[Federal Register Volume 66, Number 186 (Tuesday, September 25, 2001)]
[Rules and Regulations]
[Pages 48961-48968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23609]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301177; FRL-6802-9]
[RIN 2070-AB78]
Spinosad; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
spinosad in or on asparagus at 0.020 part per million (ppm), bushberry
subgroup (crop subgroup 13B) at 0.250 ppm, cranberry at 0.01 ppm,
foliage of legume vegetable group (crop group 7) at 8.0 ppm, garden
beet roots at 0.10 ppm, globe artichoke at 0.30 ppm, juneberry at 0.250
ppm, leaves of root and tuber vegetable group (crop group 2) at 10.0
ppm, lingonberry at 0.250 ppm, okra at 0.40 ppm, pistachio at 0.020
ppm, pome fruit group (crop group 11) at 0.20 ppm, salal at 0.250 ppm,
strawberry at 1.0 ppm, sugar beet roots at 0.10 ppm, and the tree nut
group (crop group 14) at 0.020 ppm. The Interregional Research Project
Number 4 (IR-4) requested these tolerances under the Federal Food,
Drug, and Cosmetic Act, as amended by the Food Quality Protection Act
of 1996. This final rule establishes permanent tolerances for spinosad
and as part of that process the Agency has reassessed existing
tolerances. By law, EPA is required to reassess 66% of the tolerances
in existence on August 2, 1996, by August 2002, or about 6,400
tolerances. All permanent tolerances for spinosad were established
after August 2, 1996. Consequently, regarding the actions in this final
rule, no tolerance reassessments are counted toward the August 2002
review deadline of FFDCA section 408(q).
DATES: This regulation is effective September 25, 2001. Objections and
requests for hearings, identified by docket control number OPP-301177,
must be received by EPA on or before November 26, 2001.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301177 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Hoyt Jamerson, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection
[[Page 48962]]
Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; telephone
number: (703) 308-9368; and e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
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Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to theFederal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently
under development.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301177. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of June 6, 2001 (66 FR 30463) (FRL-6785-1),
EPA issued a notice pursuant to section 408 of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality
Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the
filing of pesticide petitions (PP) for tolerances by IR-4, 681 U.S.
Highway #1, South, North Brunswick, NJ 08902-3390. This notice included
a summary of the petitions prepared by Dow Agrosciences, the
registrant. There were no comments received in response to the notice
of filing.
The petitions requested that 40 CFR 180.495 be amended by
establishing tolerances for residues of the insecticide spinosad, in or
on food commodities, as follows:
1. PP 0E6173 proposed the establishment of tolerances for the pome
fruit group at 0.2 ppm and foliage of legume vegetable group at 8.0
ppm.
2. PP 0E6217 proposed the establishment of a tolerance for
asparagus at 0.02 ppm.
3. PP 1E6230 proposed the establishment of tolerances for the tree
nut group, and pistachio at 0.02 ppm.
4. PP 1E6236 proposed the establishment of a tolerance for okra at
0.4 ppm.
5. 1E6245 proposed the establishment of tolerances for garden beet
roots and sugar beet roots at 0.1 ppm, cranberry at 0.01 ppm, and the
leaves of root and tuber vegetable group at 10 ppm.
6. PP 1E6255 proposed the establishment of tolerances for the
bushberry subgroup, juneberry, lingonberry, and salal at 0.25 ppm.
7. PP 1E6256 proposed the establishment of a tolerance for globe
artichoke at 0.3 ppm.
8. PP 1E6260 proposed the establishment of a tolerance for
strawberry at 0.75 ppm. The petition was subsequently amended to
propose a tolerance for strawberry at 1.0 ppm.
Spinosad is a fermentation product of Saccharopolyspora spinosa.
The product consists of two related active ingredients: Spinosyn A
(Factor A; CAS #131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-
-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-
tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D;
CAS #131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl-
-L-manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-
tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-
as-Indaceno[3,2-d]oxacyclododecin-7,15-dione. Typically, the two
factors are present at an 85:15 (A:D) ratio.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. * * *.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available
[[Page 48963]]
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure, consistent with section 408(b)(2),
for tolerances for residues of spinosad on asparagus at 0.020 part per
million (ppm), bushberry subgroup (crop subgroup 13B) at 0.250 ppm,
cranberry at 0.01 ppm, foliage of legume vegetable group (crop group 7)
at 8.0 ppm, garden beet roots at 0.10 ppm, globe artichoke at 0.30 ppm,
juneberry at 0.250 ppm, leaves of root and tuber vegetable group (crop
group 2) at 10.0 ppm, lingonberry at 0.250 ppm, okra at 0.40 ppm,
pistachio at 0.020 ppm, pome fruit group (crop group 11) at 0.20 ppm,
salal at 0.250 ppm, strawberry at 1.0 ppm, sugar beet roots at 0.10
ppm, and the tree nut group (crop group 14) at 0.020 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by spinosad are
discussed in Unit III.A. of the Federal Register of September 23, 1999
(64 FR 51451) (FRL-6381-9),
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for spinosad used for human risk assessment is shown in the
following Table 1:
Table 1.-- Summary of Toxicological Dose and Endpoints for Spinosad for Use in Human Risk Assessment
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FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
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Acute dietary Not applicable Not applicable No appropriate endpoint
available. There were
no effects observed in
oral toxicity studies
including oral
developmental toxicity
studies in rats and
rabbits that could be
attributable to a
single dose
(exposure). Therefore,
a dose and endpoint
were not selected for
this risk assessment.
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Chronic dietary (all populations) NOAEL= 2.68 mg/kg/day FQPA SF = 1X Chronic feeding study
UF = 100............... cPAD = chronic RfD/FQPA in dogs
Chronic RfD = 0.027 mg/ SF = 0.027 mg/kg/day. LOAEL = 8.46 mg/kg/day
kg/day. based on the
occurrence of
vacuolation in
glandular cells
(parathyroid) and
lymphatic tissues,
arteritis, and
increases in serum
enzymes such as
alanine
aminotranferase, and
aspartate
aminotransferase, and
triglyceride levels in
dogs fed spinosad in
the diet at dose
levels of 1.44, 2.7,
8.46 mg/kg/day for 52
weeks.
----------------------------------------------------------------------------------------------------------------
Dermal (short-and intermediate-term) Not applicable Not applicable No appropriate endpoint
(residential)........................ available. No toxicity
at 2,000 mg/kg/day in
a 21-day dermal
toxicity study in
rats. No dermal
absorption expected
based on molecular
structure and size.
----------------------------------------------------------------------------------------------------------------
[[Page 48964]]
Long-term dermal (several months to Not applicable Not applicable No appropriate endpoint
lifetime) available. Long-term
(residential)........................ exposure is not
expected from
registered use
patterns.
----------------------------------------------------------------------------------------------------------------
Inhalation (any time period) Not applicable Not applicable Low toxicity, use
(residential)........................ pattern and
application rate does
not indicate a need
for risk assessment
via inhalation.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Not applicable Not applicable Spinosad is classified
as a ``Not Likely''
carcinogen.
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.495) for residues of spinosad, in or on a
variety of raw agricultural commodities. Spinosad is registered for use
on a large number of agricultural commodities. Due to a section 18 use
for control of Mediterranean fruit fly, tolerances for residues of
spinosad have been established for all agricultural commodities not
covered by other registrations. Risk assessments were conducted by EPA
to assess dietary exposures from spinosad in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1 day or
single exposure. An endpoint was not identified for acute dietary
exposure and risk assessment because no effects were observed in oral
toxicity studies including developmental toxicity studies in rats or
rabbits that could be attributable to a single dose (exposure).
Therefore, an acute dietary exposure assessment was not performed.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEMTM)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1989-1999 nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The following assumptions were made for the chronic
exposure assessments:
The chronic dietary analysis used residue values at the established
and recommended tolerance levels for all commodities having spinosad
tolerances with the exception of meat (all non-poultry sources) and
milk. Anticipated residues were used for meat and milk from beef and
dairy cattle as follows: Muscle at 0.09 ppm, fat at 2.54 ppm, kidney at
0.19 ppm, liver at 0.48, whole milk at 0.19 ppm, cream at 0.74 ppm,
skim milk at 0.037 ppm. The chronic dietary analysis also assumed that
100 percent crop treatment for registered uses and the proposed uses.
iii. Cancer. Spinosad has been classified as ``not likely to be
carcinogenic in humans'' based on the results of a carcinogenicity
study in mice and the combined chronic toxicity and carcinogenicity
study in rats. Therefore, a cancer risk assessment was not performed.
iv. Anticipated residue and percent crop treated information.
Section 408(b)(2)(E) authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. As required by section 408(b)(2)(E), EPA will
issue a Data Call-In for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance.
2. Dietary exposure from drinking water. Available data on spinosad
show that the compound is not mobile or persistent, and therefore has
little potential to leach to ground water. Spinosad may however
contaminate surface water upon the release of water from flooded fields
to the environment.
The Agency lacks sufficient monitoring exposure data to complete a
comprehensive dietary exposure analysis and risk assessment for
spinosad in drinking water. Because the Agency does not have
comprehensive monitoring data, drinking water concentration estimates
are made by reliance on simulation or modeling taking into account data
on the physical characteristics of spinosad.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. The PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use EECs from these models
to quantify drinking water exposure and risk as a percent of the
reference dose (%RfD) or percent of the population
[[Page 48965]]
adjusted dose (%PAD). Instead drinking water levels of comparison
(DWLOCs) are calculated and used as a point of comparison against the
model estimates of a pesticide's concentration in water. DWLOCs are
theoretical upper limits on a pesticide's concentration in drinking
water in light of total aggregate exposure to a pesticide in food, and
from residential uses. Since DWLOCs address total aggregate exposure to
spinosad, they are further discussed in the aggregate risk sections
below.
Based on the PRZM/EXAMS model, the EECs of spinosad for chronic
exposures are estimated to be 0.092 parts per billion (ppb) for surface
water. The chronic surface water EEC value for spinosad is based on
application of the insecticide to cole crops at 0.13 lb active
ingredient per acre per application with a maximum of 0.45 lb active
ingredient/acre/season.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Registered residential uses for spinosad currently include Conserve
SC Turf and Ornamental (EPA Reg. No. 62719-291) and Conserve Fire Ant
Bait (EPA Reg. No. 62719-291). Both products are registered for outdoor
use only. The risk assessment was conducted using the following
residential exposure assumptions: The turf/ornamental and fire ant bait
uses may result in non-dietary ingestion of spinosad-treated plant
material or soil by children. Half-life estimates for spinosyn A on
various plant foliage ranges from 1.6 to 16 days and generally is
dependent on the amount of sunlight received on the plant surfaces. To
calculate a quantitative risk from a potential ingestion of grass (in
the absence of acute-, short-, or intermediate-term oral endpoints),
EPA would need to default to the chronic dietary endpoint. This
scenario would represent a child eating grass for > 6 months
continuously. Based on the low application rate for spinosad on turf
(0.41 lb/a.i./acre), its non-systemic nature, its short half-life
(especially in sunlight), and the rapid incorporation of spinosad
metabolites into the general carbon pool, EPA believes that residues of
spinosad on turf/ornamentals and soil after application would be low
and decrease rapidly over time. EPA believes that it is inappropriate
to perform a quantitative dietary risk representing a chronic scenario
from children ingesting spinosad-treated plants or soil. Qualitatively,
the risk from children's ingestion of plant or soil as a result of
turf/ornamental and fire ant bait uses does not exceed EPA's level of
concern.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether spinosad has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
spinosad does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that spinosad has a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
D. Safety Factor for Infants and Children
1. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. There is no indication of
increased susceptibility of rat or rabbit fetuses to in utero and/or
postnatal exposure.
3. Conclusion. There is a complete toxicity data base for spinosad
and exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures. EPA determined that the
10X safety factor to protect infants and children should be removed.
This recommendation is based on (1) the completeness of the
toxicological data base, (2) no indication of increased susceptibility
of rat or rabbit fetuses to in utero and/or postnatal exposure, and (3)
no requirement for a developmental neurotoxicity study.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water EECs. DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
[[Page 48966]]
1. Acute risk. Acute aggregate risk consists of the combined
dietary exposures from food and drinking water sources. The total
exposure is compared to the acute RfD. An acute RfD was not identified
since no effects were observed in oral toxicity studies that could be
attributable to a single dose. Therefore, the Agency concludes that
there is a reasonable certainty of no harm from acute aggregate
exposure to spinosad.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to spinosad
from food will utilize 29% of the cPAD for the U.S. population, 26% of
the cPAD for infants, and 57% of the cPAD for children 1 to 6 years
old, the subpopulation at greatest risk. Based on the use pattern,
spinosad's short half-life and non-systemic nature, and the rapid
incorporation of spinosad metabolites into the general carbon pool,
chronic residential exposure to residues of spinosad is not expected.
In addition, there is potential for chronic dietary exposure to
spinosad in drinking water. After calculating DWLOCs and comparing them
to the EECs for surface water, EPA does not expect the aggregate
exposure to exceed 100% of the cPAD, as shown in the following Table 2:
Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Spinosad
----------------------------------------------------------------------------------------------------------------
Surface
Population Subgroup cPAD mg/kg/ %cPAD Water EEC Chronic
day (Food) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.027 29 0.092 670
----------------------------------------------------------------------------------------------------------------
All infants 0.027 26 0.092 200
----------------------------------------------------------------------------------------------------------------
Children (1 to 6 years) 0.027 57 0.092 120
----------------------------------------------------------------------------------------------------------------
Children (7 to 12 years) 0.027 40 0.092 160
----------------------------------------------------------------------------------------------------------------
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposures takes into account residential exposure plus
chronic exposure to food and water (considered to be a background
exposure level).
Though residential exposure could occur with the use of spinosad,
no toxicological effects have been identified for short- or
intermediate-term toxicity. Therefore, the aggregate risk is the sum of
the risk from food and water, which do not exceed the Agency's level of
concern.
4. Aggregate cancer risk for U.S. population. Spinosad has been
classified as ``not likely to be carcinogenic in humans'' based on the
results of a carcinogenicity study in mice and the combined chronic
toxicity and carcinogenicity study in rats. Therefore, spinosad is not
expected to pose a cancer risk to humans.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to spinosad residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (HPLC/UV is available to enforce
the tolerance expression. The method may be requested from: Calvin
Furlow, PIRIB, IRSD (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address:
[email protected].
B. International Residue Limits
No Codex, Canadian, or Mexican maximum residue limits have been
established for residues of spinosad on any crops.
V. Conclusion
Therefore, the tolerances are established for residues of spinosad
in or on asparagus at 0.020 ppm, bushberry subgroup (crop subgroup 13B)
at 0.250 ppm, cranberry at 0.01 ppm, foliage of legume vegetable group
(crop group 7) at 8.0 ppm, garden beet roots at 0.10 ppm, globe
artichoke at 0.30 ppm, juneberry at 0.250 ppm, leaves of root and tuber
vegetable group (crop group 2) at 10.0 ppm, lingonberry at 0.250 ppm,
okra 0.40 ppm, pistachio at 0.020 ppm, pome fruit group (crop group 11)
at 0.20 ppm, salal at 0.250 ppm, strawberry at 1.0 ppm, sugar beet
roots at 0.10 ppm, and tree nut group (crop group 14) at 0.020 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301177 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before November
26, 2001.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in
[[Page 48967]]
40 CFR part 2. A copy of the information that does not contain CBI must
be submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at [email protected],
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-301177, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: [email protected]. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any other Agency action under
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note). Since tolerances and exemptions that are established on the
basis of a petition under FFDCA section 408(d), such as the tolerance
in this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
government and the Indian tribes, or on the distribution of power and
[[Page 48968]]
responsibilities between the Federal government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 10, 2001.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
2. Section 180.495 is amended by deleting the entries for almonds,
apple, and turnip greens; revising the entry for pistachio; and by
alphabetically adding the following commodities to the table in
paragraph (a) to read as follows:
Sec. 180.495 Spinosad; tolerances for residues.
(a)* * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per Revocation
million Date
------------------------------------------------------------------------
* * * * *
Artichoke, globe.............................. 0.30 None
Asparagus..................................... 0.020 None
* * * * *
Beet, garden, roots........................... 0.10 None
Beet, sugar, roots............................ 0.10 None
* * * * *
Bushberry subgroup............................ 0.250 None
* * * * *
Cranberry..................................... 0.01 None
* * * * *
Fruit, pome, group............................ 0.20 None
* * * * *
Juneberry..................................... 0.250 None
* * * * *
Lingonberry................................... 0.250 None
* * * * *
Nut, tree, group.............................. 0.020 None
* * * * *
Okra.......................................... 0.40 None
* * * * *
Pistachio..................................... 0.020 None
* * * * *
Salal......................................... 0.250 None
* * * * *
Strawberry.................................... 1.0 None
* * * * *
Vegetable, foliage of legume, group........... 8.0 None
Vegetable, leaves of root and tuber, group.... 10.0 None
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 01-23609 Filed 9-24-01; 8:45 am]
BILLING CODE 6560-50-S