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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, 
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
------------------------------------------------------------------------
* * * * *
[FR Doc. 02-24653 Filed 9-26-02; 8:45 am]
BILLING CODE 6560-50-S