[Federal Register Volume 69, Number 178 (Wednesday, September 15, 2004)]
[Notices]
[Pages 55625-55629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-20680]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0223; FRL-7674-9]


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-
2004-0223, must be received on or before October 15, 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:[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

     You may be potentially affected by this action if your rule stated 
``perform renovations of target housing for compensation. Target 
housing is defined (see Sec. 745.103) as any housing constructed prior 
to 1978''. Potentially affected entities may include, but are not 
limited to:
     Industry (NAICS code 111)
     Crop production (NAICS code 1112)
     Animal production, (NAICS code 311)
     Food Manufacturing, (NAICS code 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.

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-2004-0223. 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 in 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

[[Page 55626]]

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-2004-0223. 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 [email protected], 
Attention: Docket ID number OPP-2004-0223. 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-2004-0223.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information 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-2004-0223. 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: August 30, 2004.
Donald R. Stubbs,
Acting 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., 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

PP 4F6833

    EPA has received a pesticide petition (PP 4F6833) from Nippon Soda 
Co., Ltd. c/o Nisso America Inc., 220 East 42nd

[[Page 55627]]

Street, Suite 3002, New York, NY, 10017. This petition proposes, 
pursuant to Section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 
CFR part 180 by establishing tolerances for the residues of acetamiprid 
in/on cucurbits, stone fruit, and tree nuts 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 ppm and the method limit of detection 
(LOD) is 0.003-0.004 ppm for cucurbits, stone fruit, almond and pecan 
nutmeat. The LOQ and LOD for almond hulls is 0.02 ppm and 0.006 ppm, 
respectively.
    3. Magnitude of residues. Magnitude of residue studies were 
conducted in cucumber, cantaloupe, and squash as the representative 
commodities for the cucurbit crop grouping. 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 tolerance is proposed for the commodities in the cucurbit 
crop group: 0.5 ppm.
     Magnitude of residue studies were conducted in peach, plum (fresh 
and dried), sweet cherry, and tart cherry as the representative 
commodities for the stone fruit crop grouping. 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 tolerance is proposed for the commodities in the stone 
fruit crop group except plum, prune, fresh and dried: 1.2 ppm. The 
proposed tolerance for plum, prune, fresh and dried is 0.3 ppm.
     Magnitude of residue studies were conducted in almonds and pecans 
as the representative commodities for the tree nut crop grouping. 
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 tolerance is proposed for the 
commodities in the tree nut crop group except almond hulls: 0.1 ppm. 
The proposed tolerance for almond hulls is 5.0 ppm.

B. Toxicological Profile

    1. Acute toxicity for technical acetamiprid. The acute oral 
LD50 for acetamiprid was 146 milligrams/kilogram (mg/kg) for 
female Sprague-Dawley rats and 217 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 effect 
level (NOEL) for acute neurotoxicity was 10 mg/kg and no evidence of 
neuropathy was noted.
     Acute toxicity for formulated acetamiprid 70WP. 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. Genetic toxicity 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 E. 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 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 NOEL of 100 ppm was established based on 
decreased body weight gains and a reproduction NOEL of 800 parts per 
million (ppm) highest dose tested (HDT) was established for 
reproductive performance and fertility. In the rat teratology study the 
developmental NOEL was 50 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.
     A developmental neurotoxicity study in rats with acetamiprid was 
conducted. The test article was administered orally by gavage to 
Crl:CD(SD)IGS BR rats once daily from gestation day 6 through lactation 
day 21 inclusive at dosage levels of 2.5, 10, and 45 mg/kg/day. One 
female in the 45 mg/kg/day group died during parturition on gestation 
day 23, following delivery of one pup. All other females survived to 
the scheduled necropsies. No adverse clinical signs were noted. F0 
maternal toxicity was expressed at a dose level of 45 mg/kg/day by a 
single mortality and reductions in body weight gain and food

[[Page 55628]]

consumption. No maternal toxicity was exhibited at dose levels of 2.5 
and 10 mg/kg/day. F1 developmental toxicity was expressed at 
a dose level of 45 mg/kg/day by early postnatal mortality and reduced 
post-weaning body weights. No developmental toxicity was exhibited at 
dose levels of 2.5 and 10 mg/kg/day. Deficits in auditory startle 
response occurred in the 45 mg/kg/day group F1 males and 
females without concomitant effects in other functional endpoints 
(FOB), neuropathology or brain morphometry. Based on the results of 
this study, the no observed adverse effect level (NOAEL) for maternal 
toxicity, developmental toxicity and developmental neurotoxicity is 
considered to be 10 mg/kg/day.
    4. Subchronic toxicity. In the 3-month dog feeding study a NOEL of 
800 parts per million (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 milligrams/kilogram/day (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 in plants, 
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 or 
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, tuberous and corm vegetable crop 
group, cucurbit crop group, stone fruit crop group, and tree nut crop 
group using the DEEMTM FCID software. Exposure estimates to 
drinking water were made based on conservative tier 1 FIRST and SCIGROW 
modeling.
    2. Food. The acute dietary exposure estimates at the 
99.9th percentile for the U.S. population was calculated to 
be 6.2% of the acute reference dose (aRfD)f. The population subgroup 
with the highest exposure was children, 1-2 years old at 19.6% of the 
aRfD. The acute RfD was based on the NOEL of 10 mg/kg/day in the acute 
neurotoxicity study in rats. Chronic dietary exposure estimates from 
residues of acetamiprid and the animal metabolite for the U.S. 
population was 0.1% of the chronic population adjusted dose (cPAD). The 
subpopulation with the highest exposure was children 1-2 with 0.6% 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 pre-harvest interval (PHI) 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 and, an uncertainty factor of 100 to 
account for inter-species and intra-species variations. In the final 
rule establishing tolerances for acetamiprid on canola and mustard, 
(September 3, 2003, 68 FR 52343; FRL-7324-1), EPA concluded that a data 
base uncertainty factor (e.g., FQPA factor) was not needed to account 
for the lack of a developmental neurotoxicity study with acetamiprid 
and that reliable data supported removing the additional safety factor 
(e.g., additional 3-fold or 3X) for the protection of infants and 
children. Since that time, an oral exposure developmental neurotoxicity 
study in the rat was conducted with acetamiprid and submitted to EPA. 
Based on the results of this and other developmental toxicology 
studies, the inclusion of an additional FQPA uncertainty factor is 
unwarranted.
    3. Drinking water. EPA's draft Standard Operating Procedure (SOP) 
for incorporating estimates of drinking water exposure into aggregate 
risk assessments was used to perform the drinking water analysis for 
acetamiprid. This SOP utilizes a variety of tools to conduct drinking 
water assessments. These tools include water models such as SCI-GROW, 
first index reservoir screening tool (FIRST), 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, FIRST and SCIGROW models were used to estimate acetamiprid 
residues in surface and ground water, respectively. The short-term were 
greater than 2,000 parts per bilion (ppb) while the modeled drinking 
water estimated concentration (DWEC) was 17 ppb for surface water and 
0.0008 ppb for ground water. The intermediate-term DWLOCs were also 
greater than 2,000 ppb while the modeled DWEC was 4 ppb for surface 
water and 0.0008 ppb for ground water. The modeled DWEC surface and 
ground water residues were less than the calculated DWLOCs for short-
term and intermediate-term exposures for all adults and toddlers (1-2 
years old).
    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 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. 
Additionally a pending use allowing residential applications of 
formulated acetamiprid both indoors and outdoors resulted in short-term 
applicator

[[Page 55629]]

exposure MOEs of greater than 1,500 and short-term post-application 
exposure MOEs of greater than 2,000 for adult and toddler exposure 
scenarios. For intermediate-term post-application exposure following 
indoor applications, the MOEs for toddlers and adults were greater than 
2,500. Short-term and intermediate-term aggregate exposure assessments 
were conducted using EPA's Draft Guidance for Performing Aggregate 
Exposure and Risk Assessments which suggests using the total MOE method 
for aggregating exposures. In the case of acetamiprid, an MOE greater 
than 100 provides a reasonable certainty that no harm will occur from 
the assessed uses. Using the total MOE method for aggregating 
exposures, adults had the lowest MOE estimates in the short-term 
aggregate assessment while toddlers had the lowest MOE estimates in the 
intermediate-term aggregate assessment. All short-term aggregate MOEs 
were greater than 900 and all intermediate-term aggregate MOEs were 
greater than 2,000. Therefore, there is reasonable certainty that no 
harm will result from aggregate (food, drinking water, and residential) 
exposure to acetamiprid residues.

D. Cumulative Effects

     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 and, based on the completeness and reliability of the toxicity 
data, it is concluded, that aggregate exposure from the existing and 
proposed uses of acetamiprid will utilize at most 6.2% of the acute 
reference dose (aRfD) at the 99.9 percentile of exposure and 0.1% of 
the chronic population adjusted dose (cPAD) for the U.S. population. 
These percentages are likely to be much less, as more realistic 
exposure data and models are developed. EPA generally has no concern 
for exposures below 100% of the aRfD and cPAD. Drinking water levels of 
comparison (DWLOCs) based on these is exposure estimates are much 
greater than conservative estimated concentrations, and would be 
expected to be well below the 100% level, if they occur at all. 
Existing and pending uses allowing residential applications of 
acetamiprid both indoors and outdoors resulted in short-term applicator 
exposure MOEs of greater than 1,500 and short-term post-application 
exposure MOEs of greater than 2,000 for adult and toddler exposure 
scenarios. For intermediate-term post-application exposure following 
indoor applications, the MOEs for adults and toddlers were greater than 
2,500. 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. There is no indication of 
developmental neurotoxicity associated with acetamiprid. Using the 
conservative assumptions described in the exposure section above, the 
percent of the acute reference dose (aRfD) that will be used is 19.6% 
for children 1-2 years old (the most highly exposed sub-group) at the 
99.9 percentile of exposure and 0.6% of the chronic population adjusted 
dose (cPAD). 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. MOEs resulting from post-application exposure to 
acetamiprid in residential areas are greater than 2,000. 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.

[FR Doc. 04-20680 Filed 9-14-04; 8:45 am]
BILLING CODE 6560-50-S