Document ID: EPA-HQ-OPP-2012-0938-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-03-20T04:00Z

Pesticide Reregistration Performance Measures and Goals;
                            Annual Progress Report;
                               Fiscal Year 2012
           Docket identification (ID) number:  EPA-HQ-OPP-2012-0938

I.  Introduction  
      The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to publish information about EPA's annual achievements in meeting its performance measures and goals for pesticide reregistration.  This report addresses EPA's achievements in this area during fiscal year 2012.  This report discusses the integration of tolerance reassessment with the reregistration process, and describes the status of various regulatory activities associated with reregistration and tolerance reassessment.  The report also gives total numbers of products reregistered and products registered under the "fast-track" provisions of  FIFRA.
II.  Background
      EPA must establish and publish in the Federal Register its annual performance measures and goals for pesticide reregistration, tolerance reassessment, and expedited registration, under section 4(l) of FIFRA, 7 U.S.C. 136a-1(l).  Specifically, such measures and goals are to include:
   * The status of reregistration. 
   * The number of products reregistered, canceled, or amended.
   * The number and type of data requests of Data Call-In (DCI) notices under FIFRA section 3(c)(2)(B) issued to support product reregistration by active ingredient.
   * Progress in reducing the number of unreviewed, required reregistration studies.
   * The aggregate status of tolerances reassessed.
   * The number of applications for registration submitted under FIFRA section 4(k)(3) (which provides for expedited processing and review of certain applications) that were approved or disapproved.
   * The future schedule for reregistrations in the current and succeeding fiscal year.
   * The projected year of completion of the reregistrations under FIFRA section 4.
	FIFRA authorized EPA to conduct a comprehensive pesticide reregistration program -- a complete review of the human health and environmental effects of older pesticides originally registered before November 1, 1984.  Pesticides meeting today's scientific and regulatory standards could be declared "eligible" for reregistration.  To be eligible, an older pesticide must have a substantially complete data base, and must not cause unreasonable adverse effects to human health or the environment when used according to Agency approved label directions and precautions.
	In addition, all pesticides with food uses must meet the safety standard of section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) 21 U.S.C. 346a.  Under FFDCA, EPA must make a determination that pesticide residues remaining in or on food are "safe"; that is, "that there is reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue" from dietary and other sources.  In determining allowable levels of pesticide residues in food, EPA must, among other requirements, perform a comprehensive assessment of each pesticide's risks, considering:
   * Aggregate exposure (from food, drinking water, and residential uses).
   * Cumulative effects from all pesticides sharing a common mechanism of toxicity.
   * Possible increased susceptibility of infants and children.
   * Possible endocrine or estrogenic effects.
	The 1996 FFDCA amendments also required the reassessment of all existing tolerances (pesticide residue limits in food) and tolerance exemptions within 10 years, to ensure that they met the safety standard of the law.  EPA was directed to give priority to the review of those pesticides that appeared to pose the greatest risk to public health. The Agency completed the last of 9,721 required tolerance reassessment decisions in September 2007, ensuring that all pesticides used on food in the United States meet the law's safety standard.  EPA's approach to tolerance reassessment under FFDCA was described fully in the Agency's document, "Raw and Processed Food Schedule for Pesticide Tolerance Reassessment" (62 FR 42020, August 4, 1997) (FRL-5734-6).
	The Pesticide Registration Improvement Act (PRIA) of 2003 became effective on March 23, 2004 (Pub. Law 108-199, Div. G, Title V, Sec. 501, 118 Stat. 419). Among other things, PRIA amended FIFRA section 4(g)(2) to require EPA to complete Reregistration Eligibility Decisions (REDs) for pesticides with food uses/tolerances by August 3, 2006, and to complete all non-food use REDs by October 3, 2008.  The Agency completed decisions for the last of 613 reregistration pesticide cases in September 2008, meeting the PRIA deadline.  REDs are available on the Agency's Pesticide Reregistration Status web page, http://www.epa.gov/pesticides/reregistration/status.htm.
III.  Program Accountability
	Through this summary of performance measures and goals for pesticide reregistration, tolerance reassessment, and expedited registration, EPA describes progress made during the past year in each of the program areas included in FIFRA section 4(l).
A.  Status of Reregistration
	The last reregistration eligibility decisions for 613 reregistration cases were completed in FY 2008.  During FY 2012, the Agency focused on completing product reregistration decisions.
B.  Product Reregistration; Numbers of Products Reregistered, Canceled, and Amended
	At the end of the reregistration process, after EPA has issued a RED and declared a pesticide reregistration case eligible for reregistration, individual end-use products that contain pesticide active ingredients included in the case still must be reregistered. This concluding part of the reregistration process is called "product reregistration."
	In issuing a completed RED document, EPA sends registrants a DCI notice requesting any product-specific data and specific revised labeling needed to complete reregistration for each of the individual pesticide products covered by the RED.  Based on the results of EPA's review of these data and labeling, products found to meet FIFRA and FFDCA standards may be reregistered. 
	A variety of outcomes are possible for pesticide products completing this final phase of the reregistration process.  Ideally, in response to the DCI, the pesticide producer, or registrant, will submit the required product-specific data and revised labeling, which EPA will review and find acceptable.  At that point, the Agency may reregister the pesticide product.  If, however, the product contains multiple active ingredients, the Agency instead would first require the registrant to amend the product's registration, incorporating the labeling changes specified in the RED as interim measures.  A product with multiple active ingredients could not be fully reregistered until the last active ingredient in its formulation was eligible for reregistration.  In other situations, the Agency may temporarily suspend a product's registration if the registrant has not submitted required product-specific studies within the time frame specified. The Agency may cancel a product's registration because the registrant did not pay the required registration maintenance fee.  Alternatively, the registrant may request a voluntary cancellation of their end-use product registration.
	1.  Product reregistration actions in FY 2012.  EPA counts each of the post-RED product outcomes described above as a product reregistration action.  A single pesticide product may be the subject of several product reregistration actions within the same year. For example, a product's registration initially may be amended, then the product may be reregistered, or the product may first be suspended and later it may be voluntarily canceled. During FY 2012, EPA completed the product reregistration actions detailed in Table 1. 
        TABLE 1. -- PRODUCT REREGISTRATION ACTIONS COMPLETED IN FY 2012 
                          (AS OF SEPTEMBER 30, 2012)
                                       
                                    Actions
                                                                        FY 2012
Product reregistration actions      
                                                                          186  
Product amendment actions
   980                                                                         
Product cancellation actions
   92                                                                          
Product suspension actions
26                                                                             
Total actions
     1,284                                                                     

	2.  Status of the product reregistration universe for FY 2012.  EPA also keeps track of the status of the universe of products subject to reregistration, that is, the overall number of products reregistered, amended, canceled, and sent for suspension, as well as the number of products with actions pending, as of the end of the fiscal year. This overall status information is not "cumulative" -- it is not derived from summing up a series of annual actions.  Adding annual actions would result in a larger overall number since each individual product is subject to multiple actions -- it can be amended, reregistered, and/or canceled, over time.  Instead, the "big picture" status information in Table 2 should be considered a snapshot in time.  As registrants and EPA make marketing and regulatory decisions in the future, the status of individual products may change, and numbers in this table are expected to fluctuate.
TABLE 2. -- STATUS OF THE UNIVERSE OF PRODUCTS SUBJECT TO PRODUCT REREGISTRATION, FOR FY 2012 (AS OF SEPTEMBER 30, 2012)
                                       
                                    Status
                                                                        FY 2012
Products reregistered
                                                                          4,929
Products amended
           2,593                                                               
Products canceled
            10,641                                                             
Products sent for suspension
         45                                                                    
Total products with actions completed
            18,208                                                             
Products with actions pending
            6,375                                                              
Total products in product reregistration universe
            24,583                                                             

      At the end of FY 2012, 6,375 products had product reregistration decisions pending.  Some pending products awaited science reviews, label reviews, or reregistration decisions by EPA.  Others were not yet ready for product reregistration actions, but were associated with more recently completed REDs.  Their product-specific data were not yet due to be submitted to or reviewed by the Agency. 
	The universe of products in product reregistration has increased in some years and decreased in other years.  Generally, an increase resulted from products associated with the most recently completed REDs, while a decrease was due to fluctuations in numbers of products associated with product-specific Data Call-Ins (PDCIs).
		3.  Product reregistration goal in FY 2013.  EPA's goal is to complete 1,200 product reregistration actions during FY 2013.  Additional information is available on EPA's Product Reregistration web page, http://www.epa.gov/pesticides/reregistration/product-reregistration.htm.
C.  Applications for Registration Requiring Expedited Processing; Numbers Approved and Disapproved

	By law, EPA must expedite its processing of certain types of applications for pesticide product registration, i.e., applications for end-use products that would be identical or substantially similar to a currently registered product (me-too products); amendments to current product registrations that do not require review of scientific data; and products for public health pesticide uses.  During FY 2012, EPA considered and approved the numbers of applications for registration requiring expedited processing (also known as "fast track" applications) shown in Table 3.
                       TABLE 3. -- FAST TRACK APPLICATIONS APPROVED IN FY 2012
                               Application Type
                                                                        FY 2012
Me-too product registrations/Fast track
                                                                            407
Amendments/Fast track
                                                                          2,555
Total applications processed by fast track means 
                                                                          2,962

	For those applications not approved, the Agency generally notifies the registrant of any deficiencies in the application that need to be corrected or addressed before the application can be approved.  Applications may have been withdrawn after discussions with the Agency, but none were formally "denied" during FY 2012.
	On a financial accounting basis, EPA devoted 20 full-time equivalents (FTEs) in FY 2012 to reviewing and processing applications for fast track me-too product registrations and label amendments.  The Agency spent approximately $2.8 million in FY 2012 in direct costs (i.e., time on task, not including administrative expenses, computer systems, management overhead, and other indirect costs) on expedited processing and reviews.
D.  Projected Year of Completion of Reregistrations
	EPA completed the last reregistration eligibility decisions in FY 2008.  The agency plans to complete product reregistration for conventional pesticides in 2014.  

IV. Can I Comment on this Report?
      Although not subject to a formal comment period, EPA welcomes input from stakeholders and the general public. Written comments, identified by the docket identification number EPA-HQ-OPP-2012-0938, would be most helpful if received by EPA on or before [insert date 60 days after date of publication in the Federal Register].
      Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2012-0938, by one of the following methods:	
      ::  Federal eRulemaking Portal:  http://www.regulations.gov.  Follow the on-line instructions for submitting comments.
      ::  Mail:  Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
V.  For Further Information Contact  
      Carol P. Stangel, Pesticide Re-evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:  (703) 308-8007; e-mail address:  stangel.carol@epa.gov.
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