"One registers a pesticide product, and a facility to make it"

It is now 25 years since I was directly involved with Ag registration stuff.  But when I did work in the area there was no production or formulation facility registration, nor inspection process for such facilities by EPA simply because they made a pesticide.  You surely did have to comply with all the EPA emission rules for any streams leaving the plant site just like any other chemical manufacturer.  Production and formulation facilities for pesticides were not required to operate under Good Manufacturing Practices.  Production and formulations facilities were under the rules of OSHA for worker safety just like any other chemical manufacturing operation.  I find nothing on the current EPA pesticide registration web site that says production or formulation facilities require any registration today.

https://www.epa.gov/pesticide-registration

Now, this is not true of FDA registered drug products.  In that case production and formulation facility registration is a clear requirement to insure those operations are complying with Good Manufacturing Practices and regular unannounced inspections are normal.  When FDA inspectors show up unannounced you will do whatever they ask of you and provide access to all facilities and records as they request.  If they show up with armed security agents you are in for a very bad day.

James is correct that you can cite a competitors registration package and avoid repeating most of the tox and E Fate and residue work required for a pesticide registration if you are registering a me to product.  But, this is not without cost.  The cost is called "data compensation" where EPA will decide how much market share you will chew up and the orginal registrant will tell EPA their cost in producing the studies cited.  Say EPA decides you will get 25% market share.  They will require you to pay the original registrant 25% of his cost to produce the data you cite minus whatever the discounted value of those studies is as the original registrant has made a lot of money off them in prior years.  So a 25 year old study does not have a great value but a six month old study has full value.  Also, when you cite such data you do not get to see the data or reports.  For any future required studies you will be required to pay your fair share of the price depending on market share and may, or may not be able to see actual data from such studies.  You will be required to pay full costs on any studies that are particular to your formulation as you can not buy information on the competitors inert ingredient package via the data compensation system.  Even if you tear his formulation apart, which is very doable technically, and duplicate his ingredients the agency is still going to require you to provide any required studies on your particular formulation.  After all, you might use a different supplier for clay or surfactant than your competitor.  While data compensation sounds like an easy out you will spend a bunch of money on lawyers doing negotiations and arguing your costs should not be so high and still write a check to the registrant.

There is no requirement that you actually manufacture the pesticide molecule.  No one selling oxalic acid or formic acid or thymol as a miticide is going to manufacture any of these chemicals.  They are going to buy the chemical and do whatever analyses are deemed appropriate to make sure the purchased product is what they claim it is on the label.  It is the use of that molecule as a pesticide that is registered.  So, pretty much anyone could register a pesticide even if their manufacturing consisted of no more than relabeling a purchased chemical in their garage. Or even more likely hiring some third party with a nice packaging line all set up to repackage and relabel the purchased chemical.

Dick

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