[Federal Register Volume 78, Number 118 (Wednesday, June 19, 2013)]
[Rules and Regulations]
[Pages 36671-36677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-14653]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0626; FRL-9391-2]


Acetamiprid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances and modifies existing 
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 June 19, 2013. Objections and 
requests for hearings must be received on or before August 19, 2013, 
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-2012-0626, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., 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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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://www.ecfr.gov/cgi-bin/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-2012-0626 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 
August 19, 2013. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0626, 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 CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (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 February 27, 2013 (78 FR 13295) (FRL-
9380-2), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
3E8147) by IR-4, 500 College Road East, Suite 201W., Princeton, NJ 
08540. The petition requested that 40 CFR 180.578 be amended by 
establishing tolerances 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 corn, sweet, kernel 
plus cob with husks removed at 0.01 ppm; corn, sweet, forage at 15 ppm; 
and corn, sweet, stover at 30 ppm. The petition also proposed 
increasing the existing tolerances in fat, meat, and meat byproducts of 
cattle, goat, horse, and sheep, and milk. Tolerances in cattle, goat, 
horse, and sheep meat are proposed at 0.30 ppm; cattle, goat, horse, 
and sheep fat at 0.20 ppm; cattle, goat, horse, and sheep meat 
byproducts at 0.70 ppm; and milk at 0.30 ppm. That document referenced 
a summary of the petition prepared by Nisso America Incorporated, the 
registrant, which is available in the docket, http://www.regulations.gov.
    In the Federal Register of September 28, 2012 (77 FR 59578) (FRL-
9364-6), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
2F8060) by Nippon Soda Co., Ltd. c/o Nisso America Inc., 88 Pine St., 
14th Fl., New York, NY 10005. The petition requested that 40 CFR 
180.578 be amended by increasing the existing tolerances for residues 
of the insecticide, acetamiprid, (1E)-N-[(6-chloro-3-pyridinyl)methyl]-
N'-cyano-N-methylethanimidamide, including its metabolites and

[[Page 36672]]

degradates, in or on the citrus fruit crop group 10-10 at 1.0 ppm; and 
citrus, dried pulp at 2.4 ppm. That document referenced a summary of 
the petition prepared by Nisso America Incorporated, the registrant, 
which is available in the docket, http://www.regulations.gov.
    There were no comments received in response to either notice of 
filing.
    Based upon review of the data supporting the petition, EPA has 
determined that the existing tolerance for dried citrus pulp does not 
need to be increased. The reason for these changes is explained in Unit 
IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is 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 (1) the absence of an increase 
in the incidence of tumors in a mouse carcinogenicity study; and (2) 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 the New Use on Sweet Corn and Increased Tolerance 
on Citrus'' on pages 27-32 in docket ID number EPA-HQ-OPP-2012-0626.

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

[[Page 36673]]

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 used for 
human risk assessment is shown in Table 1 of this unit.

  Table 1--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..  Acute RfD = 0.10 mg/kg/ Co-critical studies
                                     UFA = 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 Neurotoxicity
 Incidental Oral (1-30 days and 1-6  UFA = 10x.............                           in rat.
 mo.).                               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.
Short- and Intermediate-term Dermal  Oral study NOAEL = 10   LOC for MOE = 100.....  Developmental Neurotoxicity
 (1-30 days, 1-6 mo.).                mg/kg/day dermal                                in rat.
                                      absorption rate = 10%.                         LOAEL = 45 mg/kg/day based
                                     UFA = 10x.............                           on decreased body weight
                                     UFH = 10x.............                           and body weight gains in
                                     FQPA SF = 1x..........                           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   LOC for MOE = 100.....  Developmental Neurotoxicity
 Inhalation (1-30 days, 1-6 mo.).     mg/kg/day (inhalation                           in rat.
                                      absorption rate =                              LOAEL = 45 mg/kg/day based
                                      100%).                                          on decreased body weight
                                     UFA = 10x.............                           and body weight gains in
                                     UFH = 10x.............                           offspring, decreased early
                                     FQPA SF = 1x..........                           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). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

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 2003-2008 U.S. Department of 
Agriculture's (USDA's) National Health and Nutrition Examination 
Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in 
food, EPA assumed 100 percent crop treated (PCT) and tolerance level 
residues in the assessment. 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.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the 2003-2008 USDA 
NHANES/WWEIA. As to residue levels in food, EPA assumed 100 PCT and 
tolerance level residues in the assessment. 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 
anticipated residue and/or PCT information in the dietary assessment 
for acetamiprid. Tolerance level

[[Page 36674]]

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 
acute exposures are estimated to be 95.2 parts per billion (ppb) for 
surface water and 0.035 ppb for ground water and for chronic exposures 
are estimated to be 26.6 ppb for surface water and 0.035 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 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 mattress treatments. 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 post-application 
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.
    In the previous risk assessment for acetamiprid, EPA had concluded 
that a subchronic inhalation study was required, and an additional 10X 
FQPA factor was retained as a database uncertainty factor, which raised 
the LOC to 1,000 for inhalation scenarios. Because the LOC values were 
different (i.e. dermal and oral LOC = 100, while inhalation LOC = 
1,000) the respective risk estimates were combined using the aggregate 
risk index (ARI) approach. Since then, however, this conclusion was 
reevaluated based on a request from the registrant, and EPA has now 
concluded that this study is not required. Please refer to section 
D.3.i for further details on this inhalation study requirement 
conclusion. Therefore, the risk estimates utilize the combined MOE 
approach, as opposed to the ARI approach.
    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 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. That decision is based on the following 
findings:
    i. The toxicology data base is complete and acceptable guideline 
studies for developmental, reproductive toxicity, neurotoxicity 
(including DNT) and immunotoxicity are available.
    In determining the need for a subchronic inhalation study, EPA's 
weight of evidence decision process included both hazard and exposure 
considerations as well as incorporation of a presumed 10X Database 
Uncertainty Factor (UFdb) for the lack of this study. Thus, the 
Agency's Level of Concern in the weight of the evidence evaluation for 
inhalation exposure risk assessment is a Margin of Exposure (MOE) of 
1,000, which includes the 10X inter-species extrapolation factor, 10X 
intra-species variation factor, and the 10X UFdb. The Agency had 
previously determined that the required 21/28-day inhalation study in 
rats was needed to address data uncertainties related to potential 
inhalation risk primarily associated with occupational exposure, which 
presented the scenarios with the highest potential inhalation exposure. 
After reconsideration, EPA has determined that the inhalation study is 
no longer required, primarily because exposure levels are expected to 
be lower than

[[Page 36675]]

previously anticipated, and residential exposures are expected to be 
very low. In fact, for residential, non-dietary exposures, the use of 
an oral Point of Departure (POD) resulted in MOEs higher than the LOC 
of 1,000. This indicates that the lack of an inhalation study does not 
reduce the overall confidence in the risk assessment or result in an 
uncertainty (i.e., the study will not provide a POD sufficiently low to 
result in a risk of concern). Additionally, in the case of acetamiprid, 
the oral POD is based on a very sensitive endpoint (effects in rat 
pups) seen in a developmental neurotoxicity study. Therefore, there is 
high confidence that the Agency is not underestimating risks in the 
absence of this study. Because EPA's decision to waive the study 
essentially incorporates an additional 10X UFdb (i.e. the study was 
only waived because risks were at least 10X lower than required by use 
of the inter- and intraspecies safety factors), a second additional 10X 
FQPA SF is not being retained for the protection of infants and 
children.
    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.
    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. 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 the Dietary Exposure Evaluation Model (DEEM) default processing 
factors 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 
aPAD and 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 68% 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 60% 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 330 for adults and 120 for children. Because EPA's 
level of concern for acetamiprid is an 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 Liquid chromotagraphy with tandem 
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.
    There are currently no established Codex MRLs for acetamiprid on 
sweet corn. There are Codex MRLs on livestock commodities, with the 
revised livestock tolerances for the U.S. being higher than the Codex 
values. Given the

[[Page 36676]]

revised use pattern including sweet corn, these higher U.S. livestock 
commodity tolerances are warranted. However, this is not considered to 
be a significant trade irritant, as livestock commodities are rarely 
shipped internationally. With the citrus (crop group 10-10) tolerance 
increase to 1.0 ppm, the U.S. will be harmonized with Codex MRLs.

C. Revisions to Petitioned-For Tolerances

    For citrus, dried pulp, based on a review of the residue data, the 
Agency has determined that a revised citrus pulp tolerance is not 
needed and that the existing tolerance of 1.2 ppm is adequate.

 V. Conclusion

    Therefore, tolerances are established for residues of acetamiprid, 
(1E)-N-[(6-chloro-3-pyridinyl)methyl]-N'-cyano-N-methylethanimidamide, 
including its metabolites and degradates, in or on corn, sweet, forage 
at 15 ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; 
and corn, sweet, stover at 30 ppm. In addition, existing tolerances are 
increased as follows: Cattle, fat at 0.20 ppm; cattle, meat at 0.30 
ppm; cattle, meat byproducts at 0.70 ppm; fruit, citrus, group 10-10 at 
1.0 ppm; goat, fat at 0.20 ppm; goat, meat at 0.30 ppm; goat, meat 
byproducts at 0.70 ppm; horse, fat at 0.20 ppm; horse, meat at 0.30 
ppm; horse, meat byproducts at 0.70 ppm; milk at 0.30 ppm; and sheep, 
fat at 0.20 ppm; sheep, meat at 0.30 ppm; sheep, meat byproducts at 
0.70 ppm.

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) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: June 13, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR part 180 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. In paragraph (a)(1), add alphabetically the commodities ``corn, 
sweet, kernel plus cob with husks removed,'' ``corn, sweet, forage,'' 
``corn, sweet, stover'' to the table; and revise the entry for ``fruit, 
citrus, group 10-10''.
0
ii. In paragraph (a)(2), revise the entries for and ``cattle, fat'', 
``cattle, meat'', ``cattle, meat byproducts''; goat, fat'', ``goat, 
meat'', ``goat, meat byproducts''; ``horse, fat'', ``horse, meat'', 
``horse, meat byproducts''; ``milk''; and ``sheep, fat'', ``sheep, 
meat'', and ``sheep, meat byproducts''.
    The additions and revisions read as follows:


Sec.  180.578  Acetamiprid; tolerances for residues.

    (a)(1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Corn, sweet, kernel plus cob with husks removed.........            0.01
Corn, sweet, forage.....................................              15
Corn, sweet, stover.....................................              30
 
                                * * * * *
Fruit, citrus, group 10-10..............................             1.0
 
                                * * * * *
------------------------------------------------------------------------

    (a)(2) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Cattle, fat.............................................            0.20
Cattle, meat............................................            0.30
Cattle, meat byproducts.................................            0.70
 
                                * * * * *
Goat, fat...............................................            0.20
Goat, meat..............................................            0.30
Goat, meat byproducts...................................            0.70
 
                                * * * * *
Horse, fat..............................................            0.20
Horse, meat.............................................            0.30
Horse, meat byproducts..................................            0.70
Milk....................................................            0.30

[[Page 36677]]

 
 
                                * * * * *
Sheep, fat..............................................            0.20
Sheep, meat.............................................            0.30
Sheep, meat byproducts..................................            0.70
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-14653 Filed 6-18-13; 8:45 am]
BILLING CODE 6560-50-P