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Flufenacet. August 6, 1999. Pesticide Tolerances for Emergency Exemptions.
Final Rule
. Federal Register.


Note from EC: The chemical formula cited below is for Flufenacet.

http://www.epa.gov/fedrgstr/EPA-PEST/1999/August/Day-06/p20317.htm


[Federal Register: August 6, 1999 (Volume 64, Number 151)]
[Rules and Regulations]               
[Page 42839-42846]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06au99-9]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300897; FRL-6091-9]
RIN 2070-AB78

 
N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-
1,3,4-thiadiazol-2-yl]oxy]acetamide; Pesticide Tolerances for Emergency 
Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
combined residues of 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 wheat grain, wheat forage, wheat hay, wheat straw, and meat, fat, 
meat byproducts, and kidney of cattle, goats, horses, hogs, and sheep. 
This action is in response to EPA's granting of emergency exemptions 
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act authorizing use of the pesticide on wheat. This regulation 
establishes a maximum permissible level for residues of N-(4-
fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide in this food commodity pursuant to 
section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act, as 
amended by the Food Quality Protection Act of 1996. These tolerances 
will expire and are revoked on July 31, 2001.

DATES: This regulation is effective August 6, 1999. Objections and 
requests for hearings must be received by EPA on or before October 5, 
1999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number [OPP-300897], must be submitted to: Hearing Clerk 
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., 
Washington, DC 20460. Fees accompanying objections and hearing requests 
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA 
Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. 
Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing 
requests filed with the Hearing Clerk identified by the docket control 
number, [OPP-300897], must also be submitted to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticide Programs, Environmental

[[Page 42840]]

Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 119, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: opp-docket@epa.gov. Copies of electronic objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 
or ASCII file format. All copies of electronic objections and hearing 
requests must be identified by the docket control number [OPP-300897]. 
No Confidential Business Information (CBI) should be submitted through 
e-mail. Copies of electronic objections and hearing requests on this 
rule may be filed online at many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Barbara Madden, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail address: Rm. 284, Crystal Mall 
#2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-6463; e-mail: 
madden.barbara@epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 
21 U.S.C. 346a, is establishing tolerances for 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, in or on wheat grain at 1 part per 
million (ppm), wheat forage at 10 ppm, wheat hay at 2 ppm, wheat straw 
at 0.5 ppm, meat, kidney, and fat of cattle, goats, horses, hogs, and 
sheep at 0.05 ppm and meat byproducts (other than kidney) of cattle, 
goats, horses, hogs, and sheep at 0.1 ppm. These tolerances will expire 
and are revoked on July 31, 2001. EPA will publish a document in the 
Federal Register to remove the revoked tolerance from the Code of 
Federal Regulations.

I. Background and Statutory Findings

    The Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) 
was signed into law August 3, 1996. FQPA amends both the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et 
seq. The FQPA amendments went into effect immediately. Among other 
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting 
activities under a new section 408 with a new safety standard and new 
procedures. These activities are described in this preeamble and 
discussed in greater detail in the final rule establishing the time-
limited tolerance associated with the emergency exemption for use of 
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
    New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by FQPA. EPA has established regulations governing such 
emergency exemptions in 40 CFR part 166.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment.
    Because decisions on section 18-related tolerances must proceed 
before EPA reaches closure on several policy issues relating to 
interpretation and implementation of the FQPA, EPA does not intend for 
its actions on such tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.

II. Emergency Exemption for N-(4-fluorophenyl)-N-(1-methylethyl)-2-
[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide on Wheat 
and FFDCA Tolerances

    Italian ryegrass or annual ryegrass is one of the most difficult to 
control weeds in wheat. It is extremely competitive with wheat; as few 
as 20 plants per square meter can reduce wheat yield by 30%. Ryegrass 
is not a new species to the Pacific Northwest. It has been effectively 
controlled in past years by herbicides such as diclofop. However, 
resistance to diclofop was first identified in Oregon in the early 
1980s. Diclofop is now ineffectual against controlling annual ryegrass 
in wheat. Other registered pesticides do not always provide adequate 
control of annual ryegrass. EPA has authorized under FIFRA section 18 
the use of N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide on wheat in 
Idaho, Oregon, and Washington. After having reviewed these submissions, 
EPA concurs that emergency conditions exist for these states.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of N-(4-fluorophenyl)-N-(1-
methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-
yl]oxy]acetamide in or on wheat. In doing so, EPA considered the safety 
standard in FFDCA section 408(b)(2), and EPA decided that the necessary 
tolerances under FFDCA section 408(l)(6) would be consistent with the 
safety standard and with FIFRA section 18. Consistent with the need to 
move quickly on the emergency exemption in order to address an urgent 
non-routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing these tolerances without notice and opportunity 
for public comment under section 408(e), as provided in section 
408(l)(6). Although these tolerances will expire and are revoked on 
July 31, 2001, under FFDCA section 408(l)(5), residues of the pesticide 
not in excess of the amounts specified in these tolerances remaining in 
or on wheat grain, wheat, forage, wheat hay, wheat, straw, and meat, 
fat, meat byproducts, and kidney of cattle, goats, horses, hogs, and 
sheep after that date will not be unlawful, provided the pesticide is 
applied in a manner that was lawful under FIFRA, and the residues do 
not exceed a level that was authorized by these tolerances at the time 
of that application. EPA will take action to revoke these tolerances 
earlier if any experience with, scientific

[[Page 42841]]

data on, or other relevant information on this pesticide indicate that 
the residues are not safe.
    Because these tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether N-(4-
fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide meets EPA's registration requirements for 
use on wheat or whether permanent tolerances for this use would be 
appropriate. Under these circumstances, EPA does not believe that these 
tolerances serve as a basis for registration of (N-(4-fluorophenyl)-N-
(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-
yl]oxy]acetamide by a State for special local needs under FIFRA section 
24(c). Nor do these tolerances serve as the basis for any State other 
than Idaho, Oregon, and Washington to use this pesticide on this crop 
under section 18 of FIFRA without following all provisions of EPA's 
regulations implementing section 18 as identified in 40 CFR part 166. 
For additional information regarding the emergency exemption for N-(4-
fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide, contact the Agency's Registration 
Division at the address provided under the ``ADDRESSES'' section.

III. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of N-(4-
fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide and to make a determination on aggregate 
exposure, consistent with section 408(b)(2), for time-limited 
tolerances for combined residues of 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 on wheat grain at 1 ppm, wheat forage at 10 
ppm, wheat hay at 2 ppm, wheat straw at 0.5 ppm, meat, kidney, and fat 
of cattle, goats, horses, hogs, and sheep at 0.05 ppm and meat 
byproducts (other than kidney) of cattle, goats, horses, hogs, and 
sheep at 0.1 ppm. EPA's assessment of the dietary exposures and risks 
associated with establishing these tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by N-(4-fluorophenyl)-
N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-
yl]oxy]acetamide are discussed in this unit.

B. Toxicological Endpoint

    1. Acute toxicity. An acute reference dose (aRfD) has been 
identified. The lowest observed adverse effect level (LOAEL) of 75 
milligrams/kilograms/day (mg/kg/day) lowest dose tested (LDT) from an 
acute neurotoxicity study was selected for acute dietary risk 
assessment. At the LOAEL, the males displayed decreased motor activity. 
An uncertainty factor (UF) of (300 10x for interspecies extrapolation, 
10x for intraspecies variability, and 3x for the lack of a no observed 
adverse effect level (NOAEL)) is appropriate. The 10x FQPA Safety 
factor to account for enhanced sensitivity of infants and children as 
required by FFDCA 408(b)(2)(C) was reduced to 3x for acute exposures. 
The acute Population Adjusted Dose (aPAD) is a modification of the aRfD 
to accommodate the FQPA Safety Factor. The aPAD is equal to the aRfD 
divided by the FQPA Safety Factor. Therefore, the dietary aPAD is 0.075 
mg/kg/day. The dietary aPAD applies to all population subgroups, since 
the endpoint of concern neurotoxicity is a systemic effect.
    2. Short- and intermediate-term toxicity. The systemic NOAEL of 20 
mg/kg/day, based on the increased liver weight and decreased T3 and T4 
at the LOAEL of 150 mg/kg/day in a 21-day dermal toxicity study in rats 
was identified as the short- and intermediate-term endpoints.
    3. Chronic toxicity. EPA has established the chronic RfD (cRFD) for 
N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide at 0.004 mg/kg/day. This RfD is based on 
the LOAEL of 1.2 mg/kg/day (LDT) in chronic toxicity/carcinogenicity 
study. At the LOAEL, the effects were methemoglobinemia and systemic 
effects in various organs. An UF of 300 (10x for interspecies 
extrapolation, 10x for intraspecies variability, and 3x for the lack of 
a NOAEL) is appropriate. The 10x FQPA Safety factor to account for 
enhanced sensitivity of infants and children as required by FFDCA 
408(b)(2)(C) is not applicable because the endpoint used in deriving 
the cRfD is based on methemoglobinemia and multi-organ effects (not 
developmental or neurotoxic effects) in adult rats after chronic 
exposure and thus are not relevant for enhanced sensitivity to infants 
and children. The chronic Population Adjusted Dose (cPAD) is a 
modification of the cRfD to accommodate the FQPA Safety Factor. The 
cPAD is equal to the cRfD divided by the FQPA Safety Factor. Hence for 
chronic exposures, the cPAD and cRfD are the same (0.004 mg/kg/day).
    4. Carcinogenicity. Based on the lack of evidence of 
carcinogenicity in mice and rats at doses that were judged to be 
adequate to assess the carcinogenic potential, N-(4-fluorophenyl)-N-(1-
methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-
yl]oxy]acetamide was classified as a ``not likely'' human carcinogen.

C. Exposures and Risks

    1. Tolerances have been established (40 CFR 180.527) for the 
combined residues of 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 field corn forage, grain, stover, and soybean seed. Time-
limited tolerances have also been established for indirect or 
inadvertent residues for alfalfa, clover, crop group 15 (cereal 
grains), crop group 16 (forage, stover, and hay of cereal grains), and 
crop group 17 (grass forage, and grass hay). Risk assessments were 
conducted by EPA to assess dietary exposures and risks from N-(4-
fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide as follows:
    i. Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a 1 day or single exposure. The Dietary Exposure Evaluation Model 
(DEEM ) analysis evaluated the individual food consumption as reported 
by respondents in the USDA 1989-91 nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII) and accumulated exposure to the 
chemical for each commodity. At the 95th percentile exposure level, 
assuming

[[Page 42842]]

100% crop treated and tolerance level residues for all commodities, 10% 
of the aPAD was utilized for the U.S. Population and 16% of the aPAD 
was utilized for children (1-6 years old), the subgroup with the 
highest exposure. The results of this analysis indicate that the acute 
dietary risk associated with existing uses and the proposed use of N-
(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide is below the Agency's level of concern.
    ii. Chronic exposure and risk. In conducting this chronic dietary 
risk assessment, the DEEM analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1989-91 nationwide 
CSFII and accumulated exposure to the chemical for each commodity. 
Assuming tolerance level residues for all commodities and percent crop 
treated (PCT) values of 16% for corn, 26% for soybeans and 26% for 
cereal grains, 18% of the cPAD was utilized for the U.S. Population and 
41% of the cPAD was utilized for children (1-6 years old), the subgroup 
with the highest exposure. The results of this analysis indicate that 
the acute dietary risk associated with existing uses and the proposed 
use of N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-
1,3,4-thiadiazol-2-yl]oxy]acetamide is below the Agency's level of 
concern.
    Section 408(b)(2)(F) states that the Agency may use data on the 
actual PCT for assessing chronic dietary risk only if the Agency can 
make the following findings: 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, that the 
exposure estimate does not under estimate exposure for any significant 
subpopulation group; and if data are available on pesticide use and 
food consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F), EPA may require registrants to submit data on 
PCT.
    The Agency used PCT information as follows: PCT values of 16% for 
corn, 26% for soybeans and 26% for cereal grains.
    The Agency believes that the three conditions, discussed in section 
408 (b)(2)(F) concerning the Agency's responsibilities in assessing 
chronic dietary risk findings, have been met. The PCT estimates are 
derived from Federal and private market survey data, which are reliable 
and have a valid basis. Typically, a range of estimates are supplied 
and the upper end of this range is assumed for the exposure assessment. 
By using this upper end estimate of the PCT, the Agency is reasonably 
certain that the percentage of the food treated is not likely to be 
under estimated. The 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 N-(4-
fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide may be applied in a particular area.
    2. From drinking water. The Agency lacks sufficient water-related 
exposure data to complete a comprehensive drinking water exposure 
analysis and risk assessment for N-(4-fluorophenyl)-N-(1-methylethyl)-
2-[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide. Because 
the Agency does not have comprehensive and reliable monitoring data, 
drinking water concentration estimates must be made by reliance on some 
sort of simulation or modeling. To date, there are no validated 
modeling approaches for reliably predicting pesticide levels in 
drinking water. The Agency is currently relying on GENEEC and PRZM/
EXAMS for surface water, which are used to produce estimates of 
pesticide concentrations in a farm pond and SCI-GROW, which predicts 
pesticide concentrations in ground water. None of these models include 
consideration of the impact processing 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. Based on the GENEEC and 
SCI-GROW models the acute drinking water concentration values are 
estimated to be 12 parts per billion (ppb) for surface water, and 0.12 
ppb for ground water. The chronic drinking water concentration values 
are estimated to be 2.7 ppb for surface water and 0.12 pbb for ground 
water.
    In the absence of monitoring data for pesticides, 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, drinking water, and residential uses. A DWLOC will 
vary depending on the toxic endpoint, with drinking water consumption, 
and body weights. Different populations will have different DWLOCs. 
DWLOCs are used in the risk assessment process as a surrogate measure 
of potential exposure associated with pesticide exposure through 
drinking water. DWLOC values are not regulatory standards for drinking 
water. Since DWLOCs address total aggregate exposure to N-(4-
fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide they are further discussed in the 
aggregate risk sections below.
    3. From non-dietary exposure. N-(4-fluorophenyl)-N-(1-methylethyl)-
2-[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide is not 
registered on any use sites which would result in non-dietary, non-
occupational exposure. Therefore, EPA expects only dietary and 
occupational exposure from the use of N-(4-fluorophenyl)-N-(1-
methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-
yl]oxy]acetamide.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-
1,3,4-thiadiazol-2-yl]oxy]acetamide 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, N-(4-
fluorophenyl)-N-(1-methylethyl)-2-[[5-

[[Page 42843]]

(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide 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 
N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide has a common mechanism of toxicity with 
other substances. For more 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. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. Using the exposure assumptions of 100 PCT and 
tolerance level residues for all commodities, at the 95th percentile, 
10% of the aPAD was utilized for the U.S. Population. The major 
identifiable subgroup with the highest aggregate exposure is children, 
1-6 years old. EPA generally has no concern for exposures below 100% of 
the aPAD. Despite the potential for exposure to N-(4-fluorophenyl)-N-
(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-
yl]oxy]acetamide in drinking water, after calculating a DWLOC (2,400 
ppb) for the U.S. population and comparing it to conservative model 
estimates of acute concentrations of N-(4-fluorophenyl)-N-(1-
methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-
yl]oxy]acetamide in surface and ground water (12 ppb and 0.12 pbb, 
respectively), EPA does not expect the aggregate exposure to exceed 
100% of the aPAD.
    2. Chronic risk. Using the exposure assumptions of tolerance level 
residues for all commodities and PCT values of 16% for corn, 26% for 
soybeans and 26% for cereal grains, EPA has concluded that aggregate 
exposure to N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide from food will 
utilize less than 18% of the cPAD for the U.S. population. The major 
identifiable subgroup with the highest aggregate exposure is children, 
1-6 years old. EPA generally has no concern for exposures below 100% of 
the cPAD because the cPAD represents the level at or below which daily 
aggregate dietary exposure over a lifetime will not pose appreciable 
risks to human health. Despite the potential for chronic exposure to N-
(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide in drinking water, after calculating a 
DWLOC (120 ppb) for the U.S. population and comparing it to 
conservative model estimates of concentrations of N-(4-fluorophenyl)-N-
(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-
yl]oxy]acetamide in surface and ground water (2.7 ppb and 0.12 pbb, 
respectively), EPA does not expect the aggregate exposure to exceed 
100% of the cPAD.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account chronic dietary food and water 
(considered to be a background exposure level) plus other indoor and 
outdoor non-occupational exposure. Since there are no non-dietary, non-
occupational exposures expected from the use of this chemical, no 
short- and intermediate-term risk assessments were conducted.
    4. Aggregate cancer risk for U.S. population. N-(4-fluorophenyl)-N-
(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-
yl]oxy]acetamide has been classified as a ``Not Likely'' carcinogen 
therefore, a cancer risk assessment was not conducted.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children--i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide, EPA considered 
data from developmental toxicity studies in the rat and rabbit, and a 
2-generation reproduction study in the rat. The developmental toxicity 
studies are designed to evaluate adverse effects on the developing 
organism resulting from maternal pesticide exposure during gestation. 
Reproduction studies provide information relating to effects from 
exposure to the pesticide on the reproductive capability of mating 
animals and data on systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for prenatal and postnatal toxicity and 
the completeness of the data base unless EPA determines that a 
different margin of safety will be safe for infants and children. 
Margins of safety are incorporated into EPA risk assessments either 
directly through use of a margin of exposure (MOE) analysis or through 
using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk to humans. EPA believes that reliable data 
support using the standard MOE and uncertainty factor (usually 100 for 
combined interspecies and intraspecies variability)) and not the 
additional tenfold MOE/uncertainty factor when EPA has a complete data 
base under existing guidelines and when the severity of the effect in 
infants or children or the potency or unusual toxic properties of a 
compound do not raise concerns regarding the adequacy of the standard 
MOE/safety factor.
    ii. Developmental toxicity studies. In the developmental study in 
rats, the maternal NOAEL is 25 mg/kg/day based on decreased body-weight 
gain initially at 125 mg/kg/day (LOAEL). The developmental NOAEL is 25 
mg/kg/day based on decreased fetal body weight, delayed development 
mainly delays in ossification in the skull, vertebrae, sternebrae, and 
appendages, and an increase in the incidence of extra ribs at 125 mg/
kg/day (LOAEL).
    In a developmental toxicity study in rabbits, the maternal NOAEL is 
5 mg/kg/day based on histopathological findings in the liver at 25 mg/
kg/day (LOAEL). The NOAEL for developmental toxicity is 25 mg/kg/day 
based on increased skeletal variations at 125 mg/kg/day (LOAEL).
    iii. Reproductive toxicity study. In a 2-generation reproductive 
study in the rats, the NOAEL for maternal/paternal toxicity is 1.4 mg/
kg/day based on increased liver weight absolute and relative in F1 
females and hepatocytomegaly in F1 males at 7.4 and 8.2 mg/kg/day, 
respectively (LOAEL). The reproductive NOAEL is 1.3 mg/kg/day based on 
increased pup death in early lactation (including cannibalism) for F1 
litters at 6.9 mg/kg/day (LOAEL).
    iv. Prenatal and postnatal sensitivity. The Agency has determined 
that there is no indication of additional sensitivity to young rats or 
rabbits following prenatal and/or postnatal exposure to N-(4-
fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide in the developmental and reproductive 
toxicity studies. However, the Agency is concerned that there was no 
assessment of susceptibility of the offspring in functional/
neurological development.
    v. Conclusion. There is a complete toxicity data base for N-(4-
fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide and exposure data are complete or is 
estimated based on data that reasonably accounts for potential 
exposures. Although the data indicate

[[Page 42844]]

that there is no additional sensitivity to young rats or rabbits, 
following prenatal and/or postnatal exposure to N-(4-fluorophenyl)-N-
(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-
yl]oxy]acetamide in the developmental and reproductive toxicity 
studies, the Agency has determined that the FQPA Safety Factor should 
not be removed, instead reduced because:
    a. There was no assessment of susceptibility of the offspring in 
functional/neurological development in the developmental and 
reproductive studies.
    b. There is evidence of neurotoxicity in mice, rats and dogs.
    c. There is concern for endocrine (thyroid hormone) disruption as 
evidenced in several species (mice, rats, dogs and rabbits).
    2. Acute risk. Using the exposure assumptions of 100% PCT and 
tolerance level residues for all commodities, at the 95th percentile, 
16% of the aPAD was utilized for children, 1-6 years old, the major 
identifiable subgroup with the highest aggregate exposure. EPA 
generally has no concern for exposures below 100% of the aPAD. Despite 
the potential for exposure to N-(4-fluorophenyl)-N-(1-methylethyl)-2-
[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide in drinking 
water, after calculating a DWLOC (630 ppb) for children, 1-6 years old 
and comparing it to conservative model estimates of acute 
concentrations of N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide in surface and 
ground water (12 ppb and 0.12 pbb, respectively), EPA does not expect 
the aggregate exposure to exceed 100% of the aPAD.
    3. Chronic risk. Using the exposure assumptions of tolerance level 
residues for all commodities and PCT treated values of 16% for corn, 
26% for soybeans and 26% for cereal grains, EPA has concluded that 
aggregate exposure to N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide from food will 
utilize less than 41% of the cPAD for children, 1-6 years old, the 
major identifiable subgroup with the highest aggregate exposure. EPA 
generally has no concern for exposures below 100% of the cPAD because 
the cPAD represents the level at or below which daily aggregate dietary 
exposure over a lifetime will not pose appreciable risks to human 
health. Despite the potential for chronic exposure to N-(4-
fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide in drinking water, after calculating a 
DWLOC (24 ppb) for children, 1-6 years old and comparing it to 
conservative model estimates of concentrations of N-(4-fluorophenyl)-N-
(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-
yl]oxy]acetamide in surface and ground water (2.7 ppb and 0.12 pbb, 
respectively), EPA does not expect the aggregate exposure to exceed 
100% of the cPAD.
    4. Short- or intermediate-term risk. There are no non-dietary, non-
occupational exposures expected from the use of this chemical. 
Therefore, no short- and intermediate-term risk assessments were 
conducted.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to N-(4-fluorophenyl)-
N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-
yl]oxy]acetamide residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

    The nature of the residue in plants and livestock has been 
adequately defined for this section 18. In plants, metabolism data are 
available for N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide on corn and 
soybeans. For both crops, the residues of concern are parent 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 livestock, metabolism data are 
available for N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide in goats and 
hens. The residues of concern in ruminants and poultry are parent 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.

B. Analytical Enforcement Methodology

    Adequate enforcement methodology (example - gas chromotography) is 
available to enforce the tolerance expression. The method may be 
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location and telephone number: Rm 101FF, Crystal Mall 
#2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-5229.

C. Magnitude of Residues

    N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide and the metabolites FOE oxalate, FOE 
sulfonic acid (as its sodium salt, monohydrate), and FOE thioglycolate 
sulfoxide were tested through the FDA multi-residue methods B, C, D, 
and E. Testing through multi-residue method A is not required because 
N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide and its metabolites do not contain the N-
methylcarbamate structure. FDA will review the multi-residue methods 
data to determine sufficiency.

D. International Residue Limits

    There are no Codex, Canadian, or Mexican tolerances for N-(4-
fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide on wheat.

E. Rotational Crop Restrictions

    A field accumulation in rotational crops study has been reviewed 
and found to support the plant-back intervals of 1 and 4 months for 
potatoes and carrots, respectively. No plant-back interval is needed 
for corn, soybeans, alfalfa, clover, cereal grains, and grasses since 
they already have temporary tolerances. No other crops may be rotated.

V. Conclusion

    Therefore, tolerances are established for combined residues of 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 wheat grain at 1 ppm, wheat 
forage at 10 ppm, wheat hay at 2 ppm, wheat straw at 0.5 ppm, meat, 
kidney, and fat of cattle, goats, horses, hogs, and sheep at 0.05 ppm 
and meat byproducts (other than kidney) at 0.10 ppm.

VI. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation as was provided in 
the old section 408 and in section 409. However, the period for filing 
objections is 60 days, rather than 30 days. EPA currently has 
procedural regulations which govern the submission of objections and 
hearing requests. These regulations will require some modification to 
reflect the new law. However, until those modifications can be made, 
EPA will continue to use those procedural regulations with appropriate 
adjustments to reflect the new law.
    Any person may, by October 5, 1999, file written objections to any 
aspect of this regulation and may also request a

[[Page 42845]]

hearing on those objections. Objections and hearing requests must be 
filed with the Hearing Clerk, at the address given under the 
``ADDRESSES'' section (40 CFR 178.20). A copy of the objections and/or 
hearing requests filed with the Hearing Clerk should be submitted to 
the OPP docket for this rulemaking. The objections submitted must 
specify the provisions of the regulation deemed objectionable and the 
grounds for the objections (40 CFR 178.25). Each objection must be 
accompanied by the fee prescribed by 40 CFR 180.33(i). 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 
tolerance objection fee waivers, contact James Tompkins, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail address: Rm. 239, Crystal Mall 
#2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-5697, 
tompkins.jim@epa.gov. Requests for waiver of tolerance objection fees 
should be sent to James Hollins, Information Resources and Services 
Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.
    If a hearing is requested, the objections must include a statement 
of the factual issues on which a hearing is requested, the requestor's 
contentions on such issues, and a summary of any evidence relied upon 
by the requestor (40 CFR 178.27). A request for a hearing will be 
granted if the Administrator determines that the material submitted 
shows the following: There is 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 in the 
manner sought by the requestor would be adequate to justify the action 
requested (40 CFR 178.32). 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.

VII. Public Record and Electronic Submissions

    EPA has established a record for this regulation under docket 
control number [OPP-300897] (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Room 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    Objections and hearing requests may be sent by e-mail directly to 
EPA at:
    opp-docket@epa.gov
    E-mailed objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption.
    The official record for this regulation, as well as the public 
version, as described in this unit will be kept in paper form. 
Accordingly, EPA will transfer any copies of objections and hearing 
requests received electronically into printed, paper form as they are 
received and will place the paper copies in the official record which 
will also include all comments submitted directly in writing. The 
official record is the paper record maintained at the Virginia address 
in ``ADDRESSES'' at the beginning of this document.

VIII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a tolerance under section 408 of the 
FFDCA. 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). 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) (Pub. L. 104-4). Nor does it require special considerations as 
required by Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), or require OMB review in 
accordance with Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997).
    In addition, since tolerances and exemptions that are established 
under FFDCA section 408(l)(6), 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. Nevertheless, the Agency previously assessed whether 
establishing tolerances, exemptions from tolerances, raising tolerance 
levels or expanding exemptions might adversely impact small entities 
and concluded, as a generic matter, that there is no adverse economic 
impact. The factual basis for the Agency's generic certification for 
tolerance actions published on May 4, 1981 (46 FR 24950), and was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local or tribal government, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments. If the mandate is unfunded, EPA 
must provide to OMB a description of the extent of EPA's prior 
consultation with representatives of affected State, local, and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local, and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's rule does not create an unfunded Federal mandate on State, 
local, or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of Executive Order 12875 do not apply to this rule.

[[Page 42846]]

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide OMB, in a separately identified 
section of the preamble to the rule, a description of the extent of 
EPA's prior consultation with representatives of affected tribal 
governments, a summary of the nature of their concerns, and a statement 
supporting the need to issue the regulation. In addition, Executive 
Order 13084 requires EPA to develop an effective process permitting 
elected officials and other representatives of Indian tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory policies on matters that significantly or uniquely affect 
their communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this rule.

IX. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and 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 the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: July 28, 1999.

Peter Caulkins,

Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


    2. In Sec. 180.527, by adding paragraph (b) 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.

*    *    *    *    *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for the combined residues of N-(4-fluorophenyl)-N-(1-
methylethyl)-2-[[5-(trifluoromehtyl)-1,3,4-thiadiazol-2-
yl]oxy]acetamide and its metabolites containing the 4-fluoro-N-
methylethyl benzenamine moiety in or on the following food commodities.

------------------------------------------------------------------------
                                                     Parts   Expiration/
                    Commodity                         per     Revocation
                                                    million      Date
------------------------------------------------------------------------
Cattle, fat......................................   0.05         7/31/01

Cattle, kidney...................................   0.50         7/31/01

Cattle, meat.....................................   0.05         7/31/01

Cattle, meat byproducts..........................   0.10         7/31/01

Goats, fat.......................................   0.05         7/31/01

Goats, kidney....................................   0.50         7/31/01

Goats, meat......................................   0.05         7/31/01

Goats, meat byproducts...........................   0.10         7/31/01

Hogs, fat........................................   0.05         7/31/01

Hogs, kidney.....................................   0.50         7/31/01

Hogs, meat.......................................   0.05         7/31/01

Hogs, meat byproducts............................   0.10         7/31/01

Horses, fat......................................   0.05         7/31/01

Horses, kidney...................................   0.50         7/31/01

Horses, meat.....................................   0.05         7/31/01

Horses, meat byproducts..........................   0.10         7/31/01

Sheep, fat.......................................   0.05         7/31/01

Sheep, kidney....................................   0.50         7/31/01

Sheep, meat......................................   0.05         7/31/01

Sheep, meat byproducts...........................   0.10         7/31/01

Wheat, forage....................................  10.0          7/31/01

Wheat, grain.....................................   1.0          7/31/01

Wheat, hay.......................................   2.0          7/31/01

Wheat, straw.....................................   0.50         7/31/01
------------------------------------------------------------------------

*    *    *    *    *

[FR Doc. 99-20317 Filed 8-5-99; 8:45 am]
BILLING CODE 6560-50-F