RF.D. FACTS
Mitin FF
Pesticide
Reregistration
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 reregi strati on, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency develops
any mitigation measures or regulatory controls needed to effectively reduce
each pesticide's risks. EPA then reregisters pesticides that can be used
without posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregi strati on, 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
reregi strati on case 3097, Mitin FF.
Use Profile Mitin FF is used to moth-proof wool. It is used in the textile industry
as an 80 percent active ingredient formulated fine powder applied to wool
during the dyeing/manufacturing process.
Regulatory
History
Human Health
Assessment
Mitin FF was first registered as a pesticide in the U.S. in 1948. EPA
issued a Data Call-in for Mitin FF in October 1992 requiring the registrant
to provide appropriate product chemistry, lexicological, environmental fate
and ecological effects data on this active ingredient to support
reregi strati on. Currently, one Mitin FF product is registered.
Toxicity
In acute toxicity studies using laboratory animals, Mitin FF has been
shown to be low to moderately toxic by the acute oral, dermal and
inhalation routes and has been placed in Toxicity Category III (the second
lowest of four categories) for these effects.
Dietary Exposure
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The current use of Mitin FF does not include any food or feed uses.
Exposure through the diet therefore is not anticipated and a dietary
exposure and risk assessment is not necessary.
Occupational and Residential Exposure
While there are potential application and post-application exposures
from the use of Mitin FF in commercial and industrial settings, the Agency
believes that the handler exposures associated with the application of Mitin
FF product will not pose an adverse risk to workers. There is no identified
toxicological endpoint of concern and the worker exposure (inhalation) is
assumed to be low.
Ecological Effects
and Environmental
Fate
Human Risk Assessment
The toxicology database, although limited in its scope, suggests Mitin
FF has low mammalian toxicity. Technical Mitin FF has low acute and
subchronic toxicities from dermal and inhalation exposure; was negative for
developmental effects; and, Mitin FF did not cause mutagenic effects in a
battery of studies.
Mitin FF is slightly acutely toxic to birds, moderately to slightly toxic
to mammals and moderately acutely toxic to fish and aquatic invertebrates.
It appears to be stable to hydrolysis. Exposure to the environment is
expected to be low, and is regulated under the NPDES permitting program
of the Agency's Office of Water.
Risk Mitigation
EPA is not requiring active ingredient based risk mitigation
measures. General user safety requirements and recommendations,
application restrictions, and use directions must be included on product
labeling. NPDES statements are also required to address potential
environmental risks.
Additional Data
Required
Product Labeling
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EPA is not requiring additional generic studies for Mitin FF to
confirm its regulatory assessments and conclusions.
The Agency is requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of
Formula (CSFs), and revised labeling for reregi strati on.
All Mitin FF end-use products must comply with EPA's current
pesticide product labeling requirements. For a comprehensive list of
labeling requirements, please see the Mitin FF RED document.
Regulatory The use of the currently registered product containing Mitin FF, in
accordance with approved labeling, will not pose unreasonable risks or
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Conclusion
For More
Information
adverse effects to humans or the environment. Therefore, all uses of this
product are eligible for reregistration.
Mitin FF products will be reregistered once the required product-
specific data, revised Confidential Statements of Formula, and revised
labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for Mitin FF during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System
at 703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the Mitin FF RED document also will
be available from the National Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, telephone 703-487-4650. For
more information about EPA's pesticide reregistration program, the Mitin
FF RED, or reregistration of individual products containing [name], please
contact the Special Review and Reregistration Division (7508W), OPP, US
EPA, Washington, DC 20460, telephone703-308-8000. For information
about the health effects of pesticides, or for assistance in recognizing and
managing pesticide poisoning symptoms, please contact the National
Pesticides Telecommunications Network (NPTN). Call toll-free 1-800-858-
7378, between 9:30 am and 7:30 pm Eastern Standard Time, Monday
through Friday.
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