[Federal Register Volume 66, Number 186 (Tuesday, September 25, 2001)]
[Rules and Regulations]
[Pages 48961-48968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23609]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301177; FRL-6802-9]
[RIN 2070-AB78]


Spinosad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
spinosad in or on asparagus at 0.020 part per million (ppm), bushberry 
subgroup (crop subgroup 13B) at 0.250 ppm, cranberry at 0.01 ppm, 
foliage of legume vegetable group (crop group 7) at 8.0 ppm, garden 
beet roots at 0.10 ppm, globe artichoke at 0.30 ppm, juneberry at 0.250 
ppm, leaves of root and tuber vegetable group (crop group 2) at 10.0 
ppm, lingonberry at 0.250 ppm, okra at 0.40 ppm, pistachio at 0.020 
ppm, pome fruit group (crop group 11) at 0.20 ppm, salal at 0.250 ppm, 
strawberry at 1.0 ppm, sugar beet roots at 0.10 ppm, and the tree nut 
group (crop group 14) at 0.020 ppm. The Interregional Research Project 
Number 4 (IR-4) requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act, as amended by the Food Quality Protection Act 
of 1996. This final rule establishes permanent tolerances for spinosad 
and as part of that process the Agency has reassessed existing 
tolerances. By law, EPA is required to reassess 66% of the tolerances 
in existence on August 2, 1996, by August 2002, or about 6,400 
tolerances. All permanent tolerances for spinosad were established 
after August 2, 1996. Consequently, regarding the actions in this final 
rule, no tolerance reassessments are counted toward the August 2002 
review deadline of FFDCA section 408(q).

DATES: This regulation is effective September 25, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301177, 
must be received by EPA on or before November 26, 2001.

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 control number OPP-301177 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Hoyt Jamerson, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection

[[Page 48962]]

Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; telephone 
number: (703) 308-9368; and 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 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 theFederal 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.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301177. 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 June 6, 2001 (66 FR 30463) (FRL-6785-1), 
EPA issued a notice pursuant to section 408 of the Federal Food, Drug, 
and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality 
Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the 
filing of pesticide petitions (PP) for tolerances by IR-4, 681 U.S. 
Highway #1, South, North Brunswick, NJ 08902-3390. This notice included 
a summary of the petitions prepared by Dow Agrosciences, the 
registrant. There were no comments received in response to the notice 
of filing.
    The petitions requested that 40 CFR 180.495 be amended by 
establishing tolerances for residues of the insecticide spinosad, in or 
on food commodities, as follows:
    1. PP 0E6173 proposed the establishment of tolerances for the pome 
fruit group at 0.2 ppm and foliage of legume vegetable group at 8.0 
ppm.
    2. PP 0E6217 proposed the establishment of a tolerance for 
asparagus at 0.02 ppm.
    3. PP 1E6230 proposed the establishment of tolerances for the tree 
nut group, and pistachio at 0.02 ppm.
    4. PP 1E6236 proposed the establishment of a tolerance for okra at 
0.4 ppm.
    5. 1E6245 proposed the establishment of tolerances for garden beet 
roots and sugar beet roots at 0.1 ppm, cranberry at 0.01 ppm, and the 
leaves of root and tuber vegetable group at 10 ppm.
    6. PP 1E6255 proposed the establishment of tolerances for the 
bushberry subgroup, juneberry, lingonberry, and salal at 0.25 ppm.
    7. PP 1E6256 proposed the establishment of a tolerance for globe 
artichoke at 0.3 ppm.
    8. PP 1E6260 proposed the establishment of a tolerance for 
strawberry at 0.75 ppm. The petition was subsequently amended to 
propose a tolerance for strawberry at 1.0 ppm.
    Spinosad is a fermentation product of Saccharopolyspora spinosa. 
The product consists of two related active ingredients: Spinosyn A 
(Factor A; CAS #131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-
-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-
tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D; 
CAS #131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl-
-L-manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-
tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-
as-Indaceno[3,2-d]oxacyclododecin-7,15-dione. Typically, the two 
factors are present at an 85:15 (A:D) ratio.
    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 (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available

[[Page 48963]]

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 tolerances for residues of spinosad on asparagus at 0.020 part per 
million (ppm), bushberry subgroup (crop subgroup 13B) at 0.250 ppm, 
cranberry at 0.01 ppm, foliage of legume vegetable group (crop group 7) 
at 8.0 ppm, garden beet roots at 0.10 ppm, globe artichoke at 0.30 ppm, 
juneberry at 0.250 ppm, leaves of root and tuber vegetable group (crop 
group 2) at 10.0 ppm, lingonberry at 0.250 ppm, okra at 0.40 ppm, 
pistachio at 0.020 ppm, pome fruit group (crop group 11) at 0.20 ppm, 
salal at 0.250 ppm, strawberry at 1.0 ppm, sugar beet roots at 0.10 
ppm, and the tree nut group (crop group 14) at 0.020 ppm. EPA's 
assessment of exposures and risks associated with establishing the 
tolerances 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 
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 Dose and Endpoints for Spinosad for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                          Not applicable           Not applicable           No appropriate endpoint
                                                                                          available. There were
                                                                                          no effects observed in
                                                                                          oral toxicity studies
                                                                                          including oral
                                                                                          developmental toxicity
                                                                                          studies in rats and
                                                                                          rabbits that could be
                                                                                          attributable to a
                                                                                          single dose
                                                                                          (exposure). Therefore,
                                                                                          a dose and endpoint
                                                                                          were not selected for
                                                                                          this risk assessment.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL= 2.68 mg/kg/day    FQPA SF = 1X             Chronic feeding study
                                       UF = 100...............  cPAD = chronic RfD/FQPA   in dogs
                                       Chronic RfD = 0.027 mg/   SF = 0.027 mg/kg/day.   LOAEL = 8.46 mg/kg/day
                                        kg/day.                                           based on the
                                                                                          occurrence of
                                                                                          vacuolation in
                                                                                          glandular cells
                                                                                          (parathyroid) and
                                                                                          lymphatic tissues,
                                                                                          arteritis, and
                                                                                          increases in serum
                                                                                          enzymes such as
                                                                                          alanine
                                                                                          aminotranferase, and
                                                                                          aspartate
                                                                                          aminotransferase, and
                                                                                          triglyceride levels in
                                                                                          dogs fed spinosad in
                                                                                          the diet at dose
                                                                                          levels of 1.44, 2.7,
                                                                                          8.46 mg/kg/day for 52
                                                                                          weeks.
----------------------------------------------------------------------------------------------------------------
Dermal (short-and intermediate-term)   Not applicable           Not applicable           No appropriate endpoint
(residential)........................                                                     available. No toxicity
                                                                                          at 2,000 mg/kg/day in
                                                                                          a 21-day dermal
                                                                                          toxicity study in
                                                                                          rats. No dermal
                                                                                          absorption expected
                                                                                          based on molecular
                                                                                          structure and size.
----------------------------------------------------------------------------------------------------------------

[[Page 48964]]

 
Long-term dermal (several months to    Not applicable           Not applicable           No appropriate endpoint
 lifetime)                                                                                available. Long-term
(residential)........................                                                     exposure is not
                                                                                          expected from
                                                                                          registered use
                                                                                          patterns.
----------------------------------------------------------------------------------------------------------------
Inhalation (any time period)           Not applicable           Not applicable           Low toxicity, use
(residential)........................                                                     pattern and
                                                                                          application rate does
                                                                                          not indicate a need
                                                                                          for risk assessment
                                                                                          via inhalation.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Not applicable           Not applicable           Spinosad is classified
                                                                                          as a ``Not Likely''
                                                                                          carcinogen.
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.


C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.495) for residues of spinosad, in or on a 
variety of raw agricultural commodities. Spinosad is registered for use 
on a large number 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:
    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 1989-1999 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the chronic 
exposure assessments:
    The chronic dietary analysis used residue values at the established 
and recommended tolerance levels for all commodities having spinosad 
tolerances with the exception of meat (all non-poultry sources) and 
milk. Anticipated residues were used for meat and milk from beef and 
dairy cattle as follows: Muscle at 0.09 ppm, fat at 2.54 ppm, kidney at 
0.19 ppm, liver at 0.48, whole milk at 0.19 ppm, cream at 0.74 ppm, 
skim milk at 0.037 ppm. The chronic dietary analysis also assumed that 
100 percent crop treatment for registered uses and the proposed uses.
    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 assessment was 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. 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 EECs from these models 
to quantify drinking water exposure and risk as a percent of the 
reference dose (%RfD) or percent of the population

[[Page 48965]]

adjusted dose (%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 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 parts per billion (ppb) for surface 
water. The chronic surface water EEC value for spinosad is based on 
application of the insecticide to cole crops at 0.13 lb active 
ingredient per acre per application with a maximum of 0.45 lb active 
ingredient/acre/season.
    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).
    Registered residential uses for spinosad currently include Conserve 
SC Turf and Ornamental (EPA Reg. No. 62719-291) and Conserve Fire Ant 
Bait (EPA Reg. No. 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 generally is 
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-, short-, 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 (62 FR 62961, November 26, 1997).

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 margin of exposure 
(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, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP 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, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.

[[Page 48966]]

    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 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 29% of the cPAD for the U.S. population, 26% of 
the cPAD for infants, and 57% of the cPAD for children 1 to 6 years 
old, the subpopulation at greatest risk. Based on the use pattern, 
spinosad's short half-life and non-systemic nature, and the rapid 
incorporation of spinosad metabolites into the general carbon pool, 
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 water, EPA does not expect the aggregate 
exposure to exceed 100% of the cPAD, as shown in the following Table 2:

                Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Spinosad
----------------------------------------------------------------------------------------------------------------
                                                                                          Surface
                     Population Subgroup                      cPAD mg/kg/     %cPAD      Water EEC     Chronic
                                                                  day         (Food)       (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                                     0.027           29        0.092          670
----------------------------------------------------------------------------------------------------------------
All infants                                                         0.027           26        0.092          200
----------------------------------------------------------------------------------------------------------------
Children (1 to 6 years)                                             0.027           57        0.092          120
----------------------------------------------------------------------------------------------------------------
Children (7 to 12 years)                                            0.027           40        0.092          160
----------------------------------------------------------------------------------------------------------------

    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposures 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- 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/UV is available to enforce 
the tolerance expression. The method may be requested from: Calvin 
Furlow, PIRIB, IRSD (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-5229; 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.

V. Conclusion

    Therefore, the tolerances are established for residues of spinosad 
in or on asparagus at 0.020 ppm, bushberry subgroup (crop subgroup 13B) 
at 0.250 ppm, cranberry at 0.01 ppm, foliage of legume vegetable group 
(crop group 7) at 8.0 ppm, garden beet roots at 0.10 ppm, globe 
artichoke at 0.30 ppm, juneberry at 0.250 ppm, leaves of root and tuber 
vegetable group (crop group 2) at 10.0 ppm, lingonberry at 0.250 ppm, 
okra 0.40 ppm, pistachio at 0.020 ppm, pome fruit group (crop group 11) 
at 0.20 ppm, salal at 0.250 ppm, strawberry at 1.0 ppm, sugar beet 
roots at 0.10 ppm, and tree nut group (crop group 14) at 0.020 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 provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301177 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 November 
26, 2001.
    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

[[Page 48967]]

40 CFR part 2. A copy of the information that does not contain CBI must 
be submitted 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 control number OPP-301177, 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 other 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 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

[[Page 48968]]

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: September 10, 2001.
Peter Caulkins,
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 371.

    2. Section 180.495 is amended by deleting the entries for almonds, 
apple, and turnip greens; revising the entry for pistachio; and by 
alphabetically adding the following commodities to the table in 
paragraph (a) to read as follows:

Sec. 180.495  Spinosad; tolerances for residues.

    (a)* * *

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    Revocation
                                                  million        Date
------------------------------------------------------------------------
              *        *        *        *        *
Artichoke, globe..............................         0.30         None
Asparagus.....................................        0.020         None
              *        *        *        *        *
Beet, garden, roots...........................         0.10         None
Beet, sugar, roots............................         0.10         None
              *        *        *        *        *
Bushberry subgroup............................        0.250         None
              *        *        *        *        *
Cranberry.....................................         0.01         None
              *        *        *        *        *
Fruit, pome, group............................         0.20         None
              *        *        *        *        *
Juneberry.....................................        0.250         None
              *        *        *        *        *
Lingonberry...................................        0.250         None
              *        *        *        *        *
Nut, tree, group..............................        0.020         None
              *        *        *        *        *
Okra..........................................         0.40         None
              *        *        *        *        *
Pistachio.....................................        0.020         None
              *        *        *        *        *
Salal.........................................        0.250         None
              *        *        *        *        *
Strawberry....................................          1.0         None
              *        *        *        *        *
Vegetable, foliage of legume, group...........          8.0         None
Vegetable, leaves of root and tuber, group....         10.0         None
              *        *        *        *        *
------------------------------------------------------------------------

* * * * *

[FR Doc. 01-23609 Filed 9-24-01; 8:45 am]
BILLING CODE 6560-50-S