Diverse Parties Say Federal Biotech Rules Confusing

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By Pat Rizzuto

Nov. 27 — The federal approach to regulating bioengineered products is a confusing labyrinth, according to companies, trade associations, advocacy groups and scientists.

Companies must follow a maze to identify which agencies may have jurisdiction over a bioengineered product and then secure regulatory approval among them, said the Biotechnology Industry Organization and other trade groups.

That inhibits innovation and wastes time, they said.

“Developers of products sometimes cannot easily ascertain whether potential products would be subject to regulations,” said the American Society of Plant Biologists, which joined nearly a thousand organizations and individuals that submitted comments on the Coordinated Framework for the Regulation of Biotechnology.

Jaydee Hanson, policy director of the International Center for Technology Assessment, wrote: “The Coordinated Framework is a weak policy guidance document that gives an illusion of regulation while failing to coordinate agency actions and failing to stimulate needed regulations specific to new genetically engineered organisms.”

Coordinated Framework to Regulate Biotech Products

The Coordinated Framework, which the White House Office of Science and Technology issued in 1986 and updated in 1992, guides how each federal agency is to respond to bioengineered products under its jurisdiction.

The Environmental Protection Agency, Food and Drug Administration and U.S. Department of Agriculture (USDA) are the primary regulatory agencies that oversee bioengineered products. Others, such as the Fish and Wildlife Service, may contribute to regulatory reviews when endangered species or other issues arise.

The agencies are working to update their approach to regulating bioengineered products by July 2016 per instructions from the White House (See previous story, 07/06/15).

The American Society of Plant Biologists, BIO and the International Center for Technology Assessment were among the many organizations that submitted comments on the coordinated framework.

The nearly 1,000 comments would exceed more than 100,000 if individual signatures on advocacy group petitions are included in the total. Comments were due Nov. 13.

Agreement Regulations Are Confusing

Environmental, health and consumer groups also said the regulatory landscape is confusing.

But beyond agreeing that the federal regulatory approach for biotech products is convoluted, the comments from industry and advocacy groups had little in common.

“Genetically engineered crops have a 25-year history of safe use, and many independent studies have documented their safety,” said BIO.

In spite of this evidence and “real world experience that supports the safety of these crops,” federal agencies have continually increased their regulatory requirements, it said, offering suggestions of ways agencies could better coordinate their actions and tailor risk-based regulations.

Oversight Insufficient

The Consumers Union and many other advocacy groups said the Coordinated Framework is fundamentally flawed and fails to recognize or address risks associated with genetically engineered organisms.

Under the federal framework, the process of genetic engineering itself does not warrant specific regulatory oversight although individual products might.

Bioengineered products, like those made with any other technology, may have lesser or greater risks, according to the framework. Existing product regulatory laws provide sufficient flexibility to enable government agencies to oversee the safety of bioengineered products, the framework says.

The Consumers Union and other groups disagree with those basic principles.

“We are especially concerned that newer genetic engineering technologies that may pose health and environmental risks, such as RNAi and gene editing techniques, are escaping even limited regulatory review under the Coordinated Framework because this already stretched and contorted legal patchwork cannot be stretched any further to cover them,” the Consumers Union said. RNAi, or RNA interference, is technique to inactivate or “silence” a gene.

“The Coordinated Framework is simply incapable of coping with modern scientific advances in biotechnology,” Consumers Union said.

The debate voiced through industries' versus advocates' comments is their latest exchange in a decades-old contention.

Environmental, consumer and other advocacy groups say regulations of bioengineered products should be based on the process—the technology—by which they are manufactured.

BIO and most other industry groups agree with the fundamental precept of the framework: that regulations should be based on the risk, if any, of the final product and not by the process by which it was made.

Clearinghouse, Guidance Among Recommendations

In addition to disagreeing on the fundamental principle of the framework, most industry and advocacy groups criticized how federal agencies are implementing it and offered recommendations, from their particular perspectives, as to ways agencies could improve their biotech oversight.

“Although the government has the authority to monitor the safety and environmental impact of genetically engineered plants, animals and other organisms it has no regular program in place to do so,” said the Council for Responsible Genetics.

The patchwork regulatory framework promotes public confusion and lack of confidence, the council said.

“Clear, accurate and accessible communication with the public would therefore greatly benefit from establishment of a single clearinghouse of information regarding such products,” it said.

BIO said “agencies should publish clear guidance on what is and is not subject to their respective pre-market oversight, including clear identification of the specific risks the agencies are responsible for evaluating under their jurisdictions.”

The degree of regulatory requirements an agency imposes should be commensurate with the risks a product presents, said BIO and Novozymes North America, Inc.

Jurisdiction Should Be Clear

Each federal agency with jurisdiction over biotech should avoid regulations that are inconsistent, incompatible or duplicative of those issued by other agencies, Novozymes said.

An updated Coordinated Framework should ensure predictability and timeliness of regulatory decisions, Novozymes said.

The American Biological Safety Association said “the current framework should be simplified to clearly show which agency has responsibility for each biotechnology project.”

“When a new biotechnology product is produced and it is unclear which agency has oversight, a joint panel with members from each agency should convene, with members of the public, to decide which agency will provide oversight,” the safety association said.

D. Glass Associates Inc., a biotechnology consulting firm, said the EPA and FDA should better coordinate their reviews of microorganisms that may be used in animal feed, fuel and chemicals.

USDA should continue working to expand its Plant Protection Act authority to assess bioengineered plants for risks they may pose as noxious weeds, D. Glass Associates said. Mike Firko, lead biotechnology regulator at USDA, discussed the agency's efforts to update its regulatory authority in a March interview with Bloomberg BNA (59 DER 59, 3/27/15).

Bergeson & Campbell PC, a law firm that represents companies working with emerging technologies, supported the efforts to update the framework but described structural problems that may thwart the White House's intentions.

The regulatory infrastructure is ill-suited to address synthetic biology—a new form of genetic engineering—nimbly or comprehensibly, the law firm wrote.

Some synbio products aren't regulated at all, it wrote.

Exacerbating the problem, it said, are the “extreme and growing shortages in government staff and funding.”

Bergeson and Campbell pointed to a report it coauthored recently with the Woodrow Wilson International Center for Scholars' Synthetic Biology Project as providing insight into fundamental problems federal agencies are facing (See previous story, 10/16/15).

Scientific Organizations Weigh In, Discuss Workers

Scientific organizations shared some of the concerns industries and consultants voiced.

Regulations are too focused on the technological process by which bioengineered products are made and not on the characteristics of the resulting material, said the Forest Health Initiative.

A pest can eradicate a tree species faster than the USDA can review the potential biotechnology option that could prevent such an outcome, the initiative said.

Potential risks faced by laboratory and other workers have not been sufficiently addressed through the current framework, The American Biological Safety Association said.

“A significant public benefit would be for biotechnology products to be assigned risk groups which categorize the hazard associated with the product or Biological Safety Level (BSL) appropriate for safe work with the product,” the safety association said.

Range of Industries

Bioengineering affects the automotive, agricultural, chemical, forestry, pharmaceutical and other sectors of the economy. In 2012, U.S. revenues from bioengineered products reached at least $350 billion, approximately 2.5 percent of U.S. gross domestic product, up from $300 billion in 2010, according to Rob Carlson, of Biodesic LLC, a Seattle-based consulting firm that tracks bioeconomy data. He also is the managing director of a capital investment firm, Bioeconomy Capital, that provides startup companies funding.

To contact the reporter on this story: Pat Rizzuto in Washington at prizzuto@bna.com

To contact the editor responsible for this story: Larry Pearl at lpearl@bna.com