[Federal Register Volume 64, Number 151 (Friday, August 6, 1999)]
[Rules and Regulations]
[Pages 42839-42846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20317]
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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
