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Cleaner or pesticide

What registration actually involves

Updated

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If the product is going to make antimicrobial claims, this is the road, and it is worth understanding its size before choosing it.

A serious program

Pesticide registration is a federal approval process with data requirements, review timelines and fees. It is not a filing.

The product is reviewed, the active ingredient must be registered, the label is approved as part of the registration, and the registration is specific to what was approved.

The elements

A registered active ingredient, or registration of a new one, which is a far larger undertaking again.

Efficacy data from testing to EPA-accepted methods, at an accepted laboratory, for each organism and each claim.

Product chemistry data: composition, stability, physical properties.

Toxicology data supporting the precautionary statements.

An approved label, with the EPA registration number and establishment number on it. The label is part of the registration and changing it is a regulatory act.

Establishment registration for the facility where it is produced.

State registration in addition, in most states, each with its own fee and renewal.

Per product, and per claim

This is the part that shapes a range. A registration covers a specific formulation making specific claims.

A new organism on the label needs data for that organism. A reformulation is a change to a registered product. A second product is a second registration.

And the state registrations multiply: fifty renewals a year is an administrative function rather than a task.

What it means for a small maker

The cost is measured in tens of thousands before a bottle is sold, mostly in efficacy testing, and the timeline in many months.

Which is why almost no small maker registers, and why the honest answer for many people is the other route: sell a cleaner, label it as a cleaner, and do not make the claim.

The alternatives worth knowing: contract with a registered manufacturer, or distribute somebody else's registered product alongside your own cleaners.

References

US Environmental Protection Agency. Pesticide Registration Manual, Chapter 4: Additional Considerations for Antimicrobial Products. What an antimicrobial pesticide is, and what registration requires. epa.gov
US Environmental Protection Agency. Antimicrobial Policy and Guidance Documents, including the treated articles exemption and efficacy data requirements. epa.gov
US Environmental Protection Agency. Determining If a Cleaning Product Is a Pesticide Under FIFRA. A cleaner that claims to clean and degrease is not a pesticide; the same product claiming to kill germs is. The claim triggers it, not the chemistry. epa.gov
Written from the federal regulation and agency guidance named on each page, not from a laboratory or a legal practice. Whether a particular product and a particular label make a cleaner or a pesticide is a determination about your product, and this is not that determination.