United States     -
                  Environmental Protection
                 . Agency	  '  -.
                       Prevention, Pesticides
                       And Toxic Substances
                       (7508W)  	.
EPA-738-F^96-016
August 1996
                  R.E.D.   FACTS
     Pesticide
Reregistration
    Use Profile
    Regulatory
        History
                  Cryolite
     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.  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 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 0087, cryolite.

   . Cryolite is an insecticide used on many fruits, vegetables and
ornamental crops to protect against leaf eating pests.  Currently, the
predominant uses are on grapes, potatoes and citrus. Cryolite is formulated
as dusts, wettable powders and water dispersable granulars and can be
applied by ground or air equipment. Multiple applications at high rates are
typical. The highest single application rate is 30 Ibs/acre on citrus arid
, ornamentals; the highest seasonal rate from multiple applications is 154
Ibs/acre on lettuce. Cryolite is a naturally occurring mineral that is also
synthetically produced.     .                                     .

     Cryolite was first registered as a pesticide in the U.S. in 1957, EPA
issued a 1983 Guidance Document and,a superseding 1988 Registration
Standard requiring environmental, toxicological and residue data needed to
determine cryolites reregistration eligibility. A 1990 Data Call-In required
additional product-specific data..   .'              
     Currently, four cryolite products are registered.

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Human  Health   Toxicity
  Assessment        In studies using laboratory animals, cryolite generally has been shown
                    to be slightly to practically non-toxic on an acute basis. The acute dermal
                    LD50 in rats is 2.1 g/kg, placing cryolite in Toxicity Category III (the
                    second lowest of four categories) for this effect. Cryolite is considered a
    .                moderate irritant based on eye irritation studies and classified in Toxicity
                    Category IV for acute oral exposure, acute inhalation and skin irritation.
                    Cryolite is classified as a nori-sensitizer based on dermal sensitizatiori tests
                    conducted with Guinea pigs.
                         Cryolite has been classified as a Group "D" chemical, "not classifiable
                    as to human carcinogenicity". It has been the subject of a comprehensive
        .            review by the National Research Council (National Academy of Sciences
                    Subcommittee of Health Effects of Ingested Fluoride) who concluded that
                    "...the available data are, insufficient to demonstrate a carcinogenic effect of
                    fluoride in animals." and that "..the w,eight-of-evidence from more than 50
                    epidemiological studies does not support the hypothesis of an association-
 ,         -          between fluoride .exposure and .increased cancer risk in humans." The
                    Agency is in agreement with the conclusion reached by the National
        \            Academy of Sciences.

                    Dietary Exposure             .
                 .  ,      Pe'ople may be exposed to residues of cryolite through the diet.
                    Tolerances or maximum residue limits haye been established for the
                    fluorine compounds cryolite and synthetic cryolite in or on raw agricultural
                    commodities.  These include a regional registration tolerance for kiwi-fruit
                    and a time-limited tolerance to expire May 6, 1996, on potatoes. EPA has
                    reassessed the cryolite tolerances and found that some are acceptable,
                    others must be revoked because the registrants have chosen not to support
                    the uses; and based on new data, tolerances will be proposed/established for
                    cabbage, citrus, collards, eggplant, lettuce (head and leaf), peaches,
                    potatoes and tomatoes. Food additive tolerance increases must be proposed
                    for raisins and tomato paste, and data must be submitted to determine
                    appropriate food additive tolerance levels for prunes. The Agency has
                    completed its review of the data needed to establish a permanent tolerance
                    for potatoes. The Agency will propose in the Federal Register permanent
                    tolerances for potatoes at 2 ppm and potato waste at 22 ppm.
                         EPA has assessed the dietary risk posed by cryolite. A qualitative
                    dietary risk assessment was performed to include the daily intake of
                    fluoride from other sources, i.e. fluorinated public water sources.   The
  .-  '               Agency concluded that levels of fluoride in/on food from the agricultural
                    use of cryolite plus fluoride levels in U.S. drinking water supplies results in
                    a high-end daily dietary intake of fluoride of approximately 0.085
                    mg/kg/day. This is less  than the Agency's determined Maximum

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    Environmental
       Assessment
   Additional Data
           Required
  Product Labeling
           Changes
Required
         Regulatory
         Conclusion
Concentration Limit Goal (MCLG) of 4.0 mg/L'[0.1l4 mg/kg/day], a level
which provides no known or anticipated adverse health effects.  The MCLG
has been reviewed and is supported by the Surgeon General.

     Acute risk is not expected to birds,  mammals, aquatic organisms or
beneficial insects from exposure to cryolite.  Chronic ecological risk also is
not expected because, in the presence of sufficient water, cryolite is quickly
converted to near natural background levels of simple inorganic compounds
containing its constituent elements (sodium, aluminum, fluorine).  Once
cryolite dissolves and penetrates to shallow depths in soil or is transported
to natural waters, any minor chemical imbalances caused by its insecticidal
application are offset by the mineral buffering capacity of the environment
and/or self-correcting agricultural practices (such as calcium applications
and pH adjustments to the soil). Ground or surface water effects should be
negligible.
    '                                    '                        *
     EPA is requiring the following additional generic studies for cryolite-
to confirm its regulatory assessments and conclusions: Magnitude of the
residue in field grown cranberries and plums. Before determining the
eligibility of cryolite for use on strawberries EPA is requiring a generic
study on the magnitude of the residue in field grown strawberries. The
Agency also is requiring product-specific data including product chemistry
and acute toxicity studies, revised Confidential Statements of Formula
(CSFs), and revised labeling for reregistration.

     All cryolite end-use products must  comply with EPA's current
pesticide product labeling requirements.  Some of the required labeling are:
Worker Protection restrictions that include 12 hour restricted entry intervals
and the minimal early entry personal protective equipment requirements;
us;er safety recommendations; environmental hazards statement prohibiting
application or contamination of water or  intertidal areas;  spray drift
precautions. For a comprehensive list of labeling requirements, please see
the cryolite RED document.

     EPA has determined that the following uses of cryolite have been
supported and are eligible for reregistration: broccoli, Brussels sprouts,
cabbage, cauliflower, citrus fruits, collards, cranberries, cucumbers,
eggplant, grapes, kohlrabi,  lettuce (leaf and head), melons, peaches,
peppers, plums (fresh prunes), pumpkins, squash (winter and summer),
tomatoes, kiwi, potatoes, ornamental herbaceous plants, ornamental
nonflowering plants,  ornamental woody  shrubs and vines and shade trees.
The use on strawberries is being supported but there are no residue data at
this time upon which to base an eligibility decision. The Agency will
evaluate the eligibility of this use after the data are submitted and reviewed.

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                The use of eligible cryolite products in accordance with labeling specified
                in this RED will not pose unreasonable adverse effects to humans or the
                environment. These products will be reregistered once the required product
                specific data, CSFs, and revised labeling are received and accepted by EPA,
                Products which contain active ingredients in addition to cryolite will be
                reregistered when all of their other active ingredients also are eligible for
                reregistration.
                      There are several currently registered uses for cryolite that are riot
                being supported and their tolerances are being proposed for revocation:
                , apples, apricots, beans,'beets (roots and tops), blackberries, boysenberries,
                carrots, corn, dewberries^ kale, loganberries, mustard greens, nectarines,
                okra, peanuts, pears, peas, quinces, radishes (roots and tops), turnips (roots
                and tops) and youngberries.
   For More        EPA is requesting public comments on the Reregistration Eligibility
Information   Decision (RED) document for cryolite 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 cryolite 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 cryolite RED, or reregistration of individual products containing
            .     cryolite, please contact the Special Review and Reregistration Division
                 (7508W), OPP, US EPA, Washington, DC 20460, telephone
                 703-308-8000.   ,
                      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-

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free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday.

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