[Federal Register Volume 72, Number 228 (Wednesday, November 28, 2007)]
[Rules and Regulations]
[Pages 67256-67262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23055]


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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.

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SUMMARY: This regulation establishes tolerances for residues of 
acetamiprid 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 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 (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: [email protected].

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:

[[Page 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 (7502P), 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, N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-
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-2004-0223, 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, N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-
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.

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 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....'' These provisions were added to FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    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 
tolerance for residues of acetamiprid 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. EPA's 
assessment of exposures and risks associated with establishing the 
tolerance 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. 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-2007-0105-0003 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 be 
adaptive; it is likely that the

[[Page 67258]]

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 gain) 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 Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) 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 LOC 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 LOC by all applicable UFs. 
Short-term, intermediate-term, and long-term risks are evaluated by 
comparing aggregate exposure to the LOC 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.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 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/Commercial Insecticide/Termiticide Uses in docket ID 
number EPA-HQ-OPP-2007-0105.

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)(1) 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)(1) 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%),

[[Page 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/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 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 control on pets).
    Acetamiprid 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 determined that 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 not expected. Post-application 
exposures of adults 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; (ii) 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. For these reasons, EPA assessed only residential 
handler dermal exposures from the gel bait uses of acetamiprid.
    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 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

[[Page 67260]]

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 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

    1. 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 and 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 1X. 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 LOC 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 LOC 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).

[[Page 67261]]

    Acetamiprid 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: [email protected].

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 the 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: (1) 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, 
N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-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 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

[[Page 67262]]

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 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: November 14, 2007.
Donald R. Stubbs,
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 alphabetically adding the following 
commodities to the table in paragraph (a)(1) to read as follows:


Sec.  180.578  Acetamiprid; tolerances for residues.

    (a) General. * * *
    (1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Almond, hulls........................................                5.0
                                * * * * *
Fruit, stone, group 12, except plum, prune...........               1.20
                                * * * * *
Nut, tree, group 14..................................               0.10
Pea and bean, succulent shelled, subgroup 6B.........               0.40
Pistachio............................................               0.10
Plum, prune, dried...................................               0.40
Plum, prune, fresh...................................               0.20
                                * * * * *
Vegetable, cucurbit, group 9.........................               0.50
                                * * * * *
Vegetable, legume, edible podded, subgroup 6A........               0.60
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E7-23055 Filed 11-27-07; 8:45 am]
BILLING CODE 6560-50-S