[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