80 FR 62462 - 2-Propen-1-Aminium, N,N-Dimethyl-N-Propenyl-, Chloride, Homopolymer; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 80, Issue 200 (October 16, 2015)
Federal Register Volume 80, Issue 200 (October 16, 2015)
| Page Range | 62462-62466 | |
| FR Document | 2015-26297 |
[Federal Register Volume 80, Number 200 (Friday, October 16, 2015)] [Rules and Regulations] [Pages 62462-62466] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-26297] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0363; FRL-9933-98] 2-Propen-1-Aminium, N,N-Dimethyl-N-Propenyl-, Chloride, Homopolymer; Exemption 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 [[Page 62463]] tolerance for residues of 2-propen-1-aminium, N,N-dimethyl-N-propenyl-, chloride, homopolymer (PolyDADMAC, CAS No. 26062-79-3) when used as an inert ingredient under 40 CFR 180.940(a) as a dispersing aid in food contact surface sanitizing solutions at less than 0.6% by weight in the final product. Scientific & Regulatory Solutions, L.L.C., on behalf of SNF, Inc. submitted a petition 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 PolyDADMAC. DATES: This regulation is effective October 16, 2015. Objections and requests for hearings must be received on or before December 15, 2015, 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 docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0363, is 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: [email protected]. 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. 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-2015-0363 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 December 15, 2015. 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-2015-0363, 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. 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 July 17, 2015 (80 FR 42462) (FRL-9929- 13), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-10750) by Scientific & Regulatory Solutions, L.L.C., 3450 Old Washington Rd #303, Waldorf, MD 20602 on behalf of SNF, Inc., 1 Chemical Plant Road, Riceboro, GA 31321. The petition requested that 40 CFR 180.940(a) be amended by establishing an exemption from the requirement of a tolerance for residues of PolyDADMAC, (CAS No. 26062-79-3) when used as an inert ingredient as a dispersing aid in pesticide formulations at less than 0.6% by weight. That document referenced a summary of the petition prepared by Scientific & Regulatory Solutions, L.L.C., on behalf of SNF, Inc., the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice 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 exemption is ``safe.'' [[Page 62464]] Section 408(c)(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 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 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 PolyDADMAC including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with PolyDADMAC 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 PolyDADMAC 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. A single dose feeding study with rats classified PolyDADMAC as ``slightly toxic'' at a dose level of 5 milliliter/kilogram (mL/kg) (approx. 2,000 milligram/kilogram (mg/kg)). The results of two skin irritation studies performed with rabbits indicate that PolyDADMAC is not a skin irritant. In two eye irritation studies performed with PolyDADMAC on rabbits, the results indicate that the product was slightly irritating to the eyes and that the effects were totally reversed within 72 hours following exposure. In an eye study performed with PolyDADMAC on cultured fibroblasts, the results indicate that PolyDADMAC is slightly irritating. In a teratology study performed with Sprague-Dawley rats, the administration of 600 milligram/kilogram/day (mg/kg/day) of PolyDADMAC, and to a lesser extent, at the 450 and 150 mg/kg/day test groups, elicited a significant reduction in maternal food consumption during the first half of the dosing period. The NOAEL for PolyDADMAC on embryonic development is 600 mg/kg/day. A multi- generational study performed with PolyDADMAC using Sprague-Dawley rats dosed with 0.375, 12.5, and 125 mg/kg/day (oral gavage) showed no increase in reproductive failure, nor were there any effects upon the fertility index or any other F1 or F2 generation parameters. The inferred NOAEL from the study was 125 mg/kg/day. The two genotoxicity studies performed with PolyDADMAC were negative in both an Ames test and in a mouse micronucleus assay. There are no carcinogenicity studies available for PolyDADMAC. However, no significant systemic toxicity was observed in the teratology, multi-generational and mutagenicity toxicity studies. In the absence of significant systemic toxicity, and lack of mutagenicity concerns, PolyDADMAC is not likely to be carcinogenic. B. Toxicological Points of Departure/Levels of Concern Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL are identified. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population- adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. PolyDADMAC is a large molecular weight chemical which satisfies all of the TSCA Polymer Exemption Rule except for its cationic properties. Generally, high molecular weight polymers are unlikely to be absorbed significantly through any route of exposure. In the case of PolyDADMAC, this is evidenced by: No systemic toxicity up to 600 mg/kg/day in the teratology study, no systemic toxicity in the multi-generational reproduction study up to 125 mg/kg/day, and low acute toxicity. Therefore, no adverse effect level endpoints have been selected for PolyDADMAC, and EPA concludes that it is not necessary to assess quantitative dietary risk or risk from exposure via dermal or inhalation. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to PolyDADMAC, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from PolyDADMAC in food as follows: Acute dietary assessments take into account exposure estimates from dietary consumption of food and drinking water. Chronic dietary assessments take into account dietary food and drinking water as well as food contact surface sanitation uses. In the case of PolyDADMAC, there are no current or proposed crop pesticidal uses; therefore oral exposures from that route (including exposure through drinking water) are not expected. Dietary exposure to PolyDADMAC can occur through its use in food contact sanitizing solutions. However, PolyDADMAC is a large molecular weight chemical which is unlikely to be absorbed significantly through any route of exposure and no endpoints have been [[Page 62465]] selected for it. The Agency has not identified any concerns for carcinogenicity relating to PolyDADMAC; therefore, a cancer dietary exposure assessment was not performed. 2. Dietary exposure from drinking water. PolyDADMAC residues may be found in drinking water. However, since an endpoint of concern was not identified for the dietary assessment (food and drinking water), a quantitative dietary exposure risk assessment was not conducted. 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). While there are no current or proposed residential uses for PolyDADMAC, it is possible that PolyDADMAC may be used as an inert ingredient in pesticide products for which residential exposures may result. However, in the case of PolyDADMAC no applicable endpoints of concern for residential exposures have been identified and a quantitative exposure assessment from residential exposures was not performed. 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 or exemption from 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 PolyDADMAC to share a common mechanism of toxicity with any other substances, and PolyDADMAC does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that PolyDADMAC does 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 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10x) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10x, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. Teratology and multi- generational studies in laboratory animals indicate that PolyDADMAC caused no increase in reproductive failure nor were there any PolyDADMAC related effects upon the fertility index or any other F1 or F2 generation parameters (e.g., litter size, pup weight, fertility and parturition, reproductive indices such as mating index, fecundity index, male or female fertility indices, etc.). Finally, there was no remarkable pathology noted upon necropsy of any of the test animals. Neurotoxicity was not observed in a reproduction/developmental screening study in rats where neurotoxicity parameters were evaluated. 3. Conclusion. Based on an assessment of PolyDADMAC, EPA has concluded that there are no toxicological endpoints of concern for the U.S. population, including infants and children, and has conducted a qualitative assessment. 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. E. Aggregate Risks and Determination of Safety Determination of safety section. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. Based on the lack of any endpoints of concern, 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 PolyDADMAC residues. V. Other Considerations A. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. 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 PolyDADMAC. VI. Conclusions Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.940(a) for PolyDADMAC (CAS No. 26062-79-3) when used as an inert ingredient as a dispersing aid in food contact surface sanitizing solutions at less than 0.6% by weight in the final product. 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 [[Page 62466]] 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: October 7, 2015. Susan Lewis, 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. 180.940(a), add alphabetically the inert ingredient ``2- propen-1-aminium, N,N-dimethyl-N-propenyl-, chloride, homopolymer (CAS No. 26062-79-3)'' to the table to read as follows: Sec. 180.940 Tolerance exemptions for active and inert ingredients for use in antimicrobial formulations (Food-contact surface sanitizing solutions). * * * * * (a) * * * ------------------------------------------------------------------------ Pesticide chemical CAS Reg. No. Limits ------------------------------------------------------------------------ * * * * * * * ------------------------------------------------------------------------ 2-propen-1-aminium, N,N- 26062-79-3 When ready for use, the dimethyl-N-propenyl-, end-use concentration chloride, homopolymer. is not to exceed 0.6%. ------------------------------------------------------------------------ * * * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 2015-26297 Filed 10-15-15; 8:45 am] BILLING CODE 6560-50-P
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comments in a subsequent final action In addition, the SIP is not approved Dated: September 25, 2015.
based on the proposal. If we do not to apply on any Indian reservation land Jared Blumenfeld,
receive timely adverse comments, the or in any other area where the EPA or Regional Administrator, Region IX.
direct final approval will be effective an Indian tribe has demonstrated that a Part 52, Chapter I, Title 40 of the Code
without further notice on December 15, tribe has jurisdiction. In those areas of of Federal Regulations is amended as
2015. Indian country, the rule does not have follows:
tribal implications and will not impose
V. Statutory and Executive Order
Reviews substantial direct costs on tribal PART 52—APPROVAL AND
governments or preempt tribal law as PROMULGATION OF
Under the CAA, the Administrator is specified by Executive Order 13175 (65 IMPLEMENTATION PLANS
required to approve a SIP submission FR 67249, November 9, 2000).
that complies with the provisions of the ■ 1. The authority citation for Part 52
The Congressional Review Act, 5 continues to read as follows:
Act and applicable Federal regulations.
U.S.C. 801 et seq., as added by the Small
42 U.S.C. 7410(k); 40 CFR 52.02(a). Authority: 42 U.S.C. 7401 et seq.
Business Regulatory Enforcement
Thus, in reviewing SIP submissions, the
Fairness Act of 1996, generally provides
EPA’s role is to approve state choices, Subpart D—Arizona
that before a rule may take effect, the
provided that they meet the criteria of
agency promulgating the rule must ■ 2. Section 52.120 is amended by
the Clean Air Act. Accordingly, this
submit a rule report, which includes a adding paragraph (c)(172) to read as
action merely approves state law as
copy of the rule, to each House of the follows:
meeting Federal requirements and does
not impose additional requirements Congress and to the Comptroller General
of the United States. The EPA will § 52.120 Identification of plan.
beyond those imposed by state law. For
submit a report containing this action * * * * *
that reason, this action: (c) * * *
• Is not a significant regulatory action and other required information to the
U.S. Senate, the U.S. House of (172) The following plan was
subject to review by the Office of submitted July 2, 2014, by the
Management and Budget under Representatives, and the Comptroller
General of the United States prior to Governor’s designee.
Executive Orders 12866 (58 FR 51735, (i) [Reserved]
October 4, 1993) and 13563 (76 FR 3821, publication of the rule in the Federal
(ii) Additional materials.
January 21, 2011); Register. A major rule cannot take effect (A) Arizona Department of
• does not impose an information until 60 days after it is published in the Environmental Quality (ADEQ).
collection burden under the provisions Federal Register. This action is not a (1) MAG 2014 Eight-Hour Ozone
of the Paperwork Reduction Act (44 ‘‘major rule’’ as defined by 5 U.S.C. Plan—Submittal of Marginal Area
U.S.C. 3501 et seq.); 804(2). Requirements for the Maricopa
• is certified as not having a Under section 307(b)(1) of the Clean Nonattainment Area (June 2014),
significant economic impact on a Air Act, petitions for judicial review of excluding:
substantial number of small entities this action must be filed in the United (i) Sections titled ‘‘A Nonattainment
under the Regulatory Flexibility Act (5 States Court of Appeals for the Area Preconstruction Permit Program—
U.S.C. 601 et seq.); appropriate circuit by December 15, CAA section 182(a)(2)(C),’’ ‘‘New Source
• does not contain any unfunded 2015. Filing a petition for Review—CAA, Title I, Part D,’’ and
mandate or significantly or uniquely reconsideration by the Administrator of ‘‘Offset Requirements: 1:1 to 1 (Ratio of
affect small governments, as described this final rule does not affect the finality Total Emission Reductions of Volatile
in the Unfunded Mandates Reform Act of this action for the purposes of judicial Organic Compounds to Total Increased
of 1995 (Pub. L. 104–4); review nor does it extend the time Emissions)—CAA Section 182(a)(4)’’ on
• does not have Federalism within which a petition for judicial pages 8 and 9 and section titled ‘‘Meet
implications as specified in Executive review may be filed, and shall not Transportation Conformity
Order 13132 (64 FR 43255, August 10, postpone the effectiveness of such rule Requirements—CAA Section 176(c)’’ on
1999); or action. Parties with objections to this pages 10 and 11.
• is not an economically significant direct final rule are encouraged to file a (ii) Appendices A and B.
regulatory action based on health or comment in response to the parallel [FR Doc. 2015–26023 Filed 10–15–15; 8:45 am]
safety risks subject to Executive Order notice of proposed rulemaking for this BILLING CODE 6560–50–P
13045 (62 FR 19885, April 23, 1997); action published in the Proposed Rules
• is not a significant regulatory action section of today’s Federal Register,
subject to Executive Order 13211 (66 FR rather than file an immediate petition ENVIRONMENTAL PROTECTION
28355, May 22, 2001); for judicial review of this direct final AGENCY
• is not subject to requirements of rule, so that the EPA can withdraw this
direct final rule and address the 40 CFR Part 180
Section 12(d) of the National
Technology Transfer and Advancement comment in the proposed rulemaking. [EPA–HQ–OPP–2015–0363; FRL–9933–98]
Act of 1995 (15 U.S.C. 272 note) because This action may not be challenged later
application of those requirements would in proceedings to enforce its 2-Propen-1-Aminium, N,N-Dimethyl-N-
be inconsistent with the Clean Air Act; requirements (see section 307(b)(2)). Propenyl-, Chloride, Homopolymer;
asabaliauskas on DSK5VPTVN1PROD with RULES
and Exemption From the Requirement of a
List of Subjects in 40 CFR Part 52 Tolerance
• does not provide the EPA with the
discretionary authority to address, as Environmental protection, Air AGENCY: Environmental Protection
appropriate, disproportionate human pollution control, Incorporation by Agency (EPA).
health or environmental effects, using reference, Intergovernmental relations, ACTION: Final rule.
practicable and legally permissible Ozone, Reporting and recordkeeping
methods, under Executive Order 12898 requirements, Volatile organic SUMMARY: This regulation establishes an
(59 FR 7629, February 16, 1994). compounds. exemption from the requirement of a
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subject to OMB approval under the various levels of government or between List of Subjects in 40 CFR Part 180
Paperwork Reduction Act (PRA) (44 the Federal Government and Indian
U.S.C. 3501 et seq.), nor does it require tribes. Thus, the Agency has determined Environmental protection,
any special considerations under that Executive Order 13132, entitled Administrative practice and procedure,
Executive Order 12898, entitled ‘‘Federalism’’ (64 FR 43255, August 10, Agricultural commodities, Pesticides
‘‘Federal Actions to Address 1999) and Executive Order 13175, and pests, Reporting and recordkeeping
Environmental Justice in Minority entitled ‘‘Consultation and Coordination requirements.
Populations and Low-Income with Indian Tribal Governments’’ (65 FR Dated: October 7, 2015.
Populations’’ (59 FR 7629, February 16, 67249, November 9, 2000) do not apply Susan Lewis,
1994). to this action. In addition, this action Director, Registration Division, Office of
Since tolerances and exemptions that does not impose any enforceable duty or Pesticide Programs.
are established on the basis of a petition contain any unfunded mandate as
described under Title II of the Unfunded Therefore, 40 CFR chapter I is
under FFDCA section 408(d), such as amended as follows:
the tolerance in this final rule, do not Mandates Reform Act (UMRA) (2 U.S.C.
require the issuance of a proposed rule, 1501 et seq.).
This action does not involve any PART 180—[AMENDED]
the requirements of the Regulatory
technical standards that would require
Flexibility Act (RFA) (5 U.S.C. 601 et ■ 1. The authority citation for part 180
Agency consideration of voluntary
seq.), do not apply. continues to read as follows:
consensus standards pursuant to section
This action directly regulates growers, 12(d) of the National Technology Authority: 21 U.S.C. 321(q), 346a and 371.
food processors, food handlers, and food Transfer and Advancement Act
retailers, not States or tribes, nor does (NTTAA) (15 U.S.C. 272 note). ■ 2. In § 180.940(a), add alphabetically
this action alter the relationships or the inert ingredient ‘‘2-propen-1-
distribution of power and VIII. Congressional Review Act aminium, N,N-dimethyl-N-propenyl-,
responsibilities established by Congress Pursuant to the Congressional Review chloride, homopolymer (CAS No.
in the preemption provisions of FFDCA Act (5 U.S.C. 801 et seq.), EPA will 26062–79–3)’’ to the table to read as
section 408(n)(4). As such, the Agency submit a report containing this rule and follows:
has determined that this action will not other required information to the U.S.
have a substantial direct effect on States Senate, the U.S. House of § 180.940 Tolerance exemptions for active
or tribal governments, on the Representatives, and the Comptroller and inert ingredients for use in
antimicrobial formulations (Food-contact
relationship between the national General of the United States prior to
surface sanitizing solutions).
government and the States or tribal publication of the rule in the Federal
governments, or on the distribution of Register. This action is not a ‘‘major * * * * *
power and responsibilities among the rule’’ as defined by 5 U.S.C. 804(2). (a) * * *
Pesticide chemical CAS Reg. No. Limits
* * * * * * *
2-propen-1-aminium, N,N-dimethyl-N-propenyl-, chloride, 26062–79–3 When ready for use, the end-use concentration is not to ex-
homopolymer. ceed 0.6%.
* * * * * * *
* * * * * regulations throughout Title 46 of the IV. Discussion of the Rule
[FR Doc. 2015–26297 Filed 10–15–15; 8:45 am] Code of Federal Regulations. This rule V. Regulatory Analyses
BILLING CODE 6560–50–P will have no substantive effect on the A. Regulatory Planning and Review
B. Small Entities
regulated public.
C. Assistance for Small Entities
DATES: This final rule is effective D. Collection of Information
DEPARTMENT OF HOMELAND October 16, 2015. E. Federalism
SECURITY ADDRESSES: Documents mentioned in F. Unfunded Mandates Reform Act
this preamble as being available in the G. Taking of Private Property
Coast Guard docket are part of docket USCG–2015– H. Civil Justice Reform
I. Protection of Children
0867, which is available at http:// J. Indian Tribal Governments
46 CFR Parts 2, 5, 11, 107, 113, 114, regulations.gov.
117, 125, 159, 162, 175, and 180 K. Energy Effects
FOR FURTHER INFORMATION CONTACT: If L. Technical Standards
[Docket No. USCG–2015–0867] you have questions on this final rule, M. Environment
Shipping; Technical, Organizational, call or email Mr. Paul Crissy, Coast I. Abbreviations
asabaliauskas on DSK5VPTVN1PROD with RULES
and Conforming Amendments Guard; telephone 202–372–1093, email
CFR Code of Federal Regulations
Paul.H.Crissy@uscg.mil.
DHS Department of Homeland Security
AGENCY: Coast Guard, DHS. SUPPLEMENTARY INFORMATION: E.O. Executive Order
ACTION: Final rule. FR Federal Register
Table of Contents for Preamble
OMB Office of Management and Budget
SUMMARY: This final rule makes non- I. Abbreviations Pub. L. Public Law
substantive technical, organizational, II. Regulatory History § Section symbol
and conforming amendments to existing III. Basis and Purpose U.S.C. United States Code
VerDate Sep<11>2014 16:45 Oct 15, 2015 Jkt 238001 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 E:\FR\FM\16OCR1.SGM 16OCR1](https://thefederalregister.org/doc/80_FR_62662/page/5.svg)
Document Created: 2015-12-14 15:23:09
Document Modified: 2015-12-14 15:23:09
| 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 October 16, 2015. Objections and requests for hearings must be received on or before December 15, 2015, 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 | 80 FR 62462 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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