[Federal Register Volume 67, Number 162 (Wednesday, August 21, 2002)]
[Notices]
[Pages 54200-54203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-21281]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0177; FRL-7191-6]


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.

-----------------------------------------------------------------------

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 ID number OPP-2002-0177, must be 
received on or before September 20, 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 ID 
number OPP-2002-0177 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-3194; 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:

------------------------------------------------------------------------
                                                          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 ID number OPP-2002-0177. 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 ID number OPP-2002-0177 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 ID number OPP-2002-0177. 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.

[[Page 54201]]

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 
ID 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: August 13, 2002.
Debra Edwards,
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 FFDCA. The summary of the 
petition was prepared by the petitioner and represents the view of the 
petitioners. 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.

1E6321, 2E6354, 2E6370, 2E6384, 2E6400, and 2E6422

    EPA has received pesticide petitions (1E6321, 2E6354, 2E6370, 
2E6384, 2E6400, and 2E6422) from IR-4 New Jersey Agricultural 
Experiment Station, P.O. Box 231, Rutgers University, New Brunswick, NJ 
08903 proposing, pursuant to section 408(d) of the Federal Food, Drug, 
and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 
180.495 by establishing tolerances for residues of spinosad, Spinosyn A 
(Factor A; CAS#131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-
-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-
methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H- as 
Indaceno [3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D; 
CAS# 131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl--L-manno-
pyranosyl)oxy]-13-[[5-(dimethyl-amino)-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-methyl-1H- as Indaceno [3,2-d]oxacyclododecin-7,15-
dione in or on the following raw agricultural commodities: fig at 0.1 
parts per million (ppm) (1E6321), herbs subgroup at 8.0 ppm (2E6354), 
root vegetable subgroup at 0.1 (2E6384), dry bulb onion at 0.1 ppm 
(2E6384), caneberry subgroup at 0.7 ppm (2E6400), grape at 0.6 ppm 
(2E6422), raisin at 0.6 ppm (2E6422), grape juice at 1.2 ppm (2E6422), 
and peanut at 0.02 ppm (2E6370).
    This notice includes a summary of the petitions prepared by Dow 
Agro Sciences LLC, Indianapolis, IN 46268. EPA has determined that the 
petitions contain 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 petitions. Additional data may be needed before 
EPA rules on these petitions.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of spinosad in plants (apples, 
cabbage, cotton, tomato, and turnip) is 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 the EPA's laboratories.
    3. Magnitude of residues. The magnitude of residues for spinosad is 
adequately understood for the purpose of the proposed tolerances.

B. Toxicological Profile

    1. Acute toxicity. Spinosad has low acute toxicity. The rat oral 
lethal dose (LD)50 is 3,738 milligrams/kilograms (mg/kg) for 
males and <5,000 mg/kg for females, whereas the mouse oral lethal dose 
(LD)50 is <5,000 mg/kg. The rabbit dermal LD50 is 
<5,000 mg/kg and the rat inhalation lethal concentration 
(LC)50 is <5.18 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. Genotoxicty. Short term assays for genotoxicty consisting of a 
bacterial reverse mutation assay (Ames test), an in vitro assay for 
cytogenetic damage using the Chinese hamster ovary cells, an in vitro 
mammalian gene mutation assay using mouse lymphoma cells, an in vitro 
assay for DNA damage and repair in rat hypothecates, and an in vivo 
cytogenetic assay in the mouse bone marrow (micro nucleus test) have 
been conducted with spinosad. These studies show a lack of genotoxicty.
    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 developmental. The no observed adverse 
effect level (NOAEL) for maternal and fetal toxicity in rats were 50 
and 200 mg/kg/day, respectively. A developmental study in rabbits 
showed that spinosad caused decreased body weight gain and a few 
abortions in maternal rabbits given 50 mg/kg/day (HDT). Maternal 
toxicity was not accompanied by either embryo toxicity, fetal toxicity, 
or developmental. The NOAEL 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 (HDT). Perinatal effects (decreased litter size and 
pup weight) at 100 mg/kg/day were

[[Page 54202]]

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 a NOAEL 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 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, the 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 NOAEL found in the chronic dog study to account for inter- and 
intra-species variation. The NOAEL shown in the dog chronic study was 
2.68 and 2.72 mg/kg/day, respectively for male and female dogs. The 
NOAEL (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 
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 2 
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 NOAEL shown in the mouse carcinogenicity study was 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.
    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--i. Food. 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 these 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.
    ii. Drinking water. Another potential source of dietary exposure 
are residues in drinking water. Based on the available environmental 
studies conducted with spinosad wherein it's 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 for residues of spinosad in drinking water.
    2. Non-dietary exposure. Spinosad is currently registered for 
outdoor use on turf and ornamentals at low rates of application (0.04 
to 0.54 lb active ingedient (a.i.) 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 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.

E. Safety Determination

    1. U.S. population. Using the conservative exposure assumptions and 
the RfD, the aggregate exposure to spinosad use on existing crop uses 
utilizes 40.5% of the RfD for the U.S. population from a previous EPA 
assessment based on the chronic population adjusted dose (cPAD). 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 are 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 pre- and post-natal toxicity and the completeness of the 
database. Based on the current toxicological data requirements, the 
data base for spinosad relative to pre- and post-natal effects for 
children is complete. Further, for spinosad, the NOAEL in the dog 
chronic feeding study which was used to calculate the RfD (0.027 mg/kg/
day) is already lower than the NOAEL from the developmental studies in 
rats and rabbits by a factor of more than 10-fold.

[[Page 54203]]

    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 is not needed and that 
the RfD at 0.027 mg/kg/day is appropriate for assessing risk to infants 
and children.
    In addition, the 10X factor to account for enhanced sensitivity of 
infants and children is not needed because: (1) The data provided no 
indication of increased susceptibility of rats or rabbits to in utero 
and/or post-natal 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 which resulted in evidence of parental toxicity, (2) no 
neurotoxic signs have been observed in any of the standard required 
studies conducted, (3) the toxicology data base is complete and there 
are no data gaps, and (4) exposure data are complete or are 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 84.4% for 
children 1 to 6 years old, the most sensitive population subgroup from 
an EPA assessment based on the chronic population adjusted dose (cPAD). 
The new crop uses proposed in this notice are minor ones and are 
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 are no Codex maximum residue levels (MRLs) established for 
residues of spinosad on grapes, herbs, caneberries, root vegetables, 
dry bulb onions, or figs.
[FR Doc. 02-21281 Filed 8-16-02; 4:19 pm]
BILLING CODE 6560-50-S