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

[Federal Register: January 7, 2005 (Volume 70, Number 5)]

[Rules and Regulations]

[Page 1349-1357]

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

[DOCID:fr07ja05-18]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0042; FRL-7691-4]

Spinosad; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a tolerance for residues of spinosad in or on grain, cereal, group 15 at 1.5 ppm; grain as aspirated fractions at 200 ppm; rice hulls at 4 ppm; meat of cattle, goats, hogs, horse and sheep at 1.5 ppm; fat of cattle, goats, hogs, horse and sheep at 33 ppm; meat byproducts of cattle, goats, hogs, horse and sheep at 8 ppm; milk at 6 ppm; milk fat at 75 ppm; fat of poultry at 0.5 ppm; meat byproducts of poultry at 0.03 ppm; eggs at 0.05 ppm. EPA is also deleting certain spinosad tolerances that are no longer needed as a result of this action. Dow AgroScience 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 January 7, 2005. Objections and requests for hearings must be received on or before March 8, 2005.

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 OPP-2004-0042. All documents in the docket are listed in the EDOCKET index at http://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 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: George LaRocca, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone number: (703) 308-8587; e-mail address: larocca.george@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 under FOR 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 June 23, 2004 (69 FR 35024) (FRL-7358- 3), 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 3F6754 by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268. The petition requested that 40 CFR 180.495 be amended by establishing a tolerance for residues of the insecticide spinosad, in or on the raw agricultural commodity stored grain (wheat, barley, corn, oats, rice, and sorghum milo) at 1 ppm , soybean, sunflower, peanut, and cotton seed at 1 part per million (ppm); and birdseed at 3 ppm. That notice included a summary of the petition prepared by DowAgroScience LLC, the registrant.

   Based on EPA's review, the petition described in Unit II. was revised by the petitioner (Dow AgroSciences) to propose tolerances for residues of spinosad for cereal grains group at 1.5 ppm; grain as aspirated fractions at 200 ppm; rice hulls at 4 ppm; meat of cattle, goats, hogs, horse and sheep at 1.5 ppm; fat of cattle, goats, hogs, horse and sheep at 33 ppm; meat byproducts of cattle, goats, hogs, horse and sheep at 8 ppm; milk at 6 ppm; milk fat at 75 ppm; fat

   [[Page 1350]]

   of poultry at 0.5 ppm; meat byproducts of poultry at 0.03 ppm; eggs at 0.05 ppm. Residue data on stored seed (soybean, sunflower, cottonseed) and peanuts were not submitted, and thus not considered under this petition. The Agency does not establish tolerances for birdseed commodities.

   EPA is also revising or deleting existing tolerances for spinosad that are superceded or no longer needed, correcting administrative errors in existing tolerances, and updating tolerance terminology as follows:

   1. Tolerances for residues of spinosad in or on barley, grain; buckwheat, grain; corn, grain; corn, pop; corn pop, grain; grain, aspirated fractions; millet, pearl, grain; millet, proso, grain; oat grain; rye, grain; sorghum, grain; stored grains (barley, corn, oats, rice, sorghum/milo, and wheat); teosinte, grain; wheat bran; wheat, flour; wheat, grain; wheat midlings; wheat shorts are being revised or replaced as appropriate to reflect the new commodity terms and tolerance levels specified in Unit II.

   2. Time-limited tolerances established for residues of spinosad in or on beet, sugar, tops at 10 ppm in connection with Section 18 exemption granted by EPA has expired and is being deleted. In a prior action, EPA established a spinosad tolerance for vegetables, leaves of root and tuber, group 2, which covers beet, sugar, tops. Time limited tolerances established for residues of spinosad in/or on coffee beans at 0.02 ppm in connection with an experimental use permit granted by EPA has expired and is being deleted.

   3. Administrative errors in existing tolerances for corn, stover; sorghum, grain stover and wheat straw are being corrected as follows: The existing tolerances for these commodities are repeated more than once in the table in paragraph (a) under Sec. 180.495 and are being deleted.

   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- 5754-7).

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 spinosad on the commodities listed in Unit II. 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. The nature of the toxic effects caused by spinosad as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed- adverse-effect-level (LOAEL) from the toxicity studies reviewed are discussed in the Federal Register of September 27, 2002 (67 FR 60923) (FRL-7199-5).

   2. 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 non-dietary 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\).

      [[Page 1351]]

      Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear 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 spinosad used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of September 27, 2002 (67 FR 60923) (FRL-7199-5).

   3. Exposure Assessment

      1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.495) for the residues of spinosad, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from spinosad in food as follows:

      i. Acute exposure. Acute dietary 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. An endpoint was not identified for acute dietary exposure and risk assessment because no effects were observed in oral toxicity studies including developmental toxicity studies in rats or rabbits that could be attributable to a single dose (exposure). Therefore, an acute dietary exposure assessment was not performed.

      ii. Chronic exposure. In conducting the chronic dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID\T\), 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: A chronic dietary exposure assessment (using tolerance- level residues, DEEM default processing factors, and percent crop treated (CT) information including 10% CT for all proposed commodities) was conducted for the general U.S. population and various population subgroups. The estimated chronic dietary exposures for the U.S. population and all population subgroups, as represented by percent of the chronic Population Adjusted Dose (cPAD), is below EPA's level of concern (