fenpropathrin (Danitol) Pesticide Tolerances--Final Rule 4/93
40 CFR Parts 180, 185, and 186
[PP 2F4144 and FAP 2H5648/R1192; FRL-4580-4]
RIN 2070-AB78
Pesticide Tolerances for Fenpropathrin
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
------------------------------------------------------------
SUMMARY: These rules establish tolerances for residues of the
pesticide chemical fenpropathrin (alpha-cyano-3-phenoxybenzyl
2,2,3,3-tetramethylcyclopropanecarboxylate) in or on the raw
agricultural commodities (RACs) cottonseed at 1.0 part per million
(ppm); meat, meat byproducts, and fat of cattle, goats, hogs,
horses, poultry, and sheep at 0.02 ppm; milk fat (reflecting
0.02 ppm in whole milk) at
0.03 ppm; and eggs at 0.02 ppm; a
food additive tolerance for fenpropathrin in or on cottonseed
oil at 3 ppm; and a feed additive tolerance for fenpropathrin
in or on cottonseed soapstock at 2.0 ppm. These regulations
to establish maximum permissible levels for residues of the
pesticide chemical were requested in petitions submitted by
Valent U.S.A. Corp.
EFFECTIVE DATE: These regulations become effective April 2,
1993.
ADDRESSES: Written objections, identified by the document control
number [PP 2F4144 and FAP 2H5648/R1192], may be submitted to:
Hearing Clerk (A-110), Environmental Protection Agency, Rm.
M3708, 401 M St., Washington, DC 20460.
FOR FURTHER INFORMATION CONTACT: By mail: George T. LaRocca,
Product Manager (PM) 13, Registration Division (H-7505C), Office
of Pesticide Programs, Environmental Protection Agency, 401
M St., SW., Washington, DC 20460. Office location and telephone
number: Rm. 202, CM #2, 1921 Jefferson Davis Highway, Arlington,
VA 22202, 703-305-6100.
SUPPLEMENTARY INFORMATION: EPA issued a notice in the Federal
Register of December 9, 1992 (57 FR 58211), which announced
that Valent U.S.A. Corp., 1333 N. California Blvd., Suite 600,
P.O. Box 8025, Walnut Creek, CA 94596-8025, had submitted pesticide
petition (PP) 2F4144 proposing to establish tolerances under
section 408(b) of the Federal Food, Drug, and Cosmetic Act,
21 U.S.C. 346a (b), in or on the raw agricultural commodities
cottonseed at 1.0 ppm; meat and meat byproducts and fat of cattle,
goats, hogs, horses, and sheep at 0.02 ppm; milk fat (reflecting
0.03 ppm in whole milk) at 0.07 ppm; poultry meat, fat, meat
byproducts, and eggs 0.02 ppm and food/feed petition (FAP) 2H5648
proposing to establish tolerances in or on the food commodity
cottonseed oil at 3 ppm and feed commodity cottonseed soapstock
at 2.0 ppm. The milk fat tolerance was incorrectly announced
in the notice of filing and was subsequently corrected to milk
fat (reflecting 0.02 ppm in whole milk) at 0.03 ppm.
No comments were received in response to the notice of filing.
On March 30, 1993, the Agency issued a conditional registration
for fenpropathrin, a synthetic pyrethroid, on cotton with an
expiration date of November 15, 1993. The registration was made
conditional to be
consistent with other synthetic pyrethroids
conditionally registered for use on cotton and to allow time
for the Agency to complete its regulatory and risk reviews of
cotton use of the synthetic pyrethroids. Because synthetic pyrethroids
are toxic to fish and other aquatic organisms, the Agency is
concerned about adverse impacts on aquatic ecosystems related
to this use of the synthetic pyrethroids.
In November 1990, the Agency and five registrants of pyrethroid
cotton insecticides (collectively, the Pyrethroid Working Group
(PWG)) in collaboration with the National Cotton Council agreed
to interim risk reduction measures designed to reduce the potential
for exposure of aquatic habitats of concern to synthetic pyrethroids
applied to cotton. The interim risk reduction measures included
user surveys to assess current pyrethroid use practices on cotton,
label changes aimed at reducing the aquatic environmental exposure
to pyrethroids, and a program of data generation to estimate
the effectiveness of the steps taken. As part of this interim
risk reduction program, the Agency agreed to extend the registration
of the cotton-use synthetic pyrethroids to November 15, 1993.
By November 15, 1993, it is the Agency's intent to complete
its review of all data submitted under the data generation program
and other information and to make FIFRA Section 3(c)(5) or other
appropriate regulatory
decisions for cotton use synthetic pyrethroids.
With respect to the use of fenpropathrin on cotton, the Agency
concluded that use of fenpropathrin would not cause a significant
increase in the risk of adverse effects to the environment.
This conclusion was premised mainly on the following:
1. The short period of time the registration would be in
effect before the Agency completes its final regulatory and
risk reviews of cotton use of the synthetic pyrethroids.
2. Valent U.S.A. Corp.'s commitment to agree to the terms
and conditions stipulated by the Agency for continued registration
of current cotton pyrethroid products. These conditions include
aquatic risk mitigation language for the cotton use labeling
and conditional registration subject to an Agency determination
of aquatic risk.
3. The total number of treated acres of cotton is essentially
the same and the registration of a new pyrethroid on cotton,
such as fenpropathrin, would result in no significant increase
in the number of acres treated. Instead, it would result in
only changes in market share, i.e., the percentage of acres
that are treated with any particular cotton pyrethroid.
Therefore, as set forth below the Agency is establishing
these tolerances with an expiration date of November 15, 1994,
to cover residues expected
to be present during the period of
conditional registration. The tolerances could be made permanent
if full registration is subsequently granted.
The data submitted in the petition and other relevant material
have been evaluated. The pesticide is considered useful for
the purpose for which the tolerance is sought. The toxicology
data considered in support of the tolerances include the following:
1. A 12-month oral toxicity study (dog): Systemic no-observed-
effect level (NOEL) of 100 ppm (2.5 milligram (mg)/kilogram
(kg)/day) and a systemic lowest effect level (LEL) of 250 ppm
(6.25 mg/kg/day).
2. A 24-month chronic feeding/carcinogenicity (rat): Systemic
NOEL's of 450 ppm in males, 150 ppm in females (17.06 mg/kg/day
and 7.23 mg/kg/day, respectively). Systemic LEL of 600 ppm (HDT:
22.80 mg/kg/day) in males (increased mortality, body tremors,
increased pituitary, kidney, and adrenal weights), and systemic
LEL of 450 ppm (19.45 mg/kg/day) in females (increased mortality
and body tremors). There were no oncogenic effects observed
at any dose levels.
3. A 24-month chronic feeding/carcinogenicity study (mouse):
Systemic NOEL greater than 600 ppm HDT (males and females; 56.0
and 65.2 mg/kg/day, respectively). There were no indications
of toxicity or
carcinogenicity other than marginally increased
hyperactivity in females dosed at 600 ppm.
4. Three-generation reproduction study (rats): (Parent) systemic
NOEL of 40 ppm (M/F 3.0/3.4 mg/kg/day). Systemic LEL of 120
(M/F 8.9/10.1 mg/kg/day)- body tremors with spasmodic muscle
twitches, increased sensitivity, and maternal lethality. (Pups)
Reproductive NOEL = 120 ppm (M/F 8.9/10.1 mg/kg/day). Reproductive
LEL = 360 ppm (M/F 26.9/32.0 mg/kg/day)-Decreased mean F2B loss.
Developmental NOEL = 40 ppm (M/F 3.0/3.4 mg/kg/day). Developmental
LEL = 120 ppm (M/F 8.9/10.1 mg/kg/day)-body tremors, increased
mortality.
5. Developmental toxicity (rabbits): Maternal NOEL = 4 mg/kg/day,
maternal LEL = 12 mg/kg/day (grooming, anorexia, flicking of
the forepaws). Developmental NOEL > 36 mg/kg/day, there were
no compound-related effects on reproductions. Clinical signs
included grooming, anorexia, flicking of the forepaws and hindfeet,
shaky movements, trembling, stamping of the hindfeet, and lethargy.
6. Developmental toxicity (rats): Maternal NOEL = 6 mg/kg/day,
maternal LEL of 10 mg/kg/day (death moribundity, ataxia, sensitivity
to external stimuli, spastic jumping, tremors, prostration,
convulsion, hunched posture, squinted eyes, chromodacryorrhea,
and lacrimation). Developmental NOEL > 10 mg/day. No developmental
effects were observed at a
dose that was lethally neurotoxic
to dams.
The following genotoxicity tests were negative: A gene mutation
assay (Ames), a chromosomal aberration study in rodents, an
in vitro cytogenics assay, and DNA damage/repair in Bacillus
subtilis.
The Reference Dose (RfD) is 0.025 mg/kg/day based on a NOEL
of 2.5 mg/kg body weight (bwt)/day from a 1-year dog feeding
study and an uncertainty safety factor of 100. The Dietary Risk
Evaluation System (DRES) chronic exposure analysis used tolerance
level residues and 100 crop treated to estimate the Theoretical
Maximum Residue Contribution (TMRC) for the overall U.S. population
and 22 population subgroups. The TMRC for the overall U.S. population
from published uses is only 0.000284 mg/kg bwt/day, which represents
1.13 percent of the RfD. DRES estimates that exposure at the
tolerance level would be approximately 1 percent of the RfD
for the general population, and as high as 5 percent for nonnursing
infants less than 1 year old. When Anticipated Residues are
used, exposure is estimated to be 0.4 percent of the RfD for
the general population and 0.5 percent for nonnursing infants
less than 1 year old.
The metabolism of the chemical in plants and animals is
adequately understood for
this use. Secondary residues occurring
in meat, fat, and meat by-products of catttle, goats, hogs,
horses, poultry and sheep, and in eggs and milk will not exceed
the proposed tolerances. An analytical method (gas liquid chromatography
with an electron capture detector) is available for enforcement.
Prior to its publication in the Pesticide Analytical Manual,
Vol. II, the enforcement methodology is being made available
in the interim to anyone who is interested in pesticide enforcement
when requested from: By mail: Calvin Furlow, (H7506C), Public
Response and Program Resources Branch, Field Operation Division,
U.S. Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 1130A, CM
#2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-
5937.
The pesticide is considered useful and capable of achieving
the intended physical or technical effect. Based on the above
information, the Agency concludes that the proposed section
408 tolerances will protect the public health and that use of
the pesticide in accordance with the proposed section 409 food/feed
additive regulation will be safe. Therefore, the tolerances
and food/feed additive regulations are established as set forth
below.
The Office of
Management and Budget has exempted these rules
from the requirements of section 3 of Executive Order 12291.
Pursuant to the requirements of the Regulatory Flexibility
Act (Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator
has determined that regulations establishing new tolerances
or food/feed additive regulations or raising tolerance or food/feed
additive regulation levels or establishing exemptions from tolerance
requirements do not have a significant economic impact on a
substantial number of small entities. A certification statement
to this effect was published in the Federal Register of May
4, 1981 (46 FR 24950).
List of Subjects in 40 CFR Parts 180, 185, and 186
Administrative practice and procedure, Agricultural commodities,
Food additives, Feed additives, Pesticides and pests, Reporting
and recordkeeping requirements.
Dated: April 2, 1993.
Daniel M. Barolo,
Acting Director, Office of
Pesticide Programs.
PART 180-[AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read
as follows:
Authority: 21 U.S.C. 346a and 371.
b. By adding new 180.466, to read as follows:
180.466 Fenpropathrin; tolerance for residues.
Tolerances are established for residues of the pesticide
chemical fenpropathrin (alpha-cyano-3-phenoxybenzyl 2,2,3,3-
tetramethylcyclopropanecarboxylate) in or on the following raw
agricultural commodities:
------------------------------------------------+-------------+---------------
Commodity | Parts per | Expiration
| million | date
------------------------------------------------+-------------+---------------
| |
Cottonseed..................................... | 1.0 | Nov. 15,
| | 1994
Cattle, fat.................................... | 0.02 | Do.
Cattle, mbyp................................... | 0.02 | Do.
Cattle, meat................................... | 0.02 | Do.
Eggs........................................... | 0.02 | Do.
Goats, fat..................................... | 0.02 | Do.
Goats, mbyp ................................... | 0.02 | Do.
Goats, meat.................................... | 0.02 | Do.
Hogs, fat...................................... | 0.02 | Do.
Hogs, mbyp..................................... | 0.02 | Do.
Hogs, meat..................................... | 0.02 | Do.
Horses, fat.................................... | 0.02 | Do.
Horses, mbyp................................... | 0.02 | Do.
Horses, meat................................... | 0.02 | Do.
Milkfat (reflecting 0.02 ppm in whole milk).... | 0.03 | Do.
Poultry, fat................................... | 0.02 | Do.
Poultry, mbyp.................................. | 0.02 | Do.
Sheep, fat..................................... | 0.02 | Do.
Sheep, mbyp.................................... | 0.02 | Do.
Sheep, meat.................................... | 0.02 | Do.
------------------------------------------------+-------------+---------------
PART 185-[AMENDED]
2. In part 185:
a. The authority citation for part 185 continues to read
as follows:
Authority: 21 U.S.C. 348.
b. By adding new 185.3225, to read as follows:
185.3225 Fenpropathrin.
A food additive tolerance is established for residues of
the pesticide chemical fenpropathrin (alpha-cyano-3-phenoxybenzyl
2,2,3,3-
tetramethylcyclopropanecarboxylate) as follows:
------------------------------------------------+-------------+---------------
Commodity | Parts per | Expiration
| million | date
------------------------------------------------+-------------+---------------
| |
Cottonseed oil................................. | 3.0 | Nov. 15,
| | 1994
------------------------------------------------+-------------+---------------
PART 186-[AMENDED]
3. In part 186:
a. The authority citation for part 186 continues to read
asfollows:
Authority: 21 U.S.C. 348.
b. By adding new 186.3225, to read as follows:
186.3225 Fenpropathrin
A feed additive tolerance is established for residues of
the pesticide chemical fenpropathrin (alpha-cyano-3-phenoxybenzyl
2,2,3,3-tetramethylcyclopropanecarboxylate) as follows:
------------------------------------------------+-------------+---------------
Commodity | Parts per | Expiration
| million | date
------------------------------------------------+-------------+---------------
| |
Cottonseed soapstock........................... | 2.0 | Nov. 15,
| | 1994
------------------------------------------------+-------------+---------------
[FR Doc. 93-8571 Filed 4-
13-93; 8:45 am]
BILLING CODE 6560-50-F
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