Nicosulfuron; Pesticide Tolerances for Emergency Exemptions, 8256-8261 [2010-3673]

Download as PDF 8256 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations VII. Other Considerations A. Endocrine Disruptors There is no evidence, at this time, that suggests that laminarin will compromise the endocrine system, function in a manner similar to any known hormone, or act as an endocrine disruptor. B. Analytical Method(s) Through this action, the Agency proposes an exemption from the requirement of a tolerance of laminarin when used on food commodities, without any numerical limitations for residues. EPA has determined that residues resulting from the pesticidal use of laminarin are unlikely and that there are no significant toxicity concerns in the event that residues of the active ingredient are present. As a result, the Agency has concluded that an analytical method is not required for enforcement purposes for laminarin. C. Codex Maximum Residue Level There are no codex maximum residue levels established for residues of laminarin. cprice-sewell on DSK2BSOYB1PROD with RULES VIII. Conclusions Based on the data submitted to support this tolerance exemption, and other information available to the Agency, EPA is establishing an exemption from the tolerance requirements, pursuant to FFDCA section 408(c), for residues of laminarin in or on all food commodities. IX. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) 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, 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 VerDate Nov<24>2008 15:09 Feb 23, 2010 Jkt 220001 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 section 408(d) of FFDCA, 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 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). X. 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). PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: February 15, 2010. Steven Bradbury, Acting Director, Office of Pesticide Programs. Therefore, 40 CFR part 180 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. Section 180.1295 is added to subpart D to read as follows: ■ § 180.1295 Laminarin; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of laminarin in or on all food commodities when laminarin is applied preharvest. [FR Doc. 2010–3672 Filed 2–23–10; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 EPA–HQ–OPP–2009–0569; FRL–8812–5 Nicosulfuron; Pesticide Tolerances for Emergency Exemptions AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes time-limited tolerances for residues of nicosulfuron, [3-pyridinecarboxamide, 2-((((4,6-dimethoxypyrimidin-2-yl) aminocarbonyl) aminosulfonyl))-N,Ndimethyl]; in or on Bermudagrass, forage and Bermudagrass, hay. This action is in response to EPA granting crisis exemptions to the Texas Department of Agriculture and the Oklahoma Department of Agriculture under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on Bermudagrass, forage and Bermudagrass, hay. This regulation establishes maximum permissible levels for residues of nicosulfuron in Bermudagrass and hay. The timelimited tolerances expire and are revoked on December 31, 2011. DATES: This regulation is effective February 24, 2010. Objections and E:\FR\FM\24FER1.SGM 24FER1 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations requests for hearings must be received on or before April 26, 2010, 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–2009–0569. All documents in the docket are listed in the docket index available in https://www.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 in the electronic docket at https://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open 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: Stacey Groce, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–2505; e-mail address: groce.stacey@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information cprice-sewell on DSK2BSOYB1PROD with RULES 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: • 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 VerDate Nov<24>2008 15:09 Feb 23, 2010 Jkt 220001 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 Get Electronic Access to Other Related Information? You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office’s e-CFR cite at https:// 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), 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. 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–2009–0569 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 April 26, 2010. 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–2009-0569, by one of the following methods: • Federal eRulemaking Portal: https:// 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 Facility’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 PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 8257 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 herbicide nicosulfuron, in or on Bermudagrass, forage and Bermudagrass, hay at 10 parts per million (ppm) and 25 (ppm) respectively. 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 Code of Federal Regulations (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 FIFRA section 18 related time-limited tolerances to set binding precedents for the application of section 408 of FFDCA 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 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 Nicosulfuron on Bermudagrass Forage and Hay and FFDCA Tolerances The Texas and Oklahoma Departments of Agriculture requested emergency exemptions for use of nicosulfuron on Bermudagrass and hay to control field sandbur species, and issued crisis exemptions for this use pursuant to 40 CFR part 166, subpart C of FIFRA. The states provided information indicating that sandbur species is a serious pest that commonly infests Bermudagrass and hay. As part of its evaluation of the emergency exemption applications, EPA assessed the potential risks presented by residues of nicosulfuron in or on Bermudagrass, forage and Bermudagrass, hay. In doing so, EPA E:\FR\FM\24FER1.SGM 24FER1 8258 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations cprice-sewell on DSK2BSOYB1PROD with RULES considered the safety standard in section 408(b)(2) of FFDCA, and EPA 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 exemptions in order to address urgent non-routine situations 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 tolerances remaining in or on Bermudagrass, forage and Bermudagrass, hay 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 nicosulfuron meets FIFRA’s registration requirements for use on Bermudagrass, forage and Bermudagrass, hay 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 nicosulfuron by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for persons in any States other than Texas and Oklahoma to use this pesticide on the applicable crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemptions for nicosulfuron, 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 VerDate Nov<24>2008 15:09 Feb 23, 2010 Jkt 220001 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 nicosulfuron [3pyridinecarboxamide, 2-((((4,6dimethoxypyrimidin-2-yl) aminocarbonyl) aminosulfonyl))-N,Ndimethyl] in or on Bermudagrass, forage and Bermudagrass, hay at 10 ppm and 25 ppm respectively. EPA’s assessment of exposures and risks associated with establishing 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 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 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 https://www.epa.gov/ pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for nicosulfuron used for human risk assessment can be found at https://www.regulations.gov in the July 14, 2009 document ‘‘Nicosulfuron: Human Health Risk Assessment for Proposed Section 18 Use on Bermudagrass,’’ pages 10 and 11 of 30 in docket ID number EPA–HQ–OPP–2009– 0569. B. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to nicosulfuron, EPA considered exposure under the timelimited tolerances established by this action as well as exposures pursuant to existing tolerances in (40 CFR 180.454). EPA assessed dietary exposures from nicosulfuron in food as follows: i. Acute exposure. No acute effects were identified in the toxicological studies for nicosulfuron; therefore, a quantitative assessment of acute dietary exposure was not conducted. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used tolerance level residues and 100 percent crop treated (PCT) assumptions for all registered and proposed commodities. iii. Cancer. EPA has classified nicosulfuron as ‘‘not likely to be carcinogenic to humans’’ based on the lack of tumorigenic effects in rodent (rat and mice) bioassays at the limit doses and lack of mutagenic effects in the in vitro and in vivo genotoxicity assays. iv. Anticipated residue and PCT information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for nicosulfuron. Tolerance level residues and/or 100 PCT were assumed for all registered and proposed food commodities. E:\FR\FM\24FER1.SGM 24FER1 cprice-sewell on DSK2BSOYB1PROD with RULES Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for nicosulfuron in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of nicosulfuron. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/ oppefed1/models/water/index.htm. Based on the First Index Reservoir Screening Tool (FIRST) for surface water and the Screening Concentration in Ground Water (SCI-GROW) model for ground water, the estimated drinking water concentrations (EDWCs) of nicosulfuron for chronic exposures for non-cancer assessments are estimated to be 0.7 parts per billion (ppb) for surface water and 0.06 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 0.7 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). Nicosulfuron is not registered for any specific use patterns that would result in residential exposure. Therefore, a residential risk assessment was not conducted. 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 nicosulfuron to share a common mechanism of toxicity with any other substances, and nicosulfuron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that nicosulfuron 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 the policy statements released by EPA’s Office of Pesticide VerDate Nov<24>2008 15:09 Feb 23, 2010 Jkt 220001 Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s website at https:// 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 Food Quality Protection Act (FQPA) 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. There is no quantitative or qualitative evidence of increased susceptibility observed following in utero nicosulfuron exposure to rats or rabbits in the prenatal developmental studies or following prenatal/postnatal exposure in young rats in the 2–generation reproduction study. The toxicity database is considered adequate and includes acceptable developmental toxicity studies in the rat and rabbit and a rat reproductive study. There were no developmental or reproductive effects observed in rats, but in rabbits (clinical signs, decreased body weight gain during dosing, increased abortions), postimplantation loss and decreased fetal body weight were observed at the maternal toxicity LOAEL. However, these effects were only observed at maternally toxic doses. 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 nicosulfuron is considered adequate for purposes of assessing human health risk from this emergency exemption use. Available data suggest that nicosulfuron is poorly absorbed and that toxicity is low. Further, data suggest increased pre and/or post natal susceptibility was not observed. ii. The toxicity database for nicosulfuron is generally complete except for more recently required neurotoxicity and immunotoxicity testing requirements. PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 8259 iii. There is no evidence of neurotoxicity or immunotoxicity in the available studies. iv. There are no residual uncertainties with regard to assessing pre-and/or postnatal toxicity. v. There are no residential use patterns for this chemical and the exposure assessments are conservative and will not underestimate risks. 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. None of the toxicology studies available for nicosulfuron indentified an adverse effect resulting from a singleoral exposure; therefore, dietary exposure presents no acute risks of concern. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to nicosulfuron from food and water will utilize <1% of the cPAD for (children 3-5) the population subgroup receiving the greatest exposure. There are no residential uses for nicosulfuron. As explained in the unit regarding residential use patterns, chronic residential exposure to residues of nicosulfuron is not expected, so chronic risk is a function of dietary exposure alone. Thus, the chronic aggregate exposure for the most exposed group is below EPA’s level of concern. 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). Nicosulfuron is not registered for any use patterns that would result in residential exposure. Therefore, the short-term aggregate risk is the sum of E:\FR\FM\24FER1.SGM 24FER1 8260 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations the risk from exposure to nicosulfuron through 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). Nicosulfuron is not registered for any use patterns that would result in intermediate-term residential exposure. Therefore, the intermediate-term aggregate risk is the sum of the risk from exposure to nicosulfuron through food and water, which has already been addressed, and will not be greater than the chronic aggregate risk. 5. Aggregate cancer risk for U.S. population.There is no cancer risk associated with the proposed use. Nicosulfuron is ‘‘not likely to be carcinogenic to humans’’ based on lack of tumorigenic effects in rodent (rats and mice) bioassays at the limit doses and lack of mutagenic effects in the in vitro and in vivo genotoxicity studies. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is reasonable certainty that no harm will result to the general population, or to infants and children, from chronic aggregate exposure to nicosulfuron residues from food and drinking water. V. Other Considerations A. Analytical Enforcement Methodology An adequate enforcement methodology (Ciba-Geigy, AG-499, and High Performance Liquid Chromatography/Ultraviolet (PLC/UV) method)) is available to enforce the time-limited tolerance expression. The method was recommended for inclusion in the Pesticide Analytical Manual Vol. II (PAM II). B. International Residue Limits There are currently no Canadian, Mexican, or Codex maximum residue limits (MRLs) for nicosulfuron on the commodities for which tolerances are being established. cprice-sewell on DSK2BSOYB1PROD with RULES VI. Conclusion Therefore, time-limited tolerances are established for residues of the herbicide nicosulfuron, [3-pyridineccarboxamide, 2-((((4,6-dimethoxypyrimidin-2-yl) aminocarbonyl)aminosulfonyl))-N,Ndimethyl], in or on Bermudagrass, forage and Bermudagrass, hay at 10 ppm and 25 ppm respectively. These tolerances expire and are revoked on December 31, 2011. VerDate Nov<24>2008 15:09 Feb 23, 2010 Jkt 220001 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, 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 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 00022 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: February 5, 2010. Daniel J. Rosenblatt, Acting 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. Section 180.454 redesignate the existing paragraph as paragraph (a) and add paragraph (b) to read as follows: ■ § 180.454 Nicosulfuron; tolerances for residues. ***** (b) Section 18 emergency exemptions. Time-limited tolerances specified in the following table are established for residues of the herbicide nicosulfuron, [3-pyridineccarboxamide, 2-((((4,6dimethoxypyrimidin-2-yl) aminocarbonyl)aminosulfonyl))-N,Ndimethyl], in or on the specified agricultural commodities, resulting from use of the pesticide pursuant to FFIFRA section 18 emergency exemptions. The tolerances expire and are revoked on the date specified in the table. E:\FR\FM\24FER1.SGM 24FER1 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305– 5805. Bermuda grass, forage 10 12/31/11 Bermuda grass, hay ... 25 12/31/11 FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division (7505P), Office of Pesticide Programs, * * * * * Environmental Protection Agency, 1200 [FR Doc. 2010–3673 Filed 2–23–10; 8:45 am] Pennsylvania Ave., NW., Washington, BILLING CODE 6560–50–S DC 20460–0001; telephone number: (703) 305–7390; e-mail address: nollen.laura@epa.gov. ENVIRONMENTAL PROTECTION AGENCY SUPPLEMENTARY INFORMATION: Commodity Parts per million Expiration/ revocation date 40 CFR Part 180 I. General Information [EPA–HQ–OPP–2008–0885; FRL–8810–3] 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. Flumioxazin; Pesticide Tolerances cprice-sewell on DSK2BSOYB1PROD with RULES AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of flumioxazin in or on vegetable, cucurbit, group 9; leaf petioles subgroup 4B; and hop, dried cones. This regulation additionally deletes the existing tolerances on almond and melon, subgroup 9A, as they will be superseded by inclusion in tree nut group 14 and cucurbit vegetable group 9, respectively. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective February 24, 2010. Objections and requests for hearings must be received on or before April 26, 2010, 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–2008–0885. All documents in the docket are listed in the docket index available at https://www.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 in the electronic docket at https://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. VerDate Nov<24>2008 15:09 Feb 23, 2010 Jkt 220001 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 cite at https://www.gpoaccess.gov/ecfr. To access the OPPTS harmonized test guidelines referenced in this document electronically, please go to https:// www.epa.gov/oppts and select ‘‘Test Methods and Guidelines.’’ C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 8261 provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2008–0885 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 April 26, 2010. 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–2008–0885, by one of the following methods: • Federal eRulemaking Portal: https:// 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 Facility’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 April 13, 2009 (74 FR 16866) (FRL–8396–6), 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 8E7462) by IR-4, 500 College Rd. East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.568 be amended by establishing tolerances for residues of the herbicide flumioxazin, 2[7-fluoro-3,4-dihydro-3-oxo-4-(2propynyl)-2 H -1,4-benzoxazin-6-yl]4,5,6,7-tetrahydro-1 H -isoindole-1,3(2 H )-dione, in or on vegetable, cucurbit, group 9 at 0.03 parts per million (ppm); leaf petioles, subgroup 4B at 0.02 ppm; and hop, dried cones at 0.07 ppm. The petition additionally requested that EPA revoke the existing tolerance on almonds, as a tolerance on nut, tree, group 14 has been established; and requested that EPA delete the existing tolerance for melon subgroup 9A, E:\FR\FM\24FER1.SGM 24FER1

Agencies

[Federal Register Volume 75, Number 36 (Wednesday, February 24, 2010)]
[Rules and Regulations]
[Pages 8256-8261]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3673]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

EPA-HQ-OPP-2009-0569; FRL-8812-5


Nicosulfuron; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of nicosulfuron, [3-pyridinecarboxamide, 2-((((4,6-
dimethoxypyrimidin-2-yl) aminocarbonyl) aminosulfonyl))-N,N-dimethyl]; 
in or on Bermudagrass, forage and Bermudagrass, hay. This action is in 
response to EPA granting crisis exemptions to the Texas Department of 
Agriculture and the Oklahoma Department of Agriculture under section 18 
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
authorizing use of the pesticide on Bermudagrass, forage and 
Bermudagrass, hay. This regulation establishes maximum permissible 
levels for residues of nicosulfuron in Bermudagrass and hay. The time-
limited tolerances expire and are revoked on December 31, 2011.

DATES: This regulation is effective February 24, 2010. Objections and

[[Page 8257]]

requests for hearings must be received on or before April 26, 2010, 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-2009-0569. All documents in the 
docket are listed in the docket index available in https://www.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 in the electronic 
docket at https://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open 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: Stacey Groce, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-2505; e-mail address: groce.stacey@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. 
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 Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR cite at https://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), 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. 
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-
2009-0569 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 April 26, 2010.
    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-2009-0569, by one of the following methods:
     Federal eRulemaking Portal: https://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 Facility'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 herbicide nicosulfuron, in 
or on Bermudagrass, forage and Bermudagrass, hay at 10 parts per 
million (ppm) and 25 (ppm) respectively. 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 Code of Federal Regulations (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 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of section 408 of FFDCA 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 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 Nicosulfuron on Bermudagrass Forage and 
Hay and FFDCA Tolerances

    The Texas and Oklahoma Departments of Agriculture requested 
emergency exemptions for use of nicosulfuron on Bermudagrass and hay to 
control field sandbur species, and issued crisis exemptions for this 
use pursuant to 40 CFR part 166, subpart C of FIFRA. The states 
provided information indicating that sandbur species is a serious pest 
that commonly infests Bermudagrass and hay.
    As part of its evaluation of the emergency exemption applications, 
EPA assessed the potential risks presented by residues of nicosulfuron 
in or on Bermudagrass, forage and Bermudagrass, hay. In doing so, EPA

[[Page 8258]]

considered the safety standard in section 408(b)(2) of FFDCA, and EPA 
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 exemptions in 
order to address urgent non-routine situations 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 tolerances remaining in or on Bermudagrass, forage and 
Bermudagrass, hay 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 
nicosulfuron meets FIFRA's registration requirements for use on 
Bermudagrass, forage and Bermudagrass, hay 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 nicosulfuron by a State 
for special local needs under FIFRA section 24(c). Nor do these 
tolerances serve as the basis for persons in any States other than 
Texas and Oklahoma to use this pesticide on the applicable crops under 
FIFRA section 18 absent the issuance of an emergency exemption 
applicable within that State. For additional information regarding the 
emergency exemptions for nicosulfuron, 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 nicosulfuron [3-
pyridinecarboxamide, 2-((((4,6-dimethoxypyrimidin-2-yl) aminocarbonyl) 
aminosulfonyl))-N,N-dimethyl] in or on Bermudagrass, forage and 
Bermudagrass, hay at 10 ppm and 25 ppm respectively. EPA's assessment 
of exposures and risks associated with establishing 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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for nicosulfuron used for 
human risk assessment can be found at https://www.regulations.gov in the 
July 14, 2009 document ``Nicosulfuron: Human Health Risk Assessment for 
Proposed Section 18 Use on Bermudagrass,'' pages 10 and 11 of 30 in 
docket ID number EPA-HQ-OPP-2009-0569.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to nicosulfuron, EPA considered exposure under the time-
limited tolerances established by this action as well as exposures 
pursuant to existing tolerances in (40 CFR 180.454). EPA assessed 
dietary exposures from nicosulfuron in food as follows:
    i. Acute exposure. No acute effects were identified in the 
toxicological studies for nicosulfuron; therefore, a quantitative 
assessment of acute dietary exposure was not conducted.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used tolerance level residues and 100 percent crop 
treated (PCT) assumptions for all registered and proposed commodities.
    iii. Cancer. EPA has classified nicosulfuron as ``not likely to be 
carcinogenic to humans'' based on the lack of tumorigenic effects in 
rodent (rat and mice) bioassays at the limit doses and lack of 
mutagenic effects in the in vitro and in vivo genotoxicity assays.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for nicosulfuron. Tolerance level residues and/or 100 PCT were assumed 
for all registered and proposed food commodities.

[[Page 8259]]

    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for nicosulfuron in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of nicosulfuron. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) for 
surface water and the Screening Concentration in Ground Water (SCI-
GROW) model for ground water, the estimated drinking water 
concentrations (EDWCs) of nicosulfuron for chronic exposures for non-
cancer assessments are estimated to be 0.7 parts per billion (ppb) for 
surface water and 0.06 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 0.7 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).
    Nicosulfuron is not registered for any specific use patterns that 
would result in residential exposure. Therefore, a residential risk 
assessment was not conducted.
    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 nicosulfuron to share a common mechanism of 
toxicity with any other substances, and nicosulfuron does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
nicosulfuron 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 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 https://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 Food Quality 
Protection Act (FQPA) 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. There is no quantitative or 
qualitative evidence of increased susceptibility observed following in 
utero nicosulfuron exposure to rats or rabbits in the prenatal 
developmental studies or following prenatal/postnatal exposure in young 
rats in the 2-generation reproduction study. The toxicity database is 
considered adequate and includes acceptable developmental toxicity 
studies in the rat and rabbit and a rat reproductive study.
    There were no developmental or reproductive effects observed in 
rats, but in rabbits (clinical signs, decreased body weight gain during 
dosing, increased abortions), postimplantation loss and decreased fetal 
body weight were observed at the maternal toxicity LOAEL. However, 
these effects were only observed at maternally toxic doses.
    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 nicosulfuron is considered adequate 
for purposes of assessing human health risk from this emergency 
exemption use. Available data suggest that nicosulfuron is poorly 
absorbed and that toxicity is low. Further, data suggest increased pre 
and/or post natal susceptibility was not observed.
    ii. The toxicity database for nicosulfuron is generally complete 
except for more recently required neurotoxicity and immunotoxicity 
testing requirements.
    iii. There is no evidence of neurotoxicity or immunotoxicity in the 
available studies.
    iv. There are no residual uncertainties with regard to assessing 
pre-and/or postnatal toxicity.
    v. There are no residential use patterns for this chemical and the 
exposure assessments are conservative and will not underestimate risks.

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. None of the toxicology studies available for 
nicosulfuron indentified an adverse effect resulting from a single-oral 
exposure; therefore, dietary exposure presents no acute risks of 
concern.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
nicosulfuron from food and water will utilize <1% of the cPAD for 
(children 3-5) the population subgroup receiving the greatest exposure. 
There are no residential uses for nicosulfuron. As explained in the 
unit regarding residential use patterns, chronic residential exposure 
to residues of nicosulfuron is not expected, so chronic risk is a 
function of dietary exposure alone. Thus, the chronic aggregate 
exposure for the most exposed group is below EPA's level of concern.
    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).
    Nicosulfuron is not registered for any use patterns that would 
result in residential exposure. Therefore, the short-term aggregate 
risk is the sum of

[[Page 8260]]

the risk from exposure to nicosulfuron through 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).
    Nicosulfuron is not registered for any use patterns that would 
result in intermediate-term residential exposure. Therefore, the 
intermediate-term aggregate risk is the sum of the risk from exposure 
to nicosulfuron through food and water, which has already been 
addressed, and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population.There is no cancer 
risk associated with the proposed use. Nicosulfuron is ``not likely to 
be carcinogenic to humans'' based on lack of tumorigenic effects in 
rodent (rats and mice) bioassays at the limit doses and lack of 
mutagenic effects in the in vitro and in vivo genotoxicity studies.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is reasonable certainty that no harm will result 
to the general population, or to infants and children, from chronic 
aggregate exposure to nicosulfuron residues from food and drinking 
water.

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology (Ciba-Geigy, AG-499, and High 
Performance Liquid Chromatography/Ultraviolet (PLC/UV) method)) is 
available to enforce the time-limited tolerance expression. The method 
was recommended for inclusion in the Pesticide Analytical Manual Vol. 
II (PAM II).

B. International Residue Limits

    There are currently no Canadian, Mexican, or Codex maximum residue 
limits (MRLs) for nicosulfuron on the commodities for which tolerances 
are being established.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
the herbicide nicosulfuron, [3-pyridineccarboxamide, 2-((((4,6-
dimethoxypyrimidin-2-yl) aminocarbonyl)aminosulfonyl))-N,N-dimethyl], 
in or on Bermudagrass, forage and Bermudagrass, hay at 10 ppm and 25 
ppm respectively. 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, 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 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: February 5, 2010.
Daniel J. Rosenblatt,
Acting 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 180.454 redesignate the existing paragraph as paragraph (a) 
and add paragraph (b) to read as follows:


Sec.  180.454  Nicosulfuron; tolerances for residues.

     * * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of the 
herbicide nicosulfuron, [3-pyridineccarboxamide, 2-((((4,6-
dimethoxypyrimidin-2-yl) aminocarbonyl)aminosulfonyl))-N,N-dimethyl], 
in or on the specified agricultural commodities, resulting from use of 
the pesticide pursuant to FFIFRA section 18 emergency exemptions. The 
tolerances expire and are revoked on the date specified in the table.

[[Page 8261]]



------------------------------------------------------------------------
                                                     Parts   Expiration/
                     Commodity                        per     revocation
                                                    million      date
------------------------------------------------------------------------
Bermuda grass, forage.............................       10     12/31/11
Bermuda grass, hay................................       25     12/31/11
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-3673 Filed 2-23-10; 8:45 am]
BILLING CODE 6560-50-S
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