[Federal Register Volume 70, Number 184 (Friday, September 23, 2005)]
[Rules and Regulations]
[Pages 55752-55761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18951]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0185; FRL-7736-3]


Amicarbazone; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of amicarbazone and its metabolites in or on field corn and livestock 
commodities and indirect or inadvertent residues of amicarbazone and 
its metabolites in alfalfa, cotton, soybean and wheat. Arysta 
Lifescience North American Corporation (perviously known as Arvesta 
Corporation) 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 September 23, 2005. Objections and 
requests for hearings must be received on or before November 22, 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-2005-0185. 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.

[[Page 55753]]

119, Crystal Mall <greek-i>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: Joanne I. Miller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6224; e-mail address: 
<a href="/cdn-cgi/l/email-protection#94f9fdf8f8f1e6bafefbf5fafaf1d4f1e4f5baf3fbe2"><span class="__cf_email__" data-cfemail="365b5f5a5a5344185c59575858537653465718515940">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
    <bullet> Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
    <bullet> Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
    <bullet> Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under  FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document 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 January 22, 2004 (69 FR 3138) (FRL-7339-
3), 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 
0F6131) by Arysta Lifescience North American Corporation, 100 First 
Street, Suite 1700; San Francisco, CA 94105. The petition requested 
that 40 CFR part 180 be amended by establishing tolerances for combined 
residues of the herbicide amicarbazone, 4-amino-4,5-dihydro-N-(1,1-
dimethylethyl)-3-(1-methylethyl)-5-oxo-1H-1,2,4-triazole-1-carboxamide] 
and its metabolities DA amicarbazone (N-(1,1-dimethylethyl)-4,5-
dihydro-3-(1-methylethyl)-5-oxo-1H,2,4-triazole-1-carboxamide) and iPr-
2-OH DA amicarbazone (N-(1,1-dimethylethyl)-4,5-dihydro-3-(1-hydroxy-1-
methylethyl)-5-oxo-1H-1,2,4-triazole-1-carboxamide), in or on the raw 
agricultural commodities alfalfa forage at 0.04 parts per million 
(ppm); alfalfa hay at 0.06 ppm; corn forage at 0.8ppm; corn grain, at 
0.05 ppm; corn stover at 0.5 ppm; cotton gin by-product at 0.2 ppm; 
cottonseed hulls at 0.01 ppm; cottonseed meal at 0.01 ppm; cottonseed 
refined oil at 0.01 ppm; cotton undelinted seed at 0.04 ppm; soybean 
forage at 2.5 ppm; soybean hay at 7.0 ppm; soybean hulls at 0.2 ppm; 
soybean meal at 0.25 ppm; soybean oil at 0.01 ppm; soybean seed at 0.6 
ppm; wheat bran at 0.08 ppm; wheat flour at 0.05 ppm; wheat forage at 
0.6 ppm; wheat germs at 0.05 ppm; wheat grain at 0.09 ppm; wheat hay at 
0.9 ppm; wheat middlings at 0.05 ppm; wheat shorts at 0.06 ppm; wheat 
straw at 0.4 ppm; sugarcane at 0.15 ppm; sugarcane molasses at 0.8 ppm; 
meat (cattle, goats, hogs, horses, and sheep) at 0.01 ppm; meat 
byproducts (cattle, goats, hogs, horses,and sheep) at 0.2 ppm; and milk 
at 0.01 ppm respectively.
    Due to a lack of field trial data on sugarcane, tolerances on 
sugarcane and sugarcane molasses are not being established at this 
time.
    One comment was received in response to the notice filing. B. 
Sachau objected to the proposed tolerances because of the amounts of 
pesticides already consumed and carried by the American population. She 
further indicated that testing conducted on animals have absolutely no 
validity and are cruel to the test animals. EPA's response to these 
comments is contained in Unit IV.C.
    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 combined residues of 
amicarbazone [4-amino-4, 5-dihydro- N-(1,1-dimethylethyl)-3-(1-
methylethyl)-5-oxo-1H-1,2,4-triazole-1-carboxamide] and its metabolites 
DA amicarbazone [N-(1,1-dimethylethyl)-4,5-dihydro-3-(1-methylethyl)-5-
oxo-1H-1,2,4-triazole-1-carboxamide] and iPr-2-OH DA amicarbazone [N-
(1,1-dimethylethyl)-4,5-dihydro-3-(1-hydroxy-1-methylethyl)-5-oxo-1H-
1,2,4-triazole-1-carboxamide], calculated as parent equivalents, in or 
on corn, field, forage at 0.80 ppm; corn, field, grain at 0.05 ppm; 
corn, field, stover at 1.0 ppm; cattle, fat at 0.01 ppm; cattle, liver 
at 1.0 ppm; cattle, meat at 0.01 ppm; cattle, meat byproducts, except 
liver at 0.10 ppm; goat, fat at 0.01 ppm; goat, liver at 1.0 ppm; goat, 
meat at 0.01 ppm; goat, meat byproducts, except liver at 0.1

[[Page 55754]]

ppm; hog, fat at 0.01 ppm; hog, liver at 0.1 ppm; hog, meat at 0.01 
ppm; hog, meat byproducts, except liver at 0.01 ppm; horse, fat at 0.01 
ppm; horse, liver at 1.0 ppm; horse, meat at 0.01 ppm; horse, meat 
byproducts, except liver at 0.10 ppm; milk at 0.01 ppm; sheep, fat at 
0.01 ppm; sheep, liver at 1.0 ppm; sheep, meat at 0.01 ppm; sheep, meat 
byproducts, except liver at 0.10 ppm; poultry, liver at 0.01 ppm. EPA 
can also make a determination on aggregate exposure for the 
establishment of tolerances for the indirect or inadvertent residues of 
amicarbazone and its metabolites DA amicarbazone and iPr-2-OH DA 
amicarbazone, calculated as amicarbazone, in or on the following raw 
agricultural commodities when present therein as a result of the 
application of amicarbazone to field corn: Alfalfa, forage at 0.05 ppm; 
alfalfa, hay at 0.10 ppm; cotton, undelinted seed at 0.07 ppm; cotton, 
gin byproducts at 0.30 ppm; soybean, forage at 1.50 ppm; soybean, hay 
at 5.0 ppm; soybean, seed at 0.80 ppm; wheat, forage at 0.50 ppm; 
wheat, hay at 1.0 ppm; wheat, grain at 0.10 ppm; wheat, straw at 0.50 
ppm; wheat, grain, milled byproducts at 0.15 ppm.
    EPA's assessment of exposures and risks associated with 
establishing the tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the toxic effects caused by amicarbazone 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-Day oral         NOAEL = 33/38
                                   toxicity -          milligram/
                                   rodents (rats)      kilogram/day (mg/
                                                       kg/day)
                                                      LOAEL = 67/78 mg/
                                                       kg/day based on
                                                       decreased
                                                       bodyweight (BW)
                                                       female and
                                                       overall (weeks 1-
                                                       13) bodyweight
                                                       gain (BWG),
                                                       decreased red
                                                       cell indices,
                                                       clinical
                                                       chemistry
                                                       (increased
                                                       cholesterol, T4
                                                       and T3 males, O-
                                                       demethylase
                                                       females, N-
                                                       demethylase
                                                       males), increased
                                                       relative liver
                                                       weights females,
                                                       and
                                                       histopathology
                                                       effects in males
                                                       (minimal
                                                       hepatocytomegaly
                                                       and minimal
                                                       pigmentation in
                                                       the spleen)
------------------------------------------------------
870.3150                          90-Day oral         NOAEL = 6.28 mg/kg/
                                   toxicity -          day
                                   nonrodents (dogs)  LOAEL = 24.99 mg/
                                                       kg/day based on
                                                       increased thyroid
                                                       vacuolization and
                                                       decreased food
                                                       consumption and
                                                       glucose in
                                                       females;
                                                       increased
                                                       platelets,
                                                       phosphate, bile
                                                       acids, absolute
                                                       and relative
                                                       liver weights,
                                                       and lymphoid
                                                       hyperplasia of
                                                       the gall bladder
                                                       in males; and
                                                       decreased albumin
                                                       and increased
                                                       triglycerides, N-
                                                       demethylase, and
                                                       O-demthylase in
                                                       both sexes.
------------------------------------------------------
870.3200                          21/28-Day dermal    NOAEL = 1,000 mg/
                                   toxicity            kg/day
                                                      LOAEL = Not
                                                       Observed
------------------------------------------------------
870.3700                          Prenatal            Maternal NOAEL =
                                   developmental in    15 mg/kg/day
                                   rats               LOAEL = 100 mg/kg/
                                                       day based on
                                                       decreased BW/BWG
                                                       and food
                                                       consumption, and
                                                       increased
                                                       incidences of
                                                       hard stools.
                                                      Developmental
                                                       NOAEL = 15 mg/kg/
                                                       day
                                                      LOAEL = 100 mg/kg/
                                                       day based on
                                                       multiple skeletal
                                                       development
                                                       retardations
                                                       (incomplete
                                                       ossification/
                                                       unossification
                                                       was observed in
                                                       parietal bones,
                                                       interparietal
                                                       bones,
                                                       supraoccipital
                                                       bones, squamosal
                                                       bones, zygoma,
                                                       pubis, xiphoid,
                                                       and fontanelle
------------------------------------------------------
870.3700                          Prenatal            Maternal NOAEL = 5
                                   developmental in    mg/kg/day
                                   rabbits            LOAEL = 20 mg/kg/
                                                       day based on
                                                       decreased BWG
                                                       during treatment.
                                                      Developmental
                                                       NOAEL = 20 mg/kg/
                                                       day
                                                      LOAEL = 70 mg/kg/
                                                       day based on
                                                       decreased fetal
                                                       BW, and increased
                                                       incidences of
                                                       incomplete
                                                       ossification of
                                                       the 5th medial
                                                       phalanx
                                                       (bilateral) and
                                                       the 13th caudal
                                                       vertebra, and
                                                       slightly thick
                                                       ribs.
------------------------------------------------------
870.3800                          Reproduction and    Parental/Systemic
                                   fertility effects   NOAEL = 6.4/7.3
                                                       mg/kg/day
                                                      LOAEL = 33.9/38.7
                                                       mg/kg/day based
                                                       on decreased BW/
                                                       BWG in both
                                                       sexes.
                                                      Reproductive NOAEL
                                                       = 73.2/84.0 mg/kg/
                                                       day
                                                      LOAEL = Not
                                                       Observed
                                                      Offspring NOAEL =
                                                       6.4/7.3 mg/kg/day
                                                      LOAEL = 33.9/38.7
                                                       mg/kg/day based
                                                       on decreased pup
                                                       BW and overall
                                                       decreased BWG.
------------------------------------------------------

[[Page 55755]]

 
870.4100                          Chronic toxicity    NOAEL = 2.3/2.7 mg/
                                   in rodents (rats)   kg/day
                                                      LOAEL = 25.3/29.5
                                                       mg/kg/day based
                                                       on decreased BW
                                                       in females and
                                                       BWG in both
                                                       sexes.
                                                      At the doses
                                                       tested there was
                                                       not a treatment
                                                       related increase
                                                       in tumor
                                                       incidence when
                                                       compared to
                                                       control. Dosing
                                                       was considered
                                                       adequate based on
                                                       decreased BW in
                                                       females and BWG
                                                       in both sexes.
------------------------------------------------------
870.4100                          Chronic toxicity    NOAEL =2.5/2.3 mg/
                                   dogs (beagle)       kg/day
                                                      LOAEL = 8.9/8.7 mg/
                                                       kg/day based on
                                                       effects on the
                                                       liver, including
                                                       increased
                                                       absolute and
                                                       relative liver
                                                       weights, and O-
                                                       demethylase in
                                                       males; increased
                                                       globulin and
                                                       cytochrome P-450
                                                       in females; and
                                                       increased
                                                       triglycerides and
                                                       cholesterol in
                                                       both sexes.
------------------------------------------------------
870.4300                          Carcinogenicity-    NOAEL = 244.7/
                                   mice                275.0 mg/kg/day
                                                      LOAEL = 709.0/
                                                       806.3 mg/kg/day
                                                       based on
                                                       decreased BW and
                                                       BWG in both
                                                       sexes, and
                                                       subclinical
                                                       anemia, and
                                                       hemosiderin
                                                       pigmentation of
                                                       the spleen in
                                                       males.
                                                      no evidence of
                                                       carcinogenicity
                                                      At the doses
                                                       tested there was
                                                       not a treatment
                                                       related increase
                                                       in tumor
                                                       incidence when
                                                       compared to
                                                       control. Dosing
                                                       was considered
                                                       adequate based on
                                                       decreased BW and
                                                       BWG in both
                                                       sexes, and
                                                       subclinical
                                                       anemia, and
                                                       hemosiderin
                                                       pigmentation of
                                                       the spleen in
                                                       males.
------------------------------------------------------
870.5100                          Bacterial reverse   There was no
                                   mutation test       evidence of
                                                       induced mutant
                                                       colonies over
                                                       background.
------------------------------------------------------
870.5100                          Bacterial reverse   There was no
                                   mutation test       evidence of
                                                       induced mutant
                                                       colonies over
                                                       background.
------------------------------------------------------
870.5100                          Bacterial reverse   There was no
                                   mutation test       evidence of
                                                       induced mutant
                                                       colonies over
                                                       background.
------------------------------------------------------
870.5300                          In vitro mammalian  There was no
                                   cell gene           evidence that
                                   mutation test       MKH3586 induced
                                                       mutant colonies
                                                       over background
                                                       in the presence
                                                       or absence of S9-
                                                       activation.
------------------------------------------------------
870.5375                          In vitro mammalian  There was no
                                   chromosome          evidence of
                                   aberration test     chromosome
                                                       aberration
                                                       induced over
                                                       background in the
                                                       presence or
                                                       absence of S9-
                                                       activation.
------------------------------------------------------
870.5395                          Mammalian           There was no
                                   erythrocyte         significant
                                   micronucleus test   increase in the
                                                       frequency of
                                                       micronucleated
                                                       polychromatic
                                                       erythrocytes in
                                                       bone marrow at
                                                       any treatment
                                                       time.
------------------------------------------------------
870.6200                          Acute               NOAEL = 10 mg/kg/
                                   neurotoxicity       day
                                   screening battery  LOAEL = 20 mg/kg/
                                   in rats (Fischer-   day based on
                                   344)                eyelid ptosis,
                                                       decreased
                                                       approach response
                                                       (both sexes), and
                                                       red nasal
                                                       staining in
                                                       males.
                                                      A series of acute
                                                       neurotoxicity
                                                       studies were
                                                       performed, the
                                                       NOAEL for this
                                                       study comes from
                                                       45121527.
------------------------------------------------------
870.6200                          Subchronic          Female: NOAEL =
                                   neurotoxicity       7.8 mg/kg/day
                                   screening battery  LOAEL = 38.2 mg/kg/
                                   in rats (Fischer-   day based on
                                   344)                decreased BW and
                                                       overall BWG in
                                                       females.
                                                      Male: NOAEL = 66.5
                                                       mg/kd/day
                                                      LOAEL = was not
                                                       observed for
                                                       males.
------------------------------------------------------
870.6300                          Developmental       Maternal NOAEL = 8
                                   neurotoxicity in    mg/kg/day
                                   rats               LOAEL = 39 mg/kg/
                                                       day based
                                                       primarily on
                                                       decreased feed
                                                       efficiency
                                                       (combination of
                                                       decreased BWG and
                                                       increased food
                                                       consumption)
                                                       during lactation.
                                                      Offspring NOAEL =
                                                       39 mg/kg/day
                                                      LOAEL = 91 mg/kg/
                                                       day based on
                                                       decreased BWG.
------------------------------------------------------
870.7485                          Metabolism and      95% of the
                                   pharmacokinetics    radioactive dose
                                                       was recovered
                                                       within 72 hours
                                                       following dosing.
                                                       The majority of
                                                       the dose was
                                                       recovered from
                                                       the urine within
                                                       24 hours (64%),
                                                       indicating
                                                       substantial
                                                       absorption. Fecal
                                                       excretion
                                                       accounted for 27%
                                                       of the dose
                                                       within 24 hours.
                                                       Major metabolites
                                                       were DA MKH, N-
                                                       methyl DA MKH,
                                                       and
                                                       decarboxamide.
------------------------------------------------------

[[Page 55756]]

 
870.7485                          Metabolism and      91% of the
                                   pharmacokinetics    radioactive dose
                                                       was recovered
                                                       within 96 hours.
                                                       Urinary excretion
                                                       accounted for 70%
                                                       of the
                                                       radioactive dose
                                                       within 12 hours,
                                                       showing
                                                       substantial
                                                       absorption. Only
                                                       8% of the
                                                       radioactive dose
                                                       was excreted via
                                                       the feces within
                                                       24 hours.
------------------------------------------------------
Non-guideline                     Subchronic          Thyroid hormones
                                   mechanistic         were increased in
                                   feeding in rats     the >19.4 mg/kg/
                                                       day females and
                                                       40.0 mg/kg/day
                                                       males. However,
                                                       thyroid to blood
                                                       ratios of \125\I
                                                       in treated groups
                                                       were comparable
                                                       to negative
                                                       controls,
                                                       indicating there
                                                       was no impairment
                                                       of thyroid
                                                       hormone
                                                       synthesis. Thus,
                                                       the differences
                                                       in thyroid
                                                       hormones is
                                                       probably due to
                                                       metabolism at an
                                                       extra-thyroidal
                                                       site. The liver
                                                       was implicated as
                                                       this site because
                                                       liver weights and
                                                       UDP-
                                                       glucuronosyltrans
                                                       ferase activity
                                                       were increased.
------------------------------------------------------
Non-guideline                     In vitro studies    MKH 3586 does not
                                   on enzymes of       affect the iodide
                                   thyroid hormone     organification
                                   regulation          step of thyroid
                                                       hormone synthesis
                                                       or the peripheral
                                                       metabolism of
                                                       thyroid hormones
                                                       via Type I or
                                                       Type II
                                                       deiodinases in
                                                       vivo. These
                                                       findings support
                                                       the subchronic
                                                       mechanistic
                                                       studies in rats
                                                       which indicate
                                                       that upregulation
                                                       of UDP-
                                                       glucuronosyl
                                                       transferase in
                                                       the liver may
                                                       account for
                                                       alterations in
                                                       thyroid hormone
                                                       profile.
------------------------------------------------------
Non-guideline                     Behavioral study    The following
                                   in rats             clinical signs
                                                       were observed:
                                                       Sedation, ptosis,
                                                       salivation.
                                                       Additionally at
                                                       the HDT,
                                                       piloerection,
                                                       Straub
                                                       phenomenon, and
                                                       prone position
                                                       were observed.
                                                       The effects were
                                                       observed at 30
                                                       minutes post
                                                       dose, and no
                                                       effect was
                                                       observed at 150
                                                       minutes post
                                                       dose, with the
                                                       higher dose
                                                       groups showing
                                                       greater
                                                       persistence of
                                                       effects. A dose-
                                                       and time-
                                                       dependent effect
                                                       was demonstrated
                                                       on motor activity
                                                       - decreased
                                                       travel distance,
                                                       increased resting
                                                       time, and
                                                       decreased
                                                       rearing.
------------------------------------------------------
Non-guideline                     Study of central    The data indicate
                                   nervous system      that a single
                                   safety              dose of MKH 3586
                                   pharmacology in     at 100 mg/kg
                                   mice                causes minimal
                                                       CNS functional
                                                       impairment,
                                                       characterized by
                                                       increased
                                                       reaction times to
                                                       nociceptive
                                                       stimuli, reduced
                                                       traction force,
                                                       impaired motor
                                                       coordination,
                                                       sedation, partial
                                                       ptosis, and a
                                                       mild
                                                       anticonvulsive
                                                       effect.
------------------------------------------------------------------------

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, 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 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.
    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 = NOAE/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 non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. 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<SUP>-5</SUP>), one in a million (1 
X 10<SUP>-6</SUP>), one in a ten million (1 X 10<SUP>-7</SUP>). 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

[[Page 55757]]

derived from the dose response curve. To estimate risk, a ratio of the 
point of departure to exposure (MOE cancer = point of departure/
exposures) is calculated.
    A summary of the toxicological endpoints for amicarbazone used for 
human risk assessment is shown in Table 2 of this unit:

    Table 2.--Summary of Toxicological Doses and Endpoints for Amicarbazone for Use in Human Risk Assessments
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk       Special FQPA SF* and   Study and Toxicological
          Exposure Scenario                 Assessment UF       LOC for Risk Assessment          Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                          NOAEL = 10 mg/kg/day     Special FQPA SF = 1X     Acute neurotoxicity
(females 13-49 years of age).........  UF = 100X..............  aPAD = 0.10 mg/kg/day..   screening battery
                                       Acute RfD = 0.10 mg/kg/                           LOAEL = 20 mg/kg/day,
                                        day.                                              based on eyelid
                                                                                          ptosis, decreased
                                                                                          approach response, red
                                                                                          nasal staining in male
                                                                                          rats.
----------------------------------------------------------------
Acute dietary                          NOAEL = 10 mg/kg/day     Special FQPA SF = 1X     Acute neurotoxicity
(general population).................  UF = 100X..............  aPAD = 0.10 mg/kg/day..   screening battery
                                       Acute RfD = 0.10 mg/kg/                           LOAEL = 20 mg/kg/day,
                                        day.                                              based on eyelid
                                                                                          ptosis, decreased
                                                                                          approach response, red
                                                                                          nasal staining in male
                                                                                          rats.
----------------------------------------------------------------
Chronic dietary                        NOAEL = 2.3 mg/kg/day    Special FQPA SF = 1X     Chronic rat and chronic
(all populations)....................  UF = 100X..............  cPAD = 0.023 mg/kg/day.   dog
                                       Chronic RfD = .023 mg/                            LOAEL = 25.3 and 8.7,
                                        kg/day.                                           respectively, based on
                                                                                          rat - decreased BW and
                                                                                          BWG dog - liver
                                                                                          effects, including
                                                                                          increased absolute and
                                                                                          relative liver
                                                                                          weights, and O-
                                                                                          demethylase in male
                                                                                          dogs; increased
                                                                                          globulin and
                                                                                          cytochrome p450 in
                                                                                          female dogs; and
                                                                                          increased
                                                                                          triglycerides and
                                                                                          cholesterol in both
                                                                                          sexes
----------------------------------------------------------------
Dermal (all durations)                  Not required: No systemic toxicity by dermal route was seen at the limit
                                                        dose. Evidence of low dermal absorption.
----------------------------------------------------------------
Inhalation short-term                  NOAEL = 6.28 mg/kg/day   LOC for MOE = 100        90-Day oral toxicity in
(1 - 30 days)........................                                                     dogs
                                                                                         LOAEL = 24.99 mg/kg/
                                                                                          day, based on
                                                                                          increased thyroid
                                                                                          vacuolization and
                                                                                          decreased food
                                                                                          consumption and
                                                                                          glucose in females;
                                                                                          increased platelets,
                                                                                          phosphate, bile acids,
                                                                                          absolute and relative
                                                                                          liver weights, and
                                                                                          lymphoid hyperplasia
                                                                                          of the gall bladder in
                                                                                          males; and decreased
                                                                                          albumin and increased
                                                                                          triglycerides, N-
                                                                                          demethylase, and O-
                                                                                          demethylase in both
                                                                                          sexes
----------------------------------------------------------------
Inhalation intermediate-term           NOAEL = 6.28 mg/kg/day   LOC for MOE = 100        90-Day oral toxicity in
(1-6 months).........................                                                     dogs
                                                                                         LOAEL = 24.99 mg/kg/
                                                                                          day, based on
                                                                                          increased thyroid
                                                                                          vacuolization and
                                                                                          decreased food
                                                                                          consumption and
                                                                                          glucose in females;
                                                                                          increased platelets,
                                                                                          phosphate, bile acids,
                                                                                          absolute and relative
                                                                                          liver weights, and
                                                                                          lymphoid hyperplasia
                                                                                          of the gall bladder in
                                                                                          males; and decreased
                                                                                          albumin and increased
                                                                                          triglycerides, N-
                                                                                          demethylase, and O-
                                                                                          demethylase in both
                                                                                          sexes
----------------------------------------------------------------
Cancer (oral, dermal, inhalation)           Classification: There was no treatment related increase in tumor
                                        incidence when compared to control. Dosing was considered adequate. This
                                                       chemical is not likely to be a carcinogen.
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. No tolerances have 
been established in 40 CFR part 180 previously for the combined 
residues of amicarbazone, in or on a variety of raw agricultural 
commodities. Risk assessments were conducted by EPA to assess dietary 
exposures from amicarbazone in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    The Dietary Exposure Evaluation Model (DEEM\TM\) analysis evaluated 
the individual food consumption 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 following assumptions were made for the acute exposure 
assessments: For the acute analyses, tolerance-level residues were 
assumed for all food commodities with proposed amicarbazone tolerances, 
and it was assumed that 100% of all of the crops included in the 
analysis were treated. The DEEM\TM\ analyses included drinking water in 
addition to the food sources of residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM software with the

[[Page 55758]]

Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates food 
consumption data as reported by respondents in the USDA 1994-1996 and 
1998 Nationwide CSFII, and accumulated exposure to the chemical for 
each commodity. The following assumptions were made for the chronic 
exposure assessments: For the chronic analyses tolerance-level residues 
were assumed for all food commodities with proposed amicarbazone 
tolerances, and it was assumed that 100% of all of the crops included 
in the analysis were treated. As with the acute analyses, drinking 
water was included in the assessment.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for amicarbazone 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 amicarbazone.
    Based on the FIRST and SCI-GROW models, the estimated environmental 
concentrations (EECs) of amicarbazone for acute exposures are estimated 
to be 21.4 parts per billion (ppb) for surface water and 102.9 ppb for 
ground water. The EECs for chronic exposures are estimated to be 13.4 
ppb for surface water and 102.9 ppb for ground water. The ground water 
EEC was used in both the acute and chronic DEEM analyses described 
earlier in this section.
    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).
    Amicarbazone is not registered for use on any sites that would 
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the 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.''
    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 amicarbazone and any other 
substances and amicarbazone 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 amicarbazone 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 website at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional 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 additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of rat or rabbit fetuses following in utero 
exposure in the developmental studies with amicarbazone. There is no 
evidence of increased susceptibility of rats in the reproduction study 
with amicarbazone. EPA concluded that there are no residual 
uncertainties for prenatal and/or postnatal exposure.
    3. Conclusion. There is a complete toxicity data base for 
amicarbazone and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. The Agency 
concluded that there was reliable data to remove the 10X children's 
safety factor based upon the following: The toxicity database showed no 
increase in susceptibility in fetuses and pups with in utero and post-
natal exposure; the dietary exposure assessment is based on HED-
recommended tolerance-level residues, assumes 100% crop treated for all 
commodities, and utilizes high-end estimates of concentrations in 
water; and there are no residential uses proposed for this chemical at 
this time.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and 
drinking water to amicarbazone will occupy 7% of the aPAD for the U.S. 
population, 6% of the aPAD for females 13 years and older, 23% of the 
aPAD for the all infant subpopulation, which is the subpopulation with 
the greatest exposure, and 12% of the aPAD for children 1-2 years old. 
Therefore, EPA does not expect the acute aggregate risk exposure to 
exceed 100% of the aPAD.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
amicarbazone from food and drinking water will utilize 14% of the cPAD 
for the U.S. population, 39% of the cPAD for for the all infant 
subpopulation, which is the subpopulation with the greatest exposure, 
and 26% of the cPAD for children 1-2 years old. There are no 
residential uses for amicarbazone that result in chronic residential 
exposure to amicarbazone. Therefore, the aggregate risk is the sum of 
the risk from food and water, which do not exceed the Agency's LOC.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Amicarbazone is not 
registered for use on any sites that would result in residential 
exposure. Therefore, the chronic aggregate risk is the sum of the risk 
from food and water, which do not exceed the Agency's LOC.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Amicarbazone 
is not registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is the sum of the risk from 
food and water, which does not exceed the Agency's LOC.
    5. Aggregate cancer risk for U.S. population. A cancer dietary 
exposure analysis was not performed because the

[[Page 55759]]

Agency determined that amicarbazone was not likely to cause cancer.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to amicarbazone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass 
spectrometry/mass spectrometry) is available to enforce the tolerance 
expression. The methods for both plant and livestock commodities may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: <a href="/cdn-cgi/l/email-protection#5e2c3b2d373a2b3b333b2a36313a2d1e3b2e3f70393128"><span class="__cf_email__" data-cfemail="d8aabdabb1bcadbdb5bdacb0b7bcab98bda8b9f6bfb7ae">[email protected]</span></a>.

B. International Residue Limits

    There are currently no established Codex, Canadian or Mexican 
residue limits for amicarbazone.

C. Response to Comments

    Ms. Sachau's comments regarding general exposure to pesticides 
contained no scientific data or evidence to rebut the Agency's 
conclusion that there is a reasonable certainty that no harm will 
result from aggregate exposure to amicarbazone, including all 
anticipated dietary exposures and all other exposures for which there 
is reliable information. This comment as well as her comments regarding 
animal testing have been responded to by EPA on several occasions. 70 
FR 1349 (January 7, 2005)(FRL-7691-4); 69 FR 63083, (October 29, 
2004)(FRL-7681-9).

V. Conclusion

    Therefore, tolerances are established for combined residues of 
amicarbazone [4-amino-N-(1,1-dimethyl)-4,5-dihydro-3-(1-methylethyl)-5-
oxo-1H-1,2,4-triazole-1-carboxamide] and its metabolites DA 
amicarbazone [N-(1,1-dimethylethyl)-4,5-dihydro-3-(1-methylethyl)-5-
oxo-1H-1,2,4-triazole-1-carboxamide] and iPr-2-OH DA amicarbazone [N-
(1,1-dimethylethyl)-4,5-dihydro-3-(1-hydroxy-1-methylethyl)-5-oxo-1H-
1,2,4-triazole-1-carboxamide], calculated as parent equivalents, in or 
on corn, field, grain at 0.05 ppm; corn, field, forage at 0.80 ppm; 
corn, field, stover at 1.0 ppm; cattle, fat at 0.01 ppm; cattle, liver 
at 1.0 ppm; cattle, meat at 0.01 ppm; cattle, meat byproducts, except 
liver at 0.10 ppm; goat, fat at 0.01 ppm; goat, liver at 1.0 ppm; goat, 
meat at 0.01 ppm; goat, meat byproducts, except liver at 0.1 ppm; hog, 
fat at 0.01 ppm; hog, liver at 0.1 ppm; hog, meat at 0.01 ppm; hog, 
meat byproducts, except liver at 0.01 ppm; horse, fat at 0.01 ppm; 
horse, liver at 1.0 ppm; horse, meat at 0.01 ppm; horse, meat 
byproducts, except liver at 0.10 ppm; milk at 0.01 ppm; sheep, fat at 
0.01 ppm; sheep, liver at 1.0 ppm; sheep, meat at 0.01 ppm; sheep, meat 
byproducts, except liver at 0.10 ppm; poultry, liver at 0.01 ppm.
    Tolerances are also established for the indirect or inadvertent 
residues of amicarbazone and its metabolites DA amicarbazone and iPr-2-
OH DA amicarbazone, calculated as amicarbazone, in or on the following 
raw agricultural commodities when present therein as a result of the 
application of amicarbazone to field corn: Alfalfa, forage at 0.05 ppm; 
Alfalfa, hay at 0.10 ppm; Cotton, undelinted seed at 0.07 ppm; Cotton, 
gin byproducts at 0.30 ppm; Soybean, forage at 1.50 ppm; Soybean, hay 
at 5.0 ppm; Soybean, seed at 0.80 ppm; Wheat, forage at 0.50 ppm; 
Wheat, hay at 1.0 ppm; Wheat, grain at 0.10 ppm; Wheat, straw at 0.50 
ppm; Wheat, grain, milled byproducts at 0.15 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 
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-2005-0185 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 November 
22, 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 issue(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 VIA, 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-2005-0185, 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: <a href="/cdn-cgi/l/email-protection#4a253a3a672e2529212f3e0a2f3a2b642d253c"><span class="__cf_email__" data-cfemail="234c53530e474c40484657634653420d444c55">[email protected]</span></a>. 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.

[[Page 55760]]

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 issue(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 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: September 12, 2005.
James Jones,
Director, 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 180.615 is added to subpart C to read as follows:


Sec.  180.615  Amicarbazone; tolerances for residues

    (a) General. Tolerances are established for combined residues of 
the herbicide, amicarbazone [4-amino-4, 5-dihydro- N-(1,1-
dimethylethyl)-3-(1-methylethyl)-5-oxo-1H-1,2,4-triazole-1-carboxamide] 
and its metabolites DA amicarbazone [N-(1,1-dimethylethyl)-4,5-dihydro-
3-(1-methylethyl)-5-oxo-1H-1,2,4-triazole-1-carboxamide] and iPr-2-OH 
DA amicarbazone [N-(1,1-dimethylethyl)-4,5-dihydro-3-(1-hydroxy-1-
methylethyl)-5-oxo-1H-1,2,4-triazole-1-carboxamide], calculated as 
parent equivalents, in or on the following commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Cattle, fat..........................................               0.01
Cattle, liver........................................                1.0
Cattle, meat.........................................               0.01
Cattle, meat byproducts, except liver................               0.10
Corn, field, forage..................................               0.80
Corn, field, grain...................................               0.05
Corn, field, stover..................................                1.0
Goat, fat............................................               0.01

[[Page 55761]]

 
Goat, liver..........................................                1.0
Goat, meat...........................................               0.01
Goat, meat byproducts, except liver..................               0.10
Hog, fat.............................................               0.01
Hog, liver...........................................               0.10
Hog, meat............................................               0.01
Hog, meat byproducts, except liver...................               0.01
Horse, fat...........................................               0.01
Horse, liver.........................................                1.0
Horse, meat..........................................               0.01
Horse, meat byproducts, except liver.................               0.10
Milk.................................................               0.01
Sheep, fat...........................................               0.01
Sheep, liver.........................................                1.0
Sheep, meat..........................................               0.01
Sheep, meat byproducts, except liver.................               0.10
Poultry, liver.......................................               0.10
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established 
for the indirect or inadvertent residues of amicarbazone [4-amino-4, 5-
dihydro-N-(1,1-dimethylethyl)-3-(1-methylethyl)-5-oxo-1H-1,2,4-
triazole-1-carboxamide] and its metabolites DA amicarbazone [N-(1,1-
dimethylethyl)-4,5-dihydro-3-(1-methylethyl)-5-oxo-1H-1,2,4-triazole-1-
carboxamide] and iPr-2-OH DA amicarbazone [N-(1,1-dimethylethyl)-4,5-
dihydro-3-(1-hydroxy-1-methylethyl)-5-oxo-1H-1,2,4-triazole-1-
carboxamide], calculated as parent equivalents, in or on the following 
commodities when present therein as a result of application of 
amicarbazone to the growing crops in paragraph (a) of this section:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Alfalfa, forage......................................               0.05
Alfalfa, hay.........................................               0.10
Cotton, gin byproducts...............................               0.30
Cotton, undelinted seed..............................               0.07
Soybean, forage......................................               1.50
Soybean, hay.........................................                5.0
Soybean, seed........................................               0.80
Wheat, forage........................................               0.50
Wheat, grain.........................................               0.10
Wheat, grain, milled byproducts......................               0.15
Wheat, hay...........................................                1.0
Wheat, straw.........................................               0.50
------------------------------------------------------------------------


[FR Doc. 05-18951 Filed 9-22-05; 8:45 am]
BILLING CODE 6560-50-S


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