[Federal Register Volume 77, Number 60 (Wednesday, March 28, 2012)]
[Rules and Regulations]
[Pages 18710-18716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7461]



[[Page 18710]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0403; FRL-9340-7]


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 or on food/feed handling establishments and soybeans. 
Nippon Soda Co., Ltd., c/o Nisso America, Inc., requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 28, 2012. Objections and 
requests for hearings must be received on or before May 29, 2012, 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-2011-0403. 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: Jennifer Urbanski, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 347-0156; email 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).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     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 site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 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-2011-0403 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
May 29, 2012. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2011-0403, by one of the following methods:
     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 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. Summary of Petitioned-For Tolerance

    EPA has received two petitions for tolerances for the insecticide 
acetamiprid. In the Federal Register of March 29, 2011 (76 FR 17374) 
(FRL-8867-4), 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 0F7812) 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 acetamiprid, N 1-[(6-chloro-3-pyridyl)methyl]-N 2-cyano-N 1-
methylacetamidine, including its metabolites and degradates, in or on 
food/feed handling establishments at 0.05 parts per million (ppm). That 
notice referenced a summary of the petition prepared by Nippon Soda 
Co., Ltd., the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    In the Federal Register of July 6, 2011 (76 FR 39358) (FRL-8875-6), 
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 1F7844) 
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 acetamiprid, N 1-
[(6-chloro-3-pyridyl)methyl]-N 2-cyano-N 1-methylacetamidine, in or on 
soybean, seed at 0.02 ppm and soybean, hulls at 0.04 ppm. That notice 
referenced a summary of the petition prepared by

[[Page 18711]]

Nippon Soda Co., Ltd., the registrant, which is available in the 
docket, http://www.regulations.gov. One comment was received on the 
notice of filing. EPA's response to this comment is discussed in Unit 
IV.C.
    Based upon review of the data supporting the petitions, EPA has 
revised the tolerance associated with use in food handling 
establishments to 0.01 ppm in all food/feed items other than those 
covered by a higher tolerance from use on growing crops. EPA has also 
revised the tolerance to 0.03 ppm in soybean, seed and has added a 
tolerance of 5.0 ppm for grain, aspirated fractions. The reason for 
this change is explained in Unit IV.D.

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. * * 
*''
    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 acetamiprid including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with acetamiprid 
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 and vaginal opening 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.
    In 4-week immunotoxicity studies performed in both sexes of rats 
and mice, no effects on the immune system were observed up to the 
highest dose, although significant reductions in body weight and body 
weight gain were noted at that dose.
    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 New Uses on Soybean and in Food/Feed Handling 
Establishments'' at pages 29-34 in docket ID number EPA-HQ-OPP-2011-
0403.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). 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 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 human risk 
assessment is shown in Table 1 of this unit.

[[Page 18712]]



  Table 1--Summary of Toxicological Doses and Endpoints for Acetamiprid for Use in Human Health Risk Assessment
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                                      Point of departure and
         Exposure/scenario              uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors                assessment                  effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population    NOAEL = 10 mg/kg/day     Acute RfD = 0.10 mg/kg/ Developmental
 including infants and children).    UFA = 10x                 day                     Neurotoxicity in Rat
                                     UFH = 10x                aPAD = 0.10 mg/kg/day    LOAEL = 45 mg/kg/day
                                     FQPA SF = 1x                                      based on decreased early
                                                                                       pup survival on PND 0-1,
                                                                                       and decreased startle
                                                                                       response on PND 20/60 in
                                                                                       males.
                                                                                      Acute Neurotoxicity Study
                                                                                       in Rat.
                                                                                      LOAEL = 30 mg/kg/day based
                                                                                       on decreased locomotor
                                                                                       activity.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)..  NOAEL= 7.1 mg/kg/day     Chronic RfD = 0.071 mg/ Chronic Toxicity/
                                     UFA = 10x                 kg/day                  Oncogenicity Study in
                                     UFH = 10x                cPAD = 0.071 mg/kg/day   Rats.
                                     FQPA SF = 1x                                     LOAEL = 17.5 mg/kg/day
                                                                                       based on decreased body
                                                                                       weight and body weight
                                                                                       gains in females and
                                                                                       hepatocellular
                                                                                       vacuolation in males.
----------------------------------------------------------------------------------------------------------------
Incidental oral short- and           NOAEL = 10 mg/kg/day     LOC for MOE = 100       Developmental
 intermediate-term (1 to 30 days     UFA = 10x                                         Neurotoxicity in Rat.
 and 1 to 6 months).                 UFH = 10x                                        LOAEL = 45 mg/kg/day based
                                     FQPA SF = 1x                                      on decreased body weight
                                                                                       and body weight gains in
                                                                                       offspring, decreased
                                                                                       early pup survival on PND
                                                                                       0-1, and decreased
                                                                                       startle response on PND
                                                                                       20/60 in males.
----------------------------------------------------------------------------------------------------------------
Dermal short- and intermediate-term  Dermal (or oral) study   LOC for MOE = 100       Developmental
 (1 to 30 days and 1 to 6 months).   NOAEL = 10 mg/kg/day                              Neurotoxicity in Rat.
                                      (dermal absorption                              LOAEL = 45 mg/kg/day based
                                      rate = 10%                                       on decreased body weight
                                     UFA = 10x                                         and body weight gains in
                                     UFH = 10x                                         offspring, decreased
                                     FQPA SF = 1x                                      early pup survival on PND
                                                                                       0-1, and decreased
                                                                                       startle response on PND
                                                                                       20/60 in males.
----------------------------------------------------------------------------------------------------------------
Inhalation short- and intermediate-  Inhalation (or oral)     LOC for MOE = 100       Developmental
 term (1 to 30 days and 1 to 6        study NOAEL = 10 mg/kg/                          Neurotoxicity in Rat.
 months).                             day (inhalation                                 LOAEL = 45 mg/kg/day based
                                      absorption rate =                                on decreased body weight
                                      100%)                                            and body weight gains in
                                     UFA = 10x                                         offspring, decreased
                                     UFH = 10x                                         early pup survival on PND
                                     FQPA SF = 1x                                      0-1, and decreased
                                                                                       startle response on PND
                                                                                       20/60 in males.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..  Not likely to be carcinogenic to humans (2005 revised Agency cancer
                                      guidelines).
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies).
UFH = potential variation in sensitivity among members of the human population (intraspecies).
FQPA SF = Food Quality Protection Act Safety Factor.
PAD = population adjusted dose (a = acute, c = chronic).
RfD = reference dose.
MOE = margin of exposure.
LOC = level of concern.

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. Such effects were identified 
for acetamiprid.
    In estimating acute dietary exposure, EPA used food consumption 
information from the United States Department of Agriculture (USDA) 
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII). As to residue levels in food, EPA performed acute 
analyses based on tolerance level residues and assumed 100% crop 
treated. Empirical processing factors were used for processed 
commodities unless such data were not available, in which case 
DEEMTM default processing factors from Version 7.81 were 
used.
    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 performed chronic 
analyses based on tolerance level residues and assumed 100% crop 
treated. Empirical processing factors were used for processed 
commodities unless such data were not available, in which case DEEM\TM\ 
default processing factors from Version 7.81 were used.
    iii.  Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that acetamiprid does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for acetamiprid. Tolerance level residues and/or 
100% CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary

[[Page 18713]]

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 95.2 parts per billion (ppb) for acute exposures 
and 26.6 ppb for chronic exposure. For ground water, the EDWC is 0.035 
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 95.2 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 26.6 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 uses that 
could result in residential exposures: Indoor and outdoor residential 
settings, including crack and crevice and spray applications. Mattress 
treatments were also assessed as there is a pending application for 
this use. EPA assessed the following residential exposure scenarios: 
Exposure for adults (from short-term dermal and inhalation exposure) 
applying crack and crevice and mattress treatments; and postapplication 
exposure for adults (from short- and intermediate-term dermal and 
inhalation exposure) and for children 3-6 years old (from short- and 
intermediate-term dermal, inhalation and hand-to-mouth exposure) 
following crack and crevice and mattress treatments. Further 
information regarding EPA standard assumptions and generic inputs for 
residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 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 Web site 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 Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor 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 and vaginal opening, 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. With the exception of a subchronic inhalation study, the 
toxicity database for acetamiprid is complete. Currently, inhalation 
exposure is being assessed by

[[Page 18714]]

using hazard information from the developmental neurotoxicity study, 
which is an oral study. The inhalation risks estimated by this approach 
are very low. Application of a 10-fold factor to account for the 
uncertainty associated with this approach would not result in risk 
estimates of concern.
    ii. Acetamiprid produced signs of neurotoxicity in the high dose 
groups in the acute and developmental neurotoxicity studies in rats. 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. However, no neurotoxic findings were reported in the subchronic 
neurotoxicity study. There was a decrease in the auditory startle 
response in the male rats in the DNT. Tremors in the high dose female 
mice in the subchronic feeding study were the only other potentially 
neurotoxic effects observed in the other studies. EPA has selected 
doses and endpoints for risk assessment that account for these 
neurological effects; therefore, the Agency has no residual concern 
regarding neurotoxicity with respect to being protective of human 
health.
    iii. EPA determined that neither quantitative nor qualitative 
evidence of increased susceptibility of fetuses to in utero exposure to 
acetamiprid was observed in either the developmental toxicity study in 
rat or rabbit. However, in the 2-generation reproduction study, 
qualitative evidence of increased susceptibility of rat pups was 
observed. While parental and offspring NOAELs and LOAELs are set at the 
same doses, the effects in the offspring (including decreased 
viability) are considered to be more severe than those observed in the 
parents (decreased body weight and decreased weight gain). In the DNT 
study, maternal and offspring effects were observed at the same dose. 
However, the offspring effects included decreased pup viability which 
is considered to be more severe than the maternal body weight effects. 
Therefore, EPA concluded that there was evidence of increased 
qualitative susceptibility to fetuses exposed in utero and/or during 
lactation in the DNT study. Quantitative evidence of increased 
susceptibility was not observed in any study.
    Since there is evidence of increased qualitative susceptibility of 
the young following in utero exposure to acetamiprid in the rat 
reproduction study, and increased qualitative susceptibility to pups in 
the DNT study, 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.
    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 
study as low, noting that there is a clear NOAEL for the offspring 
effects and regulatory doses were selected to be protective of these 
effects. No other residual uncertainties were identified. EPA believes 
that the endpoints and doses selected for acetamiprid are protective of 
adverse effects in both offspring and adults.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary exposure assessments were based on tolerance 
level residues and assumed 100% crop treated. Empirical processing 
factors were used for processed commodities unless such data were not 
available, in which case DEEM\TM\ default processing factors from 
Version 7.81 were used. EPA made conservative (protective) assumptions 
in the ground water 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 dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    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 50% of the aPAD for children 1-2 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 33% of the cPAD for 
children 1-2 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- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- 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- and 
intermediate-term residential exposure, and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with short- and intermediate-term residential exposures to 
acetamiprid.
    Using the exposure assumptions described in this unit for short- 
and intermediate-term exposures, EPA has concluded the combined short- 
and intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 350 for adults and 160 for children aged 3-5 years. 
Because EPA's level of concern for acetamiprid is a MOE of 100 or 
below, these MOEs are not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, 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

    Adequate enforcement methodology (LC-MS/MS, Method KP-
216R0 and its variant KP-216R1) is available to enforce the 
tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email 
address: [email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural

[[Page 18715]]

practices. EPA considers the international maximum residue limits 
(MRLs) established by the Codex Alimentarius Commission (Codex), as 
required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint 
U.N. Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level. The Codex has not 
established a MRL for acetamiprid.

C. Response to Comments

    An anonymous citizen objected to the presence of any pesticide 
residues on food. The Agency understands the commenter's concerns and 
recognizes that some individuals believe that pesticides should be 
banned completely. However, the existing legal framework provided by 
section 408 of the FFDCA contemplates that tolerances greater than zero 
may be set when persons seeking such or exemptions have demonstrated 
that the pesticide meets the safety standard imposed by that statute. 
This citizen's comment appears to be directed at the underlying statute 
and not EPA's implementation of it; the citizen has made no contention 
that EPA has acted in violation of the statutory framework.

D. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petition, EPA has 
determined that the requested tolerance (0.02 ppm) for soybean seed is 
too low. Residues in field trials (maximum = 0.025 ppm) exceed the 
requested tolerance level and therefore the Agency has established a 
tolerance of 0.03 ppm for soybean seed using the Organization for 
Economic Cooperation and Development tolerance calculation procedures. 
Although there was no petitioned-for tolerance for aspirated grain 
fractions and residue data was not provided for this commodity, EPA 
determined that such a tolerance is needed. In processing studies, 
residues concentrated in soybean hulls by 1.65X, indicating the 
potential for concentration into aspirated grain fractions. In lieu of 
empirical data, the Agency used a theoretical concentration factor of 
200X to derive a tolerance level for aspirated grain fractions of 5.0 
ppm. EPA is establishing a tolerance at that level. The petitioned-for 
tolerance for food-feed handling establishments (0.05 ppm) has the 
potential to confound enforcement actions for field crops that have a 
tolerance for residues of acetamiprid of less than 0.05 ppm. Given the 
residue levels observed in the food-feed handling establishment study 
in conjunction with the exaggerated application rate in that study, 
residues of acetamiprid are not expected to exceed 0.01 ppm as a result 
of the requested use in such facilities. Therefore, the Agency has 
established a tolerance of 0.01 ppm in all food/feed items other than 
those covered by a higher tolerance from use on growing crops. EPA has 
also revised the tolerance expression in paragraphs (a)(1), (a)(2) and 
(c) to correct the name of the chemical to (1E)-N-[(6-chloro-3-
pyridinyl)methyl]-N'-cyano-N-methylethanimidamide.

V. Conclusion

    Therefore, tolerances are established for residues of acetamiprid, 
(1E)-N-[(6-chloro-3-pyridinyl)methyl]-N'-cyano-N-methylethanimidamide, 
in or on soybean, seed at 0.03 ppm; soybean, hulls at 0.04 ppm; grain, 
aspirated fractions at 5.0 ppm; and commodities treated in food/feed 
handling establishments 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 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 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) (Pub. L. 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.


[[Page 18716]]


    Dated: March 16, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    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 as follows:
0
i. Revising the introductory text of paragraphs (a)(1), (a)(2), and 
(c).
0
ii. Adding alphabetically the commodities ``Grain, aspirated 
fractions'', ``Soybean, hulls'' and ``Soybean, seed'' to the table in 
paragraph (a)(1).
0
iii. Adding paragraph (a)(3).


Sec.  180.578  Acetamiprid; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide acetamiprid (1E)-N-[(6-chloro-3-pyridinyl)methyl]-N'-cyano-
N-methylethanimidamide, 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.

 
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Grain, aspirated fractions..................................        5.0
 
                                * * * * *
Soybean, hulls..............................................        0.04
Soybean, seed...............................................        0.03
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (2) Tolerances are established for residues of the insecticide 
acetamiprid (1E)-N-[(6-chloro-3-pyridinyl)methyl]-N'-cyano-N-
methylethanimidamide, 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 (1E)-N-[(6-chloro-3-
pyridinyl)methyl]-N'-cyano-N-ethanimidamide in or on the following 
commodities.
* * * * *
    (3) A tolerances of 0.01 ppm is established for residues of the 
insecticide acetamiprid, including its metabolites and degradates, in 
or on all food/feed items (other than those covered by a higher 
tolerance in paragraph (a)(1) or (a)(2) of this section as a result of 
the use on growing crops) as a result of the application of acetamiprid 
in food/feed handling establishments. Compliance with the 0.01 ppm 
tolerance level is to be determined by measuring only acetamiprid (1E)-
N-[(6-chloro-3-pyridinyl)methyl]-N'-cyano-N-methylethanimidamide in or 
on the commodities.
* * * * *
    (c) Tolerances with regional registrations. Tolerances with 
regional registrations are established for residues of the insecticide 
acetamiprid (1E)-N-[(6-chloro-3-pyridinyl)methyl]-N'-cyano-N-
methylethanimidamide, 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.
* * * * *
[FR Doc. 2012-7461 Filed 3-27-12; 8:45 am]
BILLING CODE 6560-50-P