            Pesticide Reregistration Performance Measures and Goals;
                            Annual Progress Report;
                               Fiscal Year 2016
           Docket identification (ID) number:  EPA-HQ-OPP-2014-0125

I.  Introduction  
      The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136a et seq.) 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 2016.  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 presents 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 required 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 a 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 REDs for the last of 613 reregistration pesticide cases in September 2008, meeting the PRIA deadline.  REDs are available on the Agency's Pesticide Chemical Search web page at https://iaspub.epa.gov/apex/pesticides/f?p=chemicalsearch:1.
III.  Program Accountability
	Through this summary of performance measures and goals for pesticide reregistration, tolerance reassessment, and expedited registration, EPA describes progress made during 2016 in each of the program areas specified in FIFRA section 4(l).
A.  Status of Reregistration
	The last reregistration eligibility decisions for 613 reregistration cases (representing pesticide active ingredients or groups of pesticide active ingredients) were completed in FY 2008.  Product reregistration was not complete in FY 2016; the Agency's progress towards completion is discussed in detail below.  During FY 2016, as in the intervening years, the Agency focused on implementing the reregistration eligibility decisions as applicable to individual pesticide products.
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.  However, some products contain multiple active ingredients and receive multiple DCIs issued at different times.  Products containing multiple active ingredients may require more than one round of label revisions depending on the timing of the REDs and DCIs.  A product with multiple active ingredients could not be fully reregistered until the last active ingredient in its formulation was determined to be eligible for reregistration and all requirements of the applicable REDs satisfied (e.g., label changes, data requirements).  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 2016.  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 2016, with a goal of 600 total product reregistration actions, the EPA completed the product reregistration actions detailed in Table 1. 
                                       
                                       
                                       
        TABLE 1. -- PRODUCT REREGISTRATION ACTIONS COMPLETED IN FY 2016 
                          (AS OF SEPTEMBER 30, 2016)
                                       
                                    Actions
                                                                        FY 2016
Product reregistration actions      
                                                                             14
Product amendment actions
                                                                             65
Product cancellation actions
                                                                            404
Product suspension actions
                                                                              0
Total actions
                                                                            483

	2.  Status of the product reregistration universe for FY 2016.  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 2016 (AS OF SEPTEMBER 30, 2016)
                                       
                                    Status
                                                                        FY 2016
Products reregistered
                                                                         5,121 
Products amended
                                                                          3,491
Products canceled
                                                                         11,702
Products sent for suspension
                                                                             40
Total products with actions completed
                                                                         20,354
Products with actions pending 
                                                                          4,621
Total products in product reregistration universe 
                                                                         24,975

      At the end of FY 2016, 4,621 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 or decrease can be due to fluctuations in numbers of products associated with product-specific Data Call-Ins (PDCIs).
	3.  Product reregistration goal in FY 2017.  EPA's goal is to complete 600 product reregistration actions during FY 2017.  Additional information is available on EPA's Reregistration and Other Review Programs Predating Pesticide Registration Review web page at https://www.epa.gov/pesticide-reevaluation/reregistration-and-other-review-programs-predating-pesticide-registration.
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 2016, 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 2016
                               Application Type
                                                                        FY 2016
Me-too product registrations/Fast track
                                                                            242
Amendments/Fast track
                                                                          2,180
Total applications processed by fast track means 
                                                                          2,422

	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, and 4 (RD=3, BPPD=1) were formally "denied" during FY 2016.
	On a financial accounting basis, EPA devoted 24 full-time equivalents (FTEs) in FY 2016 to reviewing and processing applications for fast track me-too product registrations and label amendments.  The Agency spent approximately $3.4 million in FY 2016 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 FY 2019 and antimicrobial pesticides in FY 2024.
IV. Can I Comment on this Report?
      EPA does not expect these reports to lead to any particular action and therefore is not seeking particular public comment.  However, EPA welcomes input from stakeholders and the general public.  Written comments, identified by the docket identification number EPA-HQ-OPP-2014-0125, and received by EPA on or before 60 days after date of publication in the Federal Register, will be taken into consideration in the event that EPA determines that further action in warranted.
      Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2014-0125, by one of the following methods:	
      ::  Federal eRulemaking Portal:  http://www.regulations.gov.  Follow the on-line instructions for submitting comments.  Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
      ::  Mail:  Office of Pesticide Programs (OPP) Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
 	:: Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/where-send-comments-epa-dockets.
      Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.
V.  For Further Information Contact  
      Ramé Cromwell, Antimicrobials Division (7510P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-9068; e-mail address: cromwell.rame@epa.gov.
