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cyfluthrin (Baythroid) Pesticide Tolerance 6/99

 

[Federal Register: June 30, 1999 (Volume 64, Number 125)]
[Rules and Regulations]               
[Page 35058-35067]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jn99-29]                         

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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 (LD<INF>50</INF> <gr-thn-eq>16.2 miligrams/kilograms (mg/kg)), 
dermal (LD<INF>50</INF> >5,000 mg/kg), inhalation (LC<INF>50</INF> 
<gr-thn-eq>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 <gr-thn-eq>10 mg/kg/day). A developmental LOAEL was not observed. 
The developmental NOAEL is <gr-thn-eq>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/m<SUP>3</SUP>/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/m<SUP>3</SUP> 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/
m<SUP>3</SUP> and the maternal LOAEL was 4.7 mg/m<SUP>3</SUP> (reduced 
motility, dyspnea, piloerection, ungroomed coats and eye irritation). 
The developmental NOAEL was 0.59 mg/m<SUP>3</SUP> and the developmental 
LOAEL was 1.1 mg/m<SUP>3</SUP> based on increases in the incidence of 
runts and skeletal anomalies in the sternum (1.1 mg/m<SUP>3</SUP> and 
above); and increases in post-implantation losses and decreases in pup 
weights (4.7 mg/m<SUP>3</SUP> and above) and increased incidences of 
late embryonic deaths, in skeletal anomalies in the extremities, pelvis 
and skull and microphthalmia (23.7mg/m<SUP>3</SUP>). 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/m<SUP>3</SUP> 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/
m<SUP>3</SUP> based on decreased body weight gain and reduced relative 
food efficiency. The developmental NOAEL/LOAEL were 0.46/2.55 mg/
m<SUP>3</SUP> 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/m<SUP>3</SUP>, 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/m<SUP>3</SUP> 
for 6 hours/day, 5 consecutive days/week for 3 weeks (total of 15 
exposures). The LOAEL was 10.5 mg/m<SUP>3</SUP>, based on the 
treatment-related behavioral effects as well as effects on body and 
organ (spleen) weights. The NOAEL is 1.4 mg/m<SUP>3</SUP>. 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/m<SUP>3</SUP> for 6 hours/
day, 5 consecutive days/week for 4 weeks (20 exposures). The LOAEL is 
6.04 mg/m<SUP>3</SUP> 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/m<SUP>3</SUP>. 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/m<SUP>3</SUP> 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/
m<SUP>3</SUP>, 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/
m<SUP>3</SUP>. 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 <greek-m>g/L for acute surface water and 
0.044 <greek-m>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 <greek-m>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 (<greek-
       Population Category\2\           aPAD (mg/kg/day)              day)                (mg/kg/day)               m>g/L)         DWEC,7 (<greek-m>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 (<greek-m>g/L) = Max. water exposure (mg/kg/day) x body wt (kg) <divide> [(10<SUP>-3</SUP> mg/<greek-m>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 <greek-m>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\(<greek-m>g/  DWEC,\7\(<greek-m>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 (<greek-m>g/L) = Max. water exposure (mg/kg/day) x body wt (kg) <divide> [(10-3 mg/<greek-m>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 10<SUP>-8</SUP> 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 <ls-thn-eq> 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