[Federal Register Volume 63, Number 184 (Wednesday, September 23, 1998)]
[Rules and Regulations]
[Pages 50784-50791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25451]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300712; FRL-6028-8]
RIN 2070-AB78
Flufenacet; Time-Limited Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
indirect or inadvertent 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 hereafter referred to as flufenacet, the
proposed common chemical name, in or on certain raw agricultural
commodities when present therein as a result of the application of
flufenacet to field corn and soybeans as a herbicide. Bayer Corporation
requested this tolerance under the Federal Food, Drug and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (Pub. L.
104-170). The tolerance will expire on April 30, 2003.
DATES: This regulation is effective September 23, 1998. Objections and
requests for hearings must be received by EPA on or before November 23,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300712],
[[Page 50785]]
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-300712], 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 also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.g. 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
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300712]. 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, e-
mail: tompkins.jim@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 23,1998 (63
FR 34179)(FRL-5795-1), EPA, issued a notice pursuant to section 408 of
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e)
announcing the filing of a pesticide petition (PP 6F4631) for tolerance
by Bayer Corporation, 8400 Hawthorn Road, P.O. Box 4913, Kansas City,
MO 64120-0013. This notice included a summary of the petition prepared
by Bayer Corporation, the registrant. There were no comments received
in response to the notice of filing.
The petition requested that 40 CFR 180.527 be amended by
establishing tolerances for inadvertent residues of the herbicide, N-
(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide, flufenacet, and metabolites containing
the 4-fluoro-N-methylethyl benzenamine moiety in or on the raw
agricultural commodities of Crop Group 15 (cereal grains), Crop Group
16 (forage, stover and hay of cereal grains), Crop Group 17 (grass
forage, and grass hay), alfalfa forage, alfalfa hay, alfalfa seed,
clover forage, and clover hay at 0.1 parts per million (ppm) when
present therein as a result of the application of flufenacet to field
corn and soybeans. This tolerance will expire on April 30, 2003.
I. Risk Assessment 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).
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100 percent or less of the
RfD) is generally considered acceptable by EPA. EPA generally uses the
RfD to evaluate the chronic risks posed by pesticide exposure. For
shorter term risks, EPA calculates a margin of exposure (MOE) by
dividing the estimated human exposure into the NOEL from the
appropriate animal study. Commonly, EPA finds MOEs lower than 100 to be
unacceptable. This hundredfold MOE is based on the same rationale as
the hundredfold uncertainty factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure
[[Page 50786]]
that the public is adequately protected from any pesticide exposure
scenario. Both short and long durations of exposure are always
considered. Typically, risk assessments include ``acute,'' ``short-
term,'' ``intermediate term,'' and ``chronic'' risks. These assessments
are defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all
three sources are not typically added because of the very low
probability of this occurring in most cases, and because the other
conservative assumptions built into the assessment assure adequate
protection of public health. However, for cases in which high-end
exposure can reasonably be expected from multiple sources (e.g.
frequent and widespread homeowner use in a specific geographical area),
multiple high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOEL is selected to be
adequate for at least 7 days of exposure. (Toxicity results at lower
levels when the dosing duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
The TMRC is a ``worst case'' estimate since it is based on the
assumptions that food contains pesticide residues at the tolerance
level and that 100% of the crop is treated by pesticides that have
established tolerances. If the TMRC exceeds the RfD or poses a lifetime
cancer risk that is greater than approximately one in a million, EPA
attempts to derive a more accurate exposure estimate for the pesticide
by evaluating additional types of information (anticipated residue data
and/or percent of crop treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances.
Percent of crop treated estimates are derived from Federal and
private market survey data. 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 percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup non-nursing
infants was not regionally based.
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
flufenacet and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
indirect or inadvertent residues of flufenacet and its metabolites in
certain raw agricultural commodities at 0.1 ppm when present therein as
a result of the application of flufenacet to field corn and soybeans as
a herbicide. 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 flufenacet are
discussed below.
1. A rat acute oral study with a LD50 of 1,617
milligrams (mg)/kilogram (kg) for males and 589 mg/kg for females.
2. A 84-day rat feeding study with a No Observed Effect Level
(NOEL) less than 100 ppm (6.0 mg/kg/day) for males and a NOEL of 100
ppm (7.2 mg/kg/day) for females and with a Lowest Observed Effect Level
(LOEL) of 100 ppm (6.8 mg/kg/day) for males based on suppression of
thyroxine (T4) level and a LOEL of 400 ppm (28.8 mg/kg/day) for females
based on hematology and clinical chemistry findings.
3. A 13-week mouse feeding study with a NOEL of 100 ppm (18.2 mg/
kg/day for males and 24.5 mg/kg/day) for females and a LOEL of 400 ppm
(64.2 mg/kg/day for males and 91.3 mg/kg/day) for females based on
histopathology of the liver, spleen and thyroid.
4. A 13-week dog dietary study with a NOEL of 50 ppm (1.70 mg/kg/
day for males and 1.67 mg/kg/day for females) and a LOEL of 200 ppm
(6.90 mg/kg/day for males and 7.20 mg/kg/day for females) based on
evidence that the biotransformation capacity of the liver has been
exceeded, (as indicated by increase in LDH, liver weight, ALK and
hepatomegaly), globulin and spleen
[[Page 50787]]
pigment in females, decreased T4 and ALT values in both sexes,
decreased albumin in males, and decreased serum glucose in females.
5. A 21-day rabbit dermal study with the dermal irritation NOEL of
1,000 mg/kg/day for males and females and a Systemic NOEL of 20 mg/kg/
day for males and 150 mg/kg/day for females and a Systemic LOEL of 150
mg/kg/day for males and 1,000 mg/kg/day for females based on clinical
chemistry data (decreased T4 and FT4 levels in both sexes) and
centrilobular hepatocytomegaly in females.
6. A 1-year dog chronic feeding study with a NOEL was 40 ppm (1.29
mg/kg/day in males and 1.14 mg/kg/day in females) and a LOEL of 800 ppm
(27.75 mg/kg/day in males and 26.82 mg/kg/day in females) based on
increased alkaline phosphatase, kidney, and liver weight in both sexes,
increased cholesterol in males, decreased T2, T4 and ALT values in both
sexes, and increased incidences of microscopic lesions in the brain,
eye, kidney, spinal cord, sciatic nerve and liver.
7. A rat chronic feeding/carcinogenicity study with a NOEL less
than 25 ppm (1.2 mg/kg/day in males and 1.5 mg/kg/day in females) and a
LOEL of 25 ppm (1.2 mg/kg/day in males and 1.5 mg/kg/day in females)
based on methemoglobinemia and multi-organ effects in blood, kidney,
spleen, heart, and uterus. Under experimental conditions the treatment
did not alter the spontaneous tumor profile.
8. In a mouse carcinogenicity study the NOEL was less than 50 ppm
(7.4 mg/kg/day) for males and the NOEL was 50 ppm (9.4 mg/kg/day) for
females and the LOEL was 50 ppm (7.4 mg/kg/day for males) and the LOEL
was 200 ppm (38.4 mg/kg/day) for females based on cataract incidence
and severity. There was no evidence of carcinogenicity for flufenacet
in this study.
9. A two-generation rat reproduction study with a parental
systemic NOEL of 20 ppm (1.4 mg/kg/day in males and 1.5 mg/kg/day in
females) and a reproductive NOEL of 20 ppm (1.3 mg/kg/day) and a
Parental Systemic LOEL of 100 ppm (7.4 mg/kg/day in males and 8.2 mg/
kg/day in females) based on increased liver weight in F1
females and hepatocytomegaly in F1 males and a reproductive
LOEL of 100 ppm (6.9 mg/kg/day) based on increased pup death in early
lactation (including cannibalism) for F1 litters and the
same effects in both F1 and F2 pups at the high
dose level of 500 ppm (37.2 mg/kg/day in F1 males and 41.5
mg/kg/day in F1 females, respectively).
10. A rat developmental study with a maternal NOEL of 25 mg/kg/day
and with a maternal LOEL of 125 mg/kg/day based on decreased body
weight gain initially and a developmental NOEL of 25 mg/kg/day and a
developmental LOEL of 125 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.
11. A rabbit developmental study with a maternal NOEL of 5 mg/kg/
day and a maternal LOEL of 25 mg/kg/day based on histopathological
findings in the liver and a developmental NOEL of 25 mg/kg/day and a
developmental LOEL of 125 mg/kg/day based on increased skeletal
variations.
12. An acute rat neurotoxicity study with a NOEL less than 75 mg/
kg/day and a LOEL of 75 mg/kg/day based on decreased motor activity in
males.
13. A rat subchronic neurotoxicity study with a NOEL of 120 ppm
(7.3 mg/kg/day in males and 8.4 mg/kg/day in females) and a LOEL of 600
(38.1 mg/kg/day in males and 42.6 mg/kg/day in females) based on
microscopic lesions in the cerebellum/medulla and spinal cords.
14. Flufenacet was negative for mutagenic/genotoxic effects in a
Gene mutation/In vitro assay in bacteria, a Gene mutation/In vitro
assay in chinese hamster lung fibroblasts cells, a Cytogenetics/In
vitro assay in chinese hamster ovary cells, a Cytogenetics/In vivo
mouse micronucleus assay, and an In vitro unscheduled DNA synthesis
assay in primary rat hepatocytes.
15. A rat metabolism study showed that radio-labeled flufenacet was
rapidly absorbed and metabolized by both sexes. Urine was the major
route of excretion at all dose levels and smaller amounts were excreted
via the feces.
16. A 55-day dog study with subcutaneous administration of thiadone
flufenacet metabolite supports the hypothesis that limitations in
glutathione interdependent pathways and antioxidant stress result in
metabolic lesions in the brain and heart following flufenacet exposure.
B. Toxicological Endpoints
1. Acute toxicity. EPA has concluded that a risk estimate is
required based on the LOEL of 75 mg/kg/day established in the Acute
Neurotoxicity Study. For this risk assessment a Margin of Exposure
(MOE) of 900 is required based on 10X for inter-species extrapolation,
10X for intra-species variation, 3X required to protect infants and
children, and 3X for the use of a LOEL.
2. Short-and intermediate-term toxicity. EPA has concluded that
available evidence does not indicate any evidence of significant
toxicity from short term and intermediate term dietary exposure.
3. Chronic toxicity. EPA has established the RfD for flufenacet at
0.004 milligrams/kilogram/day (mg/kg/day). This RfD is based on LOEL of
1.2 mg/kg/day in the combined chronic toxicity/carcinogenicity study in
rats with a 300-fold safety factor to account for inter-species
extrapolation (10X), intra-species variability (10X), lack of a NOEL in
a critical study (3X). An extra safety factor to protect infants and
children is not needed because the NOEL used in deriving the RfD 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.
4. Carcinogenicity. The Health Effects Division RfD/Peer Review
Committee has classified flufenacet as ``not likely'' to be
carcinogenic to humans based on the lack of carcinogenicity in rats and
mice.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.527 (63 FR 17692)(FRL-5782-9)) 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 the raw agricultural
commodities field corn and soybeans. There is no reasonable expectation
of residues of flufenacet or its metabolites occurring in meat, milk,
poultry, or eggs. Risk assessments were conducted by EPA to assess
dietary exposures from flufenacet 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. An acute dietary risk assessment was
conducted for flufenacet and its metabolites containing the 4-fluoro-N-
methylethyl benzenamine moiety based on the LOEL of 75.0 mg/kg/day from
the acute neurotoxicity study. The acute analysis estimates the
distribution of single-day exposures for the overall U.S. population
and certain subgroups. The Margin of Exposure (MOE) is a measure of how
closely the exposure comes to the LOEL and is calculated as a ratio of
the LOEL to the exposure. The calculated MOE for acute risk of
[[Page 50788]]
flufenacet and its metabolites for the General U.S. population was
50,000 and for the most exposed subgroups, Infants (< 1="" year="" old)="" and="" children="" (1-6="" years="" old),="" the="" moe="" was="" 37,500.="" these="" figures="" are="" above="" the="" moe="" of="" 900="" which="" is="" the="" level="" of="" concern="" based="" on="" interspecies="" extrapolation="" (10x),="" intraspecies="" variability="" (10x),="" the="" lack="" of="" a="" noel="" in="" the="" acute="" neurotoxicity="" study="" (3x),="" and="" providing="" additional="" protection="" to="" infants="" and="" children="" (3x).="" ii.="" chronic="" exposure="" and="" risk.="" the="" reference="" dose="" (rfd)="" for="" flufenacet="" is="" 0.0004="" mg/kg/day.="" this="" value="" is="" based="" on="" the="" systemic="" loel="" of="" 1.2="" mg/kg/day="" in="" the="" rat="" chronic="" feeding/carcinogenicity="" study="" with="" a="" 300-fold="" safety="" factor="" to="" account="" for="" interspecies="" extrapolation="" (10x),="" intraspecies="" variability="" (10x),="" and="" the="" lack="" of="" a="" noel="" in="" the="" rat="" chronic="" feeding/carcinogenicity="" study="" (3x).="" a="" dres="" chronic="" exposure="" analysis="" was="" conducted="" using="" tolerance="" levels="" for="" field="" corn,="" soybeans="" and="" rotated="" crops="" and="" percent="" crop="" treated="" information="" to="" estimate="" dietary="" exposure="" for="" the="" general="" population="" and="" 22="" subgroups.="" the="" chronic="" analysis="" showed="" that="" exposures="" from="" the="" tolerances="" in="" or="" on="" field="" corn,="" soybeans="" and="" rotated="" crops="" for="" non-nursing="" infants="" (the="" subgroup="" with="" the="" highest="" exposure)="" would="" be="" 6.5%="" of="" the="" reference="" dose="" (rfd).="" the="" exposure="" for="" the="" general="" u.s.="" population="" would="" be="" 2.6%="" of="" the="" rfd.="" section="" 408(b)(2)(f)="" states="" that="" the="" agency="" may="" use="" data="" on="" the="" actual="" percent="" of="" food="" treated="" for="" assessing="" chronic="" dietary="" risk="" only="" if="" the="" agency="" can="" make="" the="" following="" findings:="" (a)="" 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;="" (b)="" 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.="" the="" agency="" used="" percent="" crop="" treated="" (pct)="" information="" as="" follows.="" a="" routine="" chronic="" dietary="" exposure="" analysis="" for="" flufenacet="" was="" based="" on="" 16%="" of="" field="" corn="" crop="" treated="" and="" 26%="" of="" the="" soybean="" crop="" treated.="" the="" agency="" believes="" that="" the="" three="" conditions="" listed="" above="" have="" been="" met.="" with="" respect="" to="" unit="" ii.="" b.1.ii.(a),="" epa="" finds="" that="" the="" (pct)="" information="" described="" above="" for="" flufenacet="" used="" on="" field="" corn="" is="" reliable="" and="" has="" a="" valid="" basis.="" bayer="" corporation's="" flufenacet="" production="" capacity="" does="" not="" exceed="" that="" needed="" to="" treat="" 16%="" of="" the="" total="" corn="" and="" 26%="" of="" the="" total="" soybean="" acres="" planted="" in="" the="" united="" states.="" at="" the="" average="" application="" rates="" for="" products="" containing="" flufenacet.="" before="" the="" petitioner="" can="" increase="" production="" of="" product,="" permission="" from="" the="" agency="" must="" be="" obtained.="" as="" to="" unit="" ii.b.1.ii.(b)="" and="" (c),="" regional="" consumption="" information="" and="" consumption="" information="" for="" significant="" subpopulations="" is="" taken="" into="" account="" through="" epa's="" computer-based="" model="" for="" evaluating="" the="" exposure="" of="" significant="" subpopulations="" including="" several="" regional="" groups.="" use="" of="" this="" consumption="" information="" in="" epa's="" risk="" assessment="" process="" ensures="" that="" epa's="" exposure="" estimate="" does="" not="" understate="" exposure="" for="" any="" significant="" subpopulation="" group="" and="" allows="" the="" agency="" to="" be="" reasonably="" certain="" that="" no="" regional="" population="" is="" exposed="" to="" residue="" levels="" higher="" than="" those="" estimated="" by="" the="" agency.="" other="" than="" the="" data="" available="" through="" national="" food="" consumption="" surveys,="" epa="" does="" not="" have="" available="" information="" on="" the="" regional="" consumption="" of="" food="" to="" which="" flufenacet="" may="" be="" applied="" in="" a="" particular="" area.="" 2.="" from="" drinking="" water.="" drinking="" water="" estimated="" concentrations="" (dwecs)="" for="" groundwater="" (parent="" flufenacet="" and="" degradate="" thiadone)="" were="" calculated="" from="" the="" monitoring="" data="" to="" be="" 0.18="" parts="" per="" billion="" (ppb)="" for="" acute="" and="" 0.03="" ppb="" for="" chronic="" concentrations.="" the="" dwecs="" for="" surface="" water="" based="" on="" the="" computer="" models="" pesticide="" root="" zone="" method="" (przm)="" 2.3="" and="" exams="" 2.97.5="" were="" calculated="" to="" be="" 17.0="" ppb="" for="" the="" acute="" concentration="" and="" 14.2="" ppb="" for="" chronic="" concentration="" (parent="" flufenacet="" and="" degradate="" thiadone).="" 3.="" from="" non-dietary="" exposure.="" there="" are="" no="" non-food="" uses="" of="" flufenacet="" 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="" flufenacet="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances="" or="" how="" to="" include="" this="" pesticide="" in="" a="" cumulative="" risk="" assessment.="" flufenacet="" is="" structurally="" a="" thiadiazole.="" unlike="" other="" pesticides="" for="" which="" epa="" has="" followed="" a="" cumulative="" risk="" approach="" based="" on="" a="" common="" mechanism="" of="" toxicity,="" flufenacet="" does="" not="" appear="" to="" produce="" a="" toxic="" metabolite="" produced="" by="" other="" substances.="" for="" the="" purposes="" of="" this="" tolerance="" action,="" therefore,="" epa="" has="" not="" assumed="" that="" flufenacet="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances.="" for="" information="" regarding="" epa's="" efforts="" to="" determine="" which="" chemicals="" have="" a="" common="" mechanism="" of="" toxicity="" and="" to="" evaluate="" the="" cumulative="" effects="" of="" such="" chemicals,="" see="" the="" 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.="" the="" acute="" endpoint="" for="" flufenacet="" and="" its="" metabolites="" is="" 75="" mg/kg/day.="" the="" acute="" exposure="" for="" flufenacet="" and="" its="" metabolites="" is="" 0.0015="" mg/kg/day="" for="" the="" general="" u.s.="" population="" and="" 0.002="" mg/kg/day="" for="" children="" 1-6="" years="" of="" age.="" the="" drinking="" water="" level="" of="" concerns="" (dwlocs)="" for="" acute="" exposure="" to="" flufenacet="" in="" drinking="" water="" calculated="" for="" u.s.="" population="" was="" 2.87="" ppm="" and="" for="" children="" (1-6="" years="" old)="" was="" 813="" ppb.="" these="" figures="" were="" calculated="" as="" follows.="" first,="" the="" acceptable="" acute="" exposure="" flufenacet="" in="" drinking="" water="" was="" obtained="" by="" subtracting="" the="" acute="" dietary="" food="" exposures="" from="" the="" ratio="" of="" the="" acute="" loel="" to="" the="" acceptable="" moe="" for="" aggregate="" exposure.="" then,="" the="" dwlocs="" were="" calculated="" by="" multiplying="" the="" acceptable="" exposure="" to="" flufenacet="" in="" drinking="" water="" by="" estimated="" body="" weight="" (70="" kg="" for="" adults,="" 10="" kg="" for="" children)="" and="" then="" dividing="" by="" the="" estimated="" daily="" drinking="" water="" consumption="" (2="" l/day="" for="" adults,="" 1="" l/day="" for="" children).="" the="" agency's="" sci-grow="" model="" estimates="" peak="" levels="" of="" flufenacet="" and="" its="" metabolite="" thiadone="" in="" groundwater="" to="" be="" 15.3="" ppb.="" przm/exams="" estimates="" peak="" levels="" of="" flufenacet="" and="" its="" metabolite="" thiadone="" in="" surface="" water="" to="" be="" 17="" ppb.="" epa's="" acute="" drinking="" water="" level="" of="" concern="" are="" well="" above="" the="" estimated="" exposures="" for="" flufenacet="" in="" water="" for="" the="" u.s.="" population="" and="" subgroup="" with="" highest="" estimated="" exposure.="" 2.="" chronic="" risk.="" the="" chronic="" endpoint="" for="" flufenacet="" is="" 0.0004="" mg/="" kg/body="" weight(bwt)/day.="" using="" tolerance="" levels="" and="" percent="" crop="" treated,="" the="" residues="" in="" the="" diet="" (food="" only)="" are="" calculated="" to="" be="" 0.0001="" mg/kg="" bwt/day="" or="" 2.6%="" of="" the="" rfd="" for="" the="" general="" u.s.="" population="" and="" 0.00023="" mg/kg="" bwt/day="" or="" 5.8%="" of="" the="" rfd="" for="" children="" aged="" 1-6.="" therefore,="" residues="" of="" flufenacet="" in="" drinking="" water="" [[page="" 50789]]="" may="" comprise="" up="" to="" 0.0039="" mg/kg="" bwt/day="" (0.0040-0.0001="" mg/kg="" bwt/day)="" for="" the="" u.s.="" population="" and="" 0.0038="" mg/kg="" bwt/day="" (0.0040-0.00023="" mg/kg="" bwt/day)="" for="" children="" 1-6="" years="" old="" (the="" highest="" exposed="" group="" from="" residues="" of="" flufenacet="" in="" both="" food="" and="" water).="" the="" drinking="" water="" level="" of="" concerns="" (dwlocs)="" for="" chronic="" exposure="" to="" flufenacet="" in="" drinking="" water="" calculated="" for="" u.s.="" population="" was="" 136="" ppb="" assuming="" that="" an="" adult="" weighs="" 70="" kg="" and="" consumes="" a="" maximum="" of="" 2="" liters="" of="" water="" per="" day="" and="" for="" children="" (1-6="" years="" old)="" the="" dwloc="" was="" 37.7="" ppb="" assuming="" that="" a="" child="" weighs="" 10="" kg="" and="" consumes="" a="" maximum="" of="" 1="" liter="" of="" water="" per="" day.="" the="" drinking="" water="" estimated="" concentration="" (dwecs)="" for="" groundwater="" (parent="" flufenacet="" and="" degradate="" thiadone)="" calculated="" from="" the="" monitoring="" data="" is="" 0.03="" ppb="" for="" chronic="" concentrations="" which="" does="" not="" exceed="" dwloc="" of="" 37.7="" ppb="" for="" children="" (1-6="" years="" old).="" the="" dwec="" for="" surface="" water="" based="" on="" the="" computer="" models="" przm="" 2.3="" and="" exams="" 2.97.5="" was="" calculated="" to="" be="" 14.2="" ppb="" for="" chronic="" concentration="" (parent="" flufenacet="" and="" degradate="" thiadone)="" which="" does="" not="" exceed="" the="" dwloc="" of="" 37.7="" ppb="" for="" children="" (1-6="" years="" old).="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" flufenacet="" residues.="" e.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" infants="" and="" children="" 1.="" safety="" factor="" for="" infants="" and="" children.="" in="" assessing="" the="" potential="" for="" additional="" sensitivity="" of="" infants="" and="" children="" to="" residues="" of="" flufenacet,="" epa="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" the="" rat="" and="" rabbit="" and="" a="" two-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.="" although="" there="" is="" no="" indication="" of="" increased="" sensitivity="" to="" young="" rats="" or="" rabbits="" following="" pre-and/or="" post-natal="" exposure="" to="" flufenacet="" in="" the="" standard="" developmental="" and="" reproductive="" toxicity="" studies,="" an="" additional="" developmental="" neurotoxicity="" study,="" which="" is="" not="" normally="" required,="" is="" needed="" to="" access="" the="" susceptibility="" of="" the="" offspring="" in="" functional/="" neurological="" development.="" therefore,="" epa="" has="" required="" that="" a="" developmental="" neurotoxicity="" study="" be="" conducted="" with="" flufenacet="" and="" a="" three="" fold="" safety="" factor="" for="" children="" and="" infants="" will="" be="" used="" in="" the="" aggregate="" dietary="" acute="" and="" chronic="" risk="" assessments.="" although="" there="" is="" no="" indication="" of="" additional="" sensitivity="" to="" young="" rats="" or="" rabbits="" following="" pre-and/or="" post-natal="" exposure="" to="" flufenacet="" in="" the="" developmental="" and="" reproductive="" toxicity="" studies;="" the="" agency="" concluded="" that="" the="" fqpa="" safety="" factors="" should="" not="" be="" removed="" but="" instead="" reduced="" because:="" (a)="" there="" was="" no="" assessment="" of="" susceptibility="" of="" the="" offspring="" in="" functional/neurological="" development="" and="" reproductive="" studies,="" (b)="" there="" is="" evidence="" of="" neurotoxicity="" in="" mice,="" rats,="" and="" dogs,="" (c)="" there="" is="" concern="" for="" thyroid="" hormone="" disruption.="" iii.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" nature="" of="" the="" residue="" in="" field="" corn,="" soybeans,="" rotational="" crops,="" and="" livestock="" is="" adequately="" understood.="" the="" residues="" of="" concern="" for="" the="" tolerance="" expression="" are="" parent="" and="" metabolites="" containing="" the="" 4-fluoro-n-methylethyl="" benzenamine="" moiety.="" based="" on="" the="" results="" of="" animal="" metabolism="" studies="" it="" is="" unlikely="" that="" secondary="" residues="" would="" occur="" in="" animal="" commodities="" from="" the="" use="" on="" field="" corn="" and="" soybeans.="" b.="" analytical="" enforcement="" methodology="" an="" adequate="" analytical="" method,="" gas="" chromatography/mass="" spectrometry="" with="" selected="" ion="" monitoring,="" is="" available="" for="" enforcement="" purposes.="" because="" of="" the="" long="" lead="" time="" from="" establishing="" these="" tolerances="" to="" publication="" of="" the="" enforcement="" methodology="" in="" the="" pesticide="" analytical="" manual,="" vol.="" ii,="" the="" analytical="" methodology="" is="" being="" made="" available="" in="" the="" interim="" to="" anyone="" interested="" in="" pesticide="" enforcement="" when="" 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="" 22202,="" (703-305-5229).="" c.="" endocrine="" effects="" epa="" is="" required="" to="" develop="" a="" screening="" program="" to="" determine="" whether="" certain="" substances="" (including="" all="" pesticides="" and="" inerts)="" ``may="" have="" an="" effect="" in="" humans="" that="" is="" similar="" to="" an="" effect="" produced="" by="" a="" naturally="" occurring="" estrogen,="" or="" such="" other="" effect="" .="" .="" .="" ''="" the="" agency="" is="" currently="" working="" with="" interested="" stakeholders,="" including="" other="" government="" agencies,="" public="" interest="" groups,="" industry="" and="" research="" scientists="" in="" developing="" a="" screening="" and="" testing="" program="" and="" a="" priority="" setting="" scheme="" to="" implement="" this="" program.="" congress="" has="" allowed="" 3="" years="" from="" the="" passage="" of="" fqpa="" (august="" 3,="" 1999)="" to="" implement="" this="" program.="" at="" that="" time,="" epa="" may="" require="" further="" testing="" of="" this="" active="" ingredient="" and="" end="" use="" products="" for="" endocrine="" disrupter="" effects.="" based="" on="" the="" toxicological="" findings="" for="" flufenacet="" relating="" to="" endocrine="" disruption="" effects,="" flufenacet="" should="" be="" considered="" as="" a="" candidate="" for="" evaluation="" as="" an="" endocrine="" disrupter="" when="" the="" criteria="" are="" established.="" d.="" 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="" on="" corn="" and="" soybeans.="" due="" to="" the="" following="" data="" gaps:="" (1)="" data="" regarding="" the="" stability="" of="" the="" glucoside="" conjugate="" and="" the="" malonylalanine="" conjugate="" of="" thiadone="" and="" subsequent="" bioavailability="" of="" any="" release="" free="" thiadone="" or="" thiadone="" glucuronide;="" (2)="" a="" revised="" analytical="" method;="" (3)="" validation="" of="" the="" product="" chemistry="" enforcement="" analytical="" methods;="" (4)="" additional="" rotational="" crop="" data;="" (5)="" additional="" water="" monitoring="" data;="" and="" (6)="" a="" developmental="" neurotoxicity="" study;="" epa="" believes="" it="" is="" inappropriate="" to="" establish="" permanent="" tolerances="" for="" the="" uses="" of="" flufenacet="" at="" this="" time.="" epa="" believes="" that="" the="" existing="" data="" support="" time-limited="" tolerances="" to="" april="" 30,="" 2003.="" the="" nature="" of="" the="" residue="" in="" plants="" is="" adequately="" understood="" for="" the="" purposes="" of="" these="" time-limited="" tolerances.="" e.="" international="" residue="" limits="" there="" are="" no="" codex="" alimentarius="" commission="" (codex)="" maximum="" residue="" levels="" (mrls)="" for="" flufenacet.="" f.="" rotational="" crop="" restrictions="" tolerances="" for="" indirect="" or="" inadvertent="" residues="" of="" flufenacet="" established="" by="" this="" regulation="" will="" cover="" any="" residues="" in="" the="" crops="" planted="" in="" treated="" soybean="" and="" corn="" fields="" in="" accordance="" with="" the="" restrictions="" that="" appear="" on="" the="" labeling="" proposed="" for="" registration="" under="" the="" federal="" insecticide,="" fungicide,="" and="" rodenticide="" act="" (fifra),="" as="" amended.="" [[page="" 50790]]="" iv.="" conclusion="" therefore,="" the="" tolerances="" are="" established="" for="" indirect="" or="" inadvertent="" 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="" moiety="" in="" or="" on="" crop="" group="" 15="" (cereal="" grains),="" crop="" group="" 16="" (forage,="" stover="" and="" hay="" of="" cereal="" grains),="" crop="" group="" 17="" (grass="" forage,="" and="" grass="" hay),="" alfalfa="" forage,="" alfalfa="" hay,="" alfalfa="" seed,="" clover="" forage,="" and="" clover="" hay="" at="" 0.1="" ppm="" when="" present="" therein="" as="" a="" result="" of="" the="" application="" of="" flufenacet="" to="" field="" corn="" and="" soybeans="" as="" a="" herbicide.="" these="" time-limited="" tolerances="" will="" expire="" on="" april="" 30,="" 2003="" v.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" issued="" by="" epa="" under="" new="" section="" 408(e)="" and="" (l)(6)="" 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="" november="" 23,="" 1998,="" 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="" above="" (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).="" 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.="" vi.="" public="" record="" and="" electronic="" submissions="" epa="" has="" established="" a="" record="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300712]="" (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="" highway,="" arlington,="" va.="" electronic="" comments="" may="" be="" sent="" directly="" to="" epa="" at:="">opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above 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 rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking 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 FFDCA section 408(d)
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).
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing Intergovernmental
Partnerships (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 the Office of Management and Budget (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
[[Page 50791]]
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 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.
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(d), 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 has
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.
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 to 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 record
keeping requirements.
Dated: September 10, 1998.
James Jones,
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. 346a and 371.
2. In Sec. 180.527, by adding paragraph (d) 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.
* * * * *
(d) Indirect or inadvertent residues. (1) Time-limited tolerances
are established for indirect or inadvertent 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 moiety in or on the following raw
agricultural commodities from application of this herbicide to the raw
agricultural commodities listed in paragraph (a)(1) of this section:
------------------------------------------------------------------------
Parts Expiration/
Commodity per Revocation
million Date
------------------------------------------------------------------------
Alfalfa, forage................................... 0.1 4/30/03
Alfalfa, hay...................................... 0.1 4/30/03
Alfalfa, seed.................................... 0.1 4/30/03
Clover, forage.................................... 0.1 4/30/03
Clover, hay....................................... 0.1 4/30/03
Crop Group 15 (cereal grains)..................... 0.1 4/30/03
Crop Group 16 (forage, stover and hay of cereal
grains).......................................... 0.1 4/30/03
Crop Group 17 (grass forage, and grass hay)....... 0.1 4/30/03
------------------------------------------------------------------------
(2) Residues in these commodities not in excess of the established
tolerance resulting from the use described in paragraph (d)(1) of this
section remaining after expiration of the time-limited tolerance will
not be considered to be actionable if the herbicide is applied during
the term of and in accordance with the provisions of the above
regulation.
[FR Doc. 98-25451 Filed 9-22-98; 8:45 am]
BILLING CODE 6560-50-F
