[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<a href="/cdn-cgi/l/email-protection#3c1158535f5759487c594c5d515d555012594c5d125b534a"><span class="__cf_email__" data-cfemail="406d242f232b2534002530212d21292c6e2530216e272f36">[email protected]</span></a>.
    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: <a href="/cdn-cgi/l/email-protection#e78b869588848486c9808288958082a78297868a868e8bc9829786c9808891"><span class="__cf_email__" data-cfemail="0a666b786569696b246d6f65786d6f4a6f7a6b676b6366246f7a6b246d657c">[email protected]</span></a>.
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-<greek-a>-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-<greek-a>-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 <gr-thn-eq>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 <SUP>14C-Spinosad (Factor A) and <SUP>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 <gr-thn-eq>200 mg/kg/day highest dose tested 
(HDT). The NOEL for maternal toxicity is <gr-thn-eq>200 mg/kg/day HDT. 
An oral developmental toxicity study in rabbits with a developmental 
NOEL of <gr-thn-eq>50 mg/kg/day HDT. The NOEL for maternal toxicity is 
<gr-thn-eq>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 <gr-thn-eq>50 mg/kg/day in 
rabbits (HDT) and <gr-thn-eq>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-
<greek-a>-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-<greek-a>-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


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