EPA. 730-N-00-003
                UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                               WASHINGTON, D.C. 20460
                                                                           OFFICE OF
                 PESTICmE REGISTRATION (PR) NOTICE 2000-6  PREVENTION. PESTICIDES AND
                                                                        TOXIC SUBSTANCES

       NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS AND
                     REGISTRANTS OF PESTICIDE PRODUCTS
ATTENTION:

SUBJECT:
Persons Responsible for Registration of Pesticide Products

Minimum Risk Pesticides Exempted under FIFRA Section 25(b)
Clarification of Issues
I.  PURPOSE

       This notice clarifies several aspects of the exemption for minimum risk pesticides by the
FIFRA Section 25(b) rule, including composition, labeling, food tolerances, and state regulation.
It is being issued to answer questions frequently asked of EPA about such products.

II. BACKGROUND

       Section 2(u) of FIFRA defines a "pesticide" as "(1) any substance or mixture of
substances intended for preventing, destroying, repelling, or mitigating any pest, (2) any
substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant,
and (3) any nitrogen stabilizer." Except in very limited circumstances, any substance falling
within this definition of a pesticide must be registered by EPA before it can be legally sold or
distributed. One such exception to the registration requirement is for those pesticides that the
Administrator, under section 25(b) of FIFRA, has determined "to be of a character which is
unnecessary to be subject to this Act," and that have been exempted from the requirements of
FIFRA by regulation.

       In 1996, EPA exempted certain minimum risk pesticides from FIFRA requirements if
they satisfy certain conditions. EPA exempted the products described in 40 CFR section
152.25(g) in part to reduce the cost and regulatory burdens on businesses as well as the public for
pesticides posing little or no risk, and to focus EPA's limited resources on pesticides which pose
greater risk to humans and the environment.  This exemption provision is located in section
152.25(g) of Title 40 of the Code of Federal Regulations.

       To qualify for an exemption as a minimum risk pesticide, each active ingredient in the
pesticide product must be listed in 40 CFR 152.25(g)(l).  Appendix A is a list of these
ingredients. Currently, this list contains more than 30 active ingredients. In addition, 40 CFR
            ReeycJod/Rocyeiable - Printed with Vegetable Oil Based Inks on 100% Recyded Paper (4Q% Postconsumer)

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 152.25(g)(2) provides that these pesticide products may only contain minimal risk inert
 ingredients listed in the most current List 4A. Appendix B is the most current list of these inert
 ingredients. Additionally, to be exempted and remain exempted, products must also meet a
 series of exemption conditions described in 40 CFR 152.25(g)(3).
                                                                 !  I  'I
        EPA does not review or issue notices of exemption for products which meet the
 conditions for exemption.  Sale or distribution of a pesticide product meeting all the criteria in
 40 CFR 152.25(g) without a federal registration is not a violation of FIFRA. However if a
 product does not meet all of the exemption criteria, the product is not exempt from FIFRA and its
 sale or distribution if not registered would be a violation of FIFRA.

 How tc Determine if a Product Qualifies for Exemption as a Minimum Risk Pesticide
 Under 4Q CFR 152.25(g).

 QUESTION: How can I tell if my product qualifies for the minimum risk pesticide exemption?

 ANSWER: To qualify as a minimum risk pesticide under 40 CFR 152.25(g) (and be exempt
 from pesticide registration), a product must meet certain conditions. These conditions fall into
 the following two categories.
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 1.     Composition:

             active ingredients: may contain only those active ingredients that are listed in 40
             CFR 152.25(g)(l) and shown in Appendix A.

       *     othel (inert) ingredients: may contain only List 4A inerts, including commonly
             consumed foods. (See Appendix B).

2.      Labeling:

            All ingredients in an exempted product must be listed on its label:

                    Active ingredients must be listed by name and percentage (by weight).
                    All other ingredients must be listed by name (see above for inerts).

             No false or misleading statements under 40 CFR 156.10 (a)(5)(i)-(viii) may
             appear on an exempted product's label.

            Labeled Uses:

            The product may not bear any claims to control or mitigate microorganisms in a
            way that links the microorganism to a threat to human health (including but not
            limited to disease transmitting bacteria or viruses) or claims to control rodent or
            insect pests in a way that links the pest to specific diseases (for example, the label
            may not say "controls ticks that carry Lyme disease" or "controls mosquitoes that

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              can transmit malaria or encephalitis," but can say "controls ticks," or, "controls
              mosquitoes," etc.).

       It is important to note that even if a pesticide product meets the conditions for exemption
from regulation under FIFRA, it is still subject to any applicable requirements of the Federal
Food, Drug, and Cosmetic Act (FFDCA) if its use results in pesticide chemical residues on or in
food commodities or animal feed.  In addition, producers of pesticides must meet any applicable
state registration or other regulatory requirements.  Each state has its own statutes and regulations
concerning pesticide registration and regulation, and the states are not required to permit the sale
of an exempted product simply because it meets the 40 CFR 152.25(g) conditions for  minimum
risk exemption. An address and telephone list of the state agencies which regulate pesticides
may be found at: http://aapco.ceris.purdue.edu and at
http://www.epa.gov/pesticides/biopesticides/otherdocs/statelist.htm. You may also call (703)
305-7973 to obtain a paper copy.

III.    COMPOSITION OF "MINIMUM RISK PESTICIDES"

              1.     Active Ingredients

              QUESTION: What active ingredients may be used in an exempted pesticide
              product?

              ANSWER: Only active ingredients listed in 40 CFR 152.25(g)(l) may be in
              exempt products. Appendix A to this PR Notice lists all of the active ingredients
              which are currently permissible ingredients in exempt products.

              QUESTION: Can other active ingredients be added to this list? How?

             ANSWER: The Agency may modify this list in the future, but any additions (or
              deletions) would have to be accomplished through rule making.  Companies
             cannot obtain an exemption on an ad hoc basis as part of the application process.
             EPA cannot exempt an ingredient or product as part of the application process
             without having completed the required rule making.

             2.    Other Ingredients

             QUESTION: What other ingredients may be used in exempted products?

             ANSWER:  The only other ingredients an exempt product may contain are listed
             in the most current List 4A inert ingredients, which the Agency last published in
             the Federal Register of September 28, 1994.  List 4A inert ingredients are
             considered to be minimal risk inert ingredients, and are recognized as safe for use
             in pesticide products. The current List 4A minimal risk inerts are listed in
             Appendix B to this PR Notice.

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              QUESTION: Can common foods be used as inert ingredients in exempted
              products?

              ANSWER: Yes. EPA's policy is that "commonly consumed foods" are
              considered List 4A inerts of minimal concern, even if they are not already
              included on the list of minimal risk inerts. (See 59 FR 49400, September 28,
              1994) "Inert Ingredients in Pesticide Products; List of Minimal Risk Inerts."

              QUESTION: Will additions to the List 4A be possible?

              ANSWER: Yes. Additions to List 4A are being considered by the Agency. Any
              changes will be published hi the Federal Register

              QUESTION: If a List 4A minimal risk inert has active, pesticidal properties, am
              I allowed to use it as the active ingredient in an exempt product?
                                                            If.: ii!
                                                            	I.1:.
             ANSWER: No. The two lists are not interchangeable. In other words, you may
             not use a List 4A inert ingredient as an active ingredient, and you also may not use
             one pf the active ingredients listed in 40 CFR part 152.25(g)(l) as an inert. Only if
             the ingredient is included on both lists can it be used without regard to its active
             or inert function. Even then, the ingredient must be designated on the label as
             either active or inert (See Labeling below).

IV.    LABELING OF MINIMUM RISK PESTICIDES

       QUESTION: What should I include on my product's label?'
  " .    ''      '!,    ,i       	    ,            ' |     ,    '      'fli'l,;,, ".'Hi i ,    i  i
       ANSWER: In order to qualify for the minimum risk pesticide exemption, the pesticide
       product must meet certain labeling conditions. These conditions, all of which must be
       met in order to qualify for exemption, are as follows:
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                	     '       , "  "       '     '     ' ' '      	       !| ' "
             1      The pesticide product containing permissible  substances must bear a label
                    identifying the name and percentage (by weight) of each active ingredient
                    and the name of each inert ingredient;

             2.     The product may not bear any claims to control or mitigate
                    microorganisms hi a way that links the microorganisms to a threat to
                    human health (including but not limited to disease transmitting bacteria or
                   viruses) or claims to control rodent or insect pests in a way that links the
                   pest to specific diseases (for example, the label may not say "controls ticks
                   that carry Lyme disease" or "controls mosquitoes that can transmit malaria
                   or encephalitis," but can say "controls ticks," or, "controls mosquitoes,"
                   etc.);

                   and

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3.      The product must not include any false or misleading labeling statements
       prohibited by 40 CFR 156.10 (a)(5) (i)-(vm).  To follow is a list of
       unacceptable types of statements that Agency regulations provide are false
       or misleading, along with some examples:
       a.
       b.
       c.
      e.
      f.
 A false or misleading statement concerning the composition of the
 product;

 A false or misleading statement concerning the effectiveness of the
 product as a pesticide or device;

 A false or misleading statement about the value of the product for
 purposes other than as a pesticide or device;
      d.     A false or misleading comparison with other pesticides or devices;
Any statement directly or indirectly implying that the pesticide or
device is recommended or endorsed by any agency of the Federal
Government;

Example:  "Recommended by EPA as safe and exempt." This
kind of statement leads the consumer to believe that the Federal
Government has made such a determination for a particular
product.  Because exempted products are not reviewed by EPA,
this kind of statement is misleading.

Example:  "It is a Violation of Federal Law to Use this Product in
a Manner Inconsistent with its Labeling."

Example: "EPA Registration No." or "EPA Establishment No."

The latter two examples are false or misleading because they imply
that the product is registered by EPA.
Example: An example of a statement that the Agency would likely
consider acceptable would be: "This product has not been
registered by the United States Environmental Protection Agency.
[The name of the company] represents that this product qualifies
for exemption from registration under the Federal Insecticide,
Fungicide, and Rodenticide Act."

The name of a pesticide which contains two or more principal
active ingredients if the name suggests one or more, but not all
such principal active ingredients, even though the names of the
other ingredients are stated elsewhere in the labeling;

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              g.     A true statement used in such a way as to give a false or misleading
                     impression to the purchaser;
                                                  :  -.._       I :

              h.     Label disclaimers which negate or detract from labeling statements
                     required under the act and these regulations, including as
                     conditions of exemption.

 QUESTION: I have found mosquito and tick repellents on the market shelf that do not
 have EPA registration numbers. I thought that exempted pesticide products could not be
 labeled to control these kinds of pests?

 ANSWER: Claims that the exempted pesticide controls these kinds of pests are allowed,
 but no claims may be made to make the consumer believe that they would be protected by
 using the product from a disease that these insects can carry, such as Lyme disease.
 Remember: the claim may only be for the pest, as a pest, and not as a disease vector.
                    ,        '                ' '.       ..'' '     !  i '
 Example of an appropriate claim: "repels mosquitoes and ticks."

 Examples of an inappropriate claim: "repels mosquitoes that can transmit
 malaria,"or, "Will repel ticks that cause Lyme disease."
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 QUESTION: I have seen products that say they are "the natural way to control pests," or
 "safe for kids and pets." Aren't these considered by EPA to be false and misleading
 claims?
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 ANSWER:  No, not for exempted minimum risk pesticides. Products that meet the
 criteria for exemption from regulation may make safety claims if true. On the other hand,
 claims cannot be worded in such a way that implies or states endorsement by EPA or
 another federal agency or department.

 V.     FOOD TOLERANCES FOR "MINIMUM RISK PESTICIDES"
 QUESTION: What are the requirements if my product is to be used on or around food,
 food crops, food contact surfaces, or animal feed?

 ANSWER:  Even if a product is exempt under FIFRA, it must have a tolerance or
 tolerance exemption under FFDCA, if the product is to be used on food, food crops, food
 contact surfaces, or animal feed commodities.                               

The minimum risk pesticide exemption, 40 CFR 152.25(g), only exempts qualifying
pesticide products from certain requirements of FIFRA.  The use of pesticides on food,
food crops, food contact surfaces, and animal feed can result in residues of pesticide
products on or in treated foods or foods which come into contact with treated surfaces.
Tolerances are maximum legally permissible levels of pesticide residues, including active
and inert ingredients, which may be found in foods. In some instances, pesticides are

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        exempted from the requirement of a tolerance, because the pesticide is considered to be
        safe enough for use at any level. Tolerances aiid exemptions from tolerance are
        established and regulated by the EPA under the Federal Food, Drug and Cosmetic Act
        (FFDCA), not FIFRA.  The pesticide label may bear only those food uses for which there
        are tolerances or exemptions from tolerances for the active and inert ingredients  If the
        tolerance exemption is for all food commodities, then any food crops, food surfaces or
        animal feed can be listed on the label.

        QUESTION: How can Lfind out if my active and inert ingredients have tolerances or
        are exempt from the requirement of a tolerance?

        ANSWER: Tolerances and exemptions for foods are listed in Parts 180, 185, and 186 of
        Title 40 of the Code of Federal Regulations for each active ingredient and inert
        ingredient.  Appendices A and B can be used to identify which actives and inerts are
        exempt from tolerances on all crops as of the date of this notice. In addition, tolerances
        and exemptions are published throughout the year in the Federal Register.  This source is
       frequently more up-to-date than the latest version of 40 CFR and thus, needs to be
       checked to verify that no changes have occurred since the last printing of the 40 CFR.

       QUESTION: How do I get a tolerance if I need one?

       ANSWER: The first step to receive a tolerance is to petition the Agency by following the
       guidelines found in 40 CFR section 180.7 (see www.gpo.gov). Additional guidance can
       be found at www.epa.gov/PesticideApplicatinTi. The Agency will then announce the
       receipt of the petition in the Federal register. Tolerance fees are required, but may be
       waived on a case-by-case basis.

VI.    STATE  REGULATION OF "MINIMUM RISK PESTICIDE" PRODUCTS

       QUESTION: What must I do to meet any applicable state registration requirements?
       ANSWER: Even if a pesticide product is exempt from FIFRA requirements, the product
        may not be exempt from state registration or other regulatory requirements.  Each state
        has its own statutes and regulations concerning pesticide registration and regulation. A
       pesticide product exempted from federal regulation is not automatically exempt in a state
        It is important that you contact the state agencies responsible for pesticide regulation in
        those states in which you would like to sell your product, so you can find out what you
       need to do in order to satisfy their requirements for pesticide registration if required. An
         address and telephone list of the state agencies which regulate pesticides is available
            online ht: http://www.epa.gov/pesticides/biopesticides/otherdocs/statelist.htm
      You may also call (703) 305-7973 to obtain a paper copy.

      QUESTION: What happens if a state won't accept my product as an exempted pesticide?

      ANSWER: You may:

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             1.     Comply with the State's requirements in order to sell and distribute the
                    product; or

             2.     Not sell or distribute the product in that state; or
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             3.     You may register the product with the EPA if EPA determines that your
                    product meets all the health and safety standards and all other applicable
                    requirements. You must also meet any applicable State requirements for
                    your product.                       

       If a pesticide product does not meet the conditions for minimum risk pesticide exemption,
or if states will not accept the product without an EPA registration, a registration kit may be
obtained by calling 703-305-6549.  The kit is also available on our website, at
www.epa.gov/pesticides/registrationkit.

       Please note that the sale or distribution of a pesticide without an EPA registration that
does not meet the conditions for a minimum risk pesticide and does not fall within any other
exemption from FIFRA is a violation of FIFRA. (See, e.g., FIFRA section 12(a)(l).)
 '"              ,'.                             "        .   ' ;"     !  !
VII. FOR FURTHER INFORMATION
                 i                      '              '      :!'      i  I
       If you have any further questions, please contact Brian Steinwand at (703) 305-7973
(e-mail: stemwand.brian@epa.gov).
                                 Marcia E. Mulkey, Director
                                 Office of Pesticide Programs

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                                                           Appendix A
                                                           PR Notice 00-X

  Active Ingredients Which May Be in Minimum Risk Pesticide Products Exempted under
                                section 25(b) of FIFRA

 1.  Castor Oil (U.S.P. or equivalent)
 2.  Cedar Oil
 3.  Cinnamon* and Cinnamon Oil *
 4.  Citric Acid*                                       :
 5.  Cirronella and Citronella Oil
 6.  Cloves* and Clove Oil*
 7.  Corn Gluten Meal*
 8.  Corn Oil*
 9.  Cottonseed Oil*
 10. Dried Blood
 11. Eugenol
 12. Garlic* and Garlic Oil*                             :
 13. Geraniol
 14. Geranium Oil
 15. Lauryl Sulfate
 16. Lemon grass Oil*
 17. Linseed Oil
 18. Malic Acid*
 19. Mint* and Mint Oil*
 20. Peppermint* and Peppermint Oil*
 21. 2-Phenemyl Propionate (2-phenylethyl
       propionate)
 22. Potassium Sorbate
 23. Purrescent Whole Egg Solids (See 180.1071)
 24. Rosemary * and Rosemary Oil*
 25. Sesame* (includes ground Sesame plant stalks) (See 180.1087)
       and Sesame Oil*
 26. Sodium Chloride (common salt)*
 27. Sodium Lauryl Sulfate
 28. Soybean Oil
 29. Thyme* and Thyme Oil*
 30. White Pepper*
 31. Zinc Metal Strips (consisting solely of
    zinc metal and impurities)

 * These active ingredients are exempt for use on all food commodities from the requirement of
a tolerance on all raw agricultural commodities at 40 CFR 180.1164(d).

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                                                                            Appendix B
                                                                            PR Notice 00-X
                                     LIST 4A Minimal Risk Inerts
 Parentheses indicate exemption from tolerance as inerts if all the conditions set forth in the text and
 tables shown for the particular substance at 40 CFR 180.1001(c), (d) and/or (e) are met
 Acetic acid (c, d, e)
 Agar
 Alfalfa
 Alfalfa meal
 Almond hulls
 Almond shells (c)
 Alpha cellulose (c)   "
 Apple pomace (c)
 Attapulgite-type clay
 (c, e)
 Beef fat
 Beeswax (c)
 Beet powder
 Bentonite (c)
 Bone Meal
 Bran
 Bread crumbs
 Calcareous shale (c)
 Calcite (c)
 Calcium
 carbonate (c,e)
 Canary seed
 Cane syrup
 Carbon dioxide
 Cardboard
 Carragevjnan (c, d, e)
 Carrots
 Casein (c)
 Cheese
 Chlorophyll
 Cinnamon (d)
 Citric acid (c, e)
 Citrus meal (c)
 Citrus pectin
 Citrus pulp
         Clam shells
 Cloves (d)
 Cocoa
 Cocoa shells (c)
Cocoa shell flour
Cod liver oil (c)
Coffee grounds (c)
Cookies
 Cork
 Corn (d)
 Corn cobs (c)
 Corn flour
 Corn meal (c)
 Corn oil (c)
 Cornstarch(c)
 Corn syrup (c, e)
 Cotton
 Cottonseed meal
 Cottonseed oil  (c)
 Cracked oats
 Cracked wheat
 Dextrin (c, e)
 Dextrose (c, e)
 Dolomite (c)
 Douglas-fir bark, ground
 (d)
 Eggs
 Egg Shells
 Edible fish meal (c)
 Edible fish oil (c)
 Flour (wheat, d)
 Fuller's earth
 Gelatin
 Glue, as depolymerized
 animal collagen
 Glycerin (glycerol; c, d, e)
 Granite (c)
 Grape pomace (c)
 Graphite (c, d, e)
 Ground oats
 Guar gum (c)
 Gum arabic (c)
 Gum tragacanth
 Gypsum (c)
 Hearts of corn flour
 Hydrogenated vegetable
        oils
Honey
Invert sugar (c)
Invert syrup (c)
Kaolinite-type clay (c, e)
 Lactose (c)
 Lanolin (d)
 Lard (c)
 Latex
 Lecithin (c)
 Lime
 Limestone
 Linseed oil
 Malt flavor
 Meat meal
 Meal scraps
 Medicated feed
 Mica (c)
 Milk
 Millet seed
 Mineral oil, U.S.P. (c,
 e)       :
 Molasses (c)
 Montmorillonite-type
        clay (c, e)
 Nitrogen
 Nutria meat
 Nylon
 Oatmeal (c)
 Oats (c)
 Olive oil
 Onions
 Orange pulp (as pomace
 c)
 Oyster shells
 Paper (fiber; d)
 Paprika
 Paraffin wax
 Peanut butter
 Peanut oil
 Peanuts
 Peanut shells (c)
 Peat moss
 Pecan shell flour
 Pectin
Polyethylene film (c)
Polyethylene pellets
Potatoes
 Pumice
 Raisins
 Red cedar chips
 Red dog flour
 Rice
 Rice hulls
 Rubber
 Rye Flour
 Safflower oil
 Sawdust
 Seaweed, edible
 Shale
 Soapstone (c,  e)
 Sodium
 bicarbonate (c)
 Sodium chloride (c)
 Sorbitol (c, e)
 Soybean hulls
 Soybean meal
 Soybean oil (c, e)
 Soy flour (c)
 Soy protein (c, e)
 Sucrose (c, e)
 Sugarbeet meal
 Sunflower seeds
 Tallow
 Vanillin (d)
 Vermiculite (c)
 Vitamin C
 Vitamin E
 Walnut flour
 Walnut shells (c)
 Water
 Wheat (d)
 Wheat germ oil
 Whey
 Wintergreen oil (c)
 Wool
Xanthan gum (c, e)
 Yeast
180.1001 (c) = exempt for both growing crops & crops after harvest
         (d) = exempt for growing crops only
         (e) = exempt for animal applications only

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