[Federal Register Volume 66, Number 246 (Friday, December 21, 2001)]
[Rules and Regulations]
[Pages 65839-65850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-31497]


=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301184; FRL-6806-7]
RIN 2070-AB78


Fluthiacet-methyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
fluthiacet-methyl in or on field corn grain, field corn forage, field 
corn stover, pop corn grain, pop corn stover, sweet corn, kernels plus 
cob husk removed (K+CWHR), sweet corn forage, and sweet corn stover. K-
I Chemical, U.S.A. Inc., 11 Martine Avenue, 9th Floor, White Plains, 
New York 10606 requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act 
(FQPA) of 1996.

DATES: This regulation is effective December 21, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301184, 
must be received by EPA on or before February 19, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301184 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460; telephone number: (703) 305-6224; and e-mail 
address: <a href="/cdn-cgi/l/email-protection#660b0f0a0a0314480c09070808032603160748010910"><span class="__cf_email__" data-cfemail="107d797c7c75623e7a7f717e7e75507560713e777f66">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS Codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply

[[Page 65840]]

to certain entities. If you have questions regarding the applicability 
of this action to a particular entity, consult the person listed under 
FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301184. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of April 14, 1997 (62 FR 18116) (FRL-5599-
7), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a as amended by the of FQPA 1996 (Public Law 104-170) announcing the 
filing of a pesticide petition (PP) for tolerance by K-I Chemical 
U.S.A., Inc., 11 Martine Avenue, 9th Floor, White Plains, NY 10606. 
This notice included a summary of the petition prepared by K-I Chemical 
U.S.A. Inc., the registrant. There were no comments received in 
response to the notice of filing. In the Federal Register of October 6, 
1998 (63 FR 53656) (FRL-6033-8), EPA issued a notice pursuant to the 
same Acts, announcing an amendment to the petition. There were no 
comments received in response to the notice of filing. Addition 
tolerances for residues of fluthiacet-methyl per se in or on cottonseed 
and cotton gin by products were requested; however, a revised Section F 
to the petition was submitted in which these tolerances were not 
requested.
    The petition requested that 40 CFR 180.551 be amended by 
establishing a tolerance for residues of the herbicide, fluthiacet-
methyl, acetic acid, [2-chloro-4-fluoro-5-[(tetrahydro-3-oxo-1H,3H-
[1,3,4]thiadiazolo[3,4-<greek-a>]pyridazin-1-
ylidene)amino]phenyl]thio]-methyl ester), in or on corn, field, grain 
at 0.010 part per million (ppm); corn, field, forage at 0.050 ppm; 
corn, field, stover at 0.050 ppm; corn, pop, grain at 0.010 ppm; corn, 
pop, stover at 0.050 ppm; corn, sweet, forage at 0.050 ppm; corn, 
sweet, K + CWHR at 0.010 ppm; and corn, sweet, stover at 0.050 ppm.
    Section 408(b)(2)(A)(i) of the 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) 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) 
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 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961) (FRL-5754-7) November 26, 1997.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for tolerances for residues of fluthacet-methyl on corn, 
field, grain at 0.010 ppm; corn, field, forage at 0.050 ppm; corn, 
field, stover at 0.050 ppm; corn, pop, grain at 0.010 ppm; corn, pop, 
stover at 0.050 ppm; corn, sweet, forage at 0.050 ppm; corn, sweet, K + 
CWHR at 0.010 ppm; and corn, sweet, stover at 0.050 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 fluthiacet-methyl 
are discussed in the following Table 1 as well as the no observed 
adverse effect level (NOAEL) and the lowest observed adverse effect 
level (LOAEL) from the toxicity studies reviewed.

[[Page 65841]]



            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
          Guideline No.               Study Type            Results
------------------------------------------------------------------------
870.3100                          90-day oral         Rats:
                                  Toxicity, rats and  NOAEL = 6.19
                                   mice.               milligrams/
                                                       kilograms day (mg/
                                                       kg/day) in males
                                                                6.80 mg/
                                                       kg/day in females
                                                      LOAEL =   216 mg/
                                                       kg/day in males
                                                                249 mg/
                                                       kg/day in females
                                                      Mice:
                                                      NOAEL = 1.3 mg/kg/
                                                       day in males
                                                                1.6 mg/
                                                       kg/day in females
                                                      LOAEL =   66 mg/kg/
                                                       day in males
                                                                83 mg/kg/
                                                       day in females
                                                      Based on decreased
                                                       body weight gains
                                                       as well as
                                                       effects on
                                                       hematology,
                                                       clinical
                                                       chemistry,
                                                       urinalysis
                                                       parameters, liver
                                                       weights and
                                                       microscopic
                                                       pathology in
                                                       rats; and on
                                                       effects on the
                                                       erythropoietic
                                                       system and liver
                                                       in mice.
------------------------------------------------------------------------
870.3150                          6-week oral         NOAEL = 236 mg/kg/
                                   toxicity in dogs    day in males
                                                                77.7 mg/
                                                       kg/day in females
                                                      LOAEL = 709 mg/kg/
                                                       day in males
                                                                232 mg/
                                                       kg/day in females
                                                       based on
                                                       decreased body
                                                       weight gain.
------------------------------------------------------------------------
870.3200                          28-day dermal       NOAEL = 1,000 mg/
                                   toxicity in rats    kg/day, the
                                                       highest dose
                                                       tested (HDT).
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal in rats:
                                   developmental in   NOAEL = 1,000 mg/
                                   rats                kg/day, HDT
                                  and rabbits.......  Maternal in
                                                       rabbits:
                                                      NOAEL = 1,000 mg/
                                                       kg/day, HDT
                                                      Developmental in
                                                       rabbits:
                                                      NOAEL = 300 mg/kg/
                                                       day
                                                      Developmental in
                                                       rabbits:
                                                      LOAEL of 1,000 mg/
                                                       kg/day based on
                                                       slight non-
                                                       significant
                                                       increased
                                                       incidence of
                                                       irregularly
                                                       shaped sternebrae
                                                       attributed to a
                                                       delay in fetal
                                                       development. (See
                                                       section D., 2.)
------------------------------------------------------------------------
870.3800                          2-generation        Parental/systemic
                                  Reproduction and    NOAEL = 1.59 mg/kg/
                                   fertility effects.  day in males
                                                      LOAEL = 31.8 mg/kg/
                                                       day in males
                                                      NOAEL = 1.73 mg/kg/
                                                       day in females
                                                      LOAEL = 35.2 mg/kg/
                                                       day in females
                                                       based on
                                                       reduction in male
                                                       body weights/
                                                       gains and hepatic
                                                       pathology
                                                      Reproductive in
                                                       males:
                                                      NOAEL = 31.8 mg/kg/
                                                       day
                                                      LOAEL =313 mg/kg/
                                                       day
                                                      Reproductive in
                                                       females:
                                                      NOAEL = 37.1 mg/kg/
                                                       day
                                                      LOAEL = 388 mg/kg/
                                                       day based on
                                                       decreases in mean
                                                       litter body
                                                       weights.
------------------------------------------------------------------------
870.4100                          Chronic toxicity    NOAEL in males =
                                   dogs                57.6 mg/kg/day
                                                      LOAEL in males =
                                                       582 mg/kg/day
                                                      NOAEL in females =
                                                       30.3 mg/kg/day
                                                      LOAEL in females =
                                                       145 mg/kg/day
                                                      The LOAELs were
                                                       based on effects
                                                       observed in the
                                                       erythropoietic
                                                       system and liver.
------------------------------------------------------------------------
870.4200                          Carcinogenicity     NOAEL in males =
                                   rats                2.1 mg/kg/day
                                                      LOAEL in males =
                                                       130 mg/kg/day
                                                      NOAEL in females =
                                                       2.5 mg/kg/day
                                                      LOAEL in females =
                                                       154 mg/kg/dayIn
                                                       males there were
                                                       decreased body
                                                       weight, liver
                                                       toxicity,
                                                       pancreatic
                                                       toxicity and
                                                       microcytic
                                                       anemia. In
                                                       females there
                                                       were liver
                                                       toxicity, uterine
                                                       toxicity and
                                                       slight microcytic
                                                       anemia. In males
                                                       only at 130 and
                                                       219 mg/kg/day
                                                       there was
                                                       respectively, an
                                                       increase in the
                                                       trend toward
                                                       pancreatic
                                                       exocrine adenomas
                                                       and pancreatic
                                                       islet cell
                                                       adenomas.
------------------------------------------------------------------------

[[Page 65842]]

 
870.4300                          Carcinogenicity     NOAEL in males and
                                   mice                females = 0.1 mg/
                                                       kg/day
                                                      LOAEL in males and
                                                       females = 0.1 and
                                                       1.2 mg/kg/day,
                                                       respectively,
                                                       based on non-
                                                       neoplastic liver
                                                       findings. In
                                                       males, and
                                                       possibly females,
                                                       at 10 mg/kg/day
                                                       for males and 12
                                                       mg/kg/day for
                                                       females; and at
                                                       32 gm/kg/day for
                                                       males and 37 mg/
                                                       kg/day for
                                                       females, there
                                                       was an increase
                                                       in the number of
                                                       mice with
                                                       hepatocellular
                                                       adenomas,
                                                       carcinomos and or
                                                       adenomas/
                                                       carcinomas.
------------------------------------------------------------------------
870.1000                          Gene mutation       Flutiacet-methyl
                                                       was negative for
                                                       mutagenic/
                                                       genotoxic effects
                                                       in bacterial or
                                                       cultured
                                                       mammalian cells
                                                       and did not cause
                                                       DNA damage in
                                                       bacterial or
                                                       primary rat
                                                       hepatocytes.
------------------------------------------------------------------------
870.5375                          Cytogenetics        In vitro
                                                       cytogenetic
                                                       assays performed
                                                       with two
                                                       different
                                                       mammalian cell
                                                       lines
                                                       demonstrated that
                                                       fluthiacet-methyl
                                                       is clastogenic
                                                       both in the
                                                       presence and
                                                       absence of S9
                                                       activation.
------------------------------------------------------------------------
870                               Other effects       Flutiacet-methyl
                                                       was negative for
                                                       micronuclei
                                                       induction in
                                                       mouse bone
                                                       marrow, a
                                                       significant
                                                       increase in
                                                       micronuclei was
                                                       seen in
                                                       stimulated rat
                                                       liver cells
                                                       following in vivo
                                                       exposure.
------------------------------------------------------------------------
870.6200                          Acute               NOAEL = 2,000 mg/
                                   neurotoxicity       kg/day, with no
                                   screening battery   effects at HDT
                                   in rats
------------------------------------------------------------------------
870.6200                          Subchronic          NOAEL in males =
                                   neurotoxicity       0.576 mg/kg/day
                                   screening battery   (systemic)
                                   in rats            LOAEL in males =
                                                       556 mg/kg/day
                                                       based on
                                                       decreased body
                                                       weight and food
                                                       consumption
                                                      NOAEL in females =
                                                       1,345 mg/kg/day
                                                       (HDT) (systemic)
                                                      NOAEL in males =
                                                       1,128 mg/kg/day
                                                       (neurotoxicity)
                                                      NOAEL in females =
                                                       1,345 mg/kg/day
                                                       (neurotoxicity)
------------------------------------------------------------------------
870.7485                          Metabolism and      Fluthiacet-methyl
                                   pharmaco-kinetics   was absorbed
                                   in rats             rapidly at both
                                                       low and high
                                                       dosages in both
                                                       male and female
                                                       rats. Repeated
                                                       oral dosing had
                                                       no effect on
                                                       extent of
                                                       absorption.
                                                       Tissue levels of
                                                       radio active
                                                       fluthiacet-methyl
                                                       in single and
                                                       repeated low dose
                                                       groups did not
                                                       exceed 0.018 ppm
                                                       in any tissue. At
                                                       the single high
                                                       dose, female rats
                                                       showed higher
                                                       levels of
                                                       radioactivity in
                                                       tissues than
                                                       males except for
                                                       muscle, brain,
                                                       fat and plasma.
                                                       Excretion in
                                                       males was
                                                       predominantly in
                                                       feces for all
                                                       dose groups, with
                                                       between 67 to 87%
                                                       of administered
                                                       radioactivity
                                                       excreted by this
                                                       route. In
                                                       females, the
                                                       percentage of
                                                       administered
                                                       radioactivity in
                                                       urine across all
                                                       dose groups 40 to
                                                       48% was
                                                       approximately
                                                       equivalent to the
                                                       percent excreted
                                                       in feces, 39 to
                                                       52%. The greater
                                                       fecal excretion
                                                       in males was
                                                       based on a
                                                       greater
                                                       percentage
                                                       excretion in bile
                                                       for males, 37%
                                                       vs. females 19%.
------------------------------------------------------------------------
870.7600                          Dermal penetration  No dermal
                                                       penetration
                                                       studies were
                                                       submitted.
------------------------------------------------------------------------
                                  Special studies     There were no
                                                       required special
                                                       studies
------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which 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 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 intra species differences.
    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 the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, 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 FQPA 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

[[Page 65843]]

the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is 
calculated and compared to the LOC.
    The linear default risk methodology (Q<SUP>*</SUP>) is the primary 
method currently used by the Agency to quantify carcinogenic risk. The 
Q<SUP>*</SUP> approach assumes that any amount of exposure will lead to 
some degree of cancer risk. A Q<SUP>*</SUP> is calculated and used to 
estimate risk which represents a probability of occurrence of 
additional cancer cases (e.g., risk is expressed as 1 x 10<SUP>-6</SUP> 
or one in a million). 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 
(MOE<INF>cancer</INF> = point of departure/exposures) is calculated. A 
summary of the toxicological endpoints for fluthiacet-methyl used for 
human risk assessment is shown in the following Table 2:

 Table 2. --Summary of Toxicological Doses and Endpoints for Fluthiacet-methyl for Use in Human Risk Assessment.
----------------------------------------------------------------------------------------------------------------
          Exposure Scenario                Dose (mg/kg/day)             Endpoint                  Study
----------------------------------------------------------------------------------------------------------------
Acute Dietary                          None                     No appropriate endpoint  None
                                                                 attributable to a
                                                                 single dose (exposure)
                                                                 was identified in oral
                                                                 toxicity studies.
                                                                 Therefore, an acute
                                                                 reference dose (RfD)
                                                                 was not established.
                                                                 Thus, an acute
                                                                 exposure/risk
                                                                 assessment was not
                                                                 conducted.
----------------------------------------------------------------------------------------------------------------
                                                                NOT REQUIRED
----------------------------------------------------------------------------------------------------------------
Chronic Dietary                        NOAEL = 0.1 mg/kg/day    Non-neoplastic liver     18-month
General population...................                            findings (increase in    carcinogenicity in the
                                                                 absolute and relative    mouse
                                                                 liver weights, fatty
                                                                 changes, chronic
                                                                 inflammation,
                                                                 karyomegaly, single
                                                                 cell necrosis and
                                                                 ceroid/lipofuscin
                                                                 pigmentation).
                                      --------------------------------------------------
                                       UF = 100                 Chronic RfD = 0.001 mg/
                                       FQPA SF = 1............   kg/day
                                                                Chronic PAD = 0.001 mg/
                                                                 kg/day.
----------------------------------------------------------------------------------------------------------------
Short-term and intermediate-term       None                     No dermal or systemic    28-day dermal in the
 (dermal)                                                        toxicity was seen at     rat
                                                                 the limit-dose
                                                                 following repeated
                                                                 dermal applications to
                                                                 rats.
----------------------------------------------------------------------------------------------------------------
Long-term (dermal) see footnote 1      NOAEL = 0.1 mg/kg/day    Non-neoplastic liver     18-month
 below table                                                     findings (increase in    carcinogenicity in the
                                                                 absolute and relative    mouse
                                                                 liver weights, fatty
                                                                 changes, chronic
                                                                 inflammation,
                                                                 karyomegaly, single
                                                                 cell necrosis and
                                                                 ceroid/lipofuscin
                                                                 pigmentation).
----------------------------------------------------------------------------------------------------------------
Inhalation (Any time period)           None                     The LC<SUP>50</SUP> for males and   None
                                                                 females was >5,048
                                                                 <plus-minus> 225 mg/m<SUP>3</SUP>
                                                                 (>5.0 mg/L). Based on
                                                                 the low acute toxicity
                                                                 (Toxicity Category 4),
                                                                 the composition of the
                                                                 end-use product
                                                                 (5.36%) and the
                                                                 application rate
                                                                 (0.0089 lb ai/acre/
                                                                 season or 4.0 g ai/
                                                                 acre/season), an
                                                                 inhalation exposure/
                                                                 risk assessment was
                                                                 not conducted.
----------------------------------------------------------------------------------------------------------------

[[Page 65844]]

 
Cancer (Chronic)                       Q<INF>1<SUP></INF>*</SUP> = 2.07E<SUP>-1</SUP>            The HED, CARC (HED       78-week carcinogenicity
                                       (mg/kg/day)<SUP>-1</SUP>..........   Cancer Assessment        in the mouse
                                       (In human equivalents).   Review Committee)
                                                                 recommended a linear
                                                                 low-dose approach
                                                                 (Q<INF>1<SUP></INF>*</SUP>) for human risk
                                                                 characterization and
                                                                 determined that
                                                                 extrapolation should
                                                                 be based on the
                                                                 combined
                                                                 hepatocellular tumors
                                                                 (adenomas and
                                                                 carcinomas) in male
                                                                 mice.
----------------------------------------------------------------------------------------------------------------
<SUP>1</SUP>= Long-term dermal Since an oral study was selected and there is no dermal absorption study, a 100% dermal
  absorption factor (default value) was used.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.551) for the residues of fluthiacet-methyl, in 
or on a variety of raw agricultural commodities. There are presently no 
tolerances established for meat, milk, poultry and eggs. Based upon the 
results of a ruminant feeding study and a goat metabolism study, this 
Agency concluded that there is no reasonable expectation of finite 
residues in ruminant tissues and milk. Based upon the results of a 
poultry metabolism study, fluthiacet-methyl and its metabolite (CGA-
300403) are unlikely to occur in poultry or eggs. Risk assessments were 
conducted by EPA to assess dietary exposures from fluthiacet-methyl 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. There were no toxicological effects that could be 
attributed to a single oral exposure (dose) in an appropriate 
toxicological study. Thus, an acute exposure/risk assessment was not 
conducted for fluthiacet-methyl.
    ii. Chronic exposure. Percent crop treated (PCT), anticipated 
market share percentages and tolerance level residues were used.
    A chronic reference dose (RfD) (0.001 mg/kg/day) was identified for 
fluthiacet-methyl, based on non-neoplastic liver findings (increase in 
absolute and relative liver weights, fatty changes, chronic 
inflammation, karyomegaly, single cell necrosis and ceroid/lipofuscin 
pigmentation). The chronic PAD is the same as the chronic RfD since the 
FQPA factor was reduced to 1X. The chronic PAD was used to assess 
chronic risk.
    EPA's Office of Pesticide Programs (OPP) Health Effects Division 
used Dietary Exposure Evaluation Model (DEEM<SUP>TM</SUP>), version 
7.075) software for conducting a chronic dietary (food) exposure 
analysis. DEEM <SUP>TM</SUP> is a dietary exposure analysis system 
developed by Novigen Sciences, Inc. that is used to estimate exposure 
to pesticide residues in foods comprising the diets of the U.S. 
population, including population subgroups. DEEM<SUP>TM</SUP> contains 
food consumption data as reported by respondents in the USDA Continuing 
Surveys of Food Intake by Individuals conducted in 1989-1992.
    A Tier 2 chronic DEEM<SUP>TM</SUP> analysis was performed. The 
assumptions of this Tier 2 analysis were tolerance level residues and 
estimates of PCT for soybeans and projected market-share for corn 
commodities. The following tolerance levels were used in the analysis: 
soybeans at 0.01 ppm, sweet corn at 0.01 parts per million (ppm), pop 
corn at 0.01 ppm, and corn grain (field corn) at 0.01 ppm. These values 
were also used for corresponding processed commodities since processing 
studies for soybeans and field corn showed no concentration of residues 
into processed commodities. Thus, default concentration factors for 
corn grain, bran; corn grain, endosperm; corn grain, oil; soybean, 
other; soybeans, sprouted seeds; soybeans, flour (defatted, low fat, 
and full fat); soybean, oil; and soybean, protein isolate were set to 
1X. DEEM<SUP>TM</SUP> default processing factors for corn grain/sugar/
hfcs (1.5X), and corn grain/sugar-molasses (1.5X) were retained as 
processing data for these commodities are not available. A PCT value of 
1% was used for soybeans and a projected market share value of 1% was 
used for all types of corn. These estimates of PCT/projected market 
share were derived based on Agency analysis of information on weed-
pests for the use sites.
    The chronic dietary exposure (food only) to fluthiacet-methyl for 
some population subgroups are presented in Table 3. The resulting 
dietary food exposures occupy <1% of the Chronic PAD for all population 
subgroups included in the analysis. The results of this dietary 
exposure analysis should be viewed as partially refined. Refinements 
such as use of anticipated residue values may yield even lower 
estimates of chronic dietary exposure.

  Table 3.--Summary: Chronic Dietary Exposure Analysis by DEEM (Tier 2)
------------------------------------------------------------------------
                                   Exposure (mg/kg/
      Population Subgroup<SUP>1</SUP>               day)          % of Chronic PAD<SUP>2</SUP>
------------------------------------------------------------------------
U.S. population (total)           <0.000001           <1.0
------------------------------------------------------------------------
All Infants (<1 year)             0.000001            <1.0
------------------------------------------------------------------------
Children (1-6 years)              <0.000001           <1.0
------------------------------------------------------------------------
Children (7-12 years)             <0.000001           <1.0
------------------------------------------------------------------------
Males (20+ years)                 <0.000001           <1.0
------------------------------------------------------------------------
Females (13-50 years)             <0.000001           <1.0
------------------------------------------------------------------------
<SUP>1</SUP>The subgroups listed are: (1) The U.S. population (total); (2) those
  for infants and children; and, (3) the most highly exposed of the
  adult females and males subgroups (in this case, females, 13 to 50
  years and males 20+ years).
<SUP>2</SUP> Percent chronic PAD = (exposure <divide> chronic PAD) x 100%.
Note: There are no other subgroup(s) (other than All Infants) for which
  the percentage of the Chronic PAD occupied is greater than that
  occupied by the subgroup U. S. population (total).


[[Page 65845]]

    iii. Cancer. Fluthiacet-methyl has been classified as ``likely to 
be a human carcinogen'' by EPA. The Office of Pesticide Programs, Heath 
Effects Division, Cancer Assessment Review Committee recommended a 
linear low-dose approach (Q<INF>1</INF><SUP>*</SUP>) for human risk 
assessment. The Q<INF>1</INF><SUP>*</SUP> is 0.207 (mg/kg/day)-1 in 
human equivalents and is based upon the combined hepatocellular tumors 
(adenomas and carcinomas) in male mice.
    EPA conducted a cancer assessment analysis (food) using DEEM 
software and Tier 2 chronic dietary exposure assumptions. The 
assumptions of this Tier 2 chronic dietary analysis are as specified 
above.
    The cancer risk estimate (food only) for the U.S. population 
(total) is 3.93 x 10<SUP>-8</SUP>. This risk estimate translates to a 
dietary exposure of 1.90 x 10<SUP>-7</SUP> mg/kg/day. This dietary 
exposure value was back-calculated based upon the cancer risk estimate 
and the Q<INF>1</INF><SUP>*</SUP>. As cancer risk = Exposure x 
Q<INF>1</INF> <SUP>*</SUP> Thus, Exposure = cancer risk estimate/ 
Q<INF>1</INF> <SUP>*</SUP> or Exposure = 3.93 x 10<SUP>-8</SUP>/0.207.
    iv. Anticipated residue and PCT information. Anticipated residues 
estimates were not used in the exposure analysis. Tolerance levels were 
used and a projected market share estimate was used as described in the 
chronic exposure section above.
    Section 408(b)(2)(F) states that the Agency may use data on the 
actual percent of food treated for assessing chronic dietary risk only 
if the Agency can make the following findings: Condition 1, that the 
data used are reliable and provide a valid basis to show what 
percentage of the food derived from such crop is likely to contain such 
pesticide residue; Condition 2, that the exposure estimate does not 
underestimate exposure for any significant subpopulation group; and 
Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F), EPA may require registrants to submit data on 
PCT.
    The Agency used PCT information as follows: Percent projected 
market share: Corn, 1% and soybeans, 1%. Currently the largest market 
share for a pesticide for control of velvetleaf in corn or cotton is 
less than 20%. While the Agency does not expect the PCT to exceed 1% 
for corn or soybeans, it would be highly unlikely that the PCT approach 
the 20% share. EPA has determined that if PCT was to reach 20% there is 
still a reasonable certainty that no harm will result to the general 
population, and to infants and children from aggregate exposure to 
fluthiacet-methyl residues.
    The Agency believes that the three conditions listed above have 
been met. With respect to Condition 1, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. EPA uses a weighted average PCT for chronic dietary 
exposure estimates. This weighted average PCT figure is derived by 
averaging State-level data for a period of up to 10 years, and 
weighting for the more robust and recent data. A weighted average of 
the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. EPA believes the PCT used in this analysis is reasonable 
based on factors used in the analysis; in particular, the number of 
acres of corn and soybeans currently treated for the control of the 
weed pest, velvetleaf, the primary target weed pest for which 
fluthiacet-methyl will be used. This analysis also included competing 
currently registered herbicides for this market. EPA estimates that 
currently about 25 million acres of soybeans and 50 million acres of 
corn are treated for control of velvetleaf. Corn acres are treated with 
41 different herbicidal active ingredients (a.i.), and soybeans acres 
are treated with 34 different herbicidal a.i.. For acute dietary 
exposure estimates, EPA uses an estimated maximum PCT. The exposure 
estimates resulting from this approach reasonably represent the highest 
levels to which an individual could be exposed, and are unlikely to 
underestimate an individual's acute dietary exposure. The Agency is 
reasonably certain that the percentage of the food treated is not 
likely to be an underestimation. As to Conditions 2 and 3, regional 
consumption information and consumption information for significant 
subpopulations is taken into account through EPA's computer-based model 
for evaluating the exposure of significant subpopulations including 
several regional groups. Use of this consumption information in EPA's 
risk assessment process ensures that EPA's exposure estimate does not 
understate exposure for any significant subpopulation group and allows 
the Agency to be reasonably certain that no regional population is 
exposed to residue levels higher than those estimated by the Agency. 
Other than the data available through national food consumption 
surveys, EPA does not have available information on the regional 
consumption of food to which fluthiacet-methyl may be applied in a 
particular area.
    1. Dietary exposure from drinking water. The Agency currently lacks 
sufficient water-related exposure data from monitoring to complete a 
quantitative drinking water exposure analysis and risk assessment for 
fluthiacet-methyl. Therefore, the Agency is presently relying on 
computer-generated estimated environmental concentrations (EECs). The 
PRZM/EXAMS Index Reservoir (IR) model was used to generate EECs for 
surface water and the SCI-GROW2 (an empirical model based upon actual 
monitoring data collected for a number of pesticides that serve as 
benchmarks) was used to predict EECs in ground water. These models take 
into account the use patterns and the environmental profile of a 
pesticide, but do not include consideration of the impact that 
processing raw water for distribution as drinking water would likely 
have on the removal of pesticides from the source water. The primary 
use of these models by the Agency at this stage is to provide a coarse 
screen for determining that pesticides residues (and its metabolites) 
in water are not of concern.
    For any given pesticide, the SCI-GROW2 model generates a single EEC 
value of pesticide concentration in ground water. That EEC is used in 
assessments of both acute and chronic dietary risk. It is not unusual 
for the ground water EEC to be significantly lower than the surface 
water EECs. The PRZM/EXAMS IR model generates several time-based EECs 
of pesticide concentration in surface water for acute exposure (upper 
10<SUP>th</SUP> percentile of peak values), non-cancer chronic exposure 
(upper 10<SUP>th</SUP> percentile of 90-day values), and cancer 
exposure (mean annual value).
    A drinking water level of comparison (DWLOC) is the concentration 
of a pesticide in drinking water that would be acceptable as a 
theoretical upper limit in light of total aggregate exposure to that 
pesticide from food, water, and residential uses. HED uses DWLOCs 
internally in the risk assessment process as a surrogate measure of 
potential exposure associated with pesticide exposure through drinking 
water. In the absence of monitoring data for a pesticide, the DWLOC is 
used as a point of comparison against the conservative EECs provided by 
computer modeling.

[[Page 65846]]

    EPA, OPP, HED back-calculates DWLOCs by a two-step process: 
exposure [food + residential (if applicable)] is subtracted from the 
PAD to obtain the maximum acceptable exposure allowed in drinking 
water; DWLOCs are then calculated using that value and HED default body 
weight and drinking water consumption figures. In assessing human 
health risk, DWLOCs are compared to EECs. When EECs are less than 
DWLOCs, HED considers the aggregate risk from [food + water + 
residential (if applicable) exposures] to be acceptable.
    2. Environmental profile. In soil, fluthiacet-methyl and its 
metabolites are considered to be mobile and persistent (effective or 
combined aerobic soil half-life of 305 days). The uncertainty of this 
half-life is large as indicated by a 95% confidence range of roughly 
200 to 1,100 days. Due to the large uncertainty a soil half-life of 915 
days was used in the models. Fluthiacet-methyl is expected to be a 
ground and surface water contaminant.
    EPA, HED, Metabolism Assessment Review Committee (MARC) determined 
that the residues of concern for risk assessment purposes in water are 
residues that comprised greater than or equal to 10% of the total 
radioactive residues in the environmental fate studies. These residues 
include, but are not limited to, CGA-300402, CGA-300404, CGA-330057, 
component E, CGA-300403, CGA-327066, CGA-327067, CGA-330059, A-CFPSA, 
and ACA-CFPSA.
    3. Estimated environmental concentrations (EECs). The modeling 
results below are based on the combined concentrations of six 
chemicals. These chemicals are the parent compound and metabolites CGA-
300402, CGA-300403, CGA-327066, CGA-327067, and A-CFPSA. The modeling 
was conducted based on the environmental profile and two applications 
at the rate of 0.0045 lbs ai/A (or a seasonal rate of 0.009 lbs ai/A).
    The EECs are shown in Table 4.

      Table 4.--EFED Estimated Environmental Concentrations (EECs)
------------------------------------------------------------------------
                                            PRZM/EXAMS IR Model (<greek-
         SCI-GROW2 (<greek-m>g/L)<SUP>1</SUP>                     m>g/L)
------------------------------------------------------------------------
0.08                                        0.8
(acute and chronic).......................  (for acute exposure)
                                            0.5
                                            (for chronic (non-cancer)
                                             exposure)
                                            0.06
                                            (for cancer exposure)
------------------------------------------------------------------------
1 <greek-m>g/L = parts per billion or ppb.

    The Agency lacks sufficient monitoring exposure data to complete a 
comprehensive dietary exposure analysis and risk assessment for 
fluthiacet-methyl 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 fluthiacet-methyl.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), 
to produce estimates of pesticide concentrations in an index reservoir. 
The SCI-GROW model is used to predict pesticide concentrations in 
shallow ground water. For a screening-level assessment for surface 
water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a 
tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that 
uses a specific high-end runoff scenario for pesticides. While both 
FIRST and PRZM/EXAMS incorporate an index reservoir environment, the 
PRZM/EXAMS model includes a percent crop (PC) area factor as an 
adjustment to account for the maximum PC coverage within a watershed or 
drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    As the models used are considered to be screening tools in the risk 
assessment process, the Agency does not use estimated environmental 
concentrations (EECs) from these models to quantify drinking water 
exposure and risk as a %RfD or %PAD. Instead 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. 
Because DWLOCs address total aggregate exposure to fluthiacet-methyl 
they are further discussed in the aggregate risk sections below.
    Based on the PRZM/EXAMS and SCI-GROW 2 models the estimated 
environmental concentrations (EECs) of fluthiacet-methyl for acute 
exposures are estimated to be 0.8 ppb for surface water and 0.08 ppb 
for ground water. The EECs for chronic exposures (non-cancer) are 
estimated to be 0.5 ppb for surface water and 0.08 ppb for ground 
water. The EEC for chronic (cancer) exposures are estimated to be 0.08 
ppb for ground water and 0.06 ppb for surface water.
    4. 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).
    Fluthiacet-methyl is not registered for use on any sites that would 
result in residential exposure.
    5. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) 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 fluthiacet-methyl has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
fluthiacet-methyl 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 fluthiacet-methyl 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 final rule for

[[Page 65847]]

Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. In general. FFDCA section 408 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 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 margin of exposure 
(MOE) analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. There was no indication of 
quantitative or qualitative increased susceptibility of rats or rabbits 
to in utero and/or prenatal/postnatal exposure to fluthiacet-mthyl. In 
rabbits, in utero exposure did not result in maternal toxicity at 1,000 
mg/kg/day. Developmental toxicity, however, was seen at this dose 
characterized as an increase in irregular sternebrae (a variation which 
is reversible). The occurrence of developmental toxicity at which no 
maternal toxicity was noted indicates an apparent increase in 
susceptibility. The Office of Pesticide Program's Hazard Identification 
Assessment Review Committee (HIARC), however, determined that the 
apparent susceptibility is not convincing because of the equivocal 
nature of the effect based on: (1) The increased incidence of irregular 
sternebrae was not statistically significant when compared to 
concurrent controls; (2) the increase occurred at the Limit-Dose (1,000 
mg/kg/day; (3) it was the only anomaly seen (i.e., a single variation); 
(4) the dose response was not strong because there was only a small 
increase in the litter incidence between the low- (5 mg/kg/day) and the 
high-dose (1,000 mg/kg/day), with the mid- and high-dose groups having 
8 litters with this variation;, and (5) this endpoint is appropriate to 
establish a LOAEL and not appropriate for risk assessments. Based on 
these factors, the HIARC concluded that there is no increased 
susceptibility in the rabbit study. Therefore, the 10X FQPA safety 
factor to ensure the protection of infants and children was not applied 
in the risk assessments.
    3. Conclusion. There is a complete toxicity data base for 
fluthiacet-methyl and exposure data are complete or are estimated based 
on data that reasonably accounts for potential exposures. The 10X FQPA 
safety factor to protect infants and children was removed based on the 
lack of increased susceptibility of rats or rabbits to in utero and/or 
postnatal exposure to this chemical.

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 the model estimates of 
a pesticide's concentration in water (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 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 USEPA Office of Water are used to calculate 
DWLOCs: 2L/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, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP 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, OPP 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. An acute dietary endpoint for fluthiacet-methyl has 
not been identified; therefore, fluthiacet-methyl is not expected to 
pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
fluthiacet-methyl from food will utilize <1% of the cPAD for the U.S. 
population, <1% of the cPAD for all infants <1 year and <1% of the cPAD 
for all children. There are no residential uses for fluthiacet-methyl 
that result in chronic residential exposure to fluthiacet-methyl. Based 
the use pattern, chronic residential exposure to residues of 
fluthiacet-methyl is not expected. In addition, there is potential for 
chronic dietary exposure to fluthiacet-methyl 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 cPAD, as shown in the following Table 5:

           Table 5.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Fluthiacet-methyl
----------------------------------------------------------------------------------------------------------------
                                                                           Surface       Ground
                    Population Subgroup                        %cPAD      Water EEC    Water EEC     Chronic
                                                               (Food)       (ppb)        (ppb)     DWLOC (ppb)
---------------------------------------------------------------------------------------------------------------
U.S. population                                                    <1.0          0.5         0.08           35
----------------------------------------------------------------------------------------------------------------
All infant                                                         <1.0          0.5         0.08          1.0
----------------------------------------------------------------------------------------------------------------
Females (13-20 years)                                              <1.0          0.5         0.08           30
----------------------------------------------------------------------------------------------------------------

[[Page 65848]]

 
Males (20 + years)                                                 <1.0          0.5         0.08           35
----------------------------------------------------------------------------------------------------------------
Chronic PAD (cPAD) in mg/kg/day is 0.001 for all population subgroups.

    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).
    Fluthiacet-methyl 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 do not exceed the Agency's 
level of concern.
    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).
    Fluthiacet-methyl 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 do not exceed the Agency's 
level of concern.
    5. Aggregate cancer risk for U.S. population. Fluthiacet-methyl has 
been classified as ``likely to be a human carcinogen'' based upon the 
combined hepatocellular tumors (adenomas and carcinomas in male mice.
    6. Cancer aggregate risk conclusions. As summarized previously, the 
cancer risk estimate (food only) for the U.S. population (total) is 
3.93 x 10<SUP>-8.</SUP> This risk estimate translates to an exposure of 
1.90 x 10<SUP>-7</SUP> mg/kg/day. The results of this dietary exposure 
analysis should be viewed as partially refined (health protective). 
Refinements such as use of anticipated residue values may yield even 
lower estimates of cancer exposure.
    The EECs provided by EFED for assessing cancer risk are 0.08 
<greek-m>g/L (for ground water, based on SCI-GROW2) and 0.06 
<greek-m>g/L (for surface water, based on PRZM/EXAMS IR modeling). The 
back-calculated DWLOC for assessing cancer aggregate dietary risk is 
0.17 <greek-m>g/L for the U.S. population (total).
    The SCI-GROW2 and PRZM/EXAMS cancer EECs are less than the Agency's 
level of comparison for fluthiacet-methyl residues in drinking water as 
a contribution to chronic (cancer) aggregate exposure. HED thus 
concludes with reasonable certainty that residues of fluthiacet-methyl 
in drinking water will not contribute significantly to the aggregate 
cancer human health risk and that the chronic (cancer) aggregate 
exposure from fluthiacet-methyl residues in food and drinking water 
will not exceed the Agency's level of concern (1X 10<SUP>6</SUP>) for 
the U.S. population. EPA generally has no concern for exposures below 
which result in cancer risks in the range of 1 x 10<SUP>-6</SUP>, 
because it is a level at or below which daily aggregate dietary 
exposure over a lifetime will not pose appreciable risks to the health 
and safety of any population subgroup. This risk assessment is 
considered high confidence, very conservative, and protective of human 
health.
    7. 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 fluthiacet-methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Method AG-603B, MRID No. 442345-
02), gas-liquid chromotography with a nitrogen/phosphorus detector, is 
available to enforce the tolerances for fluthiacet-methyl in or on corn 
and soybean commodities. The method may be requested from: Calvin 
Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW, 
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: 
<a href="/cdn-cgi/l/email-protection#eb8d9e9987849cc5888a879d8285ab8e9b8ac58c849d"><span class="__cf_email__" data-cfemail="335546415f5c441d50525f455a5d735643521d545c45">[email protected]</span></a>.

B. International Residue Limits

    There are no Codex Alimentarius Commission (Codex), Canadian, or 
Mexican Maximum Residue Levels (MRLs) for fluthiacet-methyl at this 
time.

C. Conditions

    Conditions for registration under the Federal Insecticide, 
Fungicide and Rodenticide Act (FIFRA) will include Agency monitoring 
for PCT as addressed within this Final Rule.

V. Conclusion

    Tolerances are established for residues of fluthiacet-methyl in or 
on corn. field, grain at 0.010 ppm; corn, field, forage, at 0.050 ppm; 
corn, field, stover at 0.050 ppm; corn, pop, grain at 0.010 ppm; corn, 
pop, stover at 0.050 ppm; corn, sweet, stover at 0.050 ppm; corn, 
sweet, forage at 0.050 ppm; and corn, sweet, K + CWHR at 0.010 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the 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 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
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 control number OPP-301184 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 February 
19, 2002.
    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

[[Page 65849]]

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 (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. 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) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at <a href="/cdn-cgi/l/email-protection#4632292b362d2f2835682c2f2b0623362768212930"><span class="__cf_email__" data-cfemail="40342f2d302b292e336e2a292d002530216e272f36">[email protected]</span></a>, 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. 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 Unit I.B.2. Mail your 
copies, identified by docket control number OPP-301184, 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. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: <a href="/cdn-cgi/l/email-protection#90ffe0e0bdf4fff3fbf5e4d0f5e0f1bef7ffe6"><span class="__cf_email__" data-cfemail="fe918e8ed39a919d959b8abe9b8e9fd0999188">[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.

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. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this 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 prior consultation as specified in 
Executive Order 13084, entitled Consultation and Coordination with 
Indian Tribal Governments (63 FR 27655, May 19, 1998); 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 FFDCA section 408(d), such 
as the tolerance in this final rule, do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.) do not apply. 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 FFDCA section 408(n)(4). 
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

[[Page 65850]]

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, 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. Submission to Congress and the Comptroller General

    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 record 
keeping requirements.


    Dated: December 8, 2001.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180-- [AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

    2. Section 180.551 is amended by alphabetically adding commodities 
to the table in paragraph (a) to read as follows:


Sec. 180.551  Fluthiacet-methyl; tolerances for residues.

    (a) General. *  *  *  

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Corn, field, forage                         0.050
Corn, field, grain                          0.010
Corn, field, stover                         0.050
Corn, pop, grain                            0.010
Corn, pop, stover                           0.050
Corn, sweet, forage                         0.050
Corn, sweet, (K + CWHR)                     0.010
Corn, sweet, stover                         0.050
              *        *        *        *        *
------------------------------------------------------------------------

* * * * *

[FR Doc. 01-31497 Filed 12-20-01; 8:45 am]
BILLING CODE 6560-50-S


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