Pesticides; tolerances in food, animal feed and raw agricultural products: Kasugamycin,

[Federal Register: September 23, 2005 (Volume 70, Number 184)]

[Rules and Regulations]

[Page 55748-55752]

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

[DOCID:fr23se05-14]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0017; FRL-7736-4]

Kasugamycin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a tolerance forresidues of kasugamycin in or on fruiting vegetables, crop group 8. Arysta Lifescience North American Corporation (previously know as Arvesta Corporation), agent for Hokko Chemical Industry Corporation, 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 September 23, 2005. Objections and requests for hearings must be received on or before November 22, 2005.

ADDRESSES: To submit a written objection or hearing request follow the detailed instructions as provided in Unit VI. of theSUPPLEMENTARY INFORMATION. EPA has established a docket for this action under Docket identification (ID) number OPP-2005-0017. All documents in the docket are listed in the EDOCKET index athttp://www.epa.gov/edocket. 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 Mall2, 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: Mary L. Waller, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-9354; e-mail address: waller.mary@epa.gov.

SUPPLEMENTARY INFORMATION:

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 (http://www.epa.gov/edocket/), you may

      access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180

      is available at E-CFR Beta Site Two 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.gpo/opptsfrs/home/guidelin.htm/ .

2. Background and Statutory Findings

   In the Federal Register of April 8, 2005 (70 FR 17997) (FRL-7704- 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 3E6579) by Arysta Lifescience North American Corporation, 100 First Street, Ste. 1700; San Fransisco, CA 94105; agent for Hokko Chemical Industry Corporation Ltd., 4-20, Nihonbashi Hongochkucho 4 Chome, Chuo- Ku, Tokyo 103-8341, Japan. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of the fungicide kasugamycin, 1L-1,3,4/2,5,6-1-deoxy-2,3,4,5,6-pentahydroxy-cyclohexyl- 2-amino-2,3,4,6-tetradeoxy-4-([[alpha]]-iminoglycino)-[[alpha]]-D- arabino-hexapyranoside, in or on fruiting vegetables (Crop Group 8) at 0.04 parts per million (ppm), tomato juice at 0.06 ppm, tomato puree at 0.06 ppm, and tomato paste at 0.25 ppm. That notice included a summary of the petition prepared by Arysta Life Science North American Corporation, agent for Hokko Chemical Industry Corporation, LLC, the registrant. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C. below.

   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

   [[Page 55749]]

   http://www.epa.gov/pesticides/factsheets/riskassess.htm

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 kasugamycin on fruiting vegetables(Crop Group 8) at 0.04 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 toxic effects caused by kasugamycin 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 at http://www.epa.gov/edocket .

   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. More information can be found on the general principles of EPA uses in risk characterization at http://www.epa.gov/oppfead1/trac/science/.

      A summary of the toxicological endpoints for kasugamycin used for human risk assessment is shown in Table 1 of this unit:

      Table 1.--Summary of Toxicological Dose and Endpoints for kasugamycin for Use in Human Risk Assessment

      Dose Used in Risk Assessment,

      Special FQPA SF and Exposure/Scenario

      Interspecies and Level of Concern for Study and Toxicological Intraspecies and any Risk Assessment

      Effects Traditional UF

      Acute dietary (females 13-50 years of None

      None

      Not Selected age and general population including

      No appropriate dose and infants and children)

      endpoint could beidentified for these population groups

      Chronic dietary (all populations) NOAEL = 11.3 mg/kg/day Special FQPA SF = 1 Combined chronic UF = 100............... cPAD = chronic RfD/ toxicity/oncogenicity Chronic RfD = 0.113 mg/ Special FQPA SF =

      study in rats kg/day.

      0.113 mg/kg/day.

      LOAEL = 116 mg/kg/day based on increased testicular softening and atrophy

      Cancer (oral, dermal, inhalation)

      Classification: No oncogenic potential was noted in the mouse oncogenicity or in the rat combined chronic/carcinogenicity studies; additionally, no mutagenic potential was noted in any of the five mutagenicity studies. Classification of kasugamycin is ``not likely to be carcinogenic to humans.''

   3. Exposure Assessment

      1. Dietary exposure from food and feed uses. This final rule reflects the establishment of the first tolerance for kasugamycin. Since there are no registered uses in the United States, the only exposure expected is from imported foods. Risk assessments were conducted by EPA to assess dietary exposures from kasugamycin 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 kasugamycin; therefore, a quantitative acute dietary exposure assessment is unnecessary. No appropriate dose or endpoint could be identified for acute dietary exposure in the general population or any population subgroup.

         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: The analysis is based on tolerance-level residues (modified by DEEM default processing factors for tomato processed commodities) and the assumption that 100% of the crop will be treated.

         iii. Cancer. The Agency classified kasugamycin as ``not likely to be carcinogenic to humans,'' based on the lack of evidence of carcinogenicity in mice and rats. Therefore, a quantitative cancer exposure assessment was not conducted.

      2. Dietary exposure from drinking water. There is no expectation that kasugamycin residues would occur in surface or ground water sources of drinking water. There are no registered uses of kasugamycin in the United States.

      3. From non-dietary exposure. The term ``residential exposure'' is used in this document to refer to non-

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         occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

         Kasugamycin 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 kasugamycin and any other substances and kasugamycin 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 kasugamycin 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 http://www.epa.gov/pesticides/cumulative/ .

   4. Safety Factor for Infants and Children

      1. In general. Section 408 of FFDCA provides that EPA shall apply an 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 margin of exposure 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. No increased quantitative or qualitative susceptibility was observed in the developmental rat or rabbit studies or in the 2-generation reproduction study. No offspring toxicity was observed at any of the doses tested in these three studies. Reproductive toxicity was noted in the F1 generation of the 2- generation reproduction study. However, because parental toxicity (decreased body weights and body weight gains) occured at a lower dose than that which resulted in effects on reproduction, there is no increased quantitative or qualitative susceptibility of the offspring. The toxicology database for kasugamycin is complete with respect to prenatal and postnatal toxicity and shows no evidence of increased qualitative or quantitative susceptibility in the offspring. Therefore, there are no residual uncertainties for prenatal and/or postnatal toxicity.

      3. Conclusion. There is a complete toxicity data base for kasugamycin and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. Additionally, a developmental neurotoxicity study is not required because there was no evidence of neurotoxicity in any studies. Based on the above information, EPA concludes that it has reliable data that supports the conclusion that it is safe to remove the additional children's safety factor.

   5. Aggregate Risks and Determination of Safety

      1. Acute risk. No appropriate dose or endpoint was identified for acute dietary exposure in the general population or any population subgroup. Therefore, no acute risk is expected from exposure to Kasugamycin.

      2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to kasugamycin from food will utilize