[Federal Register Volume 62, Number 38 (Wednesday, February 26, 1997)]
[Rules and Regulations]
[Pages 8626-8632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4625]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300454; FRL-5590-8]
RIN 2070-AC78
Spinosad; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final Rule.
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SUMMARY: This regulation establishes a time-limited tolerance with an
[[Page 8627]]
expiration date of November 15, 1999 for residues of the insecticide
Spinosad in or on the raw agricultural commodity cottonseed. DowElanco
submitted a petition to EPA under the Federal Food Drug and Cosmetic
Act (FFDCA) as amended by the Food Quality Protection Act of 1996 (Pub.
L. 104-170) requesting the tolerance.
EFFECTIVE DATE: This regulation becomes effective February 26, 1997.
The tolerance expires on November 15, 1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300454], 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-300454], should be submitted to: Public Response
and Program Resources Branch, Field Operations 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 Highway, Arlington, VA
22202. A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: OPP-docket@epamail.epa.gov.
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 number [OPP-300454]. 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: George T. LaRocca, Product
Manager (PM) 13, Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location, telephone number and e-mail address: Rm.
204, CM #2, 1921 Jefferson Davis Highway, Arlington, VA 22202, (703)
305-6100, e-mail: larocca.george@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, issued a notice, published in the
Federal Register of July 10, 1996, (61 FR 36373)(FRL-5380-7), which
announced that DowElanco, 9330 Zionsville Road, Indianapolis, IN 46268-
1054, had submitted a pesticide petition (PP 6F4735) to EPA requesting
that the Administrator, pursuant to section 408 of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), establish a
tolerance for residues of the insecticide Spinosad in or on the raw
agricultural commodity cottonseed at 0.02 parts per million (ppm).
Spinosad is a fermentation derived tetracyclic macrolide product
produced by the actinomycete, saccharopolyspora spinosa and consists of
two structurally related compounds, namely, Spinosyn A (CAS No. 131928-
60-7) and Spinosyn D (CAS No. 131929-63-) whose chemical structures
differ by a single methyl group. Spinosyn A is 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. Spinosyn D is 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-4,14-dimethyl-
1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione.
In the Federal Register of November 22, 1996 (61 FR 59437) EPA
issued a second notice of filing to amend the petition to bring it into
conformity with the Food Quality Protection Act (FQPA) of 1996. The
notice contained a summary of the petition prepared by the petitioner
and this summary contained conclusions and assessments to support its
conclusion that the petition complied with FQPA.
In March 1995 Spinosad was accepted by EPA as a reduced risk
pesticide. Reduce risk status was granted primarily due to Spinosad's
low acute mammalian toxicity, low non-target organism toxicity and
compatibility with integrated pest management. The criteria initiating
EPA's reduced risk pesticide process are set forth in Pesticide
Regulation Notice 93-9 dated July 21, 1993 and the January 22, 1993
Federal Register (58 FR 5854).
There were no comments or requests for referral to an advisory
committee received in response to the notice.
I. Background and Statutory Authority
The FQPA of 1996 (Pub. L. 104-170) was signed into law August 3,
1996. FQPA amends both the 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.
New section 408(b)(2)(A)(i) 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, 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 408(b)(2)(D) specifies factors EPA is to consider
in establishing a tolerance. Section 408(b)(3) requires EPA to
determine that there is a practical method for detecting and measuring
levels of the pesticide chemical residue in or on food and that the
tolerance be set at a level at or above the limit of detection of the
designated method. Section 408(b)(4)requires EPA to determine whether a
maximum residue level has been established for the pesticide chemical
by the Codex Alimentarius Commission. If so, and EPA does not propose
to adopt that level, EPA must publish for public comment a notice
explaining the reasons for departing from the Codex level. Section
408(b)(2)(A) governs EPA's establishment of tolerances and
incorporating the provisions of section 408(b)(2)(C) and (D).
II. 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
[[Page 8628]]
adverse health effects, including (but not limited to) reproductive
effects, developmental toxicity, toxicity to the nervous system, and
carcinogenicity. For many of these studies, a dose response
relationship can be determined, which provides a dose that causes
adverse effects (threshold effects) and doses causing no observed
effects (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
significant 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.
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 margin of exposure 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.
In examining aggregate exposure, FQPA 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, and other non-occupational exposures, such
as where residues leach into groundwater or surface water that is
consumed as drinking water. 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. 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 percent 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.
Consistent with sections 408(b)(2)(C) and (D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has also assessed the toxicology data base for
spinosad in its evaluation of applications for registration on cotton.
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 the time-limited tolerances for residues of Spinosad on cottonseed
at 0.02 ppm. EPA's assessment of the database, dietary exposures and
risks associated with establishing these tolerances follows:
A. Toxicology Data Base
The data submitted in the petition and other relevant material have
been evaluated. The toxicological data considered in support of the
tolerance include the following:
1. A battery of acute toxicity studies placing the technical
Spinosad in Toxicity Category III and IV.
2. In a 21-day dermal study in rabbits the NOEL for dermal and
systemic toxicity was 1,000 milligrams per kilogram per day (mg/kg/day)
(limit dose). New Zealand White strain rabbits were given 15 dermal
applications at 0, 100, 500, or 1,000 mg/kg/day for 21 days . Under the
conditions of the test, there was no evidence of treatment-related
toxicity from dermal application at doses up to 1,000 mg/kg/day.
3. In a 13-week feeding neurotoxicity study, Fischer 344 strain
rats were given daily levels of 0, 2.2, 4.3, 8.6, or 42.7 mg/kg body
weight for males and 0, 2.6, 5.2, 10.4 or 52.1 mg/kg/day for females.
There were no effects observed on the functional observational battery
(FOB), motor activity, or histological observations of the nervous
system. Therefore, the NOEL for acute mammalian neurotoxicity in rats
is 42.7 or 52.1 mg/kg/day for male and female rats,
respectively.
4. A chronic 2-year feeding study in dogs at dietary doses of 1.44,
2.68, or 8.46 mg/kg/day in males, and 1.33, 2.72 or 8.22 mg/kg/day
respectively in females with a NOEL of 2.68 mg/kg/day (100/120 ppm).
5. Two mouse carcinogenicity studies have been submitted and
fulfill the requirement for mouse carcinogenicity testing. In the first
study mice were dosed at 0, 3.4, 11.4 and 50.9 mg/kg/day in males and
4.2, 13.8, and 67.0 mg/kg/day respectively in females with systemic
NOEL of 11.4 mg/kg/day for males and 13.8 mg/kg/day in females. In the
second study, involving only females, dosing was at 0, 1.3 and 41.5 mg/
kg/day highest dose tested (HDT). These studies, along with additional
information from the petitioner do not indicate a potential for
carcinogenicity.
6. A 24-month chronic feeding/carcinogenicity study in rats. The
chronic feeding study using rats indicates that the rat is a less
sensitive species than the dog with respect to Spinosad. The rat
feeding study data support the NOEL selected from the dog feeding study
as the basis of the RfD. The rat feeding study is currently determined
to be supplemental since additional histopathology data on the animals
that died during the study are required to upgrade the study from
supplementary status. NOELs and lowest observed effect levels (LOELs)
will be established for this study once the additional data are
reviewed. There were no treatment related carcinogenic effects observed
at any dose level.
7. Mutagenicity studies including an in vitro forward mutation
assay (mouse lymphoma cells), in vitro chromosome aberration assay
(Chinese hamster ovary cells), an in vivo micronucleus assay (mice),
and an in vitro unscheduled DNA synthesis assay (primary rat
hepatocytes) showed no mutagenic activity associated with Spinosad.
8. A metabolism study in rats demonstrates that there were no major
differences between the bioavailability, routes of excretion, or
metabolism of 14C-Spinosad (Factor A) and 14C-Spinosad
(Factor D). Urine and fecal excretions were almost completed at 48
hours post-dosing.
[[Page 8629]]
9. An oral developmental toxicity study in rats with a
developmental NOEL of 200 mg/kg/day highest dose tested
(HDT). The NOEL for maternal toxicity is 200 mg/kg/day HDT.
An oral developmental toxicity study in rabbits with a developmental
NOEL of 50 mg/kg/day HDT. The NOEL for maternal toxicity is
50 mg/kg/day HDT. With respect to both studies there were no
developmental effects that could be attributed to administration of
Spinosad up to the HDT.
10. A two generation reproduction study in rats at dietary doses of
0, 3, 10, and 100 mg/kg/day with a NOEL for parental effects at 10 mg/
kg/day based upon increases in heart, kidney, liver, spleen, and
thyroid weights (both sexes), corroborative histopathology in the
spleen and thyroid (both sexes), heart and kidney (males only), and
histopathologic lesions in the lungs and mesenteric lymph nodes (both
sexes), stomach (females only), and prostate in the high dose group
(100 mg/kg/day).
The NOEL for reproductive effects was also 10 mg/kg/day based upon
both maternal and reproductive effects including decreases in litter
size, survival (F2 litters only), and body weights in the offspring,
and increased incidence of dystocia and/or vaginal bleeding after
parturition with associated increases in mortality in the dams in the
high dose group (100 mg/kg/day).
B. Toxicological Profile
1. Chronic effects. Based on the available chronic toxicity data,
EPA has established the Reference Dose (RfD) for spinosad at 0.0268 mg/
kg/day based on a NOEL of 2.68 mg/kg/day and an uncertainty factor of
100. The NOEL is based on a 2-year dog chronic feeding study.
2. Acute toxicity. Based on the available acute toxicity data, EPA
has determined that Spinosad does not pose any acute dietary risk.
3. Carcinogenicity. Based on the available carcinogenicity studies
in two rodent species Spinosad has not been determined to be a human
carcinogen. A final cancer classification using the Guidelines for
Carcinogen Risk Assessment published September 24, 1986 (51 FR 33992)
is pending; however, the current data does not indicate that a cancer
risk assessment will be necessary.
III. Aggregate Exposure
1. Food and fee uses. For purposes of assessing the potential
dietary exposure from use of Spinosad on cotton EPA has estimated
aggregate exposure based on the TMRC from the tolerance for spinosad on
cottonseed at 0.02 ppm. The TMRC is obtained by multiplying the
tolerance level residue for cottonseed (0.02 ppm) by the food
consumption factors for foods derived from cottonseed. Cottonseed is
fed to animals thus exposure to residues in cottonseed might result if
such residues are transferred to meat, milk, poultry or eggs. However,
based upon the results of animal metabolism studies, EPA concludes
there is no reasonable expectation of finite residues of spinosad in
poultry tissues and eggs from cotton uses. With respect to meat and
milk extrapolation from existing ruminant metabolism, studies indicates
that secondary residues of spinosad in ruminant commodities are
expected to be negligible. The analysis also included two commodities
processed from cottonseed; cottonseed oil and cottonseed meal.
Tolerance level residues on the oil and meal were assumed however EPA
notes that Spinosad residues do not concentrate in processed
commodities, and therefore this risk estimate is very conservative. The
dietary risk assessment will be reevaluated with respect to secondary
residues in ruminant tissues and milk upon submission and review of the
field trial data for cotton gin by-products. There are no other
established U.S. tolerances for Spinosad, and there are no registered
uses for Spinosad on food or feed crops in the United States.
As indicated above, in conducting this exposure assessment, EPA has
made very conservative assumptions--100 percent of cottonseed will
contain spinosad residues including cottonseed oil and meal, and those
residues would be at the level of the tolerance --which results in an
overestimate of human exposure. Thus, in making a safety determination
for these tolerances, EPA is taking into account this conservative
exposure assessment.
2. Potable water. There is no established Maximum Concentration
Level (MCL) for residues of Spinosad in drinking water. Because the
Agency lacks specific water-related exposure data for most pesticides,
EPA has begun and nerly 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. EPA
then applied the estimated residue levels, in conjunction with
appropriate toxicological endpoints (RfD's or acute dietary NOELs) and
assumptions about body weight and consumption, to calculate, for each
pesticide, the increment of aggregate risk contributed by consumption
of contaminated water. This analysis can be found in the Special Record
for the FQPA. While EPA has not yet pinpointed the appropriate bounding
figure for consumption of contaminated water, the ranges EPA is
continuing to examine are all well below the level that would cause
spinosad to exceed the RfD, if the tolerance being considered in this
document are granted. EPA has therefore concluded that the potential
exposure associated with spinosad in water, even at the higher levels
EPA is considering as a conservative upper bound, would not prevent EPA
from determining that there is a reasonable certainty of no harm if the
proposed tolerance on cottonseed is granted.
3. Non-dietary uses. EPA has not estimated non-occupational
exposure for Spinosad since there are no chronic or acute residential
risks expected from the use of Spinosad on cotton. The potential for
non-occupational exposure to the general population is, thus, not
expected to be significant.
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.'' While 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 in a
meaningful way. EPA is commencing 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 enable the
Agency to apply common mechanism issues to its pesticide risk
assessments. At present, however, the Agency does not know how to apply
the information in its files concerning common mechanism issues to risk
assessments, and therefore believes that in most cases there is no
available information concerning common mechanism that can be
scientifically applied to tolerance decisions. Where it is clear that a
particular pesticide may share a significant common mechanism with
other chemicals, a tolerance decision may be affected by common
mechanism issues. The Agency expects that most tolerance decisions will
fall into the area in between, where EPA can not reasonably determine
whether a pesticide does or does not share a
[[Page 8630]]
common mechanism of toxicity with other chemicals (and, if so, how that
common mechanism should be factored into a risk assessment). In such
circumstances, the Agency will reach a tolerance decision based on the
best, currently available and useable information, without regard to
common mechanism issues. However, the Agency will also revisit such
decisions when the Agency learns how to apply common mechanism
information to pesticide risk assessments.
In the case of Spinosad, it is unlikely that this pesticide shares
a common mechanism of toxicity with other pesticides since Spinosad is
a unique insecticide structurally unrelated to other registered
pesticides. However since EPA has determined that it does not now have
the capability to apply the information in its files to a resolution of
common mechanism issues in a manner that would be useful in a risk
assessment, this tolerance determination does not take into account
common mechanism issues. The Agency will reexamine the tolerance for
Spinosad, if reexamination is appropriate, after the Agency has
determined how to apply common mechanism issues to its pesticide risk
assessments.
IV. Determination of Safety for Infants and Children
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 2-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.
Available data indicate that no developmental toxicity was observed
in the rabbit study at the HDT (50 mg/kg/day). Slight maternal toxicity
was observed in the rabbit at the HDT and consisted of marginal
reductions in body weight gain, defecation, and food consumption. In
the rat developmental study, a slight 1-day reduction in maternal body
weight gain and body weight was observed at the HDT, but otherwise no
developmental or maternal toxicity was observed at a high dose level
(200 mg/kg/day). Developmental toxicity studies established the NOELs
for maternal and developmental toxicity at 50 mg/kg/day in
rabbits (HDT) and 200 mg/kg/day in rats HDT.
Reproductive toxicity appears to be related to systemic maternal
toxicity, and was characterized by decreases in mean litter size and
body weight throughout lactation. The NOEL for reproductive toxicity is
10 mg/kg/day.
FFDCA section 408 provides that EPA shall apply an additional
safety factor 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 such additional factor is not
necessary to protect the safety of infants and children. EPA believes
that reliable data support using a different safety factor (usually
100x) and not the additional safety factor when EPA has a complete data
base and when the 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 traditional safety factors.
Based on current data requirements, the database relative to pre-
and post-natal toxicity is complete. These data taken together suggest
minimal concern for developmental or reproductive toxicity and do not
indicate any increased pre- or postnatal sensitivity.
Therefore, EPA concludes that reliable data support use of a 100-
fold safety factor and an additional 10-fold safety factor is not
needed to protect the safety of infants and children.
V. Determination of Safety for U.S. Population Including Infants
and Children
1. Reference dose (RfD). A chronic dietary exposure/risk assessment
was performed for Spinosad using an RfD of 0.02 mg/kg/day based on a
NOEL of 2.68 mg/kg/day from a 2-year dog feeding study with an
uncertainty factor of 100. Using the conservative exposure assumptions
described above and based on the completeness and reliability of the
toxicity data base, EPA has concluded that aggregate exposure to
Spinosad from it use on cotton will utilize less than 1 percent of the
RfD for the U.S. population and for all of the 22 population subgroups
including children and infants. EPA generally has no concern for
exposures below 100 percent of the RfD because the RfD represents the
level at or below which daily aggregate dietary exposure over a
lifetime will not pose significant risks to human health.
2. Aggregate risks. Based upon the available toxicity and exposure
data and worst case assumptions for dietary exposure aggregate chronic
risks are expected to be less than 1% of the RfD for the general U.S.
population, including all population subgroups. As indicated above
although EPA has not yet identified a water exposure figure based on
available environmental data, Spinosad is not expected to be mobile in
soil or water environments and poses relatively little threat to ground
and drinking water. EPA therefore concludes that there is reasonable
certainty that no harm will result to consumers, including infants and
children, from aggregate exposure to spinosad residues.
VI. Other Considerations
A. Endocrine Effects
An evaluation of the potential effects on the endocrine systems of
mammals has not been determined; however no evidence of such effects
were reported in the toxicology studies described above. There is no
evidence at this time that Spinosad causes endocrine effects.
B. Metabolism in Plants and Animals
The metabolism of spinosad in plants and animals is adequately
understood for the purpose of this tolerance. There are no Codex
maximum residue levels established for residues of Spinosad on
cottonseed. There is a practical analytical method for detecting and
measuring levels of spinosad in or on food with a limit of detection
that allows monitoring of food with residues at or above the levels set
in the tolerance. EPA has provided information on this method to FDA.
The method is available to anyone who is interested in pesticide
residue enforcement from: By mail, Calvin Furlow, Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St. SW.,
Washington, DC 20460. Office location and telephone number: Crystal
Mall #2, Rm 1128, 1921 Jefferson Davis Hwy., Arlington, VA 22202, 703-
305-5805.
C. Summary of Findings
Tolerances are time limited to allow for development and review of
residue field trials on cotton gin by products. The analysis for
Spinosad using tolerance level residues shows that the proposed use on
cotton will not cause exposure to exceed the levels at which EPA
believes there is an appreciable risk. All population subgroups
examined by EPA are exposed to Spinosad residues at levels well below
100 percent of the RfD for chronic effects. Based on the information
and data considered, EPA concludes that the proposed time-limited
tolerance will be safe. Therefore, the tolerance is established as set
forth below.
[[Page 8631]]
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
the new section 408(d) 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 its current procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by April 28, 1997, file written objections to any
aspect of this regulation (including the automatic revocation
provision) 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 Docket
A record has been established for this rulemaking under docket
number [OPP-300454]. A public version of this record, 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 Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
The official record for this rulemaking, as well as the public
version, as described above, is kept in paper form. Accordingly, in the
event there are objections and hearing requests, 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. 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
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and, since this
action does not impose any information collection requirements as
defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is
not subject to review by the Office of Management and Budget. In
addition, this action does not impose any enforceable duty or contain
any unfunded mandate as described in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104-4), or require prior consultation with State
officials as specified by Executive Order 12875 (58 FR 58093, October
28, 1993), or special considerations as required by Executive Order
12898 (59 FR 7629, February 16, 1994).
Pursuant to the requirements of the Regulatory Flexibility Act (5
U.S.C. 601-612), the Administrator has determined that regulations
establishing new tolerances or raising tolerance levels or establishing
exemptions from tolerance requirements do not have a significant
economic impact on a substantial number of small entities. A
certification statement to this effect was published in the Federal
Register of May 4, 1981 (46 FR 24950).
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA 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 the
rule in today's Federal Register. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2) of the APA as amended.
List of Subjects In 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Recordkeeping requirements.
Dated: February 13, 1997.
Daniel M.Barolo,
Director, Office of Pesticide Programs.
Therefore, 40 CFR Chapter I is amended as follows:
PART 180--[AMENDED]
1. The statutory authority for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
b. By adding a new Sec. 180.495 to read as follows:
Sec. 180.495 Spinosad; tolerances for residues.
(a) [Reserved]
(b) A time-limited tolerance is established for residues of the
insecticide Spinosad. Factor A is 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,
6b-tetradecahydro-14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-
dione. Factor D is 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-
4,14-dimethyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione.
[[Page 8632]]
------------------------------------------------------------------------
Parts per
Commodity million Expiration Date
------------------------------------------------------------------------
Cottonseed........................ 0.02 November 15, 1999
------------------------------------------------------------------------
[FR Doc. 97-4625 Filed 2-25-97; 8:45 am]
BILLING CODE 6560-50-F
