[Federal Register Volume 64, Number 125 (Wednesday, June 30, 1999)]
[Rules and Regulations]
[Pages 35058-35067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16637]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300887; FRL-6088-9]
RIN 2070-AB78
Cyfluthrin: [cyano[4-fluoro-3-phenoxyphenyl]-methyl-3-[2,2-
dichloroethenyl]-2,2-dimethyl-cyclopropanecarboxylate]; Pesticide
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of the
insecticide cyfluthrin: [cyano[4-fluoro-3-phenoxyphenyl]-methyl-3-[2,2-
dichloroethenyl]-2,2-dimethyl-cyclopropanecarboxylate] in or on
potatoes at 0.01 parts per million (ppm). It also removes time
limitations for tolerances for residues of cyfluthrin on sweet corn,
field corn, and pop corn (including forage and fodder). Bayer
Corporation requested this tolerance under the Federal Food, Drug, and
Cosmetic Act, as amended by the Food Quality Protection Act of 1996.
DATES: This regulation is effective June 30, 1999. Objections and
requests for hearings must be received by EPA on or before August 30,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300887], 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-300887], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of
[[Page 35059]]
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-300887]. 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: Mark Dow, 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) 305-5533, dow.mark@epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 5, 1995 (60
FR 34874) (FRL-4963-2), EPA issued a time-limited tolerance for
cyfluthrin use in or on corn (field, pop, and sweet) in combination
with another insecticide, the organophosphate tebupirimifos (originally
known as phostebupirim) (O-[2-(1-dimethylethyl)-5-pyrimidinyl]O-ethyl-
O-ethyl-O-(1-methylethyl)phosphorothioate) with an expiration date of 5
July 1999. These time-limited tolerances were established due to a lack
of mammalian neurotoxicity data and the need for confirmatory soil
metabolism and product chemistry data for tebupirimiphos. Bayer
Corporation requested the Agency to remove the time limitations for
cyfluthrin on corn in a notice of filing published in the Federal
Register of September 25, 1997 (62 FR 50337) (FRL-5748-2), and in a
March 8, 1999 letter based on the fact that the time limitation was due
to data deficiencies for tebupirimifos and not for cyfluthrin. Since
(1) cyfluthrin is registered for use on corn; (2) the data base is
complete for tolerance assessment purposes and ; (3) these tolerances
were considered by EPA for risk assessment purposes, EPA has no
objection to the removal of the time-limitations and the establishment
of permanent tolerances for the residues of cyfluthrin on corn. In the
Federal Register of August 14, 1998 (63 FR 43705) (FRL-6019-8), 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) (Public Law 104-170) announcing the
filing of a pesticide petition (PP) 4F4330 for tolerance by Bayer
Corporation, 8400 Hawthorn Road, Kansas City, MO 64120. This notice
included a summary of the petition prepared by Bayer Corporation, the
registrant.
The petition requested that 40 CFR 180.436 be amended by
establishing a tolerance for residues of the insecticide cyfluthrin:
[cyano[4-fluoro-3-phenoxyphenyl]-methyl-3-[2,2-dichloroethenyl]-2,2-
dimethyl-cyclopropanecarboxylate], in or on potatoes at 0.01 ppm.
Cyfluthrin controls cabbage looper, potato leafhopper, Colorado potato
beetle, European corn borer, flea beetles, potato tuberworm, potato
psyllid, tarnished plant bug and aphids on potatoes.
There were no comments received in response to the Notices of
Filing.
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
cyfluthrin: [cyano[4-fluoro-3-phenoxyphenyl]-methyl-3-[2,2-
dichloroethenyl]-2,2-dimethyl-cyclopropanecarboxylate] and to make a
determination on aggregate exposure, consistent with section 408(b)(2),
for a tolerance for residues of cyfluthrin on potatoes at 0.01 ppm and
removal of time limitations for tolerances for residues of cyfluthrin
on corn (field, pop, and sweet). 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 cyfluthrin are
discussed in this unit.
1. Acute toxicity. The required toxicity battery studies for acute
oral (LD50 16.2 miligrams/kilograms (mg/kg)),
dermal (LD50 >5,000 mg/kg), inhalation (LC50
0.468 mg/liter (L)), primary eye irritation (category III),
primary dermal irritation (category IV), and dermal sensitization have
been conducted and were found adequate. Cyfluthrin is not a dermal
sensitizer.
2. Mutagenicity. There are seven acceptable studies upon which the
Agency based its evaluation: three reverse mutation assays (Salmonella
typhimurium, E. coli and Saccharomyces cerevisiae); one reverse
mutation, mitotic recombination and conversion assay in Saccharomyces
cerevisiae); one Chinese Hampster Ovary/ Hypoxanthine guanine
phophoribosyl transferase (CHO/HGPRT) assay; one sister chromatid
exchange assay in CHO cells; and one Unscheduled DNA synthesis (UDS)
assay in primary rat hepatocytes. All these studies were negative.
There is no mutagenicity concern.
3. Reproductive and developmental toxicity -- i. Oral developmental
study in rats. Cyfluthrin was administered via gavage to pregnant
female rats during
[[Page 35060]]
days 6-15 of gestation at dose levels of 0, 1, 3, or 10 mg/kg/day. A
maternal Lowest Observable Adverse Effect Level (LOAEL) was not
observed (i.e., the maternal No Observable Adverse Effect Level (NOAEL)
is 10 mg/kg/day). A developmental LOAEL was not observed.
The developmental NOAEL is 10mg/kg/day. This developmental
study in rats was classified core guideline.
ii. Oral developmental study in rabbits. Cyfluthrin was
administered via gavage to pregnant female rabbits during days 6-18 of
gestation at dose levels of 0, 20, 60, or 180 mg/kg/day. The maternal
LOAEL is 60 mg/kg/day based on decreased body weight gain and food
consumption during the dosing period. The maternal NOAEL is 20 mg/kg/
day. The developmental LOAEL is 60 mg/kg/day based on increased numbers
of resorptions and percent incidence of postimplantation loss. The
developmental NOAEL is 20 mg/kg/day. This study was classified core
guideline.
iii. Rat developmental studies via inhalation. In the first study,
pregnant female rats at day 0 gestation were exposed head-only to
cyfluthrin concentrations of 0, 1.1, 4.7 or 23.7mg/m3/day
(milligrams per cubic meter per day) for 6 hours/day on gestation days
6-15. In the second study, the dams were exposed to analytical
concentrations of 0, 0.09, 0.25, 0.59 or 4.2 mg/m3 of the
test material. The dams were sacrificed on day 20 and their pups
removed by caesarian section. The maternal NOAEL was 1.1 mg/
m3 and the maternal LOAEL was 4.7 mg/m3 (reduced
motility, dyspnea, piloerection, ungroomed coats and eye irritation).
The developmental NOAEL was 0.59 mg/m3 and the developmental
LOAEL was 1.1 mg/m3 based on increases in the incidence of
runts and skeletal anomalies in the sternum (1.1 mg/m3 and
above); and increases in post-implantation losses and decreases in pup
weights (4.7 mg/m3 and above) and increased incidences of
late embryonic deaths, in skeletal anomalies in the extremities, pelvis
and skull and microphthalmia (23.7mg/m3). The study was
graded core minimum.
In a third study, a developmental toxicity study via inhalation,
cyfluthrin was administered to female rats at 0.46, 2.55, 11.9 or 12.8
mg/m3 exposure levels for gestational days 6-15 in a nose
only inhalation chamber. The rats were exposed to the test material 6
hr/day, 7 days/week. The maternal NOAEL/LOAEL were <0.46><0.46 mg/="">3 based on decreased body weight gain and reduced relative
food efficiency. The developmental NOAEL/LOAEL were 0.46/2.55 mg/
m3 based on reduced fetal and placental weight, reduced
ossification in the phalanx, metacarpals and vertebrae. This study was
classified as core guideline.
iv. 3-Generation reproduction study. Cyfluthrin was administered in
the diet to male and female rats dose levels of 0, 50, 150, or 450 ppm
(actual animal intake; 0, 2.5, 7.5, or 22.5 mg/kg/day). The LOAEL for
parental toxicity was 450 ppm (22.5 mg/kg/day) based on decreased body
weight gains. The NOAEL for parental toxicity is 150 ppm (7.5 mg/kg/
day). The LOAEL for reproductive toxicity was 150 ppm (7.5 mg/kg/day)
based on decreased viability and lactational indices and decreased pup
body weight gains. The reproductive NOAEL was 50 ppm (2.5 mg/kg/day).
The multigeneration reproductive study in the rat was classified core
minimum.
4. Subchronic toxicity -- i. 28-Day oral toxicity study in rats.
Cyfluthrin was administered to SPF-Wistar rats via gavage at 0, 5, 20,
or 80 (40) mg/kg/day. The high dose was 80 mg/kg/day during the first
and third weeks and 40 mg/kg/day during the second and fourth weeks.
The LOAEL was 80 (40) mg/kg/day in both sexes based on clinical signs
of nerve toxicity, decreases in body weight gain, and changes in liver
and adrenal weights. The NOAEL was 20 mg/kg/day. This study was
classified as core minimum.
ii. 28-Day oral toxicity study in rats. Rats were dosed with
cyfluthrin in the diet at 0, 100, 300, or 1,000 ppm (equivalent to 0,
5, 15, or 50 mg/kg/day). The LOAEL was 15 mg/kg/day in both sexes based
on decreased blood glucose. The NOAEL was 5 mg/kg/day. This study was
classified core supplementary.
iii. 3-Month feeding study in rats. SPF Wistar rats were dosed with
cyfluthrin in the diet at 0, 30, 100, or 300 ppm (equivalent to 0, 1.5,
5, or 15 mg/kg/day) for 3 months. No treatment related effects were
observed at any of the levels tested, thus the NOAEL for this 3-month
rat feeding study was 15 mg/kg/day for both sexes. This study was
classified core minimum.
iv. 6-Month dog feeding study. Cyfluthrin was administered in the
diet to dogs at 0, 65, 200 or 600 ppm (equivalent to 0, 1.62, 5 or 15
mg/kg/day) for 26 weeks. The LOAEL for this study was 15 mg/kg/day for
both sexes, based on neurological effects (hindlimb abnormalities) and
gastrointestinal disturbances. The NOAEL was 5 mg/kg/day for males and
females. The study was classified as core minimum.
v. 21-Day dermal study in rats. In a 21-day repeated dose dermal
toxicity study, male and female rats were treated with cyfluthrin by
dermal occlusion at target doses of 0, 100, 340, or 1,000 mg/kg/day for
6 hours/day (average actual dose levels were 0, 113, 376, or 1,077 mg/
kg/day). No mortality was observed, and there were no treatment-related
effects on body weight, ophthalmology, organ weights, clinical
biochemistry, or hematology. The LOAEL for dermal effects was 376 mg/
kg/day for male and female Sprague-Dawley rats based on gross and
histological skin lesions. The NOAEL for dermal effects for technical
Baythroid was 113 mg/kg/day. The LOAEL for systemic effects was 1,077
mg/kg/day based on decreased food consumption, red nasal discharge and
urine staining. The NOAEL for systemic effects was 376 mg/kg/day. This
study was classified as acceptable.
vi. 3-Week inhalation toxicity studies in rats --a. Wistar rats
were dynamically exposed by nose-only inhalation to cyfluthrin at
concentrations of 0, 2.3, 11.5, or 69.6 mg/kg/day for 6 hours/day, 5
consecutive days/week for 3 weeks (total of 15 exposures). The LOAEL
was 2.3 mg/m3, based on the treatment-related effects on
body weight and temperature observed during the 3-week exposure period.
A NOAEL was not established; therefore this study was repeated using
lower doses.
b. Wistar rats were dynamically exposed by nose-only inhalation to
cyfluthrin at concentrations of 0, 0.4, 1.4, or 10.5 mg/m3
for 6 hours/day, 5 consecutive days/week for 3 weeks (total of 15
exposures). The LOAEL was 10.5 mg/m3, based on the
treatment-related behavioral effects as well as effects on body and
organ (spleen) weights. The NOAEL is 1.4 mg/m3. These
studies were classified as core minimum.
vii. 4-Week inhalation toxicity study in rats. Rats were
dynamically exposed by inhalation (nose only) to cyfluthrin at
concentrations of 0, 0.44, 6.04, or 46.6 mg/m3 for 6 hours/
day, 5 consecutive days/week for 4 weeks (20 exposures). The LOAEL is
6.04 mg/m3 based on the decrease in body and thymus weights,
hypothermia, reduction in leukocytes counts (females), and low serum
protein. The NOAEL is 0.44 mg/m3. This subacute inhalation
toxicity study in rats was classified as supplementary.
viii. 13-Week inhalation toxicity study in rats. Rats were
dynamically exposed by head-only inhalation to cyfluthrin at
concentrations of 0, 0.09, 0.71, or 4.51 mg/m3 for 6 hours/
day, 5 consecutive days/week for 13 weeks. All animals survived the 13-
week study, and no treatment-related changes were observed in organ
weight, gross pathology and histopathology. The LOAEL was 0.71 mg/
m3, based on the
[[Page 35061]]
treatment-related behavioral effects in females as well as the
increased urinary protein in males. The NOAEL was 0.09 mg/
m3. This study was classified as core minimum.
5. Chronic toxicity -- i. 1-Year dog study. Cyfluthrin was fed to
beagle dogs at 0, 40, 160, or 640 ppm (equivalent to 0, 1, 4, or 16 mg/
kg/day) for 52 weeks. The NOAEL was 4 mg/kg bw/day. The LOAEL was 16
mg/kg bw/day for both sexes, based on slight ataxia in two dogs on
single occasions, decreased body weight in males, and on observations
of increased vomiting and diarrhea at the high dose. The NOAEL is 4 mg/
kg bw/day. This study was classified as core minimum.
ii. Chronic/carcinogenicity-rat. Cyfluthrin was administered for 24
months in the diet to rats at dose levels of 0, 50, 150, or 450 ppm
(equivalent to 2.02, 6.19, or 19.20 mg/kg bw/day in males and 2.71,
8.15, or 25.47 mg/kg/day in females based on food consumption and body
weights). The chronic LOAEL was 150 ppm (equivalent to 6.19 mg/kg/day
in males and 8.15 mg/kg/day in females) based on decreased body weights
in the high-dose animals and the mid-dose males. The chronic NOAEL was
50 ppm (equivalent to 2.02 mg/kg/day in males and 2.71 mg/kg/day in
females). Under the conditions of this study, there was no evidence of
carcinogenic potential. The study was classified core minimum for both
chronic toxicity and oncogenicity.
iii. Chronic/carcinogenicity- mouse. In a chronic/carcinogenicity
study, cyfluthrin was administered in the diet for 23 months to mice at
dose levels of 0, 50, 200, or 800 ppm (equivalent to 11.6, 45.8, or
194.5 mg/kg/day in males and 15.3, 63.0, or 259.9 in females based on
food consumption and body weights). There were no treatment related
changes noted in the clinical observation, food consumption,
hematology, gross observation, organ weight, and microscopic data. The
chronic LOAEL is 50 ppm (equivalent to 11.6 mg/kg/day in males and 15.3
mg/kg/day in females) based on increased alkaline phosphatase activity
in the dosed males. A chronic NOAEL was not established in male and
female mice. Under the conditions of this study, there was no evidence
of carcinogenic potential. This study was classified core minimum for
carcinogenicity and supplementary for chronic toxicity.
6. Animal metabolism. Metabolism studies in rats showed that
cyfluthrin is rapidly absorbed and excreted, mostly as conjugated
metabolites in the urine, within 48 hours. An enterohepatic circulation
was observed.
7. Neurotoxicity. Other studies evaluated included a subacute oral
neurotoxicity study in rats (LOAEL of 50 mg/kg/day; no NOAEL observed);
a second subacute oral neurotoxicity study (NOAEL of 40 mg/kg/day); a
subchronic neurotoxicity study in rats (NOAEL <60 mg/kg/day),="" and="" a="" subacute="" inhalation="" study="" in="" mice="" noael="" for="" pups,="" 0.006="" mg/l;="" parental="" noael="" 0.058="" mg/l="" highest="" dose="" tested="" (hdt).="" these="" studies="" were="" all="" graded="" acceptable/guideline.="" additional="" neurotoxicity="" data="" may="" be="" required="" under="" a="" special="" data-call-in="" letter="" pursuant="" to="" section="" 3(c)(2)(b)="" of="" fifra.="" although="" these="" data="" are="" lacking,="" epa="" has="" a="" sufficient="" toxicity="" data="" base="" to="" support="" these="" tolerances="" and="" these="" additional="" studies="" are="" not="" expected="" to="" significantly="" change="" its="" risk="" assessment.="" b.="" toxicological="" endpoints="" the="" agency="" has="" determined="" that="" an="" additional="" uncertainty="" factor="" (uf)="" is="" needed="" for="" risk="" assessments="" for="" cyfluthrin="" because="" there="" was="" evidence="" of="" increased="" sensitivity="" of="" pups="" in="" the="" 3-generation="" reproduction="" study="" based="" on="" decreased="" pup="" weight="" gains="" at="" a="" dose="" in="" which="" there="" were="" no="" effects="" in="" the="" parents.="" the="" fqpa="" factor="" of="" 10="" was="" reduced="" to="" 3x="" because="" of="" the="" lack="" of="" severity="" of="" effects="" (reduced="" body="" weight="" gain="" in="" pups)="" and="" the="" availability="" of="" acceptable="" reproduction="" (rat)="" and="" developmental="" (rats="" and="" rabbits)="" toxicity="" studies.="" 1.="" acute="" toxicity="" --="" acute="" dietary.="" to="" assess="" acute="" dietary="" risk,="" the="" agency="" used="" an="" endpoint="" of="" 20="" mg/kg/day="" from="" the="" rabbit="" developmental="" study.="" this="" endpoint="" is="" due="" to="" increases="" in="" resorption="" and="" percent="" incidence="" of="" postimplantation="" loss="" at="" the="" lowest="" effect="" level="" (lel)="" of="" 60="" mg/kg/day.="" the="" population="" adjusted="" dose="" for="" acute="" dietary="" (apad)="" is="" determined="" by="" dividing="" noael="" by="" ufs="" of="" 300="" (10x="" for="" interspecies="" differences,="" 10x="" for="" intraspecies="" variability="" and="" 3x="" fqpa="" safety="" factor):="" apad="20/" (10x="" 10x="" 3)="0.07" mg/kg="" bwt/day.="" this="" apad="" applies="" to="" all="" population="" subgroups.="" 2.="" short="" and="" intermediate="" term="" toxicity.="" for="" the="" short="" and="" intermediate="" term="" dermal="" endpoints,="" a="" noael="" of="" 20="" mg/kg/day="" was="" determined="" from="" the="" rabbit="" developmental="" study="" due="" to="" an="" increase="" in="" resorption="" and="" percent="" incidence="" of="" postimplantation="" loss="" at="" the="" lel="" of="" 60="" mg/kg/day.="" the="" dermal="" absorption="" rate="" is="" 25%.="" this="" rate="" is="" based="" on="" the="" weight="" of="" the="" evidence="" available="" for="" structurally="" related="" synthetic="" pyrethroids.="" for="" short="" term="" inhalation="" a="" noael="" of="" 0.00044="" mg/l="" is="" based="" on="" decreases="" in="" body="" and="" thymus="" weights,="" hypothermia,="" and="" clinical="" pathology="" at="" 0.00604="" mg/l="" in="" a="" 28-day="" inhalation="" study.="" for="" the="" intermediate="" term="" inhalation="" endpoint="" a="" noael="" of="" 0.00009="" mg/l="" is="" based="" on="" behavioral="" effects="" in="" rats="" at="" 0.00071="" mg/l="" in="" a="" 90-day="" inhalation="" study.="" the="" 3x="" fqpa="" uf="" was="" included="" for="" inhalation="" because="" an="" inhalation="" study="" is="" available="" in="" the="" mouse="" which="" indicates="" increased="" sensitivity="" of="" the="" pups="" in="" comparison="" to="" the="" dams.="" 3.="" chronic="" toxicity="" --="" chronic="" dietary.="" a="" noael="" of="" 2.5="" mg/kg/day="" was="" determined="" from="" the="" rat="" chronic="" toxicity/="" carcinogenicity="" study="" and="" is="" based="" on="" decreased="" body="" weight="" gains="" in="" males="" and="" inflammatory="" foci="" in="" the="" kidneys="" of="" females="" at="" the="" lel="" of="" 6.2="" mg/kg/day.="" the="" chronic="" population="" adjusted="" dose="" (cpad)="" is="" determined="" by="" dividing="" the="" noael="" by="" ufs:="" cpad="2.5/" (10x10x3)="0.008" mg/kg="" bwt/day.="" this="" cpad="" applies="" to="" all="" population="" subgroups.="" long-term="" dermal="" endpoint="" for="" the="" chronic="" dermal="" endpoint,="" the="" same="" study="" used="" for="" determining="" the="" chronic="" dietary="" endpoint="" was="" used="" here.="" 4.="" carcinogenicity.="" cyfluthrin="" has="" been="" classified="" as="" a="" group="" e="" chemical="" (evidence="" of="" non-carcinogenicity="" in="" humans),="" since="" carcinogenicity="" studies="" in="" rats="" and="" mice="" were="" negative.="" c.="" exposures="" and="" risks="" 1.="" from="" food="" and="" feed="" uses.="" tolerances="" have="" been="" established="" (40="" cfr="" 180.436)="" for="" the="" residues="" of="" cyfluthrin,="" in="" or="" on="" a="" variety="" of="" raw="" agricultural="" commodities.="" for="" purposes="" of="" dietary="" risk="" assessment,="" residue="" data="" generated="" from="" residue="" field="" trials="" conducted="" at="" maximum="" application="" rates="" and="" minimum="" preharvest="" intervals="" were="" used.="" to="" assess="" secondary="" exposure="" from="" edible="" animal="" commodities,="" animal="" dietary="" burdens="" were="" calculated="" using="" mean="" field="" trial="" residues,="" adjusted="" for="" percent="" crop="" treated="" (pct)="" and="" applying="" appropriate="" processing="" factors="" for="" all="" feed="" items.="" risk="" assessments="" were="" conducted="" by="" epa="" to="" assess="" dietary="" exposures="" from="" cyfluthrin="" as="" follows:="" i.="" acute="" dietary="" exposure="" and="" risk.="" apad="0.07" mg/kg="" bwt/day.="" apad="NOAEL/UFs" =="" 20/(10="" x="" 10="" x="" 3)="0.07" mg/kg="" bwt/day.="" an="" acute="" dietary="" (food)="" risk="" assessment="" was="" conducted.="" in="" the="" assessment,="" a="" monte="" carlo="" analysis="" (tier="" 3)="" was="" used.="" the="" anticipated="" residue="" values="" used="" were="" determined="" from="" field="" trial="" data="" reflecting="" maximum="" application="" rates="" and="" minimum="" preharvest="" intervals.="" field="" trial="" residue="" distributions="" were="" used="" in="" the="" monte="" carlo="" simulation="" for="" those="" foods="" [[page="" 35062]]="" identified="" by="" epa="" as="" single-serving="" commodities.="" for="" those="" considered="" to="" be="" blended="" or="" processed,="" mean="" field="" trial="" residues="" were="" calculated,="" substituting="" the="" full="" limit="" of="" detection="" (lod)="" for="" those="" samples="" for="" which="" residues="" were="" reported="" below="" the="" lod.="" for="" the="" analysis,="" current="" registered="" uses="" plus="" potatoes="" were="" used.="" in="" the="" monte="" carlo="" analysis="" for="" potatoes,="" the="" tolerance="" used="" is="" 0.01="" ppm="" and="" 100%="" crop="" treated="" was="" assumed.="" data="" files="" used="" include="" (a)="" the="" highest="" field="" trial="" data="" for="" dried="" hops="" (16.6="" ppm)="" and="" radishes="" (0.38="" ppm)="" were="" used="" instead="" of="" the="" tolerances="" (dried="" hops:="" 20="" ppm,="" radishes:="" 1.0="" ppm);="" (b)="" processing="" factors="" for="" corn="" were="" used="" since="" the="" processing="" study="" was="" available="" (concentration="" factor="" for="" corn="" oil:="" 7.6="" );="" (c)="" new="" available="" residue="" levels="" on="" potato="" and="" its="" commodities,="" all="" at="" 0.01="" ppm="" (lod),="" were="" used;="" (d)="" secondary="" residues="" in="" milk,="" milk="" sugar,="" milk="" based="" water,="" and="" animal="" fat="" were="" adjusted="" (decreased)="" due="" to="" the="" slight="" change="" of="" dietary="" burden="" as="" a="" result="" of="" the="" above="" changes.="" analysis="" evaluates="" individual="" food="" consumption="" as="" reported="" in="" the="" usda="" continuing="" surveys="" of="" food="" intake="" by="" individuals="" conducted="" in="" 1989="" through="" 1992.="" the="" model="" accumulates="" exposure="" to="" the="" chemical="" for="" each="" commodity="" and="" expresses="" risk="" as="" a="" function="" of="" dietary="" exposure.="" resulting="" exposure="" values="" (at="" the="" 99.9th="" percentile)="" and="" percentage="" of="" the="" apad="" utilized="" are="" shown="" in="" table="" 1.="" the="" most="" highly="" exposed="" population="" subgroup="" (non-nursing="" infants,=""><1 year)="" utilizes="" 9.7%="" of="" the="" apad.="" an="" acceptable="" acute="" dietary="" exposure="" (food="" plus="" water)="" of="" 100%="" or="" less="" of="" the="" apad="" is="" needed="" to="" protect="" the="" safety="" of="" all="" population="" subgroups.="" epa="" generally="" has="" no="" concern="" for="" apad="" of="" less="" than="" 100%.="" table="" 1.="" acute="" dietary="" (food="" only)="" exposure="" analysis="" by="" dietary="" exposure="" evaluation="" model="" (deem)="" for="" cyfluthrin="" ----------------------------------------------------------------------------------------------------------------="" exposure="" @="" 99.9th="" percentile="" (mg/="" population="" subgroup="" kg="" bwt/day)="" percent="" apad\1\="" ----------------------------------------------------------------------------------------------------------------="" u.s.="" population="" (48="" contiguous="" states)..="" 0.0045="" 6.4%="" all="" infants="">< 1="" yr)....................="" 0.0062="" 8.9%="" nursing="" infants="">< 1="" yr)................="" 0.0037="" 5.3%="" non-nursing="" infants="">< 1="" yr)............="" 0.0068="" 9.7%="" children="" (1-6="" yrs)......................="" 0.0059="" 8.4%="" children="" (7-12="" yr)......................="" 0.0042="" 6.0%="" ----------------------------------------------------------------------------------------------------------------="" \1\percentage="" acute="" pad="" (%="" apad)="Exposure" x="" 100%="" apad="" the="" subgroups="" listed="" above="" are:="" (1)="" the="" u.s.="" population="" (48="" contiguos="" states)="" and="" (2)="" those="" for="" infants="" and="" children.="" ii.="" chronic="" dietary="" exposure="" and="" risk.="" cpad="0.008" mg/kg="" bwt/day.="" cpad="NOAEL/" ufs="2.5/" (10="" x10="" x3)="0.008" mg/kg="" bwt/day.="" in="" the="" deem="" analysis="" for="" chronic="" dietary="" (food="" only)="" risk="" assessment="" the="" anticipated="" residue="" values="" used="" were="" determined="" from="" field="" trial="" data="" conducted="" at="" maximum="" application="" rates="" and="" minimum="" preharvest="" intervals.="" mean="" anticipated="" residue="" values="" were="" calculated="" substituting="" half="" of="" the="" lod="" for="" those="" samples="" for="" which="" residues="" were="" reported="" below="" the="" lod.="" for="" the="" chronic="" dietary="" analysis,="" all="" registered="" food="" uses="" plus="" potatoes="" were="" included.="" in="" the="" analysis,="" the="" residue="" levels="" used="" for="" potatoes="" and="" potato="" commodities="" are="" all="" 0.005="" ppm,="" and="" 100%="" crop="" treated="" was="" assumed.="" other="" ``assumptions''="" are:="" (1)="" mean="" field="" trial="" data="" for="" radishes="" (0.09="" ppm)="" and="" hops="" (13.7="" ppm)="" have="" been="" used="" instead="" of="" tolerances;="" (2)="" residue="" for="" alfalfa="" sprout="" was="" adjusted="" for="" the="" percent="" crop="" treated="" (from="" 0.01="" ppm="" to="" 0.14="" ppm);="" (3)="" processing="" factors="" for="" citrus,="" corn,="" cottonseed,="" sugarcane,="" sunflower,="" and="" tomatoes="" were="" used="" since="" these="" processing="" studies="" were="" available;="" (4)="" residue="" levels="" used="" for="" potatoes="" and="" potato="" commodities="" were="" changed="" from="" 0.05="" ppm="" to="" 0.005="" ppm(half="" of="" lod);="" (5)="" secondary="" residues="" in="" meat,="" milk,="" poultry,="" and="" eggs="" were="" adjusted="" since="" the="" slight="" change="" of="" dietary="" burden="" as="" a="" result="" of="" the="" above="" changes="" (meat="" and="" poultry:="" slight="" decrease="" in="" residue="" levels,="" milk="" and="" milk-based="" water:="" slight="" increase="" in="" residue="" levels).="" 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="" anticipated="" residue="" concentration="" (arc)="" and="" their="" representations="" as="" percentages="" of="" cpad="" for="" the="" general="" population="" and="" subgroups="" of="" interest="" are="" in="" table="" 2.="" the="" most="" highly="" exposed="" population="" subgroup="" (non-nursing="" infants="">< 1yr)="" will="" utilize="" 1.9%="" of="" the="" cpad.="" an="" acceptable="" chronic="" dietary="" exposure="" (food="" plus="" water)="" of="" 100%="" or="" less="" of="" the="" cpad="" is="" needed="" to="" protect="" the="" safety="" of="" all="" population="" subgroups.="" epa="" generally="" has="" no="" concern="" for="" cpad="" of="" less="" than="" 100%.="" table="" 2.="" chronic="" exposure="" analysis="" by="" the="" deem="" system="" for="" cyfluthrin="" ----------------------------------------------------------------------------------------------------------------="" population="" subgroup="" exposure="" (mg/kg/day)="" percent="" cpad\1\="" ----------------------------------------------------------------------------------------------------------------="" u.s.="" population="" (48="" contiguous="" states)..="" 0.000067="" 0.8%="" non-nursing="" infants=""><1 year="" old).......="" 0.00015="" 1.9%="" children="" (1-6="" years="" old)................="" 0.00014="" 1.8%="" ----------------------------------------------------------------------------------------------------------------="" \1\percentage="" cpad="Exposure" x="" 100%="" cpad="" the="" subgroups="" listed="" above="" are:="" (1)="" the="" u.s.="" population="" (48="" contiguous="" states);="" (2)="" highest="" exposed="" population="" subgroup="" that="" includes="" infants="" and="" children.="" section="" 408(b)(2)(e)="" authorizes="" epa="" to="" use="" available="" data="" and="" information="" on="" the="" anticipated="" residue="" levels="" of="" pesticide="" residues="" in="" food="" and="" the="" actual="" levels="" of="" pesticide="" chemicals="" that="" have="" been="" measured="" in="" food.="" if="" epa="" relies="" on="" such="" information,="" epa="" must="" require="" that="" data="" be="" provided="" 5="" years="" after="" the="" tolerance="" is="" established,="" modified,="" or="" left="" in="" effect,="" demonstrating="" that="" the="" levels="" in="" food="" are="" not="" above="" the="" levels="" anticipated.="" following="" the="" initial="" data="" submission,="" epa="" is="" authorized="" to="" require="" similar="" data="" on="" a="" time="" frame="" it="" deems="" appropriate.="" [[page="" 35063]]="" as="" required="" by="" section="" 408(b)(2)(e),="" epa="" will="" issue="" a="" data="" call-in="" for="" information="" relating="" to="" anticipated="" residues="" to="" be="" submitted="" no="" later="" than="" 5="" years="" from="" the="" date="" of="" issuance="" of="" the="" tolerance.="" section="" 408(b)(2)(f)="" states="" that="" the="" agency="" may="" use="" data="" on="" the="" actual="" pct="" for="" assessing="" chronic="" dietary="" risk="" only="" if="" the="" agency="" can="" make="" the="" following="" findings:="" (1)="" 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;="" (2)="" that="" the="" exposure="" estimate="" does="" not="" underestimate="" exposure="" for="" any="" significant="" subpopulation="" group="" and;="" (3)="" 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="" the="" section="" 408="" (b)(2)(f),="" epa="" may="" require="" registrants="" to="" submit="" data="" on="" pct.="" 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.="" with="" respect="" to="" (1),="" percent="" crop="" treated="" 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="" percent="" of="" crop="" treated,="" the="" agency="" is="" reasonably="" certain="" that="" the="" percentage="" of="" the="" food="" treated="" is="" not="" likely="" to="" be="" an="" underestimate.="" as="" to="" (2)="" and="" (3),="" regional="" consumption="" information="" and="" consumption="" information="" for="" significant="" sub="" populations="" 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="" sub="" population="" group="" and="" allows="" the="" agency="" to="" be="" reasonably="" certain="" that="" no="" regional="" pupulation="" 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.="" epa="" finds="" that="" the="" pct="" information="" is="" reliable="" and="" has="" a="" valid="" basis.="" 2.="" from="" drinking="" water.="" there="" is="" no="" established="" maximum="" concentration="" level="" for="" residues="" of="" cyfluthrin="" in="" drinking="" water.="" although="" data="" indicate="" little="" potential="" for="" soil="" mobility="" or="" leaching,="" cyfluthrin="" is="" moderately="" persistent.="" estimates="" of="" potential="" concentrations="" of="" cyfluthrin="" in="" water="" were="" generated="" with="" the="" pesticide="" root="" zone="" model="" (="" przm="" 1)="" and="" exposure="" analysis="" modeling="" system="" (exams)="" computer="" models="" in="" 1993="" for="" comparative="" ecological="" risk="" assessment="" for="" cyfluthrin.="" the="" estimated="" environmental="" concentrations="" (eecs)="" of="" cyfluthrin="" residues="" are="" 0.236="">g/L for acute surface water and
0.044 g/L for chronic surface water. The primary use of these
models is to provide a screen for sorting out pesticides for which EPA
has a high degree of confidence tht the true levels of the pesticide in
drinking water will be less that the human health drinking water levels
of concern (DWLOCs). A DWLOC is a theoretical upper limit of a
pesticide's concentration in drinking water in light of total aggregate
exposure to that pesticide in food and through residential uses. A
DWLOC will vary depending on the toxic endpoint, consumption and body
weight. Different populations will have different DWLOCs. EPA uses
DWLOCs internally in the risk assessment process as a surrogate measure
of potential exposure associated with pesticide exposure through
drinking water. In the absence of monitoring data for pesticides, the
DWLOC is used as a point of comparison against conservative model
estimates of potential pesticide concentration in water. DWLOC values
are not regulatory standards for drinking water.
For this acute risk assessment, the estimated maximum concentration
for cyfluthrin in surface and ground waters (which is 0.236 g/
L) is used for comparison to the back-calculated human health drinking
water levels of concern (DWLOCs) for the acute endpoint. These DWLOCs
for various population categories are summarized in Table 3.
Table 3. Drinking Water Levels of Comparison for Acute Exposure to Cyfluthrin\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Food Exposure (mg/kg/ Max. Water Exposure3 DWLOC 4,5,6 (g/L) DWEC,7 (g/L)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population (48 Contiguous 0.07.................. 0.0045................ 0.066................ 2300................. 0.24
States) Male.
U.S. Population (48 Contiguous 0.07.................. 0.0045................ 0.066................ 2000................. 0.24
states) Females.
Non-Nursing Infants (<1 year="" old)..="" 0.07..................="" 0.0068................="" 0.063................="" 630..................="" 0.24="" --------------------------------------------------------------------------------------------------------------------------------------------------------="" \1\="" values="" are="" expressed="" to="" 2="" significant="" figures.="" \2\="" within="" each="" of="" these="" categories,="" the="" subgroup="" with="" the="" highest="" food="" exposure="" was="" selected.="" \3\="" maximum="" water="" exposure="" (chronic="" or="" acute)="" (mg/kg/day)="[aPAD" or="" cpad="" (mg/kg/day)="" -="" food="" exposure="" (mg/kg/day).="" \4\="" dwloc="">g/L) = Max. water exposure (mg/kg/day) x body wt (kg) [(10-3 mg/g) x water consumed daily (L/day)].
\5\ HED Default body weights are: General U.S. Population, 70 kg; Males (13+ years old), 70 kg; Females (13+ years old), 60 kg; Other Adult Populations,
70 kg; and, All Infants/Children, 10 kg.
\6\ HED Default daily drinking rates are 2 L/day for adults and 1 L/day for children.
\7\ DWEC: Drinking Water Estimate Concentration. (Acute value).
For purposes of chronic risk assessment, the estimated maximum
concentration for cyfluthrin in surface and ground waters (which is
0.04 g/L) should be used for comparison to the back-calculated
human health DWLOCs for the chronic (non-cancer) endpoint. These DWLOCs
for various population categories are summarized in Table 4.
[[Page 35064]]
Table 4. Drinking Water Levels of Comparison for Chronic Exposure to Cyfluthrin\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Max. Water DWLOC
Population Category\2\ cPAD (mg/kg/day) Food Exposure (mg/ Exposure\3\ (mg/ \4\,\5\,\6\(g/ DWEC,\7\(g/
kg/day) kg/day) L) L)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population (48 Contiguous States) Male..... 0.008 0.000067 0.0079 270 0.044
U.S. Population (48 Contiguous States) Female... 0.008 0.000067 0.0079 240 0.044
Non-Nursing infants < 1="" yr......................="" 0.008="" 0.00015="" 0.0079="" 80="" 0.044="" --------------------------------------------------------------------------------------------------------------------------------------------------------="" \1\="" values="" are="" expressed="" to="" 2="" significant="" figures.="" \2\="" within="" each="" of="" these="" categories,="" the="" subgroup="" with="" the="" highest="" food="" exposure="" was="" selected.="" \3\="" maximum="" water="" exposure="" (chronic="" or="" acute)="" (mg/kg/day)="[aPAD" or="" cpad="" (mg/kg/day)="" -="" food="" exposure="" (mg/kg/day).="" \4\="" dwloc="">g/L) = Max. water exposure (mg/kg/day) x body wt (kg) [(10-3 mg/g) x water consumed daily (L/day)].
\5\ HED Default body weights are: General U.S. Population, 70 kg; Males (13+ years old), 70 kg; Females (13+ years old), 60 kg; Other Adult Populations,
70 kg; and, All Infants/Children, 10 kg.
\6\ HED Default daily drinking rates are 2 L/day for adults and 1 L/day for children.
\7\DWEC: Drinking Water Estimate Concentration. (Acute value).
As indicated in the Tables above, the estimated maximum
concentration of cyfluthrin in surface and ground water are less than
the DWLOCs as a contribution to acute and chronic exposure. The
estimated concentrations of cyfluthrin in surface and ground water are
conservative estimates. Therefore the Agency concludes with reasonable
certainty that residues of cyfluthrin in food and drinking water will
not result in an unacceptable estimate of acute or chronic human health
risk.
3. From non-dietary exposure. Cyfluthrin is currently registered
for use on the following residential non-food sites: outdoor lawn/
gardens, inside households, carpets and as a termiticide. Exposure to
cyfluthrin may occur as a result of inhalation or contact from indoor
and outdoor uses. Thus these uses constitute a short- and intermediate-
term exposure scenario. A worst case scenario which aggregates all the
above exposure routes was conducted for risk assessment purposes.
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.''
Cyfluthrin is a member of the Synthetic Pyrethroids. Other members
of this class include bifenthrin, cypermethrin, lambda-cyhalothrin,
zeta-cypermethrin, deltamethrin, esfenvalerate, permethrin,
fenpropathrin, tefluthrin and tralomethrin. Four members of this class
produce a common metabolite known as DCVA. These pyrethroids are
cyfluthrin, cypermethrin, z- cypermethrin and permethrin. Although the
residues of DCVA can be estimated, no toxicology data on the compound
per se are available to directly conduct a hazard evaluation and therby
establish an appropriate endpoint for use in a joint risk assessment.
To date, for the purpose of assessing the risk of the parent compound
the toxicity of DCVA has been assumed to be equivalent to the parent
compound. However, due to the different toxicological profiles of
cyfluthrin, cypermethrin, z-cypermethrin, and permethrin, EPA does not
believe that it would be appropriate to cumulate DCVA for these
pesticides, or DCVA residues from one of these pesticides with the
parent of another of these pesticides, in conducting the risk
assessment for these pesticides.
EPA does not have, at this time, available data to determine
whether cyfluthrin 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,
cyfluthrin 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 cyfluthrin has a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. Using a Monte Carlo analysis, it is estimated the
acute exposure to cyfluthrin from food for the population subgroup
(U.S. Population- all season) will utilize 6.4% of the aPAD, and for
the most highly exposed population subgroup that includes children
(Non-Nursing infants, <1 year)="" will="" utilize="" 9.7%="" of="" the="" apad,="" as="" shown="" in="" table="" 1.="" it="" was="" determined="" that="" an="" acute="" dietary="" exposure="" (food="" plus="" water)="" of="" 100%="" or="" less="" of="" the="" apad="" is="" needed="" to="" protect="" the="" safety="" of="" all="" population="" subgroups.="" despite="" the="" potential="" for="" exposure="" to="" cyfluthrin="" in="" drinking="" water,="" the="" agency="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" apad="" for="" adults,="" infants="" and="" children.="" the="" maximum="" concentration="" of="" cyfluthrin="" in="" surface="" and="" ground="" water="" for="" acute="" exposure="" is="" very="" small="" compared="" to="" the="" dwloc="" as="" shown="" in="" table="" 3.="" under="" current="" agency="" guidelines,="" non-dietary="" uses="" of="" cyfluthrin="" do="" not="" constitute="" an="" acute="" exposure="" scenario.="" the="" agency="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" adults,="" infants="" and="" children="" from="" acute="" aggregate="" exposure="" to="" cyfluthrin="" residues.="" 2.="" chronic="" risk.="" using="" the="" exposure="" assumptions="" described="" above,="" it="" is="" estimated="" that="" the="" chronic="" exposure="" to="" cyfluthrin="" from="" food="" for="" the="" most="" highly="" exposed="" population="" subgroup="" (non-nursing="" infants="">< 1yr)="" will="" utilize="" 1.9%="" of="" the="" cpad="" as="" shown="" in="" table="" 2.="" it="" was="" determined="" that="" a="" chronic="" dietary="" exposure="" (food="" plus="" water)="" of="" 100%="" or="" less="" of="" the="" cpad="" is="" needed="" to="" protect="" the="" safety="" of="" all="" population="" subgroups.="" despite="" the="" potential="" for="" exposure="" to="" cyfluthrin="" in="" drinking="" water,="" the="" agency="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" cpad.="" the="" maximum="" concentration="" of="" cyfluthrin="" in="" surface="" and="" ground="" water="" for="" chronic="" exposure="" is="" very="" small="" compared="" to="" the="" dwloc="" as="" shown="" in="" table="" 4.="" although="" the="" registered="" residential="" termiticide="" use="" of="" cyfluthrin="" constitutes="" a="" possible="" chronic="" exposure="" scenario="" (inhalation),="" it="" is="" not="" aggregated="" into="" dietary="" exposure="" due="" to="" the="" fact="" that="" the="" toxicological="" endpoints="" were="" from="" different="" studies="" [[page="" 35065]]="" with="" different="" toxicological="" effects.="" the="" agency="" also="" concludes="" that="" a="" single="" source="" chronic="" risk="" from="" exposure="" to="" a="" termiticide="" use="" is="" negligible="" due="" to="" the="" fact="" that="" the="" vapor="" pressure="" of="" cyfluthrin="" is="" very="" low="" (3.3="" x="">-8 torr). The Agency concludes that there
is a reasonable certainty that no harm will result to adults, infants
and children from chronic aggregate exposure to cyfluthrin residues.
3. Short- and intermediate-term risk. The short- and intermediate-
term aggregate risks are estimated by combining exposure from food
(chronic), water and residential uses.
Since residue values in water from monitoring data were not
available, the DWLOCs have to be back calculated for the short- and
intermediate-term aggregate risk assessments.
For cyfluthrin, the registered residential use sites include
outdoor lawn/gardens, inside households and termiticide. These uses
constitute a short, and intermediate term exposure scenario. Endpoints
have been selected for short- and intermediate-term dermal and
inhalation exposures. For adults, the routes of exposure from these
registered residential uses include dermal and inhalation, and for
infants and children, the routes of exposure include dermal,
inhalation, and oral (nondietary).
According to Agency aggregate risk assessment guidelines, exposures
with toxicological endpoints selected from different studies with
different toxicological effects should not be aggregated. Since the
toxicological effects through the inhalation exposure route is
different from those toxicological effects through the dermal, chronic
food, and oral non-dietary routes, short- and intermediate-term
aggregate risk assessment should only include dermal, chronic food and
water, and oral non-dietary exposure routes. However, a worst case
scenario which aggregated all exposure routes (includes inhalation,
dermal, chronic food and water, and oral non-dietary) has previously
been calculated (see the Final Rule on Cyfluthrin Residue Tolerances
(62 FR 62961), November 26, 1997 (FRL-5755-2), and the Margin of
Exposure (MOE) is above 2,000 for all population subgroups. The current
action does not change this previous assessment. EPA generally has no
concern for MOEs greater than 300.
4. Aggregate cancer risk for U.S. population. The Agency has
concluded that there is no evidence of carcinogenicity in studies of
either the rat or mouse. Therefore a carcinogenicity risk assessment is
not required.
5. Determination of safety. Based on the above risk assessments,
EPA concludes that there is a reasonable certainty that no harm will
result from aggregate exposure to cyfluthrin 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 cyfluthrin, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure gestation. Reproduction
studies provide information relating to effects from exposure to the
pesticide on the reproductive capability of mating animals and data on
systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre-and postnatal toxicity and the
completeness of the 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.
The Agency has determined that an additional UF is needed for risk
assessments for cyfluthrin. This is due to evidence of increased
sensitivity of pups in the 3-generation reproduction study. It was
observed that there were decreased pup weight gains at a dose in which
there were no effects in the parents. The additional UF is determined
to be 3x due to the lack of severity of effects (reduced body weight
gain in pups) and the availability of acceptable reproduction (rat) and
developmental (rats and rabbits) toxicity studies.
ii. Conclusion. There is a complete toxicity database for
cyfluthrin and exposure data is complete or is estimated based on data
that reasonably accounts for potential exposures. Taking into account
the completeness of the data base, EPA concludes the use of the
additional safety factor would be safe for infants and children.
2. Acute risk. For nonnursing infants >1 year old, the aggregate
acute exposure is 0.0068 mg/kg bw/day and a MOE 2000. For
cyfluthrin, EPA has no concern for MOEs over 300.
3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to cyfluthrin from food
will utilize 9.7% of the aPAD for the most highly exposed population
subgroup (non-nursing infants less than 1-year). It is determined that
an acceptable chronic dietary exposure (food plus water) of 100% or
less of the cPAD is neede to protect the safety of all populations
subgroups. The Agency 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.
4. Short or intermediate term risk. For children and non-nursing
infants < 1="" year,="" epa="" estimates="" the="" aggregate="" short="" and="" intermediate="" term="" exposures="" are="" 0.007662="" and="" 0.008255="" mg/kg="" bw/day="" respectively="" with="" resulting="" moe's="" of="" 2600="" and="" 2400="" respectively.="" for="" cyfluthrin,="" epa="" has="" no="" concern="" for="" moe's="" over="" 300.="" 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="" cyfluthrin="" residues.="" iii.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" metabolism="" of="" cyfluthrin="" in="" plants="" and="" animals="" is="" aequately="" understood.="" studies="" have="" been="" conducted="" to="" delineate="" the="" metabolism="" of="" radio="" labeled="" cyfluthrin="" in="" various="" crops="" and="" animals="" all="" showing="" similar="" results.="" the="" residue="" of="" concern="" is="" cyfluthrin.="" b.="" analytical="" enforcement="" methodology="" adequate="" analytical="" methodology="" (gas/liquid="" chromatography="" with="" an="" electron="" capture="" detector)="" is="" available="" for="" enforcement="" purposes.="" c.="" magnitude="" of="" residues="" field="" trial="" residue="" and="" feeding="" study="" data="" have="" been="" submitted="" and="" reviewed="" in="" support="" of="" the="" tolerance="" on="" potatoes.="" [[page="" 35066]]="" d.="" international="" residue="" limits="" there="" are="" no="" codex,="" canadian,="" or="" mexican="" limits="" established="" for="" cyfluthrin="" on="" potatoes.="" there="" are="" not="" canadian="" or="" mexican="" limits="" established="" for="" corn.="" there="" is="" a="" codex="" maximum="" residuce="" limit="" for="" maize="" (0.05="" mg/kg).="" the="" u.s.="" tolerances="" are="" 0.05="" ppm="" for="" sweet="" corn="" and="" 0.01="" ppm="" for="" field="" corn="" and="" pop="" corn.="" these="" differences="" could="" be="" caused="" by="" differences="" in="" methods="" to="" establish="" tolerances,="" calculation="" of="" animal="" dietary="" exposure,="" and="" as="" a="" result="" of="" different="" agricultural="" practices.="" the="" agency="" will="" specifically="" address="" these="" differences="" when="" this="" pesticide="" is="" reregistered.="" e.="" endocrine="" disrupter="" effects="" epa="" is="" required="" to="" develop="" a="" screening="" program="" to="" determine="" whether="" certain="" substances="" (including="" all="" pesticides="" and="" inerts)="" ``may="" have="" an="" effect="" in="" humans="" that="" is="" similar="" to="" an="" effect="" produced="" by="" a="" naturally="" occurring="" estrogen,="" or="" such="" other="" endocrine="" effect....''="" the="" agency="" is="" currently="" working="" with="" interested="" stakeholders,="" including="" other="" government="" agencies,="" public="" interest="" groups,="" industry="" and="" research="" scientists="" in="" developing="" a="" screening="" and="" testing="" program="" and="" a="" priority="" setting="" scheme="" to="" implement="" this="" program.="" congress="" has="" allowed="" 3="" years="" from="" the="" passage="" of="" fqpa="" (august="" 3,="" 1999)="" to="" implement="" this="" program.="" at="" that="" time,="" epa="" may="" require="" further="" information.="" iv.="" conclusion="" therefore,="" the="" tolerance="" is="" established="" for="" residues="" of="" cyfluthrin="" in="" potatoes="" at="" 0.01="" ppm="" and="" the="" tolerances="" for="" corn="" and="" corn="" byproducts="" are="" made="" permanent..="" v.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" as="" was="" provided="" in="" the="" old="" section="" 408="" and="" in="" section="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" 60="" days,="" rather="" than="" 30="" days.="" epa="" currently="" has="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" hearing="" requests.="" these="" regulations="" will="" require="" some="" modification="" to="" reflect="" the="" new="" law.="" however,="" until="" those="" modifications="" can="" be="" made,="" epa="" will="" continue="" to="" use="" those="" procedural="" regulations="" with="" appropriate="" adjustments="" to="" reflect="" the="" new="" law.="" any="" person="" may,="" by="" august="" 30,="" 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. 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-300887] (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
[[Page 35067]]
Low-Income Populations (59 FR 7629, February 16, 1994), or require OMB
review in accordance with Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997).
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(d), such as the
tolerance in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency previously
assessed whether establishing tolerances, exemptions from tolerances,
raising tolerance levels or expanding exemptions might adversely impact
small entities and concluded, as a generic matter, that there is no
adverse economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and the Comptroller General of the United
States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 24, 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. Section 180.436, is amended to read as follows:
i. By alphabetically adding ``Potatoes'' to the table under
paragraph (a)(1).
ii. By transferring the entries in the table in paragraph (a)(2) to
the table in paragraph (a)(1) and removing the expiration dates; and
removing the remainder of paragraph (a)(2).
iii. By redesignating paragraphs (a)(3) and (a)(4) as paragraphs
(a)(2) and (a)(3).
The additions and amendments to Sec. 180.436 read as follows:
180.436 Cyfluthrin; tolerances for residues
(a)(1) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Corn, forage and fodder field and pop..... 0.01
Corn, grain, field and pop................ 0.01
Corn, sweet, (K+CWHR)..................... 0.05
Corn, sweet, fodder....................... 15.00
Corn, sweet, forage....................... 30.00
* * * * *
Potatoes.................................. 0.01
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-16637 Filed 6-29-99; 8:45 am]
BILLING CODE 6560-50-F
