Pesticide Tolerances: Boscalid
Federal Register: September 16, 2009 (Volume 74, Number 178)
Rules and Regulations
Page 47440-47445
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr16se09-5
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180
EPA-HQ-OPP-2008-0624; FRL-8431-1
Boscalid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of boscalid in or on coffee, green bean imported and amends the tolerance for banana, imported. BASF, Inc., requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation is also a removing tolerance for cucumber, and one tolerance for vegetable, root, subgroup 1A, except sugar beet, garden beet, radish, and turnip which are superceded with higher tolerances formerly published in the Federal
Register of March 28, 2008 (73 FR 16553) (FRL-8354-4).
DATES: This regulation is effective September 16, 2009. Objections and requests for hearings must be received on or before November 16, 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-2008-0624. 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: Bryant Crowe, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-0025; e-mail address: crowe.bryant@epa.gov.
SUPPLEMENTARY INFORMATION:
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General Information
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Does this Action Apply to Me?
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
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How Can I Access Electronic Copies of this Document?
In addition to accessing electronically available documents at http://www.regulations.gov, you may access
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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 cite at http://www.gpoaccess.gov/ecfr.
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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-2008-0624 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 16, 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 this copy, identified by docket ID number
EPA-HQ-OPP-2008-0624, 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.
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Petition for Tolerances
In the Federal Register of November 5, 2008 (73 FR 65849) (FRL- 8385-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 8E7366, PP 8E7367) by BASF Corporation, P.O. Box 13528, 26 Davis Drive,
Research Triangle, NC 27709. The petitions requested that 40 CFR 180.589 be amended by increasing the tolerance for residues of the fungicide boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro(1,1'- biphenyl))-2-yl, in or on banana from 0.2 parts per million (ppm) to 0.5 ppm (PP 8E7366), and establishing a tolerance for coffee, green bean at 0.05 ppm (PP 8E7367). That notice referenced a summary of the petitions prepared by BASF Corporation, the registrant, which is available to the public in the docket, http://www.regulations.gov. One comment was received from a private citizen. EPA's response to comment is discussed in Unit IV.C.
Additionally, in this action EPA is correcting an error in a prior tolerance rulemaking for boscalid (73 FR 16553) (March 28, 2008). In that action, EPA amended the boscalid tolerances for cucumber and vegetable, root, subgroup 1A , except sugar beet, garden beet, radish, and turnip by increasing the level of each of those tolerances.
Inadvertently, however, the revised tolerance levels were added to the
CFR without removing the prior tolerances. This action removes the prior tolerances.
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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 section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for residues of boscalid on banana, imported at 0.40 ppm, and coffee, green bean, imported at 0.05 ppm. EPA's assessment of exposures and risks associated with establishing tolerances follow.
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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.
Boscalid has low acute toxicity via the oral, dermal, and inhalation routes of exposure and is not an eye or skin irritant.
Dermal sensitization could not be determined because the skin sensitization study was inadequate. The target organs for boscalid are the thyroid and liver.
An acute endpoint was not selected because no adverse effects attributable to a single exposure to boscalid were seen in the database, including the developmental toxicity studies. The chronic dietary, incidental oral, dermal, and inhalation endpoints were all selected from three co-critical studies: The chronic rat study, the rat carcinogenicity study, and a 1-year feeding study in dogs. The dose selected for regulation of oral, dermal, and inhalation risk at all durations, for all populations, is the ``no- observed-adverse-effect level'' of 21.8 milligrams/kilogram/day (mg/kg/day) based on thyroid and hepatic toxicity seen in rats and dogs at higher dose levels.
Boscalid is classified as exhibiting ``suggestive evidence of carcinogenicity.'' Evidence of carcinogenicity was seen in males
(significant trend, and pair-wise at the high dose) and in females
(trend only) in rats or mice or both; however, in both sexes no malignancies were seen. Only benign tumors were observed, and these occurred at dose levels above the dose level used to establish the chronic population adjusted dose (cPAD). Additionally, there is no concern for mutagencity. EPA has concluded that the cPAD is protective of any tumor response seen in the boscalid cancer studies.
Specific information on the studies received and the nature of the adverse effects caused by boscalid as well as the no-observed-adverse- effect-level (NOAEL) and the lowest-observed-
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adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the ``Boscalid - Human Health Risk
Assessment of the Proposed Food Use of the Fungicide on Imported
Coffee'' on pages 16-21 in docket ID number EPA-HQ-OPP-2008-0624.
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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 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; http://www.epa.gov/oppfead1/trac/ science, and http://www.epa.gov/pesticides/trac/science/aggregate.pdf.
A summary of the toxicological endpoints for boscalid used for human risk assessment can be found at http://www.regulations.gov in the
``Boscalid - Human Health Risk Assessment of the Proposed Food Use of the Fungicide on Imported Coffee'' on pages 6-7 in docket ID number
EPA-HQ-OPP-2008-0624.
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Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to boscalid, EPA considered exposure under the petitioned-for tolerances as well as all existing boscalid tolerances in (40 CFR part 180.589). EPA assessed dietary exposures from boscalid in food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for boscalid; therefore, a quantitative acute dietary exposure assessment was not conducted. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the U.S. Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. As to residue levels in food, EPA made the following assumption for the chronic exposure assessments: The assessment was based on tolerance level residues for existing uses, recommended tolerance levels for banana and coffee, and 100% crop treated assumptions. iii. Cancer. For the reasons set forth in Unit II.A., EPA has concluded that the cPAD is protective of any cancer effects with boscalid. EPA's estimate of chronic exposure as described above is relied upon to evaluate whether any exposure could exceed the cPAD and thus pose a cancer risk. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for boscalid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of boscalid. 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.
The current requests for an increased tolerance in banana, and a new use on coffee, do not affect the estimated drinking water concentrations (EDWCs) because both requests are for tolerances on imported commodities. As a result, the EDWCs used in the previous assessment ``Boscalid - Human Health Risk Assessment to support proposed new uses on fresh herbs (herbs subgroup 19A), avocado, black sapote, canistel, mamey sapote, mango, papaya, sapodilla, star apple and cotton'' on page 15 in docket ID number EPA-HQ-OPP-2008-0624 at http://www.regulations.gov were used in this assessment as well. The
EDWCs were based on the turf use.
Based on the First Index Reservoir Screening Tool (FIRST), and
Screening Concentration in Ground Water (SCI-GROW) models, the EDWCs of boscalid for chronic exposures for non-cancer assessments are estimated to be 29.6 ppb for surface water and 0.63 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 0.029 ppm was used to assess the contribution to drinking water. 3. From non-dietary exposure. The term ``residential exposure'' is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).
Boscalid is currently registered for the following uses that could result in residential exposures: Golf course turf, strawberries, caneberries, and tree fruit grown at ``U-pick'' farms and orchards. EPA assessed residential exposure using the following assumptions: Dermal post-application exposure for golfers exposed to treated turf. The duration of exposure is anticipated to be short-term.
Based on the low vapor pressure of boscalid (7 x 10-9 hPa), the outdoor nature of the uses, and the weight of evidence from available residue studies, the Agency does not anticipate post-application inhalation exposures from the currently approved uses of boscalid.
In addition, U-pick activities are considered to be one-time (
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