routes in rats. The substances are expected to be a slight skin and eye irritant. A structurally similar quaternary ammonium clay substance did not cause skin sensitization in guinea pigs. Multiple 28-day repeat-dose studies consistently showed high No Observed [[Page 31174]] Adverse Effect Levels (NOAELs), typically the highest dose tested, which was 1,000 milligrams/kilogram/day (mg/kg/day) in rats. There was an absence of test substance-related toxicologically significant effects at any of the doses administered, including for neurological and immunological endpoints. Similarly, there were no effects on reproductive or developmental endpoints and no evidence for genotoxicity in multiple in vitro and in vivo assays (OECD 471, 474 and 476 on multiple quaternary ammonium compounds). Clays treated with quaternary ammonium compounds have low water solubility, a high hydrophobic partition coefficient and relatively high molecular weight. All three factors indicate likely limited absorption following ingestion, dermal exposure or inhalation. Based on similarities to other quaternary ammonium clays (high molecular weights, low water solubility, high hydrophobicity), both benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite would also be almost completely eliminated from the body shortly after oral dosing. Therefore, the biological availability is expected to be low. B. Toxicological Points of Departure/Levels of Concern 1. The available toxicity studies indicate that both quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite have very low overall toxicity. The NOAELs were 1,000 mg/kg/day (limit dose). Since signs of toxicity were not observed at the limit dose an endpoint of concern for risk assessment purposes were not identified. Therefore, since no endpoint of concern was identified for the acute and chronic dietary exposure assessment and short and intermediate dermal and inhalation exposure, quantitative risk assessments for both quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite are not necessary. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to both quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from both quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite in food as follows: Under this exemption from the requirement of a tolerance, residues of quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite may be found on foods from crops that were treated with pesticide formulations containing both quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite. However, quantitative dietary exposure assessments were not conducted since endpoints for risk assessment were not identified. 2. Dietary exposure from drinking water. Since hazard endpoints of concern were not identified for the acute and chronic dietary assessments, quantitative dietary exposure risk assessments for drinking water were not conducted, although exposures may be expected from use on food crops. 3. From non-dietary exposure. The term ``residential exposure'' is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables). Both quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite may be used in pesticide products and non- pesticide products that may be used around the home. Based on the discussion in Unit IV.B., quantitative residential exposure assessments for both quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite was not conducted. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.'' EPA has not found either quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite or with saponite to share a common mechanism of toxicity with any other substances, and both quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that both quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite do not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children As part of its qualitative assessment, the Agency did not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children. Based on the lack of toxicity of ammonium acetate in the available studies and its chemical properties, EPA has concluded that there are no toxicological endpoints of concern for the U.S. population, including infants and children. E. Aggregate Risks and Determination of Safety Taking into consideration all available information both quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite when used as an inert ingredient (suspending or structuring agent) with a limitation of 2.0% in formulation, asbestos free and containing less than 1% crystalline silica and quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite when used as an inert ingredient (suspending or structuring agent) with a limitation of 1.0% in formulation, EPA has determined that there is a reasonable certainty that no harm to any population subgroup will result from aggregate exposure to both [[Page 31175]] quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite under reasonable foreseeable circumstances. Therefore, the establishment of an exemption from tolerance under 40 CFR 180.920 for residues of both quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite when used as an inert ingredient in pesticide formulations applied to growing crops with a limitation of 2.0% in formulation, asbestos free and containing less than 1% crystalline silica and quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite when used as an inert ingredient (suspending or structuring agent) with a limitation of 1.0% in formulation, is safe under FFDCA section 408. 1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, both quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite are not expected to pose an acute risk. 2. Chronic risk. A chronic aggregate risk assessment takes into account subchronic and chronic exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a subchronic or chronic oral exposure were identified and no chronic dietary endpoints were selected. Therefore, quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl) dimethylammonium salts with sepiolite is not expected to pose a chronic risk. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because no short-term adverse effect was identified, both quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite were not expected to pose short-term risks. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because no intermediate-term adverse effect was identified, both quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite were not expected to pose intermediate-term risks. 5. Aggregate cancer risk for U.S. population. As discussed in Unit IV.A., EPA does not expect either quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite or with saponite to pose a cancer risk to humans. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to either quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite or with saponite residues. V. Other Considerations A. Analytical Enforcement Methodology Although EPA is establishing a limitation on the amount of quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite; and quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite that may be used in pesticide formulations, an analytical enforcement methodology is not necessary for this exemption from the requirement of tolerance. The limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will not register any pesticide for sale or distribution for use on growing crops with concentrations of quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite exceeding 2.0% by weight of the formulation, asbestos free and containing less than 1% crystalline silica; and quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite exceeding 1.0% by weight of the formulation. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nation Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite, and quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite. VI. Conclusions Therefore, exemptions from the requirement of a tolerance are established under 40 CFR 180. 920 for quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite (CAS Reg. No. 1574487-61-8) when used as an inert ingredient (suspending or structuring agent) in pesticide formulations applied to growing crops with a limitation of 2.0% in formulation, asbestos free and containing less than 1% crystalline silica; and for quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite (CAS Reg. No. 1588523-05-0) when used as an inert ingredient (suspending or structuring agent) in pesticide formulations applied to growing crops with a limitation of 1.0% in formulation. [[Page 31176]] VII. Statutory and Executive Order Reviews This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. 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). Because this action has been exempted from review under Executive Order 12866, 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) or Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). VIII. 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 in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 10, 2016. G. Jeffery Herndon, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180--[AMENDED] 0 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 0 2. In Sec. 180.920, add alphabetically the inert ingredients ``Quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite'' and ``Quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite'' to the table to read as follows: Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the requirement of a tolerance. * * * * * ---------------------------------------------------------------------------------------------------------------- Inert ingredients Limits Uses ---------------------------------------------------------------------------------------------------------------- * * * * * * * Quaternary ammonium compounds, Not to exceed 1.0% by Suspending or structuring agent. benzylbis(hydrogenated tallow weight of pesticide alkyl)methyl, bis(hydrogenated formulation. tallow alkyl)di-methylammonium salts with saponite (CAS Reg. No. 1588523-05-0). Quaternary ammonium compounds, Not to exceed 2.0% by Suspending or structuring agent. benzylbis(hydrogenated tallow weight of pesticide alkyl)methyl, bis(hydrogenated formulation, tallow alkyl)di-methylammonium asbestos free and salts with sepiolite (CAS Reg. No. containing less than 1574487-61-8). 1% crystalline silica. * * * * * * * ---------------------------------------------------------------------------------------------------------------- [FR Doc. 2016-11743 Filed 5-17-16; 8:45 am] BILLING CODE 6560-50-P
![31172 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Rules and Regulations
In accordance with 33 CFR 117.35(e), Federal Food, Drug, and Cosmetic Act applies to them. Potentially affected
the drawbridge must return to its regular (FFDCA), requesting establishment of an entities may include:
operating schedule immediately at the exemption from the requirement of a • Crop production (NAICS code 111).
end of the effective period of this tolerance. This regulation eliminates the • Animal production (NAICS code
temporary deviation. This deviation need to establish a maximum 112).
from the operating regulations is permissible level for residues of • Food manufacturing (NAICS code
authorized under 33 CFR 117.35. quaternary ammonium compounds, 311).
Dated: May 13, 2016, benzylbis(hydrogenated tallow • Pesticide manufacturing (NAICS
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[FR Doc. 2016–11713 Filed 5–17–16; 8:45 am]
tallow alkyl)methyl, bis(hydrogenated You may access a frequently updated
BILLING CODE 9110–04–P
tallow alkyl)dimethylammonium salts electronic version of 40 CFR part 180
with saponite. through the Government Printing
DATES: This regulation is effective May Office’s e-CFR site at http://
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AGENCY 18, 2016. Objections and requests for
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Benzylbis(hydrogenated tallow ADDRESSES: The dockets for these C. How can I file an objection or hearing
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Sepiolite; and Quaternary Ammonium OPP–2015–0018, EPA–HQ–OPP–2015– U.S.C. 346a, any person may file an
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tallow alkyl)methyl, bis(hydrogenated www.regulations.gov or at the Office of and may also request a hearing on those
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With Saponite; Exemptions From the Docket (OPP Docket) in the or request a hearing on this regulation
Requirement of a Tolerance Environmental Protection Agency in accordance with the instructions
AGENCY: Environmental Protection Docket Center (EPA/DC), West William provided in 40 CFR part 178. To ensure
Agency (EPA). Jefferson Clinton Bldg., Rm. 3334, 1301 proper receipt by EPA, you must
Constitution Ave. NW., Washington, DC identify docket ID number EPA–HQ–
ACTION: Final rule.
20460–0001. The Public Reading Room OPP–2015–0018 (CAS Reg. No.
SUMMARY: This regulation establishes an is open from 8:30 a.m. to 4:30 p.m., 1574487–61–8), EPA–HQ–OPP–2015–
exemption from the requirement of a Monday through Friday, excluding legal 0020 (CAS Reg. No. 1588523–05–0) in
tolerance for residues of quaternary holidays. The telephone number for the the subject line on the first page of your
ammonium compounds, Public Reading Room is (202) 566–1744, submission. All objections and requests
benzylbis(hydrogenated tallow and the telephone number for the OPP for a hearing must be in writing, and
alkyl)methyl, bis(hydrogenated tallow Docket is (703) 305–5805. Please review must be received by the Hearing Clerk
alkyl)dimethylammonium salts with the visitor instructions and additional on or before July 18, 2016. Addresses for
sepiolite (CAS Reg. No. 1574487–61–8) information about the docket available mail and hand delivery of objections
when used as an inert ingredient at http://www.epa.gov/dockets. and hearing requests are provided in 40
(suspending or structuring agent) in FOR FURTHER INFORMATION CONTACT: CFR 178.25(b).
pesticide formulations applied to Susan Lewis, Registration Division In addition to filing an objection or
growing crops at a concentration not to (7505P), Office of Pesticide Programs, hearing request with the Hearing Clerk
exceed 2.0% by weight in the Environmental Protection Agency, 1200 as described in 40 CFR part 178, please
formulation, asbestos free and Pennsylvania Ave. NW., Washington, submit a copy of the filing (excluding
containing less than 1% crystalline DC 20460–0001; main telephone any Confidential Business Information
silica. This regulation also establishes number: (703) 305–7090; email address: (CBI)) for inclusion in the public docket.
an exemption from the requirement of a RDFRNotices@epa.gov. Information not marked confidential
tolerance for residues of quaternary pursuant to 40 CFR part 2 may be
SUPPLEMENTARY INFORMATION:
ammonium compounds, disclosed publicly by EPA without prior
benzylbis(hydrogenated tallow I. General Information notice. Submit the non-CBI copy of your
alkyl)methyl, bis(hydrogenated tallow objection or hearing request, identified
A. Does this action apply to me?
alkyl)dimethylammonium salts with by docket ID number EPA–HQ–OPP–
saponite (CAS Reg. No. 1588523–05–0) You may be potentially affected by 2015–0018, EPA–HQ–OPP–2015–0020
when used as an inert ingredient this action if you are an agricultural by one of the following methods:
sradovich on DSK3TPTVN1PROD with RULES
(suspending or structuring agent) in producer, food manufacturer, or • Federal eRulemaking Portal: http://
pesticide formulations applied to pesticide manufacturer. The following www.regulations.gov. Follow the online
growing crops at a concentration not to list of North American Industrial instructions for submitting comments.
exceed 1.0% by weight in the Classification System (NAICS) codes is Do not submit electronically any
formulation. Technology Sciences not intended to be exhaustive, but rather information you consider to be CBI or
Group on behalf of BYK Additives Inc. provides a guide to help readers other information whose disclosure is
submitted petitions to EPA under the determine whether this document restricted by statute.
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![31176 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Rules and Regulations
VII. Statutory and Executive Order retailers, not States or tribes, nor does General of the United States prior to
Reviews this action alter the relationships or publication of the rule in the Federal
This action establishes a tolerance distribution of power and Register. This action is not a ‘‘major
under FFDCA section 408(d) in responsibilities established by Congress rule’’ as defined by 5 U.S.C. 804(2).
response to a petition submitted to the in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency List of Subjects in 40 CFR Part 180
Agency. The Office of Management and
Budget (OMB) has exempted these types has determined that this action will not Environmental protection,
of actions from review under Executive have a substantial direct effect on States Administrative practice and procedure,
Order 12866, entitled ‘‘Regulatory or tribal governments, on the Agricultural commodities, Pesticides
Planning and Review’’ (58 FR 51735, relationship between the national and pests, Reporting and recordkeeping
October 4, 1993). Because this action government and the States or tribal requirements.
has been exempted from review under governments, or on the distribution of
power and responsibilities among the Dated: May 10, 2016.
Executive Order 12866, this action is
not subject to Executive Order 13211, various levels of government or between G. Jeffery Herndon,
entitled ‘‘Actions Concerning the Federal Government and Indian Acting Director, Registration Division, Office
Regulations That Significantly Affect tribes. Thus, the Agency has determined of Pesticide Programs.
Energy Supply, Distribution, or Use’’ (66 that Executive Order 13132, entitled
FR 28355, May 22, 2001) or Executive ‘‘Federalism’’ (64 FR 43255, August 10, Therefore, 40 CFR chapter I is
Order 13045, entitled ‘‘Protection of 1999) and Executive Order 13175, amended as follows:
Children from Environmental Health entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR PART 180—[AMENDED]
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not 67249, November 9, 2000) do not apply
contain any information collections to this action. In addition, this action ■ 1. The authority citation for part 180
subject to OMB approval under the does not impose any enforceable duty or continues to read as follows:
Paperwork Reduction Act (PRA) (44 contain any unfunded mandate as
Authority: 21 U.S.C. 321(q), 346a and 371.
U.S.C. 3501 et seq.), nor does it require described under Title II of the Unfunded
any special considerations under Mandates Reform Act (UMRA) (2 U.S.C. ■ 2. In § 180.920, add alphabetically the
Executive Order 12898, entitled 1501 et seq.). inert ingredients ‘‘Quaternary
‘‘Federal Actions to Address This action does not involve any ammonium compounds,
Environmental Justice in Minority technical standards that would require benzylbis(hydrogenated tallow
Populations and Low-Income Agency consideration of voluntary alkyl)methyl, bis(hydrogenated tallow
Populations’’ (59 FR 7629, February 16, consensus standards pursuant to section alkyl)dimethylammonium salts with
1994). 12(d) of the National Technology saponite’’ and ‘‘Quaternary ammonium
Since tolerances and exemptions that Transfer and Advancement Act compounds, benzylbis(hydrogenated
are established on the basis of a petition (NTTAA) (15 U.S.C. 272 note). tallow alkyl)methyl, bis(hydrogenated
under FFDCA section 408(d), such as tallow alkyl)dimethylammonium salts
VIII. Congressional Review Act
the tolerance in this final rule, do not with sepiolite’’ to the table to read as
require the issuance of a proposed rule, Pursuant to the Congressional Review follows:
the requirements of the Regulatory Act (5 U.S.C. 801 et seq.), EPA will
Flexibility Act (RFA) (5 U.S.C. 601 et submit a report containing this rule and § 180.920 Inert ingredients used pre-
seq.), do not apply. other required information to the U.S. harvest; exemptions from the requirement
This action directly regulates growers, Senate, the U.S. House of of a tolerance.
food processors, food handlers, and food Representatives, and the Comptroller * * * * *
Inert ingredients Limits Uses
* * * * * * *
Quaternary ammonium compounds, benzylbis(hydrogenated Not to exceed 1.0% by weight of pes- Suspending or structuring agent.
tallow alkyl)methyl, bis(hydrogenated tallow alkyl)di- ticide formulation.
methylammonium salts with saponite (CAS Reg. No.
1588523–05–0).
Quaternary ammonium compounds, benzylbis(hydrogenated Not to exceed 2.0% by weight of pes- Suspending or structuring agent.
tallow alkyl)methyl, bis(hydrogenated tallow alkyl)di- ticide formulation, asbestos free
methylammonium salts with sepiolite (CAS Reg. No. and containing less than 1% crys-
1574487–61–8). talline silica.
* * * * * * *
[FR Doc. 2016–11743 Filed 5–17–16; 8:45 am]
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BILLING CODE 6560–50–P
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![Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Rules and Regulations 31177
ENVIRONMENTAL PROTECTION NW., Washington, DC 20460; telephone • Provide specific examples to
AGENCY number: (202) 564–5218; email address: illustrate your concerns, and suggest
odend’hal.julianne@epa.gov. alternatives.
48 CFR Parts 1503 and 1552 SUPPLEMENTARY INFORMATION: • Explain your views as clearly as
[EPA–HQ–OARM–2015–0662; FRL 9943–61– I. Why is EPA using a direct final rule? possible, avoiding the use of profanity
OARM] or personal threats.
EPA is publishing this rule without a
Environmental Protection Agency prior proposed rule because EPA views • Make sure to submit your
Acquisition Regulation; Improper this as a noncontroversial action and comments by the comment period
Business Practices and Personal anticipates no adverse comment. deadline identified.
Conflicts of Interest, Solicitation EPAAR parts 1503 and 1552 are IV. Background
Provisions and Contract Clauses amended to conform to the format of the
Federal Acquisition Regulation (FAR) EPAAR parts 1503 and 1552 are
AGENCY: Environmental Protection and to correct, clarify and update amended to conform to the format of the
Agency (EPA). information. If EPA receives adverse Federal Acquisition Regulation (FAR)
ACTION: Direct final rule. comment, a timely withdrawal will be and to correct, clarify and update
published in the Federal Register information.
SUMMARY: The Environmental Protection
informing the public that the rule will
Agency (EPA) is issuing a final rule to V. Final Rule
not take effect. Any parties interested in
make administrative changes to the
commenting must do so at this time.
Environmental Protection Agency This direct final rule makes the
Acquisition Regulation (EPAAR). EPA II. Does this action apply to me? following changes: (1) Updates the title
does not anticipate any adverse The EPAAR applies to contractors and clarifies the information in section
comments. who have a contract with the EPA. 1503.101–370 including correcting
DATES: This rule is effective on July 18, statute citations; (2) corrects section
III. What should I consider as I prepare number ‘‘1503.104–5’’ to read
2016 without further action, unless EPA my comments for EPA?
receives adverse comment by June 17, ‘‘1503.104–4’’ and corrects the reference
2016. If EPA receives adverse comment, A. Submitting CBI. Do not submit this to ‘‘FAR 3.104–5’’ to read ‘‘FAR 3.104–
a timely withdrawal will be published information to EPA through http:// 4’’; (3) removes section 1503.408,
in the Federal Register informing the www.regulations.gov or email. Clearly Evaluation of the SF 119, because the
public that the rule will not take effect. mark the part or all of the information form no longer exists; (4) updates the
ADDRESSES: Submit your comments,
that you claim to be CBI. For CBI subpart number and title of ‘‘1503.5’’
identified by Docket ID No. EPA–HQ– information in a disk or CD–ROM that including ‘‘1503.500–70’’, ‘‘1503.500–
OARM–2015–0662, at http:// you mail to EPA, mark the outside of the 71’’ and ‘‘1503.500–72’’ to read
www.regulations.gov. Follow the online disk or CD–ROM as CBI, and then ‘‘1503.10 Contractor Code of Business
instructions for submitting comments. identify electronically within the disk or Ethics and Conduct’’, ‘‘1503.1002
Once submitted, comments cannot be CD–ROM the specific information that Policy’’, ‘‘1503.1003 Requirements’’,
edited or removed from Regulations.gov. is claimed as CBI. In addition to one and ‘‘1503.1004 Contract clause’’ to
The EPA may publish any comment complete version of the comment that conform to the FAR, updates the
received to its public docket. Do not includes information claimed as CBI, a reference to ‘‘EPAAR 1503.500–71(b)’’
submit electronically any information copy of the comment that does not to read ‘‘EPAAR 1503.1003(b)’’; (5)
you consider to be Confidential contain the information claimed as CBI replaces the term ‘‘regular employee’’
Business Information (CBI) or other must be submitted for inclusion in the with ‘‘employee’’ which is defined at 5
information whose disclosure is public docket. Information so marked U.S.C. 2505, and replaces the term
restricted by statute. Multimedia will not be disclosed except in ‘‘special employee’’ with ‘‘special
submissions (audio, video, etc.) must be accordance with procedures set forth in government employee’’ which is
accompanied by a written comment. 40 CFR part 2. defined at 18 U.S.C. 202 in sections
B. Tips for Preparing Your Comments. 1503.600–71, 1503.601, and 1552.203–
The written comment is considered the
When submitting comments, remember 70; and (6) updates the EPA OIG contact
official comment and should include
to: information in section 1552.203–71.
discussion of all points you wish to
• Identify the rulemaking by docket
make. The EPA will generally not
number and other identifying VI. Statutory and Executive Order
consider comments or comment
information (subject heading, Federal Reviews
contents located outside of the primary
Register date and page number).
submission (i.e. on the web, cloud, or • Follow directions—The agency may A. Executive Order 12866: Regulatory
other file sharing system). For ask you to respond to specific questions Planning and Review and Executive
additional submission methods, the full or organize comments by referencing a Order 13563: Improving Regulation and
EPA public comment policy, Code of Federal Regulations (CFR) part Regulatory Review
information about CBI or multimedia or section number.
submissions, and general guidance on This action is not a significant
• Explain why you agree or disagree,
making effective comments, please visit regulatory action and was therefore not
suggest alternatives, and substitute
http://www2.epa.gov/dockets/ submitted to the Office of Management
language for your requested changes.
and Budget (OMB) for review.
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commenting-epa-dockets. • Describe any assumptions and
FOR FURTHER INFORMATION CONTACT: provide any technical information and/ B. Paperwork Reduction Act
Julianne Odend’hal, Policy, Training, or data that you used.
and Oversight Division, Acquisition • If you estimate potential costs or This action does not impose an
Policy and Training Service Center burdens, explain how you arrived at information collection burden under the
(3802R), Environmental Protection your estimate in sufficient detail to PRA because it does not contain any
Agency, 1200 Pennsylvania Avenue allow for it to be reproduced. information collection activities.
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Document Created: 2016-05-18 00:06:06
Document Modified: 2016-05-18 00:06:06
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This regulation is effective May 18, 2016. Objections and requests for hearings must be received on or before July 18, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). | |
| Contact | Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone | |
| FR Citation | 81 FR 31172 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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