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Cyfluthrin (Bayer; IR-4). September 27, 2002. 69 Pesticide Tolerances. Final Rule. Federal Register.


http://www.epa.gov/fedrgstr/EPA-PEST/2002/September/Day-27/p24653.htm


[Federal Register: September 27, 2002 (Volume 67, Number 188)]
[Rules and Regulations]
[Page 60976-60991]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27se02-25]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0193; FRL-7199-8]
 
Cyfluthrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
cyfluthrin in or on soybean, seed; soybean, forage; soybean, hay; corn, 
field, forage; corn, field, stover and corn, pop, stover; grain, 
cereal, group; corn, field, refined oil; corn, field, milled byproduct; 
grain, aspirated fractions; wheat milled byproducts, except flour; 
rice, hulls; rice, bran; barley, bran, oat, bran and rye, bran; milk; 
milk, fat; cattle, fat, goat, fat, hog, fat, horse, fat and sheep, fat; 
mustard greens; lettuce, leaf; lettuce, head; brassica, head and stem, 
subgroup; pea, southern, succulent; and pea, dry. Bayer Corporation and 
the Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act (FQPA) of 1996.

DATES: This regulation is effective September 27, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0193, 
must be received on or before November 26, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket ID number OPP-2002-0193 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Susan Stanton, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-5218; e-mail address: 
stanton.susan@epa.gov.

SUPPLEMENTARY INFORMATION:

[[Page 60977]]

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112...............  Animal production
                                  311...............  Food manufacturing
                                  32532.............  Pesticide
                                                       manufacturing
------------------------------------------------------------------------


    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, Exit Disclaimer a beta site currently 
under development. To access the OPPTS Harmonized Guidelines referenced 
in this document, go directly to the guidelines at http://www.epa.gov/
opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0193. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of November 20, 1998 (63 FR 64484-64489) 
(FRL-6030-9); March 1, 2000 (65 FR 11052-11057) (FRL-6489-9); and April 
4, 2001 (66 FR 17887-17891) (FRL-6772-5), EPA issued notices pursuant 
to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public 
Law 104-170), announcing the filing of pesticide petitions (PP 8F5023, 
5F4475, and 0F6084) by Bayer Corporation, and (PP 0E6184 and PP 0E6075) 
by the IR-4. These notices included summaries of the petitions prepared 
by Bayer Corporation, the registrant. There were no comments received 
in response to the notice of filings.
    These petitions requested that 40 CFR 180.436 be amended by 
establishing tolerances for residues of the insecticide cyfluthrin, 
cyano (4-fluoro-3-phenoxyphenyl) methyl-3-(2,2-didichloroethenyl)-2,2-
dimethyl-cyclopropane-carboxylate, as follows:
    1. PP 8F5023 proposed establishment of tolerances for soybean, bean 
at 0.03 ppm; soybean, forage at 8.0 ppm; soybean, hay at 4.0 ppm; field 
corn forage at 3.0 ppm; and field corn, fodder at 6.0 ppm.
    2. PP 5F4475 proposed establishment of tolerances for cereal grains 
group; corn, starch; corn, refined oil (wet milling); corn, flour; 
corn, refined oil (dry milling); wheat, bran; corn, milled byproducts; 
rice, hulls; and wheat, milled by-products at 2.0, 3.0, 12, 4.0, 15, 
3.0, 4.0, 9.0, and 3.0 ppm, respectively.
    3. PP 0F6084 proposed establishment of tolerances for mustard 
greens, greens; lettuce, head; lettuce, leaf; and head and stem 
brassica subgroup (5A) at 7.0, 2.0, 3.0, and 2.0 ppm, respectively.
    4. PP 0E6184 proposed establishment of a tolerance for southern pea 
at 0.23 ppm.
    5. PP 0E6075 proposed establishment of a tolerance for dry peas 
(pigeon peas, chickpeas/garbanzo beans, lentils) at 0.05 ppm.
    In the Federal Register of May 24, 2002 (67 FR 36596-36598) (FRL-
7178-2), EPA issued a notice pursuant to section 408 of the FFDCA, 21 
U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the 
amended filing of PP 0F6084 by Bayer Corporation. The amended petition 
requested that the proposed tolerance for the head and stem brassica 
subgroup (5A) be increased from 2.0 ppm to 2.5 ppm. There were no 
changes in the proposed tolerances for mustard greens, greens; lettuce, 
head; or lettuce, leaf. There were no comments received in response to 
the amended notice of filing.
    Based on EPA's review, the petitions described in Unit II. were 
revised by the petitioners (Bayer Corporation and IR-4) to propose 
tolerances for residues of cyfluthrin in or on soybean, seed at 0.03 
ppm; soybean, forage at 8.0 ppm; soybean, hay at 4.0 ppm; corn, field, 
forage at 3.0 ppm; corn, field, stover and corn, pop, stover at 6.0 
ppm; grain, cereal, group at 4.0 ppm; corn, field, refined oil at 30 
ppm; corn, field, milled byproduct at 7.0 ppm; grain, aspirated 
fractions at 600 ppm; wheat milled byproducts, except flour at 5.0 ppm; 
rice, hulls at 18 ppm; rice, bran at 6.0 ppm; barley, bran, oat, bran 
and rye, bran at 5.0 ppm; milk at 1.0 ppm; milk, fat at 30 ppm; cattle, 
fat, goat, fat, hog, fat, horse, fat and sheep, fat at 10 ppm; mustard 
greens at 7.0 ppm; lettuce, leaf at 3.0 ppm; lettuce, head at 2.0 ppm; 
brassica, head and stem, subgroup at 2.5 ppm; pea, southern, succulent 
at 0.25 ppm; and pea, dry at 0.15 ppm.
    Although EPA requested a number of changes to the initial 
petitions, the nature of the changes (i.e., clarification and 
correction of commodity terms and changes in tolerance levels) are not 
considered significant. Therefore, EPA is issuing this as a final 
action.
    EPA is also revising or deleting existing tolerances for cyfluthrin 
that are superseded or no longer needed, correcting administrative 
errors in existing tolerances, and updating tolerance terminology as 
follows:
    1. Tolerances for residues of cyfluthrin in or on corn, forage and 
fodder, field and pop at 0.01 ppm; corn, grain, field and pop at 0.01 
ppm; aspirated grain fractions at 300 ppm; milkfat (reflecting 0.5 ppm 
in whole milk) at 15.0 ppm; sorghum, grain at 4.0 ppm; and fat of 
cattle, goats, hogs,

[[Page 60978]]

horses, and sheep at 5.0 ppm are being revised or replaced as 
appropriate to reflect the new commodity terms and tolerance levels 
specified in Unit II.
    2. Time-limited tolerances established for residues of cyfluthrin 
in or on barley, oat and wheat grain at 2.0 ppm and fat of cattle, 
goat, hog, horse, and sheep at 6.0 ppm in connection with section 18 
emergency exemptions granted by EPA are no longer needed and are being 
deleted.
    3. Administrative errors in existing tolerances for radishes, sweet 
corn forage and sweet corn fodder are being corrected as follows: The 
existing tolerance for residues of cyfluthrin in or on radishes at 1.0 
ppm is being revised to specify the commoditiy as ``radish, roots.'' 
The existing tolerances for corn, sweet, fodder at 15 ppm and corn, 
sweet, forage at 30 ppm were inadvertantly reversed. They are being 
corrected and the commodity terminology is being updated to read 
``corn, sweet, stover'' at 30 ppm and ``corn, sweet, forage'' at 15 
ppm.
    4. Commodity terms for existing tolerances are being updated to 
conform to the current Food and Feed Commodity Vocabulary. The 
Vocabulary data base is available on the EPA internet site at the 
following address: http://www.epa.gov/pesticides/foodfeed/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) of the FFDCA 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) of the FFDCA 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 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of the FFDCA, for a tolerance for residues of cyfluthrin on 
soybean, seed at 0.03 ppm; soybean, forage at 8.0 ppm; soybean, hay at 
4.0 ppm; corn, field, forage at 3.0 ppm; corn, field, stover and corn, 
pop, stover at 6.0 ppm; grain, cereal, group at 4.0 ppm; corn, field, 
refined oil at 30 ppm; corn, field, milled byproduct at 7.0 ppm; grain, 
aspirated fractions at 600 ppm; wheat milled byproducts, except flour 
at 5.0 ppm; rice, hulls at 18 ppm; rice, bran at 6.0 ppm; barley, bran, 
oat, bran and rye, bran at 5.0 ppm; milk at 1.0 ppm; milk, fat at 30 
ppm; cattle, fat, goat, fat, hog, fat, horse, fat and sheep, fat at 10 
ppm; mustard greens at 7.0 ppm; lettuce, leaf at 3.0 ppm; lettuce, head 
at 2.0 ppm; brassica, head and stem, subgroup at 2.5 ppm; pea, 
southern, succulent at 0.25 ppm; and pea, dry at 0.15 ppm. EPA's 
assessment of exposures and risks associated with establishing the 
tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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 and its 
enriched isomer, beta-cyfluthrin are discussed in Table 1 of this unit 
as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies 
reviewed.
    Beta-cyfluthrin is an enriched isomer of cyfluthrin. Bridging data 
on beta-cyfluthrin were submitted so that the toxicity of beta-
cyfluthrin could be compared with that of cyfluthrin and the data bases 
could be combined to form one complete data base for both chemicals.

                                Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
                                                                    Results (NOAEL/LOAEL in milligram/kilogram/
             Guideline No.                      Study Type                        day (mg/kg/day))
----------------------------------------------------------------------------------------------------------------
870.3100                                90-Day oral toxicity--     NOAEL = 9.5/10.9 male/female (M/F)
                                         rats                      LOAEL = 37.0/43.0 (M/F) based on gait
                                        Beta-cyfluthrin (99.7%      abnormalities, necrosis in head and neck
                                         active ingredient          region, mortality (2), decreased body weight
                                         (a.i.)).                   gain.
---------------------------------------
870.3100                                90-Day oral toxicity--     NOAEL = 22.3/28.0 for males and
                                         rats                       females LOAEL not established
                                        Cyfluthrin (84.2% a.i.)..
---------------------------------------
870.3150                                90-Day oral toxicity--     LOAEL = 13.9/15.4 (M/F) based on gait
                                         dogs                       abnormalities (both sexes), vomiting (both
                                        Beta-cyfluthrin (99%        sexes) and suggestive decrease in body
                                         a.i.).                     weight gain
---------------------------------------
870.3200                                21/28-Day dermal           Dermal NOAEL = 113
                                         toxicity--rats            Systemic NOAEL = 376
                                        Cyfluthrin (95.5%).......  Dermal LOAEL = 376 based on gross and
                                                                    histological skin lesions.
                                                                   Systemic LOAEL = 1077 based on decreased food
                                                                    consumption, red nasal discharge and urine
                                                                    staining.
---------------------------------------

[[Page 60979]]

Non-guideline                           28-Day oral toxicity       NOAEL = 15.0 (males & females) based on
                                        Cyfluthrin...............   minimal decrease in blood glucose.
                                                                   LOAEL = 50 based on, gait abnormalities,
                                                                    salivation, nervousness, decrease in body
                                                                    weight, food consumption, changes in
                                                                    hematological, clinical chem. & urinalysis
                                                                    parameters, increases in selected organ
                                                                    wts., cytoplasmic swelling of glandular
                                                                    epithelium of submaxillary gland, minimal
                                                                    degrees of fiber degeneration in sciatic
                                                                    nerve (# not reported) which
                                                                    disappeared after recovery period.
---------------------------------------
870.3465                                90-Day inhalation          NOAEL = 0.00009 mg/liter (L) (0.02 mg/kg/day;
                                         toxicity study--rats       both sexes)
                                        Cyfluthrin (94.9% a.i.)..  LOAEL = 0.00071 mg/L (0.16 mg/kg/day) based
                                                                    on decreased body weights and body weight
                                                                    gains in males and clinical signs in females
---------------------------------------
Non-guideline                           4-Week inhalation          NOAEL = 0.00044 mg/L (0.12 mg/kg/day; males &
                                         toxicity study--rats       females)
                                        Cyfluthrin (93.8% a.i.)..  LOAEL = 0.006 mg/L (1.6 mg/kg/day; males &
                                                                    females) based on decreases in body weight
                                                                    and body weight gain in males, hypothermia,
                                                                    reduction in leukocyte counts (F) and low
                                                                    serum protein.
---------------------------------------
Non-guideline                           4-Week subacute            NOAEL = 0.00026 mg/L (0.07 mg/kg/day)
                                         inhalation study--rat     LOAEL = 0.0027 mg/L (0.73 mg/kg/day) based on
                                        Beta-cyfluthrin (97.9%      decreased body weights, 9 urine pH in males
                                         a.i.).
---------------------------------------
Non-guideline                           5-Day range-finding        NOAEL = 0.00025 mg/L (0.07 mg/kg/day)
                                         inhalation study--rat     LOAEL = 0.0038 mg/L (1.03 mg/kg/day) based on
                                        Beta-cyfluthrin (98%        unpreened hair coat, piloerection, hepatoid
                                         a.i.).                     foci in lungs.
---------------------------------------
Non-guideline                           28-Day dog feeding study   NOAEL = 2.0 (both sexes)
                                        Beta-cyfluthrin..........  LOAEL = 8.0 based on impaired movement and
                                                                    conjunctival irritation.
---------------------------------------
870.3700                                Prenatal developmental     Maternal NOAEL = 3
                                         toxicity study--rats      Developmental NOAEL = 10
                                        Beta-cyfluthrin (96.5-     Maternal LOAEL = 10 based on reduced body
                                         97.3%).                    weight gain and reduced food consumption
                                                                    with post-treatment recovery.
                                                                   Developmental LOAEL = 40 based on reduced
                                                                    fetal body weights and increased skeletal
                                                                    variations.
---------------------------------------
870.3700                                Prenatal developmental     Maternal NOAEL > 10 mg/kg/day
                                         toxicity study--rats      Maternal LOAEL not established
                                        Cyfluthrin (93.4%).......  Developmental NOAEL > 10 mg/kg/day
                                                                    developmental LOAEL not established
---------------------------------------
870.3700                                Prenatal developmental     Maternal NOAEL = 20.0
                                         toxicity--rabbits         Developmental NOAEL = 180.0
                                        Cyfluthrin (96% a.i.)....  Maternal LOAEL = 60.0 based on decreased body
                                                                    weight gain and food consumption during the
                                                                    dosing period
                                                                   Developmental LOAEL > 180 mg/kg/day
---------------------------------------
870.3700                                Prenatal developmental     Maternal NOAEL <0.00046 mg/L (< 0.125 mg/kg/
                                         toxicity via inhalation-   day)
                                         rat                       Developmental NOAEL = 0.00046 mg/L (0.125 mg/
                                        Cyfluthrin (96.2%).......   kg/day)
                                                                   Maternal LOAEL = 0.00046 mg/L (0.125 mg/kg/
                                                                    day) based on decreased body weight gain and
                                                                    relative food efficiency
                                                                   Developmental LOAEL = 0.00255 mg/L (0.692 mg/
                                                                    kg/day) based on reduced fetal and placental
                                                                    weights and reduced ossification in phalanx,
                                                                    metacarpals, vertebrae
---------------------------------------
870.3700                                Prenatal developmental     Combined maternal NOAEL = 0.0011 mg/L (0.299
                                         toxicity via inhalation--  mg/kg/day
                                         rat                       Developmental NOAEL = 0.00059 mg/L (0.160 mg/
                                        Cyfluthrin (92.9% and       kg/day)
                                         93%) 2 studies combined.  Combined maternal LOAEL= 0.0047 mg/L (1.277
                                                                    mg/kg/day) based on reduced motility,
                                                                    dyspnea, piloerection, ungroomed coats, eye
                                                                    irritation
                                                                   Developmental LOAEL = 0.0011 mg/L (0.299 mg/
                                                                    kg/day) based on increased incidence of
                                                                    runts and skeletal anomalies in sternum.
---------------------------------------
Non-guideline                           7-Day postnatal            Maternal NOAEL = 0.058 mg/L (24.0 mg/kg/day;
                                         inhalation study (both     highest dose tested (HDT)
                                         pups & dams) in mice      Offspring NOAEL = 0.006 mg/L (2.48 mg/kg/day)
                                         with spontaneous motor    Maternal LOAEL > 0.058 mg/L (> 24.0 mg/kg/
                                         activity measurements      day)
                                        Cyfluthrin (96.8%).......  Offspring LOAEL = 0.015 mg/L (6.21 mg/kg/day)
                                                                    based on clinical signs of toxicity and
                                                                    spontaneous motor activity observed in
                                                                    females 4 months after exposure.
---------------------------------------

[[Page 60980]]

870.3800                                Reproduction and           Parental NOAEL = Parental: 3/4 (M/F)
                                         fertility effects study-- Offspring NOAEL = 7 (M/F)
                                         rat (dietary)             Parental LOAEL = 9/10 (M/F) based on
                                        Cyfluthrin (95.4% a.i.)..   reductions in body weights and food
                                                                    consumption.
                                                                   Offspring LOAEL = 19 based on coarse tremors
                                                                    in pups during lactation and decreases in
                                                                    mean litter weight .
---------------------------------------
Non-guideline                           ``Supplemental'' 2-        Systemic parental NOAEL = 3.8/4.2
                                         generation reproduction   Systemic offspring NOAEL = 3.8/4.2 (Male/
                                         study--rat (1997)          Female)
                                        Cyfluthrin (95.5% a.i.)..  Systemic parental LOAEL > 3.8/4.2
                                                                   Systemic offspring LOAEL > 3.8/4.2 (Male/
                                                                    Female)
---------------------------------------
Non-guideline                           Pilot 1-generation         Parental systemic NOAEL = 22.9
                                         reproduction study--rat   Offspring systemic NOAEL = 7.8
                                        Cyfluthrin (95.7-96.2%     Parental systemic LOAEL = 59.6 based on hind
                                         a.i.).                     leg splay, ataxia, reduction in body weight
                                                                    gain.
                                                                   Pup systemic LOAEL = 22.9 based on tremors
                                                                    during lactation and pup weight decreases.
---------------------------------------
Non-guideline                           Multigeneration            Parental NOAEL = 12.3/15.1
                                         reproduction study--rats  Offspring NOAEL = 5.4
                                        Cyfluthrin...............  Parental LOAEL = 37.2/48.5 based on decreased
                                                                    body weight gain.
                                                                   Offspring LOAEL = 15.1 based on decreased
                                                                    viability during lactation period and
                                                                    decreased body weight gains
---------------------------------------
870.4100                                Chronic toxicity--feeding  NOAEL = 2.43/3.61 (M/F)
                                         study--dog                LOAEL = 10.64/10.74 (M/F) based on clinical
                                        Cyfluthrin (94.9-95.1%      signs, gait abnormalities, and abnormal
                                         a.i.).                     postural reactions in males and females.
---------------------------------------
870.4100                                Chronic toxicity--feeding  NOAEL = 4.0 (males & females)
                                         study--dog                LOAEL = 16.0 (males & females) based on gait
                                        Cyfluthrin 50%...........   abnormalities, vomiting, liquid feces,
                                                                    decreased body weights (males).
---------------------------------------
870.4100                                Chronic toxicity--6-month  NOAEL = 5.0 (males & females)
                                         dog feeding study         LOAEL = 15.0 (males & females). Gait
                                        Cyfluthrin...............   abnormalities, arching backs, vomiting,
                                                                    diarrhea.
---------------------------------------
870.4200                                 Carcinogenicity feeding   NOAEL = 31.9 (males) and 140.6 (females)
                                         study--mice               LOAEL = 114.8 (males) based on ear skin
                                        Cyfluthrin (93.9% a.i.)..   lesions and reduced body weight gains. 309.7
                                                                    (females) based on clinical signs;
                                                                    macroscopic and microscopic pathology
                                                                    findings; and reduced body weights, body
                                                                    weight gains, and food consumption.
                                                                   Under the conditions of this study, there was
                                                                    no evidence of carcinogenic potential.
---------------------------------------
870.4200                                Carcinogenicity feeding    No evidence of carcinogenic potentialstudy
                                         study--mice                not acceptable for chronic toxicity
                                        Cyfluthrin (49.7-51.0%
                                         a.i.).
---------------------------------------
870.4300                                Combined chronic toxicity/ NOAEL = 2.6 (males), 3.3 (females)
                                         carcinogenicity feeding   LOAEL = 11.6 (males), 14.4 (females) based on
                                         study--rat                 overall declines in body weight gain by 12
                                        Cyfluthrin (94.7% a.i.)..   and 10% in males and females, respectively.
                                                                   No carcinogenic effects.
---------------------------------------
870.4300                                Combined chronic toxicity/ NOAEL = 6.19 (males), 8.15 (females)
                                         carcinogenicity feeding   LOAEL = 19.20 (M), 25.47 (F) based on
                                         study--rat                 decreased body weights and body weight
                                        Cyfluthrin (49.7-51.0%)..   gains. No carcinogenic effects.
---------------------------------------
870.5100                                Gene mutation--bacterial   No increases in reverse mutations with and
                                         reverse mutation assay     without activation
                                         with cyfluthrin
---------------------------------------
870.5100                                Gene mutation--yeast       No increase in number of revertants with S138
                                         reverse mutation assay     cultures increase in number of revertants
                                         with cyfluthrin            with S211 culture but not dose-related; no
                                                                    increase in number of revertants when assay
                                                                    repeated
---------------------------------------
870.5100                                Gene mutation--bacterial   In rec-assay, no inhibition at doses of 100-
870.5500..............................   reverse mutation assay     10,000 [mu]g/disk in reverse mutation assay,
                                         with cyfluthrin            no increase in number of revertant colonies,
                                        Bacterial DNA damage with   with and without activation
                                         cyfluthrin.
---------------------------------------

[[Page 60981]]

870.5300                                In vitro mammalian cell    Cyfluthrin did not induce forward mutations
                                         gene mutation with         under conditions of assay
                                         cyfluthrin
---------------------------------------
870.5575                                Saccharomyces cerevisiae   Not mutagenic under conditions of assay
                                         mitotic gene conversion
                                         with cyfluthrin
---------------------------------------
870.5550                                Unscheduled DNA Synthesis  No increase in UDS
                                         (UDS) in rat hepatocytes
                                         with cyfluthrin
---------------------------------------
870.5915                                Sister Chromatid Exchange  No increase in SCE frequency in treated cells
                                         (SCE) in Chinese Hamster
                                         Ovary (CHO) cells with
                                         cyfluthrin
---------------------------------------
870.5550                                DNA damage and repair in   No induction of inhibition, both with and
                                         E. coli with cyfluthrin    without activation
---------------------------------------
870.5100                                Gene mutation--bacterial   No increases in reverse mutations in S.
                                         reverse mutation assay     typhimurium strains TA 1535, TA 1537, TA 98,
                                         with beta-cyfluthrin       or TA 100 with and without activation
---------------------------------------
87.5300                                 In vitro mammalian cell    No mutagenic response in CHO cells
                                         gene mutation test with    hypoxanthine guanine phophoribosyl
                                         beta-cyfluthrin            transferase (HGPRT) assay with and without
                                                                    activation
---------------------------------------
870.5395                                Mammlian erythrocyte       No increased frequency of micronucleated
                                         micronucleus test with     polychromatic erythrocytes in mice bone
                                         beta-cyfluthrin            marrow cells
---------------------------------------
870.5375                                In vitro mammalian         Not clastogenic in human lymphocytes
                                         chromosome aberration
                                         test with beta-
                                         cyfluthrin
---------------------------------------
870.5550                                UDS in mammalian cells in  No evidence of UDS in rat hepatocytes
                                         culture with beta-
                                         cyfluthrin
---------------------------------------
870.6100                                Neurotoxic esterase        All hens died within 3 days; NTE activity was
                                         (NTE)--hen                 not inhibited
                                        Cyfluthrin...............
---------------------------------------
870.6100                                 Neurotoxicity oral        In the single-dose study, at 5,000 mg/kg,
                                         studies--hen               five of the ten hens died. Moderate fiber
                                        Cyfluthrin...............   alterations (axon fragmentation, occasional
                                                                    swelling and eosinophilia of the axon
                                                                    fragments and vacuolation of the myelin
                                                                    sheaths) in the sciatic nerve were observed
                                                                    in two hens. Six hens at 2,500 mg/kg showed
                                                                    signs of excitation during the first 3 days
                                                                    following treatment. In the two-dose study,
                                                                    hens showed initial signs of intoxication
                                                                    during the first 3 days but were normal
                                                                    until the second dose was administered when
                                                                    four hens died. Symptoms following the
                                                                    second treatment subsided; however, a second
                                                                    set of symptoms developed in 4/30 hens.
                                                                    These symptoms resembled delayed type
                                                                    neurotoxicity. Nerve fiber degeneration was
                                                                    present in the majority of the hens. The
                                                                    myelin sheath was distended and the myelin
                                                                    sheath was described as being optically void
                                                                    or granularly disintegrated. The axons were
                                                                    described as swollen or fragmented and in
                                                                    some areas activated or proliferated
                                                                    Schwann's cells were noted. The nerves also
                                                                    contained macrophages in which cytoplasm
                                                                    contained granular material. In the 5-day
                                                                    study, 4/10 hens died. All hens showed
                                                                    initial toxic responses which eventually
                                                                    disappeared. Behavioral disorders
                                                                    accompanied by drowsiness and a cramped gait
                                                                    were observed in 3 of the 6 survivors.
                                                                    Mottled kidneys and brittle livers were
                                                                    noted at necropsy. Treatment-related fiber
                                                                    degeneration (distension or granular
                                                                    disintigration of the medullary sheath,
                                                                    swollen or fragmented axis cylinders and
                                                                    proliferated Schwann's cell in the sciatic
                                                                    nerve were reported. One hen had similar
                                                                    lesions in the spinal marrow.
---------------------------------------
870.6100                                Neurotoxicity oral         In the single-dose study, the hens showed an
                                         studies--hen               initial weight loss but recovered. No other
                                        Cyfluthrin...............   treatment-related effects were observed. In
                                                                    the two-dose study, one hen showed some
                                                                    signs of neurotoxicity on day 30. There were
                                                                    no microscopic lesions in the nervous
                                                                    system.
---------------------------------------

[[Page 60982]]

870.6100                                Neurotoxicity dermal       In the first study there were 2 deaths on the
                                         studies--hen               3rd and 10th day. All other hens had
                                        Cyfluthrin...............   symptoms (apathy and disturbed behavior) but
                                                                    recovered. Local irritation and weight loss
                                                                    were also noted. Two hens had minimal
                                                                    segment-like nerve fiber degeneration
                                                                    (sciatic nerve), but this type is often
                                                                    found in hens. In the second study, the hens
                                                                    were apathetic. These symptoms disappeared
                                                                    after the first week in all hens except 2,
                                                                    in which they persisted until the 38th and
                                                                    51st day after the start of the treatment,
                                                                    respectively. Local irritation and body
                                                                    weight loss were also observed. No other
                                                                    neurologic effects were observed, including
                                                                    microscopic.
---------------------------------------
870.6100                                Acute delayed              Nine of 10 hens died at 0.596 mg/L and none
                                         neurotoxicity--hen         died in any of the lower concentrations.
                                        Cyfluthrin...............   These had some nonspecific symptoms
                                                                    (behavior disturbances, sedation, eye
                                                                    irritancy), which disappeared after 2 days.
                                                                    Some initial weight loss was also noted. In
                                                                    the 3-week study, one hen died. Nonspecific
                                                                    symptoms were again observed. Nothing
                                                                    remarkable was noted at necropsy.
---------------------------------------
870.6100                                Acute delayed              4,300, 1,500: Mortality, aggression,
                                         neurotoxicity and NTE--    somnolence, cyanosis of crest. Sl. axonal
                                         hen                        degenration of sciatic nerve in one hen
                                        Cyfluthrin...............   given a single dose; sl. axonal degeneration
                                                                    of spinal cord in one hen given two doses.
                                                                    No treatment-related changes in NTE
                                                                    activity.
---------------------------------------
870.6200                                Acute oral neurotoxicity   NOAEL = 2
                                         [gavage]--rat             LOAEL = 10 based on clinical signs, changes
                                        Beta cyfluthrin (   in functional observational battery (FOB)
                                         =96.9% a.i.).           parameters and decreases in motor activity.
---------------------------------------
870.6200                                Subchronic oral            NOAEL = 7.99 (males) 9.40 (females)
                                         neurotoxicity [feeding]-- LOAEL = 26.81 (males) 30.83 (females) based
                                         rat                        on clinical signs, changes in FOB
                                        Beta-cyfluthrin (   measurements and possibly decreased body
                                         =96.5% a.i.).           weights, body weight gains, and food
                                                                    consumption
---------------------------------------
870.7485                                Metabolism and             Following oral administration, the test
                                         pharmacokinetics           material was rapidly and nearly completely
                                        Cyfluthrin (98%).........   absorbed. Greater than 95% of the
                                                                    administered radioactivity was excreted
                                                                    within 48 hours. Radioactivity was excreted
                                                                    in the urine and feces with virtually none
                                                                    being excreted in expired air. By 48 hours
                                                                    after dosing, >98% of the total retrieved
                                                                    radioactivity was recovered in the urine and
                                                                    feces. The ratio of radioactivity in urine/
                                                                    feces was higher in males than in females.
                                                                    About 50% of the total urinary radioactivity
                                                                    was recovered during the first 6-8 hours
                                                                    after dosing and about 90% within the first
                                                                    24 hours. At 48 hours, only the fat tissue
                                                                    (renal fat) contained levels of
                                                                    radioactivity that clearly exceeded the
                                                                    overall mean body level, being 6-11X higher.
                                                                    Levels of radioactivity in brain were quite
                                                                    low, being 15-20X lower than the overall
                                                                    mean body level. Different dose levels (0.5
                                                                    or 10 mg/kg) or pretreatment (14X) did not
                                                                    appreciably affect the above findings. Some
                                                                    sex differences, however, were observed as
                                                                    indicated by higher urine/feces ratios in
                                                                    males and slightly higher organ/tissue
                                                                    levels of redioactivity in females (except
                                                                    for fat tissue).
                                                                   Following intravenous administration, a 2
                                                                    phase plasma elimination pattern was
                                                                    observed with plasma half-lives of about 2.1
                                                                    and 20 hours. Greater than 90% of the
                                                                    administered radioactivity was excreted
                                                                    within 48 hours. By 48 hours after dosing,
                                                                    about 93-94% of the total retrieved
                                                                    radioactivity was recovered in the urine and
                                                                    feces. Residual levels of radioactivity in
                                                                    the body and in individual organs/tissues
                                                                    were higher than after oral administraiton.
                                                                    In other respects, the results following
                                                                    intravenous dosing were quite similar to
                                                                    those described for oral dosing. Studies in
                                                                    male rats with bile fistulas indicated an
                                                                    enterhepatic circulation of test material.
---------------------------------------

[[Page 60983]]

870.7485                                Metabolism and             Excretion of radioactivity was rapid.
                                         pharmacokinetics           Following oral administration, >95% of the
                                        Cyfluthrin (98%).........   administered radioactivity was excreted
                                                                    within 48 hours, and following intravenous
                                                                    injection, >90% within 48 hours. Most of the
                                                                    radioactivity was excreted in urine, the
                                                                    urine/fecal ratio being about 2-3X in males
                                                                    and about 1.6-1.8X in females following oral
                                                                    administration and about 2.5X in males and
                                                                    about 2.6X in females following intravenous
                                                                    injection. Parent cyfluthrin is cleaved at
                                                                    the ester bond and then oxidized to yield 3-
                                                                    phenoxy-4-fluorobenzoic acid. This
                                                                    intermediate is then either hydroxylated and
                                                                    subsequently conjugated and excreted or
                                                                    first bound to glycine and then
                                                                    hydroxylated, conjugated, and excreted.
                                                                    Identified metabolites and parent cyfluthrin
                                                                    (in urine, feces, and body) accounted for 65-
                                                                    73% of the recovered radioactivity after a
                                                                    single oral or intravenous dose of 0.5 mg/kg
                                                                    and about 82-83% of the recovered
                                                                    radioactivity after a single-oral dose of 10
                                                                    mg/kg or after 14 daily-oral doses.
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where 
the RfD is equal to the NOAEL divided by the appropriate UF (RfD = 
NOAEL/UF). Where an additional safety factor (SF) is retained due to 
concerns unique to the FQPA, this additional factor is applied to the 
RfD by dividing the RfD by such additional factor. The acute or chronic 
Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to 
accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for Cyfluthrin used for human risk assessment is shown in 
Table 2 of this unit. The toxicology data bases for cyfluthrin and its 
enriched isomer, beta-cyfluthrin, were considered together in selecting 
endpoints for risk assessment.

      Table 2.--Summary of Toxicological Dose and Endpoints for Cyfluthrin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and level of
          Exposure scenario              Dose used in risk         concern for risk      Study and toxicological
                                           assessment, UF             assessment                 effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary                         NOAEL = 2.0 mg/kg/day    FQPA SF = 1               Acute mammalian
general population including infants  UF = 100...............  aPAD = acute RfD/FQPA SF   neurotoxicity (beta-
 and children.                        Acute RfD = 0.02 mg/kg/   = 0.02 mg/kg/day.         cyfluthrin)
                                       day.                                              LOAEL = 10 mg/kg/day
                                                                                          based on clinical
                                                                                          signs, changes in FOB
                                                                                          parameters and
                                                                                          decreases in motor
                                                                                          activity.
-------------------------------------
Chronic Dietary                       NOAEL = 2.4 mg/kg/day    FQPA SF = 1               53-Week chronic
all populations.....................  UF = 100...............  cPAD = chronic RfD/FQPA    toxicity--feeding--dog
                                      Chronic RfD = 0.024 mg/   SF = 0.024 mg/kg/day.     (cyfluthrin)
                                       kg/day.                                           LOAEL = 10.64 mg/kg/day
                                                                                          based on clinical
                                                                                          signs, gait
                                                                                          abnormalities, and
                                                                                          abnormal postural
                                                                                          reactions.
-------------------------------------

[[Page 60984]]

Incidental Oral Short- and            NOAEL = 2.36/2.5 mg/kg/  LOC for MOE = 100         90-Day dog feeding
 Intermediate-Term                     day                     (Residential)...........   study (beta-
(Residential).......................                                                      cyfluthrin)
                                                                                         LOAEL = 13.9/15.4 mg/kg/
                                                                                          day for males/females,
                                                                                          based on gait
                                                                                          abnormalities,
                                                                                          increased incidence of
                                                                                          vomiting, and
                                                                                          suggestive decreased
                                                                                          body weight gain.
-------------------------------------
Short-Term Dermal (1 to 30 days);     Oral study NOAEL = 2.36/ LOC for MOE = 100         90-Day dog feeding
 and Intermediate-Term Dermal (1 to    2.5 mg/kg/day (dermal    (Residential)             study (beta-
 6 months)                             absorption rate = 5%)                              cyfluthrin)
(Residential).......................                                                     LOAEL = 13.9/15.4 mg/kg/
                                                                                          day for males/females,
                                                                                          based on gait
                                                                                          abnormalities,
                                                                                          increased incidence of
                                                                                          vomiting, and
                                                                                          suggestive decreased
                                                                                          body weight gain.
-------------------------------------
Long-Term Dermal (several months to   Oral study NOAEL = 2.4   LOC for MOE = 100         53-Week chronic
 lifetime)                             mg/kg/day (dermal        (Residential)             toxicity--feeding--dog
(Residential).......................   absorption rate =                                  (cyfluthrin)
                                       5%when appropriate)                               LOAEL = 10.64 mg/kg/day
                                                                                          based on clinical
                                                                                          signs, gait
                                                                                          abnormalities, and
                                                                                          abnormal postural
                                                                                          reactions.
-------------------------------------
Short-Term Inhalation (1 to 30 days)  Inhalation study NOAEL   LOC for MOE = 100         28-Day inhalation
(Residential).......................   = 0.07 mg/kg/day         (Residential)             study--rat (beta-
                                                                                          cyfluthrin)
                                                                                         LOAEL = 0.73 mg/kg/day
                                                                                          based on decreases in
                                                                                          body weight in both
                                                                                          sexes and decreased
                                                                                          urinary pH in males.
-------------------------------------
Intermediate-Term Inhalation (1 to 6  Inhalation study NOAEL   LOC for MOE = 100         13-Week inhalation
 months); and Long-Term Inhalation     = 0.02 mg/kg/day         (Residential)             study--rat
 (several months to lifetime)                                                             (cyfluthrin)
(Residential).......................                                                     LOAEL = 0.16 mg/kg/day
                                                                                          based on decreases in
                                                                                          body weight and body
                                                                                          weight gain in males
                                                                                          and clinical signs in
                                                                                          females
-------------------------------------
Cancer (oral, dermal, inhalation)     N/A                                                Cyfluthrin is
                                                                                          classified as ``not
                                                                                          likely to be
                                                                                          carcinogenic in
                                                                                          humans''
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor (SF) refers to any additional SF retained due to concerns unique to
  the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.180.436) for the residues of cyfluthrin, in or 
on a variety of raw agricultural commodities. Tolerances have been 
established on plant commodities ranging from 0.01 ppm for corn grain 
and potatoes to 300 ppm for aspirated grain fractions and on animal 
commodities ranging from 0.01 ppm for poultry commodities to 15 ppm for 
milk fat, and a tolerance of 0.05 ppm has been established in food or 
feed commodities exposed to the insecticide during treatment of food-
handling or feed-handling establishments where food and food products, 
or feed and feed products, are held, processed, prepared, or served. 
Risk assessments were conducted by EPA to assess dietary exposures from 
cyfluthrin in food as follows:
    i. Acute exposure. 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 one day 
or single exposure. The Dietary Exposure Evaluation Model (DEEM\TM\) 
analysis evaluated the individual food consumption as reported by 
respondents in the United States Department of Agriculture (USDA) 1989-
1992 nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII) and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the acute exposure assessments: 
A refined acute probabilistic assessment was conducted using 
anticipated residues from field trials and percent of crop treated 
(%CT) and market share information. For existing uses, the acute 
assessments are moderately refined based on field trial residues and 
estimated %CT information. For new uses, tolerance level residues and 
100 %CT were assumed for dried peas and soybeans, but field trial 
residues and market share information were used to estimate cyfluthrin 
residues in brassica, lettuce, mustard greens, and certain stored 
grains.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis 
evaluated the individual food consumption as reported by respondents in 
the USDA 1989-1992 nationwide CSFII and accumulated exposure to the 
chemical for each commodity. The following assumptions were made for 
the chronic exposure assessments: For existing uses, the chronic 
assessments are moderately refined based on field trial residues and 
estimated %CT information. For

[[Page 60985]]

proposed uses, tolerance level residues and 100 %CT were assumed with 
the exception of stored grains for which there are existing time-
limited tolerances; for these grains, %CT estimates and market share 
information were used.
    iii. Cancer. Cyfluthrin has been classified as ``not likely to be 
carcinogenic in humans'' based on the results of a carcinogenicity 
study in mice and the combined chronic toxicity and carcinogenicity 
study in rats. Therefore, a dietary exposure assessment was not 
conducted.
    iv. Anticipated residue and %CT information. Section 408(b)(2)(E) 
of the FFDCA 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. As required by section 408(b)(2)(E) of the FFDCA, 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 this 
tolerance.
    Section 408(b)(2)(F) of the FFDCA states that the Agency may use 
data on the actual percent of food treated for assessing chronic 
dietary risk only if the Agency can make the following findings: 
Condition 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; Condition 2, that the exposure estimate 
does not underestimate exposure for any significant subpopulation 
group; and Condition 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 %CT as required 
by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to 
submit data on %CT.
    The Agency used %CT information as follows.
    For existing uses, the Agency used estimates of %CT for the acute 
and chronic exposure assessments which were determined using Doanes 
Market Survey Data (1996-2000). The following chronic and acute %CT 
estimates were used for existing registrations: Carrot (3.9 chronic; 
8.0 acute); citrus--orange (5.4 chronic; 11.0 acute); citrus--lemon 
(3.3 chronic; 7.0 acute); citrus--grapefruit (1.2 chronic; 2.5 acute); 
corn, field and pop, grain (3.0 chronic; 6.0 acute); corn, sweet (2.1 
chronic; 3.5 acute); cottonseed (9.3 chronic; 19 acute); peppers (20.0 
chronic; 40.0 acute); potatoes (8.0 chronic; 16.0 acute); radishes (1.0 
chronic; 2.0 acute); sugarcane (2.5 chronic; 5.0 acute); sunflowers 
(0.8 chronic; 2.0 acute); tomatoes (4.0 chronic; 9.0 acute); food 
handling establishments (13.7 chronic; N/A acute).
    The Agency believes that the three conditions listed in Unit 
III.C.1.iv. have been met. With respect to Condition 1, %CT estimates 
are derived from market survey data, which are reliable and have a 
valid basis. EPA uses an average %CT for chronic dietary exposure 
estimates. An average of the %CT reasonably represents a person's 
dietary exposure over a lifetime, and is unlikely to underestimate 
exposure to an individual because of the fact that pesticide use 
patterns (both regionally and nationally) tend to change continuously 
over time, such that an individual is unlikely to be exposed to more 
than the average %CT over a lifetime. For acute assessments, the Agency 
incorporates %CT information by creating a residue distribution file 
which includes the measured residue values from field trials, and zero 
residue values added to account for the percent of crop not treated. 
This approach is used only for non-blended or partially blended 
commodities as defined under EPA SOP99.6. For blended commodities, a 
single-point estimate is created from the residue value multiplied by 
the upper bound %CT. The Agency is reasonably certain that the 
percentage of the food treated is not likely to be an underestimation.
    For the new uses, the Agency used %CT estimates for the acute 
exposure assessment based on market share projections as follows: 
Stored grain--wheat, oats, barley (9.0 %); stored grain, sorghum (3.7 
%); mustard greens (9.0 %); lettuce, leaf (19.0 %); lettuce, head (19.0 
%); broccoli (14.0 %); brussels sprouts (9.0 %); cabbage (9.0 %); and 
cauliflower (16.0 %).
    The following methods were used to estimate market share for the 
new uses: For cole crops and leafy vegetables, the year 2000 base acres 
treated with all pyrethroids/pyrethrins were used along with the 
assumption of up to 25% market share within 3 years of market entry. 
For stored cereal grains, the market share estimate for cyfluthrin was 
based on usage data for chlorpyrifos-methyl.
    The Agency believes that the three conditions previously discussed 
have been met regarding %CT estimates for the new cyfluthrin 
registrations. With respect to Condition 1, EPA finds that the %CT 
information described in Unit II.C.1.iv. for cyfluthrin on cole crops, 
leafy vegetables, and stored cereal grains is reliable and has a valid 
basis. For cole crops, leafy vegetables, dry peas, and soybeans, the 
%CT estimates are based on usage data for all pyrethroids/pyrethrins 
and the generous assumption that cyfluthrin will gain 25% of the total 
market within 3 years. For stored grains, the estimate is derived from 
usage data for chlorpyrifos-methyl, historically the most widely used 
insecticide for control of insect pests in stored grains. These 
estimates should not underestimate actual usage of cyfluthrin on the 
new crops/sites. To further support the reliability of these %CT 
estimates, as a condition of registration, the registrant will be 
required to agree to report annually on the market share attained for 
the new uses for which cyfluthrin is registered. As a condition of 
registration, they will also be required to agree to mitigate dietary 
risk as deemed appropriate by the Agency should the market share data 
raise a concern for increased dietary risk. The Agency will then 
compare that market share information with the %CT estimates used to 
evaluate potential dietary risk. In those instances where percent 
market share is approaching or exceeding the predicted %CT estimate 
used in the Agency's risk assessment, EPA will conduct a new dietary 
risk assessment to evaluate the new dietary risk. If the market share 
data raise a concern for increased pesticide risk, the Agency will act 
to mitigate that dietary risk and could employ several approaches, 
including but not limited to production caps, geographical limitations, 
removal of uses, or other means deemed appropriate by the Agency. As to 
Conditions 2 and 3, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those

[[Page 60986]]

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 cyfluthrin may be applied in 
a particular area.
    2. Dietary exposure from drinking water. Cyfluthrin has low 
mobility and moderate persistence and will remain sorbed to the soil 
for weeks following a treatment. The low mobility indicates that 
groundwater contamination with the insecticide is highly unlikely. 
However, under runoff conditions cyfluthrin is likely to reach surface 
water resources bound to soil particles. Once in the water system, 
cyfluthrin tends to partition to sediments.
    The Agency lacks sufficient monitoring exposure data to complete a 
comprehensive dietary exposure analysis and risk assessment for 
cyfluthrin in drinking water. Because the Agency does not have 
comprehensive monitoring data, drinking water concentration estimates 
are made by reliance on simulation or modeling taking into account data 
on the physical characteristics of cyfluthrin.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW, which predicts pesticide concentrations in groundwater. In 
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS 
(a tier 2 model) for a screening-level assessment for surface water. 
The GENEEC model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. GENEEC incorporates a 
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir 
environment in place of the previous pond scenario. The PRZM/EXAMS 
model includes a percent crop area factor as an adjustment to account 
for the maximum percent crop coverage within a watershed or drainage 
basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to cyfluthrin they are further 
discussed in the aggregate risk sections in Unit III.E.
    Based on the PRZM/EXAMS and SCI-GROW models the EECs of cyfluthrin 
for acute exposures are estimated to be 1.2 parts per billion (ppb) for 
surface water and 0.006 ppb for ground water. The EECs for chronic 
exposures are estimated to be 1.2 ppb for surface water and 0.006 ppb 
for ground water. The EECs for cyfluthrin are based on the simulated 
aerial application of the insecticide on Mississippi cotton at a total 
annual use rate of 0.50 lbs ai/acre (0.050 lbs a.i./acre) applied 10 
times per year.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Cyfluthrin is currently registered for use on the following 
residential non-dietary sites: Ornamental gardens, lawns, turf, and 
general insect control in, around and on buildings, structures, and 
immediate surroundings. There are also uses for spot treatments and 
crack and crevice treatments for insects in, on, and around homes, 
buildings, and other structures and for subsoil treatment around 
structures for control of termites (termiticide use). The risk 
assessment was conducted using the following residential exposure 
assumptions: Residential MOEs were assessed for indoor (carpet 
treatment) and outdoor (lawn) uses of cyfluthrin, including application 
and post-application exposure. The assessments were based on the 
conservative assumption that lawn and carpet treatments would occur on 
the same day. The residential exposure assessment for adults included 
estimates of exposure via the inhalation and dermal routes; the 
assessment for infants and children included estimates of exposure via 
the inhalation, dermal, and oral (hand-to-mouth) routes. Residential 
applicator exposure from the indoor total release fogger use was not 
assessed, because homeowner exposure from outdoor lawn treatments is 
considered to represent the worst-case exposure scenario.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether 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. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional 10-fold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
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.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
increased susceptibility of rats or rabbits to in utero exposure in 
developmental oral studies; however, there was some indication of 
increased susceptibility in developmental inhalation studies. The data 
also demonstrated increased

[[Page 60987]]

susceptibility of rats and mice to postnatal exposure to cyfluthrin.
    3. Conclusion. The scientific quality of the toxicity data base for 
cyfluthrin and beta-cyfluthrin is relatively high, and the toxicity 
profiles of both cyfluthrin and beta-cyfluthrin can be characterized 
for all effects, including potential developmental, reproductive and 
neurotoxic effects. A developmental neurotoxicity (DNT) study is 
required based on evidence of neurotoxicity seen throughout the 
toxicology data bases with cyfluthrin and beta-cyfluthrin. 
Nevertheless, the toxicology data bases together are considered 
adequate for selecting toxicity endpoints for risk assessment. 
Cyfluthrin toxicity data have been used as bridging data for beta-
cyfluthrin.
    The degree of concern for the effects observed in the inhalation 
developmental studies was considered low, noting that a clear NOAEL was 
established for the fetal effects in every case. No residual 
uncertainties were identified. The NOAEL used for short-term inhalation 
exposure scenarios is protective of the effects seen in the 
developmental studies via the inhalation route. The degree of concern 
for the effects observed in the reproductive studies was considered 
low, noting that a clear NOAEL was established for the offspring 
effects in every case. No residual uncertainties were identified. The 
NOAEL used to establish the cRfD for all populations is protective of 
the effects seen in the young in the reproduction studies.
    Preliminary results from the required DNT study on beta-cyfluthrin 
corroborate these findings. The data indicate a similar NOAEL for 
parents and pups, based on decreases in body weight. Furthermore, the 
preliminary NOAEL is comparable to the NOAELS used as the basis for the 
aRfDs and cRfDs. This information supports the dose analysis conducted 
by EPA as well as the removal of the special FQPA SF required for the 
protection of infants and children. Therefore, the FQPA SF (as 
discussed in the February 2002, OPP 10X guidance document) was reduced 
to 1X.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the EECs. DWLOC values 
are not regulatory standards for drinking water. DWLOCs are theoretical 
upper limits on a pesticide's concentration in drinking water in light 
of total aggregate exposure to a pesticide in food and residential 
uses. In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure at the 99.9\th\ 
percentile of exposure from food to cyfluthrin will occupy 50% of the 
aPAD for the U.S. population, 51% of the aPAD for females 13 years and 
older, 82% of the aPAD for infants less than 1 year old and 77% of the 
aPAD for children 1 to 6 years old. In addition, there is potential for 
acute dietary exposure to cyfluthrin in drinking water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the aPAD, as shown in Table 3 of this unit:

                      Table 3.--Aggregate Risk Assessment for Acute Exposure to Cyfluthrin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. Population                                 0.02           50          1.2        0.006          350
------------------------------------------------
All infants                                             0.02           82          1.2        0.006           40
(<1 year old)..................................
------------------------------------------------
Children                                                0.02           77          1.2        0.006           50
(1-6 years old)................................
------------------------------------------------
Females                                                 0.02           51          1.2        0.006          300
(13-50 years old)..............................
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
cyfluthrin from food will utilize 9% of the cPAD for the U.S. 
population, 6% of the cPAD for all infants less than 1 year old and 17% 
of the cPAD for children 1 to 6 years old. The registered residential 
termiticide uses of cyfluthrin do constitute a chronic inhalation 
exposure scenario; however, the vapor pressure of cyfluthrin is so low 
(3.3 x 10-\8\ torr) that such exposures are anticipated to 
be negligible. In addition, there is potential

[[Page 60988]]

for chronic dietary exposure to cyfluthrin in drinking water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD, as shown in Table 4 of this unit:

               Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Cyfluthrin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. Population                                0.024            9          1.2        0.006          770
------------------------------------------------
All infants                                            0.024            6          1.2        0.006          230
(< 1 year old).................................
------------------------------------------------
Children                                               0.024           17          1.2        0.006          200
(1-6 years old)................................
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Cyfluthrin is currently 
registered for use that could result in short-term residential exposure 
and the Agency has determined that it is appropriate to aggregate 
chronic food and water and short-term exposures for cyfluthrin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 360 for adults, 330 for children 
1 to 6 years old and 470 for infants less than 1 year old. These 
aggregated MOEs include average exposure from cyfluthrin residues in 
food as well as inhalation and dermal exposure of adults; and 
inhalation, dermal and oral (hand-to-mouth) exposure of infants and 
children from the residential uses of cyfluthrin on lawns and indoors 
on carpet.. These aggregate MOEs do not exceed the Agency's level of 
concern for aggregate exposure to food and residential uses. In 
addition, short-term DWLOCs were calculated and compared to the EECs 
for chronic exposure of cyfluthrin in ground and surface water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect short-term aggregate exposure to 
exceed the Agency's level of concern, as shown in Table 5 of this unit:

                    Table 5.--Aggregate Risk Assessment for Short-Term Exposure to Cyfluthrin
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Adult male                                               360          100          1.2        0.006          610
-----------------------------------------------
Adult female                                             360          100          1.2        0.006          520
-----------------------------------------------
Child                                                    330          100          1.2        0.006          170
-----------------------------------------------
Infants                                                  470          100          1.2        0.006          190
----------------------------------------------------------------------------------------------------------------

    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Cyfluthrin is currently registered for use(s) that could result in 
intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and 
intermediate-term exposures for cyfluthrin.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food and 
residential exposures aggregated result in aggregate MOEs of 210 for 
adults, 230 for children 1 to 6 years old and 260 for infants less than 
1 year old. These aggregated MOEs include average exposure from 
cyfluthrin residues in food as well as inhalation and dermal exposure 
of adults; and inhalation, dermal and oral (hand-to-mouth) exposure of 
infants and children from the residential uses of cyfluthrin on lawns 
and indoors on carpet. These aggregate MOEs do not exceed the Agency's 
level of concern for aggregate exposure to food and residential uses. 
In addition, intermediate-term DWLOCs were calculated and compared to 
the EECs for chronic exposure of cyfluthrin in ground and surface 
water. After calculating DWLOCs and comparing them to the EECs for 
surface and ground water, EPA does not expect intermediate-term 
aggregate exposure to exceed the Agency's level of concern, as shown in 
Table 6 of this unit:

[[Page 60989]]

                Table 6.--Aggregate Risk Assessment for Intermediate-Term Exposure to Cyfluthrin
----------------------------------------------------------------------------------------------------------------
                                                             Aggregate
                                                Aggregate     Level of     Surface       Ground    Intermediate-
             Population Subgroup               MOE (Food +    Concern     Water EEC    Water EEC     Term DWLOC
                                              Residential)     (LOC)        (ppb)        (ppb)         (ppb)
----------------------------------------------------------------------------------------------------------------
Adult male                                             210          100          1.2        0.006           440
---------------------------------------------
Adult female                                           210          100          1.2        0.006           370
---------------------------------------------
Child                                                  230          100          1.2        0.006           140
---------------------------------------------
Infants                                                260          100          1.2        0.006           150
----------------------------------------------------------------------------------------------------------------

    5. Aggregate cancer risk for U.S. population. Cyfluthrin has been 
classified as ``not likely to be carcinogenic in humans'' based on the 
results of a carcinogenicity study in mice and the combined chronic 
toxicity and carcinogenicity study in rats. Therefore, cyfluthrin is 
not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to cyfluthrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A GC method with electron capture detection (GC/ECD) is available 
for the enforcement of tolerances for cyfluthrin residues in/on plant 
commodities. This method has an LOQ of 0.05 ppm for cyfluthrin and was 
previously described in Mobay Report 85823 (``A Gas Chromatographic 
Method for Baythroid[reg]
2 Residues in Crops,'' MRID 40301501). This 
method has undergone a successful petition method validation and is 
available in PAM, Vol II. A GC/ECD method is also available for 
enforcing tolerances for cyfluthrin residues in animal commodities and 
is published in PAM II.

B. International Residue Limits

    There are no established Codex Maximum Residue Limits (MRLs) for 
residues of cyfluthrin in/on the commodities for which tolerances are 
being established, with the exception of maize (field corn grain) at 
0.05 ppm. Codex MRLs are currently expressed in terms of cyfluthrin per 
se. Due to the post harvest use on stored grains, the U.S. tolerance 
for corn grain is much higher than the Codex maize MRL.

V. Conclusion

    Therefore, tolerances are established for residues of cyfluthrin, 
cyano (4-fluoro-3-phenoxyphenyl) methyl-3-(2,2-didichloroethenyl)-2,2-
dimethyl-cyclopropane-carboxylate in or on soybean, seed at 0.03 ppm; 
soybean, forage at 8.0 ppm; soybean, hay at 4.0 ppm; corn, field, 
forage at 3.0 ppm; corn, field, stover and corn, pop, stover at 6.0 
ppm; grain, cereal, group at 4.0 ppm; corn, field, refined oil at 30 
ppm; corn, field, milled byproduct at 7.0 ppm; grain, aspirated 
fractions at 600 ppm; wheat milled byproducts, except flour at 5.0 ppm; 
rice, hulls at 18 ppm; rice, bran at 6.0 ppm; barley, bran, oat, bran 
and rye, bran at 5.0 ppm; milk at 1.0 ppm; milk, fat at 30 ppm; cattle, 
fat, goat, fat, hog, fat, horse, fat and sheep, fat at 10 ppm; mustard 
greens at 7.0 ppm; lettuce, leaf at 3.0 ppm; lettuce, head at 2.0 ppm; 
brassica, head and stem, subgroup at 2.5 ppm; pea, southern, succulent 
at 0.25 ppm; and pea, dry at 0.15 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of the FFDCA, as was provided in the old sections 408 and 409 of the 
FFDCA. However, the period for filing objections is now 60 days, rather 
than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2002-0193 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before November 
26, 2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please

[[Page 60990]]

identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket ID number OPP-2002-0193, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.2. You may also send an electronic copy of 
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). 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 under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, 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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (59 FR 22951, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does 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 to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other

[[Page 60991]]

required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
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: September 18, 2002.
Debra Edwards,
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. 321(q), 346(a) and 371.

    2. Section 180.436 is amended by removing from the table in 
paragraph (b) the entries barley, grain; cattle, fat; goat, fat; hog, 
fat; horse, fat; oat, grain; sheep, fat; and wheat, grain and by 
revising paragraph (a)(1) to read as follows:

Sec.  180.436  Cyfluthrin; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide cyfluthrin (cyano(4-fluoro-3-phenoxyphenyl)methyl-3-(2,2-
dichloroethenyl)-2,2dimethyl-cyclopropane-carboxylate; CAS No. 68359-
37-5) in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Alfalfa........................................                      5.0
Alfalfa, hay...................................                     10.0
Barley, bran...................................                      5.0
Brassica, head and stem, subgroup..............                      2.5
Carrot.........................................                     0.20
Cattle, fat....................................                     10.0
Cattle, meat...................................                     0.40
Cattle, meat byproducts........................                     0.40
Citrus, dried pulp.............................                      0.3
Citrus, oil....................................                      0.3
Corn, field, forage............................                      3.0
Corn, field, milled byproducts.................                      7.0
Corn, field, refined oil.......................                     30.0
Corn, field, stover............................                      6.0
Corn, pop, stover..............................                      6.0
Corn, sweet, forage............................                    15.00
Corn, sweet, kernel plus cob with husks removed                     0.05
Corn, sweet, stover............................                    30.00
Cotton, hulls..................................                      2.0
Cotton, refined oil............................                      2.0
Cotton, seed...................................                      1.0
Egg............................................                     0.01
Fruit, citrus, group...........................                      0.2
Goat, fat......................................                     10.0
Goat, meat.....................................                     0.40
Goat, meat byproducts..........................                     0.40
Grain, aspirated fractions.....................                      600
Grain, cereal, group...........................                      4.0
Hog, fat.......................................                     10.0
Hog, meat......................................                     0.40
Hog, meat byproducts...........................                     0.40
Hop, dried cones...............................                     20.0
Hop, fresh.....................................                      4.0
Horse, fat.....................................                     10.0
Horse, meat....................................                     0.40
Horse, meat byproducts.........................                     0.40
Lettuce, head..................................                      2.0
Lettuce, leaf..................................                      3.0
Milk...........................................                      1.0
Milk, fat......................................                     30.0
Mustard greens.................................                      7.0
Oat, bran......................................                      5.0
Pea, dry.......................................                     0.15
Pea, southern, succulent.......................                     0.25
Pepper.........................................                     0.50
Potato.........................................                     0.01
Poultry, fat...................................                     0.01
Poultry, meat..................................                     0.01
Poultry, meat byproducts.......................                     0.01
Radish, roots..................................                      1.0
Rice, bran.....................................                      6.0
Rice, hulls....................................                     18.0
Rye, bran......................................                      5.0
Sheep, fat.....................................                     10.0
Sheep, meat....................................                     0.40
Sheep, meat byproducts.........................                     0.40
Sorghum, grain, forage.........................                      2.0
Sorghum, grain, stover.........................                      5.0
Soybean, forage................................                      8.0
Soybean, hay...................................                      4.0
Soybean, seed..................................                     0.03
Sugarcane, cane................................                     0.05
Sugarcane, molasses............................                     0.20
Sunflower, forage..............................                      5.0
Sunflower, seed................................                     0.02
Tomato.........................................                     0.20
Tomato, paste..................................                      0.5
Tomato, pomace.................................                      5.0
Wheat milled byproducts, except flour..........                      5.0
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[FR Doc. 02-24653 Filed 9-26-02; 8:45 am]
BILLING CODE 6560-50-S