[Federal Register Volume 70, Number 70 (Wednesday, April 13, 2005)]
[Rules and Regulations]
[Pages 19283-19293]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-7225]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0029; FRL-7705-7]


Acetamiprid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

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: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     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
------------------------------------------------------------------------
          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.
------------------------------------------------------
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.
------------------------------------------------------
870.3200                          21-day dermal       NOAEL: 1,000 mg/kg/
                                   toxicity - rabbit   day - Highest
                                                       Dose Tested (HDT)
                                                      LOAEL: >1,000 mg/
                                                       kg/day
------------------------------------------------------
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.
------------------------------------------------------

[[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
------------------------------------------------------
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.
------------------------------------------------------
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.
------------------------------------------------------
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.
------------------------------------------------------
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.
------------------------------------------------------
870.5100                          Reverse gene        Salmonella
                                   mutation assay      typhimurium/E.
                                                       coli - Not
                                                       mutagenic under
                                                       the conditions of
                                                       the study.
------------------------------------------------------
870.5300                          Mammalian cells in  Not mutagenic
                                   culture             under the
                                  Forward gene         conditions of the
                                   mutation assay -    study.
                                   CHO cells.
------------------------------------------------------
870.5375                          In vitro mammalian  Acetamiprid is a
                                   chromosomal         clastogen under
                                   aberrations - CHO   the conditions of
                                   cells               the study.
------------------------------------------------------
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.
------------------------------------------------------
870.5395                          In vivo mammalian   Acetamiprid is not
                                   cytogenetics -      a clastogen in
                                   micronucleus        the mouse bone
                                   assay in mice       marrow
                                                       micronucleus
                                                       test.
------------------------------------------------------
870.5550                          UDS assay in        Acetamiprid tested
                                   primary rat         negatively for
                                   hepatocytes/        UDS in mammalian
                                   mammalian cell      hepatocytes in
                                   culture             vivo.
------------------------------------------------------
870.6200                          Acute               NOAEL: 10 mg/kg
                                   neurotoxicity -    LOAEL: 30 mg/kg
                                   rat                 based on
                                                       reduction in
                                                       locomotor
                                                       activity.
------------------------------------------------------
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.
------------------------------------------------------
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.
------------------------------------------------------

[[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.
----------------------------------------------------------------------------------------------------------------
                                          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.
----------------------------------------------------------------
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).
----------------------------------------------------------------
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.
----------------------------------------------------------------
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.
----------------------------------------------------------------
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.
----------------------------------------------------------------

[[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: [email protected]. 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