Browse: Departments   Dates   Agencies  

CFR Citation: 40 CFR Part 180

OPP ID: [OPP-2004-0075; FRL-7353-1]

NOTICE: RULES

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

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: Boscalid; Pesticide Tolerance

DATES: This regulation is effective April 14, 2004. Objections and requests for hearings, identified by docket ID number OPP20040075, must be received on or before June 14, 2004.

DOCUMENT SUMMARY: This regulation establishes a tolerance for residues of boscalid, 3pyridinecarboxamide, 2chloroN(4'chloro[1,1'biphenyl] 2yl) in or on certain commodies and establishes a tolerance for the residues of boscalid in or on pome fruit crop group, group 11 at 3.0 ppm, apple pomace, wet at 10.0 ppm, hops cones, dried at 35.0 ppm, soybean, vegetable at 2.0 ppm, soybean seed at 0.1 ppm, soybean hulls at 0.2 ppm and aspirated grain fractions at 3.0
[[Page 19768]]
ppm. BASF Corporation requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

SUMMARY: Boscalid,

SUPPLEMENTAL 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 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 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 provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPP20040075. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 3055805.

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://. http://www.gpoaccess.gov/ecfr/, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm/ .

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select ``search,'' then key in the appropriate docket ID number.

II. Background and Statutory Findings

In the Federal Register of November 6, 2003 (68 FR 215) (FRL7321 1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petitions (PP 2F6434 and 3F6580) by BASF Corporation, P.O. Box 13528, Research Triangle Park, North Carolina 277082000. That notice included a summary of the petitions prepared by BASF Corporation, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.589 be amended by establishing a tolerance for residues of the fungicide boscalid in or on pome fruit crop group, group 11 at 3.0 ppm, apple pomace, wet at 20.0 ppm, hops cones, dried at 35.0 ppm, soybean, vegetable at 2.2 ppm, soybean seed at 0.1 ppm, soybean hulls at 0.2 ppm and soybean aspirated grain fractions at 2.5 ppm.

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. * * *''

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL 57547).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with 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, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of boscalid. EPA's assessment of exposures and risks associated with establishing the tolerance follows. This assessment involves adding tolerances for commodities of pome fruit crop group, group 11 at 3.0 ppm, apple pomace, wet at 10.0 ppm, hops cones, dried at 35.0 ppm, soybean, vegetable at 2.0 ppm,
[[Page 19769]]
soybean seed at 0.1 ppm, soybean hulls at 0.2 ppm and soybean aspirated grain fractions at 3.0 ppm.

A. Toxicological Profile

EPA previously 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. The nature of the toxic effects caused by boscalid as well as the noobservedadverseeffectlevel (NOAEL) and the lowestobservedadverseeffectlevel (LOAEL) from the toxicity studies reviewed are discussed in the Federal Register of July 30, 2003 (68 FR 44640) (FRL73196). No new information which would change the toxicological profile has been submitted or reviewed since the analysis.

B. Toxicological Endpoints

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect 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. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.

Three other types of safety or uncertainty factors may be used: ``Traditional uncertainty factors;'' the ``special FQPA safety factor;'' and the ``default FQPA safety factor.'' By the term ``traditional uncertainty factor,'' EPA is referring to those additional uncertainty factors used prior to FQPA passage to account for database deficiencies. These traditional uncertainty factors have been incorporated by the FQPA into the additional safety factor for the protection of infants and children. The term ``special FQPA safety factor'' refers to those safety factors that are deemed necessary for the protection of infants and children primarily as a result of the FQPA. The ``default FQPA safety factor'' is the additional 10X safety factor that is mandated by the statute unless it is decided that there are reliable data to choose a different additional factor (potentially a traditional uncertainty factor or a special FQPA safety factor).

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 100 to account for interspecies and intraspecies differences and any traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor or the default FQPA safety factor is used, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of safety factor.

For nondietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10x to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk). An example of how such a probability risk is expressed would be to describe the risk as one in one hundred thousand (1 x 10\5\), one in a million (1 x 10\6\), or one in ten million (1 x 10 \7\). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this nonlinear approach, a ``point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOEcancer = point of departure/exposures) is calculated.

A summary of the toxicological endpoints for boscalid used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of July 30, 2003 (68 FR 44640) (FRL 73196).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.589) for the residues of boscalid, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from boscalid in food as follows:

i. Acute exposure. Acute dietary risk assessments are performed for a fooduse pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a oneday or single exposure. There were no toxic effects attributable to a single dose. An endpoint of concern was not identified to quantitate acute dietary risk to the general population, including infants and children, or to the subpopulation females 1350 years old. Therefore, there is no acute reference dose (aRfD) or acute populationadjusted dose (aPAD).

ii. Chronic exposure. In conducting the chronic dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEMFCID\TM\), which incorporates food consumption data as reported by respondents in the USDA 19941996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments:

The chronic dietary exposure analysis was performed using two separate models: DEEM FCID\TM\ and Lifeline\TM\. The analysis was based on tolerancelevel residues (in some cases modified by DEEM\TM\ (Version 7.81) default processing factors), and assume 100% crop treated. In both cases, the risk estimates are well below the Agency's level of concern for the general U.S. population and all population subgroups. The results of the DEEMFCID\TM\ and Lifeline\TM\ analyses are comparable. The most highly exposed population subgroup from DEEM\TM\ is children 12 years, which has an exposure estimate of 0.057 mg/kg/day, and utilizes 26% of the cPAD. The most highly exposed population subgroup from Lifeline\TM\ is also children 12 years, which has an exposure estimate of 0.053 mg/kg/day, and utilizes 24% of the cPAD.
[[Page 19770]]
Table 1.Summary of Dietary Exposure and Risk for Boscalid

FOR FURTHER INFORMATION CONTACT Cynthia Giles-Parker, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460 0001; telephone number: (703) 3057740; email address:
gilesparker.cynthia@epa.gov.