[Federal Register Volume 67, Number 113 (Wednesday, June 12, 2002)]
[Rules and Regulations]
[Pages 40196-40203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-14634]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0099; FRL-7182-1]
RIN 2070-AB78


Spinosad; Time-Limited Pesticide Tolerance

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: 
[email protected].

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 
(MOEcancer = 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,: g/   EEC: g/L5
                                                  mg/kg/day1                mg/kg/day3       L4
----------------------------------------------------------------------------------------------------------------
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 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: 
[email protected].

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 [email protected], 
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: [email protected]. 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