WASHINGTON, April 20, 2016 - Biotechnology innovation is happening so quickly, federal regulators can’t keep up, which is why they have asked the National Academies of Sciences and Engineering for help predicting the future.

On Monday, the scientists appointed to a biotech panel got their first chance to ask federal officials – including representatives from FDA, EPA and USDA – how they can be of assistance navigating the ever-changing biotechnology landscape.

“To the extent that you are able to identify for us what the future five to 10 years out looks like, it would be very helpful for the (Executive Office of the President) and the agencies, to understand what other refinements and adjustments need to be made to federal policies,” Robbie Barbero, assistant director for biological innovation in the White House Office of Science & Technology Policy, told the panel.

“Gene driving” is one of the new technologies that could be making the existing regulatory framework obsolete. A gene drive is the practice of stimulating the “biased inheritance” of particular genes to alter entire populations. Neil Hoffman, science adviser in the Biotechnology Regulatory Services (BRS) office at USDA’s Animal and Plant Health Inspection Service, called gene drives “a game changer.”

For example, three U.S. labs are already working on a gene drive for the mosquito blamed for spreading the Zika virus, causing babies to have shrunken heads and other illnesses. If deployed, the technology could theoretically drive the mosquito species to extinction and provide a much quicker solution to the public health crisis sweeping Latin America and other countries.

Speaking hypothetically, Hoffman said, “What happens if you eliminate (a) species? It’s not something we typically have dealt with in our risk assessment process.”

A separate NAS committee is examining gene drive technology, which is being used to develop mosquitoes resistant to the parasite that carries malaria. That committee is expected to release its report this year.

Another technology spurring the revolution in biotechnology is CRISPR-Cas9, a new gene editing method that greatly speeds up the ability to alter species’ DNA. “It’s precise, it’s powerful, it’s easy, and you can apply it to an amazingly wide range of species,” Ethel Jackson, who is now retired but was a DuPont researcher for 29 years, told the panel during the public comment period at the end of the meeting.

Mark Segal, a senior microbiologist in EPA’s Office of Pollution Prevention and Toxics, said he would like the panel to examine biocontainment using xenobiology, which involves creation of synthetic DNA.

Do-it-yourself biotech operations, some using crowdfunding to raise money for their inventions, are also ripe for the panel’s attention. “They tend to be stakeholders that we’re not used to engaging,” Hoffman said. “I think it would be very valuable” to learn more about them.

The panel will be working on its report at the same time the agencies are working to update their regulations, which all agreed badly need an overhaul. Mike Firko, BRS deputy administrator, told the committee, “Our biotech regulations are 29 years old. I would certainly hope we could do better than (that).”

APHIS published a proposed rule to update its regulations in 2008, but eventually withdrew it. “The science had moved on already,” Firko said.

He said the agency plans to publish a proposed biotech rule this summer and try to finalize it during the next administration. “In terms of changing regulations, it’s difficult if not impossible to do it” in a single presidential term, he said.

The panel’s composition was criticized by Food & Water Watch. FWW food researcher Tim Schwab said the group is concerned that too many of the committee members have conflicts of interest that have not been disclosed.

In comments submitted to the National Research Council (NRC), the operating arm of the NAS, FWW Executive Director Wenonah Hauter said that “at least nine of the 13 members have conflicts of interests, ties to the biotechnology industry or histories of promoting commercialization of biotechnology.”

“NRC’s committee is neither balanced nor independent, and it cannot possibly provide meaningful, impartial advice to the federal government, which will have to decline reviewing any findings the NRC makes under the Federal Advisory Committee Act,” she said.

NAS spokesperson Jennifer Walsh said the committee would discuss conflicts of interest in a closed-door meeting April 19, but no results have yet become available.  

The NRC already disclosed two members’ conflicts of interest. Steven Evans, a fellow at Dow AgroSciences in Seeds Discovery R&D, and Jeffrey Wolt, a professor in Agronomy, Environmental Science, and Toxicology programs at Iowa State University who “holds investments in a company whose financial interests could be affected by the outcome of the study.” Yet, NAS deemed the expertise of both to be essential for the study, and therefore, “unavoidable.”  

The NAS/NRC conflict-of-interest policy says that “potential sources of bias are not necessarily disqualifying for purposes of committee service. Indeed, it is often necessary, in order to ensure that a committee is fully competent, to appoint members in such a way as to represent a balance of potentially biasing backgrounds or professional or organizational perspectives.”

Richard Amasino, a professor in the Department of Biochemistry at the University of Wisconsin–Madison, was identified by FWW as having a conflict because he holds biotech patents and has “engaged in political advocacy to reduce regulations over GMO crops.”

Amasino told Agri-Pulse after the meeting, “I don’t have any companies and I don’t get paid by any companies.” He noted that patents can go unused for years. “I don’t know the extent to which anything’s been used.”


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