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October 09, 2012
Pesticide registration fees reauthorized

A 5-year reauthorization of the Pesticide Registration Improvement Renewal Act of 2007 (PRIA 2) took effect on October 1, 2012.  PRIA 2 and its statutory partner, PRIA 3, established service fees for pesticide registration actions conducted by the EPA. The category of action, the amount of the pesticide registration service fee, and the corresponding decision review periods are prescribed by year in the PRIA statutes.  According to the EPA, the goal of the laws is to create a more predictable evaluation process for pesticide decisions.  The laws are also intended to promote shorter application review periods for reduced-risk pesticides.

Different actions, different fees

Regulatory actions for pesticides are categorized first by type of chemical (i.e., conventional, antimicrobial, or biopesticide chemical product) and then by the type of action (e.g., new active ingredient (nonfood use), new food use, new registration of an old product).  Under this system, each individual category corresponds to a certain registration service fee and decision review period.

The fees and decision review periods may change between fiscal years, and fees are periodically increased as prescribed by statute.  Before paying a fee, applicants should refer to EPA's fee determination decision tree.

A fee or a waiver from paying the fee is required in 14 specific areas, including new active ingredients, new uses, new products, certain inert ingredients, certain combination products, cancer reassessments, manufacturing use products, and human study protocols.

Actions not covered by fees include review of confirmatory data submitted in support of an already-issued registration, label amendments involving an advisory statement, certain emergency exemption requests, and minor formulation amendments that meet specific guidelines. 

Small business discount

A reduction of 50 percent or 75 percent of a prescribed fee can be granted for a qualified small business.  Fees may be reduced or exempted for minor uses.   Twenty-five percent of the fee is nonrefundable once an application is submitted even if it is rejected or withdrawn by the applicant.  If any fee is unpaid 30 days after it is due, it is treated as a claim of the U.S. government.  The statutes direct the EPA to reject any application submitted without the required registration service fee. 

The PRIA 3 time frame–the period of time in which the EPA must make a determination–begins 21 days after receipt of the application and fee.  Each PRIA 3 fee category has an associated period of time in which the Agency must make a determination.  A case-specific due date may be negotiated by the applicant and the Agency, generally as a result of data deficiencies identified during EPA’s in-depth review of the application.

Maintenance fees, too

Federal law also authorizes annual pesticide registration maintenance fees.  The amount of this fee varies from year to year depending on the authorizing legislation. The 2012 maintenance fee was $3,250 per product, up to preset limits determined by legislation. 

There are procedures for requesting a fee waiver for individual products, but maintenance fees will be reduced by 25 percent for the first registration only provided certain conditions are met.  There also are maintenance fee waivers for products that meet certain narrow criteria in two categories: minor agricultural use products and public health pesticides. 

All the above and much more is discussed in detail in EPA’s Pesticide Registration Manual(Blue Book). An update of Chapter 5 of the Blue Book, which covers registration fees, was published in September 2012. 

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