beta-cyfluthrin	0.022	0.049	1500 scouting 	0.00042	5,600

1.  Among the grass crop sites (pasture, rangeland, grasses grown for
hay and seed, grass mixed-stands with alfalfa), grass grown for seed is
expected to have the maximum postapplication activities.

2.  DFR :

(app. rate)(fraction of ai retained on foliage [20%])(fraction of
residue that dissipates daily [10%])(conversion factor [4.54
E+8][2.47E-8])

3. Transfer coefficient (TC) is for alfalfa (surrogate crop) with medium
exposure potential.

4. Dermal Dose: (dislodgeable foliar residue on designated
day)(conversion factor [10E-3])(transfer coefficient)(dermal absorption
factor)(exposure time [8 hrs]) ÷ body weight

5. Dermal MOE: NOAEL/dermal dose

Table 9.  Short- and Intermediate-Term Risks to Seed Treatment Workers
and Planters From the Use of beta-Cyfluthrin Containing Poncho Beta on
Sugar 	  Beet. 1

Exposure

Scenarios	Worker

Type

PPE 2	Qty Treated / Planted/day      (lbs)	Unit Exp. Dermal/day

(mg/lb ai)	Unit Exp. Inhal./day

(µg/lb ai)	Dermal

Dose/day

(mg/kg) 3 	Inhalation

Dose/day

(mg/kg) 4	Total        Short-term          MOE 5	Total      Interm.-
term           MOE 5

Loading/Treating	L/T	S, G	52,000	0.023	0.34	0.00365	0.00108	59	18

Loading/Treating	L/T	S, G, R	52,000	0.023	0.068 *	0.00365	0.00022	220	81

Bagging, treated seed	Bagger	S	52,000	0.0091	0.16	0.00144	0.00051	130	38

Bagging, treated seed	Bagger	S, R	52,000	0.0091	0.032 *	0.00144	0.00010
490	180

Sewing, bagged seed	Sewer	S	52,000	0.0062	0.23	0.00098	0.00073	92	27

Sewing, bagged seed	Sewer	S, R	52,000	0.0062	0.046 *	0.00098	0.00015	400
130

Doing multiple jobs	Multiple	S, G	52,000	0.0420	1.6	0.00666	0.00508	13	4

Doing multiple jobs	Multiple	S, G, R	52,000	0.0420	0.32 *	0.00666
0.00102	58	19

Handling/ Planting 6 	Farmer, Postappl.	S, #	640	0.25	3.4	0.00049
0.00013	470	150

2.  S = Single layer (long sleeve shirt and long pants) and no gloves, G
= chemical resistant gloves, R = dust/mist respirator

3.  Dermal dose = (app. rate)(area treated/day)(dermal unit
exposure)(dermal absorption factor)(conversion factor [0.01]) ÷ body
weight

4.  Inhalation dose = (app. rate)(area treated/day)(inhalation unit
exposure)(conversion factor [0.01]) ÷ body weight

5.  Total Short-term or Total Intermediate-term MOE: 1 ÷ 1/dermal MOE +
1/ inhalation MOE

6.  Postapplication exposure.

* Applied an 80% reduction factor to the inhalation unit exposure for
the use of dust/mist respirator, which is a PPE requirement on the label
for all seed treatment workers. Ref: Exposure Mitigating Table (PHED).

#.  For handlers/planters, label specifies gloves for loading only.

Appendix B.  Toxicology Profile of Cyfluthrin and Beta-cyfluthrin

The requirements (40 CFR 158.340) for food uses for beta-cyfluthrin are
in Table 1.  Use of the new guideline numbers does not imply that the
new (1998) guideline protocols were used.

Appendix B, Table 1

Toxicology Data Requirements – cyfluthrin/beta-cyfluthrin

Test

	Technical

	Required	Satisfied

870.1100    Acute Oral Toxicity

870.1200    Acute Dermal Toxicity

870.1300    Acute Inhalation Toxicity

870.2400    Primary Eye Irritation

870.2500    Primary Dermal Irritation

870.2600    Dermal Sensitization		yes

yes

yes

yes

yes

yes	yes

yes

yes

yes

yes

yes

870.3100    Oral Subchronic (rodent)

870.3150    Oral Subchronic (nonrodent)

870.3200    21-Day Dermal

870.3250    90-Day Dermal

870.3465    90-Day Inhalation		yes

yes

yes

no

no	yes

yes

yes

-

yes

870.3700a  Developmental Toxicity (rodent)

870.3700b  Developmental Toxicity (nonrodent)

870.3800    Reproduction		yes

yes

yes	yes

yes

yes

870.4100a  Chronic Toxicity (rodent)

870.4100b  Chronic Toxicity (nonrodent)

870.4200a  Oncogenicity (rat)

870.4200b  Oncogenicity (mouse)

870.4300    Chronic/Oncogenicity		yes

yes

yes

yes

yes	yes1

yes

yes

yes

yes

870.5100    Mutagenicity—Gene Mutation - bacterial

870.5300    Mutagenicity—Gene Mutation - mammalian

870.5375    Mutagenicity—Structural Chromosomal Aberrations

870.5550   Mutagenicity—Other Genotoxic Effects		yes

yes

yes

yes	yes

yes

yes

yes

870.6100a  Acute Delayed Neurotox. (hen)

870.6100b  90-Day Neurotoxicity (hen)

870.6200a  Acute Neurotox. Screening Battery (rat)

870.6200b  90-Day Neurotox. Screening Battery (rat)

870.6300    Developmental Neurotoxicity		yes

no

yes

yes

yes	yes

-

yes

yes

yes

870.7485    General Metabolism

870.7600    Dermal Penetration		yes

no	yes

-

1  Satisfied with combined chronic toxicity/carcinogenicity study

Appendix B  Toxicology Profile of Cyfluthrin and Beta-cyfluthrin

Appendix B, Table 2

Acute Toxicity Profile – Cyfluthrin

Guideline No.	Study Type	MRID(s)	Results	Toxicity Category

870.1100	Acute oral – rat	00131499

00131518	In cremophor

g/kg (♂)

In acetone

LD50 = 254 mg/kg (♂)

In N-methyl pyrollidone

LD50 = 500 -1000 mg/kg (♂)	I

II

III

870.1200	Acute dermal – rat	00131499

00131518	In cremophor

LD50 > 5000 mg/kg (♂+♀)

In 0.9% NaCl

LD50 > 5000 mg/kg (♂+♀)

Undiluted

LD50 > 5000 mg/kg (♂+♀)	IV

870.1300	Acute inhalation – rat	00131509	Aqueous cremophor

LC50 > 0.735 mg/L (♂)

LC50 = 0.468 mg/L (♀)

DMSO/polyethylene glycol LC50 = 0.575 mg/L (♂)

LC50 = 0.490 mg/L (♀)	II

870.2400	Acute eye irritation – rabbit	00131499	No corneal opacity;
transient irritation for 3 days	III

870.2500	Acute dermal irritation – rabbit	00131499

Non-irritating.  Primary irritation score = 0	IV

870.2600	Skin sensitization – guinea pig	00131512

00131513	Not a sensitizer (Draize test)

Not a sensitizer

(Maximization test)	N/A

Appendix B  Toxicology Profile of Cyfluthrin and Beta-cyfluthrin

Appendix B, Table 3

Acute Toxicity Profile – Beta-Cyfluthrin

Guideline No.	Study Type	MRID(s)	Results	Toxicity Category

870.1100	Acute oral – rat	41244101	In xylene

Fasted:

LD50 = 211 mg/kg (♂)

LD50 = 336 mg/kg (♀)

Fed:

LD50 = 307 mg/kg (♂)

LD50 = 343 mg/kg (♀)	II

870.1100	Acute oral – rat	41244102	In PEG 400

Fasted:

LD50 = 380 mg/kg (♂)

LD50 = 651 mg/kg (♀)

Fed:

LD50 = 655 mg/kg (♂)

LD50 = 1369 mg/kg (♀)	II (♂)

III (♀)

870.1100	Acute oral – rat	41244104	In acetone/peanut oil

Fasted:

LD50 = 84 mg/kg (♂)

LD50 = 77 mg/kg (♀)

Fed:

LD50 = 141 mg/kg (♂)

LD50 = 108 mg/kg (♀)	II

870.1100	Acute oral – mouse	41244103	In PEG 400

Fasted:

LD50 = 91 mg/kg (♂)

LD50 = 165 mg/kg (♀)	II

870.1200	Acute dermal – rat	41244105	In xylene

LD50 > 5000 mg/kg (♂)

LD50 > 5000 mg/kg (♀)	IV

870.1200	Acute dermal – rat	41244106	In PEG 400

LD50 > 5000 mg/kg (♂)

LD50 > 5000 mg/kg (♀)	IV

870.1300	Acute inhalation – rat	41205701	Aerosol

LC50 = 0.081-0.082 mg/L (♂+♀)

Dust

LC50 = 0.532 mg/L (♂+♀)	II

III

870.2400	Acute eye irritation – rabbit	41205702	Slight ocular irritant
III

870.2500	Acute dermal irritation – rabbit	41205702	Very slight dermal
irritant  	IV

870.2600	Skin sensitization – guinea pig	43611601	Not a sensitizer;
however, positive control data not available	N/A

Appendix B  Toxicology Profile of Cyfluthrin and Beta-cyfluthrin

Appendix B, Table 4

Subchronic, Chronic and Other Toxicity Profile – Cyfluthrin and
Beta-Cyfluthrin

Guideline No.	Study Type	MRID No. (year)/ Classification /Doses	Results

870.3100

	90-Day oral toxicity (rat)

Beta-cyfluthrin (99.7% a.i.)	41244108 (1986)

Acceptable/guideline

M:  0, 2.3, 9.5, 18.9 mg/kg/day

F:  0, 2.5, 10.9, 42.4 mg/kg/day

M:  0, 37.0 mg/kg/day

F:  0, 43.0 mg/kg/day	NOAEL = 9.5/10.9 mg/kg/day (M/F)

LOAEL = 37.0/43.0 mg/kg/day (M/F) based on gait abnormalities, necrosis
in head and neck region, mortality (2), decreased body weight gain.

870.3100

	90-Day oral toxicity (rat)

Cyfluthrin (84.2% a.i.)	00131524 (1980)

Unacceptable/guideline

M:  0, 2.2, 7.4, 22.3 mg/kg/day

F:  0, 2.7, 8.8, 28.0 mg/kg/day	NOAEL = 22.3/28.0 mg/kg/day (M/F)

LOAEL = not observed

870.3150

	90-Day oral toxicity (dog)

Beta-cyfluthrin (99% a.i.)	41267801 (1987)

Acceptable/guideline

M:  0, 0.39, 2.36, 13.9 mg/kg/day

F:  0, 0.39, 2.5, 15.4 mg/kg/day	NOAEL = 2.36/2.5 mg/kg/day (M/F)

♂) or 17 applications within 22 days (♀)	Dermal NOAEL = 113
mg/kg/day

Dermal LOAEL = 376 mg/kg/day based on gross and histological skin
lesions.

Systemic NOAEL = 376 mg/kg/day

Systemic LOAEL = 1077 mg/kg/day based on decreased food consumption, red
nasal discharge and urine staining.

Non-guideline	28-Day oral toxicity (rat)

Cyfluthrin	00131525 (1983)

Supplementary

0, 5, 15, 50 mg/kg/day	NOAEL = 15 mg/kg/day

LOAEL = 50 mg/kg/day 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.

Note: The NOAEL was changed to 15 mg/kg/day and the LOAEL to 50
mg/kg/day by the HIARC (May 21, 2002 report).

870.3465

	90-Day inhalation toxicity (rat)

Cyfluthrin (94.9% a.i.)	00157793 (1984), 40082901, 40239301

Acceptable/guideline

0, 0.00009, 0.00071, 0.00451 mg/L

(0, 0.02, 0.16, 0.91 mg/kg/day)

In ethanol/PEG 400 (1:1),

6 hrs/day, 5 consecutive days/week	NOAEL = 0.00009 mg/L (0.02 mg/kg/day)

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 toxicity (rat)

Cyfluthrin (93.8% a.i.) 	41842601 (1989)

Acceptable/non-guideline

0, 0.00044, 0.006,  0.047 mg/L

(0, 0.12, 1.6, 12.8 mg/kg/day)

In ethanol/PEG 400 (1:1),

6 hrs/day, 5 consecutive days/week	NOAEL = 0.00044 mg/L (0.12 mg/kg/day)

LOAEL = 0.006 mg/L (1.6 mg/kg/day) 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 inhalation toxicity (rat)

Beta-cyfluthrin (97.9% a.i.)	41783001 (1989)

Acceptable/non-guideline

0, 0.00026, 0.0027, 0.023  mg/L

(0, 0.07, 0.73, 6.3 mg/kg/day)

In ethanol/PEG 400 (1:1),

6 hrs/day, 5 consecutive days/week	NOAEL = 0.00026 mg/L (0.07 mg/kg/day)

LOAEL = 0.0027 mg/L (0.73 mg/kg/day) based on decreased body weights, (
urine pH in males.

Non-guideline	5-Day  inhalation study (rat)

Beta-cyfluthrin (98% a.i.)	41205708 (1988)

Acceptable/non-guideline

0, 0.00025, 0.0038, 0.028 mg/L

(0, 0.07, 1.03, 7.6 mg/kg/day)

In ethanol/PEG 400 (1:1),

6 hrs/day	NOAEL = 0.00025 mg/L (0.07 mg/kg/day)

LOAEL = 0.0038 mg/L (1.03 mg/kg/day) based on unpreened hair coat,
piloerection, hepatoid foci in lungs.

Non-guideline	28-Day oral toxicity (dog)

Beta-cyfluthrin	41244109 (1986)

Acceptable/non-guideline

0, 0.25, 2.0, 16.0/8.0 mg/kg/day

(2 dogs/sex/dose)	NOAEL = 2.0 mg/kg/day (both sexes)

LOAEL = 8.0 mg/kg/day based on impaired movement and conjunctival
irritation.

870.3700a

	Prenatal oral developmental toxicity in rodents (rat)

Beta-cyfluthrin (96.5-97.3% a.i.)	44116501 (1996)

Acceptable/guideline

0, 3, 10, 40 mg/kg/day

1% Cremophor in municipal tap water	Maternal NOAEL = 3 mg/kg/day

Maternal LOAEL = 10 mg/kg/day based on reduced body weight gain and
reduced food consumption with post-treatment recovery.

Developmental NOAEL = 10 mg/kg/day

Developmental LOAEL = 40 mg/kg/day based on reduced fetal body weights
and increased skeletal variations.

870.3700a	Prenatal oral developmental toxicity in rodents (rat)

Cyfluthrin (93.4%)	00157794 (1983)

Unacceptable/guideline

0, 1, 3, 10 mg/kg/day

1% Cremophor EL in distilled water	Maternal NOAEL = 10 mg/kg/day

Maternal LOAEL = not observed

Developmental NOAEL = 10 mg/kg/day

Developmental LOAEL = not observed

870.3700b

	Prenatal oral developmental toxicity in non-rodents (rabbit)

Cyfluthrin

(96% a.i.) 	42675401 (1992)

Acceptable/guideline

0, 20, 60, 180 mg/kg/day

In corn oil, by gavage	Maternal NOAEL = 20 mg/kg/day

Maternal LOAEL = 60 mg/kg/day based on decreased body weight gain and
food consumption during the dosing period.

Developmental NOAEL = 180 mg/kg/day

Developmental LOAEL = not observed

870.3700a	Prenatal inhalation developmental toxicity in rodents (rat )

Cyfluthrin (96.2% a.i.)

	43393401 (1991-1994)

Acceptable/guideline

0, 0.00046, 0.00255, 0.0119, 0.0128 mg/L/day (0.125, 0.692, 3.234, 3.478
mg/kg/day)

In PEG-400:ethanol for 6 hrs/day	Maternal NOAEL = not determined

Maternal LOAEL = 0.00046 mg/L (0.125 mg/kg/day) based on decreased body
weight gain and relative food efficiency.

Developmental NOAEL = 0.00046 mg/L (0.125 mg/kg/day)

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.

870.3700a	Prenatal inhalation developmental toxicity in rodents (rat )

Cyfluthrin (92.9% and 93%)

	40780401 (1988)

Acceptable/guideline

1.   0, 0.0011, 0.0047, 0.0237 mg/L/day

(0, 0.299, 1.277, 6.44 mg/kg/day)

2.  0, 0.00009, 0.00025, 0.00059, 0.0042 mg/L/day

(0, 0.0245, 0.0679, 0.160, 1.141 mg/kg/day)

Dissolved in a 1:1 mixture of Lutrol and ethanol for 6 hrs/day.	Maternal
NOAEL = 0.0011 mg/L (0.299 mg/kg/day)

Maternal LOAEL = 0.0047 mg/L (1.277 mg/kg/day) based on reduced
motility, dyspnea, piloerection, ungroomed coats, eye irritation.

Developmental NOAEL = 0.00059 mg/L (0.160 mg/kg/day)

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 inhalation study (pups & dams) in mice
with spontaneous motor activity measurements

Cyfluthrin (96.8% a.i.)	44373401 (1997)

Acceptable/non-guideline

0, 0.006, 0.015, 0.058 mg/L

(0, 2.48, 6.21, 24.0 mg/kg/day)

In PEG 400, 6 hrs/day, for 7 consecutive days	Maternal NOAEL = 0.058
mg/L (24.0 mg/kg/day)

Maternal LOAEL = not determined

Offspring NOAEL = 0.006 mg/L (2.48 mg/kg/day)

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.

870.3800	Reproduction and fertility effects

(rat)

Cyfluthrin (95.4% a.i.), corn oil/acetone premix	44371401 (1996)

Acceptable/guideline

Premating and gestation:

M:  0, 3, 9, 29 mg/kg/day

F:  0, 4, 10, 33 mg/kg/day

First 2 weeks of lactation:

0, 7, 19, 59 mg/kg/day

	Parental/Systemic NOAEL = 3/4 mg/kg/day (M/F)

Parental/Systemic LOAEL = 9/10 mg/kg/day (M/F) based on reductions in
body weights and food consumption.

Offspring NOAEL = 7 mg/kg/day (M/F)

Offspring LOAEL = 19 mg/kg/day based on coarse tremors in pups during
lactation and decreases in mean litter weight.

Non-guideline	“Supplemental” 2-generation reproduction study (rat)

Cyfluthrin (95.5% a.i.)	44371402 (1997)

Acceptable/non-guideline

M:  0, 1.9, 3.8 mg/kg/day

F:  0, 2.1, 4.2 mg/kg/day

Corn oil/acetone premix	Parental/Systemic NOAEL = 3.8/4.2 mg/kg/day
(M/F)

Parental/Systemic LOAEL = not determined

Offspring NOAEL = 3.8/4.2 mg/kg/day (M/F)

Offspring LOAEL = not determined

Non-guideline	Pilot one-generation reproduction study (rat)

Cyfluthrin (95.7-96.2% a.i.), corn oil/acetone premix

	43792901 (1995)

Acceptable/non-guideline

M:  0, 3.4, 9.3, 24.2, 38.9 mg/kg/day

F:  0, 4.1, 10.5, 27.2, 43.9 mg/kg/day

Gestation:

0, 3.9, 10.1, 27.2, 45.0 mg/kg/day

Lactation:

0, 7.8, 22.9, 59.6, 95.9 mg/kg/day	Parental/Systemic NOAEL = 22.9
mg/kg/day

Parental/Systemic LOAEL = 59.6 mg/kg/day based on hind leg splay,
ataxia, reduction in body weight gain.

Offspring NOAEL = 7.8 mg/kg/day

Offspring LOAEL = 22.9 mg/kg/day based on tremors during lactation and
pup weight decreases.

Dosages for the NOAEL and LOAEL calculated from weekly mean test
material consumption during lactation because both the large variation
in consumption values and the increased test material consumption during
the time that the effects were noted.

870.3800	Reproduction and fertility effects (rat)

	(1983)

Cyfluthrin	00131532 (1983)

Acceptable

M:  0, 3.8, 12.3, 37.2 mg/kg/day

F:  0, 5.4, 15.1, 48.5 mg/kg/day

This study was classified core minimum, although it had a number of
deficiencies:  test article 50% premix with Wessalon S, no individual
litter observations, limited necropsy & histopathology, other reporting
deficiencies.	Parental/Systemic NOAEL = 12.3/15.1 mg/kg/day (M/F)

Parental/Systemic LOAEL = 37.2/48.5 mg/kg/day (M/F) based on decreased
body weight gain.

Offspring NOAEL = 5.4 mg/kg/day

Offspring LOAEL = 15.1 mg/kg/day based on decreased viability during
lactation period and decreased body weight gains.

870.4100b

	Chronic toxicity (dog)

Cyfluthrin

(94.9-95.1% a.i.)	44435401 (1997)

Acceptable/guideline

M:  0, 1.36, 2.43, 10.64, 15.47 mg/kg/day

F:  0, 1.46, 3.61, 10.74, 17.99 mg/kg/day

Corn oil premix	NOAEL = 2.43/3.61 mg/kg/day (M/F)

LOAEL = 10.64/10.74 mg/kg/day (M/F) based on clinical signs, gait
abnormalities, and abnormal postural reactions in males and females.

870.4100b	Chronic toxicity (dog)

Cyfluthrin 	00151358 (1983)

Core minimum

0, 1, 4, 16 mg/kg/day

50% premix with Wessalon S	NOAEL = 4.0 mg/kg/day

LOAEL = 16.0 mg/kg/day based on gait abnormalities, vomiting, liquid
feces, decreased body weights (males).

870.4100b	6-Month oral toxicity (dog)

Cyfluthrin	00131530 (1981)

Core minimum

0, 1.62, 5, 15 mg/kg/day	NOAEL = 5.0 mg/kg/day

LOAEL = 15.0 mg/kg/day based on gait abnormalities, arching backs,
vomiting, diarrhea.

870.4200	Carcinogenicity (mouse)

Cyfluthrin ((93.9% a.i.)	44589701 (1998)

Acceptable/guideline

M:  0, 31.9, 114.8, 232.7 mg/kg/day

F:  0, 38.4, 140.6, 309.7 mg/kg/day

Corn oil premix	NOAEL = 31.9/140.6 mg/kg/day (M/F)

LOAEL = 114.8 mg/kg/day (M) based on ear skin lesions and reduced body
weight gains.  309.7 mg/kg/day (F) based on clinical signs, macroscopic
and microscopic pathology findings, and reduced body weights, body
weight gains, and food consumption.

No evidence of carcinogenicity

870.4200	Carcinogenicity (mouse)

Cyfluthrin

(49.7-51.0% a.i.)	00137304 (1983)

Acceptable/guideline

M:  0, 11.6, 45.8, 194.5 mg/kg/day

F:  0, 15.3, 63.0, 259.9 mg/kg/day

Premix in Wessalon S	Study not acceptable for chronic toxicity.

No evidence of carcinogenicity

870.4300	Combined chronic feeding/ carcinogenicity (rat)

Cyfluthrin (94.7% a.i.), 	44459301 (1997)

Acceptable/guideline

M:  0, 2.6, 11.6, 22.8 mg/kg/day

F:  0, 3.3, 14.4, 28.3 mg/kg/day

Acetone/corn oil pre-mix	NOAEL = 2.6/3.3 mg/kg/day (M/F)

LOAEL = 11.6/14.4 mg/kg/day (M/F) based on overall declines in body
weight gain by 12 and 10% in males and females, respectively.

No evidence of carcinogenicity

870.4300	Combined chronic feeding/ carcinogenicity (rat)

Cyfluthrin

(49.7-51.0% purity as a premix concentrate in Wessalon S)	00137303
(1983)

Acceptable/guideline

M:  0, 2.02, 6.19, 19.20 mg/kg/day

F:  0, 2.71, 8.15, 25.47 mg/kg/day

	NOAEL = 6.19/8.15 mg/kg/day (M/F)

LOAEL = 19.20/25.47 mg/kg/day (M/F) based on decreased body weights and
body weight gains.

No evidence of carcinogenicity

870.5100	Gene mutation – bacterial reverse mutation assay

Cyfluthrin	00131539 (1982)

Acceptable/guideline

5-5000 ug/plate

	Negative.

No increases in reverse mutations with and without activation.

870.5100	Gene mutation – yeast reverse mutation assay

Cyfluthrin	00131541, 00144017 (1982)

Acceptable/guideline

312.5-1000 ug/mL	Negative.

No increase in number of revertants with S138 cultures.  Increase in
number of revertants with S211 culture but not dose-related; no increase
in number of revertants when assay repeated.

870.5100	Gene mutation – bacterial reverse mutation assay

Cyfluthrin	00131540 (1982)

Acceptable/guideline	Negative.

No increases in reverse mutations with and without activation.

870.5100	Gene mutation – bacterial reverse mutation assay

Beta-cyfluthrin	41244110 (1986)

Acceptable/guideline

Initial assay:

20-12500 ug/plate

Confirmatory assay:

500-8000 ug/plate	Negative.

No increases in reverse mutations in S. typhimurium strains TA 1535, TA
1537, TA 98 or TA 100 with and without activation.

870.5300	Gene mutation –

in vitro mammalian cell gene forward mutation assay

Cyfluthrin	00157796 (1985)

Acceptable/guideline

3, 5, 7, 9, 10 ul/ml

	Negative.

Cyfluthrin did not induce forward mutations under conditions of assay

870.5300	Gene mutation –

in vitro mammalian cell gene forward mutation assay

Beta-cyfluthrin	41244112 (1989)

Acceptable/guideline

50-100 ug/mL (insoluble), 20-40 ug/mL (soluble)	Negative.

No mutagenic response in CHO cells HGPRT assay with and without
activation.

870.5375	Cytogenetics -  in vitro mammalian cell chromosome aberration
test

Beta-cyfluthrin	41205703 (1988)

Acceptable/guideline

500, 1000, 5000 ug/mL	Negative.

Not clastogenic in human lymphocytes.

870.5395	Cytogenetics –

mammalian erythrocyte micronucleus test

Beta-cyfluthrin	4124411 (1988)

Acceptable/guideline

80 mg/kg

	Negative.

No increased frequency of micronucleated polychromatic erythrocytes in
mice bone marrow cells.

870.5500	Other effects – bacterial DNA damage

Cyfluthrin	00131540 (1982)

Acceptable/guideline	Negative.

In rec- assay, no inhibition at doses of 100-10000 ug/disk.

870.5550	Other effects – bacterial DNA damage and repair in E. coli

Cyfluthrin	00131538 (1981)

Acceptable/guideline

62.5-1000 ug/plate	Negative.

No induction of inhibition, both with and without activation.

870.5550	Other effects –

unscheduled DNA synthesis in cultured rat hepatocytes

Cyfluthrin	00157798 (1985)

Acceptable/guideline

17, 50, 167, 500, 1667, 5000 ug/ml	Negative.

870.5550	Other effects –

unscheduled DNA synthesis in mammalian cells in culture

Beta-cyfluthrin 	41205704 (1987)

Acceptable/guideline

1.01-1010 ug/mL

	Negative.

870.5575	Other effects –

mitotic gene conversion in Saccharomyces cerevisiae

Cyfluthrin	00131542 (1982)

Acceptable/guideline

625-10000 ug/ml

	Negative.

870.5915	Other effects – in vivo sister chromatid exchange assay in
Chinese hamster ovary cells

Cyfluthrin	00157795 (1985)

Acceptable/guideline

Non-activated assays:  3, 5, 10, 20 ug/ml

Activated assays:  125, 250, 500, 1000 ug/ml 	Negative.

no increase in SCE frequency in treated cells

870.6100	Delayed neurotoxicity (hen)

Cyfluthrin	00156585 (1985)

Supplementary

0 and 5000 mg/kg/day for 3 days	All hens died within 3 days; NTE
activity was not inhibited

870.6100	Oral delayed neurotoxicity (hen)

Cyfluthrin	00131543 (1981)

Supplementary

10 hens:  1000 (1x), 2500 (1x), 5000 (1x) mg/kg;

30 hens:  5000 mg/kg (2x, 21 days apart);

10 hens:  5000 mg/kg (5x daily for 1 week)

	In the single dose study, at 5000 mg/kg, five of the ten hens died.
Moderate fiber alterations (axon fragmentation, occasional swelling and
eosinophilia of the axon fragments and vacuolation of the myelin
sheaths) in the sciatic nerve were observed in 2 hens.  Six hens at 2500
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 4 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 disintegration 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	Oral delayed neurotoxicity (hen)

Cyfluthrin	 00131544 (1982)

10 hens: (5000 mg/kg, 1 x) or  20 hens: (5000 mg/kg, 2 x, 7 days apart).
  The first study was classified as Core supplementary - no
histopathology conducted) and the second study was classified as Core
minimum.	In the single dose study, the hens showed an initial weight
loss but recovered.  No other treatment-related effects were observed.
In the two-dose study, 1 hen showed some signs of neurotoxicity on day
30.  There were no microscopic lesions in the nervous system.

870.6100	Dermal delayed neurotoxicity (hen)

Cyfluthrin	00131545 (1982)

Minimum

5000 mg/kg (paste with cellulose powder); in the first study, 10 hens
were exposed for 5 days for 23 hours/day.  In the second study, 10 hens
were exposed for 3 weeks, 5 days/week, 6 hours/day.	In the first study
there were 2 deaths on the 3rd and 10th day.  All other hens had
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 neurotoxicity (hen)

Cyfluthrin	00131510 (1983)

Core minimum

 single 4-hour exposure or to 15 six-hour exposures over a 3-week period
at concentrations of  0.285, 0.445 or 0.596 mg/L in the single dose
study and 0.614 mg/L in the 3 week study	Nine of 10 hens died at 0.596
mg/L and none died in any of the lower concentrations.  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 neurotoxicity (hen)

Cyfluthrin	00163040 (1986)

Core Minimum

4300 (1x), 4300 (2x: days 1 & 21), 1500 (5 consecutive days). 	4300,
1500: mortality, aggression, somnolence, cyanosis of crest.  Sl. axonal
degeneration of sciatic nerve in 1 hen given a single dose; sl. axonal
degeneration of spinal cord in 1 hen given 2 doses.  No
treatment-related changes in NTE activity.

870.6200a

	Acute neurotoxicity (rat)

Beta-cyfluthrin

((96.9% a.i.)	44401101  (1997) Acceptable/guideline

0, 0.5, 2, 10 mg/kg

In 1% Cremophor EL in deionized water	NOAEL = 2 mg/kg

LOAEL = 10 mg/kg based on clinical signs, changes in FOB parameters, and
decreases in motor activity.

870.6200b	Subchronic neurotoxicity (rat)

Beta-cyfluthrin ((96.5% a.i.) 	44296001 (1997) Acceptable/guideline

M:  0, 2.02, 7.99, 26.81 mg/kg/day

F:  0, 2.34, 9.40, 30.83 mg/kg/day

In corn oil, 1% by weight in diet	NOAEL = 7.99/9.40 mg/kg/day (M/F)

LOAEL = 26.81/30.83 mg/kg/day (M/F) based on clinical signs, changes in
FOB measurements and possibly decreased body weights, body weight gains,
and food consumption

870.6300	Developmental neurotoxicity (rat)

Beta-cyfluthrin (95.1-97.6% a.i.)	46054101 (2003)

Acceptable/non-guideline

0, 30, 125, 200 ppm

(Gestation:  0, 2.4, 11.0, 17.8 mg/kg/day)	Maternal NOAEL = 17.8
mg/kg/day

Maternal LOAEL = not observed

Offspring NOAEL = 11.0 mg/kg/day

Offspring LOAEL = 17.8 mg/kg/day based on decreased body weight and body
weight gain and decreased brain weights in females at termination.

870.7485	Metabolism and Pharmacokinetics

Cyfluthrin

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remophor EL)	00072007 (1983)

Core Minimum when considered together with metabolism part of study

Single oral dose:

0.5 and 10 mg/kg

Single i.v. dose:

0.5 and 10 mg/kg

Repeated oral dose:

0.5 mg/kg/day unlabeled for 14 days, then single dose labeled	Following
oral administration, the test material was rapidly and nearly completely
absorbed.  Peak plasma levels of radioactivity were observed at about 2
hours after dosing.  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
radioactivity 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.
The apparent volume of distribution (Vd) was about 17% of the total body
volume, corresponding to the “readily diffusable part of the
extracellular fluid”.  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 administration.
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 enterohepatic circulation of test material.

870.7485	Metabolism and Pharmacokinetics

Cyfluthrin

(98% purity in 5% Cremophor EL)	00072007 (1983)

Core Minimum when considered together with biokinetic part of study

Single oral dose:

0.5 and 10 mg/kg

Single i.v. dose:

0.5 and 10 mg/kg

Repeated oral dose:

0.5 mg/kg/day unlabeled for 14 days, then single dose labeled

Excretion of radioactivity was rapid.  Following oral administration,
>95% of the 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.

 TC \l1 " Appendix D:  Review of Human Research

Appendix C  Summary of Cyfluthrin/Beta-cyfluthrin Tolerances

Appendix C; Table 1

Tolerance  Summary Table for Cyfluthrin/Beta-cyfluthrin

Commodity	Established Tolerance (ppm)	Proposed Tolerance (ppm)
Recommended Tolerance (ppm)	Comments; Correct Commodity Definition

Grass, forage, fodder and hay, group 17, forage	6.0 1	13.0	12	Adequate
grass field trial data are available.

Grass, forage, fodder and hay, group 17, hay	8.0 1	40.0	50

	Alfalfa, forage	-	5.0	5.0	Adequate alfalfa field trial data are
available.

Alfalfa, hay	10.0	15.0	13

	Beet, sugar, roots	-	0.09	0.10	Adequate field trial data are available

Beet, sugar, dried pulp	-	11	1.0	Maximum expected residues are 0.59 ppm
based on HAFT residues of 0.049 ppm and a 12x processing factor for
dried pulp.

Grain, cereal; Crop Group 15 (except Rice)	4.0	4.0	0.15	Wheat grain,
barley grain, buckwheat grain, millet grain, oat grain, rye grain,
triticale grain

Grain, cereal; Crop Group 15 (except Rice)	4.0	4.0	0.05	Corn, field,
grain

Grain, cereal; Crop Group 15 (except Rice)	4.0	4.0	0.05	Corn, sweet,
kernel plus cob with husks removed

Grain, cereal; Crop Group 15 (except Rice)	4.0	4.0	3.5	Sorghum, grain,
grain

Wheat, bran	6.5	-	0.5	Stored grain uses have been revoked

Corn, field, refined oil	30.0	-	-	The field corn, grain tolerance will
cover residues in corn oil

Rice, bran	6.0	-	-	Stored grain uses have been revoked

Rice, hulls	18.0	-	-	Stored grain uses have been revoked

Grain, cereal, forage, fodder and straw, Crop Group 16 (except Rice)	-2
7.0	25	Grain, cereal, forage, fodder and hay, group 17, forage, except
rice

Grain, cereal, forage, fodder and straw, Crop Group 16 (except Rice)	- 3
7.0	30	Grain, cereal, forage, fodder and hay, group 17, stover, except
rice

Grain, cereal, forage, fodder and straw, Crop Group 16 (except Rice)	- 4
7.0	7.0	Grain, cereal, forage, fodder, and hay, group 17, straw, except
rice

Grain, cereal, forage, fodder and straw, Crop Group 16 (except Rice)	- 5
7.0	6.0	Grain, cereal, forage, fodder and hay, group 17, hay, except
rice

Wheat, forage	5.0	-	-	Crop group tolerance is being established for
Forage of Grain, Cereal, except Rice (Crop Group 16)

Corn, field, forage	3.0	-	-

	Corn, sweet, forage	15	-	-

	Sorghum, grain, forage	2.0	-	-

	Corn, field, stover	6.0	-	-	Crop group tolerance is being established
for Stover of Grain, Cereal, except Rice (Crop Group 16)

Corn, pop, stover	6.0	-	-

	Corn, sweet, stover	30.0	-	-

	Sorghum, grain, stover	5.0	-	-

	Wheat, hay	6.0	-	-	Crop group tolerance is being established for Hay of
Grain, Cereal, except Rice (Crop Group 16)

Wheat, straw	6.0	-	-	Crop group tolerance is being established for Straw
of Grain, Cereal, except Rice (Crop Group 16)

Cattle, fat	10	NA	2.0	Based on the recalculated maximum dietary burdens
(MDBs) for beef cattle (20.9 ppm), dairy cattle (27.1 ppm) and swine
(3.21 ppm) and the residue data from the available cattle feeding study,
tolerances for livestock commodities can be substantially reduced.

Cattle, meat	0.4	NA	0.10

	Cattle, meat byproducts	0.4	NA	0.10

	Goat, fat	10	NA	2.0

	Goat, meat	0.4	NA	0.05

	Goat, meat byproducts	0.4	NA	0.05

	Hog, fat	10	NA	0.5

	Hog, meat	0.4	NA	0.01

	Hog, meat byproducts	0.4	NA	0.01

	Horse, fat	10	NA	2.0

	Horse, meat	0.4	NA	0.05

	Horse, meat byproducts	0.4	NA	0.05

	Milk	1.0	NA	0.2

	Milk, fat	30	NA	5.0

	Sheep, fat	10	NA	2.0

	Sheep, meat	0.4	NA	0.05

	Sheep, meat byproducts	0.4	NA	0.05

	NA = not applicable

1 Regionally restricted tolerances for grass grown in CA, OR, ID and WA.

2 Forage tolerances are established for wheat (5.0 ppm), field corn (3.0
ppm), sweet corn (15 ppm), and sorghum (2.0 ppm)

3 Stover tolerances are established for field corn (6.0 ppm), popcorn
(6.0 ppm), sweet corn (30 ppm), and sorghum (5.0 ppm)

4 A Straw tolerance is established for wheat (6.0 ppm)

5 A hay tolerance is established for wheat (6.0 ppm)

 Ware, G.W. The Pesticide Book. Fresno, CA, Thomson Publications, 1994,
pgs 171-172.

Page   PAGE  10  of   NUMPAGES  66


[Federal Register Volume 88, Number 186 (Wednesday, September 27, 2023)]
[Notices]
[Page 66475]
[FR Doc No: 2023-21028]

-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4728-DR; Docket ID FEMA-2023-0001]

Illinois; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Illinois (FEMA-4728-DR), dated August 15,
2023, and related determinations.

DATES: The declaration was issued August 15, 2023.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated August 15, 2023, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the State
of Illinois resulting from severe storms and flooding during the
period of June 29 to July 2, 2023, is of sufficient severity and
magnitude to warrant a major disaster declaration under the Robert
T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (the ``Stafford Act''). Therefore, I declare that such
a major disaster exists in the State of Illinois.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Individual Assistance and Hazard
Mitigation in the designated areas. Consistent with the requirement
that Federal assistance be supplemental, any Federal funds provided
under the Stafford Act for Hazard Mitigation and Other Needs
Assistance under section 408 will be limited to 75 percent of the
total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The time period prescribed for the implementation of section
310(a), Priority to Certain Applications for Public Facility and Public
Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed
six months after the date of this declaration.
    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Andrew D. Friend, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Illinois have been designated
as adversely affected by this major disaster:

    Cook County for Individual Assistance.
    Cook County is eligible for assistance under the Hazard
Mitigation Grant Program.
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-21028 Filed 9-26-23; 8:45 am]
BILLING CODE 9111-23-P