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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)1requires 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 2011. 

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 

 

1

7 U.S.C. 136a et seq.
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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 
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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 2011, 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 
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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 2011. 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 2011

(AS OF SEPTEMBER 30, 2011)

Actions FY 2011

Product reregistration actions 373

Product amendment actions 460

Product cancellation actions 379

Product suspension actions 6

Total actions 1,218
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2. Status of the product reregistration universe for FY 2011. 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 2011 (AS OF SEPTEMBER 30, 2011)

Status FY 2011

Products reregistered 4,742

Products amended 1,639

Products canceled 10,545

Products sent for suspension 26

Total products with actions completed 16,952

Products with actions pending 7,624

Total products in product reregistration universe 24,576

At the end of FY 2011, 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 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).

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 FY 
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2011. By identifying and including products that were canceled between the time when REDs were 

signed and PDCIs were issued, the Agency has been able to more precisely 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 progress in meeting program goals, 

and carry out plans to complete remaining product reregistration decisions during the next few years. 

3. Product reregistration goal in FY 2012. EPA’s goal is to complete 1,200 product 

reregistration actions during FY 2012. 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 2011, 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 2011

Application Type FY 2011

Me-too product registrations/Fast track 507

Amendments/Fast track 3,074

Total applications processed by fast track means 3,581

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 2011.

On a financial accounting basis, EPA devoted 20.2 full-time equivalents (FTEs) in FY 2011 to 

reviewing and processing applications for fast track me-too product registrations and label amendments.
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The Agency spent approximately $2.86 million in FY 2011 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. Product reregistration 

will not likely be completed before 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-OPP2011-0959, would be most helpful if received by EPA on or before [insert date 60 days after date of 

publication in the Federal Register].

Submit your 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. 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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