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fluthiacet-methyl (action) Pesticide Tolerance 3/99

 

[Federal Register: April 14, 1999 (Volume 64, Number 71)]
[Rules and Regulations]               
[Page 18351-18357]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ap99-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300829; FRL 6072-2]
RIN 2070-AB78

 
Fluthiacet-methyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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, 
1999.
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-

[[Page 18352]]

docket@epa.gov. 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; 
tompkins.jim@epa.gov.

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-
[1,3,4]thiadiazolo[3,4-<greek-a>]pyridazin-1-
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 
chemical residue.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 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 
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 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 
pathology.
     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 
gain.
     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.

[[Page 18353]]

     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 
HDT.
     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. 
females 19%.

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 
mice.

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 
acid, [[2-chloro-4-fluoro-5-[(tetrahydro-3-oxo-1H,3H-
[1,3,4]thiadiazolo[3,4-<greek-a>]pyridazin-1-
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 
follows:
    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 
particular area.
    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

[[Page 18354]]

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 
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 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

[[Page 18355]]

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 
following reasons:
    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/
day).
    c. It was the only anomaly observed in the study (i.e., a single 
variation).
    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 
considerations:
    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 
time.

E. Rotational Crop Restrictions

     No tolerances for inadvertent residues of fluthiacet-methyl are 
required in rotational crops.

IV. Conclusion

    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, 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

[[Page 18356]]

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.

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 
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.

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 
23, 1997).
    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 
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.

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

[[Page 18357]]

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: March 31, 1999.

Susan B. Hazen,
Acting Director, 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. 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-
[(tetrahydro-3-oxo-1H,3H-[1,3,4]thiadiazolo[3,4-<greek-a>]pyridazin-1-
ylidene)amino]phenyl]thio]-methyl ester, in or on the food commodity:

------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
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