And so I just have to ask what's the fee required to register a new Pesticide product at the EPA if it hasn't been tried out yet. That's the EPA registration fee for the year 2009-2010.

Even with the reduced risk submission, the fee due EPA is $542,115.00 And counting the regulatory consultant's fees, it could easily balloon to more than $1.5M.


Action Code Interpretation:

An application that proposes a food use for an active ingredient that is not currently contained as an active ingredient in any U.S. registered pesticide product. The use may require the establishment of or the exemption from the requirement of a tolerance under section 408 of the FFDCA. The application submission must contain a petition to establish tolerances or exemption(s) from tolerance for all food/feed commodities covered by the pending registration application(s). All uses (food and non-food) included in any original application or petition for a new active ingredient are covered by the base fee for the application in this category if submitted simultaneously. Some examples of food uses include corn, apples, and aquatic uses involving potable water, irrigation, or requiring tolerances for fish, or shellfish, pasture, rangeland, home garden, beehive, livestock, livestock housing, livestock dips, and livestock ear tags.

A "reduced risk"submission must accompany the application for registration. The Agency’s Reduced Risk Committee will evaluate the submission and make the determination, based on criteria listed in PR Notice 97-3 and FIFRA 3(c)(10) (B) (-iv) , whether the requested use(s) qualify as “reduced risk” when compared to currently registered pesticides for the same use(s). The reduced risk status of any use of a chemical is an initial assessment. Should information warrant, or should the Agency determine at any time that the data base for the chemical is unacceptable or upon a more thorough review found to be insufficient to demonstrate that the use/application is reduced risk, the Agency may reject reduced risk status. In the event that any uses do not qualify as “reduced risk” by decision of the Reduced Risk Committee, the application will not receive the reduced risk decision timeframes. The fee category will be changed to the non-reduced risk category and the action will receive the longer timeframes (e.g. from an R020 New Active Ingredient, Food Use, “reduced risk” to an R010 New Active Ingredient, Food Use).

Welcome, to the world of self employment. Joe wrote....."easily balloon to more than $1.5M.", ....... EPA's chump change???


"Reduced Risk Committee will evaluate the submission and make the determination, based on criteria listed in PR Notice 97-3 and FIFRA 3(c)(10) (B) (-iv)

.............Joe, a Reduced Risk evaluation procedure can easily take a year or more to complete. - Millet (1,356-)

One other thought Joe . . . I wouldn't think the ingredients in AZ41 are unknown chemicals to the EPA. Maybe you can piggyback on studies that have already been completed for the individual ingredients.

I'm not familiar with EPA evaluations, but for environmental reports there's often other studies have already been done that can save a lot of time and money on the specific project I happen to be working on at the time.

Good luck.

Phillip

I do not know much about EPA's registration process, but I can say that just because an ingredient is natural, does not mean it is not toxic. Man has yet to beat Mother Nature in the creation of toxic compounds, so all ingredients that go onto our food do need to be evaluated.

As Phillip said, hopefully there is a significant amount of published information on the ingredients of AZ41, so that you do not have to start at ground zero.

The other issue here is that as EPA has evolved, most of the burden and cost of pesticide registration has been passed on to the companies, so that EPA is not having to do the work of the chemical companies at taxpayer expense.