[Federal Register Volume 77, Number 143 (Wednesday, July 25, 2012)]
[Rules and Regulations]
[Pages 43524-43529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18059]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0792; FRL-9352-8]


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 multiple commodities which are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective July 25, 2012. Objections and 
requests for hearings must be received on or before September 24, 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2011-0792, is available at http://www.regulations.gov or at the OPP Docket in the Environmental 
Protection Agency Docket Center (EPA/DC), located in EPA West, Rm. 
3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; 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-2011-0792 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 
September 24, 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-2011-0792, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting 
comments. Do not submit electronically any information you consider to 
be Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection 
Agency Docket Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania 
Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for 
hand delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of November 9, 2011 (76 FR 69690) (FRL-
9325-1), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
1E7919) by Interregional Research Project Number 4 (IR-4), 500 College 
Road East, Suite 201 W, Princeton, NJ 08540. The petition requested 
that 40 CFR 180.578 be amended by establishing tolerances for residues 
of the insecticide acetamiprid, N 1-[(6-chloro-3-pyridyl)methyl]- N 2-
cyano- N 1-methylacetamidine, in or on asparagus at 0.8 ppm; Brassica, 
leafy greens, subgroup 5B at 15 parts per million (ppm); turnip greens 
at 15 ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; 
corn, sweet, forage at 10 ppm; corn, sweet, stover at 30 ppm; 
vegetable, fruiting, group 8-10 at 0.20 ppm; fruit, citrus, group 10-10 
at 0.50 ppm; fruit, pome, group 11-10 at 1.0 ppm; and Brassica, head 
and stem, subgroup 5A at 1.20 ppm. It also requested that upon approval 
of the aforementioned tolerances, to remove the established tolerances 
in 40 CFR 180.578 for fruit, citrus, group 10 at 0.50 ppm; fruit, pome, 
group 11 at 1.0 ppm; vegetable, fruiting, group 8 at 0.20 ppm; and 
vegetable, Brassica, leafy, group 5 at 1.20 ppm. The fruit, citrus, 
group 10; fruit, pome, group 11; and vegetable, fruiting, group 8 
tolerances will be superseded by the updated crop group tolerances. The 
vegetable, Brassica, leafy group 5 tolerance will be superseded by the 
Brassica, leafy greens, subgroup 5B and Brassica, head and stem, 
subgroup 5A tolerances. That

[[Page 43525]]

notice referenced a summary of the petition prepared by Nisso America, 
Inc., 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 petition, EPA is not 
establishing tolerances for sweet corn and its related commodities. The 
reason for these changes 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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for 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 in acute lethality studies 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); the effects were considered to be 
adaptive. Other effects observed in the oral studies include 
amyloidosis of multiple organs in the mouse oncogenicity study, tremors 
in high dose females in the mouse subchronic study, and 
microconcretions in the kidney papilla and mammary hyperplasia in the 
rat chronic/oncogenicity study. No effects were observed in a dermal 
toxicity study in rabbits.
    In the rat developmental study, fetal shortening of the 13th rib 
was observed in fetuses at the same dose level that produced maternal 
effects (reduced body weight and body weight gain and increased liver 
weights). In the developmental rabbit study, no developmental effects 
were observed in fetuses at doses that reduced maternal body weight and 
food consumption. In the reproduction study, decreased body weight, 
body weight gain, and food consumption were observed in parental 
animals while significant reductions in pup weights were seen in the 
offspring in both generations. Also observed were reduction in litter 
size, and viability and weaning indices among F2 offspring 
as well as significant delays in the age to attain vaginal opening and 
preputial separation. In the developmental neurotoxicity study, 
parental effects were limited to decreased body weight and body weight 
gains, while the offspring effects noted were decreased body weights 
and body weight gains, decreased pre-weaning survival (post-natal days 
(PNDs) 0-1), and decreased maximum auditory startle response in males 
on PNDs 20 and 60.
    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 
developmental neurotoxicity study; additionally, tremors were noted in 
female mice at the HDT in the subchronic feeding study.
    In four 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.'' The classification is based on the absence of an increase in 
the incidence of tumors in a mouse carcinogenicity study; and in a rat 
chronic/carcinogenicity study, the absence of a dose-response and the 
lack of a statistically significant increase in the mammary 
adenocarcinoma incidence by pair-wise comparison of the mid- and high-
dose groups with the controls (although the incidence exceeded the 
historical control data from the same laboratory, it was within the 
range of values from the supplier). There was no clear evidence of a 
mutagenic effect. Acetamiprid tested positive as a clastogen in an in 
vitro study but not in an in vivo study.
    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 titled ``Acetamiprid: Human Health 
Risk Assessment for New Uses on Asparagus; Brassica, Leafy Greens, 
Subgroup 5B, and Turnip Greens; and Sweet Corn; and Updated Crop Group 
Definitions for Fruiting Vegetables, Citrus, and Pome Fruit'', pp. 35-
40 in docket ID number EPA-HQ-OPP-2011-0792.

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

[[Page 43526]]

reference dose (RfD)--and a safe margin of exposure (MOE) or aggregate 
risk index (ARI). 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 used for 
human risk assessment is shown in the Table of this unit.

   Table--Summary of Toxicological Doses and Endpoints for Acetamiprid for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                     Point of departure and
        Exposure/scenario              uncertainty/safety      RfD, PAD, LOC for risk    Study and toxicological
                                            factors                  assessment                  effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)..  NOAEL = 10 mg/kg/day UFA   Acute RfD = 0.10 mg/kg/   Co-critical studies.
                                    = 10x                      day                      Developmental
                                   UFH = 10x                  aPAD = 0.10 mg/kg/day      Neurotoxicity in rat.
                                   FQPA SF = 1x                                         LOAEL = 45 mg/kg/day
                                                                                         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.
----------------------------------------------------------------------------------------------------------------
Short- and Intermediate-Term       NOAEL= 10 mg/kg/day        LOC for MOE = 100         Developmental
 Incidental Oral. (1-30 days and   UFA = 10x                                             Neurotoxicity in rat.
 1-6 months).                      UFH = 10x                                            LOAEL = 45 mg/kg/day
                                   FQPA SF = 1x                                          based on decreased body
                                                                                         weight and body weight
                                                                                         gains in offspring,
                                                                                         decreased early pup
                                                                                         survival on PND 0-1,
                                                                                         and decreased startle
                                                                                         response on PND 20/60
                                                                                         in males.
----------------------------------------------------------------------------------------------------------------
Short- and Intermediate-term       NOAEL= 10 mg/kg/day        LOC for MOE = 100         Developmental
 Dermal. (1-30 days, 1-6 months).  Dermal Absorption Rate =                              Neurotoxicity in rat.
                                    10%                                                  LI>LOAEL = 45 mg/kg/day
                                   UFA= 10x                                              based on decreased body
                                   UFH= 10x                                              weight and body weight
                                   FQPA SF = 1x                                          gains in offspring,
                                                                                         decreased early pup
                                                                                         survival on PND 0-1,
                                                                                         and decreased startle
                                                                                         response on PND 20/60
                                                                                         in males.
----------------------------------------------------------------------------------------------------------------
Short- and Intermediate-term       Oral study NOAEL= 10 mg/   LOC for MOE = 1,000       Developmental
 Inhalation (1-30 days, 1-6         kg/day. UFA = 10x                                    Neurotoxicity in rat.
 months).                          UFH = 10x                                            LOAEL = 45 mg/kg/day
                                   FQPA SF = 1x                                          based on decreased body
                                   UFDB = 10x                                            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.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies). PND = post-natal day.

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 the 
acute analysis based on tolerance level residues and assumed 100 
percent crop treated (PCT). Empirical processing factors were used for 
processed commodities unless such data were not available, in which 
case dietary exposure evaluation model (DEEM) 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 the chronic 
analysis based on tolerance level residues and assumed 100 PCT. 
Empirical processing factors were used for processed commodities unless 
such data were not available, in which case DEEM 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 PCT information. EPA did not use

[[Page 43527]]

anticipated residue and/or PCT information in the dietary assessment 
for acetamiprid. Tolerance level residues and/or 100 PCT were assumed 
for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for acetamiprid in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of acetamiprid. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models the estimated 
drinking water concentrations (EDWCs) of acetamiprid for surface water 
are estimated to be 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 residential exposure using the following 
assumptions: 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.
    Dermal, oral, and inhalation risks for short- and intermediate-term 
exposures were combined since the toxicological endpoints and points of 
departure were the same. However, due to the lack of the required 
inhalation toxicity study, the Agency has determined that a 10X FQPA 
factor must be retained as a database uncertainty factor for inhalation 
exposure only, raising the LOC to 1,000 for inhalation scenarios. As 
such, the level of concern (LOC) values were different (i.e. dermal and 
oral LOC = 100, while inhalation LOC = 1,000) and therefore, the 
respective risk estimates are combined using the aggregate risk index 
(ARI) approach. This approach reflects risk estimates resulting from 
exposure via the dermal, inhalation, and oral routes. An ARI of greater 
than 1 indicates risks that are not of concern.
    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.''
    EPA has not found acetamiprid to share a common mechanism of 
toxicity with any other substances, and acetamiprid does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
acetamiprid does not have 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 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 pre- and postnatal 
toxicology database for acetamiprid includes rat and rabbit 
developmental toxicity studies, a 2-generation reproduction toxicity 
study in rats and a developmental-neurotoxicity study (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 
developmental neurotoxicity and 2-generation reproduction studies 
showed an increase in qualitative susceptibility of pups to 
acetamiprid. 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 developmental neurotoxicity 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 maternal toxicity (decreased 
body weight and body weight gain. No evidence of increased quantitative 
susceptibility was observed in the studies.
    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 for dermal and oral exposure pathways. 
However, a 10X SF is being retained as a database uncertainty factor 
for assessing inhalation exposure and risk only. This decision is based 
on the following findings:
    i. The toxicology data base is complete (with the exception of an 
inhalation study) and acceptable guideline studies for developmental, 
reproductive toxicity, neurotoxicity (including DNT) and immunotoxicity 
are available.
    ii. Acetamiprid produced signs of neurotoxicity in the high dose 
groups in the acute and developmental neurotoxicity studies in rats and 
the subchronic toxicity study in mice. However, no neurotoxic findings 
were reported in the subchronic neurotoxicity study in rats. 
Additionally, there are clear NOAELs identified for the effects 
observed in the toxicity studies. The doses and endpoints selected for 
risk assessment are protective and account for all toxicological 
effects observed in the database.

[[Page 43528]]

    iii. No quantitative or qualitative evidence of increased 
susceptibility of fetuses to in utero exposure to acetamiprid was 
observed in either the developmental toxicity study in rats or rabbits. 
Although increased qualitative susceptibility was seen in the 
reproduction toxicity and the DNT study, the degree of concern for the 
effects is low. There are clear NOAELs for the offspring effects and 
regulatory doses were selected to be protective of these effects. No 
other residual uncertainties were identified with respect to 
susceptibility. The endpoints and doses selected for acetamiprid are 
protective of adverse effects in both offspring and adults.
    iv. Currently, inhalation exposure is being assessed using hazard 
information from the developmental neurotoxicity study, which is an 
oral study. In the absence of an inhalation study, there is uncertainty 
about potential portal of entry effects occurring via the inhalation 
route of exposure. Therefore, EPA is recommending a 28-day inhalation 
study and retaining a 10X FQPA factor as a database uncertainty factor 
for the inhalation route of exposure only, pending submission of the 
required study.
    v. The exposure databases (dietary food, drinking water, and 
residential) are complete and the risk assessment for each potential 
exposure scenario includes all metabolites and/or degradates of concern 
and does not underestimate the potential risk to infants or children. 
The dietary exposure assessments were based on tolerance level residues 
and assumed 100 PCT. Empirical processing factors were used for 
processed commodities unless such data were not available, in which 
case DEEM default processing factors from Version 7.81 were used. EPA 
made conservative (protective) assumptions in the ground and surface 
water modeling used to assess exposure to acetamiprid in drinking 
water. EPA used similarly conservative assumptions to assess 
postapplication exposure of children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by acetamiprid.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic 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 ARI 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 52% 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 ARIs of 3.41 for adults and 1.45 for children. Because EPA's 
level of concern for acetamiprid is an ARI of 1 or below, these ARIs 
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 liquid chromatography/mass 
spectrometry mass spectrometry (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 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 United Nations 
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.
    For the specific new use commodities associated with this tolerance 
petition, 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 the EPA has acted in violation of the statutory framework.

D. Revisions to Petitioned-For Tolerances

    EPA has determined that the available data are insufficient for 
establishing the proposed tolerances on sweet corn. Five additional 
field trials are required to support this use.

[[Page 43529]]

V. Conclusion

    Therefore, tolerances are established for residues of acetamiprid, 
N 1-[(6-chloro-3-pyridyl)methyl]- N 2-cyano- N 1-methylacetamidine, in 
or on asparagus at 0.80 ppm; Brassica, leafy greens, subgroup 5B at 15 
ppm; turnip greens at 15 ppm; vegetable, fruiting, group 8-10 at 0.20 
ppm; fruit, citrus, group 10-10 at 0.50 ppm; fruit, pome, group 11-10 
at 1.0 ppm; and Brassica, head and stem, subgroup 5A at 1.20 ppm.
    Also, due to the tolerances established in this unit by this 
document, the following existing tolerances are removed as unnecessary: 
Fruit, citrus, group 10; fruit, pome, group 11; vegetable, fruiting, 
group 8; and vegetable, Brassica, leafy, group 5.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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.

    Dated: July 17, 2012.
Daniel J. Rosenblatt,
Acting 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 by removing the entries for ``fruit, 
citrus, group 10''; ``fruit, pome, group 11''; ``vegetable, fruiting, 
group 8''; and ``vegetable, Brassica, leafy, group 5'' and by 
alphabetically adding the following entries to the table in paragraph 
(a)(1) to read as follows:


Sec.  180.578  Acetamiprid; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Asparagus....................................................       0.80
 
                                * * * * *
Brassica, head and stem, subgroup 5A.........................       1.20
Brassica, leafy greens, subgroup 5B..........................         15
 
                                * * * * *
Fruit, citrus, group 10-10...................................       0.50
Fruit, pome, group 11-10.....................................        1.0
 
                                * * * * *
Turnip greens................................................         15
 
                                * * * * *
Vegetable, fruiting, group 8-10..............................       0.20
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-18059 Filed 7-24-12; 8:45 am]
BILLING CODE 6560-50-P