United States Environmental Protection Agency March 14, 2012

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### Pesticide Reregistration **Performance Measures and Goals ;** 

**Annual Progress Report; Fiscal Year 2011**  Docket identification (ID) number: EPA - HQ - OPP - 2011 - 0959 **I. Introduction** The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 1 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 ye ar 2011. This report discusses the integration o f 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 F IFR A. **I I**  **. 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 numbe r and t yp e of data requests of Data Ca ll - In(DCI) notices under FIFRA s ection 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

1 7 U.S.C. 136a et seq.United States Environmental Protection Agency March 14, 2012

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 The future schedule for reregistrations in the current and succeeding fiscal y ear.  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 environme ntal effects of older pesticides originall y 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 substantiall y c omplete 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 safet y standard of sect ion 408 o f 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 certaint y that no harm will result from aggregate exposure to the pesticide chemical residue” from dietary and other sources. Indetermining 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 y ears, to ensure that they met the safet y 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 theUnited States Environmental Protection Agency March 14, 2012

Page 3 of 7 United States meet the law’s safet y standard. EPA’s approach to tolerance reassessment under FFDCA was described full y 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 I mprovement Act (PRIA) of 2003 became effective on March 23, 2004 (Pub. L aw 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 Decis ions (REDs) for pesticides with food uses/tolerances b y August 3, 2006, and to complete all non - food use REDs b y October 3, 2008. The Agency completed decisions for the last of 613 reregistration pesticide cases in September 2008, meeting the PRIA deadlin e. REDs are available on the Agency ’s Pesticide Reregistration Status w eb page, http://www.epa.gov/pesticides/reregistration/status.htm . **II I**  **. 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 ye ar 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 201 1 , the Agency focused on completing product reregistration decisions. B. Product Reregistration; Numbers of Products Reregi stered, 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 an y product - specific data and specific revised l abeling needed to complete reregistration for each of theUnited States Environmental Protection Agency March 14, 2012

Page 4 of 7 individual pesticide products covered b y 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 variet y of outcomes are possible for pesticide products completing this final phase of the reregistration process. Id eally , in response to the DCI , the pesticide producer, or registrant, will submit the required product - specific data and revised labeling, which E PA 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 full y reregistered until the last active ingredient in its formulation was eligible for reregistration. In other situatio ns, the Agency may temporaril y 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 201 1 . 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 2011, EPA completed the product reregistration actions detailed in Table 1.

**TABLE 1. —**  **PRODUCT REREGISTRATION ACTIONS COMPLETED IN FY 201 1**  **(AS OF SEPTEMBER 30, 201 1**  **) Actions**  **FY 2011** Product reregistration actions 37 3 Product amendment actions 46 0 Product cancellation actions 379 Product suspension actions 6 **Total actions 1,2**  **18**United States Environmental Protection Agency March 14, 2012

Page 5 of 7 2. Status of the product reregistration universe for FY 201 1 . 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 ye ar. This overall status information is not “cumulative”

— it is not derived from summing up a s eries 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 UN IVERSE OF PRODUCTS SUBJECT TO PRODUCT REREGISTRATION, FOR**  **FY 201 1**  **(AS OF SEPTEMBER 30, 201 1**  **) Status**  **FY 2011** Products reregistered 4,74 2 Products amended 1,6 39 Products canceled 10,545 Products sent for suspension 26 Total products with actions completed 16,9 52 Products with actions pending 7,6 24 **Total products in product reregistration universe 24,576**  At the end of FY 201 1 , 7,624 products had product reregistration decisions pending. Some pending products awaited science reviews, label reviews, or reregistration decisions by EPA. Others were not yet read y for product reregistration actions, but were associated with more recently completed REDs. Their product - specific data were not y et due to be submitted to or reviewed b y the Agency. The universe of products in product reregistration has increased in some ye ars and decreased in other y ears. Generall y, an increas e resulted from products associated with the most recentl y completed REDs, while a decrease was due to fluctuations in numbers of products associated with product - specific Data Call - Ins (PDCIs). EPA refined the number and status of products in the product reregistration universe in FY 2010 , and the Agency has used the revised numbers in reporting on the status of the universe starting in FYUnited States Environmental Protection Agency March 14, 2012

Page 6 of 7 2011. By identify ing and including products that were canceled between the time when REDs were signed and P DCI s were issued, the Agency has been able to more precisel y define the universe of products that are subject to product reregistration. This is enabling the Agency to more accurately

track the status of products undergoing product reregistration, describe progres s in meeting program goals, and carry out plans to complete remaining product reregistration decisions during the next few y ears. 3. Product reregistration goal in FY 201 2 . EPA’s goal is to complete 1, 2 00 product reregistration actions during FY 201 2 . Additional information is available on EPA’s Product Reregistration w eb 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 ty pes of applications for pesticide product registration, i.e., applications for end - use products that would be identica l or substantially similar to a currentl y 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 201 1 , 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 201 1**  **Application Ty pe**  **FY 2011** Me - too product registrations/Fast track 507 Amendments/Fast track 3,074 **Total applications processed by fast track m eans**  **3,581** For those applications not approved, the Agency generall y notifies the registrant of an y 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 201 1 . On a financial accounting basis, EPA devoted 20.2 full - time equivalents (FTEs) in FY 201 1 to reviewing and processing applications for fast track me - too product registrations and label amendments.United States Environmental Protection Agency March 14, 2012

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spent approximately $2.86 million in FY 201 1 in direct costs (i.e., time on task, not including administrative expenses, computer s ys tems, 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. Product reregistration will not likely

be completed before 2014. **I V**  **. 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 2011 - 0959, would be most helpful if received by EPA on or before [ insert date 60 days after date of publication in the **Federal Register** ]. Submit y our comments, identified by docket identification (ID) number EPA - HQ - OPP - 2011 - 0959, by one of the following methods: • Federal eRulemaking Portal : http://www.regulations.gov . F ollow the on - line instructions for submitting comments. • Mail : Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency , 1200 Pennsy lvania Ave., NW., Washington, DC 20460 - 0001. **V. Fo**  **r Further Information Cont act**  Carol P. Stangel, Pesticide Re - evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency , 1200 Penns yl vania Ave., NW., Washington, DC 20460 - 0001; telephone number: (703) 308 - 8007; e - mail address: stangel.carol@epa.gov . **##**