Petition for Acetamiprid June 2, 2009


     US Environmental Protection Agency
*r    Office of Pesticide Programs
     Petition for Acetamiprid
     June 2, 2009

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N1SSO AMERICA INC.
45 BROADWAY, SUITE 2120
NEW YORK, NY 10006

PHONE: (212) 490-0350 FAX: (212) 072-9361

June 2,2009
Ms. Karen Angulo
Registration Division
EPA - Office of Pesticide Programs [7505PJ
Ariel Rios Building
1200 Pennsylvania Ave., NW
Washington, DC 20460

Ms. Pat Cimino
Specialty Crops Advisor
EPA - Office of Pesticide Programs
Ariel Rios Building
1200 Pennsylvania Ave., NW
Washington, DC 20460

Mr. Robert Perlis
EPA - Office of General Council [2333A]
Ariel Rios Building
1200 Pennsylvania Ave., NW
Washington, DC 20460

Dear Ms. Angulo, Ms. Cimino, and Mr. Perlis:

PURPOSE

The purpose of this letter is to foilow-up on the Nippon Soda Co., Ltd. (c/o Nisso America Inc.) (Nisso)
August 11,2008 request for an extension of the acetamiprid exclusive use period (Enclosure 1). We wish to ensure
that the US Environmental Protection Agency (EPA or the Agency) has all the information it needs to make a prompt
and affirmative decision on the requested extension and therefore are providing additional supportive information to
serve this end.

We recognize that the Agency resources required to review this extension are substantial, and as the
exclusive use data submitter, we wish to do all we can to facilitate an efficient EPA review. In that spirit, we are
providing in this letter additional information available from U.S. Department of Agriculture (USDA) websites. This
additional information supports the extension of the acetamiprid exclusive use period based on acetamiprid's role as
an important product for use in integrated pest management (IPM) programs. The IPM justification is in addition to
the strong rationale for granting the extension based on acetamiprid's reduced risk profile that is discussed in our
August 11,2008 submission and further amplified in this submission. It is our understanding that if each of the minor
crop uses that form the basis for the extension request meets one of these criteria, then we have met the statutory
requirements for an extension. To qualify for the maximum extension of three years, there must be nine minor uses
that meet at least one of the extension criteria. We have identified 21 uses that meet at least one of the criteria and
were registered by EPA within seven years of the first acetamiprid registration.
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NISSO AMERICA INC.
The extension of the exclusive use period for acetamiprid is critically important to Nisso. Given the
practicalities of business planning, we would be very appreciative if EPA could complete its review soon.
DISCUSSION

Extending the Exclusive Use Period for Minor Uses

The 1996 Food Quality Protection Act (FQPA) amended the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) to provide for the extension of the period during which only the data submitter for the original registration
of a new active ingredient may use data entitled to exclusive use protection to support additional registrations.
FIFRA section 3(c)(1)(F)(ii) states that the exclusive use period can be extended one additional year for each three
minor uses registered within seven years of the beginning of the exclusive use period. One of four specified criteria
must be met in order for the Agency to extend the exclusive use period.

Acetamiprid meets at least two of these four criteria as follows:

1. "the alternatives to the minor use pesticide pose greater risks to tie environment or human health'
(EPA designated acetamiprid as a reduced risk and organophosphate (OP) replacement compound).

2. "the minor use pesticide plays or will play a significant part in an integrated pest management
program."

As stated earlier, our August 11,2008, submission focused on the strong reduced risk record of
acetamiprid. This submission addresses both extension period criteria.

Enclosure 2 is a table that provides information concerning acetamiprid uses registered by EPA. The table
identifies the uses registered, the dates of registration, whether the use is a minor use, and whether the use meets
the reduced risk extension period criterion, the IPM extension period criterion, or both.

EPA's Reduced Risk Program

The EPA website provides a detailed discussion of the Agency's reduced risk pesticide program. While
FQPA formalized the reduced risk program, EPA had a program in place even prior to the passage of the FQPA in
1996. EPA's reduced risk program is clearly one of the Agency's success stories. Registrants were encouraged to
develop reduced risk products. In return, the Agency agreed to expedite the review of the registration submissions.
The pubic good of this program consisted of the introduction of reduced risk pesticides that competed with and took
market share from riskier alternative products. It is important to note that the public health benefits begin to accrue
as soon as EPA registers and allows marketing to begin for the reduced risk pesticides. Over the years, EPA has
applauded the growing impact of reduced risk pesticides that took market share and reduced use of riskier
alternatives including organophosphate, carbamate, and pyrethroid pesticides.

Reduced Risk and Minor Uses

There is less financial incentive for registrants to pursue the registration of pesticides for minor uses
compared to major crops The FQPA amendments concerning the extension of the exclusive use period provided
additional incentive for the pesticide industry to spend resources to support minor uses. Linking the extension to the
reduced risk criterion created the potential not only to stimulate ttie development of minor use pesticides but also to
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NISSO AMERICA INC.
extend the reduced risk safety net beyond major crops to the minor uses. Nisso embraced this incentive by
continuing to generate data supporting minor uses for acetamiprid even after the initial registration.

Justification and Support for Meeting Reduced Risk Criterion

EPA approved two reduced risk and OP replacement submissions for acetamiprid. Enclosure 3 provides
the cover page, the executive overview and the executive summary for the initial submission, dated October 29,
1999. This submission covered a variety of uses including a number of minor uses. Enclosure 4 provides the same
material for the submission dated March 15,2003. This submission covered a requested use on potatoes, which is
not considered a minor use crop, but is provided as part of the background of EPA's assessment of acetamiprid as a
reduced risk pesticide.

Both Enclosures 3 and 4 summarize the human health, ecological effects and environmental fate
characteristics of acetamiprid, and also summarize the reduced risk rationale. In each case, the enclosures also
explain that acetamiprid presented reduced dietary and drinking risk, reduced worker exposure and risk, reduced
ecological risk, and reduced environmental burden and replacement of OP compounds. The MRID numbers for
these documents are 44988401 and 46900501. It is also noteworthy that both documents discuss the compatibility
of acetamiprid in resistance management and IPM programs (acetamiprid's IPM use is addressed in further detail
below).

Nisso will provide the complete reduced risk and OP replacement submissions if that will be helpful to EPA.

Enclosure 5 is a current data matrix that identifies the studies (including MRID Numbers) that support the
continued registration and reduced risk and OP replacement status of acetamiprid.

On March 15,2002, EPA registered the first acetamiprid uses. The initial registration included five crop
groupings containing minor use crops. Nisso submitted residue data for twelve (12) individual minor use crops to
support the reduced-risk registration for these crop groupings. Since the initial registration, Nisso submitted
additional residue data to expand the label and increase the number of crop groupings that contain crops meeting the
definition of minor use (Enclosure 2). Note that Nisso chose not pursue subsequent reduced risk designations after it
submitted its reduced risk justification for potatoes on March 15,2003 because the introduction of PRIA fees
removed much of the expedited review incentive for devoting the time and resources needed to justify a reduced risk
rationale.

On May 25,2005, the Agency registered acetamiprid for use on potatoes. While not a minor use, the
registration demonstrates the continued reduced risk status of acetamiprid.

On November 28,2007, EPA published a final rule (72 FR 67256; Enclosure 6) establishing additional minor
use tolerances for acetamiprid. This Federal Register publication contained a summary of the Agency's updated
view of the toxicology and dietary risk presented by acetamiprid, and referenced an EPA docket that includes a
detailed human health risk assessment (Enclosure 7; dated October 25,2007) and a dietary exposure assessment
(Enclosure 8; dated October 12,2007).

On January 16,2008, EPA published another final rule (73 FR 2809; Enclosure 9) establishing yet
additional minor use tolerances for acetamiprid. In this rule, EPA referenced the risk discussion provided in the
November 28,2007 FR notice.

Enclosures 6,7,8 and 9 document the Agency has continued to actively review and reconsider the data
base supporting acetamiprid. There are numerous food crop, ornamental crop, and residential uses for the
compound. EPA has continued to carefully evaluate the toxicity of acetamiprid, and as recently as January 16,2008,
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N1SSO AMERICA INC.
        concluded that no additional FQPA safety factor is required, and all risks (dietary, water, residential, and aggregate)
        are more than acceptable.

                Most recenfly, on March, 12,2009, the lR-4 Project submitted a request to EPA to designate additional
        minor uses of acetamiprid as reduced risk (Enclosure 10) and establish new or revised tolerances.

                Finally, to ttiis day, EPA's website continues to identify acetamiprid as a reduced risk and OP replacement
        compound.

                White reduced risk pesticides have dearly had a positive impact in the reduced use of riskier alternatives,
        acetamiprid continues to compete with organophosphate, carbamate, and pyrethroid pesticides as it has since 2002.
        The reduced  risk benefits of acetamipfW began to accrue in 2002, and  ftese benefits continue to Ws day.
        Acetamiprid applications to registered minor crops reduces the quantity of OP and carbamate compounds released
        to tw environment.
                                    Justification and Support for Meeting IPM Criterion

                 In addition to fulfilling a criterion for the exclusivity extension under FIFRA § 3(c)(1)(F}(i)(l!) by being
         categorized as a reduced risk pesticide, several acetamiprid minor uses meet a second criterion for the exclusivity
         extension under FIFRA § 3(c)(1)(F)(H) 0V);that is "...the minor use pesticide plays or will play a significant part in an
         integrated pest management program.*

                 Information on Pest Management Strategic Plans (PMSP) derived from the USDA's National Information
         System for the Regional IPM Centers website [htto://www.ipmcenters,org/pmsp] draws that there are currently 25
         PMSPs representing 13 states and/or regions of the US where acetamiprid is listed as an alternative  (or possible
         alternative) insecticide product for 16 minor use (i.e., OOO.OOO A) crops or crop groups. The list of minor use
         crop/state PMSPs and their respective websites are included in Enclosure 11.

                 Likewise the USDA's National Information System for the Regional IPM Centers website
         [htto://www.ipmcenters.org/CropProfiles/] lists 19 Minor Crop/State profiles in which acetamiprid is referenced as an
         alternative insecticide product The list of minor crop profiles and the associated websites are included in Enclosure
         12.  Nine of these are among the 21 uses listed on Enclosure 2 as supporting the extension of exclusive use
         protection for acetamiprid data.
         CONCLUSION

                 Nisso made a timely request to extend the exclusive use period for acetamiprid and demonstrates that there
         are 21 minor crop uses meeting the statutory criteria for the extension ttius there are more than the required 9 minor
         uses to achieve the maximum extension period.  These 21 minor uses were registered within the first seven years of
         the acetamprid exclusive use period and each of these minor uses meets either the reduced risk criterion or the IPM
         criterion of the statute, or botii. Therefore, the Agency has sufficient grounds to extend ttie exclusivity period for
         acetamiprid for an additional three years as provided by FIFRA.

                 Again, because of flie importance of this matter from a business perspective, Nisso would very much
         appreciate a timely response from EPA.

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NISSO AMERICA INC.
                Thank you for your consideration of our request Please contact Mr. John Wrubel of my staff should you
        wish further details.

                                                               Sincerely,
         cc:      D. Edwards, EPA
                 L. Rossi, EPA
                                                               President
                                                               Nisso America Inc.
                                                                                            z>

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                           N1SSO AMERICA INC.
                            45 BROADWAY, SUFTE 2120
                               NEW YORK, NY 10006

 PHONE; (212) 490-0350                                             FAX: (212) 972-9361
                                         August 11, 2008
Pat Cimino
Specialty Crops Advisor
Office of Pesticide Programs [7503PJ
US Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460

Venus Eagle
PM Team 1
Insecticide/Rodenticide Branch
Office of Pesticide Programs [7505P]
US Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460

Meredith Laws
Branch Chief
Insecticide/Rodenticide Branch
Office of Pesticide Programs [7505P]
US Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460

Robert Perlis
EPA- Office of General Council [2333A]
1200 Pennsylvania Avenue, NW
Washington, DC 20460

ATTENTION: Minor Use - Exclusive Use Request

Re:  Request for Extension of Exclusive Use Data Protection for Acetamiprid

Dear Ms. Cimino, Ms. Eagle, Ms. Laws, and Mr. Perlis,

Nippon Soda Co., Ltd. (Nisso), the sole registrant of the proprietary insecticide,
acetamiprid, is hereby petitioning the Environmental Protection Agency for an extension
of the exclusive  use data protection under FIFRA § 3(c)(1)(F)(ii) for agricultural products
containing acetamiprid.

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NISSO AMERICA INC,
      Based on both the residue data generated by Nisso on 28 minor use food crops (twelve
      of which were categorized as "reduced-risk" uses) as well as the use on non-food
      greenhouse/nursery ornamentals that are currently on the acetamiprid product labels
      and registered on or after March 15, 2002, Nisso is formally petitioning to extend the
      data exclusivity period for acetamiprid for an additional three (3) years.

      The current registrations held by Nisso for acetamiprid products used in the agriculture
      sector that are subject to extended exclusive use data protection are as follows:

      Product Name	EPA Reg. No.

      Acetamiprid Technical                                   8033-20
      Acetamiprid RTU Insecticide                              8033-21
      TriStar 70 WSP Insecticide                               8033-22
      Assail 70 WP Insecticide                                 8033-23
      Assail 30 SG Insecticide                                 8033-36
      TriStar 30 SG Insecticide                                 8033-94
      Acetamiprid 50 FS Insecticide Seed Treatment             8033-95

      As mentioned previously, the active ingredient acetamiprid was originally approved by
      US EPA on March 15, 2002. It was registered as a reduced-risk, organophosphate
      replacement product under the Agency's "Safer Pesticide Policy" that was in place at
      the time. The original registration included use on the following crop groups containing
      minor use crops: citrus, fruiting vegetables (except cucurbits), leafy vegetables,  pome
      fruit (excluding apples), and cole crops. Additionally the compound was initially
      approved for insect control on greenhouse and outdoor ornamentals that are considered
      another minor use area.

      Since the original registration, Nisso has expanded the label to include uses in the stone
      fruit, cucurbit, tree nut, bulb vegetable, berries, and succulent legume crop groups, all of
      which contain crops fitting the definition of minor use.  Minor crop growers find the
      acetamiprid labels very useful due to the flexibility offered by the range of approved crop
      groupings.

      Because the current acetamprid labels allows use on nine (9) crop groups containing
      minor use crops and is based on residue data generated by Nisso on 28 individual
      representative minor use food crops, Nisso petitions the Agency to extend the exclusive
      use data protection for the acetamiprid registrations listed above for an additional three
      (3) years beyond the standard 10 year exclusive use period.

      Attached Table 1 provides a summary list of the following: 1) the currently registered
      food crop or crop group on the acetamiprid labels, 2) the representative commodity on
      which residue data were generated, 3) the minor use determination (i.e., < 300,000
      acres), 4) the registration date, 5) the "reduced-risk" status,  and 6) the MRID number of
      the study that contains the residue data on the minor use crops. This concise tabular
      format allows for an expeditious review of this petition as it summarizes  all pertinent
      information for the Agency.

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NISSO AMERICA INC.
Alternative products used on the minor use crops approved on the acetamiprid labels
include various compounds in the organophosphate, carbamate, and pyrethroid classes
of chemistry. In general, these chemistry classes are considered to pose greater risk to
man and the environment than acetamiprid. Also acetamiprid is considered to be an
"azinphos-methyl replacement product11 and exhibits broad spectrum of activity against
various insect pests.

Likewise, being a neonicotinoid, acetamiprid products are used in spray rotation
programs with other mode of action chemistry and thereby reduce the possibility of
insect resistance development.

Lastly, aside from providing an alternative mode of action, acetamiprid is known to be
"soft" on beneficial insects and therefore plays an important role in integrated pest
management programs.

For reasons addressed above, Nisso believes that acetamiprid has fully met and
exceeded the statutory minimum number of required minor use registrations. We look
forward to receiving the additional three years of exclusive use data protection under
FIFRA § 3(c}(1 )(F)(ii) for acetamiprid products.

Please contact me directly at 212-490-0351 should you have any questions or wish
further detail regarding our request. Thank you in advance for your review of this
petition.

Sincerely,
John J. Wrubel
Regulatory Affairs Director

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NISSO AMERICA INC. 1301© 1 .
Acetamiprid Crop Registrations and Minor Use Determination
For Extension of the Exclusive Use Data Protection Period
Crop
or Crop
Group
Brassicas

Citrus

Pome Fruit

Fruiting
Vegetables

Leafy Vegetables

Grapes
Canola
Tuberous
vegetables
Cucurbits*

Legumes"

Stone fruit4

Tree nuts"

Berries4

Bulb vegetables4

Commodity
Broccoli
Cabbage
Mustard greens
Grapefruit
Lemon
Orange
Apples
Pears
Eggplant
Peppers
Tomatoes
Celery
Head lettuce
Leaf lettuce
Spinach
Grapes
Canola
Potato
Cantaloupe
Cucumber
Squash
Green beans
Green peas
Lima beans
Peas in pod
Peach
Plum
Sweet cherry
Tart cherry
Almond
Pecan
Blackberry
Blueberry
Raspberry
Strawberry3
Bulb onion
Green onion
<300K
Acres1
s
•/
s
s
s

s
•/
•/

•/
•/
-/
•/

•/

s
•/
s
s

s
s
•/
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Enclosure 2.

Crop Registrations, Minor Use Determination, and Reduced Risk / IPM Status
for Extension of the Exclusivity Period for Acetamiprid
Crop
or Crop
Group
Brassicas

Citrus

Pome Fruit

Fruiting
Vegetables

Leafy
Vegetables

Grapes
Canola
Tuberous
vegetables
Cucurbits

Legumes

Stone fruit

Tree nuts

Berries

Bulb vegetables

Specific
Commodity
&9Jg($ti*
Cabbage
Mustard greens
Grapefruit

Orange
Apples

Tomatoes
Ctfijjy
B«#!«tte«!
Leaf lettuce-
Spinach
Grapes
Canola
Potato
Ganfe0QUtHJ
Gtowlif
Squash
Green beans
Green peas
Lima beans
Peas in pod

Plum
Sweet cherry
fwf^hiw
Almond
Pecan
Blackberry

Raspberry
Srw>6%«
Bulb onion
Green onion
Registration
Date2
3/15/02
"
"
3/15/02
H
It
3/15/02
a
3/15/02
"
"
3/15/02
11
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REPORT TITLE

Reduced Risk and Organophosphate Replacement Rationale for
Acetamiprid - Agricultural Uses

DATA REQUIREMENT

None

AUTHORS

Monty L. Christian
Helen Cunny, Ph. D.
Warren A. Davis
Dan Gant, Ph. D.
Richard Gibson, M.Sc.
Richard W. Heintzelman, Ph.D.
Keith A. Holmes
Dan Horriere
Curt Lunchick
Christopher Olsen
Lisa Ortego, Ph.D.
Jennifer L. Phillips, Ph.D.

COMPLETION DATE

October 29,1999

SUBMITTED BY

Rhone-Poulenc Ag Company
P.O. Box 12014
2 T.W. Alexander Drive
Research Triangle Park, NC 27709

IDENTIFICATION NUMBER

RR/OP/CROP-1

TOTAL PAGES = 370
REPORT TOTAL PAGES = 319
CONFIDENTIAL ATTACHMENT PAGES = 51
RR/OP/CROP-1
Pagel
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EXECUTIVE OVERVIEW

Rhone-Poulenc Ag Company (Rhone-Poulenc) is submitting two related reduced risk and
organophosphate (OP) replacement documents for the active ingredient acetamiprid to the US
Environmental Protection Agency (EPA or Agency). This document covers two acetamiprid-
containing products, ASSAIL™ brand 70WP Insecticide for use on cotton, pome fruits, citrus,
grapes, cole crops, leafy vegetables, and fruiting vegetables, and ADJUST™ brand 70WP
Insecticide Seed Treatment for use on canola and mustard seed. The second reduced risk
document covers non-agricultural uses of acetamiprid. Again, two products are involved;
namely, PRISTINE™ brand RTU Insecticide, a ready-to-use product for homeowner use on
outdoor ornamentals and in gardens, and CHIPCO® brand TriStar™ 70WSP Insecticide for
professional use in greenhouses and nurseries and on established, outdoor ornamentals in
commercial and residential landscapes. Rhone-Poulenc prepared two separate documents to
facilitate Agency review of the multiple products and uses. In each case, the company believes
there is a very strong reduced risk rationale.

Rhone-Poulenc requests an accelerated review of this acetamiprid submission for the following
reasons:

* Acetamiprid is a strong reduced risk candidate.

• Acetamiprid is a strong OP replacement candidate. Over 4,000,000 pounds of OP
active ingredients will be replaced during the first five years of acetamiprid use.

« Acetamiprid is a strong candidate for joint EPA-Canadian PMRA review. It
clearly meets the criteria identified by EPA and the Pest Management Regulatory
Agency (PMRA), the Canadian pesticide regulatory agency for joint review.
Acetamiprid is a new chemical with major uses in common in both countries,
applications for registration are being submitted simultaneously, and the labeling,
packaging, and residue profiles are substantially similar in both countries.
Acetamiprid will reduce risk in the United States; it will do the same in Canada
where it can eliminate the use of lindane to treat canola and mustard seed.

• Based on PR Notice 97-2, acetamiprid will be used on crops falling under the
minor use definition for EPA priority purposes (e.g., cole crops, leafy vegetables,
fruiting vegetables).

• Acetamiprid meets the criteria for EPA priority attention related to vulnerable
crop/pest combinations (e.g., cole crops/aphids, leafy vegetables/aphids).

Acetamiprid is very effective against a number of key pests for the crops mentioned above
including whiteflies, aphids, codling moths, flea beetles, bud worms, Colorado potato beetles,
leaf miners, citrus thrips, red scale, leaf hoppers, Japanese beetles, pyslla, and mealybugs. The
compound offers equal to superior efficacy at lower application rates than most of the alternative
compounds. In addition, unlike competitive products, acetamiprid has ovicidal activity.
RR/OP/CROP-1
Page 15
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Acetamiprid is not oncogenic. It is not a developmental or reproductive toxicant. It has very low
neurotoxic potential. Based on the weight of the evidence, acetamiprid is not mutagenic or
genotoxic. It degrades rapidly in the environment, is unlikely to drift, run-off or leach, and
presents a very positive ecological risk profile compared to all alternatives including
imidacloprid. Conservative risk assessments demonstrate little cause for concern. Acetamiprid
meets the Food Quality Protection Act (FQPA) "reasonable certainty of no harm" standard, and
the Federal Fungicide, Insecticide, and Rodenticide Act (FIFRA) no unreasonable risk standard.
This stands in sharp contrast to many of the alternative insecticides.

The major alternatives are OPs (such as azinphos-rnethyl, methyl parathion, and chlorpyrifos),
pyrethroids, carbaryl, and imidacloprid. Imidacloprid is in the same chemical family as
acetamiprid; it has achieved important market shares in a number of areas. Acetamiprid will
primarily replace OPs, pyrethroids and carbaryl. From a human risk perspective, the alternatives
tend to have lower No Observed Effect Levels (NOELs) than acetamiprid. The alternatives tend
to exhibit cholinesterase (ChE) inhibiting and neurotoxic properties. The OPs present significant
dietary, aggregate, worker, and risk concerns. OPs are known to accumulate in mammalian
systems following repeated exposure. Finally, the OPs and other alternatives, particularly the
pyrethroids, raise significant ecological risk concerns. (While acetamiprid is very toxic to mysid
shrimp, its overall ecological risk profile is far better than the alternatives).

In regards to the Canadian situation, canola and mustard seed are major crops representing
significant economic value to Canadian agriculture. Lindane is currently the only insecticide
used to treat canola and mustard seed for use in Canada. Imidacloprid is registered only for use
on canola and mustard seed to be exported to the US. Lindane, an organochlorine compound,
raises significant risk concerns. The product is undergoing a "special review" process in Canada;
a final decision is expected in December, 2000. In addition to risk issues, the use of lindane in
Canada creates a trade issue. Most canola and mustard seed used in the US comes from Canada;
yet, there are no tolerances for the use of lindane on canola or mustard seed. The reduced risk
characteristics of acetamiprid and problems with lindane use in Canada make acetamiprid an
ideal candidate for joint US-Canada review. Such a review will address the need to facilitate the
cross-border movement of treated seeds in parallel with the commitments of EPA and PMRA to
facilitate making replacement products available for the 2001 season.

hi conclusion, this document demonstrates folly the reduced risk and OP replacement potential
presented by acetamiprid. In addition, acetamiprid can replace lindane use in Canada, and meets
minor use and vulnerable crop/pest criteria. Moving forward on this compound makes sense for
EPA, Canadian authorities, and growers and consumers on both sides of the border. Rhone-
Poulenc trusts that the Agency will reach these same conclusions.
RR/OP/CROP-1
Page 16
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REDUCED RISK AND OP REPLACEMENT
RATIONALE FOR ACETAMIPRID

A. EXECUTIVE SUMMARY

1. Chemical Name: IUPAC: (E)-N1-[(6-chloro-3-pyridyI)methyl]-N2-cyano-NI
methylacetamidine

2. Common Name: Acetamiprid

3. Chemical Abstract Service Registry Number: 135410-20-7

4. Chemical Structure:
5. Chemical Family: Chloronieotinyl

6. Mode of Action of the Active Ingredient

Acetamiprid acts as an agonist of the nicotinic acetylcholine receptor (nACHR) of the
postsynaptic membrane of nerve cells. The active ingredient interrupts the function of the insect
nervous system. Biochemical radioligand binding studies show that acetamiprid interacts with
high affinity at the insect nACHR binding site and with low affinity at the vertebrate nACHR.
The differences in the affinities of acetamiprid at the insect and vertebrate nACHR may indicate
that there are structural differences between insect and vertebrate nACHRs, and may account for
acetamiprid's selective toxicity to insects.

7. Proposed Use Pattern

There are two acetamiprid products covered by this reduced risk document. The first, ASSAIL™
brand 70WP Insecticide, is a wettable powder formulation for use on cotton, pome fruit, citrus,
grapes, leafy vegetables, fruiting vegetables, cole crops, and canola and mustard seeds. The
second product, ADJUST™ brand 70WP Insecticide Seed Treatment, is an identical formulation
for use in treating canola and mustard seed. Draft labels for both products are provided in
Appendix 1.

The ASSAIL™ product is effective against whiteflies, aphids, coddling moths and a number of
other very harmful pests. It can be applied by ground or air. The canola and mustard seed
treatment product will be used against flea beetles. Seed treatment is usually done by seed
RR/OP/CROP-i
Page 17
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companies, which then sell the treated seed to growers. Most of the canola and mustard treated
seed used by growers in the United States is imported from Canada. Rhone-Poulenc is not only
requesting that EPA determine that acetamiprid is a reduced risk pesticide that will reduce the
use of OP products, but is also requesting EPA and PMRA to conduct a joint review of
acetamiprid so that it can be registered rapidly in both countries. In Canada, acetamiprid will
become a major alternative to lindane, which is the only currently registered insecticide in
Canada for treating canola and mustard seed.

8. Competitive Products

Insects can be highly destructive causing significant reductions in yield and quality that lead to
substantial economic losses. This is true for each of the crops addressed in this reduced risk
document.

Conventional pesticides, BT products, and BT cotton are all used, generally as part of an IPM
program, to control the various insect pests that are problematic in the crops in question. Older
chemistry (the OPs, carbamates, pyrethroids) tend to dominate the market. Imidacloprid, a newer
compound related to acetamiprid, has achieved important market shares.

Tables 1 and 2 provide information concerning acetamiprid and its major alternatives. Table 1
provides common and trade names for the alternatives; Table 2 identifies the major alternatives
by crop, and also gives maximum application rate and maximum number of application
information.
RR/OP/CROP-1
Page 18
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Table 1. Acetamiprid and Alternative Pesticides: Common Names and
Representative Trade Names
Common Name
Acetamiprid
Trade Name
ASSAIL™ and ADJUST™ brand 7QWP
Insecticide
OP Alternatives
Acephate
Azinphos-methyl
Chlorpyrifos
Diazinon
Dicrotophos
Dimethoate
Ethion
Malathion
Methamidophos
Methyl Parathion
Oxydemeton-methyl
Phosmet
Profenofos
Orthene 90S, Orthene 75 S
Guthion Solupak
Lorsban 4E, Lorsban SOW
D-Z-N Diazinon SOW
Bidrin 8
Dimethoate 4EC, Dimethoate 400
Ethion 4 Miscible
Malathion 5
Monitor 4
Penncap-M
Metasystox-R
Imidan 70W
Curacron 8E
Non-OP Alternatives
Abamectin
Carbaryl
Carbofuran
Cyfluthrin
Endosulfan
Esfenvalerate
Formetanate
Hydrochloride
Imidacloprid
Methomyl
Permethrin
Agri-mek 0.15 EC
Sevin Brand XLR PLUS
Furadan 4F
Baythroid 2
Phaser 50WSB
Asana XL
Carzol SP
Provado 1 ,6F, Admire 2F, Gaucho
Lannate SP
Ambush 25 W
RR/OP/CROP-1
Page 19
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Maximum Aj
Active Ingredient
Acetamiprid
Table 2, Acetamiprid and Alternative Pesticides:
>plication Rates by Crop (Ibs ai/acrc) and (Maximum Number of Applications per Season
Cotton
0.1 (4)
Pome
0.15(4)
Citrus
0.075 (4),
0.25(1)
Grapes
0.05 (2)
Cole
0.075 (5)
Leafy
Veg.
0.075 (5)
Fruit Veg.
0.075 (4)

Canola and
Mustard Seed
«_ j™^
OP Alternatives
Acephate
Azinphos-methyl
Chlorpyrifos
Diaziricm
Dicrotophos
Dimcthoate
Ethion
Malathion
Methamidophos
Methyl Parathion
Oxydemeton-methyl
Phosmet
Profenofos
1.0(6)

1,0(6)

0.5 (3)
0.25 (6)

2.5 (6)

1.0(6)

0.5(10est.)

1.5(4)
1.5(8)

3.5 (6)

3.5 (2)

2.0 (2)
3.0 (3)

2.0 (5)

2.0(6)

0.5(10
est)
0.5 (5)

0.5 (6)

0.75 (3)

1.0(5)

0.5 (5)

0.25 (6
est)

0.25 (6 est)

1.0(5)

RR/OP/CROP-I
Page 20
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Table 2. Acetaniiprid and Alternative Pesticides:
Maximum Application Rates by Crop (Ibs ai/acre) and (Maximum Number of Applications per Season) (cont.)
Active Ingredient
Cotton
Pome
Citrus
Grapes
Cole
Leafy
Veg.
Fruit Veg.
Canola and
Mustard Seed
Non-OP Alternatives
Abamectin
Carbaryl
Carbofuran
Cyfluthrin
Endosulfan
Esfenvalerate
Formetanate
Hydrochloride
Imidacloprid
Methomyl
Pertnethrin

0.25 (2)

0.05 (6)

0.023 (2)

1.0(3)

0.1 (5)
0.9(5)

0.023 (2)

0.025 (!)_,

1.4(3)

2.0(5)

0.008 (2)
0.9(5)

0.05 (5)

0.2(5)

1.5(2)

0.05 (10)

0.2(10)

1.0(6)
0.05(10)

0.05 (5)

0.0271

5,0 g ai/kg seed which is equivalent to 0.027 Ibs ai/acre based upon a seeding rate of 6 Ibs seed/acre.
RR/OP/CROP-1
Page 21
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9. Summary of Human Health, Ecological Effects, and Environmental
Fate Characteristics

Acetamiprid presents a low toxicity, low exposure, low risk profile. The uses covered by this
reduced risk document meet all FQPA and FIFRA safety standards as will be demonstrated by
the following discussion. The potential risks resulting from the use of acetamiprid are far less
than the possible risks presented by alternative compounds.

a. Human Health

Acetamiprid has low mammalian toxicity. It is not oncogenic, and based on the weight of the
evidence it is not mutagenic or genotoxic. It does not cause developmental or reproductive
toxicity. It presents low neurotoxic potential, and does not have any cumulative effects such as
ChE inhibition associated with the OP compounds. There is no indication of any effects on the
endocrine system. There is no indication of any increased sensitivity of infants or children.

The two end-use products are Toxicity Category III requiring the use of the signal word
"Caution".

Conservative risk assessments show that dietary exposure utilizes only a small portion of the
RfD; 6% of the acute RfD and 0.5% of the chronic RfD for the most exposed subpopulations.
Drinking water exposure to acetamiprid and its metabolites is projected to be extremely low, and
therefore, is not of concern; especially when acetamiprid's toxicity profile is considered.

MOEs for applying the ASSAIL ™ acetamiprid product range from over 14,000 to over 526,000.
Day 0 MOEs for re-entry workers range from over 1,500 to over 20,000; the REI for all uses will
be 12 hours. For the ADJUST™ seed treatment product, worker MOEs range from 370 to 476.

b. EnvironmentalFate

A complete battery of environmental fate studies show that acetamiprid has a low environmental
risk profile. The primary route of degradation is through microbial degradation. Acetamiprid
degrades rapidly in the environment; the major soil metabolites degrade more slowly. Field soil
dissipation studies show little potential for acetamiprid or its metabolites to leach into ground
water.
RR/OP/CROP-1
Page 22
-------
c. Ecological Effects

The proposed uses of acetamiprid present minimal risk to non-target organisms including
endangered species, and certainly present less risk than the alternatives.

Avian and mammalian risk assessments were performed using worst-case models. No Levels of
Concern (LOG) are exceeded for the foliar or seed treatment uses of acetamiprid.

No LOCs are exceeded for freshwater organisms or marine fish. LOCs are exceeded for
mysid shrimp; more refined modeling may reduce the Risk Quotients (RQs) below the LOG.

Acetamiprid is non- toxic to aquatic plants. For a few terrestrial plants, LOCs are exceeded
for worst-case, channelized runoff scenarios.

Finally, acetamiprid is moderately toxic to honey bees when contacted by a foliar spray;
however, there is no residual toxicity once sprays have dried. Acetamiprid is much less toxic
to bees than imidacloprid and many of the other alternative pesticides.

10. Tier I Statement - Meeting FQPA Reduced Risk Criteria

As will be demonstrated by this reduced risk submission, the proposed uses of acetamiprid meet
each of the four FQPA reduced risk criteria. Namely, acetamiprid:

• Reduces the risk of pesticides to human health;

• Reduces the risk of pesticides to non-target organisms;

• Reduces the potential for contamination of ground water, surface water, or other
valued environmental resources; and

• Broadens the adoption of integrated pest management strategies, or makes such
strategies more available or more effective.

11. Reduced Risk Statement

The market introduction of the two acetamiprid products, ASSAIL™ brand 70WP Insecticide,
and ADJUST™ brand 70WP Insecticide Seed Treatment, will reduce exposure, will reduce risk,
and will reduce pounds of pesticides used. The reduction in pesticide use will be accomplished,
to a large extent, at the expense of the OP alternatives. Workers, consumers, non-target
organisms, and the environment will benefit. In addition to the reduced risk benefits that will
result from the use of acetamiprid in the United States, Rhone-Poulenc is also hopeful that a
timely registration of acetamiprid in Canada will contribute to the reduction in the use of lindane
as a canola and mustard seed treatment. Thus, a prompt joint review by US and Canadian
regulatory authorities can achieve reduced risk in both countries. (Note that, in addition to

RR/OP/CROP-1
Page 23
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canola, Rhone-Poulenc is seeking a joint review for grapes, pome fruit, cole crops, and leafy and
fruiting vegetables. Harmonization of tolerances will be a benefit for both countries). The
reduced risk benefits that will be achieved in the US are discussed in more detail below.

a. Reduced Dietary and Drinking Water Risk

The acetamiprid products will compete against a variety of alternatives including OP and
pyrethroid compounds. Acetamiprid has an excellent toxicity profile compared to the
alternatives. Lower exposure (acetamiprid is efficacious at very low application rates) and fewer
toxicity concerns translates to reduced dietary risk. Acetamiprid presents no drinking water risk.
Acetamiprid will be used on foods that are typical risk drivers for children (e.g., apples, pears,
grapes, and oranges). These foods and the current OP insecticides are of particular concern to the
Agency. When methyl parathion use on apples, pears and grapes was voluntarily cancelled in
August, growers were left with the basic option of switching to another OP compound. With
acetamiprid, real reduced use of OPs on children's foods and real reduced risk can be achieved.

hi some cases, dietary risk from individual OP compounds may be acceptable. However, the
Agency appears to be moving toward a decision that most or all of the OPs share a common
mechanism of toxicity. Thus, risk from cumulative use and exposure would be added together;
almost guaranteeing that OP dietary exposure is excessive. Acetamiprid provides EPA and
growers a different class of chemistry whose "risk cup" is dramatically less full compared to the
current OP pesticides. For example, a conservative dietary risk assessment shows that only 6%
of the acute Reference Dose (RfD) will be utilized by children from one to six years of age, the
most exposed subpopulation.

b. Reduced Worker Exposure

Rhone-Poulenc has performed risk assessments for mixer-loaders, applicators, re-entry workers
and seed company workers (who will treat canola and mustard seed with acetamiprid). MOEs
for acetamiprid are well in excess of acceptable standards - in the hundreds for workers treating
seed, in the thousands for re-entry workers based on estimated day 0 dislodgeable residues, and
in the hundreds of thousands for other workers. This risk picture is quite different from the
worker risk information being released by EPA as it conducts worker risk assessments in
conjunction with the FQPA reassessment of the OPs - often the Agency concludes that MOEs
for OP use are less than acceptable even when maximum worker protection measures are
considered. Consider the alternatives. With acetamiprid, workers can re-enter apple orchards
and perform hand labor in 12 hours, the minimum time period under current regulations. On the
other hand, in the case of azinphos-methyl, for example, EPA has reported that risk estimates for
reentry workers pose "serious risk concerns based on current application rates and REIs" (reentry
intervals). The Agency has stated that the registrant is significantly increasing the REIs for a
number of crops, but EPA still has serious risk concerns.
RR/OP/CROP-1
Page 24
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c. Reduced Ecological Risk

The low application rates for acetamiprid and relatively rapid environmental degradation
combined with a favorable ecological toxiciry profile means that non-target organisms will be
faced with less exposure and less risk when growers use acetamiprid. A detailed ecological risk
assessment was performed on a crop-by-crop basis to evaluate the potential ecological impact of
acetamiprid compared to its alternatives. In summary, acetamiprid has substantially lower risk
quotients (RQs) than the vast majority of competitor active ingredients for all crops.
Acetamiprid has RQs approximately equal to imidacloprid except for bee toxicity; acetamiprid is
much less toxic to honey bees than imidacloprid. RQ values for both compounds are well below
EPA's levels of concern (LOCs) for all animal groups for all crops except for mysid shrimp. In
contrast, the other active ingredients exceed LOCs for a variety of animal groups and uses by a
large margin.

d. Reduced Environmental Burden and OP Replacement

The introduction of acetamiprid will result in a substantial reduction in the pounds of active
ingredients placed in the environment each year. Acetamiprid's application rates are lower than
most of the alternatives, particularly the OPs. Acetamiprid degrades rapidly, and fate data
indicate that the compound is not likely to drift, run-off or leach. In the first year of use, Rhone-
Poulenc estimates that slightly more than 76,000 pounds of acetamiprid will replace over
360,000 pounds of alternative active ingredients; almost 300,000 pounds of this total represents a
reduction in OP use. In the fifth year of sales, slightly more than 226,000 pounds of acetamiprid
will replace over 1,270,000 pounds of alternative pesticide active ingredients; over 1,000,000
pounds of this total consists of OP active ingredients. Cumulatively, a reduction of over
4,800,000 pounds of competitive active ingredients, including over 4,000,000 pounds of OP
active ingredients will be achieved during the first five years of use. That total will be offset by
the use of about 890,000 pounds of acetamiprid.

e. Compatible with Resistance Management and 1PM Programs

Rhone-Poulenc has established a global resistance monitoring program for acetamiprid. The
company has an ongoing, product stewardship program to work with growers in order to reduce
the potential for resistance to develop. Acetamiprid offers growers the ability to use a low
application rate of a low toxicity insecticide to achieve fast control of a wide spectrum of
difficult to control pests. Acetamiprid is generally not a problem for beneficials. Acetamiprid
also has been shown to have ovicidal activity allowing for more complete control and decreasing
the potential for the development of resistant pest populations. In addition, acetamiprid has been
shown to have ovicidal activity allowing for more complete control and thus, a decreased
potential for the development of resistant insect populations. In short, it will work well in
resistance management and integrated pest management (IPM) programs.
RJR/OP/CROP-1
Page 25
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Title

Reduced Risk and Organophosphate Replacement Rationale for
Acetamiprid - Potato Use

Company Product Code
Ni-25

Authors
M. Christian
H. Cunny
R. Heintzelman
J. Huang
J. Hudson
C, Lunchick
M. Parrish
J. Pascual
J. Phillips
G. Werner
J. Wrubel
H. Yang

Guideline Reference
EPA Pesticide Regulation Notice 97-3
Guidelines for Expedited Review of Conventional Pesticides Under the
Reduced-Risk Initiative and for Biological Pesticides

Report No.

Acet-RR-01

Completed On
15 March 2003

Submitted Bv

Nippon Soda Co., Ltd.
c/o Nisso America Inc
220 E. 42nd St., Suite 3002
New York, NY 10017

Page 1 of
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Report No. Acet-RR-01

Page 10

A, EXECUTIVE OVERVIEW

Nippon Soda Co. Ltd. (Nisso) is requesting expedited review under the Reduced-Risk
Initiative for the use of Assail" brand 70WP Insecticide on potatoes. Assail contains 70%
acetamiprid as the single active ingredient

Acetamiprid active ingredient and the formulated product, Assail Insecticide are currently
registered on cotton, pome fruit, citrus, grape, leafy vegetables and cole crops and fruiting
vegetables. Registration is pending as a seed treatment for canola and mustard seed.
The petition for tolerances on potatoes has been submitted to the EPA.
Nisso requests an accelerated review of this acetamiprid submission for the following
reasons:

• Acetamiprid was previously registered as a reduced risk product and is a
strong reduced risk candidate for this use.

• Acetamiprid is a strong OP and carbamate replacement candidate. Over
580,000 pounds of cholinesterase inhibitor products (OP and carbamate
active ingredients) will be replaced during the first five years of acetamiprid
use in potatoes. In addition, thousands of pounds of potential carcinogenic
compounds will be replaced by acetamiprid.

Acetamiprid is very effective against a number of key pests in potatoes, (e.g., aphids,
Colorado potato beetles) and sweet potato (sifverieaf whiteflies). The compound offers
equal to superior efficacy at lower application rates than most of the alternative
compounds. In addition, unlike competitive products, acetamiprid has ovicidal activity and
has shown a broader spectrum of control, for example, lepidopteran, than other
compounds in this class.

Acetamiprid is not oncogenic or a teratogenic. It has very low neurotoxic potential. Based
on the weight of the evidence, acetamiprid is not mutagenic or genotoxic. It degrades
rapidly in the environment, is unlikely to drift, run-off or leach, and presents a very positive
ecological risk profile compared to all alternatives Conservative risk assessments
demonstrate little cause for concern. Risk assessments conducted by EPA show that
acetamiprid meets tfie Food Quality Protection Act (FQPA) "reasonable certainty of no
harm" standard, and the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) no
unreasonable risk standard. This stands in sharp contrast to many of the alternative
insecticides.

The major alternative insecticides are OP (methamidophos and dimethoate) and
carbamate (oxamy! and carbofuran) insecticides, as well as pyrethroids, other
chloronicotinoids and pymetrozine. Imidacloprid is in the same chemical family as
acetamiprid and has achieved important market shares in a number of areas. This
indicates that there is a significant market for chloronicotinoids in potatoes in addition to
other crops. Acetamiprid will primarily replace OPs and carbamates with lesser amounts
of pyrethroids, other chloronicotinoids and pymetrozine.
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Report No. Acet-RR-01

Page 11
From a human risk perspective, many of the alternatives tend to have lower No Observed
Effect Levels (NOELs) than acetamiprid. The primary alternatives being replaced exhibit
cholinesterase (ChE) inhibiting properties. The OPs present significant dietary and
aggregate risk concerns. OPs are known to cause cumulative ChE inhibition in
mammalian systems. Finally, the OPs and other alternatives, particularly the pyrethroids,
raise significant ecological risk concerns. (While acetamiprid is very toxic to mysid shrimp,
its overall ecological risk profile is far better than most of the alternatives).

In conclusion, this document demonstrates fully the reduced risk and OP replacement
potential presented by acetamiprid. It will replace significant amounts of compounds with
both human health and ecological risk concerns.
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Report No. Acet-RR-01

Page 12

B. EXECUTIVE SUMMARY

1. Chemical Name

IUPAC: (E)-N1-[(6-chIoro-3-pyridyI)methyl3-N2-cyano-N1-methylacetamidine

2. Common Name:

Acetamiprid

3. Chemical Abstract Service Registry Number:

135410-20-7

4. ChemjgaJ Structure:

CH3

CH2Nv CH3
C
II
Nx
CN

5- ChemicalFamily:

Chloronicotinyl

6. Mode of Action of the Active Ingredient

Acetamiprid acts as an agonist of the nicotinic acetylcholine receptor (nACHR) of the
postsynaptic membrane of nerve cells. The active ingredient interrupts the function of the
insect nervous system. Biochemical radioligand binding studies show that acetamiprid
interacts with high affinity at the insect nACHR binding site and with low affinity at the
vertebrate nACHR. The differences in the affinities of acetamiprid at the insect and
vertebrate nACHR may indicate that there are structural differences between insect and
vertebrate nACHRs, and may account for acetamiprid's selective toxicity to insects.

7. Proposed Use Pattern

Assail™ brand 70WP Insecticide is a wettable powder formulation containing 70%
acetamiprid as the single active ingredient. It will be labeled for the control of Colorado
potato beetles and aphids in potatoes. The draft label for Assail is provided in Appendix
1.
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Report No. Acet-RR-01

Page 13

8. Competitive Products

Insects can be highly destructive causing significant reductions in yield and quality that
lead to substantial economic losses. Conventional pesticides are used, generally as part
of an IPM program, to control the various insect pests that are problematic in potatoes.
Older chemistry (the OPs, carbamates, pyrethroids) tend to dominate the market.
Imidacloprid, a compound related to acetamiprid, has achieved important market shares.

Table 1 provides information concerning acetamiprid and its major alternatives. Active
ingredients, trade names, producers and the major application parameters are shown.
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Report No. Acet-RR-01

14
Table 1: Summary of Acetamiprid and the Major Competitive Insecticides Presently Registered for Insect Control
In Potatoes in the U.S.
Active Ingredient
Acetamiprid
Carbofuran
Cyfluthrin
Cyfluthrln and
Imidacloprid
Esfenvalerate
Imidacloprid
Methamidophos
Oxamyl
Pymetrozine
Permethrln
Thiamethoxam
Trade Name
Assail™ 70WP
Furadan® 4F
Baythroid* 2
Leverage™ 2.7
Asarta* XL
Provadow1.6F
Monitor* 4
Vydate®
Fulfill"
Ambush* 25WP
Actara™
Company
Nisso
FMC
Bayer
Bayer
DuPont
Bayer
Bayer
Dupont
Syngenta
Amvac
(formerly Syngenta)
Syngenta
Maximum Single
Application Rate
(Lbs. A.I./A)
0.076
1.000
0.044
0.032
0.047
0.050
0.047
1.000
1.000
0.086
0.200
0.047
Maximum
Number of
Applications/
Season*
4
2
B
4
4
7
4
4
6
2
8
1
Maximum
Seasonal
Application
Rate
(Lbs. A.I./A)
0.30
2.00
0.263
0.128
0.188
0.35
0.188 (foliar)
4.00
6.00
0.172
1,60
0.047
Application
Method(s)
Ground & aerial
Ground & aerial
Ground & aerial
Ground & aerial
Ground & aerial
Ground & aerial
Ground & aerial
Ground & aerial
Ground & aerial
Ground & aerial
Ground & aerial
Ground & aerial
NS = Not specified
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Report No. Acet-RR-01

Page 15

9, Summary of Human Health. Ecological Effects, and Enyironmentai Fjte
Characteristics

Acetamiprid presents a low toxitity, low exposure, low risk profile. The use on potatoes
covered by this reduced risk document meets all FQPA and FIFRA safety standards as
will be demonstrated by the following discussion. The potential risks resulting from the
use of acetamiprid are far less than the possible risks presented by alternative
compounds.

9.1 Human Health

Acetamiprid has low mammalian toxicity. It is not oncogenic, and based on the weight of
the evidence it is not mutagenic or genotoxic. It is not teratogenic. It presents low
neurotoxic potential, and does not have any cumulative effects such as ChE inhibition
associated with the OP and carbamates compounds.

The end-use product is Toxicity Category III requiring the use of the signal word "Caution".

A Tier 3 dietary risk assessment shows that dietary exposure utilizes only a small portion
of the RfD/PAD; 15.4% of the acute RfD and 1.3% of the chronic PAD for the most
exposed subpopulation. Drinking water exposure to acetamiprid is projected to be
extremely low, consuming less than 2% of the aRfD and significantly less than 1% of the
cPAD for the worst case scenario.

The MOEs for applying Assail acetamiprid product on potatoes are 1,162 for open-cab
groundboom mix/load/application, 433 for endosed-cab groundboom mix/load/application
and for aerial mix/load, and 26,700 for pilots. The Day 0 MOE for re-entry workers is
1,050; the REI for the use on potatoes will be 12 hours.

9.2 Environmental Fate

9.3 Ecological Effects

The proposed use of acetamiprid on potatoes presents low risk to non-target organisms
including endangered species, and certainly presents less risk than most of the
alternatives.

Avian and mammalian risk assessments were performed using worst-case models. No
Levels of Concern (LOCs) are exceeded for the foliar use of acetamiprid on potatoes.

No LOCs are exceeded for freshwater organisms or marine fish. LOCs are slightly
exceeded for mysid shrimp (RQ = 1.97) based in tier I modeling; more refined modeling is
expected to reduce the Risk Quotients (RQs) below the LOG.
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Report No. Acet-RR-01

Page 16
Acetamiprid use in potatoes poses negligible risk to aquatic plants. Most terrestrial plants
are at minimal risk from acetamiprid. For a few terrestrial plants, LOCs are slightly
exceeded for worst-case, channelized runoff scenarios.

Finally, acetamiprid is moderately toxic to honey bees when contacted by a foliar spray;
however, there is no residual toxicity once sprays have dried. The duration of residual
toxicity is less than 3 hours at rates above the rate proposed for potatoes, Acetamiprid is
much less toxic to bees than all of the major alternative pesticides with the exception of
pymetrozine.
10. Tier I Statement - Meeting FQPA Reduced Risk Criteria

As will be demonstrated by this reduced risk submission, the proposed use of acetamiprid
on potatoes meets each of the four FQPA reduced risk criteria. Namely, acetamiprid:

* Reduces the risk of pesticides to human health;

» Reduces the risk of pesticides to non-target organisms;

» Reduces the potential for contamination of ground water, surface water, or
other valued environmental resources; and

* Broadens the adoption of integrated pest management strategies, or makes
such strategies more available or more effective.

11. Reduced Risk Statement

The market introduction of ttie acetamiprid product, Assail 70WP Insecticide, for use on
potatoes will reduce exposure, will reduce risk, and will reduce pounds of pesticides used.
The reduction in pesticide use will be accomplished, to a large extent, at the expense of
the OP and carbamate alternatives. Workers, consumers, non-target organisms, and the
environment will benefit The reduced risk benefits that will be achieved in the US are
discussed in more detail below.

11.1 Reduced Dietary and Drinking Water Risk

The acetamiprid product will compete against a variety of alternatives including OP and
carbamates insecticides, other chloroniatinoids and pyrethroid compounds. Acetamiprid
has an excellent toxicity profile compared to the alternatives. Low exposure (acetamiprid
is efficacious at very low application rates) and fewer toxicity concerns translates to
reduced dietary risk. Acetamiprid presents no significant drinking water risk.

The Agency has determined that the OPs share a common mechanism of toxicity. Thus,
risk from cumulative use of OPs on potatoes and other crops (and resulting exposure)
would be added together; resulting in a risk significantly higher than that for acetamiprid.
Acetamiprid can provide potato growers with an alternative to OPs and carbamates and is
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Report No. Aeet-RR-01

Page 17

a compound whose "risk cup" is less full compared to the current OP and carbamate
pesticides. For example, a conservative dietary risk assessment shows that only 15.4%
of the aRfD and 1.3% of the cPAD will be utilized by the most exposed subpopulation.
Drinking water exposure to acetamiprid is projected to be extremely low, consuming less
than 2% of the aRfD and significantly less than 1% of the cPAD for the worst case
scenario.
11.2 Reduced Worker Exposure

Risk assessments for mixer-loaders, applicators and re-entry workers have been
preformed. MOEs for acetamiprid are well in excess of acceptable standards with the
lowest MOEs well over 400. This risk picture is quite different from the worker risk
information for OPs and carbamates which are cholinesterase inhibitors (CEIs). The Day 0
MOE for re-entry workers is 1,050; the REI for the use on potatoes will be 12 hours. The
Agency has often concluded that MOEs for OP use are less than acceptable even when
maximum worker protection measures are considered.

11.3 Reduced Ecological Risk

The low application rate for acetamiprid and relatively rapid environmental degradation to
less toxic or practically non-toxic metabolites combined with a favorable ecotoxicity profile
means that non-target organisms are much less likely to be impacted when potato
growers use acetamiprid. A detailed ecological risk assessment was performed for the
potato use to evaluate the potential ecological impact of acetamiprid compared to its
alternatives. Only one chemical (pymetrozine) has a similar favourable profile. All the
other competitors present a dearly higher risk than acetamiprid for at least one group of
non-target organisms.

The RQs of acetamiprid for birds and wild mammals are below the LOCs, but are
exceeded for a number of the competitors (carbofuran, methamidophos, oxamyl and
permethrin). Acetamiprid is significantly less toxic to aquatic invertebrates than several
competitors, particularly pyrethroids, making acetamiprid a desirable alternative to
pyrethroids.

The moderate toxicity of acetamiprid to honeybees and the low risk posed by the
proposed use in potatoes makes this product one of the safest among competitors in the
market. Eight of the nine insecticides included in the analysis are highly toxic to bees and
their use in potatoes presents a potential risk of mortality based in a theoretical hazard
quotient In comparison with imidacloprid and thiomethoxam, the other two chemicals of
the family dass of chloronicotinoids, acetamiprid dearly has safer bee profile.
11.4 Reduced Environmental Burden and OP Replacement

Page 18
pyrethroids. Acetamiprid degrades rapidly, and fate data indicate that the compound is
not likely to drift, run-off or leach. In the first five years of use, Nisso estimates that over
500,000 pounds of alternative active ingredients will be reduced; 376,000 pounds of this
total represents a reduction in OP use and over 130,000 ibs of this total represents
carbamate use.

11.5 Compatible with Resistance Management and IPM Programs

Nisso supports resistance management concepts as a means to preserve the
chloronicotinyl class of chemistry for long-term insecticidal use. Label information and
product stewardship education efforts will strive to ensure that growers follow the
guidance given them,

Because resistance to imidadoprid by both Colorado potato beetle and green peach
aphid has developed in some populations, the introduction of another chloronicotinyl,
acetamiprid, may result in some cross resistance unless adequate safeguards are
instituted. An alternate strategy of making foliar applications to discrete generations and
rotating chemistry can reduce the ability of a population to adapt and therefore extend the
usefulness of pesticides such as chloronicotinyls.
12. Data Matrix

A data matrix identifying the data submitted in support of the applications to register
acetamiprid and establish tolerances is provided in a separate addendum (Appendix 2).
-------
«
,'*%'«
w
Form Approved OMB No 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
401 M Street, S.W.
WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice; The public reporting burden for this collection of information is estimated to average 0 25 hours per response for registration activities and 0.25 hours per response for
reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of
information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do
not send the form to this address.
DATA MATRIX
Date 4-14-09
Applicant's/Registrant's Name & Address
Nippon Soda Co . Ltd. c/o Nisso America Inc., 45 Broadway, Suite 2120, New York, NY 10006
EPA Reg No,/File Symbol 8033-20
Page 1 of 19
Product
Acetamiprid Technical
Ingredient acetamiprid
Guideline Reference Number
N/A
N/A
N/A
Guideline Study Name
Crop Reduced Risk Package/OP Replacement
Ornamental Reduced Risk Package/OP Replacement
Tuberous and Corm Vegetable Reduced Risk Package /
OP Replacement
N/A Potato Market Analysis Data
N/A Potato Efficacy and Comparative Performance Data
N/A
N/A
N/A
N/A
N/A
Tier II and Tier III OECD Summary Documents
Novigen Dietary Exposure and Risk Assessment for
Acetamiprid Project Identification: Acetamiprid 99-01
Exponent Dietary Exposure and Risk Assessment including
Potato Use
Assessment of the Non-Dietary Exposure to Acetamiprid
From Use on Agricultural Crops and Outdoor Residential
Sites. August 27, 1 999.
Dietary and Aggregate Exposure and Risk Assessments
for Acetamiprid, ACETAMIPRID 04-01
N/A I Exposure Estimates and Risk Assessment for Acetamiprid.
August 30, 1999
N/A
N/A
" N/A"
Assessment of Handler Exposure Resulting from toe
commercial Application of Acetamiprid to Canola and
Mustard Seed, May 8, 2002
Assessment of the Non-Dietary Exposure to Acetamiprid
From Use on Potatoes and Tobacco
Dietary and Aggregate Exposure and Risk Assessments
for Acetamiprid ; Acetamiprid 06-01
| Petition for Tolerance Establishment
| Petition for Potato Tolerance Establishment
MRID Number
44988401
44988402
Submitter
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
45900501 Nippon Soda
45900502
45900503
44988403
44988404
45900504
45039701
46255601
44988405
45673401
45900505
46785501
Admin.
A"3mih.
\U-\ UJ^J
Nippon Soda
Nippon Soda
Aventis fransferred to Nippon Soda
Aventis transferred to Nippon Soda
Nippon Soda
Aventis transferred to Nippon Soda
Nippon Soda
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Nippon Soda
Nippon ioaa
Aventis iransrerrea to Nippon t>oaa
Nippon Soda
Status
OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN
UWN
UWW
uvVN

Note

Date
,?-/f-0?
EPA Form 8570'
I35Y9-97) Electronic and Paper versions available. Submit only Paper version.
EPA File Copy
-------
/«•%
fe1
Form Approved OMB No. 2070-0060
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
401 M Street, S.W.
WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0,25 hours per response for
reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (21 37), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460.
Do not send the form to this address.
DATA MATRIX
Date 4-14-09
Applicant's/Registrant's Name & Address
Nippon Soda Co., Ltd. c/o Nisso America Inc., 45 Broadway, Suite 2120, New York, NY 10006
Ingredient acetamlprld
Guideline Reference Number
N/A
N/A
N/A
f~ -
N/A
~<" '"-I
L: ; .__:
62-1(830,1700)
62-2(830.1750)
62-3(8301800
62-3(830.1800)
62-3(830.1800)
I 63-2 (830 6302)
63-3 (830.6303)
63-4 (830.63041
63-5 (830.7200)
63- 7 (830,7300)
63-8 (unasslgned)
63-8 (830.7840)
63-9(830.7950
63-10(830,7370)
63-10 (830.7370)
63-11(830,7550)
EPA Reg No./Fite Symbol 8033-20
Page 2 of 19
Product
Acetamiprid Technical

OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN
UWN
OWN
UWN

Note

Date
?
EPA Fori
570-35 v8-9j7) Electronic and Paper versions available. Submit only Paper version.
EPA File Copy
-------
-*,_
•' A ,
I®/'
Form Approved OMB No 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
401 M Street, S.W.
WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours par response for registration activities and 0.25 hours per response for
reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division {21 37), U.S. Environmental Protection Agency, 401 M Street, S.W,, Washington, DC 20460.
Do not send the form to this address.
DATA MATRIX
Date 4-14-09
Applicant's/Registrant's Name & Address
Nippon Soda Co., Ltd. c/o Nisso America Inc., 45 Broadway, Suite 2120, New York, NY 10006
E PA Reg No./Fite Symbol 8033-20
Page 3 of 19
Product
Acetamiprid Technical
Ingredient acetamiprld
Guideline Reference Number
63-12(830.7000)
63-13830.6313)
63-15(830.6315)
63-16(830.6316)
None (830.7050)
71-1 (850.2100)
71-2 (850.2200)
71-2(850.2200)
Guideline Study Name
pH of Aqueous Suspension of acetamiprid Lab No. 2-9621
Stability of Acetamiprid Project No. 2-9618
Acetamiprid Physio-Chemical Properties Surface Tension,
Flammability Explosive Properties and Relative Self-
Ignition Project No. NOD-005
MRID Number
44651815
44651816
44651817
Spectra (UVNIS. IR, NMR, MS) ofNI-25 Project No. 2-9713 j 44651818
NI-25 Acute Oral Toxicity (LD50) to the Mallard Duck AARC.I OKQ
(technical) Nisso No. 62932516 wtnesa
NI-25 Subacute Dietary Toxicity (LC50) to Bobwhite Quail ,,„, , flfin
(technical) Nisso No. RD 9436N IBOU
NI-25 Subacute Dietary Toxicity (LC 50) to Mallard Ducks AAKZI OKI
HRC NPS60942075 44to1Bb1
•;•» i ianr< -jonm 1 5-Day Dietary Toxicity Test with IM-l-4 Metabolite in the
1 H-/ (850.^00) , Ma|lard Duck EBA No .019803
71-4 (850.2300) Reproduction study in Bobwhite Quail EBA No. 029604
71 A /BKO OIA/M i Reproduction Study with Acetamiprid in Mallard Ducks
n-4 (85u,
-------
Form Approved OMB No. 2070-0060
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
401 M Street, S.W.
WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for
reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Sand comments regarding the burden estimate or any other aspect of this collection
of information, including suggestions for reducing (he burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460.
Do not send the form to this address.

DATA MATRIX
Date 4-14-09
EPA Reg No./File Symbol 8033-20
Page 4 of 19
Applicant's/Registrant's Name & Address

Nippon Soda Co,, Ltd. c/o Nisso America Inc.. 45 Broadway, Suite 2120, New York, NY 10006
Product
Acetamiprid Technical
Ingredient acetamiprid
Guideline Reference Number
72-1 (850.1075)
Guideline Study Name
72-1 (850.1075)
72-2(850 1010
1 Acute Toxicity Study in Rainbow Trout Under Semi-Static
) jConditjons _Project.NpJ_H088
IM-l-4 Acute Toxicity to Rainbow Trout Under Semi-Static
I Conditions SANo 97231 _ . ,
Acute Toxicity Study in Daphnids Nisso No. H-IOO
MRID Number
72-2(850.1010)
72-2(850.1010)

72-2(850.1010)
72-2(850.1010)
IM-1-2 Metabolite Acute Toxicity (48 hour) to Daphnids SA
No,97046
IM-1-4 Acute Toxicity (48 hour) to Daphnids SA 97047
IC-O Metabolite Acute Toxicity to Daphnids under Semi-
_StatlcConditipns SA No. 970j45 _
IM-T-5 (N'-[(6-chlofo-3-pyridyl)methyl]-N1-
methylacetamidme). Acute toxicity to Daphnia magna;
NCAS02-197
(850.1020)
72-2
72-2
72-3(850.1035)
72-3(850,1035)
72-3(850,1025)
72-3(850.1075)
Acetamiprid Technical: Acute Toxicity to Gammartds
I (Gammarus faciatus) Under StaticConditions
Acetamiprid Technical: Acute Toxicity to Midge
I (Chironomus nparius) Under Static Conditions
I IM-1 -5 Acute Toxicity to Midge (Chironomus riparius)
J Under Static Conditions; 13798.6111
| Acetamtprid Technical Acute Toxicity to Mysids Under
Flow-Through Conditions SLI 97-9-7100
IM 1-4 Acute Toxicity to Mysids Under Static Conditions
_SLJ.No. 98:3:7276,
Acetamiprid Acute Toxicity to Eastern Oyster under Flow
j Jhrpugh Conditions SU No. 97:10-7105
j Acetamiprid Acute Toxicity to Sheepshead Minnows Under
i Flow-Throuflh Cgndiligns SLI No- 97-10-7104
44651864

44651865

44651866

44651867

44651868

44988409

46255608
Submitter
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Aventts transferred to Nippon Soda
Avenfo transferred to Nippon Soda
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
i Nippon Soda
45932501

45916201

46255610

44651869

44651870

44988410

Note

Note

Date
4-rfo9
EPA FWmj8570-35 (9-a7) Electronic and Paper versions available. Submit only Paper version.
EPA File Copy
-------
Form Approved OMB No. 2070-0060
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
401 M Street, S.W.
WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for
reregisttaUon and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W . Washington, DC 20460.
Do not send the form to this address.
DATA MATRIX
Date 4-14-09
Applicant's/Registrant's Name & Address
Nippon Soda Co., Ltd. c/o Nisso America Inc., 45 Broadway, Suite 2120, New York, NY 10006
EPA Reg No./File Symbol 8033-20
Page 7 of 19
Product
Acetamiprid Technical
Ingredient acetamiprid
Guideline Reference Number
81-6(870.2600)
81-8(8706200)
81-8(870.6200)
82-1 (870.3150)
Guideline Study Name
Skin Sensltization in the Guinea-Pig (technical) Nisso
NODNo .0089731 69SS
Dose Range Finding Neurotoxicity to Rats by Acute Oral
Administration RPN No.51 09701 45
Neurotoxicity to Rats by Acute Oral Administration RPN
509970851
A Subchronic (3-month) Oral Toxicity Study of NI-25 in the
Dog Via Dietary Administration. Study Number 91-3727
' ' "NI-25 -4 Week Oral Toxicity related to MRID #44988424
I and 44651846 Study in the Dog Dietary Administration"
82-1 (870.3100)
82-1 (870.3100)
82-1 (870.3100)
82-1 (870.3100)
82-2 (870.3200)
82-5 (870.6200)
870.6300
Supplement to 82-5 (870.6200)
^"-" \£Lvu
Acetamiprid 13 Week Dietary Sub chronic Toxicity Study in
Mice Project No. G-0769
MRID Number
44651840
44651841
Submitter
Aventis transferred to Nippon Soda
Aventts transferred to Nippon Soda
44651842 j Aventis transferred to Nippon Soda
44988424 Aventis transferred to Nippon Soda
._„.,_,.,, i Aventis transferred to Nippon Soda
45245306 j
44988425 ' ^ventls transferred to Nippon Soda
Acetamiprid Thirteen Week Dietary Subchronic Toxicity to ddfwiRdi Aventis transferred to Nippon Soda
Rats Nisso No. G-0768 *roai&4j j
IM-1-4 Metabolite Sub chronic Toxicity Study in Rats
Covance No. 6840-102
44988426
IM-O Metabolite Thirteen Week Dietary Subchronic toxicity AAQaaA*>7
Study in Rats Nisso No. G-0889 altwi|
Acetamiprid Neurotoxicity to Rats by Dietary Administration
for 13 weeks RPN51 1971 179
An Oral Developmental Neurotoxicity Study of Acetamiprid
inRats;WIL-21193
Supplemental Statistical Analysis and Historical
Background Data for the Report Titled" Acetamiprid -
Neurotoxicity to Rats by Dietary Administration for 1 3
Weeks (MRID # 44651845)"
44651845
46255619
45130801

JU
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Nippon Soda
Aventis transferred to Nippon Soda
Status
OWN
OWN
OWN
OWN
OWN
OWN
UWN
UWN
OWN
OWN
OWN
OWN
OWN

Note

Date
*-/* -o 9
EPA Form 8^70-35 (f-9Y) Electronic and Paper versions available. Submit only Paper version. EPA File Copy
-------
igi
Form Approved OMB No, 2070-0060
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
401 M Street, S.W.
WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0,25 hours per response for registration activities and 0.25 hours per response for
reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street. S.W., Washington, DC 20460.
Do not send One form to this address.

DATA MATRIX
Date 4-14-09
EPA Reg No /File Symbol 8033-20
Page 8 of 19
Applicant's/Registrant's Name & Address

Nippon Soda Co., Ltd. do Nisso America Inc., 45 Broadway, Suite 2120, New York, NY 10006
Product
Acetamiprid Technical
Ingredient acetamiprid
Guideline Reference Number
870.6300
Guideline Study Name
870.6300
Supplement to 870.6300
Supplement to 870.6300
Rebuttal of Data Evaluation Record for Acetamiprid (WIL
No. 21193, EPA Acetamiprid 099050, MRID 46255619);
J*e£ojlNoJ4AKXM)04_
A Dose Range-Finding Study for a Developmental
Neurotoxicity Study of Acetamiprid in Rats; Report No.
.WIL^21192
Validation of Developmental Neurotoxicity Endpints in Rats
Administered Methimazole in Drinking Water; Report No,
WIL-99199
870.6300
83-1 (8704100)
83-2 (870,4200)
h-
83-3 (870.3700)
A Validation Study for Developmental Neurotoxicity
Endpoints at WIL Research Laboratories, Inc.: Effect of
PropylthiouracJI (PTU) on Developmental Neurotoxicity
Enpoints in Crl:CD(SD)IGS BR Rats (WIL-99126); Report
! NoLWJL-99J26
! Acetamiprid DNT study: Response to EPA CEB statistical
! analysis. Report No. WD0771.000 EOTO
A Chronic (12-Month) Oral Toxicity Study ofNI-25 in the
Dog Via Dietary Administration Pharmaco No. 92-3-117 __
"NI-25 - 4 Week Oral Toxicity Study in the Dog Dietary
_ j Administration' related to MRID # 44988424 and 44651846
I 18-Month Dietary Oncogenicity Study in Mice. Laboratory
I Project Identification 449-016
"Supplemental Historical Background Data" 10/16/00 as
Supplemental Report to MRID # 44988428
Acetamiprid Teratogenicity Study in Rats Nisso No. G0829
"Litter-baaed Incidence 10/16/00 as Supplemental Report
to MRID # 44651847of Fetal Observations and Historical
Control Data"
MRID Number

46779201

46779202

46779203

46779204

47237401
Submitter
Nippon Soda
Nippon Soda
Nippon Soda
Nippon Soda
Nippon Soda
44651846

45245306

44988428

"45245305

44651847

45245302
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Status
OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN
Note
Date
EPA Fo?mJ&70-35 (9^97\ Electronic and Paper versions available. Submit only Paper version.
EPA File Copy
-------
Form Approved OMB No 2070-0060
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
401 M Street, S.W.
WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0,25 hours per response for registration activities and 0,25 hours per response for
reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any othor aspect of this collection
of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460.
Do not send the form to this address.
DATA MATRIX
Date 4-14-09
Applicant's/Registrant's Name & Address
Nippon Soda Co., Ltd. c/o Nisso America Inc., 45 Broadway, Suite 2120, New York, NY 10006
Ingredient acetamiprld
Guideline Reference Number
83-3 (870.3700)

EPA Reg NoJFtle Symbol 8033-20
Page 9 of 19
Product
Acetamiprid Technical

Guideline Study Name
Acetamipfid Teratogenicity Study in Rabbits Nisso No.
G0830
"Litter-based Incidence of Fetal Observations and
Historical Control Data* 10/16/00 as Supplemental Report
to MRID #44651 848
Two-Generation Reproduction Study with NI-25 in
83-4 (870.3800) Rats,(Reproduction and Fertility Effects) Covance Report
Number 6840- 108
"Mean Pup Weights Per Litter (Male and Female
83-4 (870.3800) Combined)" 10/16/00 as Supplemental Report to MRID #
44988430
83-5 (870.4300)
I
I

Note

Date
EPA Fonr<857to-35 (9-97)tleotronic and Paper versions available. Submit only Paper version,
EPA Fite Copy
-------
Form Approved OMB No 2070 0060
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
401 M Street, S.W.
WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0,25 hours per response for
reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggestions for reducing the burden to; Director, OPPE Information Management Division (2137). U.S. Environmental Protection Agency, 401 M Street, S.W,, Washington, DC 20460.
Do not send (he form to this address.

DATA MATRIX
Date 4-14-09
EPA Reg No./File Symbol 8033-20
Page 10 of 19
Applicant's/Registrant's Name & Address
Nippon Soda Co., Ltd. do Nisso America Inc., 45 Broadway, Suite 2120, New York, NY 10006
Product : Acetamiprid Technical
Ingredient acetamipnd
Guideline Reference Number
84-2 (870.5385
84-2 (870.5550)
84-2 (870,5385)
84-
Guideline Study Name

84-2(870.5550)
84-2 (870.5300)
84-2 (870.5300)

84-2(870.5100)
84-2(870.5100)
Mutagenidty Test on NI-25 in an In Vivo Mouse
Mlcronudeus Assay Covance No. 159010455
Unscheduled DNA Synthesis (UDS) Test with Mammalian
Liver Cell in Vivo with technical acetamiprid G97 AG26.381
Metaphase Analysis in the Rat Bone Marrow In Vivo with
| technical Acatamlprid Nisso No. 235017R2
j Acetamiprid Chromosomal Aberration Study in Chinese
Hampsler Ovary(CHO) Cell Nisso No. G0800
I Genotoxicity Test on NI-25 in the Assay of Unscheduled
DNA Synthesis in Rat Liver Primary Ceil Cultures with a
[ C^nfinnajor^A8»ayjCoyanc^No._5901044R
Acetamiprid Mammalian Cell Mutagenicity Assav NOD
No.006971139 ..,
IM 1-4 Metabolite CHO/HGPRT Forward Mutation
_A88ay^Ngj584(M06_.
IM -0 Metabolite Reverse Mutation Study in Bacteria Nisso
No. G949 _ _
IM 2 1 Metabolite Reverse Mutation Study in Bacteria
Nisso No. G-932
MRID Number

44651852

44651853

44651854

44651855

44661856
Submitter
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Aventls transferred to Nippon Soda
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
84-2 (870.5385)
84-2 870.5100)

85-1 (870,7485)
85-1 (870.7485)
85-1 (870.7485)
85-1 (870.7485)
IM 1 -4 Metabolite In Vivo Mouse Micronucteus Assay
Covance No J898JJ}~455_ __.
IC-O Metabolite Reverse Mutation Study in Bacteria Nisso
No. G942
C-14 Acetamiprid Metabolism Study in Rats (Summary
Report) NCASNpJECJ)12_
C-14 Acetamiprid Study in Rats (Qualitative and
Quantitative Analysis of Metabolites in Group C NCAS EC
No,95-108
C-14 Acetamiprid Metabolism Study in Rats NCAS 2-94
EC-724
Adsorption, Distribution, Metabolism Elimination and
Pharmacokinetics After Chronic Dosing of 14-C
Acetamiprid in Rats Study No.42207
44561857

44988431

44988432

44988433

44988501

44988502

44988503

44988504

44988505

Submitter
Aventis transferred to Nippon Soda
Nippon Soda
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Nippon Soda
Nippon Soda
Nippon Soda
Nippon Soda
Nippon Soda
Nippon Soda
Nippon Soda
Status
UWN
UWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN

Note

Date
4-M-O^
EPA Fbrmj 8570-35 (9\97) Electronic and Paper versions available. Submit only Paper version. EPA File Copy
-------
<*••
i " "»
^
Form Approved OMB No. 2070-0060
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
401 M Street, S.W.
WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for
reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Proteclion Agency, 401 M Street, S.W., Washington, DC 20460.
Do not send the form to this address.
DATA MATRIX
Date 4-14-09
Applicant's/Registrant's Name & Address
Nippon Soda Co., Ltd. c/o Nisso America Inc., 45 Broadway, Suite 2120, New York, NY 10006
Ingredient acetamiprid
Guideline Reference Number
161-1
161-1
Supplement to1 61-1
161-2
Supplement to1 61 -2
161-2
No Guideline Number
161-3
162-1
Supplement to1 62-1
Supplement to 162-1
Supplement to 162-1
Supplement to 162-1
EPA Reg No./File Symbol 8033-20
Page 12 of 19
Product
Acetamiprid Technical

Note

Note

Date
4-i4>o1
EPA Fori
70-35 (%9T) Electronic and Paper versions available. Submit ortly Paper version.
EPA File Copy
-------
®
Form Approved OMB No. 2070-0060
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
401 M Street, S.W.
WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for
reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (21 37), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460.
Do not send the form to this address.
DATA MATRIX
Date 4-14-09
Applicant's/Registrant's Name & Address
Nippon Soda Co., Ltd. c/o Nisso America Inc., 45 Broadway, Suite 2120, New York, NY 10006
Ingredient acetamiprid
Guideline Reference Number
None (850.71 00)
No Guideline Number
(860.1000(fX3))
171-4(860.1300)
171-4(860.1300)
171-4(860.1300)
171-4(860.1300)
171-4(860.1300)
171-4(860.1300)
EPA Reg No./File Symbol 8033-20
Page 14 of 19
Product
Acetamiprid Technical

Guideline Study Name
Independent Laboratory Validation of Analytical Methods
for NI-25 acetamiprid) and its Metabolites IC-O, IM-1-2 and
IM-1-4 in Soil Using LC/MS/MSEC No.98-447
Position Statement on Persistence and Mobility of IM-1-5 in
Soil; NAI04-003
Identification of Pyrolysis Products of [>4C] Acetamiprid in
Cigarette Smoke
Foliar Applied 14-C Acetamiprid: Metabolic Fate and
Distribution in Cotton EC No.97-367
C-14 Metabolism in Carrots Lab No. 11253
C-14 Acetamiprid Nature of Residue in Apple Plants
Report No. 742-1
C-14 Nature of Residue in Egg Plants EC No.391-3
C-14 Nature of Residue in Cabbage Plants EC No. 743-1
C-14 NI-25 Acetamiprid Adsorption, Distribution,
Metabolism and Excretion After Repeated Oral
Administration to Laying Hens RCC 628143
I C-14 NI-25 Acetamiprid Adsorption, Distribution,
171-4 (860.1300) Metabolism and Excretion After Repeated Oral
I Administration to Lactating Goats RCC No. 628132
MRID Number
44988517
46255605
45900506
44988518
44988519
44988520
44988521
44988522
44988523
44988524
Signature \ft V ^^Jj^
— — — -• • — ( -V'-1" •• - '"• /---V ""• — "-" — ~- -" • —1—.— — ., ,„_
Submitter
Aventis transferred to Nippon Soda
Nippon Soda
Nippon Soda
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Status
OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN

Note

Note

Guideline Study Name
Magnitude of Acetamiprid Residues in/on Cottonseed and
Gin Trash Study Number 97512104
Grapefruit, Lemon Treated with Five Applications of EXP-
8067A Insecticide with a 7 day PHI. Study Number
97512102
Magnitude of Residues in or on Apple RAC Resulting from
Foliar Applications of EXP 80667A Insecticide (Pome Fruit
Representative crop group) RPAC No. 97512648
] Magnitude of the Residues in or on Pear RAC Resulting
171-4(k) (860-1500) from Foliar Applications of EXP 80667A Insecticide (Pome
J Fruit Representative crop group) RPAC No. 96512649
1 71 -4(k) (860-1500)

171-4(k) (860-1500)
1 71 -4(k) (860-1 500)
m-4(k)(8B01500)
171-4(k) (860.1500)
171-4
-------
/x\
VS1
Form Approved OMB No, 2070-0060
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
401 M Street, S.W.
WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0,25 hours par response for
reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460,
Do not send the form to this address.
DATA MATRIX
Date 4-14-09
Applicant's/Registrant's Name & Address
Nippon Soda Co., Ltd. c/o Nlsso America Inc., 45 Broadway, Suite 2120, New York, NY 10006
EPA Reg NoTFile Symbol 8033-20
Page 18 of 19
Product
Acetamiprid Technical
Ingredient acetamiprid
Guideline Reference Number
171-4(k) (860. 1500)
171-4(k)(8601500)
171-4(k) (860. 1500)
171-4(k) (860. 1500)
171-4(k)(860.1500)
171-4(k) (860,1500)
171-4{k)(8601500)
171-4(k) (860.1500)
171-4(k) (860.1500)
171-4(k) (860. 1500)
171-4(k)(860.1500)
Guideline Study Name
Assail 7QWP: Magnitude of Acetamiprid Residues In/On
Potatoes Treated with Four Applications of EXP -61842A
Insecticide with a 7 Day PHI (2001 )
Assail 70 WP Insecticide Field Residue Study in Cucurbit
Crop Group, Study No. KP-2003-23
Assail 70 WP Insecticide Field Residue Study in Stone
Fruit Crop Group, Study No. KP-2003-19
Assail 70 WP Insecticide Field Residue Study in Tree Nut
Crop Group; Study No. KP-2003-20
Assail 70 WP Insecticide Field Residue Study in Berry
Crop Group, Study No. KP-2004-14
Assail 70 WP Insecticide Field Residue Study in Legume
Crop Group, Study No. KP-2004-13
Assail 70 WP Insecticide Field Residue Study in Onion
Crop Group, Study No. KP-2004-15
Acetamiprid • Magnitude of the Residue on Strawberry
PR# 09058
Acetamiprid: Magnitude of the Residue on Grape
PR# 09057
Acetamiprid: Magnitude of the Residue on Tomato
(Greenhouse), PR# 08354
Acetamiprid: Magnitude of the Residue on Red Clover
(Grown for Seed Only), PR# 09600
MRID Number
45900508
46265701
46265702
46265703
46785502
Submitter
Nippon Soda
Nippon Soda
Nippon Soda
Nippon Soda
Nippon Soda
46785504 Nippon Soda
46785503
47013601
47716902
47716903
47716901
— ^L\\j,J^
Nippon Soda
IR-4
IR-4
IR-4
IR-4
Status
OWN
OWN
OWN
OWN
OWN
OWN
OWN

Note

Date . -
4-tf'Ol
EPA Fottn 8570-35 (SHy) Electronic and Paper versions available. Submit only Paper version
EPA File Copy
-------
1*1
(Sgl
Form Approved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
401 M Street, S W.
WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for
reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W,, Washington, DC 20460,
Do not send the form to this address.
DATA MATRIX
Date 4-14-09
Applicant's/Registrant's Name & Address
Nippon Soda Co., Ltd. c/o Nisso America Inc., 45 Broadway, Suite 2120, New York, NY 10006
EPA Reg No./File Symbol 8033-20
Page 19 of 19
Product
Acetamiprid Technical
Ingredient acetamiprid
Guideline Reference Number
171-4(1) (860-1520)
171-4(1) (860-1520)
171 -4(1) (860- 1520)
171 -4(1) (860-1 520)
171-4(1) (860- 1520)
171-4(k) (860.1520)
165-1 (860-1850)
t 165-1 (860.1850)
(875.2100)

Guideline Study Name
Acetamiprid: Magnitude of Residues in Grape Processed
Fractions Resulting from Foliar Applications of EXP80667A
RPAC 97512651
Cotton Processing Study for acetamiprid Report Number
97512105
Fruit and Citrus Processed Fractions (dry pulp, oil, and
juice) Derived from Oranges from Orchards Treated with
EXP-80667 A Insecticide RP AC No. 97512103
Acetamiprid Magnitude of Residues in/on Tomato
Processed Fractions RPAC No. 7512108
Magnitude of Residues in Apple Processed Commodities
Resulting From Foliar Applications of EXP 80667A
Insecticide RPAC No. 97512650
Assail 70WP: Magnitude of Acetamiprid Residues In/On
Potatoes and Potato Processed Fractions (Flakes, Chips,
Wet Peel) Derived from Potatoes Treated with EXP-
618942A Insecticide (2001)
C-14 Acetamiprid Foliar Treatment: Accumulation Study in
Confined Rotational Crops EC-97-368
NI-25 (Acetamiprid): Consideration of the Storage Stability
in the Confined Rotational Crop Study of Acetamiprid; NAi
06-003
ACETAMIPRID: Dissipation of Dislodgeable Residues on
cotton.
MRID Number
44988617
44988618
44988619
Submitter
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
Aventis transferred to Nippon Soda
44988621 Aventis transferred to Nippon Soda
44988622
45900509
44888623
46729102
45323001

*~. y^UVl-f
Aventis transferred to Nippon Soda
Nippon Soda
Aventis transferred to Nippon Soda
Nippon Soda
Aventis transferred to Nippon Soda

Status
OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN
OWN

Note

Date
4-M-tf
EPA Form 85VO-35 (9-97) Electronic and Paper versions available. Submit only Paper version.
EPA File Copy
-------
67256 Federal Register/Vol. 72, No. 228/Wednesday, November 28, 2007/Rules and Regulations
his or her designated representatives, no
person or vessel is allowed within 100
yards of the Hawaii Superferry when it
is underway, moored, position-keeping,
or at anchor, unless authorized by the
Captain of the Port or his or her
designated representatives.
(4) Persons desiring to transit the
security zone in this section may
contact the Captain of the Port at
telephone number (808) 927-0865 or on
VHP channel 12 to seek permission to
transit the area. If permission is granted,
all persons and vessels must comply
with the instructions of the Captain of
the Port or his or her designated
representatives. When conditions
permit, the Captain of the Port, or his or
her designated representatives, may
permit vessels that are at anchor,
restricted in their ability to maneuver,
or constrained by draft to remain within
the security zone in order to ensure
navigational safety.
(e) Enforcement. Any Coast Guard
commissioned, warrant, or petty officer,
and any other Captain of the Port
representative permitted by law, may
enforce this temporary security zone.
Dated: November 21, 2007.
Sally Brice-O'Hara,
Rear Admiral, U.S. Coast Guard, Commander,
Fourteenth Coast Guard District.
[FR Doc. 07-5872 Filed 11-26-O7; 1:53 pml
BILLING CODE 4910-1S-P
ENVIRONMENTAL PROTECTION
AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0105; FRL-8340-6]

Acetamiprid; Pesticide Tolerance

AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.

SUMMARY: This regulation establishes
tolerances for residues of acelamiprid in
or on almond, hulls; fruit, stone, group
12, except plum, prune; nut, tree, group
14; pea and bean, succulent shelled,
subgroup 6B; pistachio; plum, prune,
dried; plum, prune, fresh; vegetable,
cucurbit, group 9; and vegetable,
legume, edible podded, subgroup 6A.
Nippon Soda Co., Ltd. requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
November 28, 2007. Objections and
requests for hearings must be received
on or before January 28, 2008, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA-HQ-
OPP-2007-0105. To access the
electronic docket, go to http;//
www.regulations.gov, select "Advanced
Search," then "Docket Search." Insert
the docket FD number where indicated
and select the "Submit" button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
index, some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
http://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-
4400, One Potomac Yard (South Bldg.),
2777 S, Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305-
5805.
FOR FURTHER INFORMATION CONTACT:
Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460-0001; telephone number:
(703) 305-5218; e-mail address:
sronton.susan@epo.gov.
SUPPLEMENTARY INFORMATION:

I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing [NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather to provide 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 Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at http://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the "Federal Register" listings at
http://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA's tolerance
regulations at 40 CFR part 180 through
the Government Printing Office's pilot
e-CFR site at http://www.gpoaccess.gov/
ecfr,
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, any
person-may file an objection to any
aspect of this regulation and may also
request a hearing on those objections.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178, To ensure
proper receipt by EPA, you must
identify docket ID number EPA-HQ-
OPP-2007-0105 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
as required by 40 CFR part 178 on or
before January 28, 2008.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA-
HQ-OPP-2007-0105, by one of the
following methods:
-------
Federal Register/Vol. 72, No. 228/Wednesday, November 28, 2007/Rules and Regulations 67257
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
* Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7S02P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW,, Washington,
DC 20460-0001.
• Delivery. OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket's
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket Facility telephone number is
(703) 305-5805.

II, Petition for Tolerance
In the Federal Register of September
15, 2004 (69 FR 55625) (FRL-7674-9),
EPA issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 4F6833) by
Nippon Soda Co., Ltd., c/o Nisso
America Inc., 220 East 42nd Street,
Suite 3002, New York, NY, 10017. The
petition requested that 40 CFR 180.578
be amended by establishing tolerances
for residues of the insecticide
acetamiprid, Nl-[(6-chloro-3-
pyridyl)methyl]-N2-cyano-Nl-
methylacetamidine, in or on the
cucurbit crop group at 0.5 parts per
million (ppm); the stone fruit crop
group, except plum, prune, fresh and
dried at 1.2 ppm; plum, prune, fresh
and dried at 0.3 ppm; the tree nut crop
group, except almond hulls at 0,1 ppm;
and almond hulls at 5.0 ppm. That
notice included a summary of the
petition prepared by Nippon Soda Co.,
Ltd., the registrant, which is available to
the public in the docket ID Number
EPA-HQ-OPP-2004-Q223, http://
www.regulations.gov. Comments were
received on the notice of filing from a
private citizen. EPA's response to these
comments is discussed in Unit IV.C
below.
In the Federal Register of September
22, 2006 (71 FR 55468) (FRL-8091-9),
EPA issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 6F7051) by
Nippon Soda Co., Ltd., c/o Nisso
America Inc., 45 Broadway, Suite 2120,
New York, NY, 10006. The petition
requested that 40 CFR 180.578 be
amended by establishing tolerances for
residues of the insecticide acetamiprid,
Nl-[(6-chloro-3-pyridyl)methyl)-N2-
cyano-Nl-methylacetamidine, in or on
bulb vegetables crop group 3 at 3 ppm;
edible podded legume vegetables, crop
subgroup 6a at 0.5 ppm; succulent
shelled pea and beans, crop subgroup
6b, at 0.5 ppm; and berries, crop group
13 at 1 ppm. The notice also announced
the filing of amended pesticide petition
4F6833, requesting a tolerance for
residues of acetamiprid in or on
pistachio at 0.1 ppm in addition to the
tolerances described in the preceding
paragraph. That notice referenced a
summary of the petition prepared by
Nippon Soda Co., Ltd., the registrant,
which is available to the public in the
docket ID Number EPA-HQ-OPP-2006-
0733, http://www.regulations.gov. There
were no comments received in response
to the notice of filing.
EPA is deferring to a later date the
decision regarding the proposed
tolerances for residues of acetamiprid
on bulb vegetables crop group 3 and
berry crop group 13, Based upon review
of the data supporting the petitions,
EPA has modified the tolerance levels
and/or commodity terms for several of
the other proposed tolerances. The
reasons for these changes are explained
in Unit V.

A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the adverse effects caused
by acetamiprid as well as the no-
observed-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies
can be found at http://
www.regulations.gov in the document
Acetamiprid: Human Health Risk
Assessment for Proposed Food Uses on
Stone Fruits, Cucurbit Vegetables, Tree
Nuts, Berries, Strawberries, Bulb
Vegetables, Legumes (Peas and Beans)
and for Residential/Commercial
Insecticide/Termiticide Uses. The
referenced document is available in the
docket established by this action, which
is described under ADDRESSES, and is
identified as document ID number EPA-
HQ-OPP-2007-0105-O003 in that
docket.
The toxicity database for acetamiprid
is complete. The acute toxicity data
indicate that acetamiprid is moderately
toxic via the oral route and is minimally
toxic via the dermal and inhalation
routes. Acetamiprid is not an eye or skin
irritant, and it is not a dermal sensitizer.
Based on subchronic, chronic,
developmental and reproductive studies
in rats, rabbits, and dogs, acetamiprid
does not appear to have specific target
organ toxicity. Generalized nonspecific
toxicity was observed as decreases in
body weight, body weight gain, food
consumption and food efficiency when
determined. Generalized effects were
also observed in the liver in the form of
hepatocellular hypertrophy in both mice
and rats and hepatocellular vacuolation
in the rat. The hepatocellular
hypertrophy in mice is considered to he
adaptive; it is likely that the
-------
67258 Federal Register/Vol. 72, No. 228/Wednesday, November 28, 2007/Rules and Regulations
vacuolization in rats is more related to
liver activity in response to the presence
of the chemical rather than frank
toxicity. Neurotoxicity was observed in
the form of decreased locomotor activity
in the acute neurotoxicity study in rats
and as decreased auditory startle
response in the developmental
neurotoxicity study in rats.
Developmental studies showed no
evidence of either quantitative or
qualitative susceptibility of the rat or
rabbit fetuses from in utero exposure.
However, both the developmental
neurotoxicity (DNT) study and the
multi-generation reproduction studies
showed an increase in qualitative
susceptibility of pups. Effects in pups in
the reproduction study included delays
in preputial separation, vaginal opening
and pinna unfolding as well as reduced
litter size, decreased early pup viability
and weaning indices; offspring effects
observed in the DNT study included
decreased body weight and body weight
gains, decreased early pup viability and
decreased maximum auditory startle
response in males. These effects were
seen in the presence of less severe
effects (decreased body weight and body
weight sain) in the maternal animals.
Based on acceptable carcinogenicity
studies in rats and mice, EPA has
determined that acetamiprid is not
likely to be carcinogenic to humans.
This determination is based on the
absence of a dose-response or statistical
significance for the increased incidence
in mammary adenocarcinomas observed
in the rat carcinogenicity study, as well
as the lack of evidence of carcinogenic
effects in the mouse cancer study.

B. Toxicological End points
For hazards that have a threshold
below which there is no appreciable
risk, the toxicological level of concern
(LOG) is derived from the highest dose
at which the NOAEL in the toxicology
study identified as appropriate for use
in risk assessment. However, if a
NOAEL cannot be determined, the
LOAEL is sometimes used for risk
assessment. Uncertainty/safety factors
(UFs) are used in conjunction with the
LOG to take into account uncertainties
inherent in the extrapolation from
laboratory animal data to humans and in
the variations in sensitivity among
members of the human population as
well as other unknowns. Safety is
assessed for acute and chronic risks by
comparing aggregate exposure to the
pesticide to the acute population
adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The
aPAD and cPAD are calculated by
dividing the LOG by all applicable UFs.
Short-term, intermediate-term, and long-
term risks are evaluated by comparing
aggregate exposure to the LOG to ensure
that the margin of exposure (MOE)
called for by the product of all
applicable UFs is not exceeded.
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk and
estimates risk in terms of the probability
of occurrence of additional adverse
cases. Generally, cancer risks are
considered non-threshold. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see http://
www. epa.go v/pesticides/factsh eets/
riskassess.htm.
A summary of the toxicological
endpoints for acetamiprid used for
human risk assessment can be found at
http://www.regulations.gov at pages 21—
22 in the document Acetamiprid:
Human Health Risk Assessment for
Proposed Food Uses on Stone Fruits,
Cucurbit Vegetables, Tree Nuts, Berries,
Strawberries, Bulb Vegetables, Legumes
(Peas and Beans) and for Residential/
Com m ere JQ / In secticide/Termiticide
Uses in docket ID number EPA-HQ-
OPP-20Q7-0105.

C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to acetamiprid, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing acetamiprid tolerances in (40
CFR 180.578). EPA assessed dietary
exposures from acetamiprid in food as
follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide if
a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1-day or single
exposure. In estimating acute dietary
exposure to acetamiprid, EPA used food
consumption information from the U.S.
Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII), As to residue levels
in food, EPA relied upon anticipated
residues derived from field trial data for
certain commodities (apples; broccoli;
cabbage, celery; grapefruit; grapes;
lettuce; oranges; pears; peppers;
spinach; tomatoes; stone fruits; and
cucurbits) and assumed residues were
present at tolerance levels in all other
commodities. EPA also relied on
percent crop treated (PCT) information
for some of the currently registered
commodities [apples, broccoli , celery,
lettuce, pears, grapefruit, grapes,
oranges, peppers, spinach and tomatoes)
but assumed 100 PCT for all of the new
commodities.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 1994-1996 and 1998
CSFII. As to residue levels in food, EPA
assumed all foods for which there are
tolerances or for which tolerances are
being established contain tolerance-
level residues. EPA relied on PCT
information for two currently registered
crops (apples and oranges) but assumed
100 PCT for all other commodities.
iii. Cancer. As noted above, EPA has
determined that acetamiprid is not
likely to be carcinogenic to humans.
Therefore, an exposure assessment for
use in a quantitative cancer risk
assessment is unnecessary.
iv. Anticipated residue and PCT
information. Section 408(b)(2)(E) of
FFDCA authorizes EPA to use available
data and information on the anticipated
residue levels of pesticide residues in
food and the actual levels of pesticide
residues that have been measured in
food. If EPA relies on such information,
EPA must pursuant to section 408(f)(l)
of FFDCA require that data be provided
5 years after the tolerance is established,
modified, or left in effect, demonstrating
that the levels in food are not above the
levels anticipated. For the present
action, EPA will issue such data call-ins
as are required by section 408(b)(2)(E) of
FFDCA and authorized under section
408(f)(l) of FFDCA. Data will be
required to be submitted no later than
5 years from the date of issuance of this
tolerance.
Section 408(b)(2)(F) of FFDCA states
that the Agency may use data on the
actual percent of food treated for
assessing chronic dietary risk only if:
a. The data used are reliable and
provide a valid basis to show what
percentage of the food derived from
such crop is likely to contain such
pesticide residue.
b. The exposure estimate does not
underestimate exposure for any
significant subpopulation group.
c. Data are available on pesticide use
and food consumption in a particular
area, the exposure estimate does not
understate exposure for the population
in such area. In addition, the Agency
must provide for periodic evaluation of
any estimates used. To provide for the
periodic evaluation of the estimate of
PCT as required by section 408(b)(2)(F)
of FFDCA, EPA may require registrants
to submit data on PCT.
The Agency used PCT information as
follows:
For the acute assessment, maximum
PCT estimates were used for the
following commodities: Apples (15%),
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Federal Register/Vol. 72, No. 228/Wednesday, November 28, 2007/Rules and Regulations 67259
broccoli (5%), celery (15%), lettuce
(10%), pears (25%), and grapefruit,
grapes, oranges, peppers, spinach and
tomatoes, each at 2.5%.
For the chronic assessment, average
PCT estimates were used for the
following commodities: Apples (10%)
and oranges (1%).
EPA uses an average PCT for chronic
dietary risk analysis. The average PCT
figure for each existing use is derived by
combining available Federal, state, and
private market survey data for that use,
averaging by year, averaging across all
years, and rounding up to the nearest
multiple of 5% except for those
situations in which the average PCT is
less than one. In those cases <1% is
used as the average and <2.5% is used
as the maximum. EPA uses a maximum
PCT for acute dietary risk analysis. The
maximum PCT figure is the single
maximum value reported overall from
available Federal, state, and private
market survey data on the existing use,
across all years, and rounded up to the
nearest multiple of 5%. In most cases,
EPA uses available data from USDA/
National Agricultural Statistics Service
(USDA/NASS), Proprietary Market
Surveys, and the National Center for
Food and Agriculture Policy (NCFAP)
for the most recent six years.
The Agency believes that the three
conditions listed in this unit have been
met. With respect to Condition A, PCT
estimates are derived from Federal and
private market survey data, which are
reliable and have a valid basis. The
Agency is reasonably certain that the
percentage of the food treated is not
likely to be an underestimation. As to
Conditions B and C, regional
consumption information and
consumption information for significant
subpopulations is taken into account
through EPA's computer-based model
for evaluating the exposure of
significant subpopulations including
several regional groups. Use of this
consumption information in EPA's risk
assessment process ensures that EPA's
exposure estimate does not understate
exposure for any significant
subpopulation group and allows the
Agency to be reasonably certain that no
regional population is exposed to
residue levels higher than those
estimated by the Agency. Other than the
data available through national food
consumption surveys, EPA does not
have available information on the
regional consumption of food to which
acetamiprid may be applied in a
particular area.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring data to complete a
comprehensive dietary exposure
analysis and risk assessment for
acetamiprid in drinking water. Because
the Agency does not have
comprehensive monitoring data,
drinking water concentration estimates
are made by reliance on simulation or
modeling taking into account data on
the environmental fate characteristics of
acetamiprid. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at http://www.epa.gov/
oppefedl/models/water/index.htm.
Based on the First Index Reservoir
Screening Tool (FIRST) and Screening
Concentration in Ground Water (SCI-
GROW) models, the estimated
environmental concentrations [EECs) of
acetamiprid for acute exposures are
estimated to be 20.1 parts per billion
(ppb) for surface water and 1.6 ppb for
ground water. The EECs for chronic
exposures are estimated to be 4.9 ppb
for surface water and 1.6 ppb for ground
water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 20.1 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration of
value 4.9 ppb was used to assess the
contribution to drinking water.
3. From non-dietary exposure. The
term "residential exposure" is used in
this document to refer to non-
occupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick cqntrpLpnjjetsl.
Acetarniprid is currently registered for
the following residential non-dietary
sites: As a pre- and post-construction
termiticide/insecticide for use in
subterranean or hard-to-reach structure
components and building perimeters;
and as a crack, crevice or spot
application using gel bait formulations
for control of ants and cockroaches in
residential settings. EPA assessed
residential exposure using the following
assumptions: The pre- and post-
construction termiticide/insecticide
uses of acetamiprid are limited to
licensed Pest Control Operators (PCOs);
therefore, homeowner handler
exposures are not expected to occur.
Nor are post-application exposures of
adults or children expected as a result
of these uses, since applications are
limited to subterranean or hard-to-reach
structure components and building
perimeters.'EPA has defermfriecrtEat"
short-term and intermediate-term
dermal exposure of residential handlers
may occur from use of the gel bait
formulations in residential settings;
however, due to the low vapor pressure
of acetamiprid and its formulation as a
gel, inhalation^exposure of handlers is
,ri£it._ex|)ecteol^l'ost-application " ~
exposures of Idults and children from
this use are expected to be negligible for
the following reasons: (i) Homeowners
are unlikely to revisit the crack, crevice
or spot where the gel bait has been
applied, thereby minimizing potential
exposure; fii) inhalation exposure is
expected to be minimal due to
acetamiprid's low vapor pressure and its
formulation as a gel; and (iii) the gel bait
products contain a bittering agent which
is used to prevent ingestion by children
and animals, thereby further reducing
potential for incidental oral exposures
of children.lPor thesereasons; EPA
assesseirbmy residential handler
dermal exposures from the gel bait uses
of acetamiprid.
4. Cumulative effects from substances
with a common mechanism oftoxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
"available information" concerning the
cumulative effects of a particular
pesticide's residues and "other
substances that have a common
mechanism of toxicity."
Acetamiprid is a member of the
neonicotinoid class of pesticides which
also includes thiamethoxam,
clothianidin, imidacloprid and several
other active ingredients. Structural
similarities or common effects do not
constitute a common mechanism of
toxicity. Evidence is needed to establish
that the chemicals operate by the same,
or essentially the same sequence of
major biochemical events. Although the
neonicotinoids bind selectively to insect
nicotinic acetylcholine receptors
(nAChR), the specific binding site(s)/
receptor(s) are unknown at this time.
Additionally, the commonality of the
binding activity itself is uncertain, as
preliminary evidence suggests that
clothianidin operates by direct
competitive inhibition, while
thiamethoxam is a non-competitive
inhibitor. Furthermore, even if future
research shows that neonicotinoids
share a common binding activity to a
specific site on insect nicotinic
acetylcholine receptors, there is not
necessarily a relationship between this
pesticidal action and a mechanism of
toxicity hi mammals. Structural
variations between the insect and
mammalian nAChRs produce
quantitative differences in the binding
affinity of the neonicotinoids towards
these receptors, which, in turn, confers
the notably greater selective toxicity of
this class towards insects, including
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67260 Federal Register/Vol. 72, No. 228/Wednesday, November 28, 2007/Rules and Regulations
apliids and leafhoppers, compared to
mammals. Additionally, the most
sensitive toxicological effect in
mammals differs across the
neonicotiiioids (e.g., testicular tubular
atrophy with thiamethoxam;
mineralized particles in thyroid colloid
with imidaclopid). Thus, there is
currently no evidence to indicate that
neonicotinoids share common
mechanisms of toxicity, and EPA is not
following a cumulative risk approach
based on a common mechanism of
toxicity for the neonicotinoids. In
addition, acetamiprid does not appear to
produce a toxic metabolite produced by
other substances. Therefore, for the
purposes of this tolerance action, EPA
has not assumed that acetamiprid has a
common mechanism of toxicity with
other substances. For more information
regarding EPA's efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and
Children
I. In general. Section 408 of FFDCA
provides that EPA shall apply an
additional ["10X") tenfold margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA safety factor. In applying this
provision, EPA either retains the default
value of 10X when reliable data do not
support the choice of a different factor,
or, if reliable data are available, EPA
uses a different additional FQPA safety
factor value based on the use of
traditional UFs and/or special FQPA
safety factors, as appropriate.
2. Prenatal and postnatal sensitivity.
The pre- and postnatal toxicology
database for acetamiprid includes rat
and rabbit developmental toxicity
studies, a 2-generation reproduction
toxicity study in rats and a DNT study
in rats. There was no evidence of
quantitative or qualitative susceptibility
of rat or rabbit fetuses following in utero
exposure to acetamiprid in the
developmental toxicity studies.
However, both the DNT and multi-
generation reproduction studies showed
an increase in qualitative susceptibility
of pups. Effects in pups in the
reproduction study included delays in
preputial separation, vaginal opening
and pinna unfolding, as well as reduced
litter size, decreased early pup viability
and weaning indices; offspring effects
observed in the DNT study included
decreased body weight and body weight
gains, decreased early pup viability and
decreased maximum auditory startle
response in males. These effects were
seen in the presence of decreased body
weight and body weight gain in the
maternal animals, indicating increased
qualitative susceptibility of fetuses and
offspring to acetamiprid. Quantitative
evidence of increased susceptibility was
not observed in any study.
In considering the overall toxicity
profile and the endpoints and doses
selected for the acetamiprid risk
assessment, EPA characterized the
degree of concern for the effects
observed in the acetamiprid DNT and
the 2—generation reproduction study as
low, noting that there is a clear NOAEL
for the offspring effects in both studies,
the toxicology database is complete, and
regulatory doses were selected to be
protective of potential offspring effects
in both the DNT and the 2-generation
study. No other residual uncertainties
were identified. Based on the available
data, EPA determined that changes in
motor activity, auditory startle reflex,
learning and memory assessments, and
even changes in the brain
morphometrics can occur as the result
of a single exposure at a critical junction
during pregnancy or from multiple
exposures throughout pregnancy and
lactation. Therefore, the NOAEL for
offspring effects observed in the DNT
was selected as the dose for acute
dietary exposures (co-critical with the
acute neurotoxicity study), as well as
short-term and intermediate-term non-
dietary risk assessment. Use of the DNT
NOAEL is protective of effects seen in
the 2-generation study (the NOAEL from
the DNT is 10.0 mg/kg/day and the
NOAEL from the 2-generation study is
17.9 mg/kg/day). The chronic dietary
study in rats yielded a lower long-term
NOAEL (7.1 mg/kg/day) and was,
therefore, used for assessing chronic
dietary risk. EPA believes that the
endpoints ana doses selected for
acetamiprid are protective of adverse
effects in both offspring and adults.
3. Conclusion. EPA has determined
that reliable data show that it would be
safe for infants and children to reduce
the FQPA safety factor to IX. That
decision is based on the following
findings:
i. The toxicity database for
acetamiprid is complete.
ii. There is no evidence that
acetamiprid results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies.
Although there is qualitative evidence
of increased susceptibility in the multi-
generation reproduction study and in
the DNT study, the risk assessment team
did not identify any residual
uncertainties after establishing toxicity
endpoints and traditional UFs to be
used in the risk assessment of
acetamiprid. The degree of concern for
pre- and/or postnatal toxicity is low.
iii. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on tolerance-level
residues or anticipated residues derived
from reliable field trial data. The PCT
estimates used in the dietary assessment
were derived from valid, reliable
Federal and private market survey data
and are unlikely to be exceeded.
Conservative ground and surface water
modeling estimates were used to assess
exposures to acetamiprid from drinking
water; and residential, non-dietary
exposure of infants and children to
acetamiprid is not expected to occur.
EPA believes these assessments will not
underestimate the exposure and risks
posed by acetamiprid.

E. Aggregate Risks and Determination of
Safety

Safety is assessed for acute and
chronic risks by comparing aggregate
exposure to the pesticide to the aPAD
and cPAD. The aPAD and cPAD are
calculated by dividing the LOG by all
applicable UFs. For linear cancer risks,
EPA calculates the probability of
additional cancer cases given aggregate
exposure. Short-term, intermediate-
term, and long-term risks are evaluated
by comparing aggregate exposure to the
LOG to ensure that the MOE called for
by the product of all applicable UFs is
not exceeded.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
acetamiprid will occupy 35% of the
aPAD for children 1 to 2 years old, the
population group receiving the greatest
exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to acetamiprid from food
and water will utilize 35% of the cPAD
for children 1 to 2 years old, the
population group with greatest
exposure. Based on the use pattern,
chronic residential exposure to residues
of acetamiprid is not expected.
3. Short-term risk. Short-term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
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Federal Register/Vol. 72, No. 228/Wednesday, November 28, 2007/Rules and Regulations 67261
Acetarniprid is currently registered for
use that could result in short-term
residential exposure and the Agency has
determined that it is appropriate to
aggregate chronic food and water and
short-term exposures for acetamiprid.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded that
food, water, and residential exposures
aggregated result in aggregate MOEs of
900 for adults 20 to 49 years old and 930
for adults 50 years and older who apply
gel bait acetamiprid products for ant
and cockroach control.
4. Intermediate-term risk.
intermediate-term aggregate exposure
takes into account residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level). Acetamiprid is
currently registered for use that could
result in intermediate-term residential
exposure and the Agency has
determined that it is appropriate to
aggregate chronic food and water and
intermediate-term exposures for
acetamiprid. Since the short-term and
intermediate-term dermal exposures and
endpoints for acetamiprid are the same,
intermediate-term aggregate MOEs for
adult residential handlers are the same
as the short-term aggregate MOEs
reported above (900 to 930).
5. Aggregate cancer risk for U.S.
population. EPA has classified
acetamiprid as "Not likely to be
carcinogenic to humans. Acetamiprid is
not expected to pose a cancer risk.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to acetamiprid
residues.

IV. Other Considerations

A. Analytical Enforcement Methodology
Adequate residue analytical methods
are available for the enforcement of
established and new tolerances for plant
commodities (gas chromotography
/electron capture detector and high
performance liquid chromotography/
ultra violet detection (GC/ECD and
HPLC/UV) and animal commodities
(HPLC/UV)). These methods may be
requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.

B. International Residue Limits
There are no Codex, Canadian or
Mexican maximum residue levels
(MRLs) established on the commodities
associated with these petitions.

C. Response to Comments
Comments were received from a
private citizen objecting to establishing
these tolerances or any exemptions for
acetamiprid or approval of its sale. The
commenter objected to acetamiprid
residues in food as well as EPA's
reliance on animal testing on the basis
that animal tests are inhumane and not
relevant to human toxicity. The Agency
has received these same or similar
comments from this commenter on
numerous previous occasions. Refer to
Federal Register 70 FR 37686 (June 30,
2005), 70 FR 1354 (January 7, 2005}, and
69 FR 63096 (October 29, 2004) for Ihe
Agency's response to these objections.

V. Conclusion
Based upon review of the data
supporting the petitions, EPA has
modified the proposed tolerances as
follows: (I) PP 4F6833: Modified the
commodity terms for stone fruit, tree
nuts and cucurbit vegetables to agree
with recommended commodity terms in
the Office of Pesticide Program's Food
and Feed Commodity Vocabulary (Fruit,
stone, group 12, except plum, prune;
Nut. tree, group 14; and Vegetable,
cucurbit, group 9); and modified the
commodity terms and established
separate tolerances for Plum, prune,
dried at 0.40 ppm and Plum, prune,
fresh at 0.20 ppm (fresh) based on the
field trial results showing different
residues in the dried and fresh forms.
(2) PP 6F7051: Revised the commodity
terms and tolerance levels for edible
podded legumes and succulent shelled
peas and beans to read "Vegetable,
legume, edible podded, subgroup 6A" at
0.60 ppm and "Pea and bean, succulent
shelled, subgroup 6B" at 0.40 ppm. EPA
revised these tolerance levels based on
analyses of the residue field trial data
using the Agency's Tolerance
Spreadsheet in accordance with the
Agency's Guidance for Setting Pesticide
Tolerances Based on Field Trial Data
Standard Operating Procedure (SOP).
EPA is deferring to a later date the
decision regarding the proposed
tolerances for residues of acetamiprid
on bulb vegetables crop group 3 and
berry crop group 13.
Therefore, tolerances are established
for residues of acetamiprid, Nl-((6-
chloro-3-pyridyl)methyl]-N2-cyano-Nl-
methylacetamidine, in or on Almond,
hulls at 5.0 ppm; Fruit, stone, group 12,
except plum, prune at 1.20 ppm; Nut.
tree, group 14 at 0.10 ppm; Pea and
bean, succulent shelled, subgroup 6B at
0.40 ppm; Pistachio at 0.10 ppm; Plum,
prune, dried at 0.40 ppm; Plum, prune,
fresh at 0.20 ppm; Vegetable, cucurbit,
group 9 at 0.50 ppm; and Vegetable,
legume, edible podded, subgroup 6A at
0.60 ppm.

VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this rule has
been exempted from review under
Executive Order 12866, this rule is not
subject to Executive Order 13211,
Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental fustice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 40«fn)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply
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67262 Federal Register /Vol. 72, No. 228/Wednesday, November 28, 2007/Rules and Regulations
to this rule. In addition, This rule does
not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act of 1995 (UMRA)
(Public Law 104-4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National, Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section
12fd) (15 U.S.C. 272 note).

VD. Congressional Review Act

The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a "major rule" as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180

Environmental protection.
Administrative practice and procedure,
Agricultural commodities. Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: November 14, 2007.
Donald R. Stubbs,
Acting Director, Registration Division, Office
of Pesticide Programs,

• Therefore, 40 CFR chapter! is
amended as follows:

PART 180—{AMENDED]

• 1. The authority citation for part 180
continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
• 2. Section 180,578 is amended by
alphabetically adding the following
commodities to the table in paragraph
(a)(l) to read as follows:

§ 180.578 Acetamiprid; tolerances for
residues.
(a) General. * * *
(I)*'-
Commodity
Commodity
Almond, hulls
Parts per million
Fruit, stone, group 12,
except plum, prune .
Nut, tree, group 14
Pea and bean, succulent
shelled, subgroup 68 ..
Pistachio
Plum, prune, dried
Plum, prune, fresh .,
Vegetable, cucurbit,
group 9
Vegetable, legume, edi-
ble podded, subgroup
6A ,
Parts per million
1.20

0.10

0.40
0.10
0.40
0.20
0.50
0.60
(FR Doc. E7-2305S Filed 11-27-07: 8:45 amj
BILLING CODE SS6O-50-S
5.0
-------
DATE: 10/25/07
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
MEMORANDUM

SUBJECT: Acetamiprid: Human Health Risk Assessment for Proposed Food Uses on Stone
Fruits, Cucurbit Vegetables, Tree Nuts, Berries, Strawberries, Bulb Vegetables,
Legumes (Peas and Beans) and for Residential/Commercial
Insecticide/Termiticide Uses.
Regulatory Action: Section 3 Registration
Risk Assessment Type: Single Chemical Aggregate
PC Code: 099050
Petition Nos: 4F6833, 6F7051, 6E7163
DP Barcode: D303171
FROM: Kimberly D. Harper, Toxicology
William Drew, Chemistry
Margarita Collantes and Zaida Figueroa, Occupational and Residential Exposure
Tom Mori arty. Risk Assessment
Registration Action Branch 2
Health Effects Division (7509P)

THROUGH: Christina Swartz, Branch Chief
Richard Loranger, Branch Senior Scientist
Registration Action Branch 2
Health Effects Division (7509P)

TO: Akiva Abramovitch/John Hebert, PM Team 07
Insecticide/Rodenticide Branch
Registration Division (7505P)

Summary: HED has completed a risk assessment for the three petitions (4F6833, 6F7051,
and, 6E7163) submitted by Nisso America, and the IR-4 for proposed uses of
acetamiprid on stone fruits, tree nuts, cucurbits, legumes (pea and beans), and
berry and bulb vegetables. The dietary assessment incorporates exposure from
currently registered uses along with those being proposed. The aggregate
assessment incorporates estimated dietary {food + water) exposure with
residential exposure estimates from currently registered uses. Occupational and
residential risk assessments have also been performed for the proposed uses.
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Table of Contents
1.0 Executive Summary 4
1.1 Summary of Recommendations (see also Section 10.0) 6
1.2 Summary of Proposed Uses 6
2.0 Ingredient Profile 8
3.0 Hazard Characterization/Assessment 9
3.1 Hazard Characterization 9
3.2 FQPA Hazard Considerations 12
3.2.1 Adequacy of the Toxicity Database 12
3.2.2 Determination of Susceptibility 12
3.2.3 Degree of Concern Analysis and Residual Uncertainties 13
3.3 FQPA Safety Factor(s) For Infants and Children 13
3.4.1 Acute Dietary Endpoint 14
3.4.2 Chronic Dietary Endpoint 15
3.4.3 Dermal Absorption 17
3.4.4 Short- and Intermediate-Term Dermal Endpoints... 18
3.4.5 Short-and Intermediate-Term Inhalation Endpoints 18
3.4.6 Level of Concern for Margin of Exposure (MOE) 19
3.4.7 Recommendation for Aggregate Exposure Risk Assessment 19
3.4.8 Classification of Carcinogenic Potential 20
3.5 Endocrine Disruption 23
4.0 Public Health Data 23
5.0 Dietary Exposure/Risk Characterization 23
5.1 Metabolism in Crops and Livestock.
23
5.1.1 Analytical Methodology 24
5.1.2 Metabolism and Degradates of Concern 25
5.1.3 Drinking Water Residue Profde 26
5.1.4 Food Residue Profile 27
5.1.4.1 Crop Field Trials 27
5.1.4.2 International Residue Limits 29
5.1.4.3 Livestock Commodities 29
5.2 Dietary Exposure/Risk Pathway. 31
5.2.1 Dietary Exposure and Risk 31
6.0 Residential (Non-Occupational) Exposure/Risk Pathway 33
6.1 Spray Drift 34
7.0 Aggregate Risk Assessment and Risk Characterizations 34
7.2 Short-Term and Intermediate-Term Aggregate Risk 35
7.3 Chronic Aggregate Risk 36
8.0 Cumulative Risk Characterization/Assessment 36
9.0 Occupational Exposure/Risk Pathway 37
9.1 Agricultural Handlers and Pesticide Control Operators 37
9.2 Handler and Pesticide Control Operator Risk Characterization 38
9.3 Post-application Exposure and Risk 39
10.0 Data Needs, Deficiencies, and Label Recommendations 40
Appendix A. References.. 41

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Appendix B. Occupational Exposure and Risk Table.. ,.,.., 42
Appendix C. Acetamiprid Toxicology Assessment 45
Appendix D. Tolerance Summary Table for Petitions 49
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1.0 Executive Summary

Acetamiprid {NI-[(6-chloro-3-pyridyI)methyl]-N2-cyano-NI-methylacetamidine} is a
chloronicotinyl insecticide registered to control sucking type insects (e.g., aphids, whitefly, etc.)
on a wide variety of crops including cotton, leafy vegetables, fruiting vegetables, and citrus
fruits. Tolerances are established for acetamiprid residues in assorted crops and livestock
commodities under 40 CFR 180.578. The majority of the agricultural uses are for broadcast
foliar spray (via ground or aerial equipment), but there are also registered seed treatment uses on
mustard and canola. Ready-to-use, and bait formulations are registered for residential uses. The
petitioner, Nisso America Incorporated, is seeking Section 3 registrations for use of acetamiprid
on several agricultural crops under the two product labels ASSAIL® 70WP, and Assail® 30SG.
HED has also included an assessment of the termiticide/insecticide (product F4688 50WP) for
use by commercial operators at residential sites.

The acute toxicity data indicate that acetamiprid is moderately toxic via the oral route and is
minimally toxic via the dermal and inhalation routes. Acetamiprid is not an eye or skin irritant,
and it is not a dermal senstitizer. The toxicity data base for acetamiprid is complete. Based on
subchronic, chronic, developmental and reproductive studies in rats, rabbits, and dogs,
acetamiprid does not appear to have specific target organ toxicity. Since the last review of
acetamiprid hazard data in 2003, an acceptable developmental neurotoxicity (DNT) study has
been submitted and reviewed.

Developmental studies showed no evidence of either quantitative or qualitative susceptibility of
the rat or rabbit fetuses from in utero exposure. However, both the DNT study and the multi-
generation reproduction studies showed an increase in qualitative susceptibility of pups; effects
in pups consisted of decreased pup viability, and maternal toxicity consisted of decreased body
weight and body weight gain. HED has reduced the FQPA Safety Factor to IX, because: (i) the
endpoints selected for risk assessment are based upon the effects of concern in offspring; (ii)
there is a clear NOAEL for the offspring effects; (iii) the toxicology database is complete; and,
(iv) HED has no residual uncertainties with regards to pre- and postnatal toxicity. HED has
determined that acetamiprid is not likely to be carcinogenic to humans.

With the exception of chronic dietary, HED has chosen the NOAEL (10 mg/kg/day) from the
DNT study (LOAEL = 45 mg/kg/day) as the endpoint and dose for dietary, non-occupational and
occupational risk assessments for all durations and routes of exposure. For the chronic dietary
assessment, HED has chosen the NOAEL (7.1 mg/kg/day) from the chronic
toxicity/oncogenicity study (LOAEL = 17.5 mg/kg/day).

HED has refined the dermal penetration value to 10% (from 30% in the previous assessment)
based upon a closer examination of structural/chemical characteristics of related compounds.
The default 100% absorption factor was used for all inhalation exposure scenarios.

The nature of the residue is adequately understood for both plants and animals, and acceptable
method validation has been submitted for all proposed uses. Acceptable residue data have been
submitted to support the proposed uses as well as the tolerances recommended at the conclusion
of this section. The proposed use on strawberry was part of a joint review with PMRA Canada.

The dietary assessment is partially refined, using field trial data, percent crop-treated values, and

Page 4 of 51
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various empirical processing factors. Estimated drinking water concentrations (EDWCs), which
are based upon the highest application values of all registered and proposed uses, have been
incorporated directly into the dietary exposure model. Both acute and chronic dietary risk
estimates for all population subgroups did not indicate a risk of concern. Children 1-2 years old
are the highest exposed population subgroup for both acute and chronic exposure scenarios.
Acute exposure constituted 35% of the acute population adjusted dose (aPAD), and the chronic
exposure constituted 35% of the chronic population adjusted dose (cPAD).

Petition 4F6833 initially included a proposed insecticide/termiticide for use (label F4688
50WSP) in residential sites. Based upon a draft HED assessment, this product was approved in
May, 2007. However, since that time new toxicity endpoints have been chosen and, therefore,
HED has included these uses in the current assessment. The proposed uses of F4688
Insecticide/Termiticide are to subterranean structural components during construction;
subterranean, and hard-to-reach structural components post construction and outdoor perimeter
use. Based upon the uses of F4688, HED believes no residential/non-occupational exposures
will occur; however, the anticipated occupational exposures were assessed.

Aggregate risk assessments for acute, short-term, and chronic durations were conducted.
Residential exposures incorporated into the aggregate assessments were based on currently
registered residential uses (ant and cockroach gel bait products). All aggregate assessments
indicated no risks of concern (aggregate MOEs > 900).

Occupational handler (mixer/loaders, applicators, and flaggers) assessments were conducted for
the proposed agricultural uses of acetamiprid. HED's assessment indicated that exposures to
occupational handlers were not a risk concern when the personal protective equipment (PPE)
specified on the proposed labels was assumed to be worn by the handler. HED identified no
post-application risk concerns for the proposed uses on the day of application, and set the
restricted entry interval (RET) at 12 hours based upon the acute toxicity categories of
acetamiprid.

For the termiticide/insecticide use, HED determined that exposures to licenced certified
operators (LCOs) were not of concern when the PPE specified on the label was assumed to be
worn by the handler.
Environmental Justice Considerations

Potential areas of environmental justice concerns, to the extent possible, were considered for this
human health risk assessment, in accordance with US Executive Order 12898, Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income Populations,
^
As a part of every pesticide risk assessment, OPP considers a large variety of consumer
subgroups according to well-established procedures. In line with OPP policy, HED estimates
risks to population subgroups from pesticide exposures that are based on patterns of that
subgroup's food and water consumption, and activities in and around the home that involve
pesticide use in a residential setting. Extensive data on food consumption patterns are compiled
by USDA under the CSFII, and are used in pesticide risk assessments for all registered food uses

Page 5 of 51
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of a pesticide. These data are analyzed and categorized by subgroups based on age, season of the
year, ethnic group, and region of the country. Whenever appropriate, non-dietary exposures
based on home use of pesticide products, associated risks for adult applicators, and for toddlers,
youths, and adults entering or playing on treated areas post-application are evaluated. Further
considerations are currently in development as OPP has committed resources and expertise to the
development of specialized software and models that consider exposure to bystanders and farm
workers as well as lifestyle and traditional dietary patterns among specific subgroups.
Review of Human Research

This risk assessment relies in part on data from studies in which adult human subjects were
intentionally exposed to a pesticide or other chemical. These studies, which comprise the
Pesticide Handlers Exposure Database (PHED), have been determined to require a review of
their ethical conduct, and have received that review. The studies in PHED were considered
appropriate (or ethically conducted) for use in risk assessments
l.l Summary of Recommendations (see also Section 10.0)

» Current labels for use on berries, bulb vegetables, edible podded legume vegetables,
succulent shelled beans, and peas, or strawberries and other low-growing berries should
be amended to remove directions regarding the use of surfactants.

• The tolerance expression proposed in Section F ofPP#6E7163 by IR-4 with respect to
strawberry, bearberry, bilberry, blueberry (lowbush), cloudberry, cranberry, lingonberry,
muntries, and partridgeberry should be revised to exclude the word "combined."

» HED recommends the establishment of acetamiprid tolerances listed in Appendix D,
Table 1.

• HED recommends the establishment of Section 3 registrations for the proposed uses of
the subject petitions.

» Dermal absorption data from other neonicitinoids (thiamethoxam, and clothianidin) was
used to refine the dermal absorption factor for acetamiprid. HED recommends that RD
consider whether any data compensation issues are associated with this refinement.
1.2 Summary of Proposed Uses

Table 1 below summarizes the uses associated with the subject petitions.
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Ingredient Profile
Acetamiprid {NI-[(6-chloro-3-pyridyl)methyI]-N2-cyano-Nl-methylacetamidine} is an
insecticide that falls into the chloronicotinyl class of compounds. It has a molecular weight of
222.68 Daltons and is not volatile (vapor pressure = 7.5x10"9 Torr at 25°C; Henry's Law
Constant = 5.17x10"" aim MJ/mole at 25°C). Acetamiprid is quite soluble In water (4.25 g/L)
as well as organic solvents (>200 g/L in ethanol, acetone, and dichloromethane). The log KOW of
acetamiprid is 0.8. Based on these data, acetamiprid vapors should not present a significant
inhalation risk and this compound is not expected to concentrate in fatty tissues. Technical-
grade acetamiprid does not contain impurities of known or potential toxicological concern. The
nomenclature and physioehemical properties of acetamiprid are presented below in Tables 2 and
3.
Table 2. Test Compound Nomenclature
Compound
Common Name
Company Experimental Name
IUPAC Name
CAS Name
CAS#
End-Use Product
Chemical Name of Acetamiprid
Metabolite 1M-2-I
Chemical Name of Acetamiprid
Metabolite
IM-2-1 -amide
(lisa referred to as IM-2-2)
C1NXS
^VN-cf'
| ^N —
CH,
Chemical Structure
Acetamiprid
EXP-61842A, AEF124370, NI-25
(£)-jV/.|(6-chloro-3-pyrJdyl)methyl]-ArI-cyaiio-/V'-methylacetamidine
( I E)-A?-|(6-ehloro-3-pyridinyl)methyl|-/V'-cyan0-/V-
methylethanimidaniide
135410-20-7
Assail® 70WP, Assail® 30SG, F4688 50WSP
N '-l(6-chIoro-3-pyridyl)niethyl|-jV "'-cyano-acetamidine
jV**-aininocarboiifI-/V'-H6-chloro-3-pyridfI)methyI|acetainidine
Page 8 of 51
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Table3, Phystcochemical Properties of Acetamiprid
Parameter
Melting Point/Range (°C)
pH (20°C)
Density (20°C)
Water Solubility (25°C)
Solvent Solubility (25°C) in:
Acetone
Ethanol
Dichlorornethane
n-Hexane
Vapor Pressure (mm Hg)
Dissociation Constant (pK4)
Octanol/Water Partition Coefficient, Log Kow (20°C)
UV/Visible Absorption Spectrum
Value
9g.9
6.08 {Aqueous Solution)
1 .33 g/cm3
4.25 g/L
>20g/lOOg
>20g/100g
>20g/IOOg
6.54 ppm
7.5 x 109
0.7
0.8
(Not Available)
3.0
Hazard Characterization/Assessment
Since HED's last hazard assessment of acetamiprid in 2003, a DNT study has been received and
reviewed. The toxtcity data base is complete for the purpose of human health risk assessment.
3.1
Hazard Characterization
The scientific quality of the toxicology database is high and the toxicity profile can be
characterized for all effects, including potential developmental, reproductive, carcinogenic, and
neurotoxic effects. The acute toxicity data indicate that acetamiprid is moderately toxic via the
oral route (Toxicity Category II) and is minimally toxic via the dermal and inhalation routes
(Toxicity Category III). Acetamiprid is not an eye or skin irritant, nor is it a dermal sensitizer.

Acetamiprid does not appear to have specific target organ toxicity. In all species tested,
generalized nonspecific toxicity was observed as decreases in body weight, body weight gain,
food consumption and food efficiency when determined. Generalized effects were also observed
in the liver in the form of hepatocellular hypertrophy in both mice and rats and hepatocellular
vacuolation in the rat. Hepatocellular hypertrophy was observed in the rat subchronic feeding
study at doses of 50 mg/kg/day and above, and in the rat chronic feeding study at doses of 17.5
mg/kg/day and above at both the 12-month sacrifice as well as at study termination. In mouse
studies, hepatocellular hypertrophy was observed at 430 mg/kg/day at 90 days and at 186
mg/kg/day at 12 and 18 months. These effects are considered to be adaptive. Hepatocellular
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vacuolation was observed at 17.5 mg/kg/day in the rat chronic study. In light of the lack of
major liver effects in the rat studies, it is likely that the vacuolization is more related to liver
activity in response to the presence of the chemical rather than frank toxicity. Other effects
observed in the oral studies include amyloidosis of multiple organs in the mouse oncogenicity
study, tremors in high dose females in the mouse subchronic study, and microconcretions in the
kidney papilla and mammary hyperplasia in the rat chronic feeding/oncogenicity study.

No effects were observed in the 21-day dermal study in the rabbit and no inhalation studies were
conducted.

A dermal absorption study with acetamiprid was conducted using male rats with exposure
durations of 0.5, I, 2, 4, 10 and 24 hours. Measured absorption was small and increased with
duration of exposure. The quantity absorbed also generally increased with dose. In the previous
acetamiprid risk assessment, the highest dermal absorption value (6.34% at 24 hours) was added
to the residue remaining on the skin at 24 hours (25%) to estimate a 30% dermal absorption
value. However, HED has refined the dermal absorption value (to 10%) based upon comparison
to clothianidin. which is structurally related. HED believes that a refined dermal penetration
value for acetamiprid of 10% is reasonable and protective. See Section 3.4.3 for more details.

There is no quantitative or qualitative evidence of increased susceptibility of rat or rabbit fetuses
to in utero exposure in the developmental studies. In the rat, an increase in the incidence of
shortening of the 13th rib was observed in fetuses at the same LOAEL as the dams. Maternal
effects included reduced mean body weight, body weight gain and food consumption and
increased liver weights. No developmental toxicity was observed in the rabbit fetuses at dose
levels that induced maternal effects including body weight loss and decreased food consumption.

In the multi-generation reproduction study, qualitative evidence of increased susceptibility of rat
pups was observed. The parental and offspring systemic NOAELs were 17.9/21.7 (M/F)
mg/kg/day and the offspring/parental systemic LOAELs were 51.0/60.1 mg/kg/day based on a
decrease in mean body weight, body weight gain, and food consumption in the parents and
significant reductions in pup weights in both generations. Also observed was reduction in litter
size, and viability and weaning indices among FI offspring as well as significant delays in the
age to attain vaginal opening and preputial separation in the offspring. These offspring effects
were considered to be more severe than the parental effects.

In the DNT study there was evidence of increased qualitative susceptibility. The purpose of the
DNT study is to evaluate the potential functional and morphological effects to the nervous
system which may arise in the offspring from exposure of the mother during pregnancy and
lactation. It provides data on sensorimotor function and on habituation which is considered to be
a simple form of learning. In the acetamiprid DNT, the offspring NOAEL was 10 mg/kg/day
based on decreased body weights and body weight gains in males and females, decreased pre-
weaning survival (PND 0-1), and decreased maximum auditory startle response in males on PND
20 and PND 60, at the LOAEL of 45 mg/kg/day. Although there were reductions in the
maximum auditory startle response in the 10 mg/lkg/day in males on PND 20 and PND 60, the
mean response was within the range of historical control means and standard deviations among
other DNT studies conducted (by the same laboratory) within a 5-year span of the Acetamiprid
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DNT study. HED noted that statistical significance could only be achieved by combining data
for both sexes at both time points (PND 20, and PND 60). Agency scientists agreed that it was
appropriate to combine the data for the sexes, but there was no definitive consensus regarding
combining the data from the different time points. The discussion regarding the combining the
data from the two time points centred around the equipment used to measure the auditory startle
reflex, and how it is calibrated differently to account for increases in body weight as the animals
grow. Based upon the analysis of the DNT, technical arguments submitted by the registrant, and
consideration of all other data in the acetamiprid toxicity profile, HED believes that the decrease
in maximum startle response in males is only treatment related only at the high-dose level of 45
mg/kg/day.

In the acute neurotoxicity study, decreased locomotor activity was seen in both sexes post dosing
at 30 mg/kg/day. HED has low confidence in the locomotor activity data presented in the DNT
study due to problems with the controls. The decreased auditory startle response in males in
conjunction with the decreases in pup body weight and body weight gains and decreased pup
viability lead the Agency to a weight-of-evidence LOAEL determination of 45 mg/kg/day. For
a more detailed discussion of the DNT study refer to the DNT DER (MRID 46255619) and cover
memo entitled Acetamiprid: Data Evaluation Record for Acetamiprid Developmental
Neurotoxicity Study and EPA Response to Rebuttals Submitted by Nisso America, (TXR
0054508). The decrease in auditory startle response observed in pups occurred in the presence of
maternal toxicity. However, the maternal toxicity observed in this study was restricted to
decreased body weight and body weight gains during gestation only. The decreased pup
viability at 45 mg/kg/day is considered to be more severe than the maternal effects. Other
maternal effects observed in the DNT included a dose-related increased incidence of clinical
signs including hair loss, dried red material and scabbing on the forelimbs as well as animals
wiping their mouths/burying their heads in the bedding post- dosing. These clinical signs began
during gestation but were of unknown toxicological significance and were not used to determine
the study NOAEL/LOAEL.

In an acute rat neurotoxicity study, a decrease in locomotor activity was observed in both sexes
on the day of dosing. A slight decrease in the duration of movements persisted in some males on
days 7 and 14. Functional observational battery evaluations revealed several treatment-related
observations on the day of dosing. High-dose males exhibited tremors, difficulty in handling,
walking on toes, dilated pupils and coldness to the touch. High-dose males also had decreased
forelimb grip strength and hind limb foot splay. High-dose females displayed tremors, chewing,
coldness to the touch, and dilated pupils. High-dose females had decreased hind limb foot splay
and were seen to have abnormal gaits and/or posture, including walking on toes and hunched
posture. However, in a subchronic rat neurotoxicity study, the only effects observed were related
to decreases in body weight/body weight gain, food consumption and food efficiency. No
neuropathology was observed in any of the three neurotoxicity studies. Tremors in high dose
female mice in the subchronic feeding study were the only other potentially neurotoxic effects
observed in any other studies.

Acetamiprid tested negative in a Salmonella typhimurium (Ames) assay, a forward mutation
assay in Chinese hamster ovary cells, an in vivo chromosome aberration assay in Sprague-
Dawley (CD) rats, a mouse micronucleus assay, and in repeat assays for unscheduled DNA
Page 11 of 51
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synthesis (UDS) in rat liver primary cell cultures. Acetamiprid tested positive as a clastogen in
an in vitro mammalian chromosome aberration assay in Chinese hamster ovary (CHO) cells.
However, the in vivo chromosomal aberration study does not support the results of the in vitro
study. All acetamiprid metabolites tested were negative for mutagenicity.

As stated previously, acelamiprid does not appear to have specific target organ toxicity.
Generalized non-specific toxicity was observed in subchronic and chronic studies as decreases in
body weight, body weight gain, food consumption and food efficiency when estimated, and
hepatocellular hypertrophy as well as hepatocellular vacuolation, which are likely to be related to
pharmacological activity rather than frank toxicity. Two studies in which the toxicological
effects are more significant are the multigeneration reproduction study and the developmental
neurotoxicity study. In the two-generation reproduction study, delays in preputial separation,
vaginal opening and pinna unfolding and reduced litter size, viability and weaning indices were
observed at dose levels where only reduced body weight and food consumption were observed in
the parents, indicating increased qualitative susceptibility in the pups exposed in utero. Similar
offspring effects were observed in the DNT where offspring exposed in ttiero and/or post-natally
showed signs of decreased body weight and body weight gains in males and females, decreased
pup viability and decreased maximum auditory startle response in males on PND 20 and PND
60. These effects were seen in the presence of decreased body weight and body weight gains in
the maternal animals, The decrease in pup viability is considered more severe than the maternal
effects; therefore, there is evidence of increased qualitative susceptibility in the DNT study.
3.2 FQPA Hazard Considerations

3.2.1 Adequacy of the Toxicity Database

The acetamiprid data base is adequate to characterize potential pre- and/or postnatal risk for
infants and children. Acceptable guideline studies for developmental and reproductive toxicity
are available for FQPA assessment. The registrant has also submitted an acceptable DNT study
(MRID 46255619) to the Agency in 2004.

3.2.2 Determination of Susceptibility

HED determined that neither quantitative nor qualitative evidence of increased susceptibility of
fetuses to in utero exposure to acetamiprid was observed in either the developmental toxicity
study in rat, or in rabbit. However, in the multigeneration reproduction study, qualitative
evidence of increased susceptibility of rat pups was observed. While parental and offspring
NOAELs and LOAELs are set at the same doses (17.9 and 51.0 mg/kg/day, respectively), the
effects in the offspring are considered to be more severe than the parental effects. Likewise, in
the DNT study maternal and offspring effects were observed at the same dose (45 mg/kg/day).
However, the offspring effects included decreased pup viability which is considered to be more
severe than the maternal body weight effects. Therefore, HED concluded that there was
evidence of increased qualitative susceptibility to fetuses exposed in utero and/or during
lactation in the DNT study. Quantitative evidence of increased susceptibility was not observed
in any study.
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3.2 J Degree of Concern Analysis and Residual Uncertainties

Since there is evidence of increased qualitative susceptibility of the young following in utero
exposure to acetamiprid in the rat reproduction study, and increased qualitative susceptibility to
pups in the DNT study, HED performed a degree of concern analysis to: 1) determine the level
of concern for the effects observed when considered in the context of all available toxicity data;
and, 2) identify any residual uncertainties after establishing toxicity endpoints and traditional
uncertainty factors to be used in the acetamiprid risk assessment. If residual uncertainties are
identified, HED examines whether the residual uncertainties can be addressed by a FQPA safety
factor, and if so, what factors should be retained.

Considering the overall toxicity profile and the endpoints and doses selected for the acetamiprid
risk assessment, HED characterized the degree of concern for the effects observed in the
acetamiprid DNT study as low, noting that there is a clear NOAEL for the offspring effect, the
toxicology database is complete, and regulatory doses were selected to be protective of potential
offspring effects. No other residual uncertainties were identified. Based on the available data,
HED determined that changes in motor activity, auditory startle reflex, learning and memory
assessments, and even changes in the brain morphometrics can occur as the result of a single
exposure at a critical junction during pregnancy or from multiple exposures throughout
pregnancy and lactation. Therefore, the NOAEL for offspring effects observed in the DNT was
selected as the dose for acute dietary exposures (co-critical with the acute neurotoxicity study),
as well as. short-term and long-term non-dietary risk assessment. The chronic dietary study in
rats yielded a lower long-term NOAEL (7.1 mg/kg/day) and will be used for assessing chronic
dietary risk. HED believes that the endpoints and doses selected for acetamiprid are protective
of adverse effects in both offspring and adults.
3.3 FQPA Safety Factor(s) For Infants and Children

HED has determined that no additional FQPA safety factor is needed for acetamiprid (i.e. the
Safety Factor has been reduced to 1X) for the following reasons: (I) the toxicology database is
complete; (2) HED is regulating based upon the effects of concern, i.e., developmental effects in
pups following pre-and/or post-natal exposure; (3) the rat appears to be the most sensitive
species tested, and the NOAEL and LOAEL selected from the DNT study in rats are protective
of effects observed in other species throughout the toxicology database; and, (4) there are no
residual uncertainties for pre- and/or post-natal toxicity. The recommended FQPA safety factor
also reflects HED's conclusion that the exposure databases (dietary food, drinking water, and
residential) are complete and that the risk assessment for each potential exposure scenario
includes all metabolites and/or degradates of concern and does not underestimate the potential
risk to infants or children.
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3.4 Hazard Identification and Toxicity F.ndpoint Selection

3.4.1 Acute Dietary Endpoint
Study Selected: Developmental Neurotoxicity Study in Rats
MRiDNo.: 46255619

Executive Summary: In a developmental neurotoxicity study (MRID 46255619), Acetamiprid
(>99% a.i., lot # NNI-03) was administered to 25 mated female Crl:CD®(SD)IGS BR rats/dose
by gavage at doses of 0, 2.5, 10 and 45 mg/kg/day from gestation day (GD) 6 through lactation
day (LD) 21 in a volume of 5 mL/kg body weight. A Functional Operational Battery (FOB) was
performed on 10 dams/dose on GDs 6 and 12, and on LDs 4 and 7. On postnatal day (PND) 4,
litters were culled to yield four males and four females (as closely as possible). Offspring were
allocated for FOB and assessment of motor activity, auditory startle reflex habituation, learning
and memory, and neuropathology at study termination (day 72 of age). On postnatal day 11, the
whole brain was collected from 10 pups/sex/dose group for micropathologic examination and
morphometric analysis. Pup physical development was assessed by body weight. The age of
sexual maturation (vaginal opening in females and preputial separation in males) was assessed.

In the dams, no systemic toxicity was seen at the doses tested. The maternal toxicity observed
was restricted to decreased body weight and body weight gains during gestation at the LOAEL
of 45 mg/kg/day (NOAEL 10 mg/kg7day).

Treatment-related effects in the offspring at the high dose (45 mg/kg/day) include decreased
body weights, and body weight gains in males and females post-weaning, decreased pup viability
and decreased maximum auditory startle response in males on PND 20 and PND 60. Treatment
had no adverse effects on clinical signs, developmental landmarks. FOB, brain weight or brain
morphology. There is low confidence in the motor activity data because of problems with the
control data (i.e. the normal developmental pattern was not seen in control animals). Therefore,
no conclusions could be made on motor activity evaluation. The maximum auditory startle
response amplitude was decreased 27% (PND 20) and 40% (PND 60) at 10 mg/kg/day, and it
was decreased 42% (PND 20) and 53% (PND 60) at 45 mg/kg/day; only the decreased
maximum auditory startle response in the 45 mg/kg/day males (PND 20 and PND 60) was
considered treatment related. No conclusions can be made on the effects of acetamiprid on
learning and memory because of the high variability in the data.

The offspring LOAEL is 45 mg/kg/day based on decreased body weights and body weight gains
in males and females, decreased pre-weaning survival (PND 0-1), and decreased maximum
auditory startle response in males on PND 20 and PND 60. The offspring NOAEL is 10
mg/kg/day.

ACN Executive Summary: In an acute neurotoxicity study (MRID 44651842), groups of fasted
male and female Crl:CD-BR rats (10/sex/dose), were given a single oral dose of acetamiprid
(99.9%) by gavage, in 0.5% sodium carboxymethylcellulose at doses of 0, 10, 30, or 100 mg/kg
bw and observed for 14 days. There were no mortalities during the study. Body weight gain,
food consumption, and food efficiency were unaffected in females. Treatment with acetamiprid
had no effect on brain size or weight and there was no evidence of neuropathology. Clinical
Page 14 of 51
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signs of toxieity were limited to the high-dose animals, and included tremors, hunched posture,
unsteady gait and coldness to touch. In addition, one high-dose female had slight brown nasal
staining from study day 2 until termination.

High-dose males and females had significantly reduced body temperature on the day of dosing.
Significantly decreased motor activity was observed in the mid- and high-dose males and in
high-dose females on the day of dosing. A slight decrease in the duration of movements
persisted in mid- and high-dose males on days 7 and 14. Functional observational battery
evaluations revealed several treatment-related observations on the day of dosing. High-dose
males exhibited tremors, difficulty in handling, walking on toes, dilated pupils and coldness to
touch. High-dose males also had decreased forelimb grip strength and hind limb foot splay.
High-dose females displayed tremors, chewing, coldness to touch, and dilated pupils. High-dose
females had decreased hind limb foot splay. High-dose females were seen to have abnormal
gaits and/or posture, including walking on toes and hunched posture.

The LOAEL for neurotoxicity was 30 mg/kg bw, based on the observed reduction in locomotor
activity in males. The NOAEL for neurotoxicity was 10 mg/kg bw.

Dose and Endpoint for Risk Assessment: NOAEL = 10 mg/kg/day based on decreased body
weights and body weight gains in males and females, decreased pre-weaning survival (PND 0-1),
and decreased maximum auditory startle response in males on PND 20 and PND 60 of the DNT
study at 45 mg/kg/day. as well as, decreased locomotor activity in males in the ACN study at 30
mg/kg bw.

Comments about Studv/Endppint/Uncertaintv^actors: These endpoints and dose were selected
because 1) the oral route of exposure is relevant to dietary risk assessment, 2) the duration of
exposure is relevant to acute dietary risk (both endpoints can be considered the result of a single
dose), and 3) they are protective of potential offspring effects. Based on the available data, HED
determined that changes in motor activity, auditory startle reflex, learning and memory
assessments, and changes in the brain morphometrics can occur as the result of a single exposure
at a critical junction during pregnancy or from multiple exposures throughout pregnancy and
lactation. The standard uncertainty factors (lOOx) were applied to all dietary exposure scenarios
(lOx for intraspecies variability and I Ox for interspecies extrapolation).

3,4.2 Chronic Dietary Endpoint
Studies Selected: Chronic/Oncogenicity Study in the Rat
IVfRID Nos.: 44988429, 45245304

Executive Summary: In a chronic toxicity/oncogenicity study (MRID 44988429 & 45245304),
acetamiprid, [NI-25 (>99% a.i.; Lot No. NNI-Ol)] was administered to groups of 60 male and 60
female Crl-CD*BR rats in the diet at concentrations of 0, 160. 400, and 1000 ppm (0, 7.1, 17.5,
and 46.4 mg/kg/day for males and 0, 8.8, 22.6, and 60 mg/kg/day for females). Ten rats per sex
per dose were sacrificed at 12 months for interim evaluations; the remaining animals were
maintained on their respective diets for up to 24 months.

There were no treatment-related effects on mortality; eyes; hematology, clinical chemistry or

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urinaiysis parameters; or gross findings in either sex administered any dose of the test material.
Clinical signs that were observed at significantly increased incidences in treated animals
included rales in high dose males (7/48 vs 0/46 for controls) during weeks 66-78 and at all doses
in males during weeks 79-91 (0/44, 8/49, 19/45, and 17/48 at 0, 160, 400, and 1000 ppm,
respectively). Also in high-dose male rats, the incidences of labored breathing (15/48 vs 5/46 for
controls, p<0.05) was increased during weeks 66-78, red material around the nose during weeks
1-13 (7/60 vs 0/60 for controls) and weeks 92-104 (5/46 vs 0/37), and hunched posture (5/46 vs
0/37) during weeks 92-104. The lack of pathologic correlates indicates that the clinical signs are
not biologically significant.

Treatment-related effects on body weight, body weight gain, and food consumption were
observed in both sexes. High-dose male rats, weight 10-13% (p<0.0l) less than controls
throughout the study, gained 44%less weight during week 1, 14% less during the first year and
18% less over the entire study. High-dose group males also consumed 19% (p<0.01) less food
(g/animal/day) during week I and 4-9% (p<0.01 or <0.05) less at different time points during the
remaining weeks of the study. Food efficiency measured during the first 14 weeks was reduced
for males in all dose groups during the first week of the study and showed an inconsistent pattern
for the remaining 13 weeks. Mid-dose female rats weighed 4-1 7% (p<0.0l) less than controls
throughout the study and high-dose females weighed 6-27% (p<0.01) less. Mid- and high-dose
group females, respectively, gained 27 and 42% less weight than controls during week I. 15%
and 32% less during the first year, and 16% and 23% less over the entire study. Food
consumption was 6-10% and 9-19% less for mid- and high-dose group females, respectively, for
most of the study. Food efficiency was reduced for mid- and high-dose group females during
week 1 and showed inconsistent patterns tor the remaining 13 weeks.

The postmortem examination showed statistically significant changes in absolute and/or relative
weights of several organs in high-dose group male and female rats, and these changes are
attributed to the decreased terminal body weight. Treatment-related microscopic changes were
observed in the liver, kidney, and mammary glands. Trace to mild hepatocyte hypertrophy in the
liver of mid- and high-dose male rats and high-dose female rats at interim sacrifice and in the
main study groups is considered an adaptive response rather than an adverse effect. Hepatocyte
vacuolation also was observed in mid- and high-dose group male rats; the incidence was 10/12
and 10/11, respectively, compared with 2/12 for controls at interim sacrifice and 22/48 and
29/48, respectively, compared with 10/48 for the controls in the main study. An increased
incidence of microconcretions in the kidney papilla was noted for high-dose male rats (37/49 vs
17/48 for controls, p<0.01) in the main study. The incidence of 24/49 (p<0.05) for mammary
hyperplasia in high-dose group females compared with 14/49 for controls appeared to be
treatment related, but the toxicologic significance of this finding is uncertain.

The lowest-obeserved-adverse-effect-level (LOAEL) for acetamiprid is 400 ppm (17.5
mg/kg/day for males and 22.6 mg/kg/day for females) for male and female rats based on reduced
body weight and body weight gains for females and hepatocellular vacuolation for males. The
no-observed-adverse-effect-level (NOAEL) is 160 ppm (7.1 mg/kg/day for males and 8.8
mg/kg/day for females)
Page 16 of 51
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Dose and Endpoint for Risk Assessment: NOAEL = 7,1 mg/kg/day based on decreased body
weights and body weight gains in females and hepatocellular vacuolation in males observed at
the LOAEL of 17.5 mg/kg/day.

Comments about Study/Endpoint/Uncertainty Factors: This endpoint and dose was selected
because: 1) the oral route of exposure is relevant to dietary risk assessment, 2) the duration of
exposure is relevant to chronic risk scenarios, and 3) it is the lowest endpoint in the toxicology
database and is therefore protective of both chronic and potential offspring effects. The standard
uncertainty factors were applied to all dietary exposure scenarios (lOx for intraspecies variability
and lOx for interspecies extrapolation).
3.4.3 Dermal Absorption

In the previous risk assessment (3/11/2002; D263648), HED used a 30% dermal penetration
value derived from an acetamiprid dermal penetration study in rats (MRID 44651858), in which
multiple doses were tested for durations ranging from 0.5 to 24 hours. To arrive at the 30%
value, HED added the highest dermal absorption value (6.34%) to the amount sequestered in the
skin at 24 hours (approximately 25%). To validate this estimate and determine whether further
refinement was needed, HED reexamined the dermal penetration study with acetamiprid, and
reviewed the dermal penetration information of several other neonicitinoid insecticides.

To refine its assumption regarding treatment of sequestered acetamiprid on the skin, HED looked
at the amount of radioactivity remaining at the application site. The amount of radiolabeled
material remaining at the application site at various intervals varied between 0-5% percent
between time points. If the radioactivity remaining at the application site is added to that which
is absorbed, a maximum penetration value for acetamiprid would be 11%. However, since the
duration of the acetamiprid study was only 24 hours, HED examined the thiamethoxam dermal
penetration study, another neonicitinoid, which was terminated after 336 hours (14 days).
Results from that study indicate little additional absorption (1 - 3%) occurred between 24 hours
post dosing and 14 days post dosing.

HED also considered the K^, and octanol/water coefficient data of other neonicitinoid
compounds, and found acetamiprid is most closely related to clothianidin with respect to its log
Kow and octanol/water coefficient, and therefore would likely act most similarly to clothianidin
when applied to the skin. The dermal penetration value for clothianidin (1%) is based upon
dermal penetration study with monkeys. See Table 4 below.
Table 4. Absorption Parameters for Selected Neonicitinoids.
Compound
Acetamiprid
Clothianidin
LogK^
0.8
0.9
OctanoI/Water Coefficient
6.3
8
Dermal Penetration Value
30%
(dermal penetration study with rat)
1%
(dermal penetration study in monkeys)
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Adjustment of the monkey dermal penetration value for clothianidin to account for the 2-10 fold
increased dermal sensitivity of rats compared to humans (dermal penetration of monkey is
considered equivalent to human) would yield a comparative rat dermal penetration value for
acetamiprid of 2% - 10%. Likewise, if the current dermal penetration value for acetamiprid is
adjusted downward to account for the increased sensitivity of rats to humans, then a value of
10% - 15% results. Since the acetamiprid study shows 6% dermal penetration at 24 hours, a
refined dermal penetration value reflecting a longer dermal exposure, would likely be greater
than 6%, and may lie between 10 -15 %.

Based upon its reconsideration of the acetamiprid dermal penetration study, and on comparison
of acetamiprid to the structurally related clothianidin, HED determined that a refined dermal
penetration value for acetamiprid of 10% is reasonable and protective. Based upon this, HED
would not require any additional dermal penetration data for acetamiprid.

3.4.4 Short- and Intermediate-Term Dermal Endpoints
Study Selected: Developmental Neurotoxieity Study in Rats
MR[DNo.:462556l9

Executive Summary: see Section 4.3.1

Dose and Exdpoint_for_R.|.sk Assessment: NOAEL = 10 mg/kg/day based on decreased body
weights and body weight gains in males and females, decreased pre-weaning survival (PND 0-1),
and decreased maximum auditory startle response in males on PND 20 and PND 60 of the DNT
study at 45 mg/kg/day, as well as decreased locomotor activity in males in the ACN study at 30
mg/kg bw.

Comments about Study/Endpoint/Uncertainty Factors: The NOAEL and LOAEL from the DNT
study were selected for dermal risk assessment because they are protective of developmental
effects present in rat pups seen in the presence of less severe maternal effects at similar doses.
Although a dermal (route specific) toxicity study in rabbits was submitted, no effects were seen
at the highest dose tested of 1000 mg/kg/day. Use of the route-specific study for dermal risk
assessment would not be protective of the offspring effects observed in both the DNT, and the
muldgeneration reproduction studies because the effects seen could occur as a result of a single
exposure at a critical junction during pregnancy or from multiple exposures throughout
pregnancy lactation. Therefore, the NOAEL for offspring effects observed in the DNT was
selected as the dose for both short-term, and intermediate-term dermal exposure scenarios. The
standard uncertainty factors were applied to all exposure scenarios (I Ox for intraspecies
variability and lOx for interspecies extrapolation).

3.4.5 Short- and Intermediate-Term Inhalation Endpoints
Study Selected: Developmental Neurotoxieity Study in Rats
o,: 462556 19
Executive Summary: see Section 4.3.1
Page 18 of 51
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Dose and Endpoint for Risk Assessment: NO A EL = 10 mg/kg/day based on decreased body
weights and body weight gains in males and females, decreased pre-weaning survival (PND 0-1),
and decreased maximum auditory startle response in males on PND 20 and PND 60 of the DNT
study at 45 mg/kg/day, as well as, decreased locomotor activity in males of the ACN study at 30
mg/kg bw.

Comments about Study/Endpoint/Uncertainty Factors: No route-specific information is
available for the inhalation toxicity of acetamiprid. In the absence of a route-specific study, the
NOAEL and LOAEL from an oral study, along with an inhalation absorption factor (100%), are
used to estimate inhalation exposure and the associated risk. In this case, the NOAEL and
LOAEL from the DNT study were selected because the duration is appropriate for short- and
intermediate-term exposures and it is protective of potential effects in offspring. Because effects
seen in the DNT can occur as the result of a single exposure at a critical junction during
pregnancy or from multiple exposures throughout pregnancy and lactation, the NOAEL for
offspring effects observed in the DNT was selected as the dose for both short- and intermediate-
term inhalation exposure scenarios. The standard uncertainty factors were applied to all
exposure scenarios (I Ox for intraspecies variability and I Ox for interspecies extrapolation).

Based upon the proposed use patterns, HED dose not anticipate any long-term dermal or
inhalation exposure scenarios. Therefore, no long-term dose/endpoints were selected.
3.4.6 Level of Concern for Margin of Exposure (MOE)
Table 5. Level of Concern for Margin of Exposure*
Route
Short-Term
(1-30 Days)
Intermediate-Term
(1-6 Months)
Long-Term
(> 6 Months)
Occupational (Worker) Exposure
Dermal
Inhalation
100
100
100
100
N/A
N/A
Residential Exposure
Dermal
Inhalation
Incidental Oral
100
100
100
100
100
100
N/A
N/A
N/A
* The level of concern is based upon a I OX intra-speeies variability factor, and a I OX inter-species extrapolation
factor.
3.4.7 Recommendation for Aggregate Exposure Risk Assessment

The FQPA requires that HED aggregate pesticide exposures from the three major exposure
routes (oral, dermal, and inhalation) when there is potential residential exposure to a pesticide.
HED has chosen a single endpoint and dose from the DNT study as the appropriate endpoint for
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all exposure scenarios and all durations for acetamiprid, with the exception of chronic dietary
exposure. Therefore, short-, and intermediate-term dermal, oral and inhalation exposures can be
combined and aggregated with the dietary (food + water) exposures.
3.4.8 Classification of Carcinogenic Potential

HED has determined that acetamiprid is not likely to be carcinogenic to humans (EPA Draft
Guidelines for Carcinogen Risk Assessment; July, 1999). The classification is based on the
absence of a dose-response and the lack of a statistically significant increase in the mammary
adenocarcinoma incidence by pair-wise comparison of the mid- and high- dose groups with the
controls; although the incidence exceeded the historical control data from the same laboratory, it
was within the range of values from the supplier.
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Table 6. Summary of Toxicolugical Doses and End
Exposure Scenario
Acule Dietary
general population including
infants and children
Chronic Dietary
all populations
Short- and Intermediate-
Term Incidental Oral
(1-30 day sand 1 - 6 mo.)
Residential setting
Short- and Intermediate-term
Dermal
(1-30 days, I -6 mo.)
Residential setting
Short- and imermediute-teim
Inhalation
(1-30 days, 1 -6 mo,)
Residential setting
Dose Used in Risk
Assessment
NOAEL1 = 10
mg/kg/day
NOAEL = 7.1
mg/kg/day
NOAEL = 10
mg/kg/day
NOAEL - 10
mg/kg/day
NOAEL = 10
mg/kg/day
points of Acetamiprid for Use in Dietary and Non-Occupational Human Health Risk Assessment
Uncertainty
Faclors/FQPA Safety
Factors
UFA '= lOx
UFH '= lOx
FQI'A SF2 = l.x
UFA = I Ox
UFn = iOx
FQPASF=lx
UFA = IOx
UFM = IOx
FQPASF2=ix
UFA = IOx
UFH= IOx
FQPASF2= Ix
dermal absorption rale
= 10%
UFA= IOx
UF,,= IOx
FQPASF2= Ix
inhalation absorption
rate = 100%
RID, PAD Level of
Concern for Risk
Assessment
aPAD = O.IO
mg/kg/day
cPAD = 0.071
mg/kg/day
TZ>cTbrl\SjEr=
100
(Residential)
LOC lbrMOE= 100
(Residential)
LOC Ibi MOE= 100
{Residential)
Study and Toxiculogkal Effect
Developmental Neuroloxicity in rat
LOAEL* = 45 mg/kg/day based on decreased body weight and body
weight gains in offspring, decreased early pup survival on PND 0-1,
and decreased startle response on PND 20/60 in males.
Acute Neurotoxicity Study in rat
LOAEL = 30 mg/kg/day based on decreased locomotor activity
Chronic Toxicity/Oncogenicity Study in rats
LOAEL = 17.5 mg/kg/day based on decreased body weight and body
weight gains in females and hepatoceliular vacualation in males.
Developmental Neurotoxicity in rat
LOAEL5 = 45 mg/kg/day based on decreased body weight and body
weight gains in offspring, decreased early pup survival on PND 0-1,
and decreased startle response on PND 20/60 in males.
Developmental Neurotoxicity in rat
LOAEL5 = 45 mg/kg/day based on decreased body weight and body
weight gains in offspring, decreased early pup survival on PND 0-1,
and decreased startle response on PND 20/60 in males.
Developmental Neuroloxiciry in rat
LOAEL = 45 mg/kg/day based on decreased body weight and body
weight gains in offspring, decreased early pup survival on PND 0-1,
and decreased startle response on PND 20/60 in males.
Cancer (oral, dermal, inhalation) - not likely to be carcinogenic to humans.
UFA: uncertainty factor applied tor extrapolation from animal to human (inlerspeeies)
UFH: uncertainty factor applied for extrapolation from human lo human due to potential variation in sensitivity among members of the human population (intra-species)
2: FQPA SF= Food Quality Protection Act Safely Factor
3: LOC = Level of Concern
4: MOE = Margin of Exposure
5: LOAEL = Lowest Observed Adverse Effect Level
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Table 7. Summary of Toxicologkal Doses and Endpuints of Acetamiprid for Use in Occu
Exposure Scenario
Short-, Intermediate-term
Dermal
(1 -30 days, 1 -6 mo.)
Short- and Intermediate-
term Inhalation
(1 -30 days, 1 -6 mo.)
Dose Used in
Risk
Assessment
oral study
NOAEL'=
1 0 mg/kg/day
dermal
absorption rate -
10%
Oral study
NOAEL=
1 0 mg/kg/day
inhalation
absorption rate =
100%
Uncertainty Factors
UFA '= lOx
UFH '= 10x
UFA = lOx
UFH= lOx
Level of Concern
for Risk
Assessment
LOC2 for MOE3 =
100
(Occupational)
LOC for MOE =
100
(Occupational)
pational Human Health Risk Assessment
Study and Toxicological Effect
Developmental Neurotoxicity in rat
LOAEL4 = 45 mg/kg/day based on decreased body weight and
body weight gains in offspring, decreased early pup survival on
PND 0- 1 , and decreased startle response on PND 20/60 in
males.
Cancer (oral, dermal, inhalation) - not likely to be carcinogenic to humans.
1: NOAEL = No Observed Adverse Effect Level.
UFA: uncertainty Factor applied lor extrapolation from animal lo human (interspecies)
UFH: uncertainty factor applied for extrapolation form human to human due to potential variation in sensitivity among members of the human population (intra-species)
2: LOC = Level of Concern
3: MOE = Margin of Exposure
4: LOAEL = Lowest Observed Adverse Effect Level
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3.5 Endocrine Disruption

EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to
determine whether certain substances (including all pesticide active and other ingredients) "may
have an effect in humans that is similar to an effect produced by a naturally occurring estrogen,
or other such endocrine effects as the Administrator may designate." Following
recommendations of its Endocrine Disrupter Screening and Testing Advisory Committee
(EDSTAC), EPA determined that there was a scientific basis for including, as part of the
program, the androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of
potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that
effects in wildlife may help determine whether a substance may have an effect in humans,
FFDCA authority to require the wildlife evaluations. As the science develops, and resources
allow, screening of additional hormone systems may be added to the Endocrine Disrupter
Screening Program (EDSP).

When the appropriate screening and/or testing protocols being considered under the Agency's
EDSP have been developed, acetamiprid may be subjected to additional screening and/or testing
to better characterize effects related to endocrine disruption.
4,0 Public Health Data

No public health data were considered at this time.

5.0 Dietary Exposure/Risk Characterization

5.1 Metabolism in Crops and Livestock

The nature of acetamiprid residue in plants has been adequately delineated and is based on
radiolabeled studies with carrot, cabbage, cotton, apple, and eggplant. In plants, there appears to
be little translocation of acetamiprid following foliar application. In cabbage, there was
significant uptake and translocation of acetamiprid to the above ground portions of the plant
following a soil application. However, due to the rapid dissipation of acetamiprid in the field,
root uptake is not a likely source of residues in plants.

The qualitative nature of acetamiprid residue in livestock is also adequately understood based
upon metabolism studies in ruminants (lactating goat) and laying hens. HED has determined that
for risk assessment purposes, the residues of concern in livestock tissue (except ruminant
muscle) are acetamiprid/wr se, plus its IM-2-1 metabolite. In ruminant muscle, the residues of
concern for risk assessment are acetamiprid plus IM-2-1 plus IM-2-1-amide. Residues of IM-2-
1-amide in ruminant muscle tissue can be estimated by applying a 10-fold factor to residues of
IM-2-1 in muscle.
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HED has concluded that the tolerance expression should include acetamiprid per se for plant
commodities and combined residues of acetamiprid and IM-2-1 [Nl-[(6-chloro-3-
pyridyl)methyl]-N2-cyano-acetamidine] for livestock commodities. Based upon available
rotational crop data, HED has determined that the residue of concern in rotational crops would be
acetamiprid, .per se, but tolerances for acetamiprid are not needed in rotational crops. Discussion
of the nature of the acetamiprid residue and analytical methodology associated with the subject
petitions can be found in the following HED memoranda: for cucurbit vegetables, stone fruits,
and tree nuts, see HED memorandum, W.Drew, 11/5/2004, D303623; and, for berries, bulb
vegetables, succulent shelled pea and beans, and strawberry and other low growing berries, see
HED memorandum, W.Drew, 10/23/2007, D328216.

5.1.1 Analytical Methodology

The method used to analyze samples for acetamiprid residues in/on raw agricultural commodities
(RACs) was Method Number 45800, entitled Methods for the Analysis of Acetamiprid (NI-25) In
Plants and Plant Processed Fractions (MRID # 44988529). This method is adequate for data
collection based on acceptable concurrent method recovery data. Acetamiprid is not recovered
through the FDA Multiresidue Protocols.

Adequate residue analytical methods are available for the enforcement of established and
proposed tolerances for plant commodities (GC/ECD and HPLC/UV) and animal commodities
(HPLC/UV). These methods were submitted to ACB/BEAD for petition method validation
(PMV) and were successfully validated. The registrant has also requested that the
HPLC/MS/MS method utilized for data collection (in PP#3F6575 and PP#4F6833) replace the
current tolerance enforcement method (GC/ECD) for the proposed uses on stone fruits, tree nuts,
and cucurbit vegetables. An independent laboratory validation (TLV) for this method was
previously required by HED. These data have been submitted (MRID 47185401), and are
currently under review. Table 8 summarizes the analytical methodologies for acetamiprid.
Page 24 of 51
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Table 8. Summary of Analytical Methods for Acetamiprid.
Target Matrices
Vegetables and
Non-Citrus Fruits
• Citrus Fruits
Eggs, Milk, and
Ruminant and
Poultry Tissues
Method/
Method Description
GC/ECD Method
Methanol extraction, residues
partitioned into dichloromethane,
Florisil/silica gel column cleanup,
and GC/ECD determination
Proposed
HPLOMS/MS Method
HPLC'UV Method
Acetonitrile extraction,
coextractives partitioned into
hexane, residues partitioned into
dichloromethane, Florisil/C 1 8
column cleanup, and HPLC/UV
determination.
HPLC/UV Method
Aeetonitriie extraction, residues
partitioned into dichloromethane,
FIorisil/CI8 column cleanup, and
HPLC/UV determination. The
method determines both
acetamiprid and IM-2-1.
Validated for
Enforcement
Yes
The submitted
fLV for this
method is
currently
under review
Yes
Yes
LOQ
(PP««)
0.010

0,050
0.010 ppm
(muscle,
fat, milk,
and eggs)
0.050
(liver and
kidney)
Method Validation
Fortification
levels (ppm)
0.010,0.050

O.OSO, 0.250
0.010,0,100
0.050, 0.500
Recovery
Range (%)
68-112

77-100
78-103
(acetamiprid)
81-109
(IM-2-1)
5.1.2 Metabolism and Degradates of Concern

The residue chemistry database for acetamiprid has been previously examined and can be found
in earlier RED memorandum (H.Bietlot, 11/16/2001, D278652; and, M.Doherty, 12/31/2001,
D264I54),

A comparison of the available acute toxicity data for the parent versus the metabolites indicates
that the metabolites IC-0, IM-Q, IM-2-1, IM-1-4, [M-l-2, are either similar, or less acutely toxic
than the parent. In subchronic feeding and mutagenicity studies the tested metabolites were
shown to be either equivalent to, or less toxic than the parent. The acute toxicity and
mutagenicity data indicate that the metabolite of concern in livestock, IM-2-1, is less toxic than
the parent and is of similar mutagenic potential to the parent. Subchronic studies were not
submitted to address the long-term toxicity of the IM-2-1 metabolite. Table 9 summarizes the
residues of concern (parent and metabolites) that will be considered for regulation.
Page 25 of 51
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Table 9. Summary of Metabolism Findings for Acetamiprid
Matrix
Target Crops
Livestock
Rotational Crops
Drinking Water
Residues of Concern
Risk Assessment
Acetamiprid
Acetamiprid and IM-2-1
(and 1M-2-1 -amide in ruminant muscle only)
Acetamiprid
Acetamiprid
Tolerance Expression
Acetamiprid
Acetamiprid and IM-2-1
None at this time
Not applicable
5.1.3 Drinking Water Residue Profile

The drinking water residues used in the dietary risk assessment were provided by EFED
(G.Orrick, 6/21/2005, D303582, and G.Orrick, 6/24/2007, D331596 and D336256), and were
incorporated directly into the dietary assessment. Acute and chronic estimates of drinking water
concentrations (EDWCs) in surface water were generated using the screening mechanistic
model, FIRST vl ,0 (Aug. 1, 2001). Ground water concentration estimates were generated using
the screening regression model SCI-GROW v2.3 f Jul 29, 2003). For the surface water
assessment, the application rate for citrus was used (0.25 Ib ai/acre, at 2 applications), which
represents the highest label rate for a single application of any currently registered or proposed
use of acetamiprid. For the groundwater assessment, the maximum application rate for tree nut,
was used which represents the highest label rate on a seasonal basis (0.72 Ib ai/acre/season,
applied in four applications at 0.18 Ib ai/acre). Concentrations of acetamiprid degradates were
not estimated since HED has determined that they are not of concern in drinking water. Because
the EDWCs are based on the highest application rates, the estimated concentrations can be
considered conservative. EDWCs are summarized in Table 10.
Table 10. Estimated Drinking Water Concentrations for Acetamiprid
Drinking Water Source
Surface water
Ground water
Maximum Use Pattern
Citrus fruit
Tree nut
Exposure Duration
Acute
Chronic
Acute and Chronic
EDWC
20.1 ppb
4.9 ppb
1 .6 ppt
Page 26 of 51
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5.1.4 Food Residue Profile
5.1.4.1 Crop Field Trials

Crop Field Trials

HED has reviewed the field trial data submitted to support the three subject petitions, 4F6833,
6F7051, and, 6E7163. The MRID's for the submitted studies are listed in Table 11 below. In an
earlier review, completed in connection with PP# OF6082 (M.Doherty, 12/2004, D264154) HED
noted a data gap associated with rotational crop storage stability. Since that time, these data have
been submitted (MRID 46729102) and reviewed and, therefore, are no longer considered a data
gap.
Table 11.
Summaiy of Field Trial Data Submitted in Connection with Petitions 4F6833, 6F7051, and6E7I63,
Petition
4F6833
6F705 1
6E7I63
Crop(s)
Cucurbit Vegetables (Crop Group 9)
Stone Fruits (Crop Group 12)
Tree Nuts (Crop Group 14)
Bulb vegetables (Crop Group 3)
Berries (crop group 13)
Edible Podded Legum Vegetables (Crop
Subgroup 6A )
Succulent Shelled Peas and Beans (Crop
Subgroup 6B)
Strawberry
Field Trial Data
MRID 46265701
MRID 46265702
MRID 46265703
MRID 46785503
MRID 46785502
MRID 46785504
MRID 46785504
MRID 470 13601
Cucurbit Vegetables, Stone Fruits, Tree Nuts
The data submitted to support the uses on the cucurbit vegetables crop group, the stone fruits
crop group, and the tree nuts crop group are adequate. Based upon submitted residue data, HED
has determined that a group tolerance in the stone fruits group can be established at 1.20 ppm,
(where the petitioner requested 1.2 ppm); and, a separate tolerance (0.20 ppm) in prune plum is
recommended, (where the petitioner requested 0.30 ppm). In addition, although the submitted
almond and pecan field trial data may be used to support use on pistachios, a separate tolerance
must be established in pistachios until the Code of Federal Regulations No. 40 is modified to
include pistachio in the crop group definition for tree nuts.

Processing data indicate that residues of acetamiprid may concentrate in dried prunes. Based
upon the average processing factor (2.9X) reported in the data, and the residue data for plum
(HAFT residue of 0.112), HED recommends a separate tolerance of 0.40 ppm in dried prune
plum.

Based upon the data submitted in connection with PP# 4F6833, HED recommends establishing
the tolerances for acetamiprid, per se, in/on the commodities listed below in Table 12.
Page 27 of 51
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Bulb Vegetables
Field trial data have been submitted on the representative commodities (bulb and green onions)
for Crop Group 3. While no residue decline data were submitted with the field trial data,
previously submitted residue decline data indicate that residues of acetamiprid do not increase
with increasing harvest intervals. Because the residues in the green onions exceeded those of the
bulb onions by more than 5x, HED does not recommend a single group tolerance, as requested
by the petitioner. Rather, HED recommends that tolerances be set on the individual crops in the
two pending bulb vegetable subgroups (i) a 0.02 ppm tolerance in bulb onion subgroup 3A; and
(ii) a 4.5 ppm tolerance in the green onion subgroup 3B.
Eddible Podded Legume Vegetables (Crop Subgroup 6A) and Succulent Shelled Pea and Beans
(Crop Subgroup 6B)
Adequate field trial data have been submitted on the representative commodities of the two crop
subgroups, 6A and 6B. Even though reported residues from representative commodities within
the 6B crop subgroup differed greater than the usual 5x limit, (i.e., 5.9x), HED can recommend a
single crop subgroup tolerance be set because the residues were all relatively low. Therefore,
HED recommends a 0.60 ppm acetamiprid tolerance in edible podded legume vegetables (Crop
Subgroup 6A) and a 0.40 ppm acetamiprid tolerance in succulent shelled pea and beans (Crop
Subgroup 6B).
Berries (Crop Group 13)
At the time of the review, HED determined that inadequate field trial data were submitted in
connection with the petition for a Berries group tolerance (Crop Group 13). The data submitted
for one of the two representative crops (a bushbeny crop for crop subgroup 13 A) were sufficient.
However, the data submitted for the other representative crop (a caneberry crop for crop
subgroup 13B) were inadequate. These data have already been submitted and currently are
under review (MRID 47224701). Based upon the adequate bushberry crop field trial data and
HED's preliminary review of the caneberry data, HED recommends that a 1.6 ppm tolerance for
berries (Crop Group 13) be established.

HED also recommends a separate 1.6 ppm acetamiprid tolerance be set in lingonberry, which is
pending to become a member of Crop Subgroup 13B.

Strawberry
Field trial data submitted for strawberries are adequate. Residue decline data submitted with the
strawberries indicate that acetamiprid residues decline with lengthened sampling intervals. The
submitted data on strawberries are also adequate to support acetamiprid tolerances on the
following crops: bearberries, bilberries, cloudberries, cranberries, muntries, and partridgeberries.
Since the establishment of a crop subgroup is pending for these crops (Crop Subgroup \ 3G),
HED currently recommends a 0.60 ppm tolerance be set in each commodity.

In its submission, the petitioner requested a tolerance for acetamiprid on lowbush blueberries,
and included this request in conjunction with its strawberry petition. HED notes that an
acetamiprid tolerance for lowbush blueberry would be covered by the recommended tolerance
Page 28 of 51
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for Berries (Crop Group 13). A summary of recommended tolerances for the commodities
associated with the three subject petitions is listed below in Table 12.

Based upon the submitted data, HED recommends establishing unconditional registrations and
tolerances for acetamiprid, per se, in connection with the three subject petitions. The
acetamiprid tolerances should be revised not only to reflect the HED recommended tolerance
levels, including individual and crop group tolerances while the establishment of various crop
groups is pending, but also to reflect the correct commodity definitions. A summary table of
proposed and recommended tolerances for acetamiprid associated with all three subject petitions
can be found in Appendix D, Table I.
5.1.4.2 International Residue Limits

There are no Codex, Canadian or Mexican MRL's established on the commodities associated
with these petitions.

5.1.4.3 Livestock Commodities

Adequate cattle feeding study data are also available to support the proposed uses of acetamiprid.
No poultry feed items are associated with this petition. The existing tolerances for residues in
livestock commodities are adequate to cover all uses associated with the present petitions.
Page 29 of 51
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Table 12. Summary of Crop and Crop Groups Recommended for Tolerances in Connection witli Subject Petitions
Petition No.
m
4F6833
PVtt
6F705 !
PP#
6E7163
Crop Group or Commodity
Recommended for Tolerance
Tree Nuts (Crop Group 14)
Pistachio
Almond, hulls
Fruit, stone, except plum, prune fresh
and dried (Crop Group 12)
Plum, prune, fresh
Plum, prune, dried
Vegetable, cucurbit group (Crop
Group 9)
Vegetable, legume, edible podded,
(Subgroup 6A)
Pea and bean, succulent, shelled
(Subgroup 6B)
Bushberry Subgroup I3B
Bulb Onion (Subgroup 3A)
Green Onion (Subgroup 3B)
Berry, group 1 3
Berries, low-growing, subgroup 1 3G
Recommended
Tolerance (ppm)
O.I
0,10
5.0
1.2
0.2
0.4
0.5
0.6
0,4
1.6
0.02
4.5
1.6
0.6
List of Commodities Included
almonds; beechnut; butternut; cashew; chestnut; chinquapin; filbert; brazil nut; hickory nut; maeadamia nut;
processed nutmeal (except petuiut); nuts; pecan; walnut
Pistachio
Almond, hulls
apricot; cherry (sweet and tart); nectarine; peach; plum; plum, ehickasaw; plum, damson; plum, Japanese
plum, prune; plum, prune, fresh
plum, prune, dried
balsam apple; balsam pear; cantaloupe; chayotc fruit: cucumber; cucumber, Chinese; gherkin, West Indian; gourd,
edible: melon; melon, citron; muskmelon; pumpkin; squash: squash, summer: squash, winter; watermelon;
waxgourd, Chinese
Bean, moth; bean, runner; bean, snap; bean, wax; bean, yardlong; jaekbean; longbean, Chinese; pea, dwarf; pea,
edible podded; pea, pigeon; pea, snow; pea. sugar snap; soybean, immature seed; swordbean.
Bean, broad; bean, lima succulent; cowpea: covvpea seed; pea, blackeyed; pea, English; pea, garden; pea, green;
jea, pigeon; pea, southern
Blueberry: currant: elderberry; gooseberry; huckleberry; Aronia berry; Buffalo currant; Chilean guava; European
aarberry; Highbush cranberry; Honeysuckle; Jostaberry; Juneberry; Lingonberry; Native currant; Salal: Sea
auckthorn
Onion, bulb; Fritillaria, bulb; Daylily, bulb; Garlic, bulb; Garlic, great headed, bulb; Garlic, Serpent, bulb; Lily,
bulb; Onion, Chinese, bulb; Onion, Pearl; Onion, potato, bulb; Shallot, bulb
Onion, green; Chive, fresh leaves; Chive, Chinese, fresh leaves; Elegans hosia; Fritillaria, leaves; Kurral; Lady's
,eek; Leek; Leek, wild; Onion, Beltsville bunching; Onion, fresh; Onion, macrostem; Onion, tree, tops; Onion,
Welsh, tops; Shallot, fresh leaves
Blackberry; blueberry; canebcrry; currant; elderberry: gooseberry; huckleberry; loganberry; raspberry
jearberry, bilberry, cloudberry, cranberry, munlries. partridgeberry, strawberry
Page 30 of 51
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5.2 Dietary Exposure/Risk Pathway

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute
and chronic dietary risk assessments, the risk is expressed as a percentage of the population
adjusted dose (PAD). The acute PAD (aPAD) is derived by dividing the selected acute dietary
dose (NOAEL) by the appropriate uncertainty and FQPA safety factors. The chronic PAD
(cPAD) is derived by dividing the selected chronic dietary dose (NOAEL) by the appropriate
uncertainty and FQPA safety factors. Typically. HED has dietary risk concerns when the
estimated exposure exceeds 100% of the aPAD and/or cPAD.
5.2.1 Dietary Exposure and Risk

Acute and chronic dietary risk assessments were conducted for acetamiprid using the Dietary
Exposure Evaluation Model (DEEM-FCID™, Version 2.03) which uses food consumption data
from the USDA's Continuing Surveys of Food Intakes by Individuals (CSFH, 1994-1996 and
1998). The acute and chronic dietary analyses are considered partially refined by the inclusion
of percent crop treated values and processing data. The full dietary analysis for the subject
peitions can be found in the HED memorandum Acelamiprid: Acute and Chronic Dietary
Exposure Assessments, 10/12/07, D335205.

The current acute and chronic dietary exposure assessments include existing uses and the
tolerances proposed by Nisso America Incorporated (representing Nippon Soda Company
Limited), and IR-4 associated with PP# 4F6833, 6F7051, and 6E7163. The recommended
tolerances incorporated into the dietary analysis are shown above in Table 12. These crops are
supported by adequate field trial data.

For the acute dietary assessment, field trial residues were refined when possible. If field trial
residues were reported below the limit of quantification (LOQ), HED assumed Vi LOQ (i.e.,
0.005 ppm). In certain cases where it was appropriate, HED translated field trial data from one
commodity to another (e.g., peaches to nectarines, or plum to apricots). Percent crop treated
estimates, which exist for only several of the subject crops (apples, broccoli, celery, lettuce,
pears, grapefruit, grapes, oranges, peppers, spinach, and tomatoes), were incorporated into the
acute dietary assessment as a refinement. Average percent crop treated values for apples and
oranges were applied to the chronic dietary assessment, and maximum percent crop treated
values were applied to the acute dietary assessment. Processing data is applied to the dietary
analysis in order to further characterize the effect (reduction or concentration) on pesticide
residues on a commodity as a result of various processing or preparation procedures (such as
washing, juicing, trimming, etc). Processing factors based on submitted studies were
incorporated into the acute dietary analyses for the following commodities: apple juice, orange
juice, grape juice, raisins, dried prunes, tomato paste, and tomato puree. For all other
commodities included in the acute assessment, the DEEM™ Version 7.87 default processing
factors were used. Those default factors were used for all processed commodities in the chronic
Page 31 of 51
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assessment except for dried prunes. Finally, tolerance level residues were also used for livestock
commodities.

As mentioned above, under Section 5.1.3, HED incorporated EDWCs directly into the DEEM™
FCID model for "water, direct, all sources" and "water, indirect, all sources." For the acute
assessment, an EDWC of 20.1 ppb was entered into the model, and for the chronic assessment,
the value of 4.9 ppb was used.
5.2.2 Exposure and Risk Characterization

The dietary analyses reflect all currently registered and proposed acetamiprid uses and indicate
that both the acute and chronic dietary exposure do not present a risk concern for HED for the
general U.S. population or any of population subgroup.

The most highly exposed population subgroup for both acute and chronic dietary exposure
durations is children 1-2 years old. Children 1-2 years old are exposed to approximately 35% of
both the aPAD and the cPAD. The general population is exposed to approximately 18% of the
aPAD and 9% of the cPAD. Dietary exposure and risk estimates are summarized below in Table
13.
Table 13. Summary of Dietary (Food •«• Water) Exposure and Risk for Acetamiprid
Population Subgroup
General U.S. Population
All Infants (< 1 year old)
Children 1-2 years old
Children 3-5 years old
Children 6-12 years old
Youth 13-19 years old
Adults 20-49 years old
Adults 50+ years old
Females 1 3-49 years old
Acute Dietary
(99.9* Perceotile)
Dietary Exposure
(mg/kg/day)
0.018258
0.026198
0.034993
0.024443
0.016024
0.0 111 52
0.011895
0.009593
0.009539
% aPAD
18
26
35
24
16
11
12
9.6
9.5
Chronic Dietary
Dietary Exposure
(mg/kg/day)
0.006186
0.014224
0.024647
0.016879
0.008748
0.004819
0.004189
0.004486
0.004414
%cPAD
8.7
20
35
24
12
6.8
5.9
63
6.2
Page 32 of 51
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5.2.3 Cancer Dietary Risk

HED has classified acetamiprid as "not likely to be carcinogenic to humans." Based upon this
classification, HED has determined there is no cancer risk associated with the proposed uses.
6.0 Residential (Non-Occupational) Exposure/Risk Pathway

Residential Handler Exposure

Product F4688 50WSP, which was assessed at the time PP^ 4F6833 was originally submitted for
review, is currently registered for use in commercial and residential settings (EPA stamped
approved 5/2007). The registration approval was based upon a draft occupational/residential risk
assessment. The draft assessment indicated that, based on the then proposed uses of F4688
50WSP, residential handler (and residential post-application) exposures were negligible.
Intended uses of F4688 50WSP included subterranean structure components during construction,
subterranean, and hard-to-reach structure components associated with post construction and
outdoor perimeter uses. In addition, the label specified that application was permitted by
licensed individuals only (also known as Pest Control Operators - PCO's), not homeowners.
The draft assessment also indicated that the occupational exposures were not of risk concern to
HED.

Even though this product is now registered, HED has included it in this assessment in order to
formalize its risk conclusions. HED continues to believe that no residential exposures result
from its use, and therefore, it does not present any residential risks concerns for HED.

HED previously conducted a residential assessment on acetamiprid products, such as the "Bait
GeT products for ant and cockroach control, used in a residential setting (2/17/2005; DP
304214). In this previous assessment, HED determined that the Bait products could result in
potential handler exposure. Since completion of the previous assessment, HED has selected a
new toxicological endpoint (10 mg/kg/day from the DNT study). Based upon the updated
toxicological endpoint, the recalculated residential handler risks from the bait products remain
below HED's level of concern (for both short-, and intermediate-term durations). A summary of
updated residential handler risks from the acetamiprid bait products is presented below in Table
14.

As discussed in its previous assessment cited above, HED believes that potential post-application
exposures from the "bait" products are negligible for the following reasons. First, HED does not
anticipate homeowners are likely to revisit the crack crevice or spot where the Gel Bait has been
applied, thereby minimalizing potential dermal or incidental oral exposure. Secondly, inhalation
exposure is expected to be minimal due to acelamiprid's low vapor pressure, and gel formulation
which further reduces the potential of acetamiprid to become airborne. Finally, gel bait products
contain a bittering agent, (Bitrex*), which is used to prevent ingestion by children and animals,
further reducing potential incidental ingestion. Based on these reasons, HED determined that a
Pas»e33of5l
-------
quantitative post-application exposure assessment was not required.
Table 14,
Short- and Intermediate-term Dermal Handler (Mtxer/Loadcr/Applicator) Exposure and Risk for Acetamiprid Bait and Gel
Products
Product
Acetamiprid (F5025) 15% products
(EPA Reg.Nos.: 8033-28;8033-29;
8033-30; and 8033-3 1 )
Acetamiprid (F5025) 35% products
(EPA Reg. Nos.: 8033-32; and
8033-35
Weight Fraction
(ai)"
0.0015
0.0035
Dermal Daily
Dosch
0.0283
0.0659
Absorbed Dermal Daily
Dosec (mg/kg/day)
0.00283
0.00659
MOE"
3500
1500
a. Weight Fraction (ai)- Fraction of active ingredient on product (0.0015 or 0.0035)
h. Daily Dermal Dose (ODD) =• [ weight fraction (0.15% ai or 0.35% ai) x formulation density (1.0 g/cm1) x conversion factor
11.0 x I0! mg/g) x gel thickness (2.0 x 10"' cm) \ skin surface area (565 cm1)] / BW (60 kg)
c. Absorbed Daily Dermal Dose (mg/kg/day) = ODD x DA (0.10)
d. MOE= NOAEL (10 mg/kg/day)/ Absorbed Daily Dermal Dose (mg/kg/day)
6.1 Spray Drift

Spray drift is a potential source of exposure for residents living in close proximity to spraying
operations. This situation is particularly the case with aerial application. However, to a lesser
extent spray drift resulting from the ground application of acetamiprid could also be a potential
source of exposure. The Agency has been working with the Spray Drift Task Force (a
membership of US pesticide registrants), EPA Regional Offices, State lead Agencies for
pesticide regulation, and other patties to develop the best spray drift management practices. The
Agency is now requiring interim mitigation measures for aerial applications that must be placed
on product labels/labeling. The Agency has completed its evaluation of the new database
submitted by the Spray Drift Task Force, and is developing a policy on how to appropriately
apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied
by air, orchard airblast, and ground hydraulic methods. After the policy is in place, the Agency
may impose further refinements in spray drift management practices to reduce off-target drift
and risks associated with pesticide application.
7.0 Aggregate Risk Assessment and Risk Characterizations

Consistent with FQPA, HED considers aggregate risk to a pesticide from the three major routes
(dermal, oral, and inhalation) when potential residential exposures exist. In its acetamiprid
aggregate assessment, HED combined dietary (food +• water) and non-dietary (residential
handler) exposure sources to obtain an estimated aggregate exposure. When aggregating
exposures and risks from various sources, HED considers both the route and duration of
exposure. Based upon the residential use pattern of acetamiprid products, HED has determined
that acute, short-term, intermediate-term and chronic aggregate risk assessments are appropriate.
Page 34 of 51
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7.1 Acute Aggregate Risk

The acute aggregate risk is equal to the acute dietary exposure via food and drinking water, and
therefore is identical to the exposure and risk characterization found in Section 5.2.2. The acute
aggregate risks for acetamiprid are less than 100% of the aPAD for all population subgroups and,
therefore, do not pose a risk concern for HED.
7.2 Short-Term and Intermediate-Term Aggregate Risk

Short-term aggregate risk is based on the chronic (average) dietary exposure (food + water)
combined with short-term residential exposure. Intermediate-term aggregate risk is based on the
chronic (average) dietary exposure combined with intermediate-term residential exposure.

As noted above, HED does not believe that the uses of F4688 50WSP result in either handler or
post-application residential exposures. However, other currently registered acetamiprid
products, such as "bait" products have residential (handler) exposures. HED incorporated the
(high-end) residential handler exposure estimates from the "bait" products into the short-term
and intermediate-term aggregate assessment (see Table 14, above).

Because the short-term and intermediate-term dermal exposures and endpoints are the same, the
short-term and intermediate term residential risks are also the same. Consequently, short-term
and intermediate-term aggregate risks are identical.

HED assessed short-term and intermediate-term aggregate risk to the population subgroups it
believes are most likely to be exposed to acetamiprid from residential uses, i.e., "adults 20 - 49
years" and "adults 50+ years." Estimated short-term and intermediate-term aggregate risks do
not pose a risk concern to HED (MOE > 100), and are summarized below in Table 15.
Page 35 of 51
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Table 15. Acetamiprid Short- and Intermediate— term Aggregate Risk Calculations
Population
Subgroup1
Adults 20 - 49
years old
Adults 50+ years
old
Dietary
Exposure1
(mg/kg/day)
0.004189
0.004486
Dietary MOE
2400
2200
Residential
Dermal
Exposure4
0.00659
0.00659
Residential
Dermal
MOE5
1500
1500
Aggregate
MOE6
930
900
1. Population subgroup chosen was adults 20 - 49 yrs old and 50+ years since these individuals would likely handle
Bait products.
2. Dietary exposure = [food exposure •*• drinking water exposure] taken from Table 13,
3, Dietary MOE = short-term, and intermediate-term incidental oral NOAEL (10 mg/kg/day) •*• average dietary
exposure (mg/kg/day) from DEEM
4. Residential dermal exposure estimated for adults who handle Bail products. Table 14.
5. Residential dermal MOE = short-, and intermediate-term NOAEL {10 mg/kg/day) +• residential dermal exposure
(mg/kg/day).
6. Aggregate MOE : since short-, and intermediate term incidental oral endpoint and short-,and intermediate dermal
endpoints are the same, the exposures from these two routes can be added. Therefore, aggregate MOE= NOAEL [10
mg/kg/day]) + dietary exposure + residential dermal exposure.
7.3 Chronic Aggregate Risk

The dietary exposure pathway (food and drinking water) is the only source of chronic exposure
to acetamiprid (i.e., 180 consecutive days or more). Therefore, the chronic aggregate exposure
and risk estimates are equivalent to the chronic dietary exposure and risk estimates discussed in
Section 5.2.2 above. The chronic aggregate risks for acetamiprid are less than 100% of the
cPAD for all population subgroups and, do not pose a risk concern for HED.
8.0 Cumulative Risk Characterization/Assessment

FQPA (1996) stipulates that when determining the safety of a pesticide chemical, EPA shall base
its assessment of the risk posed by the chemical on, among other things, available information
concerning the cumulative effects to human health that may result from dietary, residential, or
other non-occupational exposure to other substances that have a common mechanism of toxicity.
The reason for consideration of other substances is due to the possibility that low-level exposures
to multiple chemical substances that cause a common toxic effect by a common mechanism
could lead to the same adverse health effect as would a higher level of exposure to any of the
other substances individually. A person exposed to a pesticide at a level that is considered safe
may in fact experience harm if that person is also exposed to other substances that cause a
common toxic effect by a mechanism common with that of the subject pesticide, even if the
individual exposure levels to the other substances are also considered safe.

Acetamiprid is a member of the neonicotinoid class of pesticides which also includes
thiamethoxam, clothianidin, imidacloprid and several other active ingredients. Structural
Page 36 of 5!
-------
similarities or common effects do not constitute a common mechanism of toxicity. Evidence is
needed to establish that the chemicals operate by the same, or essentially the same sequence of
major biochemical events (EPA, 2002). Although the neonicotinoids bind selectively to insect
nicotinic acetylcholine receptors (nAChR), the specific binding site(s)/receptor(s) are unknown
at this time. Additionally, the commonality of the binding activity itself is uncertain, as
preliminary evidence suggests that clothianidin operates by direct competitive inhibition, while
thiamethoxam is a non-competitive inhibitor. Furthermore, even if future research shows that
neonicotinoids share a common binding activity to a specific site on insect nicotinic
acetylcholine receptors, there is not necessarily a relationship between this pesticidal action and a
mechanism of toxicity in mammals. Structural variations between the insect and mammalian
nAChRs produce quantitative differences in the binding affinity of the neonicotinoids towards
these receptors, which, in turn, confers the notably greater selective toxicity of this class towards
insects, including aphids and leafhoppers, compared to mammals. Additionally, the most
sensitive toxicological effect in mammals differs across the neonicotinoids (e.g., testicular
tubular atrophy with thiamethoxam; mineralized particles in thyroid colloid with imidaclopid).
Thus, there is currently no evidence to indicate that neonicotinoids share common mechanisms
of toxicity, and EPA is not following a cumulative risk approach based on a common mechanism
of toxicity for the neonicotinoids. In addition, acetamiprid does not appear to produce a toxic
metabolite produced by other substances. Therefore, for the purposes of this tolerance action,
EPA has not assumed that acetamiprid has a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the
policy statements concerning common mechanism determinations and procedures for cumulating
effects from substances found to have a common mechanism released by EPA's Office of
Pesticide Programs on EPA's website at littp:''/w\v\v;epa,gov/pesticides/cuinulative/.
9.0 Occupational Exposure/Risk Pathway

9.1 Agricultural Handlers and Pesticide Control Operators

No chemical-specific data for assessing handler exposures were submitted to the Agency in
support of the proposed uses associated with the three subject petitions. Therefore, when
estimating occupational exposures, HED used surrogate data from the Pesticide Handlers
Exposure Data Base (PHED) vl.l, Outdoor Residential Exposure Task Force (ORETF) data, and
standard assessment variables established by the Health Effects Division Science Advisory
Council for Exposure (e.g. maximum application rates, standard acres treated per day, 70 kg
body weight for workers, and standard protection factors assumed with specified personal
protective equipment). The estimated exposures are believed to be reasonable high-end
estimates.

Based on the anticipated application practices for the Assail® 70WP and Assail® 30 SG
products, and the currently registered F4688 50WSP product label, as well as information
provided by the registrant, HED anticipates that handler exposures are of short- and
Page 37 of 51
-------
intermediate-term duration. Table 16 below summarizes che proposed personal protective
equipment for each label and associated occupational exposure scenario conducted for each
label/formulation/use.
Table 16. Summary of Exposure Scenarios Assessed and PPE as Stated on the Proposed Labels
Exposure I
Scenario
Assessed
Mixer/Loader

Applicator
I

Flagger
1
Mixer/Loader/
Applicator
Product/
Formulation
Wettable Powder
Assail® 70 WP
soluble granule
Assail®30 SG

Formulation is nol
relevant to applicator
exposure
Assail* 70 WP
Assail<«30 SG
A pp. Methods
Assessed
groundboom
airblasl
aerial
groundboom
air blast
aerial

groundboom,
airblast,
aerial

Formulation is not
relevant to applicator
exposure
Assail* 70 WP
Assai!®30 SG

Liquid, and
Water Soluble
Packets.
F4688 50 WSP
Insecticide
Termiticide
,
groundboom,
jirbiast,
jenat

low pressure hand
wand;
handgun sprayer,
injector;
foam application;
sprinkling can
hose-end sprayer
Use Sites
Cucurbits, stone fruits,
legumes, peas and beans, berry,
including strawberry and bulb
vegetables

Cucurbits, stone fruits,
legumes, peas and beans, berry.
including strawberry and bulb
vegetables

Cucurbits, stone fruits.
legumes, peas and beans, berry.
including strawberry and bulb
vegetables

Outdoor pests, ants, termite
control
PPE Specified on Proposed Label
- long pants, long-sleeved shirt, shoes plus
socks;
- waterproof gloves.
- chemical resistant headgear for overhead
exposures
- 12 hour Restricted Entry Interval (RED

- long pants, long-sleeved shirt, shoes plus
socks;
- chemical resistant gloves (for mixing).
- after the product is diluted, or when using
closed system, or in-line system, handlers must
wear shirt, pants, shoes plus socks, and water
proof gloves.
- respitory protection and protective eyewear
when working in a non-ventilated space or
applying by rodding or sub-slab injection.
- No Restricted Entry Interval (REI) is
specified
9.2 Handler and Pesticide Control Operator Risk Characterization

Since both dermal and inhalation endpoints for occupational exposures were the same, the route
specific exposure values were combined to calculate a total exposure which was compared to the
NOAEL (10 mg/kg/day from the DNT) to determine the MOEs. Estimated exposures for all
scenarios of the three product labels do not present a risk concern to HED when the PPE stated
on the proposed label is assumed. That is, exposures to agricultural handlers associated with the
Page 38 of 51
-------
proposed uses on Assail® 70WP, and Assail® 30SG are not a risk concern to HED provided
handlers obey the persona! protection directions specified on the proposed labels. Likewise,
exposures to PCO's from the labeled uses of F4688 50WSP are not a risk concern to HED
provided PCO's obey the personal protection directions specified on the label. An expanded
table of handler MOEs is attached as Appendix B.

9.3 Post-application Exposure and Risk

No chemical specific post-application data were submitted in support of the subject petitions.
Therefore, exposures during post-application agricultural activities were estimated using dermal
transfer coefficients from the Science Advisory Council for Exposure SOP Number 3.1., and
standard assumptions with respect to dislodgeable residues. Both short-term, and intermediate-
term post-application MOEs were greater than 100 on day zero after application and, do not
present a risk concern to HED. However, as per the Worker Protection Standard, (WPS), a
restricted entry interval (REI) of 12 hours is required based on the acute toxicity of acetamiprid
technical material which is classified as Category III and IV for acute dermal, dermal irritation,
and eye irritation. Therefore, the 12-hour REI which appears on the proposed labels Assail®
70 WP. and Assail® 30SG is adequate. A summary of post-application MOEs is provided below
in Table 17.
Table 1 7. Post-application Risks for Acetamiprid
Crop
Stone Fruits
Cucurbit
Vegetables
Bulb
Vegetables
Tree nuts
Legumes
Low Berry
High Berry
App.
Rate
0.15
Ib ai/A
0.10
Ib ai/A
0.15
Ib ai/A
0.18
Ib ai/A
O.I Ibai/a
Contact Activity
Potential
tow
high
low
high
low
high
low
high
low
high
low
high
low
high
Propping, scouting, irrigation, and
hand harvesting
Thinning
Scouting, thinning, irrigation and
hand weeding
Leaf pulling, turning, thinning, hand
harvesting and pruning
Irrigation, scouting, thinning, and
hand weeding
Hand harvesting
Scouting, thinning, and irrigation
Thinning, hand harvesting and
pruning
Scouting, irrigation, hand weeding ,
and thinning
Hand harvest
Pruning, thinning, and scouting
Hand pruning and harvesting
Hedging, irrigation, hand weeding
Transfer
Coefficient Value
1,500
3,000
1,500
2,500
300
2,500
500
2,500
100
2,500
400
1.500
500
Hand harvest, pruning, training, tying 5,000
MOE2 At Day
Zero
1500
750
2,200
1,300
7,700
910
3,700
740
33,000
1,300
8.300
2.200
6,700
670
The information in the table is based on proprietary and non-proprietary data.
I: daily dose = [BFR (tig/cm2) x Tc (cnr/tir) x 0.001 mg/ug x dermal absorption (O.I) x 8 hrs/day) *• body weight (60
2: NOAEL'Daily Dose (Short- and Intermediate-term NOAEL = 10 nig/kg/day)
kg)
Page 39 of 51
-------
10.0 Data Needs, Deficiencies, and Label Recommendations

Directions for Use:
Current labels for use on berries, bulb vegetables, edible podded legume vegetables, succulent
shelled beans, and peas, or strawberries and other low-growing berries should be amended to
remove directions regarding the use of surfactants. The field trials submitted to support these
crops were not conducted with surfactants, and the labels should be amended to be consistent
with the field trial data.

Petition for Tolerances for "Combined" Residues:
The tolerance expression proposed by IR-4 with respect to strawberry, bearberry, bilberry,
blueberry (lowbush), cloudberry, cranberry, lingonbery, muntries, and, pattridgeberry should be
revised to exclude the word "combined." HED has determined that combined residues of
acetamiprid and its IM-2-1 metabolite are only valid with respect to residues in livestock
commodities,

Unconditional Registrations:
HED recommends unconditional registrations for the following proposed uses:
Tree nuts,
Cucurbit vegetables.
Stone fruit,
Edible podded legume vegetables (crop subgroup 6A)
Succulent shelled peas and beans (crop subgroup 6B)
Bulb vegetables (crop subgroups 3A, and 3B)
Berries (crop subgroup OBand I3G)

Tolerances:
HED recommends tolerances for acetamiprid be established as specified in Appendix D, Table 1.
Page 40 of 51
-------
Appendix A. References

Acetamiprid. Acute and Chronic Dietary Exposure Assessments to Support Section 3
Registration of Uses on Tree Nuts; Cucurbits; Stone Fruit; Legumes (Subgroup 6A); Pea and
bean (Subgroup 6B); Berry (Subgroups 13B and I3G); and Bulb vegetables (Subgroups 3 A and
3B). October 12, 2007; D335205.

Acetamprid: Occupational/Residential Exposure and Risk Assessment for Proposed Food Use
on Stone Fruits, Cucurbit Vegetables, Tree Nuts, Berries, Bulb Vegetables, Edible Podded
Legumes and Succulent Shelled Peas and Beans and Insectictde/Termitieide Uses, October 23,
2007; Z.Figueroa, M.Collantes; D345240.

Acetamiprid: Occupational and Residential Exposure Assessment for Proposed Section 3
Registration for General Pest Control Uses. 02/17/05; D304214.

Acetamiprid. Tolerance Petition Requesting Section 3 Registration for Food Use of the
Insecticide on Cucurbit Vegetables (Crop Group 9), Stone Fruits (Crop Group 12), and Tree Nuts
(Crop Group 14). Summary of Analytical Chemistry and Residue Data. Petition Number
4F6833. 11/5/2004; W.T.Drew; D303623.

Acetamiprid. Petitions Requesting the Establishment of Permanent Tolerances (Associated with
Section 3 Registration) for New Food/Feed Uses of the Insecticide on Berries (Crop Group 13),
Bulb Vegetables (Crop Group 3), Edible Podded Legume Vegetables (Crop Subgroup 6A),
Succulent Shelled Pea and Bean (Crop Subgroup 6B), and Strawberry and Other Low-growing
Berries. Summary of Analytical Chemistry and Residue Data. Petition Numbers 6F7051
(Various Crops) and 6E7163 (Strawberry). 10/23/2007; W.T.Drew; D3282I6.

Tier I Drinking Water Exposure Assessment for Acetamiprid on Cucutbit, Stone Fruit, and Tree
Nut Crop Groups. June 21,2005; G.Orrick; D303582.

Acetamiprid New Uses (Bulb Vegetables, Succulent Legumes, Strawberries, and Other Berries):
Transrnittal of Tier I Drinking Water Exposure Assessment. July 24, 2007; D331596, and
D336256.
Pa»e 41 of 51
-------
Appendix B. Occupational Exposure and Risk Table
Appendix B, Table 1 Occupational Handler Exposure and Risk for Proposed Uses of Acetamiprid
Exposure
Scenario
Crop
Mtigation
Level
Dermal
Unit
Exposure
(mg/lb
a.i.)
Inhalation
Unit
Exposure
(mg/lb
a.i.)
Maximum
Application
Rate
{Ib a.i./A)
Area
Treated
(A/Day)
Dermal
Dose
(nig/kg/day)
Inhalation
Dose
(mg/kg/day)
Total Dose
(mg/kg/day)
Total
MOE
MIXER/LOADER
Groundboom
Wettable Powder
Groundboom
Soluble Granule
Airblast
Wettable Powder
Airblast
Soluble Granule
Aerial
Wettable Powder
Aerial
Soluble Granule
Curcurbits,
berries,
legumes
Bulb
vegetables
Curcurbits,
berries,
legumes
Bulb
vegetables
Stone fruit
Tree nuts
Stone Fruit
Tree nuts
Curcurbit,
berry, legume
Stone fruit,
bulb
vegetables
Tree nut
Curcurbit,
berry, legume
Stone fruit,
bulb
^vegetables
Tree nut
Baseline
Single layer
& Gloves
Baseline
Single layer
& Gloves
Single layer
& Gloves
3.7
0.066
3.7
0.066
0.17
0.066
.043
0.00077
0.043
0.00077
0.043
0.00077
0.1
0.15
0.1
0.15
0.15
0.18
0.15
0.1S
O.I
0.15
0.18
O.I
0.15
0.18
80
40
350
350
0.04933
0.074
0.00088
0.00132
0.037
0.0444
0.00066
0.000792
0.009917
0.0148
0.01785
0.00385
0.005775
0.00693
0.005733
0.0086
0.0001
0.000154
0.0043
0.00516
0.000077
0.00000924
0.025
0.0376
0.04515
0.000449
0.000674
0.0008
0.055
0.0826
0.00098
0.00147
0.0413
0.04956
0.000737
0.00084
0.035
0.0525
0.063
0.004299
0.006445
0.007739
180
120
10,000
6,800
240
200
14,000
11,000
290
190
160
2,300
1600
1,300
Page 42 of 51
-------
Appendix B, Table 1 Occupational Handler Exposure and Risk for Proposed Uses of Acetiimiprid
Exposure
Scenario
Crop
Mligalion
Level
Dermal
Unit
Exposure
(nig/lb
a.i.)
Inhiilution
Unit
Exposure
(ing/lb
a.!.)
Maximum
Application
Rate
(Ib a.i./A)
Area
Treated
(A/Day)
Dermal
Dose
(ing/kg/day)
Inhalation
Dose
(ing/kg/day)
Total Dose
(mg/kg/day)
Total
MOE
APPLICATOR
Gruundboom
Airblasl
Aerial
Flagger
Curcurbit,
berry, legume
Bulb
vegetables
Stonefruit
Tree Nut
Curcurbit,
berry, legume
Bulb Veg.
Stone Fruit
Tree Nut
Curcurbit,
berry, legume
Bulb Veg.,
Stone Fruit
Tree Nut
Single layer
& Gloves
Baseline
Engineering
Controls
Baseline
0,014
0.36
0.005
0.0 II
0.00074
0.0045
0.000068
0.00035
O.I
0.15
0.15
0.18
O.I
0.15
0.18
O.I
0.15
0.18
80
40
350
. _
0.000187
0.00028
0.0036
0.00432
0.00029
0.00044
0.000525
0.000642
0.00096
0.001155
0.000098
0.000148
0.0004S
0.00054
3.9E-5
5.9E-5
7.IE-5
0.0002
0.0003
0.000368
0.000285
0,000430
0.00405
0.00486
0.00033
0.000497
0.00059
0.000846
0.00127
0.001523
35,000
23,000
2500
2100
30,000
20,000
17,000
12,000
7900
6600
MIXER/LOADER/APPLICATOR
Liquids for Low
Pressure
liandwitnd
(ORETF data
surrogate for
WSP)
Water Soluble
Packets for
Handgun Sprayer
(LCD ORETF)
Liquids w/
Injector
Outdoor pest,
ant, termite
control
Outdoor pest,
ant, termite
control
Termiticide
Baseline
Single
Layer,
Gloves
15
0.64
0.36
0.0027
0.0072
0.0022
0.0043
(Ib ai/gal)
40
gats/day
100
gals./day
1000
gul/ Jay
0.0043
0.00046
0.00258
0.0000077
0.0000516
0.000158
0.0043
0.00051
0.00274
2300
20,000
3700
Page 43 of 51
-------
Appendix B, Table 1 Occupational Handler Exposure and Risk for Proposed Uses of Aeetamiprid
Exposure
Scenario
Crop
Mtigation
Level
Dermal
Unit
Exposure
(mg/lb
a.i.)
Inhalation
Unit
Exposure
(tng/lb
a,i.)
Maximum
Application
Rate
(Ib ti.UA)
Area
Treated
(A/Day)
Dermal
Dose
(mg/kg/day)
Inhalation
Dose
(mg/kg/day)
Total Dose
(mg/kg/day)
Total
MOF
MlXER/LOADER/APPLiCATOR (continued}
Water Soluble
Packets for Foam
Application (using
PHED data for
low pressure
handwand)
Liquids with u
Paint Brush
Liquids with
Sprinkling Can
(ORETF hose-end
data as surrogate
for WSP)
Liquids with
Hose-end Sprayer
(ORETF data as
surrogate for
WSP)
Ant control,
Tenniticide
Outdoor pest,
unt control
Single
Layer,
Gloves
Baseline
8.6
ISO
5
I.I
0.2SO
0.017
0.0043
(Ibai/gul)
40
gals/day
2
_ga|s/dajL
10
gals/day
100
gals/day
0.00247
0.00258
0.00036
0.00358
0.0032
0.00004
0.000012
0.000122
0.0056
0.00262
0.000371
0.0037
1800
3800
27,000
2700
Dermal Dose (mg/kgAJuy) = Rale (Ib ai/A) x UE (me /Ib ai ) x PAiMLAj^VcresTreuJtfd iAAjaylojrJjtaj/di»yj
BW (60 kg)
2; Inhalation Dose (mu/kg/tiay) - SMtellh.ii.i/Al x 111- (mg /jh aj i x_ Acres I'rculcd tA/duy) nr tgal/tkiv 1
BW (60 kg)
5: Total Dtise (mg/kg/day) Dermal Dose (i»g/kg/day) + Inhalation Dose (mg/kg/day)
6: Total MOl: '• NOAI-I. (10 mg/kg/day)/'I'otul Dose (mg/kg/day)
Page 44 of 51
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Appendix C. Acetamipritl Toxicology Assessment

Toxicity Profile for Acetamiprid
Appendix C, Table I.
Acute Toxicity of Technical Acetamiprid
GDLN
870.1100
870.12
870,13
870.24
870.25
870
Study Type
Acute Oral - rat
Acute Dermal - rat
Acute Inhalation - rat
Primary Eye Irritation - rabbit
Primary Skin Irritation - rabbit
Dermal Sensitization - Guinea pig
\IR1D
44651833
44651836
44651837
44651838
44651839
44651840
Results
LD»:2l7mg/kg(M>
LD50: 146mg/kg(F)
LD« > 2000 mg/kg
LCso:>1.15mg/L(~)
> l.l5mg/LH
Not irritating to the eye
Not irritating to the skin
Is not a sensitizer under
conditions of study.
TOT Category
II
III
III
IV
IV
N/A
Page 45 of 51
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Subchronic. Chronic and Ocher Toxicity Profile for Acetamiprid
Appendix C, Table 2.
Toxicity Profile of Technical Acetamiprid
Guideline NoJStudy Type
870.3100
I 3-Week feeding - rat
870.3100
1 3- Week feeding - mouse
870,3150
3-Month feeding - dog
8703200
21 -Day dermal toxicity - rabbit
870.3700
Developmental toxicity - rat
870.3700
Developmental toxicity - rabbit
870.3800
2-Generation reproduction - rat
870.4100
1 -Year oral - dog
870.4200
Carcinogenicity - mouse
870.4300
Chronie/'carcinogenicity - rat
870.5100
Salmonella typhimuriuiti'E. colt
Reverse gene mutation assay
Results
NOAEL; 12,4/14.6 mg/kg/day (M/F)
LOAEL: 50.8/56.0 mg/kg/day {M/F: decreased BW, BW gain and food
consumption).
NOAEL: 106.1/129.4 mg/kg/day (M/F)
LOAEL: 21 1.1/249.1 mg/kg/day (reduced BW and BW gain, decreased
glucose and cholesterol levels, reduced absolute organ weights).
NOAEL: 13/14 mg/kg/day (M/F)
LOAEL: 32 mg/kg/day (reduced BW gain in both sexes).
NOAEL: 1000 mg/kg/day (HDT)
LOAEL: >1000 mg/kg/day
Maternal NOAEL: 1 6 mg/kg/day
Maternal LOAEL: 50 mg/kg/day (reduced BW & BW gain and food
consumption, increased liver weights).
Developmental NOAEL: 16 mg/kg/day
Developmental LOAEL: 50 mg/kg/day (increased incidence of shortening
of the 1 3"' rib)
Maternal NOAEL: 1 5 mg/kg/day
Maternal LOAEL: 30 mg/'kg/day ( BW loss and decreased food
consumption).
Developmental NOAEL: 30 mg/kg/day (HDT)
Developmental LOAEL: > 30 mg/kg/day
Parental systemic NOAEL: 1 7.9/21 .7 mg/kg/day (M/F)
Parental systemic LOAEL: 51.0/60.1 mg/kg/day (M/F) (decreased body
weight, body weight gain and food consumption).
Offspring systemic NOAEL: 1 7.9/21 ,7 mg/kg/day (M/F)
Offspring systemic LOAEL: 5 1 .0/60. 1 mg/kg/day (M/F: reductions in pup
weight, litter size, viability and weaning indices; delay in age to attain
preputiai separation and vaginal opening).
Reproductive N'OAEL: 17.9/21.7 mg/kg/'day (M/F)
Reproductive LOAEL: 51.0/60.1 mg/kg/day (M/F: reductions in litter
weights and individual pup weights on day of delivery).
NOAEL: 20/21 mg/'kg/day (M/F)
LOAEL: 55/61 mg/kg/day (M/F: initial BW loss and overall reduction in
BW gain).
NOAEL: 20.3/75.9 mg/'kg/day (M/F)
LOAEL: 65.6/214.6 mg/kg/day (M/F: decreased BW &. BW gain and
amyloidosis in numerous organs (M) and decreased BW and BW gain (F)).
Not oncogenic under conditions of study.
NOAEL: 7.1/8.8 mg/'kg/day (M/F)
LOAEL: 17.5/22.6 mg/'kg/day (M/F, decreases in mean BW & BW gain (F)
and hepatocellular vacuolation (M))
Evidence of treatment-related increase in mammary tumors.
Not mutagenic under the conditions of the study.
Page 46 of 51
-------
Appendix C, Table 2.
Toxicity Profile of Technical Acetamiprid
Guideline No./Study Type
870.5300
Mammalian cells in culture
-orward gene mutation assay - CHO
cells
870.5375
In vitro mammalian chromosomal
aberrations - CHO cells
870.5385
In vivo mammalian chromosome
aberrations - rat bone marrow
970.5395
In vivo mammalian cytogenetics -
micronucleus assay in mice
870.5550
UDS assay in primary rat
liepatocytes/mammalian cell culture
870.6200
Acute neurotoxicity - rat
870.6200
Subchronic neurotoxicity - rat
870.6300
Developmental neurotoxicity study -
rat
N/A
28-Day feeding - dog
870.7485
Metabolism - rat
870.7485
Metabolism - mice, rats, rabbits
Special study
Results
Not mutagenic under the conditions of the study.
Acetamiprid is a clastogen under the conditions of the study.
Acetamiprid did not induce a significant increase in chromosome aberrations
in bone marrow cells when compared to the vehicle control group.
Acetamiprid is not a clastogen in the mouse bone marrow micronucleus test.
Acetamiprid tested negatively for UDS in mammalian hepatocytes in vivo.
NOAEL: lOmg/kg
LOAEL: 30 mg/kg (reduction in locomotor activity).
NOAEL: 14.8/16.3 mg/kg/day (M/F)
LOAEL: 59,7/67.6 mg-kg/day (M/F: reductions in BW, BW gain, food
consumption and food efficiency).
Maternal NOAEL: 1 0 mg/kg/day
Maternal LOAEL: 45 mg/kg/day, (decreased body weight and body weight
gains during gestation only)
Developmental NOAEL: 10 mg/kg/day
Developmental LOAEL: 45 mg/kg/day (decreased maximum auditory
startle response in males on PND 20 and PND 60, and decreased body
weight and body weight gain, and pup viability.
NOAEL: 16.7/19.1 mg/kg/day (M/F)
LOAEL: 28.0/35.8 mg/kg/day (reduced BW gain).
Extensively and rapidly metabolized. Metabolites 79-86% of administered
dose. Profiles similar for males and females for both oral and intravenous
dosing. Thirty-seven percent of dose recovered in urine and feces as
unchanged test article. Urinary and fecal metabolites from 15-day repeat
dose experiment only showed minor differences from single-dose test.
Initial Phase I biotransformation: demethylation of parent. 6-chloronicotinic
acid was the most prevalent metabolite. Phase II metabolism shown by the
increase in glycine conjugate.
Male mice, rats or rabbits were administered single doses of acetamiprid by
gavage, intraperitoneal injection (i.p.) or intravenous injection (i.v.) up to 60
mg/kg. The animals were assessed for a variety of neurobehavioral
parameters. In vitro experiments were also done using isolated ileum
sections from guinea pigs to assess contractile responses in the absence and
presence of agonists (acetyicholine, histamine diphosphate, barium chloride
and nicotine tartrate). Acetamiprid was also assessed via i.v. in rabbits for
effects on respiratory rate, heart rate and blood pressure; via gavage in mice
for effects on gastrointestinal motility; and via i.p. in rats for effects on water
and electrolyte balance in urine, and blood coagulation, hemolytic potential
and plasma cholinesterase activity. Based on a number of
neuromuscular, behavioral and physiological effects of acetamiprid in
Page 47 of 51
-------
Appendix C, Table 2.
Toxicity Profile of Technical Acetamiprid
Guideline No./Study Type

§ 870.7600
Dermal absorption
Results
male mice, under the conditions of this study, a overall NOAEL of 10
mg/kg (threshold) and LOAEL of 20 tng/kg could be estimated for a
single dose by various exposure routes.
Revised dermal absorption rate of 10% (from 30%) is based upon the dermal
absorption study with aceiamiprid (MRID 4465 \ 858) and consideration of
dermaJ penetration valyes from other neonicitinoid insecticides
(thiamethoxarn), and consideration of K«, and octanol/water coefficient data
of other neonicitinoid compounds (clothianidin).
Page 48 of 51
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Appendix D. Tolerance Summary Table for Petitions
Appendix D, Table 1 .
Tolerance Summary far Acetamiprid PP# 4F6833, PP#6F705l, and PP#6E?I63
Commodity
Proposed
Tolerance (ppm )
Rec om mended
Tolerance
(ppm)
Comments; Correct Commodity
Definition *
Proposed Tolerances
Almond hulls
Bulb vegetables crop group
(Group 3)
Edible podded legume
vegetables (Subgroup 6A)
Succulent shelled peas and
beans (Subgroup 68)
Berries crop group (Group
13)
Bearberry
Bilberry
Blueberry, lowbush
Cloudberry
Cranberry
Lingonberry
Muntries
Partridgeberry
Strav¥berry
5,0
3.0
0.5
0.5
i.O
0.60
0.60
0.60
0.60
0.60
0.60
0.60
0.60
0.60
5.0
Remove
0,60
0.40
1.6
0.60
0.60
Remove {not
needed).
0.60
0.60
1.6
0.60
0.60
0.60
Almond, hulls
Separate tolerances should be proposed
for the individual crops in the pending
green onion and bulb onion subgroups.
I'egetable, legume, edible podded,
subgroup 6A
Pea and bean, succulent shelled.
subgroup 6B
Berry, group 13
Tolerances on commodities included in
the pending low-growing berries
subgroup 13G.
Lowbush blueberry is already a member
of the berries group 13.
Tolerances on commodities included in
the pending low-growing berries
subgroup I3G.
Lingonberry is a member of the pending
bushberries subgroup I3B, for which a
higher tolerance is recommended.
Tolerances on commodities included in
the pending low-growing berries
subgroup 13G.
Page 49 of 51
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Appendix D, Table 1 .
Tolerance Summary for Acetamiprid PP# 4F6833, PP06F7051, and PPS6E7163
Commodity
Proposed
Tolerance (ppm)
Recommended
Tolerance
{ppm)
Comments; Correct Commodity
Definition *
Tolerances That Need to be Proposed
Aronia berry
Buffalo currant
Chilean guava
European barberry
Highbush cranberry
Honeysuckle, edible
Jostaberry
Juneberry
Native currant
Salal
Sea buckthorn
Onion, bulb
Fritillaria, bulb
Daylity, bulb
Garlic, bulb
Garlic, great headed, bulb
Garlic, Serpent, bulb
Lily, bulb
Onion, Chinese, bulb
Onion, Pearl
Onion, potato, bulb
Shallot, bulb
_
—
_.
„
..
—
~
—
—
—
..
—
—
„
~
—
_
_
„
—
_
_
1.6
1.6
.6
.6
,6
.6
.6
.6
.6
.6
,6
0,02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
Tolerances on commodities included in
the pending bushberries subgroup 13B,
along with lingonberry.
Tolerances on commodities included in
the pending bulb onion subgroup 3A.
Paec50of5!
-------
Appendix D, Table t.
Tolerance Summary for Acetamiprid PP# 4F6S33, PP#i»F?0§l, and PP#6E7163
Commodity
Onion, green
Chive, fresh leaves
Chive, Chinese, fresh leaves
Elegans hosta
Fritillaria, leaves
Kurrat
Lady's leek
Leek
Leek, wild
Onion, Beltsville bunching
Onion, fresh
Onion, macrostem
Onion, tree, tops
Onion, Welsh, tops
Shallot, fresh leaves
Stone Fruit group, except
prune plum
Fresh prune plum
Dried prune plum
Tree nut group
Pistachio
Cucurbit vegetable group
Proposed
Tolerance (ppm)
—
_
_
~
—
_
_
--
--
..
--
—
_.
„
-
1.2
0.30
0.30
0.10
None proposed
0.50
Recommended
Tolerance
(PPm)
4.5
4,5
4.5
4.5
4.5
4.5
4.5
4.5
4.5
4.5
4.5
4.5
4.5
4.5
4.5
1. 20
0.20
0.40
0,10
0.10
0.50
Comments; Correct Commodity
Definition *
Tolerances on commodities included in
the pending green onion subgroup 3B.
Fruit, stone, group 12 (except plum,
prune)
Proposed tolerance was too high.
Plum, prune, fresh
Proposed tolerance was too low.
Plum, prune, dried
\'ut, tree, group 14
Although tree nut field trial data may be
used to support use on pistachio, a
separate tolerance is needed for pistachio.
Pistachio
Vegetable, cucurbit, f*roup9
* Refer to HED Memorandum dated 6/14/2006 by Bernard Schneider for pending changes to crop groups, and
commodity definitions.
Page 51 of 51
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Acetamiprid Dietary Exposure and Risk Assessment DP No.: 335205
PC Code: 099050
"* UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460

OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
MEMORANDUM

DATE: October 12, 2007

SUBJECT: Acetamiprid. Acute and Chronic Dietary Exposure Assessments to Support
Section 3 Registration of Uses on Tree Nuts; Cucurbits; Stone Fruit; Legumes
(Subgroup 6A); Pea and bean (Subgroup 6B); Berry (Subgroups 13B and 13G);
and bulb vegetables (Subgroups 3A and 3B).

PC Code: 099050
Data Package No.: D335205
Petition Nos,: 4F6833; 6F7051; and 6E7163

REVIEWER: Christina Swartz, Chemist
Registration Action Branch 2
Health Effects Division (7509P)

THROUGH: Thurston Morton, Chemist
Mohsen Sahafeyan, Chemist
Dietary Exposure Science Advisory Council (DESAC)
Health Effects Division (7509P)

and

Richard Loranger, Ph.D., Branch Senior Scientist
Registration Action Branch 2
Health Effects Division (7509P)

TO: Thomas Moriarty, Env. Prot. Specialist
Registration Action Branch 2
Health Effects Division (7509P)
Executive Summary

Acute and chronic dietary (food + water) risk assessments were conducted using the Dietary
Exposure Evaluation Model (DEEM-FCID™, Version 2.03) which uses food consumption data

Page 1 of 28
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Acetamiprid Dietary Exposure and Risk Assessment DP No.: 335205
PC Code: Q99Q50
from the USDA's Continuing Surveys of Food Intakes by Individuals (CSFII, 1994-1996 and
1998). The analyses were performed to support the requested Section 3 registration of
acetamiprid on stone fruit, tree nut and cucurbit vegetables; a previous assessment (C. Swartz,
DP Barcode No. D309740, 10/28/2004) has been revised to reflect updated dose and endpoint
selection for acute and chronic dietary exposure and risk, as well as the incorporation of percent
crop treated (%CT) information. In addition, the current assessment includes additional
proposed uses on legumes, berries, and bulb vegetables; petitions for tolerances associated with
these uses were received before the previous assessment was completed, so the 2 actions have
been combined.

Acute Dietary (Food and Drinking Water) Exposure Results and Characterization

The probabilistic acute dietary exposure assessment included anticipated residues from field
residue trials, processing factors, maximum %CT estimates (for existing uses only) generated by
the Biological and Economic Analysis Division (BEAD), and the modeled peak concentration of
acetamiprid residues in surface water sources of drinking water. Although the acute assessment
has been refined, the resulting exposure estimates are still somewhat conservative because field
trial data were the basis for the anticipated residues, and because a lower tier drinking water
model (FIRST) was used to estimate residues in drinking water. No food or water monitoring
data were available to further refine the exposure estimates.

Acute dietary exposure estimates, based on the existing and proposed uses for acetamiprid, are
below HED's level of concern for the general US population and all other population subgroups.
The estimated exposure of 0.018 rag/kg/day for the general US population corresponds to 18%
of the acute population adjusted dose (aPAD); children 1-2 years old were the highest exposed
subpopulation, with an acute dietary exposure estimate of 0.035 mg/kg/day, or 35 %aPAD.

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization

For the chronic analysis, tolerance-level residues were assumed for all food commodities with
current and proposed acetamiprid tolerances; in addition, an assumption of 100 %CT was used
for all commodities except apples and oranges, for which the average %CT was used. The
chronic analysis also included the modeled surface water annual average residue in drinking
water. Even though %CT information was used in the chronic analysis, the exposure and risk
estimates are still conservative since tolerance level residues were used, because 100 %CT was
assumed for all crops other than apples and oranges, and because a lower tier drinking water
model (FIRST) was used.

Chronic dietary exposure to acetamiprid, including existing and proposed uses, is below HED's
level of concern for the US population and all other population subgroups. For the general US
population, and estimated exposure of 0.006 mg/kg/day corresponds to 9% of the chronic
population adjusted dose (cP AD); children 1 -2 years old were the highest exposed population
subgroup, with an estimate of 0.025 mg/kg/day, or 35 %cPAD. Risks for all population
subgroups are less than 100 %cPAD, and are not of concern.

Page 2 of28
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Acetamiprid Dietary Exposure Assessment DP No.: 335205
PC Code: 099050
I. Introduction
Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute
and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose
(i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).
This dose is referred to as the population adjusted dose (PAD). The PAD is equivalent to a point
of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk
exceeds 100% of the PAD. References which discuss the acute and chronic risk assessments in
more detail are available on the EPA/pesticides web site: "Available Information on Assessing
Exposure from Pesticides, A User's Guide," 6/21/2000, web link:
http://www.epa.gov/fedrgstr/EPA-PEST/2000/Julv/Dav-12/6061 .pdf: or see SOP 99.6 (8/20/99).

The most recent dietary risk assessment for acetamiprid was conducted by C. Swartz (DP
Barcode No. D309740, 10/28/04) which included proposed uses on tuberous and corm
vegetables as well as additional proposed uses on cucurbits, tree nuts and stone fruit. Tolerances
for residues in or on tuberous and corm vegetables were subsequently established under 40 CFR
§180.578(a).

II. Residue Information

Tolerances are established for residues of the insecticide acetamiprid [40 CFR §180.578(a)], Nl-
[(6-chloro-3-pyridyl)methyl]-N2-cyano-Nl- methylacetamidine, in or on canola, seed, 0.01 ppm;
mustard, seed, 0.01 ppm; citrus, dried pulp, 1.20 ppm; cotton, gin byproducts, 20 ppm; cotton,
undelinted seed, 0.60 ppm, fruit, citrus group, 0.50 ppm; fruit, pome group, 1.0 ppm; grape, 0.20
ppm; tomato, paste, 0.40 ppm; vegetable, Brassica, leafy, (group 5), 1.20 ppm; vegetable,
fruiting (group 8), 0.20 ppm; vegetable, leafy, except Brassica, (group 4), 3.00 ppm; tuberous
and corm vegetables (Group 1C), 0.01 ppm. Tolerances are established for the combined
residues of the insecticide acetamiprid, Nl-[(6-chloro-3-pyridyl)methyl]-N2-cyano-Nl-
methylacetamidine, and its metabolite Nl-[(6-chloro-3-pyridyl)methyl]-N2-cyano- acetamidine
[40 CFR §180.578(b)] in or on fat and meat of cattle, goat, hog, horse and sheep, 0.1 ppm; meat
by-products of cattle, goat, hog horse and sheep, 0.2 ppm; milk, 0.1 ppm; poultry meat and fat,
0.01 ppm; poultry liver, 0.05 ppm; and egg, 0.01 ppm.

The current acute and chronic dietary exposure assessments include existing uses and the Section
3 tolerances proposed by Nisso America Incorporated (representing Nippon Soda Company
Limited) associated with the proposed uses on tree nuts (Crop Group 14), Stone Fruit (Crop
Group 12), Cucurbits (Crop Group 9), Legumes (Subgroup 6A); Pea and Bean (Subgroup 6B);
Berry (Subgroups 13B and 13G); and Bulb Vegetables (Subgroups 3A and 3B). The
recommended tolerances shown below are supported by adequate residue data.
Page 3 of28
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Acetamiprid
PC Code: 099050
Dietary Exposure Assessment
DP No.: 335205
Crop Group or Commodity
Tree Nuts {Crop Group 14)
Pistachio
Almond, hulls
Fruit, stone, except plum, prune fresh and dried
(Crop Group 12)
Plum, prune, fresh
Plum, prune, dried
Vegetable, cucurbit group (Crop Group 9)
Vegetable, legume, edible podded, (Subgroup
6A)
Pea and bean, succulent, shelled (Subgroup 6B)
Berry, group 1 3
Berries, low-growing, subgroup 1 3G
List of Commodities Included
almonds; beechnut; butternut;
cashew; chestnut; chinquapin;
filbert; brazil nut; hickory nut;
macadamia nut; processed
nutmeat (except peanut); nuts;
pecan; walnut
Pistachio
Almond, hulls
apricot; cherry (sweet and tart);
nectarine; peach; plum; plum,
chickasaw; plum, damson; plum,
Japanese
plum, prune; plum, prune, fresh
plum, prune, dried
balsam apple; balsam pear;
cantaloupe; chayote fruit;
cucumber; cucumber, Chinese;
gherkin, West Indian; gourd,
edible; melon; melon, citron;
muskmelon; pumpkin; squash;
squash, summer, squash, winter;
watermelon; waxgourd, Chinese
Bean, moth; bean, runner; bean,
snap; bean, wax; bean, yardlong;
jackbean; longbean, Chinese;
pea, dwarf, pea, edible podded;
pea, pigeon; pea, snow; pea,
sugar snap; soybean, immature
seed; swordbean.
Bean, broad; bean, lima
succulent; cowpea; cowpea seed;
pea, blackeyed; pea, English;
pea, garden; pea, green; pea,
pigeon; pea, southern
Blackberry; blueberry;
caneberry; currant; elderberry;
gooseberry; huckleberry;
loganberry, raspberry
bearberry, bilberry, cloudberry
cranberry, muntries,
parttidgeberry, strawberry
Recommended Tol. (ppm)
0,1
0.1
5.0
1.2
0.2
0.4
0.5
0.6
0.4
1.6
0.6
Page 4 of28
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Acetamiprid
PC Code: 099050
Dietary Exposure Assessment
DP No.: 335205
Crop Group or Commodity
List of Commodities Included
Recommended Tol. (ppm)
Bushberry Subgroup 13B
Blueberry; currant; elderberry;
gooseberry; huckleberry; Aronia
berry; Buffalo currant; Chilean
guava; European barberry;
Highbush cranberry;
Honeysuckle; Jostaberry;
Juneberry; Lingonberry; Native
currant; Salal; Sea buckthorn
1.6
Bulb Onion (Subjpx>up 3A)
Onion, bulb; Fritillaria, bulb;
Daylily, bulb; Garlic, bulb;
Garlic, great headed, bulb;
Garlic, Serpent, bulb; Lily, bulb;
Onion, Chinese, bulb; Onion,
Pearl; Onion, potato, bulb;
Shallot, bulb
0.02
Green Onion (Subgroup 3B)
Onion, green; Chive, fresh
leaves; Chive, Chinese, fresh
leaves; Elegans hosta; Fritillaria,
leaves; Kurrat; Lady's leek;
Leek; Leek, wild; Onion,
Beltsville bunching; Onion,
fresh; Onion, macrostem; Onion,
tree, tops; Onion, Welsh, tops;
Shallot, fresh leaves
4.5
Acute Dietary Exposure Assessment

The acute dietary assessment was conducted using anticipated residues from field trials [apples;
broccoli; cabbage, celery; grapefruit; grapes; lettuce; oranges; pears; peppers; spinach; tomatoes;
stone fruit (crop group 12); and cucurbits (crop group 9)]. For each of the above-listed
commodities, the individual field trial residue values (from trials reflecting the IX application rate
and label PHI) were incorporated into a residue distribution file (RDF) for the probabilistic acute
dietary exposure assessment. For field trial residues below the limit of quantification (LOQ) of
0.01 ppm, a residue value of Vi LOQ, or 0.005 ppm was assumed. For cabbage and head lettuce,
residues in the RDF were for the raw agricultural commodity (RAC) without wrapper leaves. For
commodities with %CT data available, the RDF includes an indication of the number of zeroes
assumed for the percent of the commodity not treated. For the proposed uses on legumes, berries
and bulb vegetables, proposed tolerance level residues were used in the dietary assessment.
Tolerance level residues were also used for livestock commodities.

A summary of the rdfs is included in Attachment 1. The peach RDF was translated to nectarines,
the orange RDF was translated to grapefruit, and the plum RDF was translated to apricots. These
translations are appropriate since the field trials were conducted on the representative crops, and
cover potential residues in the related crops, and since no adjustment for %CT was made in these
RDFs.
Page 5 of 28
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Acetamiprid
PC Code: 099050
Dietary Exposure Assessment
DP No.: 335205
Chronic Dietary Exposure Assessment

For the chronic dietary exposure assessment, cuirent and recommended tolerance-level residues
were used, for all RACs and livestock commodities.

Processing Factors

The acute dietary exposure assessment was refined with processing factors for apple juice, orange
juice, grape juice, raisins, dried prunes, tomato paste and tomato puree. The processing factors
were reviewed in conjunction with residue data used to determine if separate tolerances were
needed for processed commodities. For all other commodities, the DEEM™ Version 7.81 default
processing factors were used. Processing factors from study data were incorporated into the acute
dietary assessment as follows (Table 1):
Table I . Summary of Processing Studies Conducted with Acetamiprid.
RAC
Apple
Citrus
Grape
Tomato
Plum
Processed Commodity
Juice
Juice
Juice
Raisins
Puree
Paste
Prune, dried
Processing Factor
0.88
<0.16
t
0.9
1.4
3.0
2.9X
Comments
Also used for pear juice
0. 1 6X used for both orange and grapefruit juice
Study data showed RAC tolerance would cover
residues in juice. 1 X factor used in acute assessment.
0.9X used in assessment
1 .4X used for puree in assessment
1 X used for paste in acute assessment, since there is a
separate tolerance for residues in paste.
1 X used for dried prunes used in acute assessment,
since there is a separate tolerance for residues in dried
prunes. The drying factor was translated to dried
apricots and dried peaches in the acute dietary
assessment.
For the chronic dietary exposure assessment, the DEEM™ Version 7.81 default processing
factors were used, with the exception of dried prunes, for which a separate tolerance is
recommended.

Usage Data

In order to refine the dietary exposure estimates for acetamiprid, HED requested a Screening
Level Usage Analysis (SLUA), which was conducted by the Biological and Economic Analysis
Division (BEAD), 7/7/05. The SLUA includes estimates of maximum %CT for the acute
assessment and average %CT for determining chronic exposure. Commodities with the most
significant acetamiprid usage in terms of maximum %CT include pears (25%), apples (15%),
celery (15%), and lettuce (10%). Commodities with the most significant usage in terms of Ibs ai
applied include apples (9,000), cotton (8,000), and pears (3,000). The SLUA is included as
Page 6 of 28
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Acetamiprid Dietary Exposure Assessment DP No.: 335205
PC Code: 099050
Attachment 3.

For the acute analysis, %CT was incorporated into RDFs for the following commodities:

• apples (15%), broccoli (5%), celery (15%), lettuce (10%), pears (25%)
• grapefruit, grapes, oranges, peppers, spinach and tomatoes, all at 2.5%.

For the chronic analysis, average %CT was included (as adjustment factor 2) for apples (10%)
and oranges (I %).

Incorporation of Potential Residues in Drinking Water

In conjunction with the proposed uses, the Environmental Fate and Effects Division (EFED) of
OPP prepared an estimate of potential residues in drinking water [G. Orriek, Tier I Drinking
Water Exposure Assessment for Acetamiprid on Cucurbit, Stone Fruit and Tree Nut Crop Groups,
6/21/05, D303582]. Estimated drinking water concentrations for acetamiprid in surface water
were generated using the FIRST (FQPA Index Reservoir Screening Fool, v. 1.0) model. The
results of the model reflect potential residues in a small drinking water reservoir surrounded by a
runoff-prone watershed, assuming maximum pesticide application rates and no buffer between the
reservoir and treated fields. Acetamiprid residues in ground water sources of drinking water were
estimated using the screening regression model SCI-GROW (Screening Concentration In Ground
Water, v. 2.3). The SCI-GROW residue estimate is based on environmental fate properties of the
pesticide, maximum application rates, and existing data from small-scale prospective ground-
water monitoring studies in vulnerable sites.

For surface water, the maximum application rate for the existing use of acetamiprid on citrus was
used to provide model estimates of drinking water concentrations; for ground water, the proposed
use on tree nut crops was used. However, since modeled surface water residues were
considerably higher than ground water residues, only the surface water residues were used
quantitatively in the dietary (food + water) assessment. In a memo dated 7/24/07 [G. Orriek,
D331596 and D336256], EFED notified HED that new drinking water estimates would not be
provided for the proposed use on bulb vegetables, legumes, strawberries and other berries because
the drinking water estimates derived from the uses on citrus and tree nuts reflect the maximum
use patterns for acetamiprid.

For the acute assessment, an estimated drinking water concentration of 20.1 ppb was entered into
the DEEM™-FCID model for "water, direct, all sources" and "water, indirect, all sources." For
the chronic assessment, the value of 4.9 ppb was used. The ground water estimate of 1.6 ppt was
much lower than surface water residues; therefore, dietary exposure and risk calculated using
surface water residues are considered protective of potential exposure through ground water.

III. Exposure Model and Consumption Information

Acetamiprid acute and chronic dietary exposure assessments were conducted using the Dietary

Page 7 of 28
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Acetamiprid Dietary Exposure Assessment DP No.: 335205
PC Code: 099050
Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-
FCID™,Version 2.03 which incorporates consumption data from USDA's Continuing Surveys of
Food Intakes by Individuals (CSFI1), 1994-1996 and 1998. The 1994-96, 98 data are based on the
reported consumption of more than 20,000 individuals over two non-consecutive survey days.
Foods "as consumed" (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples,
peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using
publicly available recipe translation files developed jointly by USDA/ARS and EPA. For chronic
exposure assessment, consumption data are averaged for the entire U.S. population and within
population subgroups, but for acute exposure assessment are retained as individual consumption
events. Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account
dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk
for the following population subgroups: the general U.S. population, all infants (<1 year old),
children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults
50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-
form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average
daily consumption estimate for that food/food form to produce a residue intake estimate. The
resulting residue intake estimate for each food/food form is summed with the residue intake
estimates for all other food/food forms on the commodity residue list to arrive at the total average
estimated exposure. Exposure is expressed in mg/kg body weight/day and as a percent of the
cPAD. This procedure is performed for each population subgroup.

For acute exposure assessments, individual one-day food consumption data are used on an
individual-by-individual basis. The reported consumption amounts of each food item can be
multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a
deterministic exposure assessment, or "matched" in multiple random pairings with residue values
and then summed in a probabilistic assessment. The resulting distribution of exposures is
expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating
relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant
commodities as well as those who did not) basis. In accordance with HED policy, per capita
exposure and risk are reported for all tiers of analysis. However, for tiers 1 and 2, any significant
differences in user vs. per capita exposure and risk are specifically identified and noted in the risk
assessment.

IV. Toxicologicai Information

Doses and endpoints selected for acute and chronic dietary exposure and risk assessments are
summarized as shown in Table 2, below. Details regarding hazard characterization and endpoint
selection can be found in the risk assessment associated with the proposed uses [ref. here].
Page 8 of28
-------
Acetamiprid
PC Code: 099050
Dietary Exposure Assessment
DP No.: 335205
Table 2. Acetamiprid Toxicological Doses/Endpoints for Dietary Risk Assessment.
Exposure
Scenario
Acute Dietary
f All Populations]
Chronic Dietary
1 [all populations]
Cancer (All
, routes)
Point of
Departure
NOAEL=10.0
mg/kg/day
NOAEL = 7. 1
mg/kg/day
Uncertainty/FQPA
Safety Factors
UFA- 10x
UFif= lOx
FQPASF= IK
Total UF=100X
UFA= lOx
UFH= lOx
FQPASF= Ix
Total UF=1 OCX
RfD, PAD, Level of
Concern
Acute RfD = 0,10
mg/kg/day
aP AD = 0.10
mg/kg/day
Chronic RfD =
0.071 mg/kg/day
cPAD = 0.071
mg/kg/day
Study and Toxicological
Effects
Developmental Neurotox., Rat
LOAEL = 45.0 mg/kg/day
based on decreased startle
response on PND20/60 in males
Co Critical study -
Acute Neurotox., Rat
LOAEL = 30 mg/kg/day based
on reduced locomotor activity in
males.
Chronic/oncogenicity, Rat
LOAEL= 17.5 mg/kg/day based
on reduced body weight and
body weight gain (?) and
hepatocellular vacuolation (o ).
Not likely to be a human carcinogen.
V.
Results/Discussion
As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds
100% of the PAD. For both the acute and chronic analyses, the estimated dietary exposures are
below HED's level of concern for all population subgroups; the most highly exposed population
subgroup for both acute and chronic durations is children 1 -2 years old.

Acute dietary exposure estimates at the 99.9th percentile are below HED's level of concern for the
general US population and all other population subgroups. For the US population, the estimated
exposure of 0.018 mg/kg/day corresponds to 18 %aPAD; for children 1-2 years old, the estimated
exposure of 0.035 mg/kg/day corresponds to an acute dietary risk of 35 % aPAD.

Chronic dietary exposure and risk are below HED's level of concern for the general US
population and all other population subgroups. For the general US population, an estimated
exposure of 0.006 mg/kg/day corresponds to 9 %cPAD. The most highly exposed population
subgroup, children 1-2 years old had an estimated exposure of 0.025 mg/kg/day, or 35 %cPAD.

The results of the acute and chronic analyses are shown in Tables 3 and 4.
Page 9 of 28
-------
Acetamiprid
PC Code: 099050
Dietary Exposure Assessment
DP No.; 335205
Table 3. Results of Acetamiprid Acute Dietary (Food + Water) Exposure Analysis.
Population Subgroup
General U.S. Population
All Infants (< 1 year old)
Children 1-2 years old
Children 3-5 years old
Children 6- 1 2 years old
Youth 13-19 years old
Adults 20-49 years old
Adults 50+ years old
Females 1 3-49 years old
aPAB
(ing/kg/day)
0.10
0.10
0,10
0.10
0.10
0.10
0.10
0.10
0.10
95* Pereendle
Exposure
(mg/kg/day)
0.005347
0.010857
0.013764
0.009699
0.006088
0.003534
0.003202
0.003168
0.003215
% aPAD
5.4
11
14
9.7
6.1
3.5
3.2
3.2
3.2
99th Percentile
Exposure
(mg/kg/day)
0.009821
0,018487
OJ 19750
0.014955
0.009418
0.005841
0.005199
0,005413
0.005205
% aPAD
9.8
18
20
15
9.4
5.8
5.2
5.4
5.2
99.9th Percentile
Exposure
(mg/kg/day)
0.018211
0.026037
0.034611
0.024339
0.016020
0.011135
0.011900
0.009595
0.009543
% aPAD
18
26
35
24
16
11
12
9.6
9.5
Table 4. Summary of Dietary (Food + Water) Exposure and Risk for Acetamiprid
Population Subgroup
General U.S. Population
All Infants (< I year old)
Children 1-2 years old
Children 3-5 years old
Children 6- 12 years old
Youth 13- 19 years old
Adults 20-49 years old
Adults 50+ years old
Females 13-49 years old
Acute Dietary
(99.9* Percentile)
Dietary Exposure
(mg/kg/day)
0.018211
0.026037
0.034611
0.024339
0.016020
0.011135
0.011900
0.009595
0.009543
% aPAD
18
26
35
24
16
11
12
9.6
9.5
Chronic Dietary
Dietary Exposure
(mg/kg/day)
0.006184
0.014228
0.024648
0.016880
0.008745
0.004820
0.004189
0.004481
0.004414
% cPAD
8.7
20
35
24
12
6.8
5.9
6.3
6.2
VI. Characterization of Inputs/Outputs

The acute dietary exposure assessment for acetamiprid is somewhat refined, since field trial
residue distributions were used in the probabilistic assessment, and percent crop treated
information was incorporated for some commodities. In addition, empirical processing factors for
various processed commodities, especially juices, provided an additional measure of refinement.
Page 10 of28
-------
Acetamiprid Dietary Exposure and Risk Assessment DP No.: 335205
PC Code: 099050
However, the assessment is still somewhat conservative because tolerance-level residues were
used for proposed uses and some of the existing uses, as well as livestock commodities.
Additional refinements could be made to the assessment with the use of additional field trial
residue data. Even though the acute probabilistic assessment has not been completely refined,
acute dietary exposure and risk estimates for acetamiprid are below HED's level of concern of
100%aPAD,

The chronic dietary exposure assessment is largely unrefined, with the exception of the use of
%CT data for apples and oranges. For all commodities, tolerance level residues were used, and
DEEM 7.81 default processing factors were applies. Further refinements are possible in the
future, including the use of average field trial residues, empirical processing factors and additional
%CT refinements.

VII. Conclusions

Acute and chronic dietary (food + water) risks for acetamiprid are below HED's level of concern
for dietary exposure and risk. Children 1-2 years old are the most highly exposed population
subgroup, with risks of 35 %aPAD and 35 %cPAD. Risks were lower for all other population
subgroups, including the general US population. The acute and chronic dietary exposure
assessments support the new uses proposed for acetamiprid.

VIII. List of Attachments

Attachment 1. Acetamiprid Residue Distribution Files
Attachment 2. Acetamiprid Screening Level Usage Analysis (SLUA)
Attachment 4. Acute Residue Input Files
Attachments Summary of Acute Results
Attachment 6. Chronic Residue Input File
Attachment 1'. Summary of Chronic Results
Page 11 of28
-------
Acetamiprid
PC Code: 099050
Dietary Exposure and Risk Assessment
DP No.: 335205
Attachment 1. Acetamiprid Residue Distribution Files
Acetamiprid/ Apple
TOTALZ=363
Esl. Max. %CT= 16
MRID No. 44988626
0.15,0.16,0.59,0.590.25
0.29,0.11,0.16,0.12,0.12
0.24,0.32,0.17,0.18,0.20
0.23,0.13,0.14,0.21,0.28
0.09,0.15,0.24,0.28,0.22
0.39,0.17,0.20,0.45,0.64
0.22,0.28,0.23,0.23,0.21
0.25, 0.30, 0.30, 0.25, 0.26
0.26,0.36,0.14,0.16,0.23
0.27,0.08,0.10,0.30,0.34
0.25,0.29,0.080.10,0.10
0.23,0.18,0.21,0.61,0.71
0.34,0.35,0.21,0.24
Acetamiprid/Cucurbit
Assume 100%CT
MRID No, 46265701
0.024,0.038,0.015,0.026
0.024, 0.030, 0.038, 0.045
0.082,0.091,0.017,0.019
0.070, 0.090, 0.035, 0.076
0.011,0.026,0.011,0.021
0.035,0.037,0.065,0.142,
0.091,0.094,0.075,0.136
0.053,0.068,0.166,0.221
0.004, 0.075
Acetamiprid/Orange
TOTALZ=2535
Est. max %CT=2.5
MRID No. 4498611
0.14,0.15,0.11,0.12,0.09
0.13,0.19,0.29,0.18,0.21
0.29,0.097,0.11,0.15,0.21
0.20, 0.20, 0.058, 0.084, 0.088
0.15,0.11,0.15,0,094,0.12
0.19,0.20,0.19,0.21,0.26
0.29,0.21,0.23,0.025,0.025
0.13,0.14,0.081,0.12,0.14
0.14,0.083,0.12,0.025,0.025,
0.025, 0.025, 0.025, 0.098
0.23,0.27,0.12,0.14,0.079
0.0%, 0.087, 0.12, 0.12, 0.16
0.31,0.37,0.16,0.31,0.26
0.39
Aceiamiprid/PIum
Assume 100%CT
TOTALZ=0
MRID No. 46265702
0.108,0.116,0.0648,0.119
0.0 1 39, 0.0238, 0.0 1 03, 0.0 1 54
0.0515, 0.0624, 0.0401, 0.0429
0.0305, 0.0458, 0.0258, 0.0392
Acetamiprid/Broccoli
Estimated max %CT = 5
TOTALZ=437
MRID No. 44988631
0.02,0.04,0.04,0.05,0.01
0.01,0.005,0.02,0.01,0.02
0.005,0.01,0.07,0.11,0.18
0.25,0.02,0.097,0.10,0.080
0.092,0.081,0.10
Acetamiprid/Grape
Estimated Max. %CT=2.5
TOT ALZ= 1092
MRID No. 44988634
0.12,0.14,0.08,0.08,0.04
0.05, 0.07, 0.07, 0.05, 0.06
0.02, 0.03. 0.03, 0.04, 0.02
0.03, 0.06, 0.07, 0.04, 0.07
0.06, 0.06, 0.05, 0.07, 0.04
0.08,0.071,0.084
Acetamiprid/Peach
Assume 100%CT
TOTALZ=0
MRID No. 46265702
0.294,0.344,0.311,0.565
0.184,0.225,0.163,0.188
0.182,0.223,0.117,0.138
0.153,0.166,0.283,0.387
0.205,0.233,0.192,0.240
0.211,0.242,0.0927,0.133
0.186,0.199

Acetamiprid/Spinach
Assume 100%CT
TOTALZ=858
MRID No. 44988603
0.034,0.037,0.184,0.238
0.026,0.036. 1.06, 1.20,2.46
2.58,0.516,0.588,1.95,2.22
0,463,0.466,0.15,0.23,0.18
0.18,0.19,0.22
Acetamiprid/Cabbage
w/out wrapper leaves, 5 %CT
TOTALZ=380
MRID No. 44988631
0.005, 0.02, 0.005, 0.01, 0.005
0.005, 0.005, 0,005, 0.03, 0.03
0.005,0.005,0.01,0.02,0.02
0.02,0.05,0.05,003,003

Acetamiprid/Head Lettuce
MRID No. 44988603
Estimated Max. %CT = 10%
TOTALZ=162
0.155,0.184,0.253,0.294,
0.017,0.018,0.047,0.057
0.005,0.005,0.060,0.061
0.014,0.014,0.010,0.010
0.074,0.14

Acetamiprid/Pear
TOTALZ=192
Est. Max. %CT = 25
MRID No. 44988626
0.15,0.16,0.59,0.590.25
0.29,0.11,0.16,0.12,0.12
0,24,0.32,0.17,0.18,0.20
0.23,0.13,0.14,0.21,0.28
0.09,0.15,0.24,0.28,0.22
0.39,0.17,0.20,0.45,0.64
0.22,0.28,0.23,0.23,0.21
0.25, 0.30, 0.30, 0.25, 0.26
0.26,0.36,0.14,0.16,0.23
0.27,0.08,0.10,0.30,0.34
0.25,0.29,0.080.10,0.10
0.23,0.18,0.21,0.61,0.71
0.34,0.35,0.21,0.24

Acetamiprid/Tomatoes
Estimated Max. %CT=2.5
TOTALZ=1404
MRID No. 44988616
0.01, 0.01, 0.005, 0.005, 0.005,
0.005,0.01,0.04,0.08,0.11
0.005,0.01,0.07,0.08,0.06
0.11,0.02,0.03,0.02,0.04
0.02,0.02,0.03,0.03,0.05
0.07, 0.03, 0.05, 0.06, 0.06
0.03, 0.05, 0.02, 0.02, 0.005
0.005
Acetamiprid/Celery
Estimated Max. %CT = 15
TOTALZ=9i
MRID No. 44988603
0.775,0.780,0.167,0.182
0.396, 0.426, 0.287, 0.352
0.250,0.290,0.255,0.281
0499 0 517 0068 0084

Acetamiprid/Leaf Lettuce
Estimated Maximum %CT=10
TOTALZ=180
MRID No. 44988603
0.716, 1.02,0.108,0.123
0.565, 0.646, 0.265, 0.330
0.374,0.449,0.848, 1.07
0.098,0.114,0.435,0.479
0.12,0.18,0.074,0 14

Acetamiprid/Peppers
Estimated Max. %CT = 2.5
TOTALZ=1170
MRID No, 44988616
0.005,0.005,0.01,0.02,0.01
0.01,0.03,0.05,0.03,0.04
0.01,0.01,0.02,0.03,0.02
0,02, 0,08, 0.09, 0.03, 0.03
0,06, 0.07, 0.04, 0.07, 0.05
0.06,0.12,0.16,0.08,0.08

Page 12 of 28
-------
Acetamiprid Dietary Exposure and Risk Assessment DP No,: 335205
PC Code: 099050
Attachment 2. Acetamiprid Screening Level Usage Analysis (SLUA)

Aeetamiprid (099050)
Screening Level Usage Analysis (SLUA)
Date: July?,2005

What is a Screening Level Usage Analysis (SLUA)?
• Available estimates of pesticide usage data for a particular active ingredient that is
used on agricultural crops in the United States.

What does it contain?
• Pesticide usage data for a single active ingredient only.
• Agricultural use sites (crops) that the pesticide is reported to be used on.
• Available pesticide usage information (i.e., does not include all of the United States).
• Annual percent of crop treated (average & maximum) for each agricultural crop.
» Average annual pounds of the pesticide applied for each agricultural crop (i.e., for the
states surveyed, not for the entire United States).

What assumptions can 1 make about the reported data?
• Average pounds of active ingredient applied - Values are calculated by merging
pesticide usage data sources together; averaging by year, averaging across all years, &
then rounding. Note: If the estimated value is less than 500, then that value is labeled
<500. Estimated values between 500 & <1,000,000 are rounded to I significant digit.
Estimated values of 1,000,000 or greater are rounded to 2 significant digits.)
• Average percent of crop treated - Values are calculated by merging data sources
together; averaging by year, averaging across all years, & rounding to the nearest
multiple of 5. Note: If the estimated value is less than 1, then the value is labeled
-------
Acetamiprid Dietary Exposure and Risk Assessment DP No.: 335205
PC Code: 099050
• Lack of reported usage data for the pesticide on a crop does not imply zero usage.
• Usage data on a particular site may be noted in data sources, but not quantified. In
these instances, the site would not be reported in the SLUA,
• Non-agricultural use sites (e.g., turf, post-harvest, mosquito control, etc.) are not
reported in the SLUA. A separate request must be made to receive these estimates.

Who do I contact for further information and/or questions on this SLUA?
• Cynthia Doucoure
• 703-308-8133 or doucoure.cynthia@epa.gov

Thursday, July 7, 2005
Screening Level Estimates of Agricultural Uses of Acetamiprid
Sorted Alphabetically
Pounds of Percent Maximum
Active of Crop Percent of
Crop Ingredient Treated Crop Treated

I Apples 9,000 10 15
2 Broccoli <500 <1 5
3 Celery <500 5 15
4 Cotton 8,000 <1 <2.5
5 Grapefruit <500 <1 <2.5
6 Grapes <500 <1 <2.5
7 Lemons <500 5 5
8 Lettuce 1,000 5 10
9 Oranges 2,000 <1 <2.5
10 Pears 3,000 20 25
11 Peppers <500 <1 <2.5
12 Spinach <500 <1 <2.5
13 Tomatoes <500 <1 <2.5
All numbers rounded.
'<500* indicates less than 500 pounds of active ingredient.
*<2.5' indicates less than 2.5 percent of crop is treated.
Page 14 of 28
-------
Acetamiprid
PC Code: 099050
Dietary Exposure and Risk Assessment
DP No.: 335205
Attachment 3. DEEM-FCID™ Acute Residue Input File

U.S. Environmental Protection Agency Ver. 2.02
DEEM-FCID Acute analysis for ACETAMIPRID
Residue file name: C:\Documents and Settings\cswatt02\My
Documents\RAB2chemicala\Acetamiprid\DEEM_Lifeline inputs \PRlAacetasuprid_acuteAR_berrybulb.R98
Analysis Date 10-12-2007 Residue file dated: 10-12-2007/18:33:43/8
Reference dose: aRfD ^ 0.1 mg/kg b«/day MOEL « 10 nig/kg bw/day
Comment: Acute/Chronic - OFs = 100

2
2
2
2
2
2
2
2
-1
&
6
6
6
6
6

8
8
8

8
9
9
9

13
13
13
13
13
13
1
1

10
11

1
1
1
1

5
5
5
5
5
5
7
7
7
7
7

14
14
14
14
14
14
14

6
6
6
6
6
6
6
6

12
12

3
3
12
12
12
12

15
15
15
15
15
15
15
15
15
15

12
12

Page 19 of28
-------
Acetamiprid
PC Code: 099050
Dietary Exposure and Risk Assessment
DP No.: 335205
Sunnary of Residue Distribution Files {ROF} listed in C:\Docuraents and Settings\cswart02\My
Docunents\RAB2chemicals\Acetamprid\DEEM_Lifeline inputs\PRI&acetasdprid_acuteRR_berrybttib,R98
RDF
1
I
2
3
4
5
6
7
8
9
10
11
12
13
14
15
File 8
Mane w
orange . RDF
Apple . RDF
spinach. rdf
cabbage . RDF
peach . RDF
Plum. RDF
Pear . RDF
Broccoli .RDF
Celery. RDF
HeadLettuce.RDF
LeafLettuce . RDF
cucurbit .RDF
Grapes. RDF
Peppers .RDF
Tomatoes . RDF
residues
f req's
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1! residues
w/o freg's
65
64
22
20
26
16
64
23
16
18
20
34
28
30
36
N LODs
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
too
Value
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
H Zeros
2S35
363
ssa
380
0
0
192
437
91
162
180
0
1092
1170
1404
Page 20 of 28
-------
Acetamiprid
PC Code: 099050
Dietary Exposure and Risk Assessment
DP No.: 335205
Attachment 4. Summary of DEEM-FCID™ Acute Results
U.S. Environmental Protection Agency Ver. 2.02
DEEM-FCID ACUTE Analysis for ACETAMIPRID {1994-98 dataj
Residue file: PRXAacetamiprict_acuteAR_berrybulb.ft9B
Adjustment factor 12 SOT used.
Analysis Date: 10-12-2007/18:46:11 Residue file dated: 10-12-2007/18:33:43/8
NOEL (Acute) = 10.000000 mg/kg body-wt/day
Daily totals for food and foodfom consumption used.
MC iterations = 1000 MC list in residue file MC seed - 1026
Run Comment: "Acute/Chronic - UFs = 100"
Summary calculations [per capita):
95th Percentile
Exposure % aRfD MOE
99th Percentile
Exposure % aRfD MOE
99.9th Percentile
Exposure % aRfD MOE
U.S. Population:
0.005347 5.35
All infants:
0.010857 10.86
Children 1-2 yes:
0.013764 13.76
Children 3-5 yrs:
0.009669 9.67
Children 6-12 yrs:
0.006088 6.09
Youth 13-19 yrs:
0.003534 3.53
Adults 20-49 yrs:
0.003202 3.20
Adults 50+ yrs:
0.003168 3.17
Females 13-49 yrs:
0.003215 3.22

1870

921

726

1034

1642

2829

3123

1156

3110

.009821

.018487

.019750

.014955

.009418

.005841

.005199

.005413

.005205

18.

19.

14.

,82

,49

,75

.96

.42

.84

.20

.41

.20

1018

540

506

668

1061

1712

1923

1847

1921

.018211

,026037

.034611

.024339

.016020

.011135

.011900

.009595

.009543

.21

.04

.61

.34

.02

.14

.90

.59

.54

549

384

288

410

624

398

840

1042

1017
Page 21 of 28
-------
Acetamiprid
PC Code: 099050
Dietary Exposure and Risk Assessment
DP No,: 335205
U.S. Environmental Protection Agency Ver. 2.02
DEEM-FCID ACOTE Analysis for ACETAMIPRID (1994-98 data)
Residue file: ?RIAacetamiprid_acuteAR_berrybulb.R98
Adjustment factor 12 NOT used.
Analysis Date: 10-12-2007/18:46:11 Residue file dated: 10-12-2007/18:33:43/8
NOEL (Acute) =• 10.000000 mg/kg body-wt/day
Acute Reference Dose {aRfD) = 0.100000 mg/kg body-wt/day
Daily totals for food and foodforis consuiaption used.
MC iterations « iOOO MC list in residue file MC seed = 1026
Run Comment: "Acute/Chronic - OFs = 100"
U.S. Population
Mean
Standard Deviation
Margin of Exposure
Percent of aRfD
Daily Exposure Analysis
{mg/kg body-weight/day}
per Capita per User
/a
0.001841
0.001961
5,430
1.84
Percent of Person-Days that are User-Days
0.001845
0.001962
5,421
1.84

99.83%
Estimated percentiie of user-days falling below calculated exposure
in tag/kg body-wt/day with Margin of Exposure {MOE) and Percent of aRfD
Perc. Exposure
% aRfD
Perc. Exoosure
% aRfD
LO.OO
20.00
30.00
40.00
50.00
60.00
70.00
80.00
0,
0.
0,
0.
0.
0.
0.
0,
.000471
.000672
.000854
.001046
.001262
.001530
.00190'?
.002522
0.
0.
0,
1.
1 ,
1,
1.
2,
.47
.67
.85
.05
.26
.53
.91
.52
21,
14,
11.
9,
7,
6,
5,
3,
235
870
706
557
927
535
242
965
90
95
97
99
99
99
99

.00
.00
.50
.00
.50
.75
.90

0.
0,
0,
0,
0,
0.
0.

.003774
.005352
.007170
.009827
.012234
.014613
.018217

3
5,
7,
9,
12,
14,
18,

,77
.35
.17
.83
.23
.61
.22

2,649
1,868
1,394
1,017
817
684
548

Estimated percentiie of per-capita days falling below calculated exposure
in mg/kg body-wt/day with Margin of Exposure (MOE! and Percent of aRfD
Perc.
Exposure
aRfD
MOE
Perc. Exposure
% aRfD
MOE
10,
20,
30,
40.
50,
60.
70.
80.
.00
.00
.00
.00
.00
.00
.00
.00
0,
0,
0,
0,
0,
0,
0,
0,
.000467
.000670
.000852
,001044
.001259
.001528
.001905
.002519
0
0
0
1
1
1
1
2
.47
.67
.85
.04
.26
.53
.91
.52
21,
14,
11,
9,
7,
6,
5,
3,
405
927
739
576
940
545
248
969
90.
95.
97.
99.
99.
99.
99.

,00
,00
,50
,00
.50
.75
,90

0
0
0
0
0
0
0

.003770
.005347
.007165
.009821
.012227
.014605
.018211

3
5
7
9
12
14
18

.77
.35
.17
.82
.23
.60
.21

2,652
1,870
1,395
1,018
817
684
549

a/ Analysis based on all two-day participant records in CSFII 1994-98
with 2 days of valid drinking water records.
21 Margin of Exposure = NOEL/ Dietary Exposure.
Page 22 of 28
-------
Acetamiprid
PC Code: 099050
Dietary Exposure and Risk Assessment
DP No.: 335205
Attachment 5. DEEM-FCID™ Chronic Inputs
U.S. Environmental Protection Agency
DEEM-FCID Chronic analysis for ACETAMIPRID
Residue file: C:\Documents and Settings\cswartG2\My
Documents\RAB2chemicals\Acetamiprid\DEEM_Lifeline
inputs\PRIADNTacetamipridCT_berrybulb_chronic.R98

U.S. Environmental Protection Agency Ver. 2.00
DEEM-FCID Chronic analysis for ACETAMIPRID [1994-98 data}
Residue file name: C:\Documents and Settings\cswart02\My
Documents\RAB2chemicals\Acetamiprid\DEEM_Lifeline
inputs\PRIADNTacetamipridCT_foerrybulb_chronic.R98
Adjustment factor #2 NOT used.
Analysis Date 10-12-2007/18:35:42 Residue file dated: 10-12-2007/18:35:20/8
Reference dose (RfD, Chronic) = .071 mg/kg bw/day
COMMENT 1: Acute/Chronic - OFs = 100

Total exposure by population subgroup
Total Exposure
Population
Subgroup
mg/kg
body wt/day
U.S. Population (total)
0.006184
Percent of
Rfd

8.7%
U.S. Population {spring season)
U.S. Population {summer season)
U.S. Population (autumn season!
U.S. Population (winter season)
Northeast region
Midwest region
Southern region
Western region
Hispanics
Non-hispanic whites
Non-hispanic blacks
Non-hisp /non-white /non -black
All infants {< 1 year)
Nursing infants
Son-nursing infants
Children 1-6 yrs
Children 7-12 yrs
Females 13-19 (not preg or nursing)
Females 20-1- (not preg or nursing)
Females 13-50 yrs
Females 13+ (preg/not nursing)
Females 13-t- (nursing)
Males 13-19 yrs
Males 20+ yrs
Seniors 55 +
Children 1-2 yrs
Children 3-5 yrs
Children 6-12 yrs
Youth 13-19 yrs
Adults 20-49 yrs
Adults 50+ yrs
Females 13-49 yrs
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
.006213
.006202
.006146
.006176
.006988
.006102
.005475
.006676
.006955
.005984
.006050
.007994
.014228
.007533
.016769
.018720
.008087
.004703
.004427
.004803
.005414
.005804
.004890
.004119
.004512
.024648
.016880
.008745
.004820
.004189
.004481
.004414
8.
8.
8.
8.
9.
8.
7,
9,
9,
8.
8,
11,
20,
10,
23,
26.
11,
6.
6.
6,
7,
8,
6
5
6.
34
23
12.
6
5
6.
6.
.8%
.7%
,7%
.7%
.3%
.6%
,7%
,4%
,8%
.4%
.5%
.3%
,0%
.6%
.6%
,4%
.4%
.6%
.2%
.8%
.6%
.2%
.9%
.8%
.4%
.7%
.8%
.3%
.8%
.9%
.3%
.2%
Page 28 of 28
-------
Federal Register/Vol. 73, No. 11/Wednesday, January 16, 2008/Rules and Regulations
2809
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS

• t. The authority citation for 21 CFR
part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
• 2. In § 322.970, revise paragraph (b)(2)
and add paragraph (b)(4) to read as
follows:

§522.970 Flunixin.
*****
(b)* * *
(2) See Nos. 057561, 059130, and
061623 for use as in paragraphs (e)(l),
(e)(2)(i)(A). (e)(2)(ii)(A), and (e)(2)(iii). of
this section.
* * # * *
(4) See No. 055529 For use as in
paragraphs (e)(l) and (e)(2) of this
section.
Dated: January 4. 2008,
Bemadette Dunham,
Deputy Director, Center far Veterinary
Medicine.
[FR Doc. E8-699 Filed 1-15-08; 8:45 am]
BILLING CODE 4160-01-S
ENVIRONMENTAL PROTECTION
AGENCY

40 CFR Part 180
[EPA-HQ-OPP-2006-0733; FRL-8348-1]

Acetamiprid; Pesticide Tolerance

AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.

SUMMARY: This regulation establishes
tolerances for residues of acetamiprid in
or on bushberry subgroup 13-07B;
caneberry subgroup 13-07A; low
growing berry subgroup 13-07G; onion,
bulb, subgroup 3-07A; and onion,
green, subgroup 3—07B. Nippon Soda
Co., Ltd. requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective
January 16, 2008. Objections and
requests for hearings must be received
on or before March 17, 2008, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit LC. of the
SUPPLEMENTARY INFORMATION.
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA-HQ-
OPP-2006-0733. To access the
electronic docket, go to http://
ivww.regulations.gov, select "Advanced
Search," then "Docket Search." Insert
the docket ID number where indicated
and select the "Submit" button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
index, some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain otiier material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
http://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S—
4400, One Potomac Yard (South Bldg.j,
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305-
5805.
FOR FURTHER INFORMATION CONTACT:
Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460-0001; telephone number:
(703) 305-5218; e-mail address:
sfanton.susan@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by diis 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
\vhether 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 Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at http://
ivww.regulations.gov, you may access
this Federal Register document
electronically dirough the EPA Internet
under the "Federal Register" listings at
http:/'/www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA's tolerance
regulations at 40 CFR part 180 through
the Government Printing Office's pilot
e-CFR site at http://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, any
person may file an objection to any
aspect of this regulation and may also
request a hearing on those objections.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA-HQ-
OPP-2006-0733 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
as required by 40 CFR part 178 on or
before March 17, 2008.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA-
HQ-OPP-2006-0733, by one of the
following methods:
• Federal eRulemaking Portal: http://
ivww.regulations.gov. Follow the on-line
instructions for submitting comments.
• Ma/7: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460-0001.
-------
2810
Federal Register/Vol. 73. No. 11/Wednesday, January 16, 2008/Rules and Regulations
• Delivery. OPP Regulatory Public
Docket |75Q2P), Environmental
Protection Agency, Rm. S—1400. One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr.. Arlington. VA. Deliveries
are only accepted during the Docket's
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday.
excluding legal holidavs). Special
arrangements should be made for
deliveries of boxed information. The
Docket Facility telephone number is
(703)305-5805.

II. Petition for Tolerance

In the Federal Register of September
22, 2006 (71 FR 55468) (FRL-8091-9),
EPA issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 6F7051) by
Nippon Soda Co., Ltd.. c/o Nisso
America Inc., 45 Broadway. Suite 2120,
New York, NY. 10006. The petition
requested that 40 CFR 180.578 be
amended by establishing tolerances for
residues of the insecticide acetamiprid,
A/l-|(6-chloro-3-pyridyl)methyll-A/2-
cyano-jVl-methylacetamidine, in or on
bulb vegetables crop group 3 at 3 ppm;
edible podded legume vegetables, crop
subgroup 6a at 0.5 ppm: succulent
shelled peas and beans, crop subgroup
6b, at 0.5 ppm; and berries, crop group
13 at 1 ppm. That notice referenced a
summary of the petition prepared by
Nippon Soda Co., Ltd., the registrant,
which is available to the public in She
docket ID Number EPA-HQ-QPP-2Q06-
0733, http://www.regulations.gov. There
were no comments received in response
to the notice of filing.
in the Federal Register of April 2,
2007 (72 FR 16352) (FRL-8119-2), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 6E7163) by
Interregional Research Project Number 4
(IR-4), 500 College Road East, Suite 201
W. Princeton, NJ 08540. The petition
requested that 40 CFR 180.578 be
amended by establishing tolerances for
residues of the insecticide acetamiprid,
iVl-|(6-chloro-3-pyridyl)methyll-iV2-
cyano-iVl-methylacetamidine, in or on
strawberry, bearberry, bilberry, lowbush
blueberry, cloudberry, cranberry,
lingonberry, muntries and
partridgeberry at 0.60 parts per million
(ppm). That notice referenced a
summary of the petition prepared by
Nippon Soda Co.. Ltd.. the registrant.
which is available to the public in the
docket ID Number EPA-HQ-OPP-2007-
0105, http://www.regulations.gov. There
ware no comments received in response
to the notice of filing.
In the Federal Register of November
28, 2007 (72 FR 67256) (FRL-8340-6).
EPA issued a final rule establishing
tolerances for residues of acetamiprid
in/on edible-podded legume vegetables
and succulent shelled peas and beans
but deferred to a later date the decision
on the petitioned-for tolerances on the
bulb vegetable and berry commodities
requested in these petitions. EPA is
establishing the bulb vegetable and
berry tolerances at this time but has
modified the commodity terms and
most of the proposed tolerance levels.
The reasons for these changes are
explained in Unit V.

III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is "safe."
Section 408(b)(2)(A)(ii) of FFDCA
defines "safe" to mean that "there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and ail
other exposures for which there is
reliable information." This includes
exposure through drinking water and in
residential settings, but dews not include
occupational exposure. Section
408(b){2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to "ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . ." These provisions
were added to FFDCA by the Food
Quality Protection Act (FQPA) of 1996.
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for the petitioned-for
tolerance for residues of acetamiprid on
bushberry subgroup 13-07B at 1.6 ppm;
caneberry subgroup 13-07A at 1.6 pprn:
low growing berry subgroup 13-07G at
0.60 ppm; onion, bulb, subgroup 3-07A
at 0.02 ppm; and onion, green, subgroup
3-07B at 4.5 ppm. EPA's assessment of
exposures and risks associated with
establishing the tolerance follows.
As noted above, on November 28,
2007, EPA issued a final rule in the
Federal Register establishing tolerances
for residues of acetamiprid in/on edible-
podded legume vegetables and
succulent shelled peas and beans. When
the Agency conducted the risk
assessments in support of this tolerance
action it assumed that acetamiprid
residues would be present on bulb
vegetables and commodities in the
aforementioned berry subgroups as well
as on all foods covered by the proposed
and established tolerances. Therefore.
establishing the bulb vegetable and
berry tolerances will not change the
most recent estimated aggregate risks
resulting from use of acetamiprid. as
discussed in the November 28, 2007
Federal Register. Refer to the November
28, 2007 Federal Register document (72
FR 67256) (FRL-8340-6), available at
http://www.regulations.gov, for a
detailed discussion of the aggregate risk
assessments and determination of
safety. EPA relies upon those risk
assessments and the findings made in
the Federal Register document in
support of this action.
Based on the risk assessments
discussed in the final rule published in
the Federal Register of November 28,
2007 (72 FR 67256) (FRL-8340-6), EPA
concludes that there is a reasonable
certainty that no harm will result to the
general population, and to infants and
children from aggregate exposure to
acetamiprid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology
Adequate residue analytical methods
gas chromatography/electron-capture
detection (GC/ECD) and high-
performance liquid chromatography/
ultraviolet detector (HPLC/UV)) are
available for the enforcement of
established and new tolerances for plant
and animal commodities. These
methods may be requested from: Chief,
Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd.. Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; e--
mail address: residuemethods@epa.gov.

B. International Residue Limits
There are no Codex, Canadian or
Mexican MRLs established for
acetamiprid on the commodities
associated with these petitions.

V. Conclusion
The registrant. Nippon Soda Co.. Ltd.,
petitioned for tolerances on bulb
vegetables group 3 and berries group 13
as those crop groups were defined at the
time of the petition. IR-4 also petitioned
for individual tolerances on strawberry,
bearberry, bilberry, lowbush blueberry,
cloudberry, cranberry, lingonberry,
muntries and partridgeberry (PP
6E7163). In the Federal Register of
-------
Federal Register/Vol. 73, No. 11/Wednesday, January 16, 2008/Rules and Regulations 2811
December 7. 2007 (72 FR 69150) (FRL-
8340-6!, EPA issued a final rule that
revised the crop grouping regulations.
As part of diis action. EPA expanded
and revised bulb vegetables group 3 and
berries group 13. Changes to crop group
3 (bulb vegetables) included adding new
commodities, creating subgroups for
bulb and green onions, and changing the
name of one of the representative
commodities from "onion, dry bulb" to
"onion, bulb". Changes to crop group 13
(berries) included adding new
commodities, revising existing
subgroups and creating new subgroups
(including a low growing berry
subgroup consisting of the commodities
requested in PP 6E7163 and cultivars,
varieties, and/or hybrids of these).
EPA indicated in the December 7,
2007 final rule as well as the earlier May
23, 2007 proposed rule (72 FR 28920)
(FRL-8126-l) that, for existing petitions
for which a notice of filing had been
published, the Agency would attempt to
conform these petitions to the rule.
Therefore, consistent with this rule.
EPA is establishing tolerances on
bushberry subgroup 13—078; caneberry
subgroup 13-07A; low growing berry
subgroup 13-07G; onion, bulb,
subgroup 3—07A; and onion, green.
subgroup 3—0/B. The low growing berry
subgroup 13—07G consists of the berries
for which tolerances were requested in
PP 6E7163. The other subgroups include
the remaining berries and bulb
vegetables for which tolerances were
requested in PP 6F7051.
EPA concludes it is reasonable to
revise the petitioned-for tolerances so
that they agree with the recent crop
grouping revisions because (1) although
the new crop groups/subgroups include
several new commodities, the added
commodities are closely related minor
crops which contribute little to overall
dietary or aggregate exposure and risk;
and acetamiprid exposure from these
added commodities was considered
when EPA conducted the dietary and
aggregate risk assessments supporting
this action; and (2) the representative
commodities for die revised crop
groups/subgroups have not changed.
Based upon review of the data
supporting PP 6F7051. EPA has also
revised the tolerance levels for
bushberry subgroup 13—07B and
caneberry subgroup 13-07A to 1.6 ppm;
onion, bulb, subgroup 3-07A to 0.02
ppm; and onion, green, subgroup 3-07B
to 4.5 ppm. EPA revised these tolerance
levels based on analyses of the residue
field trial data using the Agency's
Tolerance Spreadsheet in accordance
with the Agency's Guidance for Setting
Pesticide Tolerances Based on Field
Trial Data Standard Operating
Procedure (SOP).
Therefore, tolerances are established
for residues of acetamiprid, jVl-{(6-
chloro-3-pyridyl)methyll-iV2-cyano-iVt-
rnethylacetamidine, in or on bushberry
subgroup 13-07B at 1.6 ppm; caneberrv
subgroup 13-07A at 1.8 ppm; low
growing berry subgroup 13-07G at 0.60
ppm; onion, bulb, subgroup 3-07A at
0.02 ppm; and onion, green, subgroup
3-07B at 4.5 ppm.

VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency, The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4. 1993). Because this rule has
been exempted from review under
Executive Order 12866, this rule is not
subject to Executive Order 13211.
Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28335, May
22. 2001} or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885. April 23. 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898. entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such.
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments.
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255. August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply
to this rub. In addition, This rule does
not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act of 1995 (UMRA)
(Public Law 104-4],
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section
12(d) (15 U.S.C. 272 note).

VII. Congressional Review Act

The Congressional Review Act. 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a "major rule" as defined by 5 U.S.C.
804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements,
Dated: January 8. 2008.
Donald K. Stubbs,
Acting Director. Registration Division. Office
of Pesticide Programs.
• Therefore. 40 CFR chapter 1 is
amended as follows:

PART 180—{AMENDED]

• 1. The authority citation for part 180
continues to read as follows:
Authority: 21 U.S.C. 321(q). 346a and 371.
• 2. Section 180.578 is amended by
alphabetically adding the following
commodities to the table in paragraph
(aj(l) to read as follows:

180.578 Acetamiprid; tolerances lor
residues.
(a) •*•(!)**•
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2812 Federal Register/Vol. 73, No. 11/Wednesday, January 16, 2008/Rules and Regulations
Commodity
Parts per million
Berry, tow growing subgroups 13-Q7G
Bushberry subgroup 13-078
Caneberry subgroup 13-07A
Onion, bulb, subgroup 3-^07A ...
Onion, green, subgroup 3-073
060
1.6
1.6

002
4.5
|FR Doc. E8-«83 Filed 1-15-08; 8:45 ami
BILUNG CODE SSSO-50-S
ENVIRONMENTAL PROTECTION
AGENCY

40 CFR Part 180
[6PA-HQ-OPP-2007-0461; FRL-8346-6J

Mandipropamic; Pesticide Tolerance

AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final ruie.

SUMMARY: This regulation establishes a
tolerance for residues of
mandtpropamid, 4-chloro-N-|2-|3-
methoxy-4-{2-
propynyloxy)phenyllethyl!-alpha-(2-
propynyloxyj-benzeneacetamide in or
on Brassica. head and stem, subgroup
5A; Brassica, leafy greens, subgroup SB:
vegetable, cucurbit, group 9; vegetable.
fruiting, group 8: okra; vegetable, leafy
except brassica, group 4: vegetable,
tuberous and conn, subgroup 1C; grape:
grape, raisin; onion, dry bulb; onion.
green; and potato, wet peel. Syngenta
Crop Protection Inc. requested this
tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective
January 16, 2008. Objections and
requests for hearings must be received
on or before March 17. 2008. and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA-HQ-
OPP-2007-0461. To access the
electronic docket, go to http://
www.regulations.gov. select "Advanced
Search," then "Docket Search." Insert
the docket ID number where indicated
and select the "Submit" button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
index, some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
http://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S—
4400, One Potomac Yard (Soudi Bldg.),
2777 S. Crystal Dr.. Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m.. Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305—
5805. '
FOR FURTHER INFORMATION CONTACT: Rose
Mary Kearns, Registration Division
(7505PJ, Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave.. NW., Washington,
DC 20460-0001; telephone number:
(703) 305-5611; e-mail address:
kearns.rosemofy@epo.gov.
SUPPLEMENTARY INFORMATION:
I. General Information

A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAlCS code 111),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and fanners,
dairy cattle Farmers, livestock farmers.
• Food manufacturing {NAICS code
311}, e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather to provide 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 Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at http://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the "Federal Register" listings at
http://wmv.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA's tolerance
regulations at 40 CFR part 180 through
the Government Printing Office's pilot
e-CFR site at http://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, any
person may File an objection to any
aspect of this regulation and may also
request a hearing on those objections.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA-HQ-
OPP-2007-0461 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
as required by 40 CFR part 178 on or
before March 17, 2008.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
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IR-4 Project Headquarters
Rutgers, The State University of New Jersey
500 College Road East, Suite 2OiW
Princeton, NJ 08540
732.932.9575 fax: 609-514-2612
www.ir4.rutgers.edu
Providing Safe andwective Ptot
Management Solutions for
Specialty Crop Gtowen
March 12, 2009

Mr, Stephen Schaible
c/o Document Processing Desk
Registration Division (7505C)
U.S. Environmental Protection Agency
1 Potomac Yard
2777 Crystal Drive
Arlington, VA 22202

Dear Mr. Schaible,

RE: Reduced Risk Status for IR-4 Aceiarnipnd Petitions
Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F
Berry, low growing, subgroup 13-Q7G
Clover (grown for seed)
Tomato (greenhouse)

On behalf of the IR-4 Project I request that the subject IR-4 acetamiprid uses be designated as reduced risk.
IR-4 feels it would be beneficial to officially classify these uses as reduced risk, EPA has previously granted
reduced risk status to other proposed uses of this insecticide, including grape and field-grown fruiting vegetables on
March 15, 2002.

Acetamiprid (the active ingredient in Assail insecticide from Nisso America, Inc.) is an insecticide in the
pyridylmethylamine class that controls aphids, Japanese beetles, lygus bugs, plant bugs, thrips, grape berry moths,
and whiteflies. The attached table contains labeled insecticide options capable of controlling these insects in some
of the target crops.

Strawberry growers currently use pyrethroids, carbamates, and organophosphates for control of aphids,
Japanese beetle, lygus bugs, plant bugs, thrips, and whiteflies. Lowbush blueberry growers currently use
organophosphates, carbaryl, pyrethroids, other neonicotinoids, and pyriproxyfen for control of blueberry maggot,
blueberry spanworm, cranberry fruilworm, Japanese beetle, oblique-banded leafroller, aphids, and leafhoppers.
Cranberry growers currently use tebufenozide, along with organophosphates, carbaryl, and indoxacarb for control of
cranberry fruit worm, fire worms, and flea beetles. Clover growers currently rely on chlorpyrifos for control of
aphids and need an alternative that is safe to bees. Acetamiprid is currently registered on grape, but a 3-day PHI is
needed in order for this Reduced Risk product to be useful at harvest time. Growers of other vine climbing small
fruit have few or no insecticide options. Greenhouse tomato growers are limited to a small subset of insecticides
registered on tomato (field) for control of aphids, thrips, whiteflies, and lepidopterous pests, including bifenthrin and
malathion. Acetamiprid will increase the margin of safety compared to these and should qualify as a reduced risk
insecticide. Thank you very much for your consideration.

Sincerely,
Cenneth S. Samoil
Technical Coordinator
IR-4 Project
KSS
Enclosure
Major funding for IR-4 is provided by Special Research Grants and Hatch Acl Funds from USDA-CSREES.
(it cooperation with the State Agricultural Experimental Stations and USDA-ARS.
THE STATE UNIVERSITY OF NEW JERSEY
RUTGERS
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Page
Crop

Strawberry

Blueberry,
InwKn^h
I\J W UU£MI

Cranberry

i InvjpT
V»IU ¥ ti

Grape and
Crop subpoup
13-07F

Tomato
(greenhouse)

PP No,

6E7163

Pests
Japanese beetle
Plant bugs
Sap beetles
Thrips
Whiteflies
Aphids
Spittlebug

Blueberry maggot
Blueberry spanworm
Cranberry fruitworm
Japanese beetle
Oblique-banded
leafroller
Aphids
Leafhoppers

Cranberry fruitworm
Fireworms
Flea beetles

Clover aphid
Pea aphid

Grape berry moth
Japanese beetle
Grape leafhopper
Grape cane girdler
Vine mealybug
Thrips

Aphids
Lepidopterous pests
Thrips
Whiteflies

Proposed Use Pattern for Acetamiprid
2.0-6.9 oz. Assail 30 SG/acre
Total 13.8 oz. Assail 30 SG/acre/year
7 day interval between applications
PHI=1 day

2.0-6.9 oz. Assail 30 SG/acre
Total 13.8 oz. Assail 30 SG/acre/year
7 day interval between applications
PHl=i day

4.0-6.9 oz. Assail 30 SG/acre
Total 13.8 oz. Assail 30 SG/acre/year
7 day interval between applications
PHI=1 day

2.5-4.0 oz. Assail 30 SG/acre or
1 . 1 - 1 .7 oz. Assail 70 WP/acre
Maximum 1 application/year
PHI=28 days

2.5-5.3 oz. Assail 30 SG/acre or
1. 1-2.3 oz. Assail 70 WP/acre
Maximum 10.6 oz. Assail 30 SO or
4.6 oz. Assail 70 WP/acre per year
14 day interval between applications
PHI= 3 days

0.4 oz. Tristar 30 SO per 1000 plants
(0.075 Ib ai/acre @ 10,000 plants/acre)
Maximum two applications via chemigaiion
PHI=1 day

Labeled Insecticides
Abamectin
Bifenthrin
Fenpropathrin
Diazinon
Methomyl
Malathion
Dibrom
Spinetoram
Carbaryl
Tebufenozide
Thiamelhoxam
Tebufenozide
Fenpropathrin
Pyriproxyfen
Methoxyfenozide
Malathion
Imidacloprid
Carbaryl
Spinosad
Thiamethoxam
Indoxacarb
Methoxyfenozide
Diazinon
Phosmet
Acephate
Carbaryl
Spinosad
Azadirachtin
Bifenthrin
Malathion
Chlorpyrifos
Oxydemeton-methyl
Zeta-cypermethrin
Abamectin
Acephate
Thiamethoxam
Chlorantraniliprole
Azadirachtin
Bifenthrin
Carbaryl
Clothianidin
Fenpropathrin
Diazinon
Spinosad
Pyriproxyfen
Malathion
Zeta-cypermethrin
Dinotefuran
Thiodan
Malathion
Lambda-cyhalothrin
Azadirachtin
Pyriproxyfen
Bifenthrin
Wcyor/ii/idirig/or IR-4 is prowled by Special Research Grains and Hatch Act Funds .from USDA-CSREES.
in cooperation irilh tlie State Agricultural Experimental Stations and USBA-ARS.
THE STATE UMVEA9TY OF NSW JBtScY

RUTGERS
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In addition to fulfilling a criterion for the data exclusivity extension under FIFRA § 3(c)(l)(F)(ii)(ll) by
being categorized as a reduced-risk pesticide, a second criterion for the data exclusivity extension is
fulfilled under FIFRA § 3(c)(l){F){ii) (IV). That is "...the minor use pesticide plays or will play a significant
part in an integrated pest management program."

Information on Pest Management Strategic Plans (PMSP) derived from the USDA's National Information
System for the Regional IPM Centers website [http://www.ipmcenters.org/pmsp] shows that there are
currently 25 PMSPs representing 13 states and/or regions of the US where acetamiprid is listed as an
alternative (or possible alternative) insecticide product for 17 minor use (i.e., <300,000 A) crops or crop
groups. The list of minor use crop/state PMSPs and their respective websites are as follows:

1) Peach / Eastern US
http://www.ipmceruers.ore/pmsp/pdf/EastPeach.pdf

2) Peach / New Jersey
^
3) Peach / California
http://www.ipmcenters.org/pmsp/pdf/CAPEACHPMSP.pdf

4) Cherry, tart /General
^^
5) Plum /California
h tt|) :// ww w . j .p_m cen te r s ...g rg/p m sg/pd f/C AP LU M P M SP . pd f

6) Nectarine / California
http://www.ipmcenters.org/pmsp/pdf/CANECTARlNEPMSP.pdf

7) Pear /California
http://www.ipmcenters.orfl/pmsp/pdf/CAPear.pdf

8) Citrus (except orange) / California
)://www.ipmcenters.org/prnsp/pdf/CACitrusPMSP%20._pdf
9) Leeks / New Jersey
http://wwwJpnicenters.org/pfTisp/pdf/NJleekPMSP.j3df

10) Snap Beans/Virginia, North Carolina, Delaware
http://www.ipmcenters.org/pmsp/pdf/VA-NC-DEsnapbeanPMSP.pdf

11) Snap Beans / Oregon and Washington
;pj//www.iprricenters.prg/p_msp/pdf/QRWA%20SnapBean.pdf
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12) Spinach / Texas
hl-IP :// wwwjfifnce .nter s - Q rg/ pm so/ p d f / TX spinachPMSP. {J df

13) Spinach / Delaware, Maryland, New Jersey
htra://www.ipmcenters.oro/prnsp/pdf/DESpinach.pdf

14) Celery / California
15) Parsley /Ohio
mc_ejTtej^Jor^^
16) Pepper/ Delaware, Maryland, New Jersey
£^
17) Pepper /California
18) Pepper /Ohio
19) Eggplant / General
http://www.ipmcentefS.org/pmsp/pdf/EKgplant.pdf

20) Cucumbers / Delaware, Maryland
http://www.ipmcenters.org/pmsp/pdf/DEpickle.pdf

21) Cucurbits / Tennessee
http://www.ipmcenters.org/pmspypdf/TNcucurbit.pdf

22) Watermelon/ Delaware, Maryland, New Jersey, North Carolina
http:// www .ipmcenters.org/prnsp/pdf/DE-M D-NJ-NCWatermelonPiV1SP.pdf

23) Blueberry / Oregon and Washington
0! IB: // w w v.'. i o m c e n t e r s. o rg/ p m s p / p d f ,/O R W A BI u e b e r ry. o d f

24) Blueberry / North Central US
http://www.ipmcenters.org/omso/pdf/MI-iNblueberr/PMSP.pdf

25) Strawberry/ Tennessee
^
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The USDA's National Information System for the Regional IPM Centers website also lists 19 Minor Crop /
State profiles in which acetamiprid is listed as an alternative insecticide product. The list of minor crop
profiles and the associated websites can be found below:

1) Citrus (excluding oranges) / California
'-"•'-_! >•''•'•_'/ "-'"'' ' •- ..>.".! " V >J 'cs/CAcitru_s2j3dJ

2) Citrus (minor) / Florida
3) Arugula / New Jersey
4) Peppers / Delaware
5) Peppers / New Jersey
6) Peppers/Ohio
7) Eggplant / New Jersey
jpjT^
8) Eggplant / Florida
h 1 1 o : //www . i pjri c e nte rs.p rj[/o^p_p^ofiles/docs/R..eggpJa n_t_. p_df

9) Greens, leafy / Tennessee
b_tt 2. ://ww '-'- i r i n r •-• 1 1 r e rs . o rg/cro o pro f i j _e s/d ocs/TN Ig a fy g re e n s .
10) Spinach / Delaware
11) Spinach / Oklahoma
c^ntere . w^ oof
12) Spinach / New Jersey
13) Lettuce/Florida
-------
14) Parsley (in Rosemary profile) / Florida
jDm^
15) Celery / Florida
Jl^^
16) Cabbage / Virginia
ejnj^^ a ge . jjdf
17) Kale /New Jersey
18) Onions, green / Ohio
tej^^^
19) Watermelons / Delaware
l^^^^
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