Minimum Risk Pesticide Criteria
What makes a pesticide qualify as minimum risk?
Under US federal law, a pesticide is "minimum risk" only if it meets every condition in 40 CFR 152.25(f). Its active ingredients must all come from EPA's Table 1, its inert ingredients must all be permitted ones, and its label must meet set content and claim limits. A product that meets all of these is exempt from all provisions of FIFRA. If it misses any one, it is not exempt.
Legal basis. FIFRA section 25(b) (7 U.S.C. 136w(b)) says EPA "may exempt from the requirements of this subchapter by regulation any pesticide" that is "of a character which is unnecessary to be subject to this subchapter in order to carry out the purposes of this subchapter" [us_fifra_7_usc_136:…]. In the regulation, 40 CFR 152.25 lists the pesticides EPA has found to be "of a character not requiring regulation under FIFRA." They are exempt "when intended for use, and used, only in the manner specified" (eCFR, 40 CFR 152.25).
The four conditions
- Active ingredients come only from Table 1 (§152.25(f)(1)). A product may use one listed active ingredient alone or combine it with other Table 1 substances, and "all of the criteria of this section" must be met.
- Table 1 is a closed list. Examples are castor oil (U.S.P. or equivalent), cedarwood, cinnamon, citronella, clove and peppermint oils, citric acid, corn gluten meal, dried blood, eugenol, geraniol, potassium sorbate, sodium chloride, sodium lauryl sulfate and white pepper [1][2].
- Some entries have specifications. Zinc is limited to "zinc metal strips (consisting solely of zinc metal and impurities)" [3]. Chitosan salts count only if they are formed with acids listed in Table 1 or Table 2.
- Inert ingredients come only from the permitted categories (§152.25(f)(2)). The product "may only include" these four types of inert:
- commonly consumed food commodities (§180.950(a));
- animal feed items (§180.950(b));
- edible fats and oils (§180.950(c));
- the specific chemicals in Table 2, such as zinc oxide and zinc stearate [4][5]. Some Table 2 entries have their own limits: diatomaceous earth must contain less than 1% crystalline silica, and zeolites exclude erionite.
- Food and feed uses need Part 180 coverage. Every listed active and inert ingredient may be used in non-food products. For a product used on food or feed, each ingredient also needs a tolerance or tolerance exemption under 40 CFR Part 180 (for example §§180.950, 180.1071, 180.910, 180.920).
- Labelling conditions (§152.25(f)(3)). "All of the following conditions must be met":
- (i) Ingredient statement: the label must give the Table 1 label display name and percentage by weight of each active ingredient. It must also list all inert ingredients by their Table 2 label display names.
- (ii) No public-health claims: the product "must not bear claims" to control or mitigate microorganisms that threaten human health (such as disease-carrying bacteria or viruses). It also must not claim to control insects or rodents that carry specific diseases, for example ticks that carry Lyme disease.
- (iii) Company identity: the label must show the producer's name, or the company it was produced for with wording such as "Packed for", "Distributed by" or "Sold by". It must also show a street address with ZIP code and a telephone number, displayed prominently.
- (iv) No false or misleading statements: this includes the statements listed in 40 CFR 156.10(a)(5)(i) through (viii).
EPA's guidance on minimum risk pesticides is referenced at §152.25(f)(4). The section was last amended at 87 FR 67370 (Nov. 8, 2022).
Approach: I searched the FIFRA text in the U.S. Code and the 40 CFR 152.25(f) ingredient tables in the datasets. The conditions in paragraph (f) were not held as text there, so I took them from the current official eCFR. I did not cover state-level registration rules.
Which ingredients and label claims are allowed?
A minimum risk product may contain only the 45 active ingredient entries in Table 1 of 40 CFR 152.25(f)(1) and inert ingredients from the four categories in §152.25(f)(2). The rule does not list approved claims. It sets out claims the label "must not bear" and things the label must show. Any other pest-control claim is not ruled out by §152.25(f), provided it is not false or misleading. The full Table 1 and Table 2 lists, with chemical names, CAS numbers and specifications, are in the panel document.
Permitted active ingredients (Table 1)
Actives may be used "alone or in combination with other substances listed in table 1," as long as all the criteria are met (eCFR §152.25(f)(1)). There are 45 entries under 43 label names; Cedarwood oil is listed three times.
| Group | Label display names |
|---|---|
| Plant oils | Castor oil, Cedarwood oil (Virginia, Texas and China entries), Cinnamon oil, Citronella oil, Clove oil, Corn oil, Cornmint oil, Cottonseed oil, Garlic oil, Geranium oil, Lemongrass oil, Linseed oil, Peppermint oil, Rosemary oil, Sesame oil, Soybean oil, Spearmint oil, Thyme oil |
| Whole plants or spices | Cinnamon, Citronella, Cloves, Cornmint, Garlic, Peppermint, Rosemary, Sesame, Spearmint, Thyme, White pepper |
| Defined chemicals | 2-Phenylethyl propionate, Citric acid, Eugenol, Geraniol, Lauryl sulfate, Malic acid, Potassium sorbate, Sodium chloride, Sodium lauryl sulfate |
| Other | Chitosan, Corn gluten meal, Dried blood, Putrescent whole egg solids, Zinc |
Four entries have specifications:
- Castor oil: must be "United States Pharmacopeia (U.S.P.) or equivalent" [6].
- Chitosan: includes only salts formed with acids listed in Table 1 or Table 2 [7].
- Sesame: "Includes ground sesame plant" [8].
- Zinc: "Zinc metal strips (consisting solely of zinc metal and impurities)" [3].
Permitted inert ingredients
A product "may only include" inerts from these categories (eCFR §152.25(f)(2)):
- commonly consumed food commodities (§180.950(a));
- animal feed items (§180.950(b));
- edible fats and oils (§180.950(c));
- the specific chemicals in Table 2: 288 entries, from Acetyl tributyl citrate to Zinc stearate (full list in the panel document).
Some Table 2 entries carry limits in their chemical names:
- Diatomaceous earth: "less than 1% crystalline silica" [9]
- Zeolites: "excluding erionite (CAS Reg. No. 66733-21-9)" [10]
- Silica: "crystalline free" [11]
- Silica, amorphous, fumed: "crystalline free" [12]
Food and feed uses. Any listed active or inert may be used in non-food products. Food and feed may carry residues only of ingredients that have a tolerance or tolerance exemption in 40 CFR Part 180.
Label claims and content (§152.25(f)(3))
"All of the following conditions must be met" (eCFR):
- Claims that are not allowed (ii): the product "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."
- No false or misleading statements (iv): this includes those listed in 40 CFR 156.10(a)(5)(i) through (viii).
- Ingredient statement (i): the label "must" give the Table 1 label display name and percentage by weight of each active ingredient. It must also list all inert ingredients by their Table 2 label display names.
- Company name and contact (iii):
- The label must show the producer's name, or the company it was produced for.
- If that company is not the producer, the name must be qualified, for example "Packed for", "Distributed by" or "Sold by".
- The label must also show a street address with ZIP code and a telephone number.
- All of this must be "displayed prominently."
Natural cedar. Products made only of untreated cedarwood fall under a separate exemption, §152.25(e). For those, claims are limited "solely to repel arthropods other than ticks or to retard mildew." That exemption "does not apply to cedar oil" or to mixtures containing cedar oil, other cedar extracts or ground cedar wood. A cedar oil product therefore has to meet the minimum risk conditions in paragraph (f).
Approach: I took the Table 1 and Table 2 ingredient entries from the 40 CFR 152.25(f) dataset and checked them against the current eCFR. The labelling conditions came from the eCFR text, last amended at 87 FR 67370 (Nov. 8, 2022). I did not cover state registration requirements or the food, feed and edible-oil items under §180.950, which are not itemised in Table 2.
Do states still require registration?
Yes. Exemption under FIFRA 25(b) only removes the federal EPA registration requirement, and each state decides for itself. EPA's current guidance says "the states are not required to permit the sale of an exempted product simply because it is exempted under federal pesticide law," and that each state has its own statutes and regulations on registration, sale and use (EPA, State Regulation of Minimum Risk Pesticides). There is no single national rule. In the four states I checked, the answers differ.
Federal position
- FIFRA §24(a) says a State "may regulate the sale or use of any federally registered pesticide or device in the State" [13]. For 25(b) products, state authority rests on each state's own law, which is how EPA's guidance describes it.
- States also "routinely monitor the marketplace" for compliance of minimum risk products with state and federal law. They may take enforcement action under state rules, or refer misleading claims to the Federal Trade Commission (EPA, Enforcement Related to Minimum Risk Pesticides).
- EPA's older PRN 2000-6 said the same thing: an exempted product "is not automatically exempt in a state" [14]. If a state won't accept it, the options are to meet that state's requirements or not sell the product there [15]. EPA's January 2015 web guidance replaced that notice, so it is historical only.
State examples
| State | Registration of 25(b) products | Key conditions |
|---|---|---|
| Washington (WSDA) | 25(b) products "must be registered" by WSDA as state-only registrations |
|
| California (DPR) | Exempt only if the product meets both the EPA conditions and 3 CCR §6147. "Certain 25(b) Minimum Risk Pesticides require registration in California," for example topical products with more than 1% citronella or citronella oil |
|
| New York (DEC) | "Currently, the DEC does not require registration" of 25(b) products |
|
| Texas (TDA) | "Registration is not required in Texas" | Texas label requirements in 4 TAC §7.11(2) still apply (TDA) |
For a product sold in several states, check each state's lead agency before distribution. A product can be exempt federally and still need state registration, a fee, label approval or efficacy data in some of them.
Approach: I searched the FIFRA text in the U.S. Code and EPA's Pesticide Registration Notices, then read EPA's current minimum risk guidance and the official pages of the Washington, California, New York and Texas pesticide agencies. The datasets hold no state-by-state register of 25(b) requirements, and I did not check the other states.