Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Quinclorac,

[Federal Register: September 28, 2007 (Volume 72, Number 188)]

[Rules and Regulations]

[Page 55068-55073]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr28se07-13]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0191; FRL-8149-5]

Quinclorac; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a tolerance for residues of quinclorac in or on imported barley grain. BASF Corporation requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 28, 2007. Objections and requests for hearings must be received on or before November 27, 2007, 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-2006-0191. To access the electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where indicated and select the ``Submit'' button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available 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: Hope Johnson, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-5410; e-mail address: johnson.hope@epa.gov.

SUPPLEMENTARY INFORMATION:

[[Page 55069]]

1. General Information

   1. 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), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

      Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.

      Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.

      Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

      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.

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

      In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov , you may access this Federal Register document

      electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr. You may also access a

      frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.

   3. Can I File an Objection or Hearing Request?

      Under section 408(g) of the FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0191 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before November 27, 2007.

      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-2006-0191, by one of the following methods:

      Federal eRulemaking Portal: http://www.regulations.gov.

      Follow the on-line instructions for submitting comments.

      Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

      Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

2. Petition for Tolerance

   In the Federal Register of August 16, 2006 (71 FR 47216) (FRL-7776- 6), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0E6114) by BASF Corporation, 26 Davis Dr., P.O. Box 13528, Research Triangle Park, NC 27709-3528. The petition requested that 40 CFR 180.463 be amended by establishing a tolerance for residues of the herbicide quinclorac, 3,7-dichloro-8-quinoline carboxylic acid, in or on imported barley grain at 1.5 parts per million (ppm). That notice referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the

   notice of filing.

   Based upon review of the data supporting the petition, EPA has determined it appropriate to establish the tolerance for residues of the herbicide quinclorac in or on imported barley grain at 2.0 ppm. The reason for these changes is explained in Unit IV.C.

3. Aggregate Risk Assessment and Determination of Safety

   Section 408(b)(2)(A)(i) of the 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 the 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 the 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....'' These provisions were added to the FFDCA by the Food Quality Protection Act (FQPA) of 1996.

   Consistent with section 408(b)(2)(D) of the FFDCA, and the factors specified in section 408(b)(2)(D) of the 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 for the petitioned-for tolerance for residues of quinclorac on imported barley grain at 2.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

   1. Toxicological Profile

      EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by quinclorac as well as the no-observed- adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect- level (LOAEL) from the toxicity studies are discussed in the final rule published in the Federal Register of March 26, 1999 (64 FR 14626) (FRL- 6069-5).

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   2. Toxicological Endpoints

      For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern (LOC) is derived from 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) is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the LOC 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 risks by comparing aggregate 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 LOC by all applicable UFs. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded.

      For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm .

      A summary of the toxicological endpoints for quinclorac used for human risk assessment is shown in the following Table of this unit.

      Summary of Toxicological Dose and Endpoints for Quinclorac for Use in Human Risk Assessment

      Dose Used in Risk Assessment,

      FQPA SF and Level of Exposure/Scenario

      Interspecies and

      Concern for Risk Study and Toxicological Intraspecies and any

      Assessment

      Effects Traditional FQPA, SF

      Acute dietary (Females 13-49 years of NOAEL = 200 milligram/ FQPA SF = 1x aPAD = Developmental toxicity age)

      kilogram/day (mg/kg/ acute RfD / FQPA SF = study in rabbits LOAEL day) UF = 100Acute 2.0 mg/kg/day

      = 600 mg/kg/day based reference dose (RfD) =

      on increased early 2.0 mg/kg/day

      resorptions and postimplantation loss, decreased live fetuses, decreased fetal weight.

      Chronic dietary (All populations) NOAEL= 37.5 mg/kg/day FQPA SF = 1x cPAD = Dietary carcinogenicity UF = 100Chronic RfD chronic RfD / FQPA SF in mice LOAEL = 150 mg/ =0.38 mg/kg/day

      = 0.38 mg/kg/day

      kg/day based on decreased body weight

      Incidental Oral Short-term (1-30 NOAEL = 70 mg/kg/day FQPA SF = 0.38 LOC for Developmental toxicity days) and Intermediate-term (1-6

      MOE = 100

      study in rabbits LOAEL months)

      (Residential)

      = 200 mg/kg/day based on decreased maternal body weight gain and food consumption (and increased water consumption)

      Dermal (All durations)

      Not applicable. A dermal endpoint was not selected because an appropriate endpoint was not available (no dermal toxicity at limit dose of 1,000 mg/ kg/day in 21-day dermal toxicity study).

      Short-term inhalation (1 to 30 days) NOAEL= 70 mg/kg/day FQPA SF = 0.38 LOC for Developmental toxicity and Intermediate-term inhalation (1- (inhalation absorption MOE = 100

      study in rabbits. 6 months)

      rate = 100% relative (Residential)

      LOAEL = 200 mg/kg/day to oral absorption)

      based on decreased maternal body weight gain and food consumption (and increased water consumption.

      Long-term inhalation (>6 months)

      Not applicable. Long-term inhalation exposure is not anticipated under current use scenarios.

      Cancer (Oral, dermal, inhalation)

      Classification: ``Not classifiable as to carcinogenicity to humans'' based on an equivocal increase in pancreatic acinar cell adenomas in the male rat only and no increases in female rats or in mice.

   3. Exposure Assessment

      1. Dietary exposure from food and feed uses. In evaluating dietary exposure to quinclorac, EPA considered exposure under the petitioned- for tolerances 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. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

         In estimating acute dietary exposure, EPA used food consumption information from the U.S. 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 all foods for which there are tolerances were treated and contain tolerance-level residues. Percent crop treated and/or anticipated residues were not used.

         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 all foods for which there are tolerances were treated and contain tolerance-level residues. Percent crop treated and/or anticipated residues were not used.

      2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for quinclorac in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of quinclorac. Further information regarding EPA drinking water models used in pesticide exposure assessment

         [[Page 55071]]

         can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

         Based on the Pesticide Root Zone Model /Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI- GROW) models, the estimated drinking water concentrations (EDWCs) of quinclorac for acute exposures are estimated to be 22.9 parts per billion (ppb) for surface water and 29 ppb for ground water. The EDWCs for chronic exposures are estimated to be 14.5 ppb for surface water and 29 ppb for ground water. The EDWCs were directly entered into the dietary exposure model (DEEM-FCID(\TM\)).

      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 residential non-dietary sites: Ornamental plantings and turfgrass. EPA assessed residential post-application exposure using the following assumptions:

         i. Five percent of the application rate has been used to calculate the day-zero turf transferable residue (TTR) residue levels used for assessing risk 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 risk 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 percent is also used).

         iii. Three year old toddlers are expected to weigh 15 kilograms (representing an average weight from years one to six)

         iv. Hand-to-mouth exposures are based on a frequency of 20 events/ hour and a surface area per event of 20 cm2, representing the palmar surfaces of three fingers.

         v. Saliva extraction efficiency is 50 percent meaning that every time the hand goes in the mouth approximately [frac12] of the residues on the hand are removed.

         vi. Object-to-mouth exposures are based on 25 cm2 surface area.

         vii. Exposures durations for turfgrass scenarios are estimated to be 2 hours based on information in HED's Exposure Factors Handbook.

         viii. Soil residues are contained in the top centimeter and soil density is 0.67 mL/gram.

      4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of the 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.''

         Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to quinclorac and 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 not assumed that quinclorac has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

   4. Safety Factor for Infants and Children

      1. In general. Section 408 of the FFDCA provides that EPA shall apply an additional (``10X'') tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional UFs and/or special FQPA safety factors, as appropriate.

      2. Prenatal and postnatal sensitivity. There is no evidence of increased pre- and/or postnatal susceptibility from exposure to quinclorac. Offspring effects were only noted at or above maternally toxic dose levels.

      3. Conclusion. EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings:

      i. The toxicity database for quinclorac is complete for the purposes of this action.

      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.

      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. The dietary food exposure assessments were performed based on 100% crop treated and tolerance-level residues. Conservative ground and surface water modeling estimates were used. Similarly conservative Residential SOPs were used to assess post-application exposure to children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by quinclorac.

   5. Aggregate Risks and Determination of Safety

      Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the 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