[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
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Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
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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.
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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.
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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.
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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