[Federal Register: November 28, 2007 (Volume 72, Number 228)]
[Rules and Regulations]
[Page 67256-67262]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28no07-13]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0105; FRL-8340-6]
Acetamiprid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
acetamiprid in or on almond, hulls; fruit, stone, group 12, except
plum, prune; nut, tree, group 14; pea and bean, succulent shelled,
subgroup 6B; pistachio; plum, prune, dried; plum, prune, fresh;
vegetable, cucurbit, group 9; and vegetable, legume, edible podded,
subgroup 6A. Nippon Soda Co., Ltd. requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective November 28, 2007. Objections and
requests for hearings must be received on or before January 28, 2008,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0105. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5218; e-mail address: stanton.susan@epa.gov.
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), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
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 Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 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-2007-0105 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before January 28, 2008.
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 that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0105, by one of the following methods:
[[Page 67257]]
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of September 15, 2004 (69 FR 55625) (FRL-
7674-9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
4F6833) by Nippon Soda Co., Ltd., c/o Nisso America Inc., 220 East 42nd
Street, Suite 3002, New York, NY, 10017. The petition requested that 40
CFR 180.578 be amended by establishing tolerances for residues of the
insecticide acetamiprid, N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-
methylacetamidine, in or on the cucurbit crop group at 0.5 parts per
million (ppm); the stone fruit crop group, except plum, prune, fresh
and dried at 1.2 ppm; plum, prune, fresh and dried at 0.3 ppm; the tree
nut crop group, except almond hulls at 0.1 ppm; and almond hulls at 5.0
ppm. That notice included a summary of the petition prepared by Nippon
Soda Co., Ltd., the registrant, which is available to the public in the
docket ID Number EPA-HQ-OPP-2004-0223, http://www.regulations.gov.
Comments were received on the notice of filing from a private citizen.
EPA's response to these comments is discussed in Unit IV.C below.
In the Federal Register of September 22, 2006 (71 FR 55468) (FRL-
8091-9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6F7051) by Nippon Soda Co., Ltd., c/o Nisso America Inc., 45 Broadway,
Suite 2120, New York, NY, 10006. The petition requested that 40 CFR
180.578 be amended by establishing tolerances for residues of the
insecticide acetamiprid, N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-
methylacetamidine, in or on bulb vegetables crop group 3 at 3 ppm;
edible podded legume vegetables, crop subgroup 6a at 0.5 ppm; succulent
shelled pea and beans, crop subgroup 6b, at 0.5 ppm; and berries, crop
group 13 at 1 ppm. The notice also announced the filing of amended
pesticide petition 4F6833, requesting a tolerance for residues of
acetamiprid in or on pistachio at 0.1 ppm in addition to the tolerances
described in the preceding paragraph. That notice referenced a summary
of the petition prepared by Nippon Soda Co., Ltd., the registrant,
which is available to the public in the docket ID Number EPA-HQ-OPP-
2006-0733, http://www.regulations.gov. There were no comments received
in response to the notice of filing.
EPA is deferring to a later date the decision regarding the
proposed tolerances for residues of acetamiprid on bulb vegetables crop
group 3 and berry crop group 13. Based upon review of the data
supporting the petitions, EPA has modified the tolerance levels and/or
commodity terms for several of the other proposed tolerances. The
reasons for these changes are explained in Unit V.
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....'' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerance for residues of acetamiprid on Almond, hulls at 5.0 ppm;
Fruit, stone, group 12, except plum, prune at 1.20 ppm; Nut, tree,
group 14 at 0.10 ppm; Pea and bean, succulent shelled, subgroup 6B at
0.40 ppm; Pistachio at 0.10 ppm; Plum, prune, dried at 0.40 ppm; Plum,
prune, fresh at 0.20 ppm; Vegetable, cucurbit, group 9 at 0.50 ppm; and
Vegetable, legume, edible podded, subgroup 6A at 0.60 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerance 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. Specific information on the studies received and the nature
of the adverse effects caused by acetamiprid as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in the document Acetamiprid: Human Health Risk
Assessment for Proposed Food Uses on Stone Fruits, Cucurbit Vegetables,
Tree Nuts, Berries, Strawberries, Bulb Vegetables, Legumes (Peas and
Beans) and for Residential/Commercial Insecticide/Termiticide Uses. The
referenced document is available in the docket established by this
action, which is described under ADDRESSES, and is identified as
document ID number EPA-HQ-OPP-2007-0105-0003 in that docket.
The toxicity database for acetamiprid is complete. The acute
toxicity data indicate that acetamiprid is moderately toxic via the
oral route and is minimally toxic via the dermal and inhalation routes.
Acetamiprid is not an eye or skin irritant, and it is not a dermal
sensitizer. Based on subchronic, chronic, developmental and
reproductive studies in rats, rabbits, and dogs, acetamiprid does not
appear to have specific target organ toxicity. Generalized nonspecific
toxicity was observed as decreases in body weight, body weight gain,
food consumption and food efficiency when determined. Generalized
effects were also observed in the liver in the form of hepatocellular
hypertrophy in both mice and rats and hepatocellular vacuolation in the
rat. The hepatocellular hypertrophy in mice is considered to be
adaptive; it is likely that the
[[Page 67258]]
vacuolization in rats is more related to liver activity in response to
the presence of the chemical rather than frank toxicity. Neurotoxicity
was observed in the form of decreased locomotor activity in the acute
neurotoxicity study in rats and as decreased auditory startle response
in the developmental neurotoxicity study in rats.
Developmental studies showed no evidence of either quantitative or
qualitative susceptibility of the rat or rabbit fetuses from in utero
exposure. However, both the developmental neurotoxicity (DNT) study and
the multi-generation reproduction studies showed an increase in
qualitative susceptibility of pups. Effects in pups in the reproduction
study included delays in preputial separation, vaginal opening and
pinna unfolding as well as reduced litter size, decreased early pup
viability and weaning indices; offspring effects observed in the DNT
study included decreased body weight and body weight gains, decreased
early pup viability and decreased maximum auditory startle response in
males. These effects were seen in the presence of less severe effects
(decreased body weight and body weight gain) in the maternal animals.
Based on acceptable carcinogenicity studies in rats and mice, EPA
has determined that acetamiprid is not likely to be carcinogenic to
humans. This determination is based on the absence of a dose-response
or statistical significance for the increased incidence in mammary
adenocarcinomas observed in the rat carcinogenicity study, as well as
the lack of evidence of carcinogenic effects in the mouse cancer study.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which the NOAEL in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the LOAEL is sometimes used for risk
assessment. Uncertainty/safety factors (UFs) are used in conjunction
with the LOC to take into account uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. Safety is assessed for acute and chronic risks by
comparing aggregate exposure to the pesticide to the acute population
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The
aPAD and cPAD are calculated by dividing the LOC by all applicable UFs.
Short-term, intermediate-term, and long-term risks are evaluated by
comparing aggregate exposure to the LOC to ensure that the margin of
exposure (MOE) called for by the product of all applicable UFs is not
exceeded.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. 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 can be found at http://www.regulations.gov at
pages 21-22 in the document Acetamiprid: Human Health Risk Assessment
for Proposed Food Uses on Stone Fruits, Cucurbit Vegetables, Tree Nuts,
Berries, Strawberries, Bulb Vegetables, Legumes (Peas and Beans) and
for Residential/Commercial Insecticide/Termiticide Uses in docket ID
number EPA-HQ-OPP-2007-0105.
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. In estimating acute dietary
exposure to acetamiprid, EPA used food consumption information from the
U.S. Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA relied upon anticipated residues derived from field
trial data for certain commodities (apples; broccoli; cabbage, celery;
grapefruit; grapes; lettuce; oranges; pears; peppers; spinach;
tomatoes; stone fruits; and cucurbits) and assumed residues were
present at tolerance levels in all other commodities. EPA also relied
on percent crop treated (PCT) information for some of the currently
registered commodities (apples, broccoli , celery, lettuce, pears,
grapefruit, grapes, oranges, peppers, spinach and tomatoes) but assumed
100 PCT for all of the new commodities.
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 assumed all foods for
which there are tolerances or for which tolerances are being
established contain tolerance-level residues. EPA relied on PCT
information for two currently registered crops (apples and oranges) but
assumed 100 PCT for all other commodities.
iii. Cancer. As noted above, EPA has determined that acetamiprid is
not likely to be carcinogenic to humans. Therefore, an exposure
assessment for use in a quantitative cancer risk assessment is
unnecessary.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must pursuant to section 408(f)(1) of
FFDCA require that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by section
408(b)(2)(E) of FFDCA and authorized under section 408(f)(1) of FFDCA.
Data will be required to be submitted no later than 5 years from the
date of issuance of this tolerance.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
a. The data used are reliable and provide a valid basis to show
what percentage of the food derived from such crop is likely to contain
such pesticide residue.
b. The exposure estimate does not underestimate exposure for any
significant subpopulation group.
c. Data are available on pesticide use and food consumption in a
particular area, the exposure estimate does not understate exposure for
the population in such area. In addition, the Agency must provide for
periodic evaluation of any estimates used. To provide for the periodic
evaluation of the estimate of PCT as required by section 408(b)(2)(F)
of FFDCA, EPA may require registrants to submit data on PCT.
The Agency used PCT information as follows:
For the acute assessment, maximum PCT estimates were used for the
following commodities: Apples (15%),
[[Page 67259]]
broccoli (5%), celery (15%), lettuce (10%), pears (25%), and
grapefruit, grapes, oranges, peppers, spinach and tomatoes, each at
2.5%.
For the chronic assessment, average PCT estimates were used for the
following commodities: Apples (10%) and oranges (1%).
EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available Federal, state, and private market survey data for that use,
averaging by year, averaging across all years, and rounding up to the
nearest multiple of 5% except for those situations in which the average
PCT is less than one. In those cases <1% is used as the average and
<2.5% is used as the maximum. EPA uses a maximum PCT for acute dietary
risk analysis. The maximum PCT figure is the single maximum value
reported overall from available Federal, state, and private market
survey data on the existing use, across all years, and rounded up to
the nearest multiple of 5%. In most cases, EPA uses available data from
USDA/National Agricultural Statistics Service (USDA/NASS), Proprietary
Market Surveys, and the National Center for Food and Agriculture Policy
(NCFAP) for the most recent six years.
The Agency believes that the three conditions listed in this unit
have been met. With respect to Condition A, PCT estimates are derived
from Federal and private market survey data, which are reliable and
have a valid basis. The Agency is reasonably certain that the
percentage of the food treated is not likely to be an underestimation.
As to Conditions B and C, regional consumption information and
consumption information for significant subpopulations is taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which acetamiprid
may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for acetamiprid in drinking water. Because
the Agency does not have comprehensive monitoring data, drinking water
concentration estimates are made by reliance on simulation or modeling
taking into account data on the environmental fate 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 environmental concentrations (EECs) of acetamiprid for acute
exposures are estimated to be 20.1 parts per billion (ppb) for surface
water and 1.6 ppb for ground water. The EECs for chronic exposures are
estimated to be 4.9 ppb for surface water and 1.6 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 20.1 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 4.9 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 residential
non-dietary sites: As a pre- and post-construction termiticide/
insecticide for use in subterranean or hard-to-reach structure
components and building perimeters; and as a crack, crevice or spot
application using gel bait formulations for control of ants and
cockroaches in residential settings. EPA assessed residential exposure
using the following assumptions: The pre- and post-construction
termiticide/insecticide uses of acetamiprid are limited to licensed
Pest Control Operators (PCOs); therefore, homeowner handler exposures
are not expected to occur. Nor are post-application exposures of adults
or children expected as a result of these uses, since applications are
limited to subterranean or hard-to-reach structure components and
building perimeters. EPA has determined that short-term and
intermediate-term dermal exposure of residential handlers may occur
from use of the gel bait formulations in residential settings; however,
due to the low vapor pressure of acetamiprid and its formulation as a
gel, inhalation exposure of handlers is not expected. Post-application
exposures of adults and children from this use are expected to be
negligible for the following reasons: (i) Homeowners are unlikely to
revisit the crack, crevice or spot where the gel bait has been applied,
thereby minimizing potential exposure; (ii) inhalation exposure is
expected to be minimal due to acetamiprid's low vapor pressure and its
formulation as a gel; and (iii) the gel bait products contain a
bittering agent which is used to prevent ingestion by children and
animals, thereby further reducing potential for incidental oral
exposures of children. For these reasons, EPA assessed only residential
handler dermal exposures from the gel bait uses of acetamiprid.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Acetamiprid is a member of the neonicotinoid class of pesticides
which also includes thiamethoxam, clothianidin, imidacloprid and
several other active ingredients. Structural similarities or common
effects do not constitute a common mechanism of toxicity. Evidence is
needed to establish that the chemicals operate by the same, or
essentially the same sequence of major biochemical events. Although the
neonicotinoids bind selectively to insect nicotinic acetylcholine
receptors (nAChR), the specific binding site(s)/receptor(s) are unknown
at this time. Additionally, the commonality of the binding activity
itself is uncertain, as preliminary evidence suggests that clothianidin
operates by direct competitive inhibition, while thiamethoxam is a non-
competitive inhibitor. Furthermore, even if future research shows that
neonicotinoids share a common binding activity to a specific site on
insect nicotinic acetylcholine receptors, there is not necessarily a
relationship between this pesticidal action and a mechanism of toxicity
in mammals. Structural variations between the insect and mammalian
nAChRs produce quantitative differences in the binding affinity of the
neonicotinoids towards these receptors, which, in turn, confers the
notably greater selective toxicity of this class towards insects,
including
[[Page 67260]]
aphids and leafhoppers, compared to mammals. Additionally, the most
sensitive toxicological effect in mammals differs across the
neonicotinoids (e.g., testicular tubular atrophy with thiamethoxam;
mineralized particles in thyroid colloid with imidaclopid). Thus, there
is currently no evidence to indicate that neonicotinoids share common
mechanisms of toxicity, and EPA is not following a cumulative risk
approach based on a common mechanism of toxicity for the
neonicotinoids. In addition, acetamiprid does not appear to produce a
toxic metabolite produced by other substances. Therefore, for the
purposes of this tolerance action, EPA has not assumed that acetamiprid
has a common mechanism of toxicity with other substances. For more
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 website at http://www.epa.gov/pesticides/
cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (``10X'') tenfold 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. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
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 DNT and multi-generation
reproduction studies showed an increase in qualitative susceptibility
of pups. Effects in pups in the reproduction study included delays in
preputial separation, vaginal opening and pinna unfolding, as well as
reduced litter size, decreased early pup viability and weaning indices;
offspring effects observed in the DNT study included decreased body
weight and body weight gains, decreased early pup viability and
decreased maximum auditory startle response in males. These effects
were seen in the presence of decreased body weight and body weight gain
in the maternal animals, indicating increased qualitative
susceptibility of fetuses and offspring to acetamiprid. Quantitative
evidence of increased susceptibility was not observed in any study.
In considering the overall toxicity profile and the endpoints and
doses selected for the acetamiprid risk assessment, EPA characterized
the degree of concern for the effects observed in the acetamiprid DNT
and the 2-generation reproduction study as low, noting that there is a
clear NOAEL for the offspring effects in both studies, the toxicology
database is complete, and regulatory doses were selected to be
protective of potential offspring effects in both the DNT and the 2-
generation study. No other residual uncertainties were identified.
Based on the available data, EPA determined that changes in motor
activity, auditory startle reflex, learning and memory assessments, and
even changes in the brain morphometrics can occur as the result of a
single exposure at a critical junction during pregnancy or from
multiple exposures throughout pregnancy and lactation. Therefore, the
NOAEL for offspring effects observed in the DNT was selected as the
dose for acute dietary exposures (co-critical with the acute
neurotoxicity study), as well as short-term and intermediate-term non-
dietary risk assessment. Use of the DNT NOAEL is protective of effects
seen in the 2-generation study (the NOAEL from the DNT is 10.0 mg/kg/
day and the NOAEL from the 2-generation study is 17.9 mg/kg/day). The
chronic dietary study in rats yielded a lower long-term NOAEL (7.1 mg/
kg/day) and was, therefore, used for assessing chronic dietary risk.
EPA believes that the endpoints and doses selected for acetamiprid are
protective of adverse effects in both offspring and adults.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
i. The toxicity database for acetamiprid is complete.
ii. There is no evidence that acetamiprid results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies. Although there is qualitative evidence of
increased susceptibility in the multi-generation reproduction study and
in the DNT study, the risk assessment team did not identify any
residual uncertainties after establishing toxicity endpoints and
traditional UFs to be used in the risk assessment of acetamiprid. The
degree of concern for pre- and/or postnatal toxicity is low.
iii. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on tolerance-level residues or anticipated residues derived from
reliable field trial data. The PCT estimates used in the dietary
assessment were derived from valid, reliable Federal and private market
survey data and are unlikely to be exceeded. Conservative ground and
surface water modeling estimates were used to assess exposures to
acetamiprid from drinking water; and residential, non-dietary exposure
of infants and children to acetamiprid is not expected to occur. EPA
believes these assessments will not underestimate the exposure and
risks posed by acetamiprid.
E. Aggregate Risks and Determination of Safety
Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-term, intermediate-term,
and long-term risks are evaluated by comparing aggregate exposure to
the LOC to ensure that the MOE called for by the product of all
applicable UFs is not exceeded.
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 35% of the aPAD for children 1 to 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 exposure to
acetamiprid from food and water will utilize 35% of the cPAD for
children 1 to 2 years old, the population group with greatest exposure.
Based on the use pattern, chronic residential exposure to residues of
acetamiprid is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
[[Page 67261]]
Acetamiprid is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for acetamiprid. Using the exposure assumptions described in
this unit for short-term exposures, EPA has concluded that food, water,
and residential exposures aggregated result in aggregate MOEs of 900
for adults 20 to 49 years old and 930 for adults 50 years and older who
apply gel bait acetamiprid products for ant and cockroach control.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Acetamiprid
is currently registered for use that could result in intermediate-term
residential exposure and the Agency has determined that it is
appropriate to aggregate chronic food and water and intermediate-term
exposures for acetamiprid. Since the short-term and intermediate-term
dermal exposures and endpoints for acetamiprid are the same,
intermediate-term aggregate MOEs for adult residential handlers are the
same as the short-term aggregate MOEs reported above (900 to 930).
5. Aggregate cancer risk for U.S. population. EPA has classified
acetamiprid as ``Not likely to be carcinogenic to humans. Acetamiprid
is not expected to pose a cancer risk.
6. 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 residue analytical methods are available for the
enforcement of established and new tolerances for plant commodities
(gas chromotography /electron capture detector and high performance
liquid chromotography/ultra violet detection (GC/ECD and HPLC/UV) and
animal commodities (HPLC/UV)). These methods may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905;
e-mail address: residuemethods@epa.gov.
B. International Residue Limits
There are no Codex, Canadian or Mexican maximum residue levels
(MRLs) established on the commodities associated with these petitions.
C. Response to Comments
Comments were received from a private citizen objecting to
establishing these tolerances or any exemptions for acetamiprid or
approval of its sale. The commenter objected to acetamiprid residues in
food as well as EPA's reliance on animal testing on the basis that
animal tests are inhumane and not relevant to human toxicity. The
Agency has received these same or similar comments from this commenter
on numerous previous occasions. Refer to Federal Register 70 FR 37686
(June 30, 2005), 70 FR 1354 (January 7, 2005), and 69 FR 63096 (October
29, 2004) for the Agency's response to these objections.
V. Conclusion
Based upon review of the data supporting the petitions, EPA has
modified the proposed tolerances as follows: (1) PP 4F6833: Modified
the commodity terms for stone fruit, tree nuts and cucurbit vegetables
to agree with recommended commodity terms in the Office of Pesticide
Program's Food and Feed Commodity Vocabulary (Fruit, stone, group 12,
except plum, prune; Nut, tree, group 14; and Vegetable, cucurbit, group
9); and modified the commodity terms and established separate
tolerances for Plum, prune, dried at 0.40 ppm and Plum, prune, fresh at
0.20 ppm (fresh) based on the field trial results showing different
residues in the dried and fresh forms. (2) PP 6F7051: Revised the
commodity terms and tolerance levels for edible podded legumes and
succulent shelled peas and beans to read ``Vegetable, legume, edible
podded, subgroup 6A'' at 0.60 ppm and ``Pea and bean, succulent
shelled, subgroup 6B'' at 0.40 ppm. EPA revised these tolerance levels
based on analyses of the residue field trial data using the Agency's
Tolerance Spreadsheet in accordance with the Agency's Guidance for
Setting Pesticide Tolerances Based on Field Trial Data Standard
Operating Procedure (SOP).
EPA is deferring to a later date the decision regarding the
proposed tolerances for residues of acetamiprid on bulb vegetables crop
group 3 and berry crop group 13.
Therefore, tolerances are established for residues of acetamiprid,
N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine, in or on
Almond, hulls at 5.0 ppm; Fruit, stone, group 12, except plum, prune at
1.20 ppm; Nut, tree, group 14 at 0.10 ppm; Pea and bean, succulent
shelled, subgroup 6B at 0.40 ppm; Pistachio at 0.10 ppm; Plum, prune,
dried at 0.40 ppm; Plum, prune, fresh at 0.20 ppm; Vegetable, cucurbit,
group 9 at 0.50 ppm; and Vegetable, legume, edible podded, subgroup 6A
at 0.60 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply
[[Page 67262]]
to this rule. In addition, This 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) (Public Law 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: November 14, 2007.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
0
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 alphabetically adding the following
commodities to the table in paragraph (a)(1) to read as follows:
Sec. 180.578 Acetamiprid; tolerances for residues.
(a) General. * * *
(1) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Almond, hulls........................................ 5.0
* * * * *
Fruit, stone, group 12, except plum, prune........... 1.20
* * * * *
Nut, tree, group 14.................................. 0.10
Pea and bean, succulent shelled, subgroup 6B......... 0.40
Pistachio............................................ 0.10
Plum, prune, dried................................... 0.40
Plum, prune, fresh................................... 0.20
* * * * *
Vegetable, cucurbit, group 9......................... 0.50
* * * * *
Vegetable, legume, edible podded, subgroup 6A........ 0.60
* * * * *
------------------------------------------------------------------------
[FR Doc. E7-23055 Filed 11-27-07; 8:45 am]
BILLING CODE 6560-50-S