[Federal Register Volume 78, Number 118 (Wednesday, June 19, 2013)]
[Rules and Regulations]
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
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: firstname.lastname@example.org.
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
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,
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
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
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
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
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
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
LOAEL = 30 mg/kg/day based
on decreased locomotor
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
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
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
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
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
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
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
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
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
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
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
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
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
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:
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
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.
Therefore, tolerances are established for residues of acetamiprid,
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
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
Dated: June 13, 2013.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.578 is amended as follows:
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''.
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) * * *
* * * * *
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) * * *
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
* * * * *
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