[Federal Register Volume 63, Number 195 (Thursday, October 8, 1998)]
[Rules and Regulations]
[Pages 54066-54073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26905]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300739; FRL-6034-1]
RIN 2070-AB78
Sethoxydim; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for combined residues
of sethoxydim (2-[1-(ethoxyimino]butyl)-5-[2-(ethylthio)propyl]-3-
hydroxy-2-cyclohexen-1-one) and its metabolites containing the 2-
cyclohexen-1-one moiety(calculated as the herbicide) in or on apricots,
cherries (sweet and sour), nectarines, peaches, succulent beans, bean
forage, soybeans, grapes, raisins, cilantro, leafy vegetable (except
Brassica) crop group, tuberous and corm vegetable subgroup, garden
beets, caneberry crop sub group, and globe artichoke. This regulation
also deletes the established tolerances for raisin waste, grape pomace,
celery, head lettuce, leaf lettuce, spinach, endive(escarole), potato,
sweet potato, and raspberry. BASF Corporation and Interregional
Research Project Number (IR-4) requested these tolerances under the
Federal Food, Drug and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (Pub. L. 104-170).
DATES: This regulation is effective October 8, 1998. Objections and
requests for hearings must be received by EPA on or before December 7,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300739], 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-300739], 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.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
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-300739]. 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: Jim Tompkins or Hoyt
Jamerson, 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: Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA, Jim Tompkins (703) 305 5697,
Hoyt Jamerson (703) 308 9368, e-mail: Tompkins.jim or
Jamerson,hoyt]@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 16, 1997 (62
FR 27028)(FRL-5717-6) and August 5, 1998(63 FR 41829)(FRL-5799-6), 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) for tolerance by BASF Corporation, P.O. Box
13528, Research Triangle Park, NC 27709, and Interregional Research
Project Number 4 (IR-4), New Jersey Agricultural Experimental Station,
Rutgers University, New Brunswick, New Jersey 08903. These notices
included a summary of the petitions prepared by BASF Corporation, the
registrants, and IR-4. There were no comments received in response to
the notice of filing.
The petition requested that 40 CFR 180.412 be amended by
establishing tolerances for combined residues of the herbicide
sethoxydim (2-[1-ethoxyimino]butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-
2-cyclohexen-1-one and its metabolites containing the 2-cyclohexen
moiety (calculated as the herbicide), in or on 9F3408 (62 FR 27028)
apricots at 0.2 part per million (ppm), cherries (sweet and sour) at
0.2 ppm, nectarine at 0.2 ppm, and peaches at 0.2 ppm; 6F4695 (63 FR
41829) grapes at 1.0 ppm, succulent beans at 15.0 ppm; bean forage at
15.0 ppm, soybeans at 16.0 ppm, and raisins at 2.0 ppm; 6E4953 (63 FR
41829) leafy vegetable (except Brassica) crop group at 4.0 ppm and
cilantro at 4.0 ppm; 6E4725 (63 FR 41829)--tuberous and corm vegetable
subgroup at 4.0 ppm and garden beet at 1.0 ppm; 6E4698 (63 FR 41829)
artichokes at 5.0 ppm; and 6E4697(63 FR 41829) caneberry crop subgroup
at 5.0 ppm.
The notice issued August 5, 1998 (63 FR 41829) for 6F4695 proposed
deleting the established tolerances for raisin waste at 1.0 ppm and
grape pomace at 6.0 ppm since they are considered insignificant animal
feed commodities and are no longer of regulatory concern.
The August 5, 1998 notice also proposed to remove or delete the
established tolerances for celery at 1.0 ppm, head lettuce at 1.0 ppm,
leaf lettuce at 2.0 ppm, spinach at 4.0 ppm, endive(escarole) at 2.0
ppm (6E4753); potato at 4.0 ppm, and sweet potato at
[[Page 54067]]
4.0 ppm (6E4725); and raspberry at 5.0 ppm (6E4797) since these
commodities are members of the crop groups or subgroups for which
tolerances are being established.
The correct terminology for artichoke is globe artichoke. The
Agency is correcting the terminology in this rule.
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).
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
sethoxydim and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a tolerance for combined
residues of 2-[1-ethoxyimino)butyl]-5-[2-(ethiothio)propyl]-3-hydroxy-
2-cyclohexen-1-one and its metabolites containing the 2-cyclohexen-1-
one moiety(calculated as the herbicide) on [apricots at 0.2 ppm,
cherries (sweet and sour) at 0.2 ppm, nectarines at 0.2 ppm, peaches at
0.2 ppm, grapes at 1.0 ppm, succulent beans at 15.0 ppm, bean forage at
15.0 ppm, soybeans at 16.0 ppm, raisins at 2.0 ppm, leafy vegetable
(except Brassica) crop group at 4.0 ppm., cilantro at 4.0 ppm, tuberous
and corm vegetable subgroup at 4.0 ppm, garden beet at 1.0 ppm, globe
artichoke at 5.0 ppm, and caneberry crop subgroup at 5.0 ppm. 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 sethoxydim are
discussed below.
1. Acute toxicity. Based on the available acute toxicity data,
sethoxydim does not pose any acute dietary risks. A summary of the
acute toxicity studies follows.
i. Acute oral toxicity, rat. Toxicity Category III;
LD50=3,125 millgrams/kilogram (mg/kg) (male), 2,676 mg/kg
(female)
ii. Acute dermal toxicity, rat. Toxicity Category III;
LD50 > 5,000 mg/kg (male and female)
iii. Acute inhalation toxicity, rat. Toxicity Category III;
LC50 (4-hour)=6.03 mg/L (male), 6.28 mg/L (female)
iv. Primary eye irritation, rabbit. Toxicity Category IV; no
irritation.
v. Primary dermal irritation, rabbit. Toxicity Category IV; no
irritation.
vi. Dermal sensitization, guinea pig. Waived because no
sensitization was seen in guinea pigs dosed with the end-use product
Poast (18% active ingredient).
2. Genotoxicity. Ames assays were negative for gene mutation in
Salmonella typhimurium strains TA98, TA100, TA1535, and TA 1537, with
and without metabolic activity. A Chinese hamster bone marrow
cytogenetic assay was negative for structural chromosomal aberrations
at doses up to 5,000 mg/kg in Chinese hamster bone marrow cells in
vivo. Recombinant assays and forward mutations tests in Bacillus
subtilis, Escherichia coli, and S. typhimurium were all negative for
genotoxic effects at concentrations of greater than or equal to 100%.
3. Reproductive and developmental toxicity. A 2-generation
reproduction study with rats fed diets containing 0, 150, 600, and
3,000 ppm (approximately 0, 7.5, 30, and 150 mg/kg/day) with no
reproductive effects observed under the conditions of the study.
A developmental toxicity study in rats fed dosages of 0, 50, 180,
650, and 1,000 mg/kg/day with a maternal NOAEL of 180 mg/kg/day and a
maternal LEL of 650 mg/kg/day (irregular gait, decreased activity,
excessive salivation, and anogenital staining); and a developmental
NOAEL of 180 mg/kg/day, and a developmental LEL of 650 mg/kg/day (21 to
22% decrease in fetal weights, filamentous tail, and lack of tail due
to the absence of sacral and/or caudal vertebrae, and delayed
ossification in the hyoids, vertebral centrum and/or transverse
processes, sternebrae and/or metatarsal, and pubes).
A developmental toxicity study in rabbits fed doses of 0, 80, 160,
320, and 400 mg/kg/day with a maternal NOAEL of 320 mg/kg/day and a
maternal LOEL of 400 mg/kg/day (37% reduction in body weight gain
without significant differences in group mean body weights and
decreased food consumption during dosing); and a developmental NOAEL
greater than 400 mg/kg/day (highest dose tested).
4. Subchronic toxicity. A 21-day dermal study in rabbits with a No-
Observed-Adverse-Effect-Level (NOAEL) of > 1,000 mg/kg/day (limit
dose). The only dose-related finding was slight epidermal hyperplasia
at the dosing site in nearly all males and females dosed at 1,000 mg/
kg/day. This was probably an adaptive response.
5. Chronic toxicity. A 1-year feeding study with dogs fed diets
containing 0, 8.86/9.41, 17.5/19.9, and 110/129 mg/kg/day (males/
females) with a No-Observed-Adverse-Effect-Level (NOAEL) of 8.86/9.41
mg/kg/day (males/females) based on equivocal anemia in male dogs at the
17.5-mg/kg/day dose level.
A 2-year chronic feeding/carcinogenicity study with mice fed diets
containing 0, 40, 120, 360, and 1,080 ppm (equivalent to 0, 6, 18, 54,
and 162 mg/kg/day) with a systemic NOAEL of 120 ppm (18 mg/kg/day)
based on non-neoplastic liver lesions in male mice at the 360-ppm (54
mg/kg/day) dose level. There were no carcinogenic effects observed
under the conditions of the study. The maximum tolerated dose (MTD) was
not achieved in female mice. The need for a new study will be based on
the adequacy of the rat study currently under review.
A 2-year chronic feeding/carcinogenic study with rats fed diets
containing 0, 2, 6, and 18 mg/kg/day with a systemic NOAEL greater than
or equal to 18 mg/kg/day (highest dose tested). There were no
carcinogenic
[[Page 54068]]
effects observed under the conditions of the study. This study was
reviewed under current guidelines and was found to be unacceptable
because the doses used were insufficient to induce a toxic response and
an MTD was not achieved.
A second chronic feeding/carcinogenic study with rats fed diets
containing 0, 360, and 1,080 ppm (equivalent to 18.2/23.0, and 55.9/
71.8 mg/kg/day (males/females). The dose levels were too low to elicit
a toxic response in the test animals and failed to achieve an MTD or
define a lowest effect level (LEL). Slight decreases in body weight in
rats at the 1,080-ppm dose level, although not biologically
significant, support a free-standing NOAEL of 1,080 ppm (55.9/71.8 mg/
kg/day (males/females)). There were no carcinogenic effects observed
under the conditions of the study.
A third chronic feeding/carcinogenicity study has been submitted.
Male and female rats were dosed at nominal concentrations of 0, 300,
1,000, and 3,000 ppm. Clinical findings at the high-dose included
changes in food consumption, food efficiency, and body weight; and
liver pathology. Upon initial review, it appears that the dose
selection was adequate, and that there was no evidence of
carcinogenicity.
6. Animal metabolism. In a rat metabolism study, excretion was
extremely rapid and tissue accumulation was negligible.
B. Toxicological Endpoints
1. Acute toxicity. In a rat developmental study rats received doses
of 0, 50, 180, 650, and 1,000 mg/kg/day. The maternal toxicity NOAEL
was 180 mg/kg/day and the LOEL was 650 mg/kg/day based on irregular
gait, decreased activity, excessive salivation, and ano-genital
staining. For developmental toxicity the NOAEL was 180 mg/kg/day and
the LOEL was 650 mg/kg/day based on 21-22% decrease in fetal weights,
filamentous tail and lack of tail due to the absence of accral and/or
caudal vertebrae, and delayed oss ification in the hyoids, vertebral
centrum and/or transverse processes, sternebrae and/or metatarsal, and
pubes. The endpoint for use in the risk assessment is the maternal
NOAEL of 180 mg/kg/day. The endpoint is set on maternal effects because
the NOAEL for developmental effects is also 180 mg/kg/day.
2. Short- and intermediate-term toxicity. No short or intermediate
dermal or inhalation endpoints were identified. In a 21-day dermal
study with rabbits dosed at 0, 40, 200, and 1,000 mg/kg/day, there was
no evidence of compound related toxicity on clinical signs, body
weights, food consumption, food efficiency, eye health, clinical
pathology, organ weights, or gross pathology. The NOAEL was greater
than 1,000 mg/kg/day (limit dose). In the acute inhalation study with
rats the LC50 was 6.03 mg/l (males) and 6.28 mg/l (females
placing sethoxydim in Category IV.
3. Chronic toxicity. EPA has established the Reference dose (RfD)
for sethoxydim at 0.09 mg/kg/day. This RfD is based on a finding of
equivocal anemia in the 1-year dog study. The NOAEL was 8.86 mg/kg in
males and 9.41 mg/kg in females.
4. Carcinogenicity. Sethoxydim is not classified. Avialable studies
show no evidence of carcinogenicity in rats or mice.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.412) for the combined residues of 2-[1-(ethoxyimino]butyl)-5-
[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one and its metabolites
containing the 2-cyclohexen-1-one moiety (calculated as the herbicide),
in or on a variety of raw agricultural commodities. Tolerances are
established on cattle, goats, horses, and sheep meat, fat, and meat by
products at 0.2 ppm, eggs at 2.0 ppm, poultry meat and fat at 0.2 ppm
and poultry meat by products at 2.0 ppm. Risk assessments were
conducted by EPA to assessed dietary exposures from sethoxydim as
follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a 1 day or single exposure. The acute dietary endpoint is 180 mg/kg/
day based on NOAELs of 180 mg/kg/day for maternal and developmental
effects in the rabbit developmental study. The FQPA safety factor of 3x
was applied to females 13+ years old only because the endpoint (based
on decrease in fetal weights, filamentous tail and lack of tail due to
absence of sacral and/or caudal vertebrae, delayed ossification in the
hyoids, vertebral centrum and/or transverse processes, sternebrae and/
or metatarsal) occurs only during in utero exposure and is not a
postnatal effect. Since the effects occur during in utero exposure, it
is not an appropriate endpoint for acute dietary risk assessment of
infants and children.
In conducting this acute dietary risk assessment, the Agency made
very conservative assumptions 100% of all commodities having sethoxydim
tolerances will contain sethoxydim regulable residues and those
residues will be at the level of the tolerance which result in an over
estimation of human dietary exposure.
From the acute dietary (food only) risk assessment, a high-end
exposure estimate of 0.2 mg/kg/day was calculated. This exposure
yielded dietary (food only) MOEs ranging from 420 for childern (1-6
years old) to 622 for female 13+ years old and greater than 500 for all
other subgroups.
ii. Chronic exposure and risk. The FQPA Safety Factor will not be
applied for chronic dietary risk assessment because the endpoint is
based on anemia in male dogs. The endpoint for which the FQPA safety
factor is based is an in utero effect and can not result from postnatal
exposure. There was no indication of increased susceptibility in the
prenatal developmental study in rabbits following in utero exposure. In
the 2-generation reproduction study in rats, effects in offspring were
observed only at above treatment levels which resulted in evidence of
appreciable parental toxicity. No incresed susceptibility was
demonstrated in the developmental toxicity study with rats when the
maternal and developmnetal NOAEL/LOELs were compared.
In conducting this chronic dietary risk assessment, The Agency has
made very conservative assumptions no percent crop-treated data were
used and all commodities having sethoxydim tolerances will contain
sethoxydim residues ans those residues will be at the level of the
tolerance which will result in an overestimate of human dietary
exposure.
The sethoxydim tolerances (published and pending) result in a
Theoretical Maximum Residue Contribution (TMRC) that is equivalent to
the following percentages of the RfD:
------------------------------------------------------------------------
Percent
Subgroup TMRC RFD
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U.S. Population.................................... 0.039187 44
Nursing Infants.................................... 0.018957 21
Non-Nursing Infants (< 1="" year="" old).................="" 0.072949="" 81="" children="" (1-6="" years="" old)...........................="" 0.085308="" 95="" children="" (7-12="" years="" old)..........................="" 0.058101="" 65="" female="" (13+,="" nursing)..............................="" 0.040144="" 45="" males="" (13-19="" years="" old)............................="" 0.040429="" 45="" u.s="" population="" (summer="" season).....................="" 0.039408="" 44="" hispanics..........................................="" 0.039428="" 44="" non-hispanic="" others................................="" 0.040452="" 45="" non-hispanic="" whites................................="" 0.039238="" 44="" ------------------------------------------------------------------------="" the="" subgroups="" listed="" above="" are="" (1)="" the="" u.s.="" population="" (48="" states);="" (2)="" those="" for="" infants,="" children,="" females,="" 13+="" nursing;="" [[page="" 54069]]="" and="" other="" subgroups="" for="" which="" the="" percentage="" of="" rfd="" occupied="" is="" greater="" than="" occupied="" by="" the="" subgroup="" u.s.="" population="" iii.="" chronic,="" carcinogenic="" risk.="" sethoxydim="" has="" not="" been="" classified.="" at="" the="" present="" time,="" studies="" do="" not="" show="" evidence="" of="" carcinogenitcy="" in="" rats="" or="" mice.="" 2.="" from="" drinking="" water.="" limited="" monitoring="" data="" of="" ground="" water="" and="" surface="" water="" are="" available="" for="" sethoxydim.="" the="" modeling="" data="" found="" maximun="" concentrations="" in="" ground="" wate="" of="" 0.84="" micrograms/liter="">g/L) and in surface water 59.4 g/L and 56-day EECs
of 37.3 g/L. The modeling data were compared to the results of
the following equations used to calculate acute and chronic drinking
water level of concern (DWLOC) for sethoxydim in ground and surface
water (SOP for Drinking Water Exposure and Risk Assessments, 11/20/97).
Models used were SCI-GROW and GENEC to provide estimates of ground and
surface water contamination respectively from sethoxydim, but did not
consider the behavior of degradates. Agency default weights and water
consumption used in the calculations were 70kg(2L) for adult males, 60
kg(2L) for adult females, and 10 kg (1L) for child.
i. Acute exposure and risk. Based on acute dietary exposure and
using default body weights and water consumption values stated above,
acute DWLOC were calculated using the following equation.
DWLOC (acute)=(NOAEL divided by uncertainty factor)- (Acute
food + residential exposure(mg/kg/day) x (body weight)divided by
consumption(L) x 10-3 mg/g
Acute dietary water levels of concern were calculated to be 525,000
g/L for the U.S. population, 56,000 g/L for adult
males 13+ years old, 12,000 g/L for adult females 13+ years
old (including 3x safety factor) and 14,000 g/L for child (
infant < 1="" year="" old).="" ii.="" chronic="" exposure="" and="" risk.="" based="" on="" chronic="" dietary="" (food)="" exposure="" and="" using="" default="" body="" weights="" and="" water="" consumption="" values="" above="" the="" chronic="" dwloc="" for="" drinking="" water="" were="" calculated="" using="" the="" following="" equation:="" dwloc="" (chronic)="RfD" -="" (chronic="" food="" +="" residential="" exposure="" (mg/kg/day="" 0="" x="" (body="" weight)="" divided="" by="" consumption="" (l)="" x="" 105-3="" mg/="">g
Chronic DWLOCs were calculated to be 1,760 g/L for the
U.S. population, 1,780 g/L for adult males 13-19 years old,
1,700 for adult female 13+ years old, nursing and 135 for child (1-6
years old).
The above calculations indicate that the exposure to sethoxydim in
drinking water using the modeling data are below the calculated
drinking water level of concern for all populations.
3. From non-dietary exposure. sethoxydim is currently registered
for use on the following residential non-food sites: ornamentals and
flowering plants, recreational areas, and buildings/structures (non-
agricultural-outdoor). These residential uses compromise a short- and
intermediate-term exposure scenario, but does not comprise a chronic
exposure scenario.
i. Acute exposure and risk. There is a potential for exposure to
sethoxydim by homeowner mixers/applicators. However, since endpoints
for dermal or inhalation were selected, therefore the use on
residential non-food sites is not expected to pose an unaccpetable
acute risk.
ii. Chronic exposure and risk. The registered uses for sethoxydim
do not comprise a chronic exposure scenario. A chronic non-dietary
endpoint was not selected, therefore the use on residental non-food
sites is not expected to pose an unacceptable chronic risk.
iii. Short- and intermediate-term exposure and risk. Short term or
intermediate term endpoints were not identified. However, the following
scenarios may result if herbicides containing sethoxydim are applied to
residential turf, and/or ornamental plants: incidental non-dietary
ingestion of residues on lawns from hand-to-mouth transfer, ingestion
of pesticide-treated turfgrass, and incidental ingestion of soil from
treated lawns. A residential exposure estimate and risk assessment was
co#nducted for post application exposure following the application of
sethoxydim on turf and ornamental gardens. The acute dietary endpoint
was used for this risk assessment because the acute dietary endpoint
provides the worst case estimate of risk and exposure for these use
patterns. The assessment was performed using Draft SOPs for Residential
Exposure Assessments (12/18/98). The proposed post-application
aggregate exposure assessment takes into account chronic dietary
exposure plus outdoor residential exposures. These exposure assessments
assume that 20 % of the application rated is available from the turf
grass as dislodgeable residue and 2 hours as the duration of exposure.
These assumptions are considered conservative and protective.
Exposures and margins of exposures ( MOEs) were calculated to be
0.053 mg/kg/day (MOE of 3,400) for hand-to-mouth transfer for treated
lawns (toddlers), 0.0012 mg/kg/day (MOE of 150,000 ) for ingestion of
treated turf grass (toddler), and 0.000025 (MOE of 7 million) for
incidental ingestion of soil (toddlers). MOEs exceeded 100 for all
three scenarios. MOEs greater or equal to 100 do not exceed the Agencys
level of concern.
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 sethoxydim 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,
sethoxydim 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 sethoxydim 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. Using the published and pending tolerances, the
dietary (food only) acute MOEs range from 420 for childern (1-6 years
old) to 622 tor females 13+ years old. The level of concern for females
13 + years old is 300 for acute sethoxydim exposure (3X safety factor)
and 100 for all other population subgroups. This risk estimate should
be viewed as highly conservative; refinement using anticipated residue
values and percent crop treated data in conjunction with Monte Carlo
analysis will result in a lower acute dietary exposure estimate. The
dietary exposure does not exceed the Agency's level of concern.
Sethoxydim is a non persistent, but highly mobile compound in soil
and water environments. The modeling data for sethoxydim in drinking
water indicate levels less than OPP`s DWLOC for acute exposure. Since a
refined acute risk for food only would not exceed EPAs levles of
concern for acute dietary exposures and the monitoring and modeling
levels in water are less than the acute DWLOC, EPA does not expect
[[Page 54070]]
aggregate acute exposure to sethoxydim will pose an unacceptable risk
to human health.
2. Chronic risk. Using the TMRC exposure assumptions described in
this preamble, EPA has concluded that aggregate exposure to sethoxydim
from food will utilize 44% of the RfD for the U.S. population. The
major identifiable subgroup with the highest aggregate exposure is 95%
for childern 1-6 years old; discussed below. EPA generally has no
concern for exposures below 100% of the RfD because the RfD represents
the level at or below which daily aggregate dietary exposure over a
lifetime will not pose appreciable risks to human health. Despite the
potential for exposure to sethoxydim in drinking water and from non-
dietary, non-occupational exposure, EPA does not expect the aggregate
exposure to exceed 100% of the RfD. EPA concludes that there is a
reasonable certainty that no harm will result from aggregate exposure
to sethoxydim residues.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure. Endpoints for short- or intermediate-term were
not selected. An aggregate exposure estimate and risk assessment was
conducted for post-application exposure to sethoxydim on turf and
ornamental plants taking into account chronic exposure form food and
the acute dietary NOAEL. The resulting MOEs (1,390-2,350) are not of
concern to the Agency.
4. Aggregate cancer risk for U.S. population. Sethoxydim has not
been classified. Available studies do not show evidence of
carcinogenicity in rats or mice.
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 sethoxydim residues.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children-- i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of sethoxydim, 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 and 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 data base unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a margin of exposure (MOE) analysis or through using
uncertainty (safety) factors in calculating a dose level that poses no
appreciable risk to humans. EPA believes that reliable data support
using the standard uncertainty factor (usually 100 for combined inter-
and intra-species variability)) and not the additional tenfold MOE/
uncertainty factor when EPA has a complete data base under existing
guidelines and when the severity of the effect in infants or children
or the potency or unusual toxic properties of a compound do not raise
concerns regarding the adequacy of the standard MOE/safety factor.
ii. Pre- and post-natal sensitivity. There was no indication of
increased susceptibility in the prenatal developmental toxicity study
in rabbits following in utero exposure. In the 2-generation
reproduction study in rats, effects in the offspring were observed only
at or above treatment levels which resulted in evidence of appreciable
parental toxicity. No increased susceptibility was demonstrated in the
developmental toxicity study with rats when the maternal and
developmental NOAELs/LOELs were compared; developmental toxic effects,
however, were observed at the highest dose tested (LOEL).
Acceptable developmental toxicity studies have been performed in
rats and rabbits; an acceptable 2-generaton reproduction study has also
been performed in rats. A chronic feeding/carcinogenicity guideline
study in rats has been submitted and is currently undergoing review. An
initial examination of the study supports the current findings of no
evidence of carcinogenicity. There is a complete toxicity data base for
sethoxydim and exposure data is complete or is estimated based on data
that reasonaby accounts for potential exposures.
The FQPA safety factor is to be retianed in case of developmental
toxicity in the absence of maternal toxicity. Since malformations were
seen in the rat study at levels that produced minimal maternal
toxicity, the Agency concluded that an FQPA factor is needed. However,
it was determined that the 10X factor need not be retained, instead
should be reduced to 3X based on the following weight of evidence
considerations:
a. Developmental toxicity was seen in only one species, in the
presence of maternal toxicity, and at a very high dose (650 mg/kg/day)
that approached the Limit-Dose of 1,000 mg/kg/day.
b. No developmental toxicity was observed in the rabbit study at
the highest dose tested (400 mg/kg/day).
c. There was no increased susceptibility seen in the 2-generation
reproduction study in rats at doses up to 150 mg/kg/day(highest dose
tested).
d. Lack of concern for structure activity relationship (i.e. no
significant developmental or reproductive toxicity was seen with the
structural analog, Clethodim.)
Exposure assessments do not indicate a concern for potential risk
to infants and children based on; (1) the dietary exposure assessments
use field study data and assume 100% crop treated which results in an
overestimate of dietary exposure; (2) limited monitoring data is used
for ground and surface source drinking water exposure assessments,
resulting in estimates considered to be reasonable upper-bound
concentrations; (3) there is a potential for post-application hand-to-
mouth exposure to toddlers associated with lawn use, however, the use
of conservative models and/or assumptions in the residential exposure
assessment provide adequate protection of infants and children.
The FQPA safety factor is applicable for acute dietary risk
assessment for females 13+ years old because the endpoint occurs only
during in utero exposure and is not a postnatal effect. Since the
effects occur during in utero exposure, it is not an appropriate
endpoint for acute dietary risk assessment of infants and children. The
FQPA safety factor is not applied for chronic risk assessment because
the endpoint is an in utero effect and can not result from postnatal
exposure. The FQPA safety factor is not applicable to the post-
application hand-to-mouth exposure associated with the lawn use since
this exposure scenario would only be expected for toddlers and not for
females 13+ years old.
iii. Conclusion. Acceptable developmental toxicity studies have
been performed in rats and rabbits; an acceptable 2-generation
reproduction study has also been performed in rats. A chronic feeding/
carcinogenicity guideline study in rats has been submitted and is
currently undergoing review. An initial examination of the
[[Page 54071]]
study supports the current findings of no evidence of carcinogenicity.
There is a complete toxicity data base for sethoxydim and exposure data
is complete or is estimated based on data that reasonably accounts for
potential exposures.
2. Acute risk. Using the conservative exposure assumptions that
100% of the commodities having sethoxydim tolerances will contain
sethoxydim regulable residues and that those residues will be at the
level of the tolerance, EPA calculated from the acute dietary (food
only) MOEs ranging from 420 for childern (1-6 years old) to 622 for
females 13+ years old. The level of concern is 300 (3x safety factor x
100 ) for females 13+ years old and 100 for all other subgroups.
3. Chronic risk. Using the exposure assumptions described above,
EPA has concluded that aggregate exposure to sethoxydim from food will
utilize 21% for nursing infants, 81% for non-nursing infants (< 1="" years="" old),="" 95%="" for="" children="" (1-6="" years="" old),="" and="" 65="" %="" for="" children="" (7-12="" years="" old)="" 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="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" despite="" the="" potential="" for="" exposure="" to="" sethoxydim="" in="" drinking="" water="" and="" from="" non-dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" 4.="" short-="" or="" intermediate-term="" risk.="" an="" aggregate="" exposure="" estimate="" and="" risk="" assessment="" was="" conducted="" for="" post-application="" exposure="" to="" sethoxydim="" on="" turf="" and="" ornamental="" plants="" taking="" into="" account="" chronic="" exposure="" from="" food="" and="" the="" acute="" dietary="" noael.="" the="" resulting="" moes="" (1,390-2,350)="" are="" not="" of="" concern="" to="" epa.="" 5.="" determination="" of="" safety.="" based="" on="" these="" risk="" assessments,="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" sethoxydim="" residues.="" iii.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" in="" the="" rat="" metabolism="" study,="" tissue="" accumulation="" was="" neglible="" and="" excretion="" was="" extremely="" rapid.="" elimination="" was="" 78.5%="" in="" the="" urine="" and="" 20.2%="" in="" the="" feces.="" the="" metabolism="" of="" sethoxydim="" in="" plants="" and="" animals="" is="" understood,="" the="" tolerances="" for="" plant="" and="" animal="" commodities="" are="" expressed="" as="" the="" combined="" residues="" of="" sethoxydim="" and="" its="" metabolites="" containing="" the="" 2-="" cyclohexen-1-one="" moiety="" (calculated="" as="" the="" herbicide).="" b.="" analytical="" enforcement="" methodology="" basf="" method="" 30="" as="" published="" in="" pam,vol="" ii="" is="" adequate="" for="" tolerance="" enforcement="" in="" all="" raw="" agricultural="" commodities.="" quantitation="" is="" accomplished="" by="" gas="" chromatography="" with="" flame="" photometric="" detection="" in="" the="" sulfur="" mode.="" sethoxydim="" and="" its="" metabolites="" are="" not="" recovered="" or="" not="" likely="" to="" be="" recovered="" by="" fda="" multi-residue="" methods.="" c.="" magnitude="" of="" residues="" the="" available="" crop="" field="" trial="" data="" support="" the="" establishment="" of="" tolerances="" in="" globe="" artichoke="" at="" 5.0="" ppm;="" apricots="" at="" 0.2="" ppm;="" beans,="" forage="" at="" 15.0="" ppm;="" beans,="" succulent="" at="" 15.0="" ppm;="" beets,="" garden="" at="" 1.0="" ppm;="" caneberries,="" crop="" subgroup="" at="" 5.0="" ppm;="" cherries="" (sweet="" and="" sour)="" at="" 0.2="" ppm;="" cilantro="" at="" 4.0="" ppm;="" grapes="" at="" 1.0="" ppm;="" leafy="" vegetable="" (except="" brassica)="" at="" 4.0="" ppm;="" nectarines="" at="" 0.2="" ppm;="" peaches="" at="" 0.2="" ppm;="" raisins="" at="" 2.0="" ppm;="" soybeans="" at="" 16.0="" ppm;="" and="" tuberous="" and="" corm="" vegetables="" at="" 4.0="" ppm.="" the="" available="" data="" support="" the="" deletion="" of="" the="" established="" tolerances="" for="" grape="" pomace="" (wet="" and="" dry="" at="" 6.0="" ppm="" and="" raisin="" waste="" at="" 1.0="" ppm="" because="" they="" are="" considered="" insignificant="" animal="" feed="" commodities="" and="" are="" no="" longer="" of="" regulatory="" concern.="" the="" available="" data="" support="" deletion="" of="" the="" existing="" tolerances="" for="" celery="" at="" 1.0="" ppm;="" lettuce,="" leaf="" at="" 1.0="" ppm;="" lettuce,="" leaf="" at="" 2.0="" ppm;="" spinach="" at="" 4.0="" ppm;="" endive="" at="" 2.0="" ppm;="" potato="" at="" 4.0="" ppm;="" sweet="" potato="" at="" 4.0="" ppm;="" and="" raspberry="" at="" 5.0="" ppm;="" since="" these="" commodities="" are="" members="" of="" crop="" groups="" or="" subgroups="" for="" which="" tolerances="" are="" being="" established.="" d.="" international="" residue="" limits="" there="" are="" no="" codex="" maximum="" residue="" levels="" (mrls)="" in="" effect="" for="" sethoxydim.="" however,="" there="" are="" canadian="" mrls="" based="" on="" the="" cyclohex-1-="" one="" moiety="" calculated="" as="" sethoxydim:="" beans,="" peas,="" soybeans,="" and="" lentils="" at="" 0.5.="" 0.5,="" 5.0="" and="" 4.0="" ppm,="" respectively.="" there="" are="" also="" mexican="" mrls="" based="" on="" sethoxydim:="" grapes,="" soybeans,="" lettuce,="" potatoes,="" celery,="" lentils,="" spinach,="" beans,="" and="" peas(green)="" at="" 1.0,="" 10.0,="" 1.0,="" 4.0,="" 1.0,="" 30.0,="" 4.0,="" 20.0,="" and="" 10.0="" ppm,="" respectively.="" the="" canadian="" tolerances="" on="" various="" legume="" vegetables="" are="" significantly="" less="" than="" needed="" to="" cover="" residues="" in="" the="" united="" states.="" many="" of="" the="" mexican="" mrls="" are="" the="" same="" as="" the="" united="" states.="" epa="" is="" increasing="" the="" grape="" tolerance="" to="" 1.0="" ppm="" to="" match="" mexico`s="" mrl.="" e.="" rotational="" crop="" restrictions="" tolerances="" on="" rotational="" crops="" are="" not="" necessary="" for="" crops="" planted="" greater="" than="" 30="" days="" after="" the="" primary="" crop="" is="" treated="" with="" sethoxydim.="" iv.="" conclusion="" therefore,="" tolerances="" are="" established="" for="" combined="" residues="" of="" 2-="" [1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-="" 1-one="" and="" its="" metabolites="" containing="" the="" 2-cyclohexen-1-one="" moiety="" (calculated="" as="" the="" herbicide)="" in="" apricot="" at="" 0.2="" ppm;="" globe="" artichoke="" at="" 5.0="" ppm;="" beans,="" forage="" at="" 15.0="" ppm;="" bean,="" succulent="" at="" 15.0="" ppm;="" beet,="" garden="" at="" 1.0="" ppm;="" caneberries="" crop="" subgroup="" at="" 5.0="" ppm;="" cherries="" (sweet="" and="" sour)="" at="" 0.2="" ppm;="" cilantro="" at="" 4.0="" ppm;="" grapes="" at="" 1.0="" ppm;="" leafy="" vegetable="" (except="" brassica)="" at="" 4.0="" ppm;="" nectarines="" at="" 0.2="" ppm;="" peaches="" at="" 0.2="" ppm;="" raisin="" at="" 2.0="" ppm;="" soybean="" at="" 16.0="" ppm;="" and="" tuberous="" and="" corm="" vegetable="" crop="" subgroup="" at="" 4.0="" ppm.="" the="" current="" listing="" for="" artichoke="" is="" being="" corrected="" to="" read="" as="" globe="" artichoke="" to="" reflect="" current="" terminology.="" established="" tolerances="" for="" celery="" at="" 1.0="" ppm;="" endive="" at="" 2.0="" ppm;="" grape="" pomace="" (wet="" and="" dry)="" at="" 6.0="" ppm;="" lettuce,="" head="" at="" 1.0="" ppm;="" lettuce,="" leaf="" at="" 2.0="" ppm;="" potato="" at="" 4.0;="" raisin="" waste="" at="" 1.0="" ppm;="" raspberry="" at="" 6.0="" ppm;="" spinach="" at="" 4.0="" ppm;="" and="" sweet="" potato="" at="" 4.0="" ppm="" are="" being="" revoked.="" 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="" december="" 7,="" 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="" [[page="" 54072]]="" of="" the="" regulation="" deemed="" objectionable="" and="" the="" grounds="" for="" the="" objections="" (40="" cfr="" 178.25).="" each="" objection="" must="" be="" accompanied="" by="" the="" fee="" or="" a="" request="" for="" a="" fee="" wavier="" as="" prescribed="" by="" 40="" cfr="" 180.33.="" 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="" confidential="" business="" information="" (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-300739]="" (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 tolerances 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).
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(d), such as the
tolerances 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.
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 to 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
[[Page 54073]]
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 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
recordkeeping requirements.
Dated: September 29, 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. Section 180.412 is amended as follows:
a. In the table to paragraph (a):
i. By removing the entries for celery; grape pomace (wet and dry);
lettuce, head; lettuce, leaf; potatoes; raisin waste; raspberries;
spinach; and sweet potato.
ii. By revising the entries for beans, forage; beans, succulent;
grapes; raisins; and soybeans.
iii. By adding entries for apricots; beet, garden; caneberries crop
subgroup; cherries (sweet and sour); cilantro; leafy vegetable (except
Brassica) crop group; nectarines; peaches; and tuberous and corm
vegetables crop subgroup.
b. In the table to paragraph (c) by removing the entry for endive,
and by revising the entry for artichokes.
The added and revised portions read as follows:
Sec. 180.412 Sethoxydim; tolerances for residues.
(a) General. ***
------------------------------------------------------------------------
Parts Expiration/
Commodity Per Revocation
Million date
------------------------------------------------------------------------
* * * * *
Apricots.......................................... 0.2 None
* * * * *
Beans, forage.................................... 15.0 None
Beans, succulent.................................. 15.0 None
Beet, garden...................................... 1.0 None
* * * * *
Caneberries crop subgroup......................... 5.0 None
* * * * *
Cherries (sweet and sour)......................... 0.2 None
Cilantro.......................................... 4.0 None
* * * * *
Grapes............................................ 1.0 None
* * * * *
Leafy vegetable (except Brassica) crop group...... 4.0 None
* * * * *
Nectarines........................................ 0.2 None
Peaches........................................... 0.2 None
* * * * *
Raisins........................................... 2.0 None
* * * * *
Soybeans.......................................... 16.0 None
* * * * *
Tuberous and corm vegetable crop subgroup......... 4.0 None
------------------------------------------------------------------------
* * * * *
(c) Tolerances with regional registrations. ***
------------------------------------------------------------------------
Parts Expiration/
Commodity Per Revocation
Million date
------------------------------------------------------------------------
Globe artichoke................................... 5.0 None
* * * * *
------------------------------------------------------------------------
* * * * *
FR Doc. 98-26905 Filed 10-7-98; 8:45 am]
BILLING CODE 6560-50-F
