The Pesticide Registration Improvement Act, which is being reborn as the Pesticide Registration Enhancement Act, has helped bring safer, less toxic pesticides to the marketplace at a time when the world needs to increase food production on a massive scale.
Jay Vroom, president and CEO of CropLife America and co-founder of the PRIA coalition in 2003, said, during testimony before the Senate Committee on Agriculture Nutrition and Forestry, the older PRIA has created certainty in the registration process where there was none.
The chief spokesman for the pesticide industry said Congress needs to reauthorize PRIA or PREA, as it will now be called, before the current authority for the legislation aimed at streamlining the approval of new agricultural chemicals expires on Sept. 30 to continue that record of accomplishment.
“Prior to the implementation of PRIA in 2004, there was little certainty for registration packages moving through the EPA,” Vroom said. “New product registrations would often linger with no real process or timeframe for completion. This ambiguous process would often lead to frustration, and more importantly jeopardized innovation, as there was diminished incentive to invest in the research and development of new chemistries for the marketplace.”
Vroom said the enactment of PRIA “changed that experience and not just for product registrants, but for all stakeholders. The success of PRIA has led to process improvements in the Office of Pesticide Programs at EPA, established a dedicated funding stream for the Agency, created specific block grants for training and education programs and created business certainty that keeps the wheels of innovation turning, which in turn results in the creation of jobs in the agriculture sector.”
Support U.S. agriculture
The PRIA fee framework, he said, helps ensure pesticide products will be available to support U.S. agriculture, make available the disinfectants used by building and plant facilities managers, provide the tools necessary to combat mosquito and other disease vectors, ensure the availability of structural pesticides for residential and commercial purposes, and home and garden, and turf and ornamental industries.
“Whether ensuring farmers have the tools they need or providing non-agricultural tools RISE (Responsible Industry for a Sound Environment) works to keep available for public and home use, the new PREA reauthorization is integral to the health and vitality of our communities.”
Vroom said when the registration process works in a predictable manner, “the entire agriculture supply chain benefits, which results in jobs on farms, in distribution, in transportation, in production and in innovation.”
CropLife America is the national trade association for the United States’ crop protection industry. It is closely affiliated with RISE (Responsible Industry for a Sound Environment), which represents the specialty, non-agricultural pesticide industry.
In 2003, Phil Klein of the Consumer Specialty Products Association and Vroom co-founded the PRIA Coalition, which consists of a diverse collection of interests that have come together once again to support the fee for service program.
Industry, non-industry members
Coalition participants include the American Chemistry Council Biocides Panel, Biotechnology Innovation Organization, Biological Products Industry Alliance, Consumer Specialty Products Association, CropLife America, The Worldwide Cleaning Industry Association, Responsible Industry for a Sound Environment, the National Association of State Departments of Agriculture, Farmworker Justice, and the Natural Resources Defense Council. History of PRIA
“The FIFRA amendments of 1988 put in place new and significant fees on registered pesticide products in order to provide EPA with added resources to accomplish re-registration,” said Vroom. “Those so-called “FIFRA Light” amendments did finally put EPA on a path towards achieving older products reviews. But the Food Quality Protection Act of 1996 subsequently added significant regulatory burdens to the agency, and as a result, new product approvals suffered.
“It took an additional eight years, from 1996 to 2004 – and two Administrations and four Congresses – to reach an agreement on fees for service that we now call PRIA. In the early years of PRIA, many of our companies saw wait times on registration of new food-use active ingredients drop from more than 4 years to about 2 years.”
Since then, the industry has experienced timeline erosion for almost all pesticide decision categories. The reasons for this fall into two clear categories, he said: 1. Diminished Resources Since PRIA has been in place (2004-2016), appropriations money met or exceeded the “PRIA trigger” for the first nine fiscal years, but in the last 4 years, Congress has missed its appropriations obligations by a total of $29 million. Since PRIA’s 2004 beginning, the full-time employee count in EPA;s Office of Pesticide programs has dropped by more than 21 percent (625 to 491).
“Clearly, EPA has done much to 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,” said Vroom, adding that since 2004, industry fees have been substantial – topping $521 million over 13 years.
“It has been a very good investment. PRIA 4 will extend that record – and be even better when PRIA appropriation targets are met!”
2. Increased Regulatory Complexity. “Society expects EPA to apply the best available science in its regulatory decisions regarding pesticide products. Science never stands still – so that regulatory burden on EPA increases every year. In that context, the single biggest regulatory challenge to EPA’s performance is implementing the Endangered Species Act (ESA) and the harmonization with FIFRA for pesticide registrations,” said Vroom.
Additional multiple new data requirements must be fulfilled to support pesticide registrations, meanwhile. CLA recently compared timelines for PRIA actions completed between 2012 and 2014. New active ingredient approvals took between 946 days and 1,137 days, on average, during those three years – compared to the PRIA target of 730 days.
“In other words, about one half of the timeline gains have eroded since the start of PRIA,” he said. “Working together we need to address these issues – and speedy reauthorization of PRIA 4 will be a big, positive step ahead! In recognition of this increase complexity and the increased burden on OPP, PRIA 4 substantially increases the user fees for certain registration categories.
“On behalf of the pesticide industry, I would like to emphasize the benefit of working alongside the NGO community and in concert with our state and federal regulators to extend the process improvements achieved in EPA’s pesticide regulatory program, support stable funding for EPA, and continue funding necessary training and education programs.”
Vroom said the reauthorization legislation currently under consideration by the Senate would:
· Provide for the annual collection of $31 million in product maintenance fees through 2023 (an increase of $22.4 million over the seven years covered by PRIA 4);
· Cap the fees paid by small businesses;
· Add Endangered Species Act reviews, risk reduction, and information technology system enhancements to the eligible uses of the funds collected;
· Designate $500,000 per year for the establishment of efficacy guidelines for products to address invertebrate pests of significant public health or economic consequence;
· Designate $500,000 per year for enhancements to the Good Laboratory Practices Standards compliance monitoring program;
· Continue funding of not less than $1 million per year through 2023 to enhance scientific and technical activities relating to worker protection;
· Continue funding of $500,000 per year through 2023 for partnership grants;
· Continues funding of $500,000 per year through 2023 for pesticide safety education programs;
· Extend the authority to collect registration service fees until 2023 and provides for two 5 percent increases in the fees paid in 2019 and 2021; and
· Continue the authority of the Administrator to waive fees for small businesses, under certain circumstances.
“Over the years, registrants have maintained a good working relationship with EPA,” said Vroom. “While we have had our disagreements, we respect EPA’s role, and, in fact, benefit from greater public assurance that our products meet the tough standards imposed by the law and expected by the public.
“Along with the need for more food production, the public has always wanted greater assurance of safety from our products. Over the years, the standards and requirements for pesticide registration have been toughened, laws have been amended, and public scrutiny has increased. Our industry has continued to respond to these demands through innovative products with improved environmental and safety profiles, lower application rates, more targeted modes of action, and reduced applicator risk.”