[Federal Register Volume 64, Number 115 (Wednesday, June 16, 1999)]
[Rules and Regulations]
[Pages 32189-32196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14865]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300859; FRL-6080-9]
RIN 2070-AB78
Sethoxydim; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for combined residues
of sethoxydim and its metabolites containing the 2-cyclohexen-1-one
moiety (calculated as the herbicide) in or on asparagus, carrot,
cranberry, horseradish, peppermint tops and spearmint tops. The
Interregional
[[Page 32190]]
Research Project Number 4 (IR-4) requested these tolerances under the
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality
Protection Act of 1996.
DATES: This regulation is effective June 16, 1999. Objections and
requests for hearings must be received by EPA on or before August 16,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300859], 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-300859], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 119, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: opp-docket@epa.gov. Copies of objections and hearing requests
must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Copies of objections and hearing
requests will also be accepted on disks in WordPerfect 5.1/6.1 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-300859]. 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: 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: Rm. 272, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-9368,
jamerson.hoyt@epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of December 30, 1998
(63 FR 71920) (FRL-6050-1), EPA issued a notice pursuant to section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as
amended by the Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-
170) announcing the filing of pesticide petitions (PP 3E4162, 2E4092,
0E3909, and 2E4052) for tolerances by Interregional Research Project
Number 4 (IR-4), New Jersey Agricultural Experiment Station, Rutgers
University, New Brunswick, New Jersey 08903. The notice included a
summary of the petitions prepared by BASF Corporation, the registrant.
There were no comments received in response to the notice of filing.
The petitions requested that 40 CFR 180.412 be amended by removing
the time limitations (expiration dates) on established 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-1-one moiety
(calculated as the herbicide), in or on asparagus (PP 3E4162) at 4.0
parts per million (ppm), carrot (PP 2E4092) at 1.0 ppm, cranberry (PP
0E3909) at 2.0 ppm, and peppermint and spearmint tops (PP 2E4052) at 30
ppm. Since the tolerances for asparagus, carrot, cranberry, peppermint
and spearmint tops expired December 31, 1998, after the notice of
filing was published in the Federal Register, this rule establishes the
tolerances without time limitations. In addition, in the Federal
Register of January 29, 1999 (64 FR 4650) (FRL-6055-8), PP 9E5049
proposed to amend 40 CFR 180.412 by establishing a tolerance for
residues of sethoxydim and its metabolites in or on horseradish at 4
ppm.
I. Background and Statutory Findings
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
II. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
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-(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
asparagus, carrot, cranberry, horseradish, and peppermint and spearmint
tops. EPA's assessments of the dietary exposures and risks associated
with establishing the tolerances are as 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 in this unit.
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 milligrams/kilograms (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/liter (L) (male), 6.28 mg/L (female).
[[Page 32191]]
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, or 3,000
ppm (approximately 0, 7.5, 30, or 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, or 1,000 mg/kg/day with a maternal no-observed-adverse-effect
level (NOAEL) of 180 mg/kg/day and a maternal lowest-adverse-effect
level (LAEL) 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 LAEL of 650 mg/kg/day,
based on a 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, or 400 mg/kg/
day with a maternal NOAEL of 320 mg/kg/day and a maternal lowest-
observed-adverse-effect level (LOAEL) 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
(HDT).
4. Subchronic toxicity. A 21-day dermal study in rabbits with a
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 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 HDT. There were no carcinogenic 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 the MTD was
not achieved.
A second chronic feeding/carcinogenic study with rats fed diets
containing 0, 360, or 1,080 ppm (equivalent to 18.2/23.0, or 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 the MTD or to
define a LAEL. 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 in rats has been
submitted. Male and female rats were dosed at nominal concentrations of
0, 300, 1,000, or 3,000 ppm. Clinical findings at the high-dose
included changes in food consumption, food efficiency, 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 LOAEL 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 LOAEL 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 ossification in the hyoids, vertebral
centrum and/or transverse processes, sternebrae and/or metatarsal, and
pubes. The end point for use in the risk assessment is the maternal
NOAEL of 180 mg/kg/day. The end point 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, or 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 0.9 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. Available 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. Risk assessments
conducted by EPA to assess dietary exposures from sethoxydim are as
follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed
[[Page 32192]]
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
NOAEL's 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+ 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 urtero exposure and is not a postnatal effect.
Since the effects occur during in urtero 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) margins of exposure (MOEs) ranging from 420
for children (1-6 years old) to 622 for female 13+ 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 cannot 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 increased susceptibility was
demonstrated in the developmental toxicity study with rats when the
maternal and developmental NOAELs/LOAELs 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 and 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:
------------------------------------------------------------------------
Subgroup TMRC %RFD
------------------------------------------------------------------------
U.S. Population......................... 0.039187 44
Nursing Infants......................... 00.018957 21
Non-Nursing Infants (<1 year="" old).......="" 00.072949="" 81="" children="" (1-6="" years="" old)................="" 00.085308="" 95="" children="" (7-12="" years="" old)...............="" 00.058101="" 65="" female="" (13+,="" nursing)...................="" 00.040144="" 45="" males="" (13-19="" years="" old).................="" 00.040429="" 45="" u.s="" population="" (summer="" season)..........="" 00.039408="" 44="" hispanics...............................="" 00.039428="" 44="" non-hispanic="" others.....................="" 00.040452="" 45="" non-hispanic="" whites.....................="" 00.039238="" 44="" ------------------------------------------------------------------------="" the="" subgroups="" listed="" above="" are:="" (1)="" the="" u.s.="" population="" (48="" states);="" and="" (2)="" those="" for="" infants,="" children,="" females,="" 13+="" nursing;="" and="" other="" subgroups="" for="" which="" the="" percentage="" of="" rfd="" occupied="" is="" greater="" than="" occupied="" by="" the="" subgroup="" u.s.="" population.="" 2.="" carcinogenic="" risk.="" sethoxydim="" has="" not="" been="" classified.="" at="" the="" present="" time,="" studies="" do="" not="" show="" evidence="" of="" carcinogenicity="" in="" rats="" or="" mice.="" 3.="" from="" drinking="" water.="" limited="" monitoring="" data="" of="" ground="" water="" and="" surface="" water="" are="" available="" for="" sethoxydim.="" the="" modeling="" data="" estimates="" maximum="" concentrations="" in="" ground="" water="" of="" 0.84="" microgram="">g)/
liter (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 (Standard Operating Procedures for Drinking Water Exposure and
Risk Assessments, November 20, 1997). 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 70 kg(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+, 12,000 g/L for adult females 13+ (including 3x
safety factor) and 14,000 g/L for child (infant < 1="" year="" old).="" ii.="" chronic="" 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="" (chronic)="(NOEL" divided="" by="" uncertainty="" factor)="" -="" (chronic="" food="" +="" residential="" exposure="" (mg/kg/day)="" x="" (body="" weight)="" divided="" by="" consumption(l)="" x="">-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+, 1,700
g/L for adult females 13+ (including 3x safety factor) and
14,000 g/L for child (infant < 1="" year="" old).="" 4.="" 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="" (outdoor="" non-agricultural).="" these="" residential="" uses="" comprise="" a="" short-="" and="" intermediate-term="" exposure="" scenario,="" but="" do="" 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="" no="" endpoints="" for="" dermal="" or="" inhalation="" were="" selected,="" the="" use="" on="" residential="" non-food="" sites="" is="" not="" [[page="" 32193]]="" expected="" to="" pose="" an="" unacceptable="" 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="" residential="" 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="" conducted="" for="" postapplication="" 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="" (december="" 18,="" 1998).="" the="" proposed="" postapplication="" aggregate="" exposure="" assessment="" takes="" into="" account="" chronic="" dietary="" exposure="" plus="" outdoor="" residential="" exposures.="" these="" exposure="" assessments="" assume="" that="" 20%="" of="" the="" application="" rate="" 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="" 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="" 15,000)="" for="" ingestion="" of="" treated="" turf="" grass="" (toddler),="" and="" 0.000025="" (moe="" of="" 7,000,000)="" for="" incidental="" ingestion="" of="" soil="" (toddlers).="" moes="" exceeded="" 100="" for="" all="" three="" scenarios.="" moes="" greater="" or="" equal="" to="" 100="" do="" not="" exceed="" the="" agency's="" level="" of="" concern.="" 5.="" 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="" children="" (1-6="" year)="" to="" 622="" for="" females="" 13+="" years.="" the="" level="" of="" concern="" for="" females="" 13+="" years="" is="" 300="" (includes="" 3x="" safety="" factor)="" for="" acute="" sethoxydim="" exposure="" 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="" nonpersistent,="" 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="" epa's="" levels="" of="" concern="" for="" acute="" dietary="" exposures="" and="" the="" monitoring="" and="" modeling="" levels="" in="" water="" are="" less="" than="" the="" acute="" dwloc,="" epa="" does="" not="" expect="" aggregate="" acute="" exposure="" to="" sethoxydim="" will="" pose="" an="" unacceptable="" risk="" to="" human="" health.="" 2.="" chronic="" risk.="" using="" the="" tmrc="" exposure="" assumptions="" described="" in="" this="" unit,="" 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="" children="" 1="" to="" 6="" years;="" 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="" postapplication="" 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="" 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="" 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="" postnatal="" toxicity="" and="" the="" completeness="" of="" the="" data="" base="" unless="" epa="" determines="" that="" a="" different="" margin="" of="" safety="" will="" be="" safe="" for="" infants="" and="" children.="" margins="" of="" safety="" are="" incorporated="" into="" epa="" risk="" assessments="" either="" directly="" through="" use="" of="" a="" margin="" of="" exposure="" (moe)="" analysis="" or="" through="" using="" uncertainty="" (safety)="" factors="" in="" calculating="" a="" dose="" level="" that="" poses="" no="" [[page="" 32194]]="" 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="" postnatal="" 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="" studies;="" however="" developmental="" toxic="" effects,="" were="" observed="" at="" the="" hdt.="" 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="" study="" supports="" the="" current="" findings="" of="" no="" evidence="" of="" carcinogenicity.="" there="" is="" a="" complete="" toxicity="" data="" base="" for="" sethoxydim="" and="" exposure="" data="" are="" complete="" or="" are="" estimated="" based="" on="" data="" that="" reasonably="" accounts="" for="" potential="" exposures.="" the="" fqpa="" safety="" factor="" is="" to="" be="" retained="" 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:="" (1)="" 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;="" (2)="" no="" developmental="" toxicity="" was="" observed="" in="" the="" rabbit="" study="" at="" the="" hdt="" (400="" mg/kg/day);="" (3)="" there="" was="" no="" increased="" susceptibility="" seen="" in="" the="" 2-generation="" reproduction="" study="" in="" rats="" at="" doses="" up="" to="" 150="" mg/kg/day="" hdt;="" and="" (4)="" 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="" are="" 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="" postapplication="" 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+="" because="" the="" endpoint="" occurs="" only="" during="" in="" urtero="" exposure="" and="" is="" not="" a="" postnatal="" effect.="" since="" the="" effects="" occur="" during="" in="" urtero="" 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="" urtero="" effect="" and="" cannot="" result="" from="" postnatal="" exposure.="" the="" fqpa="" safety="" factor="" is="" not="" applicable="" to="" the="" postapplication="" hand-to-mouth="" exposure="" associated="" with="" the="" lawn="" use="" since="" this="" exposure="" scenario="" would="" only="" be="" expected="" for="" toddlers="" and="" not="" for="" females="" 13+.="" 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="" study="" supports="" the="" current="" findings="" of="" no="" evidence="" of="" carcinogenicity.="" there="" is="" a="" complete="" toxicity="" data="" base="" for="" sethoxydim="" and="" exposure="" data="" are="" complete="" or="" are="" 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="" acute="" dietary="" (food="" only)="" moes="" ranging="" from="" 420="" for="" children="" (1-6="" years="" old)="" to="" 622="" for="" females="" 13+="" years.="" the="" level="" of="" concern="" is="" 300="" (3x="" safety="" factor="" x="" 100)="" for="" females="" 13+="" years="" and="" 100="" for="" all="" other="" subgroups.="" 3.="" chronic="" risk.="" using="" the="" exposure="" assumptions="" described="" in="" this="" unit,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" sethoxydim="" from="" food="" will="" utilize="" less="" than="" 100%="" of="" the="" rfd="" for="" nursing="" infants,="" non-nursing="" infants=""><1 years="" old),="" children="" (1-6="" years="" old),="" and="" children="" (7-12="" years="" old).="" 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="" postapplication="" 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="" 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="" multiresidue="" methods.="" c.="" magnitude="" of="" residues="" the="" available="" crop="" field="" data="" support="" the="" established="" tolerances="" for="" asparagus="" at="" 4.0="" ppm,="" carrot="" at="" 1.0="" ppm,="" cranberry="" at="" 2.0="" ppm,="" and="" peppermint="" and="" spearmint="" tops="" at="" 30="" ppm.="" residue="" data="" submitted="" in="" support="" of="" existing="" tolerances="" for="" carrot="" at="" 1.0="" ppm,="" potato="" at="" 4.0="" ppm,="" sugar="" beet="" at="" 1.0="" ppm,="" and="" sweet="" potato="" at="" 4.0="" ppm="" support="" the="" establishment="" of="" a="" tolerance="" for="" horseradish="" at="" 4.0="" ppm.="" [[page="" 32195]]="" d.="" international="" residue="" limits="" maximum="" residue="" levels="" (mrls)="" have="" not="" been="" established="" for="" residues="" of="" sethoxydim="" on="" asparagus,="" carrot,="" cranberry,="" horseradish,="" peppermint,="" or="" spearmint="" tops.="" iv.="" conclusion="" therefore,="" the="" 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="" or="" on="" asparagus="" at="" 4.0="" ppm,="" carrot="" at="" 1.0="" ppm,="" cranberry="" at="" 2.0="" ppm,="" horseradish="" at="" 4.0="" ppm,="" and="" peppermint="" and="" spearmint="" tops="" at="" 30="" ppm.="" at="" ppm.="" v.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" as="" was="" provided="" in="" the="" old="" section="" 408="" and="" in="" section="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" 60="" days,="" rather="" than="" 30="" days.="" epa="" currently="" has="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" hearing="" requests.="" these="" regulations="" will="" require="" some="" modification="" to="" reflect="" the="" new="" law.="" however,="" until="" those="" modifications="" can="" be="" made,="" epa="" will="" continue="" to="" use="" those="" procedural="" regulations="" with="" appropriate="" adjustments="" to="" reflect="" the="" new="" law.="" any="" person="" may,="" by="" august="" 16,="" 1999,="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" and="" may="" also="" request="" a="" hearing="" on="" those="" objections.="" objections="" and="" hearing="" requests="" must="" be="" filed="" with="" the="" hearing="" clerk,="" at="" the="" address="" given="" under="" the="" ``addresses''="" section="" (40="" cfr="" 178.20).="" a="" copy="" of="" the="" objections="" and/or="" hearing="" requests="" filed="" with="" the="" hearing="" clerk="" should="" be="" submitted="" to="" the="" opp="" docket="" for="" this="" regulation.="" the="" objections="" submitted="" must="" specify="" the="" provisions="" of="" the="" regulation="" deemed="" objectionable="" and="" the="" grounds="" for="" the="" objections="" (40="" cfr="" 178.25).="" each="" objection="" must="" be="" accompanied="" by="" the="" fee="" prescribed="" by="" 40="" cfr="" 180.33(i).="" epa="" is="" authorized="" to="" waive="" any="" fee="" requirement="" ``when="" in="" the="" judgement="" of="" the="" administrator="" such="" a="" waiver="" or="" refund="" is="" equitable="" and="" not="" contrary="" to="" the="" purpose="" of="" this="" subsection.''="" for="" additional="" information="" regarding="" tolerance="" objection="" fee="" waivers,="" contact="" james="" tompkins,="" registration="" division="" (7505c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" office="" location,="" telephone="" number,="" and="" e-mail="" address:="" rm.="" 239,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va,="" (703)="" 305-5697,="">tompkins.jim@epa.gov. Requests for
waiver of tolerance objection fees should be sent to James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
If a hearing is requested, the objections must include a statement
of the factual issues on which a hearing is requested, the requestor's
contentions on such issues, and a summary of any evidence relied upon
by the requestor (40 CFR 178.27). A request for a hearing will be
granted if the Administrator determines that the material submitted
shows the following: There is genuine and substantial issue of fact;
there is a reasonable possibility that available evidence identified by
the requestor would, if established, resolve one or more of such issues
in favor of the requestor, taking into account uncontested claims or
facts to the contrary; and resolution of the factual issues in the
manner sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). Information submitted in connection with an
objection or hearing request may be claimed confidential by marking any
part or all of that information as CBI. Information so marked will not
be disclosed except in accordance with procedures set forth in 40 CFR
part 2. A copy of the information that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice.
VI. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300859] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
opp-docket@epa.gov
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit will be kept in paper form.
Accordingly, EPA will transfer any copies of objections and hearing
requests received electronically into printed, paper form as they are
received and will place the paper copies in the official record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does
it require any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(d), such as the
tolerance in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency previously
assessed whether establishing tolerances, exemptions from tolerances,
raising tolerance levels or expanding exemptions might adversely impact
small entities and concluded, as a
[[Page 32196]]
generic matter, that there is no adverse economic impact. The factual
basis for the Agency's generic certification for tolerance actions
published on May 4, 1981 (46 FR 24950), and was provided to the Chief
Counsel for Advocacy of the Small Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and the Comptroller General of the United
States. EPA will submit a report containing this rule and other
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: May 20, 1999.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180-[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), (346a), and 371.
2. In Sec. 180.412(a), by removing the expiration date for the
entries asparagus, carrot, cranberry, peppermint, tops and spearmint
tops and inserting None in each place and adding
a new entry for horseradish at 4.0 ppm to read as follows:
Sec. 180.412 Sethoxydim; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts Expiration/
Commodity per Revocation
million Date
------------------------------------------------------------------------
* * * * *
Horseradish....................................... 4.0 None
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-14865 Filed 6-15-99; 8:45 am]
BILLING CODE 6560-50-F
