 

COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE  (7/1/2006)

EPA Registration Division contact: Shaja R. Brothers (703) 308-3194

 

TEMPLATE:

Valent USA 

7E7268

	EPA has received a pesticide petition 7E7268 from Valent USA
Corporation, 1600 Riviera Avenue, Walnut Creek, CA 94596-8025 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. by establishing a
tolerance for residues of uniconazole,
[(E)-(+)-(S)-1-(4-chlorophenyl)-4,4-dimethyl-2-(1,2,4-triazol-1-yl)-pent
-1-ene-3-ol] in or on the raw agricultural commodity vegetables,
fruiting, group 8 at 0.01 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 support granting of the petition. Additional data may be needed
before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. The submitted metabolism studies are adequate for
the tolerance request. The metabolism of uniconazole-p is adequately
understood for the purpose of the proposed tolerance.

	2. Analytical method. An adequate analytical enforcement method is
available for the determination of residues of uniconazole in plants. 
The analytical method has been validated by an independent laboratory.

	3. Magnitude of residues. Residue data to support the use of
uniconazole on fruiting vegetables has been submitted.

B. Toxicological Profile

	1. Acute toxicity.  The toxicological profile and endpoints for
uniconazole which supports this petition to establish tolerances were
previously evaluated by the US EPA.  See Federal Register, August 28,
1991 (56 FR 42622).

C. Aggregate Exposure

				 

	1. Dietary exposure. Assessments were conducted to evaluate potential
risks due to chronic and acute dietary exposure of the US population
subgroups to residues of uniconazole.  These analyses cover all uses
pending with the Agency.

	i. Food. The acute population adjusted dose (aPAD), of 0.05 mg/kg body
wt./day is derived from the NOEL for the rat developmental toxicity
study.  An uncertainty factor of 100 was applied to account for intra
and inter-species variation.  No additional uncertainty factor for FQPA
was applied.  The 99.9th percentile of acute dietary exposure
represented 2.4% of the aPAD for the most sensitive population subgroup
teenagers, 13-19 years old.  

The chronic population adjusted dose (cPAD) of 0.02 mg/kg body wt./day
is derived from a 1-year dog chronic study.  The chronic exposure value
used to calculate the percent of cPAD represents the individual in the
population with the highest annual average exposure.  The 100th
percentile of chronic dietary exposure was highest among children 1 to 2
and 3 to 5 years old representing 0.35% of the cPAD.

	ii. Drinking Water. The proposed use pattern for uniconazole is limited
to indoor greenhouse or container use; therefore there will be no
exposure of drinking water supplies.

	2. Non-dietary exposure. Uniconazole is not registered for use on any
residential non-food sites.  Therefore, there is no non-dietary acute,
chronic, short-term or intermediate-term exposure.

D. Cumulative Effects

	Section 408(b)(2)(D)(v) 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 uniconazole has a common mechanism
of toxicity with other substances or how to include this pesticide in a
cumulative risk assessment.  For the purposes of this tolerance action,
EPA has not assumed that uniconazole has a common mechanism of toxicity
with other substances.

E. Safety Determination

	1. U.S. population. The acute dietary exposure to residues of
uniconazole in food will represent no more than 2.4 % of the aPAD for
the most sensitive population subgroup teenagers, 13-19 years old. 
Acute dietary exposure estimates were determined at the 99.9th
percentile of acute exposure.  Exposure to uniconazole through drinking
water is not expected therefore the aggregate risks to uniconazole from
food and water will not exceed the risk from food alone.

The chronic dietary exposure to residues of uniconazole in food will
represent no more than 0.35 % of the cPAD for the most sensitive
population subgroups, children 1 to 2 and 3 to 5 years old.  Chronic
dietary exposure estimates were determined at the 100th percentile of
chronic exposure.  Exposure to uniconazole through drinking water is not
expected therefore the aggregate risks to uniconazole from food and
water will not exceed the risk from food alone.

2. Infants and children. Based on the completeness and reliability of
the toxicity data, the lack of toxicological endpoints of special
concern, the lack of any indication that children are more sensitive
than adults to uniconazole, and the conservative exposure assessment,
there is a reasonable certainty that no harm will result to infants and
children from acute or chronic aggregate exposure of residues of
uniconazole, including all anticipated dietary exposure, and all other
non-occupational exposures.  

F. International Tolerances

	Currently there are no Codex MRLs for uniconazole.  There are no
international MRLs established on fruiting vegetables.

