PRIA said to benefit all stakeholders
There may be no precedent for the current level of divisiveness over federal environmental laws and regulations. But within this storm there are several islands of bipartisanship that suggest it is possible to design programs that achieve that elusive balance between environmental protection and economic growth. One such exception to business as usual is the Pesticide Registration Improvement Act of 2003 (PRIA 1), an amendment to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The current PRIA, the third authorization of the law, or PRIA 3, will expire September 30, 2017, and Congress is currently considering its reauthorization, PRIA 4. Based on testimony at a May 11, 2017, hearing by the Senate Committee on Agriculture, Nutrition, and Forestry, there is no meaningful opposition to PRIA 4, including the provision that would extend the current 5-year authorization to 7 years and also empower the EPA to increase fees paid by pesticide registrants to implement the program.
PRIA 1 established a fee-for-service program. Companies seeking to have their pesticide and herbicide products registered for use in the United States pay a registration fee and a yearly maintenance fee. The EPA uses this money, along with congressional appropriations, to conduct the registration and reregistration reviews and approvals needed to bring the products to the market. While the PRIA and its reauthorization earned strong support from witnesses at the hearing, some warnings were raised about whether EPA’s Office of Pesticide Programs (OPP) will receive the appropriations it needs to fully complement the fees it receives to run the registration process efficiently. Also, witnesses raised concerns about FIFRA conflicts with other statutes, mainly the Endangered Species Act (ESA).
FIFRA and PRIA
Before any pesticide may be sold or distributed in the United States, FIFRA directs that the EPA must license its sale through registration. Under the registration provision, the Agency must examine every pesticide product intended for distribution or sale in the United States. In addition, under the Federal Food, Drug, and Cosmetic Act (FFDCA), the EPA sets tolerances—the maximum amount of a pesticide residue that may be on a food or animal feed product. FIFRA also requires registration reviews in which the EPA reexamines approved pesticides every 15 years.
The PRIA was developed with the intention of providing additional resources to the EPA to achieve faster and more predictable registration decisions. Specifically, the PRIA requires the EPA to make decisions on applications within mandated time frames; even shorter time frames are required for the registration of reduced risk pesticides.
“Before PRIA, because of limited resources, the Agency could not process all the [pesticide registration] applications it received in a timely fashion,” testified Richard R. Keigwin Jr., acting director of the OPP, at the hearing. “Large backlogs developed, and applicants could not predict when the Agency would make a decision. Pesticide companies had to establish priorities for which of their applications the EPA would review first. With the additional resources provided by PRIA, the Agency can now process new applications in a timelier manner. The EPA has approved more than 20,000 decisions since PRIA went into effect in 2004, meeting the timeframes for more than 98 percent of those actions. With this kind of consistency in the EPA’s review of registrations, pesticide companies can develop more accurate business plans for marketing their products.”
These review-time condensations are occurring as industry seeks to increase the number and types of registration actions, said Keigwin. For example, the number of fee-for-service programs started with 90 categories in PRIA 1 and progressed to 140 categories in PRIA 2, 189 categories in PRIA 3, and it would grow to 212 categories in the PRIA 4 legislation. (Under the original PRIA, actions subject to fees are categorized, first by type of chemical (conventional, antimicrobial, biopesticide, and inert ingredients) and then by type of action (new active ingredient, new use, import and other tolerances, new products, amendments, miscellaneous.))
The amount of the PRIA fee depends on the type of application, complexity of the application, and the type of entity. For example, lower fees are charged for new pesticide products that are the same or similar to products already registered (known as me too products) than for entirely new pesticides. Small businesses pay reduced fees, and the PRIA exempts government and government-supported organizations from application fees. PRIA registration service fees were intentionally set at levels that represent only a portion of the cost necessary for the EPA to complete its review—about 20 percent to 40 percent of total costs, depending on the PRIA category.
By raising fees for non-reduced-risk categories within the conventional new chemical and new-use fee tables, PRIA 4 also creates a financial incentive for registrants to develop and submit reduced-risk pesticide applications to the EPA. Other demonstrated benefits of the PRIA are an increase in the approval of pesticides for minor uses to meet the pest control needs of farmers who grow minor crops—primarily fruits, vegetables, and nut crops; distribution of some of the PRIA fees to support improved safety standards for agricultural workers and to provide pesticide safety education for farmworkers and farmworker families; and a set-aside of a portion of PRIA fees to increase funding for grants that improve understanding of integrated pest management and develop new tools to reduce pesticide use. In addition, PRIA 4 directs the EPA to look for opportunities to streamline review processes for new-chemical and new-use applications and provide prompt feedback to applicants during processing.
Stakeholders speak
As noted, at the hearing, there was little if any criticism of the PRIA legislation in general or the additional provisions in PRIA 4. But witnesses did take the opportunity to comment on the FIFRA itself and several obstacles facing the regulated community. Gary W. Black, Georgia’s Commissioner of Agriculture, testified on behalf of the National Association of State Departments of Agriculture (NASDA).
“PRIA provides a stable and predictable funding source for the EPA Office of Pesticide Programs and establishes a functional and timely process for pesticide and inert ingredient review so that registrants are able to efficiently plan for product approval and market availability,” said Black. “Equally important, PRIA provides additional resources to the states to conduct pesticide education, training, and worker protection activities.”
But Black and the NASDA believe the original intent of Congress is that FIFRA be the primary federal statute under which pesticide registration and use is regulated. Their concern is that other federal statutes creep into the picture.
“Pesticide registration and use should not be regulated under other federal statutes that were neither designed for, nor intended to be the governing statutes for pesticide distribution, sale, and use (e.g. the Clean Water Act, the Endangered Species Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act, etc.),” said Black. “Pesticide uses that have been reviewed and registered under FIFRA should not be subject to additional requirements (including costly and duplicative permit requirements) under other federal statutes.”
Black also notes that regulation of pesticides under FIFRA does not begin and end at the federal level. In 43 states and Puerto Rico, state departments of agriculture have taken the advantage provided by the statute to enforce the labeling, distribution, sale, use, and disposal of pesticides. There is clear concern that budget cuts being contemplated by the Trump EPA may limit the ability of the OPP and the states to fully implement FIFRA and an extended PRIA.
“It is essential for state departments of agriculture and the producers we serve to have a robust, transparent, and scientifically-sound FIFRA registration and reregistration process to deliver new technologies and critical crop protection tools in a timely and predictable manner,” said Black. “To achieve this, NASDA requests that Congress ensure there is a fully funded, fully resourced, and fully staffed Office of Pesticide Programs to conduct the rigorous and timely scientific review necessary for these essential crop protection tools.”
Shrinking appropriations
Concerns about OPP’s resources were also raised by Jay Vroom, president and CEO of CropLife America, which represents the interests of pesticide and herbicide manufacturers.
“Since PRIA has been in place (2004–2016), appropriations money met or exceeded the ‘PRIA trigger’ for the first 9 fiscal years, but in the last 4 years, Congress has missed its appropriations obligations by a total of $29 million,” testified Vroom. “Since PRIA’s 2004 beginning, the full-time employee count in EPA’s Office of Pesticide programs has dropped by over 21 percent (625 to 491). Clearly, EPA has done much to offset the resource constraints through efficiency improvements—but we all need Congressional appropriators to restore adequate resources to meet the statutory requirements of FIFRA.”
Conflict with the ESA
Vroom and other witnesses at the hearing also discussed the impact of the ESA on pesticide registrations. The apparent overlap of these two statutes was described by Sheryl Kunickis, PhD, director of the Office of Pest Management Policy at the U.S. Department of Agriculture (USDA).
“EPA is currently required to evaluate the ecological impact of pesticides under the ESA, even though FIFRA, the law that directly regulates the registration of pesticides, already requires EPA to prevent ‘any unreasonable risk to man or the environment’— a standard which could possibly consider endangered species,” said Kunickis. “This dual regulation under both ESA and FIFRA challenges EPA in meeting its statutory obligations to regularly review pesticide registrations. The first [ESA] Biological Evaluations released to the public were over 12,000 pages long. The current workload is not sustainable.”
“USDA has the motivation and expertise to offer advice and counsel to EPA and the Services,” continued Kunickis.
The Services are the Fish and Wildlife Service and the National Marine Fisheries Service, the two federal agencies that render a biological opinion on the effect of a federal action such as registration of a pesticide on an ESA-listed species. Kunickis’s main concern appears to be how the Services’ review of three key pesticides—chlorpyrifos, malathion, and diazinon—will impede the use of these products.
“We look forward to working with the Services and EPA on these issues,” said Kunickis. “Regulatory certainty is needed to ensure the continued safe use of pesticides, while offering necessary protections to endangered species and their habitat.”
Worker protection
Finally, the PRIA received an endorsement from Virginia Ruiz, director of Occupational and Environmental Health at Farmworker Justice. Ruiz notes that under the PRIA, money set aside from pesticide registration fees supports EPA’s worker protection activities, including:
- Pesticide safety training for farmworkers and pesticide handlers;
- Development of worker and employer training materials on pesticide safety and implementation of the Worker Protection Standard and the Certified Pesticide Applicator rule;
- Education and training for medical providers to diagnose and treat pesticide poisonings; and
- Support for state public health agencies to maintain pesticide injury surveillance programs.
Testimony on PRIA 4 and FIFRA is available here.
William C. Schillaci
BSchillaci@blr.com