Pesticide Labeling Questions & Answers - Pesticide Exemption (FIFRA 25B)
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(Note: Contact your Pesticide Product Registration Ombudsman for specific label issues about a single product).
These answers are not intended to create significant new guidance or require any changes to previously accepted labeling. The Agency will contact registrants directly about how to correct problematic labels as appropriate. Changes to EPA accepted labeling will only be required in accordance with standard agency procedures. These answers are primarily based on federal law, regulations and policies implemented by EPA. States, tribes, territories, and other federal agencies may have additional requirements relevant to their jurisdictions.
- Advertising Claims
- Antimicrobial Claims
- Contract Manufacture
- Use Sites
- Definitions of Terms
- Distributor Product Labeling
- Exception to Use in a Manner Not Permitted (FIFRA Sec 2ee)
- Existing Stocks
- General Labeling
- Labeling from Web Sites
- Multiple Products Packaged Together
- NAFTA Labeling
- Pesticide Exemption (FIFRA 25B)
- Pictures and Logos
- Repacked Products
- Service Containers
- Subject to FIFRA
- Superlative Terms
- Supplemental Labeling (NOT distributor products)
- Regarding FIFRA 25b insect repellent products [exempt under 40 CFR 152.25(f)], if the exempt pesticide product is in an impregnated formulation, such as a wet towelette or a wristband, does the carrier material (the towelette or the plastic) have to be a cleared 25b inert ingredient and does it have to be listed on the product label as an inert ingredient (per PR Notice 2000-6)? LC11-0396; 5/19/11
The Agency considers carrier materials such as the towelettes, or the plastic in a wristband to be part of the pesticide product. In the case of a registered antimicrobial towelette for example, the Agency considers the pesticide product to be the combination of the towelette and the liquid, not just the liquid that is contained within the towelette.
40 CFR 152.3 defines "inert ingredient" to mean "any substance...other than an active ingredient, which is intentionally included in the pesticide product." Since the carrier material is not the pesticidally active component of the product but it is intentionally included in the product, it is an inert ingredient. 40 CFR 152.25(f)(3)(ii) states that " Each product containing the substance must bear a label identifying the name and percentage (by weight) of each active ingredient and the name of each inert ingredient." Furthermore, 40 CFR 152.25(f)(2) states, "A pesticide product exempt under paragraph (f)(1) of this section may only include inert ingredients listed in the most current List 4A." It is on those bases that for a § 152.25(f) product, all inert ingredient(s) in the product must be acceptable under the 25(b) exemption and be listed on the product label.
The link below "Inert Ingredients Eligible for FIFRA 25(b) Pesticide Products" lists the inert ingredients that are eligible for inclusion in pesticide products under the FIFRA section 25(b). This listing of minimal risk inert ingredients updates what has been historically referred to as "4A" under Pesticide Registration Notice 2000-6 (PDF) (10 pp, 52K, About PDF).
Are there limitations to the claims that can be made for minimum risk pesticides as defined by 40 CFR 152.25(f)? For instance, can a minimum risk pesticide bear both antimicrobial and insect repellant claims? (LC08-0149, 1/31/08)
To qualify as a minimum risk pesticide under 40 CFR 152.25(f) (and be exempt from pesticide registration), a product must meet certain conditions. These conditions fall into two categories, composition and labeling. Specific to labeling claims, a minimum risk pesticide “must not bear claims either to control or mitigate microorganisms that pose a threat to human health, including but not limited to disease transmitting bacteria or viruses, or claims to control insects or rodents carrying specific diseases, including, but not limited to ticks that carry Lyme disease.” 40 CFR 152.25(f)(3)(ii). In addition, the product may not include “any false and misleading labeling statements, including those listed in 40 CFR 156.10(a)(5)(i) through (viii).” 40 CFR 152.25(f)(3)(iii).
With regard to the example posed above, antimicrobial and insect-repellency claims can appear together so long as they are not false or misleading. It is important to note that the term “antibacterial” is considered to be an impermissible public health claim, whereas the term “antimicrobial” is not. With regard to an insect-repellency claim, a minimum risk pesticide label might claim “controls mosquitoes” (if the product does in fact control mosquitoes), but not “controls mosquitoes that can transmit malaria.” If EPA were to test the efficacy of such a product and find that it does not control mosquitoes, the product would bear a false claim and therefore would not qualify for the 152.25(f) exemption, and would be deemed an unregistered pesticide.
See also PR Notice 2000-6 for more information on minimum-risk pesticides.
- For pesticides exempt from registration under section 25(b) of FIFRA,
the labeling regulations at 40 CFR Part 152.25 (f)(3) require listing each
active ingredient by name and percentage by weight, and all other (inert)
ingredients must be listed by name. Pesticide Registration Notice 2000-6
repeats this information. However, one state is requiring listing of the
other (inert) ingredients with percentage by weight also, and to have a have
a total line of 100% as required in Section 156 on labeling of EPA
registered pesticides. Since these products are exempt from EPA regulation,
can the state impose such a requirement? No other state is requesting that
additional information for section 25(b) exempted products. (LC06-0026)
Products that are exempt from Federal regulation under FIFRA Section 25(b) are still subject to State regulation, and many States continue to register these products. In certain States, selling a product may require meeting State labeling and testing requirements.
As stated in PR Notice 2000-6 "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 (3 pp, 149.25K, About PDF)conditions for minimum risk exemption.