[Federal Register Volume 64, Number 203 (Thursday, October 21, 1999)]
[Rules and Regulations]
[Pages 56690-56697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27393]
[[Page 56690]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300928; FRL-6382-6]
RIN 2070-AB78
Tebufenozide; Benzoic Acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-
(4-ethylbenzoyl) hydrazide; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time limited tolerance for the
indirect or inadvertent combined residues of tebufenozide and its
metabolite benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-4-(1-
hydroxyethyl)benzoylhydrazide in or on foliage of legume vegetables at
0.1 parts per million (ppm); forage, fodder, hay and straw of cereal
grains at 0.5 ppm; grass forage, fodder and hay at 0.5 ppm and forage,
fodder, straw and hay of non-grass animal feeds at 0.5 ppm. Rohm and
Haas Company 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 October 21, 1999. Objections and
requests for hearings, identified by docket control number OPP-300928,
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 VI. of the ``SUPPLEMENTARY
INFORMATION'' section. To ensure proper receipt by EPA, your objections
and hearing requests must identify docket control number OPP-300928 in
the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Joseph Tavano, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone
number: (703) 305-6411; and e-mail address: tavano.joseph@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS Potentially
Affected Entities
------------------------------------------------------------------------
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 in the ``FOR FURTHER INFORMATION
CONTACT'' section.
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-300928. 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
In the Federal Register of July 2, 1999 (64 FR 35999) (FRL-6085-6)
and September 1, 1999 (64 FR 47795) (FRL-6096-8), EPA issued a notice
pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act
of 1996 (FQPA) (Pub. L. 104-170) announcing the filing of a pesticide
petition (PP) for tolerance by Rohm and Haas Company, 100 Independence
Mall West, Philadelphia, PA 19106-2399. This notice included a summary
of the petition prepared by Rohm and Haas Company, the registrant.
There were no comments received inresponse to these notices of filing.
The petition requested that 40 CFR 180. 482 be amended by
establishing a tolerance for indirect or inadvertent residues of the
insecticide, tebufenozide benzoic acid, 3,5-dimethyl-1-(1,1-
dimethylethyl)-2-(4-ethylbenzoyl)hydrazide and its metabolite benzoic
acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-4-
(hydroxyethyl)benzoyl]benzoyl in or on foliage of legume vegetables;
forage, fodder, hay and straw of cereal grains; grass forage, fodder
and hay; and forage, fodder, straw and hay of nongrass animal feeds at
0.1, 0.5, 0.5 and 0.5 part per million (ppm) respectively. Tebufenozide
is a reduced risk pesticide.
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
[[Page 56691]]
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).
III. 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 and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for a tolerance for the combined residues of tebufenozide
and its metabolite benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-
[4-(1-hydroxyethyl)benzoyl]hydrazide on foliage of legume vegetables;
forage, fodder, hay and straw of cereal grains; grass forage, fodder
and hay and forage, fodder, straw and hay of nongrass animal feeds at
0.1, 0,5, 0.5 and 0.5 ppm respectively. 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 are discussed in
this unit.
1. Acute toxicity studies with technical grade: Oral
LD50 in the rat is > 5 grams for males and females -
Toxicity Category IV; dermal LD50 in the rat is = 5,000
milligram/kilogram (mg/kg) for males and females - Toxicity Category
III; inhalation LC50 in the rat is >4.5 mg/l - Toxicity
Category III; primary eye irritation study in the rabbit is a non-
irritant; primary skin irritation in the rabbit >5mg - Toxicity
Category IV. Tebufenozide is not a sentizer.
2. In a 21-day dermal toxicity study, Crl:CD rats (6/sex/dose)
received repeated dermal administration of either the technical 96.1%
product [RH-75,992] at 1,000 mg/kg/day (Limit-Dose) or the formulation
(23.1% a.i. product [RH-755,992 2F] at 0, 62.5, 250, or 1,000 mg/kg/
day, 6 hours/day, 5 days/week for 21 days. Under conditions of this
study, RH-75,992 Technical or RH-75,992 2F demonstrated no systemic
toxicity or dermal irritation at the highest dose tested (HDT) 1,000
mg/kg/day during the 21 day study. Based on these results, the NOAEL
for systemic toxicity and dermal irritation in both sexes is 1,000 mg/
kg/day HDT. A LOAEL for systemic toxicity and dermal irritation was not
established.
3. A 1-year dog feeding study with a lowest-observable-adverse-
effect level (LOAEL) of 250 ppm (9 mg/kg/day for male and female dogs)
based on decreases in RBC, HCT, and HGB, increases in Heinz bodies,
methemoglobin, MCV, MCH, reticulocytes, platelets, plasma total
bilirubin, spleen weight, and spleen/body weight ratio, and liver/body
weight ratio. Hematopoiesis and sinusoidal engorgement occurred in the
spleen, and hyperplasia occurred in the marrow of the femur and
sternum. The liver showed an increased pigment in the Kupffer cells.
The no-observed adverse effect level (NOAEL) for systemic toxicity in
both sexes is 50 ppm (1.9 mg/kg/day).
4. An 18-month mouse carcinogenicity study with no carcinogenicity
observed at dosage levels up to and including 1,000 ppm.
5. A 2-year rat carcinogenicity with no carcinogenicity observed at
dosage levels up to and including 2,000 ppm (97 mg/kg/day and 125 mg/
kg/day for males and females, respectively)
6. In a prenatal developmental toxicity study in Sprague-Dawley
rats (25/group) Tebufenozide was administered on gestation days 6-15 by
gavage in aqueous methyl cellulose at dose levels of 50, 250, or 1,000
mg/kg/day and a dose volume of 10 ml/kg. There was no evidence of
maternal or developmental toxicity; the maternal and developmental
toxicity NOAEL was 1,000 mg/kg/day.
7. In a prenatal developmental toxicity study conducted in New
Zealand white rabbits (20/group) Tebufenozide was administered in 5 ml/
kg of aqueous methyl cellulose at gavage doses of 50, 250, or 1000 mg/
kg/day on gestation days 7-19. No evidence of maternal or developmental
toxicity was observed; the maternal and developmental toxicity NOAEL
was 1,000 mg/kg/day.
8. In a 1993 two-generation reproduction study in Sprague-Dawley
rats tebufenozide was administered at dietary concentrations of 0, 10,
150, or 1,000 ppm (0, 0.8, 11.5, or 154.8 mg/kg/day for males and 0,
0.9, 12.8, or 171.1 mg/kg/day for females). The parental systemic NOAEL
was 10 ppm (0.8/0.9 mg/kg/day for males and females, respectively) and
the LOAEL was 150 ppm (11.5/12.8 mg/kg/day for males and females,
respectively) based on decreased body weight, body weight gain, and
food consumption in males, and increased incidence and/or severity of
splenic pigmentation. In addition, there was an increased incidence and
severity of extramedullary hematopoiesis at 2,000 ppm. The reproductive
NOAEL was 150 ppm. (11.5/12.8 mg/kg/day for males and females,
respectively) and the LOAEL was 2,000 ppm (154.8/171.1 mg/kg/day for
males and females, respectively) based on an increase in the number of
pregnant females with increased gestation duration and dystocia.
Effects in the offspring consisted of decreased number of pups per
litter on postnatal days 0 and/or 4 at 2,000 ppm (154.8/171.1 mg/kg/day
for males and females, respectively) with a NOAEL of 150 ppm (11.5/12.8
mg/kg/day for males and females, respectively).
9. In a 1995 2-generation reproduction study in rats tebufenozide
was administered at dietary concentrations of 0, 25, 200, or 2,000 ppm
(0, 1.6, 12.6, or 126.0 mg/kg/day for males and 0, 1.8, 14.6, or 143.2
mg/kg/day for females). For parental systemic toxicity, the NOAEL was
25 ppm (1.6/1.8 mg/kg/day in males and females, respectively), and the
LOAEL was 200 ppm (12.6/14.6 mg/kg/day in males and females), based on
histopathological findings (congestion and extramedullary
hematopoiesis) in the spleen. Additionally, at 2,000 ppm (126.0/143.2
mg/kg/day in M/F), treatment-related findings included reduced parental
body weight gain and increased incidence of hemosiderin-laden cells in
the spleen. Columnar changes in the vaginal squamous epithelium and
reduced uterine and ovarian weights were also observed at 2,000 ppm,
but the toxicological significance was unknown. For offspring, the
systemic NOAEL was 200 ppm. (12.6/14.6 mg/kg/day in males and females),
and the LOAEL was 2,000 ppm (126.0/143.2 mg/kg/day in M/F) based on
decreased body weight on postnatal days 14 and 21.
10. Several mutagenicity tests which were all negative. These
include an Ames assay with and without metabolic activation, an in vivo
cytogenetic assay in rat bone marrow cells, and in vitro chromosome
aberration assay in CHO cells, a CHO/HGPRT assay, a reverse mutation
assay with E. Coli, and an unscheduled DNA synthesis assay (UDS) in rat
hepatocytes.
11. The pharmacokinetics and metabolism of tebufenozide were
studied in female Sprague-Dawley rats (3-6/sex/group) receiving a
single oral dose of 3 or 250 mg/kg of RH-5992, 14C labeled
in one of three positions (A-ring, B-ring or N-butylcarbon). The extent
of
[[Page 56692]]
absorption was not established. The majority of the radiolabeled
material was eliminated or excreted in the feces within 48 hours within
48 hours; small amounts (1 to 7% of the administered dose) were
excreted in the urine and only traces were excreted in expired air or
remained in the tissues. There was no tendency for bioacculmulation.
Absorption and excretion were rapid.
A total of 11 metabolites, in addition to the parent compound, were
identified in the feces; the parent compound accounted for 96 to 99% of
the administered radioactivity in the high dose group and 35 to 43% in
the low dose group. No parent compound was found in the urine; urinary
metabolites were not characterized. The identity of several fecal
metabolites was confirmed by mass spectral analysis and other fecal
metabolites were tentatively identified by cochromatography with
synthetic standards. A pathway of metabolism was proposed based on
these data. Metabolism proceeded primarily by oxidation of the three
benzyl carbons,. two methyl groups on the Bring and an ethyl group on
the A ring to alcohols, aldehydes or acids. The type of metabolite
produced varies depending on the position oxidized and extent of
oxidation. The butyl group on the quaternary nitrogen also can be
leaved (minor), but there was no fragmentation of the molecule between
the benzyl rings.
No qualitative differences in metabolism were observed between
sexes, when high or low dose groups were compared or when different
labeled versions of the molecule were compared.
12. The absorption and metabolism of tebufenozide were studied in a
group of male and female bile-duct cannulated rats. Over a 72 hour
period, biliary excretion accounted for 30% (Male) to 34% (Female) of
the administered dose while urinary excretion accounted for
5% of the administered dose and the carcass accounted for
<0.5% of="" the="" administered="" dose="" for="" both="" males="" and="" females.="" thus="" systemic="" absorption="" (percent="" of="" dose="" recovered="" in="" the="" bile,="" urine="" and="" carcass="" was="" 35%="" (male)="" to="" 39%="" (female).="" the="" majority="" of="" the="" radioactivity="" in="" the="" bile="" (20%="" (male)="" to="" 24%="" (female)="" of="" the="" administered="" dose="" was="" excreted="" within="" the="" first="" 6="" hours="" postdosing="" indicating="" rapid="" absorption.="" furthermore,="" urinary="" excretion="" of="" the="" metabolites="" was="" essentially="" complete="" within="" 24="" hours="" postdosing.="" a="" large="" amount="" 67%="" (female)="" to="" 70%="" (male)="" of="" the="" administered="" dose="" was="" unabsorbed="" and="" excreted="" in="" the="" feces="" by="" 72="" hours.="" total="" recovery="" of="" radioactivity="" was="" 105%="" of="" the="" administered="" dose.="" a="" total="" of="" 13="" metabolites="" were="" identified="" in="" the="" bile;="" the="" parent="" compound="" was="" not="" identified="" i.e.="" -="" unabsorbed="" compound="" nor="" were="" the="" primary="" oxidation="" products="" seen="" in="" the="" feces="" in="" the="" pharmacokinetics="" study.="" the="" proposed="" metabolic="" pathway="" proceeded="" primary="" by="" oxidation="" of="" the="" benzylic="" carbons="" to="" alcohols,="" aldehydes="" or="" acids.="" bile="" contained="" most="" of="" the="" other="" highly="" oxidized="" products="" found="" in="" the="" feces.="" the="" most="" significant="" individual="" bile="" metabolites="" accounted="" for="" 5%="" to="" 18%="" of="" the="" total="" radioactivity="" ((female="" and/or="" male).="" bile="" also="" contained="" the="" previously="" undetected="" (in="" the="" pharmacokinetics="" study="" ``a''="" ring="" ketone="" and="" the="" ``b''="" ring="" diol.="" the="" other="" major="" components="" were="" characterized="" as="" high="" molecular="" weight="" conjugates.="" no="" individual="" bile="" metabolite="" accounted="" for="">5% of the total administered dose. Total bile
radioactivity accounted for 17% of the total administered
dose.
No major qualitative differences in biliary metabolites were
observed between sexes. The metabolic profile in the bile was similar
to the metabolic profile in the feces and urine.
B. Toxicological Endpoints
1. Acute toxicity. Toxicity observed in oral toxicity studies were
not attributable to a single dose (exposure). No neuro or systemic
toxicity was observed in rats given a single oral administration of
tebufenozide at 0, 500, 1,000, or 2,000 mg/kg. No maternal or
developmental toxicity was observed following oral administration of
tebufenozide at 1,000 mg/kg/day (Limit-Dose) during gestation to
pregnant rats or rabbits. Thus the risk from acute exposure is
considered negligible.
2. Short- and intermediate-term toxicity. No dermal or systemic
toxicity was seen in rats receiving 15 repeated dermal applications of
the technical (97.2%) product at 1,000 mg/kg/day (Limit- Dose) as well
as a formulated (23% a.i) product at 0, 62.5, 250, or 1,000 mg/kg/day
over a 21 day period. The Agency noted that in spite of the
hematological effects seen in the dog study, similar effects were not
seen in the rats receiving the compound via the dermal route indicating
poor dermal absorption. Also, no developmental endpoints of concern
were evident due to the lack of developmental toxicity in either rat or
rabbit studies. This risk is considered to be negligable.
3. Chronic toxicity. EPA has established the chronic population
adjusted dose (cPAD) for tebufenozide at 0.018 mg/kg/day. This endpoint
is based on the NOAEL of 1.8 mg/kg/day from a chronic toxicity study in
dogs. Growth retardation, alterations in hematology parameters, changes
in organ weights, and histopathological lesions in the bone, spleen and
liver were observed at the LOAEL of 8.7 mg/kg/day in this study. An
uncertainty factor (UF) of 100 was applied to account for inter- (10 x)
and intra- (10 x) species variation resulting in a chronic RfD of 1.8
mg/kg/day 100 = 0.018 mg/kg/day. For chronic dietary risk
assessment, the 10 x factor to account for the protection of infants
and children (as required by FQPA) was removed. Therefore, the chronic
population adjusted dose (cPAD) is identical to the chronic RfD, cPAD =
chronic RfD = 0.018 mg/kg/day. Removing the 10x factor is supported by
the following factors:
i. Developmental toxicity studies showed no increased sensitivity
in fetuses when compared to maternal animals following in utero
exposures in rats and rabbits.
ii. Multi-generation reproduction toxicity studies in rats showed
no increased sensitivity in pups as compared to adults and offspring.
(iii) There are no data gaps.
4. Carcinogenicity. Tebufenozide has been classified as a Group E,
``no evidence of carcinogenicity for humans,'' chemical by EPA.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.482) for the residues of tebufenozide, in or on a variety of
raw agricultural commodities. In today's action, Tolerances will be
established for the indirect or inadvertent combined residues of
tebufenozide and its metabolite benzoic acid, 3,5-dimethyl-1-(1,1-
dimethylethyl)-2-[4-(1-hydroxyethyl)benzoyl]hydrazide in or on foliage
of legume vegetables; forage, fodder, hay and straw of cereal grains;
grass forage, fodder and hay and forage, fodder, straw and hay of
nongrass animal feeds at 0.1, 0.5, 0.5 and 0.5 ppm respectively. Risk
assessments were conducted by EPA to assess dietary exposures from as
follows:
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of crop treated (PCT) for assessing chronic dietary risk
only if the Agency can make the following findings: That the data used
are reliable and provide a valid basis to show what percentage of the
food derived from such crop is likely to contain such pesticide
residue; that the exposure estimate does not underestimate exposure for
any significant subpopulation group; and if data are available on
pesticide use and food consumption in a particular area, the
[[Page 56693]]
exposure estimate does not understate exposure for the population in
such area. In addition, the Agency must provide for periodic evaluation
of any estimates used. To provide for the periodic evaluation of the
estimate of PCT as required by section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency used PCT information as follows:
Estimates of percent crop treated were used for the following
crops. In all cases the maximum estimate was used.
------------------------------------------------------------------------
Percentage
Commodity ---------------------------------------
Average Maximum
------------------------------------------------------------------------
Almonds:........................ <1><1 apples:.........................="" 1="" 2="" beans/peas,dry..................="" 0="" 1="" cotton..........................="" 1="" 4="" walnuts.........................="" 10="" 16="" cabbage,="" fresh..................="" 2="" 3="" cole="" crops......................="" 1="" 2="" spinach,="" fresh.................="" 2="" 3="" spinach,="" processed..............="" 20="" 29="" ------------------------------------------------------------------------="" the="" agency="" believes="" that="" the="" three="" conditions,="" discussed="" in="" section="" 408="" (b)(2)(f)="" in="" this="" unit="" concerning="" the="" agency's="" responsibilities="" in="" assessing="" chronic="" dietary="" risk="" findings,="" have="" been="" met.="" the="" pct="" estimates="" are="" derived="" from="" federal="" and="" private="" market="" survey="" data,="" which="" are="" reliable="" and="" have="" a="" valid="" basis.="" typically,="" a="" range="" of="" estimates="" are="" supplied="" and="" the="" upper="" end="" of="" this="" range="" is="" assumed="" for="" the="" exposure="" assessment.="" by="" using="" this="" upper="" end="" estimate="" of="" the="" pct,="" the="" agency="" is="" reasonably="" certain="" that="" the="" percentage="" of="" the="" food="" treated="" is="" not="" likely="" to="" be="" underestimated.="" the="" regional="" consumption="" information="" and="" consumption="" information="" for="" significant="" subpopulations="" is="" taken="" into="" account="" through="" epa's="" computer-based="" model="" for="" evaluating="" the="" exposure="" of="" significant="" subpopulations="" including="" several="" regional="" groups.="" use="" of="" this="" consumption="" information="" in="" epa's="" risk="" assessment="" process="" ensures="" that="" epa's="" exposure="" estimate="" does="" not="" understate="" exposure="" for="" any="" significant="" subpopulation="" group="" and="" allows="" the="" agency="" to="" be="" reasonably="" certain="" that="" no="" regional="" population="" is="" exposed="" to="" residue="" levels="" higher="" than="" those="" estimated="" by="" the="" agency.="" other="" than="" the="" data="" available="" through="" national="" food="" consumption="" surveys,="" epa="" does="" not="" have="" available="" information="" on="" the="" regional="" consumption="" of="" food="" to="" which="" may="" be="" applied="" in="" a="" particular="" area.="" 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.="" toxicity="" observed="" in="" oral="" toxicity="" studies="" were="" not="" attributable="" to="" a="" single="" dose="" (exposure).="" no="" neuro="" or="" systemic="" toxicity="" was="" observed="" in="" rats="" given="" a="" single="" oral="" administration="" of="" tebufenozide="" at="" 0,="" 500,="" 1,000="" or="" 2,000="" mg/kg.="" no="" maternal="" or="" developmental="" toxicity="" was="" observed="" following="" oral="" administration="" of="" tebufenozide="" at="" 1,000="" mg/kg/day="" (limit-dose)="" during="" gestation="" to="" pregnant="" rats="" or="" rabbits.="" this="" risk="" is="" considered="" to="" be="" negligable.="" ii.="" chronic="" exposure="" and="" risk.="" in="" conducting="" the="" deem="" (dietary="" exposure="" evaluation="" model)="" for="" chronic="" dietary="" (food="" only)="" analysis,="" epa="" used="" tolerance="" level="" residues="" and="" some="" percent="" crop="" treated="" (tier="" 2).="" for="" the="" subject="" crops,="" the="" tolerances="" used="" are:="" 0.1="" ppm="" for="" foliage="" of="" legume="" vegetables;="" 0.5="" ppm="" for="" forage,="" fodder,="" hay="" and="" straw="" of="" cereal="" grains;="" 0.5="" ppm="" for="" grass="" forage,="" fodder="" and="" hay="" and="" 0.5="" ppm="" for="" forage,="" fodder,="" straw="" and="" hay="" of="" nongrass="" animal="" feeds.="" the="" analysis="" evaluates="" individual="" food="" consumption="" as="" reported="" by="" respondents="" in="" the="" usda="" continuing="" surveys="" of="" food="" intake="" by="" individuals="" conducted="" in="" 1989="" through="" 1992.="" summaries="" of="" the="" arc="" and="" their="" representations="" as="" percentages="" of="" the="" cpad="" for="" the="" general="" population="" and="" subgroups="" of="" interest="" are="" presented="" in="" the="" following="" table.="" chronic="" exposure="" analysis="" by="" the="" deem="" system="" for="" tebufenozide="" ------------------------------------------------------------------------="" exposure="" (mg/kg/="" population="" subgroup="" day)="" cpad="">1
------------------------------------------------------------------------
U.S. Population (48 States)..... 0.0017 10
Children (1-6 years old)........ 0.0038 21
Females (13+/nursing)........... 0.0017 10
------------------------------------------------------------------------
\1\ cPAD% = Exposure/cPAD X 100%
The subgroups listed above are: (1) the U.S. population (48 states);
(2) highest exposed population subgroup that includes infants and
children; and (3) Female 13+.
This chronic dietary (food only) risk assessment should be viewed
as conservative. Further refinement using anticipated residue values
and additional % crop treated information would result in a lower
estimate of chronic dietary exposure.
2. From drinking water-- i. Acute exposure and risk. Because no
acute dietary endpoint was determined, the Agency concludes that there
is a reasonable certainty of no harm from acute exposure from drinking
water.
ii. Chronic exposure and risk. EPA calculated the Tier I Estimated
Environmental Concentrations (EECs) for tebufenozideusing GENEEC
(surface water) and SCI-GROW (ground water) for use in the human health
risk assessment. For chronic exposure, the worst case EECs for surface
water and ground water were 16.5 ppb and 1.04 ppb, respectively. These
values represent upper-bound estimates of the concentrations that might
be found in surface and ground water. These modeling data were compared
to the chronic drinking water levels of comparison (DWLOCs) for
tebufenozide in ground and surface water.
For purposes of chronic risk assessment, the estimated maximum
concentration for tebufenozide in surface and ground waters (16.5
ppb=16.5 g/L) was compared to the back-calculated human health DWLOCs
for the chronic (non-cancer) endpoint. These DWLOCs for various
population categories are summarized in the following table.
Drinking Water Levels of Comparison for Chronic Exposure to Tebufenozide
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic RfD (mg/kg/ Food Exposure (mg/kg/ Max. Water Exposure EEC Calc.Max. (g/L) m>g/L)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population (48 states)........ 0.018 0.0017 0.016 560 16.5
Female (13+ years)................. 0.018 0.0017 0.016 480 16.5
Children (1-6)..................... 0.018 0.0038 0.014 140 16.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 56694]]
In performing this risk assessment, EPA has calculated drinking
water levels of comparison (DWLOCs) for each of the DEEM population
subgroups. Within each subgroup, the population with the highest
estimated exposure was used to determine the maximum concentration of
tebufenozide that can occur in drinking water without causing an
unacceptable human health risk. As a comparison value, EPA has used the
16.5-ppb value in this risk assessment, as this represents a worst-case
scenario. The DWLOCs for tebufenozide are above the DWEC of 16.5 ppb
for all population subgroups. Therefore, the human health risk from
exposure to tebufenozide through drinking water in not likely to exceed
EPA's level of concern.
3. From non-dietary exposure. Tebufenozide is not currently
registered for use on any residential non-food sites. Therefore there
are no non-dietary acute, chronic, short- or intermediate-term exposure
scenarios.
4. Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether 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, 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 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. Since no acute toxicological endpoints were
established, no acute aggregate risk exists.
2. Chronic risk. Using the somewhat conservative exposure
assumptions described above, and taking into account the completeness
and reliability of the toxicity data, HED has concluded that dietary
(food only) exposure to tebufenozide will utilize 10% of the cPAD for
the U.S. population, and 21% of the cPAD for the most highly exposed
population subgroup (Children 1-6 yr). Submitted environmental fate
studies suggest that tebufenozide is moderately persistent to
persistent and mobile; thus, tebufenozide could potentially leach to
ground water and runoff to surface water under certain environmental
conditions. The modeling data for tebufenozide indicate levels less
than HED's DWLOCs. EPA generally has no concern for exposures below
100% of the cPAD. Since there are no registered residential uses of
tebufenozide, there is no potential for exposure to tebufenozide from
residential uses. HED concludes that there is a reasonable certainty
that no harm will result to adults, infants and children from chronic
aggregate exposure to tebufenozide 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.
Since there are currently no registered indoor or outdoor
residential non-dietary uses of tebufenozide and no short- or
intermediate-term toxic endpoints, short- or intermediate-term
aggregate risks do not exist.
4. Aggregate cancer risk for U.S. population. Since tebufenozide
has been classified as a Group E, ``no evidence of carcinogenicity for
humans,'' this risk does not exist.
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 tebufenozide 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 , EPA considered data from developmental
toxicity studies in the rat and rabbit and a 2-generation reproduction
study in the rat. The developmental toxicity studies are designed to
evaluate adverse effects on the developing organism resulting from
maternal pesticide exposure gestation. Reproduction studies provide
information relating to effects from exposure to the pesticide on the
reproductive capability of mating animals and data on systemic
toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre-and post-natal toxicity and the
completeness of the database unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a margin of exposure (MOE) analysis or through using
uncertainty (safety) factors in calculating a dose level that poses no
appreciable risk to humans. EPA believes that reliable data support
using the standard uncertainty factor (usually 100 for combined inter-
and intra-species variability) and not the additional tenfold MOE/
uncertainty factor when EPA has a complete data base under existing
guidelines and when the severity of the effect in infants or children
or the potency or unusual toxic properties of a compound do not raise
concerns regarding the adequacy of the standard MOE/safety factor.
ii. Pre- and post-natal sensitivity. The toxicology data base for
tebufenozide included acceptable developmental toxicity studies in both
rats and rabbits as well as a two-generation reproductive toxicity
study in rats.The data provided no indication of increased sensitivity
of rats or rabbits to in utero and/or postnatal exposure to
tebufenozide. No maternal or developmental findings were observed in
the prenatal developmental toxicity studies at doses up to 1000 mg/kg/
day in rats and rabbits. In the two-generation reproduction studies in
rats, effects occurred at the same or lower treatment levels in the
adults as in the offspring.
iii. Conclusion. There is a complete toxicity database for
tebufenozide and exposure data is complete and reasonably accounts for
potential exposures. For the reasons summarized above, EPA concluded
that an additional safety factor is not needed to protect the safety of
infants and children.
2. Acute risk. Since no acute toxicological endpoints were
established, no acute aggregate risk exists.
3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to tebufenozide from
food will utilize 21% of the cPAD for infants and children. Submitted
environmental fate studies suggest that tebufenozide is moderately
persistent to persistent and mobile; thus, tebufenozide could
potentially leach to ground water and runoff to surface water under
certain environmental conditions. The modeling data for tebufenozide
indicate levels less than HED's DWLOCs. EPA generally has no concern
for exposures
[[Page 56695]]
below 100% of the cPAD because the cPAD represents the level at or
below which daily aggregate dietary exposure over a lifetime will not
pose appreciable risks to human health. Since there are no registered
residential uses of tebufenozide, there is no potential for exposure to
tebufenozide from residential uses. EPA concludes that there is a
reasonable certainty that no harm will result to adults, infants and
children from chronic aggregate exposure to tebufenozide residues.
4. Short- or intermediate-term risk. Short and intermediate term
risks are judged to be negligible due to the lack of significant
toxicological effects observed.
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 tebufenozide
residues.
IV. Other Considerations
A. Metabolism in Plants and Animals
The qualitative nature of the residue in plants is adequately
understood based upon acceptable apple, sugar beet, and rice metabolism
studies. EPA has concluded that the residue of regulatory concern is
tebufenozide per se.The qualitative nature of the residues in animals
is also adequately understood based on acceptable poultry and ruminant
metabolism studies. For animals, EPA has concluded that the residues of
regulatory concern are tebufenozide and its metabolites benzoic acid,
3,5-dimethyl-1-(1,1-dimethylethyl)-2-((4-carboxymethyl)
benzoyl)hydrazide) , benzoic acid, 3-hydroxymethyl,5-methyl-1-(1,1-
dimethylethyl)-2-(4-ethylbenzoyl)hydrazide , the stearic acid conjugate
of benzoic acid, 3-hydroxymethyl,5-methyl-1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl)hydrazide and benzoic acid, 3-hydroxymethyl-5-methyl-1-
(1,1-dimethylethyl)-2-(4-(1-hydroxyethyl)benzoyl)hydrazide.
B. Analytical Enforcement Methodology
The petitioner has submitted method validation/concurrent recovery
studies for a proposed enforcement method. This HPLC/MS method, Rohm
and Haas Method TR 34-99-10 which is a combination of methods TR 34-97-
91 and TR 34-98-149, is to be used for determining residues of
tebufenozide in/on rotated crops. The method, entitled ``Tolerance
Enforcement Method for RH-5992 and Its Metabolites in Rotation Crops''
has undergone successful independent laboratory validation . It also
has been adequately radiovalidated and an HPLC/MS-MS confirmatory
method exists. The proposed enforcement method for rotated crops for
determining residues of tebufenozide and metabolites, is adequate for
collection of residue data.A copy of the method has been forwarded to
the Analytical Chemistry Branch (ACB) for petition method validation
(PMV) as a possible enforcement method. The proposed enforcement method
has not been subjected to a complete Agency method validation at this
time. EPA has conducted a preliminary review of the method that
indicates that it appears to be suitable for enforcement purposes
pending the outcome of the actual method validation. Given that the
registrant has provided concurrent fortification data to demonstrate
that the method is adequate for data collection purposes and has
provided the Agency with a successful Independent Laboratory
Validation, coupled with EPA's preliminary review, EPA concludes that
the method is suitable as an enforcement method to support tolerances
associated with a conditional registration only. As a condition of the
registration, the Agency will require a successful method validation
and the registrant will be required to make any necessary modifications
to the method resulting from the laboratory validation.
This method may be requested from: Calvin Furlow, PRRIB, IRSD
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460; telephone number: (703) 305-5229;
e-mail address: furlow.calvin@epa.gov..
C. Magnitude of Residues
The foliage portions of representative crops from the cereal grain
and legume crop groups show quantifiable residues of the tebufenozide
metabolite RH-1788 at the 30-day plantback interval. A tolerance is
required on those commodities which have quantifiable residues: cereal
grain straw and hay, and foliage of legume vegetables. Given the
limited amount of data, the cereal grain tolerances should be extended
to forage and fodder as well. Tolerances on rotated crops would
normally require the same number and geographic location of residue
field trials as those required were they primary crops. In this case,
the crops for which rotational crop tolerances are requested, small
grains and legumes, have much greater production acreage and geographic
distribution than most of the registered tebufenozide primary crop
uses. Rather than requiring the number and geographic diversity of the
rotated crop field trials, which would entail trying to grow and treat
primary crops in regions where tebufenozide is unlikely to be used, EPA
will require using the number and geographic diversity for field trials
of a primary crop likely to be rotated to grains/legumes and with a use
pattern which would produce the conditions for highest possible residue
in rotated crops.
The most significant crops or crop groups which are rotated and
have registered tebufenozide uses are Brassica (cole) and leafy
vegetables, cotton, and fruiting vegetables. The primary crops which
have the essentially the highest use pattern, (0.92 lb ai/A/season),
shortest PHI (7 days), highest current tolerances (2-10 ppm vs 0.8 for
fruiting vegetables), and are most likely to be rotated are Brassica
(cole) and leafy vegetables. Leaf lettuce is the crop within these crop
groups with the highest consumption by the general population. Eight
trials are normally required to establish a tolerance on leaf lettuce.
The registrant has submitted two trials each on small grains and
legumes. Therefore, EPA will require 6 additional crop field trials
(the number of residue trials required for leaf lettuce) for the
foliages of both rotated small cereal grains (e.g., wheat, barley, or
oats) and legumes, for a total of 12 additional trials, to establish
the requested tolerances on cereal grains and legumes for a 30-day
plantback interval. The guidelines would normally require 63 total
trials on these crops groups. A significant reduction in data will be
acceptable in this case since this is a reduced risk pesticide,
residues are found only in livestock feed items, and those residues do
not impact tolerances for animal commodities. Additional data will not
be required for grass forage, fodder, and straw and on non-grass animal
feeds (forage, fodder, straw, and hay).The small grain and legume
foliage data will be translated to these commodities. Up to 4 years may
be required to generate and review the additional rotational crop data.
To allow the rotation of crops while additional data are generated, EPA
is issuing time-limited tolerances on cereal grain forage, fodder,
straw, and hay; grass forage, fodder, and straw and non-grass animal
feeds (forage, fodder, straw, and hay) at 0.5 ppm, and legume forage at
0.1 ppm. Upon receipt of the additional data, the proposed tolerance
levels will be revisited.
D. International Residue Limits
No CODEX, Canadian or Mexican limits for tebufenozide have been
were established on cereal grain forage, fodder, straw, and hay; grass
forage,
[[Page 56696]]
fodder, and straw and non-grass animal feeds (forage, fodder, straw,
and hay) and legume forage. Therefore, international harminization is
not an issue at this time.
E. Rotational Crop Restrictions
EPA has determined that crops which the label allows to be treated
directly can be planted at any time. All other crops can not be planted
within 30 days of application.
V. Conclusion
Therefore, time limited tolerances are established for the combined
residues of tebufenozide benzoic acid, 3,5-dimethyl-1-(1,1-
dimethylethyl)-2-(4-ethylbenzoyl)hydrazide and its metabolite benzoic
acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-[4-(1-
hydroxyethyl)benzoyl]hydrazide in cereal grain forage, fodder, straw,
and hay; grass forage, fodder, and straw and non-grass animal feeds
(forage, fodder, straw, and hay) at 0.5 ppm, and legume forage at 0.1
ppm.
VI. 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-300928 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
Room 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 be 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.'' (cite). 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 VI.A. of
this preamble, you should also send a copy of your request to the PIRB
for its inclusion in the official record that is described in Unit
I.B.2. of this preamble. Mail your copies, identified by docket number
OPP-300928, 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 PRIB described in Unit I.B.2. of this preamble. You may
also send an electronic copy of your request via e-mail to: 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 5.1/6.1 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).
VII. Regulatory Assessment Requirements
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) (Public Law 104-4). Nor
does it require prior
[[Page 56697]]
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(b)(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 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.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this
rule and other required information to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
prior to publication of 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 12, 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), (346a), and 371.
2. In Sec. 180.482, by adding text to paragraph (d) to read as
follows:
Sec. 180.482 Tebufenozide; tolerances for residues.
* * * * *
(d) Indirect or inadvertent residues. Tolerances are established
for the indirect or inadvertent combined residues of tebufenozide
benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl)hydrazide and its metabolite benzoic acid, 3,5-dimethyl-1-
(1,1-dimethylethyl)-2- [4-(1-hydroxyethyl)benzoyl]hydrazide in or on
the raw agricultural commodities when present therin as a result of the
application of tebufenozide to growing crops listed in paragraph (a) of
this section to read as follows:
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Foliage of legume vegetables.... 0.1 9/30/03
Forage, fodder, hay and straw of 0.5 9/30/03
cereal grains.
Forage, fodder, straw and hay of 0.5 9/30/03
non-grass animal feeds.
Grass forage, fodder and hay.... 0.5 9/30/03
------------------------------------------------------------------------
[FR Doc. 99-27393 Filed 10-20-99; 8:45 am]
Billing Code 6560-50-F
