United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA-738-F-03-003
May 29, 2003
v-xEPA R.E.D. FACTS
Pesticide
Reregistration
Use Profile
Dinocap
All pesticides sold or distributed in the United States must be registered
by EPA, based on scientific studies showing that they can be used without
posing unreasonable risks to people or the environment. Because of advances
in scientific knowledge, the law requires that pesticides which were first
registered before November 1, 1984, be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health
and environmental effects of each pesticide. To implement provisions of the
Food Quality Protection Act of 1996, EPA considers the special sensitivity of
infants and children to pesticides, as well as aggregate exposure of the public
to pesticide residues from all sources, and the cumulative effects of pesticides
and other compounds with common mechanisms of toxicity. The Agency
develops any mitigation measures or regulatory controls needed to effectively
reduce each pesticide's risks. EPA then reregisters pesticides that meet the
safely standard of the FQPA and can be used without posing unreasonable
risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA explains the basis for
its decision in a Reregistration Eligibility Decision (RED) document. This fact
sheet summarizes the information in the RED document for reregistration case
number 2200, dinocap.
Dinocap is a foliar fungicide/miticide used to control powdery mildew.
Dinocap is applied to apples and grapes outside of the U.S., mainly in Europe, the
Middle East and northern Africa. There are currently no registered dinocap
products in the U.S. Dow AgroSciences, LLC (DAS), the registrant of dinocap,
intends to support tolerances for dinocap residues in/on apples and grapes to permit
legal importation of these commodities into the U.S., in the absence of a U.S.
registration.
Regulatory
History
Dinocap, a List B chemical, was the subject of a Phase 4 Review dated
January 30, 1991 and a Data-Call-in Notice (DCI) issued on September 10, 1991.
At that time, the current registrant Rohm and Haas Company (R&H) had indicated
that they intended to amend registrations to drop all food/feed uses for end-use
products (EPs). The registrant subsequently requested that the Agency retain
dinocap tolerances for apples and grapes as import tolerances. Following
cancellation by R&H of all dinocap food/feed uses registered in the U.S., the
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Human Health
Assessment
Agency revoked all dinocap tolerances, except those for apples and grapes (63 FR
206, October 26, 1998).
The registration for dinocap was transferred from R&H to DAS on
September 21, 2001. On February 12, 2002, DAS requested voluntary cancellation
pursuant to Section 6(f) of FIFRA of all U.S. product registrations for dinocap. The
Agency announced its receipt of the above-mentioned cancellation requests in the
Federal Register on April 26, 2002 [OPP-2002-0013; FRL-6833-8]. The Agency did
not receive any comments specific to these cancellations; therefore, the cancellation
order was effective on October 24, 2002. Because dinocap products have not been
marketed in the U.S. for several years, existing stocks are expected to be negligible.
Dietary Exposure
The FQPA committee recommended that the FQPA safety factor for the
protection of infants and children be retained at lOx for all population subgroups
when assessing acute and chronic exposure to dinocap. The reasons are: (1) there is
concern for the quantitative and qualitative increase in susceptibility observed in
fetuses following in utero exposure in the prenatal developmental studies in mice and
rabbits; and (2) there is a data gap for the developmental neurotoxicity study in rats.
The acute reference dose (aRfD) is 0.04 mg/kg/day and the acute population
adjusted dose (aPAD) is 0.004 mg/kg/day. The chronic reference dose (cRfD) is
0.0038 mg/kg/day and the chronic population adjusted dose (cPAD) is 0.00038
mg/kg/day. The population adjusted dose is the reference dose divided by the FQPA
safety factor.
The Agency has classified dinocap as a Group E "not likely" carcinogen. It
was negative for inducing mutations in all studies of the standard mutagenicity
battery except the Ames test. In Ames studies, dinocap was weakly positive at best
and only at high doses.
The dietary risk assessment was conducted two ways, using the current
tolerances of 0.1 ppm and using Maximum Residue Limits (MRLs) recommended by
the Joint FAO/WHO Meeting on Pesticide Residues (JMPR). There are European
data which have been reviewed by the JMPR. The JMPR proposes MRLs for
individual pesticides in different food and feed items, and provides advice on the
acceptable levels of pesticide residues in food moving in international trade.
Residues of dinocap in the European trials were <0.05 (ND) to 0.09 ppm in apples
and <0.05 to 0.67 ppm in grapes. In 1988, JMPR recommended MRLs of 0.2 for
apples and 1 ppm for grapes.
Irrespective of the residue data used (i.e., current U.S. tolerances or MRLs),
acute and chronic dietary risk estimates are well below the Agency's level of concern
for all supported dinocap food uses. Acute dietary risk is <1% of the aPAD for the
only subpopulation of concern, females, 13-50 years old. Chronic dietary risk is <1%
of the cPAD for the U.S. general population and all subpopulations.
There are currently no Codex MRLs established for residues of dinocap.
However, in 1988, JMPR recommended dinocap MRLs of 0.2 for apples and 1 ppm
for grapes. Harmonization of the tolerance expression/definition and tolerances
between Codex MRLs and U.S. tolerances cannot be achieved until the outstanding
metabolism and residue data have been submitted.
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Additional Data
Required
Regulatory
Conclusion
For More
Information
The Agency is requiring the following confirmatory data requirements for
supporting the apple and grape tolerances for import purposes: Acute Neurotoxicity
Screening Battery, Rat; Subchronic Neurotoxicity Study, Rat; Developmental
Neurotoxicity Study, Rat; Nature of the Residue, Plants & Livestock; Storage
Stability, Plants; Crop Field Trials (Apple & Grapes); and Processed Food (Apple &
Grapes). These data requirements are consistent with EPA's "Guidance on Pesticide
Import Tolerances and Residue Data for Imported Food," (65 FR 106; 35069-350-90,
June 1, 2000). The Agency will attempt to harmonize with international standards to
the extent possible.
The Agency has completed its reregistration eligibility decision for the
fungicide/miticide, dinocap, which consists of a voluntary cancellation of all U.S.
product registrations. Because the registrant has indicated their intention to retain the
existing tolerances for apples and grapes for import purposes, EPA has conducted a
dietary risk assessment for dinocap. Although there are Data Gaps, the Agency has
used protective assumptions including a lOx safety factor and tolerance level residue
values to determine that dietary risk is minimal, less than 1% of the acute and chronic
PADs for all population subgroups. EPA finds that there is a reasonable certainty
that no harm will result from dinocap use on apples and grapes imported into the U.S.
Confirmatory data are required as outlined in the previous section.
To obtain a copy of the dinocap RED document, please contact the OPP
Public Docket (7502C), US EPA, Ariel Rios Building, 1200 Pennsylvania Avenue
NW, Washington, DC 20460-0001, telephone: (703) 305-5805. Electronic copies of
the dinocap RED and all supporting documents are also available on the Agency's
website at hltp://cfpub.epa.sov/opprefreres/status.cfin?show —rerez.
Printed copies of the dinocap RED and fact sheet can be obtained from EPA's
National Service Center for Environmental Publications (EPA/NSCEP), P.O. Box
42419, Cincinnati, OH 45242-2419, telephone: 1-800-490-9198; fax: 513-489-8695.
The dinocap RED document also will be available from the National
Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA
22161-0001, telephone: 1-800-553-6847; fax: 703-605-6000.
For more information about EPA's pesticide reregistration program or the
dinocap RED, please contact the US EPA, OPP, Special Review and Reregistration
Division (7508C), Washington, DC 20460-0001, telephone: 703-308-8000.
For more information about the health effects of pesticides, or for assistance in
recognizing and managing pesticide poisoning symptoms, please contact the National
Pesticide Telecommunications Network (NPTN). Call toll-free 1-800-858-7378,
from 6:30 am to 4:30 pm Pacific Time, or 9:30 am to 7:30 pm Eastern Standard
Time, seven days a week. Their internet address is
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