[Federal Register Volume 68, Number 122 (Wednesday, June 25, 2003)]
[Rules and Regulations]
[Pages 37749-37759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15905]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0181; FRL-7313-9]


Flufenacet (N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide; Pesticide 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

----------------------------------------------------------------------- 
SUMMARY:

    This regulation establishes a tolerance for combined residues of 
flufenacet (N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide and its 
metabolites containing the 4-fluoro-N-methylethyl benzenamine moiety in 
or on corn, field, forage; corn, field, grain; corn, field, stover; and 
soybean, seed; and for indirect or inadvertent residues for flufenacet 
and its metabolites in or on alfalfa, forage; alfalfa, hay; alfalfa, 
seed; clover, forage; clover, hay; grain, cereal, group 15, except 
rice; grain, cereal, forage, fodder and straw, group 16, except rice; 
and grass, forage, fodder, and hay, group 17. BayerCropScience 
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 June 25, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0181, 
must be received on or before August 25, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: James A. Tompkins, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 305-5697; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 32532)
    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 Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0181. The 
official public

[[Page 37750]]

docket consists of the documents specifically referenced in this 
action, any public comments received, and other information related to 
this action. Although a part of the official docket, the public docket 
does not include Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. The official 
public docket is the collection of materials that is available for 
public viewing at the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., 
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.
    2. Electronic access. 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 http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_(--00.html, 
a beta site currently under development. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of March 20, 2003 (68 FR 13703) (FRL-7296-
5), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
pesticide petitions (PP 6F4631 and 0F6095) by BayerCropScience, P.O. 
Box 12014, 2 T. W. Alexander Drive, Research Triangle Park, NC 27709. 
That notice included a summary of the petitions prepared by 
BayerCropScience, the registrant. One comment was received in response 
to this notice of filing by B. Sachau, 15 Elm Str., Florham Park, NJ 
07932. Mr. Sachau objected generally to the presence of pesticides in 
food and specifically to the presence of flufenacet.
    Bayer requested in petition 6F4631 that 40 CFR 180.527 (a) be 
amended by making the currently time-limited tolerances for combined 
residues of the herbicide flufenacet, N-(4-fluorophenyl)-N-(1-
methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-
yl]oxy]acetamide and its metabolites containing the 4-fluoro-N-
methylethyl benzenamine moiety] permanent in or on the following 
agricultural commodities: Corn, field, forage at 0.4 ppm; corn, field, 
grain at 0.05 ppm; corn, field, stover at 0.4 ppm; and soybean, seed at 
0.1 ppm.
    Bayer requested in petition 0F6095 that the section 18 tolerances 
listed below in 40 CFR 180.527 (b) for combined residues of the 
herbicide flufenacet, N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide and it's 
metabolites containing 4-fluoro-N-methylethyl benzenamine moiety] be 
made permanent and moved to 40 CFR 180.527 (a), cattle, fat at 0.05 
ppm; cattle, kidney at 0.5 ppm; cattle, meat at 0.05 ppm; cattle, meat 
byproducts at 0.1 ppm; goat, fat at 0.05 ppm; goat, kidney at 0.5 ppm; 
goat, meat at 0.05 ppm; goat, meat byproducts at 0.1 ppm; hog, fat at 
0.05 ppm; hog, kidney at 0.5 ppm; hog, meat at 0.05 ppm; hog, meat, 
byproducts at 0.1 ppm; horse, fat at 0.05 ppm; horse, kidney at 0.5 
ppm; horse, meat at 0.05 ppm; horse, meat byproducts at 0.1 ppm; sheep, 
fat at 0.05 ppm; sheep, kidney at 0.5 ppm; sheep, meat at 0.05 ppm; 
sheep, meat byproducts at 0.1 ppm; wheat, forage at 10.0 ppm; wheat, 
grain at 1.0 ppm; wheat, hay at 2.0 ppm; and wheat, straw at 0.50 ppm.
    Bayer requested in petition 0F6095 that the currently time limited 
tolerances in 40 CFR 180.527 (d) be amended by establishing permanent 
tolerances for indirect or inadvertent residues of the herbicide 
flufenacet;N-(4-fluorophenyl)-N-(1-methylethyl)-2- [[5-
(trifluoromethyl)-1,3,4- thiadiazol-2-yl]oxy]acetamide and its 
metabolites containing the 4-fluoro-N-methylethyl benzenamine moiety in 
or on the following raw agricultural commodities from the application 
of this herbicide to the raw agricultural commodities listed in 40 CFR 
180.527 (a) and (b) at the levels listed below Table 1:

                       Table 1.--Tolerance Levels
------------------------------------------------------------------------
                                                      Level in Parts per
            Commodity              Current level in    Million proposed
                                   Parts per Million       by Bayer
------------------------------------------------------------------------
Alfalfa, forage                   0.1                 0.1
------------------------------------------------------------------------
Alfalfa, hay                      0.1                 0.1
------------------------------------------------------------------------
Alfalfa, seed                     0.1                 0.1
------------------------------------------------------------------------
Clover, forage                    0.1                 0.1
------------------------------------------------------------------------
Clover, hay                       0.1                 0.1
------------------------------------------------------------------------
Grain, cereal, group 15, except   0.1                 0.4
 rice
------------------------------------------------------------------------
Grain, cereal, forage, fodder,    0.1                 10.0
 and straw, group 16, except
 rice
------------------------------------------------------------------------
Grass, forage, fodder and hay,    0.1                 0.1
 group 17
------------------------------------------------------------------------

    The Agency's current review did not include the data submitted with 
petition 0F6095. Therefore, the Agency is leaving the section 18 time 
limited tolerances listed in 40 CFR 180.527 (b) unchanged. The time 
limited tolerances listed in 40 CFR 180.527 (b) were issued in 
connection with a section 18 and were extended to July, 2005 on January 
16, 2003 (68 FR 2242)(FRL-7284-8). The section 18 tolerances are not 
being modified in this notice but are included in the risk assessments 
discussed below. In addition, since the Agency's current review did not 
include the data submitted with petition 0F6095 and the risk assessment 
outlined below indicated that the risk cup was full, the tolerances for 
indirect or inadvertent residues listed in 40 CFR 180.527(d) will be 
made permanent but the levels will remain unchanged.
    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) of the 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

[[Page 37751]]

408(b)(2)(C) of the 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 the 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 the 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 the FFDCA, for tolerances for combined residues of 
flufenacet, ( N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide) and its 
metabolites containing the 4-fluoro-N-methylethyl benzenamine moiety on 
corn, field, forage at 0.4 ppm; corn, field, grain at 0.05 ppm; corn, 
field, stover at 0.4 ppm; soybean, seed at 0.1 ppm by establishing 
permanent tolerances for indirect or inadvertent residues of the 
herbicide flufenacet, (N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1,3,4- thiadiazol-2-yl]oxy]acetamide) and metabolites 
containing the 4-fluoro-N-methylethyl benzenamine moiety in or on the 
following raw agricultural commodities from the application of this 
herbicide to the raw agricultural commodities, listed in 40 CFR 180.527 
(a) and (b), alfalfa, forage at 0.1 ppm; alfalfa, hay at 0.1 ppm; 
alfalfa, seed at 0.1 ppm; clover, forage at 0.1 ppm; clover, hay at 0.1 
ppm; grain, cereal, group 15, except rice at 0.1 ppm; grain, cereal, 
forage, fodder, and straw, group 16, except rice at 0.1 ppm; and grass, 
forage, fodder, and hay, group 17 at 0.1 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 flufenacet are 
discussed in Table 2 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 2.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity        NOAEL = <6.0 (male [m], 7.2 (female [f])
                                          rodents - rat               milligram/kilogram/day (mg/kg/day)
                                                                     LOAEL = 6.0(m) mg/kg/day based on decreased
                                                                      T4; 28.8 mg/kg/day (f) and on hematology
                                                                      and clinical chemistry findings
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-day feeding - mouse      NOAEL(mg/kg/day)=18.2(m),24.5(f),
                                                                     LOAEL (mg/kg/day)=64.2 (m), 91.3(f) based
                                                                      on systemic toxicity and histopathology of
                                                                      the liver, spleen, and thyroid.
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day oral toxicity in     NOAEL (mg/kg/day)= 1.67 (m);1.70 (f).
                                          nonrodents                 LOAEL (mg/kg/day)= 7.20 (m); 6.90 (f) based
                                                                      on increases in LDH, globulin, and spleen
                                                                      pigment in females, decreased T4 and ALT
                                                                      values in both sexes, decreased albumin in
                                                                      males, and decreased serum glucose in
                                                                      females
----------------------------------------------------------------------------------------------------------------
870.3200                                 21/28-Day dermal toxicity    Dermal irritation
                                                                     NOAEL(mg/kg/day)=1000 (m and f) Systemic
                                                                      toxicity
                                                                     NOAEL mg/kg/day) = 20(m); 150(f)
                                                                     LOAEL(mg/kg/day)= 150(m);1,000(f) based on
                                                                      decreased T4 and FT4 levels in both sexes
                                                                      and histopathological findings in females
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental      Maternal NOAEL = 25 mg/kg/day
                                          toxicity in rodents (rat)  LOAEL = 125 mg/kg/day based on decreased
                                                                      BWG initially
                                                                     Developmental NOAEL = 25 mg/kg/day
                                                                     LOAEL = 125 mg/kg/day based on decreased
                                                                      fetal body weight, delayed ossificaition
                                                                      in skull, vertebrae, sternebrae, and
                                                                      appendages, and increased extra ribs.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental      Maternal NOAEL = 5 mg/kg/day
                                          toxicity in nonrodents     LOAEL = 25 mg/kg/day based on
                                          (rabbits)                   histopathological findings in liver.
                                                                     Developmental NOAEL = 25 mg/kg/day
                                                                     LOAEL = 125 mg/kg/day based on increased
                                                                      skeletal variations.
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  Parental/Systemic NOAEL = 1.4 (m), 1.5(f)
                                          effects - rat               mg/kg/day
                                                                     LOAEL = 7.4 (m), (8.2 (f) mg/kg/day based
                                                                      on increased liver weight in F1 females
                                                                      and hepatocytomegaly in F1 males
                                                                     Reproductive NOAEL = 1.3 mg/kg/day
                                                                     LOAEL = 6.9 mg/kg/day based on increased
                                                                      pup death in early lactation (including
                                                                      cannibalism) for F1 liters and the same
                                                                      effects in F1 and F2 pups at 36 mg/kg/day.
----------------------------------------------------------------------------------------------------------------

[[Page 37752]]

 
870.4100                                 Chronic toxicity dogs       NOAEL = 1.29(m), 1.14(f) mg/kg/day
                                                                     LOAEL = 27.75 (m), 26.82(f) mg/kg/day based
                                                                      on increased alkaline phosphatase, kidney,
                                                                      and liver weight in both sexes, increased
                                                                      cholesterol in males, decreased T3, T4,
                                                                      and ALT values in both sexes, and
                                                                      increased incidences of microscopic
                                                                      lesions in the brain, eye, kidney, spinal
                                                                      cord, sciatic nerve, and liver.
----------------------------------------------------------------------------------------------------------------
870.4300                                 Chronic toxicity/           NOAEL =1.2 (m), 1.5 (f) mg/kg/day
                                          oncogenicity in rodents    LOAEL = 19.3 (m), 24.4(f) mg/kg/day based
                                          (rat)                       on methemoglobinemia and multi-organ
                                                                      effects in blood, kidney, spleen, heart,
                                                                      brain, eye, liver and uterus.
                                                                     No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity mice        NOAEL = <7.4 ((m), 9.4 (f) mg/kg/day
                                                                     LOAEL = 7.4 (m), 38.4 (f) mg/kg/day based
                                                                      on increased incidence and severity of
                                                                      cataracts.
                                                                     No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene Mutation               Ames Assay S. typhimurium not mutagenic
870.5395                                 Cytogenetics                In vivo mammalian cytogenetics--
                                                                      micronucleus assay (mouse) not mutagenic.
870.5375                                                             In vitro mammalian cytogenetics- Chinese
                                                                      hamster lung fibroblasts (V79) cells not
                                                                      mutagenic.
870.5375                                                             In vitro cytogenetics chromosomal analysis
                                                                      of cultured CHO cells-not mutagenic.
870.5550                                 Other Effects               Unscheduled DNA synthesis in rat
                                                                      hepatocytes in vitro-not mutagenic.
----------------------------------------------------------------------------------------------------------------
870.6200                                 Acute neurotoxicity         NOAEL = <75 (m and f) mg/kg/day
                                          screening battery          LOAEL = 75 (m and f) mg/kg/day based on
                                                                      clinical signs in females (uncoordinated
                                                                      gait and decreased activity) and decreased
                                                                      motor activity in males.
----------------------------------------------------------------------------------------------------------------
870.6200                                 Subchronic neurotoxicity    NOAEL = 7.30 (m), 8.40 (f) mg/kg/day
                                          screening battery          LOAEL = 38.1 (m), 42.6 (f) mg/kg/day based
                                                                      on microscopic lesions (including axonal
                                                                      swelling in brain and spinal cord).
----------------------------------------------------------------------------------------------------------------
870.6300                                 Developmental               Maternal NOAEL = 40.8 mg/kg/day
                                          neurotoxicity              LOAEL = not determined (no adverse effects
                                                                      seen). Offspring NOAEL = <1.7 mg/kg/day
                                                                     LOAEL = 1.7 mg/kg/day based on decreased
                                                                      pre- weaning body weight and body weight
                                                                      gain.
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and              Rapidly absorbed and metabolized following
                                          pharmacokinetics            oral exposure to either single or multiple
                                                                      doses. The urine was the major route of
                                                                      excretion with small amount excreted via
                                                                      feces. Significant amounts of radiolabel
                                                                      were eliminated as CO2 and CH4. A maximum
                                                                      of 7% of the total recovered radiolabel
                                                                      was found in the tissues and residual
                                                                      carcass. Twenty-five metabolites arising
                                                                      from the fluorophenyl portion of the
                                                                      molecule were detected in excreta, and 17
                                                                      of these were identified. The total amount
                                                                      of radiolabel identified ranged from
                                                                      [Fluorophenyl-UL-\14\C] FOE 5043 67%-86%;
                                                                      [Thiadiazole-2-\14\C] FOE 5043 84%-92%;
                                                                      and [Thiadiazole-5-\14\C] FOE 5043 53%-
                                                                      69%. All unidentified residues in excreta
                                                                      were characterized .
----------------------------------------------------------------------------------------------------------------
n/a                                      Metabolism/Mechanism        Hypothesis of an extrathyroidal mechanism
                                                                      of action for FOE 5043 (flufenacet)
                                                                     Hypothesis of an extrathyroidal mechanism
                                                                      of action for FOE 5043-supplement to
                                                                      above.
----------------------------------------------------------------------------------------------------------------
n/a                                      Metabolism/Metabolite       Evaluated a hypothesis that the
                                                                      neurotoxicity observed in dogs dosed with
                                                                      high levels of FOE 5043 was caused by
                                                                      metabolic limitations.
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    The Agency imposed an additional 10X safety factor to account for 
uncertainties arising because available data support the possibility of 
decreases in thyroid hormones at dose levels similar to those used in 
the submitted rat developmental neurotoxicity study (DNT) as well as 
the lack of a NOAEL in the rat developmental neurotoxicity study. To 
address these concerns the Agency will require a special comparative 
assay on thyroid hormone levels in neonatal and adult rats as a 
condition of registration. The Agency also had a concern for a lack of 
a NOAEL in the rat developmental neurotoxicity study and for the 
decrease in morphometric measurements in adult females which were not 
measured at the lowest dose. The doses and endpoints for various risk 
assessments and the uncertainty factors applied are expected to 
adequately address uncertainties

[[Page 37753]]

arising from the missing data and a lack of a NOEL in the DNT study.
    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 (SF) 
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 SF. For 
flufenacet, the Agency concluded that the Special FQPA Safety Factor 
could be reduced to 1X, based on the low degree of concern and lack of 
residual uncertainties for pre- and post-natal toxicity as outlined in 
Unit III.D.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenicity risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated.
    A summary of the toxicological endpoints for flufenacet used for 
human risk assessment is shown in Table 3 of this unit:

      Table 3.--Summary of Toxicological Dose and Endpoints for Flufenacet for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                  Special FQPA SF* and
          Exposure Scenario               Dose Used in Risk       Level of Concern for   Study and Toxicological
                                            Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population      LOAEL = 1.7 mg/kg/day    FQPA SF = 1X             Developmental
 including infants and children)       UF = 1,000X............  aPAD = acute RfD/FQPA     Neurotoxicity study in
                                       Acute RfD =............   SF.                      rats.
                                       LOAEL/UF = 0.0017 mg/kg/ = 0.0017 mg/kg/day.....  LOAEL = 1.7 mg/kg/day
                                        day.                                              based on decreased
                                                                                          body weight/body
                                                                                          weight gain, and
                                                                                          missing morphometric
                                                                                          measurements in
                                                                                          caudate/putamen, in
                                                                                          pups.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      LOAEL= 1.7 mg/kg/day     FQPA SF = 1X             Developmental
                                       UF = 1,000.............  cPAD = chronic RfD/       Neurotoxicity study in
                                       Chronic RfD =..........   FQPA SF.                 rats.
                                       LOAEL/UF = 0.0017 mg/kg/ = 0.0017 mg/kg/day.....  LOAEL = 1.7 mg/kg/day
                                        day.                                              based on decreased
                                                                                          body weight/body
                                                                                          weight gain in pups.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)                    Classifed as 'Not Likely' to be a carcinogen.
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no-observed-adverse-effect- level, LOAEL
  = lowest-observed-adverse-effect-level, PAD = population-adjusted dose (a = acute, c = chronic) RfD =
  reference dose, MOE = margin of exposure, LOC = level of concern, NA = Not Applicable/Not Required.
* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.527) for the combined residues of flufenacet, 
N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide] and its metabolites containing the 4-
fluoro-N-methylethyl benzenamine moiety, in or on a variety of raw 
agricultural commodities. Tolerances have been established on meat, 
fat, kidney, and meat byproducts of cattle, goats, hogs, horses, and 
sheep, wheat grain, forage, hay, and straw in connection with a section 
18. These tolerances expire July, 2005 and have been included in the 
risk assessments. Risk assessments were conducted by EPA to assess 
dietary exposures from flufenacet 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 one day 
or single exposure. The Dietary Exposure Evaluation Model (DEEM\ \) 
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 expoure 
to the chemical for each commodity. The following assumptions were made 
for the acute exposure assessments:
    a. Anticipated-residue estimates were assumed for some commodities 
(field corn, soybeans, and wheat);
    b. Tolerance-level residues were assumed for some crops (cereal 
grains); and
    c. Percent crop-treated estimates were utilized for all crops.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM\ \) 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 chronic 
exposure assessments:
    a. Anticipated-residue estimates were assumed for some commodities 
(field corn, soybeans, and wheat);
    b. Tolerance-level residues were assumed for some crops (cereal 
grains); and
    c. Percent crop-treated estimates were utilized for all crops.
    iii. Cancer. Flufenacet is not carcinogenic, therefore a 
quantitative cancer risk assessment was not performed.

[[Page 37754]]

    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate. As required by section 408(b)(2)(E) of the FFDCA, 
EPA will issue a data call-in for information relating to anticipated 
residues to be submitted no later than 5 years from the date of 
issuance of this tolerance.
    Section 408(b)(2)(F) of the FFDCA 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) of the FFDCA, EPA may require registrants to 
submit data on PCT.
    The Agency used PCT information as follows.
    Based on current use, the Agency used the following percent crop 
treated estimates: Field corn 2%, soybeans1%, and wheat 1%,. For crops 
planted in rotation (cereal grains), 2% crop treated was assumed as 
this is the highest estimate for the primary crops. For livestock 
commodities, a percent crop treated estimate of 1%, corresponding to 
the use on wheat, was utilized. The Agency has previously concluded 
that secondary residues of flufenacet in livestock commodities would 
not result from the use of flufenacet on corn or soybeans but would 
result from the section 18 use on wheat.
    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. 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 flufenacet may 
be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for flufenacet 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 flufenacet.
    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 groundwater. 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 area factor as an adjustment to account 
for the maximum percent crop 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.
    Since 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 drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to flufenacet they are further 
discussed in the aggregate risk section in Unit III.E.
    Based on the PRZM/EXAMS and SCI-GROW models the estimated 
environmental concentrations (EECs) of flufenacet for acute exposures 
are estimated to be 9.9 parts per billion (ppb) for surface water and 
0.21 ppb for ground water. The EECs for chronic exposures are estimated 
to be 1.3 ppb for surface water and 0.21 ppb for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).

[[Page 37755]]

     Flufenacet is not registered for use on any sites that would 
result in residential exposure.
    4. Cumulative exposure to 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.''
    EPA does not have, at this time, available data to determine 
whether flufenacet 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, 
flufenacet 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 flufenacet 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 Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1.  In general. Section 408 of the 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 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.
    2. Prenatal and postnatal sensitivity. No increase in 
susceptibility was seen in rat and rabbit developmental studies, but 
qualitative and/or quantitative increases in susceptibility were seen 
in the rat reproduction study and in the rat developmental 
neurotoxicity studies.
    3. Conclusion. The toxicology data base for flufenacet is complete 
except for a special comparative assay on thyroid hormone levels in 
neonatal and adult rats and a 28-day inhalation toxicity study in rats. 
The exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures.
    The Agency evaluated the potential for increased susceptibility of 
infants and children from exposure to flufenacet. The Agency concluded 
that there is a low degree of concern and lack of residual 
uncertainties for pre- and post-natal toxicity in the rat reproduction 
study and the rat and rabbit developmental toxicity studies. The Agency 
determined that the concern is also low for susceptibility seen in the 
developmental neurotoxicity (DNT) study. Multiple offspring effects 
were seen at the mid- and high doses, and no adverse maternal effects 
were seen at any dose. However, the only effect seen at the lowest dose 
in offspring was a transient decrease in body weight. The concern for 
the decrease in the offspring weights was reduced because no decrease 
in body weight was seen in the offspring in the reproduction study .
    The Agency considered the lack of comparative data for thyroid 
hormone levels in adult and neonatal animals. Available data support 
the possibility of decreases in thyroid hormones in adult animals 
(decreases were observed in several studies conducted in rats, mice, 
rabbits, and dogs) at dose levels similar to those used in the 
submitted DNT study. Because of the above concern, a special 
comparative study on thyroid hormone levels in neonatal and adult rats 
is being requested by the Agency as a condition of registration. The 
Agency also noted that morphometric measurements could be incorporated 
into the comparative thyroid assay to confirm the findings observed in 
adult female offspring in the DNT (data for this endpoint were not 
available at the low dose).
    Due to the concerns regarding the possibility of decreases in 
thyroid hormones and the need for comparative susceptibility data on 
this issue as well as the lack of a NOAEL in the DNT, EPA found no 
basis to remove the 10X FQPA safety for the protection of infants and 
children. EPA considers this additional 10X factor to be an uncertainty 
factor to address the deficiencies in the database.

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: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater 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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
flufenacet will occupy 23% of the aPAD for the U.S. population, 17 % of 
the aPAD for females 13 years and older, 23% of the aPAD for all 
infants and 48% of the aPAD for children 1-2 years. In addition, there 
is potential for acute dietary exposure to flufenacet in drinking 
water. Table 4 of this unit presents the EECs and DWLOCs for the major 
populations subgroups.

[[Page 37756]]



                      Table 4.--Aggregate Risk Assessment for Acute Exposure to Flufenacet
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                       0.0017           23          9.9         0.21           46
----------------------------------------------------------------------------------------------------------------
All Infants                                           0.0017           23          9.9         0.21           13
----------------------------------------------------------------------------------------------------------------
Children (1-2 yrs)                                    0.0017           48          9.9         0.21            9
----------------------------------------------------------------------------------------------------------------
Children (3-5 yrs)                                    0.0017           42          9.9         0.21           10
----------------------------------------------------------------------------------------------------------------
Children (6-12 yrs)]                                  0.0017           29          9.9         0.21           12
----------------------------------------------------------------------------------------------------------------
Youth (13-19 yrs)                                     0.0017           21          9.9         0.21           41
----------------------------------------------------------------------------------------------------------------
Adults (20-49 years)                                  0.0017           20          9.9         0.21           47
----------------------------------------------------------------------------------------------------------------
Females (13-19 years)                                 0.0017           17          9.9         0.21           42
----------------------------------------------------------------------------------------------------------------

    The EECs are less than calculated DWLOCs for acute exposure to 
flufenacet in drinking water, except for the population subgroup, 
children 1-2 years old, where the EEC marginally exceeds the DWLOC.
    In evaluating the acceptability of these estimated risks, EPA has 
taken into account that the risk assessment was performed by estimating 
exposure at the 99.9th percentile of exposure. As EPA has explained in 
its policy regarding use of population percentiles in estimating 
exposure, EPA generally uses the 95th percentile when conducting an 
exposure assessment with unrefined residue values (i.e. assuming all 
covered food contains tolerance level residues) and the 99.9th 
percentile when using highly refined residue values (i.e. monitoring 
values). See U.S. EPA, Office of Pesticide Programs, Choosing A 
Percentile of Acute Dietary Exposure as a Threshold of Regulatory 
Concern 17 (March 16, 2000) (http://www.epa.gov/pesticides/trac/science/trac2b054.pdf). The residue values used in the flufenacet risk 
assessment fall somewhere between highly refined and unrefined. 
Although the Agency did use data bearing on percent crop treated, three 
other aspects of the assessment made it not particularly refined, and 
therefore, somewhat conservative (i.e. tending to overstate exposure). 
First, EPA assumed tolerance level residues for all crops covered by 
tolerances designed to address the possibility of flufenacet residues 
being present in crops grown at a later date in the same field as the 
treated crop. These rotational crop tolerances include rice and 
sorghum. Further, compounding this conservative assumption, EPA assumed 
that two percent of all of the crops covered by rotational crop 
tolerances would contain flufenacet residues even though the treatment 
rate for wheat and soybeans was at a one percent level (only corn was 
at the two percent level) and it is unlikely, in any event, that the 
crops covered by the rotational crop tolerances would, in their 
entirety, be grown in a rotational program.
    Second, and probably most important, for those crops for which EPA 
did not assume tolerance level residues (corn, wheat, and soybeans) EPA 
did not use monitoring data (i.e. data collected from food as it moves 
in the channels of trade) but data from crop field trials. Crop field 
trials are studies conducted to determine the maximum residue levels 
that can occur under the limits imposed by the pesticide's label. 
Accordingly, such studies involve applying the pesticide, pursuant to 
its label, the maximum number of times at the maximum application rate 
and harvesting the crop as promptly as soon as permitted following the 
last pesticide treatment. These studies overstate the residue levels 
that consumers are exposed to for two reasons. First, in crop field 
studies, residue levels are measured at harvest and thus do not reflect 
the degradation that generally occurs during the production, shipping, 
and storage of food prior to sale to the consumer. Second, farmers are 
not required to apply pesticides in the manner used in crop field 
trials but generally may use lower amounts than those specified on the 
label, apply the pesticide less frequently than the number of 
applications permitted by the label, and wait longer to harvest the 
crop than the minimum pre-harvest interval prescribed by the label. See 
7 U.S.C. 136a(ee). Such practices reduce residue values, normally by 
significant amounts. With flufenacet, the decrease will be even more 
significant than usual because some of the field trial data are based 
upon an application rate of 0.9 lbs. a.i. acre per season v.s. the 
label rate of 0.79 lbs. a.i. acre per season for field corn and 0.9 
lbs. a.i. acre per season v.s. the label rate of 0.45 lbs. a.i. per 
acre per season for soybeans.
    A third aspect of the flufenacet exposure assessment that 
overstated residue levels was the fact that EPA did not use processing 
reduction factors. Processing studies are performed in order to show 
whether or not residues concentrate in processed commodities of the 
RAC. For example wheat grain, may be processed into bran, flour, 
middlings, shorts and germ. Processing studies frequently show residues 
decreasing in the processed commodities. If the residues decrease in 
the processed commodity, we may be able to determine a reduction 
factor. The concentration and/or reduction factors are directly applied 
to the residue level used in the dietary exposure assessment for that 
commodity. The processing studies for flufenacet treated corn and 
soybeans showed no detectable residues. However, the Agency for this 
risk assessment assumed the residues in the raw agricultural commodity 
were carried through undiminished to the processed commodities.
     As EPA has made clear, even when an exposure assessment is based 
on highly refined data, an indication that exposure at the 99.9th 
percentile poses a risk of concern is merely the starting point for 
assessing the ultimate safety of the pesticide. EPA has detailed a 
number of steps that are important to assess the accuracy of any 99.9th 
percentile estimate including sensitivity analyses and scrutiny of data 
inputs. When an assessment does not rely on highly refined exposure 
data there is an even greater need for close examination of

[[Page 37757]]

any risk estimates. As outlined above, there are several aspects of the 
flufenacet exposure assessment that are likely to significantly inflate 
exposure, and thus risk, estimates. Taking this into account as well as 
the fact that a risk analysis using a 99.8th population percentile 
raises the DWLOC for children between 1 and 2 years old to 12 ppb and 
thus above the EEC of 9.9 ppb, EPA concludes that flufenacet does not 
show a acute risk of concern.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
flufenacet from food will utilize <1 % of the cPAD for the U.S. 
population, <1 % of the cPAD for all infants and 1.0 % of the cPAD for 
children (1-2 yrs). In addition, there is potential for chronic dietary 
exposure to flufenacet in drinking water. There are no residential uses 
for flufenacet and therefore, no chronic residential exposure to 
flufenacet. 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 Table 5 of this unit:

               Table 5.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Flufenacet
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                       0.0017         <1.0          1.3         0.21           59
----------------------------------------------------------------------------------------------------------------
All Infants                                           0.0017         <1.0          1.3         0.21           17
----------------------------------------------------------------------------------------------------------------
Children (1-2 yrs)                                    0.0017          1.0          1.3         0.21           17
----------------------------------------------------------------------------------------------------------------
Youth (13-19 yrs)                                     0.0017         <1.0          1.3         0.21           51
----------------------------------------------------------------------------------------------------------------
Adults (20-49 yrs)                                    0.0017         <1.0          1.3         0.21           59
----------------------------------------------------------------------------------------------------------------

    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).
     Flufenacet 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).
    Flufenacet 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. Flufenacet is not 
carcinogenic, therefore no aggregate cancer risk is expected.
    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 flufenacet residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromotography /mass 
spectrometry with selected ion monitoring) is available to enforce the 
tolerance expression. The method 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: [email protected].

B. International Residue Limits

    There are no Codex, Canadian, or Mexican tolerances for flufenacet 
on corn, soybeans, wheat or livestock commodities.

C. Conditions

    The following studies are required as a condition of registration.
    1. A special comparative sensitivity study on thyroid hormone 
levels in neonatal and adult rats.
    2. 28-day inhalation toxicity study in rats.

V. Comments

    One comment was received in response to the notice of filing from 
B. Sachau, 15 Elm St., Florham Park, NJ 07932. Mr. Sachau objected 
generally to the presence of pesticides in food and specifically to the 
presence of flufenacet. Mr. Sachau also proposed that the U.S. 
establish testing on humans instead of dogs and rats.
     Mr. Sachau comment 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 flufenacet, including 
all anticipated dietary exposures and all other exposures for which 
there is reliable information.

VI. Conclusion

    Therefore, the tolerance is established for combined residues of 
flufenacet, ( N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide) and its 
metabolites containing the 4-fluoro-N-methylethyl benzenamine moiety] 
on corn, field, forage at 0.4 ppm; corn, field, grain at 0.05 ppm; 
corn, field, stover at 0.4 ppm; soybean, seed at 0.1 ppm by 
establishing permanent tolerances for indirect or inadvertent residues 
of the herbicide flufenacet, (N-(4-fluorophenyl)-N-(1-methylethyl)-2- 
[[5-(trifluoromethyl)-1,3,4- thiadiazol-2-yl]oxy]acetamide) and its 
metabolites containing the 4-fluoro-N-methylethyl benzenamine moiety in 
or on the following raw agricultural commodities from the application 
of this herbicide to the raw agricultural commodities, listed in 40 CFR 
180.527 (a) and (b), alfalfa, forage at 0.1 ppm; alfalfa, hay at 0.1 
ppm; alfalfa, seed at 0.1 ppm; clover, forage at 0.1 ppm; clover, hay 
at 0.1 ppm; grain, cereal, group 15, except rice at 0.1 ppm; grain, 
cereal, forage, fodder, and straw, group 16, except rice, at 0.1 ppm; 
and grass, forage, fodder and hay, group 17 at 0.1 ppm. These 
tolerances replaced currently expiring tolerances in Sec.  180.527 (a) 
and (d).

VII. 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

[[Page 37758]]

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, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) of the 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 the 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-2003-0181 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 August 
25, 2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
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 Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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 
(703) 603-0061.
    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 [email protected], 
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-
0001.
    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 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.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.1. Mail your 
copies, identified by docket ID number OPP-2003-0181, 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 Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VIII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
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 the FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a

[[Page 37759]]

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 the 
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.

IX. 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 record 
keeping requirements.


    Dated: June 12, 2003.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.527 is amended by revising paragraphs (a) and (d) to 
read as follows:


Sec.  180.527  N-(4-fluorophenyl)-N-(1-methylethyl)-2-[(5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl)oxy]acetamide; tolerances for 
residues.

    (a) General. Tolerances are established for the combined residues 
of the herbicide N-(4-fluorophenyl)-N-(1-methylethyl)-2-[(5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl)oxy]acetamide and its 
metabolites containing the 4-fluoro-N-methylethyl benzenamine moiety in 
or on the following raw agricultural commodities:

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Corn, field, forage............................                      0.4
Corn, field, grain.............................                     0.05
Corn, field, stove.............................                      0.4
Soybean, seed..................................                      0.1
------------------------------------------------------------------------

* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established 
for indirect or inadvertent residues of the herbicide N-(4-
fluroophenyl)-N-(1-methylethyl)-2-[(5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl)oxy]acetamide and its metabolites containing the 4-
fluoro-N-methylethyl benzenamine moiety in or on the raw agricultural 
commodities listed in paragraph (a) of this section.

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Alfalfa, forage................................                      0.1
Alfalfa, hay...................................                      0.1
Alfalfa, seed..................................                      0.1
Clover, forage.................................                      0.1
Clover, hay....................................                      0.1
Grain, cereal, group 15, except rice...........                      0.1
Grain, cereal, forage, fodder, and straw, group                      0.1
 16, except rice...............................
Grass, forage, fodder, and hay, group 17.......                      0.1
------------------------------------------------------------------------


[FR Doc. 03-15905 Filed 6-24-03; 8:45 am]
BILLING CODE 6560-50-S