Chlorantraniliprole; Pesticide Tolerances for Emergency Exemptions, 51727-51732 [E8-20520]

Download as PDF Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations Populations (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established in accordance with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. This 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 section 408(n)(4) of FFDCA. 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) (Public Law 104–4). 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), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). hsrobinson on PROD1PC76 with RULES VIII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. 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 this final rule in the Federal Register. This final rule is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). VerDate Aug<31>2005 19:20 Sep 04, 2008 Jkt 214001 51727 List of Subjects in 40 CFR Part 180 Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the Environmental protection, pesticide on sweet corn. This regulation Administrative practice and procedure, establishes maximum permissible levels Agricultural commodities, Pesticides and pests, Reporting and recordkeeping for residues of chlorantraniliprole in or on these food commodities. The timerequirements. limited tolerances expire and are revoked on December 31, 2011. Dated: August 22, 2008. DATES: This regulation is effective Lois Rossi, September 5, 2008. Objections and Director, Registration Division, Office of requests for hearings must be received Pesticide Programs. on or before November 4, 2008, and I Therefore, 40 CFR chapter I is must be filed in accordance with the amended as follows: instructions provided in 40 CFR part 178 (see also Unit I.C. of the PART 180—[AMENDED] SUPPLEMENTARY INFORMATION). I 1. The authority citation for part 180 ADDRESSES: EPA has established a continues to read as follows: docket for this action under docket Authority: 21 U.S.C. 321(q), 346a and 371. identification (ID) number EPA–HQ– OPP–2008–0549. To access the I 2. In § 180.184 revise paragraph (b) to electronic docket, go to http:// read as follows: www.regulations.gov, select ‘‘Advanced § 180.184 Linuron; tolerances for residues. Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated * * * * * (b) Section 18 emergency exemptions. and select the ‘‘Submit’’ button. Follow Time-limited tolerances specified in the the instructions on the regulations.gov website to view the docket index or following table are established for access available documents. All combined residues of the herbicide documents in the docket are listed in linuron (3-(3,4-dichlorophenyl)-1the docket index available in methoxy-1-methylurea) and its regulations.gov. Although listed in the metabolites convertible to 3,4index, some information is not publicly dichloroaniline, calculated as linuron, available, e.g., Confidential Business in or on the specified agricultural Information (CBI) or other information commodities, resulting from use of the whose disclosure is restricted by statute. pesticide pursuant to FIFRA section 18 Certain other material, such as emergency exemptions. The tolerance copyrighted material, is not placed on expires and is revoked on the date the Internet and will be publicly specified in the table. available only in hard copy form. Publicly available docket materials are Expiration/ Parts per Commodity revocation available either in the electronic docket million date at http://www.regulations.gov, or, if only available in hard copy, at the Office of Lentil 0.1 12/31/2011 Pesticide Programs (OPP) Regulatory Public Docket in Rm. S–4400, One [FR Doc. E8–20627 Filed 9–4–08; 8:45 am] Potomac Yard (South Bldg.), 2777 S. BILLING CODE 6560–50–S Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday ENVIRONMENTAL PROTECTION through Friday, excluding legal AGENCY holidays. The Docket Facility telephone 40 CFR Part 180 number is (703) 305–5805. FOR FURTHER INFORMATION CONTACT: [EPA–HQ–OPP–2008–0549; FRL–8378–2] Marcel Howard, Registration Division (7505P), Office of Pesticide Programs, Chlorantraniliprole; Pesticide Tolerances for Emergency Exemptions Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, AGENCY: Environmental Protection DC 20460–0001; telephone number: Agency (EPA). (703) 305–6784; e-mail address: ACTION: Final rule. howard.marcel@epa.gov. This regulation establishes time-limited tolerances for residues of chlorantraniliprole in or on various sweet corn commodities and in milk. This action is in response to EPA’s granting of emergency exemptions under section 18 of the Federal SUMMARY: PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 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 E:\FR\FM\05SER1.SGM 05SER1 51728 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. hsrobinson on PROD1PC76 with RULES B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office’s pilot e-CFR site at http:// www.gpoaccess.gov/ecfr. C. Can I File an Objection or Hearing Request? Under section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. 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–2008–0549 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 4, 2008. 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 that does not VerDate Aug<31>2005 19:20 Sep 04, 2008 Jkt 214001 contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA–HQ–OPP–2008–0549, by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. II. Background and Statutory Findings EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing timelimited tolerances for residues of the insecticide chlorantraniliprole, 3bromo-N-[4-chloro-2-methyl-6[(methylamino)carbonyl]phenyl]-1-(3chloro-2-pyridinyl)-1H-pyrazole-5carboxamide), in or on corn, sweet, kernel plus cob with husks removed at 0.01 parts per million (ppm); corn, sweet, forage at 6.0 ppm; corn, sweet, stover at 6.0 ppm; corn, sweet, cannery waste at 6.0 ppm; and milk at 0.03 ppm. These time-limited tolerances expire and are revoked on December 31, 2011. EPA will publish a document in the Federal Register to remove the revoked tolerances from the CFR. Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related timelimited tolerances to set binding precedents for the application of section 408 of FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of FFDCA PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .’’ Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that ‘‘emergency conditions exist which require such exemption.’’ EPA has established regulations governing such emergency exemptions in 40 CFR part 166. III. Emergency Exemption for Chlorantraniliprole on Sweet Corn and FFDCA Tolerances The states of Illinois and Minnesota requested the use of chlorantraniliprole, formulated as the product Coragen (EPA Reg. No. 352–729), on sweet corn to control corn earworms. According to these states, the available registered alternatives were not providing adequate control of this pest and without the use of Coragen, growers would suffer significant economic losses. After having reviewed the submission, EPA determined that emergency conditions exist for these States, and that the criteria for an emergency exemption are met. EPA has authorized under FIFRA section 18 the use of chlorantraniliprole on sweet corn for control of corn earworm in Illinois and Minnesota. As part of its evaluation of the emergency exemption applications, EPA assessed the potential risks presented by residues of chlorantraniliprole in or on sweet corn and various associated sweet corn-related commodities. In doing so, EPA considered the safety standard in section 408(b)(2) of FFDCA, and EPA E:\FR\FM\05SER1.SGM 05SER1 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations hsrobinson on PROD1PC76 with RULES decided that the necessary tolerances under section 408(l)(6) of FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in section 408(l)(6) of FFDCA. Although these time-limited tolerances expire and are revoked on December 31, 2011, under section 408(l)(5) of FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on these commodities after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Because these time-limited tolerances are being approved under emergency conditions, EPA has not made any decisions about whether chlorantraniliprole meets FIFRA’s registration requirements for use on sweet corn or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that these timelimited tolerance decisions serve as a basis for registration of chlorantraniliprole by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for persons in any State other than Illinois and Minnesota to use this pesticide on this crop under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for chlorantraniliprole, contact the Agency’s Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT. IV. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including VerDate Aug<31>2005 19:20 Sep 04, 2008 Jkt 214001 all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .’’ Consistent with the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure expected as a result of these emergency exemption requests and the time-limited tolerances for residues of chlorantraniliprole on corn, sweet, kernel plus cob with husks removed at 0.01 ppm; corn, sweet, forage at 6.0 ppm; corn, sweet, stover at 6.0 ppm; corn, sweet, cannery waste at 6.0 ppm; and milk at 0.03 ppm. EPA’s assessment of exposures and risks associated with establishing these timelimited tolerances follows. A. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic dietary risks by comparing aggregate food and water exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the POD by all applicable UFs. Aggregate short-, intermediate-, and chronic-term risks are evaluated by PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 51729 comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC). 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 greater than that 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 chlorantraniliprole used for human risk assessment can be found at http://www.regulations.gov in document Chlorantraniliprole (DPXE2Y45): Human Health Risk Assessment for Proposed Uses on Pome fruit, Stone fruit, Leafy vegetables, Brassica leafy vegetables, Cucurbit vegetables, Fruiting vegetables, Cotton, Grapes, Potatoes, Rice, Turf and Ornamentals, pages 22– 24 in docket ID number EPA–HQ–OPP– 2007–0275. B. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to chlorantraniliprole, EPA considered exposure under the timelimited tolerance established by this action as well as all existing chlorantraniliprole tolerances in (40 CFR 180.628). EPA assessed dietary exposures from chlorantraniliprole in food as follows: i. Acute exposure. No acute effects were identified in the dietary toxicological studies for chlorantraniliprole; 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. EPA’s chronic dietary exposure estimates for chlorantriliprole are based on tolerance level residues, assuming 100% crops associated with the existing uses and section 18 requests are treated, and included the highest modeled estimated drinking water concentration relevant to the scenario. iii. Cancer. Chlorantraniliprole is classified as ‘‘Not likely to be Carcinogenic to Humans,’’ and therefore a cancer exposure assessment is unnecessary. iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT E:\FR\FM\05SER1.SGM 05SER1 hsrobinson on PROD1PC76 with RULES 51730 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations information in the dietary assessment for chlorantraniliprole. Tolerance level residues and/or 100 PCT 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 chlorantraniliprole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of chlorantraniliprole. 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 Screening Concentration in Ground Water (SCIGROW) models, the estimated drinking water concentrations (EDWCs) of chlorantraniliprole for chronic exposures for non-cancer assessments are estimated to be 3.65 parts per billion (PPB) for surface water and 1.06 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 3.65 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). Chlorantraniliprole is currently registered for the following uses that could result in residential exposures: Turfgrass and ornamental plants. EPA assessed residential exposure using the following assumptions: Inhalation exposure is not expected due to low vapor pressure; dermal postapplication exposure is possible for adults and children for short- and intermediateterm durations, and exposure from incidental oral ingestion is possible for children. However, due to the lack of toxicity via the dermal route, as well as the lack of toxicity over the acute, short- and intermediate- term via the oral route, no risk is expected from these exposures. 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 VerDate Aug<31>2005 19:20 Sep 04, 2008 Jkt 214001 pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ EPA has not made a common mechanism of toxicity finding as to chlorantraniliprole and any other substances, and chlorantraniliprole does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that chlorantraniliprole has 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 the policy statements released by EPA’s Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s website at http://www.epa.gov/ pesticides/cumulative. C. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional SF when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. Chlorantraniliprole did not result in developmental toxicity in either rats or rabbits or in reproductive effects in the multi–generation reproduction study. There was no indication of increased offspring susceptibility in these studies. 3. Conclusion. EPA has determined that reliable data show that the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings: i. The toxicity database for chlorantraniliprole is complete. ii. There is no indication that chlorantraniliprole 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 chlorantraniliprole results in increased PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2–generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to chlorantraniliprole in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by chlorantraniliprole. D. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. Acute risk. An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water. No adverse effect resulting from a single-oral exposure was identified, therefore, chlorantraniliprole 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 chlorantraniliprole from food and water will utilize 1% of the cPAD for (children 1-2 years old) the population group receiving the greatest exposure. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Although short-term residential exposure could occur with the use of chlorantraniliprole, no toxicological effects resulting from short-term dosing were observed. Therefore, the aggregate E:\FR\FM\05SER1.SGM 05SER1 51731 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations short-term risk is the sum of the risk from food and water and will not be greater than the chronic aggregate risk. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term non-dietary, non-occupational exposure plus chronic exposure to food and water (considered to be a background exposure level). Although intermediate-term residential exposure could result from the use of chlorantraniliprole, no toxicological effects resulting from intermediate-term dosing were observed. Therefore, the aggregate intermediate-term risk is the sum of the risk from food and water and will not be greater than the chronic aggregate risk. 5. Aggregate cancer risk for U.S. population. Chlorantraniliprole is classified as ‘‘Not likely to be Carcinogenic to Humans’’ and is therefore not expect to pose a cancer risk. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to chlorantraniliprole residues. V. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (LC/MS/MS) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; e-mail address: residuemethods@epa.gov. B. International Residue Limits There are no CODEX residue limits for residues of chlorantraniliprole on sweet corn commodities or in milk. hsrobinson on PROD1PC76 with RULES VI. Conclusion Therefore, time-limited tolerances are established for residues of chlorantraniliprole, 3-bromo-N-[4chloro-2-methyl-6[(methylamino)carbonyl]phenyl]-1-(3chloro-2-pyridinyl)-1H-pyrazole-5carboxamide), in or on corn, sweet, kernel plus cob with husks removed at 0.01 ppm; corn, sweet, forage at 6.0 ppm; corn, sweet, stover at 6.0 ppm; corn, sweet, cannery waste at 6.0 ppm; and milk at 0.03 ppm. These tolerances expire and are revoked on December 31, 2011. VerDate Aug<31>2005 19:20 Sep 04, 2008 Jkt 214001 VII. Statutory and Executive Order Reviews This final rule establishes tolerances under sections 408(e) and 408(l)(6) of FFDCA 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, 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 in accordance with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. This 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 section 408(n)(4) of FFDCA. 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 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104–4). 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), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). VIII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. 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 this final rule in the Federal Register. This final rule 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: August 22, 2008. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: I PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: I Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.628 is amended by alphabetically adding commodities to the table in paragraph (b) to read as follows: I § 180.628 Chlorantraniliprole; tolerances for residues. * * * (b) * * * Commodity Corn, sweet, cannery waste Corn, sweet, forage ................ E:\FR\FM\05SER1.SGM 05SER1 * * Parts per million Expiration/ revocation date 6.0 12/31/11 6.0 12/31/11 51732 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Corn, sweet, Regulatory Public Docket in Rm. S– kernel plus 4400, One Potomac Yard (South Bldg.), cob with 2777 S. Crystal Dr., Arlington, VA. The husks removed ........... 0.01 12/31/11 Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, Corn, sweet, stover ............ 6.0 12/31/11 excluding legal holidays. The Docket Milk ................... 0.03 12/31/11 Facility telephone number is (703) 305– * * * * * 5805. FOR FURTHER INFORMATION CONTACT: * * * * * Susan Stanton, Registration Division [FR Doc. E8–20520 Filed 9–5–08; 8:45 am] (7505P), Office of Pesticide Programs, BILLING CODE 6560–50–S Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: ENVIRONMENTAL PROTECTION (703) 305–5218; e-mail address: AGENCY stanton.susan@epa.gov. 40 CFR Part 180 SUPPLEMENTARY INFORMATION: Commodity Parts per million Expiration/ revocation date [EPA–HQ–OPP–2007–1199; FRL–8376–6] I. General Information Uniconazole-P; Pesticide Tolerances 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. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. Environmental Protection Agency (EPA). ACTION: Final rule. hsrobinson on PROD1PC76 with RULES AGENCY: SUMMARY: This regulation establishes a tolerance for combined residues of uniconazole-P, its R-enantiomer and its Z-isomer in or on vegetable, fruiting, group 8. Interregional Research Project Number 4 (IR-4) requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective September 5, 2008. Objections and requests for hearings must be received on or before November 4, 2008, 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: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2007–1199. To access the electronic docket, go to http:// www.regulations.gov, select ‘‘Advanced Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated and select the ‘‘Submit’’ button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. VerDate Aug<31>2005 19:20 Sep 04, 2008 Jkt 214001 B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s pilot PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 e-CFR site at http://www.gpoaccess.gov/ ecfr. C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, 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–2007–1199 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before November 4, 2008. 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 that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA– HQ–OPP–2007–1199, by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. II. Petition for Tolerance In the Federal Register of February 6, 2008 (73 FR 6964) (FRL–8350–9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 7E7268) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by adding a section for the fungicide uniconazole-P and E:\FR\FM\05SER1.SGM 05SER1

Agencies

[Federal Register Volume 73, Number 173 (Friday, September 5, 2008)]
[Rules and Regulations]
[Pages 51727-51732]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20520]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0549; FRL-8378-2]


Chlorantraniliprole; Pesticide Tolerances for Emergency 
Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes time-limited tolerances for 
residues of chlorantraniliprole in or on various sweet corn commodities 
and in milk. This action is in response to EPA's granting of emergency 
exemptions under section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) authorizing use of the pesticide on sweet corn. 
This regulation establishes maximum permissible levels for residues of 
chlorantraniliprole in or on these food commodities. The time-limited 
tolerances expire and are revoked on December 31, 2011.

DATES: This regulation is effective September 5, 2008. Objections and 
requests for hearings must be received on or before November 4, 2008, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0549. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the Office 
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One 
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The 
hours of operation of this Docket Facility are from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The Docket 
Facility telephone number is (703) 305-5805.

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; e-mail 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

[[Page 51728]]

pesticide manufacturer. Potentially affected entities may include, but 
are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

 B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), 
any person may file an objection to any aspect of this regulation and 
may also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. 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-2008-0549 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be mailed or delivered to the Hearing Clerk on or 
before November 4, 2008.
    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 that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2008-0549, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing 
time-limited tolerances for residues of the insecticide 
chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide), in or on corn, sweet, kernel plus cob with husks removed 
at 0.01 parts per million (ppm); corn, sweet, forage at 6.0 ppm; corn, 
sweet, stover at 6.0 ppm; corn, sweet, cannery waste at 6.0 ppm; and 
milk at 0.03 ppm. These time-limited tolerances expire and are revoked 
on December 31, 2011. EPA will publish a document in the Federal 
Register to remove the revoked tolerances from the CFR.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related time-limited tolerances to set binding precedents 
for the application of section 408 of FFDCA and the new safety standard 
to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Chlorantraniliprole on Sweet Corn and 
FFDCA Tolerances

    The states of Illinois and Minnesota requested the use of 
chlorantraniliprole, formulated as the product Coragen (EPA Reg. No. 
352-729), on sweet corn to control corn earworms. According to these 
states, the available registered alternatives were not providing 
adequate control of this pest and without the use of Coragen, growers 
would suffer significant economic losses. After having reviewed the 
submission, EPA determined that emergency conditions exist for these 
States, and that the criteria for an emergency exemption are met. EPA 
has authorized under FIFRA section 18 the use of chlorantraniliprole on 
sweet corn for control of corn earworm in Illinois and Minnesota.
    As part of its evaluation of the emergency exemption applications, 
EPA assessed the potential risks presented by residues of 
chlorantraniliprole in or on sweet corn and various associated sweet 
corn-related commodities. In doing so, EPA considered the safety 
standard in section 408(b)(2) of FFDCA, and EPA

[[Page 51729]]

decided that the necessary tolerances under section 408(l)(6) of FFDCA 
would be consistent with the safety standard and with FIFRA section 18. 
Consistent with the need to move quickly on the emergency exemption in 
order to address an urgent non-routine situation and to ensure that the 
resulting food is safe and lawful, EPA is issuing these tolerances 
without notice and opportunity for public comment as provided in 
section 408(l)(6) of FFDCA. Although these time-limited tolerances 
expire and are revoked on December 31, 2011, under section 408(l)(5) of 
FFDCA, residues of the pesticide not in excess of the amounts specified 
in the tolerance remaining in or on these commodities after that date 
will not be unlawful, provided the pesticide was applied in a manner 
that was lawful under FIFRA, and the residues do not exceed a level 
that was authorized by these time-limited tolerances at the time of 
that application. EPA will take action to revoke these time-limited 
tolerances earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
chlorantraniliprole meets FIFRA's registration requirements for use on 
sweet corn or whether permanent tolerances for this use would be 
appropriate. Under these circumstances, EPA does not believe that these 
time-limited tolerance decisions serve as a basis for registration of 
chlorantraniliprole by a State for special local needs under FIFRA 
section 24(c). Nor do these tolerances serve as the basis for persons 
in any State other than Illinois and Minnesota to use this pesticide on 
this crop under FIFRA section 18 absent the issuance of an emergency 
exemption applicable within that State. For additional information 
regarding the emergency exemption for chlorantraniliprole, contact the 
Agency's Registration Division at the address provided under FOR 
FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with the factors specified in section 408(b)(2)(D) of 
FFDCA, EPA has reviewed the available scientific data and other 
relevant information in support of this action. EPA has sufficient data 
to assess the hazards of and to make a determination on aggregate 
exposure expected as a result of these emergency exemption requests and 
the time-limited tolerances for residues of chlorantraniliprole on 
corn, sweet, kernel plus cob with husks removed at 0.01 ppm; corn, 
sweet, forage at 6.0 ppm; corn, sweet, stover at 6.0 ppm; corn, sweet, 
cannery waste at 6.0 ppm; and milk at 0.03 ppm. EPA's assessment of 
exposures and risks associated with establishing these time-limited 
tolerances follows.

A. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the Level of Concern (LOC).
    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 
greater than that 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 chlorantraniliprole 
used for human risk assessment can be found at http://
www.regulations.gov in document Chlorantraniliprole (DPX-E2Y45): Human 
Health Risk Assessment for Proposed Uses on Pome fruit, Stone fruit, 
Leafy vegetables, Brassica leafy vegetables, Cucurbit vegetables, 
Fruiting vegetables, Cotton, Grapes, Potatoes, Rice, Turf and 
Ornamentals, pages 22-24 in docket ID number EPA-HQ-OPP-2007-0275.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to chlorantraniliprole, EPA considered exposure under the 
time-limited tolerance established by this action as well as all 
existing chlorantraniliprole tolerances in (40 CFR 180.628). EPA 
assessed dietary exposures from chlorantraniliprole in food as follows:
    i. Acute exposure. No acute effects were identified in the dietary 
toxicological studies for chlorantraniliprole; 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. EPA's chronic dietary exposure estimates for 
chlorantriliprole are based on tolerance level residues, assuming 100% 
crops associated with the existing uses and section 18 requests are 
treated, and included the highest modeled estimated drinking water 
concentration relevant to the scenario.
    iii. Cancer. Chlorantraniliprole is classified as ``Not likely to 
be Carcinogenic to Humans,'' and therefore a cancer exposure assessment 
is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT

[[Page 51730]]

information in the dietary assessment for chlorantraniliprole. 
Tolerance level residues and/or 100 PCT 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 chlorantraniliprole in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of chlorantraniliprole. 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 Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
chlorantraniliprole for chronic exposures for non-cancer assessments 
are estimated to be 3.65 parts per billion (PPB) for surface water and 
1.06 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 3.65 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).
    Chlorantraniliprole is currently registered for the following uses 
that could result in residential exposures: Turfgrass and ornamental 
plants. EPA assessed residential exposure using the following 
assumptions: Inhalation exposure is not expected due to low vapor 
pressure; dermal postapplication exposure is possible for adults and 
children for short- and intermediate-term durations, and exposure from 
incidental oral ingestion is possible for children.
    However, due to the lack of toxicity via the dermal route, as well 
as the lack of toxicity over the acute, short- and intermediate- term 
via the oral route, no risk is expected from these exposures.
    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 made a common mechanism of toxicity finding as to 
chlorantraniliprole and any other substances, and chlorantraniliprole 
does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has not assumed that chlorantraniliprole has 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 the policy 
statements released by EPA's Office of Pesticide Programs concerning 
common mechanism determinations and procedures for cumulating effects 
from substances found to have a common mechanism on EPA's website at 
http://www.epa.gov/pesticides/cumulative.

C. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional SF when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. Chlorantraniliprole did not 
result in developmental toxicity in either rats or rabbits or in 
reproductive effects in the multi-generation reproduction study. There 
was no indication of increased offspring susceptibility in these 
studies.
    3. Conclusion. EPA has determined that reliable data show that the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for chlorantraniliprole is complete.
    ii. There is no indication that chlorantraniliprole 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 chlorantraniliprole results in 
increased susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to chlorantraniliprole in drinking water. EPA used 
similarly conservative assumptions to assess postapplication exposure 
of children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
chlorantraniliprole.

D. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. No adverse effect resulting from a single-oral exposure 
was identified, therefore, chlorantraniliprole 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 
chlorantraniliprole from food and water will utilize 1% of the cPAD for 
(children 1-2 years old) the population group receiving the greatest 
exposure.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Although short-term residential exposure could occur with the use 
of chlorantraniliprole, no toxicological effects resulting from short-
term dosing were observed. Therefore, the aggregate

[[Page 51731]]

short-term risk is the sum of the risk from food and water and will not 
be greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term non-dietary, non-occupational 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Although intermediate-term residential exposure could result from 
the use of chlorantraniliprole, no toxicological effects resulting from 
intermediate-term dosing were observed. Therefore, the aggregate 
intermediate-term risk is the sum of the risk from food and water and 
will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Chlorantraniliprole 
is classified as ``Not likely to be Carcinogenic to Humans'' and is 
therefore not expect to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children, from aggregate 
exposure to chlorantraniliprole residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (LC/MS/MS) is available to enforce 
the tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address: residuemethods@epa.gov.

B. International Residue Limits

    There are no CODEX residue limits for residues of 
chlorantraniliprole on sweet corn commodities or in milk.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide), in or on corn, sweet, kernel plus cob with husks removed 
at 0.01 ppm; corn, sweet, forage at 6.0 ppm; corn, sweet, stover at 6.0 
ppm; corn, sweet, cannery waste at 6.0 ppm; and milk at 0.03 ppm. These 
tolerances expire and are revoked on December 31, 2011.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under sections 408(e) and 
408(l)(6) of FFDCA 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, 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 in accordance 
with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This 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 section 408(n)(4) of FFDCA. 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) (Public Law 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: August 22, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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. Section 180.628 is amended by alphabetically adding commodities to 
the table in paragraph (b) to read as follows:


Sec.  180.628  Chlorantraniliprole; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per   revocation
                                                  million       date
------------------------------------------------------------------------
Corn, sweet, cannery waste....................         6.0      12/31/11
Corn, sweet, forage...........................         6.0      12/31/11

[[Page 51732]]

 
Corn, sweet, kernel plus cob with husks               0.01      12/31/11
 removed......................................
Corn, sweet, stover...........................         6.0      12/31/11
Milk..........................................        0.03      12/31/11
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-20520 Filed 9-5-08; 8:45 am]
BILLING CODE 6560-50-S