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REGULATORY OUTLOOK: Political climate may be favorable for GE crop reform

This article is powered by Food Chemical News

The latest from the Trump administration suggests USDA may be ready to once again try and overhaul its regulations for genetically engineered crops. 

This is the fourth in a series of outlook stories in IEG Policy as our reporters look into what to expect in food regulation for 2018.   

No concrete proposal has been issued, but the administration appears keen to reform the 30-year old USDA rules that govern GE crops and has suggested it is open to approaches favored by the biotech industry, the American Farm Bureau Federation and other agricultural interests.

The reform effort has the support of top USDA officials, including Secretary of Agriculture Sonny Perdue, and the staff at USDA's Animal and Plant Health Inspection Service (APHIS) has been told it is a priority.

"We are devoting substantial leadership and technical expertise to this," APHIS Administrator Kevin Shea said at a Jan. 31 meeting of the National Association of State Departments of Agriculture (NASDA).

Shea noted that APHIS has twice proposed revisions to its GE crop regulations –  in 2008 and in 2017 – and both times ended up withdrawing the proposals due to widespread stakeholder criticism. The need for reform the rules has not waned, he added.

"It's time for a change," Shea said. "We hope this time – the third time – will be the charm.”

But Shea did not offer a timetable for action or a clear roadmap for how APHIS might craft a new proposal and stakeholders may have cause to be wary.

A rulemaking could take several years, and Shea said the agency is well aware that time is of the essence, noting that the prior two efforts were launched in the waning days of their respective administrations.

"Our goal is to break away from that tradition of proposing biotech regulatory changes in the last couple of months of the second term of a president," he said. "That hasn't worked out. We'll try to do better this time, and certainly that is the Secretary's charge to us."

Cautious optimism

Shea's comments came two months after APHIS officially abandoned the Obama administration's proposal to reform the GE crop rules, a move that was praised by biotech companies, the American Farm Bureau and other ag groups who said the plan went too far.

The decision to withdraw the rule was a good sign that the administration heard industry concerns about the proposal and may press on with reform, according to Val Giddings, a senior fellow at the Information Technology and Innovation Foundation (ITIF).

"I have never seen such action taken so quickly after the close of a comment period," Giddings said. "Pulling the plug on it was a way to clear the decks and a better use of their resources."

Giddings praised the commitment of USDA leadership to ag biotech, noting other recent comments of support. A report released last month by the administration's interagency task force on agriculture touted the importance of biotech and called for increased cooperation among regulators. USDA and FDA signed an agreement on Jan. 30 to collaborate on their biotech regulatory processes in a bid to increase transparency, predictability and efficiency.

"Time will tell but they have said good things – that they plan to re-align the degree of regulation with the levels of actual risk," Giddings said. "But administrations of both parties have said good things for decades and almost uniformly failed to deliver on this front."

The report and the agreement, along with the withdrawal of the 2017 rule, provide good reasons for industry to be "cautiously optimistic" about the chances for reform of the GE crop regulations, said Brian Sylvester, an attorney with the law firm of Keller and Heckman.

The Trump administration has consistently touted its desire to reduce regulatory burden and the "current climate is conducive to new regulations being developed – with industry – that take a well-reasoned, science-based approach" to the issue, Sylvester told IEG Policy.

The biotech industry is waiting for APHIS and the administration to reach out, said Karen Batra, director of food and agriculture communications for the Biotechnology Innovation Organization (BIO).

"We want to see more communication with the stakeholder community before APHIS goes back to a rulemaking," Batra said.

"The system as it exists today works – it isn't holding anything up," she added. "There certainly is a need to update and we are supportive of that, but it needs to be done in the right way and not just done for the sake of it."

Environmentalists remain wary of the Trump administration's motives if it does pursue reform of the APHIS rules and are convinced the current regulations fall far short.

The administration is "attacking science-based regulations and allowing Big Ag and biotech companies to control our food system," said Dana Perls, a senior food and technology campaigner with Friends of the Earth.

There is a clear need to overhaul the "antiquated" GE crop regulations but reform should be focused on expanding oversight and requiring additional health and safety assessments.

The rules "need to be strengthened, not rolled back," Perls said.

GE animals in the cold

Although the administration has shown interest in the GE crop rules, it has yet to signal its intent with regard to FDA's oversight of GE animals.

The Obama administration in January 2017 released draft revisions to FDA's guidance on GE animals. The proposal calls for the agency to continue regulating GE animals as new animal drugs and to expand its oversight – currently FDA considers the presence of an rDNA construct from another species as its trigger for regulation.

But the draft guidance moves far beyond that in a bid to bring in new gene editing technologies, such as CRISPR and TALENs, and to subject any animal with intentionally altered genomes to FDA's new animal drug review and regulations.

The draft guidance drew sweeping criticism from ag and biotech interests, including the American Farm Bureau Federation, BIO, the National Pork Producers Association, the National Milk Producers Federation, North American Meat Institute and NASDA.

Critics worry the proposed revisions will expand the agency's authority and undermine efforts to develop and commercialize biotech innovations that could help producers control diseases, improve food safety, enhance animal welfare and decrease the environmental impacts of animal agriculture.

The vocal opposition, however, has not yet convinced FDA to change course.

An agency spokesperson told IEG Policy that it is current considering comments on the draft. "We are unable to speculate about a timeline for release of a final guidance," the FDA spokesperson said.

There are signs that USDA may soon consider wading into the debate over how to regulate animal biotechnology.

At a Feb. 6 House Agriculture Committee hearing, Rep. Neal Dunn (R-Fla.) questioned Perdue about the issue, complaining that FDA's regulatory regime is "preventing potential products like avian influenza-resistant poultry and hoof and mouth-resistant cattle from being commercialized."

Dunn asked about his plans to engage FDA on "their broken animal biotech system" and whether Perdue has considered trying to get USDA to take the lead on regulating GE animals.

Perdue noted the new cooperative agreement between USDA and FDA, but said the issue of regulating GE animals has not come up in discussions between the two agencies.

"But I love your suggestion … and we'd love to have that responsibility," Perdue said. "This is one area that I've not pursued, but you've given me another idea."

Touting benefits

Industry stakeholders are pleased with a new FDA/USDA initiative to educate the public about the benefits of agricultural biotechnology.

Congress gave FDA $3 million last year to spearhead the effort, directing the agency to work with the USDA on "consumer outreach and education regarding agricultural biotechnology" to inform the public of the "environmental, nutritional, food safety, economic, and humanitarian impacts" of GMOs.

The Agricultural Biotechnology Education and Outreach Initiative has not surprisingly been well received by biotech advocates.

A coalition of more than 60 food and agriculture groups urged lawmakers to authorize the effort because of their concerns that consumers are being fed misinformation about the safety and benefits of GMOs.

The initiative says the government has a "shared responsibility" with industry and academia to make sure the public has an informed understanding about agricultural biotechnology, BIO’s Batra said.

"We are not advocating they promote, but they educate the public on the products they regulate, especially the use of biotech technology in food products," she said.

The initiative is long overdue, ITIF’s Giddings said. "I think $3 million is a drop in the bucket compared to what is necessary, but Rome wasn't built in a day."

Giddings and other proponents are keen to see FDA vocally defend its regulatory decisions and counter "misinformation" about the safety of agricultural biotechnology.

For example, FDA should be rebuffing criticism by environmentalists about its review of AquaBounty's GE salmon, such as the claim that production of the transgenic fish in land-based aquaculture systems poses a threat to wild salmon, Giddings explained. 

"FDA should be out there saying 'It's in a closed-contained system in the exact design that the Monterey Bay Aquarium seafood watch program says is the very best way to raise Atlantic salmon,'" Giddings said. "The FDA needs to be doing that."

Critics of the initiative say it is unnecessary and a waste of taxpayer money.

It appears akin to "free PR" for biotech and ag interests, Perls said.

"We need to be addressing the risks and concerns of these biotechnologies not just the potential benefits," she added. We need a balanced approach which would include discussions of the risk … if it can't be balanced, then it shouldn't be distributed."

What route FDA will take is unclear. The agency has held two public meetings on the initiative and a spokesperson told IEG Policy that it received some 650 comments. Those comments are under review and FDA is also "conducting formative research to inform and guide the development of education and outreach information and materials," the agency said.



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