Program Highlights

Current as of June 2009

Overview of the Registration Review Program

Registration review is replacing EPA's pesticide reregistration and tolerance reassessment programs as those programs are being completed. Unlike earlier review programs, registration review operates continuously, encompassing all registered pesticides.

Through registration review, EPA is reviewing each registered pesticide every 15 years to determine whether it still meets the FIFRA standard for registration. In this way, the Agency is ensuring that all registered pesticides do not cause unreasonable risks to human health, workers, or the environment when used as directed on product labeling. The scope and depth of the Agency's reviews are tailored to the circumstances, so registration reviews are commensurate with the complexity of issues currently associated with each pesticide.

By law, the Agency must complete the first 15-year cycle of registration review by October 1, 2022. To meet this requirement, EPA will begin opening about 70 dockets annually beginning in fiscal year 2009 and continuing through 2017, so that almost all pesticides registered at the start of the program will have dockets opened by 2017. As of fiscal year 2009, 721 pesticide cases comprising 1,136 active ingredients have been scheduled for registration review. (The Agency has determined that eleven of these cases do not require registration review.) Newly registered pesticides will be folded in each year. The Agency must complete the registration review of each new pesticide active ingredient within 15 years of its initial registration. See Registration Review Schedule for Beginning Reviews, 2009 to 2012.

Current Status of Docket Openings

over 100 registration review cases have had dockets opened for comment
about 70 cases for which dockets were opened have Final Work Plans

The Docket for each pesticide case beginning registration review includes a Preliminary Work Plan, which explains what the Agency knows about the pesticide and our thought process for determining the anticipated data and assessment needs. After considering public comment, the Agency issues a Final Work Plan for each case which responds to comments received, explains the Agency's risk assessment and data needs, and presents an expected time line for the registration review. See Pesticide Registration Review Status.

Groups of Related Pesticides Beginning Registration Review

In conducting the registration review program, EPA generally will review pesticides in chronological order according to their baseline dates; that is, older cases will be reviewed first. Within this structure, however, the Agency also plans to review certain related pesticides at the same time. Pesticide cases may be related by chemical class or structure, mode of action, use, or for other reasons.

During reregistration, the Agency gained experience and efficiencies in simultaneously reviewing related pesticides in groups like the organophosphates, N-methyl carbamates, triazines, and chloroacetanilides, as well as the rodenticides and soil fumigants. Similarly, EPA expects to increase program efficiencies and promote other benefits by continuing the practice of grouping related pesticides during registration review. For example:

Technical and regulatory issues may be resolved more easily looking across an entire chemical class or group;
Resources can be maximized within EPA, among stakeholders, and within other federal agencies;
New research findings may be facilitated;
In developing decisions, a "level playing field" among chemicals in the group may be assured.

The following groups of related pesticides are scheduled to begin registration review from 2009 to 2012. See Registration Review Schedule for Beginning Reviews, 2009 to 2012.

Organophosphates (OP) and N-methyl Carbamates

EPA completed cumulative risk assessments and risk management decisions for the organophosphate (OP) pesticides in August 2006 and the N-methyl carbamate pesticides in September 2007. Further consideration is needed regarding these pesticides' effects on endangered species. In recent years, EPA and stakeholders have invested significant resources in gaining a better understanding of these classes of pesticides. Addressing endangered species effects early in registration review will ensure that this investment is not lost or eroded over time. The registration review of the OPs began in 2008, and the N-methyl carbamate review will begin in 2010.

Pesticide Registration Review Status will provide information on individual OP and N-methyl carbamate pesticides in registration review as dockets open for these pesticides.
Assessing Pesticide Cumulative Risk provides information about EPA's cumulative risk assessments for the OPs, N-methyl carbamate, and other groups of pesticides that share common mechanisms of toxicity.
Pesticide Reregistration Status provides information about the status of individual OP, N-methyl carbamate, and other pesticides in the reregistration process.

Pyrethroids, Pyrethrins and Synergists (PPS)

During fiscal year 2008, EPA completed reregistration eligibility decisions (REDs) for the last individual pyrethroids, pyrethrins and synergists (PPS) that are subject to reregistration. Meanwhile, other PPS are not subject to reregistration; they are new active ingredients first registered after November 1, 1984. The PPS pesticides have similar uses and issues but have never before been considered together. Many have residential uses that may result in urban runoff, potentially contaminating surface water and sediment, and posing ecological risks. Most of these pesticides require endangered species risk assessments. Further, the Agency is considering whether the PPS share a common mechanism of toxicity and need a cumulative risk assessment. Because the PPS pesticides may be used as alternatives for one another, it makes sense to consider them together and assess and manage their risks within a similar timeframe. EPA, therefore, plans to consider the PPS as a group during registration review, starting in 2010.

EPA has established a PPS Special Docket to provide access to documents pertaining to the Agency's review of the PPS pesticides as a group. This docket, EPA-HQ-OPP-2008-0331, is available in Regulations.gov. Dockets will also be opened for individual PPS as they begin the registration review process.

Sulfonylureas (SU)

To increase efficiencies, EPA also plans to review the sulfonylurea herbicides (SUs) as a group during registration review, starting in FY 2011. SUs are herbicides that control weeds through inhibition of the enzyme acetolactate synthase. SUs are used as pre- and post-emergent herbicides to control a variety of weeds on cereal grains, pasture and rangeland, industrial sites, and turf grass.

Many of the constituent herbicides of this chemical class were first registered in the 1980s or later and so have not undergone reregistration. Consequently, the oldest group of these chemicals is scheduled to begin registration review in 2011, and two subsequent groups of more recently registered SUs are scheduled to have dockets opened in 2012 and 2013.

Registration Review of the sulfonylureas will include an evaluation of the need for endangered species risk assessments and an examination of the potential for adverse reproductive effects of sulfonylureas on off-site non-target plant species, such as may result from spray drift.

Neonicotinoids (NN)

The neonicotinoids are a class of insecticides with a common mode of action that affects the central nervous system of insects, causing paralysis and death. All of the neonicotinoids were registered after 1984 and were not subject to reregistration. Some uncertainties have been identified since their initial registration regarding the potential environmental fate and effects of neonicotinoid pesticides, particularly as they relate to pollinators. Some of the compounds within this class have been demonstrated to persist for several years and residues have been detected in plants for several years following application. Studies conducted in Europe in the late 1990s have suggested that neonicotinic residues can accumulate in pollen and nectar of treated plants and represent a potential risk to pollinators. Adverse effects on pollinators (beekill incidents) have also been reported in Europe that have further heightened concerns regarding the potential direct and/or indirect role that neonicotinic pesticides may have in pollinator declines. Recently submitted registrant data from studies conducted in Europe have supported concerns regarding the persistence of neonicotinoids; however, the translocation of residues into pollen and nectar of treated plants and the potential effect that these residues may have on bees remains uncertain. Among the refinements to risk assessments the Agency will consider during registration review are the potential effects of the neonicotinoids to honeybees and other pollinating insects, evaluating acute risk at the time of application and potential risk from exposure to translocated neonicotinoids in nectar and pollen, whether in the field or at the hive.

The registration review docket for imidacloprid opened in December 2008, and the docket for nithiazine is scheduled to be opened in March 2009. To better ensure a “level playing field” for the neonicotinoid class as a whole, and to best take advantage of new research as it becomes available, the Agency has moved the docket openings for the remaining neonicotinoids on the registration review schedule (acetamiprid, clothianidin, dinotefuran, thiacloprid and thiamethoxam) to FY 2012.

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