[Federal Register Volume 62, Number 228 (Wednesday, November 26, 1997)]
[Rules and Regulations]
[Pages 63010-63019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31101]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 180, 185 and 186

[OPP-300582; FRL-5755-2]
RIN 2070-AB78


Cyfluthrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
cyfluthrin in or on the raw agricultural commodities in or on the 
following raw agricultural commodities: alfalfa; alfalfa, hay; 
aspirated grain fractions; carrots; cattle, fat; cattle, meat; cattle, 
meat by-products (mbyp); citrus, crop group; citrus dried pulp; citrus 
oil; cottonseed; cottonseed,

[[Page 63011]]

hulls; cottonseed, oil; eggs; goats, fat; goats, meat; goats, mbyp; 
hogs, fat; hogs, meat; hogs, mbyp; horses, fat; horses, meat; horses, 
mbyp; milkfat; peppers; poultry, fat; poultry, meat; poultry, mbyp; 
radishes; sheep, fat; sheep, meat; sheep, mbyp; sorghum, fodder; 
sorghum, forage; sorghum, grain; sugarcane; sugarcane, molasses; 
sunflower, forage; sunflower, seed; tomato; tomato, concentrated 
products; and tomato, pomace (wet and dry). It also removes time 
limitations for tolerances for residues of cyfluthrin on the same 
commodities. Bayer Ag Corporation requested these tolerances under the 
Federal Food, Drug and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act of 1996 (Pub. L. 104-170).

DATES: This regulation is effective November 26, 1997. Objections and 
requests for hearings must be received by EPA on or before January 26, 
1998.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300582], 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-300582], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 1132, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. 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 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-300582]. 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: George T. LaRocca, Product 
Manager 13, 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: 
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-
6100, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of January 25, 1988 
(53 FR 1924), EPA established time-limited tolerances under Section 408 
and 409 of the Federal Food Drug and Cosmetic Act (FFDCA), 21 U.S.C. 
346a(d) and 348 for residues of cyfluthrin. These tolerances expire on 
November 15, 1997. On September 15, 1997, Bayer requested that the time 
limitation for tolerances established for residue of the insecticide 
cyfluthrin in the above mentioned commodities be removed based on 
environmental effects data that they had submitted as a condition of 
the registration and time-limited tolerances. Bayer also submitted a 
summary of its petition as required under the FFDCA as amended by the 
Food Quality Protection Act (FQPA) of 1996 (Pub. L. 104-170).
    In the Federal Register of Thursday, September 25, 1997 (62 FR 
50337) (FRL-5748-2), EPA issued a notice pursuant to section 408 of the 
FFDCA, 21 U.S.C. 346a(e) announcing the filing of pesticide petitions 
(4F3046, 9F3731, 3F4204, 4F4313, 2F4137, and 4F4313 and food/feed 
additive petitions 4H5427, 9H5574, 3H5670, 4H5686, and 4H5687) for 
tolerances by the Bayer Ag Corporation, 8400 Hawthorn Rd., Kansas City, 
MO 64120. This notice included a summary of the petitions prepared by 
the Bayer Ag Corporation. There were no comments received in response 
to the notice of filing.
    The petitions requested that 40 CFR 180.436 be amended by 
establishing permanent tolerances for residues of the insecticide 
cyfluthrin, in or on alfalfa, carrots, citrus, cotton, peppers, 
radishes, sorghum, sugarcane, sweet corn, sunflowers and tomatoes at 
the following levels part per million (ppm): alfalfa, 5.0 ppm; alfalfa, 
hay, at 10.0 ppm; aspirated grain fractions at 300 ppm; carrots at 0.2 
ppm; cattle, fat, at 5.0 ppm; cattle, meat, at 0.4 ppm; cattle, mbyp at 
0.4 ppm; citrus, crop group, at 0.2 ppm; citrus, dried pulp at 0.3 ppm; 
citrus oil, at 0.3 ppm; cottonseed at 1.0 ppm; cottonseed, oil, at 2.0 
ppm; cottonseed, hulls, at 2.0 ppm; eggs at 0.01 ppm; goats, fat, at 
5.0 ppm; goats, meat, at 0.4 ppm; goats, mbyp at 0.4 ppm; hogs, fat, at 
5.0 ppm; hogs, meat, at 0.4 ppm; hogs, mbyp at 0.4 ppm; horses, fat, at 
5.0 ppm; horses, meat, at 0.4 ppm; horses, mbyp at 0.4 ppm; milkfat, at 
15.0 ppm (representing 0.5 ppm in whole milk); peppers, at 0.5 ppm; 
poultry, fat, at 0.01 ppm; poultry, meat, at 0.01 ppm; poultry, mbyp at 
0.01 ppm; radishes at 1.0 ppm; sheep, fat, at 5.0 ppm; sheep, meat, at 
0.4 ppm; sheep, mbyp at 0.4 ppm; sorghum, fodder, at 5.0 ppm; sorghum, 
forage,
at 2.0 ppm; sorghum, grain at 4.0 ppm; sugarcane, at 0.05 ppm; 
sugarcane, molasses, at 0.2 ppm; sunflower, forage, at 1.0 ppm; 
sunflower, seed, at 0.02 ppm; tomato, at 0.2 ppm; tomato, concentrated 
products, at 0.5 ppm; and tomato, pomace (wet and dry) at 5.0 ppm.
    In the Notice of Filing, the established tolerance levels for 
cattle, fat; goat, fat; hog, fat; and horse, fat were incorrectly 
listed as 1.0 ppm. The correct tolerance level for these commodities is 
5.0 ppm as stipulated in PP No. 2F4137 in the Federal Register of July 
31, 1996 (61 FR 39883)(FRL-5387-2). A tolerance level of 5.0 ppm was 
considered by EPA for risk assessment purposes.
    The basis for time-limited tolerances that expire November 15, 1997 
was given in the Federal Register of October 20, 1993 (58 FR 54094). 
These time-limited tolerances were predicated on the expiration of 
pesticide product registrations that were made conditional due to lack 
of certain ecological and environmental effects data. The rationale for 
using time-limited tolerances was to encourage pesticide manufacturers 
to comply with the conditions of registration in a timely manner. There 
is no regulatory requirement to make tolerances time-limed due to the 
conditional status of a product registration under the Federal 
Insecticide, Fungicide, Rodenticide Act (FIFRA) as amended. It is 
current EPA policy to no longer establish time limitations on 
tolerances with expiration dates if none of the conditions of 
registration have any bearing on human dietary risk. This current 
action meets that condition and thus expiration dates associated with 
specific crop tolerances are being deleted.

I. Risk Assessment and Statutory Findings

    New 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

[[Page 63012]]

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. First, EPA determines the 
toxicity of pesticides based primarily on toxicological studies using 
laboratory animals. These studies address many adverse health effects, 
including (but not limited to) reproductive effects, developmental 
toxicity, toxicity to the nervous system, and carcinogenicity. Second, 
EPA examines exposure to the pesticide through the diet (e.g., food and 
drinking water) and through exposures that occur as a result of 
pesticide use in residential settings.

A. Toxicity

    1. Threshold and non-threshold effects. For many animal studies, a 
dose response relationship can be determined, which provides a dose 
that causes adverse effects (threshold effects) and doses causing no 
observed effects (the ``no-observed effect level'' or ``NOEL'').
    Once a study has been evaluated and the observed effects have been 
determined to be threshold effects, EPA generally divides the NOEL from 
the study with the lowest NOEL by an uncertainty factor (usually 100 or 
more) to determine the Reference Dose (RfD). The RfD is a level at or 
below which daily aggregate exposure over a lifetime will not pose 
appreciable risks to human health. An uncertainty factor (sometimes 
called a ``safety factor'') of 100 is commonly used since it is assumed 
that people may be up to 10 times more sensitive to pesticides than the 
test animals, and that one person or subgroup of the population (such 
as infants and children) could be up to 10 times more sensitive to a 
pesticide than another. In addition, EPA assesses the potential risks 
to infants and children based on the weight of the evidence of the 
toxicology studies and determines whether an additional uncertainty 
factor is warranted. Thus, an aggregate daily exposure to a pesticide 
residue at or below the RfD (expressed as 100% or less of the RfD) is 
generally considered acceptable by EPA. EPA generally uses the RfD to 
evaluate the chronic risks posed by pesticide exposure. For shorter 
term risks, EPA calculates a margin of exposure (MOE) by dividing the 
estimated human exposure into the NOEL from the appropriate animal 
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This 
100-fold MOE is based on the same rationale as the 100-fold uncertainty 
factor.
    Lifetime feeding studies in two species of laboratory animals are 
conducted to screen pesticides for cancer effects. When evidence of 
increased cancer is noted in these studies, the Agency conducts a 
weight of the evidence review of all relevant toxicological data 
including short-term and mutagenicity studies and structure activity 
relationship. Once a pesticide has been classified as a potential human 
carcinogen, different types of risk assessments (e.g., linear low dose 
extrapolations or MOE calculation based on the appropriate NOEL) will 
be carried out based on the nature of the carcinogenic response and the 
Agency's knowledge of its mode of action.
    2. Differences in toxic effect due to exposure duration. The 
toxicological effects of a pesticide can vary with different exposure 
durations. EPA considers the entire toxicity data base, and based on 
the effects seen for different durations and routes of exposure, 
determines which risk assessments should be done to assure that the 
public is adequately protected from any pesticide exposure scenario. 
Both short and long durations of exposure are always considered. 
Typically, risk assessments include ``acute,'' ``short-term,'' 
``intermediate term,'' and ``chronic'' risks. These assessments are 
defined by the Agency as follows.
    Acute risk, by the Agency's definition, results from 1-day 
consumption of food and water, and reflects toxicity which could be 
expressed following a single oral exposure to the pesticide residues. 
High end exposure to food and water residues are typically assumed.
    Short-term risk results from exposure to the pesticide for a period 
of 1-7 days, and therefore overlaps with the acute risk assessment. 
Historically, this risk assessment was intended to address primarily 
dermal and inhalation exposure which could result, for example, from 
residential pesticide applications. However, since enaction of FQPA, 
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from 
food, water, and residential uses when reliable data are available. In 
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all 
three sources are not typically added because of the very low 
probability of this occurring in most cases, and because the other 
conservative assumptions built into the assessment assure adequate 
protection of public health. However, for cases in which high-end 
exposure can reasonably be expected from multiple sources (e.g. 
frequent and widespread homeowner use in a specific geographical area), 
multiple high-end risks will be aggregated and presented as part of the 
comprehensive risk assessment/characterization. Since the toxicological 
endpoint considered in this assessment reflects exposure over a period 
of at least 7 days, an additional degree of conservatism is built into 
the assessment; i.e., the risk assessment nominally covers 1-7 days 
exposure, and the toxicological endpoint/NOEL is selected to be 
adequate for at least 7 days of exposure. (Toxicity results at lower 
levels when the dosing duration is increased.)
    Intermediate-term risk results from exposure for 7 days to several 
months. This assessment is handled in a manner similar to the short-
term risk assessment.
    Chronic risk assessment describes risk which could result from 
several months to a lifetime of exposure. For this assessment, risks 
are aggregated considering average exposure from all sources for 
representative population subgroups including infants and children.

B. Aggregate Exposure

    In examining aggregate exposure, FFDCA section 408 requires that 
EPA take into account available and reliable information concerning 
exposure from the pesticide residue in the food in question, residues 
in other foods for which there are tolerances, residues in ground water 
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or 
buildings (residential and other indoor uses). Dietary exposure to 
residues of a pesticide in a food commodity are estimated by 
multiplying the average daily consumption of the food forms of that 
commodity by the tolerance level or the anticipated pesticide residue 
level. The Theoretical Maximum Residue Contribution (TMRC) is an 
estimate of the level of residues consumed daily if

[[Page 63013]]

each food item contained pesticide residues equal to the tolerance. In 
evaluating food exposures, EPA takes into account varying consumption 
patterns of major identifiable subgroups of consumers, including 
infants and children. The TMRC is a ``worst case'' estimate since it is 
based on the assumptions that food contains pesticide residues at the 
tolerance level and that 100% of the crop is treated by pesticides that 
have established tolerances. If the TMRC exceeds the RfD or poses a 
lifetime cancer risk that is greater than approximately one in a 
million, EPA attempts to derive a more accurate exposure estimate for 
the pesticide by evaluating additional types of information 
(anticipated residue data and/or percent of crop treated data) which 
show, generally, that pesticide residues in most foods when they are 
eaten are well below established tolerances.

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 and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for tolerances for residues of 
cyfluthrin on alfalfa, carrots, citrus, cotton, peppers, radishes, 
sorghum, sugarcane, sunflowers and tomatoes at the following levels 
(ppm): alfalfa, forage, at 5.0 ppm; alfalfa, hay, at 10.0 ppm; 
aspirated grain fractions at 300 ppm; carrots at 0.2 ppm; cattle, fat, 
at 5.0 ppm; cattle, meat, at 0.4 ppm; cattle, mbyp at 0.4 ppm; citrus, 
crop group, at 0.2 ppm; citrus dried pulp, at 0.3 ppm; citrus oil, at 
0.3 ppm; cottonseed at 1.0 ppm; cottonseed, hulls, at 2.0 ppm; 
cottonseed, oil, at 2.0 ppm; eggs at 0.01 ppm; goats, fat, at 5.0 ppm; 
goats, meat, at 0.4 ppm; goats, mbyp at 0.4 ppm; hogs, fat, at 5.0 ppm; 
hogs, meat, at 0.4 ppm; hogs, mbyp at 0.4 ppm; horses, fat, at 5.0 ppm; 
horses, meat, at 0.4 ppm; horses, mbyp at 0.4 ppm; milkfat, at 15.0 ppm 
(representing 0.5 ppm in whole milk); peppers, at 0.5 ppm; poultry, 
fat, at 0.01 ppm; poultry, meat, at 0.01 ppm; poultry, mbyp at 0.01 
ppm; radishes at 1.0 ppm; sheep, fat, at 5.0 ppm; sheep, meat, at 0.4 
ppm; sheep, mbyp at 0.4 ppm; sorghum, fodder, at 5.0 ppm; sorghum, 
forage, at 2.0 ppm; sorghum, grain at 4.0 ppm; sugarcane, at 0.05 ppm; 
sugarcane, molasses, at 0.2 ppm; sunflower, forage, at 1.0 ppm; 
sunflower, seed, at 0.02 ppm; tomato, at 0.2 ppm; tomato, concentrated 
products, at 0.5 ppm; and tomato, pomace (wet and dry) at 5.0 ppm. 
EPA's assessment of the dietary exposures and risks associated with 
establishing the tolerances 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 below.
    1. Acute toxicity. The required toxicity battery studies for acute 
oral (LD50 16.2 mg/kg), dermal (LD50 
>5,000 mg/kg), inhalation (LC50 0.468 mg/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 CHO/HGPRT assay; one sister chromatid exchange assay 
in CHO cells; and one 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 days 6-15 of gestation at dose levels of 0, 1, 3, or 
10 milligrams/kilograms/day (mg/kg/day). A maternal LOEL was not 
observed. (i.e. the maternal NOEL is >10 mg/kg/day). A developmental 
LOEL was not observed. The developmental NOEL is >10 mg/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 
LOEL is 60 mg/kg/day based on decreased body weight gain and food 
consumption during the dosing period. The maternal NOEL is 20 mg/kg/
day. The developmental LOEL is 60 mg/kg/day based on increased numbers 
of resorptions and percent incidence of postimplantation loss. The 
developmental NOEL is 20 mg/kg/day. This study was classified core 
guideline.
    iii. Rat developmental studies via inhalation. In the first two 
studies, pregnant female rats at day 0 gestation were exposed head-only 
to cyfluthrin concentrations of 0, 1.1, 4.7 or 23.7 mg/m3/
day (milligrams/per cubic meter/day) for 6 hours/day on gestation days 
6 through 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 NOEL was 1.1 mg/
m3 and the maternal LOEL was 4.7 mg/m3 (reduced 
motility, dyspnea, piloerection, ungroomed coats and eye irritation. 
The developmental NOEL was 0.59 mg/m3 and the developmental 
LOEL was 1.1 mg/m3 (increases in the incidence of runts and 
skeletal anomalies in the sternum (1.1 mg/m3 and above); 
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 
in microphthalmia (23.7 mg/m3). The study was graded core 
minimum.
    In a third study, In 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 through 15 in a 
nose only inhalation chamber. The rats were exposed to the test 
material 6 hours per day, 7 days per week. The maternal NOEL/LOEL were 
< 0.46/<0.46 mg/m3 based on decreased body weight gain and 
reduced relative food efficiency. The developmental NOEL/LOEL 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 LOEL for 
parental toxicity was 450 ppm (22.5 mg/kg/day) based on decreased body 
weight gains. The NOEL for parental toxicity is 150 ppm (7.5 mg/kg/
day). The LOEL 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 NOEL 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

[[Page 63014]]

the first and third weeks and 40 mg/kg/day during the second and fourth 
weeks. The LOEL 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 NOEL 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 LOEL was 15 mg/kg/day in both sexes based 
on decreased blood glucose. The NOEL 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 NOEL 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 LOEL for this study was 15 mg/kg/day for 
both sexes, based on neurological effects (hindlimb abnormalities) and 
gastrointestinal disturbances. The NOEL 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 LOEL for dermal effects was 376 mg/kg/
day for male and female Sprague-Dawley rats based on gross and 
histological skin lesions. The NOEL for dermal effects was for 
technical Baythroid was 113 mg/kg/day. The LOEL for systemic effects 
was 1,077 mg/kg/day based on decreased food consumption, red nasal 
discharge and urine staining. The NOEL 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 in at 
concentrations of 0, 2.3, 11.5, or 69.6 mg/ for 6 hours/day, 5 
consecutive days/week for 3 weeks (total of 15 exposures). The LOEL was 
2.3 mg/m 3, based on the treatment-related effects on body 
weight and temperature observed during the 3-week exposure period. A 
NOEL 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 LOEL was 10.5 mg/m3, based on the treatment-
related behavioral effects as well as effects on body and organ 
(spleen) weights. The NOEL 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 LOEL 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 NOEL 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 LOEL was 0.71 mg/
m3, based on the treatment-related behavioral effects in 
females as well as the increased urinary protein in males. The NOEL 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 NOEL was 4 mg/kg bw/day. The LOEL was 16 mg/
kg/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 NOEL is 4 mg/kg/
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/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 LOEL 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 NOEL 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 LOEL 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 NOEL 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 (LOEL of 50/mg/kg/day; no NOEL observed); a 
second subacute oral neurotoxicity study (NOEL of 40 mg/kg/day); a 
subchronic neurotoxicity study in rats (NOEL <60 mg/kg/day), and a 
subacute inhalation study in mice NOEL for pups, 0.006 mg/L; parental 
NOEL 0.058 mg/L 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

    1. Acute toxicity. To assess acute dietary risk, the Agency used an 
endpoint of 20 mg/kg/day, the NOEL from the oral developmental toxicity 
study in rabbits.
    2. Short - and intermediate - term toxicity. For the short and 
intermediate

[[Page 63015]]

term dermal exposures, the Agency used a NOEL of 20 mg/kg/day from the 
rabbit developmental study. The dermal absorption rate was 25%. This 
factor is based on the weight of evidence available for structurally 
related pyrethroids. For the short term inhalation exposures, the 
Agency used a NOEL of 0.00044 mg/L based on decreases in body and 
thymus weights, hypothermia, and clinical pathology at 0.00604 mg/L in 
a 28-day inhalation study. The recommended MOE is 300 which includes 
FQPA considerations. For the intermediate term inhalation exposure, the 
Agency used a NOEL of 0.00009 mg/L based on behavioral effects in rats 
at 0.00071 mg/L in a 90-day inhalation study. The additional certainty 
factor 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. EPA has established the RfD for cyfluthrin at 
0.008 mg/kg/day. This RfD is based on a chronic/carcinogenicity feeding 
study in the rat with a NOEL of 2.5 mg/kg/day and an uncertainty factor 
of 300.
    4. Carcinogenicity. Cyfluthrin has been classified as a Group E 
chemical (evidence of non-carcinogenicity for humans) by the Agency. 
The classification was based on a lack of convincing evidence of 
carcinogenicity in adequate studies with two animal species, rat and 
mouse.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.436) for the parent 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 and applying appropriate processing 
factors for all feed items. Risk assessments were conducted by EPA to 
assess dietary exposures and risks from cyfluthrin as follows:
    i.  Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a day or single exposure. For the acute dietary exposure analysis 
for cyfluthrin treated raw agricultural commodities and processed food 
items, residue field trial data incorporating percent crop treated 
refinement and anticipated residues were used in Monte Carlo modeling 
(in accordance with Tier 3 of EPA June 1996 ``Acute Dietary Exposure 
Assessment'' guidance document). The acute exposure via food was 
estimated as 0.004917 mg/kg/day for adults in the U.S., and 0.010687 
mg/kg/day for nonnursing infants < 1 year old (most highly exposed 
subgroup. To assess acute dietary risk, the Agency used an endpoint of 
20 mg/kg/day, the NOEL from the oral developmental toxicity study in 
rabbits. The resulting margin of exposure (MOE) is 4,068 for the 
general U.S. population, and 1,871 for nonnursing infants < 1 year old. 
For cyfluthrin, EPA generally has no concern for MOEs over 300.
    ii. Chronic exposure and risk. The chronic dietary exposure 
assessment incorporated tolerance values and percent crop treated 
information. The RfD used was 0.008 mg/kg/day. Exposure was estimated 
at 0.000076 mg/kg/day for the U.S. population, and 0.000151 mg/kg/day 
for nonnursing infants < 1 year old. The percent RfD occupied is 1.0 % 
for the U.S. population, and 1.9% for infants < 1 year old. EPA 
generally has no concern for RfD of less than 100%
    Section 408(b)(2)(E) authorizes EPA to consider available data and 
information on the anticipated residue levels of pesticides 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 five 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 use data on the actual 
percent of crop treated when establishing a tolerance only where the 
Agency can make the following findings: (1) That the data used are 
reliable and provide a valid basis for showing the percentage of food 
derived from a crop that is likely to contain residues; (2) that the 
exposure estimate does not underestimate the exposure for any 
significant subpopulation and; (3) where data on regional pesticide use 
and food consumption are available, that the exposure estimate does not 
understate exposure for any regional population. In addition the Agency 
must provide for periodic evaluation of any estimates used.
    The percent of crop treated estimates for cypermethrin were derived 
from federal and market basket survey data. EPA considers these data 
reliable. A range of estimates supplied by this data and upper end of 
this range was used for the exposure assessment. By using this upper 
end estimate of percent crop treated, the Agency is reasonably certain 
that exposure is not underestimated for any significant subpopulation. 
Further, regional consumption information is taken into account through 
EPA's computer based model for evaluating exposure of significant 
subpopulations including several regional groups. Review of this 
regional data allows the Agency to be reasonably certain that no 
regional population is exposed to residue levels higher than those 
estimated by the Agency. To meet the requirement for data on 
anticipated residues, EPA will issue a Data Call-In (DCI) notice 
pursuant to FFDCA section 408(f) requiring submission of data on 
anticipated residues in conjunction with approval of the registration 
under FIFRA.
    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 were generated with the 
PRZM I and EXAMS computer models in 1993 for comparative ecological 
risk assessment for these chemicals.
    i. Acute exposure and risk. The acute drinking water exposure and 
risk estimates for cyfluthrin for the general U.S. population as 
estimated by the Agency was 0.000054 mg/kg/day. The acute drinking 
water exposure and risk estimate for non-nursing infants <1 year old 
was 0.000104 mg/kg/day. Using these values and an endpoint of 20 mg/kg/
day, the margin of exposure (MOE) for the U.S. population is estimated 
at 368,982. For non-nursing infants <1 year old, the MOE is estimated 
at 192,308. For cyfluthrin, the Agency general has concern for risk 
estimates only below 300.
    ii. Chronic exposure and risk. For the U.S. population, exposure is 
estimated at 0.000001 mg/kg/day, resulting in negligible risk. For 
nonnursing infants < 1 year old, exposure is estimated as 0.000005 mg/
kg/day, which occupies 0.1% of the RfD.
    3. From non-dietary exposure. Cyfluthrin is currently registered 
for use on non-food sites including golf courses, ornamental shrubs, 
indoor foggers, wood surfaces, lawns, and carpet. Nonoccupational 
exposure to cyfluthrin may occur as a result of inhalation or contact 
from indoor residential, indoor commercial, and outdoor residential 
uses.
    Short- and intermediate-term exposure and risk. Exposure is 
estimated at 0.00524 mg/kg/day for the

[[Page 63016]]

U.S. population, and 0.00810 mg/kg/day for nonnursing infants < 1 year 
old.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. Cyfluthrin is a member of the synthetic pyrethroid class of 
pesticides. 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.''
    The Agency believes that ``available information'' in this context 
might include not only toxicity, chemistry, and exposure data, but also 
scientific policies and methodologies for understanding common 
mechanisms of toxicity and conducting cumulative risk assessments. For 
most pesticides, although the Agency has some information in its files 
that may turn out to be helpful in eventually determining whether a 
pesticide shares a common mechanism of toxicity with any other 
substances, EPA doe not at this time have the methodologies to resolve 
the complex scientific issues concerning common mechanism of toxicity 
in a meaningful way. EPA has begun a pilot process to study this issue 
further through the examination of particular classes of pesticides. 
The Agency hopes that the results of this pilot process will increase 
the Agency's scientific understanding of this question such that EPA 
will be able to develop and apply scientific principles for better 
determining which chemicals have a common mechanism of toxicity and 
evaluation the cumulative effects of such chemicals. The Agency 
anticipates, however, that even as its understanding of the science of 
common mechanisms increases, decisions on specific classes of chemicals 
will be heavily dependent on chemical specific data, much of which may 
not be presently available.
    Four members of the insecticide class Pyrethroids produce a common 
metabolite known as DCVA. These insecticides 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 thereby 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.
    Accordingly, 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 produces 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.

D. Aggregate Risks and Determination of Safety for U.S. Population

    The Agency has determined that an aggregate systemic (oral) and 
dermal exposure risk assessment is appropriate for cyfluthrin because 
of concern for the developmental effects seen after oral exposure. An 
aggregate oral and inhalation exposure risk assessment is also 
appropriate due to similarity in systemic toxicity observed in rats via 
these routes.
    1. Acute risk. Aggregate acute dietary exposure is estimated at 
0.004971 mg/kg/day resulting in a MOE of 4,023 for the U.S. population.
    2. Chronic risk. EPA has concluded that aggregate exposure to 
cyfluthrin from food and water is estimated at 0.000076 mg/kg/day and 
will utilize 1% of the RfD for the U.S. population.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account chronic dietary food and water 
(considered to be a background exposure level) plus indoor and outdoor 
residential exposure. For the general U.S. population, exposure is 
estimated at 0.0053 mg/kg/day, resulting in an MOE of 3,800.

E. Aggregate Cancer Risk for U.S. Population

    Cyfluthrin has been classified as a Group E chemical (evidence of 
non-carcinogenicity for humans) by the Agency. The classification was 
based on a lack of convincing evidence of carcinogenicity in adequate 
studies with two animal species, rat and mouse. Therefore there is no 
concern for cancer in humans.
     EPA concludes that there is a reasonable certainty that no harm 
will result from aggregate exposure to cyfluthrin residues.

F. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children-- In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of cyfluthrin, EPA considered data from a 
developmental toxicity study in the rat (see unit II.A.3. of this 
preamble). In addition, data from a 7-day inhalation study conducted 
with mouse dams and their offspring were considered (see also unit 
II.A.3.). There were no data gaps for the assessment of the effects of 
cyfluthrin following in utero or early postnatal exposure. Suggested 
sensitivity of rats to in utero exposure to cyfluthrin was 
hypothetically linked to bradypnea in the dams and was judged not be a 
valid consideration in the calculation of risk. However, evidence of 
increased sensitivity of young rats following pre- and/or postnatal 
exposure to cyfluthrin was observed in the two-generation reproduction 
study and in the 7-day inhalation study in mice.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for pre-and post-natal toxicity and the 
completeness of the data base unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a MOE analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. EPA believes a 3-fold safety factor for children is appropriate 
for cyfluthrin based on lack of severity of the effect.
    Based on the submitted studies, EPA concludes that reliable data 
support the use of a 300-fold uncertainty factor for infants and 
children.
    2. Acute exposure. For nonnursing infants <1year old, the aggregate 
acute exposure is 0.010791 mg/kg/day, with a resulting MOE of 1,853. 
For cyfluthrin, EPA has no concern for MOEs over 300.
    3. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that aggregate exposure to 
cyfluthrin from food and water will utilize 2% of the RfD for infants 
and children (nonnursing infants <1 year old). EPA generally has no 
concern for exposures below 100% of the RfD because the RfD represents 
the level at or below which daily aggregate dietary exposure over a

[[Page 63017]]

lifetime will not pose appreciable risks to human health.
    4. Short- or intermediate-term risk. Using the conservative 
exposure assumptions described above, EPA has concluded that aggregate 
nondietary exposure to cyfluthrin to infants <1 year is 0.008255 mg/kg/
day. The MOE is estimated at 2,400.
    Therefore, it may be concluded that there is reasonable certainty 
that no harm will result to infants and children from aggregate 
exposure to cyfluthrin residues.
    5. Special Docket. The complete acute and chronic exposure analyses 
(including dietary, non-dietary, drinking water, and residential 
exposure, and analysis of exposure to infants and children) used for 
risk assessment purposes can be found in the Special Docket for the 
FQPA under the title ``Risk Assessment for Extension of Tolerances for 
Synthetic Pyrethroids.'' Further explanation regarding EPA's decision 
regarding the additional safety factor can also be found in the Special 
Docket.

G. 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 the program. Congress has allowed 3 years 
from passage of FQPA (August 3, 1999) to implement this program. At 
that time, EPA may require further testing of this active ingredient 
and end use products for endocrine disruption effects.

III. Other Considerations

A. Metabolism In Plants and Animals

    The metabolism of cyfluthrin in plants and animals is adequately 
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 tolerances on alfalfa, carrots, citrus, cotton, 
peppers, radishes, sorghum, sugarcane, sunflowers and tomatoes. 
Tolerances to support these uses were proposed in pesticide petitions 
4F3046, 9F3731, 3F4204, 4F4313, 2F4137, and 4F4313 and food/feed 
additive petitions 4H5427, 9H5574, 3H5670, 4H5686, and 4H5687.

D. International Residue Limits

    Codex maximum residue levels (MRLs) are establish for residues of 
cyfluthrin in milk, whole (0.01 ppm) ; cottonseed (0.05 ppm); peppers, 
sweet (0.2 ppm); and tomatoes (0.5 ppm). Mexico has established a 
tolerance on cottonseed at 1 ppm. There are no Canadian tolerances for 
cyfluthrin. As indicated in unit II. of this preamble there are 
differences between the section 408 tolerances and the Codex MRL values 
for specific commodities. 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. 
EPA will specifically address these differences when the pesticides are 
reregistered and the tolerances made permanent.

IV. Conclusion

    Therefore, the tolerances are established for residues of 
cyfluthrin in/on alfalfa, 5.0 ppm; alfalfa, hay, at 10.0 ppm; aspirated 
grain fractions at 300 ppm; carrots at 0.2 ppm; cattle, fat, at 5.0 
ppm; cattle, meat, at 0.4 ppm; cattle, mbyp at 0.4 ppm; citrus, crop 
group, at 0.2 ppm; citrus dried pulp, at 0.3 ppm; citrus oil, at 0.3 
ppm; cottonseed at 1.0 ppm; cottonseed, oil, at 2.0 ppm; cottonseed, 
hulls, at 2.0 ppm; eggs at 0.01 ppm; goats, fat, at 5.0 ppm; goats, 
meat, at 0.4 ppm; goats, mbyp at 0.4 ppm; hogs, fat, at 5.0 ppm; hogs, 
meat, at 0.4 ppm; hogs, mbyp at 0.4 ppm; horses, fat, at 5.0 ppm; 
horses, meat, at 0.4 ppm; horses, mbyp at 0.4 ppm; milkfat, at 15.0 ppm 
(representing 0.5 ppm in whole milk); peppers, at 0.5 ppm; poultry, 
fat, at 0.01 ppm; poultry, meat, at 0.01 ppm; poultry, mbyp at 0.01 
ppm; radishes at 1.0 ppm; sheep, fat, at 5.0 ppm; sheep, meat, at 0.4 
ppm; sheep, mbyp at 0.4 ppm; sorghum, fodder, at 5.0 ppm; sorghum, 
forage, at 2.0 ppm; sorghum, grain at 4.0 ppm; sugarcane, at 0.05 ppm; 
sugarcane, molasses, at 0.2 ppm; sunflower, forage, at 1.0 ppm; 
sunflower, seed, at 0.02 ppm; tomato, at 0.2 ppm; tomato, concentrated 
products, at 0.5 ppm; and tomato, pomace (wet and dry) at 5.0 ppm. 
tomatoes at ppm.
    In addition to the tolerances being amended, since for purposes of 
establishing tolerances FQPA has eliminated distinctions between raw 
and processed food, EPA is combining the tolerances that appear in 
Secs. 185.1250 and 186.1250 with Sec. 186.436 and is removing 
tolerances under Secs. 185.1250 and 186.1250.

V. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) 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 January 26, 1998, 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 above (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 rulemaking. 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). 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

[[Page 63018]]

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 Docket

    EPA has established a record for this rulemaking under docket 
control number [OPP-300582] (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 Room 1132 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    [email protected].


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above 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 rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
Virginia address in ``ADDRESSES'' at the beginning of this document.

VII. Regulatory Assessment Requirements

    This final rule establishes tolerances under FFDCA section 408(d) 
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) (Pub. L. 104-4). Nor does 
it require any prior consultation as specified by Executive Order 
12875, entitled Enhancing the Intergovernmental Partnership (58 FR 
58093, October 28, 1993), or special considerations as required by 
Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), or require OMB review in 
accordance with Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997).
    In addition, since these tolerances and exemptions that are 
established on the basis of a petition under FFDCA section 408(d), such 
as the tolerances in this final rule, do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency has 
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.

VIII. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of this rule in 
today's Federal Register. This is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects

40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

40 CFR Part 185

    Environmental protection, Food additives, Pesticides and pests.

40 CFR Part 186

    Environmental protection, Animal feeds, Pesticides and pests.

    Dated: November 14, 1997.
James Jones,
Acting 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. 346a and 371.

    2. Section 180.436 is amended as follows:
    i. By designating the text following the heading in paragraph (a) 
as paragraph (a)(1) and by revising the table in newly designated 
paragraph (a)(1).
    ii. Paragraph (b) is redesignated as paragraph (a)(2).
    iii. New paragraphs (b), (c), and (d) are added and reserved with 
headings.
    The revised table to Sec. 180.436 reads as follows:


Sec. 180.436  Cyfluthrin; tolerances for residues.

    (a) *        *        *       
    (1) *        *        *       

                                                                        
------------------------------------------------------------------------
                   Commodity                        Parts per million   
------------------------------------------------------------------------
Alfalfa........................................                      5.0
Alfalfa, hay...................................                     10.0
Aspirated grain fractions......................                      300
Carrots........................................                     0.20
Cattle, fat....................................                      5.0
Cattle, mbyp...................................                     0.40
Cattle, meat...................................                     0.40
Citrus, crop group.............................                      0.2
Citrus, dried pulp.............................                      0.3
Citrus, oil....................................                      0.3
Cottonseed.....................................                      1.0
Cottonseed hulls...............................                      2.0
Cottonseed oil.................................                      2.0
Eggs...........................................                     0.01
Goats, fat.....................................                      5.0
Goats, mbyp....................................                     0.40
Goats, meat....................................                     0.40
Hogs, fat......................................                      5.0
Hogs, mbyp.....................................                     0.40
Hogs, meat.....................................                     0.40
Hops, dried....................................                     20.0
Hops, fresh....................................                      4.0
Horses, fat....................................                      5.0
Horses, mbyp...................................                     0.40
Horses, meat...................................                     0.40
Milkfat (reflecting 0.5 ppm in whole milk).....                     15.0

[[Page 63019]]

                                                                        
Peppers........................................                     0.50
Poultry, fat...................................                     0.01
Poultry, mbyp..................................                     0.01
Poultry, meat..................................                     0.01
Radishes.......................................                      1.0
Sheep, fat.....................................                      5.0
Sheep, mbyp....................................                     0.40
Sheep, meat....................................                     0.40
Sorghum, fodder................................                      5.0
Sorghum, forage................................                      2.0
Sorghum, grain.................................                      4.0
Sugarcane......................................                     0.05
Sugarcane, molasses............................                     0.20
Sunflower, forage..............................                      5.0
Sunflower, seed................................                     0.02
Tomato.........................................                     0.20
Tomato, concentrated products..................                      0.5
Tomato, pomace.................................                      5.0
------------------------------------------------------------------------

    (2) *       *       *       
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

PART 185--[AMENDED]

    2. In part 185:
    a. The authority citation for part 185 continues to read as 
follows:
    Authority: 21 U.S.C. 346a and 348.

Sec. 185.1250  [Removed]

    b. In Sec. 185.1250:
    i. Paragraph (c) introductory text, (c)(1), (c)(2), and (c)(3) are 
transferred to Sec. 180.436 and redesignated as paragraph (a)(3) 
introductory text, (a)(3)(i), (a)(3)(ii), and (a)(3)(iii), 
respectively.
    ii. The remainder of Sec. 185.1250 is removed.

PART 186--[AMENDED]

    3. In part 186:
    a. The authority citation for part 186 continues to read as 
follows:
    Authority: 21 U.S.C. 342, 348, and 701.

Sec. 186.1250  [Removed]

    b. In Sec. 186.1250:
    i. Paragraph (c) introductory text, (c)(1), (c)(2), and (c)(3) are 
transferred to Sec. 180.436 and redesignated as paragraph (a)(4) 
introductory text, (a)(4)(i), (a)(4)(ii), and (a)(4)(iii), 
respectively.
    ii. The remainder of Sec. 186.1250 is removed.
[FR Doc. 97-31101 Filed 11-25-97; 8:45 am]
BILLING CODE 6560-50-F