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).
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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?
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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?'
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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;
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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.
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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).)
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VII. FOR FURTHER INFORMATION
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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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