M009 Submissions

M009 When is FIFRA Product Registration Required?

Non Pesticidal Determination Submissions

When is FIFRA Product Registration Required?

Determining whether or not a product is a pesticide is not always simple or straightforward. EPA provides rules on when a product must be registered as pesticide in 40 CFR §152.15 (“Pesticide products required to be registered”). These basic criteria, however, are broad and must be interpreted.

EPA also provides rules in 40 CFR 152.6 (“Substances excluded from regulation by FIFRA”) on the various categories of products that are excluded from FIFRA, and rules in 40 CFR 152.25 (“Exemptions for pesticides of a character not requiring FIFRA regulation”) on the types of pesticide products that are exempted from registration. Unfortunately, even with all of this guidance, it can still be difficult to determine where a product falls within those categories (required to be registered, excluded from regulation, or exempt from regulation).

What is an M009 EPA submission?

An M009 submission is a request to EPA for a determination of whether or not FIFRA registration is required for a proposed product. When it is unclear whether a product is or is not regulated as a pesticide, a PRIA code M009 submission can be completed.M009 submissions are not required, but they provide a means to resolve uncertainty about a product’s status and avoid later enforcement exposure. The current PRIA cost for an M009 submission is $2,607 and the current decision timeframe after submission is 4 months.

Examples of M009 Submissions

Biostimulants – A biostimulant product is sold in another country and sales are expanding to the US. It is unclear how EPA will view the product.
Excluded products – A product needs assurance that it is excluded from FIFRA in one of the following categories:
- Liquid chemical sterilant
- Nitrogen stabilizer
- Human drugs
- Animal drugs
- Vitamin hormone product
- Plant nutrient product
- Plant inoculant product
- Soil amendment product
“Dual Use” – A microbial product that shows “dual use” characteristics as a pesticide and an inoculant. The interested party wants to make sure that it doesn’t violate FIFRA if the product is sold as an inoculant without a FIFRA registration..
A producer needs assurance that a product meets the exemption requirements for:
- 25(b) minimum risk.
- 25(d) “Food”
- A pesticidal device
Novel products – A product uses a unique process or mode of action and it is unclear as to whether or not it is a pesticide, an exempted product, or an excluded product.

M009s and Biostimulants

As interest continues to grow in products that have beneficial effects on plants that are not created from conventional chemistries, the biostimulant market is growing to meet demand. Companies that sell products in other countries as “biostimulants” run into difficulty in the US because there is no clearly defined regulatory process for this type of product. Please see our Biostimulant page for more information. Often an M009 determination is useful for a company to be comfortable with moving forward with sales in the US.

Goals for M009 submissions

The goal for excluded products (such as plant inoculants, soil amendments and some biostimulants) is centered on proving that the product is not a pesticide by showing that it does not meet any of the pesticidal criteria listed in 40 CFR §152.15 and also showing that the product meets any of the exclusion criteria that is outlined in 40 CFR 152.6. In other words, show that it is “not” a pesticide and show that it “is” an excluded product.

The objective in all M009 submissions is to show exactly which exemption or exclusion applies and how the product meets the specified criteria. The tables below give examples of our basic approach.

Table 1: Items to address to show the product is not a pesticide

40 CFR §152.15	Materials/Data to for support in EPA’s evaluation
(a) The person who distributes or sells the substance claims, states, or implies (by labeling or otherwise): That the substance (either by itself or in combination with any other substance) can or should be used as a pesticide; or That the substance consists of or contains an active ingredient and that it can be used to manufacture a pesticide; or	Label Marketing materials Patent
(b) The substance consists of or contains one or more active ingredients and has no significant commercially valuable use as distributed or sold other than se for pesticidal purpose (by itself or in combination with any other substance), use for manufacture of a pesticide; or	Efficacy data Public literature
(c) The person who distributes or sells the substance has actual or constructive knowledge that the substance will be used, or is intended to be used, for a pesticidal purpose.	Label Marketing materials Patent

Table 2 Exemption/Exclusion Examples for M009 Submission

Exemption/Exclusion	CFR to Support	Items to address
Exclusion: Product an inoculant	40 CFR 152.6(g)(2)	Is there efficacy data showing non-pesticidal activity? Can we refute any literature suggesting pesticidal activity?
Exclusion: Product is a soil amendment	40 CFR 152.6(g)(3)	Is there efficacy data showing non-pesticidal activity? Can we refute any literature suggesting pesticidal activity?
Exemption: Product is a food	40 CFR 152.25(d)	Are all ingredients food? Are all ingredients tolerance exempt inserts? Are all ingredients listed as “Food Use” inserts
Exemption: 25(b)	40 CFR 152.25(f)	Are all active ingredients 25(b) compliant? Are all inert ingredients 25(b) Is the label 25(b) compliant

Delta has experience working with clients and products that fall into most excluded or exempted categories (25(b) products, pesticide devices, food, soil amendments, biostimulants, etc..) and has a successful track record of favorable response on several M009 submissions. Delta is well suited to work with EPA and clients to navigate the M009 process as EPA refines their process more. Please reach out to info@delta-ac.com for more information.