fluthiacet-methyl (action) Pesticide Tolerance 3/99
[Federal Register: April 14, 1999 (Volume 64, Number 71)]
[Rules and Regulations]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300829; FRL 6072-2]
Fluthiacet-methyl; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes a tolerance for residues of
fluthiacet-methyl in or on soybean seed. Novartis Crop Protection, Inc.
requested this tolerance under the Federal Food, Drug, and Cosmetic
Act, as amended by the Food Quality Protection Act of 1996.
DATES: This regulation is effective April 14, 1999. Objections and
requests for hearings must be received by EPA on or before June 14,
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300829], 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-300829], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
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 be submitted electronically by sending electronic mail (e-
mail) to: opp-
email@example.com. Copies of 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 objections and hearing requests in electronic form must
be identified by the docket control number [OPP-300829]. No
Confidential Business Information (CBI) should be submitted through e-
mail. Electronic copies of objections and hearing requests on this rule
may be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: James A. 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;
SUPPLEMENTARY INFORMATION: In the Federal Register of March 26, 1997
(62 FR 14426) (FRL-5595-6), EPA issued a notice pursuant to section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as
amended by the Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-
170) announcing the filing of a pesticide petition (PP) 6F4614, for
tolerance by Novartis Crop Protection, Inc., P.O. Box 18300,
Greensboro, NC 27419. This notice included a summary of the petition
prepared by Novartis Crop Protection, Inc., the registrant. There were
no comments received in response to the notice of filing.
The petition requested that 40 CFR part 180 be amended by
establishing a tolerance for residues of the herbicide, fluthiacet-
methyl, acetic acid [[2-chloro-4-fluoro-5-[(tetrahydro-3-oxo-1H,3H-
ylidene)amino]phenyl]thio]-methyl ester, in or on soybeans at 0.01 part
per million (ppm).
I. Background and Statutory Findings
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
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).
II. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
fluthiacet-methyl and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a tolerance for residues of
fluthiacet-methyl on soybean seed at 0.01 ppm. EPA's assessment of the
dietary exposures and risks associated with establishing the tolerance
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by fluthiacet-methyl
are discussed in this unit.
1. A rat acute oral study with a LD<INF>50</INF> greater than (>)
5,000 milligrams (mg)/kilogram (kg) for males and females.
2. A 90-day rat feeding study with a no observed adverse effect
level (NOAEL) of 100 ppm 6.19 mg/kg/day for males and 6.80 mg/kg/day
for females and a lowest observed adverse effect level (LOAEL) of 3,500
ppm 216 mg/kg/day for males and 249 mg/kg/day for females based on
decreased body weight gains as well as effects on hematology, clinical
chemistry, urinalysis parameters, liver weights and microscopic
3. A 90-day mouse feeding study with a NOAEL of 10 ppm (1.3 mg/kg/
day for males and 1.6 mg/kg/day for females) and a LOAEL of 500 ppm (66
mg/kg/day for males and 83 mg/kg/day for females) based on effects on
the erythropoietic system and the liver.
4. A 6-week dog dietary study with a NOAEL of 236 mg/kg/day for
males and 77.7 mg/kg/day for females and a LOAEL of 709 mg/kg/day for
males and 232 mg/kg/day for females based on decreased body weight
5. A 28-day rat dermal study with a NOAEL of 1,000 mg/kg/day, the
highest dose tested (HDT).
6. A 1-year dog chronic feeding study with a NOAEL of 57.6 mg/kg/
day in males and 30.3 mg/kg/day for females and a LOAEL of 582 mg/kg/
day for males and 145 mg/kg/day for females based on effects observed
in the erythropoietic system and the liver.
7. A rat chronic feeding/carcinogenicity study with a NOAEL for
systemic toxicity of 50 ppm (2.1 mg/kg/day in males and 2.5 mg/kg/day
in females) and a LOAEL for systemic toxicity of 3,000 ppm (130 mg/kg/
day in males and 154 mg/kg/day in females) based on decreased body
weights, liver toxicity, pancreatic toxicity and microcytic anemia in
males; and liver toxicity, uterine toxicity and slight microcytic
anemia in females. In males only at 3,000 and 5,000 ppm (130 and 219
mg/kg/day, respectively) there was an increase in the trend toward
pancreatic exocrine adenomas and pancreatic islet cell adenomas.
8. A mouse carcinogenicity study with a NOAEL for systemic
toxicity of 1 ppm (0.1 mg/kg/day in males and females) and a LOAEL for
systemic toxicity of 10 ppm (1.0 mg/kg/day in males and 1.2 mg/kg/day
in females) based on non-neoplastic liver findings. In males (and
possibly females) at 100 (10 mg/kg/day for males and 12 mg/kg/day for
females) and 300 ppm (32 mg/kg/day for males and 37 mg /kg/day for
females) there was an increase in the number of mice with
hepatocellular adenomas, carcinomas and/or adenomas/carcinomas.
9. A 2-generation rat reproduction study with a parental systemic
NOAEL of 25 ppm (1.59 mg/kg/day for males and 1.73 mg/kg/day for
females) and a systemic LOAEL of 500 ppm (31.8 mg/kg/day for males and
35.2 mg/kg/day for females) based on reduction in male body weights/
gains and hepatic pathology; and the reproductive NOAEL of 500 ppm
(31.8 mg/kg/day for males and 37.1 mg/kg/day for females) and the
reproductive LOAEL of 5,000 ppm (313 mg/kg/day for males and 388 mg/kg/
day for females) based on decreases in mean litter body weights.
10. A rat developmental study with a maternal NOAEL and
reproductive NOAEL equal to or greater than 1,000 mg/kg/day HDT.
11. A rabbit developmental study with a maternal and developmental
NOAEL of 1,000 mg/kg/day HDT and with a developmental NOAEL of 300 mg/
kg/day and with a developmental LOAEL of 1,000 mg/kg/day based on
slight non-significant increased incidence of irregularly shaped
sternebrae attributed to a delay in fetal development.
12. An acute rat neurotoxicity study with a NOAEL of 2,000 mg/kg
13. A rat subchronic neurotoxicity study with a systemic NOAEL of
10 ppm (0.576 mg/kg/day) in males and 20,000 ppm (1,354 mg/kg/day), HDT
in females and a systemic LOAEL of 10,000 (556 mg/kg/day) in males
based on decreased body weight and food consumption and with a
neurotoxicity NOAEL of 20,000 ppm (1,128 mg/kg/day for males and 1,354
mg/kg/day for females), HDT.
14. Fluthiacet-methyl was negative for mutagenic/genotoxic effects
in bacterial or cultured mammalian cells and did not cause DNA damage
in bacterial or primary rat hepatocytes. In vitro cytogenetic assays
performed with two different mammalian cell lines demonstrated that
fluthiacet-methyl is clastogenic both in the presence and absence of S9
activation. Although the test substance is negative for micronuclei
induction in mouse bone marrow, a significant increase in micronuclei
is seen in stimulated rat liver cells following in vivo exposure.
15. Based on the results of the rat metabolism studies,
fluthiacet-methyl was absorbed rapidly at both the low and high dose
for both male and female rats. Repeated oral dosing had no effect on
extent of absorption. Tissue levels of <SUP>14</SUP>C-fluthiacet-methyl
derived radioactivity in the single and repeated low dose groups did
not exceed 0.018 ppm for any tissue. At the single high dose, female
rats showed higher levels of <SUP>14</SUP>C-fluthiacet-methyl derived
radioactivity in tissues than males except for muscle, brain, fat and
plasma. Excretion in males was predominantly in feces for all dose
groups, with between 67-87% of administered radioactivity excreted by
this route. In females, the percentage of administered radioactivity in
urine across all dose groups 40-48% was approximately equivalent to the
percent excreted in feces 39-52%. The greater fecal excretion in males
was based on a greater percentage excretion in bile for males 37% vs.
B. Toxicological Endpoints
1. Acute toxicity. EPA could not identify any toxicological effects
that could be attributable to a single oral exposure (dose) in any of
the available toxicological studies.
2. Short- and intermediate-term toxicity. EPA could not identify
any toxicological effects that could be attributable to short- or
intermediate-term dietary exposure .
3. Chronic toxicity. EPA has established the RfD for fluthiacet-
methyl at 0.001 mg/kg/day. This Reference Dose (RfD) is based on the
NOAEL of 0.1 mg/kg/day in the mouse carcinogenicity study and using an
uncertainty factor of 100 (10x for inter-species extrapolation, 10x for
intra-species variability). The LOAEL in this study, 1.0 and 1.2 mg/kg/
day for males and females, respectively, was based on non-neoplastic
liver findings (centrilobular necrosis, centrilobular cell
degeneration, histiocytic pigmentation and karyomegaly).
4. Carcinogenicity. The Health Effects Division Cancer Assessment
Review Committee has classified fluthiacet-methyl in accordance with
the Agency's Proposed Guidelines for Carcinogen Risk Assessment (April
10, 1996) as ``likely to be a human carcinogen.'' Evidence for
carcinogenicity was demonstrated by the presence of pancreatic tumors
(exocrine adenomas, islet cell adenomas and combined islet cell
adenomas + carcinomas) in male rats and liver tumors (adenomas and
combined adenomas + carcinomas) in male and female mice. The Committee
recommended a linear low-dose approach (Q<INF>1</INF>*) for human
characterization and determined that extrapolation should be based on
the combined hepatocellular tumors (adenomas and carcinomas) in male
C. Exposures and Risks
1. From food and feed uses. The proposed tolerance in or on the raw
agricultural commodity: soybean seed at 0.01 ppm is the first to be
established for residues of the herbicide, fluthiacet-methyl, acetic
ylidene)amino]phenyl]thio]-methyl ester. There is no reasonable
expectation of residues of fluthiacet-methyl occurring in meat, milk,
poultry, or eggs from its use on soybeans. Risk assessments were
conducted by EPA to assess dietary exposures from fluthiacet-methyl as
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated (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 underestimate 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 percent of crop treated as required by the section 408(b)(2)(F), EPA
may require registrants to submit data on PCT.
The Agency used PCT information as follows:
A chronic exposure analysis for soybeans was conducted assuming 25%
of the soybean crop is treated. EPA estimates that 25% of the total
soybeans crop acres will not be exceeded by this new broadleaf
herbicide within the next 5 years.
The Agency believes that the three conditions, discussed in section
408 (b)(2)(F) in this unit concerning the Agency's responsibilities in
assessing chronic dietary risk findings, have been met. EPA finds that
the PCT information is reliable and has a valid basis. Before the
petitioner can increase production of product for treatment of greater
than 25% of total soybean acres, permission from the Agency must be
obtained. 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 consumption of food bearing fluthiacet-methyl in a
i. Acute exposure and risk. EPA could not identify any
toxicological effects that could be attributable to a single oral
exposure (dose) in any of the available
toxicological studies. This risk assessment is not needed.
ii. Chronic exposure and risk. The Reference Dose (RfD) for
fluthiacet-methyl is 0.001 mg/kg/day. This value is based on the
systemic NOAEL of 0.1 mg/kg/day in the mouse carcinogenicity study with
a 100-fold safety factor to account for interspecies extrapolation
(10x) and intraspecies variability (10x).
A Dietary Exposure Evaluation Model (DEEM) chronic exposure
analysis was conducted using tolerance levels for soybeans assuming
that 25% of the crop is treated to estimate dietary exposure for the
general population and 22 subgroups. The chronic analysis showed that
exposures from the tolerance level residues in or on soybeans for non-
nursing infants less than 1 years old (the subgroup with the highest
exposure) would be 0.6% of the RfD. The exposure for the general U.S.
population would be 0.1% of the RfD.
A lifetime dietary carcinogenicity exposure analysis was conducted
for fluthiacet-methyl using the proposed tolerances along with the
assumption of 25 percent of the crop treated and a Q* of 2.07 x
10<SUP>-1</SUP> (mg/kg/day)<SUP>-1</SUP>. A lifetime risk exposure
analysis was also conducted using the DEEM computer analysis. The
estimated cancer risk (2.06 x 10<SUP>-7</SUP>) is less than the level
that the Agency usually considers negligible for cancer risk estimates.
2. From drinking water. Drinking water estimated concentrations
(DWECs) for surface water were calculated by generic expected
environmental concentration (GENEEC) computer models to be an average
of 0.3 parts per billion (ppb). The DWECs for ground water based on the
computer model screening concentration in ground water (SCI-GROW) were
calculated to be an average of 0.002 ppb.
3. From non-dietary exposure. There are no non-food uses of
fluthiacet-methyl currently registered under the Federal Insecticide,
Fungicide and Rodenticide Act, as amended. No non-dietary exposures are
expected for the general population.
4. Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether fluthiacet-methyl has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
fluthiacet-methyl does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that fluthiacet-methyl has a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62
FR 62961, November 26, 1997).
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. EPA could not identify any toxicological effects
that could be attributable to a single oral exposure (dose) in any of
the available toxicological studies.
2. Chronic risk. Using the DEEM chronic exposure assumptions
described in this unit, EPA has concluded that aggregate exposure to
fluthiacet-methyl from food will utilize 0.1% of the RfD for the U.S.
population. The major identifiable subgroup with the highest aggregate
exposure, non-nursing infants less than 1 year old, utilize 0.6% of the
RfD. EPA generally has no concern for exposures below 100% of the RfD
because the RfD represents the level at or below which daily aggregate
exposure over a lifetime will not pose appreciable risks to human
health. The drinking water level of comparisons (DWLOCs) for chronic
exposure to fluthiacet-methyl in drinking water calculated for the U.S.
population was 35 ppb and for non-nursing infants less than 1 year old
the DWLOC was 10 ppb. The estimated average concentration in surface
water for fluthiacet-methyl is 0.3 ppb and for ground water is 0.002
ppb. EPA's chronic drinking water levels of comparison are well above
the estimated exposures for fluthiacet-methyl in water for the U.S.
population and the subgroup of concern. Conservative model estimates
(GENEEC and SCI-GROW) of the concentrations of fluthiacet-methyl in
surface and ground water indicate that exposure will be minimal.
3. Short- and intermediate-term risk. EPA could not identify any
toxicological effects that could be attributable to short or
intermediate-term dermal or inhalation exposure. No systemic effects
were observed in available dermal studies. In addition, no endpoints
for short or intermediate-term exposure could be identified from
available oral studies. A short- and intermediate-term risk assessment
is not needed.
4. Aggregate cancer risk for U.S. population--combined food and
water. A lifetime dietary carcinogenicity exposure analysis for
fluthiacet-methyl estimated the cancer risk to be 2.06 x
10<SUP>-7</SUP>, a level that the Agency usually considers negligible
for cancer risk estimates. A DWLOC for cancer was calculated as 0.133
ppb. The estimated concentration in surface water and groundwater for
fluthiacet-methyl for chronic exposure are 0.1 ppb (0.3 ppb (the 56-day
concentration)/3) and 0.002 ppb, respectively. The model exposure
estimates are less than the cancer DWLOC.
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 fluthiacet-methyl residues.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children--In general. In
assessing the potential for additional sensitivity of infants and
children to residues of fluthiacet-methyl, 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 gestation. Reproduction
studies provide information relating to effects from exposure to the
pesticide on the reproductive capability of mating animals and data on
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 pre- and post-natal toxicity and the
completeness of the database 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 uncertainty factor (usually 100 for combined inter-
and intra-species 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.
In the prenatal developmental study with rabbits, in utero
exposure did not result in maternal toxicity at 1,000 mg/kg/day.
Developmental toxicity, however, was seen at this dose as a non-
statistical increase in irregular sternebrae (an effect attributed to a
delay in fetal development, a variation which is reversible). The
occurrence of developmental toxicity at a dose at which no maternal
toxicity was noted indicates an apparent susceptibility. EPA; however,
determined that the apparent susceptibility is not convincing for the
a. The increased incidence of irregular sternebrae was not
statistically significant when compared to concurrent controls.
b. The increase occurred primarily at the limit-dose (1,000 mg/kg/
c. It was the only anomaly observed in the study (i.e., a single
d. The dose response was not strong since there was only a small
increase in the litter incidences between the low-dose (5 mg/kg/day)
and the high-dose (1,000 mg/kg/day), with the mid- and high-dose groups
having 8 litters with this variation.
e. This endpoint is considered appropriate to establish a LOAEL,
but not appropriate for risk assessments.
Based on these factors, the Agency concluded that there is no
increased susceptibility in the rabbit study.
The Agency concluded that an extra safety factor to protect
infants and children is not needed based on the following
The available hazard assessment studies indicated no increased
susceptibility of rats or rabbits to in utero and/or postnatal exposure
to fluthiacet-methyl, and exposure assessments do not indicate a
concern for potential risk to infants and children, based upon the very
low application rates and quick dissipation of fluthiacet-methyl; the
dietary exposure estimates using field study data result in an
overestimate of dietary exposure; modeling data are used for ground and
surface source drinking water exposure assessments resulting in
estimates considered to be upper-bound concentrations; and there are
currently no registered residential uses for fluthiacet-methyl.
2. Conclusion. There is a complete toxicity database for
fluthiacet-methyl and exposure data is complete or is estimated based
on data that reasonably accounts for potential exposures.
III. Other Considerations
A. Metabolism In Plants and Animals
The nature of the residue in soybeans, rotational crops, and
livestock is adequately understood. The residues of concern for the
tolerance expression are parent per se. Based on the results of animal
metabolism studies it is unlikely that secondary residues would occur
in animal commodities from the use of fluthiacet-methyl on soybeans.
B. Analytical Enforcement Methodology
Adequate enforcement methodology (gas-liquid chromatography) is
available to enforce the tolerance expression. The method may be
requested from: Calvin Furlow, PIRIB, 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
Based on the results of animal metabolism studies it is unlikely
that significant residues would occur in secondary animal commodities
from the use of fluthiacet-methyl on soybeans. Residues of fluthiacet-
methyl in all treated and untreated samples of soybeans, hulls, meal,
crude oil, refined oil and aspirated grain fractions were less than the
method level of quantification (LOQ). The nature of the residue in
plants is adequately understood for the purposes of these tolerances
D. International Residue Limits
There are no Codex Alimentarius Commission (Codex), Canadian, or
Mexican Maximum Residue Levels (MRLs) for fluthiacet-methyl at this
E. Rotational Crop Restrictions
No tolerances for inadvertent residues of fluthiacet-methyl are
required in rotational crops.
Therefore, the tolerance is established for residues of fluthiacet-
methyl in soybeans seeds at 0.01 ppm.
V. 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 June 14, 1999, file written objections to any
aspect of this regulation and may also request a 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
regulation. 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, firstname.lastname@example.org. 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
VI. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300829] (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
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
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.
VII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). 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 any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or 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
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(d), such as the
tolerance/exemption 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.
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
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
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and 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
Dated: March 31, 1999.
Susan B. Hazen,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as
Authority: 21 U.S.C. 321(q), 346a, and 371.
2. Section 180.551 is added to read as follows.
Sec. 180.551 Fluthiacet-methyl; tolerances for residues.
(a) General. A tolerance is established for residues of the
herbicide, fluthiacet-methyl, acetic acid [[2-chloro-4-fluoro-5-
ylidene)amino]phenyl]thio]-methyl ester, in or on the food commodity:
Soybean seed................................................... 0.01
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 99-9057 Filed 4-13-99; 8:45 am]
BILLING CODE 6560-50-F