**[\<]{.mark}COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE
(1/1/2006)**[\>]{.mark}

**[\<]{.mark}EPA Registration Division contact: \[insert name and
telephone number with area code\][\>]{.mark}**

**[\<]{.mark}*INSTRUCTIONS:* Please utilize this outline in preparing
tolerance petition documents. In cases where the outline element does
not apply please insert "NA-Remove" and maintain the outline. The
comment notes that appear on the left margin represent hidden
typesetting codes designed to expedite the processing of the Federal
Register document. Please do not remove or alter these comment notes or
change the margins, font, or format in your document. Simply replace the
instructions that appear in italics and brackets, i.e., "****\[*insert
company name*\]," with the information specific to your
action.\][\>]{.mark}**

**[\<]{.mark}*TEMPLATE:*[\>]{.mark}**

**[\<]{.mark}Bayer CropScience[\>]{.mark}**

**[\<]{.mark}7F7200[\>]{.mark}**

**[\<]{.mark}** EPA has received a pesticide petition **(7F7200)** from
**Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research
Triangle Park, NC 27709** proposing, pursuant to section 408(d) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to
amend 40 CFR part 180.**[\>]{.mark}**

**[\<]{.mark}(Options (pick one)[\>]{.mark}**

> [\<]{.mark} 1. by establishing a tolerance for residues of[\>]{.mark}

**[\<]{.mark}** ~~2. to establish an exemption from the requirement of a
tolerance for~~**[\>]{.mark}**

**[\<]{.mark} Number range CHAPTERCyfluthrin;
cyano(4-fluoro-3-phenoxyphenyl)methyl-3-(2,2-dichloroethenyl)-2,2-dimethyl-cyclopropanecarboxylate**
in or on the raw agricultural commodities **barley, grain; buckwheat,
grain; millet, grain; oats, grain; rye, grain; triticale, grain and
wheat, grain** at **0.15** parts per million (ppm), **corn, field,
grain; corn, pop, grain; teosinte, grain and corn, sweet, kernel plus
cob with husks removed** at **0.05** parts per million (ppm), **sorghum,
grain** at **3.5** parts per million (ppm), **grain, cereal, forage,
group 16 (except Rice)** at **25.0** parts per million (ppm), **grain,
cereal, stover, group 16 (except Rice)** at **30.0** parts per million
(ppm), **grain, cereal, hay, group 16 (except Rice)** at **6.0** parts
per million (ppm), **and grain, cereal, straw, group 16 (except Rice)**
at **7.0** parts per million (ppm) and **beta-cyfluthrin;
cyano(4-fluoro-3-phenoxyphenyl)methyl-3-(2,2-dichloroethenyl)-2,2-dimethyl-cyclopropanecarboxylate
\[mixture comprising the enantiomeric pair
(R)-α-cyano-4-fluoro-3-phenoxybenzyl
(1S,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate and
(S)-α-cyano-4-fluoro-3-phenoxybenzyl
(1R,3R)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate with
the enantiomeric pair (R)-α-cyano-4-fluoro-3-phenoxybenzyl
(1S,3R)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate and
(S)-α-cyano-4-fluoro-3-phenoxybenzyl
(1R,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate\]** in
or on the raw agricultural commodities **Alfalfa, forage** at **5.0**
parts per million (ppm), **Alfalfa, hay** at **13** parts per million
(ppm), **Barley, bran** at **0.5** parts per million (ppm), **Barley,
grain** at **0.15** parts per million (ppm), **Beet, sugar, dried pulp**
at **1.0** parts per million (ppm), **Beet, sugar, roots** at **0.10**
parts per million (ppm), **Brassica, head and stem, subgroup 5A** at **2
5** parts per million (ppm), **Buckwheat, grain** at **0.15** parts per
million (ppm), **Carrot, roots** at **0.20** parts per million (ppm),
**Cattle, fat** at **2.0** parts per million (ppm), **Cattle, meat** at
**0.10** parts per million (ppm), **Cattle, meat byproducts** at
**0.10** parts per million (ppm), **Citrus, dried pulp** at **0.3**
parts per million (ppm), **Citrus, oil** at **0.3** parts per million
(ppm), **Corn, field, grain** at **0.05** parts per million (ppm),
**Corn, sweet, kernel plus cob with husks removed** at **0.05** parts
per million (ppm), **Cotton, hulls** at **2.0 parts** per million (ppm),
**Cotton, refined oil** at **2.0** parts per million (ppm), **Cotton,
seed** at **1.0 parts** per million (ppm), **Egg** at **0.01** parts per
million (ppm), **Fruit, citrus, group 10** at **0.2** parts per million
(ppm), **Goat, fat** at **2.0** parts per million (ppm), **Goat, meat**
at **0.05** parts per million (ppm), **Goat, meat byproducts** at
**0.05** parts per million (ppm), **Grain, cereal, forage, fodder and
hay, group 16, forage, except rice** at **25** parts per million (ppm),
**Grain, cereal, forage, fodder and hay, group 16, hay except rice** at
**6.0** parts per million (ppm), **Grain, cereal, forage, fodder and
hay, group 16, stover, except rice** at **30** parts per million (ppm),
**Grain, cereal, forage, fodder and hay, group 16, straw, except rice**
at **7.0** parts per million (ppm), **Grass, forage, fodder and hay,
group 17, forage** at **12** parts per million (ppm), **Grass, forage,
fodder and hay, group 17, hay** at **50** parts per million (ppm),
**Hog, fat** at **0.5 parts** per million (ppm), **Hog, meat** at
**0.01** parts per million (ppm), **Hog, meat byproducts** at **0.01**
parts per million (ppm), **Hop, dried cones** at **20.0 parts** per
million (ppm), **Hop, vine** at **4.0** parts per million (ppm),
**Horse, fat** at **2.0** parts per million (ppm), **Horse, meat** at
**0.05** parts per million (ppm), **Horse, meat byproducts** at **0.05**
parts per million (ppm), **Lettuce, head** at **2.0** parts per million
(ppm), **Lettuce, leaf** at **3.0** parts per million (ppm), **Milk** at
**0.2** parts per million (ppm), **Milk, fat** at **5.0** parts per
million (ppm), **Millet, grain** at **0.15** parts per million (ppm),
**Mustard greens** at **7.0** parts per million (ppm), **Oat, bran** at
**0.5** parts per million (ppm), **Oat, grain** at **0.15** parts per
million (ppm), **Pea, dry, seed** at **0.15** parts per million (ppm),
**Pea, southern, succulent** at **0.25** parts per million (ppm),
**Pepper** at **0.50** parts per million (ppm), **Potato** at **0.01**
parts per million (ppm), **Poultry, fat** at **0.01** parts per million
(ppm), **Poultry, meat** at **0.01** parts per million (ppm), **Poultry,
meat byproducts** at **0.01** parts per million (ppm), **Radish, roots**
at **1.0** parts per million (ppm), **Rye, bran** at **0.5** parts per
million (ppm), **Rye, grain** at **0.15** parts per million (ppm),
**Sheep, fat** at **2.0** parts per million (ppm), **Sheep, meat** at
**0.05** parts per million (ppm), **Sheep, meat byproducts** at **0.05**
parts per million (ppm), **Sorghum, grain,** at **3.5** parts per
million (ppm), **Soybean, forage** at **8.0** parts per million (ppm),
**Soybean, hay** at **4.0** parts per million (ppm), **Soybean, seed**
at **0.03** parts per million (ppm), **Sugarcane, cane** at **0.05**
parts per million (ppm), **Sugarcane, molasses** at **0.20** parts per
million (ppm), **Sunflower, forage** at **5.0** parts per million (ppm),
**Sunflower, seed** at **0.02** parts per million (ppm), **Teosinte,
grain** at **0.05** parts per million (ppm), **Tomato** at **0.20**
parts per million (ppm), **Tomato, paste** at **0.5** parts per million
(ppm), **Tomato, pomace** at **5.0** parts per million (ppm),
**Triticale, grain** at **0.15** parts per million (ppm), **Wheat,
bran** at **0.5** parts per million (ppm), **Wheat milled by product,
except flour** at **5.0** parts per million (ppm), **Wheat, grain** at
**0.15** parts per million (ppm). EPA has determined that the petition
contains data or information regarding the elements set forth in section
408 (d)(2) of the FDDCA; however, EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
supports granting of the petition. Additional data may be needed before
EPA rules on the petition.**[\>]{.mark}**

[\<]{.mark}*A. Residue Chemistry*[\>]{.mark}

**[\<]{.mark}** 1. *Plant metabolism.***[\>]{.mark} Number range
CHAPTERThe metabolism of cyfluthrin in plants is adequately understood.
Studies have been conducted to delineate the metabolism of radiolabeled
cyfluthrin in various crops all showing similar results. The residue of
concern is cyfluthrin.**

**[\<]{.mark}** 2. *Analytical method.* **Number range CHAPTERAdequate
analytical methodology using GC/EC detection is available for
enforcement purposes. [\>]{.mark}**

**[\<]{.mark}** 3. *Magnitude of residues.* **Residue trials supporting
separate tolerances for the various cereal grain (group 15, except rice)
commodities (barley, buckwheat, corn, millet, oats, rye, sorghum, and
wheat) and cereal group 16 (except rice) were previously submitted and
were reviewed by EPA. No new or additional studies are required or were
performed. The respective residue trials were conducted in sorghum (MRID
No.: 42433001, 42433003, 43567303, 43567307), wheat (MRID No.: No.:
43567301, 43567305, 45655802, 45655805, 45655806), and corn (MRID No.:
42005488, 42005489, 42005490, 42005491, 42005496, 42005497, 43567302,
43567306, 44629605, 44665701, 44815305, 46661501).**

**Proposed tolerances for beta-cyfluthrin are the same as already
established for cyfluthrin and supported by the residue trials already
accepted by EPA for cyfluthrin.**

**[\<]{.mark}***B. Toxicological Profile***[\>]{.mark}**

**[\<]{.mark}** 1. *Acute toxicity.* **Number range CHAPTERThere is a
full battery of acute toxicity studies for cyfluthrin supporting an
overall toxicity Category II for the active ingredient.[\>]{.mark}**

**[\<]{.mark}** 2. *Genotoxicty.* **Number range CHAPTERBased on the
results of a complete genotoxicity database, there is no evidence of
mutagenicity activity in a battery of studies, including several gene
mutation assays (reverse mutation and recombination assays in bacteria
and a Chinese hamster ovary(CHO)/HGPRT assay), a structural chromosome
aberration assay (CHO/sister chromatid exchange assay), and an
unscheduled DNA synthesis assay in rat hepatocytes. All tests were
negative for genotoxicity.** **[\>]{.mark}**

**[\<]{.mark}** 3. *Reproductive and developmental toxicity.* **Number
range CHAPTERA developmental toxicity study in rats with beta-cyfluthrin
indicated a maternal NOAEL of 3 mg/kg bw/day based on reduced body
weight gain and food consumption at 10 mg/kg bw/day. The developmental
NOAEL was 10 mg/kg bw/day, based on reduced fetal body weights and
increased skeletal variations at the maternally toxic dose of 40 mg/kg
bw/day. An oral developmental toxicity study in rabbits with cyfluthrin
indicated a maternal NOAEL of 20 mg/kg bw/day and a maternal LOAEL of 60
mg/kg bw/day, based on decreased body weight gain and decreased food
consumption during the dosing period. A fetal NOAEL of greater than 180
mg/kg bw/day was also observed in this study. A two-generation
reproduction study in rats indicated parental and offspring NOAELs of
3.0 mg/kg bw/day, based on reductions in body weight and food
consumption in the parents and course tremors and decreased mean litter
weights in the offspring at 9.0 mg/kg bw/day. The NOAELs were confirmed
in a supplemental two-generation study. [\>]{.mark}**

**[\<]{.mark}** 4. *Subchronic toxicity.* **Number range CHAPTER In a
90-day feeding study in rats with beta-cyfluthrin the resulting NOAEL
was 9.5 mg/kg bw/day, based on decreased body weight gain, gait
abnormalities, skin lesions and mortality seen at 37.5 mg/kg bw/day. A
six-month toxicity feeding study in dogs established a NOAEL of 5 mg/kg
bw/day for cyfluthrin. The LOAEL was 15 mg/kg bw/day based on clinical
signs of neurotoxicity and gastrointestinal disturbances.**

**Two subchronic inhalation studies were conducted with cyfluthrin. In
the first study cyfluthrin was administered via inhalation for five days
per week for 4 weeks. The resulting NOAEL was 0.44 mg/m^3^, based on
treatment-related behavioral effects, body weight decreases and clinical
chemistry changes at 6.0 mg/m^3^. In the second study cyfluthrin was
administered via inhalation for 13 weeks. The resulting NOAEL was 0.09
mg/m^3^, based treatment-related behavioral effects in females and
increased urinary protein in males at 0.71 mg/m^3^. [\>]{.mark}**

**[\<]{.mark}** 5. *Neurotoxicity.* **Number range CHAPTERAn acute
neurotoxicity study in rats was conducted using beta-cyfluthrin. The
NOAEL for this study is 2 mg/kg, based on clinical signs, changes in FOB
parameters and decreases in motor activity noted at 10 mg/kg. In a
subchronic neurotoxicity study with beta-cyfluthrin the resulting NOAEL
was 8 mg/kg, based on clinical signs, changes in FOB parameters, and
slightly decreased body weight gain and food consumption at 27
mg/kg/day. In a developmental neurotoxicity study with beta-cyfluthrin
the resulting maternal and offspring NOAEL was 11.0 mg/kg body
weight/day based on decreased body weight and a change in startle
response in PND 22 male pups. The database for cyfluthrin is complete
and there is no indication of pre- or post-natal susceptibility. There
is no indication of delayed neurotoxicity as a result of exposure to
cyfluthrin. [\>]{.mark}**

**[\<]{.mark}** 6. *Chronic toxicity.* Number range CHAPTER**A 12-month
chronic feeding study in dogs established a no-observed adverse effect
level (NOAEL) of 2.4 mg/kg bw/day (males) and 3.6 mg/kg bw/day
(females). The lowest effect level (LOAEL) for this study is established
at 11 mg/kg bw/day, clinical signs, gait abnormalities and abnormal
postural reactions in males and females. A 24-month chronic feeding/
carcinogenicity study in rats demonstrated a NOAEL of 2.6 mg/kg bw/day
and LOAEL of 11.6 mg/kg bw/day, based on decreased body weights. A
24-month carcinogenicity study in mice was conducted. The NOAEL was 31.9
(males) and 140.6 (females) mg/kg/bw/day. The LOAEL was 114.8 mg/kg
bw/day (males) based on ear skin lesions and reduced body weight gains,
and 309.7 mg/kg bw/day (females) based on clinical signs, macroscopic
and microscopic pathology findings and reduced body weights, body weight
gains, and food consumption. Under the conditions of these studies,
there was no evidence of carcinogenic potential. [\>]{.mark}**

**[\<]{.mark}** 7. *Animal metabolism.* **Number range CHAPTERA
metabolism study in rats showed that cyfluthrin is rapidly absorbed and
excreted, mostly as conjugated metabolites in the urine, within 48
hours. An enterohepatic circulation was observed. [\>]{.mark}**

**[\<]{.mark}** 8. *Metabolite toxicology*. **Number range CHAPTERThe
residue of concern is cyfluthrin. No toxicology data have been required
for cyfluthrin metabolites. Available data indicate that the metabolites
are much less toxic than the parent and are not of concern.
[\>]{.mark}**

**[\<]{.mark}** 9. *Endocrine disruption*. **Number range CHAPTERThere
is no evidence of endocrine effects in any of the studies conducted with
cyfluthrin, thus, there is no indication at this time that cyfluthrin
causes endocrine effects. [\>]{.mark}**

**[\<]{.mark}***C. Aggregate Exposure***[\>]{.mark}**

**[\<]{.mark}** 1. *Dietary exposure.* **Number range CHAPTERThe
insecticide cyfluthrin has uses on food crops in agriculture and also
non-dietary uses for homeowners. Aggregate exposure for cyfluthrin
should consider dietary exposure, both food and drinking water and
non-dietary exposure both applicator and post application exposure. For
the dietary exposure an acute Population Adjusted Dose (aPAD) of
0.02 mg/kg bw/day was selected using an uncertainty factor of 100 based
on the acute neurotoxicity study. A chronic Population Adjusted Dose
(cPAD) of 0.024 mg/kg bw/day was based on the chronic toxicity test in
dogs with an uncertainty factor of 100.**[\>]{.mark}

[\<]{.mark} i. *Food.* **Number range CHAPTERChronic and acute dietary
exposure estimates resulting from the above listed proposed use and the
registered uses of cyfluthrin are well within acceptable limits for all
sectors of the population. Potential dietary exposures from food were
estimated using the DEEM™ software system (Exponent, Inc.) and the
1994-96 and 1998 USDA consumption data. For the chronic analysis, mean
residue values were calculated from the appropriate field trial studies
conducted for cyfluthrin and submitted as part of the cyfluthrin
petitions. For the acute analysis, the entire distribution of field
trial residue values was used for non-blended and partially blended
commodities and the mean value used for blended commodities. Processing
factors were obtained from GLP processing studies for the appropriate
commodities. Percent crop treated values were based on EPA's dietary
risk assessments (15-Aug-02) and on Bayer CropScience projections for
crops added since then. For the crops from grain cereals groups 15 and
16 100 % crop treated was assumed.** **Using these data and assumptions
for the acute analysis the most highly exposed sub-population was
Children 1-2 years old at 53 % (0.0105 mg/kg bw/day for food incl.
drinking water) of the acute PAD with the US Population at 32 %
(0.00638 mg/kg bw/day for food incl. drinking water) of the acute PAD.
For the chronic analysis, the most highly exposed sub-population was
Children 1-2 utilizing 17 % (0.0041 mg/kg bw/day for food incl. drinking
water) of the chronic PAD. The US Population utilized 5 % (0.0012 mg/kg
bw/day for food incl. drinking water) of the chronic PAD. Actual
exposures are likely to be much less because of the many conservative
assumptions incorporated in this analysis.** [\>]{.mark}

[\<]{.mark} ii. *Drinking Water.* **The estimated drinking water
concentration was taken form Number range CHAPTERUS EPA's calculation of
the drinking water estimated environmental concentrations (EEC) for
cyfluthrin published in the Federal Register (FR Vol 70, no. 176,
13-Sep-05). These EECs were directly incorporated into the calculation
of the dietary exposure.** [\>]{.mark}

[\<]{.mark} 2. *Non-dietary exposure*. **Number range
CHAPTERNon-occupational exposure to cyfluthrin may occur as a result of
inhalation or contact from indoor residential, indoor commercial and
outdoor residential uses. Pursuant to the requirements of FIFRA as
amended by the Food Quality Protection Act of 1996 non-dietary and
aggregate risk analyses for cyfluthrin were conducted. The analyses
include evaluation of potential non-dietary acute application and
post-application exposures. Non-occupational, non-dietary exposure was
assessed based on the assumption that a flea infestation control
scenario represents a "worst case" scenario. For the flea control
infestation scenario indoor fogger, and professional residential turf
same day treatments were included for cyfluthrin. Deterministic (point
values) were used to present a worse case upper-bound estimate of
non-dietary exposure. The non-dietary exposure estimates were expressed
as systemic absorbed doses for a summation of inhalation, dermal and
incidental ingestion exposures. These worst-case non-dietary exposures
were aggregated with chronic dietary exposures to evaluate potential
health risks that might be associated with cyfluthrin products. The
chronic dietary exposures were expressed as an oral absorbed dose to
combine with the non-dietary systemic absorbed doses for comparison to a
systemic absorbed dose no-observed-effect-level (NOEL). Results for each
potential exposed subpopulation (of adults, children 1-6 years, and
infants \<1 year) were compared to the systemic absorbed dose NOEL for
cyfluthrin to provide estimates of margins of exposure (MOE). The large
MOEs for cyfluthrin clearly demonstrate a substantial degree of safety.
The total non-dietary MOEs are 3800, 2700, and 2500 for adults, children
(1-6 years), and infants (\<1 year), respectively. The non-dietary
methods used in the analyses can be characterized as highly conservative
due to the conservatism inherent in the calculation procedures and input
assumptions. An example of this is the conservatism inherent in the
jazzercise methodology's over-representation of residential
post-application exposures. Therefore, it can be concluded that large
MOEs associated with potential non-dietary and aggregate exposures to
cyfluthrin will result in little or no health risks to exposed
persons.** [\>]{.mark}

[\<]{.mark}*D. Cumulative Effects*[\>]{.mark}

[\<]{.mark} **Number range CHAPTERCyfluthrin is a member of the
pyrethroid class of pesticides. EPA is not currently following a
cumulative risk approach based on a common mechanism of toxicity for the
pyrethroids while research on this subject is still ongoing (FR Vol. 70,
No. 176, 13-Sep-05).** [\>]{.mark}

[\<]{.mark}*E. Safety Determination*[\>]{.mark}

[\<]{.mark} 1. *U.S. population.* **Number range CHAPTERUsing the
assumptions and data described above, based on the completeness and
reliability of the toxicity data, it is concluded that chronic dietary
exposure to the registered and proposed uses of cyfluthrin will utilize
at most 5 % of the chronic PAD for the US Population. The acute dietary
exposure to cyfluthrin will utilize at most 32 % of the acute PAD. The
actual exposure both acute and chronic is likely to be much less as more
realistic data and models are developed. EPA generally has no concern
for exposures below 100% of the PAD because the PAD represents the level
at or below which daily aggregate exposure over a lifetime will not pose
appreciable risk to human health. Potential exposure from drinking water
was included in the calculations. Large margins of safety exist for the
non-dietary and aggregate exposure. Therefore, there is a reasonable
certainty that no harm will occur to the US Population from aggregate
exposure (food, drinking water and non-dietary) to residues of
cyfluthrin.** [\>]{.mark}

[\<]{.mark} 2. *Infants and children*. **Number range CHAPTERThe
relevant toxicity studies as discussed in the toxicology section above
show no extra sensitivity of infants and children to cyfluthrin,
therefore the FQPA safety factor can be removed. Using the assumptions
and data described in the exposure section above, the percent of the
chronic PAD that will be used for exposure to residues of cyfluthrin in
food for Children 1-2 years old (the most highly exposed sub-population)
is 17 %. Infants utilize 8.6 % of the chronic PAD. For the acute
assessment Children 1-2 years old utilize 53 % of the acute PAD and
Infants utilize 38 % of the acute PAD. As in the adult situation,
drinking water exposure was included in the calculation of the PAD. As
with adults, large margins of safety exist for the non-dietary and
aggregate exposure for infants and children. Therefore, there is a
reasonable certainty that no harm will occur to infants and children
from aggregate exposure to residues of cyfluthrin. [\>]{.mark}**

**[\<]{.mark}***F. International Tolerances***[\>]{.mark}**

**[\<]{.mark} Cyfluthrin is a broad spectrum insecticide used throughout
the world to control pests in crop and non-crop use areas. CODEX MRL
exist for cyfluthrin for apples at 0.5 ppm, cattle milk at 0.01 ppm,
cotton seed at 0.05 ppm, maize at 0.05 ppm, peppers, sweet at 0.2 ppm,
rape seed at 0.05 ppm and tomatoes at 0.5 ppm. There is no existing
international tolerance for the proposed new use. [\>]{.mark}**