[Federal Register: April 13, 2005 (Volume 70, Number 70)]
[Rules and Regulations]
[Page 19283-19293]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ap05-12]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0029; FRL-7705-7]
Acetamiprid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
acetamiprid in or on tuberous and corm vegetables. Nippon Soda Company
c/o Nisso America Inc. requested this tolerance under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA).
DATES: This regulation is effective April 13, 2005. Objections and
requests for hearings must be received on or before June 13, 2005.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number OPP-2005-0029. All documents in the docket
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although
listed in the index, some information is not publicly available, i.e.,
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 either electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S.
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The docket
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Akiva Abramovitch, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8328; e-mail address:
abramovitch.akiva@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:
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 provides
a guide for readers regarding entities likely to be
[[Page 19284]]
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 and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/
.
II. Background and Statutory Findings
In the Federal Register of August 4, 2004 (69 FR 47145) (FRL-7369-
6), 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
3F6575) by Nippon Soda Company c/o Nisso America, 42 Broadway, Suite
2120, New York, NY 10006. The petition requested that 40 CFR 180.578 be
amended by establishing a tolerance for residues of the insecticide
acetamiprid, in or on tuberous and corm vegetables at 0.01 parts per
million (ppm). That notice included a summary of the petition prepared
by Nisso America, Inc.. There were two comments to the Acetamiprid
Notice of Filing and they are addressed in Unit IV.D..
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. . .
.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with 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, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of acetamiprid on
tuberous and corm vegetables at 0.01 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. The nature of the toxic effects caused by acetamiprid are
discussed in Table 1 of this unit as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies reviewed.
Table 1.--Subchronic, Chronic, and Other Toxicity
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Guideline No. Study Type Results
------------------------------------------------------------------------
870.3100 90 days oral NOAEL: 12.4/14.6
toxicity - milligrams/
rodents kilograms (mg/kg)/
day - Male/Female
(M/F)
LOAEL: 50.8/56.0
mg/kg/day (M/F)
based on
decreased Body
Weight (BW), BW
gain and food
consumption.
------------------------------------------------------
870.3100 90 days oral NOAEL: 106.1/129.4
toxicity - mouse mg/kg/day (M/F)
LOAEL: 211.1/249.1
mg/kg/day (M/F)
based on reduced
BW and BW gain,
decreased
glucoseand
cholesterol
levels, reduced
absolute organ
weights.
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870.3150 90-day oral NOAEL: 13/14 mg/kg/
toxicity in day (M/F)
nonrodents LOAEL: 32 mg/kg/
day based on
reduced BW gain
in both sexes.
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870.3200 21-day dermal NOAEL: 1,000 mg/kg/
toxicity - rabbit day - Highest
Dose Tested (HDT)
LOAEL: >1,000 mg/
kg/day
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870.3700 Prenatal Maternal NOAEL: 16
developmental mg/kg/day
toxicity in Maternal LOAEL: 50
rodents mg/kg/day based
on reduced BW and
BW gain and food
consumption,
increased liver
weights.
Developmental
NOAEL: 16 mg/kg/
day
Developmental
LOAEL: 50 mg/kg/
day based on
increased
incidence of
shortening of the
13th rib.
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[[Page 19285]]
870.3700 Prenatal Maternal NOAEL: 15
developmental mg/kg/day
toxicity in Maternal LOAEL:
nonrodents 30mg/kg/day based
on BW loss and
decreased food
consumption.
Developmental
NOAEL: 30 mg/kg/
day (HDT)
Developmental
LOAEL: > 30 mg/kg/
day
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870.3800 Reproduction and Parental systemic
fertility effects NOAEL: 17.9/21.7
mg/kg/day (M/F)
Parental systemic
LOAEL: 51.0/60.1
mg/kg/day (M/F)
based on
decreased BW, BW
gain and food
consumption.
Offspring systemic
NOAEL: 17.9/21.7
mg/kg/day (M/F)
Offspring systemic
LOAEL: 51.0/60.1
mg/kg/day (M/F)
based on
reductions in pup
weight, litter
size, viability
and weaning
indices; delay in
age to attain
preputial
separation and
vaginal opening.
Reproductive
NOAEL: 17.9/21.7
mg/kg/day (M/F)
Reproductive
LOAEL: 51.0/60.1
mg/kg/day (M/F)
based on
reductions in
litter weights
and individual
pup weights on
day of delivery.
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870.4100 Chronic toxicity NOAEL: 20/21 mg/kg/
dogs day (M/F)
LOAEL: 55/61 mg/kg/
day (M/F) based
on initial BW
loss and overall
reduction in BW
gain.
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870.4100/870.4200 Chronic toxicity/ NOAEL: 7.1/8.8 mg/
Carcinogenicity - kg/day (M/F)
rats LOAEL: 17.5/22.6
mg/kg/day (M/F)
based on
decreases in mean
BW and BW gain
(F) and
hepatocellular
vacuolation (M)
Evidence of
treatment-related
increase in
mammary tumors.
There was an
absence of a dose
- response and a
lack of
statistically
significant
increase in the
mammary
adenocarcinoma
incidence by pair
with comparison
of the mid- and
the 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.
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870.4300 Carcinogenicity NOAEL: 20.3/75.9
mice mg/kg/day (M/F)
LOAEL: 65.6/214.6
mg/kg/day (M/F)
based on
decreased BW and
BW gain and
amyloidosis in
numerous organs
(M) and decreased
BW and BW gain
(F). Not
oncogenic under
conditions of
study.
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870.5100 Reverse gene Salmonella
mutation assay typhimurium/E.
coli - Not
mutagenic under
the conditions of
the study.
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870.5300 Mammalian cells in Not mutagenic
culture under the
Forward gene conditions of the
mutation assay - study.
CHO cells.
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870.5375 In vitro mammalian Acetamiprid is a
chromosomal clastogen under
aberrations - CHO the conditions of
cells the study.
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870.5385 In vivo mammalian Acetamiprid did
chromosome not induce a
aberrations - rat significant
bone marrow increase in
chromosome
aberrations in
bone marrow cells
when compared to
the vehicle
control group.
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870.5395 In vivo mammalian Acetamiprid is not
cytogenetics - a clastogen in
micronucleus the mouse bone
assay in mice marrow
micronucleus
test.
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870.5550 UDS assay in Acetamiprid tested
primary rat negatively for
hepatocytes/ UDS in mammalian
mammalian cell hepatocytes in
culture vivo.
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870.6200 Acute NOAEL: 10 mg/kg
neurotoxicity - LOAEL: 30 mg/kg
rat based on
reduction in
locomotor
activity.
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870.6200 Subchronic NOAEL: 14.8/16.3
neurotoxicity - mg/kg/day (M/F)
rat LOAEL: 59.7/67.6
mg/kg/day (M/F)
based on
reductions in BW,
BW gain, food
consumption and
food efficiency.
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N/A 28-day feeding - NOAEL: 16.7/19.1
dog mg/kg/day (M/F)
LOAEL: 28.0/35.8
mg/kg/day based
on reduced BW
gain.
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[[Page 19286]]
870.7485(SS) Metabolism - Male mice, rats or
mouse, rat, rabbits were
rabbit Special administered
Study (SS) single doses of
acetamiprid by
gavage,
intraperitoneal
injection (i.p.)
or intravenous
injection (i.v.)
up to 60 mg/kg.
The animals were
assessed for a
variety of
neurobehavioral
parameters. In
vitro experiments
were also done
using isolated
ileum sections
from guinea pigs
to assess
contractile
responses in the
absence and
presence of
agonists
(acetylcholine,
histamine
diphosphate,
barium chloride
and nicotine
tartrate).
Acetamiprid was
also assessed via
i.v. in rabbits
for effects on
respiratory rate,
heart rate and
blood pressure;
via gavage in
mice for effects
on
gastrointestinal
motility; and via
i.p. in rats for
effects on water
and electrolyte
balance in urine,
and blood
coagulation,
hemolytic
potential and
plasma
cholinesterase
activity. Based
on a number of
neuromuscular,
behavioral and
physiological
effects of
acetamiprid in
male mice, under
the conditions of
this study, a
overall NOAEL of
10 mg/kg
(threshold) and
LOAEL of 20 mg/kg
could be
estimated for a
single dose by
various exposure
routes.
------------------------------------------------------
870.7485 Metabolism and Extensively and
pharmaco-kinetics rapidly
- rat metabolized.
Metabolites 79-
86% of
administered
dose. Profiles
similar for males
and females for
both oral and
intravenous
dosing. Three to
seven percent of
dose recovered in
urine and feces
as unchanged test
article. Urinary
and fecal
metabolites from
15-day repeat
dose experiment
only showed minor
differences from
single-dose test.
Initial Phase I
biotransformation
: demethylation
of parent. 6-
chloronicotinic
acid most
prevalent
metabolite. Phase
II metabolism
shown by increase
in glycine
conjugate.
------------------------------------------------------
870.7600 Dermal absorption The majority of
the dose was
washed off with
the percent
increasing with
dose. Skin
residue was the
next largest
portion of the
dose with the
percent
decreasing with
dose. In neither
case was there
evidence of an
exposure related
pattern.
Absorption was
small and
increased with
duration of
exposure. Since
there are no data
to demonstrate
that the residues
remaining on the
skin do not enter
the animal, then
as a conservative
estimate of
dermal
absorption,
residues
remaining on the
skin will be
added to the
highest dermal
absorption value.
The potential
total absorption
at 24 hours could
be approximately
30%.
------------------------------------------------------------------------
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect 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. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
Three other types of safety or uncertainty factors may be used:
``Traditional uncertainty factors;'' the `` special FQPA safety
factor;'' and the ``default FQPA safety factor.'' By the term
``traditional uncertainty factor,'' EPA is referring to those
additional uncertainty factors used prior to FQPA passage to account
for database deficiencies. These traditional uncertainty factors have
been incorporated by the FQPA into the additional safety factor for the
protection of infants and children. The term ``special FQPA safety
factor'' refers to those safety factors that are deemed necessary for
the protection of infants and children primarily as a result of the
FQPA. The ``default FQPA safety factor'' is the additional 10X safety
factor that is mandated by the statute unless it is decided that there
are reliable data to choose a different additional factor (potentially
a traditional uncertainty factor or a special FQPA safety factor).
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of
100 to account for interspecies and intraspecies differences and any
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF).
Where a special FQPA safety factor or the default FQPA safety factor is
used, this additional factor is applied to the RfD by dividing the RfD
by such additional factor. The acute or chronic Population Adjusted
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this
type of safety factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure
[[Page 19287]]
will lead to some degree of cancer risk. A Q* is calculated and used to
estimate risk which represents a probability of occurrence of
additional cancer cases (e.g., risk). An example of how such a
probability risk is expressed would be to describe the risk as one in
one hundred thousand (1 X 10-\5\), one in a million (1 X
10-\6\), or one in ten million (1 X 10-\7\).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated.
A summary of the toxicological endpoints for acetamiprid used for
human risk assessment is shown in Table 2 of this unit:
Table 2.--Summary of Toxicological Dose and Endpoints for Acetamiprid for Use in Human Risk Assessment.
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Dose Used in Risk FQPA SF\1\ and Endpoint Study and Toxicological
Exposure/Scenario Assessment, UF for Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary NOAEL = 10 mg/kg FQPA SF = 1 Acute mammalian
General population including infants UF = 100............... aPAD = 0.10 mg/kg/day.. neurotoxicity study in
and children. Acute RfD = 0.10 mg/kg/ the rat
day. LOAEL = 30 mg/kg based
on reduction in
locomotor activity in
males.
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Chronic dietary NOAEL= 7.1 mg/kg/day FQPA SF = 1 Chronic/oncogenicity
All populations...................... UF = 100............... cPAD = 0.071 mg/kg/day. study in the rat
Chronic RfD = 0.071 mg/ LOAEL = 17.5 mg/kg/day
kg/day. based on reduced body
weight and body weight
gain (females) and
hepatocellular
vacuolation (males).
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Short- and Intermediate-Term NOAEL = 15 mg/kg/day LOC for MOE = Co-critical studies:
Incidental oral (1 to 30 days and 1 100 (Residential)...... subchronic oral (rat);
month to 6 months). subchronic
(Residential)........................ neurotoxicity (rat)
developmental toxicity
(rat);
LOAEL = 50 mg/kg/day
based on reductions in
body weight, body
weight gain and food
consumption.
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Short- and Intermediate-Term Oral study NOAEL= 17.9 LOC for MOE = 2-generation
Dermal (1 to 30 days; and 1 month to mg/kg/day 100 (Occupational)..... reproduction study
6 months). (dermal absorption rate 100 (Residential)...... (rat)
(Residential)........................ = 30%). LOAEL = 51.0 mg/kg/day
based on reductions in
pup weights in both
generations,
reductions in litter
size and viability and
weaning indices among
F2 offspring,
significant delays in
age to attain vaginal
opening and preputial
separation.
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Long-Term Dermal (6 months to Oral study NOAEL= 7.1 LOC for MOE = Chronic/oncogenicity
lifetime) mg/kg/day 100 (Occupational)..... study in the rat
(Residential)........................ (dermal absorption rate 100 (Residential)...... LOAEL = 17.5 mg/kg/day
= 30%). based on reduced body
weight and body weight
gain (females) and
hepatocellular
vacuolation (males).
----------------------------------------------------------------
Short- and Intermediate-Term Oral study NOAEL= 17.9 LOC for MOE = 2-generation
Inhalation (1 to 30 days and 1 month mg/kg/day 100 (Occupational)..... reproduction study
to 6 months). (inhalation absorption 100 (Residential)...... (rat)
(Residential)........................ rate = 100%). LOAEL = 51.0 mg/kg/day
based on reductions in
pup weights in both
generations,
reductions in litter
size and viability and
weaning indices among
F2 offspring,
significant delays in
age to attain vaginal
opening and preputial
separation.
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[[Page 19288]]
Long-Term Inhalation (6 months to Oral study NOAEL = 7.1 LOC for MOE = Chronic/oncogenicity
lifetime) mg/kg/day 100 (Occupational)..... study in the rat
(Residential)........................ (inhalation absorption 100 (Residential)...... LOAEL = 17.5 mg/kg/day
rate = 100%). based on reduced body
weight and body weight
gain (females) and
hepatocellular
vacuolation (males).
----------------------------------------------------------------
Cancer (oral, dermal, inhalation) Not likely to be carcinogenic.
----------------------------------------------------------------------------------------------------------------
\1\ The reference to the FQPA Safety Factor refers to any additional safety factor that is retained due to
concerns unique to the FQPA. The PAD (Population-adjusted Dose) incorporates the FQPA Safety Factor into the
dose for use in risk assessment: PAD = RfD/FQPA SF.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.578) for the residues of acetamiprid, in or on
a variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from acetamiprid in food
as follows:
i. Acute exposure. Acute dietary 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 conducting the acute dietary risk assessment EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID\TM\ version 1.3), which incorporates food
consumption data as reported by respondents in the USDA 1994-1996 and
1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to the chemical for each commodity.
The assumptions made for the acute exposure assessments are discussed
in Unit III.C.1.ii.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the DEEM-FCID\TM\, which incorporates food
consumption data as reported by respondents in the USDA 1994-1996 and
1998 CSFII, and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments:
For both the acute and chronic analyses, tolerance-level residues
were assumed for all food commodities with current and proposed
acetamiprid tolerances, and it was assumed that all of the crops
included in the analysis were treated (i.e., 100% crop treated). These
assumptions result in highly conservative estimates of dietary exposure
and risk. In calculating dietary risk estimates, the Agency has
compared the acute and chronic population-adjusted doses (aPAD, cPAD)
to the estimated dietary exposures from the models. Typically, the
Agency has concerns regarding dietary risk when the exposure estimates
exceed 100% of the aPAD and/or cPAD. Even with the conservative
assumptions noted above, risk estimates associated with dietary
exposure to acetamiprid are below the Agency's LOC.
iii. Cancer. Acetamiprid has been classified as not likely to be
carcinogenic to humans; therefore, a dietary assessment for cancer risk
was not conducted. This classification is based on the absence of a
dose-response and a 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 lab, it was within the range
of values from the supplier.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure 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 physical
characteristics of acetamiprid.
Tier 1 simulated estimated drinking water concentrations (EDWCs)
for acetamiprid in surface water using the FQPA Index Resevoir
Screening Test (FIRST) to calculate surface water concentrations and
screening concentration in ground water (SCI-GROW) to calculate ground
water concentrations.
For the surface water assessment, the application rate for citrus
was used, which represents the highest label rate for a single
application of any crop (0.55 lb a.i./A/season). However, it is
important to note that due to limitations imposed by the use of two
applications at the highest single application rate (0.25 lb a.i./A),
the modeled application rate was equal to only 0.50 lb a.i./A.
The proposed applications of acetamiprid on tuberous and corm
vegetables would result in lower EDWCs than citrus, and thus has little
effect on the drinking water assessment for this chemical. By using the
application rate for citrus crops, the surface and ground water
estimated concentrations are conservative estimates for the proposed
new use scenarios (tuberous and corm vegetables) because of the higher
application rate.
The primary use of these models by the Agency at this stage is to
provide a screen for sorting out pesticides for which it is unlikely
that drinking water concentrations would exceed human health levels of
concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs), which are the model estimates of a
pesticide's concentration in water. EECs derived from these models are
used to quantify drinking water exposure and risk as a %RfD or %PAD.
Instead drinking water levels of comparison (DWLOCs) are calculated and
used as a point of comparison against the model estimates of a
pesticide's concentration in water. DWLOCs are theoretical upper limits
on a pesticide's concentration in drinking water in light of total
aggregate exposure to a pesticide in food, and from residential uses.
Since DWLOCs address total aggregate exposure to acetamiprid they are
further discussed in the aggregate risk sections.
[[Page 19289]]
Based on the FIRST and SCI-GROW models, the EECs of acetamiprid for
acute exposures are estimated to be 17 parts per billion (ppb) for
surface water and 0.0008 ppb for ground water. The EECs for chronic
exposures are estimated to be 4 ppb for surface water and 0.0008 ppb
for ground 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 use on the following
residential non-dietary sites: Ornamentals and flowers. The risk
assessment was conducted using the following residential exposure
assumptions:
Acetamiprid is currently registered for use on the following
residential non-dietary sites: Ornamentals and flowers. No chemical
specific data were available to estimate exposure and risk for
homeowners applying acetamiprid to ornamentals and flowers. The risk
assessment was conducted using the following conservative residential
exposure assumptions: Little use of any protective equipment by
residential applicators, the use of agricultural transfer coefficients
which incorporate larger acreage and greater foliar contact for dermal
exposure, and postapplication exposure to the maximum levels of
residues on the day of application. Using such assumptions for
residential applicators, total MOEs for short- and intermediate-term
residential dermal and inhalation exposures range from 1.2 X
105 to 6 X 105. For post-application activities,
short- and intermediate-term MOEs range from 1.8 X 104 to
1.8 X 105 for adults and from 2.3 X 104 to 2.2 X
105 for youth ages 10-12 years. The residential uses for
acetamiprid are not expected to result in long-term exposures.
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 does not have, at this time, available data to determine
whether acetamiprid has a common mechanism of toxicity with other
substances. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to acetamiprid
and 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 not assumed that acetamiprid has 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 the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's web site 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 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 data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. 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 safety factor
value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. In the developmental
toxicity studies in rats and rabbits, the Agency determined that
neither quantitative nor qualitative evidence of increased
susceptibility of fetuses to in utero exposure to acetamiprid were
observed. However, in the multigeneration reproduction study,
qualitative evidence of increased susceptibility of rat pups is
observed. Considering the overall toxicity profile and the doses and
endpoints selected for risk assessment for acetamiprid, the Agency
characterized the degree of concern for the effects observed in this
study as low, noting that:
i. There is a clear NOAEL for the offspring, and;
ii. These effects occurred in the presence of parental toxicity and
only at the highest dose tested. No residual uncertainties were
identified.
The NOAEL for offspring effects is used for short- and
intermediate-term dermal and inhalation exposure scenarios. All other
toxicology endpoints established for acetamiprid are based on a lower
NOAEL than this, and are thus protective of offspring effects.
3. Conclusion. The Agency concluded that there is concern for
neurotoxicity resulting from exposure to acetamiprid because:
i. Clinical signs of neurotoxicity were observed in the acute
neurotoxicity study on the day of dosing, and;
ii. Studies in literature with structurally similar chemicals from
the same chemical class (neonicotinoids) suggest that nicotine, when
administered to humans and/or animals in utero causes developmental
toxicity, including functional deficits.
The Agency concluded that the toxicology database for acetamiprid
is not complete for FQPA assessment, since a developmental
neurotoxicity (DNT) study in rats is currently under review and has not
yet been finalized and is part of a comprehensive evaluation of many
DNT studies of various pesticides, some of which have not yet been
submitted. The preliminary review of the study indicates the results
are not likely to have a significant impact on risks for the currently
proposed use, or on existing uses of acetamiprid. Based on weight of
the evidence, an uncertainty factor UFDB is not needed (1X) since
developmental neurotoxicity data received and reviewed for other
compounds in this chemical class indicate that the results of the
required DNT will not likely impact the regulatory doses selected for
the proposed uses of acetamiprid.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against EECs. DWLOC values are
not regulatory standards for drinking water. DWLOCs are theoretical
upper limits on a pesticide's concentration in drinking water in light
of total aggregate exposure to a pesticide in food and residential
uses. In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water (e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average
[[Page 19290]]
food + residential exposure)). This allowable exposure through drinking
water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default body weights and drinking water consumption
values vary on an individual basis. This variation will be taken into
account in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
acetamiprid will occupy 18 % of the aPAD for the U.S. population, 12 %
of the aPAD for females 13 years and older, 44 % of the aPAD for all
infants less than one year old, and 61 % of the aPAD for 1-2 years old
children. In addition, there is potential for acute dietary exposure to
acetamiprid in drinking water. After calculating DWLOCs and comparing
them to the EECs for surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, as shown in Table 3 of
this unit:
Table 3.--Aggregate Risk Assessment for Acute Exposure to acetamiprid
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population/Subgroup aPAD (mg/ % aPAD/ Water EEC/ Water EEC/ Acute DWLOC/
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
US Population 0.10 18 17 0.0008 2,900
--------------------------------------------------------------
All Infants < 1 year 0.10 44 17 0.0008 540
--------------------------------------------------------------
Children 1-2 years 0.10 61 17 0.0008 370
--------------------------------------------------------------
Children 3-5 years 0.10 42 17 0.0008 560
--------------------------------------------------------------
Children 6-12 years 0.10 22 17 0.0008 790
--------------------------------------------------------------
Youth 13-19 years 0.10 14 17 0.0008 2,600
--------------------------------------------------------------
Adults 20-49 years 0.10 11 17 0.0008 3,100
--------------------------------------------------------------
Adults 50+ years 0.10 10 17 0.0008 3,100
--------------------------------------------------------------
Females 13-49 years 0.10 12 17 0.0008 2,600
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
acetamiprid from food will utilize 8% of the cPAD for the U.S.
population, 16% of the cPAD for all infants < 1 year old, and 31% of the
cPAD for children 1-2 year old. Based the use pattern, chronic
residential exposure to residues of acetamiprid is not expected. In
addition, there is potential for chronic dietary exposure to
acetamiprid in drinking water. After calculating DWLOCs and comparing
them to the EECs for surface water and ground water, EPA does not
expect the aggregate exposure to exceed 100% of the cPAD, as shown in
Table 4 of this unit:
Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Acetamiprid
----------------------------------------------------------------------------------------------------------------
Surface Ground/
Population/Subgroup cPAD/mg/kg/ %/cPAD/ Water EEC/ Water EEC/ Chronic/
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
US Population 0.071 8 4 0.0008 2,300
--------------------------------------------------------------
All Infants < 1 year 0.071 16 4 0.0008 600
--------------------------------------------------------------
Children 1-2 years 0.071 31 4 0.0008 490
--------------------------------------------------------------
Children 3-5 years 0.071 21 4 0.0008 560
--------------------------------------------------------------
Children 6-12 years 0.071 11 4 0.0008 630
--------------------------------------------------------------
Youth 13-19 years 0.071 6 4 0.0008 2,000
--------------------------------------------------------------
[[Page 19291]]
Adults 20-49 years 0.071 5 4 0.0008 2,400
--------------------------------------------------------------
Adults 50+ years 0.071 5 4 0.0008 2,000
--------------------------------------------------------------
Females 13-49 years 0.071 5 4 0.0008 2,400
----------------------------------------------------------------------------------------------------------------
3. Short and intermediate-term risk. Short and 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
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 and
intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of 810-820
for adults male and female. These aggregate MOEs do not exceed the
Agency's LOC for aggregate exposure to food and residential uses. In
addition, short-term DWLOCs were calculated and compared to the EECs
for chronic exposure of acetamiprid in ground water and surface water.
After calculating DWLOCs and comparing them to- the EECs for surface
water and ground water, EPA does not expect short-term aggregate
exposure to exceed the Agency's level of concern, as shown in Table 5
of this unit:
Table 5.--Aggregate Risk Assessment for Short-Term and intermediate term Exposure to Acetamiprid
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate/ Level of Surface Ground/ Short-Term
Population/Subgroup MOE/(Food + Concern/ Water EEC/ Water EEC/ DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Adult male 820 100 4 0.0008 5,500
--------------------------------------------------------------
Adult female 810 100 4 0.0008 4,700
--------------------------------------------------------------
Adult 50+ 810 100 4 0.0008 4,700
----------------------------------------------------------------------------------------------------------------
4. Aggregate cancer risk for U.S. population. Acetamiprid is not
likely to be carcinogenic 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, and to infants and children from aggregate
exposure to acetamiprid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate analytical methods are available for enforcement of
tolerances for plant commodities (GC/ECD and HPLC/UV) and animal
comodities (HPLC/UV). However, the registrant also proposed that an
HPLC/MS method be used for enforcement of plant commodities tolerances.
The proposed HPLC/MS/MS enforcement method for plant commodities should
undergo independent laboratory validation (ILV) as a condition of
registration, and possibly Agency method validation.
B. International Residue Limits
There are no CODEX, or Canadian Maximum Residue Limits for
acetamiprid on tuberous and corm vegetables.
C. Conditions
A Developmental Neurotoxicity study (DNT) study is currently under
review.
The proposed HPLC/MS/MS enforcement method for plant commodities
should undergo independent laboratory validation (ILV) as a condition
of registration, and possibly Agency method validation.
D. Response to Comments
One commenter expressed a general objection to the approval of
pesticide tolerances and also criticized the use of animal testing to
determine the safety of pesticides. This commenter's concerns have been
addressed in previous tolerance documents. See the Federal Register of
October 29, 2004, (69 FR 63083) (FRL-7681-9). The other comment was
from the WTO (World Trade Organization) Enquiry Point in China and
asked for extra time to translate the document and prepare comments.
This comment was received after the close of the comment period on
Sepember 7, 2004 via e-mail. On February 28, 2005 EPA contacted the
commenter and requested that if it had any comments to submit them by
March 15, 2005. No further response was received by EPA.
V. Conclusion
Therefore, the tolerance is established for residues of
acetamiprid, in or on tuberous and corm vegetables at 0.01 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
[[Page 19292]]
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2005-0029 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 on or before June 13,
2005.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2005-0029, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. 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 due to its lack of
significance, 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). 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., or 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). 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); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on
[[Page 19293]]
the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, 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: April 1, 2005.
Lois Rossi,
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
commodity 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
------------------------------------------------------------------------
* * * * *
Tuberous and Corm Vegetables......................... 0.01
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 05-7225 Filed 4-12-05; 8:45 am]
BILLING CODE 6560-50-S