[Federal Register Volume 72, Number 89 (Wednesday, May 9, 2007)]
[Rules and Regulations]
[Pages 26304-26310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8936]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0965; FRL-8124-2]


Flufenacet; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes pesticide tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA) for combined residues of 
flufenacet and its metabolites containing the 4-fluoro-N-methylethyl 
benzenamine moiety in or on grass (forage, hay), sweet corn (forage, 
kernel plus cob with husk removed, stover), wheat (bran, forage, grain, 
hay, straw), cattle kidney, goat kidney, hog kidney, horse kidney, and 
sheep kidney. Bayer Cropscience petitioned EPA to establish these 
tolerances.

DATES: This regulation is effective May 9, 2007. Objections and 
requests for hearings must be received on or before July 9, 2007, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also

[[Page 26305]]

Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0965. All documents in the 
docket are listed in the index for the docket. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Jim Tompkins, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5697; e-mail address: <a href="/cdn-cgi/l/email-protection#d2a6bdbfa2b9bbbca1fcb8bbbf92b7a2b3fcb5bda4"><span class="__cf_email__" data-cfemail="53273c3e23383a3d207d393a3e133623327d343c25">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    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. You must file your objection or 
request a hearing on this regulation in accordance with the 
instructions provided in 40 CFR part 178. To ensure proper receipt by 
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0965 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 July 9, 2007.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0965, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of December 20, 2006 (71 FR 76321) (FRL-
8104-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
0F6095) by Bayer CropScience, 2 T.W. Alexander Dr., Research Triangle 
Park, NC 27709. The petition requested that 40 CFR 180.527 be amended 
by establishing a tolerance 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 in 
or on the food commodities: corn, sweet, forage at 0.4 parts per 
million (ppm); corn, sweet, kernel plus cob with husks removed at 0.05 
ppm; corn, sweet, stover at 0.4 ppm; wheat, forage at 10.0 ppm; wheat, 
grain at 1.0 ppm; wheat, hay at 2.0 ppm; wheat, straw at 0.5 ppm; seed-
grass, forage at 7.0 ppm; seed-grass, forage, regrowth at 0.1 ppm; 
seed-grass, hay, regrowth at 0.5 ppm. That notice included a summary of 
the petition prepared by Bayer CropScience, the registrant. There were 
no comments received in response to the notice of filing.
    After completing a review of the submitted data, the Agency 
determined that additional tolerances are needed in connection with the 
petitioned-for tolerances for wheat bran 0.80 ppm, grass forage at 7.0 
ppm, and grass hay at 0.4 ppm, cattle kidney at 0.05 ppm, goat kidney 
at 0.05 ppm, hog kidney at 0.05 ppm, horse kidney at 0.05 ppm, and 
sheep kidney at 0.05 ppm. EPA determined that tolerance levels are 
needed that differ from those proposed by the registrant for sweet corn 
forage at 0.45 ppm (0.4 ppm proposed) sweet corn stover at 0.30 ppm, 
(0.4 ppm proposed) wheat forage at 6.0 ppm (10.0 ppm proposed), wheat 
grain at 0.60 ppm (1.0 ppm proposed), wheat hay at 1.2 ppm (2.0 ppm 
proposed), and wheat straw at 0.35 ppm (0.5 ppm proposed). EPA 
determined that tolerances are not necessary for fat, meat, and meat 
byproducts of cattle, goat, hog, horse,

[[Page 26306]]

and sheep. Since permanent tolerances are being established for wheat 
and kidney of cattle, goat, hog, horse, and sheep, emergency exemption 
tolerances for these commodities are being deleted.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for a tolerance for combined residues of 
flufenacet. 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. Specific information on the studies received and the nature 
of the toxic effects caused by flufenacet as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document, entitled Flufenacet: HED Human 
Health Risk Assessment for Uses on Wheat, Perennial Grasses Grown for 
Seed and Sweet Corn which is in the docket for this rule.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, 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.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at http://www.epa.gov/pesticides/health/human.htm.
    A summary of the toxicological endpoints for flufenacet used for 
human risk assessment can be found in Table 4 (p.14) of the document, 
entitled Flufenacet: HED Human Health Risk Assessment for Uses on 
Wheat, Perennial Grasses Grown for Seed and Sweet Corn which is in the 
docket for this rule.

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 
and its metabolites, in or on a variety of raw agricultural 
commodities. Risk assessments were conducted by EPA to assess dietary 
exposures from flufenacet in food from existing and proposed tolerances 
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    The Dietary Exposure Evaluation Model (DEEM\TM\) analysis evaluated 
the individual food consumption as reported by respondents in the U.S. 
Department of Agriculture (USDA) 1994-1996 and 1988 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII) and 
accumulated exposure to the chemical for each commodity. The following 
assumptions were made for the acute exposure assessments: Anticipated 
residues for many crops (field corn, soybean, sweet corn, and wheat) 
were developed using field trial data. Anticipated residues for 
livestock commodities were derived using available feeding and 
metabolism studies in conjunction with the anticipated dietary burden 
to ruminants, swine and poultry. Tolerance level residues were used to 
assess flufenacet exposure from the remaining commodities (i.e., cereal 
grains other than wheat). Exposure estimates for all commodities were 
further refined using percent crop treated (PCT) data. Projected PCT 
data were used to refine anticipated residues for the new food uses 
(sweet corn and wheat). Available processing data were used to refine 
anticipated residues for cereal grains and corn. For all other 
processed commodities, DEEM (ver. 7.81) default processing factors were 
assumed.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996 
and 1998 CSFII, and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the chronic exposure 
assessments: Anticipated residues for many crops (field corn, soybean, 
sweet corn, and wheat) were developed using field trial data. 
Anticipated residues for livestock commodities were derived using 
available feeding and metabolism studies in conjunction with the 
anticipated dietary burden to ruminants, swine and poultry. Tolerance 
level residues were used to assess flufenacet exposure from the 
remaining commodities (i.e., cereal grains). Exposure estimates for all 
commodities were further refined using PCT data. Projected PCT data 
were used to refine anticipated residues for the new food uses (sweet 
corn and wheat). Available processing data were used to refine 
anticipated residues for cereal grains and corn. For all other 
processed

[[Page 26307]]

commodities, DEEM (ver. 7.81) default processing factors were assumed.
    iii. Cancer. A cancer aggregate exposure assessment was not 
performed because flufenacet is not carcinogenic.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of 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 pursuant section 408(f)(1) of 
FFDCA 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. For the present action, EPA will issue such 
Data Call-Ins for information relating to anticipated residues as are 
required by section 408(b)(2)(E) of FFDCA and authorized under section 
408(f)(1) of FFDCA. Such Data Call-Ins will be required to be submitted 
no later than 5 years from the date of issuance of this tolerance.
    Section 408(b)(2)(F) of 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 FFDCA, EPA may require registrants to submit 
data on PCT.
    The Agency used PCT information as follows:
    Chronic and acute dietary exposure analyses for sweet corn were 
based on projected PCT when treated with flufenacet of an average of 3% 
(used for chronic exposure assessment) and a maximum of 10% (used for 
acute exposure assessment). These projected PCT estimates were based on 
the following. Flufenacet has been registered and used on field corn 
since 1998. Field corn and sweet corn are the same species and there 
are many weeds and herbicides used to control those weeds which are 
common to the two crops. Therefore the use of flufenacet on field corn 
was used as the basis for predicting flufenacet use on sweet corn. EPA 
also analyzed other factors based on available information that 
included more recent usage of other acetamide herbicides on both field 
corn and sweet corn, information on new products desired for sweet 
corn, including flufenacet, to combat newly invasive weeds and 
resistant weeds, and differences in importance of individual herbicides 
between field corn and sweet corn.
    Chronic and acute dietary exposure analyses for wheat were based on 
projected PCT when treated with flufenacet of an average of 1% and a 
maximum of 3%. These projected PCT estimates were based on the 
following: Emergency exemption uses have been issued for flufenacet on 
wheat for several years. EPA initially estimated the PCT for wheat 
based on recent PCTs for winter wheat due to emergency exemption usage. 
EPA later examined acres treated in individual states and compared that 
information to the treatment acres permitted under the emergency 
exemptions. EPA also analyzed other factors based on available 
information that included usage of metribuzin on winter wheat (since a 
new use is the combination metribuzin and flufenacet), current and past 
Emergency Exemption requests for flufenacet in the Northwest and on the 
East Coast to control resistant Italian ryegrass, and more recent usage 
data.
    For all other commodities, PCT estimates were based on a screening 
level usage analysis of pesticide usage data from the following 
sources:
    <bullet> USDA-NASS (United States Department of Agriculture's 
National Agricultural Statistics Service)--pesticide usage data from 
1998 to 2003.
    <bullet> NCFAP (National Center for Food and Agricultural Policy--
pesticide usage data from 1997 and is only used if data is not 
available from the other sources.
    <bullet> Private pesticide market research--pesticide usage data 
from 1998 to 2004.
    The Agency believes that the three conditions previously discussed 
have been met. With respect to Condition 1, EPA finds that the PCT 
information described above for flufenacet on sweet corn, wheat, and 
grass forage and other commodities with existing registrations for 
flufenacet is reliable and has a valid basis. 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. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppfeed1/models/water/index.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentrations in Groundwater (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
flufenacet (plus its degradate thiadione in surface water) for acute 
exposures are estimated to be 8.64 parts per billion (ppb) for surface 
water and 0.10 ppb for ground water. The EECs for chronic exposures are 
estimated to be 2.23 ppb for surface water and 0.10 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).
    Flufenacet is not registered for use on any sites that would result 
in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider

[[Page 26308]]

``available information'' concerning the cumulative effects of a 
particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to flufenacet and any other 
substances and 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 policy statements released by EPA's Office of Pesticide Programs 
concerning common mechanism determinations and procedures for 
cumulating effects from substances found to have a common mechanism on 
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no indication of 
additional susceptibility of young rats or rabbits following prenatal 
exposure to flufenacet in the developmental toxicity studies. There was 
an indication of qualitative susceptibility in the 2-generation 
reproduction study. Effects seen in the offspring in the reproductive 
toxicity studies (including increased pup death in early lactation and 
cannibalism) were more severe than those seen in the parental animals 
(increased liver weight and cytomegaly), although there was no 
difference in the NOAELs/LOAELS between parental animals and offspring 
in that study. Increased susceptibility (qualitative and quantitative) 
was seen in the developmental neurotoxicity study in rats. Decreased 
body weight was seen in pups at all dose levels, and additional 
effects, including decreased motor activity, delayed developmental 
landmarks, and decreases in morphometric measurements were seen at mid 
and high doses. Morphometric measurements were not made at the low 
dose. A slight decrease in body weight in mid and high dose dams during 
early lactation may have been due to palatability of test substance and 
was not considered adverse.
    The selection of 1.7 milligrams/kilograms/day (mg/kg/day) as a 
LOAEL for the developmental neurotoxicity study is considered to be a 
conservative recommendation as to the decreased body weight effect, 
because the decrease in pup body weight at that dose is transient, and 
a similar decrease was not seen in the 2-generation reproduction study 
(decreased pup body weight seen in the 1-generation range-finding 
reproduction study occurred at higher doses than those evaluated in the 
developmental neurotoxicity study).
    3. Conclusion. Several factors weighed in favor of the conclusion 
that no additional safety factor is needed to protect the safety of 
infants and children. First, there was no evidence of increased 
susceptibility in the developmental toxicity studies (rats and 
rabbits), and qualitative susceptibility seen in the rat reproduction 
study did not raise concerns because the pup death may be attributable 
to maternal cannibalism, and there was a clear NOAEL for the effect. 
Second, there are also no additional residual uncertainties with 
respect to exposure data:
    <bullet> The dietary drinking water assessment utilizes water 
concentration values generated by models and associated modeling 
parameters which are designed to provide conservative, health 
protective, high-end estimates of water concentrations which will not 
likely be exceeded.
    <bullet> Although the exposure assessment from pesticide residues 
in food was somewhat refined, the assessment is based on reliable data 
and will not underestimate exposure/risk.
    <bullet> There are no residential uses for flufenacet.
    Nonetheless, for several reasons EPA determined that the 10X FQPA 
Safety Factor should be retained. The primary reason for retaining the 
additional safety factor is that there is uncertainty regarding the 
protectiveness of selected RfDs because of a lack of comparative 
susceptibility data for thyroid hormone levels. Secondarily there is 
also some uncertainty due to the lack of a NOAEL in the DNT for the 
decrease in morphometric measurements and body weight effects in pups 
and the lack of data on comparative sensitivity to neuropathologic 
lesions. Concerns with regard to these latter issues are more limited 
given dose response data on the morphometric changes indicating that 
these effects would not be expected at the low dose, the transient 
nature of the body weight effects seen at the low dose, and the fact 
that neuropathologic lesions were only seen at relatively high doses.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food plus 
drinking water to flufenacet will occupy 30% of the aPAD for the U.S. 
population, 25% of the aPAD for females 13 years and older, 89% of the 
aPAD for all infants (< 1 year old), and 42% of the aPAD for children 
1-2 years old.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
flufenacet from food plus drinking water will utilize 2.9% of the cPAD 
for the U.S. population, 9.2% of the cPAD for all infants (< 1 year 
old), and 4.4% of the cPAD for children 1-2 years old. There are no 
residential uses for flufenacet that result in chronic residential 
exposure to flufenacet. EPA does not expect the aggregate exposure to 
exceed 100% of the cPAD.
    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

[[Page 26309]]

water, which do not exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. Because flufenacet is 
classified as a ``not likely'' carcinogen, the Agency does not expect 
exposure to flufenacet to result in any cancer risk.
    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 chromatographic/single ion 
mode (GC/SIM) common moiety method) 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: <a href="/cdn-cgi/l/email-protection#c3b1a6b0aaa7b6a6aea6b7abaca7b083a6b3a2eda4acb5"><span class="__cf_email__" data-cfemail="d1a3b4a2b8b5a4b4bcb4a5b9beb5a291b4a1b0ffb6bea7">[email protected]</span></a>.

B. International Residue Limits

    Flufenacet is not in the Codex system, i.e., there are no 
established or pending Codex MRLs for flufenacet. Therefore, there are 
no harmonization issues.

V. Conclusion

    Therefore, the tolerances are 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, 
in or on grass forage at 7.0 ppm, grass hay at 0.4 ppm, sweet corn 
forage at 0.45, sweet corn kernel plus cob with husk removed at 0.05 
ppm, sweet corn stover at 0.30 ppm, wheat bran at 0.80 ppm, wheat 
forage at 6.0 ppm, wheat grain at 0.60 ppm, wheat hay at 1.2 ppm, wheat 
straw at 0.35 ppm, cattle kidney at 0.05 ppm, goat kidney at 0.05 ppm, 
hog kidney at 0.05 ppm, horse kidney at 0.05 ppm, and sheep kidney at 
0.05 ppm. Section 18 emergency exemption tolerances are deleted for 
flufenacet in or on wheat (forage, grain, hay, straw) and fat, kidney, 
meat, and meat byproducts of cattle, goat, hog, horse, and sheep.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA, such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers, and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., 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 final rule and 
other required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


[[Page 26310]]


    Dated: May 1, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--AMENDED

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

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


0
2. Section 180.527 is amended as follows:
0
i. By revising the section heading;
0
ii. By revising paragraph (a);
0
iii. By removing the text of paragraph (b) and reserving with heading;
0
iv. By revising the introductory text of paragraph (c) and adding 
commodities to the table; and
0
v. By revising the introductory text of paragraph (d).
    The amendments read as follows:


Sec.  180.527  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 
tolerances for residues.

    (a) General. Tolerances are established for the 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 in 
or on the following commodities.

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Cattle, kidney.................................                     0.05
Corn, field, forage............................                      0.4
Corn, field, grain.............................                     0.05
Corn, field, stover............................                      0.4
Corn, sweet, forage............................                     0.45
Corn, sweet, kernel plus cob with husks removed                     0.05
Corn, sweet, stover............................                     0.30
Goat, kidney...................................                     0.05
Hog, kidney....................................                     0.05
Horse, kidney..................................                     0.05
Sheep, kidney..................................                     0.05
Soybean, seed..................................                      0.1
Wheat, bran....................................                     0.80
Wheat, forage..................................                      6.0
Wheat, grain...................................                     0.60
Wheat, hay.....................................                      1.2
Wheat, straw...................................                     0.35
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances are 
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, with regional registration.

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Grass, forage..................................                      7.0
Grass, hay.....................................                      0.4
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. Tolerances are established 
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 when present therein as a result of 
application of flufenacet to the growing crops in paragraph (a) of this 
section.
* * * * *
[FR Doc. E7-8936 Filed 5-8-07; 8:45 am]
BILLING CODE 6560-50-S


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