Minimum Risk Pesticides: FIFRA 25(b) Conditions and Ingredients

To qualify for the FIFRA 25(b) minimum risk pesticide exemption, a product has to satisfy six EPA conditions at the same time: every active ingredient must come from an approved list, every inert ingredient must come from an approved source, the label must name all ingredients correctly, the label must carry the producer’s full contact information, the product cannot claim to control public health pests, and nothing on the label can be false or misleading. Miss any one of the six and the product is an unregistered pesticide, exposed to federal civil penalties of up to $24,885 per violation plus whatever the state stacks on top.¹

Section 25(b) of the Federal Insecticide, Fungicide, and Rodenticide Act lets the EPA exempt pesticides that pose minimal risk from the registration process conventional pesticides must complete. The exemption is not a blank check. The EPA never reviews a 25(b) product for safety or efficacy before it hits shelves, so the manufacturer carries the full burden of compliance from day one.

The Six Conditions

All six must be met simultaneously. A product with perfect ingredients and a single misleading label phrase is just as illegal as one containing an unapproved chemical.

Every active ingredient appears in Table 1 of 40 CFR 152.25(f)(1). There are currently 43 approved substances.
Every inert ingredient comes from Table 2 of the same regulation, or qualifies as a commonly consumed food commodity, animal feed item, or edible fat or oil under 40 CFR 180.950.
The label identifies every active ingredient by its official label display name with its percentage by weight, and names every inert ingredient.
The label makes no claim to control or repel a pest of public health importance.
The label shows the name, street address with ZIP code, and telephone number of the producer or company responsible for the product.
The label contains no false or misleading statement, a category the EPA reads broadly.

Approved Active Ingredients

Table 1 lists 43 substances, each identified by a required label display name and, where applicable, a Chemical Abstract Service number. The list is built around materials with long histories of human contact: cooking spices like cinnamon, garlic, and thyme; plant oils like cedarwood, lemongrass, peppermint, and rosemary; and common household substances like citric acid and sodium chloride.³

Three details trip manufacturers up. The label must use the exact display name from Table 1, not a trade name or synonym. The ingredient must meet purity appropriate for its use, since synthetic contaminants or unlisted additives disqualify the whole product. And similar-sounding entries are listed separately: cinnamon the spice is not cinnamon oil the essential oil extract, and calling one by the other’s name is a labeling violation.

There is no shortcut for an active ingredient that is not on the list. The product has to go through the full EPA registration process, with multi-year testing, data submissions, and substantially higher costs.

Approved Inert Ingredients

Inerts are the solvents, carriers, and other components that support the actives. Despite the name, they still need explicit authorization. Four categories are allowed:

Commonly consumed food commodities under 40 CFR 180.950(a), such as corn oil or soybean oil.
Animal feed items under 40 CFR 180.950(b).
Edible fats and oils under 40 CFR 180.950(c).
Specific chemical substances listed in Table 2 of 40 CFR 152.25(f)(2)(iv), which includes materials like beeswax, cellulose, and various plant-derived compounds.

An inert that does not fall in one of these four buckets cannot appear in an exempt product at any concentration.⁴

Watch for the outdated “List 4A” designation. Older EPA guidance used numbered inert lists, and some industry references still point manufacturers to List 4A. The current regulation makes no mention of it. Compliance turns on Table 2 and the 40 CFR 180.950 food commodity provisions, nothing else. Working from an old list can put a once-approved but no-longer-listed substance into your formulation.

What the Label Must Say

The label must list every active ingredient by its official display name from Table 1, along with the percentage by weight. Every inert ingredient must also be listed by name, though percentages for inerts are not required. The producer’s company name, full street address with ZIP code, and telephone number must appear on the label. If the name shown is not the actual producer, qualifying language such as “Distributed by” or “Packed for” is required.²

Many states also require a signal word such as “CAUTION” and a “Keep Out of Reach of Children” statement on the front panel, matching what appears on the product’s Safety Data Sheet. Federal 25(b) exemption does not override those state expectations.

What the Label Cannot Say

The federal ban on false or misleading labeling is broader than most manufacturers expect. Under 40 CFR 156.10(a)(5), which the 25(b) exemption incorporates by reference, these categories of statements make the label illegal:

Safety claims. Words like “safe,” “nonpoisonous,” “harmless,” and “nontoxic to humans and pets” are specifically prohibited, even qualified with “when used as directed.”
Comparative safety claims such as “among the least toxic chemicals known” or “contains all natural ingredients.”
False or overstated effectiveness claims.
Any statement implying that a federal agency recommends the product.
Disclaimers or fine print that contradict the label’s mandatory disclosures.

This catches manufacturers who assume that food-grade or plant-derived ingredients let them market a product as “natural” or “non-toxic.” They cannot.⁵

Public Health Pest Claims Break the Exemption

The fastest way to lose 25(b) status is to claim your product controls a pest that carries disease. The regulation prohibits claims to control or repel microorganisms that threaten human health, or insects and rodents that transmit specific diseases. The EPA maintains a formal list of pests of significant public health importance, developed with the Department of Health and Human Services and the Department of Agriculture. It includes:

Mosquitoes, which transmit malaria, Zika, West Nile virus, dengue, and encephalitis
Ticks, which transmit Lyme disease, Rocky Mountain spotted fever, and ehrlichiosis
Cockroaches, linked to asthma and food contamination
Body, head, and crab lice, which transmit typhus and trench fever
Bed bugs, which cause allergic reactions
Rats and mice, which carry rodent-borne diseases and contaminate food
Disease-causing microorganisms, including bacteria, viruses, and protozoans

A product that claims to repel mosquitoes or kill bacteria cannot qualify as a minimum risk pesticide regardless of what is in it. It has to go through full EPA registration, including efficacy data proving it works.⁶

Softer phrasing like “helps suppress” or “aids in repelling” is not a reliable workaround. Any claim a reasonable consumer would read as controlling a public health pest puts the exemption at risk.

The Federal Exemption Does Not Cover State Requirements

Clearing the six federal conditions does not authorize sale in any particular state. Most states impose their own rules on 25(b) products, and the landscape varies widely. Some require full product registration with label review, annual fees, and renewal. Others accept the federal exemption with minimal paperwork. A few exempt minimum risk products from state registration entirely.

Where registration is required, the process usually starts with submitting the product label and Safety Data Sheet to the state’s agricultural or environmental department. States can request additional documentation during review. Fees, renewal timelines, and late penalties differ by jurisdiction, so a manufacturer distributing across multiple states has to track each one separately.

State regulators enforce standards stricter than the federal baseline. A product meeting all six federal conditions can still face a stop-sale order for violating a state-specific labeling rule, using an ingredient the state has separately restricted, or lacking required state registration. Retailers and distributors, not just manufacturers, can be held responsible.

Penalties for Getting It Wrong

A product that claims 25(b) status but fails any one of the six conditions is an unregistered pesticide under FIFRA. Distributing an unregistered pesticide is a prohibited act under Section 12, as is selling a product whose label is false, misleading, or missing required information, or whose actual composition differs from what the label describes.

The federal civil penalty is currently $24,885 per violation, an amount the EPA adjusts periodically for inflation. Each product, shipment, or day of ongoing violation can count as a separate offense, so exposure grows quickly for a manufacturer moving non-compliant product through multiple retail channels.¹

Beyond fines, the EPA can issue stop-sale orders that pull a product from the market immediately, and state regulators have parallel authority that often moves faster on local complaints. The 25(b) exemption saves the time and cost of full registration, but the compliance requirements are precise, and the consequences of missing one are no lighter than for a conventional pesticide.

1
eCFR. 40 CFR 19.4 – Statutory Civil Monetary Penalties, as Adjusted for Inflation, and Tables
2
eCFR. 40 CFR 152.25 – Exemptions for Pesticides of a Character Not Requiring FIFRA Regulation
3
Environmental Protection Agency. Active Ingredients Allowed in Minimum Risk Pesticide Products
4
Environmental Protection Agency. Inert Ingredients Approved for Use in Minimum Risk Pesticide Products
5
eCFR. 40 CFR 156.10 – Labeling Requirements
6
Environmental Protection Agency. List of Pests of Significant Public Health Importance