[Federal Register Volume 64, Number 139 (Wednesday, July 21, 1999)]
[Rules and Regulations]
[Pages 39060-39068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18483]
[[Page 39060]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300896; FRL-6092-1]
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 tolerances for residues of
tebufenozide in or on pome fruit, apple pomace, cotton and cotton gin
byproducts and tolerances for the combined residues of tebufenozide and
the 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 in or on the meat of cattle, goats,
hogs, horses, and sheep; the fat of cattle, goats, hogs, horses, and
sheep; meat byproducts of cattle, goats, hogs, horses, and sheep; and
milk. 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 July 21, 1999. Objections and
requests for hearings must be received by EPA on or before September
20, 1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300896], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300896], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 119, Crystal
Mall 2 (CM #2), 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: opp-docket@epa.gov. Copies of objections and hearing requests
must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Copies of objections and hearing
requests will also be accepted on disks in WordPerfect 5.1/6.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300896]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Joseph Tavano, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location, telephone number, and e-mail address: Rm. 222, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA, (703) 305-6411,
tavano.joseph@epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 19, 1998
(63 FR 44439) (FRL-6019-6) and February 17, 1999 (64 FR 7883) (FRL-
6060-1), EPA issued notices 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) (Public Law 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. These notices included a summary of the petition prepared
by Rohm and Haas Company, the registrant. There were no comments
received in response to these notices of filing.
The petitions requested that 40 CFR 180.482 be amended by
establishing a tolerance for residues of the insecticide tebufenozide,
in or on pome fruit, apple pomace, cotton, and cotton gin byproducts at
1.25, 3.0, 1.5, and 30 part per million (ppm) respectively.
Tebufenozide is a reduced risk pesticide sold under the trade names of
Confirm 2F and Confirm 70 WSP. Tebufenozide controls beet armyworm,
cabbage looper, fall armyworm, Southern armyworm, true armyworm, and
yellowstriped armyworm on cotton. On pome fruit it controls codling
moth, lesser appleworm, obliquebanded leafroller, tufted apple bud
moth, eyespotted bud moth, fruitree leafroller, green fruitworm,
pandemis leafroller, redbanded leafroller, and variegated leafroller.
I. Background and Statutory Findings
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
II. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
tebufenozide and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a tolerance for residues of
tebufenozide on pome fruit, apple pomace, cotton, and cotton gin
byproducts at 1.5, 3.0, 1.5, and 30 ppm respectively and tolerances for
the combined residues of 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-
[[Page 39061]]
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 in or on the
meat of cattle, goats, hogs, horses, and sheep; the fat of cattle,
goats, hogs, horses, and sheep; meat byproducts of cattle, goats, hogs,
horses, and sheep; and milk at 0.08, 0.1, 0.08, and 0.04 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 tebufenozide 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 milligrams/
kilograms (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/) during the 21-day study. Based on these results, the no
observable adverse effect level (NOAEL) for systemic toxicity and
dermal irritation in both sexes is 1,000 mg/kg/day HDT. A lowest
observable adverse effect level (LOAEL) for systemic toxicity and
dermal irritation was not established.
3. A 1-year dog feeding study with a LOAEL of 250 ppm (9 mg/kg/day
for males and females dogs) based on decreases in red blood cells
(RBC), hematocrit (HCT), and hemoglobin (HGB), increases in Heinz
bodies, methemoglobin, mean corpuscuslar volume (MCV), mean corpuscular
hematocrit (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 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 milliliter (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 1,000
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 2-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 males and females), 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 males and females) based on decreased body weight on postnatal days
14 and 21.
10. Several mutagenicity tests 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 Chinese Hampster Ovary (CHO) cells, a CHO/
Hypoxanthine guanine phophoribosyl transferase (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 females 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 absorption was not established. The majority of the
radiolabeled material was eliminated or excreted in the feces 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
[[Page 39062]]
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 B-ring 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 males and females bile-duct cannulated rats. Over a 72-hour
period, biliary excretion accounted for 30% (females) to 34% (males) of
the administered dose while urinary excretion accounted for equivulant
to 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%="" (females)="" to="" 39%="" (males).="" the="" majority="" of="" the="" radioactivity="" in="" the="" bile="" (20%="" (females)="" to="" 24%="" (males)="" 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%="" (males)="" to="" 70%="" (females))="" 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="" (males="" and/or="" females).="" 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 equivalent to 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% active ingredient (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 RfD is
based on a NOAEL of 1.8 mg/kg/day and an uncertainty factor (UF) of
100. The NOAEL was established from the chronic toxicity study in dogs
where the NOAEL was 1.8 mg/kg/day based on growth retardation,
alterations in hematology parameters, changes in organ weights, and
histopathological lesions in the bone, spleen, and liver at 8.7 mg/kg/
day. EPA determined that the 10x factor to protect children and infants
(as required by FQPA) should be reduced to 1x. Therefore, the cPAD is
the same as the RfD: 0.018 mg/kg/day. Reducing the 10x factor to 1x 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 residues of tebufenozide in or on pome fruit, apple
pomace, cotton, and cotton gin byproducts at 1.5, 3.0, 1.5, and 30 ppm
respectively and tolerances for the combined residues of 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 in or on the meat of cattle, goats,
hogs, horses, and sheep; the fat of cattle, goats, hogs, horses, and
sheep; meat byproducts of cattle, goats, hogs, horses, and sheep; and
milk at 0.08, 0.1, 0.08, and 0.04 ppm respectively. Risk assessments
were conducted by EPA to assess dietary exposures from tebufenozide 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
[[Page 39063]]
exposure for any significant subpopulation group; and if data are
available on pesticide use and food consumption in a particular area,
the exposure estimate does not understate exposure for the population
in such area. In addition, the Agency must provide for periodic
evaluation of any estimates used. 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.
Estimates of PCT were used as follows. In all cases the maximum
estimates were used.
------------------------------------------------------------------------
Crop Average Maximum
------------------------------------------------------------------------
Almonds...................... <1%><1% beans/peas,="" dry..............=""><0%><1% cole="" crops...................=""><1%><2% spinach,="" fresh...............=""><2%><3% spinach,="" processed...........=""><20%><29% sugarcane....................=""><3%><5% walnuts......................=""><10%><16% ------------------------------------------------------------------------="" the="" following="" market="" share="" data="" obtained="" from="" rohm="" and="" haas="" was="" also="" used:="" ------------------------------------------------------------------------="" crop="" market="" share="" (%)="" ------------------------------------------------------------------------="" sugarcane......................................="" 81.8="" fruiting="" vegetables............................="" 9.9="" leafy="" vegetables...............................="" 14.2="" blueberries....................................="" 25="" ------------------------------------------------------------------------="" where="" market="" share="" information="" was="" available,="" it="" was="" used="" in="" preference="" over="" pct,="" since="" it="" is="" the="" larger="" more="" conservative="" number="" and="" therefore="" more="" protective="" of="" human="" health.="" the="" agency="" believes="" that="" the="" three="" conditions,="" discussed="" in="" section="" 408="" (b)(2)(f)="" 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="" is="" 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="" tebufenozide="" may="" be="" applied="" in="" a="" particular="" area.="" i.="" acute="" exposure="" and="" risk.="" acute="" 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.="" 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.="" epa="" used="" the="" dietary="" exposure="" evaluation="" model="" (deem),="" which="" incorporates="" data="" from="" the="" continuing="" survey="" of="" food="" intakes="" by="" individuals="" (csfii),="" 1989="" to="" 1992.="" in="" conducting="" this="" exposure="" assessment,="" epa="" has="" made="" very="" conservative="" assumptions="" --="" 100%="" of="" pome="" fruit="" and="" cotton="" commodities="" and="" all="" other="" commodities="" having="" tebufenozide="" tolerances="" will="" contain="" tebufenozide="" residues="" and="" those="" residues="" would="" be="" at="" the="" level="" of="" the="" tolerance,="" and="" some="" pct="" and="" market="" share="" data="" for="" selected="" commodities="" --="" which="" result="" in="" an="" overestimate="" of="" human="" dietary="" exposure="" from="" food.="" thus,="" in="" making="" a="" safety="" determination="" for="" this="" tolerance,="" epa="" is="" taking="" into="" account="" this="" conservative="" exposure="" assessment.="" the="" resulting="" estimated="" food="" exposures="" for="" the="" u.s.="" population="" and="" various="" deem="" population="" subgroups="" are="" shown="" in="" the="" following="" table.="" of="" these="" subgroups,="" the="" highest="" exposure="" is="" projected="" for="" children="" ages="" 1-6,="" whose="" chronic="" intake="" is="" estimated="" at="" 18%="" of="" the="" cpad.="" generally,="" in="" the="" absence="" of="" additional="" safety="" factors,="" epa="" is="" not="" concerned="" with="" exposures="" less="" than="" 100%="" of="" the="" cpad.="" thus,="" for="" all="" populations,="" the="" chronic="" human="" health="" risk="" from="" exposure="" to="" tebufenozide="" in="" foods="" is="" below="" epa's="" level="" of="" concern.="" ------------------------------------------------------------------------="">food (mg/kg/
Population Subgroup day) %PAD
------------------------------------------------------------------------
U.S. Population................. 0.001433 8
U.S. Population (autumn season). 0.001461 8
U.S. Population (winter season). 0.001478 8
Northeast region............... 0.001510 8
Pacific region.................. 0.001624 9
Western region.................. 0.001576 9
Non-Hispanic Blacks............. 0.001469 8
Non-Hispanic/non-white/non- 0.001709 10
black).
All infants (< 1="" year)..........="" 0.002109="" 12="" nursing="" infants.................="" 0.000871="" 5="" non-nursing="" infants.............="" 0.002631="" 15="" children="" 1-6="" yrs................="" 0.003251="" 18="" children="" 7-12="" yrs...............="" 0.001899="" 11="" females="" 13+="" (nursing)...........="" 0.001552="" 9="" males="" 13-19="" yrs.................="" 0.001139="" 6="" ------------------------------------------------------------------------="" the="" subgroups="" listed="" above="" are:="" (1)="" the="" u.s.="" population="" (48="" contiguous="" states);="" (2)="" those="" for="" infants="" and="" children;="" (3)="" the="" other="" subgroups="" for="" which="" the="" percentage="" of="" the="" pad="" occupied="" is="" greater="" than="" that="" occupied="" by="" the="" subgroup="" u.s.="" population="" (48="" contiguous="" states);="" and,="" (4)="" other="" population="" subgroups="" of="" particular="" regulatory="" interest.="" 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.="" [[page="" 39064]]="" ii.="" chronic="" exposure="" and="" risk.="" submitted="" environmental="" fate="" studies="" suggest="" that="" tebufenozide="" ranges="" from="" moderately="" persistent="" to="" persistent="" and="" is="" mobile;="" thus,="" tebufenozide="" could="" potentially="" leach="" to="" ground="" water="" and="" runoff="" to="" surface="" water="" under="" certain="" environmental="" conditions.="" there="" is="" no="" established="" maximum="" contaminant="" level="" (mcl)="" for="" residues="" of="" tebufenozide="" in="" drinking="" water.="" no="" drinking="" water="" health="" advisories="" have="" been="" issued="" for="" tebufenozide.="" there="" is="" no="" entry="" for="" tebufenozide="" in="" the="" ``pesticides="" in="" groundwater="" database.''="" monitoring="" data="" are="" not="" available="" to="" assess="" the="" human="" exposure="" to="" tebufenozide="" via="" drinking="" water.="" in="" lieu="" of="" these,="" epa="" has="" calculated="" the="" tier="" i="" estimated="" environmental="" concentrations="" in="" water="" (eecs)="" for="" tebufenozide="" using="" geneec="" (surface="" water)="" and="" scigrow="" (ground="" water)="" for="" use="" in="" the="" human="" health="" risk="" assessment.="" the="" maximum="" application="" rate="" for="" tebufenozide="" is="" 0.25="" lb="" a.i.="" 5="" applications="" per="" year="" on="" pecans.="" this="" application="" scenario="" was="" used="" to="" calculate="" the="" eec="" for="" the="" human="" health="" risk="" assessment.="" due="" to="" the="" wide="" range="" of="" aerobic="" soil="" half-life="" values,="" geneec="" and="" scigrow="" were="" run="" based="" on="" aerobic="" half-="" lives="" of="" 66="" (california="" loam)="" and="" 729="" (worst-case="" soil="" with="" low="" microbial="" activity)="" days.="" for="" surface="" water,="" the="" chronic="" (56-day)="" values="" are="" 13.3="" parts="" per="" billion="" (ppb)="" and="" 16.5="" ppb="" for="" the="" half-lives="" of="" 66="" and="" 729="" days,="" respectively.="" the="" ground="" water="" screening="" concentrations="" are="" 0.16="" ppb="" and="" 1.04="" ppb="" for="" the="" half-lives="" of="" 66="" and="" 729="" days,="" respectively.="" these="" values="" represent="" upper-bound="" estimates="" of="" the="" concentrations="" that="" might="" be="" found="" in="" surface="" and="" ground="" water="" due="" to="" the="" use="" of="" tebufenozide="" on="" pecans.="" in="" performing="" this="" risk="" assessment,="" epa="" has="" calculated="" drinking="" water="" levels="" of="" comparison="" (dwlocs)="" for="" each="" of="" the="" dietary="" exposure="" evaluation="" model="" (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="" drinking="" water="" estimated="" concentrations="" (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="" 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="" tebufenozide="" 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,="" tebufenozide="" 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="" tebufenozide="" 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="" anticipated="" residue="" contribution="" (arc)="" exposure="" assumptions="" described="" in="" this="" unit,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" tebufenozide="" from="" food="" will="" utilize="" 8%="" of="" the="" cpad="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" children="" (1-6="" years="" old)="" at="" 18%="" of="" the="" cpad="" and="" is="" discussed="" below.="" 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="" epa's="" dwloc.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" pad="" because="" the="" pad="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" there="" are="" no="" registered="" residential="" uses="" of="" tebufenozide.="" since="" there="" is="" no="" potential="" for="" exposure="" to="" tebufenozide="" from="" residential="" uses,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" cpad.="" 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.="" in="" assessing="" the="" potential="" for="" additional="" sensitivity="" of="" infants="" and="" children="" to="" residues="" of="" tebufenozide,="" 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="" 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="" uncertainty="" factor="" (usually="" 100="" for="" combined="" inter-="" and="" intraspecies="" variability)="" and="" not="" the="" additional="" tenfold="" moe/uncertainty="" factor="" when="" [[page="" 39065]]="" 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.="" prenatal="" and="" postnatal="" sensitivity.="" the="" toxicology="" data="" base="" for="" tebufenozide="" included="" acceptable="" developmental="" toxicity="" studies="" in="" both="" rats="" and="" rabbits="" as="" well="" as="" a="" 2-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="" 1,000="" mg/kg/day="" in="" rats="" and="" rabbits.="" in="" the="" 2-generation="" reproduction="" studies="" in="" rats,="" effects="" occurred="" at="" the="" same="" or="" lower="" treatment="" levels="" in="" the="" adults="" as="" in="" the="" offspring.="" conclusion.="" there="" is="" a="" complete="" toxicity="" data="" base="" for="" tebufenozide="" and="" exposure="" data="" are="" 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="" no="" more="" than="" 18%="" of="" the="" cpad="" for="" infants="" and="" children.="" epa="" generally="" has="" no="" concern="" for="" exposures="" 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.="" the="" modeling="" data="" for="" tebufenozide="" indicate="" levels="" less="" than="" epa's="" dwloc.="" despite="" the="" potential="" for="" exposure="" to="" tebufenozide="" in="" drinking="" water,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" pad.="" 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.="" iii.="" 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="" high="" pressure="" liquid="" chromatography/ultraviolet="" detection="" (hplc/uv)="" or="" mass="" spectrometry="" detection="" (ms)="" method,="" rohm="" and="" haas="" method="" tr="" 34-96-135,="" and="" its="" earlier="" versions="" tr="" 34-95-154,="" tr="" 34-96-="" 33,="" and="" tr="" 34-97-002="" used="" for="" determining="" residues="" of="" tebufenozide="" in/="" on="" cotton="" matrices="" from="" the="" submitted="" residue="" field="" trials="" and="" processing="" study="" are="" adequate="" for="" collection="" of="" residue="" data.="" adequate="" method="" validation="" and="" concurrent="" method="" recovery="" data="" have="" been="" submitted="" for="" these="" methods.="" the="" limit="" of="" quantitation="" (loq)="" for="" tebufenozide="" is="" 0.01="" ppm="" in/on="" cottonseed,="" meal="" and="" hull.="" the="" loq="" for="" tebufenozide="" is="" 0.025="" ppm="" in/on="" refined="" oil,="" and="" 0.10="" ppm="" in/on="" cotton="" gin="" byproducts.="" the="" reported="" limit="" of="" detection="" (lod)="" for="" tebufenozide="" is="" 0.003="" ppm="" for="" cottonseed,="" meal="" and="" hull,="" 0.008="" ppm="" for="" refined="" oil,="" and="" 0.03="" ppm="" for="" cotton="" gin="" byproducts.="" the="" proposed="" enforcement="" method="" (rohm="" and="" haas="" method="" tr="" 34-96-135)="" has="" undergone="" an="" adequate="" independent="" laboratory="" validation.="" as="" similar="" methods="" for="" walnuts="" and="" apples="" have="" been="" validated="" by="" the="" agency's="" analytical="" chemistry="" laboratory,="" further="" agency="" validation="" of="" method="" tr-34-96-135="" is="" not="" required.="" the="" hplc/uv="" methods,="" rohm="" and="" haas="" methods="" tr="" 34-94-38="" (the="" original="" enforcement="" method="" designation),="" 34-95-66,="" and="" 34-95-188,="" each="" versions="" of="" the="" proposed="" enforcement="" method="" for="" apples="" and="" used="" for="" determining="" residues="" of="" tebufenozide="" in/on="" pome="" fruits,="" are="" adequate="" for="" collection="" of="" residue="" data.="" adequate="" method="" validation="" and="" concurrent="" method="" recovery="" data="" have="" been="" submitted="" for="" these="" methods.="" the="" validated="" loq="" is="" 0.02="" ppm="" for="" residues="" of="" tebufenozide="" in/on="" pears="" and="" apples.="" the="" hplc/uv="" method,="" rohm="" and="" haas="" method="" tr="" 34-96-109="" is="" adequate="" for="" collecting="" data="" on="" residues="" of="" tebufenozide="" in="" animal="" tissues="" and="" milk.="" the="" validated="" loq="" for="" tebufenozide="" in="" animal="" tissue="" and="" milk="" are="" 0.02="" and="" 0.01="" ppm,="" respectively.="" the="" loq="" for="" each="" of="" the="" metabolites="" studied="" are="" as="" follows:="" rh-9526="" and="" rh-0282="" in="" milk,="" 0.01="" ppm;="" rh-2703="" in="" liver,="" 0.02="" ppm;="" rh-9886="" and="" rh-0282="" in="" meat="" 0.02="" ppm;="" rh-9526="" in="" fat,="" 0.02="" ppm.="" the="" lods="" for="" the="" analytes="" are="" 0.003="" ppm="" in="" milk="" and="" 0.006="" ppm="" in="" tissues.="" this="" method="" has="" been="" adequately="" radiovalidated="" using="" samples="" from="" the="" goat="" metabolism="" study="" and="" has="" undergone="" a="" successful="" ilv="" trial.="" a="" copy="" of="" method="" 34-96-109="" has="" been="" forwarded="" to="" the="" analytical="" chemistry="" branch="" (acb)="" for="" evaluation="" 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="" methods="" are="" suitable="" as="" enforcement="" methods="" 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.="" these="" methods="" may="" be="" requested="" from:="" calvin="" furlow,="" prrib,="" irsd="" (7502c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" office="" location="" and="" telephone="" number:="" rm="" 101ff,="" cm="" #2,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va,="" (703)="" 305-5229.="" c.="" magnitude="" of="" residues="" the="" submitted="" data="" from="" 15="" tests="" on="" cotton="" depicting="" residues="" of="" tebufenozide="" in/on="" undelinted="" cottonseed="" and="" cotton="" gin="" byproducts="" [[page="" 39066]]="" are="" adequate.="" residues="" of="" tebufenozide="" were="" 0.02="" to="" 1.43="" ppm="" in/on="" 27="" samples="" of="" undelinted="" cottonseed,="" and="" 1.23="" to="" 30.10="" ppm="" in/on="" 12="" samples="" of="" cotton="" gin="" byproducts="" harvested="" 13="" or="" 14="" days="" following="" four="" applications="" totaling="" 1.04="" lb="" ai/acre/season="" (1x="" proposed="" rate).="" the="" available="" data="" support="" the="" proposed="" 1.5="" ppm="" tolerance="" for="" residues="" of="" tebufenozide="" in/on="" undelinted="" cottonseed.="" in="" addition,="" the="" available="" data="" support="" the="" proposed="" 30.0="" ppm="" tolerance="" for="" residues="" of="" tebufenozide="" in/on="" cotton="" gin="" byproducts.="" the="" submitted="" apple="" and="" pear="" residue="" data="" are="" adequate;="" the="" petitioner="" submitted="" data="" from="" 19="" tests="" on="" apples="" and="" pears,="" representative="" commodities="" of="" the="" pome="" fruits="" crop="" group.="" residues="" of="" tebufenozide="" were="" 0.183="" to="" 1.040="" ppm="" in/on="" apples="" and="" pears="" harvested="" 14="" or="" 15="" days="" following="" the="" last="" of="" six="" foliar="" applications="" of="" tebufenozide="" (70%="" wp="" or="" 2="" lb/gal)="" at="" 0.308="" lb="" a.i./acre/application="" (1.85="" lb="" a.i./acre/season;="" 1x="" the="" proposed="" seasonal="" rate).="" epa="" determined="" that="" the="" crop="" group="" tolerance="" for="" pome="" fruit="" should="" be="" raised="" to="" 1.5="" ppm="" based="" on="" the="" field="" trial="" data.="" the="" submitted="" cow="" feeding="" study="" is="" adequate.the="" proposed="" 0.05="" ppm="" tolerances="" for="" residues="" in="" kidney,="" meat,="" and="" meat="" byproducts="" are="" not="" adequate.="" the="" combined="" residues="" of="" the="" parent="" and="" four="" metabolites="" are="" to="" be="" regulated="" in="" all="" livestock="" commodities.="" for="" tissues,="" the="" sum="" of="" the="" loqs="" for="" parent="" and="" metabolites="" is="" 0.08="" ppm.="" in="" milk,="" the="" combined="" loqs="" would="" be="" 0.04="" ppm.="" the="" appropriate="" tolerances="" for="" meat="" and="" meat="" byproducts="" (of="" cattle,="" goats,="" hogs,="" horses,="" and="" sheep)="" are="" 0.08="" ppm="" (sum="" of="" method="" loqs),="" based="" on="" the="" results="" of="" the="" feeding="" study="" for="" muscle="" and="" liver/kidney,="" respectively.="" in="" the="" case="" of="" fat,="" a="" slightly="" higher="" tolerance="" of="" 0.10="" ppm="" is="" needed.="" in="" the="" case="" of="" milk,="" each="" residue="" measured="" in="" the="" feeding="" study="" was="" below="" its="" loq="" of="" 0.01="" ppm="" at="" the="" 0.84x="" level.="" a="" milk="" tolerance="" of="" 0.04="" ppm="" representing="" the="" sum="" of="" all="" the="" loqs="" is="" appropriate.="" horses="" need="" to="" be="" added="" to="" the="" tissue="" tolerances.="" the="" current="" dietary="" burden="" for="" poultry="" indicates="" that="" finite="" residues="" are="" not="" expected="" in="" eggs="" or="" poultry="" at="" this="" time.="" tebufenozide="" residues="" do="" not="" concentrate="" in="" apple="" juice="" or="" cotton="" oil,="" meal="" and="" hulls.="" d.="" international="" residue="" limits="" codex="" mrls="" have="" been="" established="" for="" residues="" of="" tebufenozide="" in/on="" pome="" fruit="" (1.0="" ppm),="" husked="" rice="" (0.1="" ppm),="" and="" walnuts="" (0.05="" ppm).="" tebufenozide="" is="" registered="" in="" canada,="" and="" a="" tolerance="" for="" residues="" in/="" on="" apples="" is="" established="" at="" 1.0="" ppm.="" the="" u.s.="" field="" trial="" data="" that="" were="" submitted="" in="" support="" of="" the="" proposed="" u.s.="" label="" do="" not="" allow="" the="" u.s.="" tolerance="" of="" 1.5="" ppm="" to="" be="" in="" harmony="" with="" the="" codex="" and="" canadian="" levels="" of="" 1.0="" ppm.="" no="" codex="" mrls="" have="" been="" established="" on="" cotton="" commdities.="" e.="" rotational="" crop="" restrictions="" since="" pome="" fruit="" crops="" perennial="" crops,="" rotational="" crop="" restrictions="" are="" not="" required="" for="" pome="" fruit.="" in="" the="" case="" of="" cotton,="" epa="" has="" determined="" that="" crops="" which="" the="" label="" allows="" to="" be="" treated="" directly="" can="" be="" planted="" at="" any="" time.="" the="" following="" crops="" can="" be="" planted="" 30="" days="" after="" application:="" root/tuber/="" bulb="" vegetables,="" leafy/brassica="" (cole)="" vegetables,="" fruiting/cucurbit="" vegetables.="" all="" other="" crops="" cannot="" be="" planted="" within="" 12="" months="" of="" application.="" the="" latter="" would="" include="" legume="" vegetables,="" cereal="" grains,="" grasses="" and="" non-grass="" animal="" feeds.="" iv.="" conclusion="" therefore,="" the="" tolerance="" is="" established="" for="" residues="" of="" tebufenozide="" in="" pome="" fruit,="" apple="" pomace,="" cotton,="" and="" cotton="" gin="" byproducts="" at="" 1.5,="" 3.0,="" 1.5,="" and="" 30="" ppm="" respectively="" and="" tolerances="" for="" the="" combined="" residues="" of="" 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="" in="" or="" on="" the="" meat="" of="" cattle,="" goats,="" hogs,="" horses,="" and="" sheep;="" the="" fat="" of="" cattle,="" goats,="" hogs,="" horses,="" and="" sheep;="" meat="" byproducts="" of="" cattle,="" goats,="" hogs,="" horses,="" and="" sheep;="" and="" milk="" at="" 0.08,="" 0.1,="" 0.08,="" and="" 0.04="" ppm="" respectively.="" v.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" as="" was="" provided="" in="" the="" old="" section="" 408="" and="" in="" section="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" 60="" days,="" rather="" than="" 30="" days.="" epa="" currently="" has="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" hearing="" requests.="" these="" regulations="" will="" require="" some="" modification="" to="" reflect="" the="" new="" law.="" however,="" until="" those="" modifications="" can="" be="" made,="" epa="" will="" continue="" to="" use="" those="" procedural="" regulations="" with="" appropriate="" adjustments="" to="" reflect="" the="" new="" law.="" any="" person="" may,="" by="" september="" 20,="" 1999,="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" and="" may="" also="" request="" a="" hearing="" on="" those="" objections.="" objections="" and="" hearing="" requests="" must="" be="" filed="" with="" the="" hearing="" clerk,="" at="" the="" address="" given="" under="" the="" ``addresses''="" section="" (40="" cfr="" 178.20).="" a="" copy="" of="" the="" objections="" and/or="" hearing="" requests="" filed="" with="" the="" hearing="" clerk="" should="" be="" submitted="" to="" the="" opp="" docket="" for="" this="" regulation.="" the="" objections="" submitted="" must="" specify="" the="" provisions="" of="" the="" regulation="" deemed="" objectionable="" and="" the="" grounds="" for="" the="" objections="" (40="" cfr="" 178.25).="" each="" objection="" must="" be="" accompanied="" by="" the="" fee="" prescribed="" by="" 40="" cfr="" 180.33(i).="" epa="" is="" authorized="" to="" waive="" any="" fee="" requirement="" ``when="" in="" the="" judgement="" of="" the="" administrator="" such="" a="" waiver="" or="" refund="" is="" equitable="" and="" not="" contrary="" to="" the="" purpose="" of="" this="" subsection.''="" for="" additional="" information="" regarding="" tolerance="" objection="" fee="" waivers,="" contact="" james="" tompkins,="" registration="" division="" (7505c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" office="" location,="" telephone="" number,="" and="" e-mail="" address:="" rm.="" 239,="" cm="" #2,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va,="" (703)="" 305-5697,="">tompkins.jim@epa.gov. Requests for waiver of tolerance
objection fees should be sent to James Hollins, Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
If a hearing is requested, the objections must include a statement
of the factual issues on which a hearing is requested, the requestor's
contentions on such issues, and a summary of any evidence relied upon
by the requestor (40 CFR 178.27). A request for a hearing will be
granted if the Administrator determines that the material submitted
shows the following: There is genuine and substantial issue of fact;
there is a reasonable possibility that available evidence identified by
the requestor would, if established, resolve one or more of such issues
in favor of the requestor, taking into account uncontested claims or
facts to the contrary; and resolution of the factual issues in the
manner sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). Information submitted in connection with an
objection or hearing request may be claimed confidential by marking any
part or all of that information as CBI. Information so marked will not
be disclosed except in accordance with procedures set forth in 40 CFR
part 2.
[[Page 39067]]
A copy of the information that does not contain CBI must be submitted
for inclusion in the public record. Information not marked confidential
may be disclosed publicly by EPA without prior notice.
VI. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300896] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Rm. 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
opp-docket@epa.gov
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit will be kept in paper form.
Accordingly, EPA will transfer any copies of objections and hearing
requests received electronically into printed, paper form as they are
received and will place the paper copies in the official record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations as required by Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994), or require OMB review in accordance with Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997).
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(d), such as the
tolerances in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency
previously assessed whether establishing tolerances, exemptions from
tolerances, raising tolerance levels or expanding exemptions might
adversely impact small entities and concluded, as a generic matter,
that there is no adverse economic impact. The factual basis for the
Agency's generic certification for tolerance actions published on May
4, 1981 (46 FR 24950), and was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and the Comptroller General of the United
States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
[[Page 39068]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 9, 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, paragraph (a) is amended by redesignating the
introductory text to paragraph (a) as paragraph (a)(1); by adding
alphabetically four commodities to the table in newly designated
paragraph (a)(1); and adding paragraph (a)(2) to read as follows:
Sec. 180.482 Tebufenozide; tolerances for residues.
(a) General. (1) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Apple pomace................................... 3.0
Cotton......................................... 1.5
Cotton, gin byproducts......................... 30
* * * * *
Pome Fruit..................................... 1.5
* * * * *
------------------------------------------------------------------------
(2) Tolerances are established for the combined residues of
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.
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Fat of cattle, goats, hogs, horses, and sheep.. 0.1
Meat of cattle, goats, hogs, horses and sheep.. 0.08
Meat byproducts of cattle, goats, hogs, horses 0.08
and sheep.....................................
Milk........................................... 0.04
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-18483 Filed 7-20-99; 8:45 am]
BILLING CODE 6560-50-F
