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GAO Report Questions Adequacy of EPA’s Conditional Pesticide Registration System

(Beyond Pesticides, September 11, 2013) In a report released Monday, the Government Accountability Office (GAO) finds that the U.S. Environmental Protection Agency (EPA)’s use and oversight of conditional registrations is lacking and unreliable. Conditional registration allows pesticides onto the consumer market without all the required data to assess the chemical’s safety. This has created many serious human and environmental health problems, including bee decline, tree death and potential increases in human health risks. GAO recommends that EPA better track conditional registrations, however, Beyond Pesticides and other concerned groups urge the agency to cancel registrations until all relevant data is submitted and reviewed.

epabuildAccording to the findings of the GAO’s report, EPA’s system for tracking pesticides with conditional registration is unreliable and thus, the total number of conditional registrations granted is unclear.  This lack of a reliable system for managing conditional registrations constitutes an ‘internal control weakness’ because the agency lacks an effective mechanism for program oversight and decision making, according to federal internal control standards cited by GAO. The report states, “The extent to which EPA ensures that companies submit additional required data and EPA reviews these data is unknown. Specifically, EPA does not have a reliable system, such as an automated data system, to track key information related to conditional registrations, including whether companies have submitted additional data within required time frames.” However, these recommendations do not go far enough. Pesticides without all the data required for a full understanding of human and environmental toxicity should not be allowed on the market.

EPA lists several reasons for its shortcomings, including incorrectly classifying pesticides as conditional, database limitations that do not allow officials to change registration status, as well as a general weakness in guidance and training, management oversight, and data management. According to EPA documents, there is limited, organized management oversight to ensure that regulatory actions were not misclassified as conditional registrations. EPA instead relies on a variety of options including waiting on registrant changes to a pesticide’s registration to discover whether data are missing. However, these methods are dependent upon industry activity, and fall short of what is needed because they are neither comprehensive nor do they ensure timely submission of outstanding data. EPA officials told GAO that the agency has taken or is planning to take several actions to more accurately account for conditional registrations, including beginning to design a new automated data system to more accurately track conditional registrations.

Under  Section 3(c)(7) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), EPA has the authority to grant a “conditional registration” for a pesticide product under certain circumstances, if some necessary data have not been submitted by the registrant. As part of this process, EPA must determine that the pesticide will not significantly increase the risk of unreasonable adverse effects on the environment, while the data needed is generated. According to EPA, registrants typically have from 1 to 4 years to provide the missing data required by a conditional registration. An EPA attorney stated to the GAO that EPA views products conditionally registered as identical or substantially similar to currently registered pesticides, and as new uses of currently registered pesticides as meeting the same safety standards as products fully registered. According to this official, these products do not pose unreasonable adverse effects on human health or the environment.

However, this is not entirely accurate and highly doubtful given EPA’s inability to track and manage conditional registrations. In fact, recent conditional registrations have been responsible for severe environmental effects. In 2011, a new herbicide (Imprelis) granted conditional registration caused the deaths of millions of trees across the country in what some said was one of the biggest disasters of its kind. Outstanding data for this chemical included its impact on certain non-target plants, which went unevaluated. This product was quickly removed from the market after causing millions of dollars in damage. EPA has also recently granted conditional registration to nanosilver which is currently being challenged in federal court due to an inadequate review of data and the potential risks to children. Another controversial conditional registration involves that of clothianidin, which is linked to bee decline. Clothianidin was conditionally registered in 2003 without the required field studies for assessing risks to honey bees, even though EPA knew the chemical was highly toxic to bees. In 2010, EPA removed the conditional status for clothianidin and granted fully registered status, but it is still unclear whether the adequate bee data has been submitted. Read more about BEE Protective.

In 2011, EPA conducted an internal review of pesticide registrations under conditional registration and concluded that the agency may reduce its use of this “imprecise” category. In an April 25, 2011 post on its website, EPA provided details on its internal review on the use of conditional registration for pesticide products. According to the agency’s own review, which is now confirmed by this GAO report, the assignation of conditional registration for regulatory decisions has been vague. According to EPA, “There is no data system mechanism to identify or inform the agency of milestones or deadlines for conditional registration actions.” EPA states here that inaccurately termed conditional registrations have been used for decisions on label amendments, product-specific formulation data, and pesticides with already existing data based on other registrations, and finds that the term ‘conditional registration’ is misleading and will explore reducing the use of conditional registrations.

Earlier this year, the Natural Resources Defense Council (NRDC) published a scathing report on EPA’s conditional registration process noting that in terms of the agency’s ability to offer transparency and rigorously test these inherently toxic chemicals, “the public’s trust is misplaced.” This report asserts that nearly 65% of the more than 16,000 pesticides now on the market were first approved by the process of conditional registration.

GAO is recommending EPA consider implementing options for an automated system to better track conditional registrations. EPA agreed with GAO’s recommendations and noted specific actions it will take to implement them. EPA told the GAO that it intends to: (1) conduct quarterly meetings to review the status of conditional registrations, (2) develop and implement new registration categories to more accurately reflect statutory basis for registration (as of July 2013, EPA indicated that the implementation of the new codes was completed), (3) train regulatory staff to use new codes, and (4) design a new automated system that will include tools to improve the identification, tracking, reporting, and program management of conditional registrations. EPA indicated that a portion of the maintenance fees collected from registrants would be used to start developing the system, however this new tool would require additional funding and it is unclear when a new systems would be integrated.

However, these recommendations do not go far enough. Pesticides without all data for a full understanding of toxicity should not be allowed to remain on the market. Doing so increases the probability of unknown risks to threaten public and environmental health. EPA has a long history of registering pesticides without adequately analyzing human and environmental health data, which even goes beyond the faulty ‘conditional registration’ approach. Beyond Pesticides has for years said that EPA’s general registration process is flawed because the agency does not evaluate whether hazards are “unreasonable” in light of the availability of safer practices or products. Additionally, Beyond Pesticides urges EPA to take a more precautionary approach, given the history of incomplete data or assessments which can lead to mitigation measures decades after widespread pesticide use was approved. With some chronic endpoints, for example endocrine disruption, the agency has not adequately assessed chemicals for certain health risks. Several historic examples exist of pesticides that have been restricted or cancelled due to health risks decades after first registration. Chlorpyrifos, which is associated with numerous adverse health effects including reproductive and neurotoxic effects, had its residential uses cancelled in 2001. Others like propoxur, diazinon, carbaryl, aldicarb, carbofuran, and most recently endosulfan, have seen their uses restricted or canceled after years on the market due to unreasonable human and environmental effects.

For more information on pesticides and their adverse effects, visit Beyond Pesticides’ Pesticides Induced Disease Database.

Source: Government Accountability Office – Pesticides: EPA Should Take Steps to Improve Its Oversight of Conditional Registrations. GAO-13-145

All unattributed positions and opinions in this piece are those of Beyond Pesticides.


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