Spinosad; Time-Limited Pesticide Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: June 12, 2002 (Volume 67, Number 113)]
[Rules and Regulations]
[Page 40196-40203]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jn02-12]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0099; FRL-7182-1]
RIN 2070-AB78

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for
residues/combined residues of spinosad in or on stored grains (barley,
corn, oats, rice, sorghum/milo, and wheat). Dow AgroSciences LLC
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act (FQPA) of 1996.
The tolerance will expire on May 31, 2004. This time-limited tolerance
is to permit the marketing of stored grains in accordance with the
Experimental Use Permit (EUP) 62719-EUP-50 which is being issued
concurrently.

DATES: This regulation is effective June 12, 2002. Objections and
requests for hearings, identified by docket ID number
OPP-2002-0099, must be received on or before August 12,
2002.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number
OPP-2002-0099 in the subject line on the first page of your
response.

FOR FURTHER INFORMATION CONTACT: By mail: William G. Sproat, Jr.,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: 703-308-8587; e-
mail address: sproat.william@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

[[Page 40197]]

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/. A
frequently updated electronic version of 40 CFR part 180 is available
at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under
development. To access the OPPTS Harmonized Guidelines referenced in
this document, go directly to the guidelines at http://www.epa.gov/
opptsfrs/home/guidelin.htm.
2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0099. The
official record consists of the documents specifically referenced in
this action, 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 Hwy.,
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.

II. Background and Statutory Findings

In the Federal Register of December 14, 2001 (66 FR 64819)
(FRL-6813-5), EPA issued a notice pursuant to section 408
of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA of 1996 (Public
Law 104-170), announcing the filing of a pesticide petition (PP
1G6348) by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN
46268. This notice included a summary of the petition prepared by Dow
AgroSciences, the registrant. There were no comments received in
response to the notice of filing.
The petition requested that 40 CFR 180.495 be amended by
establishing a tolerance for residues of the insecticide spinosad, in
or on stored grains (barley, corn, oats, rice, sorghum/milo, and wheat)
at 1 part per million (ppm). The tolerance will expire on May 31, 2004.
On the basis of the information furnished by Dow AgroSciences, an EUP
has been issued for the pesticide under section 5 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. This
permit authorizes the use of 700 pounds of the insecticide on stored
grains for 1 year in the States of Arkansas, Georgia, Indiana, Kansas,
Oklahoma, Minnesota, and Montana.
Section 408(b)(2)(A)(i) of the 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) 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) 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 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances November 26, 1997 (62 FR 62961) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D), 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), for a tolerance for residues of spinosad on stored grains
(barley, corn, oats, rice, sorghum/milo, and wheat) at 1 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerance follows.

A. 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 are
discussed in Unit III.A. of the Federal Register of September 23, 1999
(64 FR 51451) (FRL-6381-9).

B. 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

[[Page 40198]]

interspecies differences and 10x for intraspecies differences.
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 the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, 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 FQPA 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 is expressed as 1 x 10-6
or one in a million). 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 (MOE_cancer = point of departure/exposures) is
calculated. A summary of the toxicological endpoints for spinosad used
for human risk assessment is shown in the following Table 1:

Table 1. Summary of Toxicological Doses and Endpoints for Spinosad for Use in Dietary Exposure Assessment
----------------------------------------------------------------------------------------------------------------
Exposure Scenario Dose (mg/kg/day) Endpoint Study
----------------------------------------------------------------------------------------------------------------
Acute dietary None No appropriate endpoint
available; risk
assessment not
required
----------------------------------------------------------------------------------------------------------------
Chronic dietary NOEL = 2.68 Systemic toxicity Chronic toxicity - dog
UF = 100...............
----------------------------------------------------------------------------------------------------------------
FQPA SF = 1x RfD = 0.027 mg/kg/day
cPAD = 0.027 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
Short-term (dermal) None No appropriate endpoint
available. No dermal
absorption expected
based on lack of
toxicity at 2,000 mg/
kg/day as well as
molecular structure
and size.
----------------------------------------------------------------------------------------------------------------
Intermediate-term (dermal) None No appropriate endpoint
available. No dermal
absorption expected
based on lack of
toxicity at 2,000 mg/
kg/day as well as
molecular structure
and size.
----------------------------------------------------------------------------------------------------------------
Long-term (dermal) None No appropriate endpoint
available; use pattern
does not indicate a
need for this risk
assessment.
----------------------------------------------------------------------------------------------------------------
Inhalation (any time period) None The low toxicity, use
pattern and
application rate does
not indicate a need
for risk assessment
via this route.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA.
FQPA SF = Safety factor to account for enhanced sensitivity of infants and children as required by the FQPA of
1996
cPAD = Chronic Population Adusted Dose = RfD FQPA SF

EPA's FQPA Safety Factor Committee met on April 26, 1999, and
recommended that the 10x Safety Factor to account for enhanced
sensitivity of infants and children be reduced to 1x (i.e., removed).
Thus, the chronic FQPA PAD is 0.027 mg/kg/day and is equivalent to the
chronic RfD.

C. 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. Spinosad is registered for use
on a variety of agricultural commodities. Due to a section 18 use for
control of Mediterranean fruit fly, tolerances for residues of spinosad
have been established for all agricultural commodities not covered by
other registrations. Risk assessments were conducted by EPA to assess
dietary exposures from spinosad in food as follows:

[[Page 40199]]

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. 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 this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEMTM)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1989-1992 nationwide Continuing Surveys
of Food Intake by Individuals (CSFII) and accumulated exposure to the
chemical for each commodity. The 1989-92 data are based on the
reported consumption of more than 10,000 individuals over three
consecutive days, and therefore, represent more than 30,000 unique
"person days" of data. Foods "as consumed"
(e.g., apple pie) are linked to raw agricultural commodities and their
food forms (e.g., apples-cooked/canned or wheat-flour) by recipe
translation files internal to the DEEM software. Consumption data
averaged for the entire U.S. population and within populationn
subgroups for chronic exposure assessment, but are retained as
individual consumption events for acute exposure assessment.
Dietary risk assessment incorporates both exposure and toxicity of
a given pesticide. For acute and chronic assessments, the risk is
expressed as a percentage of a maximum acceptable dose. This is the
population adjusted dose (PAD), which EPA has concluded will result in
no unreasonable adverse health effects. The PAD is the Reference Dose
(RfD) divided by the FQPA 10x Safety Factor. Dietary risk is expressed
as a percentage of the PAD. EPA is concerned when estimated dietary
risk exceeds 100% of the PAD.
For chronic exposure and risk assessment, an estimate of the
residue level in each food or food-form (e.g., orange or orange-juice)
on the commodity residue list is multiplied by the average daily
consumption estimate for that food/food form. The resulting residue
consumption estimate for each food/food form is summed with the residue
consumption estimates for all other food/food forms on the commodity
residue list to arrive at the total average estimated exposure.
Exposure is expressed in mg/kg body weight/day and as a percent of the
cPAD. This procedure is performed for each population subgroup.
EPA notes that there is a degree of uncertainty in extrapolating
exposures for certain population subgroups which may not be
sufficiently represented in the consumption surveys (e.g., nursing and
non-nursing infants or Hispanic females). Therefore, risks estimated
for these subpopulations were included in representative populations
having sufficient numbers of survey respondents (e.g., all infants or
females 13-50 years).
In conducting the chronic dietary risk assessment, EPA made very
conservative assumptions: 100% of the various agricultural commodities
having spinosad tolerances will contain spinosad residues and those
residues will be at the level of the established tolerance. The RfD
used for the chronic dietary risk assessment is 0.027 mg/kg/day and is
equivalent to the cPAD, since the 10x FQPA Safety Factor has been
reduced to 1x. The chronic assessment for the final application rate on
stored grains of 1 ppm results in risk estimates that are below EPA's
level of concern for all population subgroups. The risk estimate for
the population subgroup made up of children 1-6 years is 84.4% of
the cPAD. Risk estimates for all other population subgroups are below
the level of concern. EPA is not typically concerned with risk
estimates that are less than 100% of the cPAD.
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 cancer risk assessmentwas
not performed.
iv. Anticipated residue and percent crop treated information.
Section 408(b)(2)(E) 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 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), 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.
2. Dietary exposure from drinking water. Available data on spinosad
show that the compound is not mobile or persistent, and therefore, has
little potential to leach to ground water. Spinosad may however,
contaminate surface water upon the release of water from flooded fields
to the environment.
The Agency lacks sufficient monitoring exposure data to complete a
comprehensive dietary exposure analysis and risk assessment for
spinosad 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 spinosad.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in ground water. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. The PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure

[[Page 40200]]

to a pesticide in food and from residential uses. Since DWLOCs address
total aggregate exposure to spinosad, they are further discussed in the
aggregate risk sections below.
Based on the PRZM/EXAMS model, the EECs of spinosad for chronic
exposures are estimated to be 0.092 part per billion (ppb) for surface
water and is based on the application of spinosad to cole crops (0.13
lb ai/acre/application, 0.45 lb ai/acre/season). The EEC value is over
1,300 times less than the lowest DWLOC (Table 2). Drinking water is not
expected to be a significant source of exposure.
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).
Spinosad is currently registered for use on the following
residential non-dietary sites: Conserve SC Turf and Ornamental (EPA
Registration Number 62719-291) and Conserve Fire Ant Bait (EPA
Registration Number 62719-291). Both products are registered for
outdoor use only. The risk assessment was conducted using the following
residential exposure assumptions: the turf/ornamental and fire ant bait
uses may result in non-dietary ingestion of spinosad-treated plant
material or soil by children. Half-life estimates for Spinosyn A on
various plant foliage ranges from 1.6 to 16 days and is generally
dependent on the amount of sunlight received on the plant surfaces. To
calculate a quantitative risk from a potential ingestion of grass (in
the absence of acute-term, short-term, or intermediate-term oral
endpoints), EPA would need to default to the chronic dietary endpoint.
This scenario would represent a child eating grass for
6 months continuously. Based on the low
application rate for spinosad on turf (0.41 lb a.i./acre), its non-
systemic nature, its short half-life (especially in sunlight), and the
rapid incorporation of spinosad metabolites into the general carbon
pool, EPA believes that residues of spinosad on turf/ornamentals and
soil after application would be low and decrease rapidly over time. EPA
believes that it is inappropriate to perform a quantitative dietary
risk representing a chronic scenario from children ingesting spinosad-
treated plants or soil. Qualitatively, the risk from children's
ingestion of plant or soil as a result of turf/ornamental and fire ant
bait uses does not exceed EPA's level of concern.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) 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."
EPA does not have, at this time, available data to determine
whether spinosad has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
spinosad 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 spinosad 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 final rule
for Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961)
(FRL-5574-7).

D. Safety Factor for Infants and Children

1. In general. FFDCA section 408 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 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.
2. Prenatal and postnatal sensitivity. There is no indication of
increased susceptibility of rat or rabbit fetuses to in utero and/or
postnatal exposure.
3. Conclusion. There is a complete toxicity data base for spinosad
and exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures. EPA determined that the
10x safety factor to protect infants and children should be removed.
This recommendation is based on: (1) The completeness of the
toxicological data base, (2) no indication of increased susceptibility
of rat or rabbit fetuses to in utero and/or postnatal exposure, and (3)
no requirement for a developmental neurotoxicity study.

E. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Acute aggregate risk consists of the combined
dietary exposures from food and drinking water sources. The total
exposure is compared to the acute RfD. An acute RfD was not

[[Page 40201]]

identified since no effects were observed in oral toxicity studies that
could be attributable to a single dose. Therefore, the Agency concludes
that there is a reasonable certainty of no harm from acute aggregate
exposure to spinosad.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to spinosad
from food will utilize 40.5 of the cPAD for the U.S. population, 44.2%
of the cPAD for infants, and 84.4% of the cPAD for children 1 to 6
years. Based on the use pattern, chronic residential exposure to
residues of spinosad is not expected. In addition, there is potential
for chronic dietary exposure to spinosad in drinking water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in the following Table 2:

Table 2. Summary of Chronic Dietary Exposure and Risk and Drinking Water Levels of Comparison for Spinosad
----------------------------------------------------------------------------------------------------------------
Dietary Maximum H₂O
Population Subgroup Exposure, % cPAD2 Exposure, DWLOC,: EEC: &mu;g/
mg/kg/day1 mg/kg/day3 &mu;g/L4 L5
----------------------------------------------------------------------------------------------------------------
U.S. population (total) 0.010946 40.5 0.016054 480 0.092
----------------------------------------------------------------------------------------------------------------
All infants 0.011932 44.2 0.015068 150 0.092
----------------------------------------------------------------------------------------------------------------
Children 1-6 yrs. 0.022793 84.4 0.004207 42 0.092
----------------------------------------------------------------------------------------------------------------
Children 7-12 yrs. 0.016020 59.3 0.01098 110 0.092
----------------------------------------------------------------------------------------------------------------
Females 13-50 yrs. 0.00988 36.6 0.01712 514 0.092
----------------------------------------------------------------------------------------------------------------
Males 13-19 yrs. 0.010599 39.3 0.016401 574 0.092
----------------------------------------------------------------------------------------------------------------
Males 20 + yrs. 0.008841 32.7 0.018159 635 0.092
----------------------------------------------------------------------------------------------------------------
Seniors 55 + yrs. 0.008552 31.7 0.018448 646 0.092
----------------------------------------------------------------------------------------------------------------
1 Tier 3 dietary (food only) estimated exposure to spinosad.
2 % cPAD = Dietary Exposure (mg/kg/day)/chronic RfD (mg/kg/day) FQPA Safety Factor.
3 Maximum Water Exposure = cPAD (mg/kg/day) - Dietary Exposure (mg/kg/day).
4 DWLOC = Maximum Water Exposure (mg/kg/day) body weight (70 kg males, 60 kg females, 10 kg children) water
consumption (2 L/day adults, 1 L/day children) H 103 &mu;g/mg. Values expressed to 2 significant figures.
5 EEC = Values are Tier 2 chronic estimates for surface water.

3. Short-term and intermediate-term risk. Short-term aggregate
exposure takes into account residential exposure plus chronic exposure
to food and water (considered to be a background exposure level).
Though residential exposure could occur with the use of spinosad, no
toxicological effects have been identified for short-term or
intermediate-term toxicity. Therefore, the aggregate risk is the sum of
the risk from food and water, which do not exceed the Agency's level of
concern.
4. Aggregate cancer risk for U.S. population. 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,
spinosad is not expected to pose a cancer risk to humans.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to spinosad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (HPLC or immunoassay) is available
to enforce the tolerance expression. The method may be requested from:
Dick Griffith, BEAD ACL (7503C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (410) 305-2905; e-mail
address: griffith.francis@epa.gov.

B. International Residue Limits

No Codex, Canadian, or Mexican maximum residue limits have been
established for residues of spinosad on any crops.

C. Conditions

This is a time-limited tolerance for the use of spinosad on stored
grains at 1 ppm.

V. Conclusion

Therefore, a time-limited tolerance is established for residues of
spinosad, in or on stored grains (barley, corn, oats, rice, sorghum/
milo, and wheat) at 1 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to "object" to a regulation
for an exemption from the requirement of a tolerance issued by EPA
under new section 408(d), as was provided in the old FFDCA sections 408
and 409. However, the period for filing objections is now 60 days,
rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this
regulation in accordance with the instructions

[[Page 40202]]

provided in this unit and in 40 CFR part 178. To ensure proper receipt
by EPA, you must identify docket ID number OPP-2002-0099 in
the subject line on the first page of your submission. All requests
must be in writing, and must be mailed or delivered to the Hearing
Clerk on or before August 12, 2002.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential 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 for inclusion in the
public record. Information not marked confidential may be disclosed
publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202)
260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it "Tolerance Petition
Fees."
EPA is authorized to waive any fee requirement "when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection." For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at
tompkins.jim@epa.gov, or by mailing a request for information to Mr.
Tompkins at Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket ID number OPP-2002-0099, to:
Public Information and Records Integrity Branch, Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. In person or by courier, bring a copy to the
location of the PIRIB described in Unit I.B.2. You may also send an
electronic copy of your request via e-mail to: opp-docket@epa.gov.
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Regulatory Assessment Requirements

This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or OMB review or any
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section
12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerance in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
"meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism
implications." "Policies that have federalism
implications" is defined in the Executive Order to include
regulations that have "substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government." This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not

[[Page 40203]]

alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of FFDCA section
408(n)(4). For these same reasons, the Agency has determined that this
rule does not have any "tribal implications" as described
in Executive Order 13175, entitled Consultation and Coordination with
Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive
Order 13175, requires EPA to develop an accountable process to ensure
"meaningful and timely input by tribal officials in the
development of regulatory policies that have tribal
implications." "Policies that have tribal
implications" is defined in the Executive Order to include
regulations that have "substantial direct effects on one or more
Indian tribes, on the relationship between the Federal Government and
the Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes." This rule will
not have substantial direct effects on tribal governments, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.

VIII. Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a "major rule" as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: May 30, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180 [AMENDED]

1. The authority citation for part 180 continues to read as
follows:

Authority: 21 U.S.C. 321(q), 346(a) and 374.

2. Section 180.495 is amended by alphabetically adding the
following commodity to the table in paragraph (a) to read as follows:

Sec. 180.495 Spinosad; tolerances for residues.

(a) * * *

----------------------------------------------------------------------------------------------------------------
Expiration/revocation
Commodity Parts per million date
----------------------------------------------------------------------------------------------------------------
* * * * *
Stored grains (barley, corn, oats, 1.0 May 31, 2004
rice, sorghum/milo, and wheat)
* * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. 02-14634 Filed 6-11-02; 8:45 am]
BILLING CODE 6560-50-S

Spinosad; Time-Limited Pesticide Tolerance

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