[Federal Register: August 6, 2003 (Volume 68, Number 151)]
[Rules and Regulations]
[Page 46491-46500]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06au03-21]
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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-
Mailbox@epamail.epa.gov.
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 tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
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: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
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