[Federal Register Volume 66, Number 104 (Wednesday, May 30, 2001)]
[Notices]
[Pages 29313-29317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13420]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1024; FRL-6782-9]


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.

[[Page 29314]]


DATES: Comments, identified by docket control number PF-1024, must be 
received on or before June 29, 2001.

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-1024 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Akiva Abramovitch, 
Insecticide Rodenticide Branch, Registration Division (7505C), Office 
of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 
308-8328; 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'' ``Regulation 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-1024. 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-1024 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-1024. 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.

[[Page 29315]]

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: May 16, 2001.
James Jones,
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 
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.

Aventis CropScience (formerly, Rhone-Poulenc Ag Company)

PP 0F06082

    EPA has received a pesticide petition (0F06082) from Aventis 
CropScience (formerly, Rhone-Poulenc Ag Company), P.O. Box 12014, #2 
T.W. Alexander Drive, Research Triangle Park, NC 27709 proposing, 
pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 
CFR part 180, by establishing tolerances for residues of acetamiprid in 
or on the raw agricultural commodity brassica (cole crops) at 1.2 parts 
per million (ppm); canola seed and mustard seed at 1.2 ppm; citrus at 
0.5 ppm; cottonseed at 0.06 ppm; fruiting vegetables at 0.2 ppm; grapes 
at 0.2 ppm; leafy vegetables at 3.0 ppm; and pome fruits at 0.70 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 acetamiprid in plants is 
well understood, having been investigated in eggplant, apples, cabbage, 
carrots, and cotton. Metabolism in plants primarily involves 
demethylation of the N-methyl group with subsequent hydrolysis of the 
acetamidine function to give the N-acetyl compound. This compound is 
then hydrolyzed to the corresponding amine followed by oxidation to the 
alcohol and acid. Conjugation of the alcohol with glucose is also 
significant. Degradation of the side chain without loss of the N-methyl 
group is seen in carrots since this is the major metabolic route in 
soil.
    2. Analytical method. Based upon the metabolism of acetamiprid in 
plants and the toxicology of the parent and metabolites, quantification 
of the parent acetamiprid is sufficient to determine toxic residues. As 
a result a method has been developed which involves extraction of 
acetamiprid from crops with methanol, filtration, partitioning and 
cleanup, and analysis by gas chromatography/electron capture detector 
(GC/ECD) methods. The limit of quantification for the method is 0.01 
ppm and the method detection limit (MDL) is 0.0005 ppm.
    3. Magnitude of residues. Magnitude of residue studies were 
conducted in pome fruit (apples and pears); brassica (cole crops 
including broccoli, cabbage and mustard greens); leafy vegetables (leaf 
lettuce, head lettuce, celery, and spinach); fruiting vegetables 
(tomatoes, eggplant, and peppers); citrus (oranges, grapefruit, and 
lemon); grapes; canola seed; mustard seed; and cotton. Trials were 
conducted in all of the major use areas for each of the crops as 
specified in the Residue Chemistry Guidelines OPPTS 860.1500 with 
applications at the maximum label use rate for each crop. (Trials for 
mustard seed were conducted in Canada.). As a result of the field 
trials, the following tolerances are proposed for each of the crop 
group, crops or matrices: pome fruit at 0.70 ppm; brassica (cole crops) 
at 1.2 ppm; leafy vegetables at 3.0 ppm; fruiting vegetables at 0.2 
ppm; grapes at 0.2 ppm; citrus at 0.5 ppm; canola seed at 0.01 ppm; 
mustard seed at 0.01 ppm; cottonseed at 0.06 ppm; and cotton gin trash 
at 20 ppm. Processing studies were also conducted with apples, citrus, 
cottonseed, grapes, and tomatoes. Maximum processed commodity residues 
exceeded 1.2x the RAC tolerance only with citrus dry pulp (2.22x) and 
tomato paste (1.65x). Therefore, tolerances are proposed for these 
processed commodities as follows: citrus dry pulp at 1.2 ppm and tomato 
paste at 0.4 ppm. Tolerances are also proposed for milk, liver, kidney, 
muscle and fat at 0.05 ppm.

B. Toxicological Profile

    1. Acute toxicity. The acute oral LD50 for acetamiprid 
was 146 milligrams/kilogram (mg/kg) for female Sprague-Dawley rats and 
217 mg/kg for male rats. The acute dermal LD50 for 
acetamiprid was greater than 2,000 mg/kg in rats. The acute 4-hour 
inhalation LC50 for acetamiprid was greater than 1.15 
milligrams/Liter (mg/L), the highest attainable concentration. 
Acetamiprid was not irritating to the eyes, or skin and was not 
considered to be a sensitizing agent. The no observed adverse effect 
level (NOAEL) for acute neurotoxicity was 10 mg/kg and no evidence of 
neuropathy was noted.
    The acute oral LD50 for Acetamiprid 70WP was 944 mg/kg 
for female Sprague-Dawley rats and 1,107 mg/kg for male rats. The acute 
dermal LD50 for formulated acetamiprid was greater than 
2,000 mg/kg in rats. The acute inhalation LC50 (4-hour) for 
Acetamiprid 70WP was determined to be greater than 2.88 mg/L, the 
highest attainable concentration. Acetamiprid 70WP was concluded to be 
a mild eye irritant and slight skin irritant. There were no indications 
of skin sensitization for the formulated product.
    2. Genotoxicty. Based on the weight of the evidence provided by a 
complete test battery, acetamiprid is neither mutagenic nor genotoxic. 
The compound was found to be devoid of mutagenic activity (with and 
without metabolic activation) in Salmonella typhimurium and Escherichia 
coli (Ames assay). Acetamiprid was also not mutagenic in an in vitro 
mammalian cell gene mutation assay on Chinese hamster ovary (CHO) cells 
(Hypoxanthine guanine phophoribosyl transferase (HGPRT) locus, with and 
without metabolic activation). Acetamiprid did not induce unscheduled 
DNA synthesis unscheduled DNA synthesis (UDS) in either rat liver 
primary cell cultures or in mammalian liver cells in vivo. In an in 
vitro chromosomal aberration study using CHO cells, acetamiprid was 
positive when tested under metabolic activation at cytotoxic dose 
levels; no effect was detected without metabolic activation. 
Acetamiprid was non-

[[Page 29316]]

clastogenic in an in vivo chromosomal aberration study in rat bone 
marrow. It also was negative in an in vivo mouse bone marrow 
micronucleus assay.
    3. Reproductive and developmental toxicity. In the multi-generation 
rat reproduction study, a NOAEL of 100 ppm was established based on 
decreased body weight gains and a reproduction NOAEL of 800 ppm 
(highest dose tested) was established for reproductive performance and 
fertility. In the rat teratology study, the developmental NOAEL was 50 
mg/kg/day (maternal NOAEL of 16 mg/kg/day based on decreased body 
weight and food consumption) and in the rabbit teratology study, the 
developmental NOAEL was 30 mg/kg/day (maternal NOAEL of 15 mg/kg/day 
based on decreased body weight and food consumption). In both the rat 
and rabbit there were no fetotoxic or teratogenic findings.
    4. Subchronic toxicity.In the 3-month dog feeding study, a NOAEL of 
800 ppm (32 mg/kg/day for both males and females) was established based 
on growth retardation and decreased food consumption.
    In the 3-month rat feeding study, a NOAEL of 200 ppm (12.4 and 14.6 
mg/kg/day respectively for male and female rats) was established based 
on liver cell hypertrophy at a dose of 800 ppm.
    In the 3-month mouse feeding study, a NOAEL of 400 ppm (53.2 and 
64.6 mg/kg/day respectively for male and female rats) was established 
based on increased liver/body weight ratio and decreased cholesterol in 
females at 800 ppm.
    A 13-week dietary neurotoxicity study, for acetamiprid established 
a NOAEL of 200 ppm (14.8 and 16.3 mg/kg/day for male and female rats) 
based on reduced body weight and food consumption decreases at 800 ppm. 
There was no evidence of neurotoxicity.
    A 21-day dermal study, in rabbits at dose levels up to 1,000 mg/kg/
day caused no systemic toxicity, dermal irritation or 
histomorphological lesions in either sex tested.
    5. Chronic toxicity. In the 1-year dog study, the NOAEL was 
established at 600 ppm (20.5 and 21 mg/kg/day for male and female dogs) 
based on growth retardation and decrease of food consumption at a dose 
of 1,500 ppm.
    In the 18-month mouse study, the NOAEL was established at 130 ppm 
(20.3 and 25.2 mg/kg/day for male and female mice) based on growth 
retardation and hepatic toxicity at 400 ppm.
    In the 2-year rat study, the NOAEL was 160 ppm (7.1 and 8.8 mg/kg/
day for male and female rats) based on growth retardation and hepatic 
toxicity. There were no indications of carcinogenicity in either the 
rat or mouse chronic studies.
    6. Animal metabolism. The metabolism of acetamiprid is well 
understood and the primary animal metabolite is IM-2-1.
    7. Metabolite toxicology. Testing of IM-2-1 demonstrated that it is 
significantly less toxic than the parent acetamiprid and it is not 
being considered as part of the total toxic residue, therefore no 
tolerance is being requested by the registrant. The acute oral 
LD50 of IM-2-1 is 2,543 mg/kg for male rats and 1,762 mg/kg 
for female rats.
    8. Endocrine disruption. Acetamiprid does not belong to a class of 
chemicals known or suspected of having adverse effects on the endocrine 
system. Developmental toxicity studies in rats and rabbits and a 
reproductive study in rats gave no indication that acetamiprid has any 
effects on endocrine function. The chronic feeding studies also did not 
show any long-term effects related to endocrine systems.

C. Aggregate Exposure

    1. Dietary exposure. Acute and chronic dietary analyses were 
conducted to estimate exposure to potential acetamiprid residues in/on 
the following crops: cole crop group, citrus crop group, fruiting 
vegetable crop group, pome fruit crop group, grapes leafy vegetables, 
canola oil, mustard and cotton using the Dietary Exposure Evaluation 
Model (DEEM) software. Exposure estimates to water were made based upon 
modeling.
    i. Food. The acute dietary exposure estimates at the 99.9th 
percentile of for the U.S. Population was calculated to be 3.2% of the 
acute Reference Dose (RfD). The population subgroup with the highest 
exposure was children 1-6 at 6% of the acute RFD. The acute RfD was 
based on the NOAEL of 10 mg/kg/day in the acute neurotoxicity study. 
Chronic dietary exposure estimates from residues of acetamiprid for the 
U.S. population was 0.1% of the chronic RfD. The subpopulation with the 
highest exposure wasnon-nursing infants with 0.5% of the RfD used. 
These values are based on projected percentages for percent of crop 
treated and field trial residues at maximum label rates and minimum 
pre-harvest intervals (PHI) with no reduction factors for common 
washing, cooking, or preparation practices. These can be considered 
conservative values. The chronic RfD was based on the NOAEL of 7 mg/kg/
day in the chronic study.
    ii. Drinking water. EPA's Standard Operating Procedure (SOP) for 
Drinking Water Exposure and Risk Assessments was used to perform the 
drinking water analysis for acetamiprid. This SOP utilizes a variety of 
tools to conduct drinking water assessment. These tools include water 
models such as Screening Concentration in Ground Water (SCI-GROW), 
Generic Expected Environmental Concentration (GENEEC), EPA's Pesticide 
Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), and 
monitoring data. If monitoring data are not available then the models 
are used to predict potential residues in surface water and ground 
water. In the case of acetamiprid, monitoring data do not exist, 
therefore, GENEEC and SCI-GROW models were used to estimate a water 
residue. The calculated drinking water levels of comparison (DWLOC) for 
acute and chronic exposures for all adults and children greatly exceed 
the modeled acetamiprid water residues, drinking water estimated 
concentrations (DWEC). The acute DWLOC values are 3,360 ppb for adults 
and 940 ppb for children. The worst case DWEC for acute scenarios is 
calculated to be 13.27 ppb using the GENEEC surface water model. The 
chronic DWLOC values are 2,450 ppb for adults and 700 ppb for children. 
The DWEC for the worst case chronic scenario is 1.59 ppb GENEEC.
    2. Non-dietary exposure. A Ready to Use, dilute formulation of 
acetamiprid will be registered for insect control on outdoor 
ornamentals, vegetable and fruit trees. Based on surrogate exposure 
data obtained from a carbaryl study, the homeowner margin of exposure 
(MOE) was calculated to exceed 10 million. Post-application exposure 
resulting from contact with acetamiprid treated foliage resulted in an 
MOE in excess of 500,000.

D. Cumulative Effects

    EPA and ILSI are developing the methodologies to resolve the 
complex scientific issues concerning common mechanism of toxicity and 
how to cumulate pesticides in a quantitative manner. A determination 
has not been made that acetamiprid has a common mechanism of toxicity 
with other substances. Acetamiprid does not appear to produce a common 
toxic metabolite with other substances. A cumulative risk assessment 
was therefore not performed for this analysis.

E. Safety Determination

    1. U.S. population. Using the conservative assumptions described 
above, based on the completeness and reliability of the toxicity data, 
it is concluded that aggregate exposure to

[[Page 29317]]

the proposed uses of acetamiprid will utilize at most 3.9% of the acute 
RfD for the U.S. population, and is likely to be much less, as more 
realistic data and models are developed. EPA generally has no concern 
for exposures below 100% of the RfD because the RfD represents the 
level at or below which daily aggregate exposure over a lifetime will 
not pose appreciable risks to human health. Therefore, there is a 
reasonable certainty that no harm will occur to the U.S. population 
from aggregate exposure to acetamiprid.
    2. Infants and children. In multi-generation reproduction and 
teratology studies, NOAEL on reproduction were observed in either rats 
or rabbits. In the long-term, feeding studies in rats and mice there 
was no evidence of carcinogenicity. Acetamiprid was not mutagenic under 
the conditions of testing. Using the conservative exposure assumptions 
described in the exposure section above, the percent of the RfD that 
will be used for short-term aggregate exposure to residues of 
acetamiprid will be 6% for children 1-6 (the most highly exposed sub-
group). This value is based on dietary exposure alone as only children 
over 7 are expected to have residential post-application exposure for 
the proposed acetamiprid uses. The aggregate exposure for children 7-12 
(based on dietary and residential exposure) results in a value of 4.0% 
of the RfD being used. As in the adult situation, drinking water levels 
of comparison are much higher than the worst case drinking water 
estimated concentrations. Therefore, there is a reasonable certainty 
that no harm will occur to infants and children from aggregate exposure 
to residues of acetamiprid.

F. International Tolerances

    Acetamiprid is registered for use in Chile, Brazil, Mexico and 
Japan for use on certain food crops for domestic consumption only. 
Imported commodities containing residues of acetamiprid should not be 
encountered in the United States at this time.

[FR Doc. 01-13420 Filed 5-29-01 8:45 am]
BILLING CODE 6560-50-S