[Federal Register Volume 66, Number 241 (Friday, December 14, 2001)]
[Notices]
[Pages 64819-64823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-30913]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1061; FRL-6813-5]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket control number PF-1061, must be 
received on or before January 14, 2002.

ADDRESSES:  Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-1061 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: William G. Sproat, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-8587; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

[[Page 64820]]



------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number PF-1061. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-1061 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-1061. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified under FOR FURTHER INFORMATION 
CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data support granting of the petition. Additional data 
may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: November 29, 2001.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the

[[Page 64821]]

FFDCA. The summary of the petition was prepared by the petitioner and 
represents the view of the petitioner. EPA is publishing the petition 
summary verbatim without editing it in any way. The petition summary 
announces the availability of a description of the analytical methods 
available to EPA for the detection and measurement of the pesticide 
chemical residues or an explanation of why no such method is needed.

Dow AgroSciences LLC

PP EUP-LN

    EPA has received a pesticide petition (PP EUP-LN) from Dow 
AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268 
proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), 
to amend 40 CFR part 180 by establishing a tolerance for residues of 
spinosad in or on the raw agricultural commodity stored grain (wheat, 
barley, corn, oats, rice, and sorghum/milo) at 3 parts per million 
(ppm). EPA has determined that the petition contains data or 
information regarding the elements set forth in section 408(d)(2) of 
the FFDCA; however, EPA has not fully evaluated the sufficiency of the 
submitted data at this time or whether the data support granting of the 
petition. Additional data may be needed before EPA rules on the 
petition.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of spinosad in plants (apples, 
cabbage, cotton, tomato, and turnip) and animals (goats and poultry), 
are adequately understood for the purposes of these tolerances. A 
rotational crop study showed no carryover of measurable spinosad-
related residues in representative test crops.
    2. Analytical method. There is a practical method (immunoassay) for 
detecting (0.005 ppm) and measuring (0.01 ppm) levels of spinosad in or 
on food with a limit of detection that allows monitoring of food with 
residues at or above the level set for these tolerances. The method has 
had a successful method tryout in EPA's laboratories.
    3. Magnitude of residues. Tolerances as high as 10 ppm (Brassica) 
and 8 ppm (leafy vegetables) have been previously established for crop 
commodities treated with spinosad. Magnitude of residue studies were 
conducted at three sites for artichokes. Residues found in these 
studies ranged from 0.062 ppm to 0.156 ppm. Magnitude of residue 
studies were conducted at three sites for asparagus. Residues found in 
these studies were all less than 0.009 ppm. Magnitude of residues 
studies were conducted at five sites for garden beet tops (one of the 
representative crops for the leaves of root and tuber vegetable crop 
group). Residues found in these studies ranged from 0.03 ppm to 4.0 
ppm. Previously submitted data used in support of the established 
residue tolerance on Brassica (cole) leafy vegetables are also to be 
used in support of the proposed residue tolerance for leaves of root 
and tuber vegetables. Magnitude of residue studies were conducted at 
six sites for pears (one of the representative crops for the pome fruit 
crop group). Residues found in these studies ranged from non-detectable 
to 0.08 ppm. Previously submitted data used in support of the 
established residue tolerance on apples are to be used in support of 
the proposed residue tolerance for pome fruit. Magnitude of residue 
studies were conducted at four sites on pecans (one of the 
representative crops for the tree nut crop group). Residues found in 
these studies ranged from less than 0.0010 ppm to 0.0076 ppm. 
Previously submitted data used in support of the established residue 
tolerance on almonds are also to be used in support of the proposed 
residue tolerance for tree nuts and pistachio. A magnitude of residue 
study was conducted at 20 sites on tomatoes and peppers (two of the 
representative crops for the fruiting vegetables crop group). Residues 
found in this study ranged from less than 0.01 ppm to 0.13 ppm in 
tomatoes, and 0.01 ppm to 0.18 ppm in peppers. Previously submitted 
data used in support of the established residue tolerance on fruiting 
vegetables (except cucurbits) are to be used in support of the proposed 
residue tolerance for okra. Magnitude of residue studies were conducted 
at six sites for cranberry. No quantifiable residues (>0.01 ppm) were 
observed in any test sample. Magnitude of residue studies were 
conducted at five sites for garden beet roots (one of the 
representative crops for the root and tuber vegetable crop group) and 
tops (one of the representative crops for the leaves of root and tuber 
vegetable crop group). Residues found in beet tops ranged from 0.03 ppm 
to 4.0 ppm. Previously submitted data used in support of the 
established residue tolerance on Brassica (cole) leafy vegetables are 
also to be used in support of the proposed residue tolerance for leaves 
of root and tuber vegetables. This data support tolerances of 0.1 ppm 
in garden and sugar beet roots and a 10.0 ppm tolerance for Crop Group 
2.

B. Toxicological Profile

    1. Acute toxicity. Spinosad has low acute toxicity. The rat oral 
LD50 is 3,738 milligrams/kilograms (mg/kg) for males and 
>5,000 mg/kg for females, whereas the mouse oral LD50 is 
>5,000 mg/kg. The rabbit dermal LD50 is >5,000 mg/kg and the 
rat inhalation LC50 is >5.18 miligram/liter (mg/L) air. In 
addition, spinosad is not a skin sensitizer in guinea pigs and does not 
produce significant dermal or ocular irritation in rabbits. End use 
formulations of spinosad that are water based suspension concentrates 
have similar low acute toxicity profiles.
    2. Genotoxicity. Short-term assays for genotoxicity consisting of a 
bacterial reverse mutation assay (Ames test), an in vitro assay for 
cytogenetic damage using the chinese hamster ovary (CHO) cells, an in 
vitro mammalian gene mutation assay using mouse lymphoma cells, an in 
vitro assay for DNA damage and repair in rat hepatocytes, and an in 
vivo cytogenetic assay in the mouse bone marrow (micronucleus test) 
have been conducted with spinosad. These studies show a lack of 
genotoxicity.
    3. Reproductive and developmental toxicity. Spinosad caused 
decreased body weights in maternal rats given 200 mg/kg/day by gavage 
(highest dose tested (HDT)). This was not accompanied by either embryo 
toxicity, fetal toxicity, or teratogenicity. The no observed adverse 
effect levels (NOAELs) for maternal and fetal toxicity in rats were 50 
and 200 mg/kg/day, respectively. A teratology study in rabbits showed 
that spinosad caused decreased body weight gain and a few abortions in 
maternal rabbits given 50 mg/kg/day highest dose tested (HDT). Maternal 
toxicity was not accompanied by either embryo toxicity, fetal toxicity, 
or teratogenicity. The NOAELs for maternal and fetal toxicity in 
rabbits were 10 and 50 mg/kg/day, respectively. In a 2-generation 
reproduction study in rats, parental toxicity was observed in both 
males and females given 100 mg/kg/day highest dose tested (HDT). 
Perinatal effects (decreased litter size and pup weight) at 100 mg/kg/
day were attributed to maternal toxicity. The NOAEL for maternal and 
pup effects was 10 mg/kg/day.
    4. Subchronic toxicity. Spinosad was evaluated in 13-week dietary 
studies and showed NOAELs of 4.89 and 5.38 mg/kg/day, respectively in 
male and female dogs; 6 and 8 mg/kg/day, respectively in male and 
female mice; and 33.9 and 38.8 mg/kg/day, respectively, in male and 
female rats. No dermal irritation or systemic toxicity occurred in a 
21-day repeated dose

[[Page 64822]]

dermal toxicity study in rabbits given 1,000 mg/kg/day.
    5. Chronic toxicity. Based on chronic testing with spinosad in the 
dog and the rat, EPA has set a reference dose (RfD) of 0.027 mg/kg/day 
for spinosad. The RfD has incorporated a 100-fold safety factor to the 
NOAELs found in the chronic dog study to account for interspecies and 
intraspecies variation. The NOAELs shown in the dog chronic study were 
2.68 and 2.72 mg/kg/day, respectively for male and female dogs. The 
NOAELs (systemic) shown in the rat chronic/carcinogenicity/
neurotoxicity study were 9.5 and 12.0 mg/kg/day, respectively for male 
and female rats. Using the Guidelines for Carcinogen Risk Assessment 
published in the Federal Register September 24, 1986 (51 FR 33992), it 
is proposed that spinosad be classified as Group E for carcinogenicity 
(no evidence of carcinogenicity) based on the results of 
carcinogenicity studies in two species. There was no evidence of 
carcinogenicity in an 18-month mouse feeding study and a 24-month rat 
feeding study at all dosages tested. The NOAELs shown in the mouse 
oncogenicity study were 11.4 and 13.8 mg/kg/day, respectively for male 
and female mice. A maximum tolerated dose was achieved at the top 
dosage level tested in both of these studies based on excessive 
mortality. Thus, the doses tested are adequate for identifying a cancer 
risk. Accordingly, a cancer risk assessment is not needed.
    Spinosad did not cause neurotoxicity in rats in acute, subchronic, 
or chronic toxicity studies.
    6. Animal metabolism. There were no major differences in the 
bioavailability, routes or rates of excretion, or metabolism of 
spinosyn A and spinosyn D following oral administration in rats. Urine 
and fecal excretions were almost completed in 48-hours post-dosing. In 
addition, the routes and rates of excretion were not affected by 
repeated administration.
    7. Metabolite toxicology. The residue of concern for tolerance 
setting purposes is the parent material (spinosyn A and spinosyn D). 
Thus, there is no need to address metabolite toxicity.
    8. Endocrine disruption. There is no evidence to suggest that 
spinosad has an effect on any endocrine system.

C. Aggregate Exposure

    1. Dietary exposure. For purposes of assessing the potential 
dietary exposure from use of spinosad on the raw agricultural 
commodities listed in this notice, as well as from other existing 
spinosad crop uses, a conservative estimate of aggregate exposure is 
determined by basing the theoretical maximum residue contribution 
(TMRC) on the proposed tolerance level for spinosad and assuming that 
100% of the proposed new crops and other existing (registered for use) 
crops grown in the U.S. were treated with spinosad. The TMRC is 
obtained by multiplying the tolerance residue levels by the consumption 
data which estimates the amount of crops and related foodstuffs 
consumed by various population subgroups. The use of a tolerance level 
and 100% of crop treated clearly results in an overestimate of human 
exposure and a safety determination for the use of spinosad on crops 
cited in this summary that is based on a conservative exposure 
assessment. In addition, for the use of dermal application of spinosad 
to cattle, the risk assessment applies a conservative (overestimate) 
35% of market share for the dermal application to cattle, to the 
tolerance levels for animal commodities based on existing crop uses.
    Drinking water. Another potential source of dietary exposure is 
residues in drinking water. Based on the available environmental 
studies conducted with spinosad wherein its properties show little or 
no mobility in soil, there is no anticipated exposure to residues of 
spinosad in drinking water. In addition, there is no established 
maximum concentration level (MCL) for residues of spinosad in drinking 
water.
    2. Non-dietary exposure. Spinosad is currently registered for use 
on a number of crops including cotton, fruits, and vegetables in the 
agriculture environment. Spinosad is also currently registered for 
outdoor use on turf and ornamentals at low rates of application (0.04 
to 0.54 lb active ingredient per acre) and indoor use for drywood 
termite control (extremely low application rates used with no occupant 
exposure expected). Thus, the potential for non-dietary exposure to the 
general population is considered negligible.

D. Cumulative Effects

    The potential for cumulative effects of spinosad and other 
substances that have a common mechanism of toxicity is also considered. 
In terms of insect control, spinosad causes excitation of the insect 
nervous system, leading to involuntary muscle contractions, prostration 
with tremors, and finally paralysis. These effects are consistent with 
the activation of nicotinic acetylcholine receptors by a mechanism that 
is clearly novel and unique among known insecticidal compounds. 
Spinosad also has effects on the gamma aminobatopic acid (GABA) 
receptor function that may contribute further to its insecticidal 
activity. Based on results found in tests with various mammalian 
species, spinosad appears to have a mechanism of toxicity like that of 
many amphiphilic cationic compounds. There is no reliable information 
to indicate that toxic effects produced by spinosad would be cumulative 
with those of any other pesticide chemical. Thus, it is appropriate to 
consider only the potential risks of spinosad in an aggregate exposure 
assessment. Spinosad is classified in a mechanism-of-action group of 
its own for the purpose of resistance management in insects and for 
rotation with other crop protection products.

E. Safety Determination

    1. U.S. population. Using the conservative exposure assumptions and 
the RfD described above, the aggregate exposure to spinosad use on 
existing crop uses utilizes 36.9% of the RfD for the U.S. population 
from a previous EPA assessment based on the chronic population adjusted 
dose (cPAD) (as posted in the Federal Register of May 3, 2000 (65 FR 
25721) (FRL-6555-9)). 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. The new crop uses proposed in this 
notice are minor ones and are expected to contribute only a negligible 
impact to the RfD. Thus, it is clear that there is reasonable certainty 
that no harm will result from aggregate exposure to spinosad residues 
on existing and all pending crop uses listed in this notice.
    2. Infants and children. In assessing the potential for additional 
sensitivity of infants and children to residues of spinosad, data from 
developmental toxicity studies in rats and rabbits and a 2-generation 
reproduction study in the rat is considered. The developmental toxicity 
studies are designed to evaluate adverse effects on the developing 
organism resulting from pesticide exposure during prenatal development. 
Reproduction studies provide information relating to effects from 
exposure to the pesticide on the reproductive capability and potential 
systemic toxicity of mating animals and on various parameters 
associated with the well-being of pups.
    FFDCA section 408 provides that EPA may apply an additional safety 
factor for infants and children in the case of threshold effects to 
account for prenatal and postnatal toxicity and the completeness of the 
data base. Based on the current toxicological data requirements, the 
data base for spinosad

[[Page 64823]]

relative to prenatal and postnatal effects for children is complete. 
Further, for spinosad, the NOAELs in the dog chronic feeding study 
which was used to calculate the RfD (0.027 mg/kg/day) are already lower 
than the NOAELs from the developmental studies in rats and rabbits by a 
factor of more than 10-fold. Concerning the reproduction study in rats, 
the pup effects shown at the HDT were attributed to maternal toxicity. 
Therefore, it is concluded that an additional uncertainty factor (UF) 
is not needed and that the RfD at 0.027 mg/kg/day is appropriate for 
assessing risk to infants and children. In addition, EPA has determined 
that the 10X factor to account for enhanced sensitivity of infants and 
children is not needed because:
    i. The data provided no indication of increased susceptibility of 
rats or rabbits to in utero and/or postnatal exposure to spinosad. In 
the prenatal developmental toxicity studies in rats and rabbits and 2-
generation reproduction in rats, effects in the offspring were observed 
only at or below treatment levels that resulted in evidence of parental 
toxicity.
    ii. No neurotoxic signs have been observed in any of the standard 
required studies conducted.
    iii. The toxicology data base is complete and there are no data 
gaps.
    iv. Exposure data are complete or is estimated based on data that 
reasonably account for potential exposure.
    Using the conservative exposure assumptions previously described 
(tolerance level residues), the percent RfD utilized by the aggregate 
exposure to residues of spinosad on existing crop uses is 81.9% for 
children 1 to 6 years old, the most sensitive population subgroup from 
an EPA assessment based on the cPAD (as posted in the Federal Register 
of May 3, 2000). Additional refinements to the dietary exposure based 
on market share information would reduce the exposure of children 1 to 
6 years old to less than 50% the cPAD. Grain treated under a temporary 
tolerance is expected to contribute only a negligible impact to the 
RfD. Thus, based on the completeness and reliability of the toxicity 
data and the conservative exposure assessment, it is concluded that 
there is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to spinosad residues on the above 
proposed uses, including existing crop uses.

F. International Tolerances

    There is no Codex maximum residue levels established for residues 
of spinosad.
[FR Doc. 01-30913 Filed 12-13-01; 8:45 am]
BILLING CODE 6560-50-S