[Federal Register Volume 81, Number 199 (Friday, October 14, 2016)] [Rules and Regulations] [Pages 70970-70974] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2016-24932] [[Page 70970]] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0429; FRL-9952-59] Isofetamid; Pesticide Tolerances for Emergency Exemptions AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes time-limited tolerances for residues of the fungicide isofetamid, N-[1,1-dimethyl-2-[2-methyl-4-(1- methylethoxy)phenyl]-2-oxoethyl]-3-methyl-2-thiophenecarboxamide, in or on caneberry subgroup 13-07A and bushberry subgroup 13-07B. This action is in response to EPA's granting of an emergency exemption, under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on caneberry subgroup 13-07A and bushberry subgroup 13-07B. This regulation establishes maximum permissible levels for residues of isofetamid in or on these commodities. The time-limited tolerances expire on December 31, 2019. DATES: This regulation is effective October 14, 2016. Objections and requests for hearings must be received on or before December 13, 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 docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0429, 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: Michael L. Goodis, 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:[emsp14]Crop production (NAICS code 111). [emsp14]Animal production (NAICS code 112). [emsp14]Food manufacturing (NAICS code 311). [emsp14]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 section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 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- 2016-0429 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 13, 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-2016-0429, 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. Background and Statutory Findings EPA, on its own initiative, in accordance with FFDCA sections 408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing time-limited tolerances for the fungicide, isofetamid, N- [1,1-dimethyl-2-[2-methyl-4-(1-methylethoxy)phenyl]-2-oxoethyl]-3- methyl-2-thiophenecarboxamide, in or on caneberry subgroup 13-07A at 4.0 parts per million (ppm) and bushberry subgroup 13-07B at 5.0 ppm. These time-limited tolerances expire on December 31, 2019. Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances to set binding precedents for the application of FFDCA section 408 and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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 [[Page 70971]] 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 . . . .'' Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that ``emergency conditions exist which require such exemption.'' EPA has established regulations governing such emergency exemptions in 40 CFR part 166. III. Emergency Exemption for Isofetamid on Caneberry Subgroup 13-07A and Bushberry Subgroup 13-07B and FFDCA Tolerances The Washington State Department of Agriculture (WSDA) requested an emergency exemption for the use of isofetamid on blackberries, blueberries, and raspberries to control gray mold caused by Botrytis cinerea. Botrytis cinerea has a very wide host range which causes gray mold that becomes visible on developed fruit just prior to harvest. According to WSDA, Botrytis cinerea developed fungicide resistance and coupled with the unseasonably warm weather in Washington State, created conditions favorable for gray mold outbreaks resulting in crop damage and yield loss. After having reviewed the submission, EPA determined that an emergency condition exists for Washington, and that the criteria for approval of an emergency exemption are met. EPA has authorized a specific exemption under FIFRA section 18 for the use of isofetamid on blueberry, blackberry, and raspberry for control of gray mold (Botrytis cinerea) in Washington. As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of isofetamid in or on caneberry subgroup 13-07A and bushberry subgroup 13-07B. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in FFDCA section 408(l)(6). Although these time-limited tolerances expire on December 31, 2019, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on caneberry subgroup 13-07A and bushberry subgroup 13- 07B after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Because these time-limited tolerances are being approved under emergency conditions, EPA has not made any decisions about whether isofetamid meets FIFRA's registration requirements for use on caneberry subgroup 13-07A and bushberry subgroup 13-07B or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of isofetamid by a State for special local needs under FIFRA section 24(c). Nor does this tolerance by itself serve as the authority for persons in any State other than Washington to use this pesticide on the applicable crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for isofetamid, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT. IV. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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 . . . .'' Consistent with the factors specified in FFDCA section 408(b)(2)(D), 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 expected as a result of this emergency exemption request and the time-limited tolerances for isofetamid, N-[1,1-dimethyl-2-[2- methyl-4-(1-methylethoxy)phenyl]-2-oxoethyl]-3-methyl-2- thiophenecarboxamide, on caneberry subgroup 13-07A at 4.0 ppm and bushberry subgroup 13-07B at 5.0 ppm. EPA's assessment of exposures and risks associated with establishing time-limited tolerances follows. A. 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 no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). 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://www2.epa.gov/ pesticide-science-and- [[Page 70972]] assessing-pesticide-risks/assessing-human-health-risk-pesticides. A summary of the toxicological endpoints for isofetamid used for human risk assessment is discussed in Unit III.B of the final rule published in the Federal Register of July 30, 2015 (80 FR 45438) (FRL- 9923-86). B. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to isofetamid, EPA considered exposure under the time-limited tolerances established by this action as well as all existing isofetamid tolerances in 40 CFR 180.681. EPA assessed dietary exposures from isofetamid in food as follows: i. Acute exposure. No acute effects were identified in the toxicological studies for isofetamid; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the DEEM-FCID, Version 3.16 software with 2003-2008 food consumption data from the USDA's National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA evaluated the combined residues of parent isofetamid and its metabolite GPTC (N-[l,l-dimethyl-2-(4-[beta]-D- glucopyranosyloxy-2-methylphenyl)-2-oxoethyl]-3-methyl-2- thiophenecarboxamide). EPA's chronic dietary exposure assessment is based on mean residue levels found in field trials for each of the crops on which isofetamid is used, using empirical and default processing factors as available, and assuming 100 percent crop treated (PCT). iii. Cancer. Based on the data summarized in Unit IV.A., EPA has concluded that isofetamid does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use crop-specific PCT information in the dietary assessment for isofetamid. EPA assumed that for each food commodity on which isofetamid is used, 100% of the commodity has combined residues of parent isofetamid and GPTC equal to the mean field trial residues. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for isofetamid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of isofetamid. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide. Based on the Pesticide Flooded Application Model (PFAM) and the Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of isofetamid for chronic exposures for non-cancer assessments are estimated to be 110 ppb for surface water and 43 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 110 parts per billion (ppb) was used to assess the contribution to drinking water. 3. From non-dietary exposure. The term ``residential exposure'' is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Isofetamid is currently registered for the following uses that could result in residential exposures: Turfgrass including golf courses, residential lawns, and recreational turfgrass. Since there may be residential use sites, residential handler exposure and risk estimates were calculated for all possible residential exposure scenarios. Given that there is no dermal toxicity concern in regard to isofetamid, the residential handler assessment only includes the inhalation route of exposure. Residential handler exposure is expected to be short-term in duration as a maximum of eight applications are allowed per year. Thus, intermediate-term exposures are not likely because of the intermittent nature of applications by homeowners. Unit exposure values and estimates for area treated or amount handled were taken from the Agency's 2012 Standard Operating Procedures for Residential Pesticide Exposure Assessment (Section 3: Lawns/Turf). The algorithms used to estimate exposure and dose for residential handlers can be found in the 2012 Residential SOPs (Section 3: Lawns/Turf). For all residential exposure scenarios, isofetamid risk estimates are not of concern. Short-term inhalation MOEs range from 850,000 to 18,000,000. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at: http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide. 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 isofetamid to share a common mechanism of toxicity with any other substances, and isofetamid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that isofetamid 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides. C. 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 (SF) when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. There is no evidence of developmental toxicity or reproductive susceptibility associated with isofetamid, and there are no residual uncertainties concerning pre- or post-natal toxicity or exposure. 3. Conclusion. EPA has determined that reliable data show that the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X for isofetamid. That decision is based on the following findings: i. The toxicity database for isofetamid is complete. ii. There is no indication that isofetamid is a neurotoxic chemical and [[Page 70973]] there is no need for a developmental neurotoxicity study or additional Uncertainty Factors (UF) to account for neurotoxicity. iii. There is no evidence that isofetamid results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and average (mean) level field trial residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to isofetamid in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by isofetamid. D. Aggregate Risks and Determination of Safety 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. 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, isofetamid is not expected to pose an acute dietary risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to isofetamid from food and water will utilize <1% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in the unit regarding residential use patterns, chronic residential exposure to residues of isofetamid is not expected. 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). Isofetamid is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to isofetamid. Using the exposure assumptions described in this unit for short- term exposures, EPA has concluded the combined short-term food, water, and residential isofetamid exposures result in aggregate MOEs of 24,000 and 3,900 for adults and children (1-2 years old), respectively. Because EPA's level of concern for isofetamid is a MOE of 100 or below, these MOEs are not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term non-dietary, non-occupational exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term adverse effect was identified; however, isofetamid is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for isofetamid. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, isofetamid is not expected 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 isofetamid residues. V. Other Considerations A. Analytical Enforcement Methodology An adequate enforcement methodology (liquid chromatography with tandem mass spectrometry (LC-MS/MS)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected]. 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 Nations 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 any MRLs for isofetamid. VI. Conclusion Therefore, time-limited tolerances are established for residues of isofetamid, isofetamid, in or on caneberry subgroup 13-07A and bushberry subgroup 13-07B at 4.0 and 5.0 ppm. These tolerances expire on December 31, 2019. VII. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA sections 408(e) and 408(l)(6). 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 [[Page 70974]] Populations'' (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established in accordance with FFDCA sections 408(e) and 408(l)(6), such as the tolerances 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: September 30, 2016. Michael Goodis, 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. 180.681, revise paragraph (b) to read as follows: Sec. [emsp14]180.681 Isofetamid; tolerances for residues. * * * * * (b) Section 18 emergency exemptions. Time-limited tolerances specified in the following table are established for residues of the fungicide, isofetamid (N-[1,1-dimethyl-2-[2-methyl-4-(1- methylethoxy)phenyl]-2-oxoethyl]-3-methyl-2-thiophenecarboxamide) in or on the specified agricultural commodities, resulting from use of the pesticide pursuant to FIFRA section 18 emergency exemptions. The tolerances expire on the date specified in the table. ------------------------------------------------------------------------ Parts per Expiration Commodity million date ------------------------------------------------------------------------ Caneberry subgroup 13-07A..................... 4.0 12/31/2019 Bushberry subgroup 13-07B..................... 5.0 12/31/2019 ------------------------------------------------------------------------ * * * * * [FR Doc. 2016-24932 Filed 10-13-16; 8:45 am] BILLING CODE 6560-50-P