[Federal Register Volume 75, Number 27 (Wednesday, February 10, 2010)]
[Rules and Regulations]
[Pages 6576-6583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-2803]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0289; FRL-8809-9]


Acetamiprid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
acetamiprid in

[[Page 6577]]

or on fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-
07F; and tea, dried. It additionally establishes tolerances with 
regional registrations on clover, forage and clover, hay. Finally, this 
regulation deletes an existing individual tolerance in or on grape, as 
it will be superseded by inclusion in subgroup 13-07F. Interregional 
Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 10, 2010. Objections and 
requests for hearings must be received on or before April 12, 2010, 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-2009-0289. All documents in the 
docket are listed in the docket index available at http://www.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: Laura Nollen, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7390; e-mail address: <a href="/cdn-cgi/l/email-protection#254b4a4949404b0b4944505744654055440b424a53"><span class="__cf_email__" data-cfemail="83edecefefe6edadefe2f6f1e2c3e6f3e2ade4ecf5">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> Pesticide manufacturing (NAICS code 32532).
    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 Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr. To 
access electronically the OPPTS harmonized test guidelines referred in 
this document, please go to http//www.epa.gov/oppts and select ``Test 
Methods and Guidelines.''

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2009-0289 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 April 12, 2010.
    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-2009-0289, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> 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 Facility'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 August 19, 2009 (74 FR 41898) (FRL-8426-
7), 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 
9E7544) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 
08540. The petition requested that 40 CFR 180.578 be amended by 
establishing a tolerance for residues of the insecticide acetamiprid, 
N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine, in or on 
fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 
0.35 parts per million (ppm); and tolerances with regional restrictions 
in or on clover, forage at 0.10 ppm; clover, hay at 0.01 ppm; and tea 
at 50 ppm. That notice referenced a summary of the petition prepared on 
behalf of IR-4 by Nippon Soda Co., Ltd., the registrant, which is 
available to the public in the docket, http://www.regulations.gov. 
There were no comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
determined that the petitioned-for tolerance with regional 
registrations on tea should be established as a tolerance with no U.S. 
registrations. The reason for this change is explained in Unit IV.C.

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 all other exposures for which there is

[[Page 6578]]

reliable information.'' This includes exposure through drinking water 
and in residential settings, but does 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. . . 
.
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 
tolerances for residues of acetamiprid on fruit, small, vine climbing, 
except fuzzy kiwifruit, subgroup 13-07F at 0.35 ppm; tea, dried at 50.0 
ppm; clover, forage at 0.10 ppm; and clover, hay at 0.01 ppm. EPA's 
assessment of exposures and risks associated with establishing 
tolerances follows.

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.
    Acetamiprid is moderately toxic via the oral route of exposure and 
is minimally toxic via the dermal and inhalation routes of exposure. It 
is not an eye or skin irritant, nor is it a dermal sensitizer. 
Acetamiprid does not appear to have specific target organ toxicity. 
Generalized toxicity was observed as decreases in body weight, body 
weight gain, food consumption and food efficiency in all species 
tested. Generalized liver effects were also observed in mice and rats 
(hepatocellular vacuolation in rats and hepatocellular hypertrophy in 
mice and rats).
    In the rat developmental study, fetal shortening of the 13th rib 
was observed at the same dose level that produced maternal effects 
(reduced body weight and body weight gain and increased liver weights). 
No developmental effects were observed in the rabbit at doses that 
reduced maternal body weight and food consumption. Effects in pups in 
the 2-generation rat reproduction study included delays in preputial 
separation, vaginal opening and pinna unfolding as well as reduced 
litter size, decreased pup viability and weaning indices; offspring 
effects observed in the developmental neurotoxicity (DNT) study 
included decreased body weight and body weight gains, decreased 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 gain) in the maternal animals.
    In the acute neurotoxicity study, male and female rats displayed 
decreased motor activity, tremors, walking and posture abnormalities, 
dilated pupils, coldness to the touch and decreased grip strength and 
foot splay at the highest dose tested (HDT). There was a decrease in 
the auditory startle response in male rats at the HDT in the DNT; 
additionally, tremors were noted in female mice at the HDT in the 
subchronic feeding study.
     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. 
Acetamiprid tested positive as a clastogen in an in vitro mammalian 
chromosome aberration assay in Chinese hamster ovary cells. There was 
no sign of mutagenicity in other mutagenicity studies for acetamiprid.
    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 Clover Grown for Seed, Small Vine 
Climbing Fruits, except Kiwifruit, Subgroup 13-07F, Greenhouse Grown 
Tomatoes and Tea,'' at pages 57-61 in docket ID number EPA-HQ-OPP-2009-
0289.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a benchmark dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD 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 
dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the level of 
concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. 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.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for acetamiprid used for 
human risk assessment can be found at http://www.regulations.gov in the 
document ``Acetamiprid: Human Health Risk Assessment for Proposed Food 
Uses on Clover Grown for Seed, Small Vine Climbing Fruits, except 
Kiwifruit, Subgroup 13-07F, Greenhouse Grown Tomatoes and Tea,'' at 
pages 25-26 in docket ID number EPA-HQ-OPP-2009-0289.

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

[[Page 6579]]

possibility of an effect of concern occurring as a result of a 1-day or 
single exposure.
    In estimating acute dietary exposure, 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 utilized maximum percent 
crop treated (PCT) data for several commodities and 100 PCT for all 
proposed uses; anticipated residues derived from field trial data for 
apples, broccoli, cabbage, celery, grapefruit, grapes, lettuce, 
oranges, pears, peppers, spinach, tomatoes, stone fruit and cucurbit 
vegetables; tolerance-level residues for livestock commodities; and 
empirical processing factors for apple juice, orange juice, grapefruit 
juice, raisins, dried prunes, tomato paste and tomato puree. Dietary 
Exposure Evaluation Model (DEEM) default processing factors were used 
for all other processed 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 utilized average PCT 
data for several commodities and 100 PCT for all proposed uses, 
tolerance-level residues for all commodities and empirical processing 
data for grape juice and raisins. DEEM default processing factors were 
used for all other processed commodities.
    iii. Cancer. Based on the evidence discussed in Unit III.A., EPA 
has determined that acetamiprid is ``not likely to be carcinogenic to 
humans.'' Therefore, a quantitative exposure assessment to evaluate 
cancer risk 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 require pursuant to FFDCA section 
408(f)(1) 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 FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    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:
    <bullet> Condition 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 the pesticide residue.
    <bullet> Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
    <bullet> Condition 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 FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    For the acute assessment, EPA used maximum PCT information as 
follows:
    Apples at 30%; broccoli at 15%; cabbage at 10%; cauliflower at 15%; 
celery at 45%; cotton at 5%; grapefruit at 5%; lettuce at 20%; oranges 
at 5%; peaches at 2.5%; pears at 60%; peppers at 5%; potatoes at 2.5%; 
pumpkins at 2.5%; spinach at 15%; and squash at 2.5%.
    For the chronic assessment, EPA used average PCT information as 
follows:
    Apples at 20%; broccoli at 5%; cabbage at 5%; cauliflower at 10%; 
celery at 25%; cotton at 5%; grapefruit at 2.5%; lemons at 5%; lettuce 
at 10%; oranges at 2.5%; peaches at 1%; pears at 35%; peppers at 2.5%; 
potatoes at 2.5; pumpkins at 1%; spinach at 5%; and squash at 2.5%.
    In most cases, EPA uses available data from USDA/National 
Agricultural Statistics Service (NASS), proprietary market surveys, and 
the National Pesticide Use Database for the chemical/crop combination 
for the most recent 6 years. EPA uses an average PCT for chronic 
dietary risk analysis. The average PCT figure for each existing use is 
derived by combining available public and private market survey data 
for that use, averaging across all observations, and rounding to the 
nearest 5%, except for those situations in which the average PCT is 
less than one. In those cases, 1% is used as the average PCT and 2.5% 
is used as the maximum PCT. EPA uses a maximum PCT for acute dietary 
risk analysis. The maximum PCT figure is the highest observed maximum 
value reported within the recent 6 years of available public and 
private market survey data for the existing use and rounded up to the 
nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. 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 reliable 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 used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for acetamiprid in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of acetamiprid. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of acetamiprid for 
surface water are estimated to be 20.1 parts per billion (ppb) for 
acute exposures and 4.9 ppb for chronic exposure. For ground water, the 
EDWC is 0.0016 ppb.
    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 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,

[[Page 6580]]

indoor pest control, termiticides, and flea and tick control on pets).
    Acetamiprid is currently registered for use in indoor and outdoor 
residential settings, including crack and crevice applications on 
carpet and hard surfaces and applications to residential turf. EPA 
assessed residential exposures for adults applying bait and gel 
products; for postapplication exposure for adults (from short-term 
dermal exposure) and toddlers (from short-term dermal and incidental 
exposure) following indoor crack and crevice treatments; and 
postapplication exposure for adults (from short- and intermediate-term 
dermal exposure) and toddlers (from short-term and intermediate-term 
dermal and incidental oral exposures, including hand-to-mouth, object-
to-mouth and incidental ingestion of soil) following treatments on 
turf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. 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 nAChRs, 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 imidacloprid). 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 http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) 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 safty 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional SF when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The prenatal 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 2-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 pup viability and weaning indices; offspring 
effects observed in the DNT study included decreased body weight and 
body weight gains, decreased 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.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for acetamiprid is complete except for 
immunotoxicity testing. Recent changes to 40 CFR part 158 make 
immunotoxicity testing (OPPTS Guideline 870.7800) required for 
pesticide registration; however, the existing data are sufficient for 
endpoint selection for exposure/risk assessment scenarios, and for 
evaluation of the requirements under the FQPA. Acetamiprid does not 
show any evidence of treatment-related effects on the immune system and 
the overall weight of evidence suggests that this chemical does not 
directly target the immune system. Therefore, EPA does not believe that 
conducting the immunotoxicity study will result in a dose less than the 
point of departure currently used for overall risk assessment, and an 
additional database uncertainty factor for potential immunotoxicity 
does not need to be applied.
     ii. There is evidence of increased qualitative susceptibility of 
the young following in utero exposure to acetamiprid in the rat 
reproduction study. Additionally, a rat DNT study is available that 
shows evidence of increased qualitative susceptibility of offspring (a 
decrease in the auditory startle response in male rats) at the HDT. 
Therefore, EPA performed a degree of concern analysis to determine the 
level of concern for the effects observed when considered in the 
context of all available toxicity data, and to identify any residual 
uncertainties after establishing toxicity endpoints and traditional 
uncertainty factors to be used in the acetamiprid risk assessment.
    In considering the overall toxicity profile and the endpoints and 
doses selected for the acetamiprid risk assessment, EPA characterized 
the

[[Page 6581]]

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, 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 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. Use of the DNT NOAEL is protective of 
effects seen in the 2-generation study (the NOAEL from the DNT is 10.0 
milligrams/kilogram/day (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 and 
doses selected for acetamiprid are protective of adverse effects in 
both offspring and adults; therefore, there are no residual concerns 
regarding effects in the young.
    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 
assessments were derived from valid and reliable data and are unlikely 
to be exceeded. EPA made conservative (protective) assumptions in the 
ground and surface water modeling used to assess exposure to 
acetamiprid in drinking water. EPA used similarly conservative 
assumptions to assess postapplication exposure of children as well as 
incidental oral exposure of toddlers. These assessments will not 
underestimate the exposure and risks posed by acetamiprid.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD 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 43% 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 chronic exposure to 
acetamiprid from food and water will utilize 15% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
acetamiprid is not expected.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account short-term and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Acetamiprid 
is currently registered for uses that could result in short-term and 
intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with short-term and intermediate-term residential exposures to 
acetamiprid.
    Using the exposure assumptions described in this unit for short- 
and intermediate-term exposures, EPA has concluded that the combined 
short-term and intermediate-term food, water, and residential exposures 
aggregated result in an aggregate MOE of 270 for toddlers, the 
population group receiving the greatest combined short-term and 
intermediate-term risk (from the combined dermal and incidental oral 
postapplication exposures following indoor crack and crevice 
treatments). As the aggregate MOEs for short-term and intermediate-term 
exposure are greater than 100 (the LOC) for all population subgroups 
assessed, short-term and intermediate-term aggregate exposures to 
acetamiprid are not of concern to EPA.
    4. Aggregate cancer risk for U.S. population. Based on the adequate 
cancer studies in rats and mice, EPA has concluded that acetamiprid is 
not expected to pose a cancer risk to humans.
    5. 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

    The following adequate enforcement methodologies are available to 
enforce the tolerance expression: A gas chromatography with electron 
capture detection (GC/ECD) method and a high performance liquid 
chromatography with ultraviolet detection (HPLC/UV) method. 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: 
<a href="/cdn-cgi/l/email-protection#047661776d6071616961706c6b6077446174652a636b72"><span class="__cf_email__" data-cfemail="0f7d6a7c666b7a6a626a7b67606b7c4f6a7f6e21686079">[email protected]</span></a>.

B. International Residue Limits

    There are no Codex or Mexican maximum residue limits (MRLs) 
established for residues of acetamiprid on commodities associated with 
this petition. EPA is establishing a tolerance on tea, dried at 50.0 
ppm, which will harmonize with a Japanese MRL established for tea at 50 
ppm. Canada has established a MRL for acetamiprid residues on grape at 
0.20 ppm; however, the tolerance for subgroup 13-07F (including grape) 
cannot be harmonized with the Canadian MRL on grape at this time 
because field trial data shows residue levels for grape that are higher 
than 0.20 ppm.

C. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petition, EPA has 
determined that the petitioned-for tolerance with regional 
registrations on tea at 50 ppm should be established as a tolerance 
with no U.S. registrations on tea, dried at 50.0 ppm. At least one U.S. 
residue field trial study is required to establish a domestic 
registration on tea; however, no U.S. residue field trial data were 
submitted in support of the use of acetamiprid on tea. Therefore, the 
Agency has established a tolerance with no U.S. registrations on tea, 
dried at 50.0 ppm. EPA has also revised the tolerance expression in 
paragraphs (a)(1), (a)(2) and (c) of Sec. 180.578 to clarify (1) that, 
as provided in FFDCA section 408(a)(3), the tolerance covers 
metabolites and degradates of

[[Page 6582]]

acetamiprid not specifically mentioned; and (2) that compliance with 
the specified tolerance levels is to be determined by measuring only 
the specific compounds mentioned in the tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of acetamiprid, 
N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine, in or on 
fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 
0.35 ppm; tea, dried at 50.0 ppm; clover, forage at 0.10 ppm; and 
clover, hay at 0.01 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled 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 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 tolerances 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 9, 2000) do not apply to this final rule. In addition, 
this final 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: February 1, 2010.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.578 is amended by revising the introductory text in 
paragraphs (a)(1) and (a)(2); removing the entry for ``Grape'' from the 
table in paragraph (a)(1); alphabetically adding ``Fruit, small, vine 
climbing, except fuzzy kiwifruit, subgroup 13-07F'' and ``Tea, dried'' 
to the table in paragraph (a)(1); and revising paragraph (c). The added 
and revised text reads as follows:


Sec.  180.578  Acetamiprid; tolerances for residues.

    (a) * * *
    (1) Tolerances are established for residues of the insecticide 
acetamiprid N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-
methylacetamidine, including its metabolites and degradates, in or on 
the commodities in the table below as a result of the application of 
acetamiprid. Compliance with the tolerance levels specified below is to 
be determined by measuring only acetamiprid in or on the following 
commodities.

------------------------------------------------------------------------
              Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Fruit, small, vine climbing, except                                 0.35
 fuzzy kiwifruit, subgroup 13-07F...
                                * * * * *
Tea, dried1.........................                                50.0
                               * * * * *
------------------------------------------------------------------------
1There are no U.S. registrations as of February 10, 2010, for the use of
  acetamiprid on dried tea.

    (2) Tolerances are established for residues of the insecticide 
acetamiprid N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-
methylacetamidine, including its metabolites and degradates, in or on 
the commodities in the table below as a result of the application of 
acetamiprid. Compliance with the tolerance levels specified below is to 
be determined by measuring acetamiprid and N1-[(6-chloro-3-
pyridyl)methyl]-N2-cyano-acetamidine in or on the following 
commodities.
    * * * * *

[[Page 6583]]

    (c) Tolerances with regional registrations. Tolerances with 
regional registrations are established for residues of the insecticide 
acetamiprid N1-[(6-chloro-3-pyridyl)methyl]-N2- cyano-N1-
methylacetamidine, including its metabolites and degradates, in or on 
the commodities in the table below as a result of the application of 
acetamiprid. Compliance with the tolerance levels specified below is to 
be determined by measuring only acetamiprid in or on the following 
commodities.

------------------------------------------------------------------------
              Commodity                        Parts per million
------------------------------------------------------------------------
Clover, forage......................                                0.10
Clover, hay.........................                                0.01
------------------------------------------------------------------------

    * * * * *
[FR Doc. 2010-2803 Filed 2-9-10; 8:45 am]
BILLING CODE 6560-50-S


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