[Federal Register: August 4, 2004 (Volume 69, Number 149)]
[Notices]
[Page 47145-47149]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04au04-69]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0222; FRL-7369-6]
Acetamiprid; 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 identification (ID) number OPP-
2004-0222, must be received on or before September 3, 2004.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Akiva Abramovitch, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8328; e-mail address:
abramovitch.akiva@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
Potentially affected entities may include, but are not limited to:
Industry, (NAICS 111)
Crop production (NAICS 1112)
Animal production, (NAICS 311)
Food manufacturing, (NAICS 32532)
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 this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
[[Page 47146]]
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket ID number OPP-2004-0222. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although, a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket
is the collection of materials that is available for public viewing at
the Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1801 South Bell St., Arlington, VA. This
docket facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The docket telephone number is (703)
305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although, not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
Certain types of information will not be placed in the EPA
Dockets. Information claimed as CBI and other information whose
disclosure is restricted by statute, which is not included in the
official public docket, will not be available for public viewing in
EPA's electronic public docket. EPA's policy is that copyrighted
material will not be placed in EPA's electronic public docket but will
be available only in printed, paper form in the official public docket.
To the extent feasible, publicly available docket materials will be
made available in EPA's electronic public docket. When a document is
selected from the index list in EPA Dockets, the system will identify
whether the document is available for viewing in EPA's electronic
public docket. Although, not all docket materials may be available
electronically, you may still access any of the publicly available
docket materials through the docket facility identified in Unit I.B.
EPA intends to work towards providing electronic access to all of the
publicly available docket materials through EPA's electronic public
docket.
For public commenters, it is important to note that EPA's policy
is that public comments, whether submitted electronically or on paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and to Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also, include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/
, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2004-0222. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID number OPP-2004-0222. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID number OPP-2004-0222.
3. By hand delivery or courier. Deliver your comments to: Public
Information
[[Page 47147]]
and Records Integrity Branch (PIRIB), Office of Pesticide Programs
(OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1801 South Bell St., Arlington, VA, Attention: Docket ID
number OPP-2004-0222. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is 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 docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed 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
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 FFDCA 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: July 16, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner's summary of the pesticide petition is printed
below as required by FFDCA section 408(d)(3). The summary of the
petition was prepared by Nippon Soda Company, Ltd. % Nisson America
Inc., and represents the view of the petitioner. 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.
Nippon Soda Company, Ltd.
PP 3F6575
EPA has received a pesticide petition (PP 3F6575) from Nippon Soda
Co., Ltd., c/o Nisso America Inc., 220 East 42nd Street, Suite 3002,
New York, NY, 10017. This petition proposes, pursuant to section 408(d)
of the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d),
to amend 40 CFR 180.578, by establishing tolerances for the residues of
acetamiprid in tuberous and corm vegetables as given below. The
proposed analytical method is by LC/MS/MS. Pursuant to section
408(d)(2) of the FFDCA, as amended by the Food Quality Protection Act
(FQPA), Nippon Soda Co., Ltd. has submitted the following summary of
information, data and rationales in support of their pesticide petition
and authorization for the summary to be published in the Federal
Register in a notice of receipt of the petition. This summary was
prepared by Nippon Soda Co., Ltd. EPA is in the process of evaluating
the petition and has not determined whether the data supports granting
of the petition. EPA may have made minor edits to the summary for the
purpose of clarity.
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 LC/MS/MS methods. The limit of quantification
(LOQ) for the method is 0.01 parts per million (ppm) and the method
detection limit (MDL) is 0.0003 ppm.
3. Magnitude of residues. Magnitude of residue studies were
conducted in potatoes as the representative crop for tuberous and corm
vegetables. 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. As a result of the field trials the following tolerances are
proposed for each of the tuberous and corm crop groups: 0.01 ppm. A
processing study was also conducted with potatoes however even at 5X
the labeled rate, acetamiprid residues were below the LOQ in the raw
agricultural commodity and collected potato processing fractions were
not analyzed.
B. Toxicological Profile
1. Acute toxicity for technical acetamiprid. The acute oral LD-
50 for acetamiprid was 146 milligrams/
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kilogram (mg/kg) for female Sprague-Dawley rats and 217 for male rats.
The acute dermal LD-50 for acetamiprid was greater than
2,000 mg/kg in rats. The acute 4 hour inhalation LC-50 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
effect level (NOEL) for acute neurotoxicity was 10 gram/kilogram (g/kg)
and no evidence of neuropathy was noted.
Acute toxicity for formulated acetamiprid 70WP. The acute oral LD-
50 for Acetamiprid 70WP was 944 mg/kg for female Sprague-
Dawley rats and 1,107 mg/kg for male rats. The acute dermal LD-
50 for formulated acetamiprid was greater than 2,000 mg/kg
in rats. The acute inhalation LC-50 (4 hours) for
acetamiprid 70WP was determined to be greater than 2.88 milligrams per
Liter (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. Genoxicity for technical acetamiprid. 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 (HPRT locus, with and
without metabolic activation). Acetamiprid did not induce 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-clastogenic in an in
vivo chromosomal aberration study in rat bone marrow. It was negative
also, in an in vivo mouse bone marrow micronucleus assay.
3. Reproductive and developmental toxicity. In the multi-generation
rat reproduction study a no observed effect level (NOEL) of 100 ppm was
established based on decreased body weight gains and a reproduction
NOEL of 800 ppm (highest dose tested) was established for reproductive
performance and fertility. In the rat teratology study the
developmental NOEL was 50 milligrams/kilogram/day (mg/kg/day) (maternal
NOEL of 16 mg/kg/day based on decreased body weight and food
consumption) and in the rabbit teratology study the developmental NOEL
was 30 mg/kg/day (maternal NOEL of 15 mg/kg/day based on decreased body
weight and food consumption). In both the rat and rabbit studies there
were no fetotoxic or teratogenic findings.
4. Subchronic toxicity. In the 3-month dog feeding study a NOEL 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 NOEL 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 NOEL of 400 ppm (53.2 and
64.6 mg/kg/day respectively for male and female mice) 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 NOEL of 200 ppm (14.8 and 16.3 mg/kg 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 NOEL was
established at 600 ppm (20 and 21 mg/kg/day for male and female dogs,
respectively) based on growth retardation and decreased food
consumption at a dose of 1,500 ppm.
In the 18-month mouse study the NOEL 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 NOEL 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 seed, cotton, and the tuberous and corm vegetable
crop group using the Dietary Exposure Evaluation Model
(DEEMTM) software. Exposure estimates to water were made
based upon modeling.
2. Food. The acute dietary exposure estimates at the
99.9th percentile for the U.S. population was calculated to
be 5.9% of the acute RfD. The population subgroup with the highest
exposure was non-nursing infants at 15.4% of the acute RfD. The acute
RfD was based on the NOEL of 10 mg/kg in the acute neurotoxicity study.
Chronic dietary exposure estimates from residues of acetamiprid for the
U.S. population was 0.3% of the chronic Populaton Adjusted Dose (cPAD).
The subpopulation with the highest exposure was children 1-6 with 1.3%
of the cPAD used. These values are based on projected percentages for
percent of crop treated and field trial residues at maximum label rates
and minimum PHI's with no reduction factors for common washing,
cooking, or preparation practices. These can be considered conservative
values. The cPAD was based on the NOEL of 7.1 mg/kg/day in the chronic
rat study, an uncertainty factor of 100 to account for interspecies and
intraspecies variations, and an FQPA safety factor of 3.
3. 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), pesticide root
zone model/exposure
[[Page 47149]]
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
SCIGROW 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 parts
per billion (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).
4. Non-dietary exposure. A ready to use, dilute formulation of
acetamiprid is registered for insect control on outdoor ornamentals,
vegetables and fruit trees. Based on surrogate exposure data obtained
from a carbaryl study, the homeowner margin of exposure (MOE) was
calculated to exceed ten million. Postapplication 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 the proposed uses of
acetamiprid will utilize at most 5.9% of the acute reference dose 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. Drinking water levels of comparison
based on this exposure are much greater than conservative estimated
concentrations, and would be expected to be well below the 100% level,
if they occur at all. 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, no adverse effects 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 reference dose that will be used for short term
aggregate exposure to residues of acetamiprid will be 15.4% for non-
nursing infants (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. As in the adult situation, drinking water levels of comparison
are much higher than the worst case drinking water estimated
concentrations and would be expected to use well below 100% of the RfD,
if they occur at all. 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 on food crops in several
countries outside the United States (e.g., maximum residue levels
(MRLs) are established in Canada and Japan).
[FR Doc. 04-17507 Filed 8-3-04; 8:45 am]
BILLING CODE 6560-50-S