Minimum Risk Pesticides: Frequent Questions
Most questions EPA receives regarding minimum risk 25(b) pesticides are best answered by state pesticide regulating agencies because it is the states, not EPA, that choose to regulate these minimal risk products. The minimum risk pesticide questions fielded by EPA fall into the following general categories:
- Qualifying as a Minimum Risk Pesticide
- Composition of Minimum Risk Pesticides
- Labeling Requirements for Exempted Pesticide Products
- Minimum Risk Pesticides for Use on Food
- State Regulation of 25(b) Pesticides
- How can I tell if my product qualifies for the minimum risk pesticide exemption?
Minimum risk pesticides:
- All ingredients in an exempted product must be listed on its label:
- Active ingredients must be listed by name and percentage (by weight).
- All inert ingredients must be listed by name.
- No false or misleading statements under 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 can transmit malaria or encephalitis," but can say “controls ticks,” or, “controls mosquitoes,” etc.).
- All ingredients in an exempted product must be listed on its label:
- If my product qualifies as a minimum risk pesticide, is it exempt from all regulation?
To qualify as a minimum risk pesticide and be exempt from federal pesticide registration, a product must meet certain conditions. These conditions fall into the following two categories:
No. It is important to note that even if a pesticide product meets the conditions for exemption from registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), it is still subject to any applicable requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) if its use results in pesticide residues on or in food or feed crops. Minimum risk pesticides are also subject to labeling and advertising restrictions. In addition, producers of federally exempt pesticides must still meet any applicable state registration or other regulatory requirements. For more information on complying with state pesticide regulations, please contact the pesticide regulatory agency for your state.
- What active ingredients may be used in an exempted pesticide product?
- Can new active ingredients be added to the 25(b) list, and if so, how?
- What other ingredients may be used in exempted products?
- Can commonly consumed foods be used as inert ingredients in exempted products?
- Included within the term commonly consumed food commodities are:
- Sugars such as sucrose, lactose, dextrose and fructose, and invert sugar and syrup.
- Spices such as cinnamon, cloves, and red pepper.
- Herbs such as basil, anise, or fenugreek.
- Excluded from the term commonly consumed food commodities are:
- Any food commodity that is adulterated under 21 U.S.C. 342.
- Both the raw and processed forms of peanuts, tree nuts, milk, soybeans, eggs, fish, crustacea, and wheat.
- Alcoholic beverages.
- Dietary supplements.
- Can new inert ingredients be added to List 4A?
- 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?
Minimum risk pesticides may contain only those active ingredients that are listed under Title 40 of the Code of Federal Regulations, Part 152.25(f)(1), which are also listed on EPA's Criteria for FIFRA 25(b) Exemption Web page.
Yes, new ingredients can be added but any additions would have to be accomplished through rulemaking. Please see EPA's Web page that explains how to add an active ingredient to the list of exempted active ingredients for more information.
The only other substances an exempt pesticide product may contain are List 4A inert ingredients. List 4A inert ingredients are recognized as safe for use in pesticide products. Please see EPA's Web pages that explain List 4A inert ingredients for more information.
For the most part, yes. EPA's policy is that most "commonly consumed foods" are considered List 4A inerts of minimal concern, even if they are not explicitly included on the list of minimal risk inerts. However, there are some common foods that may not be used as inert ingredients, particularly those that can cause allergic reactions, including both the raw and processed forms of peanuts, tree nuts, milk, soybeans, eggs, fish, crustacea, and wheat. The following description is taken from 40 CFR § 180.950 Tolerance Exemptions for Minimal Risk Active and Inert Ingredients and provides important clarifications about commodities that are included and excluded from of the definition of commonly consumed foods:
Commonly consumed food commodities means foods that are commonly consumed for their nutrient properties. The term commonly consumed food commodities shall only apply to food commodities (whether a raw agricultural commodity or a processed commodity) in the form the commodity is sold or distributed to the public for consumption.
Yes. Additions to List 4A are being considered by the Agency. Any amendments to the List are published in the Federal Register. Please see EPA's Web pages that explain how to make additions to List 4A for more information.
Generally, 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 of the active ingredients listed in 40 CFR part 152.25(f)(1) as an inert. Only if the ingredient is included on both lists, as in the case of citric acid and a few others, can it be used as either an active or inert ingredient. Even then, the ingredient must be designated on the label as either active or inert relative to its intended function in the formulation.
- What should I include on my product’s label?
- The pesticide product must bear a label identifying by name and percentage (by weight) each active ingredient and the name of each inert ingredient;
- The product may not bear any claims to control or mitigate microorganisms in 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.);
- The product must not include any false or misleading labeling statements prohibited by 40 CFR 156.10 (a)(5) (i)-(viii). The following are some examples of false or misleading statements:
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 to qualify for exemption, are as follows:
- 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.” This is false or misleading because this language is a requirement on the labels of pesticides registered by EPA, implying that the product is federally registered.
- Example: “EPA Registration No.” or “EPA Establishment No.” These examples are false or misleading because they imply that the product is registered by EPA.
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.”
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 from a disease that these insects can carry, such as Lyme disease, by using the product. Remember: the claim may only be for the pest, as a pest, and not as a disease vector.
Example of an appropriate claim: “repels mosquitoes and ticks.”
Examples of inappropriate claims: “repels mosquitoes that can transmit malaria,” or, "Will repel ticks that cause Lyme disease." Also, "repels mosquitoes and ticks,” then elsewhere on the label, "Mosquitoes can transmit malaria" or "Ticks cause Lyme disease."
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.
- What are the requirements if my exempted product is to be used on or around food, food crops, or animal feed?
- How can I find out if my active and inert ingredients have tolerances or are exempt from the requirement of a tolerance?
- How do I get a tolerance if I need one?
Even if a pesticide is exempt from federal registration, it must have a tolerance or tolerance exemption under the Federal Food, Drug and Cosmetic Act (FFDCA) if the product is to be used in a manner that may result in residues on food, food crops, or animal feed commodities.
The minimum risk pesticide exemption, known in federal law as 40 CFR 152.25 Subpart B or by the abbreviation 25(b), only exempts qualifying pesticide products from federal registration. However, 25(b) pesticides that are used on food, food crops, or animal feed are not automatically exempt under FFDCA, the federal law that covers pesticide residues, among other things. When residues of pesticide active or inert ingredients can be expected to be found on food or animal feed, maximum pesticide residue levels (called tolerances by EPA) or tolerance exemptions must be established. Tolerances are generally established after the Agency reviews scientific data demonstrating the amount of residue that can remain on food without posing unnecessary risk to consumers. EPA may exempt pesticides from the requirement of a tolerance if the pesticide is considered by the Agency to be safe enough for use at any level. All pesticide labels, including those for minimum risk pesticides, may bear only those food uses for which there are tolerances or exemptions from tolerances for the active and inert ingredients.
Tolerances and exemptions from the requirement of a tolerance are listed in Parts 180, 185, and 186 of Title 40 of the Code of Federal Regulations for each active ingredient and inert ingredient. Currently, the most accurate source of tolerance information is the online version of the Code of Federal Regulations, called e-CFR, which has a search function and is available at http://ecfr.gpoaccess.gov/. Please note that though up-to-date, e-CFR is not an official, legal edition of the CFR. See http://ecfr.gpoaccess.gov/ for more information.
The first step is to petition the Agency to establish a tolerance. The Agency will then announce the receipt of the petition in the Federal Register. There are fees associated with establishing tolerances (17 pp, 715 K, about PDF), but they may be waived on a case-by-case basis. Please see the Agency's online fact sheet Setting Tolerances for Pesticide Residues in Foods for more information.
- What must I do to meet any applicable state registration requirements?
- What happens if a state won’t accept my product as an exempted pesticide?
- Comply with the state’s requirements in order to sell and distribute the product.
- Not sell or distribute the product in that state.
- You may register the product with U.S. EPA if the Agency determines that your product meets all health and safety standards and all other applicable requirements. You must also meet any applicable state requirements for your product.
Even if a pesticide product is exempt from federal registration, the product may not be exempt from state registration or other regulatory requirements. It is important that you contact the state agencies responsible for pesticide regulation in those states where you would like to sell your product, so you can find out what you need to do to satisfy any requirements for pesticide registration, which vary from state to state.
If you decide to register a pesticide product that does not meet the conditions for minimum risk pesticide exemption or because states will not accept the product without an EPA registration, you may download a federal registration kit at www.epa.gov/pesticides/registrationkit. Please note that it is a violation of federal law to sell or distribute unregistered pesticide products that do not meet the conditions for the minimum risk pesticide exemption and do not fall within any other exemption from the Federal Insecticide, Fungicide, and Rodenticide Act. Any such sale or distribution is subject to enforcement action by EPA's Office of Compliance and Enforcement.
For questions, contact the Biopesticides ombusdsman