Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Spinosad,
[Federal Register: March 8, 2006 (Volume 71, Number 45)]
[Rules and Regulations]
[Page 11519-11526]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08mr06-6]
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2005-0510; FRL-7758-2]
Spinosad; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of Spinosad in/on the following commodities: Alfalfa seed; alfalfa seed screenings; banana; food commodities; animal feed, nongrass, group 18, forage; animal feed, nongrass, group 18, hay; peanut, hay; vegetable, bulb, group 3, except green onion; onion, green; grass, forage, fodder and hay, group 17, forage; grass, forage, fodder and hay, group 17, hay; grain, cereal, group 16, stover, except rice; grain, cereal, group 16, forage, except rice; grain, cereal, group 16, hay, except rice; grain, cereal, group 16, straw, except rice; peppermint, tops; and spearment tops. The Interregional Research Project Number 4 (IR-4)] on behalf of the registrant, Dow AgroScience, LLC requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). In addition, EPA is deleting certain spinosad tolerances that are no longer needed as a result of this action. Also, the term ``Food commodities'' replaces the commodity name ``all commodities in connection with the quarantine eradication programs against exotic, non-indigenous, fruit fly species, where a separate higher tolerance in not already established'' as previously listed under Sec. 180.495(b).
DATES: This regulation is effective March 8, 2006. Objections and requests for hearings must be received on or before May 8, 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-2005-0510. 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: Sidney Jackson, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-7610, e-mail address: jackson.sidney@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:
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.
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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/
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Background and Statutory Findings
In the Federal Register of July 20, 2005 (70 FR 41730)(FRL-7721-6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of several pesticide petitions (PP 3E6699, 3E6780, 3E6782, 3E6802, 3E6804, and 4E6811) by the Interregional Research Project Number 4 (IR-4), 681 U. S. Highway 1 South, North Brunswick, NJ 08902-3390. The petitions requested that 40 CFR 180.495 be amended by establishing a tolerance for residues of the insecticide spinosad, in or on the following raw agricultural commodities (RACs):
PP 3E6699 proposes to establish tolerances for banana and plantain at 0.25 parts per million (ppm).
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PP 3E6780 proposes to establish tolerances for food commodities at 0.02 ppm.
PP 3E6782 proposes to establish tolerances for spearmint, tops at 5.0 ppm and peppermint, tops at 5.0 ppm.
PP 3E6802 proposes to establish tolerances for animal feed, nongrass, group 18, forage at 20 ppm; animal feed, nongrass, group 18 hay at 25 ppm; and peanut, hay at 25 ppm.
PP 3E6804 proposes to establish tolerances for vegetable, bulb, except green onion, group 3 at 0.1 ppm and onion, green at 2.0 ppm.
PP 4E6811 proposes to establish tolerances for: grass, forage, fodder and hay, group 17, forage at 1.5 ppm; grass, forage, fodder and hay, group 17, hay at 5 ppm; corn, field, stover; corn, pop, stover; and corn, sweet, stover at 5.0 ppm; corn, field, forage; corn, sweet, forage; and corn, pop, forage at 1.5 ppm; teosinte, forage at 1.5 ppm; millet, pearl, forage; and millet, proso, forage at 1.5 ppm; millet, pearl, hay; millet, proso, hay; millet proso,straw at 5.0 ppm; sorghum, forage, forage and sorghum, grain, forage at 1.5 ppm; sorghum, forage, hay; and sorghum, grain, stover at 5.0 ppm; wheat, forage at 1.5 ppm; wheat, hay and wheat, straw at 5.0 ppm; barley, straw and barley, hay at 5.0 ppm; rye, forage at 1.5 ppm; rye, straw at 5 ppm; oat, forage at 1.5 ppm; oat, hay and oat, straw at 5.0 ppm; triticale, forage at 1.5 ppm; and triticale, hay at 5.0 ppm.
That notice included a summary of the petition prepared by by Dow AgroSciences, LLC, Indianapolis IN, 46268, the registrant. One comment was received in response to the notice of filing. A discussion of the commenter's concerns is presented in Unit IV. C. - Public Comments.
Several of the proposed petitions described in Unit II. were subsequently amended by the petitioner as follows:
Tolerances for animal feed, nongrass, group 18, forage at 35 ppm; animal feed, nongrass, group 18 hay at 30 ppm; and separate tolerances for alfalfa seed at 0.15 ppm; and alfalfa, seed screenings at 2 ppm; banana at 0.25 ppm; grass, forage, fodder and hay, group 17, forage at 10 ppm; grain, cereal, group 16, stover, except rice at 10 ppm; grain, cereal, group 16, forage, except rice at 2.5 ppm; peppermint, tops at 3.5 ppm; and spearmint, tops at 3.5 ppm. In addition, tolerance for grain, cereal, group 16, stover, except rice at 10 ppm replaces the proposed 5.0 ppm tolerance for corn, field, stover; corn, pop, stover; corn, sweet, stover, and sorghum, grain, stover and the tolerance for grain, cereal, group 16, forage, except rice at 2.5 ppm replaces proposed tolerance of 1.5 ppm for corn, field, forage; corn, pop, forage; corn, sweet, forage; teosinte, forage; millet, pearl, forage; millet, proso, forage; sorghum, forage, forage; sorghum, grain, forage; wheat, forage; rye, forage; oat, forage; and triticale, forage. Tolerance for grain, cereal, group 16, hay, except rice at 10 ppm replaces proposed tolerance of 5.0 ppm for millet, pearl, hay; millet, proso, hay; sorghum, forage, hay; wheat, hay; barley, hay; oat, hay; and triticale, hay. Finally, tolerance for grain, cereal, group 16, straw, except rice at 1.0 ppm replaces proposed tolerance of 5.0 ppm for millet, proso, straw; wheat, straw; barley, straw; rye, straw; and oat, straw.
EPA is also deleting several established tolerances in Sec. 180.495(a) and Sec. 180.495(b) that are no longer needed, as a result of this action.
The tolerance deletions under Sec. 180.495(a) are being replaced by the establishment of the crop group tolerance for grain, cereal, group 16, stover, forage, hay, and straw. The tolerance deletions under Sec. 180.495(b) are time-limited tolerances established under section 18 emergency exemptions that are superceded by the establishment of general tolerances for spinosad under Sec. 180.495(a).
The revisions to Sec. 180.495 are as follows:
Delete the tolerances established under Sec. 180.495(a) for residues of spinosad in or on corn, forage at 1.0 ppm; corn, hay at 1.0 ppm; corn stover at 1.0 ppm; corn straw at 1.0 ppm; sorghum, forage at 1.0 ppm; sorghum, forage, hay at 1.0 ppm; sorghum, grain, stover at 1.0 ppm; sorghum, straw at 1.0 ppm; wheat, forage at 1.0 ppm; wheat, hay at 1.0 ppm and wheat, straw at 1.0 ppm. Tolerances for grain, cereal, group 16, stover, except rice at 10 ppm; grain, cereal, group 16, forage, except rice at 2.5 ppm; grain, cereal, group 16, hay, except rice at 10 ppm; and for grain, cereal, group 16, straw, except rice at 1.0 ppm replace these tolerances by this action under Sec. 180.495 (a).
Delete the time-limited tolerance for all commodities in connection with the quarantine eradication programs against exotic, non- indigenous, fruit fly species, where a separate higher tolerance is not already established at 0.02 ppm; alfalfa, forage at 4.0 ppm; alfalfa, hay at 4.0 ppm; grass, forage at 7.0 ppm; grass, hay at 7.0 ppm; peanut, hay at 10 ppm and onion, dry bulb at 0.10 ppm. Permanent tolerances for food commodities at 0.02 ppm; peanut, hay at 11 ppm; grass, forage, fodder and hay, group 17, forage at 10 ppm; grass, forage, fodder and hay, group 17, hay at 5 ppm; grain, cereal, group 16, stover, except rice at 10 ppm and vegetable, bulb, except green onion, group 3 at 0.1 ppm are established by this action under Sec. 180.495(a).
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 define ``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, at http://www. epa.gov/
fedrgstr/EPA-PEST/1997/ November/Day-26/ p30948.htm.
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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: Alfalfa seed at 0.15 ppm; alfalfa seed screenings at 2.0 ppm; banana at 0.25 parts per million (ppm); food commodities at 0.02 ppm; spearmint, tops at 3.5 ppm; peppermint, tops at 3.5 ppm; animal feed, nongrass, group 18, forage at 35 ppm; animal feed, nongrass, group 18, hay at 30 ppm; alfalfa, seed at 0.15 ppm; alfalfa, seed screenings at 2.0 ppm; peanut, hay at 11 ppm; vegetable, bulb, group 3, except green onion, group 3 at 0.1 ppm; onion, green at 2.0 ppm; grass, forage, fodder and hay, group 17, forage at 10 ppm; grass, forage, fodder and hay, group 17, hay at 5 ppm; grain, cereal, group 16, stover, except rice at 10 ppm; grain, cereal, group 16, forage, except rice at 2.5 ppm; grain, cereal, group 16, hay, except rice at 10 ppm; grain, cereal, group 16, straw, except rice at 1.0 ppm.
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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. 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).
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Toxicological Endpoints
The dose at which 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 UFs may be used: ``Traditional UF`` the ``special FQPA safety factor;'' and the ``default FQPA safety factor.'' By the term ``traditional UF,'' EPA is referring to those additional UF's used prior to FQPA passage to account for database deficiencies. These traditional UFs have been incorporated by the FQPA into the additional safety factor for the protection of infants and children. The term ``pecial 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 UF 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 (aRfD or cRfD) where the RfD is equal to the NOAEL divided by an UF of 100 to account for interspecies and intraspecies differences and any traditional UFs 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). 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 Spinosad Final Rule published in the Federal Register of September 27, 2002 (67 FR 60923) (FRL-199-5).
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Exposure Assessment
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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 RACs. 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 1-day or single exposure. The Agency did not select a dose and endpoint for an acute dietary risk assessment due to the lack of toxicological effects of concern attributable to a single exposure (dose) in studies available in the data base including oral developmental toxicity studies in rats and rabbits. In the acute neurotoxicity study, the NOAEL was 2,000 milligram/kilograms/day (mg/kg/day), highest dose tested. An acute dietary risk assessment is not required.
ii. Chronic exposure. Chronic dietary risk assessments were conducted using the Dietary Exposure Evaluation Model - Food Consumption Intake Database (DEEMTM/FCID), ver. 2.03; acute and cancer endpoints were not identified which incorporates the food consumption data from the U.S. Department of Agriculture Continuing Surveys of Food Intakes by Individuals (CSFII; 1994-1996, and 1998). The chronic dietary analyses assumed average/projected percent crop treated estimates, projected percent head treated resulting from the dermal and premise treatments to ruminants, average field trial residues, experimentally determined processing factors, and anticipated livestock residues. For drinking water, the chronic analyses assumed the modeled tier 1 FIRST chronic surface water estimate resulting from the application of spinosad to turf (highest registered/proposed rate). The chronic analysis used average field trial residues for grape, barley grain, corn grain, oat grain, rice grain, and wheat grain. The chronic analysis also used processing factors from the grape, corn and wheat processing studies. The resulting exposure estimates were 96% the cPAD and are therefore, less than EPA's level of concern (children 1-2 years old were the most highly exposed subpopulation).
iii. Cancer. Spinosad has been classified as not likely to be carcinogenic in humans based on the results of a carcinogenicity study in mice and the combined chronic toxicity and carcinogenicity study in rats. Therefore, a quantitative cancer risk assessment was not performed.
iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels
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anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. As required by section 408(b)(2)(E) of FFDCA, EPA will issue a Data Call- In for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance final rule.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT.
The Agency used PCT information as follows:
The chronic analysis assumed tolerance level residues for all crop, poultry, and egg commodities, and anticipated residues for ruminant and milk commodities. The Agency used PCT information as follows: Almond 5%; apple 30%; apricot 10%; avocado 5%; bean, green 10%; broccoli 40%; cabbage 30%; cantaloupes 10%; cauliflower 45%; celery 50%; cherry 25%; collards 25%; cotton 5%; cucumber 20%; eggplant 15%; green, mustard 15%; green, turnip 5%; kale 30%; citrus (5%; excluding lemon and orange), lemon 10%; lettuce 50%; nectarine 30%; orange 10%; peach 5%; pear 10%; pepper 35%; potato 5%; prune and plum 10%; spinach 30%; squash 10%; strawberry 35%; corn, sweet
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