Quinclorac; Pesticide Tolerance for Emergency Exemption, 51485-51490 [E9-24188]

Download as PDF Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations 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). XII. 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. erowe on DSK5CLS3C1PROD with RULES Dated: September 29, 2009. G. Jeffrey Herndon, 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: ■ VerDate Nov<24>2008 15:23 Oct 06, 2009 Jkt 220001 Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.920, the table is amended by adding alphabetically the following inert ingredient to read as follows: ■ § 180.920 Inert ingredients used preharvest; exemptions from the requirement of a tolerance. * * * * * Inert ingredients * * * Ammonium chloride (CAS Reg. No. 12125–02–9) * * * Limits * * * * Uses * * Carrier/ nutrient * * [FR Doc. E9–24161 Filed 10–6–09; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 Quinclorac; Pesticide Tolerance for Emergency Exemption AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a time-limited tolerance for residues of quinclorac in or on cranberry. This action is in response to EPA’s granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on cranberries. This regulation establishes a maximum permissible level for residues of quinclorac in this food commodity. The time-limited tolerance expires and is revoked on December 31, 2012. DATES: This regulation is effective October 7, 2009. Objections and requests for hearings must be received on or before December 7, 2009, 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–2009–0518. All documents in the docket are listed in the docket index available in http://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 Frm 00039 Fmt 4700 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 http://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: 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 [EPA–HQ–OPP–2009–0518; FRL–8434–3] PO 00000 51485 Sfmt 4700 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 Access Electronic Copies of this Document? In addition to accessing electronically available documents 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 E:\FR\FM\07OCR1.SGM 07OCR1 51486 Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations through the Government Printing Office’s e-CFR cite at http:// www.gpoaccess.gov/ecfr. erowe on DSK5CLS3C1PROD with RULES 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–2009–0518 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 December 7, 2009. 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–2009–0518, 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 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 a timelimited tolerance for residues of the herbicide quinclorac, 3,7-dichloro-8- VerDate Nov<24>2008 15:23 Oct 06, 2009 Jkt 220001 quinolinecarboxylic acid, in or on cranberries at 15.0 parts per million (ppm). This time-limited tolerance expires and is revoked on December 31, 2012. 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 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 Quinclorac on Cranberries and FFDCA Tolerances The Massachusetts Department of Agriculture Resources (MDAR) requested the use of quinclorac through PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 an emergency exemption to control dodder on cranberries. According to MDAR, dodder is a serious and devastating pest in commercial cranberry production. The MDAR stated that currently available herbicides are inadequate for dodder control and growers have experienced at least a 50% yield loss due to dodder infestation. After having reviewed the submission, EPA determined that emergency conditions exist for this State, and that the criteria for an emergency exemption are met. EPA has authorized under FIFRA section 18 the use of quinclorac on cranberries for control of dodder in Massachusetts. As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of quinclorac in or on cranberries. In doing so, EPA considered the safety standard in section 408(b)(2) of FFDCA, and EPA decided that the necessary tolerance 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 this tolerance 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, 2012, 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 cranberries 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 quinclorac meets FIFRA’s registration requirements for use on cranberries or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of quinclorac by a State for special local needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for persons in any State other than E:\FR\FM\07OCR1.SGM 07OCR1 Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations Massachusetts to use this pesticide on these crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for quinclorac, contact the Agency’s Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT. erowe on DSK5CLS3C1PROD with RULES IV. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .’’ Consistent with the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure expected as a result of this emergency exemption request and the time-limited tolerance for residues of quinclorac on cranberries at 15.0 ppm. 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 VerDate Nov<24>2008 15:23 Oct 06, 2009 Jkt 220001 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 quinclorac used for human risk assessment can be found at http://www.regulations.gov in the document Quinclorac. Human Health Risk Assessment for the Proposed Food/ Feed Use of the Herbicide (Associated with Section 18 Registation) on Cranberries in Massachusetts, pages 14– 41 in docket ID number EPA–HQ–OPP– 2009–0518. B. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to quinclorac, EPA considered exposure under the time-limited tolerances established by this action as well as all existing quinclorac tolerances in (40 CFR 180.463). EPA assessed dietary exposures from quinclorac in food as follows: i. Acute exposure. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994–1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed 100 percent crop-treated (% CT) and tolerance-level residues for all agricultural commodities. Default PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 51487 processing factors from Dietary Exposure Evaluation Model (DEEM) 7.81 were used (for dried beef and cranberry juice) in the analyses. ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used the food consumption data from the USDA 1994– 1996 and 1998 CSFII. As to residue levels in food, EPA assumed 100% CT, along with tolerance-level residues for all agricultural commodities. Default processing factors from DEEM 7.81 were used (for dried beef and cranberry juice) in the analyses. iii. Cancer. Based on an evaluation under the 1986 Agency Cancer Assessment Guidelines and the results of carcinogenicity studies in rats and mice, EPA has classified quinclorac as ‘‘not classifiable as to carcinogenicity to humans.’’ The results indicate that there was equivocal evidence of an increase in the incidence of pancreatic acinar cell adenomas in the male rat only, and no increase in female rats nor in mice. A quantification of cancer risk is not warranted because the chronic reference dose is approximately 1,200-fold lower than the dose that induced the benign pancreatic tumors. Therefore, EPA considers the chronic assessment to be protective of potential cancer impacts. iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for quinclorac. Tolerance level residues and/or 100% CT were assumed for all food commodities. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for quinclorac in drinking water. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics of quinclorac. 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 modified Tier I Provisional Cranberry Model (PRZM and EXAMS models are not based on typical properties of cranberry bogs, which involves flooding) and Screening Concentration in Ground Water (SCIGROW) models, the estimated drinking water concentrations (EDWCs) of quinclorac for acute exposures and chronic exposures for non-cancer assessments are estimated to be 0.077 parts per billion (ppb) and 0.070 ppb, respectively, for surface water and 0.019 ppb for both acute and chronic (noncancer) ground water. E:\FR\FM\07OCR1.SGM 07OCR1 erowe on DSK5CLS3C1PROD with RULES 51488 Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For both acute and chronic dietary risk assessment, the water concentration value of 0.077 ppb was used to assess the contribution to drinking water. Conservative assumptions used in these model estimates help ensure that the outputs are protective of most environments associated with agricultural uses; thus, the estimates are expected to exceed peak values found in the environment in most cases. 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). Quinclorac is currently registered for the following use that could result in residential exposures: turf and lawns. EPA assessed residential exposure using the following assumptions for toddlers: i. Five percent of the application rate has been used to calculate the day-zero turf transferable residue (TTR) levels used for assessing risks from hand-tomouth exposures, since quincloracspecific turf transferable residue study data are not available; ii. Twenty percent of the application rate has been used to calculate the dayzero turf transferable residue (TTR) residue levels used for assessing risks from object-to-mouth exposures (a higher percent transfer has been used for object-to-mouth behaviors, because it involves a teething action believed to be more analogous to DFR/leaf wash sample collection, where 20% is also used); iii. Three year-old toddlers are expected to weigh 15 kilograms (representing an average weight from years 1 to 6); iv. Hand-to-mouth exposures are based on a frequency of 20 events/hour, and a surface area per event of 20 square centimeters, representing the palm-side surfaces of three fingers; v. Saliva extraction efficiency is 50%, meaning that every time the hand goes in the mouth, approximately half of the residues on the hand are removed; vi. Object-to-mouth exposures are based on a 25 square centimeter surface area; vii. Exposure durations for turfgrass scenarios are estimated to be 2 hours, based on information in HED’s Exposure Factors Handbook; and viii. Soil residues are contained in the top centimeter, and soil density is 0.67 milliliters per gram. 4. Cumulative effects from substances with a common mechanism of toxicity. VerDate Nov<24>2008 15:23 Oct 06, 2009 Jkt 220001 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 quinclorac to share a common mechanism of toxicity with any other substances, and quinclorac does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that quinclorac 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 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 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 qualitative evidence of increased prenatal and/or postnatal susceptibility and, due to the marginal nature of the effects observed on pup viability in the multigeneration reproductive toxicity study, no residual uncertainties with regard to prenatal toxicity following in utero exposures of rats or rabbits to quinclorac (developmental toxicity studies), and prenatal and/or postnatal exposure of rats to quinclorac (reproductive toxicity study) at the estimated aggregate exposure levels. Furthermore, the exposure levels selected for use in risk assessment are measurably lower than the NOAEL from the multigeneration PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 study, and therefore protective against the marginal effects seen in pups. 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 quinclorac is sufficiently complete to inform the determination for the FQPA safety factor. Although recent changes to 40 CFR part 158 make acute and subchronic neurotoxicity testing (OPPTS Harmonized Guideline 870.6200), and immunotoxicity testing (OPPTS Harmonized Guideline 870.7800) required for pesticide registration, the available data for quinclorac do not show the potential for immunotoxic nor neurotoxic effects. However, future registration actions may require additional toxicity studies. ii. There is no indication that quinclorac is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity for purposes of this time-limited tolerance. iii. There is no evidence that quinclorac 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. EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to quinclorac in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by quinclorac. 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 E:\FR\FM\07OCR1.SGM 07OCR1 erowe on DSK5CLS3C1PROD with RULES Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations product of all applicable UFs is not exceeded. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to quinclorac will occupy less than 1% of the aPAD for females age 13 to 49, the population group receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to quinclorac from food and water will utilize 3% of the cPAD for children 1 to 2 years of age, the population group receiving the greatest exposure, while the general U.S. population utilizes 2% of the cPAD. Quinclorac is not expected to pose a chronic dietary risk for the general population (including infants and children). The chronic risk estimates for all populations, resulting from aggregate exposure to quinclorac in food and drinking water, is below EPA’s chronic LOC, and therefore not of concern. 3. Short-term and intermediate-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). 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). Because short- and intermediate-term exposure may occur as a result of quinclorac use in residential settings, both assessments were based on toddler exposure from an oral route: hand-to-mouth, object-tomouth, and incidental soil ingestion. The oral MOEs for residential postapplication exposure of toddlers range from 6,300 to 1,800,000. The combined MOE of 5,000 is greater than the LOC. These values are greater than the LOC (100) for the short-term and intermediate-term risk assessment and therefore not of concern. The postapplication exposure scenarios from the use on turf represent worst-case estimates of exposure and risk. To evaluate short- and intermediate-term aggregate risk, EPA has included the post-application combined MOE (5,000) with the MOE derived from chronic dietary exposure estimates (to reflect background dietary exposure). The behaviors associated with postapplication exposures are applicable to toddlers, so only those age groups (infants, children 1–2 years of age, and children 3–5 years of age) have been assessed for short- and intermediateterm aggregate risk. Aggregate MOEs are VerDate Nov<24>2008 15:23 Oct 06, 2009 Jkt 220001 all greater than 100 (MOEs range from 2,900 to 2,700), and are therefore below EPA’s short-term and intermediate-term LOC. 4. Aggregate cancer risk for U.S. population. Quinclorac has been classified as ‘‘not classifiable as to carcinogenicity to humans.’’ Therefore, aggregate cancer risk from quinclorac is not of concern. 5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to quinclorac residues. V. Other Considerations A. Analytical Enforcement Methodology Adequate analytical methods, utilizing gas chromatography with electron capture detection (GC/ECD), are available to enforce the tolerance expression on plant (BASF Method A8902; MRID# 41063537) and animal (BASF Method 268/1; MRID# 41063536) commodities. Both methods have undergone successful Agency method validation trials, and have been submitted to FDA for publication in PAM II as the tolerance enforcement methods. The limit of quantitation (LOQ) for both methods is 0.05 ppm in all matrices. Furthermore, FDA has reported that quinclorac can be detected by Multiresidue Protocol B. No additional data are needed. B. International Residue Limits There are currently no established Codex, Canadian, or Mexican maximum residue limits for residues of quinclorac in/on cranberry. VI. Conclusion Therefore, a time-limited tolerance is established for residues of quinclorac, 3,7-dichloro-8-quinolinecarboxylic acid, in or on cranberry at 15.0 ppm. This tolerance expires and is revoked on December 31, 2012. VII. Statutory and Executive Order Reviews This final rule establishes a tolerance under sections 408(e) and 408(l)(6) of FFDCA. 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 PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 51489 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 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). 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 E:\FR\FM\07OCR1.SGM 07OCR1 51490 Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations 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: September 25, 2009. Lois Rossi, Acting Director, 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 180.463 is amended by revising paragraph (b) to read as follows: ■ § 180.463 Quinclorac; tolerances for residues. * * * * * (b) Section 18 emergency exemptions. Time-limited tolerances specified in the following table are established for residues of quinclorac, 3,7-dichloro-8quinolinecarboxylic acid in or on the specified agricultural commodities, resulting from use of the pesticide pursuant to FIFRA section 18 emergency exemptions. The tolerances expire and are revoked on the date specified in the table. Parts per million Commodity Cranberry .......... * * * 15.0 * Expiration/ revocation date 12/31/12 * [FR Doc. E9–24188 Filed 10–06–09; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY erowe on DSK5CLS3C1PROD with RULES 40 CFR Part 180 [EPA–HQ–OPP–2008–0713; FRL–8793–2] Pyraclostrobin; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: VerDate Nov<24>2008 16:50 Oct 06, 2009 Jkt 220001 SUMMARY: This regulation establishes tolerances for combined residues of pyraclostrobin and its desmethoxy metabolite, expressed as parent compound, in or on coffee, bean, green at 0.3 parts per million (ppm; this is a new import tolerance); fruit, stone, group 12 at 2.5 ppm (this is an increase in the existing domestic tolerance); sorghum, grain, forage at 5.0 ppm; sorghum, grain, grain at 0.60 ppm; and sorghum, grain, stover at 0.80 ppm (the sorghum tolerances are new domestic tolerances). BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective October 7, 2009. Objections and requests for hearings must be received on or before December 7, 2009, 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–2008–0713. All documents in the docket are listed in the docket index available at http://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 http://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: John Bazuin, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–7381; e-mail address: bazuin.john@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may potentially be affected by this action if you are an agricultural producer, food manufacturer, or PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 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. B. How Can I Access Electronic Copies of this Document? In addition to accessing electronically available documents 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 e-CFR site at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http:// www.epa.gov/opptsfrs/home/ guidelin.htm. 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 provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2008–0713 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 December 7, 2009. 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 E:\FR\FM\07OCR1.SGM 07OCR1

Agencies

[Federal Register Volume 74, Number 193 (Wednesday, October 7, 2009)]
[Rules and Regulations]
[Pages 51485-51490]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24188]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0518; FRL-8434-3]


Quinclorac; Pesticide Tolerance for Emergency Exemption

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule

-----------------------------------------------------------------------.


SUMMARY:  This regulation establishes a time-limited tolerance for 
residues of quinclorac in or on cranberry. This action is in response 
to EPA's granting of an emergency exemption under section 18 of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing 
use of the pesticide on cranberries. This regulation establishes a 
maximum permissible level for residues of quinclorac in this food 
commodity. The time-limited tolerance expires and is revoked on 
December 31, 2012.

DATES:  This regulation is effective October 7, 2009. Objections and 
requests for hearings must be received on or before December 7, 2009, 
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-2009-0518. All documents in the 
docket are listed in the docket index available in http://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 http://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:  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 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 electronically available documents 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

[[Page 51486]]

through the Government Printing Office's e-CFR cite 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), 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-
2009-0518 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 December 7, 2009.
    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-2009-0518, 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 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 a 
time-limited tolerance for residues of the herbicide quinclorac, 3,7-
dichloro-8-quinolinecarboxylic acid, in or on cranberries at 15.0 parts 
per million (ppm). This time-limited tolerance expires and is revoked 
on December 31, 2012. 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 Quinclorac on Cranberries and FFDCA 
Tolerances

    The Massachusetts Department of Agriculture Resources (MDAR) 
requested the use of quinclorac through an emergency exemption to 
control dodder on cranberries. According to MDAR, dodder is a serious 
and devastating pest in commercial cranberry production. The MDAR 
stated that currently available herbicides are inadequate for dodder 
control and growers have experienced at least a 50% yield loss due to 
dodder infestation. After having reviewed the submission, EPA 
determined that emergency conditions exist for this State, and that the 
criteria for an emergency exemption are met. EPA has authorized under 
FIFRA section 18 the use of quinclorac on cranberries for control of 
dodder in Massachusetts.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of quinclorac in 
or on cranberries. In doing so, EPA considered the safety standard in 
section 408(b)(2) of FFDCA, and EPA decided that the necessary 
tolerance 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 this tolerance 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, 
2012, 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 
cranberries 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 
quinclorac meets FIFRA's registration requirements for use on 
cranberries or whether permanent tolerances for this use would be 
appropriate. Under these circumstances, EPA does not believe that this 
time-limited tolerance decision serves as a basis for registration of 
quinclorac by a State for special local needs under FIFRA section 
24(c). Nor does this tolerance serve as the basis for persons in any 
State other than

[[Page 51487]]

Massachusetts to use this pesticide on these crops under FIFRA section 
18 absent the issuance of an emergency exemption applicable within that 
State. For additional information regarding the emergency exemption for 
quinclorac, contact the Agency's Registration Division at the address 
provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with the factors specified in FFDCA section 
408(b)(2)(D), EPA has reviewed the available scientific data and other 
relevant information in support of this action. EPA has sufficient data 
to assess the hazards of and to make a determination on aggregate 
exposure expected as a result of this emergency exemption request and 
the time-limited tolerance for residues of quinclorac on cranberries at 
15.0 ppm. 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 http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for quinclorac used for 
human risk assessment can be found at http://www.regulations.gov in the 
document Quinclorac. Human Health Risk Assessment for the Proposed 
Food/Feed Use of the Herbicide (Associated with Section 18 Registation) 
on Cranberries in Massachusetts, pages 14-41 in docket ID number EPA-
HQ-OPP-2009-0518.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to quinclorac, EPA considered exposure under the time-limited 
tolerances established by this action as well as all existing 
quinclorac tolerances in (40 CFR 180.463). EPA assessed dietary 
exposures from quinclorac in food as follows:
    i. Acute exposure. In estimating acute dietary exposure, EPA used 
food consumption information from the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII). As to residue levels in food, EPA 
assumed 100 percent crop-treated (% CT) and tolerance-level residues 
for all agricultural commodities. Default processing factors from 
Dietary Exposure Evaluation Model (DEEM) 7.81 were used (for dried beef 
and cranberry juice) in the analyses.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA assumed 100% CT, 
along with tolerance-level residues for all agricultural commodities. 
Default processing factors from DEEM 7.81 were used (for dried beef and 
cranberry juice) in the analyses.
    iii. Cancer. Based on an evaluation under the 1986 Agency Cancer 
Assessment Guidelines and the results of carcinogenicity studies in 
rats and mice, EPA has classified quinclorac as ``not classifiable as 
to carcinogenicity to humans.'' The results indicate that there was 
equivocal evidence of an increase in the incidence of pancreatic acinar 
cell adenomas in the male rat only, and no increase in female rats nor 
in mice. A quantification of cancer risk is not warranted because the 
chronic reference dose is approximately 1,200-fold lower than the dose 
that induced the benign pancreatic tumors. Therefore, EPA considers the 
chronic assessment to be protective of potential cancer impacts.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for quinclorac. Tolerance level residues and/or 100% 
CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for quinclorac in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of quinclorac. 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 modified Tier I Provisional Cranberry Model (PRZM and 
EXAMS models are not based on typical properties of cranberry bogs, 
which involves flooding) and Screening Concentration in Ground Water 
(SCI-GROW) models, the estimated drinking water concentrations (EDWCs) 
of quinclorac for acute exposures and chronic exposures for non-cancer 
assessments are estimated to be 0.077 parts per billion (ppb) and 0.070 
ppb, respectively, for surface water and 0.019 ppb for both acute and 
chronic (non-cancer) ground water.

[[Page 51488]]

    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For both acute and chronic 
dietary risk assessment, the water concentration value of 0.077 ppb was 
used to assess the contribution to drinking water. Conservative 
assumptions used in these model estimates help ensure that the outputs 
are protective of most environments associated with agricultural uses; 
thus, the estimates are expected to exceed peak values found in the 
environment in most cases.
    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). Quinclorac is 
currently registered for the following use that could result in 
residential exposures: turf and lawns. EPA assessed residential 
exposure using the following assumptions for toddlers:
    i. Five percent of the application rate has been used to calculate 
the day-zero turf transferable residue (TTR) levels used for assessing 
risks from hand-to-mouth exposures, since quinclorac-specific turf 
transferable residue study data are not available;
    ii. Twenty percent of the application rate has been used to 
calculate the day-zero turf transferable residue (TTR) residue levels 
used for assessing risks from object-to-mouth exposures (a higher 
percent transfer has been used for object-to-mouth behaviors, because 
it involves a teething action believed to be more analogous to DFR/leaf 
wash sample collection, where 20% is also used);
    iii. Three year-old toddlers are expected to weigh 15 kilograms 
(representing an average weight from years 1 to 6);
    iv. Hand-to-mouth exposures are based on a frequency of 20 events/
hour, and a surface area per event of 20 square centimeters, 
representing the palm-side surfaces of three fingers;
    v. Saliva extraction efficiency is 50%, meaning that every time the 
hand goes in the mouth, approximately half of the residues on the hand 
are removed;
    vi. Object-to-mouth exposures are based on a 25 square centimeter 
surface area;
    vii. Exposure durations for turfgrass scenarios are estimated to be 
2 hours, based on information in HED's Exposure Factors Handbook; and
    viii. Soil residues are contained in the top centimeter, and soil 
density is 0.67 milliliters per gram.
    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 quinclorac to share a common mechanism of 
toxicity with any other substances, and quinclorac does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
quinclorac 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 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 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 qualitative 
evidence of increased prenatal and/or postnatal susceptibility and, due 
to the marginal nature of the effects observed on pup viability in the 
multigeneration reproductive toxicity study, no residual uncertainties 
with regard to prenatal toxicity following in utero exposures of rats 
or rabbits to quinclorac (developmental toxicity studies), and prenatal 
and/or postnatal exposure of rats to quinclorac (reproductive toxicity 
study) at the estimated aggregate exposure levels. Furthermore, the 
exposure levels selected for use in risk assessment are measurably 
lower than the NOAEL from the multigeneration study, and therefore 
protective against the marginal effects seen in pups.
    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 quinclorac is sufficiently complete to 
inform the determination for the FQPA safety factor. Although recent 
changes to 40 CFR part 158 make acute and subchronic neurotoxicity 
testing (OPPTS Harmonized Guideline 870.6200), and immunotoxicity 
testing (OPPTS Harmonized Guideline 870.7800) required for pesticide 
registration, the available data for quinclorac do not show the 
potential for immunotoxic nor neurotoxic effects. However, future 
registration actions may require additional toxicity studies.
    ii. There is no indication that quinclorac is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity for purposes of this time-
limited tolerance.
    iii. There is no evidence that quinclorac 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. EPA made conservative (protective) assumptions in the ground 
water and surface water modeling used to assess exposure to quinclorac 
in drinking water. EPA used similarly conservative assumptions to 
assess post-application exposure of children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by quinclorac.

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

[[Page 51489]]

product of all applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to quinclorac will occupy less than 1% of the aPAD for females age 13 
to 49, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
quinclorac from food and water will utilize 3% of the cPAD for children 
1 to 2 years of age, the population group receiving the greatest 
exposure, while the general U.S. population utilizes 2% of the cPAD. 
Quinclorac is not expected to pose a chronic dietary risk for the 
general population (including infants and children). The chronic risk 
estimates for all populations, resulting from aggregate exposure to 
quinclorac in food and drinking water, is below EPA's chronic LOC, and 
therefore not of concern.
    3. Short-term and intermediate-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). 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). Because short- and intermediate-term exposure may 
occur as a result of quinclorac use in residential settings, both 
assessments were based on toddler exposure from an oral route: hand-to-
mouth, object-to-mouth, and incidental soil ingestion. The oral MOEs 
for residential post-application exposure of toddlers range from 6,300 
to 1,800,000. The combined MOE of 5,000 is greater than the LOC. These 
values are greater than the LOC (100) for the short-term and 
intermediate-term risk assessment and therefore not of concern. The 
post-application exposure scenarios from the use on turf represent 
worst-case estimates of exposure and risk. To evaluate short- and 
intermediate-term aggregate risk, EPA has included the post-application 
combined MOE (5,000) with the MOE derived from chronic dietary exposure 
estimates (to reflect background dietary exposure). The behaviors 
associated with post-application exposures are applicable to toddlers, 
so only those age groups (infants, children 1-2 years of age, and 
children 3-5 years of age) have been assessed for short- and 
intermediate-term aggregate risk. Aggregate MOEs are all greater than 
100 (MOEs range from 2,900 to 2,700), and are therefore below EPA's 
short-term and intermediate-term LOC.
    4. Aggregate cancer risk for U.S. population. Quinclorac has been 
classified as ``not classifiable as to carcinogenicity to humans.'' 
Therefore, aggregate cancer risk from quinclorac is not of concern.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children, from aggregate 
exposure to quinclorac residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate analytical methods, utilizing gas chromatography with 
electron capture detection (GC/ECD), are available to enforce the 
tolerance expression on plant (BASF Method A8902; MRID 
41063537) and animal (BASF Method 268/1; MRID 41063536) 
commodities. Both methods have undergone successful Agency method 
validation trials, and have been submitted to FDA for publication in 
PAM II as the tolerance enforcement methods. The limit of quantitation 
(LOQ) for both methods is 0.05 ppm in all matrices. Furthermore, FDA 
has reported that quinclorac can be detected by Multiresidue Protocol 
B. No additional data are needed.

B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican 
maximum residue limits for residues of quinclorac in/on cranberry.

VI. Conclusion

    Therefore, a time-limited tolerance is established for residues of 
quinclorac, 3,7-dichloro-8-quinolinecarboxylic acid, in or on cranberry 
at 15.0 ppm. This tolerance expires and is revoked on December 31, 
2012.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under sections 408(e) and 
408(l)(6) of FFDCA. 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 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).

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

[[Page 51490]]

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: September 25, 2009.
Lois Rossi,
Acting Director, 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 180.463 is amended by revising paragraph (b) to read as 
follows:


Sec.  180.463  Quinclorac; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of 
quinclorac, 3,7-dichloro-8-quinolinecarboxylic acid in or on the 
specified agricultural commodities, resulting from use of the pesticide 
pursuant to FIFRA section 18 emergency exemptions. The tolerances 
expire and are revoked on the date specified in the table.

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
Cranberry.....................................         15.0     12/31/12
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-24188 Filed 10-06-09; 8:45 am]
BILLING CODE 6560-50-S