[Federal Register Volume 68, Number 151 (Wednesday, August 6, 2003)]
[Rules and Regulations]
[Pages 46491-46500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20017]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0207; FRL-7317-3]


Spinosad; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of spinosad in or on onion, dry bulb. This action is in 
response to EPA's granting of an emergency exemption under section 18 
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
authorizing use of the pesticide on onion, dry bulb. This regulation 
establishes a maximum permissible level for residues of spinosad in 
this food commodity. The tolerance will expire and is revoked on 
December 31, 2006.

DATES: This regulation is effective August 6, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0207, 
must be received on or before October 6, 2003.

[[Page 46492]]


ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; e-mail address: Sec-18- 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are a Federal 
or State Government Agency involved in Administration of Environmental 
quality programs (i.e., Departments of Agriculture, Environment, etc). 
Potentially affected entities may include, but are not limited to:
    [sbull] Federal or State Government Entity, (NAICS 9241), i.e., 
Departments of Agriculture, Environment, etc.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification ID number OPP-2003-0207. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing a tolerance for residues of the 
insecticide spinosad, in or on onion, dry bulb at 0.10 parts per 
million (ppm). This tolerance will expire and is revoked on December 
31, 2006. EPA will publish a document in the Federal Register to remove 
the revoked tolerance from the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 of the FFDCA and the new safety standard to 
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    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) of the FFDCA 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) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State Agency from any provision of FIFRA, if EPA determines that 
``emergency conditions exist which require such exemption.'' This 
provision was not amended by the Food Quality Protection Act (FQPA) of 
1996. EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemption for Spinosad on Onion, Dry Bulb and FFDCA 
Tolerances

    The State of New Mexico requested the use of spinosad to control 
thrips on onion, dry bulb due to documented resistance of thrips to 
pyrethroid insecticides. EPA has authorized under FIFRA section 18 the 
use of spinosad on onion for control of thrips in New Mexico. After 
having reviewed the submission, EPA concurs that emergency conditions 
exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of spinosad in or on onions. 
In doing so, EPA considered the safety standard in section 408(b)(2) of 
the FFDCA, and EPA decided that the necessary tolerance under section 
408(l)(6) of the FFDCA would be consistent with the safety standard and 
with FIFRA section 18. Consistent with the need to move quickly on the 
emergency exemption in order to address an urgent non-routine situation 
and to ensure that the resulting food is safe and lawful, EPA is 
issuing this tolerance without notice and opportunity for public 
comment as provided in section 408(l)(6) of the FFDCA. Although this 
tolerance will expire and is revoked on December 31,

[[Page 46493]]

2006, under section 408(l)(5) of the FFDCA, residues of the pesticide 
not in excess of the amounts specified in the tolerance remaining in or 
on onions after that date will not be unlawful, provided the pesticide 
is applied in a manner that was lawful under FIFRA, and the residues do 
not exceed a level that was authorized by this tolerance at the time of 
that application. EPA will take action to revoke this tolerance earlier 
if any experience with, scientific data on, or other relevant 
information on this pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether spinosad meets 
EPA's registration requirements for use on onions or whether a 
permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that this tolerance serves as a 
basis for registration of spinosad by a State for special local needs 
under FIFRA section 24(c). Nor does this tolerance serve as the basis 
for any State other than New Mexico to use this pesticide on this crop 
under section 18 of FIFRA without following all provisions of EPA's 
regulations implementing FIFRA section 18 as identified in 40 CFR part 
166. For additional information regarding the emergency exemption for 
spinosad, contact the Agency's Registration Division at the address 
provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961) (FRL-
5754-7).
    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of 
spinosad and to make a determination on aggregate exposure, consistent 
with section 408(b)(2) of the FFDCA, for a time-limited tolerance for 
residues of spinosad in or on onions at 0.10 ppm. EPA's assessment of 
the dietary exposures and risks associated with establishing the 
tolerance follows.

A. Toxicological Endpoints

    The dose at which no observed adverse effect level are observed 
(the NOAEL) from the toxicology study identified as appropriate for use 
in risk assessment is used to estimate the toxicological endpoint. 
However, the lowest dose at which observed 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 (aRfD or cRfD) 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 SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (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 Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk       FQPA SF* and LOC for   Study and Toxicological
          Exposure Scenario                 Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary females (13-50 years of  N/A                      N/A                      This risk assessment is
 age)                                                                                     not required. No
                                                                                          endpoint of concern
                                                                                          attributable to a
                                                                                          single exposure was
                                                                                          identified.
----------------------------------------------------------------------------------------------------------------
Acute dietary general population       N/A                      N/A                      This risk assessment is
 including infants and children                                                           not required. No
                                                                                          endpoint attributable
                                                                                          to a single exposure
                                                                                          of concern was
                                                                                          identified for the
                                                                                          general population,
                                                                                          including infants and
                                                                                          children.
----------------------------------------------------------------------------------------------------------------

[[Page 46494]]

 
Chronic dietary all populations        NOAEL = 2.68 milligrams/ FQPA SF = 1x             Chronic toxicity - dog
                                        kilogram/day (mg/kg/    cPAD = chronic RfD /     LOAEL = 8.22 mg/kg/day
                                        day)                     FQPA SF = 0.027 mg/kg/   based on on
                                       UF = 100...............   day.                     vacuolation in
                                       Chronic RfD = 0.02 mg/                             glandular cells
                                        kg/day.                                           (parathyroid) and
                                                                                          lymphatic tissues,
                                                                                          arteritis and
                                                                                          increases in serum
                                                                                          enzymes such as
                                                                                          alanine
                                                                                          aminotransferase, and
                                                                                          aspartate
                                                                                          aminotransferase, and
                                                                                          triglyceride levels.
----------------------------------------------------------------------------------------------------------------
Incidental oral                        NOAEL = 4.9 mg/kg/day    FQPA SF = 1x             Subchronic feeding
 Short-term (1-30 days)..............  MOE = 100..............                            study in dogs
Residential only.....................                                                    LOAEL = 9.73 mg/kg/day
                                                                                          based on microscopic
                                                                                          changes in multiple
                                                                                          organs, clinical signs
                                                                                          of toxicity, decreases
                                                                                          in mean body weights
                                                                                          and food consumption
                                                                                          and biochemical
                                                                                          evidence of anemia and
                                                                                          possible liver damage.
----------------------------------------------------------------------------------------------------------------
Incidental oral                        NOAEL = 2.7 mg/kg/day    FQPA SF = 1x             Chronic toxicity study
Intermediate-term....................  MOE = 100..............                            in dogs
(1-6 months).........................                                                    LOAEL = 8.22 mg/kg/day
Residential only.....................                                                     based on vacuolation
                                                                                          in glandular cells
                                                                                          (parathyroid) and
                                                                                          lymphatic tissues,
                                                                                          arteritis, and
                                                                                          increases in serum
                                                                                          alanine
                                                                                          aminotransferase,
                                                                                          aspartate
                                                                                          aminotransferase, and
                                                                                          triglyceride levels.
----------------------------------------------------------------------------------------------------------------
Dermal (any time period)               N/A                      N/A                      Dermal risk assessment
(Residential)........................                                                     is not required. Short-
                                                                                          term, intermediate-
                                                                                          term, and long-term
                                                                                          dermal risk
                                                                                          assessments are not
                                                                                          required because: (1)
                                                                                          Lack of concern for
                                                                                          prenatal and/or
                                                                                          postnatal toxicity;
                                                                                          (2) the combination of
                                                                                          molecular structure
                                                                                          and size as well as
                                                                                          the lack of dermal or
                                                                                          systemic toxicity at
                                                                                          1,000 mg/kg/day in a
                                                                                          21-day dermal toxicity
                                                                                          study in rats which
                                                                                          indicates poor dermal
                                                                                          absorption; and (3)
                                                                                          the lack of long-term
                                                                                          exposure based on the
                                                                                          current use pattern.
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1-30 days)      Oral NOAEL = 4.9 mg/kg/  FQPA SF = 1x             Subchronic feeding
(Residential)........................   day                     MOE = 100..............   study in dogs
                                       UF = 100...............                           LOAEL = 9.73 mg/kg/day
                                                                                          based on microscopic
                                                                                          changes in a multiple
                                                                                          organs, clinical signs
                                                                                          of toxicity, decreases
                                                                                          in mean body weights
                                                                                          and food consumption
                                                                                          and biochemical
                                                                                          evidence of anemia and
                                                                                          possible liver damage.
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1-6      Oral NOAEL = 2.7 mg/kg/  FQPA SF = 1x             Chronic toxicity study
 months)                                day                     MOE = 100..............   in dogs
(Residential)........................  UF = 100...............                           LOAEL = 8.22 mg/kg/day
                                                                                          based on vacuolation
                                                                                          in glandular cells
                                                                                          (parathyroid) and
                                                                                          lymphatic tissues,
                                                                                          arteritis, and
                                                                                          increases in serum
                                                                                          alanine
                                                                                          aminotransferase,
                                                                                          aspartate
                                                                                          aminotransferase, and
                                                                                          triglycerides levels
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (>6 months)       Oral NOAEL = 2.7 mg/kg/  FQPA SF = 1x             Chronic toxicity study
(Residential)........................   day                     MOE = 100..............   in dogs
                                       UF = 100...............                           LOAEL = 8.22 mg/kg/day
                                                                                          based on vacuolation
                                                                                          in glandular cells
                                                                                          (parathyroid) and
                                                                                          lymphatic tissues,
                                                                                          arteritis, and
                                                                                          increases in serum
                                                                                          alanine
                                                                                          aminotransferase,
                                                                                          aspartate
                                                                                          aminotransferase, and
                                                                                          triglycerides levels
----------------------------------------------------------------------------------------------------------------

[[Page 46495]]

 
Cancer (oral, dermal, inhalation)      N/A                      N/A                      Classification: Not
                                                                                          likely to be
                                                                                          carcinogenic to humans
                                                                                         Q1* = N/A
                                                                                         Risk Assessment not
                                                                                          required.
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

B. 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. Tolerances range from 0.02 ppm 
(many commodities; limit of quantitation) to 20 ppm (aspirated grain 
fractions). 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 one day 
or single exposure. An acute dietary exposure risk assessment is not 
required because the Agency did not identify an acute dietary endpoint 
that was applicable to females (13+ years) or to the general 
population, including infants and children.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis 
evaluated the individual food consumption as reported by respondents in 
the U. S. Department of Agriculture (USDA) 1989-1992 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 (food only) analysis represents a moderately refined estimate 
of dietary exposure to spinosad due to the use of default processing 
factors, percent crop treated (PCT) estimates for agricultural crops 
having previously registered uses, and anticipated residues for meat 
and milk. This Tier 3 DEEM\TM\ analysis shows that dietary (food only) 
exposure estimates are below the Agency's LOC for all population 
subgroups. The highest chronic dietary exposure was for children 1-6 
years old at 0.018540 mg/kg/day, representing 69% of the cPAD. Exposure 
for the U.S. population was 0.008127 mg/kg/day, representing 30% of the 
cPAD.
    iii. Cancer. Spinosad has been classified by the Agency as a not 
likely human carcinogen. Therefore, a cancer dietary exposure analysis 
was not performed.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of the FFDCA authorizes EPA to use available data and information on 
the anticipated residue levels of pesticide residues in food and the 
actual levels of pesticide chemicals that have been measured in food. 
If EPA relies on such information, EPA must require that data be 
provided 5 years after the tolerance is established, modified, or left 
in effect, demonstrating that the levels in food are not above the 
levels anticipated. Following the initial data submission, EPA is 
authorized to require similar data on a time frame it deems 
appropriate. As required by section 408(b)(2)(E) of the FFDCA, EPA will 
issue a data call-in for information relating to anticipated residues 
to be submitted no later than 5 years from the date of issuance of this 
tolerance.
    Section 408(b)(2)(F) of the FFDCA states that the Agency may use 
data on the actual percent of food treated for assessing chronic 
dietary risk only if the Agency can make the following findings: 
Condition 1, that the data used are reliable and provide a valid basis 
to show what percentage of the food derived from such crop is likely to 
contain such pesticide residue; condition 2, that the exposure estimate 
does not underestimate exposure for any significant subpopulation 
group; and condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to 
submit data on PCT.
    The Agency used PCT information as follows: Almond 5%; apple 28%; 
apricot 5%; avocado 5%, bean, snap 9%; broccoli 62%; cabbage 32%; 
cauliflower 54%; celery 78%; collards 24%; cherry 5%; eggplant 14%; 
grapefruit 1%; grape, wine 1%; kale 32%; lemon 11%; lettuce, head 59%; 
Lettuce, other 42%; mustard greens 17%; orange 6%; peach 4%; pepper 
45%; pistachio 1%; prune/plum 5%; spinach 32%; pumpkin 1%; squash 1%; 
sweet corn 1%; tangerine 6%; turnip, greens 6%; tomato, fresh 30%; 
tomato, processed 2%; watermelon 1%; cotton 3%; dry bean/pea 1%; peanut 
1%; potato 1%; wheat, and winter 1%.
    The Agency believes that the 3 conditions listed above have been 
met. With respect to condition 1, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. EPA uses a weighted average PCT for chronic dietary 
exposure estimates. This weighted average PCT figure is derived by 
averaging State-level data for a period of up to 10 years, and 
weighting for the more robust and recent data. A weighted average of 
the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. For acute dietary exposure estimates, EPA uses an estimated 
maximum PCT. The exposure estimates resulting from this approach 
reasonably represent the highest levels to which an individual could be 
exposed, and are unlikely to underestimate an individual's acute 
dietary exposure. The Agency is reasonably certain that the percentage 
of the food treated is not likely to be an underestimation. As to 
conditions 2 and 3, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant

[[Page 46496]]

subpopulation group and allows the Agency to be reasonably certain that 
no regional population is exposed to residue levels higher than those 
estimated by the Agency. Other than the data available through national 
food consumption surveys, EPA does not have available information on 
the regional consumption of food to which spinosad may be applied in a 
particular area.
    2. Dietary exposure from drinking water. 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 First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) 
to produce estimates of pesticide concentrations in an index reservoir. 
The screening concentration in ground water (SCI-GROW) model is used to 
predict pesticide concentrations in shallow ground water. For a 
screening-level assessment for surface water EPA will generally use 
FIRST (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The 
FIRST model is a subset of the PRZM/EXAMS model that uses a specific 
high-end runoff scenario for pesticides. While both FIRST and PRZM/
EXAMS incorporate an index reservoir environment, 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 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 FIRST and SCI-GROW models the EECs of spinosad for 
acute exposures are estimated to be 25 parts per billion (ppb) for 
surface water and 0.037 ppb for ground water. The EECs for chronic 
exposures are estimated to be 2.3 ppb for surface water and 0.037 ppb 
for ground water.
    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 residential turf and ornamentals to control a 
variety of insect pests. The registered residential products for 
spinosad are Conserve SC Turf and Ornamental (EPA Reg No. 62719-291) 
and Conserve Fire Ant Bait (EPA Reg No. 62719-304). Conserve Fire Ant 
Bait is a ready-to-use granular formulation that may be applied by 
homeowners. For adults, residential exposures may result from dermal 
and inhalation exposure while applying Conserve Fire Ant Bait and/or 
from dermal contact with treated turf. However, dermal, post-
application exposure is not of concern since no toxicological endpoint 
was established for dermal exposure. Inhalation exposure is not 
expected due to the low vapor pressure of spinosad and because the 
homeowner product is formulated as a granular. Post-application 
exposure to toddlers was not assessed for the Conserve Fire Ant Bait 
product since children are not likely to ``habit'' lawn areas where 
fire ant mounds are present. Conserve SC is labeled for use on 
turfgrass and ornamentals by commercial applicators. Since this product 
will be applied by commercial applicators, homeowner applicator 
exposure was not assessed. For toddlers, dermal and non-dietary oral 
post-application exposures may result from dermal contact with treated 
turf as well as hand-to-mouth transfer of residues from turfgrass. 
Since dermal post-application exposure is not of concern, only hand-to-
mouth, object-to-mouth and incidental ingestion of soil exposures for 
the turf and ornamental uses were performed. The average aerobic soil 
metabolism half-life of spinosad (containing factors A and D) is 13-14 
days. For the intermediate-term duration, typical lawn maintenance 
practices, such as mowing and watering, are expected to expedite the 
dissipation of spinosad on turfgrass. Since residue on turf that is 
available for transfer after day 30 is expected to be negligible, 
intermediate-term post-application incidental oral exposures were not 
assessed. The Agency developed exposure formulas and estimated doses to 
theoretically assess residential post-application incidental oral 
exposure scenarios including: (1) Hand-to-mouth, (2) object-to-mouth 
(turfgrass), and (3) incidental ingestion of soil. The resulting 
incidental oral ingestion MOEs from residential use of spinosad on turf 
are as follow:
    [sbull] MOE for oral hand-to-mouth activities on treated lawns is 
800 for short-term (1-30 days).
    [sbull] MOE for oral object-to-mouth (turfgrass) from treated lawns 
is 3,300 for short-term.
    [sbull] MOE for incidental ingestion of soil from treated lawns is 
240,000 for short-term.
    [sbull] Combined incidental oral MOE (hand-to-mouth, object-to-
mouth, and soil ingestion) is 640. All MOEs are below EPA's LOC.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA 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).

[[Page 46497]]

C. 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 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 and 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:
    i. There is no evidence of increased susceptibility of rat or 
rabbit fetuses following in utero exposure in the developmental studies 
with spinosad, and there is no evidence of increased susceptibility of 
young rats in the reproduction study with spinosad.
    ii. There are no residual uncertainties identified in the exposure 
data bases; the dietary food exposure assessment (chronic only; no 
acute endpoint was identified) is refined using Anticipated Residues 
calculated from field trial data and available PCT information (100% 
crop treated is assumed for proposed new uses).
    iii. The dietary drinking water exposure is based on conservative 
modeling estimates.
    iv. EPA's Health Effect Division Residential Standard Operating 
Procedures were used to assess post-application exposure to children as 
well as incidental oral exposure of toddlers, so these assessments do 
not underestimate the exposure and risks posed by spinosad.
    v. A developmental toxicity study is not required.

D. 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. 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 + 
chronic non-dietary, non-occupational 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 EPA Office of Water are used to calculate DWLOCs: 
2 liter (L)/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 spinosad 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 
spinosad on 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 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 unit C 
for chronic exposure, EPA has concluded that exposure to spinosad from 
food will utilize 30% of the cPAD for the U.S. population, 41% of the 
cPAD for infant <1 year old and 69% of the cPAD for children 1-6 years 
old (subpopulation at greatest exposure). 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 water 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.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Spinosad
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                        0.027           30          2.3        0.037          660
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old)                              0.027           41          2.3        0.037          160
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                               0.027           69          2.3        0.037           85
----------------------------------------------------------------------------------------------------------------
Children (7-12 years old)                              0.027           45          2.3        0.037          150
----------------------------------------------------------------------------------------------------------------
Females (13-50)                                        0.027           24          2.3        0.037          620
----------------------------------------------------------------------------------------------------------------


[[Page 46498]]

    3. Short-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).
    Spinosad is currently registered for use(s) that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for spinosad.
    Using the exposure assumptions described in Unit IV. B. for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 600 for the U.S. population, 260 
for all infants less than 1-year old, 190 for children 1-6 years old 
(greatest risk subpopulation) and 250 for children 7-12 years old. 
These aggregate MOEs do not exceed the Agency's LOC for aggregate 
exposure to food and residential uses. In addition, short-term DWLOCs 
were calculated and compared to the EECs for chronic exposure of 
spinosad in ground water and surface water. After calculating DWLOCs 
and comparing them to the EECs for surface water and ground water, EPA 
does not expect short-term aggregate exposure to exceed the Agency's 
LOC, as shown in the following Table 3:

                     Table 3.--Aggregate Risk Assessment for Short-Term Exposure to Spinosad
----------------------------------------------------------------------------------------------------------------
                                                  Aggregate                  Surface       Ground
              Population Subgroup                MOE (Food +   Aggregate    Water EEC    Water EEC    Short-Term
                                                Residential)      LOC         (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                          600          100          2.3        0.037        1,400
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old)                                260          100          2.3        0.037          300
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                                 190          100          2.3        0.037          230
----------------------------------------------------------------------------------------------------------------
Children (7-12 years old)                                250          100          2.3        0.037          290
----------------------------------------------------------------------------------------------------------------
Female (13-50)                                           760          100          2.3        0.037        1,300
----------------------------------------------------------------------------------------------------------------

    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account non-dietary, non-occupational 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, 
the average aerobic soil metabolism half-life of spinosad (containing 
factors A and D) is 13-14 days. For the intermediate-term duration, 
typical lawn maintenance practices, such as mowing and watering, are 
expected to expedite the dissipation of spinosad on turfgrass. Since 
residue on turf that is available for transfer after day 30 is expected 
to be negligible, intermediate-term post-application incidental oral 
exposures were not assessed.
    5. 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.
    6. 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.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology using high pressure liquid 
chromatography with ultraviolet detector (HPLC/UV) is available to 
enforce the tolerances in plants. Adequate livestock methods are 
available for tolerance enforcement. Method RES 94094 (GRM 95.03) is an 
HPLC/UV method suitable for determination of spinosad residues in 
ruminant commodities. Method GRM 95.03 has undergone successful 
independent laboratory validation (ILV) and EPA laboratory validation, 
and has been forwarded to FDA for inclusion in PAM Volume II. Method 
GRM 95.15 is another HPLC/UV method suitable for determination of 
spinosad residues in poultry commodities. This method has been 
forwarded to FDA for inclusion in PAM Volume II. Method RES 95114, an 
immunoassay method for determination of spinosad residues in ruminant 
commodities, underwent a successful ILV and EPA laboratory validation. 
It has been submitted to FDA for inclusion in PAM Volume II. The 
methods may be requested from: Paul Golden, U.S. EPA/OPP/BEAD/ACB, 
Environmental Science Center, 701 Mapes Road, Fort Meade, MD 20755-
5350; telephone number: (410) 305-2960; FAX (410) 305-3091; e-mail 
address: RAM Mailbox.

B. International Residue Limits

    There are no Codex, Canadian or Mexican maximum residue limits 
established for spinosad in/on root and tuber vegetables. Therefore, no 
compatibility problems exist for the proposed tolerances.

VI. Conclusion

    Therefore, the tolerance is established for residues of spinosad in 
or on onion, dry bulb at 0.10 ppm.

VII. 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, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA 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) 
of the FFDCA, as was provided in the old sections 408 and 409 of the 
FFDCA. 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

[[Page 46499]]

accordance with the instructions provided in this unit and in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number OPP-2003-0207 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 October 6, 2003.
    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 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 (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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 
(703) 603-0061.
    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-
0001.
    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 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.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.1. Mail your 
copies, identified by the docket ID number OPP-2003-0207, 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-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. 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).

VIII. Statutory and Executive Order Reviews

    This final rule establishes a time-limited tolerance under section 
408 of the FFDCA. 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 FIFRA 
section 18 exemption under section 408 of the FFDCA, 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

[[Page 46500]]

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 section 408(n)(4) of the FFDCA. 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.

IX. Congressional Review Act

    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 record 
keeping requirements.

    Dated: July 28, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

0
2. Section 180.495 is amended by alphabetically adding the following 
commodity to the table in paragraph (b) to read as follows:


Sec.  180.495  Spinosad; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   Revocation date
------------------------------------------------------------------------
                                * * * * *
Onion, dry bulb...................               0.10           12/31/06
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 03-20017 Filed 8-5-03; 8:45 am]
BILLING CODE 6560-50-S