United States
                  Environmental Protection
                  Agency	
                       Office of Prevention, Pesticides
                       And Toxic Substances
                       (7508W)	
EPA-738-F-92-016
June 1992
                  R.E.D.   FACTS
      Pesticide
Reregistration
    Use Profile
    Regulatory
        History
                  Capsaicin
     All pesticides sold or used 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 years ago 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 imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks.  EPA then reregisters pesticides that can be used without
posing undue hazards to human health or the environment.
     When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Document, or RED. This fact
sheet summarizes the information in the RED for capsaicin.

     Capsaicin, which is made from the Capsicum red chili pepper, is used
as a bird, animal and insect repellent. Specifically, it is used to repel birds,
voles, deer, rabbits, squirrels, insects and attacking dogs. Capsaicin
repellents are used indoors to protect carpets and upholstered furniture, and
outdoors to protect fruit and vegetable crops, flowers, ornamental plants,
shrubbery, trees, and lawns.
     Capsaicin is obtained by grinding dried, ripe Capsicum frutescens L^
chili peppers into a fine powder.  The oleoresin is derived by distilling the
powder in a solvent and evaporating the solvent.  The resulting highly
concentrated liquid has little odor but has an extremely pungent taste.

     The U.S. Department of Agriculture first registered a pesticide
product with the single active ingredient capsaicin in 1962. This product, a
dog-attack repellent, still is registered.  Nine additional products containing
capsaicin are registered at present. These granular, dust  and liquid
formulations contain capsaicin alone or in combination with the active
ingredients garlic or oil of mustard.

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Human Health
  Assessment
     Although EPA regulated it as a conventional pesticide for many years,
in November 1991 the Agency reclassified capsaicin as a biochemical
pesticide because it is a naturally-occurring substance and has a non-toxic
mode of action.

Toxicity
     Capsaicin is natural, processed vegetable matter that has been part of
the human diet for many years. It is unlikely that pesticide products
containing capsaicin will pose a significant threat to human health.
Excessive exposure to capsaicin may cause some slight eye and skin
irritation. However,  based on the existing acute toxicity data base, the
remaining toxicity studies usually required for reregistration are waived.
Dietary Exposure
     Red chili peppers have long been used as food additives/ components
without causing any known adverse health effects.  EPA has waived the
usual residue chemistry data requirements for capsaicin. However,  an
exemption from the tolerance (food residue limit) requirement must be
established before capsaicin products will be reregistered.
Occupational and Residential Exposure
     Capsaicin products formulated as powders/dusts and granulars may be
applied to growing crops from the ground or by air; the liquid formulations
are diluted with water and sprayed by aircraft, ground boom, hand-held
garden hose  and airblast spray equipment. During  these applications,
applicators' eyes and skin may be exposed to capsaicin.  Field workers also
may  be exposed to capsaicin from contacting the foliage of treated growing
crops.
Human Risk Assessment
     Due to the nature of capsaicin and the  required precautionary
statements on labeling, EPA concludes that products containing capsaicin
will not have adverse effects on human health.
Environmental
  Assessment
     The basic data requirements for a biochemical pesticide consist of
acute ecological effects (Tier I) studies. Environmental fate and additional
ecological effects studies are required only if adverse effects are observed in
the Tier I studies.  As explained below, EPA has waived the Tier I studies
for capsaicin.
Environmental Fate
     Since capsaicin is a biochemical pesticide and all ecological effects
studies have been waived, no environmental fate data are required.

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    Additional Data
            Required
Ecological Effects
EPA has waived all ecological effects data requirements for capsaicin
because:
      •  Capsaicin is a strong, fast-acting irritant when eaten or exposed to
     the skin.  It is used to repel birds and animals.  EPA is calling in data
     on the effectiveness of capsaicin products in repelling birds.  Pending
     the results, we assume  that earlier studies are correct and that birds
     and animals avoid excessive and prolonged exposure to capsaicin, thus
     minimizing their risks.
      •  It is difficult to assess the risks posed to aquatic species by use of
     capsaicin.  Instead of requiring studies, EPA is requiring restrictive
     product label statements to minimize aquatic species' exposure and
     reduce any risks.
      •  EPA also  is requiring maximum  application rates on all capsaicin
     product labels, to reduce overall environmental exposure and any
     attendant risks.
Ecological Effects Risk Assessment
     EPA does not foresee the potential for significant environmental risks
associated with the registered uses of capsaicin.  With  new label
requirements imposed, no risk issues need to be addressed further.

     No additional generic data are required at this time for reregistration
of pesticide products containing the active ingredient capsaicin.  Product-
specific acute toxicity, product chemistry and efficacy  studies are required.
EPA will propose the needed tolerance exemption for capsaicin's food crop
uses.
  Product Labeling
Changes Required
     The labels of end-use products containing capsaicin must comply with
EPA's current regulations and requirements. In addition, the following
labeling is required:
      •  To protect aquatic species, other wildlife and the environment,
     labels must state, "This product may be toxic to aquatic organisms.
     Do not apply to or allow runoff to reach  lakes, streams or ponds.  Do
     not contaminate water by cleaning of equipment or disposal of
     wastes."
      •  Maximum application rates must be added to all capsaicin product
     labels.  EPA will review application rates proposed by registrants.
                                       en re§istered pesticide products that contain the active
         Pnnrlncinn   ingredient capsaicin can be used without causing unreasonable adverse
                          effects in people or the environment.  Therefore, they are eligible for
                          reregistration.

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   For More
Information
      •  EPA will reregister end-use products containing capsaicin once
product-specific data and revised labeling are submitted to and accepted by
the Agency.
      •  Those capsaicin products that also contain another active ingredient
(garlic or oil of mustard) will be reregistered only after their other active
ingredient also is eligible for reregistration.

     EPA is requesting public comments on the Reregistration Eligibility
Document (RED) for capsaicin 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 or to submit written comments, please contact the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs (OPP), US EPA, Washington, DC
20460, telephone 703-305-5805.
     In the  future, the capsaicin RED 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 capsaicin or about EPA's pesticide
reregistration program, please contact the Special Review and Reregistration
Division (7508W), OPP,  US EPA,  Washington, DC 20460, telephone 703-
308-8000.  For information about reregistration of individual capsaicin
pesticide products,  please contact the Registration Division (7505C),  OPP,
US EPA, Washington, DC 20460, telephone 703-305-6784.
     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, 24 hours a day,  seven days a week, or Fax your
inquiry to  806-743-3094.

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