Pew Report spurs debate over future of biotech regulation.
Pesticide & Toxic Chemical News
April 5, 2004

The Pew Initiative on Food and Biotechnology last week released a lengthy report on the United States' review process for future biotech food products that has already stimulated debate between supporters and critics of the current system.

That debate cuts across the usual industry versus consumer lines, with some regulators and industry officials privately conceding that the current system is - if not broken - at least in need of preventive maintenance. The existing regulatory framework was assembled during the Regan administrations from a patchwork of existing laws and regulations and given to USDA, FDA and EPA to administer in a coordinated fashion.
"There's lot of unhappiness out there with the regulatory situation," Margaret Mellon, director of the food and environmental program at the Union of Concerned Scientists, told Pesticide & Toxic Chemical News. "Parts of the system are simply in paralysis. There are folks in the agencies who want to move forward but don't know howl Even the biotech industry is concerned. The scientists see no clear path forward for some of these products."
The Pew Report, "Issues in the Regulation of Genetically Engineered Plants and Animals," examines a range of options for dealing with future biotech products now coming out of laboratories.
The report acknowledges that current ag biotech products have been widely adopted without evidence of food safety or environmental problems. However, it said "the potential complexity of future products may challenge the ability of the existing Coordinated Framework for Regulation of Biotechnology to continue to protect public health and the environment and maintain public trust."
The report also examines the extent to which regulatory practices are transparent and open to public participation - "all procedural elements that will help build confidence in the integrity of the regulatory system," according to Pew.
Key findings of the report include:
o Both EPA and USDA's Animal and Plant Health Inspection Service face challenges in managing possible environmental risks raised by bioengineered plants. APHIS may not have the necessary regulations in place to comprehensively oversee biotech plants that (1) cannot easily be defined as "plant pests"; (2) consider broad environmental risks that may be posed by a biotech plant; or (3) quickly and fully manage environmental issues that arise once the plant has entered the marketplace.
o Under current FIFRA rules, EPA cannot hold growers directly liable for violations of planting restrictions intended to prevent unwanted gene flow or curb the development o insect resistance. Instead, EPA enforces these restrictions against registrants and seed companies, which Pew says raises questions about the adequacy of agency enforcement.
o FDA lacks the legal authority to require developers to prove the safety of all foods derived from biotech plants - including imported foods - before they go to market, which some critics believe is necessary. It is also unclear how agencies would conduct an early review to assess food safety risks if biotech crops grown in experimental field trials were to accidentally mix at low levels with crops intended for the food supply.
Mixed reactions
The Pew report drew mixed reactions from industry and consumer advocates. Lisa Dry, spokeswoman for the Biotechnology Industry Organization, told PTCN it would not be far-fetched to compare the coordinated framework to the U.S. Constitution.
"The document works, but it can always be expanded and amended," she said, nothing that APHIS is in the process of overhauling its regulations through an Environmental Impact Statement, and that the White House Office of Science and Technology Policy is also considering regulatory changes.
"They're clearly trying to keep up," Dry said. "It's not like the system is broken. We have a good structure and foundation. We should build on that and prepare for the future. We have the statutory authority we need."
Jeff Barach, vice president for special projects at the National Food Processors Association, described the Pew study as "basically a status report on current oversight with no specific conclusions or recommendations."
Noting that the report offers insights on possible options for the future, he told PTCN, "Our position is that the system is in place and working, but we may need to make adjustments. As the technology advances, there may need to be changes."
On of the groups that want immediate changes is the Center for Science in the Public Interest. Greg Jaffe, CSPI biotechnology project director, recently outlined his vision of an ideal biotech regulatory system in an academic journal (see PTCN, March 29, Page 16).
Praising the Pew report, Jaffe said it represented "one of the few times someone has analyzed legally the full range of issues around the Coordinated Framework and exposed its fundamental flaws and weaknesses."
"It's time for Congress to step up and write legislation to properly regulate these products," he said.
Jaffe said the report reveals the "creative but extremely shaky legal arguments" underlying the coordinated framework. "Future products won't be comprehensively regulated, and the public will bear the risks if the current system remains," he said. "We will lose the benefits of sage products because of the weak regulation of some risky applications."
Jaffe said biotech supporters should encourage reform in order to level th playing field, create well-defined regulatory pathways and bolster consumer acceptance of products.
"It's time for Congress to step in," he said.
Festering dissatisfaction
UCS' Mellon praised the Pew report as "an impressive piece of work," noting that she participated in the study process along with others.
"It provides a readable analysis of the federal framework and sets the stage for a really big debate in a couple of years," she said. "Dissatisfaction has been festering for a number of years. People expected the framework would be revisited [after its creation in 1986] but it hasn't happened. The will to actually do something about the growing regulatory hold just wasn't there."
Mellon observed that the biotech industry has been "trying to sell the technology against a very still headwind" for the past five or six years. Industry executives and regulators were loath to be seen as criticizing the existing framework in the face of domestic and overseas resistance to biotech foods.
"They were whistling past the graveyard," she said.
Renewed debate will include the possibility of new legislation, Mellon predicted.
"I think the dynamic is going to be different," she said. "There will be more players, because it's not just environmentalists who want effective regulation. There are sectors of industry that will want something to be done.
"If someone in the government wants to stand up and take the lead, they can use the Pew document as a guide," Mellon said. "We need to seriously look at the framework, identify the holes and then fill them. We can look at new legislation if necessary. Congress is a place of last resort, because no one know what will happen during the legislative process."