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Spinosad - Pesticide Petition Filing 5/01

ENVIRONMENTAL PROTECTION AGENCY
[PF-1025; FRL-6785-1]
Notice of Filing Pesticide Petitions to Establish Tolerances for
a Certain Pesticide Chemical in or on Food
AGENCY:  Environmental Protection Agency (EPA).
ACTION:  Notice.
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SUMMARY:  This notice announces the initial filing of pesticide
petitions proposing the establishment of regulations for residues of a
certain pesticide chemical in or on various food commodities.

DATES:  Comments, identified by docket control number PF-1025, must be
received on or before July 6, 2001.

ADDRESSES:  Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure
proper receipt by EPA, it is imperative that you identify docket
control number PF-1025 in the subject line on the first page of your
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Shaja R. Brothers,
Registration Division (7505W), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 308-3194; e-mail address:
brothers.shaja@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

   You may be affected by this action if you are an agricultural
producer, food manufacturer or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                         Examples of
          Categories                 NAICS codes         potentially
                                                      affected entities
------------------------------------------------------------------------
Industry                         111                 Crop production
                                 112                 Animal production
                                 311                 Food manufacturing
                                 32532               Pesticide
                                                      manufacturing
------------------------------------------------------------------------

   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 the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
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 Additional Information, Including Copies of this
Document and Other Related Documents?

   1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select "Laws and
Regulations," "Regulations and Proposed Rules," and then look up the
entry for this document under the "Federal Register--Environmental
Documents." You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/.
   2. In person. The Agency has established an official record for
this action under docket control number PF-1025. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, and other
information related to this action, including any information claimed
as confidential business information (CBI). This official record
includes the documents that are physically located in the docket, as
well as the documents that are referenced in those documents. The
public version of the official record does not include any information
claimed as CBI. The public version of the official record, which
includes printed, paper versions of any electronic comments submitted
during an applicable comment period, is available for inspection in the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

   You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number PF-1013 in the subject line on the
first page of your response.
   1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division(7502C),
 Office of Pesticide Programs (OPP), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
   2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.
   3. Electronically. You may submit your comments electronically by
e-mail to: opp-docket@epa.gov, or you can submit a computer disk as
described above. Do not submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be
identified by docket control number PF-1025. Electronic comments may
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

   Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the person identified under FOR FURTHER INFORMATION
CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

   You may find the following suggestions helpful for preparing your
comments:
   1. Explain your views as clearly as possible.
   2. Describe any assumptions that you used.
   3. Provide copies of any technical information and/or data you used
that support your views.
   4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
   5. Provide specific examples to illustrate your concerns.
   6. Make sure to submit your comments by the deadline in this
notice.
   7. To ensure proper receipt by EPA, be sure to identify the docket
control number assigned to this action in the subject line on the first
page of your response. You may also provide the name, date, and Federal
Register citation.

II. What Action is the Agency Taking?

   EPA has received pesticide petitions as follows proposing the
establishment and/or amendment of regulations for residues of a certain
pesticide chemical in or on various food commodities under section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that these petitions contain data or information
regarding the elements set forth in section 408(d)(2); however, EPA has
not fully evaluated the sufficiency of the submitted data at this time
or whether the data support granting of the petition. Additional data
may be needed before EPA rules on the petitions.

List of Subjects

   Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

   Dated: May 23, 2001.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petitions

   The petitioner summary of the pesticide petitions is printed below
as required by section 408(d)(3) of the FFDCA. The summary of the
petitions was prepared by the petitioner and represents the view of the
petitioner. EPA is publishing the petition summary verbatim without
editing it in any way. The petition summary announces the availability
of a description of the analytical methods available to EPA for the
detection and measurement of the pesticide chemical residues or an
explanation of why no such method is needed.

Interregional Research Project Number 4 (IR-4)

0E6173, 0E6217, 1E6230, 1E6236, 1E6245, 1E6255, 1E6256, and 1E6260

   EPA has received pesticide petitions from the Interregional
Research Project Number 4 (IR-4), P.O. Box 231, Rutgers University, New
Brunswick, NJ 08903 proposing, pursuant to section 408(d) of the FFDCA,
21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing tolerances
for residues of the insecticide, spinosad (spinosyn A and spinosyn D)
in or on the following raw agricultural commodities (RACs):
   1. 0E6173 proposes the establishment of tolerances for the pome
fruit group at 0.2 parts per million (ppm), and foilage of legume
vegetables at 8.0 ppm.
   2. 0E6217 proposes the establishment of a tolerance for asparagus
at 0.02.
   3. 1E6230 proposes the establishment of tolerances for tree nut
group, and pistachio at 0.02 ppm.
   4. 1E6236 proposes the establishment of a tolerance for okra at 0.4
ppm.
   5. 1E6245 proposes the establishment of tolerances for beet
(garden) roots and beet (sugar) roots at 0.1 ppm, cranberry at 0.01
ppm, and the leaves of root and tuber vegetable group at 10 ppm.
   6. 1E6255 proposes the establishment of tolerances for the
bushberry group, juneberry, lingonberry, and salal at 0.25 ppm.
   7. 1E6256 proposes the establishment of a tolerance for globe
artichoke at 0.3 ppm.
   8. 1E6260 proposes the establishment of a tolerance for strawberry
at 0.75 ppm.

A. Residue Chemistry

   1. Plant metabolism. The metabolism of spinosad in plants and
animals are adequately understood for the purposes of these tolerances.
   2.  Analytical method. There is a practical method (immun. assay)
for detecting (0.005 ppm) and measuring (0.01 ppm) levels of spinosad
in or on food with a limit of detection that allows monitoring of food
with residues at or above the level set for these tolerances. The
method has had a successful method tryout in EPA's laboratories.
   3. Magnitude of residues. The magnitude of residues are adequately
understood for the purposes of these tolerances.

B. Toxicological Profile

   1. Acute toxicity. Spinosad has low acute toxicity. The rat oral
lethal dose (LD)50 is 3,738 milligrams/kilograms (mg/kg)
(males) and > 5,000 mg/kg (females); mouse oral LD50 is >5,000 mg/
kg; rabbit dermal LD50 is >5,000 mg/kg; and rat inhalation
lethal concentration (LC)50 is >5.18 mg/L air. In addition,
spinosad is not a skin sensitizer in guinea pigs and does not produce
significant dermal or ocular irritation in rabbits.
   2. Genotoxicity. Short-term assays for genotoxicity consisting of a
bacterial reverse mutation assay (Ames test), in vitro assay for
cytogenetic damage using the Chinese hamster ovary cells, mammalian
gene mutation assay using mouse lymphoma cells, DNA damage and repair
in rat hepatocytes, and an in vivo cytogenetic assay in the mouse bone
marrow (micronucleus test) have been conducted with spinosad. These
studies show a lack of genotoxicity.
   3. Reproductive and developmental toxicity. Spinosad caused
decreased body weights in maternal rats given 200 mg/kg/day by gavage
highest dose tested (HDT). This was not accompanied by either embryo,
fetal, or developmental toxicity. The no observed adverse effect level
(NOAEL) for maternal and fetal toxicity in rats were 50 and 200 mg/kg/
day, respectively. A developmental study in rabbits showed that
spinosad caused decreased body weight gain and a few abortions in
maternal rabbits given 50 mg/kg/day HDT. Maternal toxicity was not
accompanied by either embryo, fetal, or developmental toxicity. The
NOAEL for maternal and fetal toxicity in rabbits were 10 and 50 mg/kg/
day, respectively. In a 2-generation reproduction study in rats,
parental toxicity was observed in both males and females given 100 mg/
kg/day HDT. Perinatal effects (decreased litter size and pup weight) at
100 mg/kg/day were attributed to maternal toxicity. The NOAEL for
maternal and pup effects was 10 mg/kg/day.
   4. Subchronic toxicity. Spinosad was evaluated in 13-week dietary
studies and showed the following NOAELs: 4.89 and 5.38 mg/kg/day,
respectively for male/female dogs; 6 and 8 mg/kg/day, respectively for
male/female mice; and 33.9 and 38.8 mg/kg/day, respectively for male/
female rats. No dermal irritation or systemic toxicity occurred in a
21-day repeated dose dermal toxicity study in rabbits given 1,000 mg/
kg/day.
   5. Chronic toxicity. Based on chronic testing with spinosad in the
dog and the rat, EPA has set a reference dose (RfD) of 0.027 mg/kg/day
for spinosad. The RfD has incorporated a 100-fold safety factor to the
NOAELs found in the chronic dog study to account for interspecies and
intraspecies variation. The NOAELs shown in the dog chronic study were
2.68 and 2.72 mg/kg/day, respectively for male and female dogs. The
NOAELs (systemic) shown in the rat chronic/carcinogenicity/
neurotoxicity study were 9.5 and 12.0 mg/kg/day, respectively for male
and female rats. There was no evidence of carcinogenicity in an 18-
month mouse feeding study and a 24-month rat feeding study at all
dosages tested. The NOAELs shown in the mouse carcinogenicity study
were 11.4 and 13.8 mg/kg/day, respectively for male and female mice. A
maximum tolerated dose was achieved at the HDT in both of these studies
based on excessive mortality. Thus, the doses tested are adequate for
identifying a cancer risk. Accordingly, a cancer risk assessment is not
needed.
   6. Animal metabolism. There were no major differences in the
bioavailability routes, rates of excretion, or metabolism of spinosyn A
and spinosyn D following oral administration in rats. Urine and fecal
excretions were almost completed in 48-hours post-dosing. In addition,
the routes and rates of excretion were not affected by repeated
administration.
   7. Metabolite toxicology. The residue of concern for tolerance
setting purposes is the parent material (spinosyn A and spinosyn D).
Thus, metabolite toxicity is not applicable.
   8. Endocrine disruption. There is no evidence to suggest that
spinosad has an effect on any endocrine system.

C. Aggregate Exposure

   1. Dietary exposure--i. Food. Previously for the purposes of
assessing potential dietary exposure from use of spinosad on RACs
proposed within this petition as well as from other existing spinosad
crop uses, a Tier I assessment was conducted using 100% crop treated
and use of tolerance values within the residue file. However, with the
proposal of several new uses including proposals from IR-4, a refined
and more realistic assessment is needed. Information on average
residues, market share and when available processing factors (specific
to spinosad and commodities) has been used to estimate dietary burden
of individual commodities. The theoretical maximum residue contribution
(TMRC) is obtained by multiplying estimated residue levels by the
consumption data which estimates the amount of crops and related food
consumed by various population subgroups. The use of average residues
and market share results in a refinement of the human exposure and a
safety determination for the use of spinosad on crops cited in this
summary that is based on a conservative exposure assessment.
   ii. Drinking water. Based on the available environmental studies
conducted with spinosad, its properties show little or no mobility in
soil. Therefore, no anticipated exposure to residues of spinosad in
drinking water is expected. In addition, no Maximum Concentration Level
(MCL) has been established.
   2. Non-dietary exposure. Spinosad is currently registered for
outdoor use on turf and ornamentals at low rates of application (0.04
to 0.54 lb active ingredient per acre) and indoor use for drywood
termite control (extremely low application rates used with no occupant
exposure expected). Localized baits for fire ants again at low rates
are also available. Thus, the potential for non-dietary exposure to the
general population is considered negligible.

D. Cumulative Effects

   There is no reliable information to indicate that toxic effects
produced by spinosad would be cumulative with those of any other
pesticide chemical. Thus, it is appropriate to consider only the
potential risks of spinosad in an aggregate exposure assessment.

E. Safety Determination

   1. U.S. population. Using the refined exposure assumptions and the
RfD, the aggregate exposure to spinosad use on existing crop uses
utilizes 5.5% of the RfD for the U.S. population. EPA generally has no
concern for exposures below 100% of the RfD because the RfD represents
the level at or below which daily aggregate dietary exposure over a
lifetime will not pose appreciable risks to human health. The new crop
uses proposed have been included in this refined dietary assessment.
Thus, it is clear that there is reasonable certainty that no harm will
result from aggregate exposure to spinosad residues on existing and all
pending crop uses listed in this notice.
   2. Infants and children. In assessing the potential for additional
sensitivity of infants and children to residues of spinosad, data from
developmental toxicity studies in rats and rabbits and a 2-generation
reproduction study in the rat are considered. The developmental
toxicity studies are designed to evaluate adverse effects on the
developing organism resulting from pesticide exposure during prenatal
development. Reproduction studies provide information relating to
effects from exposure to the pesticide on the reproductive capability
and potential systemic toxicity of mating animals and on various
parameters associated with the well-being of pups.
   FFDCA section 408 provides that EPA may apply an additional safety
factor for infants and children in the case of
threshold effects to account for prenatal and postnatal toxicity and
the completeness of the data base. Based on the current toxicological
data requirements, the data base for spinosad relative to prenatal and
postnatal effects for children is complete. Further, for spinosad, the
NOAELs in the dog chronic feeding study which was used to calculate the
RfD (0.027 mg/kg/day) are considerably lower than the NOAELs from the
developmental studies in rats and rabbits by a factor of more than 10-
fold.
   Concerning the reproduction study in rats, the pup effects shown at
the HDT were attributed to maternal toxicity. Therefore, it is
concluded that an additional uncertainty factor is not needed and that
the RfD at 0.027 mg/kg/day is appropriate for assessing risk to infants
and children.
   In addition, the EPA has determined that the 10X factor to account
for enhanced sensitivity of infants and children is not needed because:
(1) The data provided no indication of increased susceptibility of rats
or rabbits to in utero and/or postnatal exposure to spinosad; (2) no
neurotoxic signs have been observed in any of the standard required
studies conducted; (3) the toxicology data base is complete and there
are no data gaps; and (4) exposure data are complete or are estimated
based on data that reasonably account for potential exposure.
   Using the exposure assumptions, the percent dietary RfD utilized by
the aggregate exposure to residues of spinosad on existing crop
utilizes 15% of the chronic population adjusted dose (cPAD) for
children 1 to 6 years old, the most sensitive population subgroup. The
new crop uses have been included in this assessment. Thus, based on the
completeness and reliability of the toxicity data and the exposure
assessment, it is concluded that there is a reasonable certainty that
no harm will result to infants and children from aggregate exposure to
spinosad residues on the proposed uses including existing crop uses.

F. International Tolerances

   There are no Codex maximum residue levels established for residues
of spinosad at this time.