Forchlorfenuron; Temporary Pesticide Tolerances, 46279-46283 [2013-18182]

Download as PDF Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (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 of 1995 (NTTAA) (15 U.S.C. 272 note). 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: July 25, 2013. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: * * * * BILLING CODE 6560–50–P 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.659 is amend by: ■ i. Adding alphabetically the following commodities to the table in paragraph (a)(1); ■ ii. Adding alphabetically the following commodities to the table in paragraph (a)(2); and ■ iii. Adding paragraph (a)(4). The additions read as follows: ■ § 180.659 Pyroxasulfone; tolerances for residues. (a) * * * (1) * * * Parts per million Commodity ehiers on DSK2VPTVN1PROD with RULES 0.003 [FR Doc. 2013–18412 Filed 7–30–13; 8:45 am] ■ * * * * Cotton, undelinted seed ............. Wheat, grain ............................... (2) * * * 14:07 Jul 30, 2013 Parts per million * PART 180—[AMENDED] VerDate Mar<15>2010 in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY Cotton, gin byproducts ............. 0.20 INFORMATION). ADDRESSES: The docket for this action, * * * * * identified by docket identification (ID) Wheat, forage ........................... 6.0 number EPA–HQ–OPP–2013–0010, is Wheat, hay ............................... 1.0 Wheat, straw ............................. 0.60 available at https://www.regulations.gov or at the Office of Pesticide Programs * * * * * Regulatory Public Docket (OPP Docket) (4) Tolerances are established for in the Environmental Protection Agency residues of the herbicide pyroxasulfone, Docket Center (EPA/DC), EPA West including its metabolites and Bldg., Rm. 3334, 1301 Constitution Ave. degradates, in or on the commodities in NW., Washington, DC 20460–0001. The the following table. Compliance with Public Reading Room is open from 8:30 the tolerance levels specified in the a.m. to 4:30 p.m., Monday through following table is to be determined by Friday, excluding legal holidays. The measuring only the sum of telephone number for the Public pyroxasulfone [3-[[[5-(difluoromethoxy)- Reading Room is (202) 566–1744, and 1-methyl-3-(trifluoromethyl)-1Hthe telephone number for the OPP pyrazol-4-yl]methyl]sulfonyl]-4,5Docket is (703) 305–5805. Please review dihydro-5,5-dimethylisoxazole] and its the visitor instructions and additional metabolites [5-(difluoromethoxy)-1information about the docket available methyl-3-(trifluoromethyl)-1H-pyrazolat https://www.epa.gov/dockets. 4-yl]methanesulfonic acid (M–1) and 5FOR FURTHER INFORMATION CONTACT: (difluoromethoxy)-1-methyl-3Marcel Howard, Registration Division (trifluoromethyl)-1H-pyrazol-4(7505P), Office of Pesticide Programs, carboxylic acid (M–3), calculated as the Environmental Protection Agency, 1200 stoichiometric equivalent of Pennsylvania Ave. NW., Washington, pyroxasulfone, in or on the commodity. DC 20460–0001; telephone number: (703) 305–6784; email address: Parts per howard.marcel@epa.gov. Commodity million SUPPLEMENTARY INFORMATION: Commodity Milk ............................................. VII. Congressional Review Act Jkt 229001 * 0.04 0.03 46279 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2013–0010; FRL–9391–9] Forchlorfenuron; Temporary Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes temporary tolerances for residues of forchlorfenuron in or on multiple commodities which are identified and discussed later in this document. KIM– C1, LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA) for uses associated with an experimental use permit. The tolerances expire on December 31, 2015. DATES: This regulation is effective July 31, 2013. Objections and requests for hearings must be received on or before September 30, 2013, and must be filed SUMMARY: PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 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 https:// 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 E:\FR\FM\31JYR1.SGM 31JYR1 46280 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations ehiers on DSK2VPTVN1PROD with RULES 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–2013–0010 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 September 30, 2013. 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– 2013–0010, by one of the following methods: • Federal eRulemaking Portal: https:// 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 https:// www.epa.gov/dockets/contacts.htm. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/ dockets. II. Summary of Petitioned-For Tolerances In the Federal Register of February 15, 2013 (78 FR 11126) (FRL–9378–4), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 2F8055) by KIM– C1, LLC, 2547 West Shaw Avenue, Suite 116, Fresno, CA 93711. The petition requested that 40 CFR 180.569 be amended by establishing temporary tolerances for residues of the plant growth regulator forchlorfenuron, (N-(2chloro-4-pyridinyl)-N′-phenylurea), in VerDate Mar<15>2010 14:07 Jul 30, 2013 Jkt 229001 or on almond; cherry, sweet; fig; pear; pistachio; and plum, prune, fresh at 0.01 parts per million (ppm) and almond, hulls at 0.15 ppm. That document referenced a summary of the petition prepared by KIM–C1, LLC, the permittee, which is available to the public in the docket, https:// www.regulations.gov. A comment was received on the notice of filing. EPA’s response to that comment is discussed in Unit IV.C. These tolerances expire on December 31, 2015. III. 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 FFDCA section 408(b)(2)(D), and 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 for forchlorfenuron including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with forchlorfenuron follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its 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. Forchlofenuron is not acutely toxic via the oral, dermal, and inhalation routes. Dose-related effects noted in the PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 dog following subchronic and chronic exposure were generally limited to decreased body weight and body-weight gain. In the rat, the only organ that appeared to be affected was the kidney, which showed suppurative inflammation, suppurative pyelonephritis, non-suppurative interstitial nephritis, and cortical cysts following chronic exposure. Developmental toxicity (decreased fetal body weight and increased pup mortality) was observed in the rat only at a maternally-toxic dose. The developmental toxicity studies in rats and rabbits, as well as the reproductive toxicity study in rats, did not demonstrate any increased pre- or postnatal sensitivity. There was no evidence of neurotoxicity in any of the submitted studies. Forchlorfenuron is classified as not likely to be a human carcinogen and there is no concern for mutagenicity. There was no evidence of endocrine disruption in the forchlorfenuron database. Specific information on the studies received and the nature of the toxic effects caused by forchlorfenuron as well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found at https:// www.regulations.gov in the document titled Forchlorfenuron: Human Health Risk Assessment for Proposed Uses on the Bushberry Subgroup 13B and to Support a Requested Experimental Use Permit on Almonds, Sweet Cherries, Figs, Pears, Pistachios, and Plums/ Prunes in docket ID number EPA–HQ– OPP–2007–1065. 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 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 E:\FR\FM\31JYR1.SGM 31JYR1 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations 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 https:// www.epa.gov/pesticides/factsheets/ riskassess.htm. A summary of the toxicological endpoints for forchlorfenuron used for human risk assessment is discussed in Unit II. of the final rule published in the Federal Register of August 15, 2008 (73 FR 47843) (FRL–8375–4). ehiers on DSK2VPTVN1PROD with RULES C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to forchlorfenuron, EPA considered exposure from the petitioned-for tolerances as well as all existing forchlorfenuron tolerances in 40 CFR 180.569. EPA assessed dietary exposures from forchlorfenuron in food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for forchlorfenuron; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994–1996 and 1998 CSFII. As to residue levels in food, EPA assumed tolerance-level residues and 100% crop treated. Dietary Exposure Evaluation Model (DEEM version 7.81) default processing factors were used for apple juice, dried apples, dried pears, prune juice, cranberry juice, and grape juice. A processing factor was not used for raisins because a separate tolerance (resulting from an empirical processing study) has been established for this commodity. Additionally, the default processing factor was not used for prunes (dried plums) since data indicated that residues in prunes would not exceed the recommended plum tolerance. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that forchlorfenuron does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. VerDate Mar<15>2010 14:07 Jul 30, 2013 Jkt 229001 iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for forchlorfenuron. Tolerance level residues and/or 100% CT were assumed for all food commodities. 2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for forchlorfenuron in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of forchlorfenuron. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/ oppefed1/models/water/index.htm. The conclusions of the Agency in the 2008 human health risk assessment remain unchanged with respect to dietary exposure and risks. The Agency has verified that the previous estimated drinking water concentrations are also appropriate for use with this experimental use permit (EUP) request. Forchlorfenuron is persistent and moderately mobile in soils. Forchlorfenuron is also a substituted urea plant growth regulator that is essentially stable to all routes of dissipation except sensitized photodegradation in water. Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/ EXAMS) and Screening Concentration in Ground Water (SCI–GROW) models, the estimated drinking water concentrations (EDWCs) of forchlorfenuron from the proposed uses on almonds, sweet cherries, figs, pears, plums, and pistachios under the EUP will not exceed the EECs from the grape and kiwi uses previously assessed by the Agency in the document titled Drinking Water Assessment for Forchlorfenuron for Grape and Kiwi Uses. Therefore, the Agency has incorporated the drinking water EEC from the grape and kiwi analysis directly into this dietary assessment. For chronic exposures for non-cancer assessments are estimated to be 0.32 parts per billion (ppb) for surface water and 0.003 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 0.32 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 nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 46281 indoor pest control, termiticides, and flea and tick control on pets). Forchlorfenuron is not registered for any specific use patterns that would result in residential exposure. 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 forchlorfenuron to share a common mechanism of toxicity with any other substances, and forchlorfenuron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that forchlorfenuron 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 https://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 FQPA Safety Factor (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. The developmental and reproductive toxicity studies showed no evidence of increased sensitivity or susceptibility of young rats or rabbits following prenatal or postnatal exposure to forchlorfenuron. 3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings: i. The toxicity database for forchlorfenuron is complete. E:\FR\FM\31JYR1.SGM 31JYR1 46282 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations ehiers on DSK2VPTVN1PROD with RULES ii. There is no indication that forchlorfenuron is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that forchlorfenuron 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% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to forchlorfenuron in drinking water. EPA used similarly conservative assumptions to assess exposure and risks posed by forchlorfenuron. These assessments will not underestimate the exposure and risks posed by forchlorfenuron. E. 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, forchlorfenuron is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to forchlorfenuron from food and water will utilize < 1% of the cPAD. There are no residential uses for forchlorfenuron. 3. Short-term risk and intermediateterm risk. Short-term and intermediateterm aggregate exposure takes into account short-term and intermediateterm residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Forchlorfenuron is currently not registered for any use patterns that would result in short-term and VerDate Mar<15>2010 14:07 Jul 30, 2013 Jkt 229001 intermediate-term residential exposure. Because there is no short- or 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 short- or intermediate-term risk), no further assessment of short- or intermediate-term risk is necessary. EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for forchlorfenuron. 4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, forchlorfenuron is not expected to pose a cancer risk to humans. 5. 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 forchlorfenuron residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (HPLC/UV method (method # CCRL– MTH–029)) is available to enforce tolerances of forchlorfenuron in/on members of the Bushberry Subgroup 13–07B and the commodities that are the subject of the proposed EUP. Residues are determined by HPLC/UV using external standards and residues are confirmed by liquid chromatography (LC) mass spectrometry (MS/MS) analysis. The validated limit of quantitation (LOQ) is 0.01 ppm for fruit and nut crops. 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 PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 from the Codex level. The Codex has not established a MRL for forchlorfenuron. C. Response to Comment One comment was received in response to the notice of receipt of the EUP’s application. The commenter objected to the increase of chemical residues and expressed concerns about the effects of chemicals in general on humans and the environment. The Agency understands the commenter’s concerns regarding toxic chemicals and their potential effects on humans and the environment. Pursuant to its authority under the FFDCA, and as discussed further in this preamble, EPA conducted a comprehensive assessment of forchlorfenuron. Based on its assessment of the available data, the Agency has concluded that there is a reasonable certainty that no harm will result from aggregate exposure to residues of forchlorfenuron, including those associated with the EUP. V. Conclusion Therefore, temporary tolerances are established for residues of forchlorfenuron, (N-(2-chloro-4pyridinyl)-N′-phenylurea), including its metabolites and degradates in or on almond; cherry, sweet; fig; pear; pistachio; and plum, prune, fresh at 0.01 ppm and in or on almond, hulls at 0.15 ppm. An expiration date of December 31, 2015, is established for these uses, which are associated with the EUP (71049–EUP–5) the Agency issued to KIM–C1, LLC for plant growth regulator forchlorfenuron. In addition, consistent with EPA’s policy for clarifying its tolerance expressions, EPA is revising the tolerance expression for forchlorfenuron to clarify that the tolerance includes metabolites and degradates of forchlorfenuron and that compliance with the tolerance levels specified in the table is to be determined by measuring only the sum of forchlorfenuron, (N-(2chloro-4-pyridinyl)-N′-phenylurea). VI. Statutory and Executive Order Reviews This final rule establishes temporary tolerances under FFDCA section 408(r) 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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That E:\FR\FM\31JYR1.SGM 31JYR1 46283 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations 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 final rule 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 submitted 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 final rule 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 final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (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 of 1995 (NTTAA) (15 U.S.C. 272 note). VII. 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: July 22, 2013. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.569, revise paragraphs (a)(1) introductory text and (a)(2) to read as follows: ■ § 180.569 Forchlorfenuron; tolerances for residues. (a) General. (1) Tolerances are established for residues of forchlorfenuron, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only forchlorfenuron (N-(2chloro-4-pyridinyl)-N′-phenylurea). * * * * * (2) Temporary tolerances are established for residues of forchlorfenuron, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring on forchlorfenuron (N-(2chloro-4-pyridinyl)-N′-phenylurea). Parts per million Commodity Almond ..................................................................................................................................................................... Almond, hulls ........................................................................................................................................................... Cherry, sweet ........................................................................................................................................................... Fig ............................................................................................................................................................................ Pear ......................................................................................................................................................................... Pistachio .................................................................................................................................................................. Plum, prune, fresh ................................................................................................................................................... * * * * * [FR Doc. 2013–18182 Filed 7–30–13; 8:45 am] ENVIRONMENTAL PROTECTION AGENCY BILLING CODE 6560–50–P 40 CFR Part 721 [EPA–HQ–OPPT–2012–0864; FRL–9392–4] ehiers on DSK2VPTVN1PROD with RULES RIN 2070–AB27 Modification of Significant New Uses of Ethaneperoxoic Acid, 1,1Dimethylpropyl Ester Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: VerDate Mar<15>2010 14:07 Jul 30, 2013 Jkt 229001 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 0.01 0.15 0.01 0.01 0.01 0.01 0.01 Expiration/ revocation date 12/31/15 12/31/15 12/31/15 12/31/15 12/31/15 12/31/15 12/31/15 Under the Toxic Substances Control Act (TSCA), EPA is finalizing an amendment to the significant new use rule (SNUR) for the chemical substance identified as ethaneperoxoic acid, 1,1dimethylpropyl ester, which was the subject of premanufacture notice (PMN) P–85–680. This action requires persons who intend to manufacture or process the chemical substance for a use that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity. EPA believes that this action is necessary because new uses of the SUMMARY: E:\FR\FM\31JYR1.SGM 31JYR1

Agencies

[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Rules and Regulations]
[Pages 46279-46283]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18182]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0010; FRL-9391-9]


Forchlorfenuron; Temporary Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes temporary tolerances for residues 
of forchlorfenuron in or on multiple commodities which are identified 
and discussed later in this document. KIM-C1, LLC requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA) for 
uses associated with an experimental use permit. The tolerances expire 
on December 31, 2015.

DATES: This regulation is effective July 31, 2013. Objections and 
requests for hearings must be received on or before September 30, 2013, 
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-2013-0010, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West 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 https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marcel Howard, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6784; email address: howard.marcel@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 https://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

[[Page 46280]]

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-2013-0010 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 
September 30, 2013. 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-2013-0010, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.htm. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerances

    In the Federal Register of February 15, 2013 (78 FR 11126) (FRL-
9378-4), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
2F8055) by KIM-C1, LLC, 2547 West Shaw Avenue, Suite 116, Fresno, CA 
93711. The petition requested that 40 CFR 180.569 be amended by 
establishing temporary tolerances for residues of the plant growth 
regulator forchlorfenuron, (N-(2-chloro-4-pyridinyl)-N'-phenylurea), in 
or on almond; cherry, sweet; fig; pear; pistachio; and plum, prune, 
fresh at 0.01 parts per million (ppm) and almond, hulls at 0.15 ppm. 
That document referenced a summary of the petition prepared by KIM-C1, 
LLC, the permittee, which is available to the public in the docket, 
https://www.regulations.gov. A comment was received on the notice of 
filing. EPA's response to that comment is discussed in Unit IV.C. These 
tolerances expire on December 31, 2015.

III. 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 FFDCA section 408(b)(2)(D), and 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 for forchlorfenuron including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with forchlorfenuron 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
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.
    Forchlofenuron is not acutely toxic via the oral, dermal, and 
inhalation routes. Dose-related effects noted in the dog following 
subchronic and chronic exposure were generally limited to decreased 
body weight and body-weight gain. In the rat, the only organ that 
appeared to be affected was the kidney, which showed suppurative 
inflammation, suppurative pyelonephritis, non-suppurative interstitial 
nephritis, and cortical cysts following chronic exposure. Developmental 
toxicity (decreased fetal body weight and increased pup mortality) was 
observed in the rat only at a maternally-toxic dose. The developmental 
toxicity studies in rats and rabbits, as well as the reproductive 
toxicity study in rats, did not demonstrate any increased pre- or 
postnatal sensitivity. There was no evidence of neurotoxicity in any of 
the submitted studies. Forchlorfenuron is classified as not likely to 
be a human carcinogen and there is no concern for mutagenicity. There 
was no evidence of endocrine disruption in the forchlorfenuron 
database.
    Specific information on the studies received and the nature of the 
toxic effects caused by forchlorfenuron as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in the document titled Forchlorfenuron: Human 
Health Risk Assessment for Proposed Uses on the Bushberry Subgroup 13B 
and to Support a Requested Experimental Use Permit on Almonds, Sweet 
Cherries, Figs, Pears, Pistachios, and Plums/Prunes in docket ID number 
EPA-HQ-OPP-2007-1065.

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 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

[[Page 46281]]

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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for forchlorfenuron used 
for human risk assessment is discussed in Unit II. of the final rule 
published in the Federal Register of August 15, 2008 (73 FR 47843) 
(FRL-8375-4).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to forchlorfenuron, EPA considered exposure from the 
petitioned-for tolerances as well as all existing forchlorfenuron 
tolerances in 40 CFR 180.569. EPA assessed dietary exposures from 
forchlorfenuron in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for 
forchlorfenuron; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance-
level residues and 100% crop treated. Dietary Exposure Evaluation Model 
(DEEM version 7.81) default processing factors were used for apple 
juice, dried apples, dried pears, prune juice, cranberry juice, and 
grape juice. A processing factor was not used for raisins because a 
separate tolerance (resulting from an empirical processing study) has 
been established for this commodity. Additionally, the default 
processing factor was not used for prunes (dried plums) since data 
indicated that residues in prunes would not exceed the recommended plum 
tolerance.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that forchlorfenuron 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 anticipated residue and/or PCT information in the 
dietary assessment for forchlorfenuron. Tolerance level residues and/or 
100% CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for forchlorfenuron in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of forchlorfenuron. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at https://www.epa.gov/oppefed1/models/water/index.htm.
    The conclusions of the Agency in the 2008 human health risk 
assessment remain unchanged with respect to dietary exposure and risks. 
The Agency has verified that the previous estimated drinking water 
concentrations are also appropriate for use with this experimental use 
permit (EUP) request.
    Forchlorfenuron is persistent and moderately mobile in soils. 
Forchlorfenuron is also a substituted urea plant growth regulator that 
is essentially stable to all routes of dissipation except sensitized 
photodegradation in water. Based on the Pesticide Root Zone Model/
Exposure Analysis Modeling System (PRZM/EXAMS) and Screening 
Concentration in Ground Water (SCI-GROW) models, the estimated drinking 
water concentrations (EDWCs) of forchlorfenuron from the proposed uses 
on almonds, sweet cherries, figs, pears, plums, and pistachios under 
the EUP will not exceed the EECs from the grape and kiwi uses 
previously assessed by the Agency in the document titled Drinking Water 
Assessment for Forchlorfenuron for Grape and Kiwi Uses. Therefore, the 
Agency has incorporated the drinking water EEC from the grape and kiwi 
analysis directly into this dietary assessment.
    For chronic exposures for non-cancer assessments are estimated to 
be 0.32 parts per billion (ppb) for surface water and 0.003 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 0.32 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).
    Forchlorfenuron is not registered for any specific use patterns 
that would result in residential exposure.
    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 forchlorfenuron to share a common mechanism of 
toxicity with any other substances, and forchlorfenuron does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
forchlorfenuron 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 https://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 FQPA Safety 
Factor (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. The developmental and 
reproductive toxicity studies showed no evidence of increased 
sensitivity or susceptibility of young rats or rabbits following 
prenatal or postnatal exposure to forchlorfenuron.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for forchlorfenuron is complete.

[[Page 46282]]

    ii. There is no indication that forchlorfenuron is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that forchlorfenuron 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% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to forchlorfenuron in drinking water. EPA used 
similarly conservative assumptions to assess exposure and risks posed 
by forchlorfenuron. These assessments will not underestimate the 
exposure and risks posed by forchlorfenuron.

E. 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, 
forchlorfenuron is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
forchlorfenuron from food and water will utilize < 1% of the cPAD. 
There are no residential uses for forchlorfenuron.
    3. Short-term risk and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account short-term and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Forchlorfenuron is currently not registered for any use patterns 
that would result in short-term and intermediate-term residential 
exposure. Because there is no short- or 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 short- or intermediate-term risk), no further 
assessment of short- or intermediate-term risk is necessary. EPA relies 
on the chronic dietary risk assessment for evaluating short- and 
intermediate-term risk for forchlorfenuron.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, forchlorfenuron is not expected to pose a cancer risk to 
humans.
    5. 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 forchlorfenuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (HPLC/UV method (method  
CCRL-MTH-029)) is available to enforce tolerances of forchlorfenuron 
in/on members of the Bushberry Subgroup 13-07B and the commodities that 
are the subject of the proposed EUP. Residues are determined by HPLC/UV 
using external standards and residues are confirmed by liquid 
chromatography (LC) mass spectrometry (MS/MS) analysis. The validated 
limit of quantitation (LOQ) is 0.01 ppm for fruit and nut crops.

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 a MRL for forchlorfenuron.

C. Response to Comment

    One comment was received in response to the notice of receipt of 
the EUP's application. The commenter objected to the increase of 
chemical residues and expressed concerns about the effects of chemicals 
in general on humans and the environment. The Agency understands the 
commenter's concerns regarding toxic chemicals and their potential 
effects on humans and the environment. Pursuant to its authority under 
the FFDCA, and as discussed further in this preamble, EPA conducted a 
comprehensive assessment of forchlorfenuron. Based on its assessment of 
the available data, the Agency has concluded that there is a reasonable 
certainty that no harm will result from aggregate exposure to residues 
of forchlorfenuron, including those associated with the EUP.

V. Conclusion

    Therefore, temporary tolerances are established for residues of 
forchlorfenuron, (N-(2-chloro-4-pyridinyl)-N'-phenylurea), including 
its metabolites and degradates in or on almond; cherry, sweet; fig; 
pear; pistachio; and plum, prune, fresh at 0.01 ppm and in or on 
almond, hulls at 0.15 ppm. An expiration date of December 31, 2015, is 
established for these uses, which are associated with the EUP (71049-
EUP-5) the Agency issued to KIM-C1, LLC for plant growth regulator 
forchlorfenuron.
    In addition, consistent with EPA's policy for clarifying its 
tolerance expressions, EPA is revising the tolerance expression for 
forchlorfenuron to clarify that the tolerance includes metabolites and 
degradates of forchlorfenuron and that compliance with the tolerance 
levels specified in the table is to be determined by measuring only the 
sum of forchlorfenuron, (N-(2-chloro-4-pyridinyl)-N'-phenylurea).

VI. Statutory and Executive Order Reviews

    This final rule establishes temporary tolerances under FFDCA 
section 408(r) 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 
final rule has been exempted from review under Executive Order 12866, 
this final rule is not subject to Executive Order 13211, entitled 
``Actions Concerning Regulations That

[[Page 46283]]

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 final rule 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 submitted 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 final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. 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: July 22, 2013.
Lois Rossi,
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.  180.569, revise paragraphs (a)(1) introductory text and 
(a)(2) to read as follows:


Sec.  180.569  Forchlorfenuron; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
forchlorfenuron, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only forchlorfenuron 
(N-(2-chloro-4-pyridinyl)-N'-phenylurea).
* * * * *
    (2) Temporary tolerances are established for residues of 
forchlorfenuron, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring on forchlorfenuron (N-
(2-chloro-4-pyridinyl)-N'-phenylurea).

------------------------------------------------------------------------
                                                            Expiration/
                Commodity                    Parts per      revocation
                                              million          date
------------------------------------------------------------------------
Almond..................................            0.01        12/31/15
Almond, hulls...........................            0.15        12/31/15
Cherry, sweet...........................            0.01        12/31/15
Fig.....................................            0.01        12/31/15
Pear....................................            0.01        12/31/15
Pistachio...............................            0.01        12/31/15
Plum, prune, fresh......................            0.01        12/31/15
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-18182 Filed 7-30-13; 8:45 am]
BILLING CODE 6560-50-P