How to File for an EPA Establishment Number (Form 3540-8)

If your product is classified as a pesticide device or qualifies for the 25(b) minimum-risk exemption, you may need an EPA establishment number before you can legally produce and sell it. The good news: filing is free, does not require a consultant, and takes about 30 minutes of your time.

The short answer

An EPA establishment number is required for any facility that produces, packages, labels, or assembles a pesticide, pesticide device, or 25(b) exempt pesticide product. You file EPA Form 3540-8 directly with the EPA at no cost. The form asks for your facility address, the types of products produced, and basic company information. Processing typically takes 2 to 8 weeks. This is separate from EPA pesticide product registration — devices and 25(b) exempt products do not need product registration, only establishment registration.

How this applies to your situation

Under 40 CFR Part 167, every facility where a pesticide or pesticide device is produced must register with the EPA as a "producing establishment." This applies even if the facility only packages or labels the product — it does not matter whether the facility manufactures the active ingredient. If you use a contract manufacturer, the contract manufacturer's facility needs the establishment number, not your business address (unless you also package, label, or assemble at your own location).

The establishment number is a prerequisite for Amazon compliance. When Amazon asks for proof that your pesticide device or 25(b) product is compliant, the establishment number is one of the documents they expect to see. Without it, your appeal will be rejected even if your product is otherwise properly classified.

This requirement applies to bucket 2 (pesticide device) and bucket 4 (25(b) minimum-risk exempt) products from the self-check tool. If your product is in bucket 1 (regulated pesticide requiring full EPA registration), you also need an establishment number, but you have a much larger registration process ahead of you. If your product is in bucket 3 (fixable listing language) or bucket 5 (not a pesticide), you do not need an establishment number.

What to do next

1. Confirm your bucket by running the free self-check tool. You only need an establishment number if your product is in bucket 2 or bucket 4.
2. Download EPA Form 3540-8 from the EPA's pesticide establishment registration page.
3. Complete the form. The Compliance Template Bundle includes a line-by-line guide for every field on the form, including which product type codes to use for devices versus 25(b) exempt products.
4. Submit the form to the EPA by mail or through the EPA's CDX electronic filing system. Keep a copy of everything you submit.
5. Wait 2–8 weeks for processing. The EPA will mail your establishment number to the address on the form. Once received, add it to your Amazon Seller Central compliance documentation and reference it in your appeal.

Run the full self-check

Relevant source text

“Any establishment where a pesticide, pesticide device, or active ingredient used in producing a pesticide is produced must be registered with the Agency.” — 40 CFR §167.20. Full text at eCFR

“The term ‘produce’ means to manufacture, prepare, propagate, compound, or process any pesticide or device or active ingredient used in producing a pesticide. The term ‘produce’ includes the packaging, repackaging, labeling, and relabeling of any article.” — FIFRA §2(w), 7 U.S.C. §136(w). Full text at Cornell LII