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


[Federal Register: March 29, 2006 (Volume 71, Number 60)]

[Rules and Regulations]

[Page 15612-15617]

From the Federal Register Online via GPO Access []



40 CFR Part 180

[EPA-HQ-OPP-2004-0328; FRL-7769-6]

Fenhexamid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a tolerance for residues of fenhexamid in or on ginseng and pear. The Interregional Research Project 4 (IR-4), Center for Minor Crop Pest Management requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective March 29, 2006. Objections and requests for hearings must be received on or before May 30, 2006.

ADDRESSES: To submit a written objection or hearing request follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. EPA has established a docket for this action under Docket identification (ID) number EPA-HQ-OPP-2004-0328. All documents in the

[[Page 15613]]

docket are listed on the web site. (EDOCKET, EPA's

electronic public docket and comment system was replaced on November 25, 2005, by an enhanced Federal-wide electronic docket management and comment system located at Follow the on-

line instructions.) Although listed in the index, some information is not publicly available, i.e., 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 either electronically in EDOCKET or in hard copy at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. Bell St., 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) 305- 5805.

FOR FURTHER INFORMATION CONTACT: Maria I. Rodriguez, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001; telephone number: (703) 305-6710; e-mail


  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:

      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 underFOR FURTHER INFORMATION CONTACT.

    2. How Can I Access Electronic Copies of this Document and Other Related Information?

      In addition to using EDOCKET (, you may

      access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at A frequently updated electronic version of 40 CFR part 180

      is available on E-CFR Beta Site Two at

  2. Background and Statutory Findings

    In the Federal Register of August 27, 2004 (69 FR 52684) (FRL-7675- 2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 3E6799) by The Interregional Research Project 4 (IR-4), Center for Minor Crop Pest Management, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390. The petition requested that 40 CFR 180.553 be amended by establishing a tolerance for residues of the fungicide fenhexamid, in or on apple, wet pomace at 25 parts per million (ppm) and fruit, pome, group 11 at 10 ppm. That notice included a summary of the petition prepared by IR-4, the registrant. Comments were received from one individual in New Jersey opposing and objecting the establishment of tolerances for residues of fenhexamid. The individual criticized IR-4's involvement in the pesticide registration as well as EPA's way of conducting pesticide registration. EPA's response to the public comments received is in Unit IV. of this document. It should be noted that the petition for apple, wet pomace will be addressed at a later time in another ruling.

    In the Federal Register of November 30, 2005 (70 FR 71838)(FRL- 7735-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4E6859 and PP 4E6860) by The Interregional Research Project 4 (IR-4), Center for Minor Crop Pest Management, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390. The petition requested that 40 CFR 180.553 be amended by establishing a tolerance for residues of the fungicide fenhexamid, in or on cilantro (as part of crop subgroup 4A) at 30 ppm, ginseng at 0.3 ppm, non-bell pepper at 0.02 ppm, and pomegranate at 3.0 ppm. That notice included a summary of the petition prepared by IR-4, the registrant. It should be noted that the petition for cilantro, non-bell pepper, and pomegranate will be addressed at a later time in another ruling.

    Currently, there is an expired time-limited tolerance for fenhexamid in or on pears that is still listed in the CFR. As part of this final rule, EPA is taking the ministerial action of removing that expired tolerance.

    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 the FFDCA and a complete description of the risk assessment process, see .

  3. 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 fenhexamid in/on ginseng at 0.3 ppm and pear at 10 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

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    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 toxic effects caused by fenhexamid as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies can be found in the Federal Register of April 13, 2000 (65 FR 19842) (FRL-6553-7).

    2. Toxicological Endpoints

      For hazards that have a threshold below which there is no appreciable risk, 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.

      The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases.

      A summary of the toxicological endpoints for fenhexamid used for human risk assessment is discussed in Unit III.B. of the final rule published in theFederal Register of September 26, 2003 (68 FR 55513) (FRL-7326-7).

    3. Exposure Assessment

      1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.553) for the residues of fenhexamid, in or on a variety of raw agricultural commodities. There are existing permanent tolerances (40 CFR 180.553(a)) for fenhexamid in/on almond, hull (2.0 ppm), almond (0.02 ppm), bushberry subgroup 13B (5.0 ppm), caneberry subgroup 13A (20.0 ppm), cucumber (2.0 ppm), fruit, stone, group 12, except plum, prune, fresh, postharvest (10.0 ppm), grape (4.0 ppm), grape, raisin (6.0 ppm), juneberry (5.0 ppm), kiwifruit, postharvest (15.0 ppm), leafy greens, subgroups 4A, except spinach (30.0), lingonberry (5.0 ppm), pistachio (0.02 ppm), plum, prune, dried (2.5 ppm), plum, prune, fresh (1.5 ppm), salal (5.0 ppm), strawberry (3.0 ppm), vegetable, fruiting, group 8, except nonbell pepper (2.0 ppm). Risk assessments were conducted by EPA to assess dietary exposures from fenhexamid 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 one-day or single exposure.

        No such effects were identified in the toxicological studies for fenhexamid; therefore, a quantitative acute dietary exposure assessment is unnecessary.

        ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 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: Tolerance level residues, 100% crop treated (CT) and incorporating estimated exposure concentrations (EECs). Default processing factors were used for all commodities. This represents an unrefined conservative approach for quantifying risk. For chronic dietary risk, HED's level of concern is >100% chronic population adjusted dose (cPAD).

        iii. Cancer. EPA has classified fenhexamid as a ``not likely'' human carcinogen based on the lack of evidence of carcinogenicity in male and female rats as well as in male and female mice and on the lack of genotoxicity in an acceptable battery of mutagenicity studies. Therefore, a quantitative cancer dietary exposure assessment was not performed.

      2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for fenhexamid 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 physical characteristics of fenhexamid.

        Based on the FQPA Index Reservoir Screening Tool (FIRST), or the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/ EXAMS), and Screening Concentrations in Groundwater (SCI-GROW) models, the EECs of fenhexamid for acute exposures are estimated to be 29 parts per billion (ppb) for surface water and 0.0007 ppb for ground water. The EECs for chronic exposures are estimated to be 1.14 ppb for surface water and 0.0007 ppb for ground 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).

        Fenhexamid is not registered for use on any sites that would result in residential exposure.

      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 fenhexamid and any other substances and fenhexamid 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 fenhexamid 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 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

    4. Safety Factor for Infants and Children

      1. In general. Section 408 of FFDCA provides that EPA shall apply an

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        additional 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 data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. 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 safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate.

      2. Prenatal and postnatal sensitivity. Fenhexamid is not acutely toxic, neurotoxic, carcinogenic or mutagenic and is not a developmental or reproductive toxicant. There is low concern for prenatal and/or postnatal toxicity resulting from exposure to fenhexamid. (See Federal Register of September 26, 2003 (68 FR 55513) (FRL-7326-7). In addition, there are no concerns for developmental neurotoxicity resulting from exposure to fenhexamid.

      3. Conclusion. Because there is a complete toxicity data base for fenhexamid, and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures, and there is low concern for prenatal or postnatal toxicity, the additional 10X safety factor has been removed. (See September 26, 2003).

    5. Aggregate Risks and Determination of Safety

      1. Acute risk. An acute risk assessment was not performed. No toxicological endpoint attributable to a single (acute) dietary exposure was identified. Therefore, acute risk from exposure to fenhexamid is not expected.

      2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to fenhexamid from food will utilize 10% of the cPAD for the U.S. population, 0.55% of the cPAD for all infants