Forchlorfenuron; Pesticide Tolerances, 18467-18471 [2014-07103]

Download as PDF Federal Register / Vol. 79, No. 63 / Wednesday, April 2, 2014 / Rules and Regulations 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: March 21, 2014. 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 § 180.434, add alphabetically the following commodity to the table in paragraph (a) to read as follows: ■ § 180.434 Propiconazole; tolerances for residues. (a) * * * Parts per million Commodity ehiers on DSK2VPTVN1PROD with RULES * * * * Rapeseed subgroup 20A .......... * * * * * * * * * [FR Doc. 2014–07100 Filed 4–1–14; 8:45 am] BILLING CODE 6560–50–P VerDate Mar<15>2010 14:28 Apr 01, 2014 Jkt 232001 * 0.30 * ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2013–0011; FRL–9907–47] Forchlorfenuron; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes 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). DATES: This regulation is effective April 2, 2014. Objections and requests for hearings must be received on or before June 2, 2014, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). SUMMARY: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2013–0011, 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), 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 http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: 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 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 18467 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 EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2013–0011 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 June 2, 2014. 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– 2013–0011, 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. E:\FR\FM\02APR1.SGM 02APR1 18468 Federal Register / Vol. 79, No. 63 / Wednesday, April 2, 2014 / Rules and Regulations • 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.htm. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance 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 2F8104) 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 tolerances for residues of the plant growth regulator forchlorfenuron, (N-(2-chloro-4pyridinyl)-Nb-phenylurea), in or on almond; cherry, sweet; fig; pear; pistachio; and plum, prune, fresh at 0.04 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 petitioner, which is available in the docket, http://www.regulations.gov. A comment was received on the notice of filing. EPA’s response to that comment is discussed in Unit IV.C. Based upon review of the data supporting the petition, EPA has recommended that a tolerance of 0.01 ppm (excluding processed commodities) be establish for almond; cherry, sweet; fig; pear; pistachio; and plum, prune, fresh. KIM–C1, LLC proposed the petition to establish a tolerance of 0.04 ppm for the same commodities. The reasons for these changes are explained in Unit IV.D. ehiers on DSK2VPTVN1PROD with RULES 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 VerDate Mar<15>2010 14:28 Apr 01, 2014 Jkt 232001 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) 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 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 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 adverse 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 http:// www.regulations.gov in document Forchlorfenuron: Human Health Risk Assessment for Proposed Uses on Almond, Sweet Cherry, Fig, Pear, Pistachio, and Plum/Prune in docket ID number EPA–HQ–OPP–2013–0011 (pages 26–30). 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 amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http:// www.epa.gov/pesticides/factsheets/ riskassess.htm. A summary of the toxicological endpoints for forchlorfenuron used for human risk assessment is shown in the following table. E:\FR\FM\02APR1.SGM 02APR1 Federal Register / Vol. 79, No. 63 / Wednesday, April 2, 2014 / Rules and Regulations 18469 TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FORCHLORFENURON FOR USE IN HUMAN HEALTH RISK ASSESSMENT Point of departure and uncertainty/ safety factors Exposure/scenario RfD, PAD, LOC for risk assessment Study and toxicological effects Acute dietary (General population including infants and children). No appropriate endpoint attributable to a single exposure (dose) was identified from oral toxicity studies, including the developmental studies; therefore an acute endpoint was not selected and an acute dietary risk assessment is not required. Chronic dietary (All populations) ............... NOAEL = 7 mg/kg/ day. UFA = 10x ............... UFH = 10x ............... FQPA SF = 1x ........ Cancer (Oral, dermal, inhalation) .............. Classification: Not likely to be a human carcinogen, based on two adequate rodent carcinogenicity studies. Chronic RfD = 0.07 mg/kg/day. cPAD = 0.07 mg/kg/ day. Chronic oral toxicity study—rat LOAEL = 93 mg/kg/day based on decreased body weight/body-weight gain/food consumption, and kidney toxicity (suppurative inflammation in males; nonsuppurative interstitial nephritis in females) FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest observed adverse effect level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. NOAEL = no observed adverse effect level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). 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 under 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 United States Department of Agriculture’s (USDA) 2003–2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance-level residues and 100% crop treated. EPA noted that the temporary tolerances in/on olive and apple have expired; thus, these commodities were not included in the assessment. Dietary Exposure Evaluation Model (DEEM) (Version 7.81) default processing factors were used for dried pears, prune juice, cranberry juice, and grape juice. A processing factor was not used for raisins because a separate tolerance has been established for that commodity. In addition, a processing factor was not used for prunes (dried plums) because VerDate Mar<15>2010 14:28 Apr 01, 2014 Jkt 232001 data show that residues of forchlorfenuron in prunes are not likely to exceed 0.01 ppm, the tolerance established for fresh plums. A processing factor was also not used for dried figs because data show that residues of forchlorfenuron in dried figs are not likely to exceed the tolerance for fresh figs. 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 http://www.epa.gov/ oppefed1/models/water/index.htm. Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of forchlorfenuron for chronic exposures for non-cancer assessments are estimated to be 0.21 parts per billion PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 (ppb) for surface water and 7.3 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 7.3 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, 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 E:\FR\FM\02APR1.SGM 02APR1 18470 Federal Register / Vol. 79, No. 63 / Wednesday, April 2, 2014 / Rules and Regulations E. Aggregate Risks and Determination of Safety D. Safety Factor for Infants and Children ehiers on DSK2VPTVN1PROD with RULES http://www.epa.gov/pesticides/ cumulative. 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 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 could 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-term risk), no further assessment of short- or intermediateterm risk is necessary. EPA relies on the chronic dietary risk assessment for evaluating short-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. 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. There is no evidence of increased susceptibility following in utero exposure to forchlorfenuron in either the rat or rabbit developmental toxicity study nor is there any evidence of increased susceptibility following in utero and/or pre-/post-natal exposure in the 2-generation reproduction study in rats. 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. 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. VerDate Mar<15>2010 14:28 Apr 01, 2014 Jkt 232001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (High-Pressure Liquid Chromatography with Ultraviolet/Visible (HPLC/UV) method (Method # CCRL–MTH–029) 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: residuemethods@epa.gov. 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 Comments One comment was received in response to the notice of filing of the KIM–C1, LLC’s application. The commenter objected to the increase of chemical residues generally 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 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. D. Revisions to Petitioned-For Tolerances KIM–C1, LLC proposed tolerances for almond; cherry, sweet; fig; pear; E:\FR\FM\02APR1.SGM 02APR1 18471 Federal Register / Vol. 79, No. 63 / Wednesday, April 2, 2014 / Rules and Regulations pistachio; and plum, prune, fresh at 0.04 ppm, stating that the proposed residue level for each commodity was derived using the Organisation for Economic Cooperation and Development (OECD) MRL calculation procedures. EPA does not concur that these are the appropriate outputs from the OECD MRL calculation procedures. All residue values for all crops (not including processed commodities) are less than the analytical method limit of quantitation (LOQ) of 0.01 ppm. When all inputs for a commodity are less than the LOQ, also known as ‘‘censored’’ values, the OECD calculator recommends a tolerance level at the method LOQ. Therefore, to be consistent with the OECD MRL calculation procedures, EPA is recommending that a tolerance of 0.01 ppm be established for almond; cherry, sweet; fig; pear; pistachio; and plum, prune, fresh. V. Conclusion Therefore, tolerances are established for residues of forchlorfenuron, (N-(2chloro-4-pyridinyl)-N-phenylurea), 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. In addition, EPA is removing from 40 CFR 180.569(a)(2) the temporary tolerances, which are superseded by the permanent tolerances being established in today’s action. ehiers on DSK2VPTVN1PROD with RULES VI. Statutory and Executive Order Reviews This final rule establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this 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 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 VerDate Mar<15>2010 14:28 Apr 01, 2014 Jkt 232001 Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This 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). Dated: March 21, 2014. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. VII. Congressional Review Act [FR Doc. 2014–07103 Filed 4–1–14; 8:45 am] 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. PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 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: a. Revise paragraph (a) introductory text. ■ b. Add alphabetically the commodities to the table in paragraph (a). ■ c. Remove paragraph (a)(2). The revision and additions read as follows: ■ ■ § 180.569 Forchlorfenuron; tolerances for residues. (a) General. 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). Parts per million Commodity Almond ...................................... Almond, hulls ............................ 0.01 0.15 * * * * Cherry, sweet ........................... Fig ............................................. * 0.01 0.01 * * * * Pear .......................................... Pistachio ................................... Plum, prune, fresh .................... * 0.01 0.01 0.01 * * * * * BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 761 [EPA–HQ–RCRA–2013–0396; FRL–9908–98– OSWER] RIN 2050–AG79 Polychlorinated Biphenyls (PCBs): Manufacturing (Import) Exemption for the Defense Logistics Agency (DLA) Environmental Protection Agency (EPA). ACTION: Direct final rule. AGENCY: E:\FR\FM\02APR1.SGM 02APR1

Agencies

[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Rules and Regulations]
[Pages 18467-18471]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07103]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0011; FRL-9907-47]


Forchlorfenuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes 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).

DATES: This regulation is effective April 2, 2014. Objections and 
requests for hearings must be received on or before June 2, 2014, 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-2013-0011, 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), 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 http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2013-0011 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 
June 2, 2014. 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-2013-0011, 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.

[[Page 18468]]

     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.htm.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    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 
2F8104) 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 tolerances for residues of the plant growth regulator 
forchlorfenuron, (N-(2-chloro-4-pyridinyl)-N[squ]-phenylurea), in or on 
almond; cherry, sweet; fig; pear; pistachio; and plum, prune, fresh at 
0.04 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 petitioner, which is available in the docket, http://www.regulations.gov. A comment was received on the notice of filing. 
EPA's response to that comment is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
recommended that a tolerance of 0.01 ppm (excluding processed 
commodities) be establish for almond; cherry, sweet; fig; pear; 
pistachio; and plum, prune, fresh. KIM-C1, LLC proposed the petition to 
establish a tolerance of 0.04 ppm for the same commodities. The reasons 
for these changes are explained in Unit IV.D.

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) 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 
adverse 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 http://www.regulations.gov in document Forchlorfenuron: Human Health Risk 
Assessment for Proposed Uses on Almond, Sweet Cherry, Fig, Pear, 
Pistachio, and Plum/Prune in docket ID number EPA-HQ-OPP-2013-0011 
(pages 26-30).

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 amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for forchlorfenuron used 
for human risk assessment is shown in the following table.

[[Page 18469]]



     Table 1--Summary of Toxicological Doses and Endpoints for Forchlorfenuron for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population         No appropriate endpoint attributable to a single exposure (dose) was
 including infants and children).          identified from oral toxicity studies, including the developmental
                                           studies; therefore an acute endpoint was not selected and an acute
                                                        dietary risk assessment is not required.
                                      --------------------------------------------------------------------------
Chronic dietary (All populations)....  NOAEL = 7 mg/kg/day....  Chronic RfD = 0.07 mg/   Chronic oral toxicity
                                       UFA = 10x..............   kg/day.                  study--rat
                                       UFH = 10x..............  cPAD = 0.07 mg/kg/day..  LOAEL = 93 mg/kg/day
                                       FQPA SF = 1x...........                            based on decreased
                                                                                          body weight/body-
                                                                                          weight gain/food
                                                                                          consumption, and
                                                                                          kidney toxicity
                                                                                          (suppurative
                                                                                          inflammation in males;
                                                                                          nonsuppurative
                                                                                          interstitial nephritis
                                                                                          in females)
                                      --------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....  Classification: Not likely to be a human carcinogen, based on two
                                        adequate rodent carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest observed adverse effect level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. NOAEL = no observed adverse effect level. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation
  from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
  population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to forchlorfenuron, EPA considered exposure under 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 United States 
Department of Agriculture's (USDA) 2003-2008 National Health and 
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As 
to residue levels in food, EPA assumed tolerance-level residues and 
100% crop treated. EPA noted that the temporary tolerances in/on olive 
and apple have expired; thus, these commodities were not included in 
the assessment. Dietary Exposure Evaluation Model (DEEM) (Version 7.81) 
default processing factors were used for dried pears, prune juice, 
cranberry juice, and grape juice. A processing factor was not used for 
raisins because a separate tolerance has been established for that 
commodity. In addition, a processing factor was not used for prunes 
(dried plums) because data show that residues of forchlorfenuron in 
prunes are not likely to exceed 0.01 ppm, the tolerance established for 
fresh plums. A processing factor was also not used for dried figs 
because data show that residues of forchlorfenuron in dried figs are 
not likely to exceed the tolerance for fresh figs.
    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 http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM 
GW), the estimated drinking water concentrations (EDWCs) of 
forchlorfenuron for chronic exposures for non-cancer assessments are 
estimated to be 0.21 parts per billion (ppb) for surface water and 7.3 
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 7.3 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

[[Page 18470]]

http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the 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. There is no evidence of 
increased susceptibility following in utero exposure to forchlorfenuron 
in either the rat or rabbit developmental toxicity study nor is there 
any evidence of increased susceptibility following in utero and/or pre-
/post-natal exposure in the 2-generation reproduction study in rats.
    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.
    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 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 could 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-term risk), no further assessment of 
short- or intermediate-term risk is necessary. EPA relies on the 
chronic dietary risk assessment for evaluating short-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 (High-Pressure Liquid 
Chromatography with Ultraviolet/Visible (HPLC/UV) method (Method 
 CCRL-MTH-029) 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: 
residuemethods@epa.gov.

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 Comments

    One comment was received in response to the notice of filing of the 
KIM-C1, LLC's application. The commenter objected to the increase of 
chemical residues generally 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 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.

D. Revisions to Petitioned-For Tolerances

    KIM-C1, LLC proposed tolerances for almond; cherry, sweet; fig; 
pear;

[[Page 18471]]

pistachio; and plum, prune, fresh at 0.04 ppm, stating that the 
proposed residue level for each commodity was derived using the 
Organisation for Economic Co-operation and Development (OECD) MRL 
calculation procedures. EPA does not concur that these are the 
appropriate outputs from the OECD MRL calculation procedures. All 
residue values for all crops (not including processed commodities) are 
less than the analytical method limit of quantitation (LOQ) of 0.01 
ppm. When all inputs for a commodity are less than the LOQ, also known 
as ``censored'' values, the OECD calculator recommends a tolerance 
level at the method LOQ. Therefore, to be consistent with the OECD MRL 
calculation procedures, EPA is recommending that a tolerance of 0.01 
ppm be established for almond; cherry, sweet; fig; pear; pistachio; and 
plum, prune, fresh.

V. Conclusion

    Therefore, tolerances are established for residues of 
forchlorfenuron, (N-(2-chloro-4-pyridinyl)-N-phenylurea), 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. In addition, EPA is 
removing from 40 CFR 180.569(a)(2) the temporary tolerances, which are 
superseded by the permanent tolerances being established in today's 
action.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this 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 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 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: March 21, 2014.
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:
0
a. Revise paragraph (a) introductory text.
0
b. Add alphabetically the commodities to the table in paragraph (a).
0
c. Remove paragraph (a)(2).
    The revision and additions read as follows:


Sec.  180.569  Forchlorfenuron; tolerances for residues.

    (a) General. 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).

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond.....................................................         0.01
Almond, hulls..............................................         0.15
 
                                * * * * *
Cherry, sweet..............................................         0.01
Fig........................................................         0.01
 
                                * * * * *
Pear.......................................................         0.01
Pistachio..................................................         0.01
Plum, prune, fresh.........................................         0.01
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-07103 Filed 4-1-14; 8:45 am]
BILLING CODE 6560-50-P