[Federal Register Volume 62, Number 204 (Wednesday, October 22, 1997)]
[Rules and Regulations]
[Pages 54771-54778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27727]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300560; FRL-5746-6]
RIN 2070-AB78
Spinosad; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
spinosad (Factors A and D) in or on fruiting vegetables (except
cucurbits) crop group (8), tomato paste, leafy vegetables (except
Brassica vegetables) crop group (4), and Brassica (cole) leafy
vegetables crop group (5). This action is in response to EPA's granting
of emergency exemptions under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act authorizing use of the pesticide on
fruiting vegetables (except cucurbits) crop group (8), leafy vegetables
(except Brassica vegetables) crop group (4), and Brassica (cole) leafy
vegetables crop group (5). This regulation establishes maximum
permissible levels for residues of spinosad in these food commodities
pursuant to section 408(l)(6) of the Federal Food, Drug, and Cosmetic
Act, as amended by the Food Quality Protection Act of 1996. The
tolerances will expire and are revoked on September 30, 1998.
DATES: This regulation is effective October 22, 1997. Objections and
requests for hearings must be received by EPA on or before December 22,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300560], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300560], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7506C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected]. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300560]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Pat Cimino, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401
[[Page 54772]]
M St., SW., Washington, DC 20460. Office location, telephone number,
and e-mail address: Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 308-9357, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing tolerances for
residues of the insecticide spinosad (Factors A and D) in or on
fruiting vegetables (except cucurbits) crop group (8), tomato paste,
leafy vegetables (except Brassica vegetables) crop group (4), and
Brassica (cole) leafy vegetables crop group (5) at 0.25, 0.50, 10.0 and
10.0 parts per million (ppm) respectively. These tolerances will expire
and are revoked on September 30, 1998. EPA will publish a document in
the Federal Register to remove the revoked tolerances from the Code of
Federal Regulations.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described below and discussed in
greater detail in the final rule establishing the time-limited
tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996)(FRL-5572-9).
New 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. . . .''
Section 18 of 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 FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
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.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Spinosad on Fruiting Vegetables (except
Cucurbits) Crop Group (8), Leafy Vegetables (except Brassica
Vegetables) Crop Group (4), and Brassica (Cole) Leafy Vegetables
Crop Group (5) and FFDCA Tolerances
Florida Department of Agriculture & Consumer Services submitted a
regional specific exemption request for Florida, Georgia and Arkansas
for the use of spinosad (Spintor 2SC) to control Western Flower Thrips,
Frankliniella occidentalis, on tomatoes, peppers, eggplant and other
members of fruiting vegetable (excluding cucurbits) crop group (8).
Season long control measures for western flower thrip and the disease
that it vectors, tomato spotted wilt virus, are currently not available
and significant economic losses have already occurred.
On July 15, 1997 the Arizona Department of Agriculture requested a
specific exemption for use of spinosad (Success) to control beet
armyworm on leafy vegetables (except Brassica) crop group (4) and
Brassica leafy vegetables crop group (5). A specific exemption request
for use of tebufenozide (Confirm) to control this pest on these crops
in Arizona was granted earlier this year; however, the state indicates
that tebufenozide alone will not provide adequate control of beet
armyworm in the fall-season planted crops due to high pest pressure.
Beet armyworm pest pressure on Arizona's fall-season planted crops is,
on average, three times greater than pressure on its winter-season
planted crops. Arizona indicates that both pesticides are needed for
the fall-season planting and is recommending the following Integrated
Pest Management (IPM) program for use of both pesticides: (1) spinosad
and tebufenozide may be used where resistance to currently registered
pesticides is occurring; (2) a total of three applications per crop of
spinosad are permitted and may be used from plant emergence to thinning
when beet armyworm populations exceed 1 larva per 100 plants and after
head formation begins (and comparable susceptibility stage for non-head
forming vegtables in these crop groups); a total of three applications
per crop of tebufenozide are permitted from plant emergence to thinning
if beet armyworm populations are less than 1 larva per 100 plants and
from thinning to head formation. After having reviewed the requests,
EPA concurs: that emergency conditions exist for the states and; with
Arizona's IPM recommendations for use of both tebufenozide and spinosad
for beet armyworm control under emergency exemption specifications.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of spinosad in or on fruiting
vegetables (except cucurbits) crop group (8), tomato paste, leafy
vegetables (except Brassica vegetables crop group (4), and Brassica
(cole) leafy vegetables crop group (5). In doing so, EPA considered the
new safety standard in FFDCA section 408(b)(2), and EPA decided that
the necessary tolerance under FFDCA section 408(l)(6) would be
consistent with the new 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 these tolerances
without notice and opportunity for public comment under section 408(e),
as provided in section 408(l)(6). Although these tolerances will expire
and are revoked on September 30, 1998, under FFDCA section 408(l)(5),
residues of the pesticide not in excess of the amounts specified in the
tolerances remaining in or on fruiting vegetables (except cucurbits)
crop group (8), tomato paste, leafy vegetables (except Brassica
vegetables crop group (4), and Brassica
[[Page 54773]]
(cole) leafy vegetables crop group (5) after that date will not be
unlawful, provided the pesticide is applied in a manner that was lawful
under FIFRA. EPA will take action to revoke these tolerances earlier if
any experience with, scientific data on, or other relevant information
on this pesticide indicate that the residues are not safe.
Because these tolerances are being approved under emergency
conditions EPA has not made any decisions about whether spinosad meets
EPA's registration requirements for use on fruiting vegetables (except
cucurbits) crop group (8), leafy vegetables (except Brassica
vegetables) crop group (4), and Brassica (cole) leafy vegetables crop
group (5) or whether permanent tolerances for these uses would be
appropriate. Under these circumstances, EPA does not believe that these
tolerances serve as a basis for registration of spinosad by a State for
special local needs under FIFRA section 24(c). Nor do these tolerances
serve as the basis for any State other than Arizona, Florida, Georgia
and Arkansas to use this pesticide on this crop under section 18 of
FIFRA without following all provisions of 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 above.
III. Risk Assessment and Statutory Findings
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100 percent or less of the
RfD) is generally considered acceptable by EPA. EPA generally uses the
RfD to evaluate the chronic risks posed by pesticide exposure. For
shorter term risks, EPA calculates a margin of exposure (MOE) by
dividing the estimated human exposure into the NOEL from the
appropriate animal study. Commonly, EPA finds MOEs lower than 100 to be
unacceptable. This 100-fold MOE is based on the same rationale as the
100-fold uncertainty factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute,'' ``short-term,''
``intermediate term,'' and ``chronic'' risks. These assessments are
defined by the Agency as follows:
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all
three sources are not typically added because of the very low
probability of this occurring in most cases, and because the other
conservative assumptions built into the assessment assure adequate
protection of public health. However, for cases in which high-end
exposure can reasonably be expected from multiple sources (e.g.
frequent and widespread homeowner use in a specific geographical area),
multiple high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least seven days, an additional degree of conservatism is built
into the assessment; i.e., the risk assessment nominally covers 1-7
days exposure, and the toxicological endpoint/NOEL is selected to be
adequate for at least seven days of exposure. (Toxicity results at
lower levels when the dosing duration is increased.)
Intermediate-term risk results from exposure for seven days to
several months. This assessment is handled in a manner similar to the
short-term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
[[Page 54774]]
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
The TMRC is a ``worst case'' estimate since it is based on the
assumptions that food contains pesticide residues at the tolerance
level and that 100% of the crop is treated by pesticides that have
established tolerances. If the TMRC exceeds the RfD or poses a lifetime
cancer risk that is greater than approximately one in a million, EPA
attempts to derive a more accurate exposure estimate for the pesticide
by evaluating additional types of information (anticipated residue data
and/or percent of crop treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances.
Percent of crop treated estimates are derived from federal and
private market survey data. Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup (non-hispanic
other than black or caucasian subgroup) was not regionally based.
IV. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action, EPA has sufficient data to assess the hazards of spinosad
and to make a determination on aggregate exposure, consistent with
section 408(b)(2), for time-limited tolerances for spinosad (Factors A
and D) in or on fruiting vegetables (except cucurbits) crop group (8),
tomato paste, leafy vegetables (except Brassica vegetables) crop group
(4), and Brassica (cole) leafy vegetables crop group (5) at 0.25, 0.50,
10.0 and 10.0 ppm, respectively. EPA's assessment of the dietary
exposures and risks associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by spinosad are
discussed below.
1. Acute toxicity. None. For acute dietary risk assessment, the
Agency did not select an endpoint based on available data and
determined that this risk assessment is not required.
2. Short - and intermediate - term toxicity. No short- or
intermediate-term toxicological endpoints have been identified.
Therefore, a short- or intermediate-term aggregate risk assessment is
not required.
3. Chronic toxicity. EPA has established the RfD for spinosad at
0.0268 milligrams/kilogram/day (mg/kg/day). The RfD was established
based on a 1-year feeding study in dogs. The NOEL was 2.68 mg/kg/day
with an uncertainty factor of 100. The LOEL of 8.22 mg/kg/day was based
on increases in serum alanine aminotransferase, aspartate
aminotransferase, and triglycerides levels, and the presence of tissue
abnormalities including vacuolated cell aggregations, arteritis, and
glandular cell vacuolation (parathyroid).
4. Carcinogenicity. The Agency determined that there was no
evidence of carcinogenicity in two species.
B. Exposures and Risks
1. From food and feed uses. A time-limited tolerance which expires
November 15, 1999 has been established (40 CFR 180.495) for the
residues of spinosad (Factors A and D) in or on cottonseed at 0.02 ppm.
There are no other tolerances established for spinosad. Risk
assessments were conducted by EPA to assess dietary exposures and risks
from spinosad as follows:
i. Acute exposure and risk. 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. No acute dietary endpoint of concern was
identified by the Agency, therefore this risk assessment is not
required.
ii. Chronic exposure and risk. In conducting the chronic dietary
risk assessment, the Agency used conservative TMRC assumptions as
follows: 100% of the leafy vegetables (except Brassica vegetables) crop
group commodities, Brassica (cole) leafy vegetables crop group
commodities, fruiting vegetable (except cucurbits) crop group
commodities, and cotton commodities tolerances will contain spinosad
residues and those residues will be at the level of the tolerance.
2. From drinking water. Based on information in the EFED One-liner
Database (updated 5/6/97), spinosad is not persistent and not mobile.
There are no established Maximum Contaminant Levels (MCLs) for residues
of spinosad in drinking water. No health advisory levels for spinosad
in drinking water have been established. There is no entry for spinosad
in EPA's Pesticides in Ground Water Database (9/92).
Because the Agency lacks sufficient water-related exposure data to
complete a comprehensive drinking water risk assessment for many
pesticides, EPA has commenced and nearly completed a process to
identify a reasonable yet conservative bounding figure for the
potential contribution of water-related exposure to the aggregate risk
posed by a pesticide. In developing the bounding figure, EPA estimated
residue levels in water for a number of specific pesticides using
various data sources. The Agency then applied the estimated residue
levels, in conjunction with appropriate toxicological endpoints (RfD's
or acute dietary NOEL's) and assumptions about body weight and
consumption, to calculate, for each pesticide, the increment of
aggregate risk contributed by consumption of contaminated water. While
EPA has not yet pinpointed the appropriate bounding figure for exposure
from contaminated water, the ranges the Agency is continuing to examine
are all below the level that would cause spinosad to exceed the RfD
[[Page 54775]]
if the tolerance being considered in this document were granted. The
Agency has therefore concluded that the potential exposures associated
with spinosad in water, even at the higher levels the Agency is
considering as a conservative upper bound, would not prevent the Agency
from determining that there is a reasonable certainty of no harm if the
tolerance are granted.
3. From non-dietary exposure. Spinosad is currently registered for
residential, outdoor, non-food sites, which include: ornamental turf,
and ornamental herbaceous and woody plants. Under current Agency
guidelines, these uses do not fall under a chronic scenario, but may
constitute a short- and/or intermediate-term exposure scenario.
However, no short- or intermediate-term toxicological endpoints of
concern have been identified and the risk assessment is not required
for short- and/or intermediate-term exposure.
4. Cumulative exposure to substances with 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.'' The Agency believes that ``available
information'' in this context might include not only toxicity,
chemistry, and exposure data, but also scientific policies and
methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although
the Agency has some information in its files that may turn out to be
helpful in eventually determining whether a pesticide shares a common
mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues
concerning common mechanism of toxicity in a meaningful way. EPA has
begun a pilot process to study this issue further through the
examination of particular classes of pesticides. The Agency hopes that
the results of this pilot process will increase the Agency's scientific
understanding of this question such that EPA will be able to develop
and apply scientific principles for better determining which chemicals
have a common mechanism of toxicity and evaluating the cumulative
effects of such chemicals. The Agency anticipates, however, that even
as its understanding of the science of common mechanisms increases,
decisions on specific classes of chemicals will be heavily dependent on
chemical specific data, much of which may not be presently available.
Although at present the Agency does not know how to apply the
information in its files concerning common mechanism issues to most
risk assessments, there are pesticides as to which the common mechanism
issues can be resolved. These pesticides include pesticides that are
toxicologically dissimilar to existing chemical substances (in which
case the Agency can conclude that it is unlikely that a pesticide
shares a common mechanism of activity with other substances) and
pesticides that produce a common toxic metabolite (in which case common
mechanism of activity will be assumed).
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.
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. No acute dietary endpoint of concern was identified
by the Agency, so this risk assessment is not required.
2. Chronic risk. Using the conservative TMRC exposure assumptions
described above, EPA has concluded that aggregate exposure to spinosad
from food will utilize 20% of the RfD for the U.S. population. The
major identifiable subgroup with the highest aggregate exposure is non-
hispanics other than blacks or caucasians and aggregate exposure to
spinosad from food will utilize 32% of the RfD for this subpopulation.
EPA generally has no concern for exposures below 100% of the RfD
because the RfD represents the level at or below which daily aggregate
dietary exposure over a lifetime will not pose appreciable risks to
human health. Despite the potential for exposure to spinosad in
drinking water, EPA does not expect the aggregate exposure to exceed
100% of the RfD. Under current Agency guidelines, the registered
residential non-dietary uses do not fall under a chronic scenario. EPA
concludes that there is a reasonable certainty that no harm will result
from chronic aggregate exposure to spinosad residues from food and
water.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure.
Under current Agency guidelines, the registered residential non-
dietary uses do not fall under a chronic scenario, but may constitute a
short- and/or intermediate-term exposure scenario. However, no short-
or intermediate-term toxicological endpoints have been identified.
Therefore, a short- or intermediate-term aggregate risk assessment is
not required.
D. Aggregate Cancer Risk for U.S. Population
The Agency determined that there was no evidence of carcinogenicity
in two species. Therefore, a cancer risk assessment is not required.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children.-- a. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of spinosad, EPA considered data from
developmental toxicity studies in the rat and rabbit and a two-
generation reproduction study in the rat. The developmental toxicity
studies are designed to evaluate adverse effects on the developing
organism resulting from pesticide exposure during prenatal development
to one or both parents. Reproduction studies provide information
relating to effects from exposure to the pesticide on the reproductive
capability of mating animals and data on systemic toxicity.
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 pre-and post-natal toxicity and the
completeness of the database unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a MOE analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. EPA believes that reliable data support using the standard MOE
and uncertainty factor (usually 100 for combined inter- and intra-
species variability)) and not the additional tenfold MOE/uncertainty
factor when EPA has a complete data base under existing guidelines and
when the
[[Page 54776]]
severity of the effect in infants or children or the potency or unusual
toxic properties of a compound do not raise concerns regarding the
adequacy of the standard MOE/safety factor.
b. Developmental toxicity studies.-- i. Rats. In the developmental
study in rats, both the maternal (systemic) NOEL and the developmental
(fetal) NOEL were 200 mg/kg/day at the highest dose tested.
ii. Rabbits. In the developmental toxicity study in rabbits, both
the maternal (systemic) NOEL and the developmental (fetal) NOEL were
50 mg/kg/day at the highest dose tested. The Agency
concluded that spinosad is not a developmental toxicant.
c. Reproductive toxicity study. Rats. In the 2-generation
reproductive toxicity study in rats, the parental (systemic) NOEL was
10 mg/kg/day. The parental (systemic) LOEL of 100 mg/kg/day was based
on increases in heart, kidney, liver, spleen, and thyroid weights (both
sexes). In addition, histopathological lesions were found in the lungs
and mesenteric lymph nodes (both sexes), stomach (females), and
prostate, and increased incidence of dystocia and/or vaginal bleeding
after parturition with associated increases in mortality in the dams.
The NOEL for reproductive toxicity was 10 mg/kg/day. The LOEL for
reproductive toxicity of 100 mg/kg/day was based on decreases in litter
size, survival (F2 litters), and body weights in the
offspring.
d. Pre- and post-natal sensitivity. The toxicological data base for
evaluating pre- and post-natal toxicity for spinosad is complete with
respect to current data requirements. There are no pre- or post-natal
toxicity concerns for infants and children, based on the results of the
rat and rabbit developmental toxicity studies and the 2-generation rat
reproductive toxicity study.
e. Conclusion. Based on the data examined above, the Agency
concludes that reliable data support use of the standard 100-fold
uncertainty factor and that an additional uncertainty factor is not
needed to protect infants and children.
2. Acute risk. No endpoint of concern was identified by the Agency,
so this risk assessment is not required.
3. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that percentage of the RfD that will
be utilized by dietary exposure to residues of spinosad from food
ranges from 2 percent for nursing infants less than 1 year old, up to
23% for children 7-12 years old. EPA generally has no concern for
exposures below 100% of the RfD because the RfD represents the level at
or below which daily aggregate dietary exposure over a lifetime will
not pose appreciable risks to human health. Despite the potential for
exposure to spinosad in drinking water, EPA does not expect the
aggregate exposure to exceed 100% of the RfD. Under current Agency
guidelines, the registered residential non-dietary uses do not fall
under a chronic scenario. EPA concludes that there is a reasonable
certainty that no harm will result to infants and children from chronic
aggregate (food plus water) exposure to spinosad residues.
4. Short- or intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential uses.
Under current Agency guidelines, the registered residential non-
dietary uses do not fall under a chronic scenario, but may constitute a
short- and/or intermediate-term exposure scenario. However, no short-
or intermediate-term toxicological endpoints have been identified.
Therefore, a short- or intermediate-term aggregate risk assessment is
not required.
F. Endocrine Disrupter Effects
EPA is required to develop a screening program to determine whether
certain substances (including all pesticides and inerts) ``may have an
effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or such other endocrine effect...'' The Agency is
currently working with interested stakeholders, including other
government agencies, public interest groups, industry and research
scientists in developing a screening and testing program and a priority
setting scheme to implement this program. Congress has allowed 3 years
from the passage of FQPA (August 3, 1999) to implement this program. At
that time, EPA may require further testing of this active ingredient
and end use products for endocrine disrupter effects.
V. Other Considerations
A. Metabolism In Plants and Animals
The nature of the residue in plants is adequately understood based
on acceptable metabolism studies on cotton, apples, cabbage, tomatoes,
and turnips. The results of the metabolism studies have not yet been
reviewed by the Agency's Metabolism Committee but, for the purposes of
these section 18s only, the residues of concern are the parent
compounds (Factors A and D) only, as specified in 40 CFR 180.495.
B. Analytical Enforcement Methodology
For the purposes of these section 18 requests, DowElanco method GRM
95.04 high pressure liquid chromatography/ultraviolet (HPLC/UV) should
be adequate to enforce the tolerance expression for the fruiting
vegetable (except cucurbits) crop group, and method GRM 94.22 (HPLC/UV)
should be adequate to enforce the tolerance expression for the leafy
vegetables (except Brassica vegetables) crop group and Brassica (cole)
leafy vegetables crop subgroup.
C. Magnitude of Residues
Residues of spinosad (Factors A and D) are not expected to exceed
0.25 ppm in/on the fruiting vegetable (except cucurbits) crop grouping
and 0.50 ppm in/on tomato paste as a result of this section 18 use.
Residues are not expected to concentrate in/on tomato puree. Residues
of spinosad (Factors A and D) are not expected to exceed 10 ppm in/on
the leafy vegetables (except Brassica vegetables) crop group and 10 ppm
in/on the Brassica (cole) leafy vegetables crop group as a result of
this section 18 use. Secondary residues are not expected in animal
commodities as no feed items are associated with these section 18 uses.
D. International Residue Limits
No Codex, Canadian, and/or Mexican MRLs tolerances have been
established for spinosad.
E. Rotational Crop Restrictions
The results of a confined rotational crop study indicate that the
parent compound does not appear to be taken up and/or be translocated
within the plants tested (wheat, lettuce, and radish). Pending review
of the plant metabolism and confined rotational crop studies by the
Agency's Metabolism Committee, rotational crop field studies and
rotational crop tolerances will not need to be established to support
future section 3 permanent tolerance requests. For the purposes of
these section 18 requests, the residues of concern in plants are the
parent compounds (Factors A and D) only, and rotational crop
restrictions and/or tolerances will not be needed.
VI. Conclusion
Therefore, tolerances are established for residues of spinosad
(Factors A and D) in or on fruiting vegetables (except cucurbits) crop
group (8), tomato paste, leafy vegetables (except Brassica vegetables)
crop group (4), and Brassica (cole) leafy vegetables crop group (5) at
0.25, 0.50, 10.0 and 10.0 ppm respectively.
[[Page 54777]]
VII. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by December 22, 1997, file written objections to
any aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is 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 in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32). Information submitted
in connection with an objection or hearing request may be claimed
confidential by marking any part or all of that information as
Confidential Business Information (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.
VIII. Public Record and Electronic Submissions
EPA has established a record for this rulemaking under docket
control number [OPP-300560] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Rm. 1132 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7506C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments may be sent directly to EPA at:
[email protected].
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
This final rule establishes a time-limited 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). 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) (Pub. L. 104-4). Nor does it require any prior consultation as
specified by Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
special considerations as required by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In addition, since these tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408 (d),
such as the time-limited 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.
Nevertheless, the Agency has previously assessed whether establishing
tolerances, exemptions from tolerances, raising tolerance levels or
expanding exemptions might adversely impact small entities and
concluded, as a generic matter, that there is no adverse economic
impact. The factual basis for the Agency's generic certification for
tolerance actions published on May 4, 1981 (46 FR 24950), and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
X. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of this rule in
today's Federal Register. This 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: October 1, 1997.
James Jones,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR Chapter I is amended as follows:
[[Page 54778]]
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.495 is amended as follows:
a. By adding a heading to paragraph (a).
b. In paragraph (b) by adding a heading and alphabetically adding
the following commodities.
c. Paragraphs (c) and (d) are added and reserved with headings.
Sec. 180.495 Spinosad; tolerances for residues.
(a) General. [Reserved]
(b) Section 18 emergency exemptions.
* * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Brassica (Cole) Leafy Vegetables 10.0 9/30/98
Crop Group (5).
* * * * * * *
Fruiting Vegetables (except 0.25 9/30/98
Cucurbits) Crop Group (8).
Leafy Vegetables (except 10.0 9/30/98
Brassica vegetables) Crop Group
(4).
Tomato paste.................... 0.50 9/30/98
------------------------------------------------------------------------
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-27727 Filed 10-21-97; 8:45 am]
BILLING CODE 6560-50-F