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FIFRA (Federal Insecticide, Fungicide and Rodenticide) Section 25b Products

  1. How does a product qualify for the FIFRA 25(b)?

    Criteria 1: The product must contain only those active ingredients that are listed in the regulation. Active ingredients are those ingredients that destroy, repel, or mitigate a pest. The active ingredient list can be found here: (source: EPA)

    The official location is Title 40 Code of Federal Regulations, Part 152.25(g)(1). The amount of active ingredient or the sum of active ingredients in a product may add up to 100%.

    Criteria 2: The product must contain only those inert (other) ingredients that have been classified by EPA as List 4A "Inert Ingredients of Minimal Concern". List 4A was undergoing revision in 2001. It is strongly recommended that the list be viewed on the Agency's website to ensure that a correct and up-to-date list is used:
    [pdf; source: EPA website]

    Criteria 3: All of the ingredients (both inert and active) must be listed on the label. The active ingredient(s) must be listed by name and percentage by weight. Each inert (other) ingredient must be listed by name.

    Criteria 4: The product must not make public health claims. For example, the label may refer to controlling ticks or mosquitoes, but may not in any way refer to or claim to prevent any specific disease carried by those pests, such as Lyme disease, encephalitis, or West Nile Virus.

    Criteria 5: The label cannot include any false or misleading statements. For example, label language implying Federal registration, review or endorsement such as "It is a violation of Federal law to use this product in a manner inconsistent with the label", or the use of an EPA registration or establishment number are not allowed. Persons intending to manufacture or market FIFRA Section 25(b) products should carefully consult EPA Pesticide Regulation Notices 2000-6 and 2002-XX for a discussion of false and misleading label claims.

  2. What if my product does not meet all of the criteria listed above?

    If a product does not meet all five of the criteria listed above, it is in violation of the Federal law. The producer and distributor may be subject to enforcement penalties. If a producer cannot or does not wish to meet all the criteria, it remains an option to apply to EPA for a Federal pesticide registration. The necessary forms and instructions for a registration application may be obtained from the Agency website at: (source: EPA)

  3. Do State governments regulate these exempted pesticide products?

    Yes, Indiana and many other states continue to regulate these products. The FIFRA section 25(b) exemption is for Federal registration only.

  4. Can other substances be added to the active ingredient list?

    It is possible, but the U.S. EPA would require information adequate to demonstrate minimal toxicity and risk, which the Agency could review and evaluate. Also, since these minimal risk active ingredients are in the Code of Federal Regulations, the Agency would have to undertake a rule-making process requiring public notice and comment to amend 40 CFR to add new substances.

  5. What about adding inert ingredients to the 4A List?

    The addition must be a minimal risk inert ingredient and must be substantiated for U.S. EPA review and evaluation. List 4A, however, can be changed by publication of a Federal Register Notice. It should be noted that the Agency is in the process of restructuring the 4A List. This restructuring will expand the number of substances on List 4A, as well as providing better definition and increased flexibility but will also remove several substances from List 4A. You should consult EPA's website at: [pdf; source: EPA] to be sure of using a correct, up-to-date list.

  6. Why are some ingredients on both the active ingredient list and the inert (other) ingredient list?

    It is possible for a chemical to be an active ingredient in one pesticide product and an inert ingredient in another pesticide product. Active ingredients function as the ingredient that kills, repels, or mitigates the pest. Inert (or "other") ingredients are defined as all ingredients that are not active ingredients. Determining whether an ingredient in a pesticide product is inert or active requires information on the concentration and purpose of the ingredient in the formulation. As an example, citric acid is a disinfectant, sanitizer, and fungicide (an active ingredient) when used in combination with other active ingredients. However, citric acid can also perform as a buffer, thus functioning as an inert ingredient. Thus, to determine whether an ingredient is inert or active requires an understanding of the purpose of these chemical substances in the formulation. The ingredients on the two lists are not interchangeable. If the substance is only on the inert (other) ingredient list, then it may only be used as an inert (other) ingredient, and similarly for active ingredients.

  7. Where can I get more information?

    For more information regarding the federal pesticide regulatory programs, contact EPA or any of its Regional Offices:

    EPA Office of Pesticide Programs
    Telephone: 703-305-5017
    Fax: 703-305-5558
    Web site: