[Federal Register Volume 64, Number 203 (Thursday, October 21, 1999)]
[Rules and Regulations]
[Pages 56697-56703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27391]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300932; FRL-6385-9]
RIN 2070-AB78
Sethoxydim; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of sethoxydim and its metabolites containing the 2-
cyclohexen-1-one moiety (calculated as the herbicide) in or on
buckwheat. This action is in connection with a crisis exemption
declared under section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act authorizing use of the pesticide on buckwheat. This
regulation establishes a maximum permissible level for residues of
sethoxydim in this food commodity. The tolerance will expire and is
revoked on December 31, 2001.
DATES: This regulation is effective October 21, 1999. Objections and
requests for hearings, identified by docket control number OPP-300932,
must be received by EPA on or before December 20, 1999.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VII. of the ``SUPPLEMENTARY
INFORMATION.'' To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-300932 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone
number: (703) 308-9364; and e-mail address: pemberton.libby@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially
[[Page 56698]]
affected categories and entities may include, but are not limited to:
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Categories NAICS Examples of Potentially Affected Entities
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Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide manufacturing
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This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under ``FOR FURTHER INFORMATION
CONTACT.''
B. How Can I Get Additional Information, Including Copies of This
Document and Other Related Documents?
1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-300932. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408 (l)(6)
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is
establishing a tolerance 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 buckwheat at 10 part
per million (ppm). This tolerance will expire and is revoked on
December 31, 2001. EPA will publish a document in the Federal Register
to remove the revoked tolerance from the Code of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
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....''
Section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from
any provision of FIFRA, if EPA determines that ``emergency conditions
exist which require such exemption.'' This provision was not amended by
the Food Quality Protection Act (FQPA). EPA has established regulations
governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Sethoxydim on Buckwheat and FFDCA
Tolerances
On June 18, 1999, the North Dakota Department of Agriculture
availed itself of the authority to declare the existence of a crisis
situation within the state, thereby authorizing use under FIFRA section
18 of sethoxydim on buckwheat for control of volunteer grains, foxtail,
and quackgrass. Abnormal weather consisting of above average rainfall
and cooler temperatures combined with a lack of labeled products
available for grass control in buckwheat has resulted in increased
germination of volunteer cereal grains, foxtail and quackgrass. The
densities of these pests would cause economic loss if not controlled.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of sethoxydim in or on
buckwheat. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the safety standard
and with FIFRA section 18. Consistent with the need to move quickly on
the emergency exemption in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
comment as provided in section 408(l)(6). Although this tolerance will
expire and is revoked on December 31, 2001, under FFDCA section
408(l)(5), residues of the pesticide not in excess of the amounts
specified in the tolerance remaining in or on buckwheat after that date
will not be unlawful, provided the pesticide is applied in a manner
that was lawful under FIFRA, and the residues do not exceed a level
that was authorized by this tolerance at the time of that application.
EPA will take action to revoke this tolerance earlier if any experience
with, scientific data on, or other relevant information on this
pesticide indicate that the residues are not safe.
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether sethoxydim
meets EPA's registration requirements for use on buckwheat or whether a
permanent
[[Page 56699]]
tolerance for this use would be appropriate. Under these circumstances,
EPA does not believe that this tolerance serves as a basis for
registration of sethoxydim by a State for special local needs under
FIFRA section 24(c). Nor does this tolerance serve as the basis for any
State other than North Dakota to use this pesticide on this crop under
section 18 of FIFRA without following all provisions of EPA's
regulations implementing section 18 as identified in 40 CFR part 166.
For additional information regarding the emergency exemption for
sethoxydim, contact the Agency's Registration Division at the address
provided under ``FOR FURTHER INFORMATION CONTACT.''
IV. Aggregate Risk Assessment and Determination of Safety
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).
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 time-limited 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)
on buckwheat at 10 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 in this unit.
B. Toxicological Endpoint
1. Acute toxicity. In a rat developmental study rats received doses
of 0, 50, 180, 650, and 1,000 milligrams/kilogram/day (mg/kg/day). The
maternal toxicity no-observed-adverse-effect level (NOAEL) was 180 mg/
kg/day and the lowest-observed-adverse-effect level (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 were conducted by EPA to assess dietary exposures and risks
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 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 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) 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 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 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
[[Page 56700]]
(TMRC) that is equivalent to the following percentages of the RfD:
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Subgroup TMRC %RFD
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U.S. Population........................................ 0.03966 44
All Infants............................................ 0.06666 74
Nursing Infants........................................ 0.02027 22
Non-Nursing Infants (< 1="" year="" old).....................="" 0.08619="" 96="" children="" (1-6="" years="" old)...............................="" 0.08635="" 95="" children="" (7-12="" years="" old)..............................="" 0.05859="" 65="" female="" (13+,="" nursing)..................................="" 0.04115="" 46="" males="" (13-19="" years="" old)................................="" 0.04074="" 45="" u.s="" population="" (autumn="" season).........................="" 0.04115="" 46="" northeast="" region.......................................="" 0.04121="" 46="" hispanics..............................................="" 0.04016="" 45="" non-hispanic="" others....................................="" 0.04119="" 46="" ------------------------------------------------------------------------="" the="" subgroups="" listed="" above="" are="" (1)="" the="" u.s.="" population="" (48="" states);="" (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.="" from="" drinking="" water.="" based="" on="" information="" available,="" sethoxydim="" is="" a="" non-persistent,="" but="" highly="" mobile="" compound="" in="" soil="" and="" water="" environments.="" there="" are="" no="" maximum="" contaminant="" levels="" or="" health="" advisories="" established="" for="" sethoxydim="" residues="" in="" drinking="" water.="" for="" this="" proposed="" section="" 18="" use,="" epa="" used="" the="" screening="" concentration="" in="" ground="" water="" (sci-grow)="" model="" to="" estimate="" the="" concentration="" of="" sethoxydim="" residues="" in="" ground="" water.="" the="" maximum="" long-="" term="" estimated="" concentration="" is="" not="" expected="" to="" exceed="" 3="" parts="" per="" billion="" (ppb)="" (chronic),="" and="" the="" maximum="" residue="" concentration="" using="" an="" average="" anaerobic="" half-life="" of="" 85="" days,="" is="" predicted="" to="" be="" 33="" ppb="" (acute);="" epa="" used="" the="" generic="" expected="" environmental="" concentration="" (geneec)="" model="" to="" estimate="" the="" concentration="" of="" sethoxydim="" residues="" in="" surface="" water.="" the="" peak="" expected="" environmental="" concentration="" (eec)="" was="" 42="" ppb="" (acute),="" while="" the="" 56-day="" average="" eec="" was="" 27="" ppb="" (chronic).="" 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="" (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="" 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="" (12/18/98).="" the="" proposed="" postapplication="" aggregate="" exposure="" assessment="" takes="" into="" account="" chronic="" dietary="" exposure="" plus="" outdoor="" residential="" exposures.="" these="" exposure="" assessments="" assume="" that="" 20="" percent="" 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="" 3400)="" 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="" 7,000,000)="" for="" incidental="" ingestion="" of="" soil="" (toddlers).="" moes="" exceeded="" 100="" for="" all="" three="" scenarios.="" moes="" greater="" than="" or="" equal="" to="" 100="" do="" not="" exceed="" the="" agency's="" level="" of="" concern.="" 4.="" cumulative="" exposure="" to="" substances="" with="" a="" 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="" more="" 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="" 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="" 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="" percent="" 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="" [[page="" 56701]]="" 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.="" 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="" from="" food="" and="" the="" acute="" dietary="" noael.="" the="" resulting="" moes="" (1390-2350)="" are="" not="" of="" concern="" to="" the="" agency.="" 4.="" aggregate="" cancer="" risk="" for="" u.s.="" population.="" sethoxydim="" has="" not="" ben="" 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="" during="" 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="" prenatal="" 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="" appreciable="" risk="" to="" humans.="" epa="" believes="" that="" reliable="" data="" support="" using="" the="" standard="" moe="" and="" uncertainty="" factor="" (usually="" 100="" for="" combined="" interspecies="" and="" intraspecies="" 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.="" prenatal="" 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="" highest="" dose="" tested="" (loael).="" 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="" database="" for="" sethoxydim="" and="" exposure="" data="" is="" complete="" or="" is="" 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="" safety="" factor="" is="" needed.="" however,="" it="" was="" determined="" that="" the="" 10x="" safety="" factor="" need="" not="" be="" retained,="" instead,="" the="" safety="" factor="" 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="" highest="" dose="" tested="" (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="" (highest="" dose="" tested);="" 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="" 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="" +="" 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+.="" iii.="" conclusion.="" 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="" [[page="" 56702]]="" 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="" 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.="" v.="" 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="" adequate="" enforcement="" methodology="" (gas-liquid="" chromatography="" glc="" with="" flame="" photometric="" detection)="" is="" available="" (method="" i,="" pam="" ii)="" to="" enforce="" the="" tolerance="" expression.="" c.="" magnitude="" of="" residues="" residues="" of="" sethoxydim="" and="" its="" metabolites="" containing="" the="" 2-="" cyclohexen-1-one="" moiety="" are="" not="" expected="" to="" exceed="" 10.0="" ppm="" in/on="" buckwheat="" or="" its="" processed="" commodity="" flour="" as="" a="" result="" of="" this="" section="" 18="" use.="" secondary="" residues="" are="" not="" expected="" in="" animal="" commodities="" as="" no="" feed="" items="" are="" associated="" with="" this="" section="" 18="" use.="" d.="" international="" residue="" limits="" there="" are="" no="" codex,="" canadian,="" or="" mexican="" residue="" limits="" for="" sethoxydim="" on="" buckwheat.="" therefore,="" harmonization="" is="" not="" an="" issue="" for="" this="" section="" 18="" use.="" e.="" rotational="" crop="" restrictions="" no="" rotational="" crop="" restrictions="" are="" specified="" in="" the="" section="" 18="" or="" federal="" label.="" vi.="" conclusion="" therefore,="" the="" tolerance="" is="" 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="" buckwheat="" at="" 10="" ppm.="" vii.="" objections="" and="" hearing="" requests="" under="" section="" 408(g)="" of="" the="" ffdca,="" as="" amended="" by="" the="" fqpa,="" any="" person="" may="" file="" an="" objection="" to="" any="" aspect="" of="" this="" regulation="" and="" may="" also="" request="" a="" hearing="" on="" those="" objections.="" the="" epa="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" requests="" for="" hearings="" appear="" in="" 40="" cfr="" part="" 178.="" although="" the="" procedures="" in="" those="" regulations="" require="" some="" modification="" to="" reflect="" the="" amendments="" made="" to="" the="" ffdca="" by="" the="" fqpa="" of="" 1996,="" epa="" will="" continue="" to="" use="" those="" procedures,="" with="" appropriate="" adjustments,="" until="" the="" necessary="" modifications="" can="" be="" made.="" the="" new="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" regulation="" for="" an="" exemption="" from="" the="" requirement="" of="" a="" tolerance="" issued="" by="" epa="" under="" new="" section="" 408(d),="" as="" was="" provided="" in="" the="" old="" ffdca="" sections="" 408="" and="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" now="" 60="" days,="" rather="" than="" 30="" days.="" a.="" what="" do="" i="" need="" to="" do="" to="" file="" an="" objection="" or="" request="" a="" hearing?="" you="" must="" file="" your="" objection="" or="" request="" a="" hearing="" on="" this="" regulation="" in="" accordance="" with="" the="" instructions="" provided="" in="" this="" unit="" and="" in="" 40="" cfr="" part="" 178.="" to="" ensure="" proper="" receipt="" by="" epa,="" you="" must="" identify="" docket="" control="" number="" opp-300932="" in="" the="" subject="" line="" on="" the="" first="" page="" of="" your="" submission.="" all="" requests="" must="" be="" in="" writing,="" and="" must="" be="" mailed="" or="" delivered="" to="" the="" hearing="" clerk="" on="" or="" before="" december="" 20,="" 1999.="" 1.="" filing="" the="" request.="" your="" objection="" must="" specify="" the="" specific="" provisions="" in="" the="" regulation="" that="" you="" object="" to,="" and="" the="" grounds="" for="" the="" objections="" (40="" cfr="" 178.25).="" if="" a="" hearing="" is="" requested,="" the="" objections="" must="" include="" a="" statement="" of="" the="" factual="" issues(s)="" on="" which="" a="" hearing="" is="" requested,="" the="" requestor's="" contentions="" on="" such="" issues,="" and="" a="" summary="" of="" any="" evidence="" relied="" upon="" by="" the="" objector="" (40="" cfr="" 178.27).="" 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.="" mail="" your="" written="" request="" to:="" office="" of="" the="" hearing="" clerk="" (1900),="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" you="" may="" also="" deliver="" your="" request="" to="" the="" office="" of="" the="" hearing="" clerk="" in="" rm.="" m3708,="" waterside="" mall,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" the="" office="" of="" the="" hearing="" clerk="" is="" open="" from="" 8="" a.m.="" to="" 4="" p.m.,="" monday="" through="" friday,="" excluding="" legal="" holidays.="" the="" telephone="" number="" for="" the="" office="" of="" the="" hearing="" clerk="" is="" (202)="" 260-4865.="" 2.="" tolerance="" fee="" payment.="" if="" you="" file="" an="" objection="" or="" request="" a="" hearing,="" you="" must="" also="" pay="" the="" fee="" prescribed="" by="" 40="" cfr="" 180.33(i)="" or="" request="" a="" waiver="" of="" that="" fee="" pursuant="" to="" 40="" cfr="" 180.33(m).="" you="" must="" mail="" the="" fee="" to:="" epa="" headquarters="" accounting="" operations="" branch,="" office="" of="" pesticide="" programs,="" p.o.="" box="" 360277m,="" pittsburgh,="" pa="" 15251.="" please="" identify="" the="" fee="" submission="" by="" labeling="" it="" ``tolerance="" petition="" fees.''="" 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="" the="" waiver="" of="" these="" fees,="" you="" may="" contact="" james="" tompkins="" by="" phone="" at="" (703)="" 305-5697,="" by="" e-mail="" at="">tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by the docket control number OPP-300932, 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 or
by courier, bring a copy to the location of the PIRIB described in Unit
I.B.2. You may also send an electronic copy of your request via e-mail
to: opp-
[[Page 56703]]
docket@epa.gov. Please use an ASCII file format and avoid the use of
special characters and any form of encryption. Copies of electronic
objections and hearing requests will also be accepted on disks in
WordPerfect 6.1/8.0 file format or ASCII file format. Do not include
any CBI in your electronic copy. You may also submit an electronic copy
of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
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(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. Regulatory Assessment Requirements
This final rule establishes a tolerance under section 408 of the
FFDCA. 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) (Public Law 104-4). Nor does it require prior consultation with
State, local, and tribal government officials as specified by Executive
Order 12875, entitled Enhancing the Intergovernmental Partnership (58
FR 58093, October 28, 1993) and Executive Order 13084, entitled
Consultation and Coordination with Indian Tribal Governments (63 FR
27655, May 19, 1998), or special consideration of environmental justice
related issues under 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). The Agency has determined that this action will not have a
substantial direct effect on States, on the relationship between the
national government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 12612, entitled Federalism (52 FR 41685, October 30,
1987). This action directly regulates growers, food processors, food
handlers and food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. 346a(n)(4). This action does not involve any
technical standards that would require Agency consideration of
voluntary consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law
104-113, section 12(d) (15 U.S.C. 272 note). In addition, since
tolerances and exemptions that are established under FFDCA section
408(l)(6), 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.
IX. 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 this 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: October 5, 1999.
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. 321(q), 346(a) and 371.
2. In Sec. 180.412, the table in paragraph (b) is amended by adding
an entry for ``buckwheat'' to read as follows:
Sec. 180.412 Sethoxydim; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Parts per Expiration/revocation
Commodity million date
------------------------------------------------------------------------
Buckwheat.......................... 10 12/31/01
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-27391 Filed 10-20-99; 8:45 am]
BILLING CODE 6560-50-F
